Name:
Score: _____/31
Reading Medication Labels Activity
Visit each station and determine which scenario it would be appropriate to give the medication.
Read the label and information sheets to answer the scenario questions
Scenario One:
I have just adopted Hank. He is an eight week old Australian Shepherd. We live out in the
country and I am worried about him contracting Distemper since there is a lot of wildlife coming
on to our property,
1. What vaccine should I administer to Hank?
2. How much vaccine should I administer to him and where? How often should I
revaccinate?
3. What other diseases does this vaccine prevent?
4. How do I store and dispose of this product?
5. Where does this vaccine come from?
6. What factors should you consider before administering this medication to a canine?
Scenario Two:
Summer is approaching and I am concerned about my Chihuahua Lola. I have recently learned
that she can get heartworm from mosquitos and I want to do everything I can to keep my
companion healthy.
1. What medication would you recommend to this owner?
2. What do you need to know about Lola before giving her this medication?
3. Which parasites does this product protect against?
4. How often is this medication given? What method is used to give medicine (orally,
subcutaneously, topically, etc…)?
5. What are the two active ingredients in this product?
6. What symptoms might Lola show if she had an adverse reaction to this medication?
Scenario Three:
Porter County Animal Control just picked up a stray cat. He appears to be a six month old
Siamese mix. They are hoping to find him a new home, but first they must vaccinate him from
Rabies.
1. What product should they use to vaccinate the cat?
2. How much of the vaccine should you administer to the cat? How often?
3. What medicines would you give the cat if he had an allergic reaction to this vaccine?
4. What company produces this vaccine?
5. What species can this vaccine be used for?
Scenario Four:
Charley is a 30 lb. Shetland Sheepdog with a tooth infection that is making it hard for him to eat.
His owners want to treat the infection so he can be more comfortable.
1. What medicine should be administered to Charley?
2. What should you do if a dose is missed of this medicine?
3. What are some other names this product may be known as?
4. What is an atopic animal?
5. What other animals is this product approved for? Which animals should not be given this
product?
Scenario Five:
Rusty is slowing down lately. He is a 9 year old, 70 lb. Black and Tan Coonhound whose
osteoarthritis is making it hard to bring him on hunts anymore. I want to reduce the inflammation
in his joints so he will be in less pain.
1. Which medicine would be appropriate for Rusty?
2. How much medicine will I give him on the first day? How much will he receive after
that?
3. What is an NSAID?
4. What signs indicate you should discontinue use of this drug?
Scenario Six:
My dog gets sick and throws up every time he is in the car. He is an 8 lb., 2 year old Pomeranian
named Bear and I want to be able to travel without him getting motion sickness.
1. What product should be given to Bear?
2. How much is the minimum dose I need to give Bear?
3. What do I need to do before traveling with him? When do I need to do these thing?
4. What do humans need to be aware of when handling this drug?
5. What country is this product made in?
Reading Medication Labels (02D)Activity Key
Scenario One:
I have just adopted Hank. He is an eight week old Australian Shepherd. We live out in the
country and I am worried about him contracting Distemper since there is a lot of wildlife coming
on to our property,
7. What vaccine should I administer to Hank? Vanguard Plus 5
8. How much vaccine should I administer to him and where? How often should I
revaccinate? 1 ml dose, under the skin (SubQ) or in the muscle (IM). Vaccinate 3 times
over 3 week intervals, then once a year.
9. What other diseases does this vaccine prevent? adenovirus type 2 (and hepatitis),
parainfluenza and parvovirus
10. How do I store and dispose of this product? Store at 2°-7°C out of direct sunlight. Burn
all containers and unused contents
11. Where does this vaccine come from? Zoetis, Kalamazoo, MI
12. What factors should you consider before administering this medication to a canine? Age
(older than 6 weeks), only for healthy animals, allergies to medication, pregnancy
ZOETIS INC.
333 PORTAGE STREET, KALAMAZOO, MI, 49007
Telephone:
269-359-4414
Customer Service: 888-963-8471
Website:
www.zoetis.com
Every effort has been made to ensure the accuracy of the information published. However, it
remains the responsibility of the readers to familiarize themselves with the product information
contained on the USA product label or package insert.
VANGUARD® PLUS 5
Zoetis
Canine Distemper-Adenovirus Type 2-Parainfluenza-Parvovirus Vaccine
Modified Live Virus
For use in dogs only
Thimerosal free
For vaccination of healthy dogs 6 weeks of age or older as an aid in preventing disease caused by CD
virus, CAV-1, CAV-2, CPI virus, CPV and CPV-2c. Vanguard Plus 5 contains attenuated strains of CD
virus, CAV-2, CPI virus, and CPV. The high-titer, low-passage CPV virus in Vanguard Plus 5 is highly
immunogenic and capable of stimulating active immunity in the presence of maternal antibodies. This
product does not contain CPV type 2c. Cross protection against CPV type 2c was demonstrated in
vaccinated puppies challenged 5 weeks following second vaccination.
Vaccination and revaccination according to label directions have been demonstrated (under field
conditions) to result in serum antibody titers that persist for 12-48 months against CAV-1 (SN ≥ 1:16),
CAV-2 (SN ≥ 1:16), CPI virus (SN ≥ 1:16), and CPV (hemagglutination inhibition [HAI] titer ≥ 1:80).
Directions: Aseptically rehydrate the freeze-dried vaccine with the sterile diluent provided, shake well,
and administer 1 mL subcutaneously or intramuscularly. Healthy dogs 6 weeks of age or older should
receive 3 doses, each administered 3 weeks apart. Annual revaccination with a single dose is
recommended. Duration of immunity has not been established.
Precautions: Store at 2°-7°C. Prolonged exposure to higher temperatures and/or direct sunlight may
adversely affect potency. Do not freeze. Use entire contents when first opened. Sterilized syringes and
needles should be used to administer this vaccine. Do not sterilize with chemicals because traces of
disinfectant may inactivate the vaccine. Burn containers and all unused contents. Contains gentamicin as
preservative. Vaccination of pregnant bitches should be avoided. As with many vaccines, anaphylaxis
may occur after use. Initial antidote of epinephrine is recommended and should be followed with
appropriate supportive therapy.
Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471 (USA), (800)
461-0917 (Canada).
This product has been shown to be efficacious in healthy animals. A protective immune response may not
be elicited if animals are incubating an infectious disease, are malnourished or parasitized, are stressed
due to shipment or environmental conditions, are otherwise immunocompromised, or the vaccine is not
administered in accordance with label directions.
U.S. Veterinary License No. 190
Zoetis Inc., Kalamazoo, MI 49007
25 1-dose vials of vaccine, rehydrate each to 1 mL 13134600
25 1-mL vials of sterile diluent
NAC No.: 3690156.5
Scenario Two:
Summer is approaching and I am concerned about my Chihuahua Lola. I have recently learned
that she can get heartworm from mosquitos and I want to do everything I can to keep my
companion healthy.
7. What medication would you recommend to this owner? Advantage Multi for Dogs
Heartworm Prevention and Flea Treatment Topical Solution
8. What do you need to know about Lola before giving her this medication? Weight, age,
health
9. Which parasites does this product protect against? Adult fleas, heartworm, hookworms,
roundworms and whipworms
10. How often is this medication given? What method is used to give medicine (orally,
subcutaneously, topically, etc…)? Once per month, Topically
11. What are the two active ingredients in this product?
Imidacloprid and moxidectin.
12. What symptoms might Lola show if she had an adverse reaction to this medication?
Hematochezia, diarrhea, lethargy, inappetence, pyoderma
Advantage Multi (imidacloprid +
moxidectin) Topical Solution for Dogs
This page contains information on Advantage Multi (imidacloprid + moxidectin) Topical Solution
The information provided typically includes the following:
 Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs Indications
for Dogs for veterinary use.

Warnings and cautions for Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs

Direction and dosage information for Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs
Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs
This treatment

applies to the following species:
Dogs
for dogs
(imidacloprid + moxidectin) Topical Solution
Manufacturer: Bayer Animal Health
Once-a-month topical solution for the prevention of heartworm disease, the treatment of circulating microfilariae, kills
adult fleas, is indicated for the treatment of flea infestations, the treatment and control of sarcoptic mange, as well as the
treatment and control of intestinal parasite infections in dogs and puppies that are at least 7 weeks of age and that weigh
at least 3 lbs.
WARNING
● DO NOT ADMINISTER THIS PRODUCT ORALLY
● For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated
animals.
● Children should not come in contact with application sites for two (2) hours after application.
(See Contraindications, Warnings, Human Warnings, and Adverse Reactions, for more information.)
Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs
Caution
Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian.
Description
Advantage Multi® for Dogs (10% imidacloprid + 2.5% moxidectin) is a colorless to yellow ready-to-use solution packaged in single
dose applicator tubes for topical treatment of dogs. The formulation and dosage schedule are designed to provide a minimum of 4.5
mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin based on body weight.
Imidacloprid is a chloronicotinyl nitroguanidine insecticide. The chemical name for imidacloprid is 1-[(6-Chloro-3-pyridinyl)methyl]-Nnitro-2-imidazolidinimine. Moxidectin is a semisynthetic macrocyclic lactone endectocide derived from the
actinomycete Streptomycetes cyaneogriseus noncyanogenus. The chemical name for moxidectin is [6R, 23E, 25S(E)]-5-ODemethyl-28-deoxy-25-(1,3-dimethyl-1-butenyl)-6,28-epoxy-23-(methoxyimino) milbemycin B.
Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs
Indications
Advantage Multi for Dogs is indicated for the prevention of heartworm disease caused by Dirofilaria immitisand the treatment of
Dirofilaria immitis circulating microfilariae in heartworm-positive dogs. Advantage Multi for Dogs kills adult fleas and is indicated for
the treatment of flea infestations (Ctenocephalides felis).Advantage Multi for Dogs is indicated for the treatment and control of
sarcoptic mange caused bySarcoptes scabiei var. canis. Advantage Multi for Dogs is also indicated for the treatment and control of
the following intestinal parasites:
Intestinal Stage
Intestinal Parasite
AdultImmature AdultFourth Stage Larvae
Hookworm Species Ancylostoma caninum
X
X
X
Uncinaria stenocephala X
X
X
Roundworm SpeciesToxocara canis
X
X
Toxascaris leonina
X
Whipworm
Trichuris vulpis
X
Contraindications
Do not administer this product orally. (See WARNINGS.)
Do not use this product (containing 2.5% moxidectin) on cats.
Warnings
For the first 30 minutes after application:
Ensure that dogs cannot lick the product from application sites on themselves or other treated dogs, and separate treated
dogs from one another and from other pets to reduce the risk of accidental ingestion.
Ingestion of this product by dogs may cause serious adverse reactions including depression, salivation, dilated pupils,
incoordination, panting, and generalized muscle tremors.
In avermectin sensitive dogs,a the signs may be more severe and may include coma and death.b
a
Some dogs are more sensitive to avermectins due to a mutation in the MDR1 gene. Dogs with this mutation may develop signs of
severe avermectin toxicity if they ingest this product. The most common breeds associated with this mutation include Collies and
Collie crosses.
b
Although there is no specific antagonist for avermectin toxicity, even severely affected dogs have completely recovered from
avermectin toxicity with intensive veterinary supportive care.
HUMAN WARNINGS:
Not for human use. Keep out of the reach of children.
Children should not come in contact with application sites for two (2) hours after application.
Causes eye irritation. Harmful if swallowed. Do not get in eyes or on clothing. Avoid contact with skin. Exposure to the product has
been reported to cause headache; dizziness; and redness, burning, tingling, or numbness of the skin. Wash hands thoroughly
with soap and warm water after handling.
If contact with eyes occurs, hold eyelids open and flush with copious amounts of water for 15 minutes. If eye irritation develops or
persists, contact a physician. If swallowed, call poison control center or physician immediately for treatment advice. Have person sip
a glass of water if able to swallow. Do not induce vomiting unless told to do so by the poison control center or physician. People with
known hypersensitivity to benzyl alcohol, imidacloprid or moxidectin should administer the product with caution. In case of allergic
reaction, contact a physician. If contact with skin or clothing occurs, take off contaminated clothing. Wash skin immediately with
plenty of soap and water. Call a poison control center or physician for treatment advice.
The Material Safety Data Sheet (MSDS) provides additional occupational safety information. For a copy of the Material Safety Data
Sheet (MSDS) or to report adverse reactions call Bayer Veterinary Services at 1-800-422-9874. For consumer questions call 1-800255-6826.
Precautions
Do not dispense dose applicator tubes without complete safety and administration information.
Use with caution in sick, debilitated, or underweight animals. The safety of Advantage Multi for Dogs has not been established in
breeding, pregnant, or lactating dogs. The safe use of Advantage Multi for Dogshas not been established in puppies and dogs less
than 7 weeks of age or less than 3 lbs. body weight.
Prior to administration of Advantage Multi for Dogs, dogs should be tested for existing heartworm infection. At the discretion of the
veterinarian, infected dogs should be treated with an adulticide to remove adult heartworms. The safety of Advantage Multi for
Dogs has not been evaluated when administered on the same day as an adulticide. Advantage Multi for Dogs is not effective
against adult D. immitis. Although the number of circulating microfilariae is substantially reduced in most dogs following treatment
with Advantage Multi for Dogs, the microfilariae count in some heartworm-positive dogs may increase or remain unchanged
following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride.
(See ADVERSE REACTIONS and ANIMAL SAFETY - Safety Study in Heartworm-Positive Dogs.)
Advantage Multi for Dogs has not been evaluated in heartworm-positive dogs with class 4 heartworm disease.
Adverse Reactions
Heartworm-Negative Dogs
Field Studies: Following treatment with Advantage Multi for Dogs or an active control, dog owners reported the following posttreatment reactions:
OBSERVATIONAdvantage Multi n=128Active Control n=68
Pruritus
19 dogs (14.8%)
7 dogs (10.3%)
Residue
9 dogs (7.0%)
5 dogs (7.4%)
Medicinal Odor
5 dogs (3.9%)
None observed
Lethargy
1 dog (0.8%)
1 dog (1.5%)
Inappetence
1 dog (0.8%)
1 dog (1.5%)
Hyperactivity
1 dog (0.8%)
None observed
During a field study using 61 dogs with pre-existing flea allergy dermatitis, one (1.6%) dog experienced localized pruritus
immediately after imidacloprid application, and one investigator noted hyperkeratosis at the application site of one dog (1.6%).
In a field safety and effectiveness study, Advantage Multi for Dogs was administered to 92 client-owned dogs with sarcoptic mange.
The dogs ranged in age from 2 months to 12.5 years and ranged in weight from 3 to 231.5 pounds. Adverse reactions in dogs
treated with Advantage Multi for Dogs included hematochezia, diarrhea, vomiting, lethargy, inappetence, and pyoderma.
Laboratory Effectiveness Studies: One dog in a laboratory effectiveness study experienced weakness, depression, and
unsteadiness between 6 and 9 days after application of Advantage Multi for Dogs. The signs resolved without intervention by day 10
post-application. The signs in this dog may have been related to peak serum levels of moxidectin, which vary between dogs, and
occur between 1 and 21 days after application of Advantage Multi for Dogs.
The following clinical observations also occurred in laboratory effectiveness studies following application with Advantage Multi for
Dogs and may be directly attributed to the drug or may be secondary to the intestinal parasite burden or other underlying conditions
in the dogs: diarrhea, bloody stools, vomiting, anorexia, lethargy, coughing, ocular discharge and nasal discharge. Observations at
the application sites included damp, stiff or greasy hair, the appearance of a white deposit on the hair, and mild erythema, which
resolved without treatment within 2 to 48 hours.
Heartworm-Positive Dogs
Field Study: A 56-day field safety study was conducted in 214 D. immitis heartworm and microfilariae positive dogs with Class 1, 2
or 3 heartworm disease. All dogs received Advantage Multi for Dogs on Study Days 0 and 28; 108 dogs also received melarsomine
dihydrochloride on Study Days - 14, 14, and 15. All dogs were hospitalized for a minimum of 12 hours following each treatment.
Effectiveness against circulating D. immitis microfilariae was > 90% at five of six sites; however, one site had an effectiveness of
73.3%. The microfilariae count in some heartworm-positive dogs increased or remained unchanged following treatment
with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride.
Following treatment with Advantage Multi for Dogs alone or in a dosing regimen with melarsomine dihydrochloride, the following
adverse reactions were observed:
Adverse Reaction
Dogs Treated with Advantage Multi for Dogs
Only n=106
24 (22.6%)
14 (13.2%)
11 (10.4%)
10 (9.4%)
Dogs Treated with Advantage Multi for Dogs +
Melarsomine n=108
25 (23.1%)
42 (38.9%)
18 (16.7)
22 (20.4%)
Cough
Lethargy
Vomiting
Diarrhea, including
hemorrhagic
Inappetence
7 (6.6%)
19 (17.6%)
Dyspnea
6 (5.7%)
10 (9.3%)
Tachypnea
1 (< 1%)
7 (6.5%)
Pulmonary hemorrhage
0
1 (< 1%)
Death
0
3 (2.8%)
Three dogs treated with Advantage Multi for Dogs in a dosing regimen with melarsomine dihydrochloride died of pulmonary
embolism from dead and dying heartworms. One dog, treated with Advantage Multi for Dogs and melarsomine dihydrochloride,
experienced pulmonary hemorrhage and responded to supportive medical treatment. Following the first treatment with Advantage
Multi for Dogs alone, two dogs experienced adverse reactions (coughing, vomiting, and dyspnea) that required hospitalization. In
both groups, there were more adverse reactions to Advantage Multi for Dogs following the first treatment than the second treatment.
To report a suspected adverse reactions, call 1-800-422-9874.
Post-Approval Experience
The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse reactions are reported
to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product
exposure using this data. The following adverse events in dogs are listed in decreasing order of reporting frequency:
depression/lethargy, vomiting, pruritus, diarrhea, anorexia, hyperactivity, ataxia, trembling, hypersalivation, application site reactions
(alopecia, pruritus, lesions, and erythema), seizures, and anaphylaxis/anaphylactic reactions (hives, urticaria, facial swelling, edema
of the head).
Serious reactions, including neurologic signs and death have been reported when cats have been exposed (orally and
topically) to this product.
In humans, nausea, numbness or tingling of the mouth/lips and throat, ocular and dermal irritation, pruritus, headache, vomiting,
diarrhea, depression and dyspnea have been reported following exposure to this product. To report suspected adverse events
and/or obtain a copy of the MSDS or for technical assistance, call Bayer Animal Heath at 1-800-422-9874.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at
http://www.fda.gov/AnimalVeterinary/SafetyHealth.
Dosage and Administration
The recommended minimum dose is 4.5 mg/lb (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month, by
topical administration.
Do not apply to irritated skin.
1. Remove one dose applicator tube (tube) from the package. As specified in the following table, administer the entire contents of
the Advantage Multi for Dogs tube that correctly corresponds with the body weight of the dog.
Dog (lb.) Advantage Multi For DogsVolume (mL)Imidacloprid (mg)Moxidectin (mg)
3-9
Advantage Multi 9
0.4
40
10
9.1 - 20
Advantage Multi 20
1.0
100
25
20.1 - 55
Advantage Multi 55
2.5
250
62.5
55.1 - 88
Advantage Multi 88
4.0
400
100
88.1 - 110* Advantage Multi 110
5.0
500
125
*Dogs over 110 lbs. should be treated with the appropriate combination of Advantage Multi for Dogs tubes.
2. While holding the tube in an upright position, remove the cap from the tube.
3. Turn the cap over and push the other end of cap onto the tip of the tube.
4. Twist the cap to break the seal and then remove cap from the tube.
5. The dog should be standing for application. Part the hair on the back of the dog between the shoulder blades until the skin is
visible. For dogs weighing 20 lbs. or less, place the tip of the tube on the skin and apply the entire contents directly on the exposed
skin at one spot between the shoulder blades. For dogs weighing more than 20 lbs., place the tip of the tube on the skin and apply
the entire contents directly on the exposed skin at 3 or 4 spots on the top of the backline from the base of the neck to the upper back
in an area inaccessible to licking. Do not apply an amount of solution at any one location that could run off the side of the dog.
Do not let this product get in your dog’s mouth or eyes. Do not allow the dog to lick any of the application sites for 30
minutes. In households with multiple pets, keep each treated dog separated from other treated dogs and other pets for 30 minutes
after application to prevent licking the application sites.(See WARNINGS.)
Stiff hair, a damp appearance of the hair, pink skin, or a slight powdery residue may be observed at the application site on some
animals. This is temporary and does not affect the safety and effectiveness of the product.
Shampooing 90 minutes after treatment does not reduce the effectiveness of Advantage Multi for Dogs in the prevention of
heartworm disease.
Shampooing or water immersion 4 days after treatment will not reduce the effectiveness of Advantage Multi for Dogs in the
treatment of flea infestations. However, shampooing as often as once weekly may reduce the effectiveness of the product against
fleas.
Heartworm Prevention: For prevention of heartworm disease, Advantage Multi for Dogs should be administered at one-month
intervals. Advantage Multi for Dogs may be administered year-round or at a minimum should start one month before the first
expected exposure to mosquitoes and should continue at monthly intervals until one month after the last exposure to mosquitoes. If
a dose is missed and a 30-day interval between doses is exceeded, administer Advantage Multi for Dogs immediately and resume
the monthly dosing schedule. When replacing another heartworm preventative product in a heartworm prevention program, the first
treatment with Advantage Multi for Dogs should be given within one month of the last dose of the former medication.
Treatment of Circulating Microfilariae: For the treatment of circulating D. immitis microfilariae in heartworm-positive
dogs, Advantage Multi for Dogs should be administered at one-month intervals. Treatment with an approved adulticide therapy is
recommended because Advantage Multi for Dogs is not effective for the treatment of adult D. immitis.
(See PRECAUTIONS.)
Flea Treatment: For the treatment of flea infestations, Advantage Multi for Dogs should be administered at one-month intervals. If
the dog is already infested with fleas when the first dose of Advantage Multi for Dogs is administered, adult fleas on the dog will be
killed. However, reinfestation from the emergence of pre-existing pupae in the environment may continue to occur for six weeks or
longer after treatment is initiated. Dogs treated with imidacloprid, including those with pre-existing flea allergy dermatitis have shown
clinical improvement as a direct result of elimination of fleas from the dog.
Treatment and Control of Intestinal Nematode Infections:
For the treatment and control of intestinal hookworm infections caused by Ancylostoma caninum andUncinaria stenocephala (adults,
immature adults and fourth stage larvae) and roundworm infections caused by Toxocara canis (adults and fourth stage larvae),
and Toxascaris leonina (adults), and whipworm infections caused by Trichuris vulpis (adults), Advantage Multi for Dogs should be
administered once as a single topical dose.
Treatment and Control of Sarcoptic Mange: For the treatment and control of sarcoptic mange caused bySarcoptes scabiei var.
canis, Advantage Multi for Dogs should be administered as a single topical dose. A second monthly dose may be administered if
necessary.
ANIMAL SAFETY:
Heartworm-Negative Dogs
Field Study: In a controlled, double-masked, field safety study, Advantage Multi for Dogs was administered to 128 dogs of various
breeds, 3 months to 15 years of age, weighing 4 to 157 pounds.Advantage Multi for Dogs was used safely in dogs concomitantly
receiving ACE inhibitors, anticonvulsants, antihistamines, antimicrobials, chondroprotectants, corticosteroids, immunotherapeutics,
MAO inhibitors, NSAIDs, ophthalmic medications, sympathomimetics, synthetic estrogens, thyroid hormones, and urinary acidifiers.
Owners reported the following signs in their dogs after application of Advantage Multi for Dogs:pruritus, flaky/greasy residue at the
treatment site, medicinal odor, lethargy, inappetence, and hyperactivity.(See ADVERSE REACTIONS.)
Safety Study in Puppies: Advantage Multi for Dogs was applied topically at 1, 3 and 5X the recommended dose to 7-week-old
Beagle puppies once every 2 weeks for 6 treatments on days 0, 14, 28, 42, 56, and 70. Loose stools and diarrhea were observed in
all groups, including the controls, throughout the study. Vomiting was seen in one puppy from the 1X treatment group (day 57), in
two puppies from the 3X treatment group (days 1 and 79), and in one puppy from the 5X treatment group (day 1). Two puppies each
in the 1X, 3X, and 5X groups had decreased appetites within 24 hours post-dosing. One puppy in the 1X treatment group had
pruritus for one hour following the fifth treatment. A puppy from the 5X treatment group displayed rapid, difficult breathing from 4 to 8
hours following the second treatment.
Dermal Dose Tolerance Study: Advantage Multi for Dogs was administered topically to 8-month-old Beagle dogs at 10X the
recommended dose once. One dog showed signs of treatment site irritation after application. Two dogs vomited, one at 6 hours and
one at 6 days post-treatment. Increased RBC, hemoglobin, activated partial thromboplastin, and direct bilirubin were observed in the
treated group. Dogs in the treated group did not gain as much weight as the control group.
Oral Safety Study in Beagles: Advantage Multi for Dogs was administered once orally at the recommended topical dose to 12
dogs. Six dogs vomited within 1 hour of receiving the test article, 2 of these dogs vomited again at 2 hours, and 1 dog vomited again
up to 18 hours post-dosing. One dog exhibited shaking (nervousness) 1 hour post-dosing. Another dog exhibited abnormal
neurological signs (circling, ataxia, generalized muscle tremors, and dilated pupils with a slow pupillary light response) starting at 4
hours post-dosing through 18 hours post-dosing. Without treatment, this dog was neurologically normal at 24 hours and had a
normal appetite by 48 hours post-dosing.
(See CONTRAINDICATIONS.)
Dermal Safety Study in Ivermectin-Sensitive Collies:
Advantage Multi for Dogs was administered topically at 3 and 5X the recommended dose every 28 days for 3 treatments to Collies
which had been pre-screened for avermectin sensitivity. No clinical abnormalities were observed.
Oral Safety Study in Ivermectin-Sensitive Collies:
Advantage Multi for Dogs was administered orally to 5 pre-screened ivermectin-sensitive Collies. The Collies were asymptomatic
after ingesting 10% of the minimum labeled dose. At 40% of the minimum recommended topical dose, 4 of the dogs experienced
neurological signs indicative of avermectin toxicity including depression, ataxia, mydriasis, salivation, muscle fasciculation, and
coma, and were euthanized.
(See CONTRAINDICATIONS.)
Heartworm-Positive Dogs
Laboratory Safely Study in Heartworm-Positive Dogs: Advantage Multi for Dogs was administered topically at 1 and 5X the
recommended dose every 14 days for 3 treatments to dogs with adult heartworm infections and circulating microfilariae. At 5X, one
dog was observed vomiting three hours after the second treatment. Hypersensitivity reactions were not seen in the 5X treatment
group. Microfilariae counts decreased with treatment.
STORAGE INFORMATION:
Store at temperatures between 4°C (39°F) and 25°C (77°F), avoiding excess heat or cold.
How Supplied
Code
Applications Per Package
088914546 x 0.4 mL tubes
088914626 x 1.0 mL tubes
088914706 x 2.5 mL tubes
088914896 x 4.0 mL tubes
805602906 x 5.0 mL tubes
Advantage Multi is protected by one or more of the following U.S. patents: 6,232,328, and 6,001,858.
08944698, R.6May 2014
81970068
19340
NADA #141-251, Approved by FDA
Made in Germany
© 2014 Bayer HealthCare LLC
Bayer, the Bayer Cross and Advantage Multi are registered trademarks of Bayer.
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee Mission, Kansas 66201 U.S.A.
Regulations for product use are established by country. Information contained on this site pertains only to the United States of
America, and is not intended to provide adequate information for product use. Before using or dispensing any product, read and
carefully observe the label directions.
BAYER HEALTHCARE LLC
Animal Health Division
P.O. BOX 390, SHAWNEE MISSION, KS, 66201-0390
Customer Service Tel.:
800-633-3796
Customer Service Fax:
800-344-4219
Website:
www.bayer-ah.com
Every effort has been made to ensure the accuracy of the Advantage Multi (imidacloprid + moxidectin) Topical Solution for Dogs information published
above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or
package insert.
Scenario Three:
Porter County Animal Control just picked up a stray cat. He appears to be a six month old
Siamese mix. They are hoping to find him a new home, but first they must vaccinate him from
Rabies.
6. What product should they use to vaccinate the cat? Rabvac 3
7. How much of the vaccine should you administer to the cat? How often? 1ml annually for
two years, then every three years
8. What medicines would you give the cat if he had an allergic reaction to this vaccine?
Epinephrine, corticosteroids, and antihistamines
9. What company produces this vaccine? Boehringer Ingelheim Vetmedica
10. What species can this vaccine be used for?
Dogs, cats, horses
RABVAC® 3
Boehringer Ingelheim
Rabies Vaccine
Killed Virus
For use in dogs, cats and horses only.
This product is restricted for use by or under the supervision of a veterinarian.
Rabvac 3 is a killed virus vaccine for the vaccination of healthy dogs, cats and horses for the prevention
of disease due to rabies. This vaccine meets the three year duration of immunity requirements for dogs
and cats, and one year duration of immunity for horses.
Dosage and Administration
Dogs and Cats: Inject one 1 mL dose subcutaneously or at one site in the thigh intramuscularly at 3
months of age or older. Revaccinate one year later and every 3 years thereafter.
Horses: Inject one 2 mL dose intramuscularly at 3 months of age or older. NOTE: Two 1 mL vials must
be used. Revaccinate one year later and annually thereafter.
The PEEL-OFF LABEL I.D. SYSTEM provides a simple and effective method of recording pertinent
information on the vaccines administered to animals in a veterinary practice.
For vaccines requiring reconstitution, remove label from both vials and affix both labels to the animal’s
medical chart.
Using the System:
1. Grasp the vial label at the corner marked with an indicator arrow, between your thumb and
forefinger (figure 1).
2. Pull steadily at a slight angle until the label is separated from the vial (figure 2).
3. Place the label on the animal’s medical chart. Press down on the label to ensure adhesion.
Precautions
- Store between 2° and 7°C (35° and 45°F). Do not freeze. Shake well before use.
- The use of a biological may produce anaphylaxis and/or other inflammatory immune-mediated
hypersensitivity reactions. Antidote: Epinephrine, corticosteroids, and antihistamines may all be indicated
depending on the nature and severity of the reaction.
- A local reaction may occur at the injection site following subcutaneous administration.
- Contains gentamicin as a preservative.
Do not vaccinate horses within 21 days before slaughter.
Caution: In the absence of a veterinarian-client-patient relationship, Federal law prohibits the relabeling,
repackaging, resale, or redistribution of the individual contents of this package.
Rabvac® is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.
© 2011 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.
Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 U.S.A.
U.S. Veterinary License No. 124
10 Doses 10 mL Vials of Vaccine
50 Doses 50-1 mL Vials of Vaccine
10391
D12156C
NAC No.: 1028216.0
Scenario Four:
Charley is a 30 lb Shetland Sheepdog with a tooth infection that is making it hard for him to eat.
His owners want to treat the infection so he can be more comfortable.
6. What medicine should be administered to Charley? Clindamycin
7. What should you do if a dose is missed of this medicine? If you miss a dose, give it as
soon as you remember. If it is almost time for the next dose, skip the one you missed and
go back to the regular schedule. Do not give 2 doses at once
8. What are some other names this product may be known as? Antirobe, Cleocin
9. What is an atopic animal? Pets with allergies that cause skin problems
10. What other animals is this product approved for? Which animals should not be given this
product? Dogs, cats, and ferrets. Do not give to rabbits, guinea pigs, chinchillas, or
hamsters
Scenario Five:
Rusty is slowing down lately. He is a 9 year old, 70 lb Black and Tan Coonhound whose
osteoarthritis is making it hard to bring him on hunts anymore. I want to reduce the inflammation
in his joints so he will be in less pain.
5. Which medicine would be appropriate for Rusty? Metacam
6. How much medicine will I give him on the first day? How much will he receive after
that?
6.3 mg on day 1, 3.15 mg daily starting day 2
7. What is an NSAID?
Non-steroidal anti-inflammatory drug (NSAID). It works by inhibiting the hormones
which generate chemicals that are responsible for pain and inflammation.
8. What signs indicate you should discontinue use of this drug?
Vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption,
increased urination, pale gums due to anemia, yellowing of gums, skin or white of the eye
due to jaundice, lethargy, incoordination, seizure, or behavioral changes.
Metacam®
Boehringer Ingelheim
(meloxicam)
0.5 mg/mL Oral Suspension (equivalent to 0.02 mg per drop)
1.5 mg/mL Oral Suspension (equivalent to 0.05 mg per drop)
NADA 141-213, Approved by FDA
Non-steroidal anti-inflammatory drug for oral use in dogs only
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Warning: Repeated use of meloxicam in cats has been associated with acute renal failure and death. Do not administer additional
injectable or oral meloxicam to cats. See Contraindications, Warnings, and Precautions for detailed information.
Description: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class. Each milliliter of Metacam Oral
Suspension contains meloxicam equivalent to 0.5 or 1.5 milligrams and sodium benzoate (1.5 milligrams) as a preservative. The
chemical name for Meloxicam is 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. The
suspension formulation is a yellowish viscous suspension with the odor of honey.
Indications: Metacam Oral Suspension is indicated for the control of pain and inflammation associated with osteoarthritis in dogs.
Dosage and Administration: Always provide client information sheet with prescription. Carefully consider the potential benefits and
risk of Metacam and other treatment options before deciding to use Metacam. Use the lowest effective dose for the shortest duration
consistent with individual response. Metacam Oral Suspension should be administered initially at 0.09 mg/lb (0.2 mg/kg) body
weight only on the first day of treatment. For all treatments after day 1, Metacam Oral Suspension should be administered once
daily at a dose of 0.045 mg/lb (0.1 mg/kg). The syringe is calibrated to deliver the daily maintenance dose in pounds.
Directions for Administration (0.5 mg/mL strength):
Dogs under 10 pounds (4.5 kg)
Shake well before use, then remove cap. Particular care should be given with regard to the accuracy of dosing. To prevent
accidental overdosing of small dogs, administer drops on food only, never directly into the mouth. Carefully measure
suspension onto food to assure that the correct dose is given before presentation of the food to the dog. The syringe provided with
the meloxicam concentration of 0.5 mg/mL cannot be used to measure doses for dogs weighing less than 1 lb (0.45 kg).
For dogs less than 1 lb (0.45 kg), Metacam Oral Suspension can be given using the dropper bottle: two drops for each pound of
body weight for the 0.5 mg/mL concentration (five drops for each kilogram of body weight), dropped directly onto the food.
For dogs between 1 - 10 pounds, Metacam Oral Suspension can be given by drops or by using the measuring syringe provided in
the package (see dosing procedure below). The syringe fits on to the bottle and has a scale beginning at 1 lb, designed to deliver
the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog’s weight should be rounded down to the
nearest 1 pound increment. Replace and tighten cap after use.
Dogs over 10 pounds (4.5 kg)
Shake well before use then remove cap. Metacam Oral Suspension may be either mixed with food or placed directly into the mouth.
Particular care should be given with regard to the accuracy of dosing. Metacam Oral Suspension can be given using the measuring
syringe provided in the package (see dosing procedure below). The syringe fits on to the bottle and has a scale in pounds designed
to deliver the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog’s weight should be rounded down
to the nearest 1 pound increment. Alternatively, Metacam Oral Suspension can be given using the dropper bottle: two drops for
each pound of body weight for the 0.5 mg/mL concentration (five drops for each kilogram of body weight). Replace and tighten cap
after use.
Directions for Administration (1.5 mg/mL strength):
Dogs under 10 pounds (4.5 kg)
Shake well before use, then remove cap. Particular care should be given with regard to the accuracy of dosing. To prevent
accidental overdosing of small dogs, administer drops on food only, never directly into the mouth. Carefully measure
suspension onto food to assure that the correct dose is given before presentation of the food to the dog. The syringe provided with
the meloxicam concentration of 1.5 mg/mL cannot be used to measure doses for dogs weighing less than 5 lbs (2.3 kg).
For dogs less than 5 lbs (2.3 kg), Metacam Oral Suspension can be given using the dropper bottle: one drop for each pound of body
weight for the 1.5 mg/mL concentration (two drops for each kilogram of body weight), dropped directly onto the food.
For dogs between 5 - 10 pounds, Metacam Oral Suspension can be given by drops or by using the measuring syringe provided in
the package (see dosing procedure below). The syringe fits on to the bottle and has a scale beginning at 5 lbs, designed to deliver
the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog’s weight should be rounded down to the
nearest 5 pound increment. Replace and tighten cap after use.
Dogs over 10 pounds (4.5 kg)
Shake well before use then remove cap. Metacam Oral Suspension may be either mixed with food or placed directly into the mouth.
Particular care should be given with regard to the accuracy of dosing. Metacam Oral Suspension can be given using the measuring
syringe provided in the package (see dosing procedure below). The syringe fits on to the bottle and has a scale in pounds designed
to deliver the daily maintenance dose (0.05 mg/lb or 0.1 mg/kg). When using the syringe, the dog’s weight should be rounded down
to the nearest 5 pound increment. Alternatively, Metacam Oral Suspension can be given using the dropper bottle: one drop for each
pound of body weight for the 1.5 mg/mL concentration (two drops for each kilogram of body weight). Replace and tighten cap after
use.
Shake bottle well. Push down and unscrew bottle top. Attach the dosing syringe to the bottle by gently pushing the end on to the top
of the bottle.
Turn the bottle/syringe upside down. Pull the plunger out until the black line on the plunger corresponds to the dog’s body weight in
pounds.
Turn the bottle right way up and with a twisting movement separate the dosing syringe from the bottle.
Push the plunger to empty the contents of the syringe.
Contraindications: Dogs with known hypersensitivity to meloxicam should not receive Metacam Oral Suspension. Do not use
Metacam Oral Suspension in cats. Acute renal failure and death have been associated with the use of meloxicam in cats.
Warnings: Not for use in humans. Keep this and all medications out of reach of children. Consult a physician in case of accidental
ingestion by humans. For oral use in dogs only.
As with any NSAID all dogs should undergo a thorough history and physical examination before the initiation of NSAID therapy.
Appropriate laboratory testing to establish hematological and serum biochemical baseline data is recommended prior to and
periodically during administration. Owner should be advised to observe their dog for signs of potential drug toxicity and be given a
client information sheet about Metacam.
Precautions: The safe use of Metacam Oral Suspension in dogs younger than 6 months of age, dogs used for breeding, or in
pregnant or lactating dogs has not been evaluated. Meloxicam is not recommended for use in dogs with bleeding disorders, as
safety has not been established in dogs with these disorders.
As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to
drug-associated adverse events varies with the individual patient. Dogs that have experienced adverse reactions from one NSAID
may experience adverse reactions from another NSAID. Patients at greatest risk for renal toxicity are those that are dehydrated, on
concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of
potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal
homeostatic function. Such anti-prostaglandin effects may result in clinically significant disease in patients with underlying or preexisting disease that has not been previously diagnosed. Since NSAIDs possess the potential to induce gastrointestinal ulcerations
and/or perforations, concomitant use with other anti-inflammatory drugs, such as NSAIDs or corticosteroids, should be avoided. If
additional pain medication is needed after administration of the total daily dose of Metacam Oral Suspension, a non-NSAID or noncorticosteroid class of analgesia should be considered. The use of another NSAID is not recommended. Consider appropriate
washout times when switching from corticosteroid use or from one NSAID to another in dogs. The use of concomitantly proteinbound drugs with Metacam Oral Suspension has not been studied in dogs. Commonly used protein-bound drugs include cardiac,
anticonvulsant and behavioral medications. The influence of concomitant drugs that may inhibit metabolism of Metacam Oral
Suspension has not been evaluated. Drug compatibility should be monitored in patients requiring adjunctive therapy.
Adverse Reactions: Field safety was evaluated in 306 dogs. Based on the results of two studies, GI abnormalities (vomiting, soft
stools, diarrhea, and inappetence) were the most common adverse reactions associated with the administration of meloxicam. The
following table lists adverse reactions and the numbers of dogs that experienced them during the studies. Dogs may have
experienced more than one episode of the adverse reaction during the study.
Adverse Reactions Observed During Two Field Studies
Clinical Observation
Meloxicam (n=157) Placebo (n=149)
Vomiting
40
23
Diarrhea/Soft Stool
19
11
Bloody Stool
1
0
Inappetence
5
1
Bleeding gums after dental procedure
1
0
Lethargy/Swollen Carpus
1
0
Epiphora
1
0
In foreign suspected adverse drug reaction (SADR) reporting over a 9 year period, incidences of adverse reactions related to
meloxicam administration included: auto-immune hemolytic anemia (1 dog), thrombocytopenia (1 dog), polyarthritis (1 dog), nursing
puppy lethargy (1 dog), and pyoderma (1 dog).
Post-Approval Experience (Rev. 2010): The following adverse events are based on post-approval adverse drug experience
reporting. Not all adverse reactions are reported to FDA/CVM. It is not always possible to reliably estimate the adverse event
frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in
decreasing order of frequency by body system.
Gastrointestinal: vomiting, anorexia, diarrhea, melena, gastrointestinal ulceration
Urinary: azotemia, elevated creatinine, renal failure
Neurological/Behavioral: lethargy, depression
Hepatic: elevated liver enzymes
Dermatologic: pruritus
Death has been reported as an outcome of the adverse events listed above. Acute renal failure and death have been associated
with use of meloxicam in cats.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the MSDS, contact Boehringer Ingelheim
Vetmedica, Inc. at 1-866-METACAM (1-866-638-2226). For additional information about adverse drug experience reporting for
animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth
Information for Dog Owners: Metacam, like other drugs of its class, is not free from adverse reactions. Owners should be advised
of the potential for adverse reactions and be informed of the clinical signs associated with drug intolerance. Adverse reactions may
include vomiting, diarrhea, decreased appetite, dark or tarry stools, increased water consumption, increased urination, pale gums
due to anemia, yellowing of gums, skin or white of the eye due to jaundice, lethargy, incoordination, seizure, or behavioral
changes. Serious adverse reactions associated with this drug class can occur without warning and in rare situations result
in death (see Adverse Reactions). Owners should be advised to discontinue Metacam and contact their veterinarian
immediately if signs of intolerance are observed.
The vast majority of patients with drug related adverse reactions have recovered when the signs are recognized, the drug is
withdrawn, and veterinary care, if appropriate, is initiated. Owners should be advised of the importance of periodic follow up for all
dogs during administration of any NSAID.
Clinical Pharmacology: Meloxicam has nearly 100% bioavailability when administered orally with food. The terminal elimination
half life after a single dose is estimated to be approximately 24 hrs (+/-30%) regardless of route of administration. There is no
evidence of statistically significant gender differences in drug pharmacokinetics. Drug bioavailability, volume of distribution, and total
systemic clearance remain constant up to 5 times the recommended dose for use in dogs. However, there is some evidence of
enhanced drug accumulation and terminal elimination half-life prolongation when dogs are dosed for 45 days or longer.
Peak drug concentrations can be expected to occur within about 7.5 hrs after oral administration. Corresponding peak concentration
is approximately 0.464 mcg/mL following a 0.2 mg/kg oral dose. The drug is 97% bound to canine plasma proteins.
Effectiveness: The effectiveness of meloxicam was demonstrated in two field studies involving a total of 277 dogs representing
various breeds, between six months and sixteen years of age, all diagnosed with osteoarthritis. Both of the placebo-controlled,
masked studies were conducted for 14 days. All dogs received 0.2 mg/kg meloxicam on day 1. All dogs were maintained on 0.1
mg/kg oral meloxicam from days 2 through 14 of both studies. Parameters evaluated by veterinarians included lameness, weightbearing, pain on palpation, and overall improvement. Parameters assessed by owners included mobility, ability to rise, limping, and
overall improvement.
In the first field study (n=109), dogs showed clinical improvement with statistical significance after 14 days of meloxicam treatment
for all parameters. In the second field study (n=48), dogs receiving meloxicam showed a clinical improvement after 14 days of
therapy for all parameters; however, statistical significance was demonstrated only for the overall investigator evaluation on day 7,
and for the owner evaluation on day 14.
Palatability: Metacam Oral Suspension was accepted by 100% of the dogs when veterinarians administered the initial dose into the
mouth. Metacam Oral Suspension was accepted by 90% of the dogs (123/136) when administered by owners. Problems associated
with administration included refusal of food, resistance to swallowing and salivation.
Safety:
Six Week Study
In a six week target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no
significant clinical adverse reactions. Animals in all dose groups (control, 1, 3 and 5X the recommended dose) exhibited some
gastrointestinal distress (diarrhea and vomiting). No treatment-related changes were observed in hematological, blood chemistry,
urinalysis, clotting time, or buccal mucosal bleeding times.
Necropsy results included stomach mucosal petechiae in one control dog, two dogs at the 3X and one dog at the 5X dose. Other
macroscopic changes included areas of congestion or depression of the mucosa of the jejunum or ileum in three dogs at the 1X
dose and in two dogs at the 5X dose. Similar changes were also seen in two dogs in the control group. There were no macroscopic
small intestinal lesions observed in dogs receiving the 3X dose. Renal enlargement was reported during the necropsy of two dogs
receiving the 3X and two receiving the 5X dose.
Microscopic examination of the kidneys revealed minimal degeneration or slight necrosis at the tip of the papilla in three dogs at the
5X dose. Microscopic examination of the stomach showed inflammatory mucosal lesions, epithelial regenerative hyperplasia or
atrophy, and submucosal gland inflammation in two dogs at the recommended dose, three dogs at the 3X and four dogs at the 5X
dose. Small intestinal microscopic changes included minimal focal mucosal erosion affecting the villi, and were sometimes
associated with mucosal congestion. These lesions were observed in the ileum of one control dog and in the jejunum of one dog at
the recommended dose and two dogs at the 5X dose.
Six Month Study
In a six month target animal safety study, meloxicam was administered orally at 1, 3, and 5X the recommended dose with no
significant clinical adverse reactions. All animals in all dose groups (controls, 1, 3, and 5X the recommended dose) exhibited some
gastrointestinal distress (diarrhea and vomiting). Treatment related changes seen in hematology and chemistry included decreased
red blood cell counts in seven of 24 dogs (four 3X and three 5X dogs), decreased hematocrit in 18 of 24 dogs (including three
control dogs), dose related neutrophilia in one 1X, two 3X and three 5X dogs, evidence of regenerative anemia in two 3X and one
5X dog. Also noted were increased BUN in two 5X dogs and decreased albumin in one 5X dog.
Endoscopic changes consisted of reddening of the gastric mucosal surface covering less than 25% of the surface area. This was
seen in three dogs at the recommended dose, three dogs at the 3X dose and two dogs at the 5X dose. Two control dogs exhibited
reddening in conjunction with ulceration of the mucosa covering less than 25% of the surface area.
Gross gastrointestinal necropsy results observed included mild discoloration of the stomach or duodenum in one dog at the 3X and
in one dog at the 5X dose. Multifocal pinpoint red foci were observed in the gastric fundic mucosa in one dog at the recommended
dose, and in one dog at the 5X dose.
No macroscopic or microscopic renal changes were observed in any dogs receiving meloxicam in this six month study.
Microscopic gastrointestinal findings were limited to one dog at the recommended dose, and two dogs at the 3X dose. Mild
inflammatory mucosal infiltrate was observed in the duodenum of one dog at the recommended dose. Mild congestion of the fundic
mucosa and mild myositis of the outer mural musculature of the stomach were observed in two dogs receiving the 3X dose.
How Supplied:
Metacam Oral Suspension 0.5 mg/mL: 15 mL and 30 mL dropper bottles with measuring syringe.
Metacam Oral Suspension 1.5 mg/mL: 10, 32, 100 and 180 mL dropper bottles with measuring syringe.
Storage: Store at controlled room temperature, 68 - 77°F (20 - 25°C). Excursions permitted between 59°F and 86°F (15°C and
30°C). Brief exposure to temperature up to 104°F (40°C) may be tolerated provided the mean kinetic temperature does not exceed
77°F (25°C); however such exposure should be minimized.
Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 U.S.A.
US Patent 6,184,220
Metacam is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, licensed to Boehringer Ingelheim Vetmedica, Inc.
601413-03/6015268-03
81134790, R.3/81128685, R.3
Revised 08/2014
NAC No.: 1028144.8
Scenario Six:
My dog gets sick and throws up every time he is in the car. He is an 8 lb., 2 year old Pomeranian
named Bear and I want to be able to travel without him getting motion sickness.
6. What product should be given to Bear? Cerenia
7. How much is the minimum dose I need to give Bear? 7.2 mg, ½ tablet
8. What do I need to do before traveling with him? When do I need to do these thing?
Administer CERENIA Tablets a minimum of two hours prior to travel with a small
amount of food to mitigate vomiting associated with administration of the dose on an
empty stomach; however, refrain from feeding a full meal prior to travel.
9. What do humans need to be aware of when handling this drug?
Topical exposure may elicit localized allergic skin reactions in some individuals.
Repeated or prolonged exposure may lead to skin sensitization. Wash hands with soap
and water after administering drug.
10. What country is this product made in?
France
Cerenia® Tablets
Zoetis
(maropitant citrate)
Antiemetic
For oral use in dogs only
CAUTION: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION: Maropitant is a neurokinin (NK1) receptor antagonist that blocks the pharmacological action of substance P in the
central nervous system (CNS). Maropitant is the non-proprietary designation for a substituted quinuclidine. The empirical formula is
C32H40N2O C6H8O7 H2O and the molecular weight 678.81. The chemical name is (2S,3S)-2-benzhydryl-N-(5-tert-butyl-2methoxybenzyl) quinuclidin-3-amine citrate monohydrate. Each peach-colored oval tablet is scored and contains 16, 24, 60 or 160
mg of maropitant as maropitant citrate per tablet.
The chemical structure of maropitant citrate is:
INDICATIONS: CERENIA (maropitant citrate) Tablets are indicated for the prevention of acute vomiting and the prevention of
vomiting due to motion sickness in dogs.
DOSAGE AND ADMINISTRATION:
For Prevention of Acute Vomiting
For Prevention of Acute Vomiting in dogs 2-7 months of age: Administer CERENIA Tablets orally at a minimum dose of 2
mg/kg (0.9 mg/lb) body weight once daily for up to 5 consecutive days (see WARNINGS and Animal Safety).
For Prevention of Acute Vomiting in dogs 7 months of age and older: Administer CERENIA Tablets orally at a minimum dose
of 2 mg/kg (0.9 mg/lb) body weight once daily until resolution of acute vomiting.
If vomiting persists despite treatment, the case should be re-evaluated. CERENIA is most effective in preventing acute vomiting
associated with chemotherapy if administered prior to the chemotherapeutic agent.
For prevention of acute vomiting, dispense whole or half tablets in strength(s) that most closely result in a 2 mg/kg dose:
Dog body weight
Number of Tablets
Pounds Kilograms 16 mg 24 mg 60 mg
8
4
1/2
15
8
1
25
12
1
50
24
2
65
30
1
130
60
2
Interchangeable use with CERENIA Injectable Solution for Prevention of Acute Vomiting: In dogs that are actively vomiting, to
ensure that the full initial dose is administered, CERENIA Injectable Solution is recommended at a dose of 1 mg/kg once
daily. (See package insert for CERENIA injectable solution.) Thereafter, for the prevention of acute vomiting, CERENIA Tablets at
a dose of 2 mg/kg once daily may be used interchangeably with CERENIA Injectable Solution for up to 5 days.
For Prevention of Vomiting Due to Motion Sickness in dogs 4 months and older
Administer CERENIA Tablets orally at a minimum dose of 8 mg/kg (3.6 mg/lb) body weight once daily for up to 2 consecutive days
(see WARNINGS and Animal Safety).
Administer CERENIA Tablets a minimum of two hours prior to travel with a small amount of food to mitigate vomiting associated with
administration of the dose on an empty stomach; however, refrain from feeding a full meal prior to travel.
Prevention of Vomiting Due to Motion Sickness in Dogs 4 months of age and older:
Dispense whole or half tablets in strengths that most closely result in an 8 mg/kg dose once daily for up to 2 consecutive
days:
Dog body weight
Number of Tablets
Pounds Kilograms 16 mg 24 mg 60 mg 160 mg
2
1
1/2
3
1.5
4
2
6
3
8
4
13
6
16
7.5
22
10
33
15
44
20
1
66
30
1 1/2
88
40
2
132
60
3
1/2
1
1
2
2
1
1/2
2
CERENIA injectable solution should not be used interchangeably with CERENIA tablets for the prevention of vomiting due to motion
sickness (8mg/kg).
WARNINGS: Not for use in humans. Keep out of the reach of children. In case of accidental ingestion, seek medical advice. Topical
exposure may elicit localized allergic skin reactions in some individuals. Repeated or prolonged exposure may lead to skin
sensitization. Wash hands with soap and water after administering drug. CERENIA is also an ocular irritant. In case of accidental
eye exposure, flush with water for 15 minutes and seek medical attention.
In puppies younger than 11 weeks of age, histological evidence of bone marrow hypocellularity was observed at higher frequency
and greater severity in puppies treated with CERENIA compared to control puppies. In puppies 16 weeks and older, bone marrow
hypocellularity was not observed (seeANIMAL SAFETY).
PRECAUTIONS: The safe use of CERENIA Tablets has not been evaluated in dogs used for breeding, or in pregnant or lactating
bitches.
The safe use of CERENIA has not been evaluated in dogs with gastrointestinal obstruction, or dogs that have ingested toxins.
Use with caution in dogs with hepatic dysfunction because CERENIA is metabolized by CYP3A enzymes (see Pharmacokinetics).
Use with caution with other medications that are highly protein bound. The concomitant use of CERENIA with other protein bound
drugs has not been studied in dogs. Commonly used protein bound drugs include NSAIDs, cardiac, anticonvulsant, and behavioral
medications. The influence of concomitant drugs that may inhibit the metabolism of CERENIA has not been evaluated. Drug
compatibility should be monitored in patients requiring adjunctive therapy.
CERENIA causes dose related decreases in appetite and body weight (see ANIMAL SAFETY). To maximize therapeutic potential
of CERENIA, the underlying cause of vomiting should be identified and addressed in dogs receiving CERENIA.
ADVERSE REACTIONS:
Prevention of Acute Vomiting (minimum of 2 mg/kg)
The following adverse reactions were reported during the course of a US field study for the prevention of acute vomiting in dogs
treated with CERENIA Tablets at a minimum of 2 mg/kg orally and/or Injectable Solution at 1 mg/kg subcutaneously once daily for
up to 5 consecutive days:
Frequency of Adverse Reactions by Treatment
Placebo (n=69)
CERENIA (n=206)
Adverse Reaction
# dogs % occurrence # dogs % occurrence
Death during study
4
5.8
10
4.9
Euthanized during study
0
0
2
1
Diarrhea
6
8.7
8
3.9
Hematochezia/bloody stool
5
7.2
4
1.9
Anorexia
2
2.9
3
1.5
Otitis/Otorrhea
0
0
3
1.5
Endotoxic Shock
1
1.4
2
1
Hematuria
0
0
2
1
Excoriation
0
0
2
1
Other clinical signs were reported but were <0.5% of dogs.
Prevention of Vomiting Due to Motion Sickness (minimum of 8 mg/kg)
The following adverse reactions were reported during US studies for the prevention of vomiting due to motion sickness in dogs
treated with CERENIA Tablets at a minimum of 8 mg/kg orally one time. Dogs may have experienced more than one of the
observed adverse reactions.
Frequency of Adverse Reactions by Treatment
Placebo (n=195)
CERENIA (n=208)
Adverse Reaction
# dogs % occurrence # dogs % occurrence
Hypersalivation
19
9.7
26
12.5
Vomiting
0
0
11
5.3
Muscle Tremors
1
0.5
2
1
Sedation/Depression
3
1.5
2
1
Retching
3
1.5
1
0.5
Flatulence
0
0
1
0.5
1
Not associated with motion sickness
The following adverse reactions were reported during a European field study for the prevention of vomiting due to motion sickness in
dogs treated with CERENIA Tablets at a minimum of 8 mg/kg orally once daily for 2 consecutive days. Dogs may have experienced
more than one of the observed adverse reactions.
Frequency of Adverse Reactions by Treatment
1
Placebo (n=106)
CERENIA (n=107)
Adverse Reaction
# dogs % occurrence # dogs % occurrence
Vomiting
4
4
10
9
Drowsiness/Lethargy/Apathy
1
1
8
8
Hypersalivation
2
2
5
5
Anxiety
0
0
2
2
Trembling/Tremors
0
0
2
2
Inappetence
0
0
2
2
Mucus in stool
0
0
1
1
The following Adverse Reactions were reported during the conduct of a US clinical field trial where CERENIA Tablets were
administered once daily for 28 consecutive days to 32 dogs: lethargy, vomiting, inappetence, corneal edema, and enlarged lymph
nodes.
Post-Approval Experience
The following adverse events are based on post-approval adverse drug experience reporting. Not all adverse events are reported to
FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product
exposure using these data.
The following adverse events are listed in decreasing order of reporting frequency in dogs: depression/lethargy, anorexia,
hypersalivation, vomiting, diarrhea, ataxia, and trembling. Cases of ineffectiveness have been reported.
To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471
or www.zoetis.com.
For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at
http://www.fda.gov/AnimalVeterinary/SafetyHealth.
CLINICAL PHARMACOLOGY:
Pharmacokinetics
Mean (±SD) Plasma Pharmacokinetic Parameters for Maropitant in Beagle Dogs after single dose and repeat oral doses of
Maropitant:
PK Parameter
T
max
AUC
(0-24)
T
1
(hr)
2.0 (1.5 - 3.0)
1.5 (1.0 - 3.0)
1.5 (1.0 - 3.0)
2.5 (1.5 - 7.0)
(ng/mL)
154 (111)
304 (165)
588 (416)
1409 (516)
(ng*hr/mL)
1440 (982)
3890 (3030)
6730 (5030)
26600 (9200)
NC
7.69 (6.21 - 17.8)
NC
25.4 (6.06 - 30.0)
NA
2.46 (1.68, 3.61)
NA
4.81 (3.28, 7.05)
max
C
2 mg/kg Single Dose 2 mg/kg repeat Doses 8 mg/kg Single Dose 8 mg/kg repeat Doses
1/2
2
2
(hr)
Accumulation Ratio (R )
ac
3
Following once daily doses of maropitant for 14 days.
Median (Range)
3
Ratio=Multiple Dose AUC(0-24)/Single Dose AUC(0-24), Least square means (95% Confidence Interval)
NA= Not Applicable
1
2
1
NC= Not Calculated
Following oral administration, median time to reach Cmax was within 2.5 hr. The absolute bioavailability of maropitant was low
(24%) following oral administration of 2 mg/kg maropitant. After an oral dose, prandial status does not significantly affect the extent
of oral bioavailability. Greater than dose-proportional drug exposure can be expected with an increase in dose (1-16 mg/kg PO).
However as doses increase (20-50 mg/kg PO), the dose proportionality is re-established. Based upon in vitro enzyme kinetics,
involvement of a high capacity enzyme (CYP3A12) may contribute to this return to dose linearity. Due to dose dependent
pharmacokinetics, the maropitant concentrations reached steady state approximately after 4 and 8 days following 2 and 8 mg/kg,
respectively. The observed drug accumulation ratios were 2.46 and 4.81, after oral administration of 2 and 8 mg/kg, respectively.
The exposure of 10 week old puppies to maropitant was lower than that observed in adult dogs, particularly after repeat doses of 1
or 2 mg/kg. Systemic clearance of maropitant following IV administration was 970, 995, and 533 mL/hr/kg at doses of 1, 2 and
8 mg/kg, respectively.
Urinary recovery of maropitant and its major metabolite was minimal (<1% each). The hepatic metabolism of maropitant involves
two cytochrome P-450 isoenzymes: CYP2D15 and CYP3A12. In in vitro enzyme kinetics data suggest that the non-linear kinetics
may be partially associated with saturation of the low capacity enzyme (CYP2D15). Plasma protein binding of maropitant was high
(99.5%).
Pharmacodynamics
Vomiting is a complex process coordinated centrally by the emetic center which consists of several brainstem nuclei (area
postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and
peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid. Maropitant is a neurokininn 1 (NK1) receptor
antagonist which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family. Substance P is found in
significant concentrations in the nuclei comprising the emetic center and is considered the key neurotransmitter involved in
emesis.1 By inhibiting the binding of substance P within the emetic center, maropitant provides broad-spectrum effectiveness against
neural (central) and humoral (peripheral) causes of vomiting. In vivo model studies in dogs have shown that maropitant has
antiemetic effectiveness against both central and peripheral emetogens including apomorphine, and syrup of ipecac.
1
Diemunsch P, Grelot L. Potential of substance P antagonists as antiemetics. [Review] [60 refs]. Drugs. 2000;60:533-46.
EFFECTIVENESS:
Prevention of Acute Vomiting
In laboratory model studies, CERENIA Tablets dosed at a minimum of 2 mg/kg BW reduced the number of emetic events
associated with established neural (central) and humoral (peripheral) stimuli. Following administration of apomorphine (central
emetic stimuli), vomiting was observed in 33% (4 of 12) of Beagle dogs treated with CERENIA Tablets and 100% (12 of 12) of
Beagle dogs treated with placebo tablets. Following administration of syrup of ipecac (peripheral emetic stimuli) vomiting was
observed in 33% (4 of 12) of Beagle dogs treated with CERENIA Tablets and in 83% (10 of 12) of Beagle dogs treated with placebo
tablets.
In a study of 275 canine patients presented to veterinary hospitals with a history of acute vomiting, dogs were initially administered
CERENIA Injectable Solution or placebo on Day 0. Following the initial dose, dogs allocated to the CERENIA group were treated
with either CERENIA Tablets at a minimum of 2 mg/kg orally or Injectable Solution at 1 mg/kg subcutaneously once daily at the
discretion of the clinician. Dogs allocated to the placebo group were treated using either an injectable placebo solution or placebo
tablets once daily at the discretion of the clinician. Of the 199 dogs included in the analysis for effectiveness, 27 of 54 dogs (50%) in
the placebo group displayed vomiting at some time during the study and 31 of 145 dogs (21.4%) in the treated group displayed
vomiting during the study period.
Percent Of Vomiting For Each Study Day, Based Upon Treatment And Route Of Administration.
Days
Treatment
Route
# dogs
Day 0
Placebo (54)
SC
54
15
28%
CERENIA (145)
Day 1
# vomited % vomited
SC
145 (143*)
14
10%
PO
22
3
14%
SC
23
16
70%
PO
67
2
3%
SC
41
16
39%
PO
7
2
29%
SC
9
6
67%
PO
24
0
0%
SC
13
8
62%
PO
2
0
0%
Placebo (45)
CERENIA (108)
Day 2
Placebo (16)
CERENIA (37)
Day 3
Placebo (6)
SC
4
1
25%
PO
14
0
0%
SC
7
5
71%
PO
1
0
0%
SC
1
1
100%
CERENIA (21)
Day 4
Placebo (2)
PO
5
0
0%
SC
2
1
50%
SC
1
0
0%
CERENIA (7)
Day 5
CERENIA (1)
*2 dogs administered CERENIA were not observed on Day 0. Their vomiting status was unknown. 143 was used in the denominator
for % vomited.
In US field studies in veterinary patients, CERENIA Tablets and Injectable Solution were well tolerated in dogs presenting with
various conditions including parvovirus, gastroenteritis, and renal disease. There were no notable differences in mean laboratory
values between CERENIA-treated and placebo-treated patients.
CERENIA Tablets were used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte
replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.
CERENIA Tablets were used safely in dogs receiving other frequently used veterinary products such as fluid and electrolyte
replacement solutions, antimicrobial agents, vaccines, antacids, and antiparasitic agents.
Prevention of Vomiting due to Motion Sickness
In a study of canine veterinary patients taken on a one-hour car journey and treated with either CERENIA Tablets at a minimum
dose of 8 mg/kg BW or placebo tablets 2 hours prior to the journey, 67 of 122 (55%) of dogs vomited during the journey when
treated with placebo while 8 of 122 (7%) vomited during the journey after treatment with CERENIA Tablets. The probability that a
dog in this study, prone to motion sickness would NOT vomit during a journey if treated with CERENIA Tablets was 93%, while the
probability was 48% if treated with placebo.
ANIMAL SAFETY: Laboratory and field studies have demonstrated that CERENIA Tablets are well tolerated in dogs after oral
administration.
Target Animal Safety Study for Acute Vomiting
Fifty six Beagle dogs (28 males and 28 females) approximately 16 weeks of age were administered CERENIA Tablets orally once
daily for 15 days at 0, 2, 6, and 10 mg/kg. There were 8 dogs (4 males and 4 females) in the 2 mg/kg group and 16 dogs (8 males
and 8 females) in all other groups. CERENIA Tablets caused decreases in food consumption and body weight that were not dosedependent and did not persist after cessation of treatment.
Beagle dogs approximately 8 weeks of age were administered CERENIA Tablets orally once daily for 15 days at 0, 2, 6, and 10
mg/kg using a protocol similar to the previous study. A dose dependent increase in severity of bone marrow hypoplasia was
observed histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the
study were weaned early, minimally acclimated to the test facility, many of the dogs in the study tested positive for coccidia and
some tested positive for canine parvovirus.
Beagle dogs approximately 10 weeks of age were administered either placebo tablets for 2 days, CERENIA Tablets at 8 mg/kg for 2
days, placebo (saline) subcutaneously (SC) for 5 days, CERENIA Injectable Solution at 1 mg/kg SC for 5 days, or CERENIA Tablets
at 2 mg/kg for 5 days (8 dogs in each dose group). Mild pain associated with injection was noted in more dogs and lasted longer in
dogs that received maropitant injections compared to saline. Males administered CERENIA at 8 mg/kg orally for 2 days had a
decrease in food consumption. Body weight and food consumption were variable throughout the 4 week acclimation period. Two
dogs that received 8 mg/kg maropitant orally for 2 days were below the reference range for reticulocyte counts. Decreases in
reticulocyte counts were also seen in 4 (of 8) placebo treated dogs (SC saline for 5 days). Hypocellular femoral bone marrow
described as “minimal” was seen in 1 male that received 1 mg/kg maropitant SC for 5 days; reticulocyte counts were not available
for this dog.
Twenty four Beagle dogs (12 males and 12 females) 7 months of age were administered maropitant at doses of 0, 1, 5, and 20
mg/kg orally once daily for 93 consecutive days. Maropitant produced sporadic clinical signs (salivation, emesis), body weight loss,
and lower serum albumin levels at 20 mg/kg/day. Maropitant increased P-R interval, P wave duration, and QRS amplitude in the 20
mg/kg /day dose group. One female in the 20 mg/kg/day group had increased cellularity of the bone marrow. This female was noted
to have lower mean red cell parameters (red blood cell count, hemoglobin, hematocrit) and higher platelet counts and reticulocytes.
Target Animal Safety Study for Motion Sickness
Forty Beagle dogs (20 males and 20 females) between 16 - 18 weeks of age were administered CERENIA Tablets orally once daily
for 6 days at 0, 8 and 24 mg/kg. There were 16 dogs (8 males and 8 females) in the 0 and 24 mg/kg groups and 8 dogs (4 males
and 4 females) in the 8 mg/kg group. At 24 mg/kg, CERENIA Tablets caused decreases in food consumption, with decreases in
body weight, liver and testis weight; and an increase in RBC count indicating hemoconcentration, but the effects on feed
consumption, body weight, and RBCs did not persist in the post-treatment recovery period (beyond Day 5).
Beagle dogs approximately 8 weeks of age were administered CERENIA Tablets orally once daily for 6 days at 0, 8, and 24 mg/kg
using a protocol similar to the previous study. One dog in the 24 mg/kg/day group died of unknown causes on study day 2 and a
dose dependent increase in occurrence and severity of bone marrow hypoplasia and lymphoid depletion was observed
histologically. Interpretation of these study results is complicated by the health status of study animals. Dogs used in the study were
weaned early, minimally acclimated to the test facility, and many of the dogs in the study tested positive for coccidia. Additionally,
some dogs in the study tested positive for canine parvovirus, however, clinical parvoviral disease was not definitively diagnosed.
Tolerance Studies
Twenty four Beagle dogs (14 males and 10 females) between 11 and 25 weeks of age were administered CERENIA Tablets in 2
phases with 8 dogs per group. In the first phase the dogs were administered 0, 20 or 30 mg/kg orally once daily for 7 days and in the
second phase 0, 40, or 50 mg/kg once daily for 7 days. CERENIA Tablets administered at 20 and 30 mg/kg caused occasional
vomiting. CERENIA Tablets administered at 40 mg/kg and 50 mg/kg caused clinically relevant signs of weight loss, vomiting, soft
stools, weakness, lethargy, salivation and hypokalemia. Additionally, leukopenia characterized by a neutropenia and a trend toward
decreasing plasma phosphorus values was seen. Decreased heart rate and prolonged corrected QT intervals were seen in all
treatment groups in a dose dependent manner.
Twenty-four Beagle dogs (12 males and 12 females) approximately 28 weeks of age were administered maropitant (mesylate salt)
orally once daily for 90 days at 0, 1, 5, and 20 mg/kg. End of study body weights in the 20 mg/kg group were 8-15% lower than
baseline body weights.
STORAGE CONDITIONS: CERENIA Tablets should be stored at controlled room temperature 20°-25°C (68°-77°F) with excursions
between 15°-30°C (59°-86°F).
HOW SUPPLIED: CERENIA peach-colored tablets are scored with a break line, and contain 16, 24, 60 or 160 mg of maropitant as
maropitant citrate per tablet. Each tablet is marked with “MPT” and the tablet strength on one side and the Pfizer logo on the other.
Each tablet size is packaged in a bottle containing 60 tablets and packaged in blister packs containing 4 tablets per perforated
sheet.
NADA #141-262, Approved by FDA
Manufactured by: Farvera, Amboise, France
Distributed by: Zoetis Inc., Kalamazoo, MI 49007
Revised: April 2015
8814122
NAC No.: 3690240.4