Revised: May 2008
AN: 00346/2008
Summary of Product Characteristics
1.
Name of the Veterinary Medicinal Product
SENTINEL® Spectrum
Tablets for small Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains
Milbemycin oxime (INN)
Lufenuron
(INN)
Praziquantel
(INN)
5.75 mg
115 mg
57 mg
3.
PHARMACEUTICAL FORM
Tablets.
Brown and white, round, biconvex, palatable bi-layer tablets with a meat extract odour.
One side bears the imprint “ADA”, the other side “NA”.
4.
Pharmacological properties
Active substances:
Milbemycin oxime
Lufenuron
Praziquantel
Pharmacotherapeutic group:
Anthelmintic
Insect Growth Regulator
Anthelmintic
ATC vet Code
QP53BC51 Lufenuron combinations
4.1.
Pharmacodynamic properties
Milbemycin oxime belongs to the group of macrocyclic lactones, isolated from the
fermentation of Streptomyces hygroscopicus var. aureolacrimosus. It is active against
mites, against larval and adult stages of nematodes as well as against larvae of
Dirofilaria immitis.
The activity of milbemycin is related to its action on invertebrate neurotransmission:
Milbemycin oxime, like avermectins and other milbemycins, increases nematode and
insect membrane permeability to chloride ions via glutamate-gated chloride ion
channels (related to vertebrate GABAA and glycine receptors). This leads to
hyperpolarisation of the neuromuscular membrane and flaccid paralysis and death of
the parasite.
Lufenuron belongs to the chemical group of benzoylureas, and is an IGR (Insect
Growth Regulator) or IDI (Insect Development Inhibitor). It inhibits the development of
fleas by interfering with the normal synthesis, polymerisation and deposition of chitin,
the principal component of the arthropod exoskeleton. The adult flea absorbs lufenuron
Revised: May 2008
AN: 00346/2008
via its bloodmeal. At therapeutic levels, lufenuron has no effect on adult fleas, but
passes transovarially to act on eggs and larvae, thus interrupting the insect life cycle.
Praziquantel is an acylated pyrazino-isoquinoline derivative. Praziquantel is active
against cestodes and trematodes. It modifies the permeability for calcium (influx of
Ca2+) in the membranes of the parasite inducing an imbalance in the membrane
structures, leading to membrane depolarisation and almost instantaneous contraction of
the musculature (tetany), rapid vacuolization of the syncytial tegument and subsequent
tegumental disintegration (blebbing), resulting in easier expulsion from the
gastrointestinal tract or death of the parasite.
4.2.
Pharmacokinetic properties
Milbemycin oxime is well absorbed and reaches peak plasma concentrations within a
median of 1 hour (½ – 24 h) after oral administration at the recommended dose.
Thereafter, milbemycin oxime concentrations decrease in plasma with a half-life of
about 1 to 3 days.
Following oral administration, lufenuron is distributed via the blood within a median of 2
hours (2 – 48 h) to the adipose tissue, from which, metabolically unmodified, it is
constantly released above the minimum effective concentration for at least one month
(half life between 15 and 50 days).
Praziquantel is well absorbed and reaches peak plasma concentrations between ½ and
1 hour after oral administration at the recommended dose. There is rapid and extensive
first pass metabolism by the liver; parent praziquantel concentrations decrease in
plasma with a half-life of between 1 and 2.5 hours. Metabolites are largely excreted in
the urine within 2 days.
5.
Clinical Particulars
5.1.
Dog
Target species
Revised: May 2008
AN: 00346/2008
5.2. Indications for Use, Specifying the Target Species
For dogs harbouring, or at risk from, mixed parasitic infections:
For the prevention of flea infestation (Ct. felis, Ct. canis, preadult stages) in dogs where
concomitant treatment of mixed infections by adult cestodes and nematodes is
indicated.
SENTINEL® Spectrum is effective against adult stages of the following nematode and
cestode species;
Cestodes: Dipylidium caninum,
Taenia spp.,
Echinococcus spp.,
Mesocestoides spp..
Nematodes: Ancylostoma caninum,
Toxocara canis,
Toxascaris leonina,
Trichuris vulpis.
This product can be used in the prevention of heartworm disease (Dirofilaria immitis)
and may be used as part of a treatment strategy for flea allergy dermatitis (FAD).
5.3. Contra-indications
None.
5.4. Undesirable effects (Frequency and Seriousness)
Slight paleness of the visible mucous membranes and a slight increase in intestinal
peristalsis were observed in some dogs. The signs disappeared spontaneously.
5.5. Special precautions for use
The treatment of dogs with a high number of circulating microfilariae can sometimes
lead to the appearance of hypersensitivity reactions, such as pale mucous membranes,
vomiting, trembling, laboured breathing or excessive salivation. These reactions are
associated with the release of toxic proteins from dead or dying microfilariae and are
not a direct toxic effect of the product. The use in dogs suffering from microfilaremia
should be based on a risk benefit assessment.
If microfilaremic dogs are treated, animals should be observed closely, and, if needed,
treated symptomatically.
As with any other heartworm disease preventative, when non-protected exposure to
Dirofilaria immitis is suspected a veterinary consultation is advised to exclude the
presence of any concurrent infection before commencing SENTINEL ® Spectrum
Tablets. In the case of a positive diagnosis, adulticidal therapy is indicated before
administering SENTINEL® Spectrum Tablets.
The product should not be used in severely debilitated dogs or individuals with seriously
compromised kidney or liver function.
In dogs less than 4 weeks old, tapeworm infection is unusual. Treatment of animals less
than 4 weeks old with a combination product may therefore not be necessary.
Revised: May 2008
AN: 00346/2008
Parasite resistance to any particular class of anthelmintic may develop following
frequent, repeated use of an anthelmintic of that class.
Echinococcosis represents a hazard for humans. In case of Echinococcosis, specific
guidelines on the treatment and follow up and on the safeguard of persons have to be
followed. Experts or institutes of parasitology should be consulted
5.6. Use During Pregnancy and Lactation
The safety of SENTINEL® Spectrum Tablets has not been tested in pregnant or
lactating dogs. Therefore, use in such animals is not recommended.
Studies with milbemycin oxime, lufenuron or praziquantel performed separately in dogs
and laboratory animals did not reveal any alteration on reproductive function. Neither
foetal nor neonatal toxicity were observed.
5.7. Interaction with other Medicaments and other Forms of Interaction
During treatment with SENTINEL® Spectrum Tablets, no other antiparasitic macrocyclic
lactones should be administered.
5.8. Posology and Method of Administration
Oral administration with or after a full meal. SENTINEL Spectrum tablets, available in
four sizes, are given according to the weight of the dog, consistent with the
administration of a minimum recommended dose rate of 0.5 mg milbemycin oxime, 10
mg lufenuron and 5 mg of praziquantel per kg bodyweight. The practical dosing is as
follows:
Dog
size
Small
Weight
Posology
> 4.5 – 11 kg:
1 tablet
Milbemycin
oxime
5.75 mg
Lufenuron
Praziquantel
115 mg
57 mg
Flea control and prevention
To prevent flea infestations, lufenuron (either as a monovalent product or, in cases
where treatment for concurrent mixed gastrointestinal nematode and cestode infection
is required, as the combination product, SENTINEL® Spectrum) should be administered
at monthly intervals and, where there is a flea season, starting two months before the
fleas become active.
If the dog is already infested with fleas, no viable flea eggs are produced from 24 hours
after the first administration. The speed at which a pre-existing infestation is eliminated
is dependent on the number of flea larvae and pupae in the environment when
treatment starts and the climatic conditions. If dogs have a high level of flea infestation
at the start of the treatment, it may be necessary to administer a flea adulticide at that
time. It is important to treat all dogs and cats in the household for fleas. Cats in the
same household should be treated with an appropriate product for use in that species.
Lufenuron (either as a monovalent product or, in cases where treatment for concurrent
mixed gastrointestinal nematode and cestode infection is required, as the combination
product, SENTINEL® Spectrum) should be administered at monthly intervals when used
as part of a treatment strategy for flea allergy dermatitis.
Revised: May 2008
AN: 00346/2008
Heartworm disease prevention
For prevention of heartworm disease, milbemycin oxime (either as a monovalent
product or, in cases where prevention of flea infestation and treatment of concurrent
cestode infection is required, as the combination product, SENTINEL® Spectrum) must
be administered at regular monthly intervals during the time of the year when
mosquitoes are present. The appropriate treatment should be administered within at
least one month after the first expected exposure to mosquitoes. Treatment should
continue at regular monthly intervals until one month after the last exposure to
mosquitoes.
To establish a treatment routine, it is recommended that the same day or date be used
each month. When replacing another heartworm preventative product in a heartworm
prevention program, SENTINEL® Spectrum must be given within one month of the last
dose of the former medication. If the interval between treatments is greater than six
weeks, treatment should be resumed immediately and be continued at monthly intervals
and a veterinarian should be consulted.
Echinococcus infections
As with other praziquantel formulations SENTINEL Spectrum can be used as part of a
treatment strategy against Echinococcosis.
Roundworm infections
In ascarid infections, especially in puppies, complete elimination of worm burden cannot
be expected, resulting in a continued risk of infection for people coming into contact
with the young animals. Repeated monthly treatments should, therefore, be carried out
in puppies up to three months with milbemycin oxime (either as a monovalent product
or, in cases where prevention of flea infestation and treatment of concurrent cestode
infection is required, as the combination, SENTINEL® Spectrum).
Whipworm infections
It has been demonstrated under kennel conditions that monthly administration of
milbemycin oxime (either as a monovalent product or, as the combination product,
SENTINEL® Spectrum) significantly reduces egg shedding of Trichuris vulpis.
5.9. Overdose (Symptoms, emergency procedures, antidotes) (if necessary)
In case of overdosing, transient ataxia, trembling, depression, salivation and mydriasis
may be observed. The signs will disappear spontaneously within a day. There is no
specific antidote.
5.10. Special Warnings for each target species
Studies with milbemycin oxime indicate that the margin of safety in certain dogs of
Collie or related breeds is less than in other breeds. In these dogs, the recommended
dose should be strictly observed. The tolerance of SENTINEL ® Spectrum in young
puppies from these breeds has not been investigated and it is important that they are
accurately weighed prior to dosing. Clinical signs in Collies are similar to those seen in
the general dog population when overdosed.
5.11. Withdrawal period
Not applicable.
Revised: May 2008
AN: 00346/2008
5.12. Special Precautions to be taken by the Person Administering the Medicinal
Product to Animals
In the case of accidental ingestion, seek medical advice immediately and show the
package insert or the label to the physician.
Wash hands after use.
6.
Pharmaceutical Particulars
6.1. Major Incompatibilities
Not applicable.
6.2. Shelf - life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
6.3. Special Precautions for Storage
This medicinal product does not require any special storage conditions.
6.4.
Nature and Contents of Container
Alu/Alu blisters containing 6 tablets/blister. Cardboard box with one blister.
Sales units:
A blister card of 6 tablets
6.5
Special Precautions for the Disposal of Unused Medicinal Product or Waste
Materials, if any
Any unused product or waste material should be disposed of in accordance with
national requirements.
7.
Name or Corporate Name and Address or Registered Place of Business of
the Authorisation Holder
Novartis Animal Health UK Ltd.
Frimley Business Park
Frimley
Camberley
Surrey
GU16 7SR
Marketing Authorisation number
Vm 12501/4157
Date of first Authorisation/Renewal of the Authorisation
23 June 2005
Date of Revision the Text
May 2008