Revised: 01 March 2010
AN: 01132/2007
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
-coated tablet for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituents:
mg/tablet
Cefalexin
500
(as cefalexin monohydrate
526)
Excipients
Opadry Pink OY-S-6927
Titanium Dioxide (E171)
Erythrosine Lake (E127)
Indigo Carmine (E132)
10.0
3.05
0.30
0.007
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round, convex, pink film coated tablets, embossed with “Ceporex 500” on
one side.
4.
CLINICAL PARTICULARS
4.1
Target species
Dogs
4.2
Indications for use, specifying the target species
The tablets are indicated for oral antibiotic therapy in dogs.
When susceptible organisms are present, the product may be effective in the
treatment of infections of the respiratory tract, urogenital tract, the skin and
localised infections in soft tissue.
In dogs it may also be effective in the treatment of infections of the gastrointestinal tract.
4.3
Contra-indications
Do not use the product in animals which are known to be hypersensitive to
cefalexin (see section 4.6).
Do not use in rabbits, guinea pigs, hamsters and gerbils.
4.4
Special Warnings for each target species
None known
Revised: 01 March 2010
AN: 01132/2007
4.5
i) Special precautions for use in animals
As with other antibiotics which are excreted mainly by the kidneys, unnecessary
accumulation may occur in the body when renal function is impaired. In cases
of known renal insufficiency the dose should be reduced and the product used in
accordance with a benefit/risk assessment by the responsible veterinarian.
Use of the product should be based on susceptibility testing of the bacteria
isolated from the animal. If this is not possible, therapy should be based on
local epidemiological information about susceptibility of the target bacteria and
take into account official, national and regional antimicrobial policies.
The use of antibiotics, especially penicillins and cephalosporins, has been
associated with potentially fatal antibiotic enterotoxaemia, particularly in
rabbits.
ii) Special precautions to be taken by the person administering the product to
the animal
Cefalosporins may cause sensitisation (allergy) following injection, inhalation,
ingestion or skin contact. Sensitivity to penicillin may lead to cross sensitivity to
cephalosporin and vice versa. Allergic reactions to these substances may
occasionally be serious.
1. Do not handle this product if you know you are sensitised, or if you have
been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all
recommended precautions. Wash hands after use.
3. If you develop symptoms following exposure such as a skin rash you should
seek medical advice and show the doctor this warning. Swelling of the face,
lips or eyes or difficulty breathing are more serious symptoms and require
urgent medical attention.
4.6
Adverse reactions (frequency and seriousness)
Hypersensitivity to cefalexin is rare, however, the product should not be
administered to animals which are known to be hypersensitive to cefalexin.
4.7
Use during pregnancy, lactation or lay
The safety of the product has not been demonstrated in studies in pregnant or
lactating dogs. Use only in accordance with benefit/risk assessment by the
responsible veterinarian.
4.8
Interactions with other medicinal products and other forms of
interactions
None known
Revised: 01 March 2010
AN: 01132/2007
4.9
Amounts to be administered and administration route
Dose: The recommended dose rate is 10 to 15 mg/kg bodyweight twice daily.
To ensure a correct dosage, body weight should be determined as accurately as
possible to avoid underdosing.
The following is intended as a guide.
Dogs:
26 to 50kg bodyweight:
1 x 500 mg tablet twice daily.
51 kg and over bodyweight: 2x 500 mg tablets twice daily.
Treatment for five days is recommended. Any variation should be at the
discretion of the prescribing veterinary surgeon, e.g. in cases where the
condition requires an extended course of treatment (such as chronic pyoderma).
Administration: by the oral route, the product may be crushed or added to food
if necessary provided the dog is eating.
4.10
Overdose
The administration of cefalexin has been shown to produce no serious sideeffects at many times the recommended dose rate.
4.11
Withdrawal period(s)
Not applicable
5.
PHARMACOLOGICAL PROPERTIES
Therapeutic group: antibacterials for systemic use, cephalosporins
ATCVet code QJ01DB01
5.1
Pharmacodynamic Properties
Cefalexin is a broad spectrum cefalosporin antibiotic with bactericidal activity
against a wide range of Gram-positive and Gram-negative bacteria.
Cefalexin is a semi-synthetic bactericidal antibiotic belonging to the
cephalosporin group which acts by interference with bacterial cell wall
formation.
The following micro-organisms have been shown to be sensitive to cefalexin
in vitro: Staphylococcus spp (including penicillin-resistant strains),
Streptococcus spp, Corynebacterium spp, Pasteurella multocida, Escherichia
coli, Micrococcus spp, Moraxella spp.
Cefalexin is resistant to the action of staphylococcal penicillinase and is
therefore active against the strains of Staphylococcus aureus that are
insensitive to penicillin (or related antibiotics such as ampicillin or
amoxycillin) because of production of penicillinase.
Cefalexin is also active against the majority of ampicillin-resistant E.coli.
Revised: 01 March 2010
AN: 01132/2007
5.2
Pharmacokinetic Properties
Cefalexin is rapidly and almost completely absorbed after oral administration.
Effective blood levels are generally achieved within 2 hours of dosing.
Cefalexin is excreted in the urine in high concentrations.
Dogs receiving a 10 mg/kg oral dose achieved a Cmax in serum of
approximately 17 µg/ml within a Tmax of approximately 2 hours. Cephalexin
is rapidly eliminated via the urine; more than 50% of the dose was recovered
within 6 hours as antibiotic activity in the urine.
6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Opadry Pink OY-S-6927 Solids in the film coating:
Titanium Dioxide (E171)
Erythrosine Lake (E127)
Indigo Carmine (E132)
Hypromellose
Magnesium Stearate
Cellulose microcrystalline
Macrogol 400
6.2
Incompatibilities
None known.
6.3
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
6.4
Special precautions for storage
Do not store above 25°C. Protect from light.
6.5
Nature and composition of immediate packaging
White, opaque, polypropylene tub with a white polyethylene cap.
Contains 100, 250 or 500 tablets.
Packs of 200 tablets in foil blister pack; strips of 10 tablets in
PVC film/aluminium foil blisters, in cardboard carton.
Not all pack sizes may be marketed.
6.6
Special precautions for disposal of unused product or waste materials
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance with
local requirements.
7
MARKETING AUTHORISATION HOLDER
Schering-Plough Ltd
Shire Park
Welwyn Garden City
AL7 1TW UK
Revised: 01 March 2010
AN: 01132/2007
8.
MARKETING AUTHORISATION NUMBER
Vm 00201/4189
9.
DATE OF FIRST
AUTHORISATION
31/03/2003
10.
DATE OF REVISION OF THE TEXT
01/07/2009
AUTHORISATION/RENEWAL
OF
THE