Part II

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Clindacyl 25 mg Tablets

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains 25 mg Clindamycin (as Clindamycin Hydrochloride)

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Tablet

4. CLINICAL PARTICULARS

Dogs

4.2 Indications for use, specifying the target species

Clindacyl 25 mg Tablets are indicated for the treatment of infected wounds, abscesses, superficial pyoderma and oral cavity/dental infections caused by or associated with clindamycin-sensitive staphylococci, streptococci, bacteroidaceae, Fusobacterium necrophorum, Clostridium perfringensand osteomyelitis caused by Staphylococcus aureus. Clindacyl 25 mg Tablets can also be used to help provide antimicrobial cover during dental procedures.

4.3 Contra-indications

Do not administer to animals with hypersensitivity to clindamycin and lincomycin preparations.

Do not administer to rabbits, guinea pigs, chinchillas, hamsters, horses or ruminants.

4.4 Special warnings for each target species

Before use of Clindacyl 25 mg tablets, the identification of causative pathogenic micro-organisms should be carried out and their susceptibility to clindamycin should be established.

Clindamycin and lincomycin show parallel-resistance. There is a partial cross-resistance to erythromycin and other macrolide-antibiotics.

4.5 Special precautions for use

(i) Special precautions for use in animals

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed. Patients with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high dose clindamycin therapy.

(ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals

None

Clindamycin sometimes causes the overgrowth of non sensitive organisms such as resistant clostridia and yeasts. In cases of superinfection, appropriate measures should be taken according to the clinical situation.

Vomiting and diarrhoea are observed occasionally.

While high dose studies in rats suggests that clindamycin is not a teratogen and does not significantly affect the breeding performance of males and females, safety in gestating bitches or breeding male dogs has not been established.

Neuromuscular blocking effects have been observed with clindamycin possibly leading to an increase of efficacy of other neuromuscular blocking agents. The concomitant use of such drugs must be handled with care.

Clindamycin should not be used concomitantly with chloramphenicol or macrolides because they may antagonise each other at the site of action.

For oral administration.

For treatment of infected wounds, abscesses, oral cavity/dental infections, administer 5.5 mg/kg bodyweight every 12 hours for 7 - 10 days (i.e. 1 tablet per 4.5 kg bodyweight twice daily). Treatment may be extended to a maximum of 28 days based on clinical judgement. If no improvement is seen within 4 days, the sensitivity of the pathogens involved should be redetermined.

For the treatment of superficial pyoderma administer 11 mg/kg every 24 hours (i.e. 2 tablets per 4.5 kg bodyweight once daily). Continue treatment for at least 21 days.

For the treatment of osteomyelitis administer 11 mg/kg every 12 hours (i.e. 2 tablets per 4.5 kg bodyweight twice daily) for at least 28 days. If no improvement is seen within 14 days, the sensitivity of the pathogens involved should be redetermined.

To help provide antimicrobial cover during dental procedures, a 10 day course of 5.5 mg/kg every 12 hours is recommended (i.e. 1 tablet per 4.5 kg twice a day beginning 5 days before the intended procedure and continuing for 5 days thereafter).

Symptoms of overdose include vomiting, inappetency and diarrhoea. In such cases,

treatment should be stopped immediately and the dogs treated symptomatically.

Not applicable

5. PHARMACOLOGICAL PROPERTIES

ATC Vet Code: QJ01FF01

Clindamycin, a chlorinated analogue of lincomycin, is an antibiotic with bacteriostatic action. Bactericidal actions have also been reported.

Clindamycin is rapidly absorbed; following oral administration up to 90% of the active ingredient is absorbed from the gastro-intestinal tract.

Bioavailability is greater in fasting dogs than fed dogs.

Clindamycin crosses the placental barrier and can be detected in milk.

Microcrystalline cellulose

Ludipress

Sodium lauryl sulphate

Colloidal anhydrous silica

Magnesium stearate

Povidone K30

Crospovidone

None Known

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

The veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging

Polyethylene bottle with child resistant tamper evident snap-cap closures containing 100 tablets.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local

requirements.

Vétoquinol UK Limited Vetoquinol House Great Slade Buckingham Industrial Park Buckingham MK18 1PA

8. MARKETING AUTHORISATION NUMBER(S)

Vm 08007/4104

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

7 June 2002

7 June 2007

10. DATE OF REVISION OF THE TEXT

December 2007