SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT:

Clindaseptin 75 mg capsules for dogs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION:

Active substance: mg per capsule

Clindamycin. 75.0

(as clindamycin hydrochloride)

Excipients:

Capsule body

Azorubine (E122) 0.026

Indigo carmine FD&C Blue 2 (E132) 0.016

Capsule cap

Azorubine (E122) 0.017

Indigo carmine FD&C Blue 2 (E132) 0.011

Ink:

Iron oxide black (E172)

Titanium dioxide (E171)

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM:

Capsule, hard

Lavender body and lavender cap marked CL75 in white ink on the capsule cap.

4. CLINICAL PARTICULARS:

4.1 Target Species:

Dogs.

4.2 Indications for use (specifying the target species):

The product is 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. The product 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 the use of the product, the identification of causative pathogenic micro-organisms should be carried out and the sensitivity 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

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.

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

None

4.6 Adverse reactions (frequency and seriousness):

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

4.7 Use during pregnancy, lactation or lay:

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. Therefore the adminstration of the veterinary medicinal product during pregnancy and lactation should be the subject of a benefit/risk assessment by the veterinarian.

4.8 Interaction with other medicaments and other forms of interaction:

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.

4.9 Amounts to be administered and administration route

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 capsule per 13.5 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 capsules per 13.5 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 capsules per 13.5 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 capsule per 13.5 kg twice a day beginning 5 days before the intended procedure and continuing for 5 days thereafter).

The minimum bodyweight to be treated is 13.5 kg

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary):

Symptoms of overdose include vomiting, inappetency and diarrhoea. In such cases, treatment should be stopped immediately and the dogs treated symptomatically.

4.11 Withdrawal periods:

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antiinfectives for systemic use: Lincosamides

ATC Vet Code QJ01FF01.

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

Clindamycin is primarily a bacteriostatic antibiotic of the lincosamide group, which acts by inhibition of protein synthesis. Clindamycin is a chlorinated analogue of lincomycin. The antibiotic activity of clindamycin is based on the inhibition of bacterial synthesis. Reversible coupling to the 50 s subunit of the bacterial ribosome inhibits inter alia the translation of tRNA-bound amino acids, thereby preventing elongation of the peptide chain. Because of this, the mode of action of clindamycin is predominantly bacteriostatic.

Clindamycin has been shown to have in-vitro activity against the following organisms

Staphylococcus spp; Streptococcus spp; Bacteroides spp; Fusobacterium spp; Clostridium spp.

Clindamycin and lincomycin show cross-resistance, which is common also to erythromycin and other macrolid-antibiotics. Acquired resistance can occur, by methylation of the ribosomal binding site via chromosomal mutation in gram positive organisms, or by plasmid-mediated mechanisms in gram negative organisms.

5.2 Pharmacokinetic particulars

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

After a single administration of one capsule to fasting dogs maximum plasma levels (C_max)of 5 µg/ml are found compared to 3.4 µg/ml in non-fasting dogs. Bioavailability is greater in fasting dogs than fed dogs.

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

6. PHARMACEUTICAL PARTICULARS:

6.1 List of excipients

Lactose monohydrate

Maize starch

Magnesium stearate

Talc

Capsule body:

Azorubine (E122)

Indigo carmine FD&C blue 2 (E132)

Gelatin

Capsule cap:

Azorubine (E122)

Indigo carmine FD&C blue 2 (E132)

Gelatin

Ink

Iron oxide black (E172)

Titanium dioxide (E171)

Shellac

Propylene glycol

Sodium hydroxide

Povidone

Ammonium hydroxide 28%

Strong ammonia solution
Potassium hydroxide

6.2. Incompatibilities:

Not applicable.

6.3. Shelf-life:

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

6.4 Special Precautions for storage:

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

6.5 Nature and composition of immediate packaging

Blister strips composed of PVC/PE/PVdC film and sealed with Aluminium foil.

Capsules are presented as 2, 4, 6, 8 or 10 per strip.

Carton with blister strips of: 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40,

42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80 , 82, 84, 86, 88, 90, 92,

94, 96, 98, 100, 112, 120, 128, 130, 140, 150, 154, 160, 168, 180, 182, 186, 190, 196, 200, 210,

224, 240, 250, 252, 256, 260, 266, 270, 280, 290, 294, 300, 308, 320, 350, 390, 392, 448,

450, 500, 540, 546, 600, 602, 700, 750, 800, 798, 810, 896, 900 and 1000 capsules

Not all pack sizes may be marketed.

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 material derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Chanelle Animal Health Ltd.

7 Rodney Street

Liverpool L1 9HZ

8. MARKETING AUTHORISATION NUMBER

Vm 11990/4056

9. DATE OF FIRST AUTHORISATION

16July 2013

10. DATE OF REVISION OF THE TEXT

July 2013

Approved: 16/07/2013