CLINDASEPTIN DOG 150MG 100 CAPSULES | ANTI-INFECTIVE

Clindaseptin 300 mg capsules for dogs.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains:

Active substance:

Clindamycin (as clindamycin hydrochloride) 300 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Capsule.

Capsule with blue body and blue cap

4. CLINICAL DATA

4.1 Target species

Dogs

4.2 Indications for use, specifying the target species

For the treatment of:

Infected wounds, abscesses and oral cavity/dental infections caused by, or associated with clindamycin-susceptible species of:

Staphylococcus.

Streptococcus.

Bacteroides

Fusobacterium necrophorum

Clostridium perfringens

Osteomyelitis

Staphylococcus aureus

4.3 Contraindications

Do not use in case of hypersensitivity to clindamycin, lincomycin, or pirlimycin.

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

ingestion of clindamycin by these species can cause gastrointestinal disorders

severe.

4.4 Special warnings for each target species

None.

4.5 Special precautions for use

Special precautions for use in animals

During prolonged therapy of one month or more, periodic analysis of liver and kidney functions and blood counts should be performed.

In patients with severe renal and/or hepatic problems accompanied by severe metabolic disturbances, the administered dose should be carefully determined and their conditions should be monitored by serum control during clindamycin treatment.

Whenever possible, the veterinary medicinal product should only be used on the basis of susceptibility testing.

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

Wash hands after administration of the veterinary medicinal product. People with known hypersensitivity to lincosamides (pirlimycin, lincomycin, clindamycin) should not handle the veterinary medicinal product.

Do not eat, drink or smoke while handling the veterinary medicinal product.

4.6 Adverse reactions (frequency and seriousness)

Vomiting and diarrhea may occasionally be observed. Sometimes clindamycin can cause overgrowth of nonsusceptible organisms such as resistant clostridia and yeast.

In case of superinfection, appropriate measures should be taken taking into account the clinical status.

4.7 Use during pregnancy, lactation or lay

Although studies in rats at high doses suggest that clindamycin is not teratogenic and does not significantly affect reproductive performance in males and females, the safety of the veterinary medicinal product during pregnancy and lactation, or in breeding male dogs, has not been established. Therefore, the administration of the veterinary medicinal product during pregnancy and lactation must be carried out in accordance with the benefit/risk assessment carried out by the responsible veterinarian.

Clindamycin can cross the blood-milk barrier. As a consequence, treatment in lactating females can cause puppies to have diarrhea.

4.8 Interaction with other medicinal products and other forms of interaction

Neuromuscular blocking effects have been observed with clindamycin, which may possibly potentiate the action of other neuromuscular blocking agents. Simultaneous use with such drugs should be done with caution.

Do not administer clindamycin together with chloramphenicol or macrolides, as they share the same 50s subunit binding site and antagonistic effects may possibly occur.

When clindamycin and aminoglycosides (eg gentamicin) are used simultaneously, the risk of adverse interactions (acute renal failure) cannot be completely excluded.

Clindamycin can reduce cyclosporine levels, so its simultaneous use should be avoided.

4.9 Amounts to be administered and administration route

Orally.

Infected wounds, abscesses and infections of the oral cavity or teeth:

5,5 mg/kg clindamycin every 12 hours for 7 – 10 days (i.e. 1 capsule per 54 kg body weight twice daily).

If no improvement is observed after 4 days, the susceptibility of the pathogens involved should be reassessed.

Dental and periodontal infections – In the case of dental/surgical treatment due to infection, administration may be started prior to such treatment.

Osteomyelitis:

Clindamycin 11 mg/kg every 12 hours for a minimum period of 4 weeks (i.e. 2 capsules per 54 kg of body weight twice daily). If no improvement is observed after 14 days, the susceptibility of the pathogens involved should be reassessed.

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

Doses of 300 mg/kg body weight were tolerated in dogs without adverse effects.

Vomiting, loss of appetite, diarrhea, leukocytosis, and elevated liver enzymes (AST, ALT) were occasionally observed. In such cases, treatment should be discontinued immediately and animals treated symptomatically.

4.11 Timeout

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Anti-infective for symptomatic use, lincosamides.

ATCvet: QJ01FF01.

5.1 Pharmacodynamic properties

Clindamycin is primarily a bacteriostatic antibiotic belonging to the lincosamide group, which acts by inhibiting 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 the translation of tRNA-bound amino acids, thus preventing peptide chain elongation. For this reason, the mode of action of clindamycin is predominantly bacteriostatic.

Most aerobic Gram-negative bacteria are resistant to clindamycin.

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 also common between erythromycin and other macrolides.

Acquired resistance may occur, either by methylation of the ribosomal binding site through chromosomal mutation in gram-positive organisms, or by plasmid-mediated mechanisms in gram-negative organisms.

CLSI veterinary clindamycin breakpoints are available for dogs in Staphylococcus spp . and β-hemolytic Streptococci in skin and soft tissue infections: S = 0,5 µg/ml; I = 1-2 µg/ml; R = 4 µg/ml (CLSI July 2013).

5.2 Pharmacokinetic data

Clindamycin is almost completely absorbed after oral administration. Clindamycin is approximately 93% bound to plasma proteins. Peak serum concentrations are reached approximately 1 hour after administration at a dose of 10 mg/kg, Cmax 3,3

– 5,0 g/ml (non-fasting) – 5.0 g /ml (fasting). Clindamycin penetrates well and can concentrate in some tissues. The half-life (t½) of clindamycin is approximately 4 hours. Approximately 70% of clindamycin is excreted in feces and approximately 30% in urine.

6. PHARMACEUTICAL DATA

6.1 List of excipients

Lactose monohydrate

Talc Corn starch Magnesium stearate

The capsule consists of a blue body (Gelatin, Water, Patent Blue V E131 and Titanium Dioxide E171) and a blue cap (Gelatin, Water, Patent Blue V E131 and Titanium Dioxide E171).

6.2 Incompatibilities

Not applicable.

6.3 Validity period

Shelf-life of the veterinary medicinal product packaged for sale: 4 years

6.4. Special storage precautions

This veterinary medicinal product does not require special storage conditions.

6.5 Nature and composition of immediate packaging

Blister made of PVC/PE/PVdC film sealed with aluminum foil.

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

Cardboard box with blisters 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, 500, 450, 540, 546, 600, 602, 700, 750, 800, 798, 810, 896, 900 , 994 and 1000 capsules

Not all formats may be marketed.

6.6 Special precautions for disposal of unused veterinary medicinal product or, where appropriate, residues derived from its use

Any unused veterinary medicinal product or residues derived from it must be disposed of in accordance with local regulations.

7. MARKETING AUTHORIZATION HOLDER

Chanelle Animal Health Ltd., 7 Rodney Street, Liverpool L1 9HZ, UK.

8. MARKETING AUTHORIZATION NUMBER(S)

3043 ESP

9. DATE OF THE FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION

Date of first authorization: May 29, 2014

Date of last renewal:

10. DATE OF REVISION OF THE TEXT

February 03th 2015

PROHIBITION OF SALE, DISPENSATION AND/OR USE

Medicine subject to a veterinary prescription.

DATA SHEET 

CLINDASEPTIN