Land: Israël
Taal: Engels
Bron: Ministry of Health
CLINDAMYCIN
A.L. MEDI-MARKET LTD.
TABLETS
CLINDAMYCIN 75 MG
PER OS
Required
CHANELLE PHARMACEUTICALS MANUFACTURING LTD., IRELAND
CLINACIN VETERINARY TABLETS is indicated for use in dogs for the treatment of infected wounds,abscesses, superficial pyoderma and oral cavity/dental infections caused by or associated withclindamycin-sensitive staphylococci, streptococci, bacteroidaceae, Fusobacterium necrophorum,Clostridium perfringens and osteomyelitis caused by Staphylococcus aureus. Clinacin veterinary can also be used to help provide antimicrobial cover during dental procedures.
2022-05-31
VETERINARY MEDICINE PACKAGE LEAFLET This medicine is supplied on veterinary prescription only For use in animals only 1. NAME, FORM, AND STRENGTH OF THE VETERINARY MEDICINE CLINACIN VETERINARY TABLETS 300 MG CLINACIN VETERINARY TABLETS 75 MG 2. ACTIVE INGREDIENT Each Clinacin veterinary tablet 300 mg contains: 300 mg of clindamycin (as clindamycin hydrochloride). Each Clinacin veterinary tablet 75 mg contains: 75 mg of clindamycin (as clindamycin hydrochloride). For a list of inactive ingredients and allergens see section 11: 'Additional information'. 3. WHAT IS THIS MEDICINE INTENDED FOR? Antibiotic tablets for use in dogs to treat infected wounds, abscesses, superficial pyoderma and oral cavity/dental infections caused by or associated with clindamycin-sensitive bacteria (staphylococci, streptococci, bacteroidaceae, Fusobacterium necrophorum, Clostridium perfringens) and to treat osteomyelitis caused by Staphylococcus aureus. Clinacin can also be used to help provide antimicrobial cover during dental procedures. THERAPEUTIC GROUP: Lincosamides. 4. CONTRAINDICATIONS Clinacin veterinary tablets are contra-indicated in animals that are hypersensitive to clindamycin or lincomycin preparations. Do not administer to rabbits, guinea pigs, chinchillas, hamsters, horses or ruminants. Do not use clindamycin concomitantly with chloramphenicol or macrolides as they may antogonise each other at their target site. 5. SIDE EFFECTS Clindamycin sometimes causes the overgrowth of non-sensitive organisms such as drug-resistant clostridia and yeasts. In cases of superinfection, suitable measures must be taken based on the clinical condition. Vomiting and diarrhea have been observed occasionally. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. You can report side effects to the Ministry of Health (MoH) by following the link ‘Reporting Side Effects of Medication’ on the MoH home page (www.health.gov.il) which links to an online form for reporting side effec Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Clinacin Veterinary Tablets 75 mg Clinacin Veterinary Tablets 300 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clinacin Veterinary Tablets 75 mg contain Clindamycin 75 mg (as Clindamycin Hydrochloride) Clinacin Veterinary Tablets 300 mg contain Clindamycin 300 mg (as Clindamycin Hydrochloride) EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Clinacin Veterinary Tablets 75 mg: Round, white tablet with a breakline on one side. Clinacin Veterinary Tablets 300 mg: A plain , white to off white tablet with a cross breakline on one side. The tablets can be divided into halves or quarters. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Clinacin Veterinary 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 perfringens_ and osteomyelitis caused by _Staphylococcus aureus_. Clinacin Veterinary Tablets can also be used to help provide antimicrobial cover during dental procedures. 4.3 CONTRAINDICATIONS 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 Clinacin Veterinary Tablets, 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. Lees het volledige document