Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Clindamycin hydrochloride
Chanelle Pharmaceuticals Manufacturing Limited
QJ01FF01
Clindamycin hydrochloride
75 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
clindamycin
Authorised
1999-01-22
Health Products Regulatory Authority 22 November 2018 CRN008NGM Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clinacin 75 mg Tablets for Dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Clindamycin 75 mg (as clindamycin hydrochloride) EXCIPIENT: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. A round white tablet, with a break-line on one side. 4 CLINICAL PARTICULARS 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-sensitive species of: ·_Staphylococcus spp._ _·Streptococcus spp._ _·Bacteroides spp._ _·Fusobacterium necrophorum_ _·Clostridium perfringens Osteomyelitis_ _·Staphylococcus aureus_ 4.3 CONTRAINDICATIONS Do not use in cases of known hypersensitivity to clindamycin or lincomycin. Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants because ingestion of clindamycin by these species may result in severe gastro-intestinal disturbance. Health Products Regulatory Authority 22 November 2018 CRN008NGM Page 2 of 5 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 greater, periodic liver and kidney function tests and blood counts should be performed. Patients with severe renal and/or hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during clindamycin therapy. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Wash hands after the administration of the product. Persons with known hypersensitivity to lincosamides (lincomycin, clindamycin) should not handle the product. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Vomiting and diarrhoea are observed occasio Izlasiet visu dokumentu