Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Clindamycin hydrochloride
Chanelle Pharmaceuticals Manufacturing Limited
QJ01FF01
Clindamycin hydrochloride
25 Milligrams per capsule
Capsule
POM: Prescription Only Medicine as defined in relevant national legislation
clindamycin
Authorised
2014-07-18
Health Products Regulatory Authority 12 September 2019 CRN008W1S Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clindaseptin 25 mg capsules for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH CAPSULE CONTAINS: ACTIVE SUBSTANCE: Clindamycin (as Clindamycin Hydrochloride) 25 mg. EXCIPIENTS: For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule The capsule has an orange body and an orange cap. 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-susceptible species of _Staphylococcus _spp., _Streptococcus_ spp., _Bacteroides _spp., _Clostridium perfringens _and_ _ _Fusobacterium necrophorum._ For the treatment of osteomyelitis caused by _Staphylococcus aureus_. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to clindamycin lincomycin or pirlimycin and/or any of the excipients. 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. 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. Animals 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. Inappropriate use of the product or deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to clindamycin and may decrease the effectiveness of treatment with lincomycin or macrolide antimicrobials due to the potential for cross resistance. Whenever possible, clindamycin should only be used based on susceptibility test Läs hela dokumentet