Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Clindamycin hydrochloride
Chanelle Pharmaceuticals Manufacturing Limited
QJ01FF01
Clindamycin hydrochloride
150 Milligrams per capsule
Capsule
POM: Prescription Only Medicine as defined in relevant national legislation
clindamycin
Authorised
2013-06-28
Health Products Regulatory Authority 12 November 2018 CRN008QMW Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Clindaseptin 150 mg capsules for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains: ACTIVE SUBSTANCE: Clindamycin (as Clindamycin Hydrochloride) 150 mg EXCIPIENTS: For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Capsule The capsule has a lavender body and a maroon cap marked CL150. 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 the active substance or to any of the excipients or to lincomycin or to pirlimycin. 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 12 November 2018 CRN008QMW Page 2 of 7 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 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 potenti Olvassa el a teljes dokumentumot