Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Carprofen
Norbrook Laboratories (Ireland) Limited
QM01AE91
Carprofen
20 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
carprofen
Authorised
2006-12-08
Health Products Regulatory Authority 07 February 2019 CRN008TK5 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Carprogesic 20 mg Tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Carprofen 20 mg EXCIPIENTS: For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablets: A white/off white circular tablet with a break line on one face and “20” scored on the opposing face. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In the dog: Reduction of inflammation and pain caused by musculoskeletal disorders and degenerative joint disease. As a follow up to parenteral analgesia in the management of post operative pain. 4.3 CONTRAINDICATIONS Do not use in cats. Do not use in pregnant or lactating bitches. Do not use in puppies less than 4 months of age. Do not use in case of hypersensitivity to active substance or to any of the excipients. Do not use in dogs suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal ulceration or bleeding, or where there is evidence of a blood dyscrasia. Health Products Regulatory Authority 07 February 2019 CRN008TK5 Page 2 of 5 Do not use in animals suffering from hemorrhagic syndrome. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Refer to statements under Sections 4.3 and 4.5. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Use in aged dogs may involve additional risk. If such a use cannot be avoided, such dogs may require a reduced dosage and careful clinical management. Avoid use in any dehydrated, hypovolaemic or hypotensive dog, as there is a potential risk of increased renal toxicity. NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infection, appropriate concurrent antimicrobial therapy should be instigated. Refer to section 4.8. SPECIAL P Leggi il documento completo