Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Laboratorios Dr. Esteve, S.A.
QM01AE03
KETOPROFEN
300 Mg/Ml
Oral Solution
POM
Bovine, Porcine
Ketoprofen
N.S.A.I.D
Authorised
2009-04-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Oral solution. Clear yellowish solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening Cattle and Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Fattening Cattle and Pigs: Treatment for the reduction of pyrexia and dyspnoea associated with respiratory disease in combination with anti- infective therapy, as appropriate. 4.3 CONTRAINDICATIONS Do not administer to suckling calves. Do not administer to fasting animals or animals with limited access to feed. Do not use in animals where there is the possibility of gastrointestinal alterations, ulceration or bleeding in order not to aggravate their situation. Do not use in dehydrated or hypovolemic or hypotensive animal due to the potential risk of increased renal toxicity. Do not administer to swine fattened at extensive or semi-extensive production farms with access to soil or foreign objects that may damage the gastric mucosa, or with a high parasite burden, or under a severe stress situation. Do not use in animals suffering from cardiac, hepatic, or renal disease. Do not use where there is evidence of blood dyscrasia. Do not use in case of hypersensitivity to ketoprofen or aspirin or to any of the excipients. Do not use other non-steroidal anti-inflammatory drugs (NSAIDs) concurrently or within 24 hours of each other. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Each ml contains: Active Substance: Ketoprofen 300 mg For a full list of excipients, see section 6.1. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________ Přečtěte si celý dokument