Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
KETOPROFEN
Laboratorios Dr. Esteve, S.A.
QM01AE03
60 Mg/Ml
Solution for Injection
N.S.A.I.D
Porcine
2009-04-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dinalgen 60 mg/ml solution for injection for pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear colourless solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES PIGS Reduction of pyrexia in cases of respiratory disease and Postpartum Dysglactia Syndrome/Mastitis, Metritis, Agalactiae (MMA syndrome) in sows, in combination with appropriate anti-infective therapy. 4.3 CONTRAINDICATIONS Do not use in animals where there is the possibility of gastro-intestinal ulceration or bleeding, in order not to aggravate their situation. Do not use in animals suffering from cardiac, hepatic, or renal disease. Do not use in dehydrated or hypovolemic or hypotensive animals due to the potential risk of increased renal toxicity. Do not use in animals that have previously shown signs of hypersensitivity to ketoprofen or aspirin or any of the excipients. Do not use where there is evidence of blood dyscrasia or blood coagulation disturbances See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Since gastric ulceration is a common finding in PMWS (Post-weaning Multisystemic Wasting Syndrome), the use of ketoprofen in pigs affected by this pathology is not recommended, in order not to aggravate their situation. Each 1 ml of the product contains: Ketoprofen 60 mg Benzyl alcohol (E1519) 10 mg For a full list of excipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/12/2011_ _CRN 7011501_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not exceed the recommended Read the complete document