Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
ketoprofen 60 mg
Laboratorios Dr. Esteve S.A.
QM01AE03
Solution for injection
ketoprofen
Pigs Food
2011-07-12
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 60 mg/ml solution for injection for pigs (all countries except FI and SE) DINALGEN VET 60 mg/ml solution for injection for pigs (FI) DINALGEN VET (SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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 Page 2 of 13 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DANIDOL 60 mg/ml solution for injection for pigs (all countries except ES) EDERAL 60 mg/ml solution for injection for pigs (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 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. 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. 4.5 Read the complete document