Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
ketoprofen 10 g
Fort Dodge Animal Health
QM01AE03
Oral solution
ketoprofen
Pigs
2011-07-10
Revised: November 2011 AN: 01317/2011 Page 1 of 8 SUMMARY OF THE PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT KetoProPig 100 mg/ml Oral Solution for use in drinking water for Pigs KeProPig 100 mg/ml Oral Solution for use in drinking water for Pigs (ES and PO) 2. QUALITATIVE AND QUANITIATIVE COMPOSITION Each ml contains: Active substance Ketoprofen: 100 mg Excipients Benzyl Alcohol: 20 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution Transparent and colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening Pigs 4.2 INDICATIONS FOR USE Symptomatic treatment for reduction of pyrexia in cases of acute infectious respiratory disease in fattening pigs in combination with an appropriate anti - infective therapy_._ 4.3 CONTRA-INDICATIONS Do not use in case of hypersensitivity to ketoprofen. Do not use in animals known to be allergic to aspirin. Do not use in pregnant animals. Do not use in pigs already suffering from gastric ulcers, in order not to aggravate their situation. Revised: November 2011 AN: 01317/2011 Page 2 of 8 Revised: November 2011 AN: 01317/2011 Page 3 of 8 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Avoid use in dehydrated, hypovolaemic or hypotensive pigs as there is a potential risk of increased renal toxicity. Use in very young animals may involve additional risk: however, if used, animals require careful clinical management. As ketoprofen is ulcerogenic, the use is not recommended in case of PMWS (Post-weaning multisystemic wasting syndrome) because ulcers are already frequently associated with Read the complete document