국가: 프랑스
언어: 영어
출처: HMA (Heads of Medicines Agencies)
ketoprofen 300 mg/ml
Laboratorios Dr. Esteve S.A.
QM01AE03
Oral solution
ketoprofen
Cattle, Pigs
2011-07-12
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DANIDOL 300 mg/ml oral solution for cattle and pigs (all countries except ES) EDERAL 300 mg/ml oral solution for cattle and pigs (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the product contains: Ketoprofen 300 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution for use in drinking water 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 appropriate anti-infective therapy. 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 animals with a history of hypersensitivity to ketoprofen, aspirin or any of the excipients. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DANIDOL 300 mg/ml oral solution for cattle and pigs (all countries except ES) EDERAL 300 mg/ml oral solution for cattle and pigs (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the product contains: Ketoprofen 300 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution for use in drinking water 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 appropriate anti-infective therapy. 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 animals with a history of hypersensitivity to ketoprofen, aspirin or any of the excipients. See also section 4.7 4.4 SPECIAL WARNINGS FOR EACH 전체 문서 읽기