국가: 슬로베니아
언어: 영어
출처: HMA (Heads of Medicines Agencies)
ketoprofen 150 mg/ml
Laboratorios Dr. Esteve S.A.
QM01AE03
Solution for injection
ketoprofen
Cattle Food
2011-07-12
Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 150 mg/ml solution for injection for cattle (all countries except DK and SE) DINALGEN (DK) DINALGEN VET (SE) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the product contains: Active substance: Ketoprofen 150 mg Excipients: Benzyl alcohol (E1519) 10 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear colourless to yellowish solution 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: - Reduction of inflammation and pain associated with post-partum musculoskeletal disorders and lameness. - Reduction of fever associated with bovine respiratory disease. - Reduction of inflammation, fever and pain in acute clinical mastitis. in combination with antimicrobial therapy where appropriate. 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. Page 2 of 13 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 acetylsalicylic acid or any of the excipients. Do not use where there is 전체 문서 읽기
1/16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DANIDOL 150 mg/ml solution for injection for cattle (all countries except ES) EDERAL 150 mg/ml solution for injection for cattle (ES) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the product contains: Active substance: Ketoprofen 150 mg Excipients: Benzyl alcohol (E1519) 10 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection A clear colourless to yellowish solution 4. CLINICAL PARTICULARS 4.1. TARGET SPECIES Cattle 4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: - Reduction of inflammation and pain associated with post-partum musculoskeletal disorders and lameness. - Reduction of fever associated with bovine respiratory disease. - Reduction of inflammation, fever and pain in acute clinical mastitis. in combination with antimicrobial therapy where appropriate. 4.3. CONTRAINDICATIONS 2/16 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 acetylsalicylic acid or any of the excipients. Do not use where there is evidence of blood dyscrasia or blood coagulation disturbances 4.4. SPECIAL WARNING FOR EACH TARGET SPECIES None. 4.5. SPECIAL PRECAUTIONS FOR USE SPECIA 전체 문서 읽기