Nazione: Germania
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
doxycycline hyclate 230 mg/ml
DIVASA-FARMAVIC
QJ01AA02
Oral solution
doxycycline
Chicken
2012-02-17
1 PRODUCT LITERATURE 2 BOTTLE LABEL DOXIVET 200 MG/ML, SOLUTION FOR USE IN DRINKING WATER FOR BROILER BREEDERS . 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder and manufacturer for the batch release: DIVASA-FARMAVIC S.A. Ctra. Sant Hipòlit, km 71 08503 Gurb-Vic Barcelona (Spain) 2. NAME OF THE VETERINARY MEDICINAL PRODUCT DOXIVET 200 mg/ml, solution for use in drinking water for broiler breeders. (Doxycycline as doxycycline hyclate) IT / ES: DOXYCYCLINE DIVASA-FARMAVIC 200 mg/ml, solution for use in drinking water for broiler breeders. DK / SE: Doxivet vet, solution. (Doxycycline as doxycycline hyclate) 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS 1 ml of solution for use in drinking water contains 230 mg of doxycycline hyclate (equivalent to 200 mg of doxycycline). 4. INDICATIONS Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by _Pasteurella multocida _or to reduce morbidity and lesions in respiratory infections caused by _Ornithobacterium rhinotracheale (ORT)_. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of excipients. Do not use in animals with an impaired liver function. 6. ADVERSE REACTIONS Tetracyclines may - in very rare cases - induce photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued. If you notice any serious effects or other effects not Leggi il documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DOXIVET 200 mg/ml, solution for use in drinking water for broiler breeders. IT / ES: DOXYCYCLINE DIVASA-FARMAVIC 200 mg/ml, solution for use in drinking water for broiler breeders. DK / SE: Doxivet vet, concentrate for oral solution. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition for 1 ml: ACTIVE SUBSTANCE: Doxycycline hyclate 230 mg Equivalent to 200 mg doxycycline base EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water Clear yellow-brown solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Broiler breeders. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIE S Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by _Pasteurella multocida _or to reduce morbidity and lesions in respiratory infections caused by _Ornithobacterium rhinotracheale (ORT)_. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to the active substance or to any of excipients. Do not use in animals with an impaired liver function. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS 3 Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially susceptibility of _O. rhinotracheale _may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended. Use of Leggi il documento completo