Quốc gia: Ý
Ngôn ngữ: Tiếng Anh
Nguồn: HMA (Heads of Medicines Agencies)
doxycycline hyclate 100 %
Eurovet Animal Health
QJ01AA02
Powder for oral solution
doxycycline
Cattle Young, Pigs Food
2010-07-28
PART IB-2 LABELLING SACHETS/BAGS CENTIDOX 100% POWDER FOR USE IN DRINKING WATER OR MILK / MILK REPLACER FOR CALVES AND PIGS ONE LANGUAGE THE FULL TEXT WILL BE PRINTED ON THE ALUFOIL SACHET/BAG FORMAT USED IS REQUIRED BY DUTCH LAW FOR THIS TYPE OF LABELLING PARTICULARS TO APPEAR ON THE OUTER PACKAGE + IMMEDIATE PACKAGE + LEAFLET 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Centidox 100%, powder for use in drinking water or milk / milk replacer for calves and pigs IT, ES: Centidox 1000 mg/g, powder for use in drinking water or milk / milk replacer for calves and pigs Doxycycline hyclate 2. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT Composition per gram product Active Substance: Doxycycline hyclate 1000 mg equivalent to 867 mg/g doxycycline base. 3. PHARMACEUTICAL FORM Yellow powder for use in drinking water or milk / milk replacer. 4. PACKAGE SIZE 100 g, 10x100 gram, 250 g, 500 g, 1 kg,. 5. TARGET SPECIES Calves and pigs 6. INDICATION(S) Calves and pigs: Prevention and treatment of respiratory disease caused by _Pasteurella multocida _and _Mycoplasma spp. _susceptible to doxycycline. The presence of the clinical disease in the herd should be established before preventive treatment is started. 7. CONTRAINDICATIONS Do not use in animals with an active microbiological digestion in the rumen. Do not use in animals with known hypersensitivity to tetracyclines. Do not use in animals with hepatic disorders. Do not Đọc toàn bộ tài liệu
PART IB-1 SUMMARY OF THE PRODUCT CHARACTERISTICS CENTIDOX 100% POWDER FOR USE IN DRINKING WATER OR MILK / MILK REPLACER FOR CALVES AND PIGS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Centidox 100%, powder for use in drinking water or milk / milk replacer for calves and pigs IT, ES: Centidox 1000 mg/g, powder for use in drinking water or milk / milk replacer for calves and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 gram of powder contains ACTIVE SUBSTANCE: Doxycycline hyclate 1000 mg/g equivalent to 867 mg/g doxycycline base. EXCIPIENTS: None 3. PHARMACEUTICAL FORM Powder for use in drinking water or milk / milk replacer Yellow powder 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Calves and pigs: Prevention and treatment of respiratory disease caused by _Pasteurella multocida _and _Mycoplasma spp. _susceptible to doxycycline. The presence of the clinical disease in the herd should be established before preventive treatment is started. 4.3 CONTRAINDICATIONS Do not use in animals with an active microbiological digestion in the rumen. Do not use in animals with known hypersensitivity to tetracyclines. Do not use in animals with hepatic disorders. Do not use in animals with renal disorders. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Severely diseased animals have a different drinking pattern and must consequently be treated parenterally. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Đọc toàn bộ tài liệu