Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
tulathromycin
Zoetis Belgium SA
QJ01FA94
tulathromycin
Pigs; Cattle; Sheep
Antibacterials for systemic use
Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2–3 days.Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.
Revision: 25
Authorised
2003-11-11
33 B. PACKAGE LEAFLET 34 PACKAGE LEAFLET: DRAXXIN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE, PIGS AND SHEEP 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for batch release: FAREVA AMBOISE Zone Industrielle, 29 route des Industries 37530 Pocé-sur-Cisse FRANCE or Zoetis Manufacturing & Research Spain, S.L. Ctra. de Camprodón, s/n° Finca La Riba Vall de Bianya Gerona 17813 SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep Tulathromycin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Tulathromycin 100 mg/ml Monothioglycerol 5 mg/ml Clear colourless to slightly yellow solution for injection. 4. INDICATIONS CATTLE Treatment and metaphylaxis of bovine respiratory disease associated with _Mannheimia haemolytica_ , _Pasteurella multocida,_ _Histophilus somni _ and _ Mycoplasma bovis_ susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. Treatment of infectious bovine keratoconjunctivitis (IBK) associated with _Moraxella bovis_ susceptible to tulathromycin _. _ PIGS Treatment and metaphylaxis of swine respiratory disease associated with _Actinobacillus _ _pleuropneumoniae_ , _Pasteurella multocida,_ _Mycoplasma hyopneumoniae, Haemophilus parasuis_ and 35 _Bordetella bronchiseptica_ susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. The veterinary medicinal product should only be used if pigs are expected to develop the disease within 2–3 days. SHEEP Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent _Dichelobacter nodosus_ requiring systemic treatment. 5. CONTRAINDICATIONS Do not use in cases of hypersensitivity to macrolide antibiotics o Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Draxxin 100 mg/ml solution for injection for cattle, pigs and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Tulathromycin 100 mg/ml EXCIPIENT: Monothioglycerol 5 mg/ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear colourless to slightly yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with _Mannheimia _ _haemolytica_ , _Pasteurella multocida,_ _Histophilus somni _ and _ Mycoplasma bovis_ susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. Treatment of infectious bovine keratoconjunctivitis (IBK) associated with _Moraxella bovis_ susceptible to tulathromycin. Pigs Treatment and metaphylaxis of swine respiratory disease (SRD) associated with _Actinobacillus _ _pleuropneumoniae_ , _Pasteurella multocida,_ _Mycoplasma hyopneumoniae, Haemophilus parasuis_ and _Bordetella bronchiseptica_ susceptible to tulathromycin. The presence of the disease in the group must be established before the product is used. The veterinary medicinal product should only be used if pigs are expected to develop the disease within 2–3 days. Sheep Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent _Dichelobacter nodosus_ requiring systemic treatment. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients. 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides. Sheep: The efficacy of antimicrobial treatment of foot rot might be reduced by other factors, such as wet environmental con Прочетете целия документ