Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
gamithromycin
Boehringer Ingelheim Vetmedica GmbH
QJ01FA95
gamithromycin
Cattle; Pigs; Sheep
Antibacterials for systemic use
CattleTreatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. The presence of the disease in the herd should be established before metaphylactic use.PigsTreatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Bordetella bronchiseptica.SheepTreatment of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment.
Revision: 12
Authorised
2008-07-24
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: ZACTRAN 150 MG/ML SOLUTION FOR INJECTION FOR CATTLE, SHEEP AND PIGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS 4, Chemin du Calquet 31000 Toulouse France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs Gamithromycin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENTS 1 ml contains Active substance: 150 mg of gamithromycin Excipients: 1 mg of monothioglycerol Colourless to pale yellow solution. 4. INDICATION(S) Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with _Mannheimia _ _haemolytica_ , _Pasteurella multocida_ and _Histophilus somni_ . The presence of the disease in the herd should be established before metaphylactic use. Pigs: Treatment of swine respiratory disease (SRD) associated with _Actinobacillus pleuropneumoniae, _ _Pasteurella multocida,Haemophilus parasuis and Bordetella bronchiseptica._ Sheep: Treatment of infectious pododermatitis (foot rot) associated with virulent _Dichelobacter nodosus_ and _Fusobacterium necrophorum_ requiring systemic treatment. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to a certain type of antibiotics called macrolides or to any of the excipients. Do not use this veterinary medicinal product simultaneously with other macrolides or antibiotics known as lincosamides. 23 6. ADVERSE REACTIONS During clinical trials transient injection site swellings were observed. • Visible injection site swellings associated with occasional slight pain may develop very commonly in cattle for one day. The swellings typically resolve within 3 to 14 days but may persist in some animals for up to 35 days after treatment. • Mild to moderate i Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ZACTRAN 150 mg/ml solution for injection for cattle, sheep and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Gamithromycin 150 mg EXCIPIENT(S): Monothioglycerol 1 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with _Mannheimia _ _haemolytica_ , _Pasteurella multocida_ and _Histophilus somni_ . The presence of the disease in the herd should be established before metaphylactic use. Pigs: Treatment of swine respiratory disease (SRD) associated with _Actinobacillus pleuropneumoniae, _ _Pasteurella multocida, Haemophilus parasuis _ and _Bordetella bronchiseptica. _ Sheep: Treatment of infectious pododermatitis (foot rot) associated with virulent _Dichelobacter nodosus_ and _Fusobacterium necrophorum_ requiring systemic treatment. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients. Do not use this veterinary medicinal product simultaneously with other macrolides or lincosamides (see section 4.8). 3 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Cattle and pigs: None. Sheep: The efficacy of antimicrobial treatment of foot rot might be reduced by other factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment. Antibiotic treatment of benign foot rot is not considered appropriate. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local policies on the Прочетете целия документ