Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Tulathromycin
Huvepharma NV
QJ01FA94
Tulathromycin
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
tulathromycin
2023-02-03
1 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Huvexxin 100 mg/ml solution for injection for cattle, pigs and sheep 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains : ACTIVE SUBSTANCE: Tulathromycin 100 mg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Monothioglycerol 5 mg Propylene glycol Citric acid Hydrochloric acid, concentrated Sodium hydroxide (for pH adjustment) Water for injections Clear colourless solution, free from visible particles. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle, pigs and sheep. 3.2 INDICATIONS FOR USE FOR EACH 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 veterinary medicinal 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 veterinary medicinal 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. 3.3 CONTRAINDICATIONS 2 Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients. 3.4 SPECIAL WARNINGS Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials Lees het volledige document