Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Tulathromycin
Krka, d.d., Novo mesto
QJ01FA94
Tulathromycin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
tulathromycin
Authorised
2019-02-08
Health Products Regulatory Authority 23 November 2021 CRN00CDJ6 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Tuloxxin 100 mg/ml solution for injection for cattle, pigs and sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Tulathromycin 100 mg EXCIPIENTS: Monothioglycerol 5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection Clear, colourless to slightly yellow or slightly brown 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. 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: Health Products Regulatory Authority 2 Aqra d-dokument sħiħ