Riik: Iirimaa
keel: inglise
Allikas: 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 25 mg/ml solution for injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains : ACTIVE SUBSTANCE: Tulathromycin 25 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 Pigs. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES 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. 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the 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. 2 Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used. Use of the veterinary medicinal product deviating from the instructions Lugege kogu dokumenti