国: イギリス
言語: 英語
ソース: VMD (Veterinary Medicines Directorate)
Tylvalosin
Eco Animal Health Ltd
QJ01FA92
Tylvalosin
Premix for medicated feeding stuff
POM-V - Prescription Only Medicine – Veterinarian
Pigs
Antimicrobial
Authorized
2004-09-09
Revised: September 2023 AN: 01857/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Tylvalosin (as tylvalosin tartrate) 42.5 mg/g For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff. A beige granular powder. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of _Mycoplasma_ _hyopneumoniae_ in pigs. At the recommended dose, lung lesions and weight loss are reduced but infection with _Mycoplasma hyopneumoniae_ is not eliminated. Treatment of porcine proliferative enteropathy (ileitis) caused by _Lawsonia _ _intracellularis_ in herds where there is a diagnosis based on clinical history, post- mortem findings and clinical pathology results. Treatment and metaphylaxis of swine dysentery, caused by _Brachyspira _ _hyodysenteriae _in herds where the disease has been diagnosed. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product. Revised: September 2023 AN: 01857/2022 Page 2 of 6 Generally, strains of _B. hyodysenteriae_ have higher minimal inhibitory concentration (MIC) values in cases of resistance against other macrolides, such as tylosin. The clinical relevance of this reduced susceptibility is not fully explored. Cross-resistance between tylvalosin and other macrolides cannot be excluded. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Good management and hygiene practices should be followed to reduce the risk of re- infection. It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on 完全なドキュメントを読む