Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
tylvalosin
ECO Animal Health Europe Limited
QJ01FA92
tylvalosin
Pheasants; Chicken; Turkeys; Pigs
Antiinfectives for systemic use, Antibacterials for systemic use, Macrolides
PigsTreatment and methaphylaxis of swine enzootic pneumonia;Treatment of porcine proliferative enteropathy (ileitis);Treatment and methaphylaxis of swine dysentery.ChickensTreatment and methaphylaxis of respiratory disease associated with Mycoplasma gallisepticum in chickens.PheasantsTreatment of respiratory disease associated with Mycoplasma gallisepticum.TurkeysTreatment of respiratory disease associated with tylvalosin sensitive strains of Ornithobacterium rhinotracheale in turkeys.
Revision: 33
Authorised
2004-09-09
52 B. PACKAGE LEAFLET 53 PACKAGE LEAFLET: AIVLOSIN 42.5 MG/G PREMIX FOR MEDICATED FEEDING STUFF FOR 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: ECO Animal Health Europe Limited 6th Floor, South Bank House Barrow Street Dublin 4 D04 TR29 IRELAND Manufacturer responsible for batch release: Acme Drugs s.r.l. Via Portella della Ginestra 9/a 42025 CAVRIAGO (RE) ITALY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Aivlosin 42.5 mg/g premix for medicated feeding stuff for pigs Tylvalosin (as tylvalosin tartrate) 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS ACTIVE SUBSTANCE: Tylvalosin (as tylvalosin tartrate) 42.5 mg/g. A beige granular powder. CARRIER: Hydrated magnesium silicate, wheat flour. 4. INDICATIONS • Treatment and metaphylaxis of swine enzootic pneumonia caused by susceptible strains of _Mycoplasma hyopneumoniae_ . 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 in herds, caused by _Brachyspira hyodysenteriae,_ where the disease has been diagnosed. 5. CONTRAINDICATIONS None. 54 6. ADVERSE REACTIONS None known. If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs. 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION In-feed use. For incorporation into dry feed only. For treatment and metaphylaxis of swine enzootic pneumonia: The dose is 2.125 mg tylvalosin per kg bodyweight per day in-feed for 7 consecutive days. Secondary infection by organisms such as _Pasteurella multoci Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 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. 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. 3 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 local (regional, farm level) epidemiological information about susceptibility of ta Izlasiet visu dokumentu