País: Unió Europea
Idioma: anglès
Font: EMA (European Medicines Agency)
valnemulin
Elanco GmbH
QJ01XQ02
valnemulin
Pigs; Rabbits
Antiinfectives for systemic use
PigsThe treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with Mycoplasma hyopneumoniae is not eliminated.RabbitsReduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE). Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically.
Revision: 21
Authorised
1999-03-12
21 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE - COMBINED LABEL AND PACKAGE LEAFLET ALUMINIUM-LINED PLASTIC BAGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Elanco France S.A.S 26, Rue de la Chapelle 68330 Huningue FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT _ _ Econor 10% premix for medicated feed for pigs and rabbits Valnemulin hydrochloride 3. STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS Econor 10% premix contains valnemulin in the form of valnemulin hydrochloride. Valnemulin hydrochloride 106.5 mg/g equivalent to valnemulin 100 mg/g. OTHER INGREDIENTS: Hypromellose Talc Colloidal anhydrous silica Isopropyl myristate Lactose. White to slight yellowish powder. 4. PHARMACEUTICAL FORM _ _ Premix for medicated feeding stuff _ _ _ _ 5. PACKAGE SIZE _ _ 1 kg 25 kg 22 6. INDICATION(S) Pigs: The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight, lung lesions and weight loss are reduced, but infection with _Mycoplasma hyopneumoniae _ is not eliminated. Rabbits: Reduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE). Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically. 7. CONTRAINDICATIONS Do not administer the product to pigs or rabbits receiving ionophores. Do not overdose in rabbits – increased doses may disturb gastrointestinal flora leading to the development of enterotoxaemia. 8. ADVERSE REACTIONS _ _ Rabbits: See section “Special warning(s)” Pigs: Adverse r Llegiu el document complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Econor 50% premix for medicated feed for pigs Econor 10% premix for medicated feed for pigs and rabbits 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Econor contains valnemulin in the form of valnemulin hydrochloride. ECONOR 50% ECONOR 10% ACTIVE SUBSTANCE Valnemulin hydrochloride 532.5 mg/g 106.5 mg/g Equivalent to valnemulin base 500 mg/g 100 mg/g For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Premix for medicated feeding stuff White to slight yellowish powder 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs and rabbits 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES ECONOR 50% The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with _Mycoplasma hyopneumoniae_ is not eliminated. ECONOR 10% Pigs: The treatment and prevention of swine dysentery. The treatment of clinical signs of porcine proliferative enteropathy (ileitis). The prevention of clinical signs of porcine colonic spirochaetosis (colitis) when the disease has been diagnosed in the herd. Treatment and prevention of swine enzootic pneumonia. At the recommended dosage of 10–12 mg/kg bodyweight lung lesions and weight loss are reduced, but infection with _Mycoplasma hyopneumoniae_ is not eliminated. Rabbits: Reduction of mortality during an outbreak of epizootic rabbit enteropathy (ERE). Treatment should be started early in the outbreak, when the first rabbit has been diagnosed with the disease clinically. 3 4.3 CONTRAINDICATIONS Do not administer the veterinary medicinal product to pigs or rabbits receiving ionophores. Do not overdose in rabbits – increased doses may distu Llegiu el document complet