Land: Italien
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
sulfadiazine 250 mg/g, trimethoprim 50 mg/g
Laboratorios Calier
QJ01EW10
Medicated premix
Sulfadiazine and trimethoprim
Pigs Food
2012-10-24
1/6 LABELLING AND PACKAGE LEAFLET 2/6 A. LABELLING 3/6 LABEL - PACKAGE LEAFLET SULFAPREX 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 and manufacturer: LABORATORIOS CALIER, S.A. C/ Barcelonès, 26 (Pla del Ramassà) LES FRANQUESES DEL VALLÈS, (Barcelona) SPAIN 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Sulfaprex Premix for medicated feeding stuff for pigs (sulfadiazine + trimethoprim) 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each gram contains: Sulfadiazine................................................................ 250 mg Trimethoprim ................................................................ 50 mg EXCIPIENTS: Calcium carbonate Yellowish-white granulated powder 4. INDICATION(S) For the treatment of mastitis, metritis and agalaxia syndrome (MMA), atrophic rhinitis (when associated with _Bordetella bronchiseptica)_ and diarrhoeas caused by strains of _E. coli _sensitive to sulfadiazine and trimethoprim_._ 5. CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredients. Do not use in animals with renal or hepatic insufficiency. Do not use in animals with blood dyscrasias. 6. ADVERSE REACTIONS Not known. If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon. 7. TARGET SPECIES Pigs Læs hele dokumentet
1/6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT: Sulfaprex Premix for medicated feeding stuff for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each gram contains: ACTIVE SUBSTANCES: Sulfadiazine................................................................ 250 mg Trimethoprim ................................................................ 50 mg EXCIPIENTS: Calcium carbonate For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM: Premix for medicated feeding stuff. Yellowish-white granulated powder 4. CLINICAL PARTICULARS: 4.1 TARGET SPECIES: Pigs 4.2 INDICATIONS FOR USE, SPECIFYING TARGET SPECIES: For the treatment of mastitis, metritis and agalactia syndrome (MMA), atrophic rhinitis (when associated with _Bordetella bronchiseptica_) and diarrhoeas caused by strains of _E. coli_ sensitive to sulfadiazine and trimethoprim_._ 4.3 CONTRAINDICATIONS: Do not use in animals with known hypersensitivity to the active ingredients. Do not use in animals with renal or hepatic insufficiency. Do not use in animals with blood dyscrasias. 2/6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Bacteriological aetiology should be confirmed. Whenever possible sulfadiazine and trimethoprim association should only be used based on susceptibility testing. The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of antimicrobial should be adjusted accordingly and water consume should be guaranteed. In case the correct dosage could not be ensured Læs hele dokumentet