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benzylpenicillin procain salt 300 mg/ml
aniMedica GmbH
QJ01CE09
Suspension for injection
procaine penicillin
Cattle Food, Horses Food, Pigs Food
2010-04-16
ANIMEDICA GMBH Procapen Procapen EN SmPC VA additional pack size DE/V/0126/001/DC Version: 16.04.2010, ID approved: 16.04.2010 1 von 7 _ [Version Final] _ SUMMARY OF PRODUCT CHARACTERISTICS ANIMEDICA GMBH Procapen Procapen EN SmPC VA additional pack size DE/V/0126/001/DC Version: 16.04.2010, ID approved: 16.04.2010 2 von 7 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Procapen, 300 mg/ml, Suspension for injection for cattle, pigs and horses 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml suspension for injection contains ACTIVE SUBSTANCE: Benzylpenicillin, procaine 1 H 2 O 300.00 mg EXCIPIENTS: Methyl-4-hydroxy benzoate (E 218) 2.84 mg Propyl-4-hydroxy benzoate (E 216) 0.32 mg EXCIPIENT(S): For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection White to yellowish suspension 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs (adult pigs) and horses 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of bacterial infectious diseases, caused by Benzylpenicillin sensitive pathogens. CATTLE, CALVES, AND HORSES: General bacterial infections (septicaemias) Primary and secondary infections of the - respiratory system - urinary and genital apparatus - skin and the claws - joints PIGS (ADULT PIGS): Primary and secondary infections of the - urogenitary tract (infections with ß-haemolytic Streptococcus spp.) - musculoskeletal system (infections with Streptococcus suis) - skin (infections with Erysipelotrix rhusiopathiae) The use should be based on the result of an antibiogram. 4.3 CONTRAINDICATIONS Do not use in case of: - resistance against Penicillins - infections with ß-lactamase producing pathogens - hypersensitivity to Penicillins or Cephalosporins, Procain or against a 전체 문서 읽기