Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Benzylpenicillin procaine
Bimeda Animal Health Limited
QJ01CE09
Benzylpenicillin procaine
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
2021-06-18
Health Products Regulatory Authority 18 June 2021 CRN009PWK Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Bimprocil 300 mg/ml suspension for injection for cattle, sheep and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Benzylpenicillin procaine 300 mg (corresponding to 175.8 mg of benzylpenicillin) EXCIPIENTS Methyl Parahydroxybenzoate E218 2.0 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection. An off-white suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of acute systemic infections caused by bacteria susceptible to benzylpenicillin. 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not use in known cases of hypersensitivity to penicillin, cephalosporins, procaine or to any of the excipients. Do not use in case of severe renal dysfunction with anuria and oliguria. Do not use in very small herbivores such as guinea pigs, gerbils and hamsters. Do not use in the presence of β-lactamase producing pathogens. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Complete cross-resistance has been shown between benzylpenicillin procaine and other penicillins. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use of the product should be based 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 the target bacteria. Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other penicillins and cephalosporins due to the potential for cross-resistance. The feeding of waste milk containing resi Prečítajte si celý dokument