Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
Benzylpenicillin procaine monohydrate
FATRO S.p.A.
QJ01CE09
Benzylpenicillin procaine monohydrate
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
2020-09-18
Health Products Regulatory Authority 18 September 2020 CRN00990Z Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT PRIMOPEN 300 mg/ml suspension for injection for cattle, pigs and horses 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Benzylpenicillin (procaine) monohydrate (corresponding to 170 mg benzylpenicillin) 300 mg EXCIPIENTS: Sodium formaldeyde sulfoxylate Sodium methyl parahydroxybenzoate (E219) 2.50 mg 1.15 mg Disodium edetate 0.55 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. White to almost white, homogeneous suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, pigs and horses. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections caused by penicillin-sensitive bacteria. 4.3 CONTRAINDICATIONS Do not use in known cases of hypersensitivity to the active substance, cephalosporins, procaine or to any of the excipients. Do not use in rabbits, guinea pigs, hamsters or gerbils. Do not use intravenously. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES The product will not be effective against beta lactamase producing organisms. 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. Health Products Regulatory Authority 18 September 2020 CRN00990Z Page 2 of 5 Special precautions to be taken by the person ad Aqra d-dokument sħiħ