Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin
Bimeda Animal Health Limited
QJ01CE09
Procaine benzylpenicillin
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
1987-10-01
Health Products Regulatory Authority 19 June 2020 CRN000VYC Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Procillin 300 mg/ml Suspension for Injection for Cattle, Sheep and Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Procaine benzylpenicillin 300 mg 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 bacterial infections sensitive to penicillin. These include both gram positive and gram negative organisms as follows: _Streptococcus_ spp. _Listeria_ spp. _Leptospira_ spp. _Actinomyces pyogenes_ _Bacillus anthracis_ _Erysipelothrix rhusiopathiae_ _Corynebacterium pseudotuberculosis_ _Corynebacterium renale_ 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not administer to animals known to be sensitive to penicillin. Do not use in sheep producing milk for human consumption. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Cattle and sheep: None. Pigs: Occasionally in suckling and fattening pigs, administration of procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. Additionally in pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. Care should be taken not to overdose. Health Products Regulatory Authority 19 June 2020 CRN000VYC Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS Penicillins and cephalosporins may cause sensitization following injection, inhalation, ingestion or skin contact. Sensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not han Læs hele dokumentet