País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin; Dihydrostreptomycin sulphate
Chanelle Pharmaceuticals Manufacturing Limited
QJ01RA01
Procaine benzylpenicillin; Dihydrostreptomycin sulphate
200, 200 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
penicillins, combinations with other antibacterials
Antibacterial
Authorised
2000-08-18
Health Products Regulatory Authority 06 June 2018 CRN000XW4 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Chan Pen Strep Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Procaine Benzylpenicillin 200 mg Dihydrostreptomycin Sulphate (as dihydrostreptomycin sulphate) 200 mg EXCIPIENT Sodium formaldehyde sulfoxylate 0.432 mg Methyl Parahydroxybenzoate 1 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep, pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in cattle, sheep and pigs. 4.3 CONTRAINDICATIONS Not to be administered to animals known to be sensitive to penicillin. Not to be used when it is known that penicillinase-producing staphylococcus organisms are present. Health Products Regulatory Authority 06 June 2018 CRN000XW4 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Occasionally in sucking and fattening pigs administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordinations. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. The maximum dose volume recommended at any one site for cattle is 20 ml. 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. Whenever possible the product should only be used on the basis on susceptibility testing. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillin and cephalosporins may cause hypersensitivity ( Leer el documento completo