Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Procaine benzylpenicillin; Dihydrostreptomycin sulfate
Bimeda Animal Health Limited
QJ01RA01
Procaine benzylpenicillin; Dihydrostreptomycin sulfate
200, 200 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
penicillins, combinations with other antibacterials
Authorised
2006-03-03
Health Products Regulatory Authority 03 May 2019 CRN009112 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Dipen 100ml Suspension for Injection for cattle, sheep and pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE Procaine benzylpenicillin 200 mg Dihydrostreptomycin 200 mg (as dihydrostreptomycin sulphate) EXCIPIENTS Methyl parahydroxybenzoate 1.0 mg Sodium formaldehyde sulfoxylate 0.423 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suspension for Injection The product is a white to off-white sterile aqueous suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, sheep and 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 Do not administer to animals known to be sensitive to penicillin. Do not use when it is known that penicillinase-producing staphylococcus organisms are present. 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 incoordination. 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 this 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 of susceptibility testing. Health Products Regulatory Authority 03 May 2019 Lestu allt skjalið