País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Benzylpenicillin procaine ; Dihydrostreptomycin sulphate
Univet Limited
QJ01CE09
Benzylpenicillin procaine ; Dihydrostreptomycin sulphate
200, 200 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs, Sheep
procaine benzylpenicillin
Antibacterial
Authorised
1987-10-01
Health Products Regulatory Authority 08 May 2018 CRN000XVX Page 1 of 6 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pentomycin Suspension for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Procaine benzylpenicillin 200 mg Dihydrostreptomycin 200 mg (as dihydrostreptomycin sulphate) EXCIPIENTS Methyl parahydroxybenzoate 1.0 mg Sodium formaldehyde sulfoxylate 0.432 mg For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Suspension for injection. A white to off-white aqueous suspension. 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 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. Health Products Regulatory Authority 08 May 2018 CRN000XVX 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 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 on susceptibility testing. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS: Penicillin and cephalosporins may cause hypersensitivity (allergy) follo Llegiu el document complet