Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE
Interchem Ireland Ltd
QJ01RA01
BENZYLPENICILLIN PROCAINE, DIHYDROSTREPTOMYCIN SULPHATE
200/200 Mg/Ml
Suspension for Injection
POM
Bovine, Ovine, Porcine
Penicillins, combinations with other antibacterials
Antibacterial
Authorised
2012-02-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Pro Penstrep Suspension for Injection for Cattle, Sheep and Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 infection caused by bacteria sensitive to penicillin and dihydrostreptomcyin 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 in 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. Each ml contains: ACTIVE SUBSTANCE: Procaine benzylpenicillin 200 mg Dihydrostrepomycin 200 mg (as dihydrostreptomycin sulphate) EXCIPIENTS: Methyl parahydroxybenzoate (E218) 1.0 mg Sodium formaldehyde sulfoxylate 0.432 mg For a full list of excipents, see section 6.1 HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 27/07/2016_ _CRN 7024272_ _page number: 1_ 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 Прочитать полный документ