Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Benzylpenicillin procaine
MEVET S.A.U.
QJ01CE09
Benzylpenicillin procaine
300 milligram(s)/millilitre
Suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
procaine benzylpenicillin
Authorised
2019-05-03
2 1 . _ _ NAME OF THE VETERINARY MEDICINAL PRODUCT PROBENCIL 300 mg/ml suspension for injection for cattle and pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Procaine Benzylpenicillin …………………………….. 300 mg EXCIPIENTS: Sodium methyl parahydroxybenzoate (E219) ………… 1.25 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. White suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of systemic infections in cattle and pigs caused by bacteria sensitive to penicillin: 4.3 CONTRAINDICATIONS Do not inject intravenously. Do not use in cases of hypersensitivity to penicillins, cephalosporins, procaine or to any of the excipients. Do not use in case of severe renal dysfunction with anuria and oliguria. Do not use in the presence of β-lactamase producing pathogens. Do not use in very small herbivores such as guinea pigs, gerbils and hamsters. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Administer by deep injection only The 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. 3 Official, national and regional antimicrobial policies should be taken into account when the product is used. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to benzylpenicillin and may decrease the effectiveness of treatment with other penicillins and cephalosporins due to the potential for cross-resistance. Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhal Pročitajte cijeli dokument