Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Penethamate Hydriodide, micronised
Boehringer Ingelheim Limited
QJ01CE90
Penethamate Hydriodide, micronised
Powder and solvent for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial
Authorized
2000-03-15
Revised: October 2017 AN: 01604/2016 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Mamyzin 269.5 mg/ml Powder and Solvent for Suspension for Injection for cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5g vial contains: Penethamate hydriodide 5 million IU Each 10g vial contains: Penethamate hydriodide 10 million IU Each 15ml and 30ml vial of solvent contains: methyl parahydroxybenzoate, as preservative 1.5mg/ml Each ml of the reconstituted product contains 269.5 mg of penethamate hydriodide. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection Powder vial: White to off-white crystalline powder Solvent vial: Clear solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, dairy 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Bovine mastitis caused by penicillin sensitive organisms. 4.3 CONTRAINDICATIONS Do not use in animals known to be hypersensitive to penicillin. Do not administer by intravenous injection. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Page 1 of 5 Revised: October 2017 AN: 01604/2016 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. 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 beta-lactams due to the potential for cross-resistance. Special Precautions to be taken by the person administering the medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin conta Read the complete document