Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Penethamate Hydriodide, micronised
Divasa - Farmavic S.A
QJ01CE90
Penethamate Hydriodide, micronised
Powder and solvent for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Antimicrobial
Authorized
2015-08-18
Revised: July 2020 AN: 01181/2019 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Permacyl 236.3 mg/ml powder and solvent for suspension for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of the reconstituted suspension contains: ACTIVE SUBSTANCE Penethamate hydriodide 236.3 mg (equivalent to 182.5 mg penethamate) Equivalent to 250,000 IU of penethamate hydriodide 5,000,000 IU PRESENTATION Powder vial contains 4.75 g of powder ACTIVE SUBSTANCE Penethamate hydriodide 4726 mg (equivalent to 3649 mg of penethamate) Equivalent to 5,000,000 IU of penethamate hydriodide EXCIPIENTS, Q.S.F. Solvent vial contains 18 ml EXCIPIENTS, Q.S.F. Total amount of reconstituted suspension 20 ml 10,000,000 IU PRESENTATION Powder vial contains 9.50 g of powder ACTIVE SUBSTANCE Penethamate hydriodide 9452 mg (equivalent to 7299 mg of penethamate) Equivalent to 10,000,000 IU of penethamate hydriodide EXCIPIENTS, Q.S.F. Solvent vial contains 36 ml EXCIPIENTS, Q.S.F. Total amount of reconstituted suspension 40 ml For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for suspension for injection Powder vial: white-cream fine powder Solvent vial: clear colourless solution Reconstituted suspension: white-cream suspension 4. CLINICAL PARTICULARS Revised: July 2020 AN: 01181/2019 Page 2 of 7 4.1 TARGET SPECIES Cattle (lactating cows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of mastitis in lactating cows caused by _Streptococcus uberis_, _Streptococcus dysgalactiae_, _Streptococcus agalactiae_ and _Staphylococcus aureus_ (beta-lactamase non-producing), susceptible to penicillin. 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to penicillins, cephalosporins, and/or any of the excipients. Do not administer intravenously. Do not use in lagomorphs and rodents such as guinea pigs, hamsters or gerbils. Do not administer to animals with renal disease including anuria or oliguria. 4.4 SPECIAL WARNINGS FOR EACH TA Read the complete document