Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
PENETHAMATE HYDRIODIDE
Divasa-Farmavic S.A.
QJ01CE90
PENETHAMATE HYDRIODIDE
236.3 Mg/Ml
Pdr+Solv for Susp for Inj
POM
Bovine
Penethamate hydroiodide
Antibiotics
Authorised
2015-10-09
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 4.1 TARGET SPECIES Cattle (lactating cows) HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 09/10/2015_ _CRN 7022131_ _page number: 1_ 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), sensitive to penicillin. 4.3 CONTRAINDICATIONS Do not use in animals known Perskaitykite visą dokumentą