País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Penethamate hydriodide ; Penethamate hydriodide ; Penethamate hydriodide
Divasa-Farmavic S.A.
QJ01CE90
Penethamate hydriodide ; Penethamate hydriodide ; Penethamate hydriodide
236.3 milligram(s)/millilitre
Powder and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle
penethamate hydriodide
Antibacterial
Authorised
2015-09-03
Health Products Regulatory Authority 05 May 2020 CRN009DDX Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Penethaone 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) 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. Health Products Regulatory Authority 05 May 2020 CRN009DDX Page 2 of 5 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 Leia o documento completo