Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE)
Pharmanovo GmbH
QJ01CE90
PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE)
277.8 Mg/Ml
Pdr+Solv for Susp for Inj
POM
Bovine
Penethamate hydroiodide
Antibiotics
Authorised
2015-12-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _Powder vial contains:_ ACTIVE SUBSTANCE: Each 5 g vial contains: Penethamate hydriodide: 5 g (equivalent to 3.86 g penethamate) Each 10 g vial contains: Penethamate hydriodide: 10 g (equivalent to 7.72 g penethamate) _Solvent vial contains (15 ml or 30 ml of a sterile solvent):_ EXCIPIENTS: Methyl parahydroxybenzoate (E 218): 1.8 mg/ml Propyl parahydroxybenzoate: 0.18 mg/ml _Each ml of the reconstituted product contains:_ ACTIVE SUBSTANCE: Penethamate hydriodide: 277.8 mg (equivalent to 214.5 mg penethamate) EXCIPIENTS: Methyl parahydroxybenzoate (E 218): 1.5 mg/ml Propyl parahydroxybenzoate: 0.15 mg/ml For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder and solvent for suspension for injection. Powder vial: White to slightly yellow powder Solvent vial: Clear, colourless solution The reconstituted suspension is off-white to slightly yellow colour. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (dairy) 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 to be hypersensitive to - lactams, and/or any of the excipients. Do not use intravenously. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Perskaitykite visą dokumentą