País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Penethamate hydriodide
Lohmann Pharma Herstellung GmbH
QJ01CE90
Penethamate hydriodide
277.8 milligram(s)/millilitre
Powder and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
penethamate hydriodide
Authorised
2015-12-04
Health Products Regulatory Authority 01 April 2021 CRN009NC6 Page 1 of 5 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 of white to slightly yellow colour. 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), sensitive 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 administer to animals with renal disease including anuria or oliguria. Health Products Regulatory Authority 01 April 2021 CRN009NC6 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPE Leer el documento completo