Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Penethamate hydriodide
Pharmanovo Veterinärarzneimittel 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
Cattle
penethamate hydriodide
Antibiotics
Authorised
2015-12-04
Health Products Regulatory Authority 07 December 2018 CRN008Q3V Page 1 of 7 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) Health Products Regulatory Authority 07 December 2018 CRN008Q3V Page 2 of 7 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 β‐ lactams, and/or any of the excipients. Do not use intravenously. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological informa Прочитать полный документ