Novomate 277.8 mg/ml powder and solvent for suspension for injection for cattle

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Penethamate hydriodide

Disponible des:

Pharmanovo Veterinärarzneimittel GmbH

Codi ATC:

QJ01CE90

Designació comuna internacional (DCI):

Penethamate hydriodide

Dosis:

277.8 milligram(s)/millilitre

formulario farmacéutico:

Powder and solvent for suspension for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle

Área terapéutica:

penethamate hydriodide

indicaciones terapéuticas:

Antibiotics

Estat d'Autorització:

Authorised

Data d'autorització:

2015-12-04

Fitxa tècnica

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