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 (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE)

Disponible des:

Pharmanovo GmbH

Codi ATC:

QJ01CE90

Designació comuna internacional (DCI):

PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE), PENETHAMATE HYDRIODIDE (PENETHAMATE)

Dosis:

277.8 Mg/Ml

formulario farmacéutico:

Pdr+Solv for Susp for Inj

tipo de receta:

POM

Grupo terapéutico:

Bovine

Área terapéutica:

Penethamate hydroiodide

indicaciones terapéuticas:

Antibiotics

Estat d'Autorització:

Authorised

Data d'autorització:

2015-12-04

Fitxa tècnica

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.
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