Novomate 277.8 mg/ml Powder and Solvent for Suspension for Injection for Cattle

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Penethamate Hydriodide, micronised

Prieinama:

Pharmanovo GmbH

ATC kodas:

QJ01CE90

INN (Tarptautinis Pavadinimas):

Penethamate Hydriodide, micronised

Vaisto forma:

Powder and solvent for suspension for injection

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Cattle

Gydymo sritis:

Antimicrobial

Autorizacija statusas:

Authorized

Leidimo data:

2015-12-15

Prekės savybės

Revised: December 2018
AN: 01104/2018
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
Penethamate Pharmanovo 214.5 mg/ml powder and solvent for suspension
for
injection for cattle (FR)
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 (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.
Page 1 of 6
Revised: December 2018
AN: 01104/2018
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 l