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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Penethamate hydriodide

Available from:

Lohmann Pharma Herstellung GmbH

ATC code:

QJ01CE90

INN (International Name):

Penethamate hydriodide

Dosage:

277.8 milligram(s)/millilitre

Pharmaceutical form:

Powder and solvent for suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

penethamate hydriodide

Authorization status:

Authorised

Authorization date:

2015-12-04

Summary of Product characteristics

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