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

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

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Download 제품 특성 요약 (SPC)
02-04-2021
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02-04-2021

유효 성분:

Penethamate hydriodide

제공처:

Lohmann Pharma Herstellung GmbH

ATC 코드:

QJ01CE90

INN (국제 이름):

Penethamate hydriodide

복용량:

277.8 milligram(s)/millilitre

약제 형태:

Powder and solvent for suspension for injection

처방전 유형:

POM: Prescription Only Medicine as defined in relevant national legislation

치료 영역:

penethamate hydriodide

승인 상태:

Authorised

승인 날짜:

2015-12-04

제품 특성 요약

                                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
                                
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