Penethaone 236.3 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 ; Penethamate hydriodide ; Penethamate hydriodide

Available from:

Divasa-Farmavic S.A.

ATC code:

QJ01CE90

INN (International Name):

Penethamate hydriodide ; Penethamate hydriodide ; Penethamate hydriodide

Dosage:

236.3 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 group:

Cattle

Therapeutic area:

penethamate hydriodide

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-09-03

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2020
CRN009DDX
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Penethaone 236.3 mg/ml powder and solvent for suspension for injection
for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of the reconstituted suspension contains:
​
​
ACTIVE SUBSTANCE
Penethamate hydriodide
​236.3 mg (equivalent to 182.5 mg penethamate)
Equivalent to 250,000 IU of penethamate hydriodide
​
​
5,000,000 IU PRESENTATION
​
​
Powder vial contains 4.75 g of powder
ACTIVE SUBSTANCE
​
Penethamate hydriodide
​4726 mg (equivalent to 3649 mg of penethamate)
​
​
Equivalent to 5,000,000 IU of penethamate hydriodide
​
EXCIPIENTS, Q.S.F.
​
​
Solvent vial contains 18 ml
​
EXCIPIENTS, Q.S.F.
​
Total amount of reconstituted suspension 20 ml
10,000,000 IU PRESENTATION
​
Powder vial contains 9.50 g of powder
​
ACTIVE SUBSTANCE
​
Penethamate hydriodide
​9452 mg (equivalent to 7299 mg of penethamate)
​
Equivalent to 10,000,000 IU of penethamate hydriodide
​
EXCIPIENTS, Q.S.F.
​
​
​
Solvent vial contains 36 ml
​
EXCIPIENTS, Q.S.F.
​
Total amount of reconstituted suspension 40 ml
​
​
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
Powder vial: white-cream fine powder
Solvent vial: clear colourless solution
Reconstituted suspension: white-cream suspension
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), susceptible to
penicillin.
Health Products Regulatory Authority
05 May 2020
CRN009DDX
Page 2 of 5
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 use in lagomorphs and