PENETHAONE 236.3 MG/ML POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION FOR CATTLE

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

PENETHAMATE HYDRIODIDE

Mevcut itibaren:

Divasa-Farmavic S.A.

ATC kodu:

QJ01CE90

INN (International Adı):

PENETHAMATE HYDRIODIDE

Doz:

236.3 Mg/Ml

Farmasötik formu:

Pdr+Solv for Susp for Inj

Reçete türü:

POM

Terapötik grubu:

Bovine

Terapötik alanı:

Penethamate hydroiodide

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2015-09-03

Ürün özellikleri

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)
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 03/09/2015_
_CRN 7021802_
_page number: 1_
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 kno