Permacyl 236.3 mg/ml Powder and Solvent for Suspension for Injection for Cattle

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Penethamate Hydriodide, micronised

Saatavilla:

Divasa - Farmavic S.A

ATC-koodi:

QJ01CE90

INN (Kansainvälinen yleisnimi):

Penethamate Hydriodide, micronised

Lääkemuoto:

Powder and solvent for suspension for injection

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cattle

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2015-08-18

Valmisteyhteenveto

Revised: July 2020
AN: 01181/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Permacyl 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
Revised: July 2020
AN: 01181/2019
Page 2 of 7
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.
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 rodents such as guinea pigs, hamsters or
gerbils.
Do not administer to animals with renal disease including anuria or
oliguria.
4.4
SPECIAL WARNINGS FOR EACH TA