Cobactan 4.5% w/v powder and solvent for solution for injection for horse and cattle

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Cefquinome; Cefquinome; Cefquinome

Disponibil de la:

Intervet Ireland Limited

Codul ATC:

QJ01DE90

INN (nume internaţional):

Cefquinome; Cefquinome; Cefquinome

Dozare:

4.5 percent weight/volume

Forma farmaceutică:

Powder and solvent for solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Cattle, Horses

Zonă Terapeutică:

cefquinome

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

2008-04-25

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cobactan 4.5% w/v powder and solvent for solution for injection for
horse and cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to pale yellowish-white crystalline powder and clear colourless
solvent.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Horse (adult and foal) and cattle (adult and calf).
1 vial with powder contains:
30 ml-vial:
1.35 g
cefquinome (as sulphate)
100 ml-vial:
4.5
g
cefquinome (as sulphate)
1 ml solvent contains:
Preservative: Benzyl alcohol (E1519) 10 mg
Each ml of the reconstituted solution contains:
ACTIVE SUBSTANCE:
Cefquinome (as sulphate)
45
mg
EXCIPIENT:
Benzyl alcohol (E1519)
10
mg
For a full list of excipients, see section 6.1
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4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial infections in horses and cattle caused
by the following Gram positive and Gram negative
microorganisms sensitive to cefquinome:
HORSES:
Respiratory diseases caused by_ Streptococcus equi_ subsp._
zooepidemicus_
FOALS:
Severe bacterial infections with a high risk of septicaemia in which_
Escherichia coli_ is involved
CATTLE:
Respiratory diseases caused by_ Pasteurella multocida_ and_ Mannheimia
haemolytica_
Digital dermatitis, infectious bul