Cobactan 2.5% w/v Suspension for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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DSU DSU (DSU)
04-05-2023

Active ingredient:

Cefquinome sulfate

Available from:

Intervet Ireland Limited

ATC code:

QJ01DE90

INN (International Name):

Cefquinome sulfate

Dosage:

2.5 percent weight/volume

Pharmaceutical form:

Suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

cefquinome

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1995-09-20

Summary of Product characteristics

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cobactan 2.5% w/v Suspension for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Cefquinome sulfate equivalent to
Cefquinome
25 mg
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
A milky-white to slightly brownish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial infections in cattle and pigs caused by
the Gram positive and Gram negative
microorganisms sensitive to Cefquinome.
_Cattle:_
1.
Respiratory disease caused by_ Pasteurella multocida_ and_ Mannheimia
haemolytica._
2.
Digital dermatitis, infectious bulbar necrosis and acute interdigital
necrobacillosis (foul in the foot).
3.
Acute_ E.coli_ mastitis with signs of systemic involvement.
4.
_E.coli_ septicaemia in calves.
_Pigs:_
1.
For the treatment of bacterial infections of the lungs and respiratory
tract caused by_ Pasteurella multocida,_
_Haemophilus parasuis, Actinobacillus pleuropneumoniae, Streptococcus
suis_ and other cefquinome-sensitive
organisms.
2.
Mastitis-Metritis-Agalactia syndrome (MMA) with involvement of_
E.coli, Staphylococcu_s spp.,_ Streptococcus_
spp.,_ Corynebacterium_ spp. and other Cefquinome sensitive organisms.
4.3 CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to the active
substance.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial resistance to humans.
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