Ceffect 25 mg/ml suspension for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefquinome sulphate

Available from:

Emdoka

ATC code:

QJ01DE90

INN (International Name):

Cefquinome sulphate

Dosage:

25 milligram(s)/millilitre

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:

2012-12-07

Summary of Product characteristics

Health Products Regulatory Authority
30 April 2018
CRN000Y6S
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ceffect 25 mg/ml suspension for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
1 ml contains:
​
​
ACTIVE SUBSTANCE:
​
​
Cefquinome (as sulfate)
​25 mg
​
EXCIPIENT(S):
​
​
For the full list of excipients, see section 6.1.
​
3 PHARMACEUTICAL FORM
Suspension for injection.
White to slightly yellowish suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and 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:
Respiratory disease caused by _Pasteurella multocida_ and _Mannheimia
haemolytica_.
Digital dermatitis, infectious bulbar necrosis and acute interdigital
necrobacillosis
(foul in the foot).
Acute _E.coli_ mastitis with signs of systemic involvement.
Calves:
E.coli septicaemia in calves.
Pigs:
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.
Mastitis-Metritis-Agalactia syndrome (MMA) with involvement of
_E.coli_,
_Staphylococcus_ spp., _Streptococcus_ spp. and other cefquinome
sensitive organisms.
Health Products Regulatory Authority
30 April 2018
CRN000Y6S
Page 2 of 7
Piglets:
Reduction of mortality in cases of meningitis caused by _Streptococcus
suis_.
For the treatment of:
Arthritis caused by _Streptococcus_ spp.,_ E. coli _and other
cefquinome-sensitive
organisms.
Epidermitis (mild or moderate lesions) caused by _Staphylococcus
hyicus_.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to β-lactam antibiotics, or to
any of the
excipients.
Do not administer to animals less than 1.25 kg body weight.
Do not use in poultry (including eggs) due to risk of spread of
antimicrobial
resistance to