Qivitan 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:

LIVISTO Int'l, S.L.

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:

2017-01-27

Summary of Product characteristics

Health Products Regulatory Authority
07 January 2022
CRN00CDC1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Qivitan 25 mg/ml suspension for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Cefquinome 25 mg
(equivalent to 29.64 mg cefquinome sulfate)
EXCIPIENTS:
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.
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 cases of hypersensitivity to ß-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 humans.
Health Products Regulatory Authority
07