Qivitan LC 75 mg intramammary ointment for lactating cows

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Cefquinome sulphate

Disponible depuis:

LIVISTO Int'l, S.L.

Code ATC:

QJ51DE90

DCI (Dénomination commune internationale):

Cefquinome sulphate

Dosage:

75 mg/syringe

forme pharmaceutique:

Intramammary ointment

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Cattle

Domaine thérapeutique:

cefquinome

indications thérapeutiques:

Antibacterial

Statut de autorisation:

Authorised

Date de l'autorisation:

2018-06-01

Résumé des caractéristiques du produit

Health Products Regulatory Authority
07 June 2018
CRN000V32
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Qivitan LC 75 mg intramammary ointment for lactating cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled syringe of 8 g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg
(as cefquinome sulfate 88.92 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary ointment
White to slightly yellow, oily viscous homogeneous ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of clinical mastitis in the lactating cow caused by
the following
cefquinome-sensitive organisms: _Streptococcus uberis, Streptococcus
dysgalactiae, _
_Staphylococcus aureus_ and_ Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to cephalosporin
antibiotics, other
ß-lactam antibiotics or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
07 June 2018
CRN000V32
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
The product should be reserved for the treatment of clinical
conditions which have
responded poorly or are expected to respond poorly to other classes of
antimicrobials or narrow spectrum β-lactam antimicrobials. Use of the
product
should be based on susceptibility testing of the bacteria isolated
from the animal. If it
is not possible, therapy should be based on local (regional, farm
level)
epidemiological information about susceptibility of the target
bacteria.
Official, national and regional antimicrobial policies should be taken
into account
when the product is used.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to cefquinome and may decrease the
effectiveness of
treatment with cephalosporins due to the potential for
cross-resistance.
The feedi