Cobactan LC, 75 mg, intramammary ointment for lactating cattle

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Cefquinome sulphate

Disponible depuis:

Intervet Ireland Limited

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:

1998-05-29

Résumé des caractéristiques du produit

Health Products Regulatory Authority
27 April 2018
CRN000XTC
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cobactan LC, 75 mg, intramammary ointment for lactating cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled syringe of 8g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg (as cefquinome sulphate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White to slightly yellow, oily viscous homogeneous intramammary
ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Lactating cows.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of clinical mastitis in the lactating dairy cow
caused by the
following cefquinome-sensitive organisms : _Streptococcus uberis,
Streptococcus _
_dysgalactiae, Staphylococcus aureus_ and_ Escherichia coli_.
4.3 CONTRAINDICATIONS
Not to be administered to animals which are known to be hypersensitive
to
cephalosporin antibiotics and other ß-lactam antibiotics.
Do not use the cleaning towel if lesions are present on the teat.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
27 April 2018
CRN000XTC
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take
into account
official and local antimicrobial policies. Inappropriate use of the
product 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.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillins
may lead to cross
sensitivity to cephalosporin and vice versa. Allergic reactions to
these substances
may occasionally be serious.
1. Handle this product with great care to avoid exposure, taking all
recommended
preca