Cefquinome Norbrook DC, 150 mg Intramammary Ointment for Dry Cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefquinome sulphate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ51DE90

INN (International Name):

Cefquinome sulphate

Dosage:

150 mg/syringe

Pharmaceutical form:

Intramammary ointment

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

cefquinome

Authorization status:

Authorised

Authorization date:

2014-09-26

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2019
CRN008VQV
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefquinome Norbrook DC, 150 mg Intramammary Ointment for Dry Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g pre-filled syringe contains:
ACTIVE SUBSTANCE:
Cefquinome: 150 mg
(as cefquinome sulfate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary ointment.
Homogenous off-white oily ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Dry cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of subclinical mastitis at drying off and the
prevention of new bacterial infections of the udder during the dry
period in the dairy cow caused by the following cefquinome sensitive
organisms: _Streptococcus uberis, Streptococcus _
_dysgalactiae, Streptococcus agalactiae, Staphylococcus aureus,
_coagulase negative staphylococci.
4.3 CONTRAINDICATIONS
Do not use in cows with clinical mastitis.
Do not use in case of hypersensitivity to cephalosporin antibiotics or
other β-lactam antibiotics, or to any of the excipients.
See section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
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.
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 deviating from 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.
Official, national and regional antimicrobial policies should be taken
into account wh