Cefquinome Norbrook LC, 75 mg Intramammary Ointment for Lactating 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:

75 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:

2014-09-12

Summary of Product characteristics

Health Products Regulatory Authority
22 August 2019
CRN008VLY
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefquinome Norbrook LC, 75 mg Intramammary Ointment for Lactating Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 8 g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg
(as Cefquinome Sulfate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary ointment.
A homogeneous off-white oily ointment.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (Lactating cow).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of clinical mastitis in the lactating cow caused by
bacteria
susceptible to cefquinome, namely _Staphylococcus aureus,
Streptococcus uberis,_
_Streptococcus dysgalactiae, Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in case of hypersensitivity to cephalosporin antibiotics or
other β-lactam antibiotics, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
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.
Do not use the cleaning towel on teats with lesions.
Special precautions to be taken by the person administering the
vete