Ceffect LC, 75 mg, intramammary ointment for lactating cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefquinome sulphate

Available from:

Emdoka bvba

ATC code:

QJ01DE90

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 group:

Cattle

Therapeutic area:

cefquinome

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2014-05-09

Summary of Product characteristics

Health Products Regulatory Authority
23 July 2019
CRN008M06
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ceffect LC, 75 mg, intramammary ointment for lactating cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prefilled intramammary syringe of 8 g contains:
ACTIVE SUBSTANCE:
Cefquinome 75 mg
(Equivalent to Cefquinome sulfate 88.92 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary ointment.
White to slightly yellowish 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 dairy cow
caused by the following cefquinome-susceptible
microorganisms: _Streptococcus uberis, Streptococcus dysgalactiae,
Staphylococcus aureus_ and_ Escherichia coli._
4.3 CONTRAINDICATIONS
Do not use in 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.
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.
The feeding to calves of milk containing residues of cefquinome (i.e.
milk