Cefimam LC, 75 mg Intramammary Ointment for Lactating Cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefquinome

Available from:

Norbrook Laboratories Limited

ATC code:

QJ51DE90

INN (International Name):

Cefquinome

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:

2014-10-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefimam 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 homogenous 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
-lactam antibiotics, or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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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
-lactam antimicrobials.
Use of the product should be based on susceptibility testing of the
bacteria isolated from t