Cefimam DC, 150 mg Intramammary Ointment for Dry Cows

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cefquinome

Available from:

Norbrook Laboratories Limited

ATC code:

QJ51DE90

INN (International Name):

Cefquinome

Pharmaceutical form:

Intramammary ointment

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial intramammary

Authorization status:

Authorized

Authorization date:

2015-02-20

Summary of Product characteristics

Revised: September 2019
AN: 01539/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cefimam DC, 150 mg Intramammary Ointment for Dry Cows.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g intramammary syringe contains:
ACTIVE SUBSTANCE:
Cefquinome: (as Cefquinome Sulfate)
150 mg
EXCIPIENTS:
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 cases of known 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
Special precautions for use in animals
Revised: September 2019
AN: 01539/2018
Page 2 of 5
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 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.