Cephaguard DC 150 mg Intramammary Ointment

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Cefquinome

Fáanlegur frá:

Virbac

ATC númer:

QJ51DE90

INN (Alþjóðlegt nafn):

Cefquinome

Lyfjaform:

Intramammary ointment

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cattle

Lækningarsvæði:

Antimicrobial intramammary

Leyfisstaða:

Authorized

Leyfisdagur:

2005-02-08

Vara einkenni

Divergence from NI MA : November 2023
AN: 03908/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephaguard DC 150 mg intramammary ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3 g pre-filled syringe contains:
ACTIVE SUBSTANCE
Cefquinome (as sulphate): 150.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary ointment
Homogeneous 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 susceptible organisms: _ Streptococcus uberis,
Streptococcus dysgalactiae, _
_Streptococcus agalactiae, Staphylococcus aureus, _coagulase negative
staphylococci.
4.3
CONTRAINDICATIONS
Not to be administered to animals which are known to be hypersensitive
to cephalosporin
antibiotics or other β-lactam antibiotics.
Not to be administered to cows with clinical mastitis and (see section
4.7).
Divergence from NI MA : November 2023
AN: 03908/2022
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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.
Do not use the cleaning towel on teats with lesions.
In case of erroneous use during lactation the milk should be discarded
for 35 days.
The efficacy of the product is only established against the pathogens
mentioned in
section 4.2 “Indications for use”. Consequently, serious acute
mastitis (potentially fatal)
due to other pathogen species, mainly _ Pseudomonas aeruginosa_, can
occur after the
drying off. Good hygienic practices should be thoroughly