Arentor DC 250mg Intramammary Suspension for Dry Cows

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cephalonium

Available from:

Univet Ltd

ATC code:

QJ51DB90

INN (International Name):

Cephalonium

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial intramammary

Authorization status:

Authorized

Authorization date:

2018-11-28

Summary of Product characteristics

Issued November 2018
AN: 01643/2017
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Arentor DC 250mg Intramammary Suspension for Dry Cows_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 3g intramammary syringe contains:
ACTIVE SUBSTANCE:
Cefalonium
250 mg (as cefalonium dihydrate)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension
A pale yellow cream-coloured suspension
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 non-lactating period of
cows caused by
_Staphylococcus _
_aureus_,
_Streptococcus _
_agalactiae_,
_Streptococcus _
_dysgalactiae_,
_Streptococcus uberis_, _ Trueperella pyogenes_, _ Escherichia coli_
and _ Klebsiella _ spp.
susceptible to cefalonium.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to cephalosporins,
other ß-lactam
antibiotics or to any of the excipients.
Please refer to Section 4.7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Issued November 2018
AN: 01643/2017
Page 2 of 7
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 milk samples from the animal. If this is not possible, therapy
should be based on
local (regional, farm level) epidemiological information about
susceptibility of the
target bacteria.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to cefalonium and may decrease the
effectiveness of
treatment with other beta lactams.
Dry cow therapy protocols should take local and national policies on
antimicrobial
use into consideration, and undergo regular veterinary review.
The feeding to calves of milk containing residues of cefalonium that
could select for
antimicrobial-resi