Kepravine Dry Cow 250 mg Intramammary Suspension

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Cephalonium

Available from:

MSD Animal Health UK Limited

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:

Expired

Authorization date:

2012-09-24

Summary of Product characteristics

Revised: September 2017
AN: 01608/2016
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
UK: Kepravine Dry Cow 250 mg Intramammary suspension
AT, CY, DE, EE, LT, LV, MT, NL: Cepravin Dry Cow 250 mg Intramammary
suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH INTRAMAMMARY SYRINGE WITH 3 G SUSPENSION CONTAINS:
ACTIVE SUBSTANCE:
250 mg Cefalonium (as cefalonium dihydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension.
White to cream coloured suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dairy cattle (cows at drying off).
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 caused by _Staphylococcus aureus_,
_Streptococcus _
_agalactiae_, _Streptococcus dysgalactiae_, _Streptococcus uberis_,
_Trueperella pyogenes_,_ _
_Escherichia coli_ and _Klebsiella spp._ during the non-lactating
period of cows.
4.3
CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to cephalosporin
antibiotics and
other β-lactam antibiotics.
Please refer to section 4.7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
Revised: September 2017
AN: 01608/2016
Page 2 of 5
Special precautions for use in animals
Use of the product should be based on susceptibility testing of
bacteria isolated from
milk samples obtained from the udder quarter(s) of each cow to be
dried off. If this is
not possible, therapy should be based on local (regional, farm level)
risk based
epidemiological
information
about
the
expected
pathogen
challenge,
and
susceptibility of target bacteria. Use of the product deviating from
the instructions
given in the SPC may contribute to the development of bacterial
resistance to
cefalonium which may also decrease the effectiveness of treatment with
other beta
lactams. Dry cow therapy protocols should take local and national
policies on
antimicrobial use into con