Kepravin Dry Cow 250mg Intramammary Suspension
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
07-04-2013
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Active ingredient:
cefalonium 250 mg
Available from:
Intervet UK Limited
ATC code:
QJ51DB90
Pharmaceutical form:
Intramammary suspension
Therapeutic group:
cefalonium
Therapeutic area:
Cattle Lactating
Authorization date:
2012-07-25
Summary of Product characteristics
Issued: September 2012
AN: 00840/2011
Page 1 of 7
_ _
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:
Cefalonium (as cefalonium dihydrate)
0.25 g
For a 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_, _Arcanobacterium pyogenes_,_ _
_Escherichia coli_ and _Klebsiella spp._ during the non-lactating period of cows.
4.3 CONTRAINDICATIONS
Not to be administered to animals which are known to be hypersensitive to
cephalosporin antibiotics and other β-lactam antibiotics.
Please refer to section 4.7
Issued: September 2012
AN: 00840/2011
Page 2 of 7
4.4 SPECIAL WARNINGS
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not bend the nozzle.
Do not contaminate the nozzle.
Use of the product should be based on susceptibility testing and should take into
account official and local antimicrobial policies. Increased use, including use o
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