Seclaris DC 250 mg Intramammary Suspension for Dry Cows

Summary of Product characteristics

                                Revised: October 2022
AN: 01598/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Seclaris DC 250 mg Intramammary Suspension for dry cows
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each intramammary syringe of 3 g contains:
ACTIVE SUBSTANCE:
Cefalonium (as cefalonium dihydrate)
250 mg
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension
Shiny off-white to yellowish ointment.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (dry cow).
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 cefalosporins,
other ß-lactam
antibiotics or to any of the excipients.
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
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
Revised: October 2022
AN: 01598/2022
Page 2 of 5
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 consideration, and undergo regular veterinary
review.
The feeding to calves of milk containing residues of c
                                
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