Seclaris DC 250 mg Intramammary Suspension for dry cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalonium (as cefalonium dihydrate?)

Available from:

Ceva Santé Animale

ATC code:

QJ51DB90

INN (International Name):

Cefalonium (as cefalonium dihydrate?)

Dosage:

250 mg/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

cefalonium

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2017-12-08

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2017
CRN000TXX
Page 1 of 6
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.
Health Products Regulatory Authority
13 December 2017
CRN000TXX
Page 2 of 6
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
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 containin