Terrexine DC 250 mg Intramammary Suspension for Dry Cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalonium dihydrate

Available from:

Univet Limited

ATC code:

QJ51DB90

INN (International Name):

Cefalonium dihydrate

Dosage:

250 mg/syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

cefalonium

Authorization status:

Authorised

Authorization date:

2019-07-05

Summary of Product characteristics

Health Products Regulatory Authority
22 April 2020
CRN009KP6
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Terrexine DC 250 mg Intramammary Suspension for Dry Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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Each 3 g intramammary syringe contains:
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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 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.
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-resistant bacteria (e.g.
production of beta-lactamases) should be avoided up to the end of the
milk withdrawal period,