Cepritect 250 mg Intramammary Suspension for Dry Cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalonium dihydrate

Available from:

Norbrook Laboratories (Ireland) 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:

2017-12-15

Summary of Product characteristics

Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cepritect 250 mg Intramammary Suspension for Dry Cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each intramammary syringe of 3g contains
Cefalonium (as Cefalonium Dihydrate) 250 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary Suspension.
Homogeneous white to beige coloured suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dairy 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 cephalosporins,
other β-lactam
antibiotics or to any of the excipients.
Please refer to section 4.7.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
07 February 2019
CRN008TK5
Page 2 of 7
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 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.
The efficacy of the product is only established against the pathogens
mentioned in
section 4.2 of the SPC. Consequently, serious acute mastitis
(potentially fatal) due to
other pathogen species, particularly _Pseudomonas aeruginosa_,