Ubrolexin intramammary suspension for lactating dairy cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalexin monohydrate; Kanamycin monosulphate

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QJ51RD01

INN (International Name):

Cefalexin monohydrate; Kanamycin monosulphate

Dosage:

200 mg/100,000 IU per syringe

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

cefalexin, combinations with other antibacterials

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2007-10-26

Summary of Product characteristics

Health Products Regulatory Authority
25 May 2018
CRN000YHZ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubrolexin intramammary suspension for lactating dairy cows
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10 g (12 ml) intramammary syringe contains:
ACTIVE SUBSTANCES:
Cefalexin (as monohydrate): 200 mg
Kanamycin (as monosulphate): 100,000 I.U.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Intramammary suspension.Off-white, oily paste.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (lactating dairy cows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of clinical mastitis in lactating dairy cows for bacteria
susceptible to the
combination of cefalexin and kanamycin such as _Staphylococcus aureus
_(see section
5.1), _Streptococcus dysgalactiae_, _Streptococcus uberis _and
_Escherichia coli_.
4.3 CONTRAINDICATIONS
Do not use in lactating dairy cows with a known hypersensitivity to
cefalexin and/or
kanamycin.
Do not use in non-lactating cattle.
Do not use in the case of known resistance of cefalexin and/or
kanamycin.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
25 May 2018
CRN000YHZ
Page 2 of 6
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Recommendations for prudent use
The product should be used for treatment of clinical mastitis only.
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 and farm
level)
epidemiological information about susceptibility of the target
bacteria as well as by
taking into account official national antimicrobial policies.
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
cefalexin and kanamycin and may decrease the effectiveness of
treatment with other
cephalosporins or aminoglycosides due to the potential for
cross-resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMIN