Rilexine DC 375 mg Intramammary Suspension for Dry Cows

Land: Storbritannia

Språk: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv ingrediens:

Cefalexin

Tilgjengelig fra:

Virbac

ATC-kode:

QJ51DB01

INN (International Name):

Cefalexin

Legemiddelform:

Intramammary suspension

Resept typen:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle

Terapeutisk område:

Antimicrobial intramammary

Autorisasjon status:

Authorized

Autorisasjon dato:

2022-06-29

Preparatomtale

Issued: June 2022
AN:
01690/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rilexine DC 375 mg intramammary suspension for dry cows
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Each 8 g intramammary syringe contains:
Cefalexin 375 mg (equivalent to 500 mg of cefalexin benzathine)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Intramammary suspension.
White to yellowish oily 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 dry-off and prevention of
new
intramammary infections occurring during the dry period, caused by
_Staphylococcus _
_aureus, Streptococcus dysgalactiae _and _Streptococcus uberis_ .
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to cephalosporins,
other ß-lactam
antibiotics or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross resistance occurs with other β-lactams.
Issued: June 2022
AN:
01690/2020
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on identification and
susceptibility testing of the
target pathogen(s). If this is not possible, therapy should be based
on
epidemiological information and knowledge of susceptibility of the
target bacteria at
farm level, or at local/regional level .
Use of the product should be in accordance with official, national and
regional
antimicrobial policies.
Use of the product deviating from the instructions given in the SPC
may increase the
prevalence of bacteria resistant to cefalexin and may decrease the
effectiveness of
treatment with other beta lactam antibiotics due to the potential for
cross-resistance.
The rules of asepsis must be scrupulously followed during the
administration of the
product. The efficacy of the product has only been established against
the pathogen
s mentioned in section 4.2. Consequently,