Rilexine DC 375 mg intramammary suspension for dry cows

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cephalexin benzathine

Available from:

Virbac S.A.

ATC code:

QJ51DB01

INN (International Name):

Cephalexin benzathine

Pharmaceutical form:

Intramammary suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

cefalexin

Authorization date:

2022-07-08

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Rilexine DC 375 mg intramammary suspension for dry cows [FR, AT, BE,
BG, CZ, DE, EE, HR, HU,
IE, IT, LT, LV, NL, PL, PT, RO, SK, SI, UK(NI)]
Rilexine secado 375 mg intramammary suspension for dry cows [ES]
Cefalexin Virbac 375 mg intramammary suspension for dry cows [DK]
Cefalexin Virbac vet 375 mg intramammary suspension for dry cows [FI]
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.
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 .
2
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 follo