Rilexine 300 mg Tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Cefalexin monohydrate

Available from:

Virbac S.A.

ATC code:

QJ01DB01

INN (International Name):

Cefalexin monohydrate

Dosage:

300 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

cefalexin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

Health Products Regulatory Authority
19 January 2022
CRN00CHP7
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rilexine 300 mg Tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Cefalexin
300
mg
(as Cefalexin Monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Creamy oblong tablet with small brown spots marked with a score line.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial skin infections in dogs (including deep
and superficial pyodermas) caused by organisms
susceptible to Cefalexin.
For the treatment of urinary-tract infections in dogs (including
nephritis and cystitis) caused by organisms susceptible to
Cefalexin.
4.3 CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to penicillins and
cephalosporins.
Do not use in rabbits, guinea pigs, hamsters and gerbils.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
As with other antibiotics which are excreted mainly by the kidneys,
unnecessary accumulation may occur in the body when
renal function is impaired. In case of known renal insufficiency, the
dose should be reduced and antimicrobials known to be
nephrotoxic should not be administered concurrently.
This product should not be used to treat puppies of less than 1 kg of
bodyweight.
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
penicillins due to the potential for cross-resistance.
Health Products Regulatory Authority
19 January 2022
CRN00CHP7
Page 2 of 4
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 epidemiological informa