Cephacare flavour 250 mg tablets for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Cefalexin

Fáanlegur frá:

Animalcare Limited

ATC númer:

QJ01DB01

INN (Alþjóðlegt nafn):

Cefalexin

Skammtar:

250 mg/tablet

Lyfjaform:

Tablet

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

cefalexin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2008-12-19

Vara einkenni

Health Products Regulatory Authority
06 July 2018
CRN000YMD
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephacare flavour 250 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
250 mg cefalexin as cefalexin monohydrate.
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
Beige, flat tablets with a break mark on one side.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections of the respiratory tract, gastro-intestinal
tract, urogenital
tract, the skin and localised infections in soft tissue caused by
bacteria sensitive to
cefalexin.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance,
to other
cephalosporins, to other substances of the
b
-lactam group or to any of the excipients.
Do not use in rabbits, gerbils, guinea pigs and hamsters.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Health Products Regulatory Authority
06 July 2018
CRN000YMD
Page 2 of 5
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and take
into account
official and local 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 penicillins, due to the potential for cross resistance.
In the case of an allergic reaction, treatment should be withdrawn.
As with other antibiotics which are excreted mainly by the kidneys,
unnecessary
accumulation may occur in the body when renal function is impaired. In
cases of
known renal insufficiency the dose should be reduced, antimicrobials
known to be
nephrotoxic should not be administered concurrently and the product
should be
used only according to a risk/benefit assessment by the responsible
veterinarian.
SPECIAL PRECAUTIONS TO BE