Cephorum 250 mg film-coated tablets for dogs
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
23-02-2013
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Active ingredient:
cefalexin monohydrate 250 mg
Available from:
Forum Products Limited
ATC code:
QJ01DB01
Pharmaceutical form:
Film coated tablet
Therapeutic group:
Cefalexin
Therapeutic area:
Dogs
Authorization date:
2011-12-21
Summary of Product characteristics
Revised: February 2012
AN: 00045/2011
Page 1 of 6
SUMMARY OF PRODUCTS CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cephorum 250 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE INGREDIENT:
Cefalexin
250 mg
as cefalexin monohydrate
263 mg
EXCIPIENTS:
Titanium dioxide (E171)
0.55 mg
Excipient qsp 1 tablet of 355 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Film-coated tablet
Round, white to yellowish, biconvex tablet, scored on one side. ‘CX’ is
imprinted above the scoreline, ‘250’ is imprinted below the scoreline.
The tablets are not divisible.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment of urinary tract infections in dogs
caused by _Klebsiella pneumoniae_ and for the treatment of bacterial skin
infections in dogs, when susceptible organisms are present.
4.3
CONTRA-INDICATIONS
Do not use in cases of known hypersensitivity to the active substance, to
other cephalosporins, to other substances of the β-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
Revised: February 2012
AN: 00045/2011
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Use of the product should be based on susceptibility testing and take
in to account official and local antimicrobial policies.
Use of the p
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