Cephorum 250 mg Film-coated Tablets for Dogs
Страна: Великобритания
Език: английски
Източник: VMD (Veterinary Medicines Directorate)
Данни за продукта
(SPC)
07-10-2016
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Активна съставка:
Cefalexin
Предлага се от:
Forum Products Limited
АТС код:
QJ01DB01
INN (Международно Name):
Cefalexin
Лекарствена форма:
Film-coated tablet
Вид предписание :
POM-V - Prescription Only Medicine – Veterinarian
Терапевтична група:
Dogs
Терапевтична област:
Antimicrobial
Статус Оторизация:
Authorized
Дата Оторизация:
1999-06-11
Данни за продукта
Revised: March 2016
AN: 01390/2015
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
4.5
SPECIAL PRECAUTIONS FOR USE
Page 1 of 7
Revised: March 2016
AN: 01390/2015
Page 2 of 7
Revised: March 2016
AN: 01390/2015
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 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
potential cross-resistance.
In case of an alle
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