Ceporex Vet Oral Drops, Granules for Oral Suspension 1000 mg for Cats and Dogs

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktívna zložka:

Cefalexin

Dostupné z:

Schering-Plough Ltd

INN (Medzinárodný Name):

Cefalexin

Stav Autorizácia:

Expired

Súhrn charakteristických

Revised: 28 May 2008
AN: 00873/2007
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Ceporex Vet Oral Drops, Granules for Oral Suspension 1000mg for cats
and
dogs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active constituents
Cefalexin 1000 mg
(equivalent to 100 mg/ml once reconstituted)
_Other excipients:_
mg/bottle
mg/ml (in reconstituted product)
Sunset Yellow (E110)
8.32
0.832
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Granules for oral suspension.
Orange granules with a characteristic odour which following
reconstitution
forms an orange suspension also having a characteristic odour.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and small dogs (up to 20 kg).
4.2
INDICATIONS FOR USE
As a broad spectrum antibiotic with bactericidal activity against a
wide range
of Gram-positive and Gram-negative bacteria, for use in cats and small
dogs.
The product is effective against the following micro-organisms _in
vitro_:
_Staphylococcus _
spp. (including penicillin-resistant strains), _Streptococcus _
spp., _Corynebacterium_ spp, _Pasteurella multocida_, _Escherichia
_coli,
_Micrococcus_ spp,_ Moraxella_ spp.
Where susceptible organisms are present, the drops are indicated for
the
treatment of
infection of respiratory tract, urogenital tract, the skin and
localised infections in soft tissue.
In dogs it may also be effective in the treatment of infections of the
gastro-
intestinal tract.
Page 1
Revised: 28 May 2008
AN: 00873/2007
4.3
CONTRA-INDICATIONS
Do not administer to animals which are known to be hypersensitive to
Cefalexin. In cases of known renal insufficiency, the dose of the
product
should be reduced.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None Known
4.5
SPECIAL PRECAUTIONS FOR USE
_SPECIAL PRECAUTIONS FOR USE IN ANIMALS_
Shake the bottle before withdrawing each dose.
_SPECIAL SAFETY PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING
THE _
_PRODUCT TO _
_ANIMALS_
Cephalosporins may cause sensitisation (allergy) following injection,
inhalation, ingestion or skin contact. Sensitivity to