Amoxycare 40 mg Tablets

Summary of Product characteristics

                                Revised: 10
th
December 2008
AN: 00496/2008
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxycare 40mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Each 0.228 g tablet contains Amoxicillin Trihydrate
45.92
mg which is equivalent to 40.00 mg Amoxicillin.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet
Off-white circular tablets scored on one face.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For use in the treatment of bacterial infections of the alimentary,
respiratory
and urogenital tracts and in the eye, ear, skin and wound infections
caused by
susceptible organisms. _ In vitro_, amoxycillin is effective against a
range of
Gram-positive and Gram-negative bacteria, including:
_Bacillus cereus_
_Bordetella bronchiseptica_
_Corynebacterium_ spp
_Chromobacter_ spp
_Citrobacter freundii_
_Escherichia coli_
_Flavobacter_ spp
_Proteus mirabilis_
_Pasteurella _spp including _Pasteurella multocida_
_Salmonella_ spp
_Staphylococci _(penicillin sensitive strains)
_Streptococci_
Revised: 10
th
December 2008
AN: 00496/2008
Page 2 of 5
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to amoxycillin.
Not for administration to rabbits, guinea pigs, hamsters or gerbils.
Caution is advised when used in other small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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 information.
SPECIAL
PRECAUTIONS
TO
BE
TAKEN
BY
THE
PERSON
ADMINISTERING
THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following
injection, inhalation, ingestion or skin contact. Hypersensitivity to
penicillins
may lead to cross reactions to cephalosporin
                                
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