Betamox 40 mg Palatable Tablets

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Amoxicillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Pharmaceutical form:

Tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

1987-09-22

Summary of Product characteristics

                                Revised: 31 July 2008
AN: 00090/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox 40mg Palatable Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains :
ACTIVE SUBSTANCE:
Amoxicillin
40 mg
(as Amoxicillin Trihydrate)
45.92 mg
EXCIPIENTS:
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_, amoxicillin 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: 31 July 2008
AN: 00090/2008
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to amoxicillin.
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
None
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 cephalosporins and vice versa. Allergic reactions to
these substances may
occasionally be serious.
1.
Do not handle this product if you know you are sensitised, or if you
have been
advised not to work with such preparations.
2.
Handle this prod
                                
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