Amoxycare Palatable Drops Powder for Oral Suspension 50 mg/ml

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:

Powder for oral suspension

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1998-02-09

Summary of Product characteristics

                                Revised: 17 December 2008
A.N: 00499/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxycare Palatable Drops Powder for Oral Suspension 50mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE: Each bottle contains the equivalent of 750 mg
amoxicillin (as
Amoxicillin Trihydrate Ph.Eur.) and when reconstituted with 12 ml
water gives a
15 ml suspension containing amoxicillin at a concentration of 50
mg/ml.
EXCIPIENTS:
Erythrosine E127 2.34 mg per bottle
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for oral suspension
A pale red powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the control of infections in dogs and cats caused by susceptible
organisms,
including infections of the alimentary tract, respiratory tract and
urogenital tract,
eye and ear infections, and skin and wound infections. _ In vitro_,
amoxicillin is
effective against a wide range of Gram-positive and Gram-negative
bacteria,
including:
_Bacillus cereus_
_Bordetella bronchiseptica_
_Corynebacterium _spp
_Citrobacter freundii_
_Chromobacter_ spp
_Escherichia coli_
_Flavobacter_ spp
_Pasteurella_ spp (including _P. multocida_)
_Proteus mirabilis_
Revised: 17 December 2008
A.N: 00499/2008
_Salmonella_ spp
_Staphylococci_ (penicillin sensitive stains)
_Streptococci_
4.3
CONTRAINDICATIONS
Not to be used in animals known to be hypersensitive to penicillin.
Not to be used orally or parenterally in rabbits, guinea pigs,
hamsters or gerbils.
Caution is advised when used in any 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 PRODUC
                                
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