Betamox Palatable Drops Powder for Oral Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

114.8 milligram(s)/gram

Pharmaceutical form:

Powder for oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cats, Dogs

Therapeutic area:

amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1987-10-01

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox Palatable Drops Powder for Oral Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Each bottle contains the equivalent of 750 mg Amoxicillin (as the
Trihydrate) and when reconstituted with 12 ml water
gives a 15 ml suspension containing Amoxicillin at a concentration of
50 mg/ml.
Excipients:
Erythrosine (E127)
0.312 mg.
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
Amoxycillin is a broad spectrum semi-synthetic penicillin bactericidal
in action.
In vitro it is effective against a wide
range of
Gram-positive and Gram-negative bacteria found in dogs and cats
including:
_Bacillus cereus,_
_Bordetella_
_bronchiseptica,_
_Corynebacterium spp,_
_Citrobacter freundii_,
_Chromobacter spp,_
_Flavobacter spp,_
_Pasteurella spp_
(including P._ multocida), Salmonella_ spp, Staphylococci (penicillin
sensitive strains), Streptococci.
Some effect has been observed against_ Escherichia coli._
Betamox Palatable Drops are suitable for the control of infections
caused by susceptible organisms including:
infections of the alimentary tract, respiratory tract and urogenital
tract, eye and ear infections and skin and wound
infections
4.3 CONTRAINDICATIONS
Betamox Palatable Drops should not be given to penicillin sensitive
animals.
As with other penicillins,
amoxycillin should not
be used orally or parenterally in rabbits,
guinea pigs,
hamsters or
gerbils.
Caution is advised when used in any other very small herbivores.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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