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 (Ireland) 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 area:

amoxicillin

Authorization status:

Authorised

Authorization date:

1987-10-01

Summary of Product characteristics

Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 1 of 4
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.
Health Products Regulatory Authority
24 January 2019
CRN008TFG
Page 2 of 4
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
None.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICI