BETAMOX PALATABLE DROPS POWDER FOR ORAL SUSPENSION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE
Available from:
Norbrook Laboratories Limited
ATC code:
QJ01CA04
INN (International Name):
AMOXICILLIN TRIHYDRATE
Dosage:
114.8 mg/g
Pharmaceutical form:
Powder for Oral Suspension
Prescription type:
POM
Therapeutic group:
Canine, Feline
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.
IRISH MEDICINES BOARD
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