BETAMOX LA 150 MG/ML SUSPENSION FOR INJECTION.
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
07-01-2017
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Active ingredient:
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.)
Available from:
Norbrook Laboratories Limited
ATC code:
QJ01CA01
INN (International Name):
AMOXICILLIN (EQUIVALENT TO AMOXICILLIN TRIHYDRATE PH. EUR.)
Dosage:
150 Mg/Ml
Pharmaceutical form:
Suspension for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Feline, Ovine, Porcine
Therapeutic area:
Ampicillin
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 LA 150 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
An off-white oily suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle
Sheep
Pigs
Dogs
Cats
Each ml contains:
ACTIVE SUBSTANCE
Amoxicillin as Amoxicillin Trihydrate 150
mg
EXCIPIENTS
Butylated hydroxyanisole E320
0.08 mg
Butylated hydroxytoluene E321
0.08 mg
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 23/12/2016_
_CRN 7025442_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by a wide range of Gram-positive and Gram-negative
pathogenic bacteria including:
Betamox LA is suitable for the control of infections due to susceptible micro-organisms in
cattle, sheep, pigs, dogs and cats where a single injection giving prolonged activity is required.
It may also protect from secondary bacterial invasion in cases where bacteria are not the initial
cause of disease.
Indications include infections of:
a) Alimentary tract,
b) Respiratory tract,
c) Skin and soft tissue,
d) Urogenital tract and
e) In prevention of post-operative infection (treat before surgery).
4.3 CONTRAINDICATIONS
Not for intravenous or intrathecal use.
Do not use in rabbits, hamsters, gerbils and guinea pigs.
Do not use in known cases of hypersensitivity to amoxycillin.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
_Bacillus anthracis_
_Haemophilus _spp_._
_Bacillus cereus_
_Pasteurella _spp_._
_Bordetella bronchiseptica_
_Proteus mirabilis_
_Clostridium _spp_._
_Salmonella _spp_._
_Corynebacterium _spp_._
non-penicilli
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