Betamox LA 150 mg/ml Suspension for Injection

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Amoxicillin trihydrate

Tillgänglig från:

Norbrook Laboratories (Ireland) Limited

ATC-kod:

QJ01CA01

INN (International namn):

Amoxicillin trihydrate

Dos:

150 milligram(s)/millilitre

Läkemedelsform:

Suspension for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapiområde:

ampicillin

Bemyndigande status:

Authorised

Tillstånd datum:

1987-10-01

Produktens egenskaper

Health Products Regulatory Authority
07 January 2021
CRN00C056
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox LA 150 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Amoxicillin as Amoxicillin Trihydrate
150
mg
EXCIPIENTS
Butylated hydroxyanisole E320
0.08
mg
Butylated hydroxytoluene E321
0.08
mg
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
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:
​
_Bacillus anthracis_
​
_Haemophilus _spp_._
_Bacillus cereus_
​
_Pasteurella _spp_._
​
_Bordetella bronchiseptica_
​
_Proteus mirabilis_
_Clostridium _spp_._
​
_Salmonella _spp_._
_Corynebacterium _spp_._
​
non-penicillinase producing staphylococci
_Erysipelothrix rhusiopathiae_
​
non-penicillinase producing streptococci
​
_Escherichia coli_
​
_Fusiformis _spp_._
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.
Health Products Regulatory Authority
07 January 2021
CRN00C056
Page 2 of 4
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE