Betamox LA 150 mg/ml Suspension for Injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Amoxicillin

Dostopno od:

Norbrook Laboratories Limited

Koda artikla:

QJ01CA01

INN (mednarodno ime):

Amoxicillin

Odmerek:

150 milligram(s)/millilitre

Farmacevtska oblika:

Suspension for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cats, Cattle, Dogs, Pigs, Sheep

Terapevtsko območje:

ampicillin

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

1987-10-01

Lastnosti izdelka

Health Products Regulatory Authority
25 October 2018
CRN000YLK
Page 1 of 5
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_._
Health Products Regulatory Authority
25 October 2018
CRN000YLK
Page 2 of 5
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.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANI