Betamox 150 mg/ml Suspension for Injection

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Amoxicillin trihydrate

MAH:

Norbrook Laboratories (Ireland) Limited

ATC_code:

QJ01CA04

INN:

Amoxicillin trihydrate

dosage:

150 milligram(s)/millilitre

pharmaceutical_form:

Suspension for injection

prescription_type:

POM: Prescription Only Medicine as defined in relevant national legislation

therapeutic_area:

amoxicillin

authorization_status:

Authorised

authorization_date:

1987-10-01

SPC

Health Products Regulatory Authority
25 January 2019
CRN008SVL
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Betamox 150 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
150 mg amoxicillin (as Amoxicillin Trihydrate), and 0.08 mg butylated
hydroxytoluene
(E321) and 0.08 mg butylated hydroxyanisole (E320) as antioxidants.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
An off-white 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 _
_Bacillus cereus _
_Bordetella bronchiseptica _
_Clostridium _spp.
_Corynebacterium _spp_._
_Erysipelothrix rhusiopathiae_
_Escherichia coli_
_Fusiformis_ spp.
_Haemophilus_ spp.
_Pasteurella_ spp.
_Proteus mirabilis_
_Salmonella_ spp_._
Health Products Regulatory Authority
25 January 2019
CRN008SVL
Page 2 of 5
Non-penicillinase producing Staphylococci
Non-penicillinase producing Streptococci
4.3 CONTRAINDICATIONS
Not for intravenous or intrathecal use
Do not use in rabbits, hamsters, gerbils and guinea pigs
Do not use in sheep producing milk for human consumption.
Do not use in known cases of hypersensitivity to
amoxicillin/penicillin.
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
MEDICINAL
PRODUCT TO ANIMALS
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin
may lead to cross
sensitivity to cephalosporins and vice versa. Allergic reaction to
these substances can
occasionally be serious.
1. Do not handle this product if you know you are sensitised or if you
have been
advised n