Betamox 150 mg/ml Suspension for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cats, Cattle, Dogs, Pigs, Sheep

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1986-06-30

Summary of Product characteristics

Revised: January 2021
AN: 01480/2020
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
ACTIVE SUBSTANCE:
Amoxicillin
150 mg
(as Amoxicillin Trihydrate
172.1 mg)
EXCIPIENTS:
Butylated Hydroxyanisole
0.08 mg
Butylated Hydroxytoluene
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:
_Actinobacillus equuli_
_Actinomyces bovis_
_Actinobacillus lignieresi_
_Bacillus anthracis_
_Erysipelothrix rhusiopathiae_
_Bordetella bronchiseptica_
_Escherichia coli_
_Clostridium_ species
_Haemophilus_ species
_Corynebacterium_ species
_Pasteurella_ species
_Fusiformis_ species
_Proteus mirabilis_
_Moraxella_ species
Revised: January 2021
AN: 01480/2020
Page 2 of 5
_Salmonella_ species
_Staphylococci_
_Streptococci_
Not effective against beta-lactamase producing organisms.
4.3
CONTRAINDICATIONS
Intravenous or intrathecal use.
Use in rabbits, hamsters, gerbils and guinea pigs.
Use in known cases of hypersensitivity to amoxycillin.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Care should be taken to avoid accidental self-injection. In the case
of
accidental self-injection, seek medical advice immediately.
Penicillins and
cephalosporins may cause hypersensitivity (allergy) following
injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillins
may
lead
to
cross
reactions
to
cephalosporins
and
vice
versa.
Allergic
reactions to these substances may occasionally b