Betamox LA 150 mg/ml Suspension for Injection

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Amoxicillin

Disponible depuis:

Norbrook Laboratories Limited

Code ATC:

QJ01CA04

DCI (Dénomination commune internationale):

Amoxicillin

forme pharmaceutique:

Suspension for injection

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Cats, Cattle, Dogs, Pigs, Sheep

Domaine thérapeutique:

Antimicrobial

Statut de autorisation:

Authorized

Date de l'autorisation:

1986-06-30

Résumé des caractéristiques du produit

Revised: March 2022
AN: 01821/2021
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
ACTIVE SUBSTANCE:
Each ml contains:
150 mg (15% w/v) Amoxicillin
(as Amoxicillin Trihydrate 17.21 %w/v),
EXCIPIENTS:
0.08 mg (0.008% w/v) butylated hydroxytoluene
0.08 mg (0.008% w/v) butylated hydroxyanisole as antioxidants.
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Suspension for injection.
An off-white oily non-aqueous suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Sheep, Pigs, Dogs, Cats
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_In vitro_ Amoxicillin is effective against a wide range of
Gram-positive and Gram-
negative bacteria which include:
_Escherichia coli_
_Klebsiella pneumoniae_
_Proteus _species
_Salmonella _species
Staphylococci and
Streptococci
Not effective against beta-lactamase producing organisms.
Suitable for the control of infections due to susceptible
microorganisms in cattle,
sheep, pigs, dogs and cats where a single injection giving prolonged
activity is
required. It may also protect from secondary bacterial invasion due to
sensitive
organisms in cases where bacteria are not the initial cause of the
disease.
Revised: March 2022
AN: 01821/2021
Page 2 of 5
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
This product is not suitable for intravenous or intrathecal use
This product should not be administered to rabbits, hamsters, gerbils
or guinea pigs.
Not for use in known cases of hypersensitivity to penicillins or
cephalosporins.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
No special warnings.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated
from
t