Amoxycare LA Suspension for Injection 15% w/v

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Amoxicillin

MAH:

Norbrook Laboratories Limited

ATC_code:

QJ01CA04

INN:

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:

Expired

authorization_date:

1997-11-05

SPC

Revised: March 2022
AN: 01821/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxycare LA Suspension for Injection 15% w/v
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS
ACTIVE SUBSTANCE(S) MG
Amoxicillin
150.0
(as Amoxicillin Trihydrate)
172.1
EXCIPIENTS
Butylated Hydroxytoluene
0.08 (as antioxidant)
Butylated Hydroxyanisole
0.08 (as antioxidant)
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
_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.
Revised: March 2022
AN: 01821/2021
Page 2 of 6
Amoxycare LA Injection 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
due to sensitive organisms in cases where bacteria are not the initial
cause of the
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
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
i.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the
bacteria isolated
from
the
animal.
If
this
is