Lamoxsan 150 mg/ml Suspension for Injection for Cattle and Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin

Available from:

Alfasan Nederland B.V.

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Pharmaceutical form:

Suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2023-07-20

Summary of Product characteristics

Issued July 2023
AN: 00797/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Lamoxsan 150 mg/ml suspension for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Amoxicillin
150.0 mg
(equivalent to 172.2 mg of amoxicillin trihydrate)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS
AND OTHER CONSTITUENTS
Silica, colloidal anhydrous
Sorbitan oleate
Propylene glycol dicaprylocaprate
Suspension for injection.
White to grey-white oily suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and pigs
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
In cattle:
Treatment of respiratory infections caused by _Mannheimia haemolytica_
and
_Pasteurella multocida_.
In pigs:
Treatment of respiratory infections caused by _Pasteurella multocida_.
3.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to penicillins,
cephalosporins or to any
of the excipients.
Do not use in cases of severe renal dysfunction with anuria and
oliguria.
Do not use in case of infection with beta-lactamase-producing
bacteria.
Do not administer to Equidae, because amoxicillin – like all
aminopenicillins – may
adversely affect the bacterial flora of the caecum.
Issued July 2023
AN: 00797/2022
Page 2 of 7
Do not use in rabbits, hares, hamsters, guinea pigs or other small
herbivores.
3.4
SPECIAL WARNINGS
This veterinary medicinal product is not effective against
beta-lactamase producing
organisms.
Cross-resistance has been shown between amoxicillin and other
beta-lactam
antibiotics. Use of the veterinary medicinal product should be
carefully considered
when susceptibility testing has shown resistance to beta-lactam
antibiotics because
its effectiveness may be reduced.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Use of the veterinary medicinal product should be based on
identification and
susceptibility testing of the target pathogen(s). If this is not
possible, therapy should
be based on