Amoxival 500 mg/g Oral Powder for Pigs and Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin

Available from:

Ceva Animal Health Ltd

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Pharmaceutical form:

Oral powder

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2014-05-29

Summary of Product characteristics

Revised: June 2016
AN: 00212/2016
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxival 500 mg/g oral powder for pigs and chickens
Amoxival Vet (DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains
ACTIVE SUBSTANCE:
Amoxicillin500.00 mg
(as amoxicillin trihydrate 574.00 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder
White or almost white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (pigs after weaning) and chickens (broilers)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs (after weaning):
Treatment
of
swine
pleuropneumonia
due
to
_Actinobacillus_
_pleuropneumoniae_
(susceptible to amoxicillin).
Broiler chickens:
Prevention at the group level, when disease is present, of respiratory
infections
caused by _Escherichia coli _(susceptible to amoxicillin).
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or
other substances
of the ß-lactam group.
Do not use in animals with serious kidney malfunction including anuria
and oliguria.
Do not use in presence of β - lactamase producing bacteria.
Do not use in lagomorphs and rodents such as rabbits, guinea pigs,
hamsters or
gerbils.
Do not use in ruminants or horses.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: June 2016
AN: 00212/2016
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The uptake of medication by animals can be altered as a consequence of
illness. In
case of insufficient uptake of feed/ water animals should be treated
parenterally.
Use of the product should be based on susceptibility testing of the
bacteria isolated
from animals. If this is not possible, therapy should be based on
local (regional, farm
level) epidemiological information about susceptibility of the target
bacteria.
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
amoxicillin, other penicillins and may decrease its effectiveness..
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