AMOXY ACTIVE, 697 mg/g, oral powder for pigs and chickens

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Amoxicillin

Disponível em:

Dopharma Research B.V.

Código ATC:

QJ01CA04

DCI (Denominação Comum Internacional):

Amoxicillin

Dosagem:

697 milligram(s)/gram

Forma farmacêutica:

Oral powder

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Chickens, Other Birds, Pigs

Área terapêutica:

amoxicillin

Indicações terapêuticas:

Antibacterial

Status de autorização:

Authorised

Data de autorização:

2014-08-22

Características técnicas

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxy Active, 697 mg/g, oral powder for pigs and chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin
697 mg
as amoxicilline trihydrate
800 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
Sodium carbonate
Sodium citrate
White to off-white oral powder.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs and chickens (broilers, pullets, chickens for reproduction).
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Pigs:
Treatment of respiratory tract infections, gastro-intestinal tract
infections, urogenital infections,
secondary infections following viral infections and septicaemia caused
by
micro-organisms, susceptible to amoxicillin.
Chickens: Treatment of respiratory tract infections and
gastro-intestinal tract infections caused by
micro-organisms susceptible to amoxicillin.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to penicillin or other
substances of the beta-lactam group or to any of
the excipients.
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in lagomorphs and rodents such as guinea pigs, hamsters or
gerbils.
Do not use in animals with serious kidney malfunction including anuria
and oliguria.
Do not use in ruminants or horses.
3.4
SPECIAL WARNINGS
Sick animals have an altered drinking behaviour and should be
medicated parenterally where applicable.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Official, national and regional antimicrobial policies should be taken
into account when the veterinary
medicinal product is used.
Use of the veterinary medicinal product should be based on
susceptibility testing of the bacteria isolated
from the animal. If this is not possible, therapy should be based on
local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Use of the veterinary medicinal product deviating from the
instructions given in the SPC may increase the
pre