Amoxy Active 697 mg/g Oral Powder for Pigs and Chickens

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Amoxicillin

Saatavilla:

Dopharma Research B.V.

ATC-koodi:

QJ01CA04

INN (Kansainvälinen yleisnimi):

Amoxicillin

Lääkemuoto:

Oral powder

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Chickens, Pigs

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2014-06-27

Valmisteyhteenveto

AN: 00885/2018
Issued: May 2019
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
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:_
For the full list of excipients, see section 6.1.
3.
PHARMAPEUTICAL FORM
Oral powder .
White to off-white powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pig and chicken (broiler, pullet, breeder).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs:
Treatment of respiratory tract infections, gastro-intestinal tract
infections, urogenital infections, ear necrosis, secondary infections
following viral infections and septicemia 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.
4.3
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Sick animals have an altered drinking behaviour and should be
medicated
parenterally where applicable.
AN: 00885/2018
Issued: May 2019
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into account
when the
product is used.
Use of the 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 product deviating from t