Biocillin 1000 mg/g Powder for Use in Drinking Water for Chickens, Ducks and Turkeys

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Amoxicillin Trihydrate

MAH:

Bela-Pharm GmbH & Co. KG

ATC_code:

QJ01CA04

INN:

Amoxicillin Trihydrate

pharmaceutical_form:

Powder for use in drinking water

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Chickens, Duck, Turkeys

therapeutic_area:

Antimicrobial

authorization_status:

Authorized

authorization_date:

2016-06-22

SPC

Revised: September 2021
AN: 01032/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Biocillin 1000 mg/g Powder for use in drinking water for chickens,
ducks and turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each g contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate 1000 mg
(equivalent to 871 mg Amoxicillin)
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Powder for use in drinking water.
White, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens, ducks, turkeys
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment
of
infections
in
chickens,
turkeys
and
ducks
caused
by
bacteria
susceptible to amoxicillin.
4.3
CONTRAINDICATIONS
Do not use this product to treat infections caused by bacteria
producing the enzyme
beta lactamase.
Do not use in rabbits, hamsters, gerbils, guinea pigs or any other
small herbivore.
Do not use in cases of hypersensitivity to amoxicillin trihydrate,
penicillins or other ß-
lactam antibiotics.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: September 2021
AN: 01032/2020
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 the instructions given in the SPC
may increase the
prevalence of bacterial resistance to amoxicillin and may decrease its
effectiveness.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Penicillins
and
cephalosporins
may
cause
hypersensitivity
(allergy)
following
injection, inhalation, ingestion and skin contact. Hypersensitivity to
penicillins may
lead to cross reactions to cepha