BIOCILLIN 1000 MG/G POWDER FOR USE IN DRINKING WATER FOR CHICKENS, DUCKS AND TURKEYS

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

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SPC SPC (SPC)
21-03-2017

active_ingredient:

AMOXICILLIN TRIHYDRATE PH. EUR.

MAH:

Bela-Pharm GmbH & Co. KG

ATC_code:

QJ01CA04

INN:

AMOXICILLIN TRIHYDRATE PH. EUR.

dosage:

1000 mg/g

pharmaceutical_form:

Powder for use in drinking water

prescription_type:

POM

therapeutic_group:

Fowl - Chicken, Fowl - Duck, Fowl - Turkey

therapeutic_area:

Amoxicillin

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

2016-06-24

SPC

                                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
1.0 g powder 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 treat infections caused by bacteria producing the enzyme beta
lactamase.
Do not administer to rabbits, hamsters, gerbils, guinea pigs or any
other small herbivore.
Do not use in animals with known hypersensitivity to penicillins or
other ß-lactam antibiotics or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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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 anim
                                
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