Biocillin 1000 mg/g Powder for use in drinking water for chickens, ducks and turkeys

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin trihydrate

Available from:

Bela-Pharm GmbH & Co. KG

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin trihydrate

Dosage:

1000 milligram(s)/gram

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens, Ducks, Turkeys

Therapeutic area:

amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-06-24

Summary of Product characteristics

Health Products Regulatory Authority
18 June 2021
CRN009Z5X
Page 1 of 4
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.
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.
Health Products Regulatory Authority
18 June 2021
CRN009Z5X
Page 2 of 4
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 penicillin