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

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Amoxicillin Trihydrate

Available from:

Virbac

ATC code:

QJ01CA04

INN (International Name):

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:

Expired

Authorization date:

2013-12-16

Summary of Product characteristics

                                Revised: August 2018
AN: 02000/2017
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Stabox 1000 mg/g powder for use in drinking water for chickens, ducks,
turkeys
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1.0 g powder contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate 1000 mg (equivalent to 871.24 mg amoxicillin)
3.
PHARMACEUTICAL FORM
Powder for use in drinking water
White or almost white, crystalline powder
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chicken, duck, turkey
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 in rabbits, hamsters, gerbils and guinea pigs.
Do not use in ruminants and horses.
Do not use in known cases of hypersensitivity to penicillins or to
other β-lactam
antibiotics.
Do
not
treat
infections
caused
by
bacteria
producing
the
enzyme
beta
lactamase.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: August 2018
AN: 02000/2017
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken
into
account when the product is used.
Resistance against amoxicillin may vary. 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 bacteria resistant to the amoxicillin and
may
decrease the effectiveness of the treatment.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
Persons handling this product should avoid inhalation of any dust and
contact with skin.
Wear
either
disposable
half-mask
respirator
conforming
to
European
Standard EN 149 or a non-disposal respira
                                
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