AMOXICILLIN GLOBAL VET HEALTH 500 MG/G, POWDER FOR USE IN DRINKING WATER FOR CHICKENS, TURKEYS, DUCKS AND PIGS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOXICILLIN (EQUIVALENT TO 500 MG AMOXICILLIN TRIHYDRATE PH. EUR.)

Available from:

GLOBAL VET HEALTH SL

ATC code:

QJ01CA04

INN (International Name):

AMOXICILLIN (EQUIVALENT TO 500 MG AMOXICILLIN TRIHYDRATE PH. EUR.)

Dosage:

500 mg/g

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

POM

Therapeutic group:

Fowl - Chicken, Fowl - Duck, Fowl - Turkey, Porcine

Therapeutic area:

Amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-12-04

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
AMOXICILLIN GLOBAL VET HEALTH 500 mg/g, powder for use in drinking
water for chickens, turkeys, ducks
and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin (equivalent to 500 mg amoxicillin trihidrate)……….
436 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water
A white powder.
Clear and colourless liquid when in solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens, turkeys, ducks and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in chickens, turkeys and ducks caused by
bacteria susceptible to amoxicillin.
Pigs: For the treatment of salmonellosis and pasteurellosis.
4.3 CONTRAINDICATIONS
Do not administer to rabbits, guinea pigs, hamsters, gerbils or any
other small herbivore.
Do not use in animals with known hypersensitivity to penicillins or
other ß-lactam antibiotics or to the excipient.
Do not administer to animals with renal disease including anuria or
oliguria.
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
Not effective against beta-lactamase producing organisms.
Pigs:
The uptake of
med