AMOXICILLIN GLOBAL VET HEALTH 500 mg/g, powder for use in drinking water for chickens, turkeys, ducks and pigs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Amoxicillin trihydrate

Fáanlegur frá:

GLOBAL VET HEALTH SL

ATC númer:

QJ01CA04

INN (Alþjóðlegt nafn):

Amoxicillin trihydrate

Skammtar:

500 milligram(s)/gram

Lyfjaform:

Powder for use in drinking water

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Chickens, Ducks, Pigs, Turkeys

Lækningarsvæði:

amoxicillin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2015-12-04

Vara einkenni

Health Products Regulatory Authority
23 November 2020
CRN009RN4
Page 1 of 5
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 436 mg
(equivalent to 500 mg of amoxicillin trihydrate)
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
Chickens, turkeys and ducks: for the treatment of infections caused by
bacteria susceptible to amoxicillin.
Pigs: For the treatment of pasteurellosis caused by _Pasteurella
multocida_ susceptible to amoxicillin.
4.3 CONTRAINDICATIONS
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other
small herbivores.
Do not use in horses.
Do not use in known cases of hypersensitivity to penicillins or other
substances from the betalactam group or to the excipient.
Do not use in animals with renal disease including anuria or oliguria.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Pigs: The uptake of medication by animals may be altered as a
consequence of illness. In case of insufficient water uptake,
animals should be treated parenterally instead using a suitable
injectable product prescribed by the veterinarian.
The use of the product should be combined with good management
practices e.g. good hygiene, proper ventilation, no
overstocking.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not effective against beta-lactamase producing organisms.
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 iso