AMOXIVAL 500 MG/G ORAL POWDER FOR PIGS AND CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)

Available from:

Ceva Santé Animale

ATC code:

QJ01CA04

INN (International Name):

AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)

Dosage:

500 mg/g

Pharmaceutical form:

Oral Powder

Prescription type:

POM

Therapeutic group:

Fowl, Porcine

Therapeutic area:

Amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2016-04-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxival 500 mg/g oral powder for pigs and chickens.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains
ACTIVE SUBSTANCE:
Amoxicillin....................................................... 500.00 mg
(as amoxicillin trihydrate 574.00 mg)
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral powder.
White or almost white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (pigs after weaning) and chickens (broilers).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs (after weaning):
Treatment of swine pleuropneumonia due to _Actinobacillus pleuropneumoniae _(susceptible to amoxicillin).
Broiler chickens:
Prevention at the group level, when disease is present, of respiratory infections caused by _Escherichia coli _(susceptible
to amoxicillin).
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillins or other substances of the ß-lactam group.
Do not use in animals with serious kidney malfunction including anuria and oliguria.
Do not use in presence of
- lactamase producing bacteria.
Do not use in lagomorphs and rodents such as rabbits, guinea pigs, hamsters or gerbils.
Do not use in ruminants or horses.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 19/12/2016_
_CRN 7025199_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The uptake of medication by animals can be altered as a consequence of illness. In case of insufficient uptake of feed/
water animals should be treated parenterally.
Use of the product should be based on susceptibility testing