AMOXIVAL 500 MG/G ORAL POWDER FOR PIGS AND CHICKENS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
03-01-2017
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Ingredient activ:
AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
Disponibil de la:
Ceva Santé Animale
Codul ATC:
QJ01CA04
INN (nume internaţional):
AMOXICILLIN (AS AMOXICILLIN TRIHYDRATE)
Dozare:
500 mg/g
Forma farmaceutică:
Oral Powder
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Fowl, Porcine
Zonă Terapeutică:
Amoxicillin
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2016-04-22
Caracteristicilor produsului
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
________________________________________________________________________________________________________________________
_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
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