Amatib 800 mg/g oral powder for pigs and chickens

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Amoxicillin trihydrate

Saadav alates:

Krka, d.d., Novo mesto

ATC kood:

QJ01CA04

INN (Rahvusvaheline Nimetus):

Amoxicillin trihydrate

Annus:

800 milligram(s)/gram

Ravimvorm:

Powder for use in drinking water

Retsepti tüüp:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutiline rühm:

Chickens, Pigs

Terapeutiline ala:

amoxicillin

Näidustused:

Antibacterial

Volitamisolek:

Authorised

Loa andmise kuupäev:

2015-08-21

Toote omadused

Health Products Regulatory Authority
23 April 2021
CRN00C7RP
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amatib 800 mg/g oral powder for pigs and chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate 800 mg (corresponds to 697 mg of amoxicillin).
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral powder.
White to pale yellow powder.
Appearance of the product after dilution: Colorless to pale yellowish
solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
Chickens (broilers, pullets, breeders).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PIGS:
Treatment of respiratory tract infections, gastro-intestinal tract
infections, meningitis, arthritis and secondary infections caused
by micro-organisms susceptible to amoxicillin.
CHICKENS:
Treatment of respiratory tract infections and gastro-intestinal tract
infections (other than salmonella infections) caused by
micro-organisms susceptible to amoxicillin.
4.3 CONTRAINDICATIONS
Do not use in cases of (known) hypersensitivity to penicillin, other
substances of the beta-lactam group or to any of the
excipients.
Do not use in animals with serious kidney disease including anuria or
oliguria.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other
small herbivores.
Do not use in ruminants or horses.
Do not use in the presence of ß-lactamase-producing bacteria.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Sick animals may have reduced water and/or feed intake and
consequently, may require parenterally administered medication
instead.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Health Products Regulatory Authority
23 April 2021
CRN00C7RP
Page 2 of 5
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 isolated from the animal. If this is not possible,
ther