Amatib 800 mg/g Oral Powder for Pigs and Chickens

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Amoxicillin Trihydrate

זמין מ:

Krka d.d., Novo Mesto

קוד ATC:

QJ01CA04

INN (שם בינלאומי):

Amoxicillin Trihydrate

טופס פרצבטיות:

Oral powder

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Chickens, Pigs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

2015-09-23

מאפייני מוצר

Revised: June 2021
AN: 02139/2020 & 02140/2020
Page 1 of 7
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.
Revised: June 2021
AN: 02139/2020 & 02140/2020
Page 2 of 7
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
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, therapy should be based on
l