AMATIB 800 MG/G POWDER FOR PIGS AND CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

AMOXICILLIN TRIHYDRATE PH. EUR. (EQUIVALENT TO 697 MG AMOXICILLIN)

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01CA04

INN (International Name):

AMOXICILLIN TRIHYDRATE PH. EUR. (EQUIVALENT TO 697 MG AMOXICILLIN)

Dosage:

800 mg/g

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM

Therapeutic group:

Fowl - Chicken, Porcine

Therapeutic area:

Amoxicillin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2015-08-21

Summary of Product characteristics

                                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: Colourless to pale yellowish
solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
Chickens (chicks, 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 known cases of hypersensitivity to penicillin or other
substances of the beta-lactam group.
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.
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