Solamocta 697 mg/g powder for use in drinking water for chickens, ducks and turkeys

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Amoxicillin

Disponibil de la:

Eurovet Animal Health B.V.

Codul ATC:

QJ01CA04

INN (nume internaţional):

Amoxicillin

Dozare:

697 milligram(s)/gram

Forma farmaceutică:

Powder for oral solution

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Chickens, Ducks, Turkeys

Zonă Terapeutică:

amoxicillin

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

2016-04-01

Caracteristicilor produsului

Health Products Regulatory Authority
20 July 2020
CRN009GNZ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Solamocta 697 mg/g powder for use in drinking water for chickens,
ducks and turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram contains:
ACTIVE SUBSTANCE:
​
Amoxicillin
​697 mg
​
equivalent to amoxicillin trihydrate
​800 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for use in drinking water.
White to pale yellow-white powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chicken (broiler, pullet, breeder), duck (broiler, breeder), turkey.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in chickens, turkeys and ducks caused by
bacteria susceptible to amoxicillin.
4.3 CONTRAINDICATIONS
Do not use in the presence of ß-lactamase-producing bacteria.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other
small herbivores.
Do not use in cases of hypersensitivity to penicillins or other
substances from the beta-lactam group or to any of the excipients.
Do not use in ruminants or horses.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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 local (regional, farm level) epidemiological information
about susceptibility of the target bacteria. Use of the product
deviating from the instructions given in the SPC may increase the
prevalence of bacterial resistance to amoxicillin and may
decrease its effectiveness.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals:
Avoid inhalation of dust.
Wear either a disposable half-mask respirator conforming to European
Standard EN149 or a non-disposable respirator to
E