Zuritol 50 mg/ml oral suspension for pigs.

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
08-09-2018

Aktivni sastojci:

Toltrazuril

Dostupno od:

LABORATORIOS CALIER S.A.

ATC koda:

QP51AJ01

INN (International ime):

Toltrazuril

Doziranje:

50 milligram(s)/millilitre

Farmaceutski oblik:

Oral suspension

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapijska grupa:

Pigs

Područje terapije:

toltrazuril

Terapijske indikacije:

Coccidiostats

Status autorizacije:

Authorised

Datum autorizacije:

2013-12-20

Svojstava lijeka

                                Health Products Regulatory Authority
07 September 2018
CRN000Y6D
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Zuritol 50 mg/ml oral suspension for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
​
Active substance:
​
​
Toltrazuril
​50 mg
Excipients:
​
​
Sodium benzoate (E211)
​2.1 mg
​
Sodium propionate (E281)
​2.1 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral suspension
White or yellowish suspension
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (Piglet, 3-5 days old).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the prevention of clinical signs of coccidiosis in neonatal
piglets (3 – 5 days old)
on farms with a confirmed history of coccidiosis caused by _Isospora
suis_.
4.3 CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
As with any antiparasiticide, frequent and repeated use of
antiprotozoals from the
same class may lead to the development of resistance.
It is recommended to treat all animals in a pen.
Hygienic measures may reduce the risk of coccidiosis. It is therefore,
recommended
Health Products Regulatory Authority
07 September 2018
CRN000Y6D
Page 2 of 5
to improve concomitantly the hygienic conditions in the concerned
facility,
particularly dryness and cleanliness.
To obtain maximum benefit, animals should be treated before the
expected onset of
clinical signs, i.e. in the prepatent period.
To alter the course of an established clinical coccidial infection, in
individual animals
already showing signs of diarrhoea, additional supportive therapy may
be required.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
In case of accidental ingestion seek medical advice immediately and
show the
package leaflet or the label to the physician.
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