ZORABEL 50 mg/ml Oral Suspension for pigs

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Toltrazuril

Commercializzato da:

Vetpharma Animal Health, S.L.

Codice ATC:

QP51AJ01

INN (Nome Internazionale):

Toltrazuril

Dosaggio:

50 milligram(s)/millilitre

Forma farmaceutica:

Oral suspension

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Area terapeutica:

toltrazuril

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2020-05-08

Scheda tecnica

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT_ _
ZORABEL 50 mg/ml Oral Suspension for pigs [
CZ, DK, ES, HU, IE, PL, PT, SK]
ZORABEL vet 50 mg/ml Oral Suspension for pigs [
SE]
BUSERIL 50 mg/ml Oral Suspension for pigs [FR]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Toltrazuril
50 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Sodium Benzoate (E 211)
2.1 mg
Sodium Propionate (E 281)
2.1 mg
Sodium docusate
Simethicone emulsion
Bentonite
Citric acid, anhydrous
Xanthan gum
Propylene glycol
Purified water
White or cream suspension.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs (Piglets 3 – 5 days old).
3.2
INDICATIONS FOR USE FOR EACH 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. _
3.3
CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
3.4
SPECIAL WARNINGS
As with any antiparasiticide, frequent and prolonged use of an
antiprotozoal of the same class of active
substance and underdosing due to underestimation of the live weigh may
result in the development of
resistances.
It is recommended to treat all piglets in a litter.
Hygienic measures may reduce the risk of coccidiosis. It is therefore
recommended 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.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions to be taken by the person administering the
veterinary medicinal produc