Dozuril 50 mg/ml oral suspension for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Toltrazuril

Available from:

Dopharma Research B.V.

ATC code:

QP51AJ01

INN (International Name):

Toltrazuril

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

toltrazuril

Authorization date:

2022-05-27

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Dozuril 50 mg/ml oral suspension for pigs (FR, AT, BE, BG, CY, CZ, DE,
DK, EE, EL, ES, HR,
HU, IE, IT, LT, LU, LV, NL, PL, PT, RO, SK)
Dozuril vet 50 mg/ml oral suspension for pigs (FI, NO, SE)
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 (piglets 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 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
People with known sensitivity to the active substance or any of the
excipients should avoid contact
with this product.
Avoid skin and eye contact with the product.
Wash any splashes from skin or eyes imm