Toltarox 50 mg/ml oral suspension for pigs

מדינה: אירלנד

שפה: אנגלית

מקור: HPRA (Health Products Regulatory Authority)

מרכיב פעיל:

Toltrazuril

זמין מ:

Krka, d.d., Novo mesto

קוד ATC:

QP51AJ01

INN (שם בינלאומי):

Toltrazuril

כמות:

50 milligram(s)/millilitre

טופס פרצבטיות:

Oral suspension

סוג מרשם:

POM: Prescription Only Medicine as defined in relevant national legislation

קבוצה תרפויטית:

Pigs

איזור תרפויטי:

toltrazuril

סממני תרפויטית:

Coccidiostats

מצב אישור:

Authorised

תאריך אישור:

2010-09-24

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Toltarox 50 mg/ml oral suspension for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral suspension 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.
Thick white suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (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) 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.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
None known.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Wash any splashes from skin or eyes immediately with water.
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4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.