TOLTAROX 50 MG/ML ORAL SUSPENSION FOR PIGS
Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
Tabia za bidhaa
(SPC)
12-09-2015
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Viambatanisho vya kazi:
TOLTRAZURIL
Inapatikana kutoka:
Krka, d.d., Novo mesto
ATC kanuni:
QP51AJ01
INN (Jina la Kimataifa):
TOLTRAZURIL
Kipimo:
50 Mg/Ml
Dawa fomu:
Oral Suspension
Dawa ya aina:
POM
Kundi la matibabu:
Porcine
Eneo la matibabu:
Toltrazuril
Matibabu dalili:
Coccidiostats
Idhini hali ya:
Authorised
Idhini ya tarehe:
2010-09-24
Tabia za bidhaa
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/08/2015_
_CRN 7019462_
_page number: 1_
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
None known.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Not applicable.
4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known, e.g. there is no interaction in combination with iron supplementation.
4.9 AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE
For oral use.
Individual animal tre
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