Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
TOLTRAZURIL
Krka, d.d., Novo mesto
QP51AJ01
TOLTRAZURIL
50 Mg/Ml
Oral Suspension
POM
Porcine
Toltrazuril
Coccidiostats
Authorised
2010-09-24
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 Read the complete document