国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
TOLTRAZURIL
Bayer Limited
QP51AJ01
TOLTRAZURIL
50 Mg/Ml
Oral Suspension
POM
Porcine
Toltrazuril
Coccidiostats
Authorised
2002-11-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baycox 50 mg/ml oral suspension, pig 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 ml contains: Toltrazuril 50 mg EXCIPIENTS: Sodium benzoate (E211) 2.1 mg Sodium propionate (E281) 2.1 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral suspension White or yellowish 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 old) on farms with a confirmed history of coccidiosis caused by _Isospora suis_. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/11/2011_ _CRN 7011454_ _page number: 1_ 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. 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 Individual animal treatment. Each pig to be treated on day 3-5 of life with a single oral dose of 20 mg toltrazuril/kg body weight corresponding to 0.4 ml oral suspension per kg body weight. Due to the small volumes required to treat individual piglets, use of dosing equipment with a 完全なドキュメントを読む