Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Toltrazuril
Elanco GmbH
QP51AJ01
Toltrazuril
50 milligram(s)/millilitre
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
toltrazuril
Authorised
2002-11-11
Health Products Regulatory Authority 19 October 2020 CRN009PRZ Page 1 of 3 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 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. Health Products Regulatory Authority 19 October 2020 CRN009PRZ Page 2 of 3 4.7 USE DURING PREGNANCY, LACTATION OR LAY Not applicable 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS 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 dose accuracy of 0.1 ml is recommended. The oral suspension must be shaken before use. Treatment during an outbreak will be of limited value for the individual piglet because of damage to the small intestine having already occured. 4.10 OVERDOSE (SYMPTOMS, EME Olvassa el a teljes dokumentumot