Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
POSACONAZOLE
MERCK CANADA INC
J02AC04
POSACONAZOLE
200MG
SUSPENSION
POSACONAZOLE 200MG
ORAL
105ML
Prescription
AZOLES
Active ingredient group (AIG) number: 0152201001; AHFS:
APPROVED
2008-06-11
POSANOL® _(posaconazole)_ _ _ _Page 1 of 73_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION POSANOL® posaconazole Solution for Injection, 300 mg/vial (18 mg/mL), Intravenous Delayed-Release Tablets, 100 mg, Oral Suspension, 40 mg/mL, Oral Antifungal Agent Merck Canada Inc. 16750 route Transcanadienne Kirkland QC Canada H9H 4M7 www.merck.ca Date of Initial Authorization: March 17, 2011 Date of Revision: January 4, 2022 Submission Control Number: 254862 _ _ POSANOL® _(posaconazole)_ _ _ _Page 2 of 73_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS 12/2021 _9 DRUG INTERACTIONS, 9.4 DRUG-DRUG INTERACTION _ 12/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 5 1 INDICATIONS ............................................................................................................. 5 1.1 Pediatrics .................................................................................................................. 5 1.2 Geriatrics .................................................................................................................. 5 2 CONTRAINDICATIONS ................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION ................................................................................ 6 4.1 Dosing Considerations ............................................................................................. 6 4.2 Recommended Dose and Dosage Adjustment .................................................. Belgenin tamamını okuyun