Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
VORICONAZOLE
PFIZER CANADA ULC
J02AC03
VORICONAZOLE
200MG
POWDER FOR SOLUTION
VORICONAZOLE 200MG
INTRAVENOUS
15G/50G
Prescription
AZOLES
Active ingredient group (AIG) number: 0150242002; AHFS:
APPROVED
2004-08-20
_Product Monograph _ _ _ _VFEND (voriconazole) _ _Page 1 of 73_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR VFEND ® Voriconazole Tablets 50 mg and 200 mg, Oral 200 mg / Vial (10 mg/mL when reconstituted) for Injection Powder for Oral Suspension 3 g / Bottle (40 mg/mL when reconstituted) Antifungal Agent Pfizer Canada ULC 17300 Trans Canada Highway Kirkland, Quebec H9J 2M5 Date of Initial Authorization: AUG 20, 2004 Date of Revision: JUL 05, 2023 Submission Control Number: 272725 Registered trademark Pfizer Products Inc. Pfizer Canada ULC., licensee © Pfizer Canada ULC, 2023 _ _ _Product Monograph _ _ _ _VFEND (voriconazole) _ _Page 2 of 73_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Skin 07/2023 7 WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis 11/2022 7 WARNINGS AND PRECAUTIONS, Tyrosine kinase inhibitors (CYP3A4 substrates) 11/2022 2 CONTRAINDICATIONS 02/2021 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 .................................................................... 4 1 INDICATIONS ............................................................................................................. 4 1.1 Pediatrics .................................................................................................................. 4 1.2 Geriatrics .................................................................................................................. 4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION ....................... Perskaitykite visą dokumentą