Ország: Kanada
Nyelv: angol
Forrás: Health Canada
POSACONAZOLE
JAMP PHARMA CORPORATION
J02AC04
POSACONAZOLE
40MG
SUSPENSION
POSACONAZOLE 40MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152201001; AHFS:
APPROVED
2022-09-02
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP POSACONAZOLE posaconazole Suspension, 40 mg / mL, Oral Antifungal Agent JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec J4B 5H3, Canada Date of Initial Authorization: August 30, 2022 Submission Control Number: 248523 Product Monograph _JAMP Posaconazole (posaconzole oral suspension)_ Page 2 of 57 RECENT MAJOR LABEL CHANGES Not Applicable 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 ......................................................... 7 4.4 Administration .......................................................................................................... 8 4.5 Missed Dose ............................................................. Olvassa el a teljes dokumentumot