POSANOL TABLET (DELAYED-RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

POSACONAZOLE

Verfügbar ab:

MERCK CANADA INC

ATC-Code:

J02AC04

INN (Internationale Bezeichnung):

POSACONAZOLE

Dosierung:

100MG

Darreichungsform:

TABLET (DELAYED-RELEASE)

Zusammensetzung:

POSACONAZOLE 100MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

60

Verschreibungstyp:

Prescription

Therapiebereich:

AZOLES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0152201002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2014-05-01

Fachinformation

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
..................................................