POSANOL SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

POSACONAZOLE

Διαθέσιμο από:

MERCK CANADA INC

Φαρμακολογική κατηγορία (ATC):

J02AC04

INN (Διεθνής Όνομα):

POSACONAZOLE

Δοσολογία:

300MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

POSACONAZOLE 300MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

16.7ML

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

AZOLES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0152201003; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-10-23

Αρχείο Π.Χ.Π.

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