POSANOL SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

POSACONAZOLE

Disponibil de la:

MERCK CANADA INC

Codul ATC:

J02AC04

INN (nume internaţional):

POSACONAZOLE

Dozare:

300MG

Forma farmaceutică:

SOLUTION

Compoziție:

POSACONAZOLE 300MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

16.7ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

AZOLES

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-10-23

Caracteristicilor produsului

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