JAMP POSACONAZOLE SUSPENSION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

POSACONAZOLE

Tilgjengelig fra:

JAMP PHARMA CORPORATION

ATC-kode:

J02AC04

INN (International Name):

POSACONAZOLE

Dosering :

40MG

Legemiddelform:

SUSPENSION

Sammensetning:

POSACONAZOLE 40MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Produkt oppsummering:

Active ingredient group (AIG) number: 0152201001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2022-09-02

Preparatomtale

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