JAMP POSACONAZOLE SUSPENSION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POSACONAZOLE

Available from:

JAMP PHARMA CORPORATION

ATC code:

J02AC04

INN (International Name):

POSACONAZOLE

Dosage:

40MG

Pharmaceutical form:

SUSPENSION

Composition:

POSACONAZOLE 40MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-09-02

Summary of Product characteristics

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
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TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
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RECENT MAJOR LABEL
CHANGES ...........................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
.............................................................................................................
5
1.1
Pediatrics
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5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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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
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