JAMP ITRACONAZOLE ORAL SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ITRACONAZOLE

Available from:

JAMP PHARMA CORPORATION

ATC code:

J02AC02

INN (International Name):

ITRACONAZOLE

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ITRACONAZOLE 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

AZOLES

Product summary:

Active ingredient group (AIG) number: 0123311001; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-12-31

Summary of Product characteristics

_JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) _
_ _Page 1 of 63
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP ITRACONAZOLE ORAL SOLUTION
Itraconazole oral solution
solution, 10 mg/mL, oral
Antimycotic for systemic use, triazole and tetrazole derivatives.
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
December 31, 2018
Date of Revision:
February 2, 2024
Control Number: 278552
_JAMP Itraconazole Oral Solution (Itraconazole Oral Solution) _
_ _Page 2 of 63
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
02/2024
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
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
........................................................................................................
4
1.2
Geriatrics
........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
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.