JAMP ITRACONAZOLE ORAL SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ITRACONAZOLE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

J02AC02

INN (Nama Internasional):

ITRACONAZOLE

Dosis:

10MG

Bentuk farmasi:

SOLUTION

Komposisi:

ITRACONAZOLE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

AZOLES

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2018-12-31

Karakteristik produk

_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.