ODAN ITRACONAZOLE SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ITRACONAZOLE

Διαθέσιμο από:

ODAN LABORATORIES LTD

Φαρμακολογική κατηγορία (ATC):

J02AC02

INN (Διεθνής Όνομα):

ITRACONAZOLE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

SOLUTION

Σύνθεση:

ITRACONAZOLE 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

AZOLES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-01-31

Αρχείο Π.Χ.Π.

_Product Monograph: _
_Odan Itraconazole _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ODAN ITRACONAZOLE
Itraconazole Oral Solution, BP
Solution, 10 mg / mL, Oral
Antimycotic for systemic use, triazole and tetrazole derivatives.
ATC code: J02A C02.
Odan Laboratories Ltd
325, Stillview Ave Pointe-
Claire, QC H9R 2Y6
www.odanlab.com
Date of Initial Authorization:
January 31, 2020
Date of Revision:
January 11, 2024
Submission Control Number: 278040
_Product Monograph: _
_Odan Itraconazole _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2022
2 CONTRAINDICATIONS
05/2023
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
..............................................................