GLN-POSACONAZOLE TABLET (DELAYED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

POSACONAZOLE

Предлага се от:

GLENMARK PHARMACEUTICALS CANADA INC.

АТС код:

J02AC04

INN (Международно Name):

POSACONAZOLE

дозиране:

100MG

Лекарствена форма:

TABLET (DELAYED-RELEASE)

Композиция:

POSACONAZOLE 100MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0152201002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-10-04

Данни за продукта

GLN-POSACONAZOLE
_(posaconazole)_
Page 1 of 53
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
GLN-POSACONAZOLE
Posaconazole delayed-release tablets
100 mg, Oral
Antifungal Agent
Glenmark Pharmaceuticals Canada Inc.
1600 Steeles Ave. West, Suite 407
Concord, ON
L4K 4M2
Date of Initial Authorization:
October 3, 2023
Submission Control Number: 262010
GLN-POSACONAZOLE
_(posaconazole)_
Page 2 of 53
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
...............................................................................................................
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
..................................................... 5
4 DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1 DOSING CONSIDERATIONS
.............................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.4 ADMINISTRATION
...........................................................................................................
6
4.5 MISSED DOSE
...................................