TRECONDYV POWDER

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

TREOSULFAN

Доступна с:

MEDEXUS INC

код АТС:

L01AB02

ИНН (Международная Имя):

TREOSULFAN

дозировка:

1G

Фармацевтическая форма:

POWDER

состав:

TREOSULFAN 1G

Администрация маршрут:

INTRAVENOUS

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

ANTINEOPLASTIC AGENTS

Обзор продуктов:

Active ingredient group (AIG) number: 0163010001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2021-06-25

Характеристики продукта

_Trecondyv®_
_®_
_ _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRECONDYV
®
treosulfan for injection
Lyophilized powder, 1 g / vial and 5 g / vial, intravenous infusion
Antineoplastic agents, alkylating agents
Medexus Inc.
35 Nixon Road, Unit 1
Bolton, Ontario
L7E 1K1
Date of Initial Approval:
June 25, 2021
Submission Control No: 244137
_ _
_Trecondyv_
®
_ _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
None.
TABLE OF CONTENTS
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
4.3
Administration
.....................................................................................................
5
4.4
Reconstitution
.....................................................................................................
5
4.5
Missed Dose
.........................................................