THIOTEPA FOR INJECTION USP POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

THIOTEPA

Dostupné s:

STERIMAX INC

ATC kód:

L01AC01

INN (Mezinárodní Name):

THIOTEPA

Dávkování:

15MG

Léková forma:

POWDER FOR SOLUTION

Složení:

THIOTEPA 15MG

Podání:

INTRAVENOUS

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Přehled produktů:

Active ingredient group (AIG) number: 0107649001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2022-05-18

Charakteristika produktu

_Thiotepa for Injection USP _
_Page 1 of 46 _
“Thiotepa for Injection USP is indicated:
_- in combination with other chemotherapeutic products as part of a
high-dose chemotherapy _
_(HDCT) consolidation regimen followed by autologous stem cell
transplantation (ASCT) for _
_adult patients with central nervous system (CNS) lymphoma_
_ _
and has been issued marketing authorization with conditions. Patients
should be advised of
the nature of the authorization. For further information for Thiotepa
for Injection USP please
refer to Health Canada’s Notice of Compliance with conditions - drug
products web site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-
products/notice-compliance/conditions.html. Note that trials to verify
the clinical benefit of
the medicinal ingredient in Thiotepa for Injection USP are being
carried out by the
manufacturer of the Canadian Reference Product.”
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
THIOTEPA FOR INJECTION USP
Lyophilised powder for solution upon reconstitution and dilution,
15 mg / vial and 100 mg / vial, intravenous
USP
Antineoplastic Agent
ATC code: L01AC01
SteriMax Inc.
2770 Portland Drive
Oakville, ON, Canada
L6H 6R4
Submission Control Number: 272936
Date of Initial Authorization:
May 18, 2022
Date of Revision:
October 4, 2023
_Thiotepa for Injection USP _
_Page 2 of 46 _
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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
...............................................................................................................
5
1.1
Pediatrics
..