BORTEZOMIB FOR INJECTION POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Dostupné s:

SANDOZ CANADA INCORPORATED

ATC kód:

L01XG01

INN (Mezinárodní Name):

BORTEZOMIB

Dávkování:

3.5MG

Léková forma:

POWDER FOR SOLUTION

Složení:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG

Podání:

INTRAVENOUS

Jednotky v balení:

SC: 1.4ML / I.V: 3.5ML

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0150433001; AHFS:

Stav Autorizace:

CANCELLED PRE MARKET

Datum autorizace:

2021-04-21

Charakteristika produktu

_Bortezomib for Injection _
_Page 1 of 75_
PRODUCT MONOGRAPH
Pr
BORTEZOMIB
® FOR INJECTION
3.5 mg/vial bortezomib, as mannitol boronic ester
Sterile lyophilized powder
Antineoplastic Agent
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, Québec, Canada
J4B 1E6
Date of Revision:
February 15, 2019
Submission Control No: 224415
_Bortezomib for Injection _
_Page 2 of 75_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
29
DOSAGE AND ADMINISTRATION
.............................................................................
30
OVERDOSAGE
................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
.........................................................................................
39
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 39
PART II: SCIENTIFIC INFORMATION
..............................................................................
40
PHARMACEUTICAL INFORMATION
.........................................................................
40
CLINICAL TRIALS
....