BORTEZOMIB FOR INJECTION POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Dostupné s:

JUNO PHARMACEUTICALS CORP.

ATC kód:

L01XG01

INN (Mezinárodní Name):

BORTEZOMIB

Dávkování:

1MG

Léková forma:

POWDER FOR SOLUTION

Složení:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 1MG

Podání:

INTRAVENOUS

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Přehled produktů:

Active ingredient group (AIG) number: 0150433003; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2020-07-03

Charakteristika produktu

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PRODUCT MONOGRAPH PR
BORTEZOMIB FOR INJECTION
1 mg, 2.5 mg and 3.5 mg/vial bortezomib, as the mannitol boronic ester
Antineoplastic Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga, Ontario
L5N 2X7
Date of Revision:
June 23, 2020
SUBMISSION CONTROL NO.: 240109
_Bortezomib for Injection _
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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
..................................................................................................
28
DOSAGE AND ADMINISTRATION
..............................................................................
29
OVERDOSAGE
................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
..........................................................................................
38
SPECIAL HANDLING INSTRUCTIONS
.......................................................................
38
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 39
PART II: SCIENTIFIC INFORMATION
...............................................................................
39
PHARMACEUTICAL INFORMATION
..........................................................................
39
CLINICAL