BORTEZOMIB FOR INJECTION POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER)

Διαθέσιμο από:

JUNO PHARMACEUTICALS CORP.

Φαρμακολογική κατηγορία (ATC):

L01XG01

INN (Διεθνής Όνομα):

BORTEZOMIB

Δοσολογία:

3.5MG

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

BORTEZOMIB (BORTEZOMIB MANNITOL BORONIC ESTER) 3.5MG

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2020-07-03

Αρχείο Π.Χ.Π.

BORTEZOMIB FOR INJECTION
Page 1 of 83
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR BORTEZOMIB FOR INJECTION
Lyophilized powder, 1 mg, 2.5 mg and 3.5 mg/vial bortezomib (as the
mannitol boronic ester), Intravenous or Subcutaneous Injection
Antineoplastic Agent
Juno Pharmaceuticals Corp.
402-2233 Argentia Road
Mississauga,Ontario
L5N 2X7
Date of Initial Authorization:
January 29, 2019
Date of Revision:
October 13, 2023
Submission Control Number: 277669
BORTEZOMIB FOR INJECTION
Page 2 of 83
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
10/2023
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
................................................. 6
4.3
Reconstitution
.................................................................................