APO-POMALIDOMIDE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

POMALIDOMIDE

Saadav alates:

APOTEX INC

ATC kood:

L04AX06

INN (Rahvusvaheline Nimetus):

POMALIDOMIDE

Annus:

3MG

Ravimvorm:

CAPSULE

Koostis:

POMALIDOMIDE 3MG

Manustamisviis:

ORAL

Ühikuid pakis:

15G/50G

Retsepti tüüp:

Prescription

Toote kokkuvõte:

Active ingredient group (AIG) number: 0155290003; AHFS:

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2023-02-22

Toote omadused

Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-POMALIDOMIDE
Pomalidomide Capsules
1 mg, 2 mg, 3 mg and 4 mg Capsules for Oral Use
Antineoplastic Agent
Immunomodulatory Agent
ATC Code: L04AX06
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Approval:
September 15, 2021
Submission Control No: 246958
Page 2 of 66
TABLE OF CONTENTS
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........................................................................................6
4.1
Dosing Considerations
...........................................................................................................6
4.2
Recommended Dose and Dosage Adjustment Recommended Dose:
......................................6
4.3
Administration
........................................................................................................................8
4.5
Missed Dose
.........................................................................................................................8
5
OVERDOSAGE
.....................................................................................................................9
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
..................................9
7
WARNINGS AND PRECAUTIONS
...........