TRELSTAR POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIPTORELIN (TRIPTORELIN PAMOATE)

Available from:

KNIGHT THERAPEUTICS INC.

ATC code:

L02AE04

INN (International Name):

TRIPTORELIN

Dosage:

3.75MG

Pharmaceutical form:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Composition:

TRIPTORELIN (TRIPTORELIN PAMOATE) 3.75MG

Administration route:

INTRAMUSCULAR

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0137103001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-04-02

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
_TRELSTAR_
_®_
_ (triptorelin for injectable suspension) _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRELSTAR
®
Triptorelin for injectable suspension
Powder for injectable suspension,
3.75 mg triptorelin (as pamoate) per vial (1 month sustained-release
formulation),
11.25 mg triptorelin (as pamoate) per vial (3 month sustained-release
formulation),
22.5 mg triptorelin (as pamoate) per vial (6 month sustained-release
formulation),
intramuscular injection
Luteinizing Hormone-Releasing Hormone (LHRH) Analog
Knight Therapeutics Inc.
3400 De Maisonneuve W., Suite 1055
Montreal, QC
Canada H3Z 3B8
Date of Initial Authorization:
MAY 06, 1999
Date of Revision:
MAR 27, 2024
Submission Control Number:
280867
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_TRELSTAR_
_®_
_ (triptorelin for injectable suspension) _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
[09/2022]
4 DOSAGE AND ADMINISTRATION, 4.3 Reconstitution
[01/2024]
7 WARNINGS AND PRECAUTIONS, All Indications, Neurologic
[11/2023]
7 WARNINGS AND PRECAUTIONS, Endometriosis, Musculoskeletal
[09/2022]
7 WARNINGS AND PRECAUTIONS, Endometriosis, Endocrine and
Metabolism
[01/2024]
7 WARNINGS AND PRECAUTIONS, Prostate Cancer, Endocrine and
Metabolism
[01/2024]
7 WARNING AND PRECAUTIONS, 7.1.3 Pediatrics
[01/2024]
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
......................................................................
5
1
INDICATIONS
...............................................................................................................