LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

LEUPROLIDE ACETATE

Disponible des:

ABBVIE CORPORATION

Codi ATC:

L02AE02

Designació comuna internacional (DCI):

LEUPRORELIN

Dosis:

7.5MG

formulario farmacéutico:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Composición:

LEUPROLIDE ACETATE 7.5MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

1

tipo de receta:

Prescription

Área terapéutica:

GONADOTROPINS

Resumen del producto:

Active ingredient group (AIG) number: 0116959002; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2012-11-01

Fitxa tècnica

_ _
_LUPRON DEPOT (leuprolide acetate) _
_Page 1 of 100 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LUPRON DEPOT®
leuprolide acetate for depot suspension
3.75 mg/syringe (1-Month slow release), 7.5 mg/syringe (1-Month slow
release),
11.25 mg/syringe (3-Month slow release), 22.5 mg/syringe (3-Month slow
release),
30 mg/syringe (4-Month slow release)
pre-filled dual-chamber syringe containing sterile lyophilized
microspheres intramuscular injection
Gonadotropin-releasing hormone analog (ATC: L02AE02)
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, QC H4S 1Z1
Date of Initial Authorization:
•
Central Precocious Puberty:
NOV 26, 1986
•
Prostate Cancer: MAR 11,
1999
•
Endometriosis: MAR 11, 1999
•
Uterine Fibroids: FEB 07,
2017
Date of Revision: MAR 19, 2024
Submission Control Number: 280431
_ _
_LUPRON DEPOT (leuprolide acetate) _
_Page 2 of 100 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, PROSTATE CANCER
POPULATION (Only)
01/2024
7 WARNINGS AND PRECAUTIONS, ALL POPULATIONS
03/2024
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
...............................................................................................................
5
1.1
Pediatrics
................................................................................................................
6
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS A