LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LEUPROLIDE ACETATE

Dostopno od:

ABBVIE CORPORATION

Koda artikla:

L02AE02

INN (mednarodno ime):

LEUPRORELIN

Odmerek:

7.5MG

Farmacevtska oblika:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Sestava:

LEUPROLIDE ACETATE 7.5MG

Pot uporabe:

INTRAMUSCULAR

Enote v paketu:

1

Tip zastaranja:

Prescription

Terapevtsko območje:

GONADOTROPINS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2012-11-01

Lastnosti izdelka

_ _
_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
................................................................................................................
6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS A