SOMATULINE AUTOGEL SOLUTION (EXTENDED RELEASE)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

LANREOTIDE (LANREOTIDE ACETATE)

MAH:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC_code:

H01CB03

INN:

LANREOTIDE

dosage:

90MG

pharmaceutical_form:

SOLUTION (EXTENDED RELEASE)

composition:

LANREOTIDE (LANREOTIDE ACETATE) 90MG

administration_route:

SUBCUTANEOUS

units_in_package:

90MG/SYRINGE

prescription_type:

Prescription

therapeutic_area:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0151653007; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-09-13

SPC

_SOMATULINE_
_®_
_ AUTOGEL_
_®_
_ _(lanreotide injection)_ _
_Page 1 of 57_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SOMATULINE
® AUTOGEL
®
lanreotide injection
Extended release solution
60 mg, 90 mg, 120 mg lanreotide (as lanreotide acetate)/unit
(syringe), subcutaneous
Antigrowth hormone
Ipsen Biopharmaceuticals Canada Inc.
5050 Satellite Drive, Suite 500
Mississauga, Ontario
L4W 0G1
www.ipsen.ca
Date of Initial Authorization:
JUL 17, 2006
Date of Revision:
AUG 08, 2023
Submission Control Number: 268030
_ _
_SOMATULINE_
_®_
_ AUTOGEL_
_®_
_ (lanreotide injection) _
_Page 2 of 57_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Fertility
12/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Teratogenic Risk
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
12/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
06/2023
11 STORAGE, STABILITY AND DISPOSAL
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED
.
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
Reconsti