INCRELEX SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MECASERMIN

Available from:

IPSEN BIOPHARMACEUTICALS CANADA INC

ATC code:

H01AC03

INN (International Name):

MECASERMIN

Dosage:

40MG

Pharmaceutical form:

SOLUTION

Composition:

MECASERMIN 40MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

SOMATOTROPIN AGONISTS*

Product summary:

Active ingredient group (AIG) number: 0162642001; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-12-17

Summary of Product characteristics

_INCRELEX (mecasermin) _
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
INCRELEX
®
mecasermin injection
10 mg/mL (40 mg/4mL)
Recombinant DNA-derived human insulin-like growth factor-1 (IGF-1)
Ipsen Biopharmaceuticals Canada Inc.
5050 Satellite Dr Suite 500
Mississauga, ON L4W 0G1
Date of Initial Approval:
DEC 17, 2020
Date of Revision:
October 4, 2023
Submission Control No: 275140
Increlex is a registered trademark of Ipsen Biopharmaceuticals, Inc.
_INCRELEX (mecasermin) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
04/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
1
INDICATIONS
...................................................................................................................
3
1.1
Pediatrics
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3
2
CONTRAINDICATIONS
...................................................................................................
3
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
..........................................................................................................
4
4.5
Missed Dose
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5
5
OVERDOSAGE
...........................................................................