CUVITRU SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN (HUMAN)

Available from:

TAKEDA CANADA INC

ATC code:

J06BA01

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM

Dosage:

200MG

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN (HUMAN) 200MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106267011; AHFS:

Authorization status:

APPROVED

Authorization date:

2017-02-16

Summary of Product characteristics

_Product Monograph Master Template _
_Template Date: September 2020 _
_CUVITRU (Normal Immunoglobulin Human)_
_ _
_Page 1 of 50_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CUVITRU
Normal Immunoglobulin (Human)
200 mg/mL (20%) Solution For Subcutaneous Infusion
Pharmacopeial
Replacement Therapy for Immunodeficiencies
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Approval:
February 16, 2017
Date of Revision:
November 26, 2021
Submission Control No: 256720
CUVITRU® is a registered trademark of Baxalta Incorporated.
TAKEDA
TM
and the TAKEDA Logo® are trademarks of Takeda Pharmaceutical Company
Limited, used
under license.
_Product Monograph Master Template _
_Template Date: September 2020 _
_CUVITRU (Normal Immunoglobulin Human)_
_ _
_Page 2 of 50_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
03/2021
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..................................................................
4
1
INDICATIONS
......................................................................................................
4
1.1
Pediatrics
..................................................................................................
4
1.2
Geriatrics
..................................................................................................
4
2
CONTRAINDICATIONS
..........................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 4
4
DOSAGE AND ADMINISTRATION
...........................................................................
5
4.1
Dosing
Considerations.............