CUTAQUIG SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

IMMUNOGLOBULIN G (HUMAN)

Available from:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

ATC code:

J06BA01

INN (International Name):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR EXTRAVASC. ADM

Dosage:

1G

Pharmaceutical form:

SOLUTION

Composition:

IMMUNOGLOBULIN G (HUMAN) 1G

Administration route:

SUBCUTANEOUS

Units in package:

6ML/10X6ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0151002003; AHFS:

Authorization status:

APPROVED

Authorization date:

2018-02-15

Summary of Product characteristics

_<_Immunoglobulin (human) subcutaneous_> _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
CUTAQUIG
®
Immunoglobulin (human) subcutaneous
16.5% Solution for injection (165 mg/mL), subcutaneous use
Prescription medication, passive immunizing agent
Presentation sizes: 6 mL, 10 mL, 12 mL, 20 mL, 24 mL, 48 mL
ATC-Code: J06B A01
Manufactured by:
Octapharma Pharmazeutika Produktionsges. m.b.H.
Oberlaaer Strasse 235
1100 Vienna, Austria
and
Octapharma AB
Lars Forssells gata 23
112 75 Stockholm, Sweden
Imported and distributed by:
Octapharma Canada Inc.
1000-25 King St W
Toronto, ON M5L 1G1
Canada
Date of Initial Authorization:
FEB 15, 2018
Date of Revision:
DEC 27, 2023
Submission Control Number: 271882 Date of Approval:
_ _
_<_Immunoglobulin (human) subcutaneous_> _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
07/2021
4 Dosage and Administration, 4.1 Dosing Considerations
07/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment 07/2021
4 Dosage and Administration, 4.4 Administration
01/2023
7 Warnings and Precautions, 7.1.3 Pediatrics
07/2021
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
.........................................................................................
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
....