REMSIMA SC SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

INFLIXIMAB

Available from:

CELLTRION HEALTHCARE CO LTD

ATC code:

L04AB02

INN (International Name):

INFLIXIMAB

Dosage:

120MG

Pharmaceutical form:

SOLUTION

Composition:

INFLIXIMAB 120MG

Administration route:

SUBCUTANEOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0144162002; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-01-28

Summary of Product characteristics

_REMSIMA_
_TM_
_ SC Product Monograph _
_Page 1 of 81 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
REMSIMA
TM SC
(infliximab injection)
Solution for Subcutaneous Injection, 120 mg / ml
PROFESSED STANDARD
Biological Response Modifier
Manufactured by:
Celltrion Healthcare Co., Ltd.
19, Academy-ro 51 beon-gil,
Yeonsu-gu, Incheon
Republic of Korea
22014
Imported and distributed by:
Celltrion Healthcare Canada Limited
121 King Street W., Suite #1010
Toronto, Ontario
M5H 3T9
Date of Initial Approval:
Jan 28, 2021
Date of Revision:
Feb 15, 2024
Submission Control No: 272981
_Remsima SC_
_® _
_Product Monograph _
_Page 2 of 81 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
[02/2024]
4 DOSAGE AND ADMINITRATION, 4.2 Recommended Dose and Dosage
Adjustment, 4.4 Administration
[02/2024]
7 WARNINGS AND PRECAUTIONS
[02/2024]
8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions, 8.3 Less
Common Clinical Trial Adverse Drug Reactions, 8.5 Post-Market Adverse
Reactions
[02/2024]
10 CLINICAL PHARMACOLOGY, 10.3 Pharmacokinetics
[02/2024]
14 CLINICAL TRIALS, 14.1 Clinical Trials by Indication, 14.4
Immunogenicity,
[02/2024]
TABLE OF CONTENTS
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
......................................................... 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
.........................