RENFLEXIS POWDER FOR SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

INFLIXIMAB

Inapatikana kutoka:

SAMSUNG BIOEPIS CO., LTD

ATC kanuni:

L04AB02

INN (Jina la Kimataifa):

INFLIXIMAB

Kipimo:

100MG

Dawa fomu:

POWDER FOR SOLUTION

Tungo:

INFLIXIMAB 100MG

Njia ya uendeshaji:

INTRAVENOUS

Vitengo katika mfuko:

10ML

Dawa ya aina:

Prescription

Eneo la matibabu:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0144162001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2017-12-01

Tabia za bidhaa

_RENFLEXIS_
_®_
_ _
_Page 1 of 108_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RENFLEXIS
®
Infliximab for Injection
Powder for Solution, Sterile, Lyophilized, 100 mg /vial, Intravenous
Infusion
Professed standard
Biological Response Modifier
SAMSUNG BIOEPIS.
76, Songdogyoyuk-ro, Yeonsu-gu,
Incheon, 21987,
Republic of Korea
Distributed by:
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
DATE OF INITIAL AUTHORIZATION:
Dec 01, 2017
DATE OF REVISION:
October 4, 2023
SUBMISSION CONTROL NO: 275221
_RENFLEXIS_
_®_
_ _
_Page 2 of 108_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.4 Administration
[08/2021]
7 Warnings and Precautions, Reproductive Health:
Female and Male Potential
[08/2021]
7 Warnings and Precautions, 7.1 Special Population,
7.1.1 Pregnant Women; 7.1.2 Breast-feeding
[08/2021]
7 Warnings and Precautions, Live Vaccines/Therapeutic
Infectious Agents
[04/2023]
7 Warnings and Precautions, 7.1.2 Breast-feeding
[04/2023]
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
...............................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................