INFLECTRA POWDER FOR SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

INFLIXIMAB

Tilgængelig fra:

CELLTRION HEALTHCARE CO LTD

ATC-kode:

L04AB02

INN (International Name):

INFLIXIMAB

Dosering:

100MG

Lægemiddelform:

POWDER FOR SOLUTION

Sammensætning:

INFLIXIMAB 100MG

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2014-06-04

Produktets egenskaber

_INFLECTRA_
_® _
_Product Monograph_
Page 1 of 115
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
INFLECTRA
®
(infliximab for injection)
Powder for Solution, Sterile, Lyophilized, 100 mg/vial, Intravenous
Infusion
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:
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Approval:
January 15, 2014
Date of Revision: March 11,
2020
Submission Control No: 237374
Date of Revision: July 6, 2020
_INFLECTRA_
_® _
_Product Monograph_
Page 2 of 115
RECENT MAJOR LABEL CHANGES
NOT APPLICABLE
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
...............................................................................................................
5
1.2
Geriatrics (≥ 65_ _years of age)
.................................................................................
5
2
CONTRAINDICATIONS
..................................................................................................
6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 6
4
DOSAGE AND ADMINISTRATION
................................................................................
7
4.1
Recommended Dose and Dosage Adjustment
....................................................... 7
4.2
Administration
........................................................................................................
9
4.3
Reconstitution
......................................................................................................
10
4.4
Missed Dose
........................................................................................................
10
5
OVE