STELARA SOLUTION

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

USTEKINUMAB

Inapatikana kutoka:

JANSSEN INC

ATC kanuni:

L04AC05

INN (Jina la Kimataifa):

USTEKINUMAB

Kipimo:

90MG

Dawa fomu:

SOLUTION

Tungo:

USTEKINUMAB 90MG

Njia ya uendeshaji:

SUBCUTANEOUS

Vitengo katika mfuko:

15G/50G

Dawa ya aina:

Prescription

Eneo la matibabu:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0152506001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2008-12-12

Tabia za bidhaa

_STELARA, 267288, JANUARY 5, 2023.docx _
_ _
_EDMS-RIM-800983 v12.0 _
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_Page 1 of 91 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
STELARA
®
ustekinumab injection
Solution for Subcutaneous Injection
45 mg/0.5 mL
90 mg/1.0 mL
PR
STELARA
®
I.V.
ustekinumab for injection
Solution for Intravenous Infusion
130 mg/26 mL (5 mg/mL)
Selective Immunomodulating Agent
Janssen Inc.
19 Green Belt Drive
Toronto, Ontario
M3C 1L9
www.janssen.com/canada
Date of Initial Authorization:
December 12, 2008
Date of Revision:
Submission Control Number: 267288
All trademarks used under license.
© 2022 Janssen Inc.
_STELARA, 267288, JANUARY 5, 2023.docx _
_ _
_EDMS-RIM-800983 v12.0 _
_ _
_Page 2 of 91 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Immune, _Infant exposure _in utero
12/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
12/2022
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
..............................................................................................................
5
2
CONTRAINDICATIONS
.......................................................................................
5
4
DOSAGE AND ADMINISTRATION
.....................................................................
5
4.1
DOSING CONSIDERATIONS
........................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
........