XOLAIR SOLUTION

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

OMALIZUMAB

Saatavilla:

NOVARTIS PHARMACEUTICALS CANADA INC

ATC-koodi:

R03DX05

INN (Kansainvälinen yleisnimi):

OMALIZUMAB

Annos:

75MG

Lääkemuoto:

SOLUTION

Koostumus:

OMALIZUMAB 75MG

Antoreitti:

SUBCUTANEOUS

Kpl paketissa:

0.5ML

Prescription tyyppi:

Prescription

Terapeuttinen alue:

RESPIRATORY AGENTS, MISCELLANEOUS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0150422001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-12-15

Valmisteyhteenveto

_Pr_
_XOLAIR_
_®_
_ (omalizumab) _
_Page 1 of 86_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
XOLAIR
®
Omalizumab for Injection
150 mg/vial lyophilized powder for subcutaneous injection
Omalizumab injection
75 mg/0.5 mL solution for subcutaneous injection
150 mg/1.0 mL solution for subcutaneous injection
300 mg/2.0 mL solution for subcutaneous injection
IgE-Neutralizing Antibody (Anti-IgE)
Novartis Pharmaceuticals Canada Inc.
700 Saint-Hubert St., suite 100
Montreal, Quebec
H2Y 0C1
Date of Initial Authorization:
NOV 18, 2004
Date of Revision:
FEB 8, 2024
Submission Control Number: 275152
XOLAIR
is a registered trademark.
_Pr_
_XOLAIR_
_®_
_ (omalizumab) _
_Page 2 of 86_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
xx/2024
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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3
1
INDICATIONS
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3
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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