ORALAIR TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

GRASS POLLEN ALLERGEN EXTRACT

Saatavilla:

STALLERGENES CANADA INC

ATC-koodi:

V01AA02

INN (Kansainvälinen yleisnimi):

GRASS POLLEN

Annos:

300UNIT

Lääkemuoto:

TABLET

Koostumus:

GRASS POLLEN ALLERGEN EXTRACT 300UNIT

Antoreitti:

SUBLINGUAL

Kpl paketissa:

28/30/90

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ALLERGENIC EXTRACTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0153132002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2015-04-01

Valmisteyhteenveto

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_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ORALAIR
Grass Pollen Allergen Extract
100 IR and 300 IR Sublingual Tablets
Allergenic Substance
Stallergenes Canada Inc.
1215 North Service Road West, Suite B
Oakville, ON
L6M 2W2
Canada
Date of Preparation:
September 6, 2016
APPROVAL DATE:
NOVEMBER 18, 2016
SUBMISSION CONTROL NO: 192653
_ _
_Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
.................................................................................................19
DOSAGE AND
ADMINISTRATION..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
CLINICAL TRIALS
.....................................