ORALAIR TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
02-12-2016
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Aktiva substanser:
GRASS POLLEN ALLERGEN EXTRACT
Tillgänglig från:
STALLERGENES CANADA INC
ATC-kod:
V01AA02
INN (International namn):
GRASS POLLEN
Dos:
300UNIT
Läkemedelsform:
TABLET
Sammansättning:
GRASS POLLEN ALLERGEN EXTRACT 300UNIT
Administreringssätt:
SUBLINGUAL
Enheter i paketet:
28/30/90
Receptbelagda typ:
Prescription
Terapiområde:
ALLERGENIC EXTRACTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0153132002; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2015-04-01
Produktens egenskaper
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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
.....................................
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