ORALAIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

GRASS POLLEN ALLERGEN EXTRACT

Dostupno od:

STALLERGENES CANADA INC

ATC koda:

V01AA02

INN (International ime):

GRASS POLLEN

Doziranje:

300UNIT

Farmaceutski oblik:

TABLET

Sastav:

GRASS POLLEN ALLERGEN EXTRACT 300UNIT

Administracija rute:

SUBLINGUAL

Jedinice u paketu:

28/30/90

Tip recepta:

Prescription

Područje terapije:

ALLERGENIC EXTRACTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2015-04-01

Svojstava lijeka

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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
.....................................