ORALAIR TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

GRASS POLLEN ALLERGEN EXTRACT

Sẵn có từ:

STALLERGENES CANADA INC

Mã ATC:

V01AA02

INN (Tên quốc tế):

GRASS POLLEN

Liều dùng:

300UNIT

Dạng dược phẩm:

TABLET

Thành phần:

GRASS POLLEN ALLERGEN EXTRACT 300UNIT

Tuyến hành chính:

SUBLINGUAL

Các đơn vị trong gói:

28/30/90

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ALLERGENIC EXTRACTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2015-04-01

Đặc tính sản phẩm

_ _
_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
.....................................