ALLERGENIC EXTRACT - MIXTURE OF 4 STANDARDIZED GRASS POLLEN LIQUID

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

STANDARDIZED TIMOTHY GRASS POLLEN; STANDARDIZED ORCHARD GRASS POLLEN; STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN; STANDARDIZED REDTOP GRASS POLLEN

Sẵn có từ:

ALK-ABELLO INC

Mã ATC:

V01AA02

INN (Tên quốc tế):

GRASS POLLEN

Liều dùng:

25000UNIT; 25000UNIT; 25000UNIT; 25000UNIT

Dạng dược phẩm:

LIQUID

Thành phần:

STANDARDIZED TIMOTHY GRASS POLLEN 25000UNIT; STANDARDIZED ORCHARD GRASS POLLEN 25000UNIT; STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN 25000UNIT; STANDARDIZED REDTOP GRASS POLLEN 25000UNIT

Tuyến hành chính:

INTRADERMAL

Các đơn vị trong gói:

10ML/50ML

Loại thuốc theo toa:

Schedule D

Khu trị liệu:

ALLERGENIC EXTRACTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0457493001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2024-02-22

Đặc tính sản phẩm

_ _
_Allergenic Extracts, Pollen _
_Page 1 of 29 _
_ALK-Abelló Inc._
PRODUCT MONOGRAPH
Allergenic Extracts
Standardized Grass Pollen Extracts
Standardized Timothy Grass
Standardized Orchard Grass
Standardized June Grass
Standardized Redtop
Standardized Sweet Vernal
Standardized Perennial Rye Grass
Standardized Meadow Fescue Grass
Mix of 4 Standardized Grasses (Timothy, Orchard, June, Redtop)
Mix of 5 Standardized Grasses (Timothy, Orchard, June, Redtop, Sweet
Vernal)
Liquid, 100,000 BAU/mL
Immunotherapy
ALK-Abelló, Inc.
35 Channel Drive
Port Washington
New York, USA 11050
Date of Approval: May 8,
2009
ALK- Abelló Pharmaceuticals, Inc.
Mississauga, ON
L4Z 2H6
Submission Control No: 123862
_ _
_Allergenic Extracts, Pollen _
_Page 2 of 29 _
_ALK-Abelló_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION........................................................ 4
SUMMARY PRODUCT INFORMATION
.................................................................... 4
INDICATIONS AND CLINICAL USE
..........................................................................
6
CONTRAINDICATIONS
................................................................................................
7
WARNINGS AND PRECAUTIONS
..............................................................................
8
ADVERSE REACTIONS
...............................................................................................
12
DRUG INTERACTIONS
...............................................................................................
14
DOSAGE AND ADMINISTRATION
..........................................................................
15
OVERDOSAGE
..............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
....................................................... 20
STORAGE AND STABILITY
.......................................................................................
23
SPECIAL HANDLING INSTRUCTIONS
.........................................