ALLERGENIC EXTRACT - MIXTURE OF 4 STANDARDIZED GRASS POLLEN LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

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

Available from:

ALK-ABELLO INC

ATC code:

V01AA02

INN (International Name):

GRASS POLLEN

Dosage:

25000UNIT; 25000UNIT; 25000UNIT; 25000UNIT

Pharmaceutical form:

LIQUID

Composition:

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

Administration route:

INTRADERMAL

Units in package:

10ML/50ML

Prescription type:

Schedule D

Therapeutic area:

ALLERGENIC EXTRACTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2024-02-22

Summary of Product characteristics

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