ALLERGENIC EXTRACT - STANDARDIZED TIMOTHY GRASS POLLEN LIQUID

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

STANDARDIZED TIMOTHY GRASS POLLEN

Fáanlegur frá:

ALK-ABELLO INC

ATC númer:

V01AA02

INN (Alþjóðlegt nafn):

GRASS POLLEN

Skammtar:

100000UNIT

Lyfjaform:

LIQUID

Samsetning:

STANDARDIZED TIMOTHY GRASS POLLEN 100000UNIT

Stjórnsýsluleið:

INTRADERMAL

Einingar í pakka:

5ML/10ML/50ML

Gerð lyfseðils:

Schedule D

Lækningarsvæði:

ALLERGENIC EXTRACTS

Vörulýsing:

Active ingredient group (AIG) number: 0134163002; AHFS:

Leyfisstaða:

MARKETED

Leyfisdagur:

2009-07-30

Vara einkenni

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