ALLERGENIC EXTRACT - STANDARDIZED MEADOW FESCUE GRASS POLLEN LIQUID

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

STANDARDIZED MEADOW FESCUE GRASS POLLEN

זמין מ:

ALK-ABELLO INC

קוד ATC:

V01AA02

INN (שם בינלאומי):

GRASS POLLEN

כמות:

100000UNIT

טופס פרצבטיות:

LIQUID

הרכב:

STANDARDIZED MEADOW FESCUE GRASS POLLEN 100000UNIT

מסלול נתינה (של תרופות):

INTRADERMAL

יחידות באריזה:

10ML/50ML

סוג מרשם:

Schedule D

איזור תרפויטי:

ALLERGENIC EXTRACTS

leaflet_short:

Active ingredient group (AIG) number: 0134143001; AHFS:

מצב אישור:

MARKETED

תאריך אישור:

2009-07-30

מאפייני מוצר

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