ALLERGENIC EXTRACT - STANDARDIZED SWEET VERNAL GRASS POLLEN LIQUID

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

STANDARDIZED SWEET VERNAL GRASS POLLEN

متاح من:

ALK-ABELLO INC

ATC رمز:

V01AA02

INN (الاسم الدولي):

GRASS POLLEN

جرعة:

100000UNIT

الشكل الصيدلاني:

LIQUID

تركيب:

STANDARDIZED SWEET VERNAL GRASS POLLEN 100000UNIT

طريقة التعاطي:

INTRADERMAL

الوحدات في الحزمة:

10ML/50ML

نوع الوصفة الطبية :

Schedule D

المجال العلاجي:

ALLERGENIC EXTRACTS

ملخص المنتج:

Active ingredient group (AIG) number: 0152573001; AHFS:

الوضع إذن:

MARKETED

تاريخ الترخيص:

2009-07-30

خصائص المنتج

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