ALLERGENIC EXTRACT - STANDARDIZED REDTOP GRASS POLLEN LIQUID

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

STANDARDIZED REDTOP GRASS POLLEN

Beszerezhető a:

ALK-ABELLO INC

ATC-kód:

V01AA02

INN (nemzetközi neve):

GRASS POLLEN

Adagolás:

100000UNIT

Gyógyszerészeti forma:

LIQUID

Összetétel:

STANDARDIZED REDTOP GRASS POLLEN 100000UNIT

Az alkalmazás módja:

INTRADERMAL

db csomag:

10ML/50ML

Recept típusa:

Schedule D

Terápiás terület:

ALLERGENIC EXTRACTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0134160001; AHFS:

Engedélyezési státusz:

MARKETED

Engedély dátuma:

2009-07-30

Termékjellemzők

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