Country: Canada
Language: English
Source: Health Canada
STANDARDIZED TIMOTHY GRASS POLLEN; STANDARDIZED ORCHARD GRASS POLLEN; STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN; STANDARDIZED REDTOP GRASS POLLEN; STANDARDIZED SWEET VERNAL GRASS POLLEN
ALK-ABELLO INC
V01AA02
GRASS POLLEN
20000UNIT; 20000UNIT; 20000UNIT; 20000UNIT; 20000UNIT
LIQUID
STANDARDIZED TIMOTHY GRASS POLLEN 20000UNIT; STANDARDIZED ORCHARD GRASS POLLEN 20000UNIT; STANDARDIZED KENTUCKY BLUE/JUNE GRASS POLLEN 20000UNIT; STANDARDIZED REDTOP GRASS POLLEN 20000UNIT; STANDARDIZED SWEET VERNAL GRASS POLLEN 20000UNIT
INTRADERMAL
10ML/50ML
Schedule D
ALLERGENIC EXTRACTS
Active ingredient group (AIG) number: 0557494001; AHFS:
MARKETED
2009-07-30
_ _ _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 ......................................... Read the complete document