País: Canadà
Idioma: anglès
Font: Health Canada
INSULIN INJECTION HUMAN BIOSYNTHETIC; INSULIN ISOPHANE HUMAN BIOSYNTHETIC
NOVO NORDISK CANADA INC
A10AD01
INSULIN (HUMAN)
30UNIT; 70UNIT
SUSPENSION
INSULIN INJECTION HUMAN BIOSYNTHETIC 30UNIT; INSULIN ISOPHANE HUMAN BIOSYNTHETIC 70UNIT
SUBCUTANEOUS
10ML
Schedule D
INSULINS
Active ingredient group (AIG) number: 0223312003; AHFS:
APPROVED
2011-01-07
_ _ _Novolin_ _®_ _ge_ _ – _ _Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 52 _ _ _ PRODUCT MONOGRAPH Schedule D NOVOLIN ® GE Insulin, Human Biosynthetic Injectable Solution/Suspension Manufacturer’s Standard Antidiabetic Agent Novo Nordisk Canada Inc. 101-2476 Argentia Road Mississauga, Ontario L5N 6M1 DATE OF INITIAL APPROVAL: January 7, 2011 CONTROL NO.: 227125 DATE OF REVISION: July 26, 2019 _ _ _Novolin_ _®_ _ge_ _ – _ _Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 52 _ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................ 3 SUMMARY PRODUCT INFORMATION................................................................................. 3 DESCRIPTION ............................................................................................................................ 3 INDICATIONS AND CLINICAL USE ...................................................................................... 3 CONTRAINDICATIONS ............................................................................................................ 4 WARNINGS AND PRECAUTIONS .......................................................................................... 5 ADVERSE REACTIONS ............................................................................................................ 8 DRUG INTERACTIONS .......................................................................................................... 10 DOSAGE AND ADMINISTRATION ...................................................................................... 11 OVERDOSAGE ......................................................................................................................... 14 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 15 STORAGE AND STABILITY .................................................................................................. 16 SPECIAL HANDLING INSTRUCTIONS ........................... Llegiu el document complet