Država: Kanada
Jezik: angleščina
Source: Health Canada
ALBIGLUTIDE
GLAXOSMITHKLINE INC
A10BJ04
ALBIGLUTIDE
50MG
POWDER FOR SOLUTION
ALBIGLUTIDE 50MG
SUBCUTANEOUS
1 PEN/ 4PENS
Prescription
MISCELLANEOUS ANTIDIABETIC AGENTS
Active ingredient group (AIG) number: 0157070002; AHFS:
CANCELLED PRE MARKET
2017-10-24
_ _ _Page 1 of 66_ PRODUCT MONOGRAPH Pr EPERZAN™ albiglutide Powder for Solution for Injection in Pre-filled Pens 30 mg/0.5 mL and 50 mg/0.5 mL (after reconstitution) Antihyperglycemic Agent Human Glucagon-Like Peptide-1 (GLP-1) receptor agonist GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Preparation: February 12, 2016 DATE OF APPROVAL: FEBRUARY 19, 2016 SUBMISSION CONTROL NO: 165145 _©_ _ 2016 GlaxoSmithKline Inc. All Rights Reserved _ _EPERZAN is a trademark of Glaxo Group Limited, used under license by GlaxoSmithKline Inc. _ _ _ _Page 2 of 66_ TABLE OF CONTENTS PAGE PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ................................................................... 3 DESCRIPTION .......................................................................................................... 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS ............................................................................ 5 ADVERSE REACTIONS ............................................................................................ 8 DRUG INTERACTIONS .......................................................................................... 15 DOSAGE AND ADMINISTRATION ........................................................................ 17 OVERDOSAGE ....................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ......................................................... 19 STORAGE AND STABILITY ................................................................................... 24 SPECIAL HANDLING INSTRUCTIONS .................................................................. 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 25 PART II: SCIENTIFIC INFORMATION ................................ Preberite celoten dokument