EPERZAN POWDER FOR SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ALBIGLUTIDE

Dostopno od:

GLAXOSMITHKLINE INC

Koda artikla:

A10BJ04

INN (mednarodno ime):

ALBIGLUTIDE

Odmerek:

30MG

Farmacevtska oblika:

POWDER FOR SOLUTION

Sestava:

ALBIGLUTIDE 30MG

Pot uporabe:

SUBCUTANEOUS

Enote v paketu:

4

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTIDIABETIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0157070001; AHFS:

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2017-10-24

Lastnosti izdelka

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