PEGASYS SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PEGINTERFERON ALFA-2A

Mevcut itibaren:

HOFFMANN-LA ROCHE LIMITED

ATC kodu:

L03AB11

INN (International Adı):

PEGINTERFERON ALFA-2A

Doz:

180MCG

Farmasötik formu:

SOLUTION

Kompozisyon:

PEGINTERFERON ALFA-2A 180MCG

Uygulama yolu:

SUBCUTANEOUS

Paketteki üniteler:

1ML

Reçete türü:

Prescription

Terapötik alanı:

INTERFERONS

Ürün özeti:

Active ingredient group (AIG) number: 0149481001; AHFS:

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2017-07-27

Ürün özellikleri

PRODUCT MONOGRAPH
PR
PEGASYS
®
peginterferon alfa-2a injection
Pre-filled syringes: 180 mcg/0.5 mL
Single-use Vials: 180 mcg/1 mL
ProClick
®
Autoinjector: 180 mcg/0.5 mL
Biological Response Modifier
Professed Standard
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Authorization:
November 18, 2015
Submission Control No: 180201
PEGASYS® and ProClick® are registered trade-marks of F. Hoffmann-La
Roche AG, used under license
©Copyright 2003-2014, Hoffmann-La Roche Limited
PEGASYS
®
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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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOS