PEGASYS SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PEGINTERFERON ALFA-2A

Tilgængelig fra:

PHARMAAND GMBH

ATC-kode:

L03AB11

INN (International Name):

PEGINTERFERON ALFA-2A

Dosering:

180MCG

Lægemiddelform:

SOLUTION

Sammensætning:

PEGINTERFERON ALFA-2A 180MCG

Indgivelsesvej:

SUBCUTANEOUS

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

INTERFERONS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2024-02-01

Produktets egenskaber

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
pharmaand GmbH
Taborstrasse 1
1020 Vienna, Austria
www.pharmaand.com
Imported and Distributed by Accelera Pharma Canada Inc.,
Mississauga, ON L5L 5Z9
Date of Initial Approval:
August 13, 2003
Date of Revision:
February 1, 2024
Submission Control No: 281817
PEGASYS
®
is a registered trade-mark of
pharmaand, used under license
©
Copyright 2021-2028,
pharma& Schweiz GmbH.
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
..........................