VIRACEPT TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

NELFINAVIR (NELFINAVIR MESYLATE)

Tilgjengelig fra:

PFIZER CANADA ULC

ATC-kode:

J05AE04

INN (International Name):

NELFINAVIR

Dosering :

625MG

Legemiddelform:

TABLET

Sammensetning:

NELFINAVIR (NELFINAVIR MESYLATE) 625MG

Administreringsrute:

ORAL

Enheter i pakken:

120

Resept typen:

Prescription

Terapeutisk område:

HIV PROTEASE INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0134340003; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2021-11-12

Preparatomtale

_VIRACEPT _
_®_
_ (nelfinavir mesylate) Product Monograph _
_Page 1 of 45_
_ _
PRODUCT MONOGRAPH
PR
VIRACEPT
®
Nelfinavir tablets,
250 mg, 625 mg
(as nelfinavir mesylate)
Nelfinavir powder,
50 mg/g
(as nelfinavir mesylate)
HIV PROTEASE INHIBITOR
Pfizer Canada Inc.
Date of Revision:
17, 300 Trans-Canada Highway
Kirkland, Quebec H9J 2M5
28 October 2016
Dist. by: ViiV Healthcare ULC
Montreal, Quebec H4S 1Z1
Control No. 197422
®
Agouron Pharmaceuticals, Inc.
Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2016
_VIRACEPT _
_®_
_ (nelfinavir mesylate) Product Monograph _
_Page 2 of 45_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
..................................................................................................
11
DOSAGE AND ADMINISTRATION
..............................................................................
24
OVERDOSAGE
................................................................................................................
25
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 26
STORAGE AND STABILITY
..........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 28
PART II: SCIENTIFIC INFORMATION
...............................................................................
29
P