VIRACEPT -50MG POWDER

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

NELFINAVIR (NELFINAVIR MESYLATE)

Dostupné z:

PFIZER CANADA ULC

ATC kód:

J05AE04

INN (Medzinárodný Name):

NELFINAVIR

Dávkovanie:

50MG

Forma lieku:

POWDER

Zloženie:

NELFINAVIR (NELFINAVIR MESYLATE) 50MG

Spôsob podávania:

ORAL

Počet v balení:

144G

Typ predpisu:

Prescription

Terapeutické oblasti:

HIV PROTEASE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0134340002; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2021-11-12

Súhrn charakteristických

_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