TELZIR TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
05-07-2019

Viambatanisho vya kazi:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM)

Inapatikana kutoka:

VIIV HEALTHCARE ULC

ATC kanuni:

J05AE07

INN (Jina la Kimataifa):

FOSAMPRENAVIR

Kipimo:

700MG

Dawa fomu:

TABLET

Tungo:

FOSAMPRENAVIR (FOSAMPRENAVIR CALCIUM) 700MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

60

Dawa ya aina:

Prescription

Eneo la matibabu:

HIV PROTEASE INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0150429001; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2009-12-08

Tabia za bidhaa

                                _ _
_Page 1 of 55_
PRODUCT MONOGRAPH
PR
TELZIR
Fosamprenavir tablets 700 mg
(as fosamprenavir calcium)
Fosamprenavir oral suspension 50 mg/mL
(as fosamprenavir calcium)
Antiretroviral Agent
ViiV Healthcare ULC
245, boulevard Armand-Frappier
Laval, Quebec
H7V 4A7
Date of Revision:
July 5, 2019
Submission Control No.: 226294
© 2019 ViiV Healthcare group of companies or its licensor.
Trademarks are owned by or licensed to the ViiV Healthcare group of
companies.
_ _
_Page 2 of 55_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................28
OVERDOSAGE
................................................................................................................30
ACTION AND CLINICAL PHARMACOLOGY
............................................................30
STORAGE AND STABILITY
..........................................................................................34
SPECIAL HANDLING INSTRUCTIONS
.......................................................................34
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................34
PART II: SCIENTIFIC INFORMATION
...............................................................................36
PHARMACEUTICAL INFORM
                                
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