JAMP ATAZANAVIR CAPSULE
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
26-02-2021
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
ATAZANAVIR (ATAZANAVIR SULFATE)
Fáanlegur frá:
JAMP PHARMA CORPORATION
ATC númer:
J05AE08
INN (Alþjóðlegt nafn):
ATAZANAVIR
Skammtar:
150MG
Lyfjaform:
CAPSULE
Samsetning:
ATAZANAVIR (ATAZANAVIR SULFATE) 150MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
15G/50G
Gerð lyfseðils:
Prescription
Lækningarsvæði:
HIV PROTEASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0149741002; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2021-03-04
Vara einkenni
Page 1 of 77
PRODUCT MONOGRAPH
PR
JAMP ATAZANAVIR
Atazanavir capsules
150, 200 and 300 mg
(as atazanavir sulfate)
House Standard
Azapeptide Inhibitor of HIV-1 Protease
JAMP Pharma Corporation
Date of Preparation:
1310, rue Nobel
February 26, 2021
Boucherville, Québec
J4B 5H3
CONTROL NUMBER: 231176
Page 2 of 77
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
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
...............................................................................37
OVERDOSAGE
.................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
.............................................................40
STORAGE AND STABILITY
..........................................................................................45
DOSAGE FORMS, COMPOSITION AND PACKAGING
..............................................45
PART II : SCIENTIFIC INFORMATION
................................................................................46
PHARMACEUTICAL INFORMATION
..........................................................................46
CLINICAL TRIALS
..........................................................................................................46
DETAILED
PHARMACOLOGY.....................................
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