APO-ABACAVIR-LAMIVUDINE-ZIDOVUDINE TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
27-12-2019
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:
ABACAVIR (ABACAVIR SULFATE); LAMIVUDINE; ZIDOVUDINE
Fáanlegur frá:
APOTEX INC
ATC númer:
J05AR04
INN (Alþjóðlegt nafn):
ZIDOVUDINE, LAMIVUDINE AND ABACAVIR
Skammtar:
300MG; 150MG; 300MG
Lyfjaform:
TABLET
Samsetning:
ABACAVIR (ABACAVIR SULFATE) 300MG; LAMIVUDINE 150MG; ZIDOVUDINE 300MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
60
Gerð lyfseðils:
Prescription
Lækningarsvæði:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0345541001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2013-11-08
Vara einkenni
Page 1 of 45
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ABACAVIR-LAMIVUDINE
Abacavir and Lamivudine Tablets
600 mg abacavir (as abacavir sulfate) and 300 mg lamivudine
Antiretroviral Agent
Manufacturer’s Standard
Date of Revision:
December 27, 2019
Submission Control No: 233546
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
Page 2 of 45
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 17
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.........................................................................
22
CLINICAL TRIALS
.........................................................................................................
24
M
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