APO-NEVIRAPINE TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
09-10-2014
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:
NEVIRAPINE
Fáanlegur frá:
APOTEX INC
ATC númer:
J05AG01
INN (Alþjóðlegt nafn):
NEVIRAPINE
Skammtar:
200MG
Lyfjaform:
TABLET
Samsetning:
NEVIRAPINE 200MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Vörulýsing:
Active ingredient group (AIG) number: 0134602001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2012-11-07
Vara einkenni
_APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph_
Page 1 of 65
PRODUCT MONOGRAPH
Pr
APO-NEVIRAPINE
NEVIRAPINE TABLETS USP
200 MG
PR
APO-NEVIRAPINE XR
NEVIRAPINE EXTENDED-RELEASE TABLETS
400 MG ANTIRETROVIRAL AGENT
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR
WITH ACTIVITY AGAINST
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 11, 2014
TORONTO, ONTARIO
M9L 1T9
CONTROL NO. 177473
_APO-NEVIRAPINE and APO-NEVIRAPINEXR Product Monograph_
Page 2 of 65
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
.......................................................................................................
14
DRUG INTERACTIONS
........................................................................................................
21
DOSAGE AND ADMINISTRATION
.......................................................................................
36
OVERDOSAGE
.....................................................................................................................
37
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
38
STORAGE AND STABILITY
.................................................................................................
40
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 41
PART II: SCIENTIFIC INFORMATION
...........................................................................
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