Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
NEVIRAPINE
AURO PHARMA INC
J05AG01
NEVIRAPINE
200MG
TABLET
NEVIRAPINE 200MG
ORAL
15G/50G
Prescription
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0134602001; AHFS:
APPROVED
2010-11-16
_Page 1 of 55_ PRODUCT MONOGRAPH PR AURO-NEVIRAPINE Nevirapine Tablets USP 200 MG ANTIRETROVIRAL AGENT NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR WITH ACTIVITY AGAINST HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) AURO PHARMA INC. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, CANADA www.auropharma.ca SUBMISSION CONTROL NO.: 242225 DATE OF PREPARATION: November 16, 2020 _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 ............................................................................5 ADVERSE REACTIONS ...........................................................................................14 DRUG INTERACTIONS ...........................................................................................20 DOSAGE AND ADMINISTRATION .......................................................................32 OVERDOSAGE .........................................................................................................33 ACTION AND CLINICAL PHARMACOLOGY .....................................................34 STORAGE AND STABILITY ...................................................................................36 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................36 PART II: SCIENTIFIC INFORMATION ...............................................................................38 PHARMACEUTICAL INFORMATION ....................................................................38 CLINICAL TRIALS ....................................................................................................39 DETAILED PHARMACOLOGY ................................. Aqra d-dokument sħiħ