Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
NEVIRAPINE
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
J05AG01
NEVIRAPINE
200MG
TABLET
NEVIRAPINE 200MG
ORAL
60
Prescription
NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS
Active ingredient group (AIG) number: 0134602001; AHFS:
CANCELLED POST MARKET
2019-05-24
_ _ _VIRAMUNE Product Monograph_ _ _ _Page 1 of 62_ PRODUCT MONOGRAPH Pr VIRAMUNE® (NEVIRAPINE) IMMEDIATE-RELEASE TABLETS 200 MG Pr VIRAMUNE® XR (NEVIRAPINE) EXTENDED-RELEASE TABLETS 400 MG ANTIRETROVIRAL AGENT NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR WITH ACTIVITY AGAINST HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) BOEHRINGER INGELHEIM (CANADA) LTD. 5180 SOUTH SERVICE ROAD BURLINGTON, ONTARIO L7L 5H4 DATE OF REVISION: NOVEMBER 18, 2013 CONTROL NUMBER: 167894 For BICL use only: Tracking CCDS # 0199-17 _ _ _VIRAMUNE Product Monograph_ _ _ _Page 2 of 62_ 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 ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................21 DOSAGE AND ADMINISTRATION ..............................................................................34 OVERDOSAGE ................................................................................................................36 ACTION AND CLINICAL PHARMACOLOGY ............................................................36 STORAGE AND STABILITY ..........................................................................................39 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................39 PART II: SCIENTIFIC INFORMATION ...............................................................................41 PHARMACEUTICAL INFORMATION .............. Baca dokumen lengkapnya