TEVA-TENOFOVIR TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
11-10-2018
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Active ingredient:
TENOFOVIR DISOPROXIL FUMARATE
Available from:
TEVA CANADA LIMITED
ATC code:
J05AF07
INN (International Name):
TENOFOVIR DISOPROXIL
Dosage:
300MG
Pharmaceutical form:
TABLET
Composition:
TENOFOVIR DISOPROXIL FUMARATE 300MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Product summary:
Active ingredient group (AIG) number: 0152569001; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-07-26
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
TEVA-TENOFOVIR
tenofovir disoproxil fumarate tablets
300 mg
Antiretroviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No.: 219263
Date of Revision: October 11, 2018
2
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
........................................................................................
10
DRUG INTERACTIONS
........................................................................................
18
DOSAGE AND ADMINISTRATION
....................................................................
26
OVERDOSAGE
......................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
.................................................. 27
STORAGE AND STABILITY
................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
............................................................. 31
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 31
PART II
SCIENTIFIC INFORMATION
............................................................................
32
PHARMACEUTICAL INFORMATION
................................................................ 32
CLINICAL TRIALS
................................................................................................
33
VIROLOGY (MICROBIOLOGY)
..........................................................................
47
NON-CLINICAL TOXICOLOGY
............................................................
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