AURO-LAMIVUDINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
12-08-2017
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Aktiv bestanddel:
LAMIVUDINE
Tilgængelig fra:
AURO PHARMA INC
ATC-kode:
J05AF05
INN (International Name):
LAMIVUDINE
Dosering:
300MG
Lægemiddelform:
TABLET
Sammensætning:
LAMIVUDINE 300MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/60/100/500
Recept type:
Prescription
Terapeutisk område:
NUCLEOSIDE AND NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS
Produkt oversigt:
Active ingredient group (AIG) number: 0128157005; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2013-10-16
Produktets egenskaber
_Page 1 of 42 _
PRODUCT MONOGRAPH
PR
AURO-LAMIVUDINE
lamivudine
150 mg & 300 mg tablets
AUROBINDO STANDARD
Antiretroviral Agent
AURO PHARMA INC. Date of Revision:
3700 Steeles Avenue West, Suite # 402 March 15, 2017
Woodbridge, Ontario, L4L 8K8, Canada.
Submission Control No: 203516
_Page 2 of 42 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................... 3
INDICATIONS AND CLINICAL USE
................................................................ 3
CONTRAINDICATION
........................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................... 4
ADVERSE REACTIONS
......................................................................................
8
DRUG INTERACTIONS
....................................................................................
15
DOSAGE AND ADMINISTRATION
................................................................ 17
OVERDOSAGE
..................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
.............................................. 18
STORAGE AND STABILITY
............................................................................
19
SPECIAL HANDLING
INSTRUCTION………………………………………20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................... 20
PART II: SCIENTIFIC INFORMATION
................................................................ 21
PHARMACEUTICAL INFORMATION
............................................................ 21
CLINICAL TRIALS
............................................................................................
22
DETAILED PHARMACOLOGY
.......................................................................
25
MICROBIOLOGY
.........................................................................................
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