ELETRIPTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
04-07-2019
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Aktiv ingrediens:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)
Tilgjengelig fra:
PRO DOC LIMITEE
ATC-kode:
N02CC06
INN (International Name):
ELETRIPTAN
Dosering :
20MG
Legemiddelform:
TABLET
Sammensetning:
ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0150241001; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2019-07-05
Preparatomtale
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
ELETRIPTAN
eletriptan hydrobromide
Tablets 20 mg and 40 mg eletriptan (as eletriptan hydrobromide)
5-HT
1
Receptor Agonist
Migraine Therapy
Date of Revision
July 4, 2019
PRO DOC LTÉE
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control No: 227419
_ _
_ _
_Page 2 of 34_
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
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
15
DOSAGE AND ADMINISTRATION
.....................................................................................
17
OVERDOSAGE
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
.........................................................................
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