APO-ELETRIPTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Tilgjengelig fra:

APOTEX INC

ATC-kode:

N02CC06

INN (International Name):

ELETRIPTAN

Dosering :

20MG

Legemiddelform:

TABLET

Sammensetning:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG

Administreringsrute:

ORAL

Enheter i pakken:

6

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0150241001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-10-05

Preparatomtale

_APO-ELETRIPTAN Tablets Product Monograph_
Page 1 of 31
PRODUCT MONOGRAPH
PR
APO-ELETRIPTAN
(ELETRIPTAN HYDROBROMIDE)
20 MG AND 40 MG ELETRIPTAN TABLET
5-HT
1 RECEPTOR AGONIST
MIGRAINE THERAPY
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JANUARY 9, 2014
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 170908
_APO-ELETRIPTAN Tablets Product Monograph_
Page 2 of 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION……………………………….…………………3
SUMMARY PRODUCT
INFORMATION………………………………………………………3
INDICATIONS AND CLINICA
USE…………………………………………………………….3
CONTRAINDICATIONS…………………………………………………………………………3
WARNINGS AND
PRECAUTIONS……………………………………………………………4
ADVERSE
REACTIONS………………………………………………………………………10
DRUG
INTERACTIONS……………………………………………………………………….13
DOSAGE AND
ADMINISTRATION…………………………………………………………..15
OVERDOSAGE…………………………………………………………………………………16
ACTION AND CLINICAL
PHARMACOLOGY……………………………………………….16
STORAGE AND
STABILITY……………………….………………………………………….18
DOSAGE FORMS, COMPOSITION AND
PACKAGING…………………………………..18
PART II: SCIENTIFIC
INFORMATION……………………………………………………………….20
PHARMACEUTICAL
INFORMATION………………………………………………………..20
CLINICAL
TRIALS………………………………………………………...……………………20
DETAILED
PHARMACOLOGY……………………………………………………………..23
TOXICOLOGY……………………………………………………………………………�