APO-ELETRIPTAN TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Saatavilla:

APOTEX INC

ATC-koodi:

N02CC06

INN (Kansainvälinen yleisnimi):

ELETRIPTAN

Annos:

20MG

Lääkemuoto:

TABLET

Koostumus:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG

Antoreitti:

ORAL

Kpl paketissa:

6

Prescription tyyppi:

Prescription

Terapeuttinen alue:

SELECTIVE SEROTONIN AGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2012-10-05

Valmisteyhteenveto

_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……………………………………………………………………………�