APO-ELETRIPTAN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Commercializzato da:

APOTEX INC

Codice ATC:

N02CC06

INN (Nome Internazionale):

ELETRIPTAN

Dosaggio:

40MG

Forma farmaceutica:

TABLET

Composizione:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 40MG

Via di somministrazione:

ORAL

Confezione:

6

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE SEROTONIN AGONISTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0150241002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2012-10-05

Scheda tecnica

_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……………………………………………………………………………�