TEVA-ELETRIPTAN TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE)

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

N02CC06

SNN (starptautisko nepatentēto nosaukumu):

ELETRIPTAN

Deva:

20MG

Zāļu forma:

TABLET

Kompozīcija:

ELETRIPTAN (ELETRIPTAN HYDROBROMIDE) 20MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

6

Receptes veids:

Prescription

Ārstniecības joma:

SELECTIVE SEROTONIN AGONISTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2013-04-12

Produkta apraksts

_ _
_ _
_Page 1 of 34_
_ _
_ _
_ _
_ _
_ _
PRODUCT MONOGRAPH
PR
TEVA-ELETRIPTAN
eletriptan hydrobromide
Tablets 20 mg and 40 mg eletriptan (as eletriptan hydrobromide)
5-HT
1
Receptor Agonist
Migraine Therapy
Teva Canada Limited
30 Novopharm Limited
Toronto, Ontario
M1B 2K9
Date of Revision
October 20, 2014
Submission Control No: 178627
_ _
_ _
_Page 2 of 34_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
14
DOSAGE AND ADMINISTRATION
.....................................................................................
16
OVERDOSAGE
.......................................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 18
STORAGE AND STABILITY
.................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
...............................................................................
22
PHARMACEUTICAL INFORMATION
.................................................................................
22
CLINICAL TRIALS
............................