PMS-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ZOLMITRIPTAN

Disponível em:

PHARMASCIENCE INC

Código ATC:

N02CC03

DCI (Denominação Comum Internacional):

ZOLMITRIPTAN

Dosagem:

2.5MG

Forma farmacêutica:

TABLET (ORALLY DISINTEGRATING)

Composição:

ZOLMITRIPTAN 2.5MG

Via de administração:

ORAL

Unidades em pacote:

6/30

Tipo de prescrição:

Prescription

Área terapêutica:

SELECTIVE SEROTONIN AGONISTS

Resumo do produto:

Active ingredient group (AIG) number: 0134381001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2011-06-07

Características técnicas

PRODUCT MONOGRAPH
PR
PMS-ZOLMITRIPTAN
Zolmitriptan Film-Coated Tablets, House Standard
2.5 mg
PR
PMS-ZOLMITRIPTAN ODT
Zolmitriptan Orally Dispersible Tablets, House Standard
2.5 mg
5-HT1 RECEPTOR AGONIST
MIGRAINE THERAPY
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
April 15, 2020
Submission Control No.: 237071
_ _
_pms-ZOLMITRIPTAN and pms-ZOLMITRIPTAN ODT Product Monograph _
_Page 2 of 41 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
....................