ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

ZOLMITRIPTAN

Tillgänglig från:

SANIS HEALTH INC

ATC-kod:

N02CC03

INN (International namn):

ZOLMITRIPTAN

Dos:

2.5MG

Läkemedelsform:

TABLET (ORALLY DISINTEGRATING)

Sammansättning:

ZOLMITRIPTAN 2.5MG

Administreringssätt:

ORAL

Enheter i paketet:

6

Receptbelagda typ:

Prescription

Terapiområde:

SELECTIVE SEROTONIN AGONISTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2015-07-31

Produktens egenskaper

_ _
_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 1 of 44_
PRODUCT MONOGRAPH
PR
ZOLMITRIPTAN
Zolmitriptan
2.5 mg Tablet
PR
ZOLMITRIPTAN ODT
Zolmitriptan
2.5 mg Orally Disintegrating Tablet
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Date of Revision:
August 21, 2020
Submission Control No.:
242166
L6Y 5S5
Brampton, Ontario
1 President’s Choice Circle
Sanis Health
Inc.
_ _
_ZOLMITRIPTAN and ZOLMITRIPTAN ODT _
_Page 2 of 44_
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
.................................................................................................
11
DRUG INTERACTIONS
.................................................................................................
17
DOSAGE AND ADMINISTRATION
.............................................................................
19
OVERDOSAGE
...............................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 21
STORAGE AND STABILITY
.........................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 23
PART II: SCIENTIFIC INFORMATION
..............................................................................
25
PHARMACEUTICAL INFORMATION
.........................................................................
25
CLINICAL TRIALS
..................................................................