ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ZOLMITRIPTAN

Fáanlegur frá:

SANIS HEALTH INC

ATC númer:

N02CC03

INN (Alþjóðlegt nafn):

ZOLMITRIPTAN

Skammtar:

2.5MG

Lyfjaform:

TABLET (ORALLY DISINTEGRATING)

Samsetning:

ZOLMITRIPTAN 2.5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

6

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE SEROTONIN AGONISTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2015-07-31

Vara einkenni

_ _
_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
..................................................................