MINT-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLMITRIPTAN

Boleh didapati daripada:

MINT PHARMACEUTICALS INC

Kod ATC:

N02CC03

INN (Nama Antarabangsa):

ZOLMITRIPTAN

Dos:

2.5MG

Borang farmaseutikal:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

ZOLMITRIPTAN 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

6

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2017-06-19

Ciri produk

Page 1 of 45
PRODUCT MONOGRAPH
PR
MINT-ZOLMITRIPTAN
Zolmitriptan T
ablets
2.5
m
g
PR
MINT-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Mint Pharmaceuticals Inc.,
DATE OF PREPARATION:
1093 Meyerside Drive, Unit 1,
16 JANUARY 2014
Mississauga, Ontario
L5T 1J6
SUBMISSION CONTROL NO: 163326, 163327
Page 2 of 45
TABLE OF
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................3
SUMMARY PRODUCT
INFORMATION......................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS.................................................................................................4
WARNINGS AND PRECAUTIONS
...............................................................................4
ADVERSE REACTIONS
...............................................................................................11
DRUG
INTERACTIONS................................................................................................17
DOSAGE AND ADMINISTRATION
...........................................................................18
OVERDOSAGE
..............................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
..........................................................20
STORAGE AND STABILITY
.......................................................................................23
DOSAGE FORMS, COMPOSITION AND
PACKAGING...........................................23
PART II: SCIENTIFIC
INFORMATION.............................................................................24
PHARMACEUTICAL INFORMATION
.......................................................................24
CLINICAL TRIALS
.......................................................................................................25
DETAILED PHARMACOLOGY
...........................