NAT-ZOLMITRIPTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLMITRIPTAN

Boleh didapati daripada:

NATCO PHARMA (CANADA) INC

Kod ATC:

N02CC03

INN (Nama Antarabangsa):

ZOLMITRIPTAN

Dos:

2.5MG

Borang farmaseutikal:

TABLET

Komposisi:

ZOLMITRIPTAN 2.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

6/10/100/1000

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2015-07-13

Ciri produk

1 of 37
PRODUCT MONOGRAPH
PR
NAT-ZOLMITRIPTAN
ZOLMITRIPTAN TABLETS
2.5 MG
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Natco Pharma (Canada) Inc.
Date of Revision:
2000 Argentia Road, Plaza 1, Suite 200
February 19, 2020
Mississauga, Ontario, L5N 1P7
Canada
CONTROL#
235996
2 of 37
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
............................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 22
PART II: SCIENTIFIC INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
............................................................................
24
CLINICAL TRIALS
............................................................................................................
24
TOXICOLOGY
............................................