JAMP-ZOLMITRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ZOLMITRIPTAN

Boleh didapati daripada:

JAMP PHARMA CORPORATION

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:

APPROVED

Tarikh kebenaran:

2014-08-12

Ciri produk

_JAMP-ZOLMITRIPTAN ODT _
_Page 1 of 31_
PRODUCT MONOGRAPH
PR
JAMP-ZOLMITRIPTAN ODT
Zolmitriptan Orally Disintegrating Tablets
2.5 mg
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
JAMP Pharma Corporation
1380-203 newton
Boucherville, Québec
J4B 5H2
DATE OF PREPARATION:
August 1, 2014
SUBMISSION CONTROL NO.: 176028
_JAMP-ZOLMITRIPTAN ODT _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION................................................. 3
SUMMARY PRODUCT
INFORMATION.....................................................................
3
INDICATIONS AND CLINICAL
USE............................................................................
3
CONTRAINDICATIONS..................................................................................................
3
WARNINGS AND
PRECAUTIONS................................................................................
4
ADVERSE
REACTIONS..................................................................................................
10
DRUG
INTERACTIONS..................................................................................................
15
DOSAGE AND
ADMINISTRATION..............................................................................
16
OVERDOSAGE.................................................................................................................
17
ACTION AND CLINICAL
PHARMACOLOGY.............................................................
18
STORAGE AND
STABILITY..........................................................................................
20
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................
20
PART II: SCIENTIFIC
INFORMATION.........................................................................
21
PHARMACEUTICAL
INFORMATION..........................................................................
21
CLINICAL
TRIALS..........................................................................................................
21
DETAILED
PHARMACOLOGY...........................