VAN-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

RIZATRIPTAN (RIZATRIPTAN BENZOATE)

Tersedia dari:

VANC PHARMACEUTICALS INC

Kode ATC:

N02CC04

INN (Nama Internasional):

RIZATRIPTAN

Dosis:

10MG

Bentuk farmasi:

TABLET (ORALLY DISINTEGRATING)

Komposisi:

RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG

Rute administrasi :

ORAL

Unit dalam paket:

6

Jenis Resep:

Prescription

Area terapi:

SELECTIVE SEROTONIN AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0137841002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-08-07

Karakteristik produk

PRODUCT MONOGRAPH
PR
VAN-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Vanc Pharmaceuticals Inc.
Date of Preparation:
210-2639, Viking way 9 November, 2015
Richmond, BC V6V3B7
www.vancpharm.com
Submission Control No: 188668
_ _
_VAN-Rizatriptan ODT _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ Page 2 of 38_
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
..............................................................................................................
12
DRUG INTERACTIONS
...............................................................................................................
18
DOSAGE AND ADMINISTRATION
...........................................................................................
20
OVERDOSAGE
.............................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
22
STORAGE AND STABILITY
......................................................................................................
25
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 26
PART II: SCIENTIFIC INFORMATION