MINT-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

RIZATRIPTAN (RIZATRIPTAN BENZOATE)

Saadav alates:

MINT PHARMACEUTICALS INC

ATC kood:

N02CC04

INN (Rahvusvaheline Nimetus):

RIZATRIPTAN

Annus:

10MG

Ravimvorm:

TABLET (ORALLY DISINTEGRATING)

Koostis:

RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

6

Retsepti tüüp:

Prescription

Terapeutiline ala:

SELECTIVE SEROTONIN AGONISTS

Toote kokkuvõte:

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

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2017-06-19

Toote omadused

_MINT-RIZATRIPTAN ODT_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
MINT-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
MINT PHARMACEUTICALS INC.
Date of Preparation:
1093 MEYERSIDE DRIVE, UNIT 1
April 13, 2015
MISSISSAUGA, ONTARIO
L5T 1J6
CONTROL# 183267
_MINT-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
..............................................................................................................
11
DRUG INTERACTIONS
...............................................................................................................
17
DOSAGE AND ADMINISTRATION
...........................................................................................
19
OVERDOSAGE
.............................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
21
STORAGE AND STABILITY
......................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
....................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 25
PART II: SCIENTIFIC INFORMATION
...............