MINT-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
13-04-2015
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Aktiv ingrediens:
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
Tilgjengelig fra:
MINT PHARMACEUTICALS INC
ATC-kode:
N02CC04
INN (International Name):
RIZATRIPTAN
Dosering :
10MG
Legemiddelform:
TABLET (ORALLY DISINTEGRATING)
Sammensetning:
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG
Administreringsrute:
ORAL
Enheter i pakken:
6
Resept typen:
Prescription
Terapeutisk område:
SELECTIVE SEROTONIN AGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0137841002; AHFS:
Autorisasjon status:
CANCELLED POST MARKET
Autorisasjon dato:
2017-06-19
Preparatomtale
_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
...............
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