MAXALT RPD TABLET (ORALLY DISINTEGRATING)
Страна: Канада
Език: английски
Източник: Health Canada
Данни за продукта
(SPC)
11-05-2021
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Активна съставка:
RIZATRIPTAN (RIZATRIPTAN BENZOATE)
Предлага се от:
ORGANON CANADA INC.
АТС код:
N02CC04
INN (Международно Name):
RIZATRIPTAN
дозиране:
10MG
Лекарствена форма:
TABLET (ORALLY DISINTEGRATING)
Композиция:
RIZATRIPTAN (RIZATRIPTAN BENZOATE) 10MG
Начин на приложение:
ORAL
Броя в опаковка:
6/12
Вид предписание :
Prescription
Терапевтична област:
SELECTIVE SEROTONIN AGONISTS
Каталог на резюме:
Active ingredient group (AIG) number: 0137841002; AHFS:
Статус Оторизация:
APPROVED
Дата Оторизация:
2005-06-01
Данни за продукта
_MAXALT_
®
_ and MAXALT RPD_
®
_ (rizatriptan benzoate) _
_Page 1 of 37_
PRODUCT MONOGRAPH
MAXALT
®
rizatriptan benzoate tablets
10 mg rizatriptan
AND
MAXALT RPD
®
rizatriptan benzoate wafers
5 mg and 10 mg rizatriptan
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Organon Canada Inc.
16766 route Transcanadienne
Kirkland, Quebec
H9H 4M7
www.organon.ca
Date of Revision:
May 11, 2021 SUBMISSION CONTROL NO.: 251099
_MAXALT_
®
_ and MAXALT RPD_
®
_ (rizatriptan benzoate) _
_Page 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
..................................................................................5
ADVERSE REACTIONS
..................................................................................................11
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................19
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL
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