CCP-RIZATRIPTAN ODT TABLET (ORALLY DISINTEGRATING)

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

RIZATRIPTAN (RIZATRIPTAN BENZOATE)

متاح من:

CELLCHEM PHARMACEUTICALS INC.

ATC رمز:

N02CC04

INN (الاسم الدولي):

RIZATRIPTAN

جرعة:

5MG

الشكل الصيدلاني:

TABLET (ORALLY DISINTEGRATING)

تركيب:

RIZATRIPTAN (RIZATRIPTAN BENZOATE) 5MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

6

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE SEROTONIN AGONISTS

ملخص المنتج:

Active ingredient group (AIG) number: 0137841001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2023-08-03

خصائص المنتج

_CCP-Riztriptan ODT _
_Page 1 of 34_
PRODUCT MONOGRAPH
PR
CCP-RIZATRIPTAN ODT
Rizatriptan Benzoate Orally Disintegrating Tablets
5 mg and 10 mg Rizatriptan (as Rizatriptan Benzoate)
5-HT
1
Receptor Agonist
MIGRAINE THERAPY
Date of Revision:
June 19, 2017
CellChem Pharmaceuticals Inc.
30 Concourse Gate, Unit 1
Ottawa, Ontario
K2E 7V7
Control #
205269
_CCP-Riztriptan ODT _
_Page 2 of 34_
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
..........................................................................................................16
DOSAGE AND ADMINISTRATION
......................................................................................18
OVERDOSAGE
.........................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
....................................................................19
STORAGE AND STABILITY
..................................................................................................22
SPECIAL HANDLING INSTRUCTIONS
...............................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................23
PART II: SCIENTIFIC INFORMATION
..............................................................................
27
PHARMACEUTICAL INF