SANDOMIGRAN DS TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

PIZOTIFEN (PIZOTIFEN MALATE)

זמין מ:

PALADIN LABS INC.

קוד ATC:

N02CX01

INN (שם בינלאומי):

PIZOTIFEN

כמות:

1MG

טופס פרצבטיות:

TABLET

הרכב:

PIZOTIFEN (PIZOTIFEN MALATE) 1MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

ANTIMIGRAINE AGENTS, MISCELLANEOUS

leaflet_short:

Active ingredient group (AIG) number: 0110877001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2009-06-02

מאפייני מוצר

_Product Monograph _
_ _
SANDOMIGRAN DS (_pizotifen tablets)_
_ _
_ Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOMIGRAN DS
Pizotifen tablets
Tablets, 1 mg pizotifen (as pizotifen malate), oral
Serotonin and Tryptamine Antagonist
Migraine Prophylaxis
ATC code: N02CX
Paladin Labs Inc.
100 Alexis Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
Date of Initial Authorization:
December 31, 1980
Date of Revision:
August 23, 2023
Version 5.0
Submission Control Number: 272965
_Product Monograph _
_ _
SANDOMIGRAN DS (_pizotifen tablets)_
_ _
_ Page 2 of 21_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED._ _
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
..............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
......................................................... 5
4.5
Missed Dose
..............................................