SANDOMIGRAN DS TABLET

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

PIZOTIFEN (PIZOTIFEN MALATE)

Fáanlegur frá:

PALADIN LABS INC.

ATC númer:

N02CX01

INN (Alþjóðlegt nafn):

PIZOTIFEN

Skammtar:

1MG

Lyfjaform:

TABLET

Samsetning:

PIZOTIFEN (PIZOTIFEN MALATE) 1MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTIMIGRAINE AGENTS, MISCELLANEOUS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2009-06-02

Vara einkenni

_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
..............................................