PMS-SUMATRIPTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE)

Tilgjengelig fra:

PHARMASCIENCE INC

ATC-kode:

N02CC01

INN (International Name):

SUMATRIPTAN

Dosering :

100MG

Legemiddelform:

TABLET

Sammensetning:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 100MG

Administreringsrute:

ORAL

Enheter i pakken:

6/30

Resept typen:

Prescription

Terapeutisk område:

SELECTIVE SEROTONIN AGONISTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0123238001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2005-08-24

Preparatomtale

_pms-SUMATRIPTAN Product Monograph _
_Page 1 of 41 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-SUMATRIPTAN
Sumatriptan Tablets
Tablets, 25 mg, 50 mg and 100 mg sumatriptan (as sumatriptan
succinate), Oral
USP
5-HT
1
Receptor Agonist
Migraine Therapy
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 259228
Date of Initial Authorization:
AUG 24, 2005
Date of Revision:
MAY 11, 2022
_ _
_ _
_pms-SUMATRIPTAN Product Monograph _
_Page 2 of 41 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
05/2022
7 Warnings and Precautions, Serotonin toxicity / Serotonin Syndrome
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
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
......................................................... 6
4.4
Administration............................................................