APO-SUMATRIPTAN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE)

Предлага се от:

APOTEX INC

АТС код:

N02CC01

INN (Международно Name):

SUMATRIPTAN

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

SUMATRIPTAN (SUMATRIPTAN SUCCINATE) 50MG

Начин на приложение:

ORAL

Броя в опаковка:

6

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE SEROTONIN AGONISTS

Каталог на резюме:

Active ingredient group (AIG) number: 0123238002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2005-08-24

Данни за продукта

_APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) _
_Page 1 of 41 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-SUMATRIPTAN
Sumatriptan Succinate Tablets
tablets, 25 mg, 50 mg & 100 mg Sumatriptan (as sumatriptan succinate),
oral
Apotex Standard
5-HT
1
Receptor Agonist
Migraine Therapy
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
AUG 24,2005
Date of Revision:
JUN 20, 2023
Submission Control Number: 273039
_APO-SUMATRIPTAN (Sumatriptan Succinate Tablets) _
_Page 2 of 41 _
RECENT MAJOR LABEL CHANGES
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
4.4
Administration
...............................................................................................................
6
5
O