PANHEMATIN POWDER FOR SOLUTION

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

HEMIN

Предлага се от:

RECORDATI RARE DISEASES CANADA INC

АТС код:

B06AB01

INN (Международно Name):

HEMATIN

дозиране:

268MG

Лекарствена форма:

POWDER FOR SOLUTION

Композиция:

HEMIN 268MG

Начин на приложение:

INTRAVENOUS

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0160470001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2018-07-13

Данни за продукта

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_Page 1 of 18_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PANHEMATIN
®
Hemin for Injection
268 mg Hemin per Vial Sterile Powder for Reconstitution for Injection
Enzyme Inhibitors (ATC code: B06AB01)
Recordati Rare Diseases Canada Inc.
Toronto, Ontario, Canada M4N 3N1
Distributed by:
Recordati Rare Diseases Canada Inc.
Oakville, ON, Canada L6M 2W2
Date of Approval:
July 13, 2018
Submission Control No: 212276
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_Page 2 of 18_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
1
INDICATIONS
...................................................................................................................
3
1.1
Pediatrics
.................................................................................................................
3
1.2
Geriatrics
.................................................................................................................
3
2
CONTRAINDICATIONS
...................................................................................................
3
3
DOSAGE AND ADMINISTRATION
..................................................................................
3
3.1
Dosing Considerations
............................................................................................
3
3.2
Recommended Dose and Dosage Adjustment
....................................................... 4
3.3
Administration
..........................................................................................................
4
3.4
Reconstitution
..........................................................................................................
5
4
OVERDOSAGE
................................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
......................... 5
6
DESCRIPTION
..................................................................................................................
6
7
WARNINGS AND P