WINRHO SDF KIT

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)

Предлага се от:

APTEVO BIOTHERAPEUTICS LLC

АТС код:

J06BB01

INN (Международно Name):

ANTI-D (RH) IMMUNOGLOBULIN

дозиране:

5000UNIT

Лекарствена форма:

KIT

Композиция:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 5000UNIT

Начин на приложение:

INTRAMUSCULAR

Броя в опаковка:

1000MCG-STERILE DILUENT 8.5ML

Вид предписание :

Schedule D

Терапевтична област:

SERUMS

Каталог на резюме:

Active ingredient group (AIG) number: 0106269003; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2016-07-15

Данни за продукта

_WinRho® SDF Product Monograph _
_Page 1 of 43 _
_ _
PRODUCT MONOGRAPH
WINRHO
® SDF
Rh
o
(D) Immune Globulin (Human) for injection
Lyophilized: 600 IU (120 µg), 1500 IU (300 µg), 5000 IU (1000 µg)
Liquid: 600 IU (120 µg), 1500 IU (300 µg), 2500 IU (500 µg), 5000
IU (1000 µg), 15 000 IU
(3000 µg)
World Health Organization (WHO) Anti-D Immune Globulin (Human) 2
nd
International
Standard
Passive Immunizing Agent
Aptevo BioTherapeutics LLC,
Berwyn PA, 19312, USA
Distributor (in Canada): Cangene Corp.,
a subsidiary of Emergent BioSolutions Inc.
Winnipeg, MB, R3T 5Y3
Submission Control #: 194264
Date of Authorization: May 20, 2016
_WinRho® SDF Product Monograph _
_Page 2 of 43 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
......................................................................................