WINRHO SDF KIT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)

Available from:

APTEVO BIOTHERAPEUTICS LLC

ATC code:

J06BB01

INN (International Name):

ANTI-D (RH) IMMUNOGLOBULIN

Dosage:

600UNIT

Pharmaceutical form:

KIT

Composition:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 600UNIT

Administration route:

INTRAMUSCULAR

Units in package:

120MCG-STERILE DILUENT 8.5ML

Prescription type:

Schedule D

Therapeutic area:

SERUMS

Product summary:

Active ingredient group (AIG) number: 0106269002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-07-15

Summary of Product characteristics

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