WINRHO SDF SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN)

Dostupné s:

KI BIOPHARMA LLC

ATC kód:

J06BB01

INN (Mezinárodní Name):

ANTI-D (RH) IMMUNOGLOBULIN

Dávkování:

2500UNIT

Léková forma:

SOLUTION

Složení:

ANTI-D (RH) IMMUNOGLOBULIN (HUMAN) 2500UNIT

Podání:

INTRAMUSCULAR

Jednotky v balení:

2.2ML

Druh předpisu:

Schedule D

Terapeutické oblasti:

SERUMS

Přehled produktů:

Active ingredient group (AIG) number: 0106269005; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2022-06-27

Charakteristika produktu

KI BioPharma LLC
Page 1 of 44
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
WINRHO
®
SDF
Rh
o
(D) Immunoglobulin
(Human) for Injection
Single-Dose Vials:
600 international
units (120 mcg)
1,500 international units (300 mcg)
2,500 international units (500 mcg)
5,000 international units (1,000 mcg)
15,000 international
units (3,000 mcg)
World Health Organization (WHO) Anti-D Immunoglobulin
(Human) 2
nd
International
Standard
Passive Immunizing
Agent
KI BioPharma LLC
1209 Orange St.
Wilmington, Delaware 19801
USA
Distributor (in Canada):
Accuristix
100 Vaughan Valley Blvd.
Vaughan, Ontario L4H 3C5
Submission
Control #: 264049
Date of Approval: June 27, 2022
KI BioPharma LLC
Page 2 of 44
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
.........................................................................
17
OVERDOSAGE
.........................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 21
STORAGE AND STABILITY
....................................................................................
23
SPECIAL HANDLING
INSTRUCTIONS.......