SANDOGLOBULIN NF LIQUID SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

IMMUNOGLOBULIN (HUMAN)

Beszerezhető a:

CSL BEHRING CANADA INC

ATC-kód:

J06BA02

INN (nemzetközi neve):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

Adagolás:

120G

Gyógyszerészeti forma:

SOLUTION

Összetétel:

IMMUNOGLOBULIN (HUMAN) 120G

Az alkalmazás módja:

INTRAVENOUS

db csomag:

50ML/100ML

Recept típusa:

Schedule D

Terápiás terület:

SERUMS

Termék összefoglaló:

Active ingredient group (AIG) number: 0106267018; AHFS:

Engedélyezési státusz:

CANCELLED POST MARKET

Engedély dátuma:

2010-04-20

Termékjellemzők

_ _
_ _
_Page 1 of 26 _
PRODUCT MONOGRAPH
SANDOGLOBULIN
® NF LIQUID
IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
12 % Solution for infusion
Passive Immunizing Agent
CSL Behring Canada, Inc.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
KIP 6L5
Date of Approval:
Date of Revision:
February 15, 2007
Submission Control No: 112481
_ _
_ _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.......................................................................................3
SUMMARY
PRODUCT
INFORMATION
..............................................................................................................3
DESCRIPTION
........................................................................................................................................................3
INDICATIONS
AND
CLINICAL
USE....................................................................................................................3
CONTRAINDICATIONS
........................................................................................................................................3
WARNINGS
AND
PRECAUTIONS
.......................................................................................................................4
ADVERSE
REACTIONS
.........................................................................................................................................7
DRUG
INTERACTIONS
.......................................................................................................................................11
DOSAGE
AND
ADMINISTRATION....................................................................................................................11
OVERDOSAGE
.....................................................................................................................................................13
ACTION
AND
CLINICAL
PHARMACOLOGY
..................................................................................................13
STORAGE
AND
STABILITY
............................