SANDOGLOBULIN NF LIQUID SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

IMMUNOGLOBULIN (HUMAN)

זמין מ:

CSL BEHRING CANADA INC

קוד ATC:

J06BA02

INN (שם בינלאומי):

IMMUNOGLOBULINS, NORMAL HUMAN, FOR INTRAVASC. ADM.

כמות:

120G

טופס פרצבטיות:

SOLUTION

הרכב:

IMMUNOGLOBULIN (HUMAN) 120G

מסלול נתינה (של תרופות):

INTRAVENOUS

יחידות באריזה:

50ML/100ML

סוג מרשם:

Schedule D

איזור תרפויטי:

SERUMS

leaflet_short:

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

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2010-04-20

מאפייני מוצר

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