OCTALBIN 25% SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ALBUMIN (HUMAN)

Fáanlegur frá:

OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGES M B H

ATC númer:

B05AA01

INN (Alþjóðlegt nafn):

ALBUMIN

Skammtar:

25%

Lyfjaform:

SOLUTION

Samsetning:

ALBUMIN (HUMAN) 25%

Stjórnsýsluleið:

INTRAVENOUS

Einingar í pakka:

50ML/100ML

Gerð lyfseðils:

Schedule D

Lækningarsvæði:

BLOOD DERIVATIVES

Vörulýsing:

Active ingredient group (AIG) number: 0131452002; AHFS:

Leyfisstaða:

MARKETED

Leyfisdagur:

2015-01-06

Vara einkenni

_ _
_ _
_Page 1 of 15_
PRODUCT MONOGRAPH
OCTALBIN 25%
Albumin (Human), 250 mg/ml
Solution for Infusion
Prescription Medication
ATC code: B05AA01
Control# 208685 Approval date: October 30, 2017
Manufactured by:
Octapharma Pharmazeutika Produktionsges m.b.H.
Oberlaaer Strasse 235
A-1100 Vienna, Austria
Manufactured for:
Octapharma Canada, Inc.
308-214 King St W
Toronto, ON M5H 3S6
Canada
Date of Revision:
AUGUST 22, 2017
_ _
_ _
_Page 2 of 15_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.........................................................................
3
DESCRIPTION
....................................................................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
7
DOSAGE AND ADMINISTRATION
................................................................................
7
OVERDOSAGE
...................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 9
STORAGE AND STABILITY
............................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
........................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 10
PART II: SCIENTI