ALBUMIN (HUMAN) 5% SOLUTION, USP

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ALBUMIN (HUMAN)

Dostępny od:

GRIFOLS THERAPEUTICS LLC

Kod ATC:

B05AA01

INN (International Nazwa):

ALBUMIN

Dawkowanie:

5%

Forma farmaceutyczna:

SOLUTION

Skład:

ALBUMIN (HUMAN) 5%

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

50/250/500ML

Typ recepty:

Schedule D

Dziedzina terapeutyczna:

BLOOD DERIVATIVES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0131452001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2005-07-11

Charakterystyka produktu

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PRODUCT MONOGRAPH
ALBUMIN (HUMAN) 5% SOLUTION, USP
Albumin (Human) 5%, USP
Intravenous Solution, 5%
Manufacturer’s Standard
Plasma Substitute/Blood Derivative
Manufactured by:
Grifols Therapeutics Inc.
8368 U.S. 70 Bus. Hwy West
Clayton, North Carolina
27520
U.S.A.
Imported and Distributed by:
Grifols Canada Ltd.
5060 Spectrum Way,
Suite 405
Mississauga, Ontario
L4W 5N5
Prepared for:
Canadian Blood Services
and/or
Héma-Québec
Submission Control No: 202697 Date of Approval: August 22, 2017
_ _
Page 2 of 17
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
..........................................................................................10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................10
PART II: SCIENTIFIC INFORMATION
.......................