ALBUMIN (HUMAN) 25% SOLUTION USP

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

ALBUMIN (HUMAN)

Disponible des:

GRIFOLS THERAPEUTICS LLC

Codi ATC:

B05AA01

Designació comuna internacional (DCI):

ALBUMIN

Dosis:

25%

formulario farmacéutico:

SOLUTION

Composición:

ALBUMIN (HUMAN) 25%

Vía de administración:

INTRAVENOUS

Unidades en paquete:

50ML/100ML

tipo de receta:

Schedule D

Área terapéutica:

BLOOD DERIVATIVES

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

2005-07-11

Fitxa tècnica

_ _
Page 1 of 18
PRODUCT MONOGRAPH
ALBUMIN (HUMAN) 25% SOLUTION, USP
Albumin (Human) 25%, USP
Intravenous Solution, 25%
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 18
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
DESCRIPTION....................................................................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................6
WARNINGS AND PRECAUTIONS
..................................................................................6
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................11
PART II: SCIENTIFIC INFORMATION
.......................