BUMINATE 25% SOLUTION

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

ALBUMIN (HUMAN)

Tilgængelig fra:

BAXTER HEALTHCARE CORPORATION

ATC-kode:

B05AA01

INN (International Name):

ALBUMIN

Dosering:

25%

Lægemiddelform:

SOLUTION

Sammensætning:

ALBUMIN (HUMAN) 25%

Indgivelsesvej:

INTRAVENOUS

Enheder i pakken:

20/50/100ML

Recept type:

Schedule D

Terapeutisk område:

BLOOD DERIVATIVES

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2015-02-06

Produktets egenskaber

_Page 1 of 19_
PRODUCT MONOGRAPH
BUMINATE
5%
BUMINATE
25%
Albumin (Human), USP
5% Solution for Infusion
25% Solution for Infusion
Blood Product/ Human Plasma Derivative
Baxter Corporation
7125 Mississauga Road
Mississauga, Ontario
CANADA, L5N 0C2
Date of Approval:
March 12, 2013
Submission Control No: 160731, 160732
_Page 2 of 19_
TABLE OF
CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................3
SUMMARY PRODUCT
INFORMATION....................................................3
DESCRIPTION
...............................................................................................3
INDICATIONS AND CLINICAL USE
.........................................................4
CONTRAINDICATIONS
...............................................................................5
WARNINGS AND PRECAUTIONS
.............................................................6
ADVERSE REACTIONS
...............................................................................8
DRUG INTERACTIONS
................................................................................9
DOSAGE AND
ADMINISTRATION............................................................9
OVERDOSAGE
............................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
........................................11
STORAGE AND STABILITY
.....................................................................12
DOSAGE FORMS, COMPOSITION AND PACKAGING.........................12
PART II: SCIENTIFIC INFORMATION
.........................................................13
PHARMACEUTICAL INFORMATION
.....................................................13
CLINICAL
TRIALS......................................................................................14
DETAILED
PHARMACOLOGY.................................................................14
TOXICOLOGY
.............................................................................................14
REFERENCES
.........................................