XIGRIS (5MG/VIAL) POWDER FOR SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

DROTRECOGIN ALFA (ACTIVATED)

Tilgjengelig fra:

ELI LILLY CANADA INC

ATC-kode:

B01AD10

INN (International Name):

DROTRECOGIN ALFA

Dosering :

5MG

Legemiddelform:

POWDER FOR SOLUTION

Sammensetning:

DROTRECOGIN ALFA (ACTIVATED) 5MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

2.5ML

Resept typen:

Prescription

Terapeutisk område:

OTHER MISCELLANEOUS THERAPEUTIC AGENTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0148944001; AHFS:

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2011-11-14

Preparatomtale

_ _
_XIGRIS [drotrecogin alfa (activated)] _
_Page 1 of 36 _
_Product Monograph _
_ _
PRODUCT MONOGRAPH
Pr
XIGRIS
®
drotrecogin alfa (activated)
Sterile Powder for Intravenous Injection 5 mg or 20 mg drotrecogin
alfa (activated) per vial
ANTITHROMBOTIC PROFIBRINOLYTIC ANTI-INFLAMMATORY ENZYME
©
ELI LILLY CANADA INC.
3650 Danforth Avenue
Toronto, Ontario
M1N 2E8
1-888-545-5972
www.lilly.ca
Date of Approval:
August 20, 2009
Submission Control No: 128989
_ _
_XIGRIS [drotrecogin alfa (activated)] _
_Page 2 of 36 _
_Product Monograph _
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL
USE.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
4
ADVERSE
REACTIONS...................................................................................................
8
DRUG INTERACTIONS
.................................................................................................
12
DOSAGE AND ADMINISTRATION
.............................................................................
13
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 16
STORAGE AND
STABILITY.........................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
......................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
.............................................