ARGATROBAN SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ARGATROBAN

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

B01AE03

INN (Internationale Bezeichnung):

ARGATROBAN

Dosierung:

100MG

Darreichungsform:

SOLUTION

Zusammensetzung:

ARGATROBAN 100MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

2.5 ML

Verschreibungstyp:

Prescription

Therapiebereich:

DIRECT THROMBIN INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0143781001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2020-05-01

Fachinformation

_ _
_ARGATROBAN (argatroban for injection) Product Monograph _
_Page 1 of 31 _
PRODUCT MONOGRAPH
PR
ARGATROBAN
(argatroban for injection)
250 mg / 2.5 ml vial (100 mg / mL)
Concentrate, Solution for Injection
Intravenous Use Only
Antithrombotic
Sandoz Canada Inc.
110 de Lauzon
Boucherville, Quebec
J4B 1E6
Date of Revision:
April 30, 2020
Submission Control No.: 237735
_ _
_ARGATROBAN (argatroban for injection) Product Monograph _
_Page 2 of 31 _
_ _
_ARGATROBAN (argatroban for injection) Product Monograph _
_Page 3 of 31 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................ 4
SUMMARY PRODUCT INFORMATION
......................................................................
4
INDICATIONS AND CLINICAL USE
............................................................................
4
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND PRECAUTIONS
................................................................................
5
ADVERSE REACTIONS
..................................................................................................
6
DRUG INTERACTIONS
................................................................................................
10
DOSAGE AND ADMINISTRATION
............................................................................
13
OVERDOSAGE
..............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.......................................................... 16
STORAGE AND STABILITY
........................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 19
PART II: SCIENTIFIC INFORMATION
......................................................................
20
PH