CATHFLO POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

ALTEPLASE

Disponibil de la:

HOFFMANN-LA ROCHE LIMITED

Codul ATC:

B01AD02

INN (nume internaţional):

ALTEPLASE

Dozare:

2MG

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

ALTEPLASE 2MG

Calea de administrare:

INSTILLATION

Unități în pachet:

2.2 ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

THROMBOLYTIC AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0120086004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2002-05-10

Caracteristicilor produsului

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_Page 1 of 22_
PRODUCT MONOGRAPH
PR
CATHFLO
®
alteplase, recombinant
Lyophilized Powder for Intracatheter Instillation - 2 mg
Fibrinolytic Agent
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
SUBMISSION CONTROL NO: 210147
APPROVAL DATE: January 9, 2018
CATHFLO
®
is a registered trademark of Genentech, Inc., used under license
_ _
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_Page 2 of 22_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................3
ADVERSE REACTIONS
....................................................................................................5
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................7
OVERDOSAGE
..................................................................................................................9
ACTION AND CLINICAL PHARMACOLOGY
..............................................................9
STORAGE AND STABILITY
............................................................................................9
SPECIAL HANDLING INSTRUCTIONS ....................... ERROR! BOOKMARK
NOT DEFINED.
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................9
PART II: SCIENTIFIC INFORMATION
...............................................................................11
PHARMACEUTICAL INFORMATION
..........................................................................11
CLI