ALPROLIX KIT

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN

Saatavilla:

SANOFI-AVENTIS CANADA INC

ATC-koodi:

B02BD04

INN (Kansainvälinen yleisnimi):

COAGULATION FACTOR IX

Annos:

3000UNIT

Lääkemuoto:

KIT

Koostumus:

RECOMBINANT HUMAN COAGULATION FACTOR IX, FC FUSION PROTEIN 3000UNIT

Antoreitti:

INTRAVENOUS

Kpl paketissa:

15G/50G

Prescription tyyppi:

Schedule D

Terapeuttinen alue:

HEMOSTATICS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0155510005; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-05-17

Valmisteyhteenveto

_ALPROLIX, Coagulation Factor IX (Recombinant), Fc Fusion Protein _
_Page 1 of 42 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ALPROLIX
®
Coagulation Factor IX (Recombinant), Fc Fusion Protein
Lyophilized Powder for Solution
250, 500, 1000, 2000, 3000 and 4000 IU/vial
Antihemorrhagic Blood Coagulation Factor IX
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
March 20, 2014
Date of Revision:
November 5, 2021
SUBMISSION CONTROL NUMBER: 246919
_ _
_Alprolix Coagulation Factor IX (Recombinant), Fc Fusion Protein _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2021
7 WARNINGS AND PRECAUTIONS, 7.1.3 Pediatrics
09/2021
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND
ADMINISTRATION.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 4
4.4
Administration...................................................................................................
7
5
OVERDOSAGE
....