BERIPLEX P/N 1000 POWDER FOR SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

COAGULATION FACTOR II (HUMAN); COAGULATION FACTOR VII (HUMAN); COAGULATION FACTOR IX (HUMAN); COAGULATION FACTOR X (HUMAN); PROTEIN C; PROTEIN S

Commercializzato da:

CSL BEHRING CANADA INC

Codice ATC:

B02BD01

INN (Nome Internazionale):

COAGULATION FACTOR IX, II, VII AND X IN COMB

Dosaggio:

1600UNIT; 1000UNIT; 1240UNIT; 2040UNIT; 1640UNIT; 1360UNIT

Forma farmaceutica:

POWDER FOR SOLUTION

Composizione:

COAGULATION FACTOR II (HUMAN) 1600UNIT; COAGULATION FACTOR VII (HUMAN) 1000UNIT; COAGULATION FACTOR IX (HUMAN) 1240UNIT; COAGULATION FACTOR X (HUMAN) 2040UNIT; PROTEIN C 1640UNIT; PROTEIN S 1360UNIT

Via di somministrazione:

INTRAVENOUS

Confezione:

50ML

Tipo di ricetta:

Schedule D

Area terapeutica:

HEMOSTATICS

Dettagli prodotto:

Active ingredient group (AIG) number: 0652205004; AHFS:

Stato dell'autorizzazione:

MARKETED

Data dell'autorizzazione:

2013-11-21

Scheda tecnica

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PRODUCT MONOGRAPH
BERIPLEX
® P/N 500 / BERIPLEX
® P/N 1000
Powder and solvent for solution for injection
Human Prothrombin Complex _ _
Factor II
380 - 800 IU /
760 – 1600 IU
Factor VII 200 - 500 IU /
400 – 1000 IU
Factor IX 500 IU /
1000 IU
Factor X
500 - 1020 IU /
1000 – 2040 IU
Protein C 420 - 820 IU /
840 – 1640 IU
Protein S
240 - 680 IU /
480 – 1360 IU
Ph. Eur.
ATC: B02BD01
Human Blood Coagulation factors II, VII, IX and X combination
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CSL BEHRING CANADA, INC.
55 Metcalfe Street, Suite 1460
Ottawa, Ontario
K1P 6L5
Date of Initial Approval: November 05, 2010
Date of Revision: October 23, 2019
Submission Control No: 221855
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
DESCRIPTION...................................................................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
18
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 18
STORAGE AND STABILITY
.........................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
......................................................................