BERIPLEX P/N 500 POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

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

Διαθέσιμο από:

CSL BEHRING CANADA INC

Φαρμακολογική κατηγορία (ATC):

B02BD01

INN (Διεθνής Όνομα):

COAGULATION FACTOR IX, II, VII AND X IN COMB

Δοσολογία:

800UNIT; 500UNIT; 620UNIT; 1020UNIT; 820UNIT; 680UNIT

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

COAGULATION FACTOR II (HUMAN) 800UNIT; COAGULATION FACTOR VII (HUMAN) 500UNIT; COAGULATION FACTOR IX (HUMAN) 620UNIT; COAGULATION FACTOR X (HUMAN) 1020UNIT; PROTEIN C 820UNIT; PROTEIN S 680UNIT

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

30ML

Τρόπος διάθεσης:

Schedule D

Θεραπευτική περιοχή:

HEMOSTATICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0652205002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2010-11-05

Αρχείο Π.Χ.Π.

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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
......................................................................