Beriplex P/N 250 IU, powder and solvent for solution for injection

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Factor ii activity; Factor vii activity; Factor x activity; Factor ix activity; Protein c activity; Protein s antigen

Saadav alates:

CSL Behring GmbH

ATC kood:

B02BD; B02BD01

INN (Rahvusvaheline Nimetus):

Factor ii activity; Factor vii activity; Factor x activity; Factor ix activity; Protein c activity; Protein s antigen

Annus:

250 international unit(s)

Ravimvorm:

Powder and solvent for solution for injection

Retsepti tüüp:

Product subject to prescription which may not be renewed (A)

Terapeutiline ala:

Blood coagulation factors; coagulation factor IX, II, VII and X in combination

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2016-05-06

Infovoldik

31329A (28)
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BERIPLEX
®
P/N
250, 500 AND 1000 IU
Powder and solvent for solution for injection
Human prothrombin complex
WHAT IS IN THIS LEAFLET
1. What Beriplex is and what it is used for
2. What you need to know before you use Beriplex
3. How to use Beriplex
4. Possible side effects
5. How to store Beriplex
6. Contents of the pack and other information
1. WHAT BERIPLEX IS AND WHAT IT IS USED FOR
WHAT IS BERIPLEX?
Beriplex is presented as powder and solvent. It is a white or slightly
coloured
powder or friable solid. The made up solution is to be given by
injection into a
vein.
Beriplex is made from human plasma (this is the liquid part of the
blood) and it
contains the human coagulation factors II, VII, IX and X. Concentrates
including
these coagulation factors are called prothrombin complex products. The
coagulation factors II, VII, IX and X are vitamin K-dependent and are
important for
blood clotting (coagulation). Lack of any of these factors means that
blood does
not clot as quickly as it should and so there is an increased tendency
to bleed. The
replacement of factors II, VII, IX and X with Beriplex will repair the
coagulation
mechanisms.
WHAT IS BERIPLEX USED FOR?
Beriplex is used for the prevention (during surgery) and treatment of
bleedings
caused by the acquired or congenital lack of vitamin K-dependent
coagulation
factors II, VII, IX and X in the blood, when purified specific
coagulation factor
products are not available.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BERIPLEX
The following sections contain information that your doctor should
consider
before you are given Beriplex.
DO NOT USE BERIPLEX:
• if you are allergic to any of the active substances or other
ingredients of this
medicine (listed in section 6).
PLEASE INFORM YOUR DOCTOR IF YOU ARE ALLERGIC TO ANY MEDICINE OR FOOD.
• if you are more likely to suffer from blood clots than normal
(patients at risk of
disseminated intravascular coagulation)
• if you show an allergic response to heparin, causing a fall in the
number of
blood pla

Toote omadused

Health Products Regulatory Authority
04 March 2022
CRN00C3X5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beriplex P/N 250 IU, powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Beriplex is presented as powder and solvent for solution for injection
containing human prothrombin complex. The product
nominally contains the following IU of the human coagulation factors
tabled below:
NAME OF THE INGREDIENTS
CONTENT AFTER RECONSTITUTION (IU/ML)
BERIPLEX P/N 250 IU
CONTENT PER VIAL (IU)
ACTIVE INGREDIENTS
Human
coagulation factor II
20 – 48
200 – 480
Human
coagulation factor VII
10 – 25
100 – 250
Human
coagulation factor IX
20 – 31
200 – 310
Human
coagulation factor X
22 – 60
220 – 600
FURTHER ACTIVE INGREDIENTS
Protein C
15 – 45
150 – 450
Protein S
12 - 38
120 - 380
The total protein content is 6 – 14 mg/ml of reconstituted solution.
The specific activity of factor IX is 2.5 IU per mg total protein.
The activities of all coagulation factors as well as Protein C and S
(antigen) have been tested according to the current valid
international WHO-Standards.
Excipients with known effect:
Sodium up to 343 mg (approximately 15 mmol) per 100 ml solution.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or slightly coloured powder or friable solid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
-Treatment and perioperative prophylaxis of bleedings in acquired
deficiency of the prothrombin complex coagulation factors,
such as deficiency caused by treatment with vitamin K antagonists, or
in case of overdose of vitamin K antagonists, when rapid
correction of the deficiency is required.
-Treatment and perioperative prophylaxis of bleedings in congenital
deficiency of any of the vitamin K dependent coagulation
factors when purified specific coagulation factor products are not
available.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY_
Health Products Regulat