Beriate 500 powder and solvent for solution for injection/ infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

human blood coagulation factor VIII

Available from:

CSL Behring GmbH

ATC code:

B02BD02

INN (International Name):

human blood coagulation factor VIII

Dosage:

500IU

Pharmaceutical form:

powder and solvent for solution for injection/ infusion

Units in package:

(1) glass vial, (1) solvent in glass vial 5ml, (1) filter transfer device 20/20

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2020-09-05

Patient Information leaflet

REG-5487-02
WHAT IS IN THIS LEAFLET:
1.
What Beriate 500 is and what it is used for
2.
What you need to know before you use Beriate 500
3.
How to use Beriate 500
4.
Possible side effects
5.
How to store Beriate 500
6.
Contents of the pack and other information
1.
WHAT BERIATE 500 IS AND WHAT IT IS USED FOR
WHAT IS BERIATE 500?
Beriate 500 is a powder plus the solvent. The made up solution is to
be given by
injection or infusion into a vein.
Beriate 500 is made from human plasma (this is the liquid part of the
blood) and
it contains human coagulation Factor VIII. It is used to prevent or to
stop bleedings
caused by the lack of Factor VIII (haemophilia A) in the blood. It may
also be used
in the management of acquired Factor VIII deficiency.
WHAT IS BERIATE 500 USED FOR?
Factor VIII is involved in blood clotting (coagulation). Lack of
Factor VIII means
that blood does not clot as quickly as it should and so there is an
increased
tendency to bleed. The replacement of Factor VIII with Beriate 500
will
temporarily repair the coagulation mechanisms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BERIATE 500
The following sections contain information that you and your doctor
should
consider before you use Beriate 500.
DO NOT USE BERIATE 500:
•
If you are allergic (hypersensitive) to the human coagulation factor
VIII or to
any of the ingredients of this medicine (listed in section 6.).
WARNINGS AND PRECAUTIONS:
Talk to your doctor or pharmacist before using Beriate 500.
• Allergic type hypersensitivity reactions are possible. Your doctor
should inform
you of the EARLY SIGNS OF HYPERSENSITIVITY REACTIONS.
These include hives, generalised skin rash, tightness of the chest,
wheezing,
fall in blood pressure and anaphylaxis (a serious allergic reaction
that causes
severe difficulty in breathing, or dizziness). IF THESE SYMPTOMS
OCCUR,
YOU SHOULD STOP THE USE OF THE PRODUCT IMMEDIATELY AND CONTACT YOUR
DOCTOR.
•
The formation of INHIBITORS (neutralising antibodies) to Factor VIII
is a known
complication that can occur during tr

Summary of Product characteristics

CSL Behring
Page 1 of 13
Beriate_Data Sheet-UNE-EN_05-Aug-2022_blank
MULTI MARKET MANUSCRIPT DATA SHEET – DS/UNE/EN
BERIATE
® 250/500/1000
REVISION DATE: 05-AUG-2022
REASON FOR CHANGE: CCDS V12.0 UPDATE: FREQUENCY OF FVIII INHIBITION
Supersedes previous versions
Revision date: 04-OCT-2021 / Introduction of administration pack
Rev.: 23-AUG-2019 / Pharmaceutical Particulars - Method of
administration/General instructions
update
Rev.: 26-JUL-2016 / Section 2 update specific activity / section 4.8
CCSI editorial update
CSL BEHRING
BERIATE
® 250/500/1000
MULTI MARKET DS/UNE/EN, REV.: 05-AUG-2022 / CCDS V12.0 UPDATE:
FREQUENCY OF FVIII INHIBITION
CSL Behring
Page 2 of 13
Beriate_Data Sheet-UNE-EN_05-Aug-2022_blank
1.
NAME OF THE MEDICINAL PRODUCT
Beriate

Powder and solvent for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains nominally:
250/500/1000 IU human coagulation factor VIII (FVIII).
After reconstitution with 2.5/5/10 ml Beriate 250/500/1000 contains
100 IU/ml factor VIII.
The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The
mean specific activity of Beriate is approximately 400 IU/mg protein.
Excipient with known effect:
Sodium approximately 100 mmol/l (2.3 mg/ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection or infusion.
White powder and clear, colourless solvent for solution for
injection/infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor
VIII deficiency).
This product may be used in the management of acquired factor VIII
deficiency.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the
treatment of haemophilia.
_POSOLOGY _
The dosage and duration of the substitution therapy depend on the
severity of the factor VIII
deficiency, on the location and extent of the bleeding and on th