Beriate 1000 IU Powder and solvent for solution for injection or infusion

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Human coagulation factor VIII

Available from:

DKSH MALAYSIA SDN. BHD.

INN (International Name):

Human coagulation factor VIII

Units in package:

17 ml

Manufactured by:

CSL Behring GmbH

Patient Information leaflet

BERIATE
®
Human Coagulation Factor VIII (250IU, 500IU, 1000IU)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
WHAT IS IN THIS LEAFLET
1.
What Beriate is used for
2.
How Beriate works
3.
Before you use Beriate
4.
How to use Beriate
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Beriate
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT BERIATE
IS USED FOR
Beriate 250/500/1000 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.
HOW BERIATE WORKS
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
250/500/1000 will temporarily
repair the coagulation mechanisms
.
BEFORE YOU USE BERIATE
It is strongly recommended that every
time that Beriate 250/500/1000 is given,
you should record the date of
administration, the batch number and
the injected volume in your treatment
diary.
-
_When you must not use it _
If you are allergic (hypersensitive) to
the human coagulation factor VIII or to
any of the ingredients of this medicine
(listed in section Product Description).
_ _
_Pregnancy and lactation _
If you are pregnant or breast-feeding,
ask your doctor or pharmacist for advice
before taking this medicine.
During pregnancy and breast-feeding,
Beriate 250/500/1000 should be given
only if it is clearly indicated.
No fertility data are available.
-
_Before you start use it _
Talk to your doctor or pharmacist
before using Beriate 250/500/1000.
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 o

Summary of Product characteristics

Attachment-MY Beriate Proposed PI based on CCDS revision 23-AUG-2019
1.
NAME OF THE MEDICINAL PRODUCT
Beriate

250 IU Powder and solvent for solution for injection or infusion
Beriate

500 IU Powder and solvent for solution for injection or infusion
Beriate

1000 IU 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.
Produced from the plasma of human donors.
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 under the supervision of a physician experienced
in the treatment
of haemophilia.
Treatment monitoring
During the course of treatment, appropriate determination of factor
VIII levels is
advised to guide the dose to be administered and the frequency of
repeated infusions.
Individual patients may vary in their response to factor VIII,
demonstrating different
half-lives and recoveries. Dose based on bodyweight may require
adjustment in
underweight or overweight patients. In the case of major surgical
interventions in
particular, precise monitoring of the substitution therapy by means of
coagulation
analysis (plasma factor VIII activity) is indispensable.
Patients should be monitored for the development of