Beriate 2000 IU Powder and solvent for solution for injection or infusion

Land: Malta

Språk: engelska

Källa: Malta Medicines Authority

Aktiva substanser:

HUMAN COAGULATION, FACTOR VIII

Tillgänglig från:

CSL Behring GmbH Emil-von-Behring-Strasse 76, 35041 Marburg, Germany

ATC-kod:

B02BD02

INN (International namn):

HUMAN COAGULATION FACTOR VIII 2000 IU

Läkemedelsform:

POWDER AND SOLVENT FOR SOLUTION FOR INFUSION OR INJECTION

Sammansättning:

HUMAN COAGULATION FACTOR VIII 2000 IU

Receptbelagda typ:

POM

Terapiområde:

ANTIHEMORRHAGICS

Produktsammanfattning:

Licence number in the source country: NOT APPLICAPABLE

Bemyndigande status:

Authorised

Tillstånd datum:

2020-05-15

Bipacksedel

PAGE 1 OF 12
PACKAGE INSERT: INFORMATION FOR THE USER
BERIATE
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
Beriate 2000 IU Powder and solvent for solution for injection or
infusion
Human coagulation factor VIII
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, ask your doctor or your pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Beriate is and what it is used for
2.
What you need to know before you use Beriate
3.
How to use Beriate
4.
Possible side effects
5.
How to store Beriate
6.
Contents of the pack and other information
1.
WHAT BERIATE IS AND WHAT IT IS USED FOR
_WHAT IS BERIATE? _
Beriate is a powder plus the solvent. The made up solution is to be
given by injection or infusion
into a vein.
Beriate 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 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 will temporarily repair the coagulation
mechanisms.
PAGE 2 OF 12
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE
BERIATE
The following sections contain inf

Produktens egenskaper

PAGE 13 OF 13
SUMMARY OF THE PRODUCT CHARACTERISTICS
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
Beriate 2000 IU Powder and solvent for solution for injection or
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial contains nominally:
250/500/1000/2000 IU human coagulation factor VIII (FVIII).
After reconstitution with 2.5/5/10 ml Beriate 250/500/1000 contains
100 IU/ml factor VIII.
Beriate 2000 is to be reconstituted with 10 ml of water for injections
and contains
approximately 200 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.
PAGE 13 OF 13
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
parti