Obizur
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
20-11-2023
Produktets egenskaber
(SPC)
20-11-2023
Offentlige vurderingsrapport
(PAR)
23-11-2015
Aktiv bestanddel:
susoctocog alfa
Tilgængelig fra:
Baxalta Innovations GmbH
ATC-kode:
B02
INN (International Name):
susoctocog alfa
Terapeutisk gruppe:
Antihemorrhagics
Terapeutisk område:
Hemophilia A
Terapeutiske indikationer:
Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII. Obizur is indicated in adults.
Produkt oversigt:
Revision: 11
Autorisation status:
Authorised
Autorisation dato:
2015-11-11
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT. OBIZUR IS FOR IN
HOSPITAL USE ONLY AND IS TO BE
ADMINISTERED BY HEALTHCARE PROVIDER ONLY.
OBIZUR 500 U POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
susoctocog alfa
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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 any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OBIZUR is and what it is used for
2.
What you need to know before you are given OBIZUR
3.
How OBIZUR is given
4.
Possible side effects
5.
How OBIZUR is stored
6.
Contents of the pack and other information
1.
WHAT OBIZUR IS AND WHAT IT IS USED FOR
OBIZUR contains the active substance susoctocog alfa, antihaemophilic
factor VIII, porcine sequence.
Factor VIII is necessary for the blood to form clots and stop
bleedings.
In patients with acquired haemophilia, factor VIII is not working
properly because the patient has
developed antibodies to his own factor VIII which neutralize this
blood clotting factor.
OBIZUR is used for the treatment of bleeding episodes in adults with
acquired haemophilia (a
bleeding disorder caused by lack of factor VIII activity due to
antibody development). These
antibodies have less neutralizing effect against OBIZUR than against
human factor VIII.
OBIZUR restores this missing factor VIII activity and helps blood to
form clots at the site of bleeding.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OBIZUR
The medicine is for in-patient administration only. It requires
clinical supervision of the bleeding
status of the patient.
YOU MUST NOT BE GIVEN O
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
OBIZUR 500 U powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each powder vial contains nominally 500 units of B domain deleted
antihaemophilic factor VIII
(rDNA), porcine sequence, susoctocog alfa.
OBIZUR contains approximately 500 U/ml of susoctocog alfa after
reconstitution.
The potency (U) is determined using the one-stage coagulation assay
(OSCA). The specific activity of
OBIZUR is approximately 10,000 U/mg protein.
OBIZUR (antihaemophilic factor VIII (rDNA), porcine sequence) is a
purified protein that
has 1448 amino acids with an approximate molecular mass of 175 kDa.
It is produced by recombinant DNA technology in baby hamster kidney
(BHK) cells. The BHK cells
are cultured in media that contains foetal bovine serum. The
manufacturing process is free of human
serum and human protein products and does not contain any additional
animal derived materials.
Excipient(s) with known effect
Each vial contains 4.6 mg (198 mM) sodium per ml of reconstituted
solution.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white.
The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bleeding episodes in patients with acquired haemophilia
caused by antibodies to
factor VIII.
OBIZUR is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with OBIZUR should be under the supervision of a physician
experienced in the treatment
of haemophilia (see section 4.4).
3
Treatment monitoring
The product is for in-patient administration only. It requires
clinical supervision of the bleeding status
of the patient.
During
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