Xigris
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
21-02-2012
Charakterystyka produktu
(SPC)
21-02-2012
Sprawozdanie z oceny publicznego
(PAR)
21-02-2012
Składnik aktywny:
drotrecogin alfa (activated)
Dostępny od:
Eli Lilly Nederland B.V.
Kod ATC:
B01AD10
INN (International Nazwa):
drotrecogin alfa (activated)
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Sepsis; Multiple Organ Failure
Wskazania:
Xigris is indicated for the treatment of adult patients with severe sepsis with multiple organ failure when added to best standard care. The use of Xigris should be considered mainly in situations when therapy can be started within 24 hours after the onset of organ failure (for further information see section 5.1).
Podsumowanie produktu:
Revision: 13
Status autoryzacji:
Withdrawn
Data autoryzacji:
2002-08-22
Ulotka dla pacjenta
Medicinal product no longer authorised
36
B. PACKAGE LEAFLET
Medicinal product no longer authorised
37
PACKAGE LEAFLET: INFORMATION FOR THE USER
XIGRIS 20 MG POWDER FOR SOLUTION FOR INFUSION
Drotrecogin alfa (activated)
PLEASE READ ALL OF THIS LEAFLET CAREFULLY. PLEASE REMEMBER THAT YOU
CANNOT TAKE XIGRIS BY YOURSELF
BECAUSE BOTH YOUR ILLNESS AND THE USE OF THIS MEDICINE NEED CONSTANT
MEDICAL CARE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or your
pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist
.
IN THIS LEAFLET
:
1.
What Xigris is and what it is used for
2.
Before you are given Xigris
3.
How Xigris is used
4.
Possible side effects
5.
How to store Xigris
6.
Further information
1.
WHAT XIGRIS IS AND WHAT IT IS USED FOR
Xigris is very similar to a protein that occurs naturally in your
blood. This protein helps to control
blood clotting and inflammation. When your body has a severe
infection, clots can form in your blood.
These can block the blood supply to important parts of your body such
as the kidneys and lungs. This
causes an illness called severe sepsis which can make you very ill.
Some people will die from this
illness. Xigris helps your body to get rid of the clots and also
reduces the inflammation caused by the
infection.
Xigris is used to treat adults with severe sepsis.
2.
BEFORE YOU ARE GIVEN XIGRIS
YOU SHOULD NOT BE GIVEN XIGRIS:
-
if you are allergic (hypersensitive) to drotrecogin alfa (activated)
or any of the other ingredients
of Xigris, or bovine (cattle-derived) thrombin (protein)
-
if you are a child below the age of 18
-
if you have internal bleeding
-
if you have a brain tumour, or pressure on the brain
-
if you are being given heparin at the same time (
≥
15 International Units/kg/h
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Charakterystyka produktu
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Xigris 20 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 20 mg of Drotrecogin alfa (activated).
After reconstitution with 10 ml of Water for Injection each ml
contains 2 mg of Drotrecogin alfa
(activated).
Drotrecogin alfa (activated) is a recombinant version of the
endogenous activated Protein C and is
produced by genetic engineering from an established human cell line.
Excipient: Each vial contains approximately 68 mg sodium.
For a full list of excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion. Xigris is supplied as a lyophilised,
white to off-white
powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xigris is indicated for the treatment of adult patients with severe
sepsis with multiple organ failure
when added to best standard care. The use of Xigris should be
considered mainly in situations when
therapy can be started within 24 hours after the onset of organ
failure (for further information see
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Xigris should be used by experienced doctors in institutions skilled
in the care of patients with severe
sepsis.
Treatment should be started within 48 hours, and preferably within 24
hours, of onset of the first
documented sepsis-induced organ dysfunction (see section 5.1).
The recommended dose of Xigris is 24
μ
g/kg/hr (based on actual body weight) given as a continuous
intravenous infusion for a total duration of 96 hours. It is
recommended that Xigris be infused with an
infusion pump to accurately control the infusion rate. If the infusion
is interrupted for any reason,
Xigris should be restarted at the 24
μ
g/kg/hr infusion rate and continued to complete the full
recommended 96 hours of dosing administration. Dose escalation or
bolus doses of Xigris are not
necessary to account for the interruption in the infusion.
N
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