Refludan
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-07-2012
Charakterystyka produktu
(SPC)
27-07-2012
Sprawozdanie z oceny publicznego
(PAR)
27-07-2012
Składnik aktywny:
lepirudin
Dostępny od:
Celgene Europe Ltd.
Kod ATC:
B01AE02
INN (International Nazwa):
lepirudin
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Thromboembolism; Thrombocytopenia
Wskazania:
Anticoagulation in adult patients with heparin-induced thrombocytopenia type II and thromboembolic disease mandating parenteral antithrombotic therapy.The diagnosis should be confirmed by the heparin-induced platelet activation assay or an equivalent test.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Withdrawn
Data autoryzacji:
1997-03-13
Ulotka dla pacjenta
34
B. PACKAGE LEAFLET
Medicinal product no longer authorised
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
REFLUDAN 20 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Lepirudin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or 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 side effects
not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Refludan is and what it is used for
2.
Before you use Refludan
3.
How to use Refludan
4.
Possible side effects
5
How to store Refludan
6.
Further information
1.
WHAT REFLUDAN IS AND WHAT IT IS USED FOR
Refludan is an antithrombotic medicine.
Antithrombotics are medicines to prevent formation of blood clots
(thrombosis).
Refludan is used for anticoagulation in adult patients with
heparin-induced thrombocytopenia (HIT)
type II and thromboembolic disease requiring injected antithrombotic
medicines. HIT type II is an
illness which can occur after you have received heparin containing
medicines. It constitutes a certain
kind of allergy towards heparin. It may result in a too low number of
blood platelets and/or clots in
your blood vessels (thrombosis).
This may additionally lead to deposition of clots in organs.
2.
BEFORE YOU USE REFLUDAN
DO NOT USE REFLUDAN
-
if you are allergic (hypersensitive) to lepirudin, to hirudins or any
of the other ingredients of
Refludan.
-
if you are pregnant or breast-feeding.
TAKE SPECIAL CARE WITH REFLUDAN
If you have a bleeding tendency, your doctor will weigh the risk of
Refludan administration against its
benefit. Thus, please tell your doctor if you have or have had:
–
Recent puncture of large vessels or organs
–
Anomaly of vessels or organs
–
Recent stroke, accident or surgery involving the brain
–
High blood press
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Charakterystyka produktu
1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Refludan 20 mg powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each vial contains 20 mg lepirudin.
(Lepirudin is a recombinant DNA product derived from yeast cells)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
White to almost white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anticoagulation in adult patients with heparin-induced
thrombocytopenia (HIT) type II and
thromboembolic disease mandating parenteral antithrombotic therapy.
The diagnosis should be confirmed by the HIPAA (heparin induced
platelet activation assay) or an
equivalent test.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Refludan should be initiated under the guidance of a
physician with experience in
coagulation disorders.
Initial dosage
Anticoagulation in adult patients with HIT type II and thromboembolic
disease:
–
0.4 mg / kg body weight intravenously as a bolus dose
–
followed by 0.15 mg / kg body weight / hour as a continuous
intravenous infusion for 2 - 10
days or longer if clinically needed.
Normally, the dosage depends on the patient's body weight. This is
valid up to a body weight of
110 kg. In patients with a body weight exceeding 110 kg the dosage
should not be increased beyond
the 110 kg body weight dose (see also tables 2 and 3, below).
Monitoring and modification of the Refludan dosage regimen
Standard recommendations
_Monitoring:_
–
In general, the dosage (infusion rate) should be adjusted to the
activated partial thromboplastin
time, aPTT.
–
The first aPTT determination should be done 4 hours after start of
Refludan therapy.
Medicinal product no longer authorised
3
–
The aPTT should be monitored at least once daily. More frequent
determinations may be
necessary, for example, in patients with renal impairment or with an
increased risk of bleeding
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