Kengrexal
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
16-01-2023
Charakterystyka produktu
(SPC)
16-01-2023
Sprawozdanie z oceny publicznego
(PAR)
12-06-2015
Składnik aktywny:
cangrelor
Dostępny od:
Chiesi Farmaceutici S.p.A.
Kod ATC:
B01
INN (International Nazwa):
cangrelor
Grupa terapeutyczna:
Antithrombotic agents
Dziedzina terapeutyczna:
Acute Coronary Syndrome; Vascular Surgical Procedures
Wskazania:
Kengrexal, co-administered with acetylsalicylic acid (ASA), is indicated for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable.
Podsumowanie produktu:
Revision: 15
Status autoryzacji:
Authorised
Data autoryzacji:
2015-03-23
Ulotka dla pacjenta
22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KENGREXAL 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR
INJECTION/INFUSION
cangrelor
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 Kengrexal is and what it is used for
2.
What you need to know before you use Kengrexal
3.
How to use Kengrexal
4.
Possible side effects
5.
How to store Kengrexal
6.
Contents of the pack and other information
1.
WHAT KENGREXAL IS AND WHAT IT IS USED FOR
Kengrexal is an anti-platelet medicine that contains the active
substance cangrelor.
Platelets are very small cells in the blood that can clump together
and help the blood to clot.
Sometimes clots can form within a damaged blood vessel such as in an
artery in the heart and this can
be very dangerous as the clot can cut off the blood supply (a
thrombotic event), causing a heart attack
(myocardial infarction).
Kengrexal diminishes the clumping of platelets and so reduces the
chance of a blood clot forming.
You have been prescribed Kengrexal because you have blocked blood
vessels in your heart (coronary
artery disease) and you need a procedure (called a percutaneous
coronary intervention – PCI) to
remove the blockage. During this procedure you may have a stent
inserted in your blood vessel to help
to keep it open. Using Kengrexal reduces the risk that this procedure
will cause a clot to form and
block the blood vessels again.
Kengrexal is only for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KENGREXAL
DO NOT USE KENGREXAL
-
If you are allergic to cangrelor or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have a medical condition that is currently causing bleeding
such as bleeding from
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Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Kengrexal 50 mg powder for concentrate for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cangrelor tetrasodium corresponding to 50 mg
cangrelor. After reconstitution 1 mL
of concentrate contains 10 mg cangrelor. After dilution 1 mL of
solution contains 200 micrograms
cangrelor.
Excipient with known effect
Each vial contains 52.2 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for injection/infusion.
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Kengrexal, co-administered with acetylsalicylic acid (ASA), is
indicated for the reduction of
thrombotic cardiovascular events in adult patients with coronary
artery disease undergoing
percutaneous coronary intervention (PCI) who have not received an oral
P2Y12 inhibitor prior to the
PCI procedure and in whom oral therapy with P2Y12 inhibitors is not
feasible or desirable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Kengrexal should be administered by a physician experienced in either
acute coronary care or in
coronary intervention procedures and is intended for specialised use
in an acute and hospital setting.
Posology
The recommended dose of Kengrexal for patients undergoing PCI is a 30
micrograms/kg intravenous
bolus followed immediately by 4 micrograms/kg/min intravenous
infusion. The bolus and infusion
should be initiated prior to the procedure and continued for at least
two hours or for the duration of the
procedure, whichever is longer. At the discretion of the physician,
the infusion may be continued for a
total duration of four hours, see section 5.1.
Patients should be transitioned to oral P2Y12 therapy for chronic
treatment. For transition, a loading
dose of oral P2Y12 therapy (clopidogrel, ticagrelor or prasugrel)
should be administered immediately
following discontinuation of cangrelor infusion. Alternatively, a
loadin
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