Kengrexal 50mg powder for concentrate for solution for injection infusion vials

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Cangrelor tetrasodium

Commercializzato da:

Chiesi Ltd

Codice ATC:

B01AC25

INN (Nome Internazionale):

Cangrelor tetrasodium

Dosaggio:

50mg

Forma farmaceutica:

Powder for solution for injection

Via di somministrazione:

Intravenous

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: ; GTIN: 5028613003046

Foglio illustrativo

1 CP0058/1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
KENGREXAL 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INJECTION /
INFUSION.
Cangrelor
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 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
D

Scheda tecnica

OBJECT 1
KENGREXAL 50 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INJECTION / INFUSION
Summary of Product Characteristics Updated 07-Nov-2016 | Chiesi
Limited
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
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.
Excipients 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