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AstraZeneca

Kengrexal
cangrelor

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.

Warnings and precautions

Talk to your doctor before using Kengrexal if:


Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet.

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You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

  1. How to store Kengrexal


    Keep this medicine out of the sight and reach of children.


    Do not use this medicine after the expiry date which is stated on the label and carton after ‘EXP’. The expiry date refers to the last day of that month.


    This medicine does not require any special storage conditions.


    Reconstituted solution: the powder should be reconstituted immediately prior to dilution and use. Do not refrigerate.


    Diluted solution: From a microbiological point of view, unless the method of reconstitution/dilution precludes the risk of microbiological contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.


  2. Contents of the pack and other information What Kengrexal contains

The active substance is cangrelor. Each vial contains 50 mg cangrelor. After reconstitution 1 mL of concentrate contains 10 mg cangrelor and after dilution 1 mL of solution contains 200 micrograms cangrelor.

The other ingredients are mannitol, sorbitol and sodium hydroxide for pH-adjustment.


What Kengrexal looks like and contents of the pack

Powder for concentrate for solution for injection/infusion in a glass vial. Kengrexal is a white to off-white freeze-dried powder.

Kengrexal is available in packs of 10 vials.


Marketing Authorisation Holder

Chiesi Farmaceutici S.p.A. Via Palermo, 26/A

43122 Parma Italy


Manufacturer Hälsa Pharma GmbH Hafenweg 18-20

48155 Münster Germany


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:


België/Belgique/Belgien Ferrer Internacional, S.A.. Tél/Tel: +32 15 28 74 15

Lietuva

Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919


България

Chiesi Bulgaria EOOD Teл.: + 359 29201205

Luxembourg/Luxemburg Ferrer Internacional, S.A. Tél/Tel: +32 15 28 74 15

Česká republika

Chiesi CZ s.r.o.

Tel: +420 261221745

Magyarország Chiesi Hungary Kft. Tel.: +36-1-429 1060


Danmark

Chiesi Pharma AB Tlf: +46 8 753 35 20

Malta

Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791


Deutschland

Ferrer Deutschland GmbH Tel: +49 (0) 2407 502311-0

Nederland

Ferrer Internacional, S.A. Tél/Tel: +32 15 28 74 15


Eesti

Chiesi Pharmaceuticals GmbH Tel: +43 1 4073919

Norge

Chiesi Pharma AB Tlf: +46 8 753 35 20


Ελλάδα

Chiesi Hellas AEBE

Τηλ: + 30 210 6179763

Österreich

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919


España

Ferrer Farma, S.A. Tel: +34 93 600 3700

Polska

Chiesi Poland Sp. z.o.o. Tel.: + 48 22 620 1421


France

Bioprojet Pharma

+33 (0)1 47 03 66 33

Portugal

Ferrer Portugal, S.A Tel: +351 214449600


Hrvatska

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

România

Chiesi Romania S.R.L. Tel: + 40 212023642


Ireland

Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791

Slovenija

Chiesi Slovenija d.o.o. Tel: + 386-1-43 00 901


Ísland

Chiesi Pharma AB Tlf: +46 8 753 35 20

Slovenská republika Chiesi Slovakia s.r.o. Tel: + 421 259300060


Italia

Chiesi Italia S.p.A. Tel: + 39 0521 2791

Suomi/Finland Chiesi Pharma AB Tlf: +46 8 753 35 20


Κύπρος

Chiesi Farmaceutici S.p.A.

Τηλ: + 39 0521 2791

Sverige

Chiesi Pharma AB Tlf: +46 8 753 35 20


Latvija

Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073919

United Kingdom (Northern Ireland)

Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2791


This leaflet was last revised in {MM/YYYY}.


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The following information is intended for healthcare professionals only:


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 loading dose of ticagrelor or prasugrel, but not clopidogrel, may be administered up to 30 minutes before the end of the infusion, see section 4.5.


Instructions for preparation


Aseptic procedures should be used for the preparation of Kengrexal.


The vial should be reconsituted immediately prior to dilution and use. Reconstitute each 50 mg/vial by adding 5 mL of sterile water for injection. Swirl gently until all material is dissolved. Avoid vigorous mixing. Allow any foam to settle. Ensure that the contents of the vial are fully dissolved and the reconstituted material is a clear, colourless to pale yellow solution.


Do not use without dilution. Before administration, 5 mL reconstituted solution has to be withdrawn from each vial and must be diluted further with 250 mL sodium chloride 9 mg/mL (0.9%) solution for injection or glucose (5%) solution for injection. Mix the bag thoroughly.


The medicinal product should be inspected visually for particulate matter after reconstitution.


Kengrexal is administered as a weight-based regimen consisting of an initial intravenous bolus followed by an intravenous infusion. The bolus and infusion should be administered from the infusion solution.


This dilution will generate a concentration of 200 micrograms/mL and should be sufficient for at least two hours of dosing as required. Patients 100 kg and over will require a minimum of two bags.