Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - kengrexal

Document Subject

Generated Narrative: MedicinalProductDefinition mpeefded9fc6fc231de4e5964766009df5

identifier: http://ema.europa.eu/identifier/EU/1/15/994/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Kengrexal 50 mg powder for concentrate for solution for injection/infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-eefded9fc6fc231de4e5964766009df5

identifier: http://ema.europa.eu/identifier/EU/1/15/994/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - kengrexal

Attesters

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

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.

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 the stomach or intestines or you have a condition which makes you more prone to uncontrolled bleeding (impaired haemostasis or irreversible coagulation disorders).
• If you have recently undergone major surgery or suffered from any form of serious physical trauma such as a bone fracture or road traffic accident.
• If you have uncontrolled very high blood pressure.
• If you have ever had a stroke, or a mini-stroke (also known as a transient ischaemic attack, TIA) caused by the temporary interruption of the blood supply to the brain.

Warnings and precautions Talk to your doctor before using Kengrexal if:

• You are, or you think you may be at increased risk of bleeding. For example, if you have a medical condition that affects blood clotting or because of another medical condition that may increase the risk of bleeding such as a recent serious injury, any recent surgery, history of a stroke or a transient ischaemic attack or recent bleeding from your stomach or gut.
• You suffer from impaired kidney function or require dialysis.
• You have ever suffered from an allergic reaction to Kengrexal or any of its constituents.
• You suffer from breathing difficulties such as asthma.
• You have been told by your doctor that you have an intolerance to some sugars.

Children and adolescents Kengrexal is not recommended for children and adolescents under 18 years.

Other medicines and Kengrexal You may receive acetylsalicylic acid (ASA) while you are treated with Kengrexal or another type of anti-platelet medicine (e.g., clopidogrel) before and after you are treated with Kengrexal.

Tell your doctor if you are taking other medicines that may increase the risk of side effects such as bleeding including blood thinners (anticoagulants e.g. warfarin).

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Kengrexal is not recommended for use during pregnancy.

Driving and using machines The effect of Kengrexal wears off quickly and it is unlikely to affect your ability to drive or to use machines.

Kengrexal contains sodium and sorbitol Sorbitol is a source of fructose. If you have hereditary fructose intolerance (HFI), a rare genetic disorder, you must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects. You must tell your doctor before receiving this medicine if you have HFI.

This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free .

Your treatment with Kengrexal will be supervised by a doctor experienced in caring for patients with heart disease. The doctor will decide how much Kengrexal you receive, and will prepare the medicine.

Kengrexal is for injection, followed by infusion (drip), into a vein. The dose given depends on your weight.

The recommended dose is:

• 30 micrograms per kilogram body weight by injection, followed immediately by
• 4 micrograms per kilogram body weight per minute by infusion (drip), for at least 2 hours. The doctor will decide if you will need to be treated for longer periods.

If you use more Kengrexal than you should This medicine will be given to you by a healthcare professional. Your doctor will decide how to treat you, including stopping the medicine and monitoring for signs of side effects. If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If side effects occur, they may need medical attention.

Tell your doctor immediately if you notice any of the following:

• Bleeding from anywhere in the body. Bleeding is a common side effect of treatment with Kengrexal (may affect up to 1 in 10 people). Bleeding can be serious, and fatal outcomes have been reported.
• Allergic reaction (a rash, itching, throat tightening/swelling, swelling of the tongue or lips, difficulty breathing). Allergic reaction is a rare side effect of treatment with Kengrexal (may affect up to 1 in 1,000 people) but may be potentially serious.

Common side effects: may affect up to 1 in 10 people

• Minor bruising can occur anywhere in the body (including small red bruises on the skin or at the site of an injection under the skin causing swelling),
• dyspnoea (shortness of breath),
• bleeding leading to decreases in blood volume or red blood cell numbers,
• fluid discharge from injection or catheter sites.

Uncommon side effects: may affect up to 1 in 100 people

• Bleeding leading to fluid around the heart, blood in the chest cavity or bleeding from the nose, gastrointestinal tract, in the abdomen, or in the urine or from injection or catheter sites,
• increased levels of creatinine in the blood (identified by blood tests), indicating reduced kidney function,
• variations in blood pressure,
• rash, pruritus, urticaria,
• vessel puncture site haematoma.

Rare side effects: may affect up to 1 in 1,000 people

• Bleeding leading to low platelet count or anaemia,
• bleeding in the eye, brain (including stroke), pelvis and lung,
• bleeding from the site of wounds,
• balloon-like swelling in an artery or wall of the heart, which involves only a few layers of the vessel walls,
• severe allergic reactions,
• reduced clotting of the blood,
• bruising,
• swollen face.

Very rare side effects: may affect up to 1 in 10,000 people

• Bleeding under the skin or around the eye,
• infection of bleeding sites,
• heavy menstrual bleeding,
• bleeding from the penis, ear or pre-existing skin tumours.

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. 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.

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.

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 Diapharm GmbH & CO. KG Am Mittelhafen 48155 M nster Germany

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

Belgi /Belgique/Belgien Ferrer Internacional, S.A.. T l/Tel: +32 15 28 74 Lietuva Chiesi Pharmaceuticals GmbH
Tel: +43 1 4073
Chiesi Bulgaria EOOD
Te .: + 359 29201Luxembourg/Luxemburg Ferrer Internacional, S.A. T l/Tel: +32 15 28 74 esk republika Chiesi CZ s.r.o. Tel: +420 261221Magyarorsz g Chiesi Hungary Kft. Tel.: +36-1-429 1Danmark Chiesi Pharma AB Tlf: +46 8 753 35 Malta Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Deutschland Ferrer Deutschland GmbH Tel: +49 (0) 2407 502311-0

Nederland Ferrer Internacional, S.A. T l/Tel: +32 15 28 74 Eesti Chiesi Pharmaceuticals GmbH Tel: +43 1 4073Norge Chiesi Pharma AB Tlf: +46 8 753 35
Chiesi Hellas AEBE : + 30 210 6179 sterreich Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073Espa a Ferrer Farma, S.A. Tel: +34 93 600 3Polska Ferrer Internacional, S.A. Tel.: +48 518 630 France Bioprojet Pharma
+33 (0)1 47 03 66 Portugal Ferrer Portugal, S.A Tel: +351 214449Hrvatska Chiesi Pharmaceuticals GmbH Tel: + 43 1 4073Rom nia Chiesi Romania S.R.L. Tel: + 40 212023Ireland Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2Slovenija Chiesi Slovenija d.o.o. Tel: + 386-1-43 00 sland Chiesi Pharma AB Tlf: +46 8 753 35 Slovensk republika Chiesi Slovakia s.r.o. Tel: + 421 259300Italia Chiesi Italia S.p.A. Tel: + 39 0521 2Suomi/Finland Chiesi Pharma AB Tlf: +46 8 753 35
Chiesi Farmaceutici S.p.A. : + 39 0521 2Sverige Chiesi Pharma AB Tlf: +46 8 753 35 Latvija Chiesi Pharmaceuticals GmbH
Tel: + 43 1 4073United Kingdom (Northern Ireland) Chiesi Farmaceutici S.p.A. Tel: + 39 0521 2This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: