Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - integrilin

Document Subject

Generated Narrative: MedicinalProductDefinition mp444c9ba43fa8be9df56ba30d3dc13ea7

identifier: http://ema.europa.eu/identifier/EU/1/99/109/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: INTEGRILIN 0.75 mg/ml solution for 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-444c9ba43fa8be9df56ba30d3dc13ea7

identifier: http://ema.europa.eu/identifier/EU/1/99/109/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - integrilin

Attesters

What is in this leaflet:

1. What Integrilin is and what it is used for
2. What you need to know before you are given Integrilin
3. How to use Integrilin
4. Possible side effects
5. How to store Integrilin
6. Contents of the pack and other information

Integrilin is an inhibitor of platelet aggregation. This means that it helps to prevent blood clots from forming.

It is used in adults with manifestation of severe coronary insufficiency defined as spontaneous and recent chest pain with electrocardiographic abnormalities or biological changes. It is usually given with aspirin and unfractionated heparin.

You must not be given Integrilin:

if you are allergic to eptifibatide or any of the other ingredients of this medicine (listed in section 6).

if you have recently had bleeding from your stomach, intestines, bladder or other organs, for example if you have seen abnormal blood in your stool or urine (except from menstrual bleeding) in the past 30 days.

if you have had a stroke within the past 30 days or any haemorrhagic stroke (also, be sure your doctor knows if you ever had a stroke).

if you have had a brain tumour or a condition that affects the blood vessels around the brain.

if you had a major operation or severe injury during the past 6 weeks.

if you have or have had bleeding problems.

if you have or have had difficulty with your blood clotting or a low blood platelet count.

if you have or have had severe hypertension (high blood pressure).

if you have or have had severe kidney or liver problems.

if you have been treated with another medicineof the same type as Integrilin.

Please tell your doctor if you have had any of these conditions. If you have any questions, ask your doctor or hospital pharmacist or nurse.

Take special care with Integrilin:

Integrilin is recommended for use only in adult, hospitalised patients in coronary care units.

Integrilin is not intended for use in children or adolescents less than 18 years of age.

Before and during your treatment with Integrilin, samples of your blood will be tested as a safety measure to limit the possibility of unexpected bleeding. During use of Integrilin, you will be checked carefully for any signs of unusual or unexpected bleeding.

Other medicines and Integrilin To avoid the possibility of interactions with other medicines please tell your doctor or hospital pharmacist or nurse if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription. Particularly:

blood thinners (oral anticoagulants) or

medicines that prevent blood clots, including warfarin, dipyridamole, ticlopidine, aspirin (except those that you may be given as part of Integrilin treatment).

Pregnancy and breast-feeding Integrilin is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you might be pregnant or are planning to have a baby. Your doctor will weigh up the benefit to you against the risk to your baby of using Integrilin while you are pregnant.

If you are breast-feeding a baby, breast-feeding should be interrupted during the treatment period.

Integrilin contains sodium

This medicine contains 161 mg sodium (main component of cooking/table salt) in each 100 ml vial. This is equivalent to 8.1% of the recommended maximum daily dietary intake of sodium for an adult.

Integrilin is given into the vein by direct injection followed by an infusion (drip solution). The dose given is based on your weight. The recommended dose is 180 microgram/kg administered as a bolus (rapid intravenous injection), followed by an infusion (drip solution) of 2 microgram/kg/minute for up to 72 hours. If you have kidney disease, the infusion dose may be reduced to 1 microgram/kg/minute.

If percutaneous coronary intervention (PCI) is performed during Integrilin therapy, the intravenous solution may be continued for up to 96 hours.

You must also be given doses of aspirin and heparin (if not contraindicated in your case).

If you have any further questions on the use of this product, ask your doctor or hospital pharmacist or nurse.

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

Very common side effects These may affect more than 1 in 10 people

minor or major bleeding, (for example, blood in urine, blood in stool, vomiting blood, or bleeding with surgical procedures).

anaemia (decreased number of red blood cells).

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

inflammation of a vein.

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

reduction in the number of platelets (blood cells necessary for blood clotting).

reduced blood flow to the brain.

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

serious bleeding (for example, bleeding inside the abdomen, inside the brain, and into the lungs).

fatal bleeding.

severe reduction in the number of platelets (blood cells necessary for blood clotting).

skin rash (such as hives).

sudden, severe allergic reaction.

If you notice any signs of bleeding, notify your doctor or hospital pharmacist or nurse immediately. Very rarely, bleeding has become severe and even fatal. Safety measures to prevent this from happening include blood tests and careful checking by the healthcare professionals taking care of you.

If you develop severe allergic reaction or hives, notify your doctor or hospital pharmacist or nurse immediately.

Other events that may occur in patients, who require this type of treatment, include those that are related to the condition you are having treated, such as rapid or irregular heartbeat, low blood pressure, shock or cardiac arrest.

Reporting of side effects
If you get any side effects, talk to your doctor, hospital pharmacist or nurse. 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 (EXP) stated on the package and the vial. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C 8 C).

Keep the vial in the outer package in order to protect from light. However, protection of Integrilin solution from light is not necessary during administration.

Before using, the vial contents should be inspected. Integrilin should not be used if it is noticed that particulate matter or discoloration is present.

Any unused medicine after opening should be thrown away.

Do not throw away any medicines via wastewater or household waste. Ask your hospital pharmacist how to throw away medicines you no longer use.

What Integrilin contains

The active substance is eptifibatide. Each ml of solution for infusion contains 0.75 mg of eptifibatide. One vial of 100 ml of solution for infusion contains 75 mg of eptifibatide.

The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.

What Integrilin looks like and contents of the pack Integrilin solution for infusion: 100 ml vial, pack of one vial.

The clear, colourless solution is contained in a 100 ml glass vial, which is closed with a butyl rubber stopper and sealed with a crimped aluminium seal.

Marketing Authorisation Holder and manufacturer

Marketing Authorisation Holder:

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland

Manufacturer:

GlaxoSmithKline Manufacturing S.P.A., Strada Provinciale Asolana No. 90, San Polo di Torrile 43056, Parma, Italy

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

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. T l/Tel: + 32 (0) 10 85 52 Lietuva GlaxoSmithKline (Ireland) Limited
Tel: +370 80000
GlaxoSmithKline (Ireland) Limited . +359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien T l/Tel: + 32 (0) 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 cz.info@gsk.com

Magyarorsz g GlaxoSmithKline (Ireland) Limited Tel.: +36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GlaxoSmithKline (Ireland) Limited Tel: +356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8produkt.info@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline (Ireland) Limited Tel: +372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E. : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9France Laboratoire GlaxoSmithKline T l.: + 33 (0)1 39 17 84 diam@gsk.com

Portugal GlaxoSmithKline Produtos Farmac uticos, Lda Tel: + 351 21 412 95 FI.PT@gsk.com

Hrvatska GlaxoSmithKline (Ireland) Limited Tel: +385 800787Rom nia GlaxoSmithKline (Ireland) Limited Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955Slovenija GlaxoSmithKline (Ireland) Limited Tel: +386 80688 sland Vistor hf. S mi: + 354 535 7Slovensk republika GlaxoSmithKline (Ireland) Limited Tel: +421 800500Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30
GlaxoSmithKline (Ireland) Limited : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GlaxoSmithKline (Ireland) Limited Tel: +371 80205United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221customercontactuk@gsk.com This leaflet was last revised in

Other sources of information

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