INTEGRILIN 2 mg/ml solution for injection

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 (hypersensitive) to eptifibatide or any of the other ingredients of Integrilin (see section 6 for the list of the other ingredients)
• 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 medicinal product of 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.

Take special care with Integrilin:

• Integrilin is recommended for use only in adult, hospitalized 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.

Taking other medicines

To avoid the possibility of interactions with other medicinal products please tell your doctor or hospital pharmacist if you are taking or have recently taken 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 arepregnant, or think you could be.Your doctorwill 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 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 (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.

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

Very common side effectsThese 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 effectsThese may affect up to 1 in 10 people

• inflammation of a vein

Uncommon side effectsThese 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 effectsThese 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 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 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.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist .

Keep out of the reach and sight of children

Do not use 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 material after opening should be discarded.

What Integrilin contains

• The active substance is eptifibatide. Each ml of solution for injection contains 2 mg of eptifibatide. One vial of 10 ml solution for injection contains 20 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 injection: 10 ml vial, pack of one vial.

The clear, colourless solution is contained in a 10 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:

Glaxo Group Ltd, Greenford, Middlesex, UB6 0NN, United Kingdom

Manufacturer:

Glaxo Operations UK Ltd., (Trading as Glaxo Wellcome Operations), Harmire Road, Barnard Castle, Co. Durham, DL12 8DT, United Kingdom

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

BelgiëBelgiqueBelgien GlaxoSmithKline s.a.n.v. TélTel 32 02 656 21 11 LuxembourgLuxemburg GlaxoSmithKline s.a.n.v. BelgiqueBelgien TélTel 32 02 656 21 11

. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland GlaxoSmithKline BV Tel 31 030 6938100 nlinfogsk.com

Deutschland GlaxoSmithKline GmbH Co. KG Tel. 49 089 36044 8701 produkt.infogsk.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal GlaxoSmithKline Produtos Farmacêuticos, Lda Tel 351 21 412 95 00 FI.PTgsk.com

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Lietuva
GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

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