INTEGRILIN 2 mg/ml INJECTABLE SOLUTION
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Introduction
Patient Information Leaflet: Information for the Patient
Integrilin 2mg/ml solution for injection
eptifibatide
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, pharmacist, or nurse.
- If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
Contents of the pack
- What is Integrilin and what is it used for
- What you need to know before you are given Integrilin
- How to use Integrilin
- Possible side effects
- Storage of Integrilin
- Contents of the pack and other information
1. What is Integrilin and what is it used for
Integrilin is a platelet aggregation inhibitor. This means it helps prevent the formation of blood clots.
It is used in adults with severe coronary insufficiency characterized by spontaneous and recent chest pain with electrocardiographic changes or biological changes. It is usually given together with aspirin and unfractionated heparin.
2. What you need to know before you are given Integrilin
You should 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 a gastric, intestinal, bladder, or other organ bleeding (e.g., if you have noticed unusual blood in your stools or urine) in the last 30 days
- if you have had a stroke within the last 30 days or any previous hemorrhagic stroke (also, make sure your doctor knows if you have ever had a stroke)
- if you have had a brain tumor or a condition affecting the blood vessels in the brain
- if you have had major surgery or serious injury within the last 6 weeks
- if you have a history of bleeding problems
- if you have a history of blood coagulation problems or low platelet count
- if you have severe high blood pressure
- if you have severe liver or kidney problems
- if you have been treated with another medicine of the same type as Integrilin.
If you have had any of the above situations, tell your doctor. If you have any questions, ask your doctor, pharmacist, or nurse.
Be careful with Integrilin:
- Integrilin is only recommended for use in adult patients hospitalized in coronary care units.
- Integrilin should not be used in children or adolescents under 18 years of age.
- Before and during treatment with Integrilin, blood samples will be taken as a safety measure to limit the possibility of unexpected bleeding.
- During the use of Integrilin, you will be carefully monitored for signs of unusual or unexpected bleeding.
Using Integrilin with other medicines
To avoid the possibility of interactions with other medicines, tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use other medicines, including those bought without a prescription.
Especially:
- blood thinners (oral anticoagulants) or
- medicines that prevent blood clot formation, such as warfarin, dipyridamole, ticlopidine, aspirin (except those you may receive as part of your treatment with Integrilin).
Pregnancy and breastfeeding
The use of Integrilin is not normally recommended during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will assess whether the benefits of treatment with Integrilin for you outweigh the possible risks for your baby.
If you are breastfeeding, breastfeeding should be interrupted during the treatment period.
Integrilin contains sodium
- This medicine contains 13.8 mg of sodium (main component of cooking/table salt) in each 10 ml vial. This is equivalent to 0.69% of the maximum recommended daily intake of sodium for an adult.
3. How to use Integrilin
Integrilin is given into a vein by direct injection followed by an infusion (drip). The dose given is based on your weight. The recommended dose is 180 micrograms/kg given as a bolus (rapid intravenous injection), followed by an infusion of 2.0 micrograms/kg/minute for a maximum of 72 hours. If you have kidney disease, the infusion dose may be reduced to 1.0 microgram/kg/minute.
If you undergo percutaneous coronary intervention during treatment with Integrilin, the intravenous solution may be continued for a maximum of 96 hours.
You will also receive some doses of acetylsalicylic acid (aspirin) and heparin (if not contraindicated in your case).
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
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 (e.g., blood in the urine, stools, vomiting blood, or bleeding from surgery)
- anemia (decrease in the number of red blood cells or hemoglobin in the blood).
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
- decrease in the number of platelets (blood cells necessary for blood coagulation)
- decrease in blood flow to the brain.
Rare side effects
These may affect up to 1 in 10,000 people
- severe bleeding (e.g., bleeding inside the abdomen, brain, or lungs)
- fatal bleeding
- severe decrease in the number of platelets (blood cells necessary for blood coagulation)
- skin rash (such as hives or itching)
- severe allergic reaction.
If you notice any signs of bleeding, tell your doctor, pharmacist, or nurse immediately. Very rarely, bleeding has been severe and even fatal. Safety measures to prevent this include blood tests and close monitoring by healthcare professionals.
If you show symptoms of a severe allergic reaction or skin rash, tell your doctor, pharmacist, or nurse immediately.
Other effects that may occur in patients who need this type of treatment include those related to the condition being treated, such as rapid or irregular heartbeats, low blood pressure, shock, or cardiac arrest.
Reporting of side effects
If you experience any side effects, talk to your doctor, 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.
5. Storage of Integrilin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the outer packaging and on the vial. The expiry date is the last day of the month stated.
Store in a refrigerator (between 2°C and 8°C).
Keep the vial in the outer packaging to protect it from light. However, during administration of the Integrilin solution, protection from light is not necessary.
Before use, the contents of the vial should be examined.
Do not use Integrilin if you notice particles or a color change.
Once opened, the unused medicine should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and other information
Composition of Integrilin
- The active substance is eptifibatide. Each ml of solution for injection contains 2 mg of eptifibatide. A 10 ml vial of solution for injection contains 20 mg of eptifibatide.
- The other ingredients are citric acid monohydrate, sodium hydroxide, and water for injections.
Appearance and packaging
Integrilin solution for injection: 10 ml vial, pack containing 1 vial.
The clear, colorless solution is contained in a 10 ml glass vial, closed with a butyl rubber stopper and an aluminum cap with a folded edge.
Marketing authorization holder and manufacturer
Marketing authorization 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
You can obtain more information on this medicine by contacting the local representative of the marketing authorization holder.
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 (0) 10 85 52 00 | Lietuva GlaxoSmithKline (Ireland) Limited Tel: +370 80000334 |
???????? GlaxoSmithKline (Ireland) Limited ???. +359 80018205 | Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien Tél/Tel: + 32 (0) 10 85 52 00 |
Ceská republika GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Magyarország GlaxoSmithKline (Ireland) Limited Tel.: +36 80088309 |
Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta GlaxoSmithKline (Ireland) Limited Tel: +356 80065004 |
Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 | Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 |
Eesti GlaxoSmithKline (Ireland) Limited Tel: +372 8002640 | Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Ελλ?δα GlaxoSmithKline Μονοπρ?σωπη A.E.B.E. Τηλ: + 30 210 68 82 100 | Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
España GlaxoSmithKline, S.A. Tel: + 34 900 202 700 | Polska GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France Laboratoire GlaxoSmithKline Tél.: + 33 (0)1 39 17 84 44 | Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda Tel: + 351 21 412 95 00 |
Hrvatska GlaxoSmithKline (Ireland) Limited Tel: +385 800787089 | România GlaxoSmithKline (Ireland) Limited Tel: +40 800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenija GlaxoSmithKline (Ireland) Limited Tel: +386 80688869 |
Ísland Vistor hf. Sími: + 354 535 7000 | Slovenská republika GlaxoSmithKline (Ireland) Limited Tel: +421 800500589 |
Italia GlaxoSmithKline S.p.A. Tel: + 39 (0)45 7741 111 | Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 |
Κ?προς GlaxoSmithKline (Ireland) Limited Τηλ: +357 80070017 | Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvija GlaxoSmithKline (Ireland) Limited Tel: +371 80205045 | United Kingdom (Northern Ireland) GlaxoSmithKline (Ireland) Limited Tel: + 44 (0)800 221441 |
Date of last revision of this leaflet
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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