0.75 mg / ml Infusion solution
eptifibatide
1. What Integrilin is and what it is used for
Integrilin is a platelet aggregation inhibitor. This means that it helps to prevent the platelets from clotting.
It is used in adults with signs of severe heart failure defined as spontaneous and recently experienced chest pain with ECG changes or biological changes. It is usually given together with acetylsalicylic acid and unfractionated heparin.
2. What you need to know before you take Integrilin
You can not get 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 bleeding from the stomach, intestines, bladder or other organs, for example if you have seen blood in the stool or urine (with the exception of menstrual bleeding) in the last 30 days
- if you have had a stroke in the last 30 days or some form of cerebral haemorrhage (also make sure your doctor knows if you have ever had a stroke)
- if you have had a brain tumor or any disease that affects the blood vessels in the brain
- if you have undergone major surgery or suffered a serious injury in the last 6 weeks
- if you have or have had bleeding problems
- if you have or have had coagulation disorders or a low 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 medicine of the same type as Integrilin.
Tell your doctor if you have had any of these conditions. If you have any further questions, ask your doctor, hospital pharmacist, or nurse.
Take special care with Integrilin:
- Integrilin is only recommended for use in adult inpatients in cardiology departments.
- Integrilin is not intended for use in children or adolescents below 18 years.
- Before and during treatment with Integrilin, blood tests will be taken as a precautionary measure to limit the risk of unexpected bleeding.
- When you receive Integrilin, you will be closely monitored for signs of unusual or unexpected bleeding.
Other medicines and Integrilin
To avoid the risk of interacting with other medicines, tell your doctor, hospital pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Particularly:
- blood thinners (oral anticoagulants ) or
- medicines that prevent the blood from clotting, including warfarin , dipyridamole, ticlopidine, acetylsalicylic acid (with the exception of those that you may receive as part of your Integrilin treatment).
Pregnancy and breastfeeding
Integrilin is not usually recommended for use during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby. Your doctor will weigh the benefits for you against the risks to your baby when using Integrilin during your pregnancy.
If you are breastfeeding, you should stop breastfeeding during the treatment period.
Integrilin contains sodium
- This medicine contains 161 mg of sodium (the main ingredient in table salt / table salt) per 100 ml vial . This corresponds to 8.1% of the highest recommended daily intake of sodium for adults.
3. How to use Integrilin
Integrilin is given into a vein by direct injection followed by an infusion (drip solution). Dose one is calculated according to your body weight. The recommended dose is 180 micrograms/kg given as a bolus (rapid intravenous injection ), followed by an infusion (drip solution) of 2 micrograms/kg/minute for up to 72 hours. If you have any kidney disease, the dose may be reduced to 1 microgram/kg/minute.
If catheterization procedures (PCI) are performed during treatment with Integrilin, the intravenous solution may be given for up to 96 hours.
You must also receive acetylsalicylic acid and heparin (unless contraindicated in your case).
If you have any further questions on the use of this product, ask your doctor, hospital pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effect
Occurs in more than 1 in 10 individuals
- minor or major bleeding (eg blood in the urine, blood in the stool, blood in connection with vomiting or bleeding in connection with surgery)
- anemia (decreased number of red blood cells ).
Common side effect
Occurs in up to 1 in 10 individuals
- inflammation of blood vessels.
Uncommon side effect
Occurs in up to 1 in 100 individuals
- decreased platelet count ( blood cells needed for blood coagulation)
- reduced blood supply to the brain.
Very rare side effect
Occurs in up to 1 in 10,000 individuals
- severe bleeding (eg bleeding inside the abdomen, brain or lungs)
- bleeding leading to death
- sharp decrease in the number of platelets ( blood cells needed for blood coagulation)
- skin rash ( hives )
- sudden severe allergic reaction .
If you notice any signs of bleeding, contact your doctor, hospital pharmacist, or nurse immediately. In very rare cases, bleeding has become severe and even fatal.
Precautions to prevent this from happening to include blood tests and careful checks performed by the healthcare professional who cares for you.
If you get a severe allergic reaction or hives, contact your doctor, hospital pharmacist, or nurse immediately.
Other side effects that may occur in patients who require this type of treatment include those associated with the disease you are being treated for, 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, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Integrilin
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) on the outer carton and infusion bottle. The expiration date is the last day of the month specified.
Store in a refrigerator (2 ° C – 8 ° C).
Store the infusion bottle in the outer carton. Sensitive to light. However, the integrilin solution does not need to be protected from light during administration.
The contents of the bottle should be checked before use.
Do not use Integrilin if it contains particles or is discolored.
Any remaining medicine in the bottle should be discarded.
Medicines should not be disposed of via wastewater or household waste. Ask your hospital pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is eptifibatide. Each ml of solution for infusion contains 0.75 mg of entifibatide. One 100 ml vial contains 75 mg of eptifibatide.
- The other ingredients are citric acid monohydrate, sodium hydroxide and water for injections.
What the medicine looks like and contents of the pack
Integrilin solution for infusion: 100 ml infusion bottle, pack of one infusion bottle.
The clear, colorless liquid is supplied in a 100 ml glass infusion bottle, which is sealed with a butyl rubber stopper and sealed with an aluminum seal.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Manufacturer:
GlaxoSmithKline Manufacturing SPA, Strada Provinciale Asolana No. 90, San Polo di Torrile 43056, Parma, Italy
Contact the representative of the marketing authorization holder to find out more about this medicine.
| Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 (0) 10 85 52 00 | LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com |
| BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 | Luxembourg / Luxemburg GlaxoSmithKline Pharmaceuticals sa / nvBelgium / BelgiumTel: + 32 (0) 10 85 52 00 |
| Czech RepublicGlaxoSmithKline sroTel: + 420 222 001 111cz.info@gsk.com | HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300 |
| DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com | MaltaGlaxoSmithKline (Malta) LimitedTel: + 356 21 238131 |
| GermanyGlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com | The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 33 2081100 |
| EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com | NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00 |
| Greece GlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com |
| SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com | Poland GSK Services Sp. z ooTel .: + 48 (0) 22 576 9000 |
| FranceGlaxoSmithKline LaboratoryTel .: + 33 (0) 1 39 17 84 44diam@gsk.com | Portugal GlaxoSmithKline – Pharmaceutical Products, LdaTel: + 351 21 412 95 00FI.PT@gsk.com |
| CroatiaGlaxoSmithKline dooTel: + 385 1 6051 999 | RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208 |
| Ireland GlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 | Slovenia GlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com |
| Iceland Visitor hf.Phone: + 354 535 7000 | Slovak Republic GlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com |
| ItalyGlaxoSmithKline SpATel: + 39 (0) 45 7741 111 | Finland / Finland GlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com |
| ΚύπροςGlaxoSmithKline Cyprus Ltd:Ηλ: + 357 22 39 70gskcyprus@gsk.com | Sweden GlaxoSmithKline ABTel: + 46 (0) 8 638 93 00info.produkt@gsk.com |
| LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com | United Kingdom GlaxoSmithKline UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com |