Rapilysin (reteplase) – Package leaflet - B01AD08

Package leaflet: Information for the user

Rapilysin 10 U powder and solvent for solution for injection reteplase

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 or your pharmacist.

-If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.What Rapilysin is and what it is used for

2.What you need to know before Rapilysin is given to you

3.How to use Rapilysin

4.Possible side effects

5.How to store Rapilysin

6.Contents of the pack and other information

1.What Rapilysin is and what it is used for

Rapilysin contains the active substance reteplase(a recombinant plasminogen activator). It is a thrombolytic medicine used to dissolve blood clots that have formed in certain blood vessels and to restore the blood flow in these blocked vessels (=thrombolysis).

Rapilysin is used after an acute myocardial infarction (heart attack) in order to dissolve the blood clot causing the heart attack. It is given within 12 hours after the onset of symptoms.

2.What you need to know before Rapilysin is given to you

The doctor will ask you questions before giving you Rapilysin, to find out if you have an increased risk of bleeding.

Do not use Rapilysin

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

if you have a bleeding disorder.

if you are taking medicine to thin your blood (oral anticoagulants, e.g. warfarin).

if you have a brain tumour or a malformed blood vessel or a vessel wall dilatation (aneurysm) in the brain.

if you have other tumours associated with an increased risk of bleeding.

if you have had a stroke.

if you have had external heart massage within the past 10 days.

if you have severe uncontrolled high blood pressure (hypertension).

if you have an ulcer in the stomach or small intestine.

if you have enlarged blood vessels in the gullet (oesophagus) (frequently caused by liver disease).

if you have severe liver or kidney disease.

if you have acute inflammation of the pancreas or pericardium (the sac surrounding the heart), or an infection of the heart muscle (bacterial endocarditis).

if you have in the past 3 months had severe bleeding, a major injury or major surgery (e.g. coronary artery bypass graft, or surgery or injury to the head or spine), given birth, or had an organ biopsy or other medical / surgical procedure.

Breast-feeding

You should not breast-feed your baby during treatment with Rapilysin as it is not known whether Rapilysin is excreted into mother’s milk. Mother’s milk should be thrown away during the first 24 hours after thrombolytic treatment. Discuss with your doctor when you can take up breast-feeding again.

3.How to use Rapilysin

Rapilysin is usually given in a hospital. The medicine is supplied in vials as a powder for injection. Before use, the powder for injection must be dissolved in the water for injection supplied in the prefilled syringe that is in the package. Do not add any other medicines. The resulting solution must be used immediately. The solution must be examined to ensure that only clear, colourless solution is injected. If the solution is not clear and colourless it should be thrown away.

Treatment with Rapilysin 10 U should be started as soon as possible after the symptoms of heart attack begin.

Heparin and Rapilysin cannot be mixed in the same solution. Other medicines may also not mix well with Rapilysin. No other medicines should be added to the injection solution (see below). Rapilysin should be injected preferably through an intravenous line that is used only for the injection of Rapilysin. No other medicines should be injected through the line reserved for Rapilysin, either at the same time, or before or after Rapilysin injection. This applies to all medicines including heparin and acetylsalicylic acid, which are given before and after Rapilysin to reduce the risk of new blood clots forming.

If the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution before and after the Rapilysin injection.

Dosage of Rapilysin

Rapilysin is given as a 10 U injection followed by a second 10 U injection 30 minutes later (double bolus).

Each injection should be given slowly within 2 minutes. The injection must not be given mistakenly outside the vein. Therefore, be sure to tell the medical staff if you experience pain during the injection.

Heparin and acetylsalicylic acid are given before and after Rapilysin to reduce the risk of new blood clots forming.

Dosage of Heparin

The recommended dose of heparin is 5000 I.U. given as a single injection before Rapilysin, followed by an infusion of 1000 I.U. per hour starting after the second Rapilysin injection. Heparin should be given for at least 24 hours, preferably for 48-72 hours, in order to keep aPTT values 1.5 to 2 times normal.

Dosage of Acetylsalicylic Acid

The dose of acetylsalicylic acid given before Rapilysin should be at least 250 mg-350 mg and should be followed by 75-150 mg/day, at least until discharge from hospital.

If more Rapilysin is used than recommended

In the event of overdosage there may be an increased risk of bleeding.

4.Possible side effects

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

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

Bleeding at the injection site, e.g. blood blister (haematoma)

Chest Pain / angina, low blood pressure and heart failure /shortness of breath may reappear

Burning sensation when Rapilysin is injected

Common side effects (may affect up to 1 in 10 people)

Bleeding in the digestive tract (e.g. bloody or black vomit, or stools) in the gums or in the urinary or genital tract

Abnormal heart beats (arrhythmias), cardiac arrest, circulatory collapse or another heart attack may occur

Uncommon side effects (may affect up to 1 in 100 people)

Bleeding around the heart, in the abdomen, the brain or the eyes, under the skin, from the nose or as coughed up blood

Damage to the heart or heart valves, or a blood clot in the lung, brain or other part of body mayoccur

hypersensitivity (e.g. allergic reactions)

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

Events related to the nervous system (e.g. epileptic seizure, convulsion, speech disorder, delirium, agitation, confusion, depression, psychosis)

severe allergic reaction, causing shock or collapse

Side effects of frequency not known (cannot be estimated from the available data)Blockage of blood vessels due to cholesterol (fat)

Cardiovascular events can be life-threatening or cause death.

Patients with systolic blood pressure over 160 mmHg have a greater risk of bleeding in the brain. The risk of intracranial bleeding and fatal intracranial bleeding increases with increasing age. Blood transfusions were rarely required. Death or permanent disability are not uncommon in patients who have a stroke (including bleeding in the brain) or other serious bleeding problem.

Be sure to tell hospital staff immediately if any of these symptoms appear.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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.How to store Rapilysin

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 carton and on the label of the vial after EXP

Do not store above 25 °C.

Keep the vial in the outer carton in order to protect from light.

After reconstitution (“when dissolved”), the solution must be used immediately.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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The following information is intended for healthcare professionals only:

Instructions for use/handling

Incompatibility of some prefilled glass syringes (including Rapilysin) with certain needle free connectors has been reported. Therefore, the compatibility of the glass syringe and intravenous access should be ensured before use. In case of incompatibility an adaptor can be used and removed together with the glass syringe immediately after administration

Use aseptic technique throughout.

1.Remove the protective flip-cap from the vial of Rapilysin 10 U and clean the rubber closure with an alcohol wipe.

2.Open the package containing the reconstitution spike, remove both protective caps from the reconstitution spike.

3.Insert the spike through the rubber closure into the vial of Rapilysin 10 U.

4.Take the 10 ml syringe out of the package. Remove the tip cap from the syringe. Connect the syringe to the reconstitution spike and transfer the 10 ml of solvent into the vial of Rapilysin 10 U.

5.With the reconstitution spike and syringe still attached to the vial, swirl the vial gently to dissolve the Rapilysin 10 U powder. DO NOT SHAKE.

6.The reconstituted preparation results in a clear, colourless solution. If the solution is not clear and colourless it should be discarded.

7.Withdraw 10 ml of Rapilysin 10 U solution back into the syringe. A small amount of solution may remain in the vial due to overfill.

8.Disconnect the syringe from the reconstitution spike. The dose is now ready for intravenous administration.

9.No other medicines should be injected through the line reserved for Rapilysin either at the same time, or prior to, or following Rapilysin injection. This applies to all products including heparin and acetylsalicylic acid, which should be administered before and following the administration of reteplase to reduce the risk of re-thrombosis.

10.In those patients where the same line has to be used, this line (including Y-line) must be flushed thoroughly with a 0.9 % sodium chloride or 5 % glucose solution prior to and following the Rapilysin injection.