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Iloprost 100 Micrograms/Ml Concentrate for Solution for Infusion

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PHARMACODE Package leaflet: Information for the user POSITION GUIDE Iloprost 100 micrograms/ml GUIDE POSITION PHARMACODE Concentrate for solution for infusion Read all of this leaflet carefully before you Pregnancy, breast-feeding and fertility: start using this medicine because it Iloprost 100 micrograms/ml is not indicated contains important information for you. for pregnant or breast-feeding women. PHARMACODE ■ POSITION Keep this leaflet. You may need to read it GUIDE If you are pregnant or breast-feeding, think again. you may be pregnant or are planning to have ■ If you have any further questions, ask your a baby, ask your doctor for advice before GUIDE POSITION doctor, pharmacist or nurse. PHARMACODE using this medicine. Women of childbearing ■ This medicine has been prescribed for you potential have to use effective contraception only. Do not pass it on to others. It may during treatment. harm them, even if their signs of illness are the same as yours. Driving and using machines: ■ If you get any side effects, talk to your Iloprost 100 micrograms/ml lowers blood doctor, pharmacist or nurse. This includes pressure and may cause dizziness or any possible side effects not listed in this light-headedness in some people. Do not leaflet. ■ drive or operate any tools or machines if you The full name of this medicine is Iloprost feel these effects. 100 micrograms/ml Concentrate for solution for infusion but within the leaflet it will be referred to as Iloprost 100 3. How to use Iloprost micrograms/ml. 100 micrograms/ml What is in this leaflet Iloprost 100 micrograms/ml should be used 1. What Iloprost 100 micrograms/ml is and only under strict monitoring in hospitals or what it is used for out-patient clinics with adequate facilities. 2. What you need to know before you use Iloprost 100 micrograms/ml How Iloprost 100 micrograms/ml is 3. How to use Iloprost 100 micrograms/ml prepared for administration 4. Possible side effects Iloprost 100 micrograms/ml is a solution 5. How to store Iloprost 100 micrograms/ml contained in a glass ampoule. The content of 6. Contents of the pack and other information the ampoule is diluted with 0.9% physiological sodium chloride solution or a 5% glucose solution. The infusion solution should be 1. What Iloprost 100 micrograms/ prepared just before the infusion daily, to ml is and what it is used for ensure sterility. The content of the ampoule and the diluent must be mixed thoroughly. Iloprost 100 micrograms/ml contains the Iloprost 100 micrograms/ml must be used only active ingredient iloprost which imitates a after dilution. For further information for natural substance in the body called physicians or healthcare professionals on the prostacyclin. Iloprost 100 micrograms/ml and preparation of the dilution see section “The prostacyclin prevent unwanted blockages or following information is intended for medical narrowing of blood vessels and allow and healthcare professionals only” at the end improved blood flow in the arteries. of this leaflet. Iloprost 100 micrograms/ml promotes the healing of wounds caused by insufficient How Iloprost 100 micrograms/ml is given blood flow (ischemia) by providing better The solution is infused intravenously with a oxygenation, and relieving pain in severe, venous catheter directly into one of the veins chronic disorders of the blood circulation. in your arm or into a central intravenous catheter inserted into a vein near your neck. Iloprost 100 micrograms/ml is used in adults Iloprost 100 micrograms/ml is administered in the treatment of: as infusion over 6 hours daily. ■ Severe chronic ischaemia of lower limbs The dose is adjusted according to individual (decreased blood supply) in patients at tolerability within the range of 0.5 to 2.0 ng risk of amputation, in whom surgical iloprost/kg body weight/min. Your blood revascularisation or angioplasty (repair of pressure and heart rate will be measured at blood vessel) has failed or is not the start of the infusion and after every dose indicated, following the meeting of increase. physicians, surgeons and radiologists. ■ Severe Raynaud’s phenomena (reduced How much Iloprost 100 micrograms/ml blood flow to fingers and toes) in patients is given with progressive trophic disorders. During the first 2-3 days, the individually 2. What you need to know tolerated dose is established. before you use Iloprost For this purpose, your doctor will start the treatment at a low dose. Treatment should 100 micrograms/ml be started at an infusion rate of 0.5 ng/kg/ Do not use Iloprost 100 micrograms/ml if min for 30 minutes. The dose should then be you: increased at intervals of 30 minutes in steps ■ of 0.5 ng/kg/min up to 2.0 ng/kg/min. The have hypersensitivity (allergy) to iloprost exact infusion speed should be calculated on or any of the other ingredients of this the basis of body weight to reach an infusion medicine (listed in section 6 “Contents of within the range of 0.5 to 2.0 ng/kg/min (see the pack and other information”) ■ tables below for use with infusion pump or are at increased risk of bleeding – for syringe driver). example, if you have an active gastric (stomach) or duodenal ulcer, bleeding If adverse effects occur, such as headache from wounds or had bleeding inside the and nausea or an undesirable drop in blood skull pressure, tell your doctor immediately. The ■ have suspected fluid build-up in the infusion rate should be reduced until the lungs (pulmonary oedema) accompanied tolerable dose is found. If the adverse effects by difficulty in breathing are severe, the infusion should be ■ had a heart attack within the last six interrupted. For the remaining duration, the months treatment should be continued with the dose ■ have an irregular heart rate found to be tolerated in the first 2 to 3 days. ■ have poor blood flow to the heart muscle The doctor will determine whether Iloprost (severe coronary artery disease or 100 micrograms/ml will be infused unstable angina) intravenously by an infusion pump or with ■ are suffering withangina or chest pain syringe driver. If Iloprost 100 micrograms/ml ■ had an acute or chronic congestive heart is administered with an infusion pump, failure it will be diluted before infusion to a final ■ have congenital or acquired valvular concentration of 0.2 micrograms/ml. If defects with clinically relevant myocardial Iloprost 100 micrograms/ml is administered function disorders not related to with a syringe driver, it will be diluted before pulmonary hypertension infusion to a final concentration of 2 ■ had a stroke in the past 3 months micrograms /ml. ■ are pregnant or breast feeding If you have renal failure requiring dialysis Warnings and precautions or liver cirrhosis, iloprost elimination is reduced and a dose reduction (e.g. half the Talk to your doctor before using Iloprost 100 recommended dose) is necessary. Tell your micrograms/ml if you: doctor if you have problems with your liver ■ require urgent amputation. Surgery or kidneys. should not be delayed if you need urgent amputation (e.g. in case of infected How long Iloprost 100 micrograms/ml gangrene). is given: ■ are a smoker. You should stop smoking. The duration of treatment is up to 4 weeks. ■ have liver problems or severe kidney The safety and efficacy of Iloprost 100 problems, tell your doctor. You may be micrograms/ml have not been studied for prescribed a lower dose of Iloprost 100 treatment longer than 4 weeks or after micrograms/ml and your doctor will repetitive treatment cycles. monitor you closely. ■ have low blood pressure, care should be Continuous infusion over several days is not taken so as not to further reduce blood recommended, because it can lead to pressure (hypotension). reduced effect on platelets and increased ■ have severe heart disease, you will be platelet aggregation (platelet monitored closely. hyperaggregability) at the end of treatment. No clinical complications associated with After administration, when moving from a these phenomena have been reported. lying to upright position, your blood If you feel that the effect of Iloprost 100 pressure may fall. This can make you feel micrograms/ml is too strong or too weak, dizzy for a while until your blood pressure tell your doctor or pharmacist. returns to normal values (this is called “orthostatic hypotension”). Stand up slowly If you have any further questions about the when you get out of bed. This will help your use of this product, ask your doctor or body get used to this change in position and pharmacist. blood pressure. If you use more Iloprost 100 micrograms/ If undiluted Iloprost 100 micrograms/ml is ml than you should: infused in the veins this can lead to local Drop in blood pressure (hypotensive reaction) changes at the injection site due to can be expected, as well as headache, extravasation. redness of the face (flushing), nausea, If Iloprost 100 micrograms/ml comes into vomiting and diarrhoea. An increase in blood contact with your skin: pressure, reduced or increased heart rate and Iloprost 100 micrograms/ml solution should limb or back pain may also occur. not come into contact with your skin or eyes. No specific antidote is known. On contact with the skin, iloprost may cause In case of overdose, your doctor is advised to long-lasting but painless redness of the skin discontinue infusion of iloprost, to monitor (erythema). In the event of such contact, you and treat your symptoms. wash immediately the skin or the eyes with water or saline. If you stop using Iloprost 100 micrograms/ This medicinal product contains small ml: amounts of ethanol (alcohol), less than If the infusion therapy with Iloprost 100 100mg per dose.
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