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  • Ilomedin
    / Bayer


    Active Ingredient
    Iloprost 0.1 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    50 mcg / 0.5 ml

    partial basket chart 8878 9059

    Dosage

    Ilomedin should be used only under strict monitoring in hospitals or out-patient clinics with adequate facilities.
    In women, pregnancy should be discarded before initiating treatment. Ilomedin is administered after dilution as an intravenous infusion over 6 hours daily via a peripheral vein or a central venous catheter. The dose is adjusted according to individual tolerability within the range of 0.5 to 2.0 ng iloprost/kg body weight/min. The infusion solution should be made up freshly each day to ensure sterility. The contents of the ampoule and the diluent should be mixed thoroughly. The blood pressure and heart rate must be measured at the start of the infusion and after every increase of the dose. During the first 2 – 3 days, the individually tolerated dose is established. For this purpose, treatment should be started at an infusion rate to deliver 0.5 ng/kg/min for 30 minutes. The dose should then be increased at intervals of about 30 minutes in steps of 0.5 ng/kg/min up to 2.0 ng/kg/min. The exact infusion rate should be calculated on basis of the body weight to effect an infusion within the range of 0.5 to 2.0 ng/kg/min. Depending on the occurrence of side effects such as headache and nausea or an undesired drop of blood pressure, the infusion rate should be reduced until the tolerable dose is found. If the side effects are severe, the infusion should be interrupted. The treatment should then be continued- usually for 4 weeks – with the dose found to be tolerated in the first 2 to 3 days. Depending on the infusion technique there are two different dilutions of one ampoule. One of these two dilutions is 10 fold less concentrated than the other (0.2 μg/ml versus 2 μg/ml) and may only be applied with an infusion pump (e.g. Infusomat). In contrary the higher concentrated solution is applied via a syringe driver.
    Infusion rates [ml/h] for different doses for use with infusion pump In general, the ready-to-use infusion solution is infused intravenously by means of an infusion pump (e.g. Infusomat). For instructions for dilution for use with infusion pump see section 6.6 “Instructions for use/handling”. In the case of an Ilomedin concentration of 0.2 μg/ml, the required infusion rate should be determined according to the above described scheme to effect a dose within the range of 0.5 to 2.0 ng/kg/min. The following table can be used to calculate the infusion rate corresponding to the individual weight of the patient and the dose to be infused. Please interpolate to match the patient’s actual body weight, then set the infusion rate to the target dose in ng/kg/min.
    For Full details see prescribing information.


    Indications

    Peripheral arterial occlusive disease (stage III and IV) in advanced arteriosclerosis, diabetic angiopathy, Buerger’s disease, Raynaud’s disease.


    Contra-Indications

    Pregnancy, lactation, hypersensitivity to components, where effect of drug on platelets might increase risk of hemorrhage, severe coronary heart disease, unstable angina, myocardial infarction within last 6 months, acute or chronic congestional heart failure, arrhythmia related to prognosis, suspected pulmonary congestion.
    For full details see prescribing information.


    Special Precautions

    Surgery should not be delayed in patients requiring urgent amputation. Patients should be strongly advised to stop smoking. In patients with low blood pressure, care should be taken to avoid further hypotension. No other drug should be added to the ready-to-use infusion solution. Oral ingestion and contact with the mucous membranes must be avoided. Must not be administered to pregnant or lactating women.
    For full details see prescribing information.


    Side Effects

    SThe overall safety profile of Ilomedin is based on data from post-marketing surveillance and on pooled clinical trial data. The crude incidences were based on the cumulative database of 3325 patients having received iloprost either in controlled or uncontrolled clinical trials or in a compassionate use program from generally elderly and multimorbid patients with peripheral arterial occlusive disease (PAOD) in its advanced stages III and IV and patients with thromboangiitis obliterans (TAO), for details see table 1. The most frequently observed adverse drug reactions (≥ 10%) in patients receiving iloprost in clinical trials are headache, flushing, nausea, vomiting and hyperhidrosis. These are likely to occur while the dose is titrated at the start of treatment to identify the best tolerable dose for the individual patient. However, all these side effects usually disappear quickly with dose reduction. Overall, the most serious adverse drug reactions in patients receiving iloprost are cerebrovascular accident, myocardial infarction, pulmonary embolism, cardiac failure, convulsion, hypotension, tachycardia, asthma, angina pectoris, dyspnea and pulmonary edema. Another group of side effects is related to local infusion site reactions. For example, infusion site redness and infusion site pain may occur or a cutaneous vasodilation may give rise to streaky erythema above the infusion vein.
    The adverse drug reactions observed with Ilomedin are represented in the table below. They are classified according to System Organ Class. The most appropriate MedDRA term is used to describe a certain reaction and its synonyms and related conditions.
    For full details see prescribing information.


    Drug interactions

    Has shown additive effect on the antihypertensive activity of (-receptor blockers, calcium antagonists and vasodilators, and a potentiating effect on the antihypertensive activity of ACE inhibitors. Heparin or coumarin-type anticoagulants. Has an additive or superadditive effect on platelet function with other inhibitors of platelet aggregation (acetylsalicylic acid, or other NSAIDs and phosphodiesterase inhibitors).
    For full details see prescribing information.


    Pregnancy and Lactation

    Ilomedin must not be administered to pregnant or lactating women.
    Pregnancy: There are no adequate data from the use of iloprost in pregnant women. Preclinical studies have shown evidence of fetotoxicity in rats but not in rabbits and monkeys. As the potential risk of the therapeutic use of iloprost during pregnancy is unknown, women of child-bearing potential should use effective contraceptive measures during treatment.
    Lactation: It is not known whether iloprost enters human breast milk. As extremely low levels of iloprost pass into the milk of rats, iloprost should not be administered to nursing women.


    Overdose

    Symptoms: Hypotensive reaction might be anticipated as well as headache, flushing, nausea, vomiting and diarrhea. An increase of blood pressure, bradycardia or tachycardia and limb or back pain might be possible.
    Therapy: A specific antidote is not known.. Interruption of iloprost administration, monitoring and symptomatic measures are recommended.


    Manufacturer
    Berlimed S.A.
    Licence holder
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