GUIDE GUIDE
POSITION POSITION
PHARMACODE PHARMACODE
Possible side effects Possible 100 micrograms/ml 100 How to use Iloprost to How Tachycardia (fast heart rate) Tachycardia Hypotension (abnormally low blood blood Hypotension (abnormally low pressure) Heart failure Pulmonary embolism (difficulties Pulmonary breathing or chest pain when breathing clot in the lung) due to blood Myocardial infarction (heart attack) infarction Myocardial Cerebrovascular event (stroke) event Cerebrovascular Asthma
Convulsions
4. 3. Pregnancy, breast-feeding and fertility: breast-feeding Pregnancy, is not indicated Iloprost 100 micrograms/ml women.for pregnant or breast-feeding are pregnant or breast-feeding, think If you or are planning to have be pregnant may you doctor for advice before ask your a baby, of childbearingusing this medicine. Women to use effective contraception potential have during treatment. Driving and using machines: blood lowers Iloprost 100 micrograms/ml cause dizziness or pressure and may people. Do notlight-headedness in some tools or machines if you any drive or operate feel these effects. ■ ■ ■ ■ ■ ■ ■ Like all medicines, this medicine can cause gets them. everybody side effects, although not been side effects, which have The most severe a fatal or life-threateningreported as having effect in patients taking iloprost are: ■ If you feel that the effect tellof Iloprost your doctor 100 or pharmacist. If you use more Iloprost 100 micrograms/ ml than you should: pressure (hypotensive reaction) Drop in blood can be expected, as well as headache, redness of the face (flushing), nausea, and diarrhoea. An increase in blood vomiting and pressure, reduced or increased heart rate also occur. limb or back pain may No specific antidote is known. doctor is advised to your In case of overdose, infusion of iloprost, to monitordiscontinue symptoms. and treat your you If you stop using Iloprost 100 micrograms/ ml: with Iloprost 100 If the infusion therapy doctor your is discontinued, micrograms/ml will take care to restore the changes that been made to other medicinesmight have take, due to Iloprost 100 micrograms/ml you (e.g. dose reductions). administration Iloprost 100 micrograms/ml should be used Iloprost 100 micrograms/ml only under strict monitoring in hospitals or out-patient clinics with adequate facilities. is Iloprost 100 micrograms/ml How administration prepared for is a solution Iloprost 100 micrograms/ml contained in a glass ampoule. The content of the ampoule is diluted with 0.9% physiological or a 5% glucose chloride solution sodium solution. The infusion solution should be to prepared just before the infusion daily, The content of the ampoule ensure sterility. and the diluent must be mixed thoroughly. must be used only Iloprost 100 micrograms/ml after dilution. For further information for or healthcare professionals on the physicians of the dilution see section “The preparation is intended for medical information following and healthcare professionals only” at the end of this leaflet. is given Iloprost 100 micrograms/ml How with a The solution is infused intravenously venous catheter directly into one of the veins intravenous arm or into a central in your neck.catheter inserted into a vein near your is administered Iloprost 100 micrograms/ml daily. 6 hours as infusion over to individual The dose is adjusted according of 0.5 to 2.0 ng within the range tolerability blood weight/min. Your iloprost/kg body at will be measured pressure and heart rate dose the start of the infusion and after every increase. much Iloprost 100 micrograms/ml How is given the individually 2-3 days, During the first dose is established. tolerated doctor will start theFor this purpose, your dose. Treatment shouldtreatment at a low of 0.5 ng/kg/ be started at an infusion rate min for 30 minutes. The dose should then be of 30 minutes in steps increased at intervals of 0.5 ng/kg/min up to 2.0 ng/kg/min. The exact infusion speed should be calculated on weight to reach an infusionthe basis of body (see of 0.5 to 2.0 ng/kg/min within the range use with infusion pump or for tables below driver). syringe such as headache effects occur, If adverse drop in blood and nausea or an undesirable doctor immediately. Thepressure, tell your should be reduced until the infusion rate effects dose is found. If the adverse tolerable the infusion should be are severe, the interrupted. For the remaining duration, treatment should be continued with the dose 2 to 3 days. in the first found to be tolerated The doctor will determine whether Iloprost will be infused 100 micrograms/ml an infusion pump or with by intravenously driver. If Iloprost 100 micrograms/ml syringe is administered with an infusion pump, it will be diluted before infusion to a final If of 0.2 micrograms/ml. concentration is administered Iloprost 100 micrograms/ml it will be diluted before driver, with a syringe of 2 infusion to a final concentration /ml. micrograms renal failure requiring dialysis have If you or liver cirrhosis, iloprost elimination is reduced and a dose reduction (e.g. half the Tell your recommended dose) is necessary. liver problems with your have doctor if you or kidneys. long Iloprost 100 micrograms/ml How is given: of treatment is up to 4 weeks. The duration of Iloprost 100 and efficacy The safety not been studied for have micrograms/ml treatment longer than 4 weeks or after repetitive treatment cycles. is not days several Continuous infusion over recommended, because it can lead to reduced effect on platelets and increased platelet aggregation (platelet at the end of treatment. hyperaggregability) No clinical complications associated with been reported.these phenomena have If you have any further questions about the micrograms/ml is too strong or too weak, use of this product, ask your doctor or pharmacist.
. Surgery urgent amputation. Surgery
liver problems or severe kidney liver problems or severe pressure, care should be blood low will be heart disease, you severe suspected fluid build-up in the to the heart muscle flow poor blood hypersensitivity (allergy) to iloprost hypersensitivity pregnant or breast feeding at increased risk of bleeding – forat increased risk of What you need to know to need What you Iloprost use you before micrograms/ml 100 What Iloprost 100 micrograms/ 100 What Iloprost is and what it is used for ml . You should stop smoking. . You are a smoker be may doctor. You problems, tell your dose of Iloprost 100 a lower prescribed doctor will and your micrograms/ml closely. monitor you taken so as not to further reduce blood pressure (hypotension). monitored closely. Medicines used to treat high blood blood pressure or heart disease. Your drop much further. Tell your pressure may are taking any of these. He/ doctor if you change the dose of Iloprost 100she may should take. you micrograms/ml or inhibitMedicines that thin the blood clotting (e.g Aspirin® orblood acid, ticlopidine, acetylsalicylic beclopidogrel). The risk of bleeding may suffer from bleeding, increased. If you treatment with Iloprost 100 micrograms/ ml should be discontinued. should not be delayed if you need urgent if you should not be delayed amputation (e.g. in case of infected gangrene). (pulmonary oedema) accompanied lungs (pulmonary in breathing difficulty by had a heart attack within the last six months an irregular heart rate have disease or artery coronary (severe unstable angina) are suffering with angina or chest pain had an acute or chronic congestive heart failure congenital or acquired valvular have myocardial defects with clinically relevant not related to function disorders hypertension pulmonary in the past 3 months had a stroke example, if you have an active gastric have example, if you bleeding ulcer, (stomach) or duodenal from wounds or had bleeding inside the skull or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”) Severe chronic ischaemia of lower limbs of lower chronic ischaemia Severe supply) in patients at(decreased blood risk of amputation, in whom surgical (repair of or angioplasty revascularisation vessel) has failed or is notblood the meeting ofindicated, following surgeons and radiologists. physicians, phenomena (reduced Raynaud’s Severe and toes) in patients to fingers flow blood with progressive trophic disorders.
Keep this leaflet. You may need to read it need You may Keep this leaflet. again. further questions, ask your any have If you pharmacist or nurse. doctor, for you prescribed This medicine has been It may to others. only. Do not pass it on if their signs of illness harm them, even are the same as yours. your get any side effects, talk to If you This includes pharmacist or nurse. doctor, not listed in thisany possible side effects leaflet. The full name of this medicine is Iloprost for Concentrate 100 micrograms/ml solution for infusion but within the leaflet it will be referred to as Iloprost 100 micrograms/ml. is and What Iloprost 100 micrograms/ml what it is used for use before you need to know What you Iloprost 100 micrograms/ml 100 micrograms/ml to use Iloprost How Possible side effects 100 micrograms/ml to store Iloprost How Concentrate for solution for infusion for solution for Concentrate
Package leaflet: Information for the user for the Information leaflet: Package micrograms/ml 100 Iloprost Contents of the pack and other information other and pack the of Contents require have have have have have have are have have are
2. 1. Warnings and precautions Warnings doctor before using Iloprost 100 to your Talk if you: micrograms/ml ■ ■ ■ ■ ■ from a when moving After administration, blood lying to upright position, your feel fall. This can make you pressure may pressure blood for a while until your dizzy (this is called returns to normal values “orthostatic hypotension”). Stand up slowly get out of bed. This will help your when you get used to this change in position andbody pressure. blood is If undiluted Iloprost 100 micrograms/ml infused in the veins this can lead to local changes at the injection site due to extravasation. into comes If Iloprost 100 micrograms/ml skin: with your contact solution should Iloprost 100 micrograms/ml skin or eyes. not come into contact with your cause On contact with the skin, iloprost may long-lasting but painless redness of the skin of such contact, In the event (erythema). with wash immediately the skin or the eyes water or saline. contains small This medicinal product amounts of ethanol (alcohol), less than 100mg per dose. Other medicines and Iloprost 100 micrograms/ml are taking or have doctor if you Tell your recently taken any other medicines, including medicines obtained without a prescription. and some other Iloprost 100 micrograms/ml affect each other in the way medicines may special care to Take body. work in your they mention any of the following: ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ Do not use Iloprost 100 micrograms/ml if Do not use Iloprost 100 micrograms/ml you: ■ ■ Iloprost 100 micrograms/ml contains the Iloprost 100 micrograms/ml active ingredient iloprost which imitates a called substance in the body natural and Iloprost 100 micrograms/ml prostacyclin. unwanted blockages or prevent prostacyclin vessels and allow of blood narrowing in the arteries. flow blood improved promotes the Iloprost 100 micrograms/ml insufficient healing of wounds caused by better by providing (ischemia) flow blood pain in severe, and relieving oxygenation, circulation. of the blood chronic disorders is used in adults Iloprost 100 micrograms/ml in the treatment of: ■ ■ Read all of this leaflet carefully before you carefully before this leaflet Read all of start using this medicine because it you. for importantcontains information ■ ■ ■ ■ ■ What is in this leaflet 1. 2. 3. 4. 5. 6.
PHARMACODE PHARMACODE POSITION POSITION GUIDE GUIDE ■ Angina pectoris (chest pain or discomfort What Iloprost 100 micrograms/ml looks due to insufficient blood flow to the heart) like and contents of the pack ■ Dyspnoea (difficulty breathing) ■ Iloprost 100 micrograms/ml is a clear ■ Pulmonary oedema (difficulty breathing colourless solution, free of visible or coughing blood due to fluid buildup in particles which is diluted prior to infusion the lung) via a vein. It is supplied in glass ampoules. The most common side effects observed in ■ Iloprost 100 micrograms/ml is available in patients taking Iloprost 100 micrograms/ml the following pack sizes: include headache, flushing (redness of the 1 Box of 1 or 5 ampoules, each with 0.5 ml face), hyperhidrosis (sweating) and concentrate for solution for infusion or 1 box gastrointestinal symptoms, such as nausea of 1 or 5 ampoules, each with 1 ml and vomiting. These side effects are likely to concentrate for solution for infusion. occur during the dose titration at the start of treatment to identify the best tolerable dose Not all pack sizes may be marketed. for the individual patient. However, all these Marketing Authorisation Holder side effects usually disappear quickly with Colonis Pharma Ltd dose reduction. Quantum House Possible side effects are listed below Hobson Industrial Estate according to their frequency: Burnopfield County Durham Common (may affect up to 1 in 10 people) NE16 6EA ■ Decreased appetite United Kingdom ■ Apathy ■ Confusional state Manufacturer ■ Dizziness/vertigo (feeling of ‘spinning’) Rafarm S.A. ■ Paraesthesia (numbness and tingling)/ Thesi Pousi-Xatzi palpitations/hyperesthesia (increased Agiou Louka sensitivity to pain or touch) 19002, Paiania Attiki ■ Agitation Greece ■ Drowsiness ■ Tachycardia (fast heart rate) This leaflet was last revised in December ■ Bradycardia (slow heart rate) 2018. ■ Angina pectoris (chest pain or discomfort due to insufficient blood flow to the heart) ■ Hypotension (abnormally low blood pressure) ■ Blood pressure increased ■ Dyspnoea (difficulty breathing) ■ Diarrhoea ■ Abdominal discomfort/abdominal pain ■ Pain in jaw/trismus (jaw spasm, locking jaw) The following information is intended for ■ Myalgia (muscle pain)/arthralgia (joint pain) medical and healthcare professionals only: ■ Pain Iloprost 100 micrograms/ml should be used ■ Fever/body temperature increased only after dilution. The following sections ■ Burning sensation provide more information to your doctor ■ Asthenia (weakness)/malaise (feeling of when using an infusion pump or a syringe major weakness) driver for the administration of Iloprost 100 ■ Chills micrograms/ml. ■ Fatigue ■ Thirst Infusion rates (ml/hour) for different doses ■ Infusion site reactions such as infusion using an infusion pump site erythema, infusion site pain or In general, the ready-to-use infusion solution infusion site phlebitis (vein irritation) is infused intravenously by means of an Uncommon (may affect up to 1 in 100 people) infusion pump (e.g. Infusomat®). ■ Thrombocytopenia (blood disorder In case of an Iloprost 100 micrograms/ml characterized by easy bruising or bleeding) concentration of 0.2 micrograms/ml, the ■ Hypersensitivity (allergy) required infusion rate should be determined ■ Anxiety, depression, hallucination according to the below described scheme to ■ Syncope (short loss of consciousness) reach a dose within the range of 0.5 to 2.0 ■ Tremor (trembling or shaking) ng/kg/min. ■ Migraine The following table can be used to calculate ■ Blurred vision the infusion rate corresponding to the ■ Eye irritation individual weight of the patient and the dose ■ Eye pain to be infused. Match the patient’s actual ■ Arrhythmia/extrasystoles (abnormal heart body weight on the table, then set the rate) infusion rate based on the desired dose in ■ Deep vein thrombosis (pain in the legs ng/kg/min. due to a blood clot in the blood vessels of the legs) Body Dose [ng/kg/min] ■ Haemorrhagic diarrhoea (diarrhoea with weight 0.5 1.0 1.5 2.0 blood in stools) [kg] ■ Rectal haemorrhage Infusion rate [ml/h] ■ Dyspepsia (heartburn or stomach pain) 40 6.0 12 18.0 24 ■ Rectal tenesmus (pain due to constipation) ■ Constipation 50 7.5 15 22.5 30 ■ Dysphagia (difficulty swallowing) ■ Dry mouth 60 9.0 18 27.0 36 ■ Dyspepsia (sense of taste disorder) 70 10.5 21 31.5 42 ■ Liver disorder (hepatic impairment) ■ Jaundice (yellowing of the skin and white 80 12.0 24 36.0 48 of the eye and/or itching due to hepatic 90 13.5 27 40.5 54 disorder) ■ Pruritus (itching) 100 15.0 30 45.0 60 ■ Tetany (prolonged painful muscle spasm), 110 16.5 33 49.5 66 muscle spasms ■ Hypertonia (increased muscle tension) ■ Infusion rates (ml/hour) for different doses Kidney pain using a syringe driver ■ Vesical tenesmus (failed urinary urgency) ■ Abnormal urine A syringe driver with a 50 ml injection syringe ■ Dysuria (painful urination or difficulty (e.g. Perfusor®) may also be used to infuse urinating) Iloprost 100 micrograms/ml. Rare (may affect up to 1 in 10,000 people) In case of an Iloprost 100 micrograms/ml ■ Cough concentration of 2 micrograms/ml, the ■ Proctitis (rectal irritation) required infusion rate must be determined according to the below described scheme, to Iloprost may cause chest pain or discomfort reach a dose within the range of 0.5 to 2.0 due to angina pectoris, especially in patients ng/kg/min. with coronary artery disease. The following table can be used to calculate The risk of bleeding is increased in patients the infusion rate corresponding to the when inhibitors of platelet aggregation, individual weight of the patient and the dose heparin or anticoagulants of the coumarin- to be infused. Match the patient’s actual type are given concomitantly. body weight on the table, then set the infusion rate based on the desired dose in Reporting of side effects ng/kg/min. If you get any side effects, talk to your doctor or pharmacist. This includes any possible Body Dose [ng/kg/min] side effects not listed in this leaflet. You can weight 0.5 1.0 1.5 2.0 also report side effects directly via Yellow [kg] Card Scheme Website: www.mhra.gov.uk/ Infusion rate [ml/h] yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. 40 0.60 1.2 1.80 2.4 By reporting side effects you can help provide 50 0.75 1.5 2.25 3.0 more information on the safety of this medicine. 60 0.90 1.8 2.70 3.6 5. How to store Iloprost 100 70 1.05 2.1 3.15 4.2 micrograms/ml 80 1.20 2.4 3.60 4.8 Keep this medicine out of the sight and 90 1.35 2.7 4.05 5.4 reach of children. 100 1.50 3.0 4.50 6.0 This medicinal product does not require any 110 1.65 3.3 4.95 6.6 special storage conditions. After opening and dilution: Chemical and Due to possible interactions, no other physical in-use stability has been medicinal product should be added to the demonstrated for 24 hours at 25°C. From a ready-to-use solution for infusion. microbiological point of view, the product should be used immediately. If not used In order to ensure sterility, the ready-to-use immediately, in-use storage times and solution for infusion should be prepared conditions prior to use are the responsibility every day. of the user and would normally not be longer Instructions for handling: than 24 hours at 2-8°C, unless the dilution has taken place in controlled and validated The ampoule contents and diluent must be aseptic conditions. thoroughly mixed. Do not use this medicine after the expiry Dilution of Iloprost 100 micrograms/ml with date which is stated on the carton and an infusion pump. ampoule label. The expiry date refers to the The contents of 1 ml Iloprost 100 micrograms/ last day of that month. ml (i.e. 100 micrograms) is diluted with 500 Do not dispose of medicines via wastewater ml sterile physiological sodium chloride or household waste. Ask your pharmacist solution or a 5% glucose solution. how to dispose of medicines you no longer The contents of 0.5 ml Iloprost 100 use. These measures will help to protect micrograms/ml (i.e. 50 micrograms) is diluted the environment. with 250 ml sterile physiological sodium chloride solution or a 5% glucose solution, 6. Contents of the pack and respectively. other information Dilution of Iloprost 100 micrograms/ml with What Iloprost 100 micrograms/ml contains: an infusion syringe pump. ■ The active substance is iloprost The contents of 1 ml Iloprost 100 micrograms/ 1 ml of Iloprost 100 micrograms/ml ml (i.e. 100 micrograms) must be diluted with contains 100 micrograms of iloprost 50 ml sterile physiological sodium chloride (equivalent to 134 micrograms iloprost solution or 5% glucose solution. trometamol). The contents of 0.5 ml Iloprost 100 ■ The other ingredients are: trometamol, micrograms/ml (i.e. 50 micrograms) must be ethanol 96% (v/v), sodium chloride, diluted with 25 ml sterile physiological hydrochloric acid for pH adjustment and sodium chloride solution or 5% glucose water for injection. solution, respectively.