1 mg\/ml, 2.5 mg\/ml, 5 mg\/ml, 10 mg\/ml solution for <\/p>\n\n\n\n
infusion What Treprostinil Tillomed is<\/p>\n\n\n\n The active substance in Treprostinil Tillomed is treprostinil.<\/p>\n\n\n\n Treprostinil belongs to a group of drugs that work in a similar way to naturally occurring\u00a0prostacyclins.\u00a0Prostacyclins\u00a0are hormone-like substances that lower\u00a0blood pressure\u00a0by causing the blood vessels to relax so that they widen, which makes blood flow easier.\u00a0Prostacyclin\u00a0er may also have an effect by preventing the blood from clotting.<\/p>\n\n\n\n What Treprostinil Tillomed is used to treat<\/p>\n\n\n\n Treprostinil Tillomed is used to treat\u00a0idiopathic\u00a0or hereditary\u00a0pulmonary\u00a0arterial\u00a0hypertension<\/a>\u00a0(PAH) in patients with moderately severe symptoms.\u00a0Pulmonary\u00a0arterial\u00a0hypertension\u00a0is a condition where the\u00a0blood pressure\u00a0is too high in the blood vessels between the heart and the lungs, causing shortness of breath, dizziness, fatigue, fainting, palpitations or abnormal heartbeats, dry cough<\/a>, chest pain, and swollen ankles or legs.<\/p>\n\n\n\n Treprostinil Tillomed is initially given as a\u00a0continuous\u00a0subcutaneous\u00a0infusion\u00a0(\u00a0infusion\u00a0under the skin).\u00a0Some patients may not tolerate this due to pain and swelling at the administration site.\u00a0Your doctor will decide whether Treprostinil Tillomed can instead be given as a\u00a0continuous\u00a0intravenous\u00a0infusion\u00a0(\u00a0infusion\u00a0into a vein).\u00a0This requires a central\u00a0venous catheter\u00a0(CVK) to be inserted, which is usually done in the neck, chest, or groin area.<\/p>\n\n\n\n How Treprostinil Tillomed works<\/p>\n\n\n\n Treprostinil Tillomed lowers blood pressure et in the pulmonary artery by improving blood flow and reducing the work of the heart. Improved blood flow leads to improved oxygen supply to the body and reduced strain on the heart, making it work more efficiently. Treprostinil Tillomed improves the symptoms associated with PAH and the ability to exercise in patients who are limited in terms of activity.<\/p>\n\n\n\n Treprostinil may also be approved to treat other conditions not mentioned in this product information.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions. Talk to your doctor or pharmacist before using Treprostinil Tillomed:<\/p>\n\n\n\n During treatment with Treprostinil Tillomed, you must tell your doctor:<\/p>\n\n\n\n Tell your doctor if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Tell your doctor if you use:<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n Treprostinil is not recommended if you are pregnant, planning to become pregnant, or think you may be pregnant unless your doctor considers it necessary.\u00a0The safety of this medicine, when used during pregnancy, has not been established.<\/p>\n\n\n\n The use of treprostinil is not recommended during breastfeeding unless considered necessary by your doctor.\u00a0You should stop breastfeeding if you have been prescribed treprostinil, as it is not known whether this medicine is excreted in breast milk.<\/p>\n\n\n\n The effect of treprostinil on human fertility is currently unknown. Therefore, contraception is strongly recommended during treatment with treprostinil.<\/a><\/p>\n\n\n\n Treprostinil may cause low blood pressure with dizziness or fainting. If you experience this, you should not drive or use machines and you should ask your doctor for advice.<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.<\/p>\n\n\n\n A description of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0Discuss with your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n Tell your doctor if you are on a low-salt diet.\u00a0He will take into account that a\u00a0vial\u00a0of Treprostinil Tillomed contains the following amounts of\u00a0sodium.<\/p>\n\n\n\n Treprostinil Tillomed 1 mg\/ml, solution for infusion<\/strong><\/p>\n\n\n\n This medicine contains 74.16 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.71% of the recommended maximum intake of sodium per day for an adult.<\/p>\n\n\n\n Treprostinil Tillomed 2.5 mg\/ml solution for infusion<\/strong><\/p>\n\n\n\n This medicine contains 75.08 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.75% of the recommended maximum intake of sodium per day for an adult.<\/p>\n\n\n\n Treprostinil Tillomed 5 mg\/ml solution for infusion<\/strong><\/p>\n\n\n\n This medicine contains 78.16 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.91% of the recommended maximum intake of sodium per day for an adult.<\/p>\n\n\n\n Treprostinil Tillomed 10 mg\/ml solution for infusion<\/strong><\/p>\n\n\n\n This medicine contains 75 mg of sodium (the main component of common table salt) per bottle. This corresponds to 3.75% of the recommended maximum intake of sodium per day for an adult.<\/a><\/p>\n\n\n\n Always use this medicine as directed by your doctor or pharmacist. Consult a doctor if you are unsure.<\/p>\n\n\n\n Treprostinil Tillomed is given as a\u00a0continuous\u00a0infusion, either:<\/p>\n\n\n\n In both cases, treprostinil is pushed through the tube using a portable pump.<\/p>\n\n\n\n Before you leave the hospital or clinic, the doctor will tell you how to prepare treprostinil and at what rate the pump should give you treprostinil. You also get information on how to use the pump correctly and what to do if it stops working. You also get information about who to contact in an emergency.<\/p>\n\n\n\n Flushing the infusion line while it is connected can cause an accidental overdose.<\/p>\n\n\n\n Treprostinil is diluted only when given intravenously:<\/p>\n\n\n\n For\u00a0intravenous\u00a0infusion only:<\/strong>\u00a0If treprostinil is given as a\u00a0continuous\u00a0intravenous\u00a0infusion, dilute the treprostinil solution only with sterile water for injections or with 9 mg\/ml (0.9%) sodium chloride solution for injections (provided by your doctor).<\/p>\n\n\n\n Adult patients<\/p>\n\n\n\n Treprostinil Tillomed is available as 1 mg\/ml, 2.5 mg\/ml, 5 mg\/ml or 10 mg\/ml infusion solution , solution. Your doctor will determine the infusion rate and infusion dose that is appropriate for your condition.<\/p>\n\n\n\n Obese patients<\/p>\n\n\n\n If you are overweight (weighing 30% or more than your ideal body weight), your doctor will decide on the first\u00a0dose\u00a0and subsequent\u00a0doses\u00a0e based on your ideal body weight.\u00a0See also section 2, \u201cWarnings and precautions\u201d.<\/p>\n\n\n\n Elderly<\/p>\n\n\n\n Your doctor will determine the infusion rate and infusion dose that is appropriate for your condition.<\/p>\n\n\n\n Children and young people<\/p>\n\n\n\n There are limited data for children and adolescents.<\/p>\n\n\n\n Dose adjustment<\/p>\n\n\n\n The infusion rate can be lowered or increased individually\u00a0only under medical supervision<\/strong>.<\/p>\n\n\n\n The goal of adjusting the infusion rate is to establish an effective maintenance rate that improves the symptoms of\u00a0pulmonary\u00a0arterial\u00a0hypertension\u00a0while minimizing\u00a0potential\u00a0side effects.<\/p>\n\n\n\n If your symptoms increase you need complete rest or are bed or chair-bound, or if all physical activity causes discomfort and your symptoms occur at rest, do not increase the\u00a0dose\u00a0without a doctor’s prescription.\u00a0Treprostinil may no longer be enough to treat your disease and other treatment may be needed.<\/p>\n\n\n\n The maximum dose that can be given depends on the patient’s condition and any other concomitant diseases.<\/p>\n\n\n\n How can\u00a0infection\u00a0in the bloodstream be prevented during treatment with treprostinil given\u00a0intravenously?<\/strong><\/p>\n\n\n\n As with any long-term intravenous treatment, there is a risk of infection in the bloodstream. Your doctor will instruct you on how to avoid this.<\/p>\n\n\n\n If you accidentally overdose on treprostinil, you may experience nausea, vomiting, diarrhea, low\u00a0blood pressure\u00a0(dizziness, intoxication, or fainting), flushing, and\/or headache.<\/p>\n\n\n\n If any of these effects become severe, contact a doctor or hospital immediately. Your doctor may reduce the dose or stop the infusion until the symptoms have disappeared. Treatment with Treprostinil Tillomed solution for infusion is then restarted with a dose determined by your doctor.<\/p>\n\n\n\n If you have ingested too much medicine or if, for example,\u00a0a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.<\/p>\n\n\n\n Always use Treprostinil Tillomed as directed by your doctor or hospital specialist. Do not stop using treprostinil unless your doctor tells you to.<\/p>\n\n\n\n On the contrary, discontinuation of treatment or sudden dose reductions of treprostinil may cause pulmonary\u00a0arterial\u00a0hypertension\u00a0to return, with the risk of rapid and serious deterioration of your condition.<\/p>\n\n\n\n If you have any further questions about this medicine, ask your doctor.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Very common side effects (may affect more than 1 in 10 patients)<\/p>\n\n\n\n Common side effects (may affect up to 1 in 10 patients)<\/p>\n\n\n\n
treprostinil<\/a><\/p>\n\n\n\nWhat Treprostinil Tillomed is and what it is used for<\/h2>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before using Treprostinil Tillomed<\/h2>\n\n\n\n
Do not use Treprostinil Tillomed<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Other medicines and Treprostinil Tillomed<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Treprostinil Tillomed contains sodium<\/h2>\n\n\n\n
How to use Treprostinil Tillomed<\/h2>\n\n\n\n
If you have used too much Treprostinil Tillomed <\/h2>\n\n\n\n
If you stop using Treprostinil Tillomed<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n