Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What PHELINUN is and what it is used for</li><li>What you need to know before you are given PHELINUN</li><li>How to use PHELINUN</li><li>Possible side effects</li><li>How to store PHELINUN</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>PHELINUN contains the active substance called melphalan which belongs to a group of medicines called cytotoxics (also called chemotherapy) and it works by reducing the number of certain cells.</p><p>PHELINUN can be used, alone or in combination with other medicines or with total body irradiation for the treatment of:<br/>different types of bone marrow cancer: multiple myeloma, acute lymphoblastic leukaemia (also called acute lymphocytic leukaemia ALL) and acute myeloid leukaemia (AML)<br/>malignant lymphoma (Hodgkin lymphoma and non-Hodgkin lymphoma) - cancer that affects some types of white blood cells called lymphocytes (cells that fight against infections) neuroblastoma, a type of cancer that grows from abnormal nerve cells in the body<br/>advanced cancer of the ovaries advanced breast cancer</p><p>PHELINUN is also used, in combination with other cytotoxic medicines, as a preparation medicine before blood stem cell transplantation to treat cancer of the blood in adults and cancer and non- cancerous disorders of the blood in the paediatric population.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>If you have any doubts, do not hesitate to ask your doctor for advice.</p><p>You must not be given PHELINUN</p><ul><li>if you are allergic to melphalan or any of the other ingredients of this medicine (listed in section</li></ul><ol start="6" type="1"><li></li></ol><ul><li>if you are pregnant (only with respect to the treatment prior to blood stem cell transplantation) or breast-feeding.</li></ul><p>Warnings and precautions</p><p>If you are going to be treated with melphalan careful monitoring of the blood will be performed as this medicine is a potent cytotoxic that results in profound decrease of blood cells.</p><p>Before treatment with melphalan, tell your doctor if any of the following apply to you:</p><ul><li><p>if you have had recent radiotherapy or cancer medicines because they frequently decrease the number of blood cell levels;</p></li><li><p>if you have signs of an infection (fever, chills, etc.). In case of treatment with melphalan, your doctor may prescribe medicines such as antibiotics, antifungals or antivirals to prevent infections. Your doctor may also consider giving you blood products (for example, red blood cells and platelets);</p></li><li><p>if you are going to have a vaccination or were recently vaccinated. This is because some live attenuated vaccines (like polio, measles, mumps and rubella) may give you an infection while you are being treated with melphalan;</p></li><li><p>if you have kidney problems or kidney failure (your kidneys don t work well enough). In this case the dose of PHELINUN must be reduced;</p></li><li><p>if you ever had a blood clot in your vein (thrombosis). The use of melphalan in combination with lenalidomide and prednisone or thalidomide or dexamethasone may increase the risk of development of blood clots. Your doctor can decide to give you medication to prevent the latter from happening.</p></li></ul><p>Adequate hydration and forced diuresis (large volume of fluids given in the vein by a drip) is recommeded when you are given melphalan.</p><p>Children and adolescents<br/>Children and adolescents may be more likely to develop serious breathing and gastrointestinal complications. Tell your doctor or nurse at once if any breathing or gastrointestinal disturbances occur.</p><p>Melphalan should not be used as a preparation medicine before blood stem cell transplantation, in adolescents over the age of 12 years with acute myeloid leukaemia. Safety and efficacy of the use of melphalan as a preparation medicine before blood stem cell transplantation in children less than 2 years for the treatment of acute myeloid leukaemia and acute lymphoblastic leukemia has not been established.</p><p>Other medicines and PHELINUN Tell your doctor or nurse if you are taking or have recently taken any other medicines including medicines obtained without a prescription.</p><p>In particular, tell your doctor or nurse if you are taking any of the following:</p><ul><li>other cytotoxic medicines (chemotherapy)</li><li>vaccination or you have been recently vaccinated (see warnings and precautions) because of possible general illness which may lead to a fatal outcome</li><li>nalidixic acid (an antibiotic used to treat urinary tract infections). It can cause haemorrhagic enterocolitis with fatal outcome in children when given in combination with melphalan</li><li>busulfan (used to treat a certain type of cancer). In children, it has been reported that the administration of melphalan less than 24 hours after the last oral busulfan administration may influence the development of toxicities.</li></ul><p>Cases of impaired renal function have been reported when cyclosporin is used to prevent graft-versus- host disease after blood stem cell transplantion.</p><p>Pregnancy, breast-feeding and fertility<br/>If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine. Pregnancy Blood stem cell transplantation is contraindicated in pregnant woman. For the other indications, treatment with melphalan is not recommended during pregnancy because it may cause permanent damage to the foetus.</p><p>If you are already pregnant, it is important to talk to your doctor before being given melphalan.<br/>You and your doctor will need to consider the risks and benefits of treatment with melphalan to you and your baby.</p><p>You must take adequate contraceptive precautions to avoid pregnancy while you or your partner are having melphalan and during 6 months thereafter.</p><p>Breast-feeding It is not known if melphalan passes into breast milk. Do not breast-feed during the treatment with PHELINUN.</p><p>Fertility Melphalan can affect ovaries or sperm, which may cause infertility (inability to have a baby).<br/>In women, the ovulation, and as a consequence the menstruation, can stop (amenorrhoea). In men, based on findings in animal studies, there may be an absence or low amount of viable sperm cells. Therefore, men are advised to have a consultation on sperm preservation before treatment.</p><p>Male and female contraception<br/>It is recommended that men and female who are receiving melphalan must use effective contraceptive precautions during treatment and up to 6 months afterwards.</p><p>Driving and using machines This medicine can cause nausea and vomiting, which may reduce your ability to drive or use machines. This medicine also contains alcohol, which is likely to affect children and adolescents (see below for further information).</p><p>PHELINUN contains ethanol (alcohol)<br/>This medicine contains 0.4 g of alcohol (ethanol) in each solvent vial, which is equivalent to 42 mg/ml (0.42% w/v). The amount in solvent vial of this medicine is equivalent to 10 ml beer or 4 ml wine.</p><p>Adults The amount of alcohol in this medicine is not likely to have an effect in adults.</p><p>The amount of alcohol in this medicine may alter the effects of other medicines.<br/>Talk to your doctor or pharmacist if you are using other medicines. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before using this medicine. See also the information under pregnancy above. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.</p><p>Children and adolescents The alcohol in this preparation is likely to affect children and adolescents. These effects may include feeling sleepy and changes in behaviour. It may also affect their ability to concentrate and take part in physical activities. If you have epilepsy or liver problems, talk to your doctor or pharmacist before using this medicine.</p><p>The amount of alcohol in this medicine may alter the effects of other medicines.<br/>Talk to your doctor or pharmacist if you are using other medicines. If you are pregnant or breast-feeding, talk to your doctor or pharmacist before using this medicine. See also the information under pregnancy above. If you are addicted to alcohol, talk to your doctor or pharmacist before taking this medicine.</p><p>PHELINUN contains propylene glycol<br/>This medicine contains 6.2 g propylene glycol in each 10 ml of solvent which is equivalent to 0.62 g/ml. If your child is less than 5 years old, talk to your doctor or pharmacist before giving them this medicine, in particular if they use other medicines that contain propylene glycol or alcohol.</p><p>If you are pregnant or breast feeding, do not take this medicine unless recommended by your doctor.<br/>See also the information under pregnancy above.</p><p>If you suffer from a liver or kidney disease, do not take this medicine unless recommended by your doctor. Your doctor may carry out extra checks while you are using this medicine.</p><p>Propylene glycol in this medicine can have the same effects as drinking alcohol and increase the likelihood of side effects.</p><p>Use this medicine only if recommended by a doctor. Your doctor may carry out extra checks while you are using this medicine.</p><p>PHELINUN contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium- free .</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>PHELINUN will always be given to you by a healthcare professional with experience in the use of cancer medicines or stem cell transplantation.</p><p>Your doctor will calculate the dose of PHELINUN according to your body surface or weight and your disease and how well your kidneys are working.</p><p>When PHELINUN is used as a treatment before blood stem cell transplantation, it is always given in combination with other medicines.</p><p>Use in adults The recommended dose range is between 100 and 200 mg/m2 body surface area. The dose can be divided equally over 2 or 3 consecutive days.</p><p>Use in paediatric population The dose regimen is as follows: one dose between 100 and 240 mg/m2 body surface area. The dose can be divided equally over 2 or 3 consecutive days.</p><p>Use in patients with decreased kidney functioning<br/>The dose is usually lower depending on the severity of the kidney problem.</p><p>Administration<br/>PHELINUN will be given by infusion (drip) into your vein.</p><p>If PHELINUN is accidentally infused outside the vein and into the surrounding tissue or leaks from the vein into the surrounding tissue, the administration of PHELINUN should be interrupted immediately because it can cause severe tissue damage. This usually results in pain such as stinging and burning. If the patients cannot express that they experience pain, it should be observed if other signs such as redness and swelling of the injection site occur.</p><p>If you are given more PHELINUN than you should If you think you have been given too much or have missed a dose, tell your doctor or nurse.</p><p>If you have any further questions on the use of this medicine, ask your doctor or pharmacist or nurse.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them. You should contact your doctor, pharmacist or nurse immediately if you experience any of the following side effects.</p><p>Very common side effects (may affect more than 1 in 10 people)</p><ul><li>Graft versus host disease after blood stemcell transplantation (where transplantated cells attack your body, which is potentially life-threatening)</li><li>Decrease in blood circulating cells and platelets, which can lead to anaemia (decreased number of red blood cells), abnormal bleeding, haematoma</li><li>Alopecia (hair loss) - for high doses</li></ul><p>Common side effects (may affect up to 1 in 10 people): Infection sometimes severe and life-threatening Gastrointestinal bleeding<br/>Nausea Vomiting Diarrhoea Inflamation in and around the mouth (stomatitis) Dysfunction of two or more organ systems which may cause discomfort and can be life-threatening Fever, chills Absence of menstrual periods (amenorrhea) Female reproductive function disorders which may cause ovarian dysfunction and premature menopause For men: the absence of sperm in the semen (azoospermia) Alopecia (hair loss) - for normal doses</p><p>Uncommon side effects (may affect up to 1 in 100 people):</p><ul><li>Septic shock</li><li>Progression, relapse or recurrence of cancer, appearance of a new cancer</li><li>Leukaemia, myelodysplastic syndrome (certain type of blood cancer)</li><li>Respiratory disorders: respiratory failure, shortness of breath (acute respiratory distress syndrome), inflammation of the lungs (pneumonitis, idiopathic pneumonia syndrome), thickening of tissues in the lungs (interstitial lung disease, pulmonary fibrosis), bleeding in the lungs</li><li>Blood clot formation in small blood vessels throughout the body damaging brain, kidneys and heart</li><li>Bleeding in the brain</li><li>Liver disorders: toxic injury to the liver, blocking of a liver vein</li><li>Skin disorder: reddening of the skin with small confluent bumps (maculo-papular rash)</li><li>Kidney damage (acute kidney injury, nephrotic sindrome), reduced kidney function</li></ul><p>Rare side effects (may affect up to 1 in 1,000 people):</p><ul><li>Severe and sometimes fatal allergic reaction; the signs may include urticaria, oedema, cutaneous eruptions, loss of consciousness, labored breathing, low blood pressure, heart failure and death</li><li>Collapse (due to cardiac arrest)</li><li>Pruritus</li><li>Liver problems which may show up in your blood tests or cause jaundice (yellowing of the whites of eyes and skin)</li><li>An illness where the red blood cells are being broken down prematurely - this can make you feel very tired, breathless and dizzy and can give you headaches or make your skin or eyes yellow</li></ul><p>Not known (frequency cannot be estimated from the available data):</p><ul><li>Cardiovascular disorders: changes and abnormalities in the heart s ability to pump causing fluid retention, shortness of breath, feeling tired (cardiac failure cardiomyopathy), and inflammation around the heart (pericardial effusion)</li><li>Increased blood pressure within the arteries of the lungs</li><li>Inflammation of the bladder with blood in urine</li><li>Severe inflammatory and immunologic complications (haemophagocytic lymphohistiocytois)</li><li>Severe skin damage (e.g. lesions, bullae, flaking in severe cases peeling) potentially involving the full body surface and which can be life-threatening (Steven-Johnson Syndrome, toxic epidermal necrolysis)</li><li>Blood creatinine elevated</li><li>Bleeding</li><li>Blood clots forming in a deep vein, in particular in the legs (deep venous thrombosis) and a closing of the lung artery (lung embolism)</li></ul><p>Patients with serious blood disease may feel hot or get a tingling sensation.</p><p>Children and adolescents may be more likely to develop serious breathing and gastrointestinal complications.</p><p>If you notice any side effects not listed in this leaflet or if any of the side effects become serious, please tell your doctor or pharmacist.</p><p>Reporting of side effects If you get any side effects, talk to your doctor, nurse 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.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>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 vials label and carton after EXP . The expiry date refers to the last day of that month.</p><p>Do not refrigerate. Keep the vials in the outer carton in order to protect from light.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What PHELINUN contains</p><ul><li><p>The active substance is melphalan. One vial of powder contains 50 mg melphalan (as melphalan hydrochloride). After reconstitution with 10 ml of solvent, the final concentration of the solution is 5 mg/ml melphalan.</p></li><li><p>The other ingredients are:<br/>Powder: hydrochloride acid and povidone Solvent: water for injections, propylene glycole, ethanol and sodium citrate (see section 2).</p></li></ul><p>What PHELINUN looks like and contents of the pack PHELINUN is a powder and solvent for concentrate for solution for infusion. The powder is provided in a clear glass vial with white to pale yellow powder or cake. The solvent is a colourless clear solution provided in a clear glass vial.</p><p>Each pack of PHELINUN contains: one vial with 50 mg of powder (melphalan) and one vial with 10 ml of solvent.</p><p>Marketing Authorisation Holder<br/>ADIENNE S.r.l. S.U. Via Galileo Galilei, 20867 Caponago (MB)<br/>Italy tel: +39 0240700e-mail: <a href="mailto:adienne@adienne.com">adienne@adienne.com</a></p><p>Manufacturer NERPHARMA S.R.L.<br/>Viale Pasteur, 20014 Nerviano (MI) Italy tel: +39.0331.581Marketing Authorisation Holder and Manufacturer<br/>ADIENNE S.r.l. S.U.<br/>Via Galileo Galilei, 20867 Caponago (MB) Italy<br/>Tel: +39 02 <a href="mailto:40700adienne@adienne.com">40700adienne@adienne.com</a></p><p>This leaflet was last revised in month YYYY.</p><p>Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
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<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="PHELINUN 50 mg powder and solvent for concentrate for solution for infusion"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
Links: Table of Contents |
QA Report
The Gravitate Health project has received funding from the IMI 2 Joint Undertaking under grant agreement No 945334.
This joint undertaking receives support from the EU H2020 research and innovation programme and EFPIA.
