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 IMJUDO is and what it is used for</li><li>What you need to know before you are given IMJUDO</li><li>How you are given IMJUDO</li><li>Possible side effects</li><li>How to store IMJUDO</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>IMJUDO is an anti-cancer medicine. It contains the active substance tremelimumab, which is a type of medicine called a monoclonal antibody. This medicine is designed to recognise a specific target substance in the body. IMJUDO works by helping your immune system fight your cancer. IMJUDO in combination with durvalumab is used to treat a type of liver cancer, called advanced or unresectable hepatocellular carcinoma (HCC). It is used when your HCC:</p><p>cannot be removed by surgery (unresectable), and</p><p>may have spread within your liver or to other parts of the body. IMJUDO is used to treat a type of lung cancer called advanced non-small cell lung cancer in adults. It will be used in combination with other anti-cancer medicines (durvalumab and chemotherapy). As IMJUDO will be given in combination with other anti-cancer medicines, it is important that you also read the package leaflet for these other medicines. If you have any questions about these medicines, ask your doctor.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>You should not be given IMJUDO if you are allergic to tremelimumab or any of the other ingredients of this medicine (listed in section 6). Talk to your doctor if you are not sure. Warnings and precautions Talk to your doctor before you are given IMJUDO if:</p><p>you have an autoimmune disease (an illness where the body s immune system attacks its own cells)</p><p>you have had an organ transplant</p><p>you have lung or breathing problems</p><p>you have liver problems. Talk to your doctor before you are given IMJUDO if any of these could apply to you. When you are given IMJUDO, you can have some serious side effects. Your doctor may give you other medicines that prevent more severe complications and to help reduce your symptoms. Your doctor may delay the next dose of IMJUDO or stop your treatment with IMJUDO. Talk to your doctor straight away if you get any of the following side effects:</p><p>new or worsening cough; shortness of breath; chest pain (may be signs of lung inflammation)</p><p>feeling sick (nausea) or vomiting; feeling less hungry; pain on the right side of your stomach; yellowing of skin or whites of eyes; drowsiness; dark urine or bleeding or bruising more easily than normal may be signs of liver inflammation)</p><p>diarrhoea or more bowel movements than usual; stools that are black, tarry or sticky with blood or mucus; severe stomach pain or tenderness (may be signs of bowel inflammation, or a hole in the bowel)</p><p>fast heart rate; extreme tiredness; weight gain or weight loss; dizziness or fainting; hair loss; feeling cold; constipation; headaches that will not go away or unusual headaches (may be signs of glands being inflamed, especially the thyroid, adrenal, pituitary or pancreas)</p><p>feeling more hungry or thirsty than usual; passing urine more often than usual; high blood sugar; fast and deep breathing; confusion; a sweet smell to your breath; a sweet or metallic taste in your mouth or a different odour to your urine or sweat (may be signs of diabetes)</p><p>decrease in the amount of urine you pass (may be sign of kidney inflammation)</p><p>rash; itching; skin blistering or ulcers in the mouth or on other moist surfaces (may be signs of skin inflammation)</p><p>chest pain; shortness of breath; irregular heartbeat (may be signs of heart muscle inflammation)</p><p>muscle pain or weakness or rapid tiring of the muscles (may be signs of inflammation or other problems of the muscles)</p><p>chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness or fever (may be signs of infusion-related reactions)</p><p>seizures; neck stiffness; headache; fever, chills; vomiting; eye sensitivity to light; confusion and sleepiness (may be signs of inflammation of the brain or the membrane around the brain and spinal cord)</p><p>pain; weakness and paralysis in the hands, feet or arms (may be signs of inflammation of the nerves, Guillain-Barr syndrome)</p><p>bleeding (from the nose or gums) and/or bruising (may be signs of low blood platelets). Talk to your doctor straight away if you have any of the symptoms listed above. Children and adolescents IMJUDO should not be given to children and adolescents below 18 years of age as it has not been studied in these patients. Other medicines and IMJUDO Tell your doctor if you are taking, have recently taken or might take any other medicines. This includes herbal medicines and medicines obtained without a prescription. Pregnancy and fertility This medicine is not recommended during pregnancy. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby. If you are a woman who could become pregnant, you must use effective contraception while you are being treated with IMJUDO and for at least 3 months after your last dose. Breast-feeding Tell your doctor if you are breast-feeding. It is not known if IMJUDO passes into human breast milk. You may be advised to not breast-feed during treatment and for at least 3 months after your last dose. Driving and using machines IMJUDO is not likely to affect your driving or use of machines. However, if you have side effects that affect your ability to concentrate and react, be careful when driving or operating machines. IMJUDO has a low sodium content IMJUDO contains less than 1 mmol sodium (23 mg) in each dose, that is to say essentially sodium- free.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>IMJUDO will be given to you in a hospital or clinic under the supervision of an experienced doctor. Your doctor will give you IMJUDO as a drip into your vein (infusion) lasting about an hour. It is given in combination with durvalumab for liver cancer. The recommended dose</p><p>If you weigh 40 kg or more, the dose is 300 mg as a one-time single dose.</p><p>If you weigh less than 40 kg, the dose will be 4 mg per kg of your body weight. When IMJUDO is given in combination with durvalumab for your liver cancer, you will be given IMJUDO first, then durvalumab. It is given in combination with durvalumab and chemotherapy for lung cancer. The recommended dose:</p><p>If you weigh 34 kg or more the dose is 75 mg every 3 weeks.</p><p>If you weigh less than 34 kg, the dose will be 1 mg per kg of your body weight every 3 weeks. You will usually have a total of 5 doses of IMJUDO. The first 4 doses are given in week 1, 4, 7 and 10. The fifth dose is usually then given 6 weeks later, in week 16. Your doctor will decide exactly how many treatments you need. When IMJUDO is given in combination with durvalumab and chemotherapy, you will be given IMJUDO first then durvalumab and then chemotherapy. If you miss an appointment It is very important that you do not miss a dose of this medicine. If you miss an appointment, call your doctor straight away to reschedule your appointment. If you have any further questions about your treatment, ask your doctor.</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. When you get IMJUDO, you can have some serious side effects. See section 2 for a detailed list of these. Talk to your doctor straight away if you get any of the following side effects that have been reported in a clinical study with patients receiving IMJUDO in combination with durvalumab. The following side effects have been reported in clinical trials in patients taking IMJUDO in combination with durvalumab: Very common (may affect more than 1 in 10 people) underactive thyroid gland that can cause tiredness or weight gain cough diarrhoea stomach pain abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) skin rash itchiness fever swelling of legs (oedema peripheral) Common (may affect up to 1 in 10 people) infections of the upper respiratory tract lung infection (pneumonia) flu-like illness tooth and mouth soft tissue infections overactive thyroid gland that can cause fast heart rate or weight loss inflammation of the thyroid gland (thyroiditis) decreased secretion of hormones produced by the adrenal glands that can cause tiredness inflammation of the lungs (pneumonitis) abnormal pancreas function tests inflammation of the gut or intestine (colitis) inflammation of the pancreas (pancreatitis) inflammation of the liver (hepatitis) inflammation of the skin night sweats muscle pain (myalgia) abnormal kidney function test (blood creatinine increased) painful urination (dysuria) reaction to the infusion of the medicine that can cause fever or flushing Uncommon (may affect up to 1 in 100 people) fungal infection in the mouth underactive pituitary gland; inflammation of pituitary gland a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis) inflammation of the membrane around the spinal cord and brain (meningitis) inflammation of the heart (myocarditis) hoarse voice (dysphonia) scarring of lung tissue blistering of the skin inflammation of the muscles (myositis) inflammation of the muscles and vessels inflammation of the kidneys (nephritis) that can decrease the amount of your urine Other side effects that have been reported with frequency not known (cannot be estimated from the available data) low number of platelets with signs of excessive bleeding and bruising (immune thrombocytopenia) diabetes insipidus type 1 diabetes mellitus inflammation of the nerves (Guillain-Barr syndrome) inflammation of the brain (encephalitis) hole in the bowel (intestinal perforation) inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen. The following side effects have been reported in clinical trials in patients taking IMJUDO in combination with durvalumab and platinum-based chemotherapy: Very common (may affect more than 1 in 10 people) infections of the upper respiratory tract lung infection (pneumonia) low number of red blood cells low number of white blood cells low number of platelets underactive thyroid gland that can cause tiredness or weight gain decrease in appetite cough nausea diarrhoea vomiting constipation abnormal liver tests (aspartate aminotransferase increased; alanine aminotransferase increased) hair loss skin rash itchiness joint pain (arthralgia) feeling tired or weak fever Common (may affect up to 1 in 10 people) flu-like illness fungal infection in the mouth low number of white blood cells with signs of fever low number of red blood cells, white blood cells, and platelets (pancytopenia) overactive thyroid gland that can cause fast heart rate or weight loss decreased levels of hormones produced by the adrenal glands that can cause tiredness underactive pituitary gland; inflammation of pituitary gland inflammation of thyroid gland (thyroiditis) inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs (neuropathy peripheral) inflammation of the lungs (pneumonitis) hoarse voice (dysphonia) inflammation of the mouth or lips abnormal pancreas function tests stomach pain inflammation of the gut or intestine (colitis) inflammation of the pancreas (pancreatitis) inflammation of the liver that can cause nausea or feeling less hungry (hepatitis) muscle pain (myalgia) abnormal kidney function tests (blood creatinine increased) painful urination (dysuria) swelling of legs (oedema peripheral) reaction to the infusion of the medicine that can cause fever or flushing Uncommon (may affect up to 1 in 100 people) tooth and mouth soft tissue infections low number of platelets with signs of excessive bleeding and bruising (immune thrombocytopenia) diabetes insipidus type 1 diabetes mellitus inflammation of the brain (encephalitis) inflammation of the heart (myocarditis) scarring of lung tissue blistering of the skin night sweats inflammation of the skin inflammation of the muscle (myositis) inflammation of the muscles and vessels inflammation of the kidneys (nephritis) that can decrease the amount of your urine inflammation of the bladder (cystitis). Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen. Other side effects that have been reported with frequency not known (cannot be estimated from the available data) a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis) inflammation of the nerves (Guillain-Barr syndrome) inflammation of the membrane around the spinal cord and brain (meningitis) hole in the bowel (intestinal perforation) Talk to your doctor straight away if you get any of the side effects listed above. Reporting of side effects If you get any side effects, talk to your doctor. 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>IMJUDO will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage. 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 carton and vial label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C - 8 C). Do not freeze. Store in the original package in order to protect from light. Do not use if this medicine is cloudy, discoloured or contains visible particles. Do not store any unused portion of the infusion solution for re-use. Any unused medicine or waste material should be disposed of in accordance with local requirements.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What IMJUDO contains The active substance is tremelimumab. Each ml of concentrate for solution for infusion contains 20 mg of tremelimumab. One vial contains either 300 mg of tremelimumab in 15 ml of concentrate or 25 mg of tremelimumab in 1.25 ml of concentrate. The other ingredients are: histidine, histidine hydrochloride monohydrate, trehalose dihydrate, disodium edetate dihydrate (see section 2 IMJUDO has a low sodium content ), polysorbate 80 and water for injections. What IMJUDO looks like and contents of the pack IMJUDO concentrate for solution for infusion (sterile concentrate) is a preservative-free, clear to slightly opalescent, colourless to slightly yellow solution, free from visible particles. It is available in packs containing either 1 glass vial of 1.25 ml of concentrate or 1 glass vial of 15 ml of concentrate. Not all pack sizes may be marketed. Marketing Authorisation Holder AstraZeneca AB SE-151 85 S dert lje Sweden Manufacturer AstraZeneca AB G rtunav gen SE-152 57 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660</p><p>.: +359 24455Luxembourg/Luxemburg AstraZeneca S.A./N.V. T l/Tel: +32 2 370 48 esk republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 Magyarorsz g AstraZeneca Kft. Tel.: +36 1 883 6Danmark AstraZeneca A/S Tlf: +45 43 66 64 Malta Associated Drug Co. Ltd Tel: +356 2277 8Deutschland AstraZeneca GmbH Tel: +49 40 809034Nederland AstraZeneca BV Tel: +31 79 363 2Eesti AstraZeneca Tel: +372 6549 Norge AstraZeneca AS Tlf: +47 21 00 64<br/>AstraZeneca A.E. : +30 210 6871 sterreich AstraZeneca sterreich GmbH Tel: +43 1 711 31 0 Espa a AstraZeneca Farmac utica Spain, S.A. Tel: +34 91 301 91 Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 France AstraZeneca T l: +33 1 41 29 40 Portugal AstraZeneca Produtos Farmac uticos, Lda. Tel: +351 21 434 61 Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 Rom nia AstraZeneca Pharma SRL Tel: +40 21 317 60 Ireland AstraZeneca Pharmaceuticals (Ireland) DAC Tel: +353 1609 7Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 sland Vistor hf. S mi: +354 535 7Slovensk republika AstraZeneca AB, o.z. Tel: +421 2 5737 7Italia AstraZeneca S.p.A. Tel: +39 02 00704Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23</p><p>: +357 22490Sverige AstraZeneca AB Tel: +46 8 553 26 Latvija SIA AstraZeneca Latvija Tel: +371 67377United Kingdom (Northern Ireland) AstraZeneca UK Ltd Tel: +44 1582 836 This leaflet was last revised in 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="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="IMJUDO 20 mg/ml 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.
