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 Nyvepria is and what it is used for</li><li>What you need to know before you use Nyvepria</li><li>How to use Nyvepria</li><li>Possible side effects</li><li>How to store Nyvepria</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>Nyvepria contains the active substance pegfilgrastim. It is used in patients treated with cytotoxic chemotherapy (medicines that destroy rapidly growing cells) to reduce the duration of neutropenia (low neutrophil count, a type of white blood cell) and to help prevent febrile neutropenia (low white blood cell count with a fever). Nyvepria is for use in adults aged 18 years and over. White blood cells are important for fighting off infection. If the white blood cell count to fall too low, due to your cytotoxic chemotherapy, your body may not be able to fight off microorganisms and this will increase the chances of an infection. Pegfilgrastim, is very similar to a natural protein in the body called granulocyte colony stimulating factor and it works by encouraging your bone marrow to produce more white blood cells that help your body fight off infections.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Nyvepria</p><p>if you are allergic to pegfilgrastim, filgrastim, or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor, pharmacist or nurse before using Nyvepria:</p><p>If you have recently had a serious lung infection (pneumonia), fluid in the lungs (pulmonary oedema), inflammation of the lungs (interstitial lung disease), or an abnormal chest x-ray (lung infiltration).</p><p>If you are aware of any altered blood cell counts (e.g. increase in white blood cells or anaemia) or decreased blood platelet counts (thrombocytopenia), which reduces the ability of your blood to clot. Your doctor may want to monitor you more closely.</p><p>If you have sickle cell anaemia. Your doctor may monitor your condition more closely. Talk to your doctor, pharmacist or nurse while using Nyvepria:</p><p>If you are a patient with breast cancer or lung cancer, pegfilgrastim in combination with chemotherapy and/or radiation therapy may increase your risk of a precancerous blood condition called myelodysplastic syndrome (MDS) or a blood cancer called acute myeloid leukaemia (AML). Symptoms may include tiredness, fever, and easy bruising or bleeding.</p><p>If you get an allergic reaction including weakness, drop in blood pressure, difficulty breathing, swelling of the face, lips, tongue or other parts of the body (anaphylaxis), redness and flushing, skin rash or hives on the skin and areas of the skin that itch.</p><p>If you get a cough or fever, and have difficulty breathing. This can be a sign of acute respiratory distress syndrome (ARDS).</p><p>If you have any of the following side effects:</p><p>swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) swelling and feeling of fullness, and a general feeling of tiredness. These could be symptoms of condition called capillary leak syndrome which causes blood to leak from the small blood vessels into your body. See section 4.<br/>If you get left upper abdominal pain or pain at the tip of your shoulder. This may be a sign of a problem with your spleen (splenomegaly).</p><p>If you get fever, abdominal pain, malaise, and back pain as these may be symptoms of inflammation of the aorta (the large blood vessel which transports blood from the heart to the body). This disorder can occur rarely in cancer patients and healthy donors. Your doctor will check your blood and urine regularly as Nyvepria can damage your kidneys (glomerulonephritis). Severe skin reactions (Stevens-Johnson syndrome; a skin condition that causes painful blisters and sores of the skin and mucous membranes, especially in the mouth) have been reported with the use of pegfilgrastim. Stop using Nyvepria and get medical attention immediately if you notice any of these symptoms: reddish target like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes possibly with fever and flu-like symptoms beforehand. See section 4. You should talk to your doctor about your risks of developing cancers of the blood. If you have a cancer of the blood or have been told by your doctor that you are at risk of one, you should not use Nyvepria, unless instructed by your doctor. Loss of response to pegfilgrastim If pegfilgrastim treatment does not work or stops working, your doctor will investigate why this has happened including whether you have developed antibodies which neutralise pegfilgrastim s activity. Children and adolescents Nyvepria is not recommended for use in children and adolescents because there is insufficient information on its safety and effectiveness. Other medicines and Nyvepria Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Nyvepria has not been studied in pregnant women. Therefore, your doctor may decide that you should not use this medicine. If you become pregnant during Nyvepria treatment, speak with your doctor. Unless your doctor tells you otherwise, you must stop breast-feeding if you use Nyvepria. Driving and using machines Nyvepria has no or negligible effect on the ability to drive or use machines. Nyvepria contains sorbitol (E420) and sodium This medicine contains 30 mg sorbitol in each pre-filled syringe which is equivalent to 50 mg/mL. The additive effect of concomitantly administered medicines containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account. This medicine contains less than 1 mmol sodium (23 mg) per 6 mg dose, that is to say essentially sodium-free .</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Nyvepria is for use in adults aged 18 years and over. Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is one 6 mg subcutaneous injection (injection under your skin) using a pre-filled syringe and it should be given at least 24 hours after your last dose of chemotherapy at the end of each chemotherapy cycle. Injecting Nyvepria yourself Your doctor may decide that you can inject Nyvepria yourself. Your doctor or nurse will show you how to inject it yourself. Do not try to inject it yourself if you have not been trained. For instructions on how to inject Nyvepria, read the section at the end of this leaflet. Do not shake Nyvepria vigorously as this may affect its activity. If you use more Nyvepria than you should If you use more Nyvepria than you should contact your doctor, pharmacist or nurse for advice. If you forget to inject Nyvepria If you have forgotten a dose of Nyvepria, contact your doctor to discuss when you should inject the next dose. If you have any further questions on the use of this medicine, ask your doctor, 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. Tell your doctor immediately if you have any of the following side effects:</p><p>swelling or puffiness, passing urine less frequently, difficulty breathing, abdominal (belly) swelling and feeling of fullness, and a general feeling of tiredness. These symptoms generally develop quickly. They could be symptoms of an uncommon (may affect up to 1 in 100 people) condition called capillary leak syndrome which causes blood to leak from the small blood vessels into your body and needs urgent treatment. Very common: may affect more than 1 in 10 people</p><p>bone pain. Your doctor will tell you what you can take to ease the bone pain.</p><p>nausea and headaches. Common: may affect up to 1 in 10 people</p><p>pain at the site of injection.</p><p>general aches and pains in the joints and muscles.</p><p>some changes may occur in your blood, but these will be detected by routine blood tests. Your white blood cell count may become high for a short period. Your platelet count may become low which might result in bruising.</p><p>chest pain not related to heart disorders. Uncommon: may affect up to 1 in 100 people</p><p>allergic-type reactions, including redness and flushing, skin rash, and raised areas of the skin that itch.</p><p>serious allergic reactions, including anaphylaxis (weakness, drop in blood pressure, difficulty breathing, swelling of the face).</p><p>increased spleen size (the spleen is an organ located in the belly to the left of the stomach involved in the production and removal of blood cells and forming part of the immune system). Tell your doctor if you have an increase of volume in the upper left side of your abdomen.</p><p>spleen rupture, which can be fatal. It is important that you contact your doctor immediately if you get pain in the upper left side of the abdomen or left shoulder pain since this may relate to a problem with your spleen.</p><p>breathing problems. If you have a cough, fever and difficulty breathing tell your doctor.</p><p>Sweet s syndrome (plum-coloured, raised, painful damage on the limbs and sometimes the face and neck with fever).</p><p>cutaneous vasculitis (inflammation of the blood vessels in the skin).</p><p>damage to your kidneys (called glomerulonephritis).</p><p>redness at the site of injection.</p><p>coughing up blood (haemoptysis).</p><p>blood disorders (myelodysplastic syndrome [MDS] or acute myeloid leukaemia [AML]). Rare: may affect up to 1 in 1000 people</p><p>inflammation of aorta (the large blood vessel which transports blood from the heart to the body). See section 2.<br/>bleeding from the lung (pulmonary haemorrhage).</p><p>Stevens-Johnson syndrome, which can appear as reddish target-like or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes possibly with fever and flu-like symptoms beforehand. Stop using Nyvepria if you develop these symptoms and contact your doctor or get medical attention immediately. See also section 2. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. 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 carton and on the syringe label after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). You may take Nyvepria out of the refrigerator and keep it at room temperature (not above 25 C) for no longer than 15 days. Once a syringe has been removed from the refrigerator and has reached room temperature (not above 25 C) it must either be used within 15 days or disposed of. Do not freeze. Nyvepria may be used if it is accidentally frozen for a single period of less than 24 hours. Keep the container in the outer carton in order to protect from light. Do not use this medicine if you notice it is cloudy or there are particles in it. 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 to protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Nyvepria contains</p><p>The active substance is pegfilgrastim. Each pre-filled syringe contains 6 mg of pegfilgrastim in 0.6 mL of solution.</p><p>The other ingredients are sodium acetate trihydrate, glacial acetic acid, sorbitol (E420), polysorbate 20 and water for injections (see section 2 Nyvepria contains sorbitol (E420) and sodium acetate ). What Nyvepria looks like and contents of the pack Nyvepria is a clear, colourless, free from visible particles, solution for injection in a pre-filled syringe (6 mg/0.6 mL). Each pack contains 1 glass pre-filled syringe with an attached stainless-steel needle, needle cover and an automatic needle guard. Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium Manufacturer Hospira Zagreb d.o.o. Prudni ka cesta 10291 Prigorje Brdove ko Croatia For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder. Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 K PFIZER E A A.E. (CYPRUS BRANCH) T : +357 22 817 esk Republika Pfizer, spol. s r.o. Tel: +420-283-004-Magyarorsz g Pfizer Kft. Tel: +36 1 488 3Danmark Pfizer ApS Tlf: +45 44 20 11 Malta Drugsales Ltd Tel: +356 21 419 070/1/2 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Nederland Pfizer bv Tel: +31 (0)10800 4063 434 01 ,</p><p>Te : +359 2 970 4Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0</p><p>PFIZER E A A.E. .: +30 210 67 85 Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel: +34 91 490 99 Portugal Laborat rios Pfizer, Lda. Tel: +351 21 423 5France Pfizer T l: +33 (0)1 58 07 34 Rom nia Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: +385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti, Ljubljana Tel: +386 (0) 1 52 11 Ireland Pfizer Healthcare Ireland Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616Slovensk Republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: +421 2 3355 5 sland Icepharma hf. Tel: +354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer S.r.l. Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 Latvija Pfizer Luxembourg SARL fili le Latvij Tel. +371 67035United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0)1304 616Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel. +3705 2514This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: <a href="http://www.ema.europa.eu">http://www.ema.europa.eu</a>. Instructions for using Nyvepria: Guide to parts: Before use After use Important Before you use a Nyvepria pre-filled syringe with automatic needle guard, read this important information:</p><p>It is important that you do not give yourself the injection unless you have received training from your doctor or healthcare provider. If you have questions about how to inject, please ask your doctor or healthcare provider for help.</p><p>Make sure the name Nyvepria appears on the carton and pre-filled syringe label.</p><p>Check the carton and pre-filled syringe label to make sure the dose strength is 6 mg (6 mg/0.6 mL).</p><p>Nyvepria is given as an injection into the tissue just under the skin (subcutaneous injection).</p><p>Do not use the pre-filled syringe if the date has passed the last day of the month shown.</p><p>Do not remove the needle cover from the pre-filled syringe until you are ready to inject.</p><p>Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre- filled syringe and call your doctor or healthcare provider.</p><p>Do not activate the pre-filled syringe before injection.</p><p>Do not remove the clear automatic needle guard from the pre-filled syringe.</p><p>Do not remove the peelable label on the pre-filled syringe barrel before injecting the medicine. Call your doctor or healthcare provider if you have any questions. Step 1: Prepare A Remove the pre-filled syringe carton from the refrigerator. Remove the pre-filled syringe inner carton from the outer carton by peeling away the cover and gather the supplies needed for your injection: alcohol wipes, a cotton ball or gauze pad, a plaster and a sharps disposal container (not included). For a more comfortable injection, leave the pre-filled syringe at room temperature (not above 25 C) for about 30 minutes before injecting. Wash your hands thoroughly with soap and water. On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.</p><p>Do not warm the syringe by using a heat source such as hot water or microwave.</p><p>Do not leave the pre-filled syringe exposed to direct sunlight.</p><p>Do not shake the pre-filled syringe.</p><p>Keep pre-filled syringes out of the sight and reach of children. B Open the inner syringe carton by peeling away the cover. Grab the pre-filled syringe automatic needle guard to remove the pre-filled syringe from the carton. For safety reasons:</p><p>Do not grasp the plunger rod.</p><p>Do not grasp the needle cover. C Inspect the medicine and pre-filled syringe.</p><p>Do not use the pre-filled syringe if:</p><p>The medicine is cloudy or there are particles in it. It must be a clear and colourless liquid.</p><p>Any part appears cracked or broken.</p><p>The needle cover is missing or not securely attached.</p><p>The expiry date printed on the label has passed the last day of the month shown. In all cases, call your doctor or healthcare provider. Step 2: Get ready A Wash your hands thoroughly. Prepare and clean your injection site. You can use:</p><p>Upper part of your thigh.</p><p>Belly, except for a 5 cm (2-inch) area right around your belly button.</p><p>Outer area of upper arm (only if someone else is giving you the injection). Clean the injection site with an alcohol wipe. Let your skin dry.</p><p>Do not touch the injection site before injecting. Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks. B Hold the pre-filled syringe by the automatic needle guard. Carefully pull the needle cover straight out and away from your body. Throw away the needle cover into the sharps disposal container. Do not recap.</p><p>C Pinch your injection site to create a firm surface. It is important to keep the skin pinched when injecting. Step 3: Inject A Hold the pinch. INSERT the needle into skin at 45 to 90 degrees.</p><p>Do not touch the cleaned area of the skin. B PUSH the plunger rod with slow and constant pressure until it reaches the bottom. C When the syringe is empty, LIFT the syringe off skin. After releasing the plunger rod, the pre-filled syringe automatic needle guard will safely cover the injection needle.</p><p>Do not put the needle cover back on used pre-filled syringes. When you remove the syringe, if it looks like the medicine is still in the syringe barrel, this means you have not received a full dose. Call your doctor or healthcare provider right away. Healthcare providers only The trade name and the batch number of the administered product should be clearly recorded in the patient file. Remove and save the pre-filled syringe label. Turn the plunger rod to move the label into a position where you can remove the syringe label. Step 4: Finish A Discard the used pre-filled syringe and other supplies in a sharps disposal container. Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. Keep the syringe and sharps disposal container out of sight and reach of children.</p><p>Do not reuse the pre-filled syringe.</p><p>Do not recycle pre-filled syringes or throw them into household waste. B Check the injection site. If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp51634c89fd4b34ec036bc5c7b8243dfa"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp51634c89fd4b34ec036bc5c7b8243dfa</b></p><a name="mp51634c89fd4b34ec036bc5c7b8243dfa"> </a><a name="hcmp51634c89fd4b34ec036bc5c7b8243dfa"> </a><a name="mp51634c89fd4b34ec036bc5c7b8243dfa-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/20/1486/001</p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}">Medicinal Product</span></p><p><b>domain</b>: <span title="Codes:{http://hl7.org/fhir/medicinal-product-domain Human}">Human use</span></p><p><b>status</b>: <span title="Codes:{http://hl7.org/fhir/publication-status active}">active</span></p><p><b>legalStatusOfSupply</b>: <span title="Codes:{https://spor.ema.europa.eu/rmswi 100000072084}">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Nyvepria 6 mg solution for injection</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/20/1486/001"/>
</identifier>
<type>
<coding>
<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="Nyvepria 6 mg solution for injection"/>
<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.
