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
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:Bundle ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "bundlepackageleaflet-en-cb456248863851baf93dc89f0a0fc5bf"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:identifier [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "None" ] ] ; # fhir:type [ fhir:v "document"] ; # fhir:timestamp [ fhir:v "2023-06-27T10:09:22Z"^^xsd:dateTime] ; # fhir:entry ( [ fhir:fullUrl [ fhir:v "Composition/composition-en-cb456248863851baf93dc89f0a0fc5bf"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-cb456248863851baf93dc89f0a0fc5bf> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mpcb456248863851baf93dc89f0a0fc5bf"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mpcb456248863851baf93dc89f0a0fc5bf> ) ] ) . # <Composition/composition-en-cb456248863851baf93dc89f0a0fc5bf> a fhir:Composition ; fhir:id [ fhir:v "composition-en-cb456248863851baf93dc89f0a0fc5bf"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi> ] ) ] ; # fhir:language [ fhir:v "en"] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\" xml:lang=\"en\" lang=\"en\"><a name=\"Composition_composition-en-cb456248863851baf93dc89f0a0fc5bf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-cb456248863851baf93dc89f0a0fc5bf</b></p><a name=\"composition-en-cb456248863851baf93dc89f0a0fc5bf\"> </a><a name=\"hccomposition-en-cb456248863851baf93dc89f0a0fc5bf\"> </a><a name=\"composition-en-cb456248863851baf93dc89f0a0fc5bf-en-US\"> </a><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Language: en</p><p style=\"margin-bottom: 0px\">Profile: <a href=\"https://build.fhir.org/ig/HL7/emedicinal-product-info/StructureDefinition-Composition-uv-epi.html\">Composition (ePI)</a></p></div><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/19/1415/001</p><p><b>status</b>: Final</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000155538}\">Package Leaflet</span></p><p><b>category</b>: <span title=\"Codes:{http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs R}\">Raw</span></p><p><b>date</b>: 2022-02-16 13:28:17+0000</p><p><b>author</b>: <a href=\"Organization-mah-ema.html\">Organization ACME industry</a></p><p><b>title</b>: TEST PURPOSES ONLY - amsparity</p><h3>Attesters</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Mode</b></td><td><b>Time</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://hl7.org/fhir/composition-attestation-mode official}\">Official</span></td><td>2022-02-16 13:28:17+0000</td></tr></table></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/19/1415/001" ] ] ) ; # fhir:status [ fhir:v "final"] ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package Leaflet" ] ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"^^xsd:anyURI ] ; fhir:code [ fhir:v "R" ] ; fhir:display [ fhir:v "Raw" ] ] ) ] ) ; # fhir:subject ( [ fhir:reference [ fhir:v "MedicinalProductDefinition/mpcb456248863851baf93dc89f0a0fc5bf" ] ] ) ; # fhir:date [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime] ; # fhir:author ( [ fhir:reference [ fhir:v "Organization/mah-ema" ] ] ) ; # fhir:title [ fhir:v "TEST PURPOSES ONLY - amsparity"] ; # fhir:attester ( [ fhir:mode [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/composition-attestation-mode"^^xsd:anyURI ] ; fhir:code [ fhir:v "official" ] ] ) ] ; fhir:time [ fhir:v "2022-02-16T13:28:17Z"^^xsd:dateTime ] ] ) ; # fhir:section ( [ fhir:title [ fhir:v "B. Package Leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "B. Package Leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\">unavailable</div>" ] ; fhir:emptyReason [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/list-empty-reason"^^xsd:anyURI ] ; fhir:code [ fhir:v "unavailable" ] ] ) ] ; ( fhir:section [ fhir:title [ fhir:v "Package leaflet: Information for the user" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "Package leaflet: Information for the user" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"></div>" ] ] [ fhir:title [ fhir:v "What is in this leaflet" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "What is in this leaflet" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet</p><ol type=\"1\"><li>What Amsparity is and what it is used for</li><li>What you need to know before your child uses Amsparity</li><li>How to use Amsparity</li><li>Possible side effects</li><li>How to store Amsparity</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What amsparity is and what it is used for" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "1. What amsparity is and what it is used for" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Amsparity contains the active substance adalimumab, a medicine that acts on your child s body s immune (defence) system.</p><p>Amsparity is intended for the treatment of the following inflammatory diseases:</p><ul><li>polyarticular juvenile idiopathic arthritis</li><li>paediatric enthesitis-related arthritis</li><li>paediatric plaque psoriasis</li><li>paediatric Crohn s disease</li><li>paediatric uveitis</li></ul><p>The active ingredient in Amsparity, adalimumab, is a monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target in the body.</p><p>The target of adalimumab is another protein called tumour necrosis factor (TNF ), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above. By attaching to TNF , Amsparity blocks its action and reduces the inflammation in these diseases.</p><p>Polyarticular juvenile idiopathic arthritis</p><p>Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints that usually first appears in childhood.</p><p>Amsparity is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat his/her polyarticular juvenile idiopathic arthritis.</p><p>Paediatric enthesitis-related arthritis</p><p>Paediatric enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.</p><p>Amsparity is used to treat enthesitis-related arthritis in children and adolescents aged 6 to 17 years. Your child may first be given other disease-modifying medicines, such as methotrexate. If these medicines do not work well enough, your child will be given Amsparity to treat his/her enthesitis-related arthritis.</p><p>Paediatric plaque psoriasis</p><p>Plaque psoriasis is an inflammatory skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful. Psoriasis is believed to be caused by a problem with the body s immune system that leads to an increased production of skin cells.</p><p>Amsparity is used to treat severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.</p><p>Paediatric Crohn s disease</p><p>Crohn s disease is an inflammatory disease of the gut.</p><p>Amsparity is used to treat Crohn s disease in children and adolescents aged 6 to 17 years.</p><p>If your child has Crohn s disease, your child will first be given other medicines. If your child does not respond well enough to these medicines, your child will be given Amsparity to reduce the signs and symptoms of his/her Crohn s disease.</p><p>Paediatric uveitis</p><p>Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye. This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision). Amsparity works by reducing this inflammation.</p><p>Amsparity is used to treat children and adolescents with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.</p><p>Your child may first be given other medicines. If these medicines do not work well enough, your child will be given Amsparity to reduce the signs and symptoms of his/her disease.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take amsparity" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "2. What you need to know before you take amsparity" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Do not use Amsparity</p><ul><li><p>if your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).</p></li><li><p>if your child has a severe infection, including active tuberculosis, sepsis (blood poisoning) or opportunistic infections (unusual infections associated with a weakened immune system). It is important that you tell your child s doctor if your child has symptoms of infections, for example, fever, wounds, feeling tired, dental problems (see Warnings and precautions ).</p></li><li><p>if your child has moderate or severe heart failure. It is important to tell your child s doctor if your child has had or has a serious heart condition (see Warnings and precautions ).</p></li></ul><p>Warnings and precautions</p><p>Talk to your child s doctor or pharmacist before using Amsparity.</p><p>It is important that you and your child s doctor record the brand name and batch number of your child s medication.</p><p>Allergic reactions</p><ul><li>If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Amsparity and contact your child s doctor immediately, since in rare cases, these reactions can be life threatening.</li></ul><p>Infections</p><ul><li><p>If your child has an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer), consult your child s doctor before starting Amsparity. If you are unsure, contact your child s doctor.</p></li><li><p>Your child might get infections more easily while he/she is receiving Amsparity treatment. This risk may increase if your child has problems with his/her lungs. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections (unusual infectious organisms), and sepsis (blood poisoning). In rare cases, these infections may be life-threatening. It is important to tell your child s doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems. Your child s doctor may recommend temporarily stopping Amsparity.</p></li></ul><p>Tuberculosis (TB)</p><ul><li><p>As cases of tuberculosis have been reported in patients treated with adalimumab, your child s doctor will check your child for signs and symptoms of tuberculosis before starting Amsparity. This will include a thorough medical evaluation including your child s medical history and screening tests (for example, chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your child s patient reminder card.</p></li><li><p>It is very important that you tell your child s doctor if your child has ever had tuberculosis, or if he/she has been in close contact with someone who has had tuberculosis. If your child has active tuberculosis, do not use Amsparity.</p></li><li><p>Tuberculosis can develop during therapy even if your child had treatment for the prevention of tuberculosis.</p></li><li><p>If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy tell your child s doctor immediately.</p></li></ul><p>Travel / recurrent infection</p><ul><li><p>Tell your child s doctor if your child has lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are endemic (found).</p></li><li><p>Tell your child s doctor if your child has had infections which keep coming back or other conditions that increase the risk of infections.</p></li><li><p>You and your child s doctor should pay special attention to signs of infection while your child is being treated with Amsparity. It is important to tell your child s doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.</p></li></ul><p>Hepatitis B</p><ul><li>Tell your child s doctor if your child is a carrier of the hepatitis B virus (HBV), if he/she has active HBV infection or if you think he/she might be at risk of getting HBV. Your child s doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry the virus. In some rare cases, especially if your child is taking other medicines that suppress the immune system, reactivation of HBV infection can be life-threatening.</li></ul><p>Surgery or dental procedure</p><ul><li>If your child is about to have surgery or dental procedures, tell your child s doctor that he/she is taking Amsparity. Your child s doctor may recommend temporarily stopping Amsparity.</li></ul><p>Demyelinating disease</p><ul><li>If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your child s doctor will decide if he/she should receive or continue to receive Amsparity. Tell your child s doctor immediately if your child gets symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.</li></ul><p>Vaccination</p><ul><li>Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses that may cause infections and should not be given during treatment with Amsparity. Check with your child s doctor before your child receives any vaccines. It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Amsparity. If your child received Amsparity while she was pregnant, her baby may be at higher risk for getting an infection for up to about five months after the last Amsparity dose she received during pregnancy. It is important that you tell her baby's doctors and other health care professionals about your child s Amsparity use during her pregnancy so they can decide when her baby should receive any vaccine.</li></ul><p>Heart failure</p><ul><li>It is important to tell your child s doctor if your child has had or has a serious heart condition. If your child has mild heart failure and is being treated with Amsparity, his/her heart failure status must be closely monitored by your child s doctor. If he/she develops new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of his/her feet), you must contact your child s doctor immediately.</li></ul><p>Fever, bruising, bleeding or looking pale</p><ul><li>In some patients the body may fail to produce enough of the blood cells that fight off infections or help your child to stop bleeding. If your child develops a fever that does not go away, bruises or bleeds very easily or looks very pale, call your child s doctor right away. Your child s doctor may decide to stop treatment.</li></ul><p>Cancer</p><ul><li><p>There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNF blockers. People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affects blood cells and bone marrow). If your child takes Amsparity the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma has been seen in patients taking adalimumab. Some of those patients were also treated with the medicines azathioprine or mercaptopurine. Tell your child s doctor if your child is taking azathioprine or mercaptopurine with Amsparity.</p></li><li><p>In addition, cases of non-melanoma skin cancer have been observed in patients taking adalimumab. If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your child s doctor.</p></li><li><p>There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNF<br/>blocker. If your child has COPD, or is a heavy smoker, you should discuss with your child s doctor whether treatment with a TNF blocker is appropriate for your child.</p></li></ul><p>Autoimmune disease</p><ul><li>On rare occasions, treatment with Amsparity could result in lupus-like syndrome. Contact your child s doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.</li></ul><p>Other medicines and Amsparity</p><p>Tell your child s doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.</p><p>Amsparity can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), corticosteroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).</p><p>Your child should not take Amsparity with medicines containing the active substances anakinra or abatacept due to increased risk of serious infection. The combination of adalimumab as well as other TNF-antagonists and anakinra or abatacept is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions. If you have questions, please ask your child s doctor.</p><p>Pregnancy and breast-feeding</p><p>Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Amsparity treatment.</p><p>If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.</p><p>Amsparity should only be used during a pregnancy if needed.</p><p>According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.</p><p>Amsparity can be used during breast-feeding.</p><p>If your child receives Amsparity during her pregnancy, her baby may have a higher risk for getting an infection. It is important that you tell her baby s doctor and other health care professionals about her Amsparity use during her pregnancy before the baby receives any vaccine. For more information on vaccines see the Warnings and precautions section.</p><p>Driving and using machines</p><p>Amsparity may have a small effect on your child s ability to drive, cycle or use machines. Room spinning sensation (vertigo) and vision disturbances may occur after taking Amsparity.</p><p>Amsparity contains sodium</p><p>This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, that is to say essentially sodium-free .</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take amsparity" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "3. How to take amsparity" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Always use this medicine exactly as your child s doctor, nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.</p><p>The recommended doses for Amsparity in each of the approved uses are shown in the following table. Your child s doctor may prescribe another strength of Amsparity if your child needs a different dose.</p><p>Amsparity is injected under the skin (subcutaneous use).</p><p>Polyarticular juvenile idiopathic arthritis Age or body weight How much and how often to take? Notes Children and adolescents from 2 years of age weighing 30 kg or more 40 mg every other week Not applicable Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg 20 mg every other week Not applicable</p><p>Paediatric enthesitis-related arthritis Age or body weight How much and how often to take? Notes Children and adolescents from 6 years of age weighing 30 kg or more 40 mg every other week Not applicable Paediatric enthesitis-related arthritis Age or body weight How much and how often to take? Notes Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg 20 mg every other week Not applicable</p><p>Paediatric plaque psoriasis Age or body weight How much and how often to take? Notes Children and adolescents from 4 to 17 years of age weighing 30 kg or more First dose of 40 mg, followed by 40 mg one week later.</p><p>Thereafter, the usual dose is 40 mg every other week. Not applicable Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg First dose of 20 mg, followed by 20 mg one week later.</p><p>Thereafter, the usual dose is 20 mg every other week. Not applicable</p><p>Paediatric Crohn s disease Age or body weight How much and how often to take? Notes Children and adolescents from 6 to 17 years of age weighing 40 kg or more First dose of 80 mg, followed by 40 mg two weeks later.</p><p>If a faster response is required, your child s doctor may prescribe a first dose of 160 mg, followed by 80 mg two weeks later.</p><p>Thereafter, the usual dose is 40 mg every other week. Your child s doctor may increase the dosage to 40 mg every week or 80 mg every other week. Children and adolescents from 6 to 17 years of age weighing less than 40 kg First dose of 40 mg, followed by 20 mg two weeks later.</p><p>If a faster response is required, the doctor may prescribe a first dose of 80 mg, followed by 40 mg two weeks later.</p><p>Thereafter, the usual dose is 20 mg every other week. Your child s doctor may increase the dose frequency to 20 mg every week.</p><p>Paediatric uveitis Age or body weight How much and how often to take? Notes Children and adolescents from 2 years of age weighing less than 30 kg 20 mg every other week Your child s doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. Amsparity is recommended for use in combination with methotrexate. Children and adolescents from 2 years of age weighing 30 kg or more 40 mg every other week Your child s doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Amsparity is recommended for use in combination with methotrexate.</p><p>Method and route of administration</p><p>Amsparity is administered by injection under the skin (by subcutaneous injection).</p><p>Detailed instructions on how to inject Amsparity, the Instructions for Use, are provided at the end of this leaflet.</p><p>If you use more Amsparity than you should</p><p>If you accidentally inject your child with Amsparity more frequently than you should, call your child s doctor or pharmacist and explain that your child has taken more than required. Always take the outer carton of the medicine with you, even if it is empty.</p><p>If you forget to use Amsparity</p><p>If you forget to give your child an Amsparity injection, you should inject the next dose of Amsparity as soon as you remember. Then give your child s next dose as you would have on the originally scheduled day, had you not forgotten a dose.</p><p>If your child stops using Amsparity</p><p>The decision to stop using Amsparity should be discussed with your child s doctor. Your child s symptoms may return upon stopping treatment.</p><p>If you have any further questions on the use of this medicine, ask your child s doctor or pharmacist.</p></div>" ] ] [ fhir:title [ fhir:v "4. Possible side effects" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "4. Possible side effects" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Amsparity injection.</p><p>Seek medical attention urgently, if you notice any of the following signs:</p><ul><li>severe rash, hives or other signs of allergic reaction;</li><li>swollen face, hands, feet;</li><li>trouble breathing, swallowing;</li><li>shortness of breath with physical activity or upon lying down or swelling of the feet.</li></ul><p>Tell your child s doctor as soon as possible, if you notice any of the following:</p><ul><li>signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;</li><li>symptoms of nerve problems such as tingling, numbness, double vision, or arm or leg weakness;</li><li>signs of skin cancer such as a bump or open sore that does not heal;</li><li>signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness.</li></ul><p>The signs and symptoms described above can represent the side effects listed below, which have been observed with adalimumab:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li>injection site reactions (including pain, swelling, redness or itching);</li><li>respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);</li><li>headache;</li><li>abdominal (belly) pain;</li><li>nausea and vomiting;</li><li>rash;</li><li>pain in the muscles or joints.</li></ul><p>Common (may affect up to 1 in 10 people)</p><ul><li>serious infections (including blood poisoning and influenza);</li><li>intestinal infections (including gastroenteritis);</li><li>skin infections (including cellulitis and shingles);</li><li>ear infections;</li><li>mouth infections (including tooth infections and cold sores);</li><li>reproductive tract infections;</li><li>urinary tract infection;</li><li>fungal infections;</li><li>joint infections;</li><li>benign tumours;</li><li>skin cancer;</li><li>allergic reactions (including seasonal allergy);</li><li>dehydration;</li><li>mood swings (including depression);</li><li>anxiety;</li><li>difficulty sleeping;</li><li>sensation disorders such as tingling, prickling or numbness;</li><li>migraine;</li><li>symptoms of nerve root compression (including low back pain and leg pain);</li><li>vision disturbances;</li><li>eye inflammation;</li><li>inflammation of the eye lid and eye swelling;</li><li>vertigo (sensation of room spinning);</li><li>sensation of heart beating rapidly;</li><li>high blood pressure;</li><li>flushing;</li><li>haematoma (a solid swelling with clotted blood);</li><li>cough;</li><li>asthma;</li><li>shortness of breath;</li><li>gastrointestinal bleeding;</li><li>dyspepsia (indigestion, bloating, heart burn);</li><li>acid reflux disease;</li><li>sicca syndrome (including dry eyes and dry mouth);</li><li>itching;</li><li>itchy rash;</li><li>bruising;</li><li>inflammation of the skin (such as eczema);</li><li>breaking of finger nails and toe nails;</li><li>increased sweating;</li><li>hair loss;</li><li>new onset or worsening of psoriasis;</li><li>muscle spasms;</li><li>blood in urine;</li><li>kidney problems;</li><li>chest pain;</li><li>oedema (a build-up of fluid in the body which causes the affected tissue to swell);</li><li>fever;</li><li>reduction in blood platelets which increases risk of bleeding or bruising;</li><li>impaired healing.</li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>opportunistic (unusual) infections (which include tuberculosis and other infections) that occur when resistance to disease is lowered;</li><li>neurological infections (including viral meningitis);</li><li>eye infections;</li><li>bacterial infections;</li><li>diverticulitis (inflammation and infection of the large intestine);</li><li>cancer, including cancer that affects the lymph system (lymphoma) and melanoma (a type of skin cancer);</li><li>immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);</li><li>vasculitis (inflammation of blood vessels);</li><li>tremor (shaking);</li><li>neuropathy (nerve damage);</li><li>stroke;</li><li>double vision;</li><li>hearing loss, buzzing;</li><li>sensation of heart beating irregularly such as skipped beats;</li><li>heart problems that can cause shortness of breath or ankle swelling;</li><li>heart attack;</li><li>a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;</li><li>lung diseases causing shortness of breath (including inflammation);</li><li>pulmonary embolism (blockage in an artery of the lung);</li><li>pleural effusion (abnormal collection of fluid in the pleural space);</li><li>inflammation of the pancreas which causes severe pain in the abdomen and back;</li><li>difficulty in swallowing;</li><li>facial oedema (swelling of the face);</li><li>gallbladder inflammation, gallbladder stones;</li><li>fatty liver (build up of fat in liver cells);</li><li>night sweats;</li><li>scar;</li><li>abnormal muscle breakdown;</li><li>systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung, joints and other organ systems);</li><li>sleep interruptions;</li><li>impotence;</li><li>inflammations.</li></ul><p>Rare (may affect up to 1 in 1,000 people)</p><ul><li>leukaemia (cancer affecting the blood and bone marrow);</li><li>severe allergic reaction with shock;</li><li>multiple sclerosis;</li><li>nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barr<br/>syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);</li><li>heart stops pumping;</li><li>pulmonary fibrosis (scarring of the lung);</li><li>intestinal perforation (hole in the wall of the gut);</li><li>hepatitis (liver inflammation);</li><li>reactivation of hepatitis B infection;</li><li>autoimmune hepatitis (inflammation of the liver caused by the body s own immune system);</li><li>cutaneous vasculitis (inflammation of blood vessels in the skin);</li><li>Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and blistering rash);</li><li>facial oedema (swelling of the face) associated with allergic reactions;</li><li>erythema multiforme (inflammatory skin rash);</li><li>lupus-like syndrome;</li><li>angioedema (localised swelling of the skin);</li><li>lichenoid skin reaction (itchy reddish-purple skin rash).</li></ul><p>Not known (frequency cannot be estimated from available data)</p><ul><li>hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);</li><li>Merkel cell carcinoma (a type of skin cancer);</li><li>Kaposi s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi s sarcoma most commonly appears as purple lesions on the skin.</li><li>liver failure;</li><li>worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness);</li><li>weight gain (for most patients, the weight gain was small).</li></ul><p>Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:</p><p>Very common (may affect more than 1 in 10 people)</p><ul><li><p>low blood measurements for white blood cells;</p></li><li><p>low blood measurements for red blood cells;</p></li><li><p>increased lipids in the blood;</p></li><li><p>raised liver enzymes. Common (may affect up to 1 in 10 people)</p></li><li><p>high blood measurements for white blood cells;</p></li><li><p>low blood measurements for platelets;</p></li><li><p>increased uric acid in the blood;</p></li><li><p>abnormal blood measurements for sodium;</p></li><li><p>low blood measurements for calcium;</p></li><li><p>low blood measurements for phosphate;</p></li><li><p>high blood sugar;</p></li><li><p>high blood measurements for lactate dehydrogenase;</p></li><li><p>autoantibodies present in the blood;</p></li><li><p>low blood potassium.</p></li></ul><p>Uncommon (may affect up to 1 in 100 people)</p><ul><li>raised bilirubin measurement (liver blood test).</li></ul><p>Rare (may affect up to 1 in 1,000 people)</p><ul><li>low blood measurements for white blood cells, red blood cells and platelet count.</li></ul><p>Reporting of side effects If your child gets any side effects, talk to your doctor 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>" ] ] [ fhir:title [ fhir:v "5. How to store amsparity" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "5. How to store amsparity" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this medicine out of the sight and reach of children.</p><p>Do not use this medicine after the expiry date which is stated on the label / blister / carton after EXP.</p><p>Store in a refrigerator (2 C 8 C). Do not freeze.</p><p>Keep the pre-filled syringe in the outer carton in order to protect from light.</p><p>Alternative Storage:</p><p>When needed (for example, when travelling), a single Amsparity pre-filled syringe may be stored at room temperature (up to 30 C) for a maximum period of 30 days be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the syringe must be used within days or discarded, even if it is returned to the refrigerator.</p><p>You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your child s doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.</p></div>" ] ] [ fhir:title [ fhir:v "6. Contents of the pack and other information" ] ; fhir:code [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi/"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000155538" ] ] ) ; fhir:text [ fhir:v "6. Contents of the pack and other information" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Amsparity contains</p><p>The active substance is adalimumab.</p><p>The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose, edetate disodium dihydrate, L-methionine, polysorbate 80, and water for injections.</p><p>What the Amsparity pre-filled syringe looks like and contents of the pack</p><p>Amsparity 20 mg solution for injection in pre-filled syringe for paediatric use is supplied as a sterile solution of 20 mg adalimumab dissolved in 0.4 ml solution.</p><p>The Amsparity pre-filled syringe is a glass syringe containing a clear, colourless to very light brown solution of adalimumab.</p><p>The Amsparity pre-filled syringe is available in a pack containing 2 pre-filled syringes with 2 alcohol pads.</p><p>Amsparity may be available as a vial, a pre-filled syringe and/or a pre-filled pen.</p><p>Marketing Authorisation Holder</p><p>Pfizer Europe MA EEIG Boulevard de la Plaine 1050 Bruxelles Belgium</p><p>Manufacturer</p><p>Pfizer Service Company BV Hoge Wei Zaventem 1Belgium</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA T l/Tel: +32 (0)2 554 62 K<br/>PFIZER E A A.E. (CYPRUS BRANCH) : +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 44 201 Malta Vivian Corporation Ltd.<br/>Tel: +356 21344Deutchland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51Nederland Pfizer bv Tel: +31 (0)10 406 43<br/>,</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<br/>T l: +33 (0)1 58 07 34 Rom nia Pfizer Rom nia 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.<br/>Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520 Latvija Pfizer Luxembourg SARL fili le Latvij<br/>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</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mpcb456248863851baf93dc89f0a0fc5bf> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mpcb456248863851baf93dc89f0a0fc5bf"] ; # fhir:meta [ ( fhir:profile [ fhir:v "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"^^xsd:anyURI ; fhir:link <http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mpcb456248863851baf93dc89f0a0fc5bf\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mpcb456248863851baf93dc89f0a0fc5bf</b></p><a name=\"mpcb456248863851baf93dc89f0a0fc5bf\"> </a><a name=\"hcmpcb456248863851baf93dc89f0a0fc5bf\"> </a><a name=\"mpcb456248863851baf93dc89f0a0fc5bf-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/19/1415/001</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>: Amsparity 20 mg solution for injection in pre-filled syringe</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>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://ema.europa.eu/identifier"^^xsd:anyURI ] ; fhir:value [ fhir:v "EU/1/19/1415/001" ] ] ) ; # fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "MedicinalProduct" ] ; fhir:display [ fhir:v "Medicinal Product" ] ] ) ] ; # fhir:domain [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/medicinal-product-domain"^^xsd:anyURI ] ; fhir:code [ fhir:v "Human" ] ; fhir:display [ fhir:v "Human use" ] ] ) ] ; # fhir:status [ ( fhir:coding [ fhir:system [ fhir:v "http://hl7.org/fhir/publication-status"^^xsd:anyURI ] ; fhir:code [ fhir:v "active" ] ; fhir:display [ fhir:v "active" ] ] ) ] ; # fhir:legalStatusOfSupply [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/rmswi"^^xsd:anyURI ] ; fhir:code [ fhir:v "100000072084" ] ; fhir:display [ fhir:v "Medicinal product subject to medical prescription" ] ] ) ] ; # fhir:name ( [ fhir:productName [ fhir:v "Amsparity 20 mg solution for injection in pre-filled syringe" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000001" ] ; fhir:display [ fhir:v "Full name" ] ] ) ] ; ( fhir:part [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000002" ] ; fhir:display [ fhir:v "Invented name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000003" ] ; fhir:display [ fhir:v "Scientific name part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000004" ] ; fhir:display [ fhir:v "Strength part" ] ] ) ] ] [ fhir:part [ fhir:v "nan" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "https://spor.ema.europa.eu/lists/220000000000"^^xsd:anyURI ] ; fhir:code [ fhir:v "220000000005" ] ; fhir:display [ fhir:v "Pharmaceutical dose form part" ] ] ) ] ] ) ; ( fhir:usage [ fhir:country [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:jurisdiction [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "EU" ] ; fhir:display [ fhir:v "EU" ] ] ) ] ; fhir:language [ ( fhir:coding [ fhir:system [ fhir:v "urn:ietf:bcp:47"^^xsd:anyURI ] ; fhir:code [ fhir:v "en" ] ; fhir:display [ fhir:v "en" ] ] ) ] ] ) ] ) . #
IG © 2021+ Gravitate Health Project. Package hl7.eu.fhir.ghepi#0.1.0 based on FHIR 5.0.0. Generated 2024-10-14
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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.
