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-6b301f6c675105f98d980bf8971e8028"] ; # 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-6b301f6c675105f98d980bf8971e8028"^^xsd:anyURI ] ; ( fhir:resource <Composition/composition-en-6b301f6c675105f98d980bf8971e8028> ) ] [ fhir:fullUrl [ fhir:v "MedicinalProductDefinition/mp6b301f6c675105f98d980bf8971e8028"^^xsd:anyURI ] ; ( fhir:resource <MedicinalProductDefinition/mp6b301f6c675105f98d980bf8971e8028> ) ] ) . # <Composition/composition-en-6b301f6c675105f98d980bf8971e8028> a fhir:Composition ; fhir:id [ fhir:v "composition-en-6b301f6c675105f98d980bf8971e8028"] ; # 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-6b301f6c675105f98d980bf8971e8028\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Composition composition-en-6b301f6c675105f98d980bf8971e8028</b></p><a name=\"composition-en-6b301f6c675105f98d980bf8971e8028\"> </a><a name=\"hccomposition-en-6b301f6c675105f98d980bf8971e8028\"> </a><a name=\"composition-en-6b301f6c675105f98d980bf8971e8028-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/1/22/1688/001</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 - spevigo</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/1/22/1688/001" ] ] ) ; # 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/mp6b301f6c675105f98d980bf8971e8028" ] ] ) ; # 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 - spevigo"] ; # 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 Spevigo is and what it is used for</li><li>What you need to know before you are given Spevigo</li><li>How Spevigo will be given</li><li>Possible side effects</li><li>How to store Spevigo</li><li>Contents of the pack and other information</li></ol></div>" ] ] [ fhir:title [ fhir:v "1. What spevigo 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 spevigo 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>What Spevigo is Spevigo contains the active substance spesolimab. Spesolimab belongs to a group of medicines called interleukin (IL) inhibitors. This medicine works by blocking the activity of a protein called IL36R, which is involved in inflammation. What Spevigo is used for Spevigo is used alone in adults to treat flares of a rare inflammatory skin disease called generalised pustular psoriasis (GPP). During a flare, patients may experience painful skin blisters that develop suddenly over large areas of the skin. These blisters, also called pustules, are filled with pus. The skin may become red, itchy, dry, cracked or scaly. Patients may also experience more general signs and symptoms, such as fever, headache, extreme tiredness, or a burning sensation of the skin. Spevigo improves skin clearance and reduces symptoms of GPP during a flare.</p></div>" ] ] [ fhir:title [ fhir:v "2. What you need to know before you take spevigo" ] ; 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 spevigo" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>A doctor experienced in treating patients with inflammatory skin diseases will start and supervise your treatment. You must not receive Spevigo if you:</p><p>are allergic to spesolimab or any of the other ingredients of this medicine (listed in section 6).</p><p>have active tuberculosis or other severe infections (see Warnings and precautions ). Warnings and precautions Talk to your doctor or nurse before you are given Spevigo if you:</p><p>currently have an infection or have an infection that keeps coming back. Fever, flu-like symptoms, tiredness or shortness of breath, a cough which will not go away, warm, red and painful skin, or a painful rash with blisters can be signs and symptoms of an infection.</p><p>have, have had tuberculosis, or have been in close contact with someone with tuberculosis.</p><p>have recently had a vaccination or plan to have a vaccination. You should not be given certain types of vaccines (live vaccines) for at least 16 weeks after being given Spevigo.</p><p>experience symptoms like weakness in your arms or legs that was not there before or numbness (loss of sensation), tingling or a burning sensation in any part of your body. These might be signs of peripheral neuropathy (damage of the peripheral nerves). Infections Tell your doctor as soon as possible if you notice any signs or symptoms of an infection after you have been given Spevigo, see section 4 Possible side effects . Allergic reactions Seek medical help immediately if you notice any signs or symptoms of an allergic reaction while or after you are given this medicine. You can also have allergic reactions some days or weeks after receiving Spevigo. For signs and symptoms see section 4 Possible side effects . Children and adolescents Spevigo is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group. Other medicines and Spevigo Tell your doctor if you are:</p><p>taking, have recently taken or might take any other medicines, including any other medicines to treat GPP.</p><p>going to have or have recently had a vaccination. You should not be given certain types of vaccines (live vaccines) for at least 16 weeks after receiving Spevigo. Pregnancy and breast-feeding Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. This is because it is not known how this medicine will affect the baby. It is therefore preferable to avoid the use of Spevigo during pregnancy. If you are pregnant, you should only receive this medicine if your doctor has clearly recommended it. Breast-feeding It is not known whether Spevigo passes into breast milk. Spevigo may pass into breast milk in the first days after birth. You should therefore tell your doctor if you are breast-feeding or plan to breast-feed, so you and your doctor can decide if you can be given Spevigo. Driving and using machines Spevigo is not expected to affect your ability to drive and use machines. Spevigo contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium free .</p></div>" ] ] [ fhir:title [ fhir:v "3. How to take spevigo" ] ; 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 spevigo" ] ] ; fhir:text [ fhir:status [ fhir:v "additional" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>The recommended dose is 900 mg (2 vials of 450 mg/7.5 mL). Your doctor or nurse will give you this medicine by infusion (drip) into a vein. It will be given over a period of 90 minutes, up to a maximum of 180 minutes if the infusion is slowed down or stopped temporarily. If you still experience flare symptoms your doctor can decide to give you a second dose of Spevigo one week after the first. If you have any further questions on the use of this medicine, ask your doctor. If you are given more Spevigo than you should This medicine will be given to you by your doctor or nurse. If you think you have been given too much Spevigo, tell your doctor or nurse straight away.</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. Seek medical help immediately if you notice any signs or symptoms of an allergic reaction while or after you are given this medicine. These may include:</p><p>difficulty breathing or swallowing</p><p>swelling of the face, lips, tongue or throat</p><p>severe itching of the skin, with a red rash or raised bumps, that is different from your GPP symptoms</p><p>feeling faint. You can also have allergic reactions some days or weeks after receiving Spevigo. Seek medical help immediately if you develop any widespread skin rash that was not there before, fever, and/or facial swelling 2-8 weeks after receiving the medicine. These might be signs of a delayed allergic reaction (hypersensitivity). Tell your doctor as soon as possible if you notice any signs or symptoms of an infection. Very common (may affect more than 1 in 10 people). These may include:</p><p>fever, cough</p><p>frequent urination, pain or burning while urinating or bloody urine, which may be symptoms of urinary tract infections Tell your doctor or nurse if you get any of the following other side effects: Very common (may affect more than 1 in 10 people)</p><p>redness, swelling, hardening, warmth or pain at the injection site Common (may affect up to 1 in 10 people)</p><p>itching</p><p>feeling tired Reporting of side effects If you get any side effects, talk to your doctor 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>" ] ] [ fhir:title [ fhir:v "5. How to store spevigo" ] ; 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 spevigo" ] ] ; 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. Do not use this medicine after the expiry date which is stated on the vial and the carton after EXP. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C) (see information for Healthcare Professionals at the end of this Package leaflet). Do not freeze. Store in the original package in order to protect from light.</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\"><h2 id=\"what-spevigo-contains\">What Spevigo contains</h2><h2 id=\"the-active-substance-is-spesolimab-each-vial-contains-450-mg-spesolimab-in-75-ml-of-concentrate-for-solution-for-infusion\">The active substance is spesolimab. Each vial contains 450 mg spesolimab in 7.5 mL of concentrate for solution for infusion.</h2><p>The other ingredients are sodium acetate trihydrate (E262), glacial acetic acid (E260) (for pH adjustment), sucrose, arginine hydrochloride, polysorbate 20 (E432) and water for injections. What Spevigo looks like and contents of the pack Spevigo concentrate for solution for infusion is a clear to slightly opalescent, colourless to slightly brownish-yellow solution supplied in a 10 mL colourless glass vial (type I glass), with a coated rubber stopper and aluminium crimp cap with blue plastic button. Each pack contains two vials. Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Str. 55216 Ingelheim am Rhein Germany Manufacturer Boehringer Ingelheim Pharma GmbH & Co. KG Birkendorfer Strasse 88397 Biberach an der Riss Germany Boehringer Ingelheim France 100-104 Avenue de France 75013 Paris France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 Lietuva Boehringer Ingelheim RCV GmbH & Co KG Lietuvos filialas Tel: +370 5 2595 .</p><h2 id=\"-359-2-958-79-luxembourgluxemburg-boehringer-ingelheim-scomm-t-ltel-32-2-773-33-esk-republika-boehringer-ingelheim-spol-s-ro-tel-420-234-655-magyarorsz-g-boehringer-ingelheim-rcv-gmbh--co-kg-magyarorsz-gi-fi-ktelepe-tel-36-1-299-89-danmark-boehringer-ingelheim-danmark-as-tlf-45-39-15-88-malta-boehringer-ingelheim-ireland-ltd-tel-353-1-295-9deutschland-boehringer-ingelheim-pharma-gmbh--co-kg-tel-49-0-800-77-90-nederland-boehringer-ingelheim-bv-tel-31-0-800-22-55-eesti-boehringer-ingelheim-rcv-gmbh--co-kg-eesti-filiaal-tel-372-612-8norge-boehringer-ingelheim-norway-ks-tlf-47-66-76-13-boehringer-ingelheim-ae-t--30-2-10-89-06-sterreich-boehringer-ingelheim-rcv-gmbh--co-kg-tel-43-1-80-105-7espa-a-boehringer-ingelheim-espa-a-sa-tel-34-93-404-51-polska-boehringer-ingelheim-sp-z-oo-tel-48-22-699-0-france-boehringer-ingelheim-france-sas-t-l-33-3-26-50-45-portugal-boehringer-ingelheim-portugal-lda-tel-351-21-313-53-hrvatska-boehringer-ingelheim-zagreb-doo-tel-385-1-2444-rom-nia-boehringer-ingelheim-rcv-gmbh--co-kg-viena-sucursala-bucure-ti-tel-40-21-302-28-ireland-boehringer-ingelheim-ireland-ltd-tel-353-1-295-9slovenija-boehringer-ingelheim-rcv-gmbh--co-kg-podru-nica-ljubljana-tel-386-1-586-40-sland-vistor-hf-s-mi-354-535-7slovensk-republika-boehringer-ingelheim-rcv-gmbh--co-kg-organiza-n-zlo-ka-tel-421-2-5810-1italia-boehringer-ingelheim-italia-spa-tel-39-02-5355-1-suomifinland-boehringer-ingelheim-finland-ky-puhtel-358-10-3102-boehringer-ingelheim-ae-t--30-2-10-89-06-sverige-boehringer-ingelheim-ab-tel-46-8-721-21-latvija-boehringer-ingelheim-rcv-gmbh--co-kg-latvijas-fili-le-tel-371-67-240-united-kingdom-northern-ireland-boehringer-ingelheim-ireland-ltd-tel-353-1-295-9this-leaflet-was-last-revised-in-this-medicine-has-been-given-conditional-approval--this-means-that-there-is-more-evidence-to-come-about-this-medicine-the-european-medicines-agency-will-review-new-information-on-this-medicine-at-least-every-year-and-this-leaflet-will-be-updated-as-necessary-other-sources-of-information-detailed-information-on-this-medicine-is-available-on-the-european-medicines-agency-web-site-httpwwwemaeuropaeu\">: +359 2 958 79 Luxembourg/Luxemburg Boehringer Ingelheim SComm T l/Tel: +32 2 773 33 esk republika Boehringer Ingelheim spol. s r.o. Tel: +420 234 655 Magyarorsz g Boehringer Ingelheim RCV GmbH & Co KG Magyarorsz gi Fi ktelepe Tel: +36 1 299 89 Danmark Boehringer Ingelheim Danmark A/S Tlf: +45 39 15 88 Malta Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Deutschland Boehringer Ingelheim Pharma GmbH & Co. KG Tel: +49 (0) 800 77 90 Nederland Boehringer Ingelheim bv Tel: +31 (0) 800 22 55 Eesti Boehringer Ingelheim RCV GmbH & Co KG Eesti filiaal Tel: +372 612 8Norge Boehringer Ingelheim Norway KS Tlf: +47 66 76 13<br/>Boehringer Ingelheim A.E. T : +30 2 10 89 06 sterreich Boehringer Ingelheim RCV GmbH & Co KG Tel: +43 1 80 105-7Espa a Boehringer Ingelheim Espa a, S.A. Tel: +34 93 404 51 Polska Boehringer Ingelheim Sp. z o.o. Tel: +48 22 699 0 France Boehringer Ingelheim France S.A.S. T l: +33 3 26 50 45 Portugal Boehringer Ingelheim Portugal, Lda. Tel: +351 21 313 53 Hrvatska Boehringer Ingelheim Zagreb d.o.o. Tel: +385 1 2444 Rom nia Boehringer Ingelheim RCV GmbH & Co KG Viena Sucursala Bucure ti Tel: +40 21 302 28 Ireland Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9Slovenija Boehringer Ingelheim RCV GmbH & Co KG Podru nica Ljubljana Tel: +386 1 586 40 sland Vistor hf. S mi: +354 535 7Slovensk republika Boehringer Ingelheim RCV GmbH & Co KG organiza n zlo ka Tel: +421 2 5810 1Italia Boehringer Ingelheim Italia S.p.A. Tel: +39 02 5355 1 Suomi/Finland Boehringer Ingelheim Finland Ky Puh/Tel: +358 10 3102<br/>Boehringer Ingelheim A.E. T : +30 2 10 89 06 Sverige Boehringer Ingelheim AB Tel: +46 8 721 21 Latvija Boehringer Ingelheim RCV GmbH & Co KG Latvijas fili le Tel: +371 67 240 United Kingdom (Northern Ireland) Boehringer Ingelheim Ireland Ltd. Tel: +353 1 295 9This leaflet was last revised in This medicine has been given conditional approval . This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. 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>.</h2><p>The following information is intended for healthcare professionals only: Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Posology and method of administration The recommended dose is a single dose of 900 mg (2 vials of 450 mg) administered as an intravenous infusion. Spevigo must be diluted before use. It should not be administered as an intravenous push or bolus. If flare symptoms persist, an additional 900 mg dose may be administered 1 week after the initial dose. Following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection, Spevigo is administered as a continuous intravenous infusion through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micron) over 90 minutes. No other infusion should be administered in parallel via the same intravenous access. In the event that the infusion is slowed or temporarily stopped, the total infusion time (including stop time) should not exceed 180 minutes. Handling instructions</p><p>The vial should be visually inspected before use.</p><ul><li>Spevigo is a colourless to slightly brownish-yellow, clear to slightly opalescent solution.</li><li>If the solution is cloudy, discoloured, or contains large or coloured particulates, the vial should be discarded.</li></ul><p>Spesolimab sterile concentrate is for single use only.</p><p>Aseptic technique must be used to prepare the solution for infusion. Draw and discard 15 mL from a 100 mL container of sodium chloride 9 mg/mL (0.9%) solution for injection and replace slowly with 15 mL spesolimab sterile concentrate (complete content from two vials of 450 mg/7.5 mL). Mix gently before use. The diluted spesolimab infusion solution should be used immediately.</p><p>Spevigo must not be mixed with other medicinal products. A pre-existing intravenous line may be used for administration of the diluted spesolimab infusion solution. The line must be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection prior to and at the end of infusion. No other infusion should be administered in parallel via the same intravenous access.</p><p>Spevigo is compatible with infusion sets composed of polyvinylchloride (PVC), polyethylene (PE), polypropylene (PP), polybutadiene and polyurethane (PUR), and in-line filter membranes composed of polyethersulfone (PES, neutral and positively charged) and positively charged polyamide (PA). Storage conditions Unopened vial</p><p>Store in a refrigerator (2 C 8 C). Do not freeze.</p><p>Store in the original package in order to protect from light.</p><p>Prior to use, the unopened vial may be kept at temperatures up to 30 C for up to 24 hours, if stored in the original package in order to protect from light. After opening</p><p>From a microbiological point of view, once opened, the medicinal product should be diluted and infused immediately. After preparation of infusion</p><p>Chemical and physical in-use stability of the diluted solution has been demonstrated for 24 hours at 2 C 30 C.</p><p>From a microbiological point of view, the diluted solution for infusion should be used immediately. If not used immediately, in use storage conditions are the responsibility of the user and would normally not be longer than 24 hours at 2 C 8 C, unless dilution has taken place in controlled and validated aseptic conditions. For the time between preparation and start of administration the solution for infusion should be protected from light following local standard procedures. ANNEX IV CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY Conclusions presented by the European Medicines Agency on:</p><p>Conditional marketing authorisation The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the conditional marketing authorisation as further explained in the European Public Assessment Report.</p></div>" ] ] ) ] ) . # <MedicinalProductDefinition/mp6b301f6c675105f98d980bf8971e8028> a fhir:MedicinalProductDefinition ; fhir:id [ fhir:v "mp6b301f6c675105f98d980bf8971e8028"] ; # 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_mp6b301f6c675105f98d980bf8971e8028\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp6b301f6c675105f98d980bf8971e8028</b></p><a name=\"mp6b301f6c675105f98d980bf8971e8028\"> </a><a name=\"hcmp6b301f6c675105f98d980bf8971e8028\"> </a><a name=\"mp6b301f6c675105f98d980bf8971e8028-en-US\"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/22/1688/001</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>: Spevigo 450 mg concentrate for solution for infusion</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/1/22/1688/001" ] ] ) ; # 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 "Spevigo 450 mg concentrate for solution for infusion" ] ; 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.
