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" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What is in this leaflet:</p><ol type=\"1\"><li>What Cervarix is and what it is used for</li><li>What you need to know before you receive Cervarix</li><li>How Cervarix is given</li><li>Possible side effects</li><li>How to store Cervarix</li><li>Contents of the pack and other information</li></ol></div>"
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"title" : "1. What cervarix is and what it is used for",
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Cervarix is a vaccine intended to protect from the age of 9 years against the diseases caused by infection with Human Papillomaviruses (HPV).</p><p>These diseases include:</p><ul><li>cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb) and anal cancer,</li><li>precancerous cervical, vulvar, vaginal and anal lesions (changes in genital or anal cells that have a risk of turning into cancer).</li></ul><p>The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related pre- cancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus. Other HPV types can also cause ano-genital cancers. Cervarix does not protect against all HPV types.</p><p>When a female or a male individual is vaccinated with Cervarix, the immune system (the body s natural defence system) will make antibodies against HPV types 16 and 18. Cervarix is not infectious and so, it cannot cause HPV related diseases.</p><p>Cervarix is not used to treat HPV related diseases already present at the time of vaccination.</p><p>Cervarix should be used in accordance with official guidelines.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Cervarix should not be given:</p><ul><li>if you are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.</li></ul><p>Warnings and precautions Talk to your doctor or pharmacist before you are given Cervarix</p><ul><li>if you have a bleeding problem or bruise easily.</li><li>if you have any disease which reduces your resistance to infection such as HIV infection.</li><li>if you have a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to the doctor first.</li></ul><p>Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if you or your child fainted with a previous injection.</p><p>As with all vaccines, Cervarix may not fully protect all people who are vaccinated.</p><p>Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.</p><p>Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening. You should continue to follow your doctor s advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.</p><p>As Cervarix will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.</p><p>Cervarix will not protect against other diseases that are not caused by Human Papillomavirus.</p><p>Other medicines and Cervarix Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.</p><p>Cervarix may not have an optimal effect if used with medicines that suppress the immune system.</p><p>In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.</p><p>Tell your doctor if you are taking, have recently taken, might take any other medicines, or have recently received any other vaccine.</p><p>Pregnancy, breast-feeding and fertility If you are pregnant, if pregnancy occurs during the course of vaccination or if you are trying to become pregnant it is recommended to postpone or interrupt vaccination until after completion of the pregnancy.</p><p>If you are pregnant or breast-feeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this vaccine.</p><p>Driving and using machines Cervarix is not likely to affect your ability to drive or use machines. However, do not drive or use any machines if you are feeling unwell.</p><p>Cervarix contains sodium chloride.</p><p>This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium- free .</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>How the vaccine is given The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm.</p><p>How much is given Cervarix is intended for use from 9 years of age onwards.</p><p>The total number of injections you will receive depends on your age at the time of the first injection.</p><p>If you are between 9 and 14 years old</p><p>You will receive 2 injections:</p><p>First injection: at chosen date Second injection: given between 5 and 13 months after first injection</p><p>If you are 15 years old or above</p><p>You will receive 3 injections:</p><p>First injection: at chosen date Second injection: 1 month after first injection Third injection: 6 months after first injection</p><p>If necessary, the vaccination schedule can be more flexible. Please speak to your doctor for more information.</p><p>When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete vaccination course.</p><p>Cervarix is not recommended for use below 9 years of age.</p><p>The vaccine should never be given into a vein.</p><p>If you miss a dose It is important that you follow the instructions of your doctor or nurse regarding return visits. If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.</p><p>If you do not finish the complete vaccination course (two or three injections depending on your age at vaccination), you may not get the best response and protection from the vaccination.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Like all medicines, this vaccine can cause side effects, although not everybody gets them.</p><p>Side effects that occurred during clinical trials with Cervarix were as follows:</p><p>Very common (side effects which may occur in more than 1 per 10 doses of vaccine):</p><ul><li>pain or discomfort at the injection site</li><li>redness or swelling at the injection site</li><li>headache</li><li>aching muscles, muscle tenderness or weakness (not caused by exercise)</li><li>tiredness</li></ul><p>Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine):</p><ul><li>gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain</li><li>itching, red skin rash, hives (urticaria)</li><li>joint pain</li><li>fever ( 38 C)</li></ul><p>Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,doses of vaccine):</p><ul><li>upper respiratory tract infection (infection of the nose, throat or trachea)</li><li>dizziness</li><li>other injection site reactions such as hard lump, tingling or numbness.</li></ul><p>Side effects that have been reported during marketed use of Cervarix include:</p><p>allergic reactions. These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness. These reactions will usually occur before leaving the doctor s surgery. However, if your child gets any of these symptoms you should contact a doctor urgently. swollen glands in the neck, armpit or groin fainting sometimes accompanied by shaking or stiffness.</p><p>Reporting of side effects If you get 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>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>Keep this vaccine out of the sight and reach of children.</p><p>Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.</p><p>Store in a refrigerator (2 C 8 C). Do not freeze.<br/>Store in the original package in order to protect from light.</p><p>Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.</p></div>"
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p>What Cervarix contains</p><ul><li>The active substances are:</li></ul><p>Human Papillomavirus1 type 16 L1 protein2,3,4 20 micrograms Human Papillomavirus1 type 18 L1 protein2,3,4 20 micrograms</p><p>1Human Papillomavirus = HPV</p><p>2adjuvanted by AS04 containing: 3-O-desacyl-4 - monophosphoryl lipid A (MPL)3 50 micrograms</p><p>3adsorbed on aluminium hydroxide, hydrated (Al(OH)3)<br/>0.5 milligrams Al3+ in total</p><p>4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni.</p><ul><li>The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) and water for injections.</li></ul><p>What Cervarix looks like and contents of the pack</p><p>Suspension for injection.</p><p>Cervarix is a turbid white suspension.</p><p>Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100. Not all pack sizes may be marketed.</p><p>Marketing Authorisation Holder and Manufacturer</p><p>GlaxoSmithKline Biologicals s.a. Rue de l'Institut B-1330 Rixensart, Belgium</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:</p><p>Belgique/Belgi /Belgien GlaxoSmithKline Pharmaceuticals SA./NV T l/Tel: + 32 10 85 52 Lietuva GlaxoSmithKline Biologicals SA Tel: +370 80000<br/>GlaxoSmithKline Biologicals SA . +359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA./NV T l/Tel: + 32 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 <a href=\"mailto:cz.info@gsk.com\">cz.info@gsk.com</a></p><p>Magyarorsz g GlaxoSmithKline Biologicals SA Tel.: +36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 <a href=\"mailto:dk-info@gsk.com\">dk-info@gsk.com</a></p><p>Malta GlaxoSmithKline Biologicals SA Tel: +356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 <a href=\"mailto:360448produkt.info@gsk.com\">360448produkt.info@gsk.com</a></p><p>Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GlaxoSmithKline Biologicals SA Tel: +372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20<br/>GlaxoSmithKline A.E.B.E T : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 <a href=\"mailto:at.info@gsk.com\">at.info@gsk.com</a></p><p>Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 <a href=\"mailto:es-ci@gsk.com\">es-ci@gsk.com</a></p><p>Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0) 1 39 17 84 <a href=\"mailto:diam@gsk.com\">diam@gsk.com</a></p><p>Hrvatska GlaxoSmithKline Biologicals SA Tel.: +385 800787Portugal GlaxoSmithKline - Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 <a href=\"mailto:FI.PT@gsk.com\">FI.PT@gsk.com</a></p><p>Rom nia GlaxoSmithKline Biologicals SA Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5Slovenija GlaxoSmithKline Biologicals SA Tel: +386 80688 sland Vistor hf.<br/>S mi: +354 535 7Slovensk republika GlaxoSmithKline Biologicals SA Tel.: +421 800500Italia GlaxoSmithKline S.p.A. Tel:+ 39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30<br/>GlaxoSmithKline Biologicals SA : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 <a href=\"mailto:info.produkt@gsk.com\">info.produkt@gsk.com</a></p><p>Latvija GlaxoSmithKline Biologicals SA Tel: +371 80205United Kingdom (Northern Ireland) GlaxoSmithKline Biologicals SA Tel: +44(0)800 <a href=\"mailto:221customercontactuk@gsk.com\">221customercontactuk@gsk.com</a></p><p>This leaflet was last revised in</p><p>Other sources of information</p><p>Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>"
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"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000002",
"display" : "Invented name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000003",
"display" : "Scientific name part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000004",
"display" : "Strength part"
}
]
}
},
{
"part" : "nan",
"type" : {
"coding" : [
{
"system" : "https://spor.ema.europa.eu/lists/220000000000",
"code" : "220000000005",
"display" : "Pharmaceutical dose form part"
}
]
}
}
],
"usage" : [
{
"country" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"jurisdiction" : {
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "EU",
"display" : "EU"
}
]
},
"language" : {
"coding" : [
{
"system" : "urn:ietf:bcp:47",
"code" : "en",
"display" : "en"
}
]
}
}
]
}
]
}
}
]
}
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.
