Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build
Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/joofio/test-epi-composition/ and changes regularly. See the Directory of published versions
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<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-53506f739e6f34ca79778a9dce57bf48"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-53506f739e6f34ca79778a9dce57bf48</b></p><a name="composition-en-53506f739e6f34ca79778a9dce57bf48"> </a><a name="hccomposition-en-53506f739e6f34ca79778a9dce57bf48"> </a><a name="composition-en-53506f739e6f34ca79778a9dce57bf48-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/1/20/1507/001</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 - spikevax</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>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Spikevax is and what it is used for</li><li>What you need to know before you are given Spikevax</li><li>How Spikevax is given</li><li>Possible side effects</li><li>How to store Spikevax</li><li>Contents of the pack and other information</li></ol></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Spikevax is a vaccine used to prevent COVID-19 caused by SARS-CoV-2. It is given to adults and children aged 6 months and older. The active substance in Spikevax is mRNA encoding the SARS-CoV-2 spike protein. The mRNA is embedded in SM-102 lipid nanoparticles.</p><p>As Spikevax does not contain the virus, it cannot give you COVID-19. How the vaccine works<br/>Spikevax stimulates the body s natural defences (immune system). The vaccine works by causing the body to produce protection (antibodies) against the virus that causes COVID-19. Spikevax uses a substance called messenger ribonucleic acid (mRNA) to carry instructions that cells in the body can use to make the spike protein that is also on the virus. The cells then make antibodies against the spike protein to help fight off the virus. This will help to protect you against COVID-19.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>The vaccine must not be given if you are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).</p><p>Warnings and precautions<br/>Talk to your doctor, pharmacist or nurse before you are given Spikevax if:</p><ul><li>you have previously had a severe, life-threatening allergic reaction after any other vaccine injection or after you were given Spikevax in the past.</li><li>you have a very weak or compromised immune system</li><li>you have ever fainted following any needle injection.</li><li>you have a bleeding disorder</li><li>you have a high fever or severe infection; however, you can have your vaccination if you have a mild fever or upper airway infection like a cold</li><li>you have any serious illness</li><li>if you have anxiety related to injections</li></ul><p>There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Spikevax (see section 4).</p><p>These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. They have been observed more often in younger males, and more often after the second dose compared to the first dose.</p><p>Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen.</p><p>Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur.</p><p>If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Spikevax.</p><p>Capillary leak syndrome (CLS) flare-ups A few cases of capillary leak syndrome flare-ups (causing fluid leakage from small blood vessels (capillaries) resulting in rapid swelling of the arms and legs, sudden weight gain and feeling faint, low blood pressure) have been reported following vaccination with Spikevax. If you have previously had episodes of CLS, talk to a doctor before you are given Spikevax.</p><p>Duration of protection As with any vaccine, the primary 2-dose vaccination course of Spikevax may not fully protect all those who receive it and it is not known how long you will be protected.</p><p>Children<br/>Spikevax is not recommended for children aged under 6 months.</p><p>Other medicines and Spikevax Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Spikevax may affect the way other medicines work, and other medicines may affect how Spikevax works.</p><p>Immunocompromised individuals If you are immunocompromised, you may receive a third dose of Spikevax. The efficacy of Spikevax even after a third dose may be lower in people who are immunocompromised. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor.</p><p>Pregnancy and breast-feeding<br/>If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. Spikevax can be used during pregnancy. A large amount of information from pregnant women vaccinated with Spikevax during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination during the first trimester is limited, no change to the risk for miscarriage has been seen.<br/>Spikevax can be given during breastfeeding.</p><p>Driving and using machines Do not drive or use machines if you are feeling unwell after vaccination. Wait until any effects of the vaccine have worn off before you drive or use machines.</p><p>Spikevax contains sodium This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Table 1. Spikevax dosing for primary series, a third dose in severely immunocompromised and booster doses</p><p>Strength Vaccination type Age(s)</p><p>Dose Recommendations Spikevax 0.2 mg/mL dispersion for injection</p><p>Primary series</p><p>Individuals 12 years of age and older</p><p>2 (two) doses (0.5 mL each, containing 100 micrograms mRNA)</p><p>It is recommended to administer the second dose 28 days after the first dose.</p><p>Children 6 years through 11 years of age</p><p>2 (two) doses (0.25 mL each, containing 50 micrograms mRNA, which is half of the primary dose for individuals 12 years and older)</p><p>Third dose in severely immuno- compromised Individuals 12 years of age and older</p><p>1 (one) dose of 0.5 mL, containing 100 micrograms mRNA</p><p>A third dose may be given at least 28 days after the second dose. Children 6 years through 11 years of age</p><p>1 (one) dose of 0.25 mL, containing 50 micrograms mRNA Booster dose</p><p>Individuals 12 years of age and older</p><p>1 (one) dose of 0.25 mL, containing 50 micrograms mRNA<br/>Spikevax may be used to boost individuals 12 years of age and older who have received a primary series with Spikevax or a primary series comprised of another mRNA vaccine or adenoviral vector Strength Vaccination type Age(s)</p><p>Dose Recommendations vaccine at least 3 months after completion of the primary series.</p><p>Spikevax 0.1 mg/mL dispersion for injection and Spikevax 50 micrograms dispersion for injection in pre- filled syringe*</p><p>Primary series<br/>Children 6 years through 11 years of age 2 (two) doses (0.5 mL each, containing 50 micrograms mRNA each)</p><p>It is recommended to administer the second dose 28 days after the first dose. Children 6 months through 5 years of age 2 (two) doses (0.25 mL each, containing 25 micrograms mRNA each, which is half of the primary dose for children 6 years through years of age)*</p><p>Third dose in severely immuno- compromised<br/>Children 6 years through 11 years of age</p><p>1 (one) dose of 0.5 mL, containing 50 micrograms mRNA</p><p>A third dose may be given at least 28 days after the second dose. Children 6 months through 5 years of age</p><p>1 (one) dose of 0.25 mL, containing 25 micrograms mRNA*</p><p>Booster dose</p><p>Individuals 12 years of age and older</p><p>1 (one) dose of 0.5 mL, containing 50 micrograms mRNA<br/>Spikevax may be used to boost individuals 6 years of age and older who have received a primary series with Spikevax or a primary series comprised of another mRNA vaccine or adenoviral vector vaccine at least 3 months after completion of the primary series.</p><p>Children 6 years through 11 years of age 1 (one) dose of 0.25 mL, containing 25 micrograms mRNA*<br/>*Do not use the pre-filled syringe to deliver a partial volume of 0.25 mL. For primary series for individuals 12 years of age and older, the 0.2 mg/mL strength vial should be used. For the third dose in severely immunocompromised individuals 12 years of age and older, the 0.2 mg/mL strength vial should be used. If you miss an appointment for your primary 2nd dose of Spikevax</p><ul><li>If you miss an appointment, arrange another visit as soon as possible with your doctor, pharmacist or nurse.</li><li>If you miss a scheduled injection, you may not be fully protected against COVID-19. Your doctor, pharmacist or nurse will inject the vaccine into a muscle (intramuscular injection) in your upper arm.</li></ul><p>After each injection of the vaccine, your doctor, pharmacist or nurse will watch over you for at least 15 minutes to monitor for signs of an allergic reaction.</p><p>If you have any further questions on the use of this vaccine, ask your doctor, pharmacist or nurse.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all medicines, this vaccine can cause side effects, although not everybody gets them.</p><p>Get urgent medical attention if you get any of the following signs and symptoms of an allergic reaction:</p><ul><li>feeling faint or light-headed;</li><li>changes in your heartbeat;</li><li>shortness of breath;</li><li>wheezing;</li><li>swelling of your lips, face, or throat;</li><li>hives or rash;</li><li>nausea or vomiting;</li><li>stomach pain.</li></ul><p>Talk to your doctor or nurse if you develop any other side effects. These can include:</p><p>Very common (may affect more than 1 in 10 people):</p><ul><li>swelling/tenderness in the underarm</li><li>decreased appetite (observed in 6 month to 5 year olds)</li><li>irritability/crying (observed in 6 month to 5 year olds)</li><li>headache</li><li>sleepiness (observed in 6 month to 5 year olds)</li><li>nausea</li><li>vomiting</li><li>muscle ache, joint aches, and stiffness</li><li>pain or swelling at the injection site</li><li>redness at the injection site (some of which may occur approximately 9 to 11 days after the injection)</li><li>feeling very tired</li><li>chills</li><li>fever</li></ul><p>Common (may affect up to 1 in 10 people):</p><ul><li>diarrhoea</li><li>rash</li><li>rash or hives at the injection site (some of which may occur approximately 9 to 11 days after the injection)</li></ul><p>Uncommon (may affect up to 1 in 100 people):</p><ul><li>itchiness at the injection site</li><li>dizziness</li><li>stomach pain</li><li>raised, itchy rash (urticaria) (which may occur from the time of injection and up to approximately two weeks after the injection)</li></ul><p>Rare (may affect up to 1 in 1 000 people)</p><ul><li>temporary one-sided facial drooping (Bell s palsy)</li><li>swelling of the face (swelling of the face may occur in individuals who have had facial cosmetic injections.)</li><li>decreased sense of touch or sensation</li><li>unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)</li></ul><p>Very rare (may affect up to 1 in 10 000 people)</p><ul><li>inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain</li></ul><p>Frequency not known</p><ul><li>severe allergic reactions with breathing difficulties (anaphylaxis)</li><li>reaction of increased sensitivity or intolerance by the immune system (hypersensitivity)</li><li>a skin reaction that causes red spots or patches on the skin that may look like a target or bulls-eye with a dark red centre surrounded by paler red rings (erythema multiforme)</li><li>extensive swelling of the vaccinated limb</li><li>heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)</li><li>rash elicited by external stimulus such as firm stroking, scratching, or pressure to the skin (mechanical urticaria)</li></ul><p>Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this vaccine.</p></div>
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<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 label after EXP. The expiry date refers to the last day of that month.</p><p>Information about storage, expiry, and use and handling are described in the section intended for healthcare professionals at the end of the package leaflet.</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 protect the environment.</p></div>
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<div xmlns="http://www.w3.org/1999/xhtml"><p>What Spikevax contains</p><p>Table 2. Composition by container type</p><p>Strength Container Dose(s) Composition</p><p>Spikevax 0.2 mg/mL dispersion for injection Multidose vial Maximum 10 doses<br/>of 0.5 mL each<br/>One dose (0.5 mL) contains 100 micrograms of elasomeran, a Strength Container Dose(s) Composition</p><p>COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM-102 lipid nanoparticles).<br/>Maximum 20 doses of 0.25 mL each</p><p>One dose (0.25 mL) contains 50 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM-102 lipid nanoparticles).</p><p>Spikevax 0.1 mg/mL dispersion for injection</p><p>Multidose vial</p><p>5 doses<br/>of 0.5 mL each</p><p>Maximum 10 doses of 0.25 mL each<br/>One dose (0.5 mL) contains 50 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM-102 lipid nanoparticles).</p><p>One dose (0.25 mL) contains 25 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM-102 lipid nanoparticles).</p><p>Spikevax 50 micrograms dispersion for injection in pre-filled syringe Pre-filled syringe 1 dose of 0.5 mL</p><p>For single-use only.</p><p>Do not use the pre-filled syringe to deliver a partial volume of 0.25 mL.</p><p>One dose (0.5 mL) contains 50 micrograms of elasomeran, a COVID-19 mRNA Vaccine (nucleoside modified) (embedded in SM-102 lipid nanoparticles).</p><p>Elasomeran is a single-stranded, 5 -capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2 (original).</p><p>The other ingredients are SM-102 (heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6- (undecyloxy)hexyl]amino}octanoate), cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), 1,2-Dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG), trometamol, trometamol hydrochloride, acetic acid, sodium acetate trihydrate, sucrose, water for injections.</p><p>What Spikevax looks like and contents of the pack</p><p>Spikevax 0.2 mg/mL dispersion for injection</p><p>Spikevax is a white to off white dispersion supplied in a 5 mL glass vial with a rubber stopper and red flip-off plastic cap with aluminium seal.</p><p>Pack size: 10 multidose vials</p><p>Spikevax 0.1 mg/mL dispersion for injection</p><p>Spikevax is a white to off white dispersion supplied in a 2.5 mL glass vial with a rubber stopper and blue flip-off plastic cap with aluminium seal.</p><p>Pack size: 10 multidose vials</p><p>Spikevax 50 micrograms dispersion for injection in pre-filled syringe</p><p>Spikevax is a white to off white dispersion supplied in a pre-filled syringe (cyclic olefin polymer) with plunger stopper and a tip cap (without needle).</p><p>The pre-filled syringe is packaged in 5 clear blisters containing 2 pre-filled syringes in each blister.</p><p>Pack size: 10 pre-filled syringes</p><p>Marketing Authorisation Holder MODERNA BIOTECH SPAIN, S.L.<br/>C/ Juli n Camarillo n 28037 Madrid Spain</p><p>Manufacturers</p><p>For multidose vials</p><p>Rovi Pharma Industrial Services, S.A.<br/>Paseo de Europa, 28703. San Sebasti n de los Reyes Madrid Spain</p><p>Recipharm Monts 18 Rue de Montbazon Monts, France 37Moderna Biotech Spain S.L. C/ Juli n Camarillo n 28037 Madrid Spain</p><p>For pre-filled syringe</p><p>Rovi Pharma Industrial Services, S.A. Calle Juli n Camarillo n 28037 Madrid<br/>Spain</p><p>For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.</p><p>Belgi /Belgique/Belgien T l/Tel: 0800 81 Lietuva Tel: 88 003 1<br/>Te : 0800 115 4Luxembourg/Luxemburg T l/Tel: 800 85 esk republika Tel: 800 050 Magyarorsz g Tel: 06 809 87Danmark Tlf: 80 81 06 Malta Tel: 8006 5Deutschland Tel: 0800 100 9Nederland Tel: 0800 409 0Eesti Tel: 800 0044 Norge Tlf: 800 31<br/>: +30 800 000 0 sterreich Tel: 0800 909Espa a Tel: 900 031 Polska Tel: 800 702 France T l: 0805 54 30 Portugal Tel: 800 210 Hrvatska Tel: 08009Ireland Tel: 1800 800 Rom nia Tel: 0800 400 Slovenija Tel: 080 083 sland S mi: 800 4Slovensk republika Tel: 0800 191 Italia Tel: 800 928 Suomi/Finland Puh/Tel: 0800 774<br/>: 80091Sverige Tel: 020 10 92 Latvija Tel: 80 005 United Kingdom (Northern Ireland) Tel: 0800 085 7This leaflet was last revised in</p><p>Scan the code with a mobile device to get the package leaflet in different languages.</p><p>Or visit the URL <a href="https://www.ModernaCovid19Global.com">https://www.ModernaCovid19Global.com</a></p><p>Detailed information on this vaccine is available on the European Medicines Agency web site: <a href="http://www.ema.europa.eu">http://www.ema.europa.eu</a>.</p><p>This leaflet is available in all EU/EEA languages on the European Medicines Agency website.</p><hr/><p>The following information is intended for healthcare professionals only:</p><p>Traceability</p><p>In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.</p><p>Storage and preparation for administration</p><p>Spikevax should be administered by a trained healthcare professional.</p><p>The vaccine comes ready to use once thawed.</p><p>Do not shake or dilute.</p><p>The vaccine should be inspected visually for particulate matter and discolouration prior to administration.</p><p>Spikevax is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.</p><p>Store vials and pre-filled syringes in a freezer at -50 C to -15 C.</p><p>Keep the vial and pre-filled syringe in the outer carton in order to protect from light.</p><p>Spikevax 0.2 mg/mL dispersion for injection (multidose vials with a red flip-off cap)</p><p>Ten (10) doses (of 0.5 mL each) or a maximum of twenty (20) doses (of 0.25 mL each) can be withdrawn from each multidose vial.</p><p>Pierce the stopper preferably at a different site each time. Do not puncture the red-cap vial more than 20 times.</p><p>Verify that the vial has a red flip-off cap and the product name is Spikevax 0.2 mg/mL. If the vial has a blue flip-off cap and the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, please make reference to the Summary of Product Characteristics for that formulation.</p><p>Thaw each multidose vial before use following the instructions below (Table 3). When the vial is thawed in the refrigerator, let it sit at room temperature for 15 minutes before administering.</p><p>Table 3. Thawing instructions for multidose vials before use</p><p>Configuration Thaw instructions and duration Thaw temperature (in a refrigerator) Thaw duration</p><p>Thaw temperature (at room temperature) Thaw duration</p><p>Multidose vial<br/>2 8 C 2 hours and 30 minutes 15 C 25 C 1 hour</p><p>Spikevax 0.1 mg/mL dispersion for injection (multidose vials with a blue flip-off cap)</p><p>Five (5) doses (of 0.5 mL each) or a maximum of ten (10) doses (of 0.25 mL each) can be withdrawn from each multidose vial.</p><p>Pierce the stopper preferably at a different site each time.</p><p>Verify that the vial has a blue flip-off cap and the product name is Spikevax 0.1 mg/mL. If the vial has a blue flip-off cap and the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, please make reference to the Summary of Product Characteristics for that formulation.</p><p>Thaw each multidose vial before use following the instructions below (Table 4). When the vial is thawed in the refrigerator, let it sit at room temperature for 15 minutes before administering.</p><p>Table 4. Thawing instructions for multidose vials before use</p><p>Configuration Thaw instructions and duration Thaw temperature (in a refrigerator) Thaw duration</p><p>Thaw temperature (at room temperature) Thaw duration</p><p>Multidose vial<br/>2 8 C 2 hours and 30 minutes<br/>15 C 25 C 1 hour</p><p>Spikevax 50 micrograms dispersion for injection in pre-filled syringe</p><p>Do not shake or dilute the contents of the pre-filled syringe.</p><p>Each pre-filled syringe is for single use only. The vaccine comes ready to use once thawed.</p><p>One (1) dose of 0.5 mL can be administered from each pre-filled syringe. Do not use the pre-filled syringe to deliver a partial volume of 0.25 mL.</p><p>Spikevax is supplied in a single-dose, pre-filled syringe (without needle) containing 0.5 mL (50 micrograms) mRNA and must be thawed prior to administration.</p><p>During storage, minimise exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.</p><p>Thaw each pre-filled syringe before use following the instructions below. Syringes may be thawed in the blister packs (each blister containing 2 pre-filled syringes) or in the carton itself, either in the refrigerator or at room temperature (Table 5). When the syringe is thawed in the refrigerator, let it sit at room temperature for 15 minutes before administering.</p><p>Table 5. Thawing instructions for pre-filled syringes and cartons before use</p><p>Configuration Thaw instructions and duration Thaw temperature (in a refrigerator) ( C) Thaw duration (minutes) Thaw temperature (at room temperature) ( C) Thaw duration (minutes) Pre-filled syringe in blister pack<br/>2 8 15 Carton 2 8 15 Verify that the product name of the pre-filled syringe is Spikevax 50 micrograms. If the product name is Spikevax bivalent Original/Omicron BA.1 or Spikevax bivalent Original/Omicron BA.4-5, please make reference to the Summary of Product Characteristics for that formulation.</p><p>Handling instructions for the pre-filled syringes</p><ul><li>Let each pre-filled syringe stand at room temperature (15 C to 25 C) for 15 minutes before administering.</li><li>Do not shake.</li><li>Pre-filled syringe should be inspected visually for particulate matter and discolouration prior to administration.</li><li>Spikevax is a white to off-white dispersion. It may contain white or translucent product-related particulates. Do not administer if vaccine is discoloured or contains other particulate matter.</li><li>Needles are not included in the pre-filled syringe cartons.</li><li>Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner needles).</li><li>With tip cap upright, remove tip cap by twisting counter-clockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.</li><li>Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.</li><li>Uncap the needle when ready for administration.</li><li>Administer the entire dose intramuscularly.</li><li>After thawing, do not refreeze.</li></ul><p>Disposal</p><p>Any unused medicinal product or waste material should be disposed of in accordance with local requirements.</p><p>Dosing and schedule</p><p>Table 6. Spikevax dosing for primary series, a third dose in severely immunocompromised and booster doses</p><p>Vaccination Spikevax 0.2 mg/mL dispersion for injection Spikevax 0.1 mg/mL dispersion for injection and Spikevax 50 micrograms dispersion for injection in pre-filled syringe*</p><p>Primary series</p><p>It is recommended to get the second dose of the same vaccine 28 days after the first dose to complete the vaccination course.</p><p>Individuals 12 years of age and older two 0.5 mL injections</p><p>Not applicable<br/>Children 6 years through 11 years of age<br/>two 0.25 mL injections</p><p>Children 6 years through 11 years of age<br/>two 0.5 mL injections</p><p>Not applicable Children 6 months through 5 years of age two 0.25 mL injections* Third dose in severely immunocompromised</p><p>at least 1 month after the second dose</p><p>Individuals 12 years of age and older 0.5 mL<br/>Not applicable<br/>Children 6 years through 11 years of age<br/>0.25 mL<br/>Children 6 years through 11 years of age<br/>0.5 mL</p><p>Not applicable Children 6 months through 5 years of age 0.25 mL*</p><p>Booster dose</p><p>may be given at least 3 months after the second dose Individuals 12 years of age and older 0.25 mL<br/>Individuals 12 years of age and older 0.5 mL<br/>Not applicable Individuals 6 years of age and older 0.25 mL*</p><ul><li>Do not use the pre-filled syringe to deliver a partial volume of 0.25 mL. For primary series for individuals 12 years of age and older, the 0.2 mg/mL strength vial should be used. For the third dose in severely immunocompromised individuals 12 years of age and older, the 0.2 mg/mL strength vial should be used.</li></ul><p>As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in the event of an anaphylactic reaction following the administration of Spikevax.</p><p>Individuals should be observed by a healthcare professional for at least 15 minutes after vaccination.</p><p>High-dose quadrivalent influenza vaccine can be concomitantly administered with Spikevax.<br/>Spikevax must not be mixed with other vaccines or medicinal products in the same syringe.</p><p>Administration</p><p>The vaccine must be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm or in infants and young children, the anterolateral aspect of the thigh. Do not administer this vaccine intravascularly, subcutaneously or intradermally.</p><p>Multidose vials</p><p>Pre-filled syringes Use a sterile needle of the appropriate size for intramuscular injection (21-gauge or thinner). With tip cap upright, remove tip cap by twisting counter-clockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting. Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe. Uncap the needle when ready for administration. Administer the entire dose intramuscularly. Discard syringe after use. For single-use only.</p><p>Package leaflet: Information for the user</p><p>Spikevax bivalent Original/Omicron BA.1<br/>(50 micrograms/50 micrograms)/mL dispersion for injection<br/>Spikevax bivalent Original/Omicron BA.1<br/>25 micrograms/25 micrograms dispersion for injection<br/>Spikevax bivalent Original/Omicron BA.1<br/>25 micrograms/25 micrograms dispersion for injection in pre-filled syringe<br/>COVID-19 mRNA Vaccine elasomeran/imelasomeran</p><p>This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.</p><p>Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.</p><ul><li>Keep this leaflet. You may need to read it again.</li><li>If you have any further questions, ask your doctor, pharmacist or nurse.</li><li>If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.</li></ul></div>
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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.
