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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-6ae111423490277c4fbffcad4c0c9c2c"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi"/>
</meta>
<language value="en"/>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="None"/>
</identifier>
<type value="document"/>
<timestamp value="2023-06-27T10:09:22Z"/>
<entry>
<fullUrl
value="Composition/composition-en-6ae111423490277c4fbffcad4c0c9c2c"/>
<resource>
<Composition>
<id value="composition-en-6ae111423490277c4fbffcad4c0c9c2c"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi"/>
</meta>
<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml" xml:lang="en" lang="en"><a name="Composition_composition-en-6ae111423490277c4fbffcad4c0c9c2c"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-6ae111423490277c4fbffcad4c0c9c2c</b></p><a name="composition-en-6ae111423490277c4fbffcad4c0c9c2c"> </a><a name="hccomposition-en-6ae111423490277c4fbffcad4c0c9c2c"> </a><a name="composition-en-6ae111423490277c4fbffcad4c0c9c2c-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/1/20/1423/001</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 - vaxchora</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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/20/1423/001"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package Leaflet"/>
</type>
<category>
<coding>
<system
value="http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs"/>
<code value="R"/>
<display value="Raw"/>
</coding>
</category>
<subject>
<reference
value="MedicinalProductDefinition/mp6ae111423490277c4fbffcad4c0c9c2c"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - vaxchora"/>
<attester>
<mode>
<coding>
<system
value="http://hl7.org/fhir/composition-attestation-mode"/>
<code value="official"/>
</coding>
</mode>
<time value="2022-02-16T13:28:17Z"/>
</attester>
<section>
<title value="B. Package Leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="B. Package Leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml">unavailable</div>
</text>
<emptyReason>
<coding>
<system
value="http://terminology.hl7.org/CodeSystem/list-empty-reason"/>
<code value="unavailable"/>
</coding>
</emptyReason>
<section>
<title value="Package leaflet: Information for the user"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="Package leaflet: Information for the user"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"></div>
</text>
</section>
<section>
<title value="What is in this leaflet"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="What is in this leaflet"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What is in this leaflet</p><ol type="1"><li>What Vaxchora is and what it is used for</li><li>What you need to know before you take Vaxchora</li><li>How to take Vaxchora</li><li>Possible side effects</li><li>How to store Vaxchora</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What vaxchora is and what it is used for"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="1. What vaxchora is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Vaxchora is an oral vaccine against cholera that stimulates the immunological defence in the gut. The vaccine is used for protection from cholera in adults and children aged 2 years and older. The vaccine must be taken at least 10 days before travelling to a cholera-affected area. How Vaxchora works Vaxchora prepares the immune system (the body's defences) to defend itself against cholera. When a person takes the vaccine, the immune system makes proteins called antibodies against the cholera bacterium and its toxin (harmful substance) that causes diarrhoea. In this way the immune system is ready to fight cholera bacteria if the person comes into contact with it.</p></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take vaxchora"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text
value="2. What you need to know before you take vaxchora"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><h2 id="do-not-take-vaxchora">Do not take Vaxchora:</h2><h2 id="if-you-are-allergic-to-any-of-the-ingredients-in-this-medicine-listed-in-section-6">if you are allergic to any of the ingredients in this medicine (listed in section 6).</h2><h2 id="if-you-had-allergic-reactions-when-you-previously-took-vaxchora">if you had allergic reactions when you previously took Vaxchora.</h2><p>if you have a weakened immune system, for example, if you were born with a weakened immune system or if you are having treatments such as high-dose corticosteroid treatment, cancer medicines or radiotherapy that can weaken the immune system. Warnings and precautions Talk to your doctor, pharmacist, or nurse before taking Vaxchora. Not everyone taking Vaxchora will be fully protected against cholera. It is important to continue to follow hygiene advice and take special care with food and water in cholera-affected areas. Vaxchora may be less effective if you have HIV. Bacteria from the vaccine may be present in your stool for at least 7 days after you take the vaccine. To prevent any contamination, wash your hands thoroughly after visiting the toilet, changing nappies and before preparing food for at least 14 days after you take Vaxchora. Children and adolescents Do not give this vaccine to children younger than 2 years of age because it is not known how well it works in this age group. Other medicines and Vaxchora Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines or vaccines. This includes medicines obtained without a prescription, including herbal medicines. This is because Vaxchora can affect the way some other medicines and vaccines work.<br/>In particular tell your doctor, pharmacist or nurse if you are taking:</p><p>antibiotics Vaxchora may not work if you take it while you are also taking antibiotics. Take Vaxchora no earlier than 14 days after the last dose of an antibiotic. Avoid antibiotics for days after taking Vaxchora.</p><p>chloroquine for malaria prevention Vaxchora may not work if you take it while you are also taking chloroquine. Take Vaxchora at least 10 days before starting chloroquine or 14 days after taking chloroquine.</p><p>the typhoid vaccine Ty21a Vaxchora may not work if it is taken at the same time as Ty21a. You should take Vaxchora at least 2 hours before or after taking Ty21a. If any of the above apply to you, talk to your doctor, pharmacist or nurse before taking Vaxchora. Vaxchora with food and drink You must not eat or drink for 60 minutes before and after taking Vaxchora as this may reduce the vaccine s effectiveness. Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines Vaxchora 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. Vaxchora contains lactose, sucrose, and sodium If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicinal product. This vaccine contains 863 mg of sodium (the main component of cooking/table salt) per dose. This is equivalent to 43% of the recommended daily dietary intake of sodium for an adult. Please take this into account if you are on a controlled sodium diet.</p></div>
</text>
</section>
<section>
<title value="3. How to take vaxchora"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take vaxchora"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Always take this vaccine exactly as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. The recommended dose is the contents of both sachets in the carton. However for children 2 to less than 6 years old take note of Step 8 in the instructions on how to prepare the vaccine, shown below. Protection against cholera is established within 10 days after taking Vaxchora. Your doctor, pharmacist or nurse will tell you how soon before travelling to take the vaccine. Instructions: PREPARE THIS VACCINE EXACTLY AS DESCRIBED IN THIS LEAFLET Please read the following before you begin: Vaxchora may not work if the following occurs:</p><p>Incorrect storage; the vaccine must be stored in the refrigerator.</p><p>Using the incorrect amount of water; 100 mL must be used.</p><p>Using the incorrect type of water; bottled water that is cold or room temperature and non- carbonated or carbonated must be used.</p><p>Mixing the sachets in the wrong order; sachet 1 must be added to the water first. If the sachets are mixed in the wrong order you must discard the vaccine and request a replacement dose.</p><p>Eating or drinking; must be avoided 60 minutes before and after taking the vaccine, eating or drinking can reduce the effectiveness of the vaccine. Do not touch your eyes when you prepare the vaccine to avoid contamination. If any powder or liquid gets spilt, clean the surface with hot water and soap or an antibacterial disinfectant. If there is a significant spill (more than a few drops of liquid or grains of powder), dispose of the vaccine and get a new one from your doctor or pharmacist; DO NOT take the remaining medication. Step 1 Gather materials:</p><p>Clean cup</p><p>Utensil to stir</p><p>Bottled water (non-carbonated or carbonated, cold or room temperature, 25 C or less)</p><p>Item to measure 100 mL of bottled water (e.g. measuring jug)</p><p>Scissors Step 2 Remove the vaccine from the refrigerator. Step 3 Locate the two sachets: the sachets are labelled 1 and 2. Sachet 1 contains Sodium hydrogen carbonate effervescent powder (buffer) and is black and white. Sachet 2 contains Vaxchora Active ingredient and is blue and white. If a sachet is not intact, do not use either sachet and contact your doctor, pharmacist or nurse about acquiring a replacement dose; using a sachet that is not intact can reduce the effectiveness of the vaccine.. Step 4 Measure 100 mL of bottled cold or room temperature non-carbonated or carbonated water and pour into a clean cup. Using bottled water is necessary for the vaccine to be effective using non-bottled (e.g. tap water) may render the vaccine ineffective. Step 5 Use scissors to cut off the top of sachet 1. Do not put your fingers into the sachet. Wash your hands if you touch the sachet contents, in order to reduce the chance of contamination. Step 6 Empty the contents of sachet 1 into the water in the cup. It will fizz. Step 7 Stir until the powder completely dissolves. Step 8 For children age 2 to <6 years only:<br/>Pour away and discard half of the buffer solution. (Note: For children over 6 years and adults this step is NOT required) Step 9 Use scissors to cut off the top of sachet 2. Do not put your fingers into the sachet. Wash your hands if you touch the sachet contents, in order to reduce the chance of contamination.<br/>Step Empty the contents of sachet 2 into the cup. Step Stir for at least 30 seconds. The powder from sachet 2 may not dissolve completely. It will form a slightly cloudy mixture with some white particles. If desired, after stirring in sachet 2 for at least 30 seconds, stevia sweetener (no more than 1 gram or teaspoon) or sugar (sucrose, not more than 4 grams or 1 teaspoon) may be added, and then stirred into the suspension. DO NOT add other sweeteners as this may reduce the effectiveness of the vaccine. Step Drink the full contents of the cup within minutes of preparing it. Some residue may remain in the cup and must be discarded. If you or your child take less than half of the dose, contact your doctor, pharmacist, or nurse right away about the need for a repeat dose. Step Dispose of the empty sachets according to local biosafety guidelines. Ask your doctor, pharmacist or nurse how to throw away medicine waste material. Step If a spill occurs while stirring or drinking the medication, or there is any residue (powder or liquid left behind from a stirring utensil, cup, or other object) on the mixing surface, clean up spilled material or residue preferably with a disposable paper towel/cloth using hot water and soap or antibacterial disinfectant. Discard the paper towel together with the sachets (see above). Step Wash the cup and spoon or stirrer with soap and hot water.<br/>Step Wash your hands thoroughly with soap and hot water to prevent contamination. If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.</p></div>
</text>
</section>
<section>
<title value="4. Possible side effects"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="4. Possible side effects"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Like all vaccines, this vaccine can cause side effects, although not everybody gets them. Contact a doctor immediately if you get the following serious side effects:</p><p>serious allergic reactions causing swelling of the face or throat,hives, itchy rash, breathlessness and/or a drop in blood pressure and fainting. Other side effects: Very common side effects (may affect more than 1 in 10 people)</p><p>headache,</p><p>stomach pains,</p><p>feeling or being sick,</p><p>lack of appetite,</p><p>tiredness. Common side effects (may affect up to 1 in 10 people)</p><p>diarrhoea. Uncommon side effects (may affect up to 1 in 100 people)</p><p>flatulence,</p><p>constipation,</p><p>bloating (abdominal distension),</p><p>indigestion,</p><p>abnormal faeces,</p><p>dry mouth,</p><p>burping,</p><p>fever,</p><p>dizziness,</p><p>joint pain,</p><p>rash. Rare side effects (may affect up to 1 in 1,000 people):</p><p>chills. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.</p></div>
</text>
</section>
<section>
<title value="5. How to store vaxchora"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store vaxchora"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Keep this vaccine out of the sight and reach of children. Do not use Vaxchora after the expiry date which is stated on the carton. The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Store in the original package. Vaxchora in the original package is stable for up to 12 hours at 25 C. Avoid exposing Vaxchora to temperatures above 25 C. Do not use this vaccine if you notice the sachets are damaged and contact your doctor, pharmacist, or nurse for a replacement dose. This medicine contains genetically-modified organisms. Local biosafety guidelines should be followed for unused medicine or waste material. Ask your doctor, pharmacist or nurse how to throw away medicines you no longer use or waste material.</p></div>
</text>
</section>
<section>
<title value="6. Contents of the pack and other information"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="6. Contents of the pack and other information"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><h2 id="what-vaxchora-contains">What Vaxchora contains</h2><h2 id="each-dose-contains-4x108-to-2x109-viable-cells-of-v-cholerae-strain-cvd-103-hgr">Each dose contains 4x108 to 2x109 viable cells of V. cholerae strain CVD 103-HgR.</h2><h2 id="the-other-ingredients-are-sucrose-hydrolysed-casein-ascorbic-acid-lactose-sodium-bicarbonate-and-sodium-carbonate">The other ingredients are sucrose, hydrolysed casein, ascorbic acid, lactose, sodium bicarbonate, and sodium carbonate.</h2><p>This vaccine contains genetically modified organisms (GMOs). What Vaxchora looks like and contents of the pack The carton contains two sachets. One sachet contains white-to-off-white buffer sodium hydrogen carbonate effervescent powder. The other sachet contains white-to-beige active ingredient vaccine powder. Marketing Authorisation Holder Bavarian Nordic A/S, Philip Heymans Alle 3, DK-2900 Hellerup, Denmark. Manufacturer IL-CSM GmbH Marie-Curie-Strasse 8 D-79539 L rrach Germany This leaflet was last revised in MM/YYYY. Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site:</p></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mp6ae111423490277c4fbffcad4c0c9c2c"/>
<resource>
<MedicinalProductDefinition>
<id value="mp6ae111423490277c4fbffcad4c0c9c2c"/>
<meta>
<profile
value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"/>
</meta>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><a name="MedicinalProductDefinition_mp6ae111423490277c4fbffcad4c0c9c2c"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mp6ae111423490277c4fbffcad4c0c9c2c</b></p><a name="mp6ae111423490277c4fbffcad4c0c9c2c"> </a><a name="hcmp6ae111423490277c4fbffcad4c0c9c2c"> </a><a name="mp6ae111423490277c4fbffcad4c0c9c2c-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/20/1423/001</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>: Vaxchora effervescent powder and powder for oral suspension</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: nan</p><p><b>type</b>: <span title="Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:iso:std:iso:3166 EU}">EU</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">en</span></td></tr></table></blockquote></div>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/20/1423/001"/>
</identifier>
<type>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-type"/>
<code value="MedicinalProduct"/>
<display value="Medicinal Product"/>
</coding>
</type>
<domain>
<coding>
<system value="http://hl7.org/fhir/medicinal-product-domain"/>
<code value="Human"/>
<display value="Human use"/>
</coding>
</domain>
<status>
<coding>
<system value="http://hl7.org/fhir/publication-status"/>
<code value="active"/>
<display value="active"/>
</coding>
</status>
<legalStatusOfSupply>
<coding>
<system value="https://spor.ema.europa.eu/rmswi"/>
<code value="100000072084"/>
<display
value="Medicinal product subject to medical prescription"/>
</coding>
</legalStatusOfSupply>
<name>
<productName
value="Vaxchora effervescent powder and powder for oral suspension"/>
<type>
<coding>
<system value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000001"/>
<display value="Full name"/>
</coding>
</type>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000002"/>
<display value="Invented name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000003"/>
<display value="Scientific name part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000004"/>
<display value="Strength part"/>
</coding>
</type>
</part>
<part>
<part value="nan"/>
<type>
<coding>
<system
value="https://spor.ema.europa.eu/lists/220000000000"/>
<code value="220000000005"/>
<display value="Pharmaceutical dose form part"/>
</coding>
</type>
</part>
<usage>
<country>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</country>
<jurisdiction>
<coding>
<system value="urn:iso:std:iso:3166"/>
<code value="EU"/>
<display value="EU"/>
</coding>
</jurisdiction>
<language>
<coding>
<system value="urn:ietf:bcp:47"/>
<code value="en"/>
<display value="en"/>
</coding>
</language>
</usage>
</name>
</MedicinalProductDefinition>
</resource>
</entry>
</Bundle>