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
<Bundle xmlns="http://hl7.org/fhir">
<id value="bundlepackageleaflet-en-ad129f06143be4f32271a42d5b4c5f85"/>
<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-ad129f06143be4f32271a42d5b4c5f85"/>
<resource>
<Composition>
<id value="composition-en-ad129f06143be4f32271a42d5b4c5f85"/>
<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-ad129f06143be4f32271a42d5b4c5f85"> </a><p class="res-header-id"><b>Generated Narrative: Composition composition-en-ad129f06143be4f32271a42d5b4c5f85</b></p><a name="composition-en-ad129f06143be4f32271a42d5b4c5f85"> </a><a name="hccomposition-en-ad129f06143be4f32271a42d5b4c5f85"> </a><a name="composition-en-ad129f06143be4f32271a42d5b4c5f85-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/1/01/196/001</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 - cancidas</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/1/01/196/001"/>
</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/mpad129f06143be4f32271a42d5b4c5f85"/>
</subject>
<date value="2022-02-16T13:28:17Z"/>
<author>🔗
<reference value="Organization/mah-ema"/>
</author>
<title value="TEST PURPOSES ONLY - cancidas"/>
<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 Cancidas is and what it is used for</li><li>What you need to know before you are given Cancidas</li><li>How to use Cancidas</li><li>Possible side effects</li><li>How to store Cancidas</li><li>Contents of the pack and other information</li></ol></div>
</text>
</section>
<section>
<title value="1. What cancidas 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 cancidas is and what it is used for"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>What Cancidas is Cancidas contains a medicine called caspofungin. This belongs to a group of medicines called anti-fungals. What Cancidas is used for Cancidas is used to treat the following infections in children, adolescents and adults:</p><ul><li>serious fungal infections in your tissues or organs (called invasive candidiasis ). This infection is caused by fungal (yeast) cells called Candida. People who might get this type of infection include those who have just had an operation or those whose immune systems are weak. Fever and chills that do not respond to an antibiotic are the most common signs of this type of infection.</li><li>fungal infections in your nose, nasal sinuses or lungs (called invasive aspergillosis ) if other anti-fungal treatments have not worked or have caused side effects. This infection is caused by a mould called Aspergillus. People who might get this type of infection include those having chemotherapy, those who have had a transplant and those whose immune systems are weak.</li><li>suspected fungal infections if you have a fever and a low white cell count that have not improved on treatment with an antibiotic. People who are at risk of getting a fungal infection include those who have just had an operation or those whose immune systems are weak. How Cancidas works Cancidas makes fungal cells fragile and stops the fungus from growing properly. This stops the infection from spreading and gives the body s natural defences a chance to completely get rid of the infection.</li></ul></div>
</text>
</section>
<section>
<title value="2. What you need to know before you take cancidas"/>
<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 cancidas"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Do not use Cancidas</p><ul><li>if you are allergic to caspofungin or any of the other ingredients of this medicine (listed in section 6). If you are not sure, talk to your doctor, nurse or pharmacist before you are given your medicine. Warnings and precautions Talk to your doctor, nurse or pharmacist before you are given Cancidas if:</li><li>you are allergic to any other medicines</li><li>you have ever had liver problems - you might need a different dose of this medicine</li><li>you are already taking cyclosporin (used to help prevent organ transplant rejection or to suppress your immune system) - as your doctor may need to run extra blood tests during your treatment.</li><li>if you have ever had any other medical problem. If any of the above applies to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas. Cancidas may also cause Serious Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN). Other medicines and Cancidas Please tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Cancidas can affect the way some other medicines work. Also, some other medicines can affect the way Cancidas works. Tell your doctor, nurse or pharmacist if you are taking any of the following medicines:</li><li>cyclosporin or tacrolimus (used to help prevent organ transplant rejection or to suppress your immune system) as your doctor may need to run extra blood tests during your treatment</li><li>some HIV medicines such as efavirenz or nevirapine</li><li>phenytoin or carbamazepine (used for the treatment of seizures)</li><li>dexamethasone (a steroid)</li><li>rifampicin (an antibiotic). If any of the above apply to you (or you are not sure), talk to your doctor, nurse or pharmacist before you are given Cancidas. Pregnancy and breast-feeding Ask your doctor for advice before taking any medicine, if you are pregnant or breast-feeding or think you are pregnant.</li><li>Cancidas has not been studied in pregnant women. It should be used in pregnancy only if the potential benefit justifies the potential risk to the unborn baby.</li><li>Women given Cancidas should not breast-feed. Driving and using machines There is no information to suggest that Cancidas affects your ability to drive or operate machinery. Cancidas contains sodium This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially sodium-free .</li></ul></div>
</text>
</section>
<section>
<title value="3. How to take cancidas"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="3. How to take cancidas"/>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p>Cancidas will always be prepared and given to you by a healthcare professional. You will be given Cancidas:</p><ul><li>once each day</li><li>by slow injection into a vein (intravenous infusion)</li><li>over about 1 hour. Your doctor will determine the duration of your treatment and how much Cancidas you will be given each day. Your doctor will monitor how well the medicine works for you. If you weigh more than 80 kg, you may need a different dose. Children and adolescents The dose for children and adolescents may differ from the adult dose. If you have been given more Cancidas than you should Your doctor will decide how much Cancidas you need and for how long each day. If you are worried that you may have been given too much Cancidas, tell your doctor or nurse straight away. If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.</li></ul></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 medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor or nurse straight away if you notice any of the following side effects you may need urgent medical treatment:</p><ul><li>rash, itching, feeling warm, swelling of your face, lips or throat or difficulty breathing - you may be having a histamine reaction to the medicine.</li><li>difficulty breathing with wheezing or a rash that gets worse - you may be having an allergic reaction to the medicine.</li><li>cough, serious breathing difficulties - if you are an adult and have invasive aspergillosis you may be experiencing a serious respiratory problem that could result in respiratory failure.</li><li>rash, skin peeling, mucous membrane sores, hives, large areas of peeling skin. As with any prescription medicine, some side effects may be serious. Ask your doctor for more information. Other side effects in adults include: Common: may affect up to 1 in 10 people:</li><li>Decreased haemoglobin (decreased oxygen carrying substance in the blood), decreased white blood cells</li><li>Decreased blood albumin (a type of protein) in your blood, decreased potassium or low potassium levels in the blood</li><li>Headache</li><li>Inflammation of the vein</li><li>Shortness of breath</li><li>Diarrhoea, nausea or vomiting</li><li>Changes in some laboratory blood tests (including increased values of some liver tests)</li><li>Itching, rash, skin redness or sweating more than usual</li><li>Joint pain</li><li>Chills, fever</li><li>Itching at the injection site. Uncommon: may affect up to 1 in 100 people:</li><li>Changes in some laboratory blood tests (including disease of blood clotting, platelets, red blood cells and white blood cells)</li><li>Loss of appetite, increase in amount of body fluid, imbalance of salt in the body, high sugar level in the blood, low calcium level in the blood, increase calcium level in the blood, low magnesium level in the blood, increase in acid level in the blood</li><li>Disorientation, feeling nervous, being unable to sleep</li><li>Feeling dizzy, decreased feeling or sensitivity (especially in the skin), shaking, feeling sleepy, change in the way things taste, tingling or numbness</li><li>Blurred vision, increase in tears, swollen eyelid, yellowing of the whites of the eyes</li><li>Sensation of fast or irregular heartbeats, rapid heartbeat, irregular heartbeat, abnormal heart rhythm, heart failure</li><li>Flushing, hot flush, high blood pressure, low blood pressure, redness along a vein which is extremely tender when touched</li><li>Tightening of the bands of muscle around the airways resulting in wheezing or coughing, fast breathing rate, shortness of breath that wakes you up, shortage of oxygen in the blood, abnormal breath sounds, crackling sounds in the lungs, wheezing, nasal congestion, cough, throat pain</li><li>Belly pain, upper belly pain, bloating, constipation, difficulty swallowing, dry mouth, indigestion, passing gas, stomach discomfort, swelling due to build-up of fluid around the belly</li><li>Decreased flow of bile, enlarged liver, yellowing of the skin and/or whites of the eyes, liver injury caused by a drug or chemical, liver disorder</li><li>Abnormal skin tissue, generalised itching, hives, rash of varying appearance, abnormal skin, red often itchy spots on your arms and legs and sometimes on the face and the rest of the body</li><li>Back pain, pain in an arm or leg, bone pain, muscle pain, muscle weakness</li><li>Loss of kidney function, sudden loss of kidney function</li><li>Catheter site pain, injection site complaints (redness, hard lump, pain, swelling, irritation, rash, hives, leaking of fluid from the catheter into the tissue), inflammation of vein at injection site</li><li>Increased blood pressure and alterations in some laboratory blood tests (including kidney electrolyte and clotting tests), increased levels of the medicines you are taking that weaken the immune system</li><li>Chest discomfort, chest pain, feeling of body temperature change, generally feeling unwell, general pain, swelling of the face, swelling of the ankles, hands or feet, swelling, tenderness, feeling tired. Side effects in children and adolescents Very common: may affect more than 1 in 10 people:</li><li>Fever Common: may affect up to 1 in 10 people:</li><li>Headache</li><li>Fast heart beat</li><li>Flushing, low blood pressure</li><li>Changes in some laboratory blood tests (increased values of some liver tests)</li><li>Itching, rash</li><li>Catheter site pain</li><li>Chills</li><li>Changes in some laboratory blood tests. Reporting of side effects If you get any side effects, talk to your doctor, nurse 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.</li></ul></div>
</text>
</section>
<section>
<title value="5. How to store cancidas"/>
<code>
<coding>
<system value="https://spor.ema.europa.eu/rmswi/"/>
<code value="100000155538"/>
</coding>
<text value="5. How to store cancidas"/>
</code>
<text>
<status value="additional"/>
<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 carton and the vial (the first two numbers are the month; the next four numbers are the year). The expiry date refers to the last day of that month. Store in a refrigerator (2 C to 8 C). Once Cancidas has been prepared, it should be used straight away. This is because it does not contain any ingredients to stop the growth of bacteria. Only a trained healthcare professional who has read the complete directions should prepare the medicine (please see below Instructions of how to reconstitute and dilute Cancidas ). 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>
</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"><p>What Cancidas contains</p><ul><li>The active substance is caspofungin. Cancidas 50 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 50 mg of caspofungin. Cancidas 70 mg powder for concentrate for solution for infusion Each vial of Cancidas contains 70 mg of caspofungin.</li><li>The other ingredients are sucrose, mannitol (E421), glacial acetic acid and sodium hydroxide (please see section 2 What you need to know before you are given Cancidas). What Cancidas looks like and contents of the pack Cancidas is a sterile, white to off-white compact powder. Each pack contains one vial of powder. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Manufacturer Merck Sharp & Dohme B.V. Merck Sharp & Dohme B. V. Waarderweg Waarderweg 2031 BN Haarlem 2031 BN Haarlem The Netherlands The Netherlands or FAREVA Mirabel Route de Marsat-Riom 63963 Clermont-Ferrand Cedex 9 France For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder: Belgique/Belgi /Belgien MSD Belgium T l/Tel: +32(0)<a href="mailto:27766dpoc_belux@merck.com">27766dpoc_belux@merck.com</a> Lietuva UAB Merck Sharp & Dohme Tel.: +370 5 278 02 <a href="mailto:msd_lietuva@merck.com">msd_lietuva@merck.com</a></li></ul><p>.: +359 2 819 <a href="mailto:3info-msdbg@merck.com">3info-msdbg@merck.com</a> Luxembourg/Luxemburg MSD Belgium T l/Tel: +32(0)<a href="mailto:27766dpoc_belux@merck.com">27766dpoc_belux@merck.com</a> esk republika Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 <a href="mailto:dpoc_czechslovak@merck.com">dpoc_czechslovak@merck.com</a> Magyarorsz g MSD Pharma Hungary Kft. Tel.: +36 1 888 <a href="mailto:5hungary_msd@merck.com">5hungary_msd@merck.com</a> Danmark MSD Danmark ApS Tlf: +45 44 82 40 <a href="mailto:dkmail@merck.com">dkmail@merck.com</a> Malta Merck Sharp & Dohme Cyprus Limited Tel.: 8007 4433 (+ 356 99917558) <a href="mailto:malta_info@merck.com">malta_info@merck.com</a> Deutschland MSD Sharp & Dohme GmbH Tel: 0800 673 673 673 (+49 (0) 89 4561 0) <a href="mailto:e-mail@msd.de">e-mail@msd.de</a> Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999000 (+31 23 5153153) <a href="mailto:medicalinfo.nl@merck.com">medicalinfo.nl@merck.com</a> Eesti Merck Sharp & Dohme O Tel.: +372 6144 <a href="mailto:msdeesti@merck.com">msdeesti@merck.com</a> Norge MSD (Norge) AS Tlf: +47 32 20 73 <a href="mailto:msdnorge@msd.no">msdnorge@msd.no</a> E MSD . . . . : + 30 210 98 97 <a href="mailto:dpoc_greece@merck.com">dpoc_greece@merck.com</a> sterreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 <a href="mailto:dpoc_austria@merck.com">dpoc_austria@merck.com</a> Espa a Merck Sharp & Dohme de Espa a, S.A. Tel: +34 91 321 06 <a href="mailto:msd_info@merck.com">msd_info@merck.com</a> Polska MSD Polska Sp. z o.o. Tel.: +48 22 549 51 <a href="mailto:msdpolska@merck.com">msdpolska@merck.com</a> France MSD France T l: + 33 (0) 1 80 46 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 <a href="mailto:4465inform_pt@merck.com">4465inform_pt@merck.com</a> Hrvatska Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 <a href="mailto:croatia_info@merck.com">croatia_info@merck.com</a> Rom nia Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 <a href="mailto:msdromania@merck.com">msdromania@merck.com</a> Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href="mailto:2998medinfo_ireland@merck.com">2998medinfo_ireland@merck.com</a> Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: + 386 1 <a href="mailto:5204msd_slovenia@merck.com">5204msd_slovenia@merck.com</a> sland Vistor hf. S mi: +354 535 7Slovensk republika Merck Sharp & Dohme, s. r. o. Tel.: +421 2 <a href="mailto:58282dpoc_czechslovak@merck.com">58282dpoc_czechslovak@merck.com</a> talia MSD Italia S.r.l. Tel: 800 23 99 89 (+39 06 361911) <a href="mailto:medicalinformation.it@msd.com">medicalinformation.it@msd.com</a> Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804 <a href="mailto:info@msd.fi">info@msd.fi</a></p><h2 id="merck-sharp--dohme-cyprus-limited--800-00-673-357-22866700-cyprus_infomerckcom-sverige-merck-sharp--dohme-sweden-ab-tel-46-077-5700medicinskinfomerckcom-latvija-sia-merck-sharp--dohme-latvija-tel-371-67364-msd_lvmerckcom-united-kingdom-northern-ireland-merck-sharp--dohme-ireland-human-health-limited-tel-353-01-2998medinfonimsdcom-this-leaflet-was-last-revised-in-detailed-information-on-this-medicine-is-available-on-the-european-medicines-agency-web-site-httpwwwemaeuropaeu-the-following-information-is-intended-for-medical-or-healthcare-professionals-only-instructions-of-how-to-reconstitute-and-dilute-cancidas-reconstitution-of-cancidas-do-not-use-any-diluents-containing-glucose-as-cancidas-is-not-stable-in-diluents-containing-glucose-do-not-mix-or-co-infuse-cancidas-with-any-other-medicines-as-there-are-no-data-available-on-the-compatibility-of-cancidas-with-other-intravenous-substances-additives-or-medicinal-products-visually-inspect-the-infusion-solution-for-particulate-matter-or-discolouration-cancidas-50-mg-powder-for-concentrate-for-solution-for-infusion-instructions-for-use-in-adult-patients-50-mg-vial-step-1-reconstitution-of-conventional-vials-to-reconstitute-the-powder-bring-the-vial-to-room-temperature-and-aseptically-add-105-ml-of-water-for-injection-the-concentrations-of-the-reconstituted-vials-will-be-52-mgml-the-white-to-off-white-compact-lyophilised-powder-will-dissolve-completely-mix-gently-until-a-clear-solution-is-obtained-reconstituted-solutions-should-be-visually-inspected-for-particulate-matter-or-discolouration-this-reconstituted-solution-may-be-stored-for-up-to-24-hours-at-or-below-25-c-step-2-addition-of-reconstituted-cancidas-to-patient-infusion-solution-diluents-for-the-final-solution-for-infusion-are-sodium-chloride-solution-for-injection-or-lactated-ringer-s-solution-the-solution-for-infusion-is-prepared-by-aseptically-adding-the-appropriate-amount-of-reconstituted-concentrate-as-shown-in-the-table-below-to-a-250-ml-infusion-bag-or-bottle-reduced-volume-infusions-in-100-ml-may-be-used-when-medically-necessary-for-50-mg-or-35-mg-daily-doses-do-not-use-if-the-solution-is-cloudy-or-has-precipitated-50-mg-vial-preparation-of-the-solution-for-infusion-in-adults-dose-volume-of-reconstituted-cancidas-for-transfer-to-intravenous-bag-or-bottle-standard-preparation-reconstituted-cancidas-added-to-250-ml-final-concentration-reduced-volume-infusion-reconstituted-cancidas-added-to-100-ml-final-concentration-50-mg-10-ml-020-mgml">Merck Sharp & Dohme Cyprus Limited .: 800 00 673 (+357 22866700) <a href="mailto:cyprus_info@merck.com">cyprus_info@merck.com</a> Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0)77 <a href="mailto:5700medicinskinfo@merck.com">5700medicinskinfo@merck.com</a> Latvija SIA Merck Sharp & Dohme Latvija Tel: +371 67364 <a href="mailto:msd_lv@merck.com">msd_lv@merck.com</a> United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 <a href="mailto:2998medinfoNI@msd.com">2998medinfoNI@msd.com</a> This leaflet was last revised in 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>. The following information is intended for medical or healthcare professionals only: Instructions of how to reconstitute and dilute CANCIDAS: Reconstitution of CANCIDAS DO NOT USE ANY DILUENTS CONTAINING GLUCOSE as CANCIDAS is not stable in diluents containing glucose. DO NOT MIX OR CO-INFUSE CANCIDAS WITH ANY OTHER MEDICINES, as there are no data available on the compatibility of CANCIDAS with other intravenous substances, additives, or medicinal products. Visually inspect the infusion solution for particulate matter or discolouration. CANCIDAS 50 mg powder for concentrate for solution for infusion INSTRUCTIONS FOR USE IN ADULT PATIENTS (50 mg vial) Step 1 Reconstitution of conventional vials To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be 5.2 mg/ml. The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25 C. Step 2 Addition of reconstituted CANCIDAS to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer s solution. The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated. 50 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS DOSE* Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration 50 mg 10 ml 0.20 mg/ml</h2><h2 id="50-mg-at-reduced-volume-10-ml">50 mg at reduced volume 10 ml</h2><h2 id="047-mgml-35-mg-for-moderate-hepatic-impairment-from-one-50-mg-vial-7-ml-014-mgml">0.47 mg/ml 35 mg for moderate hepatic impairment<br/>(from one 50 mg vial) 7 ml 0.14 mg/ml</h2><h2 id="35-mg-for-moderate-hepatic-impairment-from-one-50-mg-vial-at-reduced-volume-7-ml">35 mg for moderate hepatic impairment (from one 50 mg vial) at reduced volume 7 ml</h2><p>0.34 mg/ml</p><ul><li>10.5 ml should be used for reconstitution of all vials. INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (50 mg vial) Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller2 Formula) Preparation of the 70 mg/m 2 infusion for paediatric patients >3 months of age (using a 50-mg vial)</li></ul><ol type="1"><li>Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 70 mg/m2 = Loading Dose The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.</li><li>Equilibrate the refrigerated vial of CANCIDAS to room temperature.</li><li>Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25 C.b This will give a final caspofungin concentration in the vial of 5.2 mg/ml.</li><li>Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 C or within 48 hours if stored refrigerated at 2 to 8 C. Preparation of the 50 mg/m 2 infusion for paediatric patients >3 months of age (using a 50-mg vial)</li><li>Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.</li><li>Equilibrate the refrigerated vial of CANCIDAS to room temperature. 2 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter)</li><li>Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25 C.b This will give a final caspofungin concentration in the vial of 5.2 mg/ml.</li><li>Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 C or within 48 hours if stored refrigerated at 2 to 8 C. Preparation notes: a The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained. b Visually inspect the reconstituted solution for particulate matter or discoloration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated. c CANCIDAS is formulated to provide the full labelled vial dose (50 mg) when 10 ml is withdrawn from the vial. CANCIDAS 70 mg powder for concentrate for solution for infusion INSTRUCTIONS FOR USE IN ADULT PATIENTS (70 mg vial) Step 1 Reconstitution of conventional vials To reconstitute the powder bring the vial to room temperature and aseptically add 10.5 ml of water for injection. The concentrations of the reconstituted vials will be: 7.2 mg/ml. The white to off-white compact lyophilised powder will dissolve completely. Mix gently until a clear solution is obtained. Reconstituted solutions should be visually inspected for particulate matter or discolouration. This reconstituted solution may be stored for up to 24 hours at or below 25 C. Step 2 Addition of reconstituted CANCIDAS to patient infusion solution Diluents for the final solution for infusion are: sodium chloride solution for injection, or lactated Ringer s solution. The solution for infusion is prepared by aseptically adding the appropriate amount of reconstituted concentrate (as shown in the table below) to a 250 ml infusion bag or bottle. Reduced volume infusions in 100 ml may be used, when medically necessary, for 50 mg or 35 mg daily doses. Do not use if the solution is cloudy or has precipitated. 70 mg VIAL: PREPARATION OF THE SOLUTION FOR INFUSION IN ADULTS DOSE* Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration 70 mg 10 ml 0.28 mg/ml Not Recommended 70 mg (from two 50 mg vials)** 14 ml 0.28 mg/ml Not Recommended DOSE* Volume of reconstituted CANCIDAS for transfer to intravenous bag or bottle Standard preparation (reconstituted CANCIDAS added to 250 ml) final concentration Reduced volume infusion (reconstituted CANCIDAS added to 100 ml) final concentration 35 mg for moderate hepatic impairment<br/>(from one 70 mg vial) 5 ml 0.14 mg/ml 0.34 mg/ml</li></ol><ul><li>10.5 ml should be used for reconstitution of all vials. **If 70 mg vial is not available, the 70 mg dose can be prepared from two 50 mg vials. INSTRUCTIONS FOR USE IN PAEDIATRIC PATIENTS (70 mg vial) Calculation of Body Surface Area (BSA) for paediatric dosing Before preparation of infusion, calculate the body surface area (BSA) of the patient using the following formula: (Mosteller3 Formula) Preparation of the 70 mg/m 2 infusion for paediatric patients >3 months of age (using a 70-mg vial)</li></ul><ol type="1"><li>Determine the actual loading dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 70 mg/m2 = Loading Dose The maximum loading dose on Day 1 should not exceed 70 mg regardless of the patient's calculated dose.</li><li>Equilibrate the refrigerated vial of CANCIDAS to room temperature.</li><li>Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25 C.b This will give a final caspofungin concentration in the vial of 7.2 mg/ml.</li><li>Remove the volume of medicine equal to the calculated loading dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 C or within 48 hours if stored refrigerated at 2 to 8 C. Preparation of the 50 mg/m 2 infusion for paediatric patients >3 months of age (using a 70-mg vial)</li><li>Determine the actual daily maintenance dose to be used in the paediatric patient by using the patient's BSA (as calculated above) and the following equation: BSA (m2) X 50 mg/m2 = Daily Maintenance Dose The daily maintenance dose should not exceed 70 mg regardless of the patient's calculated dose.</li><li>Equilibrate the refrigerated vial of CANCIDAS to room temperature.</li><li>Aseptically add 10.5 ml of water for injection.a This reconstituted solution may be stored for up to 24 hours at or below 25 C.b This will give a final caspofungin concentration in the vial of 7.2 mg/ml.</li><li>Remove the volume of medicine equal to the calculated daily maintenance dose (Step 1) from the vial. Aseptically transfer this volume (ml)c of reconstituted CANCIDAS to an IV bag (or bottle) containing 250 ml of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection, or Lactated Ringers Injection. Alternatively, the volume (ml)c of reconstituted CANCIDAS can be added to a reduced volume of 0.9 %, 0.45 %, or 0.225 % Sodium Chloride Injection or Lactated Ringers 3 Mosteller RD: Simplified Calculation of Body Surface Area. N Engl J Med 1987 Oct 22;317(17): 1098 (letter) Injection, not to exceed a final concentration of 0.5 mg/ml. This infusion solution must be used within 24 hours if stored at or below 25 C or within 48 hours if stored refrigerated at 2 to 8 C. Preparation notes: a. The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained. b. Visually inspect the reconstituted solution for particulate matter or discolouration during reconstitution and prior to infusion. Do not use if the solution is cloudy or has precipitated. c. CANCIDAS is formulated to provide the full labelled vial dose (70 mg) when 10 ml is withdrawn from the vial.</li></ol></div>
</text>
</section>
</section>
</Composition>
</resource>
</entry>
<entry>
<fullUrl
value="MedicinalProductDefinition/mpad129f06143be4f32271a42d5b4c5f85"/>
<resource>
<MedicinalProductDefinition>
<id value="mpad129f06143be4f32271a42d5b4c5f85"/>
<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_mpad129f06143be4f32271a42d5b4c5f85"> </a><p class="res-header-id"><b>Generated Narrative: MedicinalProductDefinition mpad129f06143be4f32271a42d5b4c5f85</b></p><a name="mpad129f06143be4f32271a42d5b4c5f85"> </a><a name="hcmpad129f06143be4f32271a42d5b4c5f85"> </a><a name="mpad129f06143be4f32271a42d5b4c5f85-en-US"> </a><p><b>identifier</b>: <code>http://ema.europa.eu/identifier</code>/EU/1/01/196/001</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>: CANCIDAS 50 mg powder for 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>
</text>
<identifier>
<system value="http://ema.europa.eu/identifier"/>
<value value="EU/1/01/196/001"/>
</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="CANCIDAS 50 mg powder for concentrate for solution for infusion"/>
<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>
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.
