From 152e412e77feb975b7199852554c249bac8b98df Mon Sep 17 00:00:00 2001 From: Craig Anderson <88413525+cander2@users.noreply.github.com> Date: Wed, 22 Nov 2023 18:30:34 -0500 Subject: [PATCH] Update Bundle xeljanz-ee-et ePI test2.xml --- .../Bundle xeljanz-ee-et ePI test2.xml | 383 +++++++++--------- 1 file changed, 194 insertions(+), 189 deletions(-) diff --git a/input/resources/Bundle xeljanz-ee-et ePI test2.xml b/input/resources/Bundle xeljanz-ee-et ePI test2.xml index 8909d89a4..82abe8590 100644 --- a/input/resources/Bundle xeljanz-ee-et ePI test2.xml +++ b/input/resources/Bundle xeljanz-ee-et ePI test2.xml @@ -30,84 +30,84 @@ - + - + - + - + - + - + - + - + - + - + - + - + @@ -182,12 +182,15 @@ + + + - + <section> @@ -1303,18 +1306,18 @@ <p>1 suukaudse manustamise süstal</p> </li> </ul> - <p><img src="image000" alt="Üks XELJANZi suukaudse lahuse karp sisaldab järgmist"/></p> + <p><img src="#image000" alt="Üks XELJANZi suukaudse lahuse karp sisaldab järgmist"/></p> <p><b>1. toiming: võtke pudel karbist välja.</b></p> - <p><img src="image001" alt="toiming 1"/></p> + <p><img src="#image001" alt="toiming 1"/></p> <p>Võtke XELJANZi suukaudse lahuse pudel karbist välja.</p> <p><b>2. toiming: avage pudel.</b></p> - <p><img src="image002" alt="toiming 2"/></p> + <p><img src="#image002" alt="toiming 2"/></p> <p>Avage pudel. Eemaldage pudeli suul olev kleebis (ainult esimesel korral).</p> <p><b>Ärge visake ära lapsekindlat korki.</b></p> <p><b>Märkus. </b>Pudelit <b>ei </b>pea enne kasutamist loksutama.</p> <p><b>3. toiming: paigaldage sissesurutav pudeliadapter.</b></p> - <p><img src="image003" alt="toiming 3"/></p> + <p><img src="#image003" alt="toiming 3"/></p> <p>Eemaldage sissesurutav pudeliadapter ja suukaudse manustamise süstal plastikümbrisest. Asetage pudel tasasele pinnale ja suruge sissesurutava pudeliadapteri rihvatud ots pöialdega lõpuni pudeli @@ -1323,31 +1326,31 @@ paigaldamist eemaldage.</p> <p><b>4. toiming: väljutage õhk suukaudse manustamise süstlast.</b></p> - <p><img src="image004" alt="toiming 4"/></p> + <p><img src="#image004" alt="toiming 4"/></p> <p>Liigse õhu eemaldamiseks suruge suukaudse manustamise süstla kolb täielikult sisse kuni süstla silindri otsani.</p> <p><b>5. toiming: sisestage suukaudse manustamise süstal.</b></p> - <p><img src="image005" alt="toiming 5"/></p> + <p><img src="#image005" alt="toiming 5"/></p> <p>Sisestage suukaudse manustamise süstal sissesurutavas pudeliadapteris oleva ava kaudu püstiasendis pudelisse, kuni see on kindlalt oma kohal.</p> <p><b>6. toiming: tõmmake pudelist annus.</b></p> - <p><img src="image006" alt="toiming 6"/></p> + <p><img src="#image006" alt="toiming 6"/></p> <p>Kui suukaudse manustamise süstal on oma kohal, pöörake pudel tagurpidi. Tõmmake kolb tagasi.</p> <p>Kui märkate suukaudse manustamise süstlas õhumulle, lükake kolb täielikult sisse ja suukaudne lahus tagasi pudelisse. Seejärel tõmmake pudelist suukaudse lahuse määratud annus.</p> <p><b>7. toiming: eemaldage suukaudse manustamise süstal.</b></p> - <p><img src="image007" alt="toiming 7"/></p> + <p><img src="#image007" alt="toiming 7"/></p> <p>Pöörake pudel püsti ja asetage see tasasele pinnale. Suukaudse manustamise süstla eemaldamiseks pudeliadapterist ja pudelist tõmmake suukaudse manustamise süstal silindrist hoides otse üles.</p> <p><b>8. toiming: kontrollige süstlasse tõmmatud annust.</b></p> - <p><img src="image008" alt="toiming 8"/></p> + <p><img src="#image008" alt="toiming 8"/></p> <p>Kontrollige, et suukaudse manustamise süstlasse oleks tõmmatud õige annus.</p> <p>Kui annus ei ole õige, sisestage suukaudse manustamise süstla ots @@ -1355,7 +1358,7 @@ suukaudne lahus voolaks tagasi pudelisse. Korrake 6. ja 7. toimingut.</p> <p><b>9. toiming: võtke XELJANZi annus.</b></p> - <p><img src="image009" alt="toiming 9"/></p> + <p><img src="#image009" alt="toiming 9"/></p> <p>Asetage suukaudse manustamise süstla ots patsiendi põse siseküljele.</p> <p>Kogu suukaudses süstlas oleva ravimi manustamiseks lükake kolb @@ -1363,13 +1366,13 @@ allaneelamiseks.</p> <p><b>10. toiming: sulgege pudel.</b></p> - <p><img src="image010" alt="toiming 10"/></p> + <p><img src="#image010" alt="toiming 10"/></p> <p>Pudeli tihedaks sulgemiseks keerake lapsekindlat korki päripäeva sissesurutavat pudeliadapterit eemaldamata.</p> <p>XELJANZi suukaudse lahuse kaitsmiseks valguse eest pange pudel karpi tagasi ja sulgege karp.</p> <p><b>11. toiming: puhastage suukaudse manustamise süstal.</b></p> - <p><img src="image011" alt="toiming 11"/></p> + <p><img src="#image011" alt="toiming 11"/></p> <p>Kolvi eemaldamiseks silindrist tõmmake kolb ja silinder üksteisest eemale.</p> <p>Pärast iga kasutamist loputage mõlemad veega.</p> @@ -1401,7 +1404,7 @@ </identifier> <status value="active"/> <for> - <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <role> <coding> @@ -1413,7 +1416,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1422,13 +1425,13 @@ <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> <code value="O1FF4DIV0D"/> - <display value="TALAZOPARIB"/> + <display value="tofacitinib citrate"/> </coding> </concept> </code> <strength> <presentationQuantity> - <value value="0.25"/> + <value value="5"/> <unit value="mg"/> </presentationQuantity> <basis> @@ -1444,10 +1447,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/xeljanz5mg"/> + <fullUrl value="Ingredient/xeljanz10mg"/> <resource> <Ingredient> - <id value="xeljanz5mg"/> + <id value="xeljanz10mg"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1472,7 +1475,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1481,13 +1484,13 @@ <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> <code value="O1FF4DIV0D"/> - <display value="TALAZOPARIB"/> + <display value="tofacitinib citrate"/> </coding> </concept> </code> <strength> <presentationQuantity> - <value value="1"/> + <value value="10"/> <unit value="mg"/> </presentationQuantity> <basis> @@ -1503,10 +1506,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientMICROCRYSTALLINECELLULOSE"/> + <fullUrl value="Ingredient/ingredientmicrocrystallinecellulose"/> <resource> <Ingredient> - <id value="ingredientMICROCRYSTALLINECELLULOSE"/> + <id value="ingredientmicrocrystallinecellulose"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1520,10 +1523,10 @@ </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1535,7 +1538,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1544,57 +1547,7 @@ <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> <code value="OP1R32D61U"/> - <display value="MICROCRYSTALLINE CELLULOSE"/> - </coding> - </concept> - </code> - </substance> - </Ingredient> - </resource> - </entry> - <entry> - <fullUrl value="Ingredient/ingredientSILICONDIOXIDE"/> - <resource> - <Ingredient> - <id value="ingredientSILICONDIOXIDE"/> - <meta> - <profile - value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" - /> - </meta> - - <identifier> - <use value="official"/> - <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="ETJ7Z6XBU4"/> - </identifier> - <status value="active"/> - <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> - </for> - <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> - </for> - <role> - <coding> - <system value="https://spor.ema.europa.eu/rmswi"/> - <code value="100000072082"/> - <display value="Excipient"/> - </coding> - </role> - <allergenicIndicator value="false"/> - <manufacturer> - <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> - </manufacturer> - </manufacturer> - <substance> - <code> - <concept> - <coding> - <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="15FIX9V2JP"/> - <display value="SILICON DIOXIDE"/> + <display value="microcrystalline cellulose"/> </coding> </concept> </code> @@ -1603,10 +1556,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientHYPROMELLOSE"/> + <fullUrl value="Ingredient/ingredientlactosemonohydrate "/> <resource> <Ingredient> - <id value="ingredientHYPROMELLOSE"/> + <id value="ingredientlactosemonohydrate "/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1616,14 +1569,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="3NXW29V3WO"/> + <value value="EWQ57Q8I5X"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1635,7 +1588,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1643,29 +1596,20 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="3NXW29V3WO"/> - <display value="HYPROMELLOSE, UNSPECIFIED"/> + <code value="EWQ57Q8I5X"/> + <display value="lactose monohydrate"/> </coding> </concept> </code> - <strength> - <basis> - <coding> - <system value="http://terminology.hl7.org/CodeSystem/v3-RoleClass"/> - <code value="ACTIB"/> - <display value="active ingredient - basis of strength"/> - </coding> - </basis> - </strength> </substance> </Ingredient> </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientFERRICOXIDEYELLOW"/> + <fullUrl value="Ingredient/ingredientcroscarmellosesodium"/> <resource> <Ingredient> - <id value="ingredientFERRICOXIDEYELLOW"/> + <id value="ingredientcroscarmellosesodium"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1675,14 +1619,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="EX438O2MRT"/> + <value value="M28OL1HH48"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1694,7 +1638,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1702,8 +1646,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="EX438O2MRT"/> - <display value="FERRIC OXIDE YELLOW"/> + <code value="M28OL1HH48"/> + <display value="croscarmellose sodium"/> </coding> </concept> </code> @@ -1721,10 +1665,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientTITANIUMDIOXIDE"/> + <fullUrl value="Ingredient/ingredientmagnesium stearate"/> <resource> <Ingredient> - <id value="ingredientTITANIUMDIOXIDE"/> + <id value="ingredientmagnesium stearate"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1734,14 +1678,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="15FIX9V2JP"/> + <value value="70097M6I30"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1753,7 +1697,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1761,8 +1705,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="15FIX9V2JP"/> - <display value="TITANIUM DIOXIDE"/> + <code value="70097M6I30"/> + <display value="magnesium stearate"/> </coding> </concept> </code> @@ -1780,10 +1724,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientFERRICOXIDERED"/> + <fullUrl value="Ingredient/ingredienthypromellose"/> <resource> <Ingredient> - <id value="ingredientFERRICOXIDERED"/> + <id value="ingredienthypromellose"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1793,14 +1737,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="1K09F3G675"/> + <value value="3NXW29V3WO"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1812,7 +1756,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1820,8 +1764,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="1K09F3G675"/> - <display value="FERRIC OXIDE RED"/> + <code value="3NXW29V3WO"/> + <display value="hypromellose"/> </coding> </concept> </code> @@ -1839,10 +1783,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientSHELLAC"/> + <fullUrl value="Ingredient/ingredienttitanium dioxide"/> <resource> <Ingredient> - <id value="ingredientSHELLAC"/> + <id value="ingredienttitanium dioxide"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1852,14 +1796,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="46N107B71O"/> + <value value="15FIX9V2JP"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1871,7 +1815,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1879,8 +1823,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="46N107B71O"/> - <display value="SHELLAC"/> + <code value="15FIX9V2JP"/> + <display value="titanium dioxide"/> </coding> </concept> </code> @@ -1898,10 +1842,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientPROPYLENEGLYCOL"/> + <fullUrl value="Ingredient/ingredientmacrogol"/> <resource> <Ingredient> - <id value="ingredientPROPYLENEGLYCOL"/> + <id value="ingredientmacrogol"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1911,14 +1855,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="6DC9Q167V3"/> + <value value="3WJQ0SDW1A"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1930,7 +1874,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1938,8 +1882,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="6DC9Q167V3"/> - <display value="PROPYLENE GLYCOL"/> + <code value="3WJQ0SDW1A"/> + <display value="macrogol"/> </coding> </concept> </code> @@ -1957,10 +1901,10 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientAMMONIUMHYDROXIDE"/> + <fullUrl value="Ingredient/ingredienttriacetin"/> <resource> <Ingredient> - <id value="ingredientAMMONIUMHYDROXIDE"/> + <id value="ingredienttriacetin"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" @@ -1970,14 +1914,14 @@ <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="5138Q19F1X"/> + <value value="XHX3C3X673"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid5mg"/> </for> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -1989,7 +1933,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -1997,8 +1941,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="5138Q19F1X"/> - <display value="AMMONIUM HYDROXIDE"/> + <code value="XHX3C3X673"/> + <display value="triacetin"/> </coding> </concept> </code> @@ -2016,27 +1960,24 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientFERROSOFERRICOXIDE"/> + <fullUrl value="Ingredient/ingredientFDCblueno2"/> <resource> <Ingredient> - <id value="ingredientFERROSOFERRICOXIDE"/> + <id value="ingredientFDCblueno2"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" /> </meta> - + <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="XM0M87F357"/> + <value value="L06K8R7DQK"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> - </for> - <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -2048,7 +1989,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -2056,8 +1997,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="XM0M87F357"/> - <display value="FERROSOFERRIC OXIDE"/> + <code value="L06K8R7DQK"/> + <display value="FD&C blue no. 2"/> </coding> </concept> </code> @@ -2075,27 +2016,24 @@ </resource> </entry> <entry> - <fullUrl value="Ingredient/ingredientPotassiumhydroxide"/> + <fullUrl value="Ingredient/ingredientFDCblueno1"/> <resource> <Ingredient> - <id value="ingredientPotassiumhydroxide"/> + <id value="ingredientFDCblueno1"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi" /> </meta> - + <identifier> <use value="official"/> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <value value="WZH3C48M4T"/> + <value value="H3R47K3TBD"/> </identifier> <status value="active"/> <for> - <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> - </for> - <for> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="ManufacturedItemDefinition/xeljanzmid10mg"/> </for> <role> <coding> @@ -2107,7 +2045,7 @@ <allergenicIndicator value="false"/> <manufacturer> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </manufacturer> <substance> @@ -2115,8 +2053,8 @@ <concept> <coding> <system value="https://gsrs.ncats.nih.gov/ginas/app/beta"/> - <code value="WZH3C48M4T"/> - <display value="Potassium hydroxide"/> + <code value="H3R47K3TBD"/> + <display value="FD&C blue no. 1"/> </coding> </concept> </code> @@ -2158,7 +2096,7 @@ </coding> </status> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> <molecularWeight> <type> @@ -2219,7 +2157,7 @@ </coding> </unitOfPresentation> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </ManufacturedItemDefinition> </resource> @@ -2256,7 +2194,7 @@ </coding> </unitOfPresentation> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> </ManufacturedItemDefinition> </resource> @@ -2392,7 +2330,7 @@ <value value="placeholder"/> </identifier> <subject> - <reference value="MedicinalProductDefinition/xeljanzmpd10mg"/> + <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> </subject> <type> <coding> @@ -2417,7 +2355,7 @@ </status> <statusDate value="2022-03-04T00:00:00Z"/> <holder> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </holder> </RegulatedAuthorization> </resource> @@ -2464,7 +2402,7 @@ </status> <statusDate value="2022-03-04T00:00:00Z"/> <holder> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </holder> </RegulatedAuthorization> </resource> @@ -2551,10 +2489,10 @@ </resource> </entry> <entry> - <fullUrl value="PackagedProductDefinition/ppdblister30"/> + <fullUrl value="PackagedProductDefinition/ppdblister182"/> <resource> <PackagedProductDefinition> - <id value="ppdblister30"/> + <id value="ppdblister182"/> <meta> <profile value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi" @@ -2566,7 +2504,7 @@ <system value="https://spor.ema.europa.eu/pmswi"/> <value value="placeholder"/> </identifier> - <name value="acme drug blister tabs"/> + <name value="Xeljanz 10 mg film-coated tablet blister (alu/PVC/alu) 182 tabs"/> <type> <coding> <system value="https://spor.ema.europa.eu/rmswi"/> @@ -2586,12 +2524,79 @@ </status> <statusDate value="2022-03-04T00:00:00Z"/> <containedItemQuantity> - <value value="0.25"/> + <value value="10"/> + <system value="http://unitsofmeasure.org"/> + <code value="mg"/> + </containedItemQuantity> + <manufacturer> + <reference value="Organization/orgpfizereuropemaeeig"/> + </manufacturer> + <packaging> + <identifier> + <system value="https://spor.ema.europa.eu/pmswi"/> + <value value="placeholder"/> + </identifier> + <type> + <coding> + <system value="https://spor.ema.europa.eu/rmswi"/> + <code value="100000073496"/> + <display value="Blister"/> + </coding> + </type> + <quantity value="182"/> + <material> + <coding> + <system value="https://spor.ema.europa.eu/rmswi"/> + <code value="200000003222"/> + <display value="PolyVinyl Chloride"/> + </coding> + </material> + </packaging> + </PackagedProductDefinition> + </resource> + </entry> + <entry> + <fullUrl value="PackagedProductDefinition/ppdblister182"/> + <resource> + <PackagedProductDefinition> + <id value="ppdblister182"/> + <meta> + <profile + value="http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/PackagedProductDefinition-uv-epi" + /> + </meta> + + <identifier> + <use value="official"/> + <system value="https://spor.ema.europa.eu/pmswi"/> + <value value="placeholder"/> + </identifier> + <name value="Xeljanz 5 mg film-coated tablet blister (alu/PVC/alu) 182 tabs"/> + <type> + <coding> + <system value="https://spor.ema.europa.eu/rmswi"/> + <code value="100000155527"/> + <display value="Chemical Medicinal Product"/> + </coding> + </type> + <packageFor> + <reference value="MedicinalProductDefinition/xeljanzmpd5mg"/> + </packageFor> + <status> + <coding> + <system value="http://hl7.org/fhir/publication-status"/> + <code value="active"/> + <display value="Active"/> + </coding> + </status> + <statusDate value="2022-03-04T00:00:00Z"/> + <containedItemQuantity> + <value value="5"/> <system value="http://unitsofmeasure.org"/> <code value="mg"/> </containedItemQuantity> <manufacturer> - <reference value="Organizationorgpfizereuropemaeeig"/> + <reference value="Organization/orgpfizereuropemaeeig"/> </manufacturer> <packaging> <identifier> @@ -2605,7 +2610,7 @@ <display value="Blister"/> </coding> </type> - <quantity value="30"/> + <quantity value="182"/> <material> <coding> <system value="https://spor.ema.europa.eu/rmswi"/>