SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI
SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
<Composition xmlns="http://hl7.org/fhir">
<id value="LantusInjectionLabelComposition"/>
<meta>
<profile
value="http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"/>
</meta>
<text>
<status value="extensions"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Composition LantusInjectionLabelComposition</b></p><a name="LantusInjectionLabelComposition"> </a><a name="hcLantusInjectionLabelComposition"> </a><a name="LantusInjectionLabelComposition-en-US"> </a><p><b>VersionNumber</b>: 11</p><p><b>identifier</b>: <a href="http://terminology.hl7.org/6.0.2/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6</p><p><b>status</b>: Final</p><p><b>type</b>: <span title="Codes:{http://loinc.org 34391-3}">HUMAN PRESCRIPTION DRUG LABEL</span></p><p><b>date</b>: 2021-01-27</p><p><b>author</b>: <a href="Organization-SanofiAventisUS.html">Organization sanofi-aventis U.S. LLC</a></p><p><b>title</b>: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000</p></div>
</text>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber">
<valueString value="11"/>
</extension>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6"/>
</identifier>
<status value="final"/>
<type>
<coding>
<system value="http://loinc.org"/>
<code value="34391-3"/>
<display value="HUMAN PRESCRIPTION DRUG LABEL"/>
</coding>
</type>
<date value="2021-01-27"/>
<author>🔗
<reference value="Organization/SanofiAventisUS"/>
</author>
<title
value="These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>
<br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000"/>
<section id="68224803-d32c-4438-9439-9c210668e295">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId">
<valueString value="S1"/>
</extension>
<title value="1 INDICATIONS AND USAGE"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="34067-9"/>
<display value="INDICATIONS &amp; USAGE SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="highlights"><p>LANTUS is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. (<a href="#S1">1</a>)</p><p><span style="text-decoration: underline">Limitations of Use</span></p><p>Not recommended for treating diabetic ketoacidosis. (<a href="#S1">1</a>)</p></div><div style="narrative"><a name="S1"/><p>LANTUS is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.</p></div></div>
</text>
<section id="0230cfa8-ff67-4666-ba57-bbad268ac6fe">
<code>
<coding>
<system value="http://loinc.org"/>
<code value="42229-5"/>
<display value="SPL UNCLASSIFIED SECTION"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p><span style="text-decoration: underline">Limitations of Use</span></p><p>LANTUS is not recommended for the treatment of diabetic ketoacidosis.</p></div></div>
</text>
</section>
</section>
<section id="f65bb254-5018-4af5-b02a-38d5d51ed901">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="48780-1"/>
<display value="SPL LISTING DATA ELEMENTS SECTION"/>
</coding>
</code>
<entry>🔗
<reference value="MedicinalProductDefinition/LantusSyringeDefinition"/>
</entry>
<entry>🔗
<reference value="MedicinalProductDefinition/LantusVialDefinition"/>
</entry>
</section>
<section id="ff673a31-f676-444c-a009-8d4a2645fd19">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5021-01<br/>Rx only</p><p>Lantus<sup>®</sup><br/>insulin glargine<br/>injection</p><p>100 units/mL<br/>(U-100)<br/>For subcutaneous<br/>injection only</p><p>Do not mix with<br/>other insulins</p><p>Use only if solution<br/>is clear and colorless<br/>with no particles visible</p><p>Use with U-100<br/>syringe only</p><p>One 10 mL multiple-dose vial</p><p>novaplus <sub>™</sub></p><img src="lantusnova-20.jpg" alt="PRINCIPAL DISPLAY PANEL - 10 mL Vial Package"/></div></div>
</text>
</section>
<section id="8ce1b409-6067-4c9d-8e21-bdb6df850c24">
<extension
url="http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime">
<valueDateTime value="2021-01-27"/>
</extension>
<title value="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/>
<code>
<coding>
<system value="http://loinc.org"/>
<code value="51945-4"/>
<display value="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/>
</coding>
</code>
<text>
<status value="additional"/>
<div xmlns="http://www.w3.org/1999/xhtml"><div style="narrative"><p>NDC 0088-5020-05<br/>Rx only</p><p>Lantus<sup>®</sup> SoloStar<sup>®</sup><br/>insulin glargine injection<br/>For Single Patient Use Only<br/>100 units/mL (U-100)<br/>Five 3 mL Prefilled Pens</p><p>Solution for injection in a disposable insulin delivery device<br/>Do not mix with other insulins<br/>For subcutaneous injection only<br/>Use only if solution is clear and colorless with no particles visible<br/>Use within 28 days after initial use *Needles not include (see back panel)</p><p>novaplus <sub>™</sub></p><img src="lantusnova-21.jpg" alt="PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package"/></div></div>
</text>
</section>
</Composition>
IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.1 based on FHIR 5.0.0. Generated 2024-10-26
Links: Table of Contents |
QA Report
| Version History |
|
Propose a change