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
: 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 - TTL Representation
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@prefix fhir: <http://hl7.org/fhir/> .
@prefix loinc: <https://loinc.org/rdf/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
# - resource -------------------------------------------------------------------
a fhir:Composition ;
fhir:nodeRole fhir:treeRoot ;
fhir:id [ fhir:v "LantusInjectionLabelComposition"] ; #
fhir:meta [
( fhir:profile [
fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/StructureDefinition/ProductSubmissionDocument> ] )
] ; #
fhir:text [
fhir:status [ fhir:v "extensions" ] ;
fhir:div "<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/6.1.0/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 \r\n\r\nThis 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: \r\n\r\nNote 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.\r\n\r\nThis 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/>\n <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000</p></div>"
] ; #
fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/versionNumber"^^xsd:anyURI ] ;
fhir:value [ fhir:v "11" ]
] ) ; #
fhir:identifier ( [
fhir:system [ fhir:v "urn:ietf:rfc:3986"^^xsd:anyURI ] ;
fhir:value [ fhir:v "urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6" ]
] ) ; #
fhir:status [ fhir:v "final"] ; #
fhir:type [
( fhir:coding [
a loinc:34391-3 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "34391-3" ] ;
fhir:display [ fhir:v "HUMAN PRESCRIPTION DRUG LABEL" ] ] )
] ; #
fhir:date [ fhir:v "2021-01-27"^^xsd:date] ; #
fhir:author ( [
fhir:reference [ fhir:v "Organization/SanofiAventisUS" ]
] ) ; #
fhir:title [ fhir:v "These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. <br/>\n <br/>LANTUS<sup>®</sup> (insulin glargine injection) for subcutaneous injection <br/>Initial U.S. Approval: 2000"] ; #
fhir:section ( [
fhir:id [ fhir:v "68224803-d32c-4438-9439-9c210668e295" ] ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-27"^^xsd:date ] ] [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/sectionLinkId"^^xsd:anyURI ] ;
fhir:value [ fhir:v "S1" ] ] ) ;
fhir:title [ fhir:v "1 INDICATIONS AND USAGE" ] ;
fhir:code [
( fhir:coding [
a loinc:34067-9 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "34067-9" ] ;
fhir:display [ fhir:v "INDICATIONS & USAGE SECTION" ] ] ) ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<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>" ] ;
( fhir:section [
fhir:id [ fhir:v "0230cfa8-ff67-4666-ba57-bbad268ac6fe" ] ;
fhir:code [
( fhir:coding [
a loinc:42229-5 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "42229-5" ] ;
fhir:display [ fhir:v "SPL UNCLASSIFIED SECTION" ] ] ) ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<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>" ] ] )
] [
fhir:id [ fhir:v "f65bb254-5018-4af5-b02a-38d5d51ed901" ] ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-27"^^xsd:date ] ] ) ;
fhir:code [
( fhir:coding [
a loinc:48780-1 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "48780-1" ] ;
fhir:display [ fhir:v "SPL LISTING DATA ELEMENTS SECTION" ] ] ) ] ;
( fhir:entry [
fhir:reference [ fhir:v "MedicinalProductDefinition/LantusSyringeDefinition" ] ] [
fhir:reference [ fhir:v "MedicinalProductDefinition/LantusVialDefinition" ] ] )
] [
fhir:id [ fhir:v "ff673a31-f676-444c-a009-8d4a2645fd19" ] ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-27"^^xsd:date ] ] ) ;
fhir:title [ fhir:v "PRINCIPAL DISPLAY PANEL - 10 mL Vial Package" ] ;
fhir:code [
( fhir:coding [
a loinc:51945-4 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "51945-4" ] ;
fhir:display [ fhir:v "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL" ] ] ) ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<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>" ]
] [
fhir:id [ fhir:v "8ce1b409-6067-4c9d-8e21-bdb6df850c24" ] ;
( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/StructureDefinition/sectionEffectiveTime"^^xsd:anyURI ] ;
fhir:value [ fhir:v "2021-01-27"^^xsd:date ] ] ) ;
fhir:title [ fhir:v "PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package" ] ;
fhir:code [
( fhir:coding [
a loinc:51945-4 ;
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
fhir:code [ fhir:v "51945-4" ] ;
fhir:display [ fhir:v "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL" ] ] ) ] ;
fhir:text [
fhir:status [ fhir:v "additional" ] ;
fhir:div "<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>" ]
] ) . #
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