SPL Mapping FHIR R5 Implementation Guide
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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

: SPL Section Codes - TTL Representation

Page standards status: Trial-use Maturity Level: 1

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@prefix fhir: <http://hl7.org/fhir/> .
@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:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "splSectionCodes"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet splSectionCodes</b></p><a name=\"splSectionCodes\"> </a><a name=\"hcsplSectionCodes\"> </a><a name=\"splSectionCodes-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://loinc.org\"><code>http://loinc.org</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td><a href=\"https://loinc.org/51945-4/\">51945-4</a></td><td>Principal display panel of package</td></tr><tr><td><a href=\"https://loinc.org/100382-1/\">100382-1</a></td><td>REMS addressed risk</td></tr><tr><td><a href=\"https://loinc.org/103572-4/\">103572-4</a></td><td>Cosmetic product listing</td></tr><tr><td><a href=\"https://loinc.org/103573-2/\">103573-2</a></td><td>Cosmetic facility registration</td></tr><tr><td><a href=\"https://loinc.org/34066-1/\">34066-1</a></td><td>Boxed warning section</td></tr><tr><td><a href=\"https://loinc.org/34067-9/\">34067-9</a></td><td>Indications and usage section</td></tr><tr><td><a href=\"https://loinc.org/34068-7/\">34068-7</a></td><td>Dosage and administration section</td></tr><tr><td><a href=\"https://loinc.org/34069-5/\">34069-5</a></td><td>How supplied section</td></tr><tr><td><a href=\"https://loinc.org/34070-3/\">34070-3</a></td><td>Contraindications section</td></tr><tr><td><a href=\"https://loinc.org/34071-1/\">34071-1</a></td><td>Warnings section</td></tr><tr><td><a href=\"https://loinc.org/34072-9/\">34072-9</a></td><td>General precautions section</td></tr><tr><td><a href=\"https://loinc.org/34073-7/\">34073-7</a></td><td>Drug interactions section</td></tr><tr><td><a href=\"https://loinc.org/34074-5/\">34074-5</a></td><td>Drug/laboratory test interactions section</td></tr><tr><td><a href=\"https://loinc.org/34075-2/\">34075-2</a></td><td>Laboratory tests section</td></tr><tr><td><a href=\"https://loinc.org/34076-0/\">34076-0</a></td><td>Information for patients section</td></tr><tr><td><a href=\"https://loinc.org/34077-8/\">34077-8</a></td><td>Teratogenic effects section</td></tr><tr><td><a href=\"https://loinc.org/34078-6/\">34078-6</a></td><td>Nonteratogenic effects section</td></tr><tr><td><a href=\"https://loinc.org/34079-4/\">34079-4</a></td><td>Labor and delivery section</td></tr><tr><td><a href=\"https://loinc.org/34080-2/\">34080-2</a></td><td>Nursing mothers section</td></tr><tr><td><a href=\"https://loinc.org/34081-0/\">34081-0</a></td><td>Pediatric use section</td></tr><tr><td><a href=\"https://loinc.org/34082-8/\">34082-8</a></td><td>Geriatric use section</td></tr><tr><td><a href=\"https://loinc.org/34083-6/\">34083-6</a></td><td>Carcinogenesis and mutagenesis and impairment of fertility section</td></tr><tr><td><a href=\"https://loinc.org/34084-4/\">34084-4</a></td><td>Adverse reactions section</td></tr><tr><td><a href=\"https://loinc.org/34085-1/\">34085-1</a></td><td>Controlled substance section</td></tr><tr><td><a href=\"https://loinc.org/34086-9/\">34086-9</a></td><td>Abuse section</td></tr><tr><td><a href=\"https://loinc.org/34087-7/\">34087-7</a></td><td>Dependence section</td></tr><tr><td><a href=\"https://loinc.org/34088-5/\">34088-5</a></td><td>Overdosage section</td></tr><tr><td><a href=\"https://loinc.org/34089-3/\">34089-3</a></td><td>Description section</td></tr><tr><td><a href=\"https://loinc.org/34090-1/\">34090-1</a></td><td>Clinical pharmacology section</td></tr><tr><td><a href=\"https://loinc.org/34091-9/\">34091-9</a></td><td>Animal pharmacology/toxicology section</td></tr><tr><td><a href=\"https://loinc.org/34092-7/\">34092-7</a></td><td>Clinical studies section</td></tr><tr><td><a href=\"https://loinc.org/34093-5/\">34093-5</a></td><td>References section</td></tr><tr><td><a href=\"https://loinc.org/38056-8/\">38056-8</a></td><td>Structured product laballing supplemental patient material</td></tr><tr><td><a href=\"https://loinc.org/42227-9/\">42227-9</a></td><td>Drug abuse and dependence section</td></tr><tr><td><a href=\"https://loinc.org/42228-7/\">42228-7</a></td><td>Pregnancy section</td></tr><tr><td><a href=\"https://loinc.org/42229-5/\">42229-5</a></td><td>Structured patient labelling unclassified section</td></tr><tr><td><a href=\"https://loinc.org/42230-3/\">42230-3</a></td><td>Structured product laballing patient package insert section</td></tr><tr><td><a href=\"https://loinc.org/42231-1/\">42231-1</a></td><td>Structured product labelling medguide section</td></tr><tr><td><a href=\"https://loinc.org/42232-9/\">42232-9</a></td><td>Precautions section</td></tr><tr><td><a href=\"https://loinc.org/43678-2/\">43678-2</a></td><td>Dosage forms and strengths section</td></tr><tr><td><a href=\"https://loinc.org/43679-0/\">43679-0</a></td><td>Mechanism of action section</td></tr><tr><td><a href=\"https://loinc.org/43680-8/\">43680-8</a></td><td>Nonclinical toxicology section</td></tr><tr><td><a href=\"https://loinc.org/43681-6/\">43681-6</a></td><td>Pharmacodynamics section</td></tr><tr><td><a href=\"https://loinc.org/43682-4/\">43682-4</a></td><td>Pharmacokinetics section</td></tr><tr><td><a href=\"https://loinc.org/43683-2/\">43683-2</a></td><td>Recent major changes section</td></tr><tr><td><a href=\"https://loinc.org/43684-0/\">43684-0</a></td><td>Use in specific populations section</td></tr><tr><td><a href=\"https://loinc.org/43685-7/\">43685-7</a></td><td>Warnings and precautions section</td></tr><tr><td><a href=\"https://loinc.org/44425-7/\">44425-7</a></td><td>Storage and handling section</td></tr><tr><td><a href=\"https://loinc.org/48779-3/\">48779-3</a></td><td>Structured product labelling indexing data elements section</td></tr><tr><td><a href=\"https://loinc.org/48780-1/\">48780-1</a></td><td>Structured product labelling listing data elements section</td></tr><tr><td><a href=\"https://loinc.org/49489-8/\">49489-8</a></td><td>Microbiology section</td></tr><tr><td><a href=\"https://loinc.org/54433-8/\">54433-8</a></td><td>User safety warnings section</td></tr><tr><td><a href=\"https://loinc.org/59845-8/\">59845-8</a></td><td>Instructions for use section</td></tr><tr><td><a href=\"https://loinc.org/60555-0/\">60555-0</a></td><td>Accessories</td></tr><tr><td><a href=\"https://loinc.org/60556-8/\">60556-8</a></td><td>Assembly or installation instructions</td></tr><tr><td><a href=\"https://loinc.org/60557-6/\">60557-6</a></td><td>Calibration instructions</td></tr><tr><td><a href=\"https://loinc.org/60558-4/\">60558-4</a></td><td>Cleaning, disinfecting, and sterilization instructions</td></tr><tr><td><a href=\"https://loinc.org/60559-2/\">60559-2</a></td><td>Components</td></tr><tr><td><a href=\"https://loinc.org/60560-0/\">60560-0</a></td><td>Intended use of the device</td></tr><tr><td><a href=\"https://loinc.org/60561-8/\">60561-8</a></td><td>Other safety information</td></tr><tr><td><a href=\"https://loinc.org/60562-6/\">60562-6</a></td><td>Route, method and frequency of administration</td></tr><tr><td><a href=\"https://loinc.org/60563-4/\">60563-4</a></td><td>Summary of safety and effectiveness</td></tr><tr><td><a href=\"https://loinc.org/60685-5/\">60685-5</a></td><td>Indexing - pharmacologic class</td></tr><tr><td><a href=\"https://loinc.org/64123-3/\">64123-3</a></td><td>Indexing - adverse reaction</td></tr><tr><td><a href=\"https://loinc.org/64124-1/\">64124-1</a></td><td>Indexing - substance</td></tr><tr><td><a href=\"https://loinc.org/66105-8/\">66105-8</a></td><td>Lot distribution data</td></tr><tr><td><a href=\"https://loinc.org/66106-6/\">66106-6</a></td><td>Pharmacogenomics section</td></tr><tr><td><a href=\"https://loinc.org/69758-1/\">69758-1</a></td><td>Diagram of device</td></tr><tr><td><a href=\"https://loinc.org/69759-9/\">69759-9</a></td><td>Risks</td></tr><tr><td><a href=\"https://loinc.org/69760-7/\">69760-7</a></td><td>Compatible accessories</td></tr><tr><td><a href=\"https://loinc.org/69761-5/\">69761-5</a></td><td>Alarms</td></tr><tr><td><a href=\"https://loinc.org/69762-3/\">69762-3</a></td><td>Troubleshooting</td></tr><tr><td><a href=\"https://loinc.org/69763-1/\">69763-1</a></td><td>Disposal and waste handling</td></tr><tr><td><a href=\"https://loinc.org/71446-9/\">71446-9</a></td><td>Indexing - billing unit</td></tr><tr><td><a href=\"https://loinc.org/71681-1/\">71681-1</a></td><td>PMI - Common side effects section</td></tr><tr><td><a href=\"https://loinc.org/71682-9/\">71682-9</a></td><td>PMI - Get emergency medical help section</td></tr><tr><td><a href=\"https://loinc.org/71683-7/\">71683-7</a></td><td>PMI - Stop taking and call your doctor section</td></tr><tr><td><a href=\"https://loinc.org/71684-5/\">71684-5</a></td><td>PMI - Directions for use section</td></tr><tr><td><a href=\"https://loinc.org/71685-2/\">71685-2</a></td><td>PMI - Tell your doctor before taking section</td></tr><tr><td><a href=\"https://loinc.org/71686-0/\">71686-0</a></td><td>PMI - Do not take section</td></tr><tr><td><a href=\"https://loinc.org/71687-8/\">71687-8</a></td><td>PMI - Important information section</td></tr><tr><td><a href=\"https://loinc.org/71688-6/\">71688-6</a></td><td>PMI - Uses section</td></tr><tr><td><a href=\"https://loinc.org/71744-7/\">71744-7</a></td><td>Health care provider letter</td></tr><tr><td><a href=\"https://loinc.org/73815-3/\">73815-3</a></td><td>Indexing - product concept</td></tr><tr><td><a href=\"https://loinc.org/77288-9/\">77288-9</a></td><td>Indexing - warning letter alert</td></tr><tr><td><a href=\"https://loinc.org/77289-7/\">77289-7</a></td><td>Identification of suspect product and notification</td></tr><tr><td><a href=\"https://loinc.org/77290-5/\">77290-5</a></td><td>Lactation</td></tr><tr><td><a href=\"https://loinc.org/77291-3/\">77291-3</a></td><td>Females and males reproductive potential</td></tr><tr><td><a href=\"https://loinc.org/77292-1/\">77292-1</a></td><td>eFacility</td></tr><tr><td><a href=\"https://loinc.org/82336-9/\">82336-9</a></td><td>REMS header</td></tr><tr><td><a href=\"https://loinc.org/82344-3/\">82344-3</a></td><td>REMS communication plan</td></tr><tr><td><a href=\"https://loinc.org/82345-0/\">82345-0</a></td><td>REMS elements to assure safe use</td></tr><tr><td><a href=\"https://loinc.org/82346-8/\">82346-8</a></td><td>REMS material</td></tr><tr><td><a href=\"https://loinc.org/82347-6/\">82347-6</a></td><td>REMS summary</td></tr><tr><td><a href=\"https://loinc.org/82348-4/\">82348-4</a></td><td>REMS elements</td></tr><tr><td><a href=\"https://loinc.org/82349-2/\">82349-2</a></td><td>REMS goals</td></tr><tr><td><a href=\"https://loinc.org/82350-0/\">82350-0</a></td><td>REMS implementation system</td></tr><tr><td><a href=\"https://loinc.org/82351-8/\">82351-8</a></td><td>Risk evaluation and mitigation strategies</td></tr><tr><td><a href=\"https://loinc.org/82352-6/\">82352-6</a></td><td>REMS timetable for submission assessments</td></tr><tr><td><a href=\"https://loinc.org/82353-4/\">82353-4</a></td><td>Indexing - risk evaluation and mitigation strategies</td></tr><tr><td><a href=\"https://loinc.org/82598-4/\">82598-4</a></td><td>REMS medication guide</td></tr><tr><td><a href=\"https://loinc.org/85273-1/\">85273-1</a></td><td>REMS conversion to shared system</td></tr><tr><td><a href=\"https://loinc.org/85274-9/\">85274-9</a></td><td>REMS release</td></tr><tr><td><a href=\"https://loinc.org/86445-4/\">86445-4</a></td><td>Blanket no changes certification of product listing</td></tr><tr><td><a href=\"https://loinc.org/87523-7/\">87523-7</a></td><td>REMS administrative information</td></tr><tr><td><a href=\"https://loinc.org/87524-5/\">87524-5</a></td><td>REMS requirements</td></tr><tr><td><a href=\"https://loinc.org/87525-2/\">87525-2</a></td><td>REMS participant requirements</td></tr><tr><td><a href=\"https://loinc.org/87526-0/\">87526-0</a></td><td>REMS applicant requirements</td></tr><tr><td><a href=\"https://loinc.org/88436-1/\">88436-1</a></td><td>Patient counseling information</td></tr><tr><td><a href=\"https://loinc.org/88437-9/\">88437-9</a></td><td>How supplied and storage and handling section</td></tr><tr><td><a href=\"https://loinc.org/88828-9/\">88828-9</a></td><td>Renal Impairment subsection</td></tr><tr><td><a href=\"https://loinc.org/88829-7/\">88829-7</a></td><td>Hepatic Impairment subsection</td></tr><tr><td><a href=\"https://loinc.org/88830-5/\">88830-5</a></td><td>Immunogenicity</td></tr><tr><td><a href=\"https://loinc.org/90374-0/\">90374-0</a></td><td>Clinical trials experience section</td></tr><tr><td><a href=\"https://loinc.org/90375-7/\">90375-7</a></td><td>Postmarketing experience section</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
fhir:v "1"^^xsd:integer ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
fhir:v "trial-use" ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/ValueSet/splSectionCodes"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.2.1"] ; # 
  fhir:name [ fhir:v "SPLSectionCodes"] ; # 
  fhir:title [ fhir:v "SPL Section Codes"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-10-26T03:36:34+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "Section Codes for SPL Product Submission documents"] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ]     ] )
  ] ) ; # 
  fhir:copyright [ fhir:v "This material contains content from LOINC (http://loinc.org). LOINC is copyright © 1995-2020, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license. LOINC® is a registered United States trademark of Regenstrief Institute, Inc."] ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://loinc.org"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "51945-4" ] ;
fhir:display [ fhir:v "Principal display panel of package" ]       ] [
fhir:code [ fhir:v "100382-1" ] ;
fhir:display [ fhir:v "REMS addressed risk" ]       ] [
fhir:code [ fhir:v "103572-4" ] ;
fhir:display [ fhir:v "Cosmetic product listing" ]       ] [
fhir:code [ fhir:v "103573-2" ] ;
fhir:display [ fhir:v "Cosmetic facility registration" ]       ] [
fhir:code [ fhir:v "34066-1" ] ;
fhir:display [ fhir:v "Boxed warning section" ]       ] [
fhir:code [ fhir:v "34067-9" ] ;
fhir:display [ fhir:v "Indications and usage section" ]       ] [
fhir:code [ fhir:v "34068-7" ] ;
fhir:display [ fhir:v "Dosage and administration section" ]       ] [
fhir:code [ fhir:v "34069-5" ] ;
fhir:display [ fhir:v "How supplied section" ]       ] [
fhir:code [ fhir:v "34070-3" ] ;
fhir:display [ fhir:v "Contraindications section" ]       ] [
fhir:code [ fhir:v "34071-1" ] ;
fhir:display [ fhir:v "Warnings section" ]       ] [
fhir:code [ fhir:v "34072-9" ] ;
fhir:display [ fhir:v "General precautions section" ]       ] [
fhir:code [ fhir:v "34073-7" ] ;
fhir:display [ fhir:v "Drug interactions section" ]       ] [
fhir:code [ fhir:v "34074-5" ] ;
fhir:display [ fhir:v "Drug/laboratory test interactions section" ]       ] [
fhir:code [ fhir:v "34075-2" ] ;
fhir:display [ fhir:v "Laboratory tests section" ]       ] [
fhir:code [ fhir:v "34076-0" ] ;
fhir:display [ fhir:v "Information for patients section" ]       ] [
fhir:code [ fhir:v "34077-8" ] ;
fhir:display [ fhir:v "Teratogenic effects section" ]       ] [
fhir:code [ fhir:v "34078-6" ] ;
fhir:display [ fhir:v "Nonteratogenic effects section" ]       ] [
fhir:code [ fhir:v "34079-4" ] ;
fhir:display [ fhir:v "Labor and delivery section" ]       ] [
fhir:code [ fhir:v "34080-2" ] ;
fhir:display [ fhir:v "Nursing mothers section" ]       ] [
fhir:code [ fhir:v "34081-0" ] ;
fhir:display [ fhir:v "Pediatric use section" ]       ] [
fhir:code [ fhir:v "34082-8" ] ;
fhir:display [ fhir:v "Geriatric use section" ]       ] [
fhir:code [ fhir:v "34083-6" ] ;
fhir:display [ fhir:v "Carcinogenesis and mutagenesis and impairment of fertility section" ]       ] [
fhir:code [ fhir:v "34084-4" ] ;
fhir:display [ fhir:v "Adverse reactions section" ]       ] [
fhir:code [ fhir:v "34085-1" ] ;
fhir:display [ fhir:v "Controlled substance section" ]       ] [
fhir:code [ fhir:v "34086-9" ] ;
fhir:display [ fhir:v "Abuse section" ]       ] [
fhir:code [ fhir:v "34087-7" ] ;
fhir:display [ fhir:v "Dependence section" ]       ] [
fhir:code [ fhir:v "34088-5" ] ;
fhir:display [ fhir:v "Overdosage section" ]       ] [
fhir:code [ fhir:v "34089-3" ] ;
fhir:display [ fhir:v "Description section" ]       ] [
fhir:code [ fhir:v "34090-1" ] ;
fhir:display [ fhir:v "Clinical pharmacology section" ]       ] [
fhir:code [ fhir:v "34091-9" ] ;
fhir:display [ fhir:v "Animal pharmacology/toxicology section" ]       ] [
fhir:code [ fhir:v "34092-7" ] ;
fhir:display [ fhir:v "Clinical studies section" ]       ] [
fhir:code [ fhir:v "34093-5" ] ;
fhir:display [ fhir:v "References section" ]       ] [
fhir:code [ fhir:v "38056-8" ] ;
fhir:display [ fhir:v "Structured product laballing supplemental patient material" ]       ] [
fhir:code [ fhir:v "42227-9" ] ;
fhir:display [ fhir:v "Drug abuse and dependence section" ]       ] [
fhir:code [ fhir:v "42228-7" ] ;
fhir:display [ fhir:v "Pregnancy section" ]       ] [
fhir:code [ fhir:v "42229-5" ] ;
fhir:display [ fhir:v "Structured patient labelling unclassified section" ]       ] [
fhir:code [ fhir:v "42230-3" ] ;
fhir:display [ fhir:v "Structured product laballing patient package insert section" ]       ] [
fhir:code [ fhir:v "42231-1" ] ;
fhir:display [ fhir:v "Structured product labelling medguide section" ]       ] [
fhir:code [ fhir:v "42232-9" ] ;
fhir:display [ fhir:v "Precautions section" ]       ] [
fhir:code [ fhir:v "43678-2" ] ;
fhir:display [ fhir:v "Dosage forms and strengths section" ]       ] [
fhir:code [ fhir:v "43679-0" ] ;
fhir:display [ fhir:v "Mechanism of action section" ]       ] [
fhir:code [ fhir:v "43680-8" ] ;
fhir:display [ fhir:v "Nonclinical toxicology section" ]       ] [
fhir:code [ fhir:v "43681-6" ] ;
fhir:display [ fhir:v "Pharmacodynamics section" ]       ] [
fhir:code [ fhir:v "43682-4" ] ;
fhir:display [ fhir:v "Pharmacokinetics section" ]       ] [
fhir:code [ fhir:v "43683-2" ] ;
fhir:display [ fhir:v "Recent major changes section" ]       ] [
fhir:code [ fhir:v "43684-0" ] ;
fhir:display [ fhir:v "Use in specific populations section" ]       ] [
fhir:code [ fhir:v "43685-7" ] ;
fhir:display [ fhir:v "Warnings and precautions section" ]       ] [
fhir:code [ fhir:v "44425-7" ] ;
fhir:display [ fhir:v "Storage and handling section" ]       ] [
fhir:code [ fhir:v "48779-3" ] ;
fhir:display [ fhir:v "Structured product labelling indexing data elements section" ]       ] [
fhir:code [ fhir:v "48780-1" ] ;
fhir:display [ fhir:v "Structured product labelling listing data elements section" ]       ] [
fhir:code [ fhir:v "49489-8" ] ;
fhir:display [ fhir:v "Microbiology section" ]       ] [
fhir:code [ fhir:v "54433-8" ] ;
fhir:display [ fhir:v "User safety warnings section" ]       ] [
fhir:code [ fhir:v "59845-8" ] ;
fhir:display [ fhir:v "Instructions for use section" ]       ] [
fhir:code [ fhir:v "60555-0" ] ;
fhir:display [ fhir:v "Accessories" ]       ] [
fhir:code [ fhir:v "60556-8" ] ;
fhir:display [ fhir:v "Assembly or installation instructions" ]       ] [
fhir:code [ fhir:v "60557-6" ] ;
fhir:display [ fhir:v "Calibration instructions" ]       ] [
fhir:code [ fhir:v "60558-4" ] ;
fhir:display [ fhir:v "Cleaning, disinfecting, and sterilization instructions" ]       ] [
fhir:code [ fhir:v "60559-2" ] ;
fhir:display [ fhir:v "Components" ]       ] [
fhir:code [ fhir:v "60560-0" ] ;
fhir:display [ fhir:v "Intended use of the device" ]       ] [
fhir:code [ fhir:v "60561-8" ] ;
fhir:display [ fhir:v "Other safety information" ]       ] [
fhir:code [ fhir:v "60562-6" ] ;
fhir:display [ fhir:v "Route, method and frequency of administration" ]       ] [
fhir:code [ fhir:v "60563-4" ] ;
fhir:display [ fhir:v "Summary of safety and effectiveness" ]       ] [
fhir:code [ fhir:v "60685-5" ] ;
fhir:display [ fhir:v "Indexing - pharmacologic class" ]       ] [
fhir:code [ fhir:v "64123-3" ] ;
fhir:display [ fhir:v "Indexing - adverse reaction" ]       ] [
fhir:code [ fhir:v "64124-1" ] ;
fhir:display [ fhir:v "Indexing - substance" ]       ] [
fhir:code [ fhir:v "66105-8" ] ;
fhir:display [ fhir:v "Lot distribution data" ]       ] [
fhir:code [ fhir:v "66106-6" ] ;
fhir:display [ fhir:v "Pharmacogenomics section" ]       ] [
fhir:code [ fhir:v "69758-1" ] ;
fhir:display [ fhir:v "Diagram of device" ]       ] [
fhir:code [ fhir:v "69759-9" ] ;
fhir:display [ fhir:v "Risks" ]       ] [
fhir:code [ fhir:v "69760-7" ] ;
fhir:display [ fhir:v "Compatible accessories" ]       ] [
fhir:code [ fhir:v "69761-5" ] ;
fhir:display [ fhir:v "Alarms" ]       ] [
fhir:code [ fhir:v "69762-3" ] ;
fhir:display [ fhir:v "Troubleshooting" ]       ] [
fhir:code [ fhir:v "69763-1" ] ;
fhir:display [ fhir:v "Disposal and waste handling" ]       ] [
fhir:code [ fhir:v "71446-9" ] ;
fhir:display [ fhir:v "Indexing - billing unit" ]       ] [
fhir:code [ fhir:v "71681-1" ] ;
fhir:display [ fhir:v "PMI - Common side effects section" ]       ] [
fhir:code [ fhir:v "71682-9" ] ;
fhir:display [ fhir:v "PMI - Get emergency medical help section" ]       ] [
fhir:code [ fhir:v "71683-7" ] ;
fhir:display [ fhir:v "PMI - Stop taking and call your doctor section" ]       ] [
fhir:code [ fhir:v "71684-5" ] ;
fhir:display [ fhir:v "PMI - Directions for use section" ]       ] [
fhir:code [ fhir:v "71685-2" ] ;
fhir:display [ fhir:v "PMI - Tell your doctor before taking section" ]       ] [
fhir:code [ fhir:v "71686-0" ] ;
fhir:display [ fhir:v "PMI - Do not take section" ]       ] [
fhir:code [ fhir:v "71687-8" ] ;
fhir:display [ fhir:v "PMI - Important information section" ]       ] [
fhir:code [ fhir:v "71688-6" ] ;
fhir:display [ fhir:v "PMI - Uses section" ]       ] [
fhir:code [ fhir:v "71744-7" ] ;
fhir:display [ fhir:v "Health care provider letter" ]       ] [
fhir:code [ fhir:v "73815-3" ] ;
fhir:display [ fhir:v "Indexing - product concept" ]       ] [
fhir:code [ fhir:v "77288-9" ] ;
fhir:display [ fhir:v "Indexing - warning letter alert" ]       ] [
fhir:code [ fhir:v "77289-7" ] ;
fhir:display [ fhir:v "Identification of suspect product and notification" ]       ] [
fhir:code [ fhir:v "77290-5" ] ;
fhir:display [ fhir:v "Lactation" ]       ] [
fhir:code [ fhir:v "77291-3" ] ;
fhir:display [ fhir:v "Females and males reproductive potential" ]       ] [
fhir:code [ fhir:v "77292-1" ] ;
fhir:display [ fhir:v "eFacility" ]       ] [
fhir:code [ fhir:v "82336-9" ] ;
fhir:display [ fhir:v "REMS header" ]       ] [
fhir:code [ fhir:v "82344-3" ] ;
fhir:display [ fhir:v "REMS communication plan" ]       ] [
fhir:code [ fhir:v "82345-0" ] ;
fhir:display [ fhir:v "REMS elements to assure safe use" ]       ] [
fhir:code [ fhir:v "82346-8" ] ;
fhir:display [ fhir:v "REMS material" ]       ] [
fhir:code [ fhir:v "82347-6" ] ;
fhir:display [ fhir:v "REMS summary" ]       ] [
fhir:code [ fhir:v "82348-4" ] ;
fhir:display [ fhir:v "REMS elements" ]       ] [
fhir:code [ fhir:v "82349-2" ] ;
fhir:display [ fhir:v "REMS goals" ]       ] [
fhir:code [ fhir:v "82350-0" ] ;
fhir:display [ fhir:v "REMS implementation system" ]       ] [
fhir:code [ fhir:v "82351-8" ] ;
fhir:display [ fhir:v "Risk evaluation and mitigation strategies" ]       ] [
fhir:code [ fhir:v "82352-6" ] ;
fhir:display [ fhir:v "REMS timetable for submission assessments" ]       ] [
fhir:code [ fhir:v "82353-4" ] ;
fhir:display [ fhir:v "Indexing - risk evaluation and mitigation strategies" ]       ] [
fhir:code [ fhir:v "82598-4" ] ;
fhir:display [ fhir:v "REMS medication guide" ]       ] [
fhir:code [ fhir:v "85273-1" ] ;
fhir:display [ fhir:v "REMS conversion to shared system" ]       ] [
fhir:code [ fhir:v "85274-9" ] ;
fhir:display [ fhir:v "REMS release" ]       ] [
fhir:code [ fhir:v "86445-4" ] ;
fhir:display [ fhir:v "Blanket no changes certification of product listing" ]       ] [
fhir:code [ fhir:v "87523-7" ] ;
fhir:display [ fhir:v "REMS administrative information" ]       ] [
fhir:code [ fhir:v "87524-5" ] ;
fhir:display [ fhir:v "REMS requirements" ]       ] [
fhir:code [ fhir:v "87525-2" ] ;
fhir:display [ fhir:v "REMS participant requirements" ]       ] [
fhir:code [ fhir:v "87526-0" ] ;
fhir:display [ fhir:v "REMS applicant requirements" ]       ] [
fhir:code [ fhir:v "88436-1" ] ;
fhir:display [ fhir:v "Patient counseling information" ]       ] [
fhir:code [ fhir:v "88437-9" ] ;
fhir:display [ fhir:v "How supplied and storage and handling section" ]       ] [
fhir:code [ fhir:v "88828-9" ] ;
fhir:display [ fhir:v "Renal Impairment subsection" ]       ] [
fhir:code [ fhir:v "88829-7" ] ;
fhir:display [ fhir:v "Hepatic Impairment subsection" ]       ] [
fhir:code [ fhir:v "88830-5" ] ;
fhir:display [ fhir:v "Immunogenicity" ]       ] [
fhir:code [ fhir:v "90374-0" ] ;
fhir:display [ fhir:v "Clinical trials experience section" ]       ] [
fhir:code [ fhir:v "90375-7" ] ;
fhir:display [ fhir:v "Postmarketing experience section" ]       ] )     ] )
  ] . #