IP Review

This publication includes IP covered under the following statements.

ISO maintains the copyright on the country codes, and controls its use carefully. For further details see the ISO 3166 web page: https://www.iso.org/iso-3166-country-codes.html
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- ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code : AllNDCProducts , Bundle/AllopurinolTabletLabelBundle ... Show 108 more
The UCUM codes, UCUM table (regardless of format), and UCUM Specification are copyright 1999-2009, Regenstrief Institute, Inc. and the Unified Codes for Units of Measures (UCUM) Organization. All rights reserved. https://ucum.org/trac/wiki/TermsOfUse
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- Unified Code for Units of Measure (UCUM) : Bundle/AllopurinolTabletLabelBundle , Bundle/EnbrelSyringeLabelBundle ... Show 41 more
This material contains content from LOINC . 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 . LOINC® is a registered United States trademark of Regenstrief Institute, Inc.
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- LOINC : Bundle/AllopurinolTabletLabelBundle , Bundle/EnbrelSyringeLabelBundle ... Show 32 more
This material derives from the HL7 Terminology (THO). THO is copyright ©1989+ Health Level Seven International and is made available under the CC0 designation. For more licensing information see: https://terminology.hl7.org/license.html
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Unless otherwise noted, the contents of the FDA website (www.fda.gov) — both text and graphics — are not copyrighted. They are in the public domain and may be republished, reprinted and otherwise used freely by anyone without the need to obtain permission from FDA. Credit to the U.S. Food and Drug Administration as the source is appreciated but not required.
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- Unique Ingredient Identifier (UNII) : Bundle/AllopurinolTabletLabelBundle , Bundle/EnbrelSyringeLabelBundle ... Show 25 more

IG © 2020+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.spl#0.2.5 based on FHIR 5.0.0. Generated 2025-03-20 Links: Table of Contents | QA Report | Version History | CC0 | Propose a change ( src )

hl7.fhir.us.hai: Healthcare Associated Infection Implementation Guide ®© HL7 | CC0 ( src )

<text> <status value="additional"/> <xhtml:div> <div xmlns="http://www.w3.org/1999/xhtml" style="narrative"> <ul> <li> Injection: 25 mg/0.5 mL and 50 mg/mL clear, colorless solution in a single-dose prefilled syringe</li> <li> Injection: 50 mg/mL clear, colorless solution in a single-dose prefilled SureClick autoinjector</li> <li> Injection: 25 mg/0.5 mL clear, colorless solution in a single-dose vial</li> <li> For Injection: 25 mg lyophilized powder in a multiple-dose vial for reconstitution</li> <li> Injection: 50 mg/mL clear, colorless solution in Enbrel Mini single-dose prefilled cartridge for use with the AutoTouch reusable autoinjector only</li> </ul> </div> <div xmlns="http://www.w3.org/1999/xhtml" style="highlight"> <ul> <li> Injection: 25 mg/0.5 mL and 50 mg/mL solution in a single-dose prefilled syringe (<a href="#S3">3</a>)</li> <li> Injection: 50 mg/mL solution in single-dose prefilled SureClick® Autoinjector (<a href="#S3">3</a>)</li> <li> Injection: 25 mg/0.5 mL solution in a single-dose vial (<a href="#S3">3</a>)</li> <li> For Injection: 25 mg lyophilized powder in a multiple-dose vial for reconstitution (<a href="#S3">3</a>)</li> <li> Injection: 50 mg/mL solution in Enbrel Mini® single-dose prefilled cartridge for use with the AutoTouch® reusable autoinjector only (<a href="#S3">3</a>)</li> </ul> </div> </xhtml:div> </text> </section> ( src )

8.138 These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 ( src )

8.159 These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 ( src )

: These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 - JSON Representation ( src )

: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 - JSON Representation ( src )

Copyright/Legal: 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 ( src )

Example Composition: These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 ( src )

Example Composition: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 ( src )

Generated Narrative: Bundle These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 ( src )

Generated Narrative: Bundle These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 ( src )

PRINCIPAL DISPLAY PANEL Contains 4 Multi-Dose TraysNDC 58406-425-34AMGEN®Enbrel®etanercept25 mg/vialMultiple-Dose VialSee package insert for full prescribing informationand instructions for preparation and administration.25 mg/vialEach vial contains a sterile lyophilized preparationof 25 mg etanercept (a recombinant CHO cell-derivedproduct), 40 mg mannitol, 10 mg sucrose, and1.2 mg tromethamine.Specific activitiy: approximately 1.7 x 106 U/mg.No U.S. standard of potency. Volume after reconstitutionwith 1 mL diluent is 1 mL.Before and after reconstitution refrigerateat 2° to 8°C (36° to 46°F). DO NOT FREEZE.For Subcutaneous Use OnlyAMGEN®Manufactured by Immunex Corporation, Thousand Oaks, CA 91320Contains diluent syringes (Made in Germany)U.S. License No. 1132©2013, 2016 Immunex CorporationPatent: http://pat.amgen.com/enbrel/ ( src )

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 0.2.5 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 ( src )

These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 ( src )

These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 ( src )

title: These highlights do not include all the information needed to use ENBREL safely and effectively. See full prescribing information for ENBREL. ENBREL® (etanercept) injection, for subcutaneous use ENBREL® (etanercept) for injection, for subcutaneous use Initial U.S. Approval: 1998 ( src )

title: These highlights do not include all the information needed to use LANTUS safely and effectively. See full prescribing information for LANTUS. LANTUS® (insulin glargine injection) for subcutaneous injection Initial U.S. Approval: 2000 ( src )

® ( src )

External References

Type	Reference	Content
web	example.org	http://example.org/
web	tel:+011-703-362-1280	+011-703-362-1280 , charles@anywhere.com
web	tel:+1-703-362-1280;ext=1234	+1-703-362-1280;ext=1234 , charles@anywhere.com
web	tel:+1-703-362-1280	+1-703-362-1280 , charles@anywhere.com
web	tel:+1-908-999-1212;ext=444	+1-908-999-1212;ext=444 , jdoe_2@npoiinc.net
web	tel:+1-908-999-1212	+1-908-999-1212 , jdoe_2@npoiinc.net
web	github.com	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 0.2.5 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
web	en.wikipedia.org	Both Bundle.link and Bundle.entry.link are defined to support providing additional context when Bundles are used (e.g. HATEOAS ).
web	www.omg.org	Mappings for ServD ( http://www.omg.org/spec/ServD/1.0/ )
web	fhir.github.io	A validator that can be used to check FHIR resource instance validity

Type

Reference

Content

web

example.org

http://example.org/

web

tel:+011-703-362-1280

+011-703-362-1280 , charles@anywhere.com

web

tel:+1-703-362-1280;ext=1234

+1-703-362-1280;ext=1234 , charles@anywhere.com