SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

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

Example Bundle: LantusInjectionLabelBundle

Document Details

Generated Narrative: Bundle 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

Document Content

1 INDICATIONS AND USAGE

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. (1)

Limitations of Use

Not recommended for treating diabetic ketoacidosis. (1)

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.

SPL UNCLASSIFIED SECTION

Limitations of Use

LANTUS is not recommended for the treatment of diabetic ketoacidosis.

SPL LISTING DATA ELEMENTS SECTION

PRINCIPAL DISPLAY PANEL - 10 mL Vial Package

​

NDC 0088-5021-01
Rx only

Lantus®
insulin glargine
injection

100 units/mL
(U-100)
For subcutaneous
injection only

Do not mix with
other insulins

Use only if solution
is clear and colorless
with no particles visible

Use with U-100
syringe only

One 10 mL multiple-dose vial

novaplus ™

PRINCIPAL DISPLAY PANEL - 10 mL Vial Package

PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package

​

NDC 0088-5020-05
Rx only

Lantus® SoloStar®
insulin glargine injection
For Single Patient Use Only
100 units/mL (U-100)
Five 3 mL Prefilled Pens

Solution for injection in a disposable insulin delivery device
Do not mix with other insulins
For subcutaneous injection only
Use only if solution is clear and colorless with no particles visible
Use within 28 days after initial use *Needles not include (see back panel)

novaplus ™

PRINCIPAL DISPLAY PANEL - 3 mL Syringe Package

Additional Resources Included in Document

Entry 1 - fullUrl = http://example.org/Composition/LantusInjectionLabelComposition

Resource Composition:

Generated Narrative: Composition LantusInjectionLabelComposition

VersionNumber: 11

identifier: Uniform Resource Identifier (URI)/urn:uuid:6328c99d-d75f-43ef-b19e-7e71f91e57f6

status: Final

type: HUMAN PRESCRIPTION DRUG LABEL

date: 2021-01-27

author: Organization sanofi-aventis U.S. LLC

title: 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

Entry 2 - fullUrl = http://example.org/Organization/SanofiAventisUS

Resource Organization:

Generated Narrative: Organization SanofiAventisUS

identifier: urn:oid:1.3.6.1.4.1.519.1/783243835

type: An organization that submits product labels.

name: sanofi-aventis U.S. LLC

Entry 3 - fullUrl = http://example.org/Organization/SanofiAventisDeutschland

Resource Organization:

Generated Narrative: Organization SanofiAventisDeutschland

identifier: urn:oid:1.3.6.1.4.1.519.1/313218430

type: An organization that provides operations in the manufacturing of a product.

name: Sanofi-Aventis Deutschland GmbH

Entry 4 - fullUrl = http://example.org/Organization/SanofiAventisSRL

Resource Organization:

Generated Narrative: Organization SanofiAventisSRL

identifier: urn:oid:1.3.6.1.4.1.519.1/338454274

type: An organization that provides operations in the manufacturing of a product.

name: Sanofi S.r.l.

Entry 5 - fullUrl = http://example.org/MedicinalProductDefinition/LantusSyringeDefinition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition LantusSyringeDefinition

identifier: National drug codes/0088-5020

route: SUBCUTANEOUS

MarketingStatuses

-StatusDateRange
*active2017-06-04 --> (ongoing)

name

productName: Lantus Solostar

type: Proprietary Name

name

productName: insulin glargine

type: Generic Name (Non-Proprietary)

operation

Types

-Concept
*ANALYSIS

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*API MANUFACTURE

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*LABEL

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*MANUFACTURE

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*PACK

organization: Organization Sanofi-Aventis Deutschland GmbH

Entry 6 - fullUrl = http://example.org/MedicinalProductDefinition/LantusVialDefinition

Resource MedicinalProductDefinition:

Generated Narrative: MedicinalProductDefinition LantusVialDefinition

identifier: National drug codes/0088-5021

route: SUBCUTANEOUS

MarketingStatuses

-StatusDateRange
*active2017-06-04 --> (ongoing)

name

productName: Lantus

type: Proprietary Name

name

productName: insulin glargine

type: Generic Name (Non-Proprietary)

operation

Types

-Concept
*ANALYSIS

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*API MANUFACTURE

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*LABEL

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*MANUFACTURE

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*PACK

organization: Organization Sanofi-Aventis Deutschland GmbH

operation

Types

-Concept
*ANALYSIS

organization: Organization Sanofi S.r.l.

operation

Types

-Concept
*LABEL

organization: Organization Sanofi S.r.l.

operation

Types

-Concept
*MANUFACTURE

organization: Organization Sanofi S.r.l.

operation

Types

-Concept
*PACK

organization: Organization Sanofi S.r.l.

Entry 7 - fullUrl = http://example.org/ManufacturedItemDefinition/LantusSolution

Resource ManufacturedItemDefinition:

Generated Narrative: ManufacturedItemDefinition LantusSolution

status: Active

manufacturedDoseForm: INJECTION, SOLUTION

Entry 8 - fullUrl = http://example.org/Ingredient/LantusActiveIngredient

Resource Ingredient:

Generated Narrative: Ingredient LantusActiveIngredient

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: active ingredient - basis of strength

substance

Codes

-Reference
*SubstanceDefinition: identifier = http://fdasis.nlm.nih.gov#Unique Ingredient Identifier (UNII)#2ZM8CX04RZ

Strengths

-Presentation[x]
*100 iU (Details: UCUM code[iU] = '[iU]')/1 mL (Details: UCUM codemL = 'mL')

Entry 9 - fullUrl = http://example.org/SubstanceDefinition/LantusIngredientDefinition

Resource SubstanceDefinition:

Generated Narrative: SubstanceDefinition LantusIngredientDefinition

identifier: Unique Ingredient Identifier (UNII)/2ZM8CX04RZ

Moieties

-IdentifierName
*Unique Ingredient Identifier (UNII)/2ZM8CX04RZINSULIN GLARGINE

Names

-Name
*INSULIN GLARGINE

Entry 10 - fullUrl = http://example.org/Ingredient/LantusIngredient1

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient1

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*ZINC

Strengths

-Presentation[x]
*30 ug (Details: UCUM codeug = 'ug')/1 mL (Details: UCUM codemL = 'mL')

Entry 11 - fullUrl = http://example.org/Ingredient/LantusIngredient2

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient2

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*METACRESOL

Strengths

-Presentation[x]
*2.7 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 12 - fullUrl = http://example.org/Ingredient/LantusIngredient3

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient3

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*GLYCERIN

Strengths

-Presentation[x]
*20 mg (Details: UCUM codemg = 'mg')/1 mL (Details: UCUM codemL = 'mL')

Entry 13 - fullUrl = http://example.org/Ingredient/LantusIngredient4

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient4

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*POLYSORBATE 20

Strengths

-Presentation[x]
*20 ug (Details: UCUM codeug = 'ug')/1 mL (Details: UCUM codemL = 'mL')

Entry 14 - fullUrl = http://example.org/Ingredient/LantusIngredient5

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient5

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*WATER

Entry 15 - fullUrl = http://example.org/Ingredient/LantusIngredient6

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient6

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*HYDROCHLORIC ACID

Entry 16 - fullUrl = http://example.org/Ingredient/LantusIngredient7

Resource Ingredient:

Generated Narrative: Ingredient LantusIngredient7

status: Active

for: ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

role: inactive ingredient

substance

Codes

-Concept
*SODIUM HYDROXIDE

Entry 17 - fullUrl = http://example.org/PackagedProductDefinition/LantusVialPackage

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition LantusVialPackage

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5021; route = SUBCUTANEOUS

MarketingStatuses

-StatusDateRange
*active2017-06-04 --> (ongoing)

packaging

identifier: National drug codes/0088-5021-01

type: PACKAGE

packaging

type: VIAL, GLASS

quantity: 1

Properties

-TypeValue[x]
*Combination Product TypeType 0: Not a Combination Product

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

amount: 10 mL (Details: UCUM codemL = 'mL')

Entry 18 - fullUrl = http://example.org/PackagedProductDefinition/LantusSyringePackage

Resource PackagedProductDefinition:

Generated Narrative: PackagedProductDefinition LantusSyringePackage

packageFor: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5020; route = SUBCUTANEOUS

MarketingStatuses

-StatusDateRange
*active2017-06-04 --> (ongoing)

packaging

identifier: National drug codes/0088-5020-05

type: PACKAGE

packaging

identifier: National drug codes/0088-5020-01

type: SYRINGE

quantity: 5

Properties

-TypeValue[x]
*Combination Product TypeType 0: Not a Combination Product

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = INJECTION, SOLUTION

amount: 3 mL (Details: UCUM codemL = 'mL')

Entry 19 - fullUrl = http://example.org/RegulatedAuthorization/LantusVialMarketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization LantusVialMarketing

identifier: urn:oid:2.16.840.1.113883.3.150/BLA021081

subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5021; route = SUBCUTANEOUS

type: BLA

region: United States of America

Entry 20 - fullUrl = http://example.org/RegulatedAuthorization/LantusSyringeMarketing

Resource RegulatedAuthorization:

Generated Narrative: RegulatedAuthorization LantusSyringeMarketing

identifier: urn:oid:2.16.840.1.113883.3.150/BLA021081

subject: MedicinalProductDefinition: identifier = http://hl7.org/fhir/sid/ndc#National drug codes#0088-5020; route = SUBCUTANEOUS

type: BLA

region: United States of America