Gravitate Health FHIR Implementation Guide
0.1.0 - CI Build

Gravitate Health FHIR Implementation Guide, published by Gravitate Health Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/gravitate-health/ and changes regularly. See the Directory of published versions

: ePI document Bundle for Enbrel 25 mg powder for solution for injection Package Leaflet for language en - JSON Representation

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            "reference" : "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072072",
              "display" : "Active"
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          ]
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            "concept" : {
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                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
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                  "display" : "Etanercept"
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              ]
            }
          },
          "strength" : [
            {
              "presentationQuantity" : {
                "value" : 25,
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                  {
                    "system" : "http://terminology.hl7.org/CodeSystem/v3-RoleClass",
                    "code" : "ACTIB",
                    "display" : "active ingredient - basis of strength"
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                ]
              }
            }
          ]
        }
      }
    },
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        "resourceType" : "Ingredient",
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        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi"
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        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_ingredient-for-enbrel-tromethamine\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient ingredient-for-enbrel-tromethamine</b></p><a name=\"ingredient-for-enbrel-tromethamine\"> </a><a name=\"hcingredient-for-enbrel-tromethamine\"> </a><a name=\"ingredient-for-enbrel-tromethamine-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta</code>/023C2WHX2V\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>for</b>: </p><ul><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li><li><a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></li></ul><p><b>role</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072082}\">Excipient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Concept</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://gsrs.ncats.nih.gov/ginas/app/beta 023C2WHX2V}\">TROMETHAMINE</span></td></tr></table></blockquote></div>"
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          "use" : "official",
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          {
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          },
          {
            "reference" : "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8"
          },
          {
            "reference" : "AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5"
          }
        ],
        "role" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072082",
              "display" : "Excipient"
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        "substance" : {
          "code" : {
            "concept" : {
              "coding" : [
                {
                  "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta",
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                  "display" : "TROMETHAMINE"
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            }
          }
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      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/SubstanceDefinition/substance-etanercept",
      "resource" : {
        "resourceType" : "SubstanceDefinition",
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          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi"
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        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_substance-etanercept\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition substance-etanercept</b></p><a name=\"substance-etanercept\"> </a><a name=\"hcsubstance-etanercept\"> </a><a name=\"substance-etanercept-en-US\"> </a><p><b>identifier</b>: <code>https://gsrs.ncats.nih.gov/ginas/app/beta/</code>/OP401G7OJC\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">Active</span></p><p><b>manufacturer</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#Organization_mah-9800de324c3962f6f767647a95e0c17e\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p></div>"
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        "identifier" : [
          {
            "use" : "official",
            "system" : "https://gsrs.ncats.nih.gov/ginas/app/beta/",
            "value" : "OP401G7OJC"
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            {
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          {
            "reference" : "Organization/mah-9800de324c3962f6f767647a95e0c17e"
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    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/AdministrableProductDefinition/ap-7f657b63823319aa7da7d2c5939e39e5",
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        "resourceType" : "AdministrableProductDefinition",
        "id" : "ap-7f657b63823319aa7da7d2c5939e39e5",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"AdministrableProductDefinition_ap-7f657b63823319aa7da7d2c5939e39e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: AdministrableProductDefinition ap-7f657b63823319aa7da7d2c5939e39e5</b></p><a name=\"ap-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"hcap-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"ap-7f657b63823319aa7da7d2c5939e39e5-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/id</p><p><b>status</b>: Active</p><p><b>formOf</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><p><b>administrableDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073866}\">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p><p><b>producedFrom</b>: <a href=\"Bundle-bundlepackageleaflet-en-7f657b63823319aa7da7d2c5939e39e5.html#ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\">Bundle: identifier = https://www.gravitatehealth.eu/sid/doc#deca01585a8d920f79dbfbe328e7acda; type = document; timestamp = 2023-06-27 10:09:22+0000</a></p><blockquote><p><b>routeOfAdministration</b></p><p><b>code</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000073633}\">Subcutaneous use</span></p><h3>TargetSpecies</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000109093}\">Human</span></td></tr></table></blockquote></div>"
        },
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          {
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        "status" : "active",
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          {
            "reference" : "MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8"
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            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000073866",
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        "unitOfPresentation" : {
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            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002158",
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          {
            "reference" : "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5"
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        "routeOfAdministration" : [
          {
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                {
                  "system" : "https://spor.ema.europa.eu/rmswi",
                  "code" : "100000073633",
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            "targetSpecies" : [
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                      "code" : "100000109093",
                      "display" : "Human"
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            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi"
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            "value" : "EU/1/99/126/003"
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                    "system" : "https://spor.ema.europa.eu/rmswi",
                    "code" : "100000073496",
                    "display" : "Blister"
                  }
                ]
              },
              "quantity" : 28,
              "material" : [
                {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/rmswi",
                      "code" : "200000003222",
                      "display" : "PolyVinyl Chloride"
                    }
                  ]
                }
              ],
              "containedItem" : [
                {
                  "item" : {
                    "reference" : {
                      "reference" : "ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5"
                    }
                  }
                }
              ]
            }
          ]
        }
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/MedicinalProductDefinition/mp25bbfa948f4a0b224f9baa1fe481efa8",
      "resource" : {
        "resourceType" : "MedicinalProductDefinition",
        "id" : "mp25bbfa948f4a0b224f9baa1fe481efa8",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_mp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition mp25bbfa948f4a0b224f9baa1fe481efa8</b></p><a name=\"mp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"hcmp25bbfa948f4a0b224f9baa1fe481efa8\"> </a><a name=\"mp25bbfa948f4a0b224f9baa1fe481efa8-en-US\"> </a><p><b>identifier</b>: <code>http://fakesys.com/ids</code>/zz</p><p><b>type</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-type MedicinalProduct}\">Medicinal Product</span></p><p><b>domain</b>: <span title=\"Codes:{http://hl7.org/fhir/medicinal-product-domain Human}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://hl7.org/fhir/publication-status active}\">active</span></p><p><b>legalStatusOfSupply</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 100000072084}\">Medicinal product subject to medical prescription</span></p><blockquote><p><b>name</b></p><p><b>productName</b>: Enbrel 25 mg powder for solution for injection</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000001}\">Full name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: Enbrel</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: Etanercept</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000003}\">Scientific name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 25 mg</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: powder for solution for injection</p><p><b>type</b>: <span title=\"Codes:{https://spor.ema.europa.eu/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Jurisdiction</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:iso:std:iso:3166 NOR}\">Norway</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 en}\">English</span></td></tr></table></blockquote></div>"
        },
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          {
            "system" : "http://fakesys.com/ids",
            "value" : "zz"
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        ],
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            {
              "system" : "http://hl7.org/fhir/medicinal-product-type",
              "code" : "MedicinalProduct",
              "display" : "Medicinal Product"
            }
          ]
        },
        "domain" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/medicinal-product-domain",
              "code" : "Human",
              "display" : "Human use"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "system" : "http://hl7.org/fhir/publication-status",
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              "display" : "active"
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          ]
        },
        "legalStatusOfSupply" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "100000072084",
              "display" : "Medicinal product subject to medical prescription"
            }
          ]
        },
        "name" : [
          {
            "productName" : "Enbrel 25 mg powder for solution for injection",
            "type" : {
              "coding" : [
                {
                  "system" : "https://spor.ema.europa.eu/lists/220000000000",
                  "code" : "220000000001",
                  "display" : "Full name"
                }
              ]
            },
            "part" : [
              {
                "part" : "Enbrel",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
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                      "display" : "Invented name part"
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                  ]
                }
              },
              {
                "part" : "Etanercept",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000003",
                      "display" : "Scientific name part"
                    }
                  ]
                }
              },
              {
                "part" : "25 mg",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000004",
                      "display" : "Strength part"
                    }
                  ]
                }
              },
              {
                "part" : "powder for solution for injection",
                "type" : {
                  "coding" : [
                    {
                      "system" : "https://spor.ema.europa.eu/lists/220000000000",
                      "code" : "220000000005",
                      "display" : "Pharmaceutical dose form part"
                    }
                  ]
                }
              }
            ],
            "usage" : [
              {
                "country" : {
                  "coding" : [
                    {
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                      "display" : "Norway"
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                    {
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                      "display" : "Norway"
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                },
                "language" : {
                  "coding" : [
                    {
                      "system" : "urn:ietf:bcp:47",
                      "code" : "en",
                      "display" : "English"
                    }
                  ]
                }
              }
            ]
          }
        ]
      }
    },
    {
      "fullUrl" : "http://hl7.eu/fhir/ig/gravitate-health/ManufacturedItemDefinition/mid-7f657b63823319aa7da7d2c5939e39e5",
      "resource" : {
        "resourceType" : "ManufacturedItemDefinition",
        "id" : "mid-7f657b63823319aa7da7d2c5939e39e5",
        "meta" : {
          "profile" : [
            🔗 "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi"
          ]
        },
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ManufacturedItemDefinition_mid-7f657b63823319aa7da7d2c5939e39e5\"> </a><p class=\"res-header-id\"><b>Generated Narrative: ManufacturedItemDefinition mid-7f657b63823319aa7da7d2c5939e39e5</b></p><a name=\"mid-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"hcmid-7f657b63823319aa7da7d2c5939e39e5\"> </a><a name=\"mid-7f657b63823319aa7da7d2c5939e39e5-en-US\"> </a><p><b>identifier</b>: <code>https://spor.ema.europa.eu/pmswi</code>/EU/1/99/126/003\u00a0(use:\u00a0official,\u00a0)</p><p><b>status</b>: Active</p><p><b>manufacturedDoseForm</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi/ 100000073866}\">Powder for solution for injection</span></p><p><b>unitOfPresentation</b>: <span title=\"Codes:{https://spor.ema.europa.eu/rmswi 200000002158}\">Vial</span></p></div>"
        },
        "identifier" : [
          {
            "use" : "official",
            "system" : "https://spor.ema.europa.eu/pmswi",
            "value" : "EU/1/99/126/003"
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        ],
        "status" : "active",
        "manufacturedDoseForm" : {
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            {
              "system" : "https://spor.ema.europa.eu/rmswi/",
              "code" : "100000073866",
              "display" : "Powder for solution for injection"
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        "unitOfPresentation" : {
          "coding" : [
            {
              "system" : "https://spor.ema.europa.eu/rmswi",
              "code" : "200000002158",
              "display" : "Vial"
            }
          ]
        }
      }
    }
  ]
}