bundlepackageleaflet-enbrelsolution
type: Bundle
node role: treeRoot
id:
  v: bundlepackageleaflet-enbrelsolution
meta:
  version id:
    v: 1
  last updated:
    v: 2023-08-16T00:00:00Z
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Bundle-uv-epi
    l: Bundle-uv-epi
language:
  v: en
identifier:
  system:
    v: https://www.minzdrav.gov.ru/
    l: www.minzdrav.gov.ru
  value:
    v: enbrel
type:
  v: document
timestamp:
  v: 2023-08-16T00:00:00Z
entry:
  full url:
    v: Composition/compositionruen
    l: compositionruen
  resource: compositionruen
entry:
  full url:
    v: Ingredient/etanercept50mg
    l: etanercept50mg
  resource: etanercept50mg
entry:
  full url:
    v: Ingredient/ingredientARGININEHYDROCHLORIDE
    l: ingredientARGININEHYDROCHLORIDE
  resource: ingredientARGININEHYDROCHLORIDE
entry:
  full url:
    v: Ingredient/ingredientSodiumChloride
    l: ingredientSodiumChloride
  resource: ingredientSodiumChloride
entry:
  full url:
    v: Ingredient/ingredientSucrose
    l: ingredientSucrose
  resource: ingredientSucrose
entry:
  full url:
    v: Ingredient/ingredientsodiumdihydrogenphosphatedihydrate
    l: ingredientsodiumdihydrogenphosphatedihydrate
  resource: ingredientsodiumdihydrogenphosphatedihydrate
entry:
  full url:
    v: Ingredient/ingredientWATERFORINJECTION
    l: ingredientWATERFORINJECTION
  resource: ingredientWATERFORINJECTION
entry:
  full url:
    v: SubstanceDefinition/substancetanercept
    l: substancetanercept
  resource: substancetanercept
entry:
  full url:
    v: ManufacturedItemDefinition/mid50mg
    l: mid50mg
  resource: mid50mg
entry:
  full url:
    v: AdministrableProductDefinition/ap50mg
    l: ap50mg
  resource: ap50mg
entry:
  full url:
    l: authorization50mg
  resource: authorization50mg
entry:
  full url:
    v: Organization/orgpfizerusinc
    l: orgpfizerusinc
  resource: orgpfizerusinc
entry:
  full url:
    v: Organization/orgpfizerbe
    l: orgpfizerbe
  resource: orgpfizerbe
entry:
  full url:
    l: ppd50mgsyringe4
  resource: ppd50mgsyringe4
entry:
  full url:
    v: MedicinalProductDefinition/mp50mg
    l: mp50mg
  resource: mp50mg

compositionruen
type: Composition
id:
  v: compositionruen
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi
    l: Composition-uv-epi
language:
  v: en
text:
  status:
    v: extensions
  div:
    v: Generated Narrative: Composition compositionruen Language: en Profile: Composition (ePI) org/fhir/dummyValidationReference: image1 org/fhir/dummyValidationReference: image2 org/fhir/dummyValidationReference: image3 org/fhir/dummyValidationReference: image4 org/fhir/dummyValidationReference: image5 org/fhir/dummyValidationReference: image7 org/fhir/dummyValidationReference: image8 org/fhir/dummyValidationReference: image9 org/fhir/dummyValidationReference: image10 org/fhir/dummyValidationReference: image11 org/fhir/dummyValidationReference: image12 identifier: https://www.minzdrav.gov.ru//0d69fdcb-33cf-407f-8209-a6529856ab4f status: Final type: Package Leaflet date: 2023-08-16 00:00:00+0000 author: Organization Pfizer Innovations LLC title: Enbrel® (etanercept) 50 mg/ml solution for subcutaneous injection Generated Narrative: Binary #image1 contentType: image/png data: (base64 data - 38,556 base64 chars) Generated Narrative: Binary #image2 contentType: image/png data: (base64 data - 12,784 base64 chars) Generated Narrative: Binary #image3 contentType: image/png data: (base64 data - 44,444 base64 chars) Generated Narrative: Binary #image4 contentType: image/png data: (base64 data - 18,332 base64 chars) Generated Narrative: Binary #image5 contentType: image/png data: (base64 data - 16,784 base64 chars) Generated Narrative: Binary #image7 contentType: image/png data: (base64 data - 19,268 base64 chars) Generated Narrative: Binary #image8 contentType: image/png data: (base64 data - 126,780 base64 chars) Generated Narrative: Binary #image9 contentType: image/png data: (base64 data - 16,852 base64 chars) Generated Narrative: Binary #image10 contentType: image/png data: (base64 data - 17,732 base64 chars) Generated Narrative: Binary #image11 contentType: image/png data: (base64 data - 68,280 base64 chars) Generated Narrative: Binary #image12 contentType: image/png data: (base64 data - 41,548 base64 chars)
contained: Binary
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contained: Binary
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contained: Binary
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contained: Binary
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contained: Binary
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contained: Binary
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contained: Binary
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contained: Binary
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  content type:
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contained: Binary
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contained: Binary
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    v: image11
  content type:
    v: image/png
contained: Binary
  id:
    v: image12
  content type:
    v: image/png
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image1
    reference:
      v: image1
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image2
    reference:
      v: image2
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image3
    reference:
      v: image3
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image4
    reference:
      v: image4
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image5
    reference:
      v: image5
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image7
    reference:
      v: image7
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image8
    reference:
      v: image8
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image9
    reference:
      v: image9
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image10
    reference:
      v: image10
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image11
    reference:
      v: image11
extension:
  url:
    v: http://example.org/fhir/dummyValidationReference
    l: dummyValidationReference
  value: Reference
    l: image12
    reference:
      v: image12
identifier:
  system:
    v: https://www.minzdrav.gov.ru/
    l: www.minzdrav.gov.ru
status:
  v: final
type:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Package Leaflet
subject:
  l: mp50mg
  reference:
    v: MedicinalProductDefinition/mp50mg
date:
  v: 2023-08-16T00:00:00Z
author:
  l: orgpfizerusinc
  reference:
    v: Organization/orgpfizerusinc
title:
  v: Enbrel® (etanercept) 50 mg/ml solution for subcutaneous injection
section:
  title:
    v: MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
  text:
    status:
      v: generated
  section:
    title:
      v: INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT

etanercept50mg
type: Ingredient
id:
  v: etanercept50mg
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient etanercept50mg Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/OP401G7OJC (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Active allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * ETANERCEPT Strengths - Presentation[x] Basis * 50 mg active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: OP401G7OJC
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072072
    display:
      v: Active
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe
substance:
  strength:
    presentation: Quantity
      value:
        v: 50
      unit:
        v: mg
    basis:
      text:
        v: active ingredient - basis of strength

ingredientARGININEHYDROCHLORIDE
type: Ingredient
id:
  v: ingredientARGININEHYDROCHLORIDE
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredientARGININEHYDROCHLORIDE Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/F7LTH1E20Y (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * ARGININE HYDROCHLORIDE
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: F7LTH1E20Y
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe

ingredientSodiumChloride
type: Ingredient
id:
  v: ingredientSodiumChloride
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredientSodiumChloride Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/451W47IQ8X (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * Sodium Chloride
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 451W47IQ8X
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe

ingredientSucrose
type: Ingredient
id:
  v: ingredientSucrose
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredientSucrose Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/C151H8M554 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * Sucrose Strengths - Basis * active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: C151H8M554
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe

ingredientsodiumdihydrogenphosphatedihydrate
type: Ingredient
id:
  v: ingredientsodiumdihydrogenphosphatedihydrate
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredientsodiumdihydrogenphosphatedihydrate Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/5QWK665956 (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * sodium dihydrogen phosphate dihydrate Strengths - Basis * active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 5QWK665956
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe

ingredientWATERFORINJECTION
type: Ingredient
id:
  v: ingredientWATERFORINJECTION
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Ingredient-uv-epi
    l: Ingredient-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: Ingredient ingredientWATERFORINJECTION Profile: Ingredient (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta/059QF0KO0R (use: official, ) status: Active for: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe role: Excipient allergenicIndicator: false Manufacturers - Manufacturer * Organization Pfizer Manufacturing Belgium NV, Belgium substance Codes - Concept * WATER FOR INJECTION Strengths - Basis * active ingredient - basis of strength
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta
    l: beta
  value:
    v: 059QF0KO0R
status:
  v: active
for:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
role:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000072082
    display:
      v: Excipient
allergenic indicator:
  v: false
manufacturer:
  manufacturer:
    l: orgpfizerbe
    reference:
      v: Organization/orgpfizerbe

substancetanercept
type: SubstanceDefinition
id:
  v: substancetanercept
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/SubstanceDefinition-uv-epi
    l: SubstanceDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: SubstanceDefinition substancetanercept Profile: SubstanceDefinition (ePI) identifier: https://gsrs.ncats.nih.gov/ginas/app/beta//OP401G7OJC (use: official, ) version: 1 status: Validated (UNII) manufacturer: Organization Pfizer Manufacturing Belgium NV, Belgium Names - Name Type * Etanercept Protein
identifier:
  use:
    v: official
  system:
    v: https://gsrs.ncats.nih.gov/ginas/app/beta/
    l: beta
  value:
    v: OP401G7OJC
version:
  v: 1
status:
  coding:
    system:
      v: https://gsrs.ncats.nih.gov/ginas/app/beta
      l: beta
    code:
      v: 1
    display:
      v: Validated (UNII)
manufacturer:
  l: orgpfizerbe
  reference:
    v: Organization/orgpfizerbe
name:
  name:
    v: Etanercept
  type:
    coding:
      system:
        v: https://gsrs.ncats.nih.gov/ginas/app/beta
        l: beta
      code:
        v: x
      display:
        v: Protein

mid50mg
type: ManufacturedItemDefinition
id:
  v: mid50mg
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/ManufacturedItemDefinition-uv-epi
    l: ManufacturedItemDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: ManufacturedItemDefinition mid50mg Profile: ManufacturedItemDefinition (ePI) identifier: https://www.minzdrav.gov.ru//99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ) status: Active manufacturedDoseForm: Solution for injection unitOfPresentation: Syringe manufacturer: Organization Pfizer Manufacturing Belgium NV, Belgium
identifier:
  use:
    v: official
  system:
    v: https://www.minzdrav.gov.ru/
    l: www.minzdrav.gov.ru
status:
  v: active
manufactured dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi/
      l: rmswi
    code:
      v: 100000073863
    display:
      v: Solution for injection
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002150
    display:
      v: Syringe
manufacturer:
  l: orgpfizerbe
  reference:
    v: Organization/orgpfizerbe

ap50mg
type: AdministrableProductDefinition
id:
  v: ap50mg
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/AdministrableProductDefinition-uv-epi
    l: AdministrableProductDefinition-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: AdministrableProductDefinition ap50mg Profile: AdministrableProductDefinition (ePI) identifier: https://www.who-umc.org/phpid/identifier status: Active formOf: MedicinalProductDefinition: identifier = http://www.mhra.gov.uk/#471bb15-7f52-4fcd-b615-8674ce6eb91e; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription administrableDoseForm: Solution for injection unitOfPresentation: Syringe producedFrom: ManufacturedItemDefinition: identifier = https://www.minzdrav.gov.ru/#99b900c6-4776-4cde-8125-4f6de8e98b98 (use: official, ); status = active; manufacturedDoseForm = Solution for injection; unitOfPresentation = Syringe routeOfAdministration code: Subcutaneous use TargetSpecies - Code * Human
identifier:
  system:
    v: https://www.who-umc.org/phpid
    l: phpid
  value:
    v: identifier
status:
  v: active
form of:
  l: mp50mg
  reference:
    v: MedicinalProductDefinition/mp50mg
administrable dose form:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000073863
    display:
      v: Solution for injection
unit of presentation:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 200000002150
    display:
      v: Syringe
produced from:
  l: mid50mg
  reference:
    v: ManufacturedItemDefinition/mid50mg
route of administration:
  code:
    coding:
      system:
        v: https://spor.ema.europa.eu/rmswi
        l: rmswi
      code:
        v: 100000073633
      display:
        v: Subcutaneous use

authorization50mg
type: RegulatedAuthorization
id:
  v: authorization50mg
meta:
  profile:
    v: http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/RegulatedAuthorization-uv-epi
    l: RegulatedAuthorization-uv-epi
text:
  status:
    v: generated
  div:
    v: Generated Narrative: RegulatedAuthorization authorization50mg Profile: RegulatedAuthorization (ePI) identifier: https://spor.ema.europa.eu/pmswi/6ae5b5d9-7372-494c-874b-7dc67d386d2e (use: official, ) subject: MedicinalProductDefinition: identifier = http://www.mhra.gov.uk/#471bb15-7f52-4fcd-b615-8674ce6eb91e; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription type: Marketing Authorisation region: Russia status: Active statusDate: 2023-08-16 00:00:00+0000 holder: Organization Pfizer Innovations LLC
identifier:
  use:
    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
subject:
  l: mp50mg
  reference:
    v: MedicinalProductDefinition/mp50mg
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 220000000061
    display:
      v: Marketing Authorisation
region:
  coding:
    system:
      v: urn:iso:std:iso:3166
      l: 3166
    code:
      v: RU
    display:
      v: Russia
status:
  coding:
    system:
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    code:
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    display:
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status date:
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holder:
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orgpfizerusinc
type: Organization
id:
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meta:
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text:
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    v: Generated Narrative: Organization orgpfizerusinc Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/placeholder (use: official, ) active: true type: Marketing authorisation holder name: Pfizer Innovations LLC Contacts - Address * 123112, Moscow, Presnenskaya nab., d. 10, BTs [Business Centre] “Bashnya na Naberezhnoy” (Blok C)(work)
identifier:
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  system:
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active:
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type:
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      l: rmswi
    code:
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    display:
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  text:
    v: Marketing authorisation holder
name:
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contact:
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    use:
      v: work
    type:
      v: physical
    text:
      v: 123112, Moscow, Presnenskaya nab., d. 10, BTs [Business Centre] “Bashnya na Naberezhnoy” (Blok C)
    line:
      v: Presnenskaya Naberezhnaya
    city:
      v: Moscow
    country:
      v: RU

orgpfizerbe
type: Organization
id:
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meta:
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    l: Organization-uv-epi
text:
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  div:
    v: Generated Narrative: Organization orgpfizerbe Profile: Organization (ePI) identifier: https://spor.ema.europa.eu/omswi/placeholder (use: official, ) active: true type: Manufacturer name: Pfizer Manufacturing Belgium NV, Belgium Contacts - Address * 12 Rijksweg, 2870 Puurs-Sint-Amands, Belgium(work)
identifier:
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  system:
    v: https://spor.ema.europa.eu/omswi
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active:
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type:
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      l: rmswi
    code:
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    display:
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  text:
    v: Manufacturer
name:
  v: Pfizer Manufacturing Belgium NV, Belgium
contact:
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    use:
      v: work
    type:
      v: physical
    text:
      v: 12 Rijksweg, 2870 Puurs-Sint-Amands, Belgium
    line:
      v: 12 Rijksweg
    city:
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    country:
      v: BE

ppd50mgsyringe4
type: PackagedProductDefinition
id:
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meta:
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    l: PackagedProductDefinition-uv-epi
text:
  status:
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    v: Generated Narrative: PackagedProductDefinition ppd50mgsyringe4 Profile: PackagedProductDefinition (ePI) identifier: https://spor.ema.europa.eu/pmswi/b42ab299-e84b-4be3-bdbb-a66cd4c8c6ab (use: official, ) name: Enbrel four syringe plastic package type: Biological Medicinal Product packageFor: MedicinalProductDefinition: identifier = http://www.mhra.gov.uk/#471bb15-7f52-4fcd-b615-8674ce6eb91e; type = Medicinal Product; domain = Human use; status = active; legalStatusOfSupply = Medicinal product subject to medical prescription status: Active statusDate: 2023-08-16 00:00:00+0000 containedItemQuantity: 50 mg (Details: UCUM codemg = 'mg') manufacturer: Organization Pfizer Manufacturing Belgium NV, Belgium Packagings - Identifier Type Quantity Material * https://spor.ema.europa.eu/pmswi/5913fadd-6172-4282-ad02-19ab9d063b66 Box 4 Plastic
identifier:
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    v: official
  system:
    v: https://spor.ema.europa.eu/pmswi
    l: pmswi
name:
  v: Enbrel four syringe plastic package
type:
  coding:
    system:
      v: https://spor.ema.europa.eu/rmswi
      l: rmswi
    code:
      v: 100000155530
    display:
      v: Biological Medicinal Product
package for:
  l: mp50mg
  reference:
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status:
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      l: publication-status
    code:
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    display:
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status date:
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contained item quantity:
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manufacturer:
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packaging:
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      code:
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      code:
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      display:
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mp50mg
type: MedicinalProductDefinition
id:
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meta:
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    l: MedicinalProductDefinition-uv-epi
text:
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    v: Generated Narrative: MedicinalProductDefinition mp50mg Profile: MedicinalProductDefinition (ePI) identifier: http://www.mhra.gov.uk//471bb15-7f52-4fcd-b615-8674ce6eb91e type: Medicinal Product domain: Human use status: active legalStatusOfSupply: Medicinal product subject to medical prescription name productName: Enbrel (etanercept) 50 mg/ml solution for subcutaneous injection Usages - Country Jurisdiction Language * Russia Russia Russian
identifier:
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    l: www.mhra.gov.uk
  value:
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type:
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      l: medicinal-product-type
    code:
      v: MedicinalProduct
    display:
      v: Medicinal Product
domain:
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    system:
      v: http://hl7.org/fhir/medicinal-product-domain
      l: medicinal-product-domain
    code:
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status:
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      l: publication-status
    code:
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legal status of supply:
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    code:
      v: 100000072084
    display:
      v: Medicinal product subject to medical prescription
name:
  product name:
    v: Enbrel (etanercept) 50 mg/ml solution for subcutaneous injection

coding:
  system:
    v: https://www.minzdrav.gov.ru/
    l: www.minzdrav.gov.ru
  code:
    v: 100000155538
text:
  v: INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT

status:
  v: generated
div:
  v: Registration number: LSR-006652/09 Invented name: Enbrel® International non-proprietary name: etanercept Pharmaceutical form: solution for subcutaneous injection Composition Composition per 1 mL of solution active substance:etanercept 50.0 mg; excipients: L-arginine hydrochloride 5.3 mg, sodium chloride 5.8 mg, sucrose 10.0 mg, sodium hydrogen phosphate dihydrate 1.2 mg, sodium dihydrogen phosphate dihydrate 2.9 mg, water for injection to 1.0 mL. Description Clear or opalescent from colorless to yellow or light brown liquid. Small transparent to white amorphous particles are permissible. Pharmacotherapeutic group: tumor necrosis factor-α (TNF-α) inhibitor ATC Code: L04AB01

title:
  v: Pharmacological properties
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Pharmacological properties
text:
  status:
    v: generated
section:
  title:
    v: Pharmacodynamics
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Pharmacodynamics
  text:
    status:
      v: generated
    div:
      v: Tumor necrosis factor (TNF-α) is the main cytokine maintaining the inflammatory process in rheumatoid arthritis. An increase in the concentration of TNF has also been found in synovial membranes and psoriatic plaques in psoriatic arthritis patients, as well as in blood plasma and synovial tissues in ankylosing spondylitis patients. Etanercept is a competitive inhibitor of the binding of TNF to its receptors on the cell surface and thereby inhibits the biological activity of TNF. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two different tumor necrosis factor receptors (TNFRs) on the cell surface: 55 kilodalton (р55) and 75 kilodalton (р75). Both TNFRs are present in the body in membrane-bound and free forms. Soluble TNFRs regulate the biological activity of TNF. TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on the cross-linking of TNFRs that are situated on the cell surface. Dimeric soluble receptors, such as etanercept, possess higher TNF binding affinity than monomeric receptors and, therefore, are significantly more potent competitive inhibitors of TNF binding to its cellular receptors. Moreover, the use of an immunoglobulin Fc region as a fusion element in the structure of a dimeric receptor prolongs the blood serum half-life period. The significant portion of pathological processes in joints in rheumatoid arthritis and ankylosing spondylitis, and also skin pathologies presenting as plaque psoriasis, develop due to the effect of pro-inflammatory molecules involved in a network controlled by TNF. The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to TNF receptors on the cell surface. Thus, etanercept prevents TNF-mediated cellular responses by rendering TNF biologically inactive. Etanercept can also modulate biological responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules or proteinases). And these responses ma…
section:
  title:
    v: Pharmacokinetics
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Pharmacokinetics
  text:
    status:
      v: generated
    div:
      v: Etanercept is slowly absorbed from the site of subcutaneous injection, reaching its maximum concentration in approximately 48 hours after the administration of a single dose of Enbrel®. The absolute bioavailability is 76%. When Enbrel® is administered twice a week, steady-state concentrations twice as high as those observed after a single administration are achieved. After the single subcutaneous administration of Enbrel® 25 mg, the mean maximum plasma concentration of etanercept was 1.65 ± 0.66 µg/mL, and the area under the concentration-time curve (AUC) was 235 ± 96.6 µg⋅h/mL. There was no apparent saturation of clearance across the dosing range. The dependence of the concentration of etanercept on time is represented by a biexponential curve. The mean volume of distribution is 7.6 L, whereas the steady-state volume of distribution is 10.4 L. Etanercept is cleared slowly from the body. The half-life (Т1/2) is about 70 hours. For patients with rheumatoid arthritis, the clearance is approximately 0.066 L/h, which is somewhat lower than a value of 0.11 L/h for healthy volunteers. The pharmacokinetic properties of etanercept in patients with rheumatoid arthritis, ankylosing spondylarthritis and psoriasis are similar. A single 50 mg dose of Enbrel® is bioequivalent to a dose consisting of two practically simultaneous injections of 25 mg of the medicinal product. Although there is elimination of radioactivity through the kidneys after the administration of radiolabeled etanercept to patients and healthy volunteers, no increase in the blood plasma concentrations of etanercept was observed in patients with acute renal or hepatic failure. In patients with acute renal or hepatic failure, no increase in the concentration of etanercept was observed. There are no significant differences in the pharmacokinetics of etanercept among men and women. Elderly patients The clearance and apparent volumes of distribution of etanercept in the group of patients aged from 65 to 87 years ar…

title:
  v: Indications for use
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Indications for use
text:
  status:
    v: generated
  div:
    v: Rheumatoid arthritis In combination with methotrexate, Enbrel® is prescribed to adults for the treatment of moderate and severe active rheumatoid arthritis when response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. Enbrel® may be prescribed as monotherapy in case of inefficacy or intolerance of methotrexate. Enbrel® is indicated for the treatment of severe active and progressive rheumatoid arthritis in adults who have not been previously treated with methotrexate. Juvenile idiopathic polyarthritis Treatment of active juvenile idiopathic polyarthritis (seropositive and seronegative) in children and adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel® in the pharmaceutical form of a solution for subcutaneous injection), who have had an ineffective response or intolerance to methotrexate. Treatment of extended oligoarthritis in children and adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection”), who have had an ineffective response or intolerance to methotrexate. Treatment of psoriatic arthritis in adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection”), who have had an ineffective response or intolerance to methotrexate. Treatment of arthritis associated with enthesitis in adolescents aged 12 years and older with a body weight of more than 62.5 kg (for Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection”), who have had an ineffective response or intolerance to standard therapy. Psoriatic arthritis Treatment of active and progressive psoriatic arthritis in adults who have had an inadequate response to DMARDs. Axial spondylarthritis Ankylosing spondylitis Treatment of severe active ankylosing spondylitis in adults for whom conventional therapy has not re…

title:
  v: Contraindications
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Contraindications
text:
  status:
    v: generated
  div:
    v: Hypersensitivity to etanercept or any other component of the medication. Sepsis or risk of sepsis. Active infection, including chronic or localized infections. Patients aged under 12 years with a body weight of less than 62.5 kg (for Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection”).

title:
  v: Precautions
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Precautions
text:
  status:
    v: generated
  div:
    v: Demyelinating diseases, chronic heart failure (CHF), immunodeficiency conditions, diseases that cause predisposition to the development or activation of infections (diabetes, hepatitis), moderate and severe alcoholic hepatitis, hepatitis C, blood dyscrasia, diseases of the nervous system (multiple sclerosis, optic neuritis, transverse myelitis).

title:
  v: Use during pregnancy and breast-feeding period
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Use during pregnancy and breast-feeding period
text:
  status:
    v: generated
section:
  title:
    v: Women of childbearing potential
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Women of childbearing potential
  text:
    status:
      v: generated
    div:
      v: Women of childbearing potential should consider the use of appropriate contraception to avoid becoming pregnant during therapy with Enbrel® and for three weeks after the discontinuation of the therapy.
section:
  title:
    v: Pregnancy
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Pregnancy
  text:
    status:
      v: generated
    div:
      v: The effects of etanercept on pregnancy outcomes have been investigated in two observational cohort studies. A higher rate of major birth defects was observed in one observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists. The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified. No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. In another observational multi-country registry study comparing the risk of adverse pregnancy outcomes in women exposed to etanercept during the first 90 days of pregnancy to those exposed to non-biologic medications, there was no observed increased risk of major birth defects. That study also showed no increased risks of minor birth defects, preterm birth, stillbirth, or infections in the first year of life for infants born to women exposed to etanercept during pregnancy. Enbrel® should only be used during pregnancy if clearly needed. Etanercept penetrates the placenta and is detected in the serum of infants born to female patients treated with Enbrel® during pregnancy. The clinical impact of this is unknown, however, infants may be at increased risk of infection. The administration of live vaccines to infants for 16 weeks after the mother’s last dose of etanercept is generally not recommended.
section:
  title:
    v: Breast-feeding
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Breast-feeding
  text:
    status:
      v: generated
    div:
      v: Limited information from the published literature indicates that etanercept has been detected at low levels in human milk. Etanercept could be considered for use during breast-feeding taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Although systemic exposure in a breastfed infant is expected to be low because etanercept is largely degraded in the gastrointestinal tract, limited data regarding systemic exposure in the breastfed infant are available. Therefore, the administration of live vaccines (eg, BCG) to a breastfed infant when the mother is receiving etanercept may be considered 16 weeks after stopping breast-feeding (or at an earlier timepoint if the infant’s etanercept serum levels are undetectable).
section:
  title:
    v: Reproductive function
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Reproductive function
  text:
    status:
      v: generated
    div:
      v: Preclinical data on the peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and overall reproductive performance are not available.

title:
  v: Posology and method of administration
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Posology and method of administration
text:
  status:
    v: generated
  div:
    v: Subcutaneously. Treatment with Enbrel® must be prescribed and monitored by a physician experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic polyarthritis, psoriatic arthritis, ankylosing spondylitis or psoriasis. Enbrel® in the form of a 25 mg ready-for-use solution (a single-use syringe containing 0.5 mL of the medicinal product) and 50 mg (a single-use syringe containing 1.0 mL of the medicinal product) or 50 mg (injection pen containing 1 mL of the medicinal product) is used for patients with a body weight of more than 62.5 kg. For patients with a body weight of less than 62.5 kg, lyophilizate for the preparation of a solution should be used. before-injecting-the-medicinal-product-it-is-necessary-to-read-the-instructions-for-use-at-the-end-of-this-section-carefully. Before injecting the medicinal product, it is necessary to read the instructions for use at the end of this section carefully.

title:
  v: Adults
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Adults
text:
  status:
    v: generated
  div:
    v: Rheumatoid arthritis The recommended dose is 25 mg of Enbrel® twice a week with an interval of three to four days. An alternative dose is 50 mg once a week, which can be administered as a single subcutaneous injection of 50 mg or two practically simultaneous injections of 25 mg. Psoriatic arthritis The recommended dose is 25 mg of Enbrel® twice a week with an interval of three to four days. An alternative dose is 50 mg once a week, which can be administered as a single subcutaneous injection of 50 mg or two practically simultaneous injections of 25 mg. Ankylosing spondylitis The recommended dose is 25 mg of Enbrel® twice a week with an interval of three to four days. An alternative dose is 50 mg once a week, which can be administered as a single subcutaneous injection of 50 mg or two practically simultaneous injections of 25 mg. Pre-radiographic axial spondylarthritis The recommended dose is 25 mg of Enbrel® twice a week with an interval of three to four days. An alternative dose is 50 mg once a week, which can be administered as a single subcutaneous injection of 50 mg or two practically simultaneous injections of 25 mg. Psoriasis The recommended dose is 25 mg of Enbrel® twice a week with an interval of three to four days. It is possible to administer 50 mg of the medicinal product once a week as a single subcutaneous injection or two practically simultaneous injections of 25 mg. As an alternative, 50 mg of Enbrel® can be used twice a week for a period of not more than 12 weeks. If treatment needs to be continued, Enbrel® should be administered at a dose of 25 mg twice a week or 50 mg once a week. Treatment should be continued until remission is reached and, as a rule, for not more than 24 weeks. The administration of the medicinal product should be discontinued if, after 12 weeks of treatment, no improvement in symptoms is observed. In some cases, the length of treatment may be more than 24 weeks. In adult patients, depending on the physician’s evaluation and indi…

title:
  v: Children (aged 12 years and older with a body weight of 62.5 kg and more)
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Children (aged 12 years and older with a body weight of 62.5 kg and more)
text:
  status:
    v: generated
  div:
    v: In children aged under 12 years with a body weight of less than 62.5 kg (see “Contraindications” section), Enbrel® in the pharmaceutical form of a lyophilizate for solution for subcutaneous injection should be used, making it possible to administer a dose of less than 25 mg. Children aged 12 years and older with a body weight of more than 62.5 kg can be administered Enbrel® in the pharmaceutical form of a solution for subcutaneous injection in single-use syringes or injection pens. Juvenile idiopathic polyarthritis (children aged 12 years and older with a body weight of more than 62.5 kg [for Enbrel ® in the pharmaceutical form of a “solution for subcutaneous injection”]) Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection” is administered in this patient group in the same way as in adult patients: a single 25 mg dose. The medicinal product is injected twice a week with an interval of three to four days. Treatment should be discontinued if, after four months of therapy, no improvement in symptoms is observed. The administration of a 50 mg dose once per week is possible. Extended oligoarthritis (children aged 12 years and older with a body weight of more than 62.5 kg [for Enbrel ® in the pharmaceutical form of a “solution for subcutaneous injection”]) Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection” is administered in this patient group in the same way as in adult patients: a single 25 mg dose. The medicinal product is injected twice a week with an interval of three to four days. Treatment should be discontinued if, after four months of therapy, no improvement in symptoms is observed. The administration of a 50 mg dose once per week is possible. Psoriatic arthritis (adolescents aged 12 years and older, and with a body weight greater than 62.5 kg [for Enbrel ® in the pharmaceutical form of a “solution for subcutaneous injection”]) Enbrel® in the pharmaceutical form of a “solution for subcutaneous injection” is admi…

title:
  v: Instructions for Use
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Instructions for Use
text:
  status:
    v: generated
  div:
    v: below-are-the-instructions-for-preparing-and-injecting-a-solution-for-subcutaneous-injection-of-enbrel-in-syringes-and-injection-pens. Below are the instructions for preparing and injecting a solution for subcutaneous injection of Enbrel® in syringes and injection pens. selecting-a-site-for-injection Three sites are recommended for the injection of Enbrel ®: (1) the front surface of the middle third of the thigh; (2) the abdomen, except for an area 5 cm in diameter around the navel; (3) the outer surface of the shoulder (see Fig. 1). If you are administering an injection to yourself, you should not use the outer surface of the shoulder. Fig. 1 Each injection should be administered in a different site. The site of each new injection should be at least 3 cm away from the site of the previous injection. DO NOT INJECT the medicinal product into areas where there is pain, skin redness, bruising or induration. Do not inject in areas with scars or stretch marks. (It may be useful to write down the sites of previous injections). If a child has psoriasis, try not to inject the medicinal product directly into raised, thickened or red areas or lesions with flaking (psoriatic plaques). 1) INSTRUCTIONS FOR PREPARATION AND INJECTION OF A SOLUTION FOR SUBCUTANEOUS INJECTION OF ENBREL® IN A SYRINGE Patients or their parents/guardians who are going to perform injections should be informed of how to do it correctly. In cases where the patient or his/her parent/guardian performs the future injections by him-/herself, the first injection must be performed under the supervision of qualified medical personnel. Preparation for Injection This medicinal product must not be mixed with any other medicinal products in a single syringe or vial! Remove the carton with pre-filled syringes of Enbrel® from the refrigerator and place it on a clean, well-lit, flat work surface. Take one pre-filled syringe. Do not shake the syringe. Put the carton with the remaining pre-filled syringes back in the ref…

title:
  v: Side effects
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 200000029813
  text:
    v: Side effects
text:
  status:
    v: generated
section:
  title:
    v: Summary of the safety profile
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 200000029814
    text:
      v: Summary of the safety profile
  text:
    status:
      v: generated
    div:
      v: Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever. Serious adverse reactions have also been reported during the use of Enbrel®. TNF-antagonists, such as etanercept, negatively affect the immune system and their use may have a negative effect on the body’s defenses against infections and malignancies. Serious infections affect fewer than one in 100 patients treated with Enbrel®. Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with the use of Enbrel®, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious hematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with the use of Enbrel®. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
  section:
    title:
      v: Tabulated list of adverse reactions
    code:
      text:
        v: Tabulated list of adverse reactions
    text:
      status:
        v: generated
      div:
        v: The following list of adverse reactions is based on experience from clinical trials and on post- marketing experience. Within the organ system classes, adverse reactions are listed under the following categories of frequency (number of patients expected to experience the reaction): very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from available data). System Organ Class Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very rare < 1/10,000 Frequency not known (cannot be estimated from available data) Infections and infestations Infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections)* Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infections)* Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections, and Legionella)* Hepatitis B reactivation, listeria Neoplasms benign, malignant and unspecified (including cysts and polyps) Non-melanoma skin cancers* (see “Special warnings” section) Malignant melanoma (see “Special warnings” section), lymphoma, leukemia Merkel cell carcinoma (see “Special warnings” section) Kaposi’s sarcoma Blood and lymphatic system disorders Thrombocytopenia, anemia, leukopenia, neutropenia Pancytopenia* Aplastic anemia* Hematophagy histiocytosis (macrophage activation syndrome)* Immune system disorders Allergic reactions (see Skin and subcutaneous tissue disorders” section), autoantibody formation* Vasculitis (including anti- neutrophilic cytoplasmic antibody positive vasculitis) Serious allergic/anaphylactic reactions (including angioedema, bronchospasm), sarcoidosis Worsening of symptoms of dermatomyositis Nervous system disorders Headache* CNS demyelinating events suggestive of multiple sclerosis or localized dem…
  section:
    title:
      v: Description of selected adverse reactions
    code:
      text:
        v: Description of selected adverse reactions
    text:
      status:
        v: generated
      div:
        v: Malignancies and lymphoproliferative disorders One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with Enbrel® for up to approximately six years, including 231 patients treated with Enbrel® in combination with methotrexate in the two- year active-controlled study. The observed rates and incidences in these clinical trials were similar to those expected for the population studied. A total of two malignancies were reported in clinical studies of approximately two years duration involving 240 psoriatic arthritis patients who received Enbrel®. In clinical studies conducted for more than two years with 351 ankylosing spondylitis patients, six malignancies were reported in patients treated with Enbrel®. In a group of 2,711 plaque psoriasis patients treated with Enbrel® in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 non-melanoma skin cancers were reported. In a group of 7,416 patients treated with Enbrel® in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported. Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the post-marketing period (see “Special warnings” section). Injection site reactions Compared to placebo, patients with rheumatic diseases treated with Enbrel® had a significantly higher incidence of injection site reactions (36% vs. 9%). Injection site reactions usually occurred in the first month. Mean duration was approximately three to five days. No treatment was given for the majority of injection site reactions in the groups receiving Enbrel®, and the majority of patients who were given treatment received topical preparations, such as corticosteroids, or oral antihistamines. Additionally, some patients developed recall injection site reactions characterized by a skin reaction at the most recent site of …
  section:
    title:
      v: Adverse reactions in children
    code:
      text:
        v: Adverse reactions in children
    text:
      status:
        v: generated
      div:
        v: Adverse events in pediatric patients with juvenile idiopathic arthritis In general, the adverse events in pediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients. Differences from adults and other special considerations are discussed in the following paragraphs. The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with those commonly seen in outpatient pediatric populations. Severe adverse events reported included varicella with signs and symptoms of aseptic meningitis, which resolved without sequelae (see also “Special warnings” section), appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, esophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection. In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving Enbrel® after three months of the study (part 1, open-label), and the frequency and severity of infections were similar in 58 patients completing 12 months of open-label extension therapy. The types and frequency of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of Enbrel® in adult patients with rheumatoid arthritis, and the majority were mild. Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving Enbrel® for three months compared to the 349 adult rheumatoid arthritis patients. These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year). There were four reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials. There have been re…

v: 200000029814

v: 200000029814

v: 200000029814

title:
  v: Overdose
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Overdose
text:
  status:
    v: generated
  div:
    v: In the case of an overdose of Enbrel ®, contact a physician or pharmacist immediately. Save the carton of Enbrel®, even if it is empty. The maximum dose of Enbrel® has not been established. In a clinical study, a single 60 mg/m2 dose was administered to healthy volunteers, which did not lead to the development of dose- limiting toxicity. In the treatment of patients with rheumatoid arthritis, no cases of the toxic dose limit being exceeded were documented. The highest dose injected intravenously was 32 mg/m2, with a subsequent subcutaneous injection of 16 mg/m2 twice a week. There is no known specific antidote for Enbrel®.

title:
  v: Interaction with other medicinal products
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Interaction with other medicinal products
text:
  status:
    v: generated
  div:
    v: Anakinra During combined therapy with etanercept and anakinra, a significant increase in the frequency of serious infections and neutropenia was observed as compared with patients who were injected with only etanercept or only anakinra. Combined therapy with etanercept and anakinra did not show any clinical benefit and, therefore, is not recommended. Abatacept The simultaneous use of abatacept and etanercept was accompanied by an increase in the frequency of serious undesirable events. This drug combination did not show any clinical benefits and, therefore, is not recommended. Sulfasalazine In patients administered etanercept during treatment with sulfasalazine, a significant reduction in leukocyte count was documented compared to patients who received only etanercept or only sulfasalazine. Absence of interaction No adverse interactions were observed during the simultaneous use of etanercept with glucocorticosteroids, salicylates (with the exception of sulfasalazine), non-steroidal anti- inflammatory drugs (NSAIDs), analgesics or methotrexate. Methotrexate Methotrexate has no effect on the pharmacokinetics of etanercept. The effect of etanercept on the pharmacokinetics of methotrexate in humans has not been studied. Digoxin No clinically significant cross-effect on the pharmacokinetics of etanercept has been found. Warfarin No clinically significant cross-effect on the pharmacokinetics of etanercept has been found. Vaccination Live vaccines should not be administered during treatment with etanercept. There is no data on the secondary transmission of an infection through a live vaccine to patients receiving etanercept. Before beginning treatment with etanercept, it is recommended that children and adolescents receive all necessary vaccinations according to the current national vaccination calendar, if possible. An increase in B-cell immune response to the pneumococcal polysaccharide vaccine was observed in the majority of patients with psoriatic arthritis who had rec…
section:
  title:
    v: Special warnings
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Special warnings
  text:
    status:
      v: generated
    div:
      v: After the discontinuation of Enbrel®, disease symptoms may recur. Infections Patients should be examined for infections before starting treatment with Enbrel®, during treatment and after completing the course of treatment, taking into account the mean half-life of etanercept, which is approximately 70 hours (seven to 300 hours). During treatment with Enbrel®, sepsis, tuberculosis, parasitic infections (including those caused by protozoa organisms) and severe infections, including opportunistic infections, such as invasive fungal infections, listeriosis and legionellosis (some with lethal outcomes), and viral infections (including caused by herpes zoster) were reported. The most commonly reported invasive fungal infections were caused by Candida Pneumocystis, Aspergillus and Histoplasma. Incorrect diagnosis of the above-mentioned infections, especially fungal and other opportunistic infections, led to the delayed prescription of necessary treatment and, in some cases, to lethal outcomes. In many cases, patients received treatment with other medicinal products, including immunosuppressants. When examining patients, it is important to consider the possible development of opportunistic infections, for example, endemic mycoses. Patients who develop new infections during treatment with Enbrel® should be kept under close observation. The administration of Enbrel® should be discontinued if a patient develops a severe infection. The administration of Enbrel® requires caution in patients with a history of frequent or chronic infections or underlying diseases, which may facilitate the development of infections (such as severe or poorly controlled diabetes mellitus). The safety and efficacy of Enbrel® in patients with chronic infections have not been evaluated. Tuberculosis During treatment with Enbrel®, cases of active tuberculosis have been reported, including miliary tuberculosis and extrapulmonary tuberculosis. Among rheumatoid arthritis patients, there is apparently a high…
section:
  title:
    v: How supplied
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: How supplied
  text:
    status:
      v: generated
    div:
      v: 50 mg/mL solution for subcutaneous injection. 0.5 mL (25 mg) or 1.0 mL (50 mg) of the medicinal product in colorless glass (type I) single- use syringes fitted with a stainless-steel needle covered with a two-layer cap, a plastic finger grip and a plunger rod with a rubber seal. Four syringes in a set with four individually wrapped alcohol wipes in a plastic package with a ventilation hole. One, two or six plastic packages (25 mg) or one, two or three plastic packages (50 mg) along with Instructions for Use in a carton with or without a tamper-evident seal. 1.0 mL (50 mg) of the drug in a single-use injection pen with a white plastic needle cap and a purple protective screen. The syringe inside the pen is of colorless glass (type I) and is fitted with a stainless-steel needle. Four injection pens in a set with four individually wrapped alcohol wipes in a plastic package with an air vent. One plastic package with Instructions for Use in a carton with or without a tamper-evident seal.
section:
  title:
    v: Storage conditions
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Storage conditions
  text:
    status:
      v: generated
    div:
      v: Store between 2 °C and 8 °C. Do not freeze. Keep out of reach of children!

title:
  v: Shelf life
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Shelf life
text:
  status:
    v: generated
  div:
    v: Three years. Do not use after the expiry date indicated on the package!
section:
  title:
    v: Dispensing conditions
  code:
    coding:
      system:
        v: https://www.minzdrav.gov.ru/
        l: www.minzdrav.gov.ru
      code:
        v: 100000155538
    text:
      v: Dispensing conditions
  text:
    status:
      v: generated
    div:
      v: Dispensed by prescription.

title:
  v: Manufacturer
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Manufacturer
text:
  status:
    v: generated
  div:
    v: Pfizer Manufacturing Belgium NV, Belgium Address: 12 Rijksweg, 2870 Puurs-Sint-Amands, Belgium

title:
  v: Marketing Authorization Holder
code:
  coding:
    system:
      v: https://www.minzdrav.gov.ru/
      l: www.minzdrav.gov.ru
    code:
      v: 100000155538
  text:
    v: Marketing Authorization Holder
text:
  status:
    v: generated
  div:
    v: Pfizer Inc, USA Organization receiving consumer claims Pfizer Innovations LLC 123112, Moscow, Presnenskaya nab., d. 10, BTs [Business Centre] “Bashnya na Naberezhnoy” (Blok C) Phone: + 7 (495) 287-5000 Fax: +7 (495) 287-5300/287-5067

v: OP401G7OJC

v: ETANERCEPT

v: ACTIB

v: F7LTH1E20Y

v: ARGININE HYDROCHLORIDE

v: 451W47IQ8X

v: Sodium Chloride

v: C151H8M554

v: Sucrose

v: ACTIB

v: active ingredient - basis of strength

v: 5QWK665956

v: sodium dihydrogen phosphate dihydrate

v: ACTIB

v: active ingredient - basis of strength

v: 059QF0KO0R

v: WATER FOR INJECTION

v: ACTIB

v: active ingredient - basis of strength

v: 100000109093

v: Human

v: urn:iso:std:iso:3166
l: 3166

v: RU

v: Russia

v: urn:iso:std:iso:3166
l: 3166

v: RU

v: Russia

v: urn:ietf:bcp:47
l: 47

v: ru

v: Russian