{ "resourceType":"Bundle", "id": "humalog-gravitate", "identifier": { "system": "https://www.gravitatehealth.eu/sid/doc", "value": "EU/1/96/007/035" }, "type": "document", "timestamp": "2018-06-23T08:38:00+02:00", "entry": [{ "resource": { "resourceType":"Composition", "id": "cfsb1641383289499", "language": "en", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1641383289499\" (Language \"en\")

: finalstatus

: Package Leaflet type (#100000155538)

: 2015-02-07T13:28:17Zdate

: authorSee above (Organization/cfsb1640870284639)

: TEST PURPOSES ONLY - Humalog Vulcan ePItitle

: Uconfidentiality

" }, "status": "final", "type": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538" }], "text": "Package Leaflet" }, "date": "2015-02-07T13:28:17Z", "author": [{ "reference": "Organization/cfsb1640870284639" }], "title": "TEST PURPOSES ONLY - Humalog Vulcan ePI", "section": [{ "title": "B. Package Leaflet", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
PACKAGE LEAFLET: INFORMATION FOR THE USER Humalog Mix50 100 units/ml suspension for injection in cartridge insulin lispro Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
" } }, { "title": "What is in this leaflet", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-0" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
What in this leaflet
  1. What Humalog Mix50 is and what it is used for
  2. What you need to know before you take Humalog Mix50
  3. How to take Humalog Mix50
  4. Possible side effects
  5. How to store Humalog Mix50
  6. Contents of the pack and other information
" } }, { "title": "1. What Humalog Mix50 is and what it is used for", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-1" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
1. What Humalog Mix50 is and what it is used for Humalog Mix50 is used to treat diabetes. Humalog Mix50 is a premixed suspension. Its active substance is insulin lispro.
" } }, { "title": "2. What you need to know before you use Humalog Mix50", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-2" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
2. What you need to know before you use Humalog Mix50 Do NOT use Humalog Mix50 if you
" } }, { "title": "3. How to use Humalog Mix50", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-3" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
3. How to use Humalog Mix50The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens.

Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, even if the needle on the delivery device is changed.

" } }, { "title": "4. Possible side effects", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-4" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

" } }, { "title": "5. How to store Humalog Mix50", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-5" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
5. How to store Humalog Mix50

Before the first use store your Humalog Mix50 in a refrigerator (2°C – 8°C). Do not freeze.

Keep your cartridge in use at room temperature (below 30°C) and discard after 28 days. Do not put it near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen with the inserted cartridge should not be stored with the needle attached.

Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry date refers to the last day of that month.

Do not use this medicine if you notice clumps of material are present or if solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

" } }, { "title": "6. Contents of the pack and other information", "code": { "coding": [{ "system": "https://spor.ema.europa.eu/", "code": "100000155538-6" }], "text": "B. PACKAGE LEAFLET" }, "text": { "status": "additional", "div": "
6. Contents of the pack and other informationWhat Humalog Mix50 100 units/ml suspension for injection in cartridge contains

The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant DNA technology’ process. It is a changed form of human insulin and so is different from other human and animal insulins. Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas. The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium phosphate 7H2O, zinc oxide and water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.

" } }] } }, { "resource": { "resourceType":"Organization", "id": "cfsb1640870284639", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640870284639\"

: id: ORG-100000426 (OFFICIAL)identifier

: trueactive

: Marketing authorisation holder type (#220000000034)

: Eli Lilly Nederland B.V.name

: Papendorpseweg 83, 3528 BJ Utrecht The Netherlands(WORK)address

" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/omswi/", "value": "ORG-100000426" }], "active": true, "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "220000000034", "display": "Marketing authorisation holder" }], "text": "Marketing authorisation holder" }, "name": "Eli Lilly Nederland B.V.", "contact": [{ "address": { "use": "work", "type": "physical", "text": "Papendorpseweg 83, 3528 BJ Utrecht The Netherlands", "line":[ "Papendorpseweg 83, 3528 BJ" ], "city": "Utrecht", "country": "NL" } }] } }, { "resource": { "resourceType":"Organization", "id": "cfsb1641381635293", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1641381635293\"

: id: ORG-100000156 (OFFICIAL)identifier

: trueactive

: Manufacturer API type (#/#220000000033)

: Eli Lilly and Companyname

: Lilly Technology Center Building 333 and 324(WORK)address

" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/omswi/#/", "value": "ORG-100000156" }], "active": true, "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "220000000033" }], "text": "Manufacturer API" }, "name": "Eli Lilly and Company", "contact": [{ "address": { "use": "work", "type": "physical", "text": "Lilly Technology Center Building 333 and 324", "line":[ "Lilly Technology Center Building 333 and 324, Indianapolis, Indiana, USA" ], "city": "Indianapolis", "country": "US" } }] } }, { "resource": { "resourceType":"Organization", "id": "cfsb1640870328895", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640870328895\"

: id: ORG-100003996 (OFFICIAL)identifier

: trueactive

: manufacturer type (#/#220000000033)

: Lilly S.A.name

: Avenida de la Industria 30(WORK)address

" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/omswi/", "value": "ORG-100003996" }], "active": true, "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "220000000033" }], "text": "manufacturer" }, "name": "Lilly S.A.", "contact": [{ "address": { "use": "work", "type": "physical", "text": "Avenida de la Industria 30", "line":[ "Avenida de la Industria 30, 28108 Alcobendas, Madrid, Spain" ], "city": "Alcobendas", "country": "ES" } }] } }, { "resource": { "resourceType":"RegulatedAuthorization", "id": "cfsb1640870220343", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640870220343\"

: id: EU/1/96/007/035 (OFFICIAL)identifier

: subjectSee above (MedicinalProductDefinition/cfsb1641212233583)

: Marketing Authorisation type (#/#100000072062)

: European Union region (unknown#eu)

: Active status (PublicationStatus

: 2015-02-07T13:28:17ZstatusDate

: holderSee above (Organization/cfsb1640870284639)

" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/rmswi/#/", "value": "EU/1/96/007/035" }], "subject": { "reference": "MedicinalProductDefinition/cfsb1641212233583" }, "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072062" }], "text": "Marketing Authorisation" }, "region": [{ "coding": [{ "system": "urn:iso:std:iso:3166", "code": "eu" }], "text": "European Union" }], "status": { "coding": [{ "system": "http://hl7.org/fhir/publication-status", "code": "active" }], "text": "Active" }, "statusDate": "2015-02-07T13:28:17Z", "holder": { "reference": "Organization/cfsb1640870284639" } } }, { "resource": { "resourceType":"MedicinalProductDefinition", "id": "cfsb1641212233583", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1641212233583\"

: Marketing Authorisation type (#/#100000072062)

: Human use domain (#/#100000000012)

: Active status (PublicationStatus

: Medicinal product subject to medical prescription legalStatusOfSupply (#/#100000072084)

name

: Humalog Mix50 Insulin KwikPen, 3ml pre-fillproductName

: Full name type (#/#220000000001)

NameParts

-PartType
*Suspension for injectionPharmaceutical dose form part (#/#220000000005)

CountryLanguages

-CountryJurisdictionLanguage
*European Union (unknown#eu)European Union (unknown#eu)English (Tags for the Identification of Languages
" }, "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072062" }], "text": "Marketing Authorisation" }, "domain": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000000012" }], "text": "Human use" }, "status": { "coding": [{ "system": "http://hl7.org/fhir/publication-status", "code": "active", "display": "Active" }] }, "legalStatusOfSupply": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072084" }], "text": "Medicinal product subject to medical prescription" }, "name": [{ "productName": "Humalog Mix50 Insulin KwikPen, 3ml pre-fill", "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "220000000001" }], "text": "Full name" }, "part": [{ "part": "Suspension for injection", "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "220000000005" }], "text": "Pharmaceutical dose form part" } }], "usage": [{ "country": { "coding": [{ "system": "urn:iso:std:iso:3166", "code": "eu" }], "text": "European Union" }, "jurisdiction": { "coding": [{ "system": "urn:iso:std:iso:3166", "code": "eu" }], "text": "European Union" }, "language": { "coding": [{ "system": "urn:ietf:bcp:47", "code": "en" }], "text": "English" } }] }] } }, { "resource": { "resourceType":"PackagedProductDefinition", "id": "cfsb1640781499340", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640781499340\"

: id: EU/1/96/007/035 (OFFICIAL)identifier

: Humalog 100 units/ml KwikPen solution for injection in a pre-filled penname

: Chemical Medininal Prodcut type (#/#100000155527)

: packageForSee above (MedicinalProductDefinition/cfsb1641212233583)

: Active status (PublicationStatus

: 2015-02-07T13:28:17ZstatusDate

: 3 mlcontainedItemQuantity

: manufacturer

Packages

-TypeQuantityMaterial
*Pre-filled pen (##100000073543)5Glass type 1 (##200000003204)
" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/pmswi/#/", "value": "EU/1/96/007/035" }], "name": "Humalog 100 units/ml KwikPen solution for injection in a pre-filled pen", "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000155527" }], "text": "Chemical Medininal Prodcut" }, "packageFor": [{ "reference": "MedicinalProductDefinition/cfsb1641212233583" }], "status": { "coding": [{ "system": "http://hl7.org/fhir/publication-status", "code": "active", "display": "Active" }] }, "statusDate": "2015-02-07T13:28:17Z", "containedItemQuantity": { "value": 3, "unit": "ml" }, "manufacturer": [{ "reference": "Organization/cfsb1640870328895" }, { "reference": "Organization/cfsb1641381635293" }], "packaging": { "type": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "#100000073543" }], "text": "Pre-filled pen" }, "quantity": "5", "material": [{ "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "#200000003204" }], "text": "Glass type 1" }] } } }, { "resource": { "resourceType":"AdministrableProductDefinition", "id": "cfsb1640606978608", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640606978608\"

: activestatus

: formOfSee above (MedicinalProductDefinition/cfsb1641212233583)

: Suspension for injection administrableDoseForm (#/#100000073864)

: Pen unitOfPresentation (#/#200000002135)

: producedFromSee above (ManufacturedItemDefinition/cfsb1640777487408)

routeOfAdministration

: Subcutaneous use code (#/#100000073633)

TargetSpecies

-Code
*Human (#/#100000109093)
" }, "status": "active", "formOf": [{ "reference": "MedicinalProductDefinition/cfsb1641212233583" }], "administrableDoseForm": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000073864" }], "text": "Suspension for injection" }, "unitOfPresentation": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "200000002135" }], "text": "Pen" }, "producedFrom": [{ "reference": "ManufacturedItemDefinition/cfsb1640777487408" }], "routeOfAdministration": [{ "code": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000073633" }], "text": "Subcutaneous use" }, "targetSpecies": [{ "code": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000109093" }], "text": "Human" } }] }] } }, { "resource": { "resourceType":"ManufacturedItemDefinition", "id": "cfsb1640777487408", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640777487408\"

: id: EU/1/96/007/035 (OFFICIAL)identifier

: activestatus

: Suspension for injection manufacturedDoseForm (#100000073864)

: Pen unitOfPresentation (#/#200000002135)

: manufacturerSee above (Organization/cfsb1640870328895)

" }, "identifier": [{ "use": "official", "system": "https://spor.ema.europa.eu/pmswi/#/", "value": "EU/1/96/007/035" }], "status": "active", "manufacturedDoseForm": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000073864" }], "text": "Suspension for injection" }, "unitOfPresentation": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "200000002135" }], "text": "Pen" }, "manufacturer": [{ "reference": "Organization/cfsb1640870328895" }] } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640607635665", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640607635665\"

: id: GFX7QIS1II (OFFICIAL)identifier

: activestatus

: active role (#00000072072)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1641381635293)

substance

Strengths

-Presentation[x]Basis
*100 units/mlactive ingredient - basis of strength (v3-RoleClassIngredientEntity#ACTIB)
" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "GFX7QIS1II" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "00000072072" }], "text": "active" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1641381635293" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "GFX7QIS1II", "display": "Insulin lispro" }] } }, "strength": [{ "presentationQuantity": { "value": 100, "unit": "units/ml" }, "basis": { "coding": [{ "system": "http://terminology.hl7.org/ValueSet/v3-RoleClassIngredientEntity", "code": "ACTIB" }], "text": "active ingredient - basis of strength" } }] } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780048702", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780048702\"

: id: PDC6A3C0OX (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "PDC6A3C0OX" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "PDC6A3C0OX", "display": "Glycerin" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780784213", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780784213\"

: id: QTT17582CB (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "QTT17582CB" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "QTT17582CB", "display": "Hydrochloric acid" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780830373", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780830373\"

: id: 55X04QC32I (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "55X04QC32I" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "55X04QC32I", "display": "Sodium Hydroxide" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780743829", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780743829\"

: id: 059QF0KO0R (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "059QF0KO0R" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "059QF0KO0R", "display": "Water for Injection" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780625902", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780625902\"

: id: SOI2LOH54Z (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "SOI2LOH54Z" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "SOI2LOH54Z", "display": "Zinc Oxide" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780419325", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780419325\"

: id: GGO4Y809LO (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "GGO4Y809LO" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "GGO4Y809LO", "display": "Metacresol" }] } } } } }, { "resource": { "resourceType":"Ingredient", "id": "cfsb1640780546710", "text": { "status": "generated", "div": "

Generated Narrative

Resource \"cfsb1640780546710\"

: id: 023C2WHX2V (OFFICIAL)identifier

: activestatus

: Excipient role (#100000072082)

Manufacturers

-Manufacturer
*See above (Organization/cfsb1640870328895)

substance

" }, "identifier": { "use": "official", "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "value": "023C2WHX2V" }, "status": "active", "role": { "coding": [{ "system": "https://spor.ema.europa.eu/rmswi/", "code": "100000072082" }], "text": "Excipient" }, "manufacturer": [{ "manufacturer": { "reference": "Organization/cfsb1640870328895" } }], "substance": { "code": { "concept": { "coding": [{ "system": "https://gsrs.ncats.nih.gov/ginas/app/beta/", "code": "023C2WHX2V", "display": "Tromethamine" }] } } } } }] }