Global Core Electronic Medicinal Product Information (ePI)
1.1.0 - trial-use International flag

Global Core Electronic Medicinal Product Information (ePI), published by HL7 International - Biomedical Research & Regulation Work Group. This guide is not an authorized publication; it is the continuous build for version 1.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/emedicinal-product-info/ and changes regularly. See the Directory of published versions

Example Bundle: bundle-epi-type3-example-aprokam

Document Subject

version: 1; Last updated: 2025-11-26 09:20:54+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition

identifier: http://ema.europa.eu/fhir/mpId/SE-100001677-00046149, http://ema.europa.eu/fhir/eurdId/615

domain: Human use

status: Current

combinedPharmaceuticalDoseForm: Powder for solution for injection

indication:

Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.

legalStatusOfSupply: Medicinal product subject to medical prescription

classification: S01AA27

name

productName: Aprokam 50 mg Pulver till injektionsvÀtska, lösning

part

part: Aprokam

type: Invented name part

part

part: 50 mg

type: Strength part

part

part: pulver till injektionsvÀtska, lösning

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*Kingdom of SwedenSwedish

Document Content

1. What Aprokam is and what it is used for

Aprokam contains cefuroxime (as sodium). It is an antibiotic used to prevent eye infections after cataract surgery.

2. What you need to know before you take Aprokam

Do not be given Aprokam if you are allergic to cefuroxime, or any of the cephalosporin antibiotics.

3. How to take Aprokam

Aprokam will be administered by an ophthalmic surgeon.

4. Possible side effects

Rare side effects include serious allergic reaction.

5. How to store Aprokam

Keep this medicine out of the sight and reach of children. Store below 25°C. Keep vial in the outer carton.

6. Contents of the pack and other information

The active substance is cefuroxime (as sodium). Each vial contains 50 mg cefuroxime.

Additional Resources Included in Document

Entry 2

Resource MedicinalProductDefinition:

version: 1; Last updated: 2025-11-26 09:20:54+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLMedicinalProductDefinition

identifier: http://ema.europa.eu/fhir/mpId/SE-100001677-00046149, http://ema.europa.eu/fhir/eurdId/615

domain: Human use

status: Current

combinedPharmaceuticalDoseForm: Powder for solution for injection

indication:

Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.

legalStatusOfSupply: Medicinal product subject to medical prescription

classification: S01AA27

name

productName: Aprokam 50 mg Pulver till injektionsvÀtska, lösning

part

part: Aprokam

type: Invented name part

part

part: 50 mg

type: Strength part

part

part: pulver till injektionsvÀtska, lösning

type: Pharmaceutical dose form part

Usages

-CountryLanguage
*Kingdom of SwedenSwedish

Entry 3

Resource RegulatedAuthorization:

version: 1; Last updated: 2025-11-26 09:23:04+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLRegulatedAuthorization

identifier: http://ema.europa.eu/fhir/marketingAuthorizationNumber/46149

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

type: Marketing Authorisation

region: Kingdom of Sweden

status: Valid

statusDate: 2012-07-12

holder: Organization Laboratoires THEA

Cases

-TypeDate[x]
*First Authorisation2012-07-12

Entry 4

Resource AdministrableProductDefinition:

version: 1; Last updated: 2025-11-26 09:24:30+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLAdministrableProductDefinition

status: Active

formOf: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

administrableDoseForm: Solution for injection

producedFrom: ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial

RouteOfAdministrations

-Code
*Intracameral use

Entry 5

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 09:27:10+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition

identifier: http://ema.europa.eu/example/pcid/?ngen-9?

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

containedItemQuantity: 10 Vial (Details: 200000000014 code200000002158 = '200000002158')

description:

Injektionsflaska, 10 x 50 mg (inkl 10 sterila kanyler)

MarketingStatuses

-CountryStatus
*Kingdom of SwedenMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Vial

quantity: 10

material: Glass

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial

amount: 10 vial (Details: 200000000014 code200000002158 = '200000002158')

Entry 6

Resource PackagedProductDefinition:

version: 1; Last updated: 2025-11-26 09:27:47+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLPackagedProductDefinition

identifier: http://ema.europa.eu/example/pcid/?ngen-9?

packageFor: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

containedItemQuantity: 10 Vial (Details: 200000000014 code200000002158 = '200000002158')

description:

Injektionsflaska, 10 x 50 mg

MarketingStatuses

-CountryStatus
*Kingdom of SwedenMarketed

packaging

type: Box

quantity: 1

material: Cardboard

packaging

type: Vial

quantity: 10

material: Cardboard

packaging

type: Vial

quantity: 1

material: Glass

containedItem

Items

-Reference
*ManufacturedItemDefinition: status = active; manufacturedDoseForm = Powder for solution for injection; unitOfPresentation = Vial

amount: 1 Vial (Details: 200000000014 code200000002158 = '200000002158')

Entry 7

Resource Ingredient:

version: 1; Last updated: 2025-11-26 09:26:31+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLIngredient

status: Active

for:

role: Active

substance

Codes

-Concept
*cefuroxime sodium

strength

concentration: 52.6 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 unit(s) (Details: 100000110633 code100000110756 = '100000110756')

referenceStrength

Substances

-Concept
*cefuroxime

strength: 50 milligram(s) (Details: 100000110633 code100000110655 = '100000110655')/1 unit(s) (Details: 100000110633 code100000110756 = '100000110756')

Entry 8

Resource ManufacturedItemDefinition:

version: 1; Last updated: 2025-11-26 09:22:19+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLManufacturedItemDefinition

status: Active

manufacturedDoseForm: Powder for solution for injection

unitOfPresentation: Vial

Entry 9

Resource Organization:

version: 1; Last updated: 2025-11-26 09:20:15+0000; Language: en

Profile: http://unicom-project.eu/fhir/StructureDefinition/PPLOrganization

identifier: https://spor.ema.europa.eu/v1/locations/LOC-100005605

name: Laboratoires THEA

Entry 10

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Carnauba Wax

Entry 11

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Silicon Dioxide

Entry 12

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Croscarmellose Sodium

Entry 13

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Glyceryl Dibehenate

Entry 14

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Hypromellose

Entry 15

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Polydextrose

Entry 16

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Polyethylene Glycol

Entry 17

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Corn Starch

Entry 18

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Titanium Dioxide

Entry 19

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Ferrosoferric Oxide

Entry 20

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Propylene Glycol

Entry 21

Resource Ingredient:

Language: en

status: Active

for:

role: Excipient

substance

Codes

-Concept
*Sodium Lauryl Sulfate

Entry 22

Resource ClinicalUseDefinition:

Language: en

type: Indication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

indication

DiseaseSymptomProcedures

-Concept
*Antibiotic prophylaxis of postoperative endophthalmitis after cataract surgery

Entry 23

Resource ClinicalUseDefinition:

Language: en

type: Contraindication

subject: MedicinalProductDefinition: identifier = http://ema.europa.eu/fhir/mpId#SE-100001677-00046149,http://ema.europa.eu/fhir/eurdId#615; domain = Human use; status = Current; combinedPharmaceuticalDoseForm = Powder for solution for injection; indication = Antibiotikaprofylax mot postoperativ endoftalmit efter kataraktoperation. Beakta de officiella riktlinjerna gÀllande korrekt anvÀndning av antibakteriella lÀkemedel, inkluderande riktlinjer för antibiotikaprofylax vid ögonkirurgi.; legalStatusOfSupply = Medicinal product subject to medical prescription; classification = S01AA27

contraindication

DiseaseSymptomProcedures

-Concept
*Hypersensitivity to Cefuroxime

Entry 24

Resource MedicationKnowledge:

Language: en

code: Cefuroxime

status: Active

indicationGuideline

dosingGuideline

treatmentIntent: Prophylaxis

dosage

Dosages

-Text
*0.1 ml of reconstituted solution (1 mg) intended for intracameral injection