From c15bfec0808c883d68d747d4236d0a86654769f1 Mon Sep 17 00:00:00 2001 From: Jens Kristian Villadsen Date: Tue, 4 Jul 2023 00:55:42 +0200 Subject: [PATCH] Added test to show a bug --- .../uhn/fhir/jpa/patch/FhirPatchCoreTest.java | 19 + .../src/test/resources/focused.json | 366 ++++++++++++++++++ .../src/test/resources/origin.json | 207 ++++++++++ 3 files changed, 592 insertions(+) create mode 100644 hapi-fhir-jpaserver-test-utilities/src/test/resources/focused.json create mode 100644 hapi-fhir-jpaserver-test-utilities/src/test/resources/origin.json diff --git a/hapi-fhir-jpaserver-test-utilities/src/test/java/ca/uhn/fhir/jpa/patch/FhirPatchCoreTest.java b/hapi-fhir-jpaserver-test-utilities/src/test/java/ca/uhn/fhir/jpa/patch/FhirPatchCoreTest.java index 1da0afb4e49..dc77d732d23 100644 --- a/hapi-fhir-jpaserver-test-utilities/src/test/java/ca/uhn/fhir/jpa/patch/FhirPatchCoreTest.java +++ b/hapi-fhir-jpaserver-test-utilities/src/test/java/ca/uhn/fhir/jpa/patch/FhirPatchCoreTest.java @@ -13,6 +13,11 @@ import org.w3c.dom.Document; import org.w3c.dom.Element; import org.w3c.dom.NodeList; import org.xml.sax.SAXException; +import java.io.DataInputStream; +import java.io.FileInputStream; +import java.io.FileNotFoundException; +import org.hl7.fhir.r5.model.Composition; +import org.junit.jupiter.api.Test; import javax.annotation.Nonnull; import javax.xml.transform.TransformerException; @@ -100,6 +105,20 @@ public class FhirPatchCoreTest extends BaseTest { return retVal; } + @Test + void doDiffOnComposition() throws FileNotFoundException { + + FhirPatch differ = new FhirPatch(FhirContext.forR5()); + + var original = FhirContext.forR5().newJsonParser().parseResource(Composition.class, new DataInputStream(new FileInputStream("src/test/resources/origin.json"))); + var focused = FhirContext.forR5().newJsonParser().parseResource(Composition.class, new DataInputStream(new FileInputStream("src/test/resources/focused.json"))); + + var diff = differ.diff(original, focused); + FhirContext.forR5().newJsonParser().encodeResourceToString(diff); + } + + + private static Element getFirstChildElement(Element theInput) { for (int i = 0; i < theInput.getChildNodes().getLength(); i++) { if (theInput.getChildNodes().item(i) instanceof Element) { diff --git a/hapi-fhir-jpaserver-test-utilities/src/test/resources/focused.json b/hapi-fhir-jpaserver-test-utilities/src/test/resources/focused.json new file mode 100644 index 00000000000..c10c854ff00 --- /dev/null +++ b/hapi-fhir-jpaserver-test-utilities/src/test/resources/focused.json @@ -0,0 +1,366 @@ +{ + "resourceType": "Composition", + "id": "Processedcompositionf4d45353edcb21af3718d3a0df94a4d8", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi" + ] + }, + "extension": [ + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "pregnancyCategory" + }, + { + "url": "concept", + "valueCodeableReference": { + "concept": { + "coding": [ + { + "system": "http://snomed.info/sct", + "code": "77386006", + "display": "Pregnancy" + } + ] + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "breastfeedingCategory" + }, + { + "url": "concept", + "valueCodeableReference": { + "concept": { + "coding": [ + { + "system": "http://snomed.info/sct", + "code": "69840006", + "display": "Normal breast feeding (finding)" + } + ] + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "indication" + }, + { + "url": "concept", + "valueCodeableReference": { + "reference": { + "reference": "ClinicalUseDefinition/cud-585e364c14debe29f6c6b564138aa400" + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "contraindication" + }, + { + "url": "concept", + "valueCodeableReference": { + "concept": { + "coding": [ + { + "system": "http://snomed.info/sct", + "code": "410536001", + "display": "Contraindicated (qualifier value)" + } + ] + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "contra-indication-pregancy" + }, + { + "url": "concept", + "valueCodeableReference": { + "reference": { + "reference": "ClinicalUseDefinition/contraindication-pregancy" + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "contra-indication-kidney" + }, + { + "url": "concept", + "valueCodeableReference": { + "reference": { + "reference": "ClinicalUseDefinition/contraindication-kidney" + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "contra-indication-diabetes-mellitus" + }, + { + "url": "concept", + "valueCodeableReference": { + "reference": { + "reference": "ClinicalUseDefinition/contraindication-diabetes-mellitus" + } + } + } + ] + }, + { + "url": "http://hl7.eu/fhir/ig/gravitate-health/StructureDefinition/HtmlElementLink", + "extension": [ + { + "url": "elementClass", + "valueString": "lactose" + }, + { + "url": "concept", + "valueCodeableReference": { + "concept": { + "coding": [ + { + "system": "http://snomed.info/sct", + "code": "190751001", + "display": "Primary lactose intolerance" + } + ] + } + } + } + ] + } + ], + "identifier": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "value": "0d69fdcb-33cf-407f-8209-a6529856ab4f" + } + ], + "status": "final", + "type": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "Package Leaflet" + }, + "category": [ + { + "coding": [ + { + "system": "http://hl7.eu/fhir/ig/gravitate-health/CodeSystem/epicategory-cs", + "code": "P", + "display": "Processed" + } + ] + } + ], + "subject": [ + { + "reference": "MedicinalProductDefinition/mp2412867d9a0e15f82f11047ad93bdbad" + } + ], + "date": "2022-02-16T13:28:17Z", + "author": [ + { + "reference": "Organization/mah-511671db37e83e520b00f8a0d817dc96" + } + ], + "title": "TEST PURPOSES ONLY - Karvea", + "section": [ + { + "title": "B. Package Leaflet", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "B. PACKAGE LEAFLET" + }, + "text": { + "status": "additional", + "div": "
unavailable
" + }, + "emptyReason": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/list-empty-reason", + "code": "unavailable" + } + ] + }, + "section": [ + { + "title": "Package leaflet: Information for the user", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "Package leaflet: Information for the user" + }, + "text": { + "status": "additional", + "div": "

Karvea 75 mg tablets

irbesartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
" + } + }, + { + "title": "What is in this leaflet", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "What is in this leaflet" + }, + "text": { + "status": "additional", + "div": "
  • What Karvea is and what it is used for
  • What you need to know before you take Karvea
  • How to take Karvea
  • Possible side effects
  • How to store Karvea
  • Contents of the pack and other information
" + } + }, + { + "title": "1. What Karvea is and what it is used for", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "1. What Karvea is and what it is used for" + }, + "text": { + "status": "additional", + "div": "

Karvea belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels causing them to tighten. This results in an increase in blood pressure. Karvea prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax and the blood pressure to lower. Karvea slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.

Karvea is used in adult patients

  • to treat high blood pressure (essential hypertension)
  • to protect the kidney in patients with high blood pressure, type 2 diabetes and laboratory evidence of impaired kidney function.
" + } + }, + { + "title": "2. What you need to know before you take Karvea", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "2. What you need to know before you take Karvea" + }, + "text": { + "status": "additional", + "div": "
Do not take Karvea
  • if you are allergic to irbesartan or any other ingredients of this medicine (listed in section 6)
  • if you are more than 3 months pregnant. (It is also better to avoid Karvea in early pregnancy – see pregnancy section)
  • if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Warning and precautions

Talk to your doctor before taking Karvea and if any of the following apply to you:

  • if you get excessive vomiting or diarrhoea
  • if you suffer from kidney problems
  • if you suffer from heart problems
  • if you receive Karvea for diabetic kidney disease. In this case your doctor may perform regular blood tests, especially for measuring blood potassium levels in case of poor kidney function
  • if you develop low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, having a fast, pounding heart beat), particularly if you are being treated for diabetes.
  • if you are going to have an operation (surgery) or be given anaesthetics
    • an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
    • aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take Karvea”.

You must tell your doctor if you think you are (or might become) pregnant. Karvea is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents

This medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.

Other medicines and Karvea

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor may need to change your dose and/or to take other precautions: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Karvea” and “Warnings and precautions”).

You may need to have blood checks if you take:
  • potassium supplements
  • salt substitutes containing potassium
  • potassium-sparing medicines (such as certain diuretics)
  • medicines containing lithium
  • repaglinide (medication used for lowering blood sugar levels)

If you take certain painkillers, called non-steroidal anti-inflammatory drugs, the effect of irbesartan may be reduced.

Karvea with food and drink

Karvea can be taken with or without food.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Karvea before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Karvea. Karvea is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Karvea is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Karvea is unlikely to affect your ability to drive or use machines. However, occasionally dizziness or weariness may occur during treatment of high blood pressure. If you experience these, talk to your doctor before attempting to drive or use machines.

Karvea contains lactose.

If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose), contact your doctor before taking this medicinal product.

Karvea contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

" + } + }, + { + "title": "3. How to take Karvea", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "3. How to take Karvea" + }, + "text": { + "status": "additional", + "div": "
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Method of administration

Karvea is for oral use. Swallow the tablets with a sufficient amount of fluid (e.g. one glass of water). You can take Karvea with or without food. Try to take your daily dose at about the same time each day. It is important that you continue to take Karvea until your doctor tells you otherwise.

  • Patients with high blood pressure

    The usual dose is 150 mg once a day (two tablets a day). The dose may later be increased to 300 mg (four tablets a day) once daily depending on blood pressure response.

  • Patients with high blood pressure and type 2 diabetes with kidney disease

    In patients with high blood pressure and type 2 diabetes, 300 mg (four tablets a day) once daily is the preferred maintenance dose for the treatment of associated kidney disease.

The doctor may advise a lower dose, especially when starting treatment in certain patients such as those on haemodialysis, or those over the age of 75 years.

The maximal blood pressure lowering effect should be reached 4-6 weeks after beginning treatment.

Use in children and adolescents

Karvea should not be given to children under 18 years of age. If a child swallows some tablets, contact your doctor immediately.

If you take more Karvea than you should

If you accidentally take too many tablets, contact your doctor immediately.

If you forget to take Karvea

If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of these effects may be serious and may require medical attention.

As with similar medicines, rare cases of allergic skin reactions (rash, urticaria), as well as localised swelling of the face, lips and/or tongue have been reported in patients taking irbesartan. If you get any of these symptoms or get short of breath, stop taking Karvea and contact your doctor immediately.

The frequency of the side effects listed below is defined using the following convention:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Side effects reported in clinical studies for patients treated with Karvea were:

  • Very common (may affect more than 1 in 10 people): if you suffer from high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increased level of potassium.
  • Common (may affect up to 1 10 people): dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme). In patients with high blood pressure and type 2 diabetes with kidney disease, dizziness when getting up from a lying or sitting position, low blood pressure when getting up from a lying or sitting position, pain in joints or muscles and decreased levels of a protein in the red blood cells (haemoglobin) were also reported.
  • Uncommon (may affect up to 1 in 100 people): heart rate increased, flushing, cough, diarrhoea, indigestion/heartburn, sexual dysfunction (problems with sexual performance), chest pain.

Some undesirable effects have been reported since marketing of Karvea. Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, decreased number of red blood cells (anaemia – symptoms may include tiredness, headaches, being short of breath when exercising, dizziness and looking pale), reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired kidney function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis), severe allergic reactions (anaphylactic shock) and low blood sugar levels. Uncommon cases of jaundice (yellowing of the skin and/or whites of the eyes) have also been reported.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

" + } + }, + { + "title": "5. How to store Karvea", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "5. How to store Karvea" + }, + "text": { + "status": "additional", + "div": "

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the blister after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help protect the environment.

" + } + }, + { + "title": "6. Contents of the pack and other information", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "6. Contents of the pack and other information" + }, + "text": { + "status": "additional", + "div": "
What Karvea contains
  • The active substance is irbesartan. Each tablet of Karvea 75 mg contains 75 mg irbesartan.
  • The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188. Please see section 2 “Karvea contains lactose”.
What Karvea looks like and contents of the pack

Karvea 75 mg tablets are white to off-white, biconvex, and oval-shaped with a heart debossed on one side and the number 2771 engraved on the other side.

Karvea 75 mg tablets are supplied in blister packs of 14, 28, 56 or 98 tablets. Unidose blister packs of 56 x 1 tablet for delivery in hospitals are also available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

sanofi-aventis groupe

54, rue La Boétie

F-75008 Paris - France

Manufacturer:

SANOFI WINTHROP INDUSTRIE

1, rue de la Vierge

Ambarès and Lagrave

F-33565 Carbon Blanc Cedex - France

SANOFI WINTHROP INDUSTRIE

30-36 Avenue Gustave Eiffel, BP 7166

F-37071 Tours Cedex 2 - France

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00

Lietuva

Swixx Biopharma UAB

Tel: +370 5 236 91 40

България

Swixx Biopharma EOOD Тел.: +359 (0)2 4942 480

Luxembourg/Luxemburg

Sanofi Belgium

Tél/Tel: +32 (0)2 710 54 00 (Belgique/Belgien)

Česká republika

sanofi-aventis, s.r.o. Tel: +420 233 086 111

Magyarország

SANOFI-A VENTIS Zrt. Tel.: +36 1 505 0050

Danmark

Sanofi A/S

Tlf: +45 45 16 70 00

Malta

Sanofi S.r.l.

Tel: +39 02 39394275

Deutschland

Sanofi-Aventis Deutschland GmbH

Tel: 0800 52 52 010

Tel. aus dem Ausland: +49 69 305 21 131

Norge

sanofi-aventis Norge AS Tlf: +47 67 10 71 00

Eesti

Swixx Biopharma OÜ Tel: +372 640 10 30

Österreich

sanofi-aventis GmbH Tel: +43 1 80 185 – 0

Ελλάδα

sanofi-aventis AEBE Τηλ: +30 210 900 16 00

Polska

sanofi-aventis Sp. z o.o. Tel.: +48 22 280 00 00

España

sanofi-aventis, S.A. Tel: +34 93 485 94 00

France

sanofi-aventis France

Tél: 0 800 222 555

Appel depuis l’étranger : +33 1 57 63 23 23

Portugal

Sanofi - Produtos Farmacêuticos, Lda Tel: +351 21 35 89 400

Hrvatska

Swixx Biopharma d.o.o. Tel: +385 1 2078 500

România

Sanofi Romania SRL Tel: +40 (0) 21 317 31 36

Ireland

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +353 (0) 1 403 56 00

Slovenija

Swixx Biopharma d.o.o. Tel: +386 1 235 51 00

Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika

Swixx Biopharma s.r.o. Tel: +421 2 208 33 600

Italia

Sanofi S.r.l. Tel: 800 536389

Suomi/Finland

Sanofi Oy

Puh/Tel: +358 (0) 201 200 300

Κύπρος

C.A. Papaellinas Ltd. Τηλ: +357 22 741741

Sverige

Sanofi AB

Tel: +46 (0)8 634 50 00

Latvija

Swixx Biopharma SIA Tel: +371 6 616 47 50

United Kingdom (Northern Ireland)

sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/

" + } + } + ] + } + ] +} \ No newline at end of file diff --git a/hapi-fhir-jpaserver-test-utilities/src/test/resources/origin.json b/hapi-fhir-jpaserver-test-utilities/src/test/resources/origin.json new file mode 100644 index 00000000000..3091cd8cf96 --- /dev/null +++ b/hapi-fhir-jpaserver-test-utilities/src/test/resources/origin.json @@ -0,0 +1,207 @@ +{ + "resourceType": "Composition", + "id": "compositionbe76bdf784deea6950583b234f789db2", + "meta": { + "profile": [ + "http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/Composition-uv-epi" + ] + }, + "language": "en", + "identifier": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "value": "00c7ed1895dfbadd44fa4ec19f02fe0e" + } + ], + "status": "final", + "type": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "Package Leaflet" + }, + "subject": [ + { + "reference": "MedicinalProductDefinition/mpbe76bdf784deea6950583b234f789db2" + } + ], + "date": "2022-02-16T13:28:17Z", + "author": [ + { + "reference": "Organization/mah-3c850a69e5187931f2198c5e63f933fe" + } + ], + "title": "TEST PURPOSES ONLY - Remsima 100 mg powder for concentrate for solution for infusion", + "attester": [ + { + "mode": { + "coding": [ + { + "system": "http://hl7.org/fhir/composition-attestation-mode", + "code": "official" + } + ] + }, + "time": "2022-02-16T13:28:17Z" + } + ], + "section": [ + { + "title": "B. Package Leaflet", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "B. PACKAGE LEAFLET" + }, + "text": { + "status": "additional", + "div": "
unavailable
" + }, + "emptyReason": { + "coding": [ + { + "system": "http://terminology.hl7.org/CodeSystem/list-empty-reason", + "code": "unavailable" + } + ] + }, + "section": [ + { + "title": "Package leaflet: Information for the user", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "Package leaflet: Information for the user" + }, + "text": { + "status": "additional", + "div": "

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

" + } + }, + { + "title": "What is in this leaflet", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "What is in this leaflet" + }, + "text": { + "status": "additional", + "div": "

What is in this leaflet

  1. What Remsima is and what it is used for
  2. What you need to know before you use Remsima
  3. How to use Remsima
  4. Possible side effects
  5. How to store Remsima
  6. Contents of the pack and other information
  7. Instructions for use
" + } + }, + { + "title": "1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "1. What Remsima 100 mg powder for concentrate for solution for infusion is and what it is used for" + }, + "text": { + "status": "additional", + "div": "

Remsima contains the active substance infliximab. Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha. Remsima belongs to a group of medicines called ‘TNF blockers’. It is used in adults for the following inflammatory diseases:

Remsima works by selectively attaching to TNF alpha and blocking its action. TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.

Rheumatoid arthritisRheumatoid arthritis is an inflammatory disease of the joints. If you have active rheumatoid arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima which you will take with another medicine called methotrexate to:

Psoriatic arthritisPsoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis. If you have active psoriatic arthritis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

Ankylosing spondylitis (Bechterew’s disease)Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

PsoriasisPsoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or treatments, such as phototherapy. If these medicines or treatments do not work well enough, you will be given Remsima to reduce the signs and symptoms of your disease. Ulcerative colitis Ulcerative colitis is an inflammatory disease of the bowel. If you have ulcerative colitis you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to treat your disease.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the bowel. If you have Crohn’s disease you will first be given other medicines. If these medicines do not work well enough, you will be given Remsima to:

" + } + }, + { + "title": "2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "2. What you need to know before you take Remsima 100 mg powder for concentrate for solution for infusion" + }, + "text": { + "status": "additional", + "div": "

You must not use Remsima if

Warnings and precautions

Talk to your doctor before or during treatment with Remsima if you have:

Had treatment with any medicine containing infliximab before

Local injection site reactions

Infections

Tuberculosis (TB)

Hepatitis B virus

Heart problems

Cancer and lymphoma

Lung disease or heavy smoking

Nervous system disease

Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Remsima. Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.

Abnormal skin openings

Vaccinations

Therapeutic infectious agents

Operations or dental procedures

Liver problems

Low blood counts

Immune system disorder

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age because there are no data that show that this medicine is safe and works in this age group.

Other medicines and Remsima

Patients who have inflammatory diseases already take medicines to treat their problem. These medicines may cause side effects. Your doctor will advise you what other medicines you must keep using while you are having Remsima.

Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.

In particular, tell your doctor if you are using any of the following medicines:

If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Remsima.

Pregnancy, breast-feeding and fertility

Driving and using machines

Remsima is not likely to affect your ability to drive or use tools or machines. If you feel tired, dizzy, or unwell after having Remsima, do not drive or use any tools or machines.

Remsima contains sodium and sorbitol

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’ and 45 mg sorbitol in each 120 mg dose.

" + } + }, + { + "title": "3. How to take Remsima 100 mg powder for concentrate for solution for infusion", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "3. How to take Remsima 100 mg powder for concentrate for solution for infusion" + }, + "text": { + "status": "additional", + "div": "

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Rheumatoid arthritis

Your doctor will start your treatment with or without two Remsima intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). If Remsima intravenous infusion doses are given to start the treatment, they are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.

Psoriatic arthritis, ankylosing spondylitis (Bechterew’s disease) and psoriasis

Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.

Crohn’s disease and ulcerative colitis

Your doctor will start your treatment with two Remsima intravenous infusion doses of 5 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours). They are administered 2 weeks apart via intravenous infusion. After 4 weeks from the last intravenous infusion, you will be given Remsima via injection under the skin (subcutaneous injection). The usual recommended dose of Remsima subcutaneous injection is 120 mg once every 2 weeks regardless of weight.

How Remsima is given

If you use more Remsima than you should

If you have used more Remsima than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor, pharmacist or nurse immediately. Always have the outer carton of the medicine with you, even if it is empty.

If you forget to use Remsima

Missed dose for up to 7 days

If you miss a dose of Remsima for up to 7 days, after the original scheduled dose, you should take the missed dose immediately. Take your next dose on the next originally planned date and then follow the original dosing schedule.

Missed dose for 8 days or more

If you miss a dose of Remsima for 8 days or more, after the original scheduled dose, you should not take the missed dose. Take your next dose on the next originally planned date and then follow the original dosing schedule. If you are not sure when to inject Remsima, call your doctor.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. However some patients may experience serious side effects and may require treatment. Side effects may also occur after your treatment with Remsima has stopped.

Tell your doctor straight away if you notice any of the following:

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Rare: may affect up to 1 in 1,000 people

Not known: frequency cannot be estimated from the available data

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

" + } + }, + { + "title": "5. How to store Remsima 100 mg powder for concentrate for solution for infusion", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "5. How to store Remsima 100 mg powder for concentrate for solution for infusion" + }, + "text": { + "status": "additional", + "div": "
" + } + }, + { + "title": "6. Contents of the pack and other information", + "code": { + "coding": [ + { + "system": "https://spor.ema.europa.eu/rmswi/", + "code": "100000155538" + } + ], + "text": "6. Contents of the pack and other information" + }, + "text": { + "status": "additional", + "div": "

What Remsima contains

What Remsima looks like and contents of the pack

Remsima is a clear to opalescent, colourless to pale brown solution which is supplied as a single use pre-filled syringe.

Each pack contains 1 pre-filled syringe with 2 alcohol pads, 2 pre-filled syringes with 2 alcohol pads, 4 pre-filled syringes with 4 alcohol pads or 6 pre-filled syringes with 6 alcohol pads.

Each pack contains 1 pre-filled syringe with automatic needle guard with 2 alcohol pads, 2 pre-filled syringes with automatic needle guard with 2 alcohol pads, 4 pre-filled syringes with automatic needle guard with 4 alcohol pads or 6 pre-filled syringes with automatic needle guard with 6 alcohol pads.

Not all pack sizes may be marketed

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