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 6ae7b5d0bc4..aba9e8dba22 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
@@ -15,6 +15,11 @@ 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.xml.transform.TransformerException;
import java.io.IOException;
@@ -105,6 +110,20 @@ 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 precautionsTalk 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 adolescentsThis medicinal product should not be used in children and adolescents because the safety and efficacy have not yet been fully established.
Other medicines and KarveaTell 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 drinkKarvea can be taken with or without food.
Pregnancy and breast-feeding PregnancyYou 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-feedingTell 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 machinesKarvea 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 administrationKarvea 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 adolescentsKarvea 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 shouldIf you accidentally take too many tablets, contact your doctor immediately.
If you forget to take KarveaIf 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 effectsIf 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 packKarvea 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.
- Keep this leaflet. You may need to read it again.
- Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remsima.
- When starting a new card, keep this card as a reference for 4 months after your last dose of Remsima.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side efects 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 is in this leaflet
- What Remsima is and what it is used for
- What you need to know before you use Remsima
- How to use Remsima
- Possible side effects
- How to store Remsima
- Contents of the pack and other information
- 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:
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis (Bechterew’s disease)
- Psoriasis
- Crohn’s disease
- Ulcerative colitis.
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:
- reduce the signs and symptoms of your disease,
- slow down the damage in your joints,
- improve your physical function.
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:
- reduce the signs and symptoms of your disease,
- slow down the damage in your joints,
- improve your physical function.
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:
- reduce the signs and symptoms of your disease,
- improve your physical function.
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:
- treat active Crohn’s disease,
- reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery
"
+ }
+ },
+ {
+ "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
- you are allergic to infliximab or any of the other ingredients of this medicine (listed in section 6),
- you are allergic to proteins that come from mice,
- you have tuberculosis (TB) or another serious infection such as pneumonia or sepsis (serious bacterial infection of the blood),
- you have heart failure that is moderate or severe. Do not use Remsima if any of the above applies to you. If you are not sure, talk to your doctor before you are given Remsima.
Warnings and precautions
Talk to your doctor before or during treatment with Remsima if you have:
Had treatment with any medicine containing infliximab before
- Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Remsima treatment again.
- If you have had a break in your treatment with infliximab of more than 16 weeks, there is a higher risk for allergic reactions when you start the treatment again.
Local injection site reactions
- Some patients receiving infliximab via injection under the skin have experienced local injection site reactions. Signs of a local injection site reaction can include redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab on the skin of the injection site.
- Most of these reactions are mild to moderate and mostly resolve on their own within a day.
Infections
- Tell your doctor before you are given Remsima if you have an infection even if it is a very minor one.
- Tell your doctor before you are given Remsima if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common. These infections are caused by specific types of fungi that can affect the lungs or other parts of your body.
- You may get infections more easily when you are being treated with Remsima. If you are 65 years of age or older, you have a greater risk.
- These infections may be serious and include tuberculosis, infections caused by viruses, fungi, bacteria or other organisms in the environment and sepsis that may be life-threatening. Tell your doctor straight away if you get signs of infection during treatment with Remsima. Signs include fever, cough, flu-like signs, feeling unwell, red or hot skin, wounds or dental problems. Your doctor may recommend temporarily stopping Remsima.
Tuberculosis (TB)
- It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
- Your doctor will test you to see if you have TB. Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB. Your doctor will record these tests on your patient reminder card.
- If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima. Tell your doctor straight away if you get signs of TB during treatment with Remsima. Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Hepatitis B virus
- Tell your doctor before you are using Remsima if you are a carrier of hepatitis B or have ever had it.
- Tell your doctor if you think you might be at risk of contracting hepatitis B.
- Your doctor should test you for hepatitis B virus.
- Treatment with TNF blockers such as Remsima may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases.
- If you experience reactivation of hepatitis B, your doctor may need to stop your treatment and may give you medicines such as effective antiviral therapy with supportive treatment.
Heart problems
- Tell your doctor if you have any heart problems, such as mild heart failure.
- Your doctor will want to closely monitor your heart. Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Remsima. Signs include shortness of breath or swelling of your feet.
Cancer and lymphoma
- Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
- Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma.
- Patients taking Remsima may have an increased risk of developing lymphoma or another cancer.
- Some patients who have received TNF-blockers, including infliximab have developed a rare type of cancer called hepatosplenic T-cell lymphoma. Of these patients, most were teenage boys or young men and most had either Crohn’s disease or ulcerative colitis. This type of cancer has usually resulted in death. Almost all patients had also received medicines containing azathioprine or mercaptopurine in addition to TNF-blockers.
- Some patients treated with infliximab have developed certain kinds of skin cancer. If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
- Some women being treated for rheumatoid arthritis with infliximab have developed cervical cancer. For women taking Remsima including those over 60 years of age, your doctor may recommend regular screening for cervical cancer.
Lung disease or heavy smoking
- Tell your doctor before you are given Remsima if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker.
- Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Nervous system disease
- Tell your doctor before you are given Remsima if you have or have ever had a problem that affects your nervous system. This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis’.
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
- Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
Vaccinations
- Talk to your doctor if you recently have had or are due to have a vaccine.
- You should receive recommended vaccinations before starting Remsima treatment. You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
- If you received Remsima while you were pregnant, your baby may also be at higher risk for getting an infection as a result of receiving a live vaccine during the first year of life. It is important that you tell your baby's doctors and other health care professionals about your Remsima use so they can decide when your baby should receive any vaccine, including live vaccines such as the BCG vaccine (used to prevent tuberculosis).
- If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. For more information see section on Pregnancy and breast-feeding.
Therapeutic infectious agents
- Talk to your doctor if you have recently received or are scheduled to receive treatment with a therapeutic infectious agent (such as BCG instillation used for the treatment of cancer)
Operations or dental procedures
- Tell your doctor if you are going to have any operations or dental procedures.
- Tell your surgeon or dentist that you are having treatment with Remsima by showing them your patient reminder card.
Liver problems
- Some patients receiving infliximab have developed serious liver problems.
- Tell your doctor straight away if you get symptoms of liver problems during treatment with Remsima. Signs include yellowing of the skin and eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
Low blood counts
- In some patients receiving infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding.
- Tell your doctor straight away if you get symptoms of low blood counts during treatment with Remsima. Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Immune system disorder
- Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
- Tell your doctor straight away if you develop symptoms of lupus during treatment with Remsima. Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
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:
- Medicines that affect your immune system.
- Kineret (which contains anakinra). Remsima and Kineret should not be used together.
- Orencia (which contains abatacept). Remsima and Orencia should not be used together. While using Remsima you should not receive live vaccines. If you were using Remsima during pregnancy or if you are receiving Remsima while breast-feeding, tell your baby’s doctor and other health care professionals caring for your baby about your Remsima use before the baby receives any vaccines.
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
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Remsima should only be used during pregnancy or while breast-feeding if your doctor feels it is necessary for you.
- You should avoid getting pregnant when you are being treated with Remsima and for 6 months after you stop being treated with it. Discuss the use of contraception during this time with your doctor.
- If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
- It is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. If you received Remsima while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 12 months after birth may result in infection with serious complications, including death. Live vaccines such as the BCG vaccine should not be given to your baby within 12 months after birth, unless your baby’s doctor recommends otherwise. For more information see section on vaccination.
- If you are breast-feeding, it is important that you tell your baby’s doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine. Live vaccines should not be given to your baby while you are breast-feeding unless your baby’s doctor recommends otherwise.
- Severely decreased numbers of white blood cells have been reported in infants born to women treated with infliximab during pregnancy. If your baby has continual fevers or infections, contact your baby’s doctor immediately.
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
- Remsima 120 mg solution for injection is administered by injection under the skin (subcutaneous use) only. It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
- For patients with rheumatoid arthritis, your doctor may start your Remsima treatment with or without two Remsima intravenous infusion doses. For patients with Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis or psoriasis, two Remsima infusion doses will be given to start your Remsima treatment.
If Remsima treatment is initiated without two Remsima intravenous infusion doses, the table below shows how often you will usually have this medicine after your first dose.
If two Remsima intravenous infusion doses are given by your doctor or nurse to start the treatment, they will be given 2 weeks apart and the first Remsima subcutaneous injection will be given 4 weeks after the last intravenous infusion followed by Remsima subcutaneous injections given every 2 weeks.
- The first subcutaneous injection of Remsima will be administered under the supervision of your doctor.
- After proper training, if you feel you are well-trained and confident to inject Remsima yourself, your doctor may allow you to inject subsequent doses of Remsima yourself at home.
- Talk to your doctor if you have any questions about giving yourself an injection. You will find detailed “Instructions for Use” at the end of this leaflet.
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:
- Signs of an allergic reaction such as swelling of your face, lips, mouth or throat which may cause difficulty in swallowing or breathing, skin rash, hives, swelling of the hands, feet or ankles. Some of these reactions may be serious or life-threatening. An allergic reaction could happen within 2 hours of your injection or later. More signs of allergic side effects that may happen up to 12 days after your injection include pain in the muscles, fever, joint or jaw pain, sore throat or headache.
- Signs of a local injection site reaction such as redness, pain, itching, swelling, hardness, bruising, bleeding, cold sensation, tingling sensation, irritation, rash, ulcer, hives, blisters and scab.
- Signs of a heart problem such as chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea (feeling sick), vomiting, fluttering or pounding in your chest, a fast or a slow heartbeat, and swelling of your feet.
- Signs of infection (including TB) such as fever, feeling tired, cough which may be persistent, shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhoea, wounds, collection of pus in the gut or around the anus (abscess), dental problems or burning sensation when urinating.
- Possible signs of cancer including but not limited to swelling of lymph nodes, weight loss, fever, unusual skin nodules, changes in moles or skin colouring, or unusual vaginal bleeding.
- Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest.
- Signs of a nervous system problem (including eye problems) such as signs of a stroke (sudden numbness or weakness of your face, arm or leg, especially on one side of your body; sudden confusion, trouble speaking or understanding; trouble seeing in one or both eyes, trouble walking, dizziness, loss of balance or coordination or a severe headache), fits, tingling/numbness in any part of your body, or weakness in arms or legs, changes in eyesight such as double vision or other eye problems.
- Signs of a liver problem (including hepatitis B infection when you have had hepatitis B in the past) such as yellowing of the skin or eyes, dark-brown coloured urine, pain or swelling in the upper right side of the stomach area, joint pain, skin rashes, or fever.
- Signs of an immune system disorder called lupus such as joint pain or a rash on cheeks or arms that is sensitive to the sun (lupus) or cough, shortness of breath, fever or skin rash (sarcoidosis).
- Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
- Signs of serious skin problems such as reddish-target-like spots or circular patches often with central blisters on the trunk, large areas of peeling and shedding (exfoliating) skin, ulcers of mouth, throat, nose, genitals and eyes or small pus-filled bumps that can spread over the body. These skin reactions can be accompanied by fever. Tell your doctor straight away if you notice any of the above. The following side effects have been observed with Remsima:
Very common: may affect more than 1 in 10 people
- Stomach pain, feeling sick Viral infections such as herpes or flu
- Upper respiratory infections such as sinusitis
- Headache
- Side effect due to an injection
- Pain.
Common: may affect up to 1 in 10 people
- Changes in how your liver works, increase in liver enzymes (shown in blood tests)
- Lung or chest infections such as bronchitis or pneumonia
- Difficult or painful breathing, chest pain
- Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
- Nettle-type rash (hives), itchy rash or dry skin
- Balance problems or feeling dizzy
- Fever, increased sweating
- Circulation problems such as low or high blood pressure
- Bruising, hot flush or nosebleed, warm, red skin (flushing)
- Feeling tired or weak
- Bacterial infections such as blood poisoning, abscess or infection of the skin (cellulitis)
- Infection of the skin due to a fungus
- Blood problems such as anaemia or low white blood cell count
- Swollen lymph nodes
- Depression, problems sleeping
- Eye problems, including red eyes and infections
- Fast heart beat (tachycardia) or palpitations
- Pain in the joints, muscles or back
- Urinary tract infection
- Psoriasis, skin problems such as eczema and hair loss
- Reactions at the injection site such as pain, swelling, redness or itching
- Chills, a build-up of fluid under the skin causing swelling
- Feeling numb or having a tingling feeling.
Uncommon: may affect up to 1 in 100 people
- Shortage of blood supply, swelling of a vein
- Collection of blood outside the blood vessels (haematoma) or bruising
- Skin problems such as blistering, warts, abnormal skin colouration or pigmentation, or swollen lips, or thickening of the skin, or red, scaly, and flaky skin
- Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
- Wounds taking longer to heal
- Swelling of the liver (hepatitis) or gall bladder, liver damage
- Feeling forgetful, irritable, confused, nervous
- Eye problems including blurred or reduced vision, puffy eyes or sties
- New or worsening heart failure, slow heart rate
- Fainting
- Convulsions, nerve problems
- A hole in the bowel or blockage of the intestine, stomach pain or cramps
- Swelling of your pancreas (pancreatitis)
- Fungal infections such as yeast infection, or fungal infection of the nails
- Lung problems (such as oedema)
- Fluid around the lungs (pleural effusion)
- Narrowed airway in the lungs, causing difficulty breathing
- Inflamed lining of the lung, causing sharp chest pains that feel worse with breathing (pleurisy)
- Tuberculosis
- Kidney infections Low platelet count, too many white blood cells
- Infections of the vagina
- Blood test result showing ‘antibodies’ against your own body
- Changes in cholesterol and fat levels in the blood.
Rare: may affect up to 1 in 1,000 people
- A type of blood cancer (lymphoma)
- Your blood not supplying enough oxygen to your body, circulation problems such as narrowing of a blood vessel
- Inflammation of the lining of the brain (meningitis)
- Infections due to a weakened immune system
- Hepatitis B infection when you have had hepatitis B in the past
- Inflamed liver caused by a problem with the immune system (autoimmune hepatitis)
- Liver problem that causes yellowing of the skin or eyes (jaundice)
- Abnormal tissue swelling or growth
- Severe allergic reaction that may cause loss of consciousness and could be life-threatening (anaphylactic shock)
- Swelling of small blood vessels (vasculitis)
- Immune disorders that could affect the lungs, skin and lymph nodes (such as sarcoidosis)
- Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
- Lack of interest or emotion
- Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
- Other skin problems such as erythema multiforme, blisters and peeling skin, or boils (furunculosis)
- Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
- Inflammation in the eye that may cause changes in the vision, including blindness
- Fluid in the lining of the heart (pericardial effusion)
- Serious lung problems (such as interstitial lung disease)
- Melanoma (a type of skin cancer)
- Cervical cancer
- Low blood counts, including a severely decreased number of white blood cells
- Small red or purple spots caused by bleeding under the skin
- Abnormal values of a blood protein called ‘complement factor’ which is part of the immune system
- Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
Not known: frequency cannot be estimated from the available data
- Cancer
- A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
- Liver failure
- Merkel cell carcinoma (a type of skin cancer)
- Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin.
- Worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
- Heart attack
- Stroke
- Temporary loss of sight during or within 2 hours of infusion
- Infection due to a live vaccine because of a weakened immune system.
- Reporting of side effects
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": "- 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 label and the carton after “EXP”. The expiry date refers to the last day of that month.
- Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the medicinal product in its outer carton to protect from light.
- This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 25°C for a single period of up to 28 days, but not beyond the original expiry date. In this situation, do not return to refrigerated storage again. Write the new expiry date on the carton including day/month/year. Discard this medicine if not used by the new expiry date or the expiry date printed on the carton, whichever is earlier.
- Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away 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 Remsima contains
- The active substance is infliximab. Each 1 ml single dose pre-filled syringe contains 120 mg of infliximab.
- The other ingredients are acetic acid, sodium acetate trihydrate, sorbitol, polysorbate 80 and water for injections.
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
"
+ }
+ }
+ ]
+ }
+ ]
+}
\ No newline at end of file