FrancophonIA/ELRC3.0 huggingface dataset:
English: It is used when standard treatment is not available or is no longer feasible.
Danish: Det anvendes, når der ikke findes nogen standardbehandling, eller hvis standardbehandling ikke længere er mulig.
English: The effects of Removab were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Removab blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: This brings the cells close together so that the T-cells can kill the cancer cells.
Danish: Dette bringer cellerne tæt sammen, så T-cellerne kan dræbe kræftcellerne.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) REMOVAB EPAR summary for the public
Danish: EUROPÆISK OFFENTLIG VURDERINGSRAPPORT (EPAR) REMOVAB EPAR - sammendrag for offentligheden
English: Removab is not recommended for use in patients below the age of 18 years because of a lack of information on safety and effectiveness in this age group.
Danish: Removab anbefales ikke til patienter under 18 år, da der ikke foreligger oplysninger om dets sikkerhed og virkning i denne aldersgruppe.
English: Removab must not be given all at once or by any other route.
Danish: Removab-dosen må ikke indgives på én gang eller ad nogen anden indgivelsesvej.
English: The full EPAR for Removab can be found here.
Danish: Den fuldstændige EPAR for Removab findes her.
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Danish: Hvis du ønsker yderligere oplysninger om grundlaget for CVMP's anbefalinger, kan du læse den faglige drøftelse (også en del af denne EPAR).
English: On average, patients who received Removab lived for 46 days without the need for further drainage.
Danish: I gennemsnit overlevede de patienter, som fik Removab, i 46 dage uden behov for yderligere drænagebehandling.
English: Patients who have severe problems with their liver, or moderate or severe kidney problems should only be given Removab treatment after careful consideration of the medicine's benefits and risks.
Danish: Patienter med svære leverproblemer eller moderate til svære nyreproblemer må kun få behandling med Removab efter nøje overvejelse af fordelene og risiciene ved lægemidlet.
English: It contains the active substance catumaxomab.
Danish: Det indeholder det aktive stof catumaxomab.
English: Removab can only be used in patients with EpCAM-positive carcinomas.
Danish: Removab må kun anvendes til patienter med EpCAM-positive karcinomer.
English: Removab treatment should only be given under the supervision of a doctor who has experience in the use of anticancer medicines.
Danish: Behandlingen med Removab må kun gennemføres under overvågning af en læge med erfaring i behandling med lægemidler mod kræft.
English: The main measure of effectiveness was how long patients lived without the need for further drainage.
Danish: Det vigtigste mål for virkningen var, hvor længe patienterne overlevede uden behov for yderligere drænagebehandling.
English: The most common side effects with Removab (seen in more than 1 patient in 10) are lymphopenia (low level of lymphocytes, a type of white blood cell), abdominal (tummy) pain, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), fatigue (tiredness), chills and pain.
Danish: De mest almindelige bivirkninger ved Removab (som optræder hos flere end 1 ud af 10 patienter) er lymfopeni (lave koncentrationer af lymfocytter, en type hvide blodlegemer), mavesmerter, kvalme, opkastning, diarré, pyreksi (feber), træthed, kulderystelser og smerter.
English: These are cancers where the tumour cells have large quantities of a molecule called EpCAM on their surface.
Danish: Ved disse kræfttyper har tumorcellerne store mængder af et molekyle kaldet EpCAM på deres overflade.
English: T-cells are part of the immune system (the body's natural defences), and are involved in coordinating the death of infected and abnormal cells.
Danish: T-celler udgør en del af immunsystemet (kroppens naturlige forsvar) og medvirker ved koordineringen af ødelæggelsen af betændte og unormale celler.
English: What is the risk associated with Removab?
Danish: Hvilken risiko er der forbundet med Removab?
English: Catumaxomab also attaches to a third substance called the Fc-gamma receptor, which also helps the body's immune system to target the cancer cells.
Danish: Catumaxomab binder sig også til et tredje stof kaldet Fcgammareceptoren, som også hjælper kroppens immunsystem med at angribe kræftcellerne.
English: The active substance in Removab, catumaxomab, is a monoclonal antibody.
Danish: Det aktive stof i Removab, catumaxomab, er et monoklonalt antistof.
English: By attaching to these two antigens, catumaxomab forms a bridge between the cancer cells and the T-cells.
Danish: Ved at angribe disse to antigener danner catumaxomab en bro mellem kræftcellerne og T-cellerne.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Removab's benefits are greater than its risks for the intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinoma where standard therapy is not available or no longer feasible.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Removab er større end risiciene ved intraperitoneal behandling af malign ascites hos patienter med EpCAMpositive karcinomer, hvor standardbehandling ikke findes eller ikke længere er mulig.
English: Removab should not be used in people who may be hypersensitive (allergic) to catumaxomab, to any of the other ingredients, or to murine (rat or mouse) proteins.
Danish: Removab må ikke anvendes til personer, som kan være overfølsomme (allergiske) over for catumaxomab, over for et eller andre af indholdsstofferne eller over for murine (rotte- og/eller muse-) proteiner.
English: Removab was studied in one main study involving 258 patients with malignant ascites caused by an EpCAM-positive cancer and for which standard therapy was not available or was no longer feasible.
Danish: Removab blev undersøgt i en hovedundersøgelse med 258 patienter med malign ascites forårsaget af EpCAM-positiv kræft, hvor standardbehandling ikke var tilgængelig eller ikke længere var mulig.
English: Catumaxomab has been designed to attach to two antigens: EpCAM, which is found in high levels on some types of cancer cells and CD3, which is found on T-cells.
Danish: Catumaxomab er udviklet til at binde sig til to antigener: EpCAM, som findes i høje koncentrationer på nogle typer af kræftceller, og CD3, som findes på T-celler.
English: For the full list of all side effects reported with Removab, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Removab fremgår af indlægssedlen.
English: Removab with drainage was more effective at treating malignant acsites than drainage alone.
Danish: Removab i kombination med drænage var mere effektivt til behandling af malign acsites end drænagebehandling alene.
English: Removab must be given as an intraperitoneal (into the peritoneal cavity) infusion using a pump system.
Danish: Removab skal indgives som en intraperitoneal infusion (i bughulen) ved hjælp af et pumpesystem.
English: Why has Removab been approved?
Danish: Hvorfor blev Removab godkendt?
English: In this study, Removab used in combination with drainage of fluid from the abdomen was compared with drainage alone.
Danish: I denne undersøgelse blev behandling med Removab i kombination med drænage af væske fra abdomen sammenlignet med drænagebehandling alene.
English: In patients with cancer, ascites forms because cancer cells develop on the peritoneum, the membrane around the peritoneal cavity, where they block the natural drainage of fluid from the abdomen.
Danish: Hos patienter med kræft dannes væskeansamlingen, fordi der udvikles kræftceller på bughinden (membranen rundt om bughulen), hvor de blokerer det naturlige afløb af væske fra abdomen (maven).
English: Removab is a concentrate that is made up into a solution for infusion (a drip).
Danish: Removab er et koncentrat, der blandes til en infusionsvæske (et drop).
English: What is Removab?
Danish: Hvad er Removab?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure
Danish: Et monoklonalt antistof er et antistof (en type protein), som er i stand til at genkende og binde sig til en særlig struktur, der kaldes et antigen, og som findes på visse celler i kroppen.
English: What benefit has Removab shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Removab?
English: This compared with 11 days for patients who were treated with drainage alone.
Danish: Til sammenligning overlevede patienter, som fik behandling med drænage alene, i 11 dage.
English: Removab is used to treat malignant ascites, fluid accumulation in the peritoneal cavity (abdominal space) that is caused by a cancer.
Danish: Removab anvendes til behandling af malign ascites, som er en væskeansamling i bughulen, der forårsages af kræft.
English: What is Removab used for?
Danish: Hvad anvendes Removab til?
English: How has Removab been studied?
Danish: Hvordan blev Removab undersøgt?
English: How is Removab used?
Danish: Hvordan anvendes Removab?
English: EU/1/19/1400/001 Rhokiinsa
Danish: EU/1/19/1400/001 Rhokiinsa µg/ml
English: 2.5 ml
Danish: Flaske (LDPE) 2,5 ml
English: Immediate Packaging
Danish: Til anvendelse i øjet
English: Content (concentration)
Danish: Øjendråber, opløsning
English: MA(EU) number
Danish: MT-nummer (EU)
English: Content (concentration)
Danish: Indre pakning Indhold (koncentration)
English: Strength Pharmaceutical Form
Danish: Styrke Lægemiddelform Administrationsvej
English: (Invented) name
Danish: Lægemiddelnavn
English: The European Commission issued a decision on 2 June 2010.
Danish: Europa-Kommissionen traf en afgørelse den 2. juni 2010.
English: Prof. Pieter de Graeff (the Netherlands)
Danish: Prof. Pieter de Graeff (Nederlandene)
English: As the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009.
Danish: Da medlemsstaterne ikke kunne nå til enighed, indbragte den tyske lægemiddelmyndighed sagen for CHMP med henblik på voldgift den 29. oktober 2009.
English: Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Orion outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States.
Danish: På basis af en vurdering af de tilgængelige data og den videnskabelige drøftelse i Udvalget er CHMP af den opfattelse, at fordelene ved Clopidogrel Orion er større end risiciene, og at der derfor bør udstedes markedsføringstilladelse for Clopidogrel Orion i alle berørte medlemsstater.
English: The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Orion and associated names.
Danish: Det Europæiske Lægemiddelagentur (EMA) har gennemført en voldgiftsprocedure efter en uoverensstemmelse mellem Den Europæiske Unions medlemsstater vedrørende markedsføringstilladelsen for lægemidlet Clopidogrel Orion og relaterede navne.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Orion outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden.
Danish: EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at fordelene ved Clopidogrel Orion er større end risiciene, og at der kan udstedes markedsføringstilladelse i Tyskland og i følgende EU-medlemsstater: Den Tjekkiske Republik, Danmark, Finland, Litauen, Letland, Norge, Slovakiet og Sverige.
English: What is Clopidogrel Orion?
Danish: Hvad er Clopidogrel Orion?
English: Why was Clopidogrel Orion reviewed?
Danish: Hvorfor blev Clopidogrel Orion vurderet igen?
English: Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it..
Danish: Clopidogrelbase er mindre stabilt end saltformen, og lægemidlet indeholder BHA for at stabilisere det.
English: Clopidogrel Orion is a generic medicine based on a ‘reference medicine', Plavix, which is authorised in the EU.
Danish: Clopidogrel Orion er et generisk lægemiddel, der er baseret på et "referencelægemiddel", som er godkendt i EU.
English: Teva Pharma B.V. submitted Clopidogrel Orion to Germany for a decentralised procedure.
Danish: indgav en ansøgning om Clopidogrel Orion til Tyskland med henblik på en decentral procedure.
English: Clopidogrel Orion is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Orion er et lægemiddel, som indeholder det aktive stof clopidogrel.
English: 2 June 2010
Danish: 2. juni 2010
English: This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden).
Danish: dette land og i andre medlemsstater (de "berørte medlemsstater", i dette tilfælde Den Tjekkiske Republik, Danmark, Finland, Litauen, Letland, Norge, Slovakiet og Sverige).
English: Zessly over 1 hour.
Danish: Zessly over 1 time.
English: Date of first authorisation: 18 May 2018
Danish: Dato for første markedsføringstilladelse: 18. maj 2018.
English: Radiographic changes were assessed in study 11.
Danish: Radiografiske ændringer blev vurderet i studie 11.
English: Zessly is indicated for:
Danish: Zessly er indiceret til:
English: Not known (frequency cannot be estimated from the available data)
Danish: Ikke kendte: (hyppigheden kan ikke estimeres ud fra forhåndenværende data)
English: 88397 Biberach an der Riss GERMANY
Danish: 88397 Biberach an der Riss TYSKLAND
English: This will depend on your disease, weight and how well you respond to Zessly.
Danish: Dette vil afhænge af din sygdom, vægt og hvor godt, du reagerer på Zessly.
English: EXP EXP, if not refrigerated
Danish: EXP EXP, hvis ikke opbevaret i køleskab
English: Switching between biological DMARDs
Danish: Skift mellem biologiske DMARDS
English: In this situation, Zessly should be reinitiated as a single dose followed by the maintenance dose recommendations described above.
Danish: I denne situation bør Zessly initieres igen som en enkelt dosis efterfulgt af vedligeholdelsesdoser som anbefalet ovenfor.
English: Zessly will generally be stored by the health professionals.
Danish: Zessly opbevares normalt af sundhedspersonalet.
English: b Absence of any draining fistulas.
Danish: b Fravær af alle drænede fistulaer.
English: • You will be monitored while you are given Zessly and also for 1 to 2 hours afterwards.
Danish: • Du vil blive overvåget, mens du får Zessly og i 1-2 timer derefter.
English: Zessly should be administered
Danish: Zessly bør administreres
English: If you are given too much Zessly
Danish: Hvis du får for meget Zessly
English: The median duration of response was 12 weeks.
Danish: Medianvarigheden af respons var 12 uger.
English: If you feel tired, dizzy or unwell after having Zessly, do not drive or use any tools or machines.
Danish: Hvis du føler dig træt, svimmel eller utilpas efter at have fået Zessly, må du ikke køre bil eller betjene nogen form for maskiner.
English: In study 2, more than 90% of patients had at least two evaluable X-rays.
Danish: I studie 2 havde mere end 90 % af patienterne mindst to bedømmelsesværdige røntgenbilleder.
English: • The medicine will be given as an infusion (drip) over a 2 hours into one of your veins,
Danish: • Medicinen vil blive givet som en infusion (drop) over 2 timer i en af dine blodårer (vener),
English: HAQ = Health Assessment Questionnaire; greater values indicate less disability.
Danish: c HAQ = Health Assessment Questionnaire; højere værdier indikerer mindre handicap.
English: Periodic screening should continue in women treated with Zessly, including those over 60 years of age.
Danish: Periodisk screening bør fortsætte hos kvinder, der er blevet behandlet med Zessly, inklusive kvinder over 60 år.
English: Median time to loss of response through week 54
Danish: Median tid til tab af respons efter uge 54
English: Zessly is a biosimilar medicinal product.
Danish: Zessly er et biosimilært lægemiddel.
English: The combination of Zessly and abatacept is not recommended.
Danish: Kombinationen af Zessly og abatacept anbefales ikke.
English: Median follow-up is based on patients treated.
Danish: 4 Medianopfølgning er baseret på behandlede patienter.
English: usually in your arm. After the third treatment, your doctor may decide to give your dose of
Danish: Efter den tredje behandling kan din læge beslutte at give dig din dosis
English: Your doctor will advise you what other medicines you must keep using while you are having Zessly.
Danish: Din læge vil rådgive dig om, hvilke andre lægemidler du skal blive ved med at tage, mens du er i behandling med Zessly.
English: Zessly, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Danish: Zessly, i kombination med methotrexat, er indiceret til reduktion af sygdomstegn og symptomer samt forbedring af fysisk funktionsevne hos:
English: b greater values indicate more joint damage.
Danish: b højere værdier indikerer mere ledskade.
English: PREGNANCY AND VACCINATIONS
Danish: GRAVIDITET OG VACCINATIONER
English: If you forget or miss your Zessly infusion
Danish: Hvis du har glemt eller kommer for sent til din Zessly-infusion
English: Cases of agranulocytosis have also been reported (see section
Danish: Der er også set tilfælde af agranulocytose (se pkt.
English: Zessly belongs to a group of medicines called ‘TNF blockers'.
Danish: Zessly tilhører en medicingruppe kaldet ”TNF-blokkere”.
English: If you forget or miss an appointment to receive Zessly, make another appointment as soon as possible.
Danish: Hvis du glemmer eller kommer for sent til en aftale, hvor Zessly gives, skal du lave en ny aftale så hurtigt som muligt.
English: Zessly is also used in adults and children 6 years of age or older for:
Danish: Zessly bruges også til voksne og børn fra 6 år og opefter til behandling af:
English: INFECTIONS Before treatment with Zessly
Danish: INFEKTIONER Før behandling med Zessly
English: In all situations described below, the benefit/risk balance of Zessly therapy should be very carefully considered.
Danish: I alle situationer beskrevet nedenfor bør benefit/risk-balancen af Zesslybehandling vurderes meget nøje.
English: Side effects may also occur after your treatment with Zessly has stopped.
Danish: Bivirkninger kan også opstå efter ophør af din behandling med Zessly.
English: Study 11*
Danish: Studie 11*
English: Zessly should be administered intravenously over a 2 hour period.
Danish: Zessly skal administreres intravenøst over en 2-timers periode.
English: • The doctor will decide your dose and how often you will be given Zessly.
Danish: • Lægen vil bestemme din dosis og hvor ofte, du skal have Zessly.
English: • Zessly will be given to you by your doctor or nurse.
Danish: • Du vil få Zessly af din læge eller sygeplejerske.
English: Fistula Response (%) a Complete fistula response (%) b a A ≥ 50% reduction from baseline in the number of draining fistulas over a period of ≥ 4 weeks.
Danish: Fistula Respons (%) a Komplet fistula respons (%) b a A ≥ 50 % reduktion fra baseline i antallet af drænede fistulaer over en periode på ≥ 4 uger.
English: Discontinuation of Zessly should be considered if these disorders develop.
Danish: Det bør overvejes at afbryde Zesslybehandlingen, hvis disse forstyrrelser fortsætter.
English: Twenty four of these patients (75.0%) regained clinical response after crossing over.
Danish: Fireogtyve af disse patienter (75,0%) genvandt klinisk respons efter cross-over.
English: • Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Zessly treatment again.
Danish: • Fortæl din læge, hvis du tidligere har været i behandling med lægemidler, der indeholder infliximab, og nu starter behandling med Zessly igen.
English: Therefore, the combination of Zessly and anakinra is not recommended.
Danish: Derfor kan kombination af Zessly og anakinra ikke anbefales.
English: Subjects randomised Percentage ACR improvement Mean ± SDa
Danish: Forsøgspersoner randomiseret Procentvis ACR forbedring Gennemsnit ± SDa
English: Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Zessly treatment.
Danish: Da humane immunglobuliner udskilles i mælk, må kvinder ikke amme i mindst 6 måneder efter Zesslybehandling.
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Danish: Den mediane AUCss hos pædiatriske patienter i alderen 2 år til under 6 år var forventet at være ca. 40% lavere end hos voksne, selvom antallet af patienter, der bekræfter dette estimat, er begrænset.
English: Before starting treatment with Zessly, all patients must be evaluated for both active and inactive (‘latent') tuberculosis.
Danish: Før initiering af behandling med Zessly skal alle patienter vurderes for både aktiv og inaktiv (“latent”) tuberkulose.
English: • 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.
Danish: • Hvis du har holdt pause i behandlingen med infliximab i over 16 uger, er der en højere risiko for at få en allergisk reaktion, når du starter behandlingen igen.
English: Keep this card with you for 4 months after your dose of Zessly, or in case of pregnancy for at least 6 months after the birth of your baby.
Danish: Opbevar dette kort på dig i 4 måneder, efter du har fået Zessly, eller i tilfælde af graviditet i mindst 6 måneder, efter du har født.
English: Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer .
Danish: Aktuelle data indikerer ikke, at infliximab-behandling påvirker risikoen for at udvikle dysplasi eller colon cancer.
English: Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies
Danish: Anti-nukleare antistoffer (ANA)/Anti-dobbeltstrengede DNA (dsDNA) antistoffer
English: Further treatment with Zessly must not be given if a patient develops a serious infection or sepsis.
Danish: Behandling med Zessly må ikke fortsættes, hvis en patient udvikler en alvorlig infektion eller sepsis.
English: Prior therapy with PUVA, methotrexate, cyclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant.
Danish: Tidligere behandling med PUVA, methotrexat, ciclosporin eller acitretin var modtaget af 71,4 % af patienterne, selv om de ikke nødvendigvis var behandlingsresistente.
English: • You are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6).
Danish: • Du er allergisk over for infliximab eller et af de øvrige indholdsstoffer i Zessly (angivet i punkt 6).
English: Your doctor may recommend temporarily stopping Zessly.
Danish: Din læge kan anbefale en midlertidig pause med Zessly.
English: Intravenous use after reconstitution and dilution.
Danish: Intravenøs anvendelse efter rekonstituering og fortynding.
English: There are no known side effects of having too much of Zessly.
Danish: Der kendes ikke til bivirkninger efter at have fået for meget Zessly.
English: Zessly infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Danish: Zessly-infusioner skal administreres af kvalificeret sundhedspersonale, som er trænet i at detektere infusionsrelateredeproblemer.