FrancophonIA/ELRC3.0 huggingface dataset:
English: It recognises a protein on the surface of cancer cells and recruits immune cells to destroy them.
Danish: Catumaxomab genkender et protein på overfladen af kræftceller og får immunsystemets celler til at destruere dem.
English: Intraperitoneal use only.
Danish: Kun til intraperitoneal anvendelse.
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk (see section 4.4).
Danish: Behandling af disse patienter med Removab bør kun overvejes efter omhyggelig afvejning af fordele og risici (se pkt.
English: All patients experienced symptoms related to catumaxomab mode of action with a safety profile comparable in nature to the first i.p.
Danish: Alle patienter oplevede symptomer relateret til catumaxomabs virkningsmekanisme med en sikkerhedsprofil, der af natur var sammenlignelig med den første intraperitoneale behandlingscyklus.
English: Constipation*, dyspepsia, abdominal distension, sub-ileus*, flatulence,
Danish: Forstoppelse*, dyspepsi, abdominal distension, subileus*, flatulens,
English: • 50 ml polypropylene syringes
Danish: • 50 ml-sprøjter af polypropylen
English: Removab is used to treat malignant ascites, when standard treatment is not available or no longer feasible.
Danish: Removab anvendes til behandling af malign ascites, når der ikke findes nogen standardbehandling, eller hvis standardbehandlingen ikke længere er mulig.
English: Uncommon Gastrointestinal haemorrhage*, intestinal obstruction*.
Danish: Ikke almindelig Gastrointestinal blødning*, intestinal obstruktion*.
English: Cancer Type
Danish: Cancertype
English: • The pump speed is adjusted according to the volume to be administered and the scheduled infusion time.
Danish: • Justér pumpens hastighed afhængigt af det volumen, der skal administreres (se pkt.
English: Uncommon Erythaema induratum*, device-related infection*.
Danish: Ikke almindelig Erythema induratum*, device-relateret infektion*.
English: • polyethylene perfusion tubings with an inner diameter of 1 mm and a length of 150 cm
Danish: • perfusionsslanger af polyethylen med en indre diameter på 1 mm og en længde på 150 cm
English: Time to first need for therapeutic ascites puncture Median time to first need for therapeutic ascites puncture (days)
Danish: Tiden indtil første behov for terapeutisk ascitespunktur Median tid til første behov for terapeutisk ascitespunktur (dage)
English: Other or additional standard pre-medication with analgesic / antipyretic / nonsteroidal antiphlogistic medicinal products is recommended.
Danish: Anden eller yderligere standard-præmedicinering med f.eks. analgetiske/antipyretiske/nonsteroidale antiphlogistiske lægemidler anbefales.
English: What you need to know before you use Removab
Danish: Det skal De vide, før De begynder at bruge Removab
English: Effective catumaxomab-mediated killing of tumour cells in vitro was observed for target cells with low and high expression of the EpCAM antigen, independent of the primary tumour type.
Danish: Der blev observeret effektiv catumaxomab-medieret destruktion af tumorceller in vitro for tumorceller med lav og høj ekspression af EpCAM-antigenet, uafhængigt af den primære tumortype.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om Removab findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Removab must not be administered by intraperitoneal bolus or by any other route of administration.
Danish: Removab må ikke administreres med intraperitoneal bolus eller via nogen anden indgivelsesvej.
English: Removab is given as 4 intraperitoneal infusions with increasing dose (10, 20, 50 and 150 micrograms), separated at least by 2 infusion-free calendar days (for example you will receive infusion on day 0, 3, 7, 10).
Danish: Removab gives som 4 intraperitoneale infusioner med stigende doser (10, 20, 50 og 150 mikrogram) med mindst 2 infusionsfrie kalenderdage imellem infusionsdagene (for eksempel vil du få infusionen på dag 0, 3, 7, 10).
English: Intraperitoneal use only.” must be attached to the 50 ml syringe containing the diluted Removab solution for intraperitoneal infusion.
Danish: Kun til intraperitoneal anvendelse.” skal sættes på 50 ml sprøjten indeholdende den fortyndede Removab-opløsning til intraperitoneal infusion.
English: The primary efficacy endpoint, puncture-free survival, was a composite endpoint defined as the time to first need for therapeutic ascites puncture or death, whichever occurred first (identical to the pivotal study).
Danish: Det primære endepunkt for virkning, punkturfri overlevelse, var et sammensat endepunkt defineret som tiden indtil det første behov for terapeutisk ascitespunktur eller død afhængigt af, hvad der indtrådte først (identisk med det pivotale studie).
English: Standard therapy or premedication, e.g. analgesic / antipyretic / nonsteroidal antiphlogistic is appropriate to limit the risk.
Danish: Standardbehandling eller præmedicinering med f.eks. analgetiske/antipyretiske/nonsteroidale antiphlogistiske lægemidler er relevant for at begrænse risikoen.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Neovii Biotech GmbH
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Neovii Biotech GmbH
English: Table 4 Overall survival of study IP-REM-AC-01 in post study phase Paracentesis + catumaxomab (N=170)
Danish: Tabel 4 Samlet overlevelse i fasen efter studie IP-REM-AC-01 Paracentese + catumaxomab (N=170)
English: Gastrointestinal reactions like abdominal pain, feeling sick, vomiting and diarrhoea occur in more than 1 in 10 patients (very common), but are mostly mild to moderate and respond well to additional treatment.
Danish: Mave-tarm-symptomer, såsom mavesmerter, kvalme, opkastning og diarré optræder hos flere end 1 ud af 10 patienter (meget almindelig), men er fortrinsvis lette til moderate og reagerer godt på behandling..
English: This is a precautionary measure to ensure that Removab is infused only via the intraperitoneal route of administration.
Danish: Dette er en sikkerhedsforanstaltning for at sikre, at Removab kun administreres via intraperitoneal infusion.
English: Removab must be administered intraperitoneally over an infusion time of at least 3 hours via a constant infusion pump system as described below:
Danish: Removab skal infunderes intraperitonealt i løbet af mindst 3 timer via en pumpe med konstant infusionshastighed som beskrevet nedenfor:
English: Uncommon Extravasation*, application site inflammation*.
Danish: Ikke almindelig Ekstravasation*, inflammation på applikationsstedet*.
English: Prior to the intraperitoneal infusion, pre-medication with analgesic / antipyretic / non-steroidal antiphlogistic medicinal products is recommended (see section 4.4).
Danish: Før den intraperitoneale infusion anbefales en præmedicinering med analgetiske/antipyretiske/ nonsteroidale antiphlogistiske lægemidler (se pkt.
English: Removab must be administered under the supervision of a physician experienced in the use of anti-neoplastic medicinal products.
Danish: Removab skal administreres under opsyn af en læge, der har erfaring med brug af antineoplastiske lægemidler.
English: Paracentesis + catumaxomab (N=170)
Danish: Paracentese + catumaxomab (N=170)
English: The most common serious side effects of Removab are infusion-related side effects and side effects related to the gastrointestinal system (stomach and gut).
Danish: De hyppigste alvorlige bivirkninger ved Removab er infusionsrelaterede bivirkninger og bivirkninger i mave-tarm-systemet.
English: Other medicines and Removab Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl altid lægen eller på apoteket, hvis De bruger anden medicin eller har gjort det for nylig.
English: • When the 50 ml syringe containing the diluted Removab solution for infusion is empty it is replaced with a 50 ml syringe containing 20 ml sodium chloride 9 mg/ml (0.9%) solution for injection until the end of the scheduled infusion time to clear the dead volume in the perfusion lead (approximately 2 ml) under unchanged conditions.
Danish: • Når 50 ml injektionssprøjten indeholdende den fortyndede Removab-opløsning er tom, erstattes den med en 50 ml injektionssprøjte indeholdende 20 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske), indtil den planlagte infusionstid er slut, for at fjerne den døde volumen i perfusionskanalen (ca. 2 ml) under uændrede betingelser.
English: Intraperitoneal use only, after dilution.
Danish: Intraperitoneal anvendelse kun efter fortynding.
English: Pharmacokinetics of catumaxomab during and after four intraperitoneal infusions of 10, 20, 50 and 150 micrograms catumaxomab were investigated in 13 patients with symptomatic malignant ascites due to EpCAM-positive carcinomas.
Danish: Catumaxomabs farmakokinetik under og efter fire intraperitoneale infusioner med 10, 20, 50 og 150 mikrogram catumaxomab blev undersøgt hos 13 patienter med symptomatisk malign ascites på grund af EpCAM-positive karcinomer.
English: Systemic Inflammatory Response Syndrome (SIRS), which may also occur commonly due to the mechanism of action of catumaxomab, develops, in general, within 24 hours after Removab infusion, showing symptoms of fever, tachycardia, tachypnoea and leucocytosis (see section 4.8).
Danish: Systemisk inflammatorisk responssyndrom (SIRS), som også kan forekomme med frekvensen "almindelig" på grund af catumaxomabs virkningmekanisme, udvikles generelt inden for 24 timer efter en infusion med Removab med symptomer som feber, takykardi, takypnø og leukocytose (se pkt.
English: Removab is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Removab bør ikke anvendes under graviditet eller til fertile kvinder, som ikke anvender sikker kontraception.
English: Thereby, a concerted immunoreaction against tumour cells is induced which includes different mechanisms of action such as T-cell activation, antibody-dependent cell-mediated cytotoxicity (ADCC), complement-dependent cytotoxicity (CDC) and phagocytosis.
Danish: Reaktionen omfatter forskellige virkningsmekanismer som T-celleaktivering, antistofafhængig, cellemedieret cytotoksicitet (ADCC), komplementafhængig cytotoksicitet (CDC) og fagocytose.
English: This confirmatory two-arm, randomized, open label, phase IIIb study in 219 epithelial cancer patients with symptomatic malignant ascites requiring therapeutic ascites puncture investigated treatment with catumaxomab plus 25 mg prednisolone premedication vs. catumaxomab alone.
Danish: Dette bekræftende to-armede, randomiserede, open-label, fase-III-studie med 219 patienter med epitelcancer og symptomatisk malign ascites, der krævede terapeutisk ascitespunktur, sammenlignede behandling med catumaxomab samt 25 mg prednisolon som præmedicinering med catumaxomab alene.
English: Symptoms of pain and pyrexia can be ameliorated or avoided by pre-medication (see sections 4.2 and 4.4).
Danish: Smerter og pyreksi kan lindres eller undgås med præmedicinering (se pkt.
English: Cytokine release syndrome*, hypersensitivity*.
Danish: Cytokinfrigivelsessyndrom*, overfølsomhed*.
English: The diluted Removab solution for infusion is administered intraperitoneally as constant rate infusion using an adequate pump system.
Danish: Den fortyndede opløsning administreres intraperitonealt med konstant infusions hastighed med et hensigtsmæssigt pumpesystem.
English: Malignant ascites is an accumulation of fluid in the abdominal space (peritoneal cavity) resulting from certain types of cancer.
Danish: Malign ascites er ophobning af væske i bughulen i forbindelse med visse kræfttyper.
English: - The other ingredients are sodium citrate, citric acid monohydrate, polysorbate 80 and water for injections.
Danish: - Øvrige indholdsstoffer: natriumcitrat, citronsyremonohydrat, polysorbat 80 og vand til injektionsvæsker.
English: Removab must not be administered as a bolus or by any route other than intraperitoneally.
Danish: Removab må ikke administreres som en bolus eller via nogen anden indgivelsesvej end intraperitonealt.
English: • polyurethane, polyurethane silicon coated catheters
Danish: • polyurethankatetere, polyurethankatetere med siliconecoating
English: Sodium citrate Citric acid monohydrate Polysorbate 80
Danish: Natriumcitrat Citronsyremonohydrat Polysorbat 80
English: Cytokine-release related reactions: SIRS a potentially life-threatening combination of tachycardia, fever and/or dyspnoea, can develop within 24 hours after a catumaxomab infusion and resolves under symptomatic treatment.
Danish: Symptomer relateret til cytokinfrigivelse: SIRS, en kombination af takykardi, feber og/eller dyspnø med potentielt livstruende intensitet observeres mindre hyppigt, udvikles i løbet af 24 timer efter en Removab-infusion og forsvinder ved symptomatisk behandling.
English: *rat-mouse hybrid IgG2 monoclonal antibody produced in a rat-mouse hybrid-hybridoma cell line For the full list of excipients, see section 6.1.
Danish: *IgG2 monoklonalt antistof, som er produceret i en rotte-muse-hybrid-hybridom-cellelinje Alle hjælpestoffer er anført under pkt.
English: • polycarbonate infusion valves / Y connections
Danish: • infusionsventiler/Y-koblinger af polycarbonat
English: Uncommon Pulmonary embolism*, hypoxia*.
Danish: Ikke almindelig Lungeemboli*, hypoksi*.
English: gastric disorder, ileus*, gastroesophageal reflux disease, dry mouth.
Danish: gastriske gener, ileus*, gastroøsfageal reflukssygdom, mundtørhed.
English: Catumaxomab is a trifunctional rat-mouse hybrid monoclonal antibody that is specifically directed against the epithelial cell adhesion molecule (EpCAM) and the CD3 antigen.
Danish: Catumaxomab er et hybridt, monoklonalt, rotte-muse-antistof med tredobbelt funktion, som er rettet specifikt mod epitelcellers adhæsionsmolekyler (EpCAM) og CD3-antigenet.
English: Kaplan Meier estimates for time to first need for therapeutic ascites puncture are given in Figure 1.
Danish: KaplanMeier-estimater for tiden indtil første behov for terapeutisk ascitespunktur vises i Figur 1.
English: Any air bubble(s) from the 50 ml syringe is eliminated.
Danish: Eventuelle luftbobler fra 50 ml injektionssprøjten skal fjernes.
English: Ovarian
Danish: Ovarie
English: 10 micrograms on day 0
Danish: 10 mikrogram på dag 0
English: How to use Removab
Danish: Sådan skal De bruge Removab
English: Hypotension*, hypertension*, flushing.
Danish: Hypotension*, hypertension*, ansigtsrødme.
English: • The perfusion tubing is connected to the Y-connection.
Danish: • Slut perfusionsslangen til Y-koblingen.
English: Gastrointestinal reactions like abdominal pain, nausea, vomiting and diarrhoea are very common and occur mostly with CTCAE grade 1 or 2, but were also observed in higher grades, and respond to adequate symptomatic treatment.
Danish: Gastrointestinale reaktioner, såsom abdominalsmerter, kvalme, opkastning og diarré, er meget almindelige og er for det meste af CTCAE grad 1 eller 2, men blev også observeret med højere grader.
English: Hepatic impairment or portal vein thrombosis / obstruction Patients with hepatic impairment of a higher severity grade than moderate and / or with more than 70% of the liver metastasised and / or portal vein thrombosis / obstruction have not been investigated.
Danish: Leverinsufficiens eller vena porta-trombose/obstruktion Patienter med leverinsufficiens med en højere sværhedsgrad end moderat og/eller med mere end 70% af leveren opfyldt af metastaser og/eller vena porta-trombose/obstruktion er ikke undersøgt.
English: LIST OF EXCIPIENTS Sodium citrate, citric acid monohydrate, polysorbate 80, water for injections
Danish: LISTE OVER HJÆLPESTOFFER Natriumcitrat, citronsyremonohydrat, polysorbat 80, vand til injektionsvæsker
English: Dyspnoea*, pleural effusion*, cough.
Danish: Dyspnø*, pleuraeffusion*, hoste.
English: Figure 1 Kaplan-Meier estimates of time to first need for therapeutic ascites puncture of study IP-REM-AC-01
Danish: Figur 1 Kaplan-Meier-estimater over tiden indtil første behov for terapeutisk ascitespunktur i studie IP-REM-AC-01
English: The remaining sodium chloride 9 mg/ml (0.9%) solution for injection can be discarded.
Danish: Den resterende 9 mg/ml (0,9 %) natriumchloridinjektionsvæske kan bortskaffes.
English: Time to first need for therapeutic ascites puncture Median time to first need for therapeutic ascites puncture (days) 95% CI for median (days) p-value (log-rank test)
Danish: Tiden indtil første behov for terapeutisk ascitespunktur Median tid til første behov for terapeutisk ascitespunktur (dage) 95% CI for median (dage) p-værdi (log-rank-test)
English: Uncommon Thrombocytopenia*, coagulopathy*.
Danish: Ikke almindelig Trombocytopeni*, koagulopati*.
English: 2nd dose
Danish: 3. dosis
English: 150 micrograms on day 10
Danish: 150 mikrogram på dag 10
English: A solid performance status expressed as Body Mass Index (BMI) > 17 (to be assessed after drainage of ascites fluid) and Karnofsky Index > 60 is required prior to Removab therapy.
Danish: Før behandlingen med Removab kræves en solid performance status udtrykt som Body Mass Index (BMI) >17 (vurderet efter drænage af ascitesvæske) og Karnofsky-indeks >60.
English: Table 5 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-CAT-AC-03
Danish: Tabel 5 Effektresultater (punkturfri overlevelse og tiden indtil første behov for terapeutisk ascitespunktur) for studie IP-CAT-AC-03
English: 20 micrograms on day 3
Danish: 20 mikrogram på dag 3
English: Table 7 Preparation of Removab solution for intraperitoneal infusion Number of infusion / Dose
Danish: Tabel 7 Klargøring af Removab-opløsning til intraperitoneal infusion
English: 50 micrograms on day 7
Danish: 50 mikrogram på dag 7
English: You are required to have a BMI above 17 (after drainage of the ascites fluid) and a Karnofsky Index above 60 to use this medicine.
Danish: - Karnofsky Index, et mål for Deres generelle velbefindende For at bruge dette lægemiddel skal De have et BMI over 17 (efter drænage af ascites-væsken) og et Karnofsky Index over 60.
English: Headache, dizziness.
Danish: Hovedpine, svimmelhed.
English: Removab has to be administered as constant rate intraperitoneal infusion with an infusion time of at least 3 hours.
Danish: Removab skal indgives som intraperitoneal infusion ved en konstant hastighed og med en infusionstid på mindst 3 timer.
English: • The plunger rod MUST NOT be drawn back to rinse the pre-filled syringe, in order to avoid contamination and to ensure that the correct volume is ejected.
Danish: • For at undgå kontaminering og for at sikre, at den korrekte volumen bliver stødt ud, MÅ stemplet IKKE trækkes tilbage for at skylle den fyldte injektionssprøjte.
English: WARNING TEXT FOR PEELABLE STICKER TO BE ATTACHED TO 50ml SYRINGE CONTAINING THE DILUTED REMOVAB SOLUTION FOR INFUSION
Danish: ADVARSELSTEKST TIL DEN AFTAGELIGE ETIKET, DER SKAL PÅSÆTTES 50 ML SPRØJTEN INDEHOLDENDE FORTYNDET REMOVAB-OPLØSNING TIL INFUSION
English: Subsequently, prior to each Removab administration 500 ml sodium chloride 9 mg/ml (0.9%) solution for injection shall be infused to support distribution of the antibody in the abdominal cavity.
Danish: Efterfølgende skal der før hver administrering af Removab infunderes 500 ml 9 mg/ml (0,9 %) natriumchloridinjektionsvæske for at understøtte fordelingen af antistoffet.
English: 4th infusion 150 micrograms
Danish: 4. infusion 150 mikrogram
English: Other serious side effects
Danish: Alvorlige bivirkninger
English: 0.1 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
Danish: 0,1 ml koncentrat til infusionsvæske, opløsning, i en fyldt injektionssprøjte (type I-glas, silikoniseret) med stempelprop (bromobutylgummi) og luer lock-system (polypropylen silikoniseret og polycarbonat) med spidslåg (styren-butadiengummi) med en kanyle; pakningsstørrelse på 1.
English: 0.5 ml concentrate for solution for infusion in a pre-filled syringe (type I glass, siliconised) with plunger stopper (bromobutyl rubber) and luer lock system (polypropylene siliconised and polycarbonate) with tip cap (styrene butadiene rubber) with a cannula; pack size of 1.
Danish: 0,5 ml koncentrat til infusionsvæske, opløsning, i en fyldt injektionssprøjte (type I-glas, silikoniseret) med stempelprop (bromobutylgummi) og luer lock-system (polypropylen silikoniseret og polycarbonat) med spidslåg (styren-butadiengummi) med en kanyle; pakningsstørrelse på 1.
English: Catumaxomab was administered as four intraperitoneal infusions with increased doses of 10, 20, 50 and 150 micrograms on day 0, 3, 7 and 10, respectively (see section 4.2).
Danish: Catumaxomab blev administreret som fire intraperitoneale infusioner med øgede doser på 10, 20, 50 og 150 mikrogram på henholdsvis dag 0, 3, 7 og 10 (se pkt.
English: Very common Abdominal pain*, nausea*, vomiting*, diarrhoea*.
Danish: Abdominalsmerter*, kvalme*, opkastning*, diarré*.
English: 95% CI for median (days) p-value (log-rank test)
Danish: 95% CI for median (dage) p-værdi (log-rank test)
English: Precautions to be taken before administering the medicinal product Before administration of Removab the concentrate for solution for infusion is diluted in sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Sikkerhedsforanstaltninger, der skal tages før administration af lægemidlet Før administration fortyndes Removab koncentrat til infusionsvæske, opløsning, med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske.
English: Table 3 Efficacy results (puncture-free survival and time to first need for therapeutic ascites puncture) of study IP-REM-AC-01
Danish: Tabel 3 Effektresultater (punkturfri overlevelse og tiden indtil første behov for terapeutisk ascitespunktur) af studie IP-REM-AC-01
English: The catheter is used for ascites drainage and infusion of diluted Removab and sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Kateteret anvendes til drænage af ascites og infusion of Removab og 9 mg/ml (0,9 %) natriumchloridinjektionsvæske.
English: • The entire content of the syringe (Removab concentrate plus air buffer) is injected from the pre-filled syringe directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: • Injicér hele sprøjtens indhold (Removab-koncentratet plus luftbuffer) fra den fyldte injektionssprøjte direkte i 9 mg/ml (0,9 %) natriumchloridinjektionsvæske.
English: Median overall survival (days) 95% CI for median (days) p-value (log-rank test) Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Danish: 95% CI for median (dage) p-værdi (log-rank-test) Hazard ratio (HR) (catumaxomab versus catumaxomab + prednisolon) 95% CI for HR
English: 1 sterile cannula
Danish: 1 steril sprøjte
English: 2nd infusion 20 micrograms
Danish: 2. infusion 20 mikrogram
English: 1st infusion 10 micrograms
Danish: 1. infusion 10 mikrogram