FrancophonIA/ELRC3.0 huggingface dataset:
English: Despite this premedication, patients experienced the adverse reactions described above with an intensity of up to grade 3, according to the Common Terminology Criteria for Adverse Events (CTCAE) of the US National Cancer Institute, version 3.0.
Danish: Til trods for denne præmedicinering oplevede patienterne de ovenfor beskrevne bivirkninger med en intensitet på op til grad 3 ifølge Common Terminology Criteria for Adverse Events (CTCAE) fra US National Cancer Institute, version 3.0.
English: Infusion-related side effects and abdominal pain are very common (see section 4).
Danish: Infusionsrelaterede bivirkninger og mavesmerter er meget almindelige (se punkt 4).
English: In order to assess the impact of prednisolone premedication on safety and efficacy the primary safety endpoint “composite safety score” and the co-primary efficacy endpoint “puncture-free survival” were investigated.
Danish: For at kunne evaluere indvirkningen af præmedicinering med prednisolon på sikkerhed og virkning blev det primære endepunkt for sikkerhed “sammensat sikkerhedsscore“ og det co-primære endepunkt for virkning “punkturfri overlevelse” undersøgt.
English: The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Danish: Den samlede sikkerhedsprofil for Removab karakteriseres af symptomer relateret til cytokinfrigivelse og gastrointestinale reaktioner.
English: This must at least include ascites drainage until stop of spontaneous flow or symptom relief, and, if appropriate, supportive replacement therapy with crystalloids and / or colloids.
Danish: Dette skal som minimum omfatte ascites-drænage indtil ophør af spontan udtømning eller symptomlindring og, hvis det er relevant, understøttende substitutionsbehandling med krystalloider og/eller kolloider.
English: This results in destruction of tumour cells.
Danish: Dette medfører, at tumorcellerne destrueres.
English: In presence of factors interfering with the immune system, in particular acute infections, the administration of Removab is not recommended.
Danish: Hvis der forekommer faktorer, som påvirker immunsystemet, især akutte infektioner, frarådes aministration af Removab.
English: This transient effect is considered partially a consequence of the intraperitoneal route of administration.
Danish: Denne forbigående bivirkning betragtes delvist som en følge af den intraperitoneale indgivelsesvej.
English: The prepared infusion solution should be used immediately.
Danish: Den klargjorte infusionsvæske skal anvendes straks.
English: CD3 is expressed on mature T-cells as a component of the T-cell receptor.
Danish: CD3 findes på modne T-celler som en komponent af T-cellereceptoren.
English: HAMAs were present in 94% of patients one month after the last catumaxomab infusion.
Danish: Der forekom HAMA'er hos 94 % af patienterne en måned efter den sidste infusion med catumaxomab.
English: Talk to your doctor or nurse before using Removab.
Danish: Kontakt lægen eller sundhedspersonalet, før De bruger Removab.
English: A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
Danish: Der bliver placeret et kateter i Deres bughule (intraperiotenealt) i hele behandlingsperioden indtil dagen for den sidste infusion.
English: The outer surface of the pre-filled syringe is not sterile.
Danish: Den ydre overflade af den fyldte injektionssprøjte er ikke steril.
English: Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Danish: Doseringsplanen for Removab består af følgende fire intraperitoneale infusioner: 1. dosis
English: Proteinuria.
Danish: Proteinuri.
English: For any information about this medicine, please contact the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til indehaveren af markedsføringstilladelsen.
English: 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.You should not use Removab if you are pregnant unless clearly necessary.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger dette lægemiddel.
English: 6 Catheter
Danish: 6 Kateter
English: Abdominal pain was commonly reported as an adverse reaction.
Danish: Abdominalsmerter blev almindeligt rapporteret som en bivirkning.
English: These symptoms occur mainly within 24 hours after a Removab infusion and can become life-threatening, but can be treated well with additional therapy.
Danish: Disse symptomer opstår hovedsagligt inden for 24 timer efter infusionen med Removab og kan blive livstruende, men symptomerne kan behandles med et godt resultat.
English: • Precision perfusion pump
Danish: • Præcisionspumpe til perfusion
English: Repeated-dose toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity studies have not been performed.
Danish: Der er ikke udført studier af toksicitet efter gentagne doser, genotoksicitet, karcinogenicitet eller reproduktions- og udviklingstoksicitet.
English: For information on the perfusion system to be used see section 4.4.
Danish: For oplysninger om det perfusionssystem, der skal anvendes, se pkt.
English: You will be given Removab under the supervision of a doctor experienced in treating cancer.
Danish: De får Removab under overvågning af en læge, som har erfaring med behandling af kræft.
English: This study compared paracentesis plus catumaxomab versus paracentesis alone (control).
Danish: Dette studie sammenlignede paracentese plus catumaxomab versus paracentese alene (kontrol).
English: The safety profile of catumaxomab using a 3h versus a 6h infusion time is in general comparable in regards to nature, frequency and severity.
Danish: Bivirkningerne af catumaxomab ved 3 timers infusionstid og 6 timers infusionstid er normalt sammenlignelige med hensyn til karakter, hyppighed og sværhedsgrad.
English: In the clinical studies in patients with malignant ascites, 1,000 mg paracetamol intravenously was routinely administered prior to Removab infusion for pain and pyrexia control.
Danish: I de kliniske studier med patienter med malign ascites blev 1.000 mg paracetamol rutinemæssigt administreret intravenøst før infusionen med Removab for at kontrollere smerter og pyreksi.
English: The prepared solution for infusion is physically and chemically stable for 48 hours at 2°C to 8°C and for 24 hours at a temperature not above 25°C.
Danish: Den klargjorte injektionsvæske, opløsning, er fysisk og kemisk stabil i 48 timer ved 2 til 8 °C og i 24 timer ved temperaturer, som ikke overstiger 25 °C.
English: Your doctor may consider reducing the infusion rate of Removab or giving you additional treatment to reduce these symptoms.
Danish: Deres læge vil måske overveje at nedsætte infusionshastigheden af Removab eller give behandling for at lindre disse symptomer.
English: Removab has minor to moderate influence on the ability to drive and use machines.
Danish: Removab påvirker i mindre til moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: Patients who developed HAMAs 8 days after catumaxomab treatment showed better clinical outcome, as measured by puncture-free survival, time to next puncture and overall survival, compared with HAMA-negative patients.
Danish: Patienter, som udviklede HAMA'er 8 dage efter behandling med catumaxomab, viste bedre klinisk udfald målt ved punkturfri overlevelse, tid til næste punktur og samlet overlevelse, sammenlignet med HAMA-negative patienter.
English: If you have any further questions on the use of this product, ask your doctor.
Danish: Spørg lægen, hvis De har yderligere spørgsmål til brugen af dette produkt.
English: For each syringe a new cannula is used.
Danish: Der skal bruges en ny kanyle til hver sprøjte.
English: The composite safety score evaluated the frequency and severity of the main known adverse reactions pyrexia, nausea, vomiting and abdominal pain in both treatment groups.
Danish: Den sammensatte sikkerhedsscore evaluerede hyppighed og sværhedsgrad af de vigtigste kendte bivirkninger, pyreksi, kvalme, opkastning og abdominalsmerter i begge behandlingsgrupper.
English: Patients receiving a higher than recommended dose of catumaxomab experienced more severe (grade 3) adverse reactions.
Danish: Patienter, som har fået en dosis af catumaxomab, som er højere end anbefalet, oplevede mere alvorlige (grad 3) bivirkninger.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes omgående, er opbevaringstid og -betingelser før anvendelse brugerens ansvar, og den klargjorte injektionsvæske, opløsning, holder sig normalt stabil i maksimalt 24 timer ved 2 °C til 8 °C, medmindre fortynding har fundet sted under kontrollerede og godkendte aseptiske forhold.
English: • The peelable sticker, which is provided on the inner side of the Removab carton box, displaying the text “Diluted Removab.
Danish: • Den aftagelige etiket, som medfølger på indersiden af Removab-kartonæsken, og som viser teksten “Fortyndet Removab.
English: Before starting and during treatment, you will be given other medicines to reduce fever, pain or inflammation caused by Removab.
Danish: Før og under behandlingen får De måske anden medicin, som reducerer feber eller betændelse, som skyldes Removab.
English: The induction of human anti-murine (rat and / or mouse) antibodies (HAMAs/HARAs) is an intrinsic effect of murine monoclonal antibodies.
Danish: Induktion af humane anti-murine (rotte og/eller muse) antistoffer (HAMA'er/HARA'er) er en reel virkning af murine monoklonale antistoffer.
English: The infusion must be administered at constant rate with duration time of at least 3 hours.
Danish: Infusionen skal administreres med en konstant hastighed med en varighed på mindst 3 timer.
English: For information on dilution and administration of Removab please refer to section 6.6 of the Summary of Product Characteristics (SmPC) included in each package of Removab 10 micrograms and Removab 50 micrograms, respectively.
Danish: For information om fortynding og administration af Removab, se punkt 6.6 i Produktresuméet, som findes i hver pakning med henholdsvis Removab 10 mikrogram og Removab 50 mikrogram.
English: Table 1 Adverse reactions reported from patients receiving catumaxomab treatment Infections and infestations
Danish: Tabel 1 Bivirkninger rapporteret fra patienter, der fik behandling med catumaxomab Infektioner og parasitære sygdomme
English: Infusion-related side effects
Danish: Infusionsrelaterede bivirkninger
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC09
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC09.
English: Paediatric population There is no relevant use of Removab in the paediatric population in the granted indication.
Danish: Pædiatrisk population Der er ingen relevante godkendte indikationer for Removab i den pædiatriske population.
English: After the Removab infusion you will be observed as decided by your doctor.
Danish: Efter infusionen med Removab bliver De overvåget efter lægens skøn.
English: The variability between subjects was high.
Danish: Der var stor variation mellem forsøgspersonerne.
English: Cytokine release related symptoms with higher intensities In 5.1% of patients pyrexia reached an intensity of CTCAE grade 3 as it was the case with cytokine release syndrome (1.0%), chills (0.8%), nausea (3.4%), vomiting (4.4%), dyspnoea (1.6%) and hypo/hypertension (2.1% / 0.8%).
Danish: Symptomer relateret til cytokinfrigivelse med større intensitet Hos 5,1 % af patienterne nåede pyreksi en intensitet på CTCAE grad 3, som det også var tilfældet med cytokinfrigivelsessyndrom (1,0 %), kulderystelser (0,8 %), kvalme (3,4 %), opkastning (4,4 %), dyspnø (1,6 %) og hypo-/hypertension (2,1 % / 0,8 %).
English: The catheter for intraperitoneal administration should be placed under ultrasound guidance by a physician experienced in intraperitoneal administration procedures.
Danish: Kateteret til intraperitoneal administration bør placeres ved hjælp af ultralyd af en læge, som har erfaring med intraperitoneale administrationsprocedurer.
English: The most common infusion-related side effects, which are mostly mild to moderate, are fever, chills, feeling sick and vomiting.
Danish: De hyppigste infusionsrelaterede bivirkninger, der fortrinsvis er lette til moderate, er feber, kulderystelser, kvalme og opkastning.
English: The geometric mean apparent terminal plasma elimination half-life (t1/2) was approximately 2.5 days (range 0.7 to 17).
Danish: Den åbenbare, terminale geometriske middelværdi for plasma-eliminerings-halveringstid (t1/2) var cirka 2,5 dage (område 0,7 til 17).
English: Appropriate medical management of ascites drainage is a prerequisite for Removab treatment in order to assure stable circulatory and renal functions.
Danish: Korrekt håndtering af acites-dræning er en forudsætning for behandling med Removab for at sikre et stabilt kredsløb og en stabil nyrefunktion.
English: An increased frequency of some adverse reactions was seen in relation to 3h administration including chills and hypotension (grades 1 / 2), diarrhoea (all grades) and fatigue (grade 1 / 2).
Danish: En øget hyppighed af nogle bivirkninger blev observeret ved 3 timers administration, herunder kulderystelser og hypotension (grad 1/2), diarré (alle grader) og træthed (grad 1/2).
English: In three patients (0.4%) an intensity of CTCAE grade 4 was observed.
Danish: Hos 3 patienter (0,4 %) blev CTCAE grad 4 intensitet observeret.
English: Transient increase in hepatic enzymes was commonly observed after the administration of Removab.
Danish: Forbigående forhøjelse af leverenzymer blev hyppigt observeret efter administration af Removab.
English: Removab should be prepared by a healthcare professional using appropriate aseptic technique.
Danish: Removab skal klargøres af sundhedspersonale med den relevante aseptiske teknik.
English: The in vivo anti-tumour activity of catumaxomab was confirmed in an immunologically compromised mouse model of ovarian carcinoma, where tumour development was delayed by an intraperitoneal treatment with catumaxomab and human peripheral blood mononuclear cells.
Danish: Catumaxomabs in vivo antitumoraktivitet blev bekræftet i en immunologisk kompromitteret musemodel med ovariekarcinom, hvor tumorudviklingen blev forsinket af en intraperitoneal behandling med catumaxomab og humane mononukleære celler i perifert blod.
English: Retrospective data from study IP-CAT-AC-03
Danish: Retrospektive data fra studie IP-CAT-AC-03
English: Removab contains the active substance catumaxomab, a monoclonal antibody.
Danish: Removab indeholder det aktive stof catumaxomab, som er et monoklonalt antistof.
English: Diluted Removab.
Danish: Fortyndet Removab.
English: If you experience side effects such as dizziness or chills during or after administration, you should not drive or use machines until they disappear.
Danish: Hvis De oplever bivirkninger som svimmelhed eller kulderystelser under eller efter infusionen, må De først køre eller anvende værktøj eller maskiner, når disse bivirkninger forsvinder, .
English: Do not use this medicine after the expiry date which is stated on the carton after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Colon
Danish: Kolon
English: A third functional binding site in the Fc-region of catumaxomab enables interaction with accessory immune cells via Fcγ receptors.
Danish: Et tredje funktionelt bindingssted i catumaxomabs Fc-region uliggør interaktion med accessoriske immunceller via Fcγ-receptorer.
English: Conditions such as hypovolaemia, hypoproteinaemia, hypotension, circulatory decompensation and acute renal impairment must be resolved prior to each Removab infusion.
Danish: Tilstande som hypovolæmi, hypoproteinæmi, hypotension, cirkulatorisk dekompensation og akut nyreinsufficiens skal behandles før hver infusion med Removab.
English: Anaemia*, lymphopenia, leukocytosis, neutrophilia.
Danish: Anæmi*, lymfopeni, leukocytose, neutrofili.
English: Cytokine release related symptoms
Danish: Symptomer relateret til frigivelse af cytokiner
English: The results for puncture-free survival and time to first need for therapeutic ascites puncture in terms of medians and hazard ratios are presented in Table 3.
Danish: Resultaterne for punkturfri overlevelse og tiden indtil første behov for terapeutisk ascitespunktur med hensyn til medianer og hazard ratio vises i Tabel 3.
English: Patients with renal impairment of a higher severity grade than mild have not been investigated.
Danish: Patienter med nyreinsufficiens af en højere sværhedsgrad end let er ikke undersøgt.
English: A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from Removab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning eller behandling med Removab skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Table 2 EpCAM expression in most relevant ascites causing cancer types
Danish: Tabel 2 EpCAM-ekspression for de mest relevante ascites-forårsagende cancertyper
English: Prior to each Removab administration the ascites fluid must be drained until stop of spontaneous flow or symptom relief (see section 4.4).
Danish: Før hver Removab-administration skal ascites-væsken udtømmes, indtil den spontane strøm ophører, eller symptomlindring forekommer (se pkt.
English: The anti-tumour activity of catumaxomab has been demonstrated in vitro and in vivo.
Danish: Catumaxomabs antitumoraktivitet er påvist in vitro og in vivo.
English: Systemic Inflammatory Response Syndrome (SIRS) In 3.8% of the patients symptoms of SIRS were observed within 24 hours after catumaxomab infusion.
Danish: Systemisk inflammatorisk responssyndrom (SIRS) Hos 3,8 % af patienterne blev der inden for 24 timer efter infusionen med catumaxomab observeret symptomer på SIRS.
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: The geometric mean plasma Cmax was approximately 0.5 ng/ml (range 0 to 2.3), and the geometric mean plasma AUC was approximately 1.7 day* ng/ml (range < LLOQ (lower limit of quantification) to 13.5).
Danish: Den geometriske middelværdi for plasma-Cmax var cirka 0,5 ng/ml (område 0 til 2,3), og det geometriske middel plasma AUC var cirka 1,7 dag*ng/ml (område < LLOQ (nedre grænse for kvantificering) til 13,5).
English: Figure 2 Illustration of the transfer of Removab from the pre-filled syringe to the 50 ml syringe
Danish: Figur 2 Illustration af overførsel af Removab fra den fyldte injektionssprøjte til 50 ml injektionssprøjten
English: Number of Removab pre-filled syringe(s)
Danish: Antal af Removab-fyldte injektionssprøjte(r)
English: Removab is indicated for the intraperitoneal treatment of malignant ascites in adults with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Danish: Removab er indiceret til intraperitoneal behandling af malign ascites hos voksne med EpCAMpositive karcinomer, hvor standardbehandling ikke findes eller ikke længere er mulig.
English: OTHER Neovii Biotech GmbH
Danish: ANDET Neovii Biotech GmbH
English: Blood and lymphatic system disorders Common
Danish: Blod- og lymfesystem
English: 4th dose
Danish: 4. dosis
English: A perfusion tubing of an inner diameter of 1 mm and a length of 150 cm must be used.
Danish: Der skal anvendes en perfusionsslange med en indre diameter på 1 mm og en længde på 150 cm.
English: In one patient (0.1%) dyspnoea and in 3 patients (0.4%) hypotension was reported in CTCAE grade 4 intensity.
Danish: Hos en patient (0,1 %) blev dyspnø, og hos 3 patienter (0,4 %) blev hypotension rapporteret med CTCAE grad 4 intensitet.
English: Decreased appetite* / anorexia, dehydration*, hypokalaemia, hypoalbuminaemia, hyponatraemia*, hypocalcaemia*, hypoproteinaemia.
Danish: Nedsat appetit* / anoreksi, dehydrering*, hypokaliæmi, hypoalbuminæmi, hyponatriæmi*, hypokalcæmi*, hypoproteinæmi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/512/001
English: Hazard ratio (HR) (Catumaxomab versus Catumaxomab + Prednisolone) 95% CI for HR
Danish: Hazard ratio (HR) (catumaxomab versus catumaxomab + prednisolon) 95% CI for HR
English: 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: Patienter med leverinsufficiens af højere sværhedsgrad end moderat og/eller med mere end 70% af leveren metastaseret og /eller vena porta-trombose/obstruktion er ikke undersøgt.
English: Removab must be administered as an intraperitoneal infusion only.
Danish: Removab må kun administreres som en intraperitoneal infusion.
English: Cholangitis*, hyperbilirubinaemia.
Danish: Kolangitis*, hyperbilirubinæmi.
English: Patients with hemodynamic insufficiency, oedema or hypoproteinaemia Blood volume, blood protein, blood pressure, pulse and renal function should be assessed before each Removab infusion.
Danish: Patienter med hæmodynamisk insufficiens, ødem eller hypoproteinæmi Blodvolumen, blodprotein, blodtryk, puls og nyrefunktion skal bedømmes før hver Removab-infusion.
English: Due to catumaxomab's binding properties, tumour cells, T-cells and accessory immune cells come in close proximity.
Danish: På grund af catumaxomabs bindingsegenskaber kommer tumorceller, T-celler og accessoriske immunceller tæt på hinanden.
English: Other cytokine-release related reactions such as fever, chills, nausea, and vomiting are very commonly reported reactions in intensity of CTCAE grade 1 and 2 (US National Cancer Institute, version 4.0).
Danish: Andre symptomer relateret til cytokinfrigivelse, såsom feber, kulderystelser, kvalme og opkastning, udgør meget almindeligt rapporterede reaktioner med en intensitet på CTCAE grad 1 og 2 (US National Cancer Institute, version 4.0).
English: • An additional air buffer of at least 3 ml is included in the 50 ml syringe.
Danish: • Inkludér en yderligere luftbuffer på 3 ml i 50 ml injektionssprøjten.
English: Before you start using Removab your doctor will check your: - Body Mass Index (BMI), which depends on your height and weight - Karnofsky Index, a measure of your general performance status.
Danish: Før De begynder at bruge Removab, vil lægen kontrollere Deres: - Body Mass Index (BMI), som afhænger af Deres højde og vægt
English: MARKETING AUTHORISATION NUMBER(S) EU/1/09/512/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/09/512/002
English: The efficacy of the treatment with paracentesis and catumaxomab in patients with malignant ascites due to EpCAM-positive carcinomas was statistically significantly superior to that with paracentesis alone in terms of puncture-free survival and time to first need for therapeutic ascites puncture.
Danish: Effekten af behandlingen med paracentese og catumaxomab hos patienter med malign ascites som følge af EpCAM-positive karcinomer var statistisk signifikant bedre end behandlingen med paracentese alene udtrykt ved punkturfri overlevelse og tid til første behov for terapeutisk ascitespunktur.
English: Paracentesis (control) (N=88)
Danish: Paracentese (kontrol) (N=88)
English: Catumaxomab was detectable in the ascites fluid and in plasma.
Danish: Catumaxomab kunne påvises i ascitesvæsken og i plasma.
English: Catumaxomab + prednisolone (N=111)
Danish: Catumaxomab + prednisolon (N=111)