FrancophonIA/ELRC3.0 huggingface dataset:
English: Probability of Progression-free Survival
Danish: Sandsynlighed for progressionsfri overlevelse
English: These could be symptoms of a blockage in the bowel, especially during the early stages of your treatment.
Danish: Det kan være symptomer på blokering i tarmen, især i de tidlige stadier af din behandling.
English: You may need extra check-ups while you are being treated with Arzerra.
Danish: Det kan være nødvendigt med ekstra kontrolbesøg, mens du behandles med Arzerra.
English: These reactions may result in temporary interruption or withdrawal of treatment.
Danish: Disse reaktioner kan medføre en midlertidig afbrydelse eller seponering af behandlingen.
English: Classical biotransformation studies have not been performed.
Danish: Klassiske biotransformationsforsøg er ikke udført.
English: There was a rapid and sustained depletion of CD20
Danish: Der sås en hurtig og vedvarende depletion af CD20
English: Your doctor may treat you with a suitable anti-viral medicine to help prevent this.
Danish: Lægen kan behandle dig med et passende antiviralt lægemiddel for at forhindre dette.
English: Your response to the vaccine may be weakened and you may not be fully protected.
Danish: Vaccinens virkning kan blive svækket, og du får muligvis ikke fuld beskyttelse.
English: After this period, planning of a pregnancy in relation to the underlying disease, should be evaluated by the treating physician.
Danish: Efter denne periode, bør planlægning af en graviditet i sammenhæng med den underliggende sygdom, vurderes af den behandlende læge.
English: The lymphocytes multiply too quickly and live too long, so there are too many of them circulating in your blood.
Danish: Lymfocytterne deler sig for hurtigt og lever for længe, så der cirkulerer for mange af dem rundt i blodet.
English: Time of Progression-free Survival (Months)
Danish: Tid for progressionsfri overlevelse (måneder)
English: IRC-assessed primary and subgroup analyses of PFS, months
Danish: IRC-vurderet primære og subgruppe analyser af PFS, måneder
English: Pre- and post-natal development studies have not been performed.
Danish: Pre- og postnatale udviklingsforsøg er ikke udført.
English: See also section 4, ‘Possible side effects'.
Danish: Se også punkt 4 "Bivirkninger".
English: Each cycle lasts 28 days and is counted from day 1 of the cycle.
Danish: Hver cyklus varer 28 dage, og der regnes fra 1 dag i cyklussen.
English: IRC-assessed secondary outcome
Danish: IRC-vurderet sekundært resultat
English: Vial 3 years.
Danish: 3 år.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Danish: ENTYDIG IDENTIFIKATOR- MENNESKELIGT LÆSBARE DATA
English: Preclinical data reveal no special hazards for humans.
Danish: Prækliniske data viser ingen speciel risiko for mennesker.
English: More than half of the patients (56%) with CR were MRD negative following the completion of study treatment.
Danish: Flere end halvdelen af patienterne (56 %) med CR var MRD-negative efter fuldført studiebehandling.
English: Ofatumumab should not be administered to pregnant women unless the possible benefit to the mother outweighs the possible risk to the foetus.
Danish: Ofatumumab bør ikke administreres til gravide kvinder, medmindre den mulige fordel for moderen opvejer den mulige risiko for fosteret.
English: If you have had hepatitis B, Arzerra could cause it to become active again.
Danish: Hvis du tidligere har haft hepatitis B, kan Arzerra medføre, at den bliver aktiv igen.
English: The response to vaccination could be impaired when B-cells are depleted.
Danish: Responset på vaccination kan være nedsat, når B-cellerne er depleterede.
English: See section 5.1 for further information.
Danish: 5.1 for yderligere information.
English: The usual dose
Danish: Den sædvanlige dosis
English: Electrolyte abnormalities should be corrected.
Danish: Unormale elektrolytniveauer skal korrigeres.
English: • low blood pressure (can cause light-headedness when you stand up)
Danish: • lavt blodtryk (kan medføre svimmelhed, når du rejser dig)
English: Efficacy endpoint or haematological parameter a
Danish: Effekt-endepunkt eller hæmatologisk parameter a
English: Ofatumumab had non-linear pharmacokinetics related to its decreasing clearance over time.
Danish: Ofatumumab havde en non-linær farmakokinetik, som er relateret til dets faldende clearance over tid.
English: • If you do become pregnant during treatment with Arzerra, tell your doctor.
Danish: • Hvis du bliver gravid under behandlingen med Arzerra, skal du fortælle det til lægen.
English: Excludes patients' visits from date of first transfusion, treatment with erythropoietin, or treatment with growth factors.
Danish: Der er ikke medtaget patientbesøg fra datoen for den første transfusion, behandling med erytropoietin eller behandling med vækstfaktorer.
English: Post-natal recovery has therefore not been demonstrated.
Danish: Postnatal bedring er derfor ikke blevet påvist.
English: Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation.
Danish: Publicerede data tyder på, at nyfødtes og spædbørns indtagelse af brystmælk ikke resulterer i væsentlig absorption og cirkulation af disse maternelle antistoffer.
English: Oral paracetamol (acetaminophen) Oral or intravenous antihistamine
Danish: Oral paracetamol (acetaminophen) Oral eller intravenøst antihistamin
English: Patients received treatment for a minimum of 3 months until best response or up to a maximum of 12 cycles.
Danish: Patienterne blev behandlet i minimum 3 måneder indtil bedste respons eller op til maksimalt 12 cyklusser.
English: The safety and efficacy of Arzerra in children aged below 18 years have not been established.
Danish: Arzerras sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Common side effects that may show up in your blood tests: • low levels of platelets in the blood (cells that help blood to clot).
Danish: Almindelige bivirkninger, der kan ses i dine blodprøver: • lavt antal blodplader i blodet (celler, der får blodet til at størkne).
English: Thus, the benefit of such a new combination over a rituximab based regimen is unknown.
Danish: Fordelen ved denne nye kombination i forhold til en rituximabbaseret behandling kendes derfor ikke.
English: The majority of infusion-related reactions were Grade 1 or Grade 2 in severity.
Danish: Størstedelen af de infusionsrelaterede reaktioner var af sværhedsgrad 1 eller 2.
English: No large changes in the mean QTc interval (i.e. >20 milliseconds) were detected.
Danish: Der blev ikke set store ændringer i det gennemsnitlige QTc-interval (dvs. >20 millisekunder).
English: How it is given Arzerra is given into a vein (intravenously) as an infusion (a drip) over several hours.
Danish: Sådan bliver du behandlet Arzerra gives i en vene (intravenøst) som en infusion (et drop) over flere timer.
English: Time after start of infusion (minutes)
Danish: Tid efter infusionsstart (minutter)
English: • blocked nose.
Danish: • tilstoppet næse.
English: Vaccination and Arzerra
Danish: Vaccination og Arzerra
English: Before each infusion of Arzerra, you will be given pre-medication - medicines which help to reduce any infusion reactions.
Danish: Før hver infusion af Arzerra får du præmedicin, der er medicin, der hjælper med at reducere enhver reaktion på infusionen.
English: The recommended dose and schedule is 12 doses administered as follows:
Danish: Den anbefalede dosis og doseringsskema er 12 doser administreret på følgende vis:
English: Two percent of the infusion-related reactions led to discontinuation of treatment.
Danish: To procent af de infusionsrelaterede reaktioner førte til seponering af behandlingen.
English: This is followed by a four- to five-week gap.
Danish: Herefter er der en pause på 4-5 uger.
English: At 6 months after the last dose, the median reductions in B-cell counts were >99%.
Danish: Seks måneder efter den sidste dosis var det mediane fald i antallet af B-celler >99 %.
English: The median number of cycles completed in patients was 6 (total Arzerra dose of 6300 mg).
Danish: Det gennemsnitlige antal gennemførte cyklusser hos patienterne var 6 (total Arzerra-dosis på 6300 mg).
English: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were enrolled into the study and 91% had an ECOG performance status of 0 or 1.
Danish: Patienter med en Eastern Cooperative Oncology Group (ECOG) performancestatus på 0 til 2 blev inkluderet i studiet, og 91 % havde en ECOG-performancestatus på 0 eller 1.
English: You will be given an initial infusion followed by a second infusion 7 days later.
Danish: Du vil blive givet en første infusion efterfulgt af den næste infusion 7 dage senere.
English: Spleen weights decreased by approximately 15% in the low-dose group and by approximately 30% in the high-dose group, compared with control values.
Danish: Miltvægten faldt med ca. 15 % i lavdosisgruppen og ca. 30 % i højdosisgruppen sammenlignet med kontrolværdier.
English: Pregnancy, breast-feeding and fertility Arzerra is not usually recommended for use during pregnancy.
Danish: Graviditet, amning og frugtbarhed Arzerra bør normalt ikke anvendes til behandling under graviditet.
English: • Tell your doctor if you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby.
Danish: • Fortæl det til lægen, hvis du er gravid eller ammer, har mistanke om at du er gravid eller planlægger at blive gravid.
English: Patients received treatment for a maximum of 6 cycles.
Danish: Patienter fik behandling i maksimalt 6 cyklusser.
English: Baseline cytogenetic (FISH) data were available for 209 patients.
Danish: Der forelå cytogenetiske data (FISH) ved baseline fra 209 patienter.
English: You will be given an infusion once a week for eight weeks.
Danish: Du får en infusion én gang om ugen i otte uger.
English: Patients should receive the following pre-medication medicinal products 30 minutes to 2 hours prior to each Arzerra infusion according to the following dosing schedules:
Danish: Patienten skal modtage præmedicinering med følgende lægemidler i 30 minutter til 2 timer inden hver infusion af Arzerra i overensstemmelse med følgende doseringsskemaer:
English: The CD20 molecule is not shed from the cell surface and is not internalised following antibody binding.
Danish: CD20-molekylet afstødes ikke fra cellens overflade og internaliseres ikke efter antistofbinding.
English: • 2000 mg every 28 days for 4 doses (infusions 9 to 12)
Danish: • 2000 mg hver 28 dag for 4 doser (infusion 9 til 12)
English: HBV reactivation has been reported up to 12 months following completion of therapy.
Danish: HBV-reaktivering er blevet rapporteret op til 12 måneder efter afsluttet behandling.
English: Arzerra and chlorambucil (N=221)
Danish: Arzerra og chlorambucil (N=221)
English: Patients received a median of 5 prior therapies, including rituximab (57%).
Danish: Patienterne modtog en median på fem forudgående behandlinger, herunder behandling med rituximab (57 %).
English: There are no data on the effects of ofatumumab on human fertility.
Danish: Der foreligger ingen data vedrørende ofatumumabs effekt på fertiliteten hos mennesker.
English: Additionally a group of patients (n=16) who were intolerant/ineligible for fludarabine treatment and/or intolerant to alemtuzumab treatment were treated with Arzerra.
Danish: Endvidere blev en gruppe af patienter (n=16), der var intolerante over for eller ikke berettiget til fludarabinbehandling og/eller intolerante over for alemtuzumabbehandling, behandlet med Arzerra.
English: Check with your doctor if you think this may apply to you.
Danish: Tal med lægen, hvis du mener, at dette gælder for dig.
English: These included bacterial, viral and fungal infections.
Danish: Disse inkluderede bakterielle, virale og fungale infektioner.
English: Intravenous ofatumumab has been associated with infusion-related reactions.
Danish: Intravenøs ofatumumab er blevet forbundet med infusionsrelaterede reaktioner.
English: Diphenhydramine 50 mg or cetirizine 10 mg (or equivalent)
Danish: Diphenhydramin 50 mg eller cetirizin 10 mg (eller tilsvarende)
English: Median Cumulative Illness Rating Score for Geriatrics (CIRS-G) was 9 and 31% of patients had a CIRS-G >10.
Danish: Median Cumulative Illness Rating Score for Geriatrics (CIRS-G) var 9, og 31 % af patienterne havde CIRS-G>10.
English: The safety of, and ability to generate a primary or anamnestic response to, immunisation with live attenuated or inactivated vaccines during treatment with ofatumumab has not been studied.
Danish: Sikkerheden ved og evnen til at generere et primært eller anamnetisk respons på immunisering med svækkede levende eller inaktiverede vacciner under behandling med ofatumumab er ikke blevet undersøgt.
English: Population (treatment) Dosing regimen
Danish: Population (behandling) Doseringsplan Cyklus
English: The risks and benefits of vaccinating patients during Arzerra therapy should be considered.
Danish: Risiciene og fordelene ved vaccination af patienter, der er i behandling med Arzerra, bør overvejes.
English: The main pharmacokinetic parameters of ofatumumab as a single agent or in combination are summarised in Table 5.
Danish: Ofatumumabs vigtigste farmakokinetiske værdier, som et enkeltstof eller i kombination, er sammenfattet i tabel 5.
English: MedDRA System Organ Class
Danish: Systemorganklasse i henhold til MedDRA
English: It is not known whether Arzerra works in children and adolescents.
Danish: Det vides ikke, om Arzerra virker hos børn og unge.
English: If you notice these symptoms, contact your doctor as soon as possible.
Danish: Hvis du får disse symptomer, skal du hurtigst muligt kontakte lægen.
English: Peripheral B-cell counts remained low throughout the remainder of therapy in most patients and remained below baseline up to 15 months after the last dose in patients who responded.
Danish: Antallet af perifere B-celler forblev lavt i resten af behandlingsforløbet hos de fleste patienter, og forblev derefter under udgangsniveauet i op til 15 måneder efter sidste dosis hos patienter, der responderede.
English: It is unknown whether Arzerra is excreted in human milk, however human IgG is secreted in human milk.
Danish: Det er ukendt, om Arzerra udskilles i human mælk - dog udskilles humant IgG i human mælk.
English: Your doctor may treat you if any electrolyte imbalance is detected.
Danish: Lægen kan behandle dig, hvis det opdages at elektrolytbalancen ikke er normal.
English: Therefore Arzerra is not recommended for use in children and adolescents.
Danish: Derfor anbefales Arzerra ikke til brug hos børn og unge.
English: As anticipated, a reduction in the IgG humoral immune response to keyhole limpet haemocyanin was noted, but there were no effects on delayed-type hypersensitivity responses.
Danish: Der blev som forventet bemærket en reduktion i det humorale IgG-immunrespons på keyhole limpet-hæmocyanin, men der sås ingen effekter på forsinkede overfølsomhedsreaktioner.
English: Due to the risk of infection, administration of live attenuated vaccines should be avoided during and after treatment with ofatumumab, until B-cell counts are normalised.
Danish: På grund af risikoen for infektion skal administration af svækkede levende vacciner undgås under og efter behandling med ofatumumab, indtil B-celletallet er normaliseret.
English: • 2000 mg weekly for 7 doses (infusions 2 to 8) followed 4-5 weeks later by
Danish: • 2000 mg ugentligt for 7 doser (infusioner 2-8) efterfulgt 4-5 uger senere af
English: If you have any questions on the use of Arzerra, ask the doctor or nurse who is giving you the infusion.
Danish: Hvis du har spørgsmål vedrørende brugen af Arzerra, skal du tale med den læge eller sygeplejerske, der giver dig infusionen.
English: No substantial differences related to age were seen in safety and efficacy (see section 5.1).
Danish: Der blev ikke set væsentlige aldersrelaterede forskelle i sikkerheden og effekten (se pkt.
English: Lymphadenopathy measured by sum of the products of greatest diameters (SPD) as assessed by physical examination.
Danish: Lymfadenopati målt ved summen af produkterne af de største diametre (SPD) bestemt ved fysisk undersøgelse.
English: There is a potential for immunogenicity with therapeutic proteins such as ofatumumab.
Danish: Der er potentiale for immunogenicitet ved administration af terapeutiske proteiner som ofatumumab.
English: • low levels of white blood cells (neutropenia)
Danish: • lavt antal hvide blodlegemer (neutropeni)
English: Sepsis (including neutropenic sepsis and septic shock) herpes viral infection, urinary tract
Danish: Sepsis (herunder neutropenisk sepsis og septisk shock), viral herpesinfektion, urinvejsinfektion
English: Intravenous corticosteroid (prednisolone or equivalent)
Danish: Intravenøst kortikosteroid (prednisolon eller tilsvarende)
English: Complete blood counts, including neutrophil and platelet counts, should be obtained at regular intervals during Arzerra therapy and more frequently in patients who develop cytopenias.
Danish: Komplet blodtælling, inklusive neutrofiler, og trombocyttælling skal foretages med regelmæssige intervaller under behandlingen med Arzerra og hyppigere hos patienter, som udvikler cytopenier.
English: CLL is a cancer of the blood which affects a type of white blood cell called lymphocytes.
Danish: CLL er en form for blodkræft, som påvirker en type af hvide blodlegemer, der kaldes lymfocytter.
English: If you have been previously treated for CLL but the disease returns you will have a maximum of 7 infusions.
Danish: Hvis du tidligere er blevet behandlet for CLL, men sygdommen er vendt tilbage, vil du maksimalt få 7 infusioner.
English: st infusion (300 mg)
Danish: 1 infusion (300 mg)
English: Chemical and physical in-use stability has been demonstrated for 48 hours at ambient conditions (less than 25°C).
Danish: Den klargjorte infusionsvæske er kemisk og fysisk stabil i 48 timer ved stuetemperatur (under 25 °C).
English: Arginine
Danish: Arginin
English: Arzerra is therefore not recommended for use in this patient population.
Danish: Arzerra bør derfor ikke anvendes til denne patientpopulation.
English: Bradycardia*
Danish: Bradykardi*
English: • low levels of red blood cells (anaemia).
Danish: • lavt antal røde blodlegemer (anæmi).
English: With a median follow-up of approximately 34 months, 67 deaths (37%) in the OFA+FC arm and 69 deaths (38%) in the FC arm were reported.
Danish: Med en median opfølgningstid på cirka 34 måneder blev der rapporteret om 67 dødsfald (37%) i OFA+FC-armen og 69 dødsfald i FC-armen.
English: 65 (6%) of the 1,168 patients experienced a fatal infection.
Danish: 65 (6 %) ud af de 1.168 patienter fik en dødelig infektion.
English: Tell your doctor or a nurse immediately if you get any of these symptoms.
Danish: Du skal omgående fortælle det til lægen eller sundhedspersonalet, hvis du får et eller flere af disse symptomer.
English: This should be taken into consideration by patients on a controlled sodium diet.
Danish: Der skal tages højde for dette hos patienter, som er på en diæt med et kontrolleret natriumindhold.
English: The clinical status of the patient and the ADR profile of ofatumumab should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills (see section 4.8).
Danish: Der skal tages højde for patientens kliniske status og ofatumumabs bivirkningsprofil ved vurdering af patientens evne til at udføre opgaver, der kræver dømmekraft, motoriske eller kognitive færdigheder (se pkt.
English: Paediatric population No pharmacokinetic data are available in paediatric patients.
Danish: Pædiatrisk population Der foreligger ingen farmakokinetiske data fra pædiatriske patienter.
English: Serum samples from more than 1,000 patients across the CLL clinical programme were tested for anti-ofatumumab antibodies during and after treatment periods ranging from 8 weeks to 2 years.
Danish: Serumprøver fra mere end 1.000 patienter i det kliniske CLL-program blev testet for antiofatumumab- antistoffer under og efter behandlingsperioder fra 8 uger til 2 år.
English: The primary endpoint was median progression-free survival (PFS) as assessed by a blinded Independent Review Committee (IRC) using the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
Danish: Det primære endepunkt var gennemsnitlig progressionsfri overlevelse (PFS) som vurderet af en blindet uafhængig vurderingskomité (IRC) ved brug af International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCI-WG) guidelines (2008).
English: Although limited formal drug-drug interaction data exist for ofatumumab, there are no known clinically significant interactions with other medicinal products.
Danish: Selvom der er begrænsede data for interaktioner mellem ofatumumab og andre lægemidler, er der ingen kendte, klinisk signifikante interaktioner med andre lægemidler.
English: Store and transport refrigerated (2 C - 8C).
Danish: Opbevares i køleskab og transporteres nedkølet (2 C - 8 C).
English: Approximately 60% of patients received 3-6 cycles of Arzerra and 32% received 7-12 cycles.
Danish: Omkring 60 % af patienterne fik 3-6 cyklusser af Arzerra, og 32 % fik 7-12 cyklusser.
English: A corresponding increase in reticulocyte counts seen in these monkeys was indicative of a regenerative response in the bone marrow.
Danish: Der blev set en tilsvarende stigning i reticulocyttallet hos disse aber, hvilket var tegn på et regenerativt respons i knoglemarven.
English: Arzerra should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available.
Danish: Arzerra skal administreres under tilsyn af en læge med erfaring i behandling af cancer og i omgivelser, hvor der er komplet genoplivningsudstyr inden for rækkevidde.
English: This dose will be increased, usually to 1000 mg or 2000 mg, for the remaining infusions.
Danish: Denne dosis øges herefter normalt til 1000 mg eller 2000 mg ved de efterfølgende infusioner.
English: A dose-ranging study (Hx-CD20-402) was conducted in 33 patients with relapsed or refractory CLL.
Danish: Et studie med forskellige doser (Hx-CD20-402) blev udført med 33 patienter med recidiveret eller refraktær CLL.
English: Lymphocyte count ≥50% decrease Normalisation (≤4x10
Danish: Lymfocyttal Fald på 50 % Normalisering (≤4 x 10
English: In a few animals, increased red cell destruction occurred, presumably as a result of monkey anti-drug antibodies coating the red cells.
Danish: Hos nogle få dyr forekom en øget destruktion af røde blodlegemer, hvilket formentlig skyldtes, at abernes antistoffer mod lægemidlet dækkede de røde blodlegemer.
English: If you think you have had such a reaction before, tell your doctor before you are given Arzerra.
Danish: Hvis du mener, at du har haft sådan en reaktion før, skal du fortælle det til lægen, inden du får Arzerra.
English: Complete resolution of constitutional symptoms (fever, night sweats, fatigue, weight loss) defined as the presence of any symptoms at baseline, followed by no symptoms present.
Danish: Komplet resolution af konstitutionelle symptomer (feber, natlige svedeture, træthed, vægttab) defineres som tilstedeværelse af ethvert symptom ved udgangsniveauet efterfulgt af fravær af symptomer.
English: If you had these symptoms prior to treatment with Arzerra, tell your doctor immediately about any changes in these symptoms.
Danish: Hvis du har haft disse symptomer inden behandling med Arzerra, skal du straks fortælle det til lægen, hvis symptomerne ændrer sig.
English: Median creatinine clearance (CrCl), assessed with the use of the Cockroft-Gault formula, was 70 ml/min and 48% of patients had a CrCl of <70 ml/min.
Danish: Den gennemsnitlige kreatininclearance (CrCl), udregnet ved brug af Cockroft-Gaults formel, var 70 ml/min, og 48 % af patienterne havde CrCL <70 ml/min.
English: Infusions 3* to 12 Infusion rate (ml/hour)
Danish: Infusioner 3* til 12 Infusionshastighed (ml/time)