FrancophonIA/ELRC3.0 huggingface dataset:
English: Use of either anticoagulants or medicinal products that inhibit platelet function (antiplatelet agents) concomitantly with IMBRUVICA increases the risk of major bleeding.
Danish: Brug af enten antikoagulantia eller lægemidler, som hæmmer blodpladernes funktion (trombocytfunktionshæmmende midler), samtidig med IMBRUVICA øger risikoen for større blødning.
English: • severe infections throughout the body (sepsis)
Danish: • alvorlige infektioner i hele kroppen (blodforgiftning)
English: Frequency calculated from monotherapy clinical studies.
Danish: Hyppighed beregnet ud fra kliniske studier med monoterapi.
English: All patients in clinical studies received IMBRUVICA until disease progression or no longer tolerated.
Danish: Alle patienter i kliniske studier fik IMBRUVICA indtil sygdomsprogression, eller indtil lægemidlet ikke længere tåltes.
English: Dizziness Uncommon Cerebrovascular accident a, #
Danish: Svimmelhed Ikke almindelig Cerebrovaskulær hændelse a,#
English: IMBRUVICA contains lactose (a type of sugar).
Danish: IMBRUVICA indeholder lactose (en sukkerart).
English: • low number of cells that help blood clot (platelets), very low number of white blood cells shown in blood tests
Danish: • et lavt antal af de celler, der hjælper blodet med at størkne (blodplader), et meget lavt antal hvide blodlegemer (påvist i blodprøver)
English: Median follow-up time on study=26.5 months.
Danish: Median opfølgningstid i studiet = 26,5 måneder.
English: If using hormonal contraceptives such as birth control pills or devices, a barrier method of contraception (e.g. condoms) must also be used.
Danish: Hvis du anvender hormonbaseret prævention, som f.eks. p-piller eller p-stav, skal du også anvende en barrieremetode (f.eks. kondom).
English: • blood thinners such as warfarin, heparin or other medicines for blood clots
Danish: • blodfortyndende midler såsom warfarin, heparin eller anden medicin mod blodpropper
English: Patients between 65 and 70 years of age were required to have at least one comorbidity that precluded the use of frontline chemo-immunotherapy with fludarabine, cyclophosphamide, and rituximab.
Danish: Patienter i alderen 65 til 70 år skulle have mindst én komorbiditet, som udelukkede behandling med førstelinje kemo-immunterapi med fludarabin, cyclophosphamid og rituximab.
English: • Mantle cell lymphoma (MCL), a type of cancer affecting the lymph nodes, when the disease has come back or has not responded to treatment.
Danish: • Mantle-celle-lymfom (MCL), en type af kræft, der påvirker lymfeknuderne, når sygdommen er vendt tilbage eller ikke har reageret på behandling.
English: • medicines to prevent seizures or to treat epilepsy, or medicines to treat a painful condition of the face called trigeminal neuralgia - carbamazepine or phenytoin.
Danish: • medicin til forhindring af krampeanfald eller til behandling af epilepsi, eller medicin til behandling af en smertefuld ansigtslidelse kaldet trigeminusneuralgi - carbamazepin eller phenytoin.
English: If symptoms persist, consider the risks and benefits of IMBRUVICA treatment and follow the dose modification guidelines.
Danish: Hvis symptomerne vedvarer, skal risici og fordele ved behandling med IMBRUVICA overvejes og retningslinjerne for modifikation af dosis følges.
English: Fatigue, dizziness and asthenia have been reported in some patients taking IMBRUVICA and should be considered when assessing a patient's ability to drive or operate machines.
Danish: Der foreligger rapporter om træthed, svimmelhed og asteni hos nogle af de patienter, der fik IMBRUVICA, og dette bør tages i betragtning ved vurderingen af en patients evne til at føre motorkøretøj eller betjene maskiner.
English: The free fraction of ibrutinib also increased with degree of impairment, with 3.0, 3.8 and 4.8% in subjects with mild, moderate and severe liver impairment, respectively, compared to 3.3% in plasma from matched healthy controls within this study.
Danish: Den frie fraktion af ibrutinib steg også med graden af funktionsnedsættelse, med 3,0, 3,8 og 4,8 % hos forsøgspersoner med hhv. let, moderat og svært nedsat leverfunktion, sammenlignet med 3,3 % i plasma fra matchede raske kontrolpersoner i dette studie.
English: IRC evaluated, ORR (complete response, complete response with incomplete marrow recovery, nodular partial response, partial response).
Danish: IRC-vurderet, ORR (komplet respons, komplet respons med ukomplet generhvervelse af knoglemarvsfunktionen, partielt nodulært respons, partielt respons).
English: Each bottle contains either 90 or 120 capsules.
Danish: Hver beholder indeholder enten 90 eller 120 kapsler.
English: Non-melanoma skin cancers were reported more frequently in patients treated with IMBRUVICA than in patients treated with comparators in pooled comparative randomised phase 3 studies.
Danish: Non-melanom hudcancer blev rapporteret hyppigere hos patienter i behandling med IMBRUVICA end hos patienter i behandling med komparatorer i puljede, komparative, randomiserede fase 3-studier.
English: The long-term safety data over 5 years from 1178 patients (treatment-naïve CLL/SLL n = 162, relapsed/refractory CLL/SLL n = 646, and relapsed/refractory MCL n = 370) treated with IMBRUVICA were analysed.
Danish: Der blev analyseret data for langtidssikkerhed over 5 år fra 1.178 patienter (behandlingsnaiv CLL/SLL n = 162, recidiverende/refraktær CLL/SLL n = 646 og recidiverende/refraktær MCL n = 370) behandlet med IMBRUVICA.
English: Effect on QT/QTc interval and cardiac electrophysiology The effect of ibrutinib on the QTc interval was evaluated in 20 healthy male and female subjects in a randomised, double-blind thorough QT study with placebo and positive controls.
Danish: Indvirkning på QT-/QTc-intervallet og kardiel elektrofysiologi Ibrutinibs indvirkning på QTc-intervallet blev evalueret hos 20 raske mænd og kvinder i et randomiseret, dobbeltblindt tilbundsgående QT-studie med placebo og positive kontroller.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE27.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, proteinkinasehæmmere, ATC-kode: L01XE27.
English: The efficacy data was further evaluated by an Independent Review Committee (IRC) demonstrating an ORR of 69%, with a 21% complete response (CR) rate and a 48% partial response (PR) rate.
Danish: Virkningsdata på effekt blev yderligere evalueret af en uafhængig review-komité (IRC), som påviste en ORR på 69 %, med en komplet respons (CR)-rate på 21 % og en delvis respons (PR)-rate på 48 %.
English: Therefore, concomitant use of IMBRUVICA with strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers should be avoided whenever possible and co-administration should only be considered when the potential benefits clearly outweigh the potential risks.
Danish: Derfor skal samtidig brug af IMBRUVICA og potente CYP3A4hæmmere samt potente eller moderate CYP3A4-induktorer undgås, når det er muligt, og coadministration bør udelukkende overvejes, når de potentielle fordele tydeligt opvejer de potentielle risici.
English: If you are taking digoxin, a medicine used for heart problems, or methotrexate, a medicine used to treat other cancers and to reduce the activity of the immune system (e.g., for rheumatoid arthritis or psoriasis), it should be taken at least 6 hours before or after IMBRUVICA.
Danish: Hvis du tager digoxin, medicin som anvendes til hjerteproblemer, eller methotrexat, medicin som anvendes til behandling af andre typer kræft og til at nedsætte immunsystemets aktivitet (f.eks. ved leddegigt eller psoriasis), skal det tages mindst 6 timer før eller efter IMBRUVICA.
English: • blood in your stomach, gut, stools or urine, heavier periods, or bleeding that you cannot stop from an injury
Danish: • blod i maven, tarmen, afføringen eller urinen, kraftigere menstruation eller blødning, som ikke kan standses, fra et sår
English: Do not break or chew them.
Danish: Du må ikke knække eller tygge dem.
English: Non-melanoma skin cancer
Danish: Non-melanom hudcancer
English: • If you miss a dose, it can be taken as soon as possible on the same day with a return to the normal schedule the following day.
Danish: • Hvis du glemmer at tage en dosis, kan du tage den snarest muligt den samme dag og fortsætte med den normale plan den efterfølgende dag.
English: A higher risk for major bleeding was observed with anticoagulant than with antiplatelet agents.
Danish: Der blev observeret en højere risiko for større blødning med antikoagulantia end med trombocytfunktionshæmmende midler.
English: Sensitivity analysis in which crossover patients from the ofatumumab arm were not censored at the date of first dose of IMBRUVICA.
Danish: Sensibilitetsanalyse, hvor patienter, der skiftede fra ofatumumab-gruppen, ikke blev censureret på den dato, hvor de fik den første dosis IMBRUVICA.
English: IMBRUVICA therapy should be withheld for any new onset or worsening grade ≥3 non-haematological toxicity, grade 3 or greater neutropenia with infection or fever, or grade 4 haematological toxicities.
Danish: Behandling med IMBRUVICA skal tilbageholdes ved ny forekomst eller forværring til grad ≥ 3 af non-hæmatologisk toksicitet, neutropeni af grad 3 eller derover med infektion eller feber eller hæmatologiske toksiciteter af grad 4.
English: Ibrutinib is metabolised primarily by CYP3A4 to produce a dihydrodiol metabolite with an inhibitory activity towards BTK approximately 15 times lower than that of ibrutinib.
Danish: Ibrutinib metaboliseres primært af CYP3A4, hvorved der produceres en dihydrodiol-metabolit med en hæmmende aktivitet over for BTK, der er ca. 15 gange lavere end ibrutinibs.
English: • unusual levels of chemicals in the blood caused by the fast breakdown of cancer cells have happened during treatment of cancer and sometimes even without treatment (tumour lysis syndrome)
Danish: • unormale niveauer i blodet af visse stoffer på grund af den hurtige nedbrydning af kræftceller er set under behandling af kræft og i visse tilfælde endda uden behandling (tumorlysesyndrom)
English: In patients who develop signs and/or symptoms of ventricular tachyarrhythmia, IMBRUVICA should be temporarily discontinued and a thorough clinical benefit/risk assessment should be performed before possibly restarting therapy.
Danish: Hos patienter, der udvikler tegn og/eller symptomer på ventrikulær takyarytmi, skal IMBRUVICA seponeres midlertidigt, og der skal udføres en grundig klinisk benefit/risk-evaluering før en eventuel genoptagelse af behandlingen.
English: Cerebrovascular accidents
Danish: Cerebrovaskulære hændelser
English: Epistaxis Petechiae
Danish: Epistaxis Petekkier
English: Ibrutinib was found to induce gastrointestinal effects (soft faeces/diarrhoea and/or inflammation) and lymphoid depletion in rats and dogs with a No Observed Adverse Effect Level (NOAEL) of 30 mg/kg/day in both species.
Danish: Ibrutinib blev fundet at inducere gastrointestinale virkninger (blød fæces/diarré og/eller inflammation) og lymfoid depletering hos rotter og hunde med et NOAEL (niveau uden observerede negative effekter) på 30 mg/kg/dag hos begge arter.
English: The capsules are provided in a plastic bottle with a child resistant polypropylene closure.
Danish: Kapslerne leveres i en plastbeholder med børnesikret polypropylenlåg.
English: Regularly monitor blood pressure in patients treated with IMBRUVICA and initiate or adjust antihypertensive medication throughout treatment with IMBRUVICA as appropriate.
Danish: Mål jævnligt blodtrykket hos patienter i behandling med IMBRUVICA, og påbegynd eller juster antihypertensiva under hele behandlingen med IMBRUVICA efter behov.
English: Preclinical studies have shown that ibrutinib effectively inhibits malignant B-cell proliferation and survival in vivo as well as cell migration and substrate adhesion in vitro.
Danish: Prækliniske studier har vist, at ibrutinib effektivt hæmmer malign B-celleproliferation og -overlevelse in vivo samt cellemigrering og substratadhæsion in vitro.
English: Infections (including sepsis, neutropenic sepsis, bacterial, viral, or fungal infections) were observed in patients treated with IMBRUVICA.
Danish: Infektioner (herunder sepsis, neutropen sepsis og infektioner med bakterier, vira eller svampe) observeredes hos patienter i behandling med IMBRUVICA.
English: IMBRUVICA in combination with rituximab is indicated for the treatment of adult patients with WM.
Danish: IMBRUVICA i kombination med rituximab er indiceret til behandling af voksne patienter med WM.
English: Lymphocytosis was not observed in patients with WM treated with IMBRUVICA.
Danish: Lymfocytose observeredes ikke hos patienter med WM, som blev behandlet med IMBRUVICA.
English: If a CYP3A4 inducer must be used, closely monitor patients for signs of IMBRUVICA lack of efficacy.
Danish: Hvis der skal anvendes en CYP3A4-induktor, skal patienterne nøje monitoreres for tegn på manglende effekt af IMBRUVICA.
English: Each carton contains one bottle of either 90 or 120 hard capsules.
Danish: Hver pakning indeholder én beholder med enten 90 eller 120 hårde kapsler.
English: If you miss a dose of IMBRUVICA, take it as soon as you remember on the same day.
Danish: Hvis du glemmer at tage en dosis IMBRUVICA, kan du tage den snarest muligt den samme dag.
English: High risk (del17p/TP53/del11q/unmutated IGHV) Yes
Danish: Højrisiko (del17p/TP53/del11q/ikke-muteret IGHV) Ja
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Bulky disease <5 cm ≥5 cm
Danish: Omfangsrig sygdom < 5 cm ≥ 5 cm
English: BTK, a member of the Tec kinase family, is an important signalling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways.
Danish: BTK, der er et medlem af Tec-kinasefamilien, er et vigtigt signalmolekyle i B-celle-antigenreceptorens (BCR) og cytokinreceptorens signalvej.
English: Women should avoid becoming pregnant while taking IMBRUVICA and for up to 3 months after ending treatment.
Danish: Kvinder skal undgå at blive gravide, mens de tager IMBRUVICA, og i op til 3 måneder efter behandlingens afslutning.
English: • high level of “uric acid” in the blood (shown in blood tests), which may cause gout
Danish: • et højt niveau af urinsyre i blodet (påvist i blodprøver), som kan medføre urinsyregigt
English: If any doubt exists, referral to a neurologist and appropriate diagnostic measures for PML including MRI scan preferably with contrast, cerebrospinal fluid (CSF) testing for JC Viral DNA and repeat neurological assessments should be considered.
Danish: I tvivlstilfælde bør henvisning til neurolog og passende diagnostiske tiltag for PML, herunder MR-scanning fortrinsvist med kontrastmiddel, undersøgelse af cerebrospinalvæsken (CSF) for JC-virus-DNA og en gentagelse af de neurologiske undersøgelser, overvejes.
English: Progression free survival (PFS) was assessed by IRC according to IWCLL criteria.
Danish: Progressionsfri overlevelse (PFS) blev vurderet af IRC i henhold til IWCLL-kriterierne.
English: • confusion, headache with slurred speech or feeling faint - these could be signs of serious internal bleeding in your brain
Danish: • forvirring, hovedpine med taleforstyrrelser eller svimmelhed - disse kan være tegn på alvorlige indre blødninger i hjernen
English: There is no information about the safety of IMBRUVICA in pregnant women.
Danish: Der er ingen oplysninger om IMBRUVICAs sikkerhed hos gravide kvinder.
English: Patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Danish: De patienter, der har risiko for tumorlysesyndrom, er dem, der har en stor tumorbyrde forud for behandlingen.
English: • if you are taking a herbal medicine called St. John's Wort, used for depression.
Danish: • hvis du tager et naturlægemiddel kaldet perikon, som anvendes mod depression.
English: Patients with mild or moderate renal impairment were treated in IMBRUVICA clinical studies.
Danish: Patienter med let eller moderat nedsat nyrefunktion blev behandlet i kliniske studier med IMBRUVICA.
English: Consider alternative agents with less CYP3A4 induction.
Danish: Overvej at bruge alternative stoffer med lavere CYP3A4-induktion.
English: Ibrutinib forms a covalent bond with a cysteine residue (Cys-481) in the BTK active site, leading to sustained inhibition of BTK enzymatic activity.
Danish: Ibrutinib danner en kovalent binding med cystein (Cys-481) på det aktive site for BTK-aktiviteten, som medfører vedvarende hæmning af BTK's enzymaktivitet.
English: Ibrutinib has no genotoxic properties when tested in bacteria, mammalian cells or in mice.
Danish: Ibrutinib har ingen genotoksiske egenskaber ved test i bakterier, pattedyrsceller eller mus.
English: Monitor patients closely and take appropriate precautions.
Danish: Patienterne skal monitoreres nøje, og der skal tages passende forholdsregler.
English: Grade 3 or higher pneumonia occurred more frequently among elderly patients treated with IMBRUVICA (12% of patients age ≥65 versus 7% of patients <65 years of age).
Danish: Pneumoni af grad 3 eller derover forekom hyppigere hos ældre patienter behandlet med IMBRUVICA (12 % hos patienter ≥ 65 versus 7 % hos patienter < 65).
English: Number of deaths (%) HR (95% CI)
Danish: Antal dødsfald (%) HR (95 % CI)
English: This may lead to changes in kidney function, abnormal heartbeat, or seizures.
Danish: Dette kan føre til ændringer i nyrefunktionen, unormal puls og kramper.
English: Sodium lauril sulfate (E487)
Danish: Natriumlaurylsulfat (E487)
English: Responses to IMBRUVICA are shown in Table 10.
Danish: Respons på IMBRUVICA er vist i tabel 10.
English: Patients who develop arrhythmic symptoms or new onset of dyspnoea, dizziness or fainting should be evaluated clinically and if indicated have an electrocardiogram (ECG) performed.
Danish: Patienter, der udvikler symptomer på arytmi eller ny forekomst af dyspnø, svimmelhed eller besvimelse, skal evalueres klinisk, og der skal tages et elektrokardiogram (EKG) på klinisk indikation.
English: Cases of invasive fungal infections, including cases of Aspergillosis, Cryptococcosis and Pneumocystis jiroveci infections have been reported following the use of ibrutinib.
Danish: Der er rapporteret tilfælde af invasive svampeinfektioner, herunder tilfælde af aspergillose, kryptokokkose og pneumocystis jiroveci-infektioner efter anvendelse af ibrutinib.
English: If you take more IMBRUVICA than you should If you take more IMBRUVICA than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget IMBRUVICA, skal du tale med en læge eller tage på hospitalet med det samme.
English: Efficacy results were also assessed by an IRC demonstrating an ORR of 83%, with a 11% VGPR rate and a 51% PR rate.
Danish: Effektresultaterne blev yderligere evalueret af en IRC, der påviste en ORR på 83 % med en VGPRrate på 11 % og en PR-rate på 51 %.
English: • if you have irregular heart beat or have a history of irregular heart beat or severe heart failure, or if you feel any of the following: shortness of breath, weakness, dizziness, light-headedness, fainting or near fainting, chest pain or swollen legs
Danish: • hvis du har uregelmæssige hjerteslag eller har en sygehistorie med uregelmæssige hjerteslag eller alvorligt hjertesvigt, eller hvis du føler eller oplever noget af følgende: kortåndethed, svaghed, svimmelhed, ørhed, besvimelse eller tæt på besvimelse, brystsmerter eller hævelser i benene
English: After confirmed disease progression, patients on chlorambucil were able to crossover to ibrutinib.
Danish: Efter bekræftet sygdomsprogression kunne patienter, som fik chlorambucil, skifte til ibrutinib.
English: • medicines called kinase inhibitors for treatment of other cancers - crizotinib or imatinib
Danish: • medicin kaldet kinasehæmmere til behandling af andre kræftformer - crizotinib eller imatinib
English: Also some other medicines can affect the way IMBRUVICA works.
Danish: Der er også nogle lægemidler, der påvirker måden, IMBRUVICA virker på.
English: Median time to initial response, months (range) Median time to CR, months (range)
Danish: Mediantid til indledende respons, måneder (område) Mediantid til CR, måneder (område)
English: A second reduction of dose by 140 mg may be considered as needed.
Danish: Dosis kan reduceres endnu en gang med 140 mg efter behov.
English: • medicines called statins to treat high cholesterol - rosuvastatin
Danish: • medicin kaldet statiner til behandling af forhøjet kolesterol - rosuvastin
English: There was a statistically significant sustained platelet or haemoglobin improvement in the ITT population in favor of ibrutinib versus chlorambucil.
Danish: Der var en statistisk signifikant forbedring i antal blodplader eller hæmoglobin i ITT-populationen til fordel for ibrutinib kontra chlorambucil.
English: When taking IMBRUVICA, tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (Progressive Multifocal Leukoencephalopathy or PML).
Danish: Når du tager IMBRUVICA, skal du straks fortælle det til din læge, hvis du bemærker, eller andre bemærker, at du har symptomer som hukommelsestab, vanskelighed med at samle tankerne, gangbesvær eller synstab - disse symptomer kan skyldes en meget sjælden, men alvorlig infektion i hjernen, som kan være dødelig (progressiv multifokal leukoencefalopati eller PML).
English: All patients had a baseline ECOG performance status of 0 (48%) or 1-2 (52%).
Danish: Alle patienterne havde en ECOG-performancestatus ved baseline på 0 (48 %) eller 1-2 (52 %).
English: Juvenile toxicity studies have not been conducted.
Danish: Der er ikke udført toksicitetsstudier hos ungdyr.
English: Efficacy results for Study CLL3001 are shown in Table 9.
Danish: Effektresultater for CLL3001-studiet er vist i tabel 9.
English: Lowest Observed Effect Level (LOEL) (60 mg/kg/day) margins in the dog are 3.6-fold (males) and 2.3-fold (females).
Danish: Marginer for LOEL (laveste observerede effektniveau) (60 mg/kg/dag) hos hunde er 3,6 gange (hanhunde) og 2,3 gange (hunhunde).
English: • medicines for HIV infection - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
Danish: • medicin mod HIV-infektion - ritonavir, cobicistat, indinavir, nelfinavir, saquinavir, amprenavir,
English: Rituximab was administered weekly at a dose of 375 mg/m2 for 4 consecutive weeks (weeks 1-4) followed by a second course of weekly rituximab for 4 consecutive weeks (weeks 17-20).
Danish: Rituximab blev administreret ugentligt ved en dosis på 375 mg/m2 i 4 på hinanden følgende uger (uge 1-4) efterfulgt af endnu en serie med ugentlig rituximab i 4 på hinanden følgende uger (uge 17-20).
English: The open-label, multi-center study (PCYC-1102-CA) included 51 patients with relapsed or refractory CLL, who received 420 mg once daily.
Danish: Det åbne multicenter-studie (PCYC-1102-CA) omfattede 51 patienter med recidiverende eller refraktær CLL, som modtog 420 mg en gang dagligt.
English: • severe fungal infections
Danish: • alvorlige svampeinfektioner
English: PFS hazard ratios for treatment-naïve patients, previously treated patients, and patients with or without MYD88 L265P mutations were consistent with the PFS hazard ratio for the ITT population.
Danish: PFShazard ratio for behandlingsnaive patienter, tidligere behandlede patienter og patienter med eller uden MYD88 L265P-mutationer var sammenlignelige med PFS-hazard ratio for ITT-populationen.
English: • inflammation within the lungs that may lead to permanent damage
Danish: • inflammation (en betændelseslignende reaktion) i lungerne, som kan medføre varig skade
English: atazanavir, or fosamprenavir
Danish: atazanavir eller fosamprenavir