FrancophonIA/ELRC3.0 huggingface dataset:
English: • Safety advice for men o The need to avoid foetal exposure o The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had a vasectomy) ▪ During pomalidomide treatment ▪ For one week following final dose o That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment o That if his partner becomes pregnant whilst he is taking pomalidomide or shortly after he has stopped taking pomalidomide he should inform his treating doctor immediately
Danish: • Råd om sikkerhed, som er relevante for mænd o Nødvendigheden af at undgå føtal eksponering o Nødvendigheden af at bruge kondom, hvis partneren, som der er seksuelt samvær med, er gravid eller fertil og ikke anvender nogen former for kontraception (også selvom manden er vasektomeret) ▪ Under behandlingen med pomalidomid ▪ I en uge efter sidste dosis o At han ikke må donere sæd eller sperm under behandlingen (herunder under dosisafbrydelser) og i 7 dage efter seponering af pomalidomid o At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid, imens han tager eller kort tid efter, at han er ophørt med pomalidomid.
English: Uncommon Decreased appetite
Danish: Ikke almindelig Nedsat appetit
English: Discontinue dexamethasone from treatment regimen.
Danish: Seponer dexamethason fra behandlingsprogrammet.
English: In the HD-Dex arm, median PFS time was 8.0 weeks (95% CI: 7.0, 9.0); the estimated 26-week event-free survival rate was 12.15% (±3.63%).
Danish: I HD-Dex-armen var den mediane PFS-tid 8,0 uger (95 % CI: 7,0-9,0), og den estimerede 26-ugers hændelsesfrie overlevelsesrate var 12,15 % ±3,63 %.
English: Kaplan-Meier curve for PFS for the ITT population is provided in Figure 2.
Danish: Kaplan-Meier-kurven for PFS for ITT-populationen kan ses i figur 2.
English: • Feeling confused.
Danish: • Forvirring.
English: The No Observed Adverse Effect Level (NOAEL) was 0.1 mg/kg/day (0.5-fold exposure ratio relative to a 4 mg clinical dose).
Danish: Niveauet for ingen observerede bivirkninger (NOAEL − No Observed Adverse Effect Level) var 0,1 mg/kg/dag (0,5 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
English: Common Confusional state
Danish: Almindelig Forvirret tilstand
English: Treatment with pomalidomide combined with bortezomib and dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Danish: Behandling med pomalidomid kombineret med bortezomib og dexamethason bør gives, indtil der opstår sygdomsprogression eller uacceptabel toksicitet.
English: • Low blood level of phosphate (hypophosphataemia), which may cause muscle weakness and irritability or confusion.
Danish: • Lavt niveau af fosfat i blodet (hypofosfatæmi), som kan forårsage muskelsvaghed og irritabilitet eller forvirring.
English: • High blood level of calcium (hypercalcaemia), which may cause slowing reflexes and skeletal muscle weaknesses.
Danish: • Højt niveau af calcium i blodet (hypercalcæmi), hvilket kan forårsage langsommere reflekser og svaghed i skeletmuskulaturen.
English: Criteria for women of non-childbearing potential
Danish: Kriterier for, at kvinder ikke er i den fertile alder
English: Interrupt dose until symptoms resolve.
Danish: Afbryd dosis, indtil symptomerne forsvinder.
English: Men Imnovid passes into human semen.
Danish: Mænd Imnovid udskilles i sæden hos mennesker.
English: For each subsequent drop < 25 x 109/l
Danish: For hvert efterfølgende fald < 25 x 10
English: Neutropenic sepsis Bronchopneumonia Bronchitis
Danish: Almindelig Neutropenisk sepsis Bronkopneumoni Bronkitis
English: • Low blood pressure, which may cause dizziness or fainting.
Danish: • Lavt blodtryk, hvilket kan forårsage svimmelhed eller besvimelse.
English: • That he should not donate semen or sperm during therapy (including during dose interruptions) and for 7 days after discontinuation of pomalidomide treatment
Danish: • At han ikke må donere sæd eller sperm under behandlingen (herunder under dosisafbrydelser) og i 7 dage efter ophør med pomalidomid
English: After a median follow-up of 15.9 months, median PFS time was 11.20 months (95% CI: 9.66, 13.73) in the Pom+Btz+LD-Dex arm.
Danish: Efter en median opfølgning på 15,9 måneder var median PFS-tid 11,20 måneder (95 % CI: 9,66; 13,73) i armen med Pom+Btz+LD-Dex.
English: ADRs reported in post-marketing use in patients treated with pomalidomide.
Danish: Bivirkninger rapporteret ved anvendelse efter markedsføring hos patienter behandlet med pomalidomid
English: • High blood levels of uric acid, which may cause a form of arthritis called gout.
Danish: • Højt niveau af urinsyre i blodet, hvilket kan forårsage en form for gigt, der kaldes podagra.
English: Neutrophil count decreased White blood cell count decreased Platelet count decreased Alanine aminotransferase increased
Danish: Nedsat neutrofiltal Nedsat antal hvide blodlegemer Nedsat trombocyttal Forhøjet alaninaminotransferase
English: In patients receiving combination therapy with pomalidomide in clinical studies, venous thromboembolic events (VTE) occurred in 3.3-11.5% of patients (1.3-5.4% Grade 3 or 4).
Danish: Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom venøse tromboemboliske hændelser (VTE) hos 3,3-11.5 % af patienterne (1,3-5,4 % grad 3 eller 4).
English: In patients receiving combination therapy with pomalidomide in clinical studies, neutropenia occurred in up to 46.8% of patients (41.7% Grade 3 or 4).
Danish: Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom neutropeni hos op til 46,8 % af patienterne (41,7 % grad 3 eller 4).
English: LD-Dex (40 mg) was administered once per day on days 1, 8, 15 and 22 of a 28-day cycle.
Danish: LD-Dex (40 mg) blev administreret én gang dagligt på dag 1, 8, 15 og 22 af en 28-dags cyklus.
English: • Pomalidomide in combination with bortezomib and dexamethasone The most commonly reported blood and lymphatic system disorders were neutropenia (46.8%), thrombocytopenia (36.7%) and anaemia (28.4%).
Danish: • Pomalidomid i kombination med bortezomib og dexamethason De mest almindeligt rapporterede forstyrrelser i blod og lymfesystem var neutropeni (46,8 %), trombocytopeni (36,7 %) og anæmi (28,4 %).
English: Titanium dioxide (E171) Simeticone
Danish: Titandioxid (E171) Simeticon
English: Unused medicinal product should be returned to the pharmacist.
Danish: Ikke anvendt lægemiddel skal afleveres på apoteket.
English: • Chest pain, or leg pain and swelling, especially in your lower leg or calves (caused by blood clots).
Danish: • Brystsmerter eller bensmerter og hævelse, især nederst på benet eller i læggen (forårsaget af blodpropper).
English: The benefit of using Imnovid with bortezomib and dexamethasone When Imnovid is used with bortezomib and dexamethasone, in people who have had at least one other treatment, it can stop multiple myeloma getting worse:
Danish: Fordelen ved at bruge Imnovid sammen med bortezomib og dexamethason Når Imnovid anvendes sammen med bortezomib og dexamethason hos personer, som har fået mindst én anden behandling, kan det forhindre, at myelomatosen forværres:
English: The adverse reactions observed in patients treated with pomalidomide plus dexamethasone are listed below in Table 8 by system organ class (SOC) and frequency for all adverse reactions (ADRs) and for Grade 3 or 4 adverse reactions.
Danish: Bivirkningerne observeret hos patienter i behandling med pomalidomid plus dexamethason er opstillet nedenfor i tabel 8 efter systemorganklasse (SOC) og hyppighed for alle bivirkninger (ADR'er) samt for grad 3 eller 4 bivirkninger.
English: • Post-authorisation efficacy study (PAES) MM-007: In order to further investigate the efficacy of pomalidomide in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide, the MAH should submit the final analysis of OS from the phase 3, randomized, open label study MM-007.
Danish: • Virkningsundersøgelse efter tilladelse til markedsføring (PAES) MM007: For at undersøge virkningen af pomalidomid i kombination med bortezomib og dexamethason yderligere til behandling af voksne patienter med myelomatose, som har fået mindst ét tidligere behandlingsprogram, der inkluderede lenalidomid, skal indehaveren af markedsføringstilladelsen indsende den endelige analyse af OS fra det randomiserede, åbne fase III-studie MM-007.
English: The adverse reactions observed in patients treated with pomalidomide in combination with bortezomib and dexamethasone are listed in Table 7 by system organ class (SOC) and frequency for all adverse reactions and for Grade 3 or 4 adverse reactions.
Danish: Bivirkninger observeret hos patienter behandlet med pomalidomid i kombination med bortezomib og dexamethason er anført i tabel 7 i henhold til systemorganklasse (SOC) og hyppighed for alle bivirkninger og for grad 3 eller 4 bivirkninger.
English: • Loss of consciousness, fainting.
Danish: • Bevidstløshed, besvimelse.
English: How to take Imnovid
Danish: Hvordan tages Imnovid
English: Bronchiolitis
Danish: Bronkiolitis
English: Uncommon Bronchitis Herpes zoster
Danish: Ikke almindelig Bronkitis Herpes zoster
English: • Brochure for women patients who are not of childbearing potential
Danish: • En brochure til kvinder, som ikke er i den fertile alder
English: Pomalidomide dose reduction∞ Dose level
Danish: Pomalidomid dosisreduktion∞ Dosisniveau
English: When to take Imnovid with other medicines
Danish: Hvornår skal du tage Imnovid sammen med anden medicin?
English: The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28day treatment cycle.
Danish: Den anbefalede dosis af dexamethason er 40 mg oralt én gang dagligt på dag 1, 8, 15 og 22 i hver 28dages behandlingscyklus.
English: If pregnancy occurs in a partner of a male patient taking pomalidomide, it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis en kvindelig partner til en mandlig patient, som tager pomalidomid, bliver gravid, anbefales det at henvise den kvindelige partner til en læge med speciale eller erfaring i teratologi for vurdering og rådgivning.
English: Very Common Hypokalaemia Hyperglycaemia
Danish: Meget almindelig Hypokaliæmi Hyperglykæmi
English: As per an interim analysis for Overall Survival (OS), using a cut-off of 15 September 2018 (median follow-up period of 26.2 months), median OS time from Kaplan-Meier estimates was 40.5 months for the Pom + Btz + LD-Dex arm and 30.5 months for the Btz + LD-Dex arm; HR = 0.91, 95% CI: 0.70, 1.18, with an overall event rate of 43.3%.
Danish: Ifølge en interimanalyse for samlet overlevelse (OS) med afskæring den 15. september 2018 (median opfølgning på 26,2 måneder) var median OS-tid fra Kaplan-Meier-estimater 40,5 måneder for Pom+Btz+LD-Dex-armen og 30,5 måneder for Btz+LD-Dex armen, HR = 0,91, 95 % CI: 0,70; 1,18, med en samlet hændelsesrate på 43,3 %.
English: For patients >75 years of age, the starting dose of dexamethasone is:
Danish: For patienter >75 år er startdosis af dexamethason:
English: The primary efficacy endpoint was Progression Free Survival (PFS) assessed by an Independent Response Adjudication Committee (IRAC) according to the IMWG criteria using the intent to treat population (ITT).
Danish: Det primære effektendepunkt var progressionsfri overlevelse (progression free survival, PFS) vurderet af en Independent Response Adjudication Committee (IRAC) i henhold til kriterierne fra International
English: • Pomalidomide in combination with dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 were excluded from clinical studies.
Danish: • Pomalidomid i kombination med dexamethason Patienter med aktuel perifer neuropati ≥ grad 2 blev ekskluderet fra kliniske studier.
English: Brochure for male patients
Danish: Brochure til mandlige patienter
English: • He understands the need for the use of a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential not using effective contraception, throughout treatment duration, during dose interruption and for 7 days after dose interruptions and/or cessation of treatment.
Danish: • Han forstår nødvendigheden af at bruge kondom ved seksuelt samvær med en kvinde, som er gravid eller i den fertile alder, der ikke anvender sikker kontraception, under hele behandlingens varighed, under dosisafbrydelse og i 7 dage efter dosisafbrydelser og/eller seponering.
English: Patients in the Pom+Btz+LD-Dex arm were administered 4 mg pomalidomide orally on Days 1 to 14 of each 21-day cycle.
Danish: Patienterne i Pom+Btz+LD-Dex-armen fik administreret 4 mg pomalidomid oralt på dag 1 til 14 i hver 21-dages cyklus.
English: Uncommon Myocardial infarction
Danish: Ikke almindelig Myokardieinfarkt
English: If pregnancy occurs in a woman treated with pomalidomide, treatment must be stopped and the patient should be referred to a physician specialised or experienced in teratology for evaluation and advice.
Danish: Hvis en kvinde, som er i behandling med pomalidomid, bliver gravid, skal behandlingen ophøre, og patienten skal henvises til en læge med speciale eller erfaring i teratologi til vurdering og rådgivning.
English: VTE was reported as serious in 1.7-4.3% of patients, no fatal reactions were reported, and VTE was associated with pomalidomide discontinuation in up to 1.8% of patients.
Danish: VTE blev rapporteret som alvorlig hos 1,7-4,3 % af patienterne, ingen dødelige reaktioner blev rapporteret, og
English: Common Dyspnoea
Danish: Almindelig Dyspnø
English: Patients should not donate blood, semen or sperm during treatment (including during dose interruptions) and for 7 days following discontinuation of pomalidomide.
Danish: Patienten må ikke donere blod, sæd eller sperm under behandlingen (samt under dosisafbrydelser) og i 7 dage efter ophør med pomalidomid.
English: • Chest pain, chest infection.
Danish: • Brystsmerter, brystinfektion.
English: • Recurrence of hepatitis B infection, which can cause yellowing of the skin and eyes, dark browncoloured urine, right-sided abdominal pain, fever and feeling nauseous or being sick.
Danish: • Tilbagevendende hepatitis B-infektion, som kan forårsage gulfarvning af hud og øjne, mørkebrun urin, smerter i den højre side af maven, feber og kvalme eller opkastning.
English: Very Common Fatigue
Danish: Meget almindelig Træthed
English: The maternal NOAEL was 10 mg/kg/day, and the developmental NOAEL was <10 mg/kg/day (AUC24h was 418 ng•h/mL on Gestation Day 19 at this lowest dose tested, which was similar to that obtained from a 4 mg clinical dose).
Danish: Den maternale NOAEL var 10 mg/kg/dag, og den udviklingsmæssige NOAEL var <10 mg/kg/dag (AUC24h var 418 ng•t/ml på gestationsdag 19 ved denne lavest testede dosis og sammenligneligt med AUC opnået ved en klinisk dosis på 4 mg).
English: • Pomalidomide in combination with bortezomib and dexamethasone Patients with ongoing peripheral neuropathy ≥ Grade 2 with pain within 14 days prior to randomisation were excluded from clinical trials.
Danish: • Pomalidomid i kombination med bortezomib og dexamethason Patienter med aktuel perifer neuropati ≥ grad 2 med smerter inden for 14 dage før randomisering blev ekskluderet fra kliniske studier.
English: Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Danish: Imnovid er i kombination med dexamethason indiceret til behandling af voksne patienter med relaps og refraktær myelomatose, som allerede har fået mindst to behandlingsprogrammer, herunder både lenalidomid og bortezomib, og som udviste sygdomsprogression under den sidste behandling.
English: Treatment with Imnovid may cause the hepatitis B virus to become active again in patients who carry the virus, resulting in a recurrence of the infection.
Danish: • hvis du har eller tidligere har haft en infektion med hepatitis B. Behandling med Imnovid kan føre til, at hepatitis B-virus igen bliver aktiv hos patienter, der er bærer af virus, og medføre, at infektionen vender tilbage.
English: Pulmonary embolism Dyspnoea
Danish: Almindelig Lungeemboli Dyspnø
English: • you experience or have experienced in the past a combination of any of the following symptoms: rash on face or extended rash, red skin, high fever, flu-like symptoms, enlarged lymph nodes (signs of severe skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis (TEN) or Stevens-Johnson Syndrome (SJS).
Danish: • hvis du oplever eller tidligere har oplevet en kombination af nogle af følgende symptomer: udslæt i ansigtet eller udbredt udslæt, hudrødme, høj feber, influenzalignende symptomer, forstørrede lymfeknuder (tegn på en alvorlig hudreaktion, der kaldes lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS) eller lægemiddeloverfølsomhedssyndrom, toksisk epidermal nekrolyse (TEN) eller StevensJohnsons syndrom (SJS).
English: For the HD-Dex arm, dexamethasone (40 mg) was administered once per day on days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle.
Danish: I HDDex-armen blev dexamethason (40 mg) administreret én gang dagligt på dag 1-4, 9-12 og 17-20 i en 28-dags cyklus.
English: • Pregnancy test regime o Before commencing treatment o During treatment (including dose interruptions), at least every 4 weeks except in case of confirmed tubal sterilisation o After finishing treatment
Danish: • Graviditetstest-regime o Før behandling påbegyndes o Mindst hver 4. uge under behandlingen (herunder dosisafbrydelser), undtagen hvis der er bekræftet æggeleder-sterilisation o Efter behandlingens afslutning
English: Platelet count return to ≥ 50 x 109/l
Danish: Trombocyttallet vender tilbage til ≥ 50 x 109/l
English: • On average, Imnovid when used with dexamethasone stopped multiple myeloma from coming back for up to 4 months - compared with 2 months for those patients who used only dexamethasone.
Danish: • Når Imnovid bruges sammen med dexamethason, har det i gennemsnit varet op til 4 måneder, før myelomatosen vendte tilbage - sammenlignet med 2 måneder, når patienterne kun fik dexamethason.
English: Resume at one dose level lower than previous dose.
Danish: Genoptag med et dosisniveau lavere end den tidligere dosis.
English: Rash = Grade 4 or blistering (including angioedema, exfoliative or bullous rash or if Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) is suspected)
Danish: Udslæt = grad 4 eller vabler (herunder angioødem, eksfoliativt eller bulløst udslæt, eller hvis der er mistanke om Stevens-Johnsons syndrom (SJS), toksisk epidermal nekrolyse (TEN) eller lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer (DRESS))
English: Imnovid with bortezomib and dexamethasone
Danish: Imnovid sammen med bortezomib og dexamethason
English: Recommended dosing scheme for Imnovid in combination with bortezomib and dexamethasone
Danish: Anbefalet doseringsskema for Imnovid i kombination med bortezomib og dexamethason
English: The median is based on Kaplan-Meier estimate.
Danish: Medianen er baseret på Kaplan-Meier-estimat.
English: Tell your doctor if you are breast-feeding or intend to breast-feed.
Danish: Fortæl det til lægen, hvis du ammer eller planlægger at amme.
English: Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.
Danish: Imnovid er i kombination med bortezomib og dexamethason indiceret til behandling af voksne patienter med myelomatose, som allerede har fået mindst et behandlingsprogram, herunder lenalidomid.
English: Grade 3−4 Adverse Reactions /Frequency
Danish: Grad 3−4 bivirkninger /hyppighed
English: Permanently discontinue treatment (see section
Danish: Permanent seponering af behandlingen (se pkt.
English: You should not donate blood during treatment and for 7 days after the end of treatment.
Danish: Du må ikke være bloddonor under behandlingen og i 7 dage efter behandlingsophør.
English: • The breakdown of cancer cells resulting in the release of toxic compounds into the bloodstream
Danish: • Nedbrydningen af kræftceller medfører, at giftige stoffer frigives til blodet (tumorlysesyndrom).
English: • On average, Imnovid when used with bortezomib and dexamethasone stopped multiple myeloma from coming back for up to 11 months - compared with 7 months for those patients who only used bortezomib and dexamethasone.
Danish: • Når Imnovid bruges sammen med bortezomib og dexamethason, har det i gennemsnit varet op til 11 måneder, før myelomatosen vendte tilbage - sammenlignet med 7 måneder, når patienterne kun fik bortezomib og dexamethason.
English: Uncommon Dizziness Tremor
Danish: Ikke almindelig Svimmelhed Tremor
English: Instructions on dose interruptions or reductions for pomalidomide related adverse reactions are outlined in the Table 2 and dose levels are defined in Table 3 below:
Danish: Instruktioner i dosisafbrydelse eller dosisreduktion for pomalidomid-relaterede bivirkninger er angivet i tabel 2, og dosisniveauerne er defineret i tabel 3 nedenfor:
English: Dexamethasone dose reduction
Danish: Dexamethason dosisreduktion
English: • For Cycles 1 to 8: 10 mg once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of each 21-day cycle
Danish: • For cyklus 1 til 8: 10 mg én gang dagligt på dag 1, 2, 4, 5, 8, 9, 11 og 12 i hver 21-dages behandlingscyklus
English: Pomalidomide is administered in combination with bortezomib and dexamethasone, as shown in Table 1.
Danish: Pomalidomid administreres i kombination med bortezomib og dexamethason som vist i tabel 1.
English: • 20 mg once daily on days 1, 8, 15 and 22 of each 28-day treatment cycle.
Danish: • 20 mg én gang dagligt på dag 1, 8, 15 og 22 i hver 28-dages behandlingscyklus.
English: • Clouding of your eye (cataract).
Danish: • Uklarhed af øjet (grå stær).
English: Other medicines and Imnovid
Danish: Brug af anden medicin sammen med Imnovid
English: Therefore, the maternal NOAEL was 1000 mg/kg/day, and the NOAEL for developmental toxicity was < 25 mg/kg/day (AUC24h was 34340 ng•h/mL on Gestation Day 17 at this lowest dose tested, and the exposure ratio was 85-fold relative to a 4 mg clinical dose).
Danish: 1000 mg/kg/dag, og NOAEL for udviklingstoksicitet var < 25 mg/kg/dag (AUC24h var 34.340 ng•t/ml på gestationsdag 17 ved denne lavest testede dosis, og eksponeringsratio var 85 gange i forhold til en klinisk dosis på 4 mg).
English: IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethasone
Danish: • IMN: Imnovid; BOR: Bortezomib; DEX: Dexamethason Cyklus 1 til 8
English: Resume pomalidomide treatment at one dose level lower than previous dose.
Danish: Genoptag behandlingen med pomalidomid med et dosisniveau lavere end den tidligere dosis.
English: Patients in the Pom+LD-Dex arm were administered 4 mg pomalidomide orally on days 1 to 21 of each 28-day cycle.
Danish: Patienterne i Pom+LD-Dex-armen fik 4 mg pomalidomid oralt på dag 1 til 21 i hver 28-dags cyklus.
English: You should not donate semen or sperm during treatment and for 7 days after the end of treatment.
Danish: Du må ikke donere sæd eller sperm under behandlingen og i 7 dage efter behandlingsophør.