FrancophonIA/ELRC3.0 huggingface dataset:
English: • each time your doctor writes a prescription for you, he will ensure you understand the necessary measures that have to be taken to prevent pregnancy.
Danish: • hver gang din læge skriver en recept til dig, vil han sikre, at du forstår de nødvendige forholdsregler, som skal tages for at undgå graviditet.
English: WARNING: Risk of severe birth defects.
Danish: ADVARSEL: Risiko for svære medfødte misdannelser.
English: This is because Imnovid can affect the way some other medicines work.
Danish: Dette skyldes, at Imnovid kan påvirke den måde, nogle af de andre lægemidler virker på.
English: • You must follow the contraception advice described in this leaflet.
Danish: • Du skal følge rådgivningen om prævention beskrevet i denne indlægsseddel.
English: See also section 4 “Possible side effects”).
Danish: Se også punkt 4 “Bivirkninger”).
English: This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body's natural defences).
Danish: Dette lægemiddel er i familie med thalidomid og tilhører en gruppe lægemidler, som påvirker immunsystemet (kroppens naturlige forsvar).
English: These patients should be monitored closely and appropriate precautions taken.
Danish: Disse patienter skal overvåges nøje, og der skal tages passende forholdsregler.
English: This can result in kidney problems.
Danish: Dette kan føre til nyreproblemer.
English: If you think you may be allergic, ask your doctor for advice.
Danish: Hvis du mener, du kan være allergisk, skal du spørge lægen til råds.
English: • That the patient should not give pomalidomide to any other person
Danish: • At patienten ikke må give pomalidomid til andre personer
English: A national controlled distribution system has been implemented in collaboration with each National Competent Authority.
Danish: Et nationalt kontrolleret udleveringssystem er implementeret i samarbejde med de enkelte nationale myndigheder.
English: • before treatment
Danish: • før behandling
English: Each cycle lasts 21 days (3 weeks).
Danish: Hver cyklus varer 21 days (3 uger).
English: Imnovid is either used with:
Danish: Imnovid bruges enten sammen med:
English: Always take your medicines exactly as your doctor has told you.
Danish: Tag altid dine lægemidler nøjagtigt efter lægens anvisning.
English: Before starting the treatment, you should tell your doctor if you are able to become pregnant, even if you think this is unlikely.
Danish: Før behandlingen indledes, skal du fortælle det til lægen, hvis du er i stand til at blive gravid, selvom du tror, det er usandsynligt.
English: The following information should also be provided in the appropriate brochure:
Danish: Følgende informationer skal også findes i de relevante brochurer:
English: Infection was the most common non haematological toxicity.
Danish: Infektion var den mest almindelige ikke-hæmatologiske toksicitet.
English: Based on these results, the observed effects were attributed to the treatment of females.
Danish: Baseret på disse resultater kunne de observerede virkninger tilskrives behandling af hunnerne.
English: Complete blood counts should be monitored at baseline, weekly for the first 8 weeks and monthly thereafter.
Danish: Fuldstændig blodtælling bør udføres ved baseline, ugentligt i de første 8 uger og derefter månedligt.
English: • Do not take this medicine if you are pregnant or could become pregnant.
Danish: • Du må ikke tage dette lægemiddel, hvis du er gravid, eller hvis du kan blive gravid.
English: Close monitoring of warfarin concentration is advised during treatment.
Danish: Omhyggelig monitorering af warfarinkoncentrationen tilrådes under behandlingen.
English: Overall Survival was the key secondary study endpoint.
Danish: Den samlede overlevelse (overall survival, OS) var det vigtigste sekundære endepunkt i studiet.
English: • Swallow the capsules whole, preferably with water.
Danish: • Slug kapslerne hele, helst med vand.
English: You may feel tired and weak, and short of breath and you are also more likely to get infections.
Danish: Du kan føle dig træt og svag og blive stakåndet, og det er også mere sandsynligt, at du får infektioner.
English: In these studies, monkeys exhibited greater sensitivity to pomalidomide effects than rats.
Danish: I disse studier udviste aberne større følsomhed for virkningen af pomalidomid end rotterne.
English: This results in damage to the bones and kidneys.
Danish: Dette fører til beskadigelse af knogler og nyrer.
English: • some antibiotics (for example ciprofloxacin, enoxacin)
Danish: • nogle antibiotika (for eksempel ciprofloxacin, enoxacin)
English: Fertility and early embryonic development
Danish: Fertilitet og tidlig embryoudvikling
English: The capsules should be swallowed whole, preferably with water, with or without food.
Danish: Kapslerne skal bør sluges hele, helst med vand, enten sammen med eller uden mad.
English: Your doctor will advise you of how and when to take Imnovid if you have kidney problems and are receiving dialysis treatment.
Danish: Lægen vil rådgive dig om, hvordan og hvornår du skal tage Imnovid, hvis du har nyreproblemer og får dialysebehandling.
English: Patients should be advised to report febrile episodes promptly.
Danish: Patienterne skal informeres om at rapportere febrile episoder øjeblikkeligt.
English: Genotoxicity/carcinogenicity
Danish: Genotoksicitet/karcinogenicitet
English: In the event of overdose, supportive care is advised.
Danish: I tilfælde af overdosering anbefales understøttende behandling.
English: Patients must avoid situations where dizziness or confusion may be a problem and not to take other medicinal products that may cause dizziness or confusion without first seeking medical advice.
Danish: Patienterne skal undgå situationer, hvor svimmelhed og forvirring kan være et problem, og de bør undgå at tage andre lægemidler, der kan forårsage svimmelhed eller forvirring uden først at søge rådgivning hos lægen.
English: A decision to take prophylactic measures should be made after a careful assessment of the individual patient's underlying risk factors.
Danish: Beslutning om profylaktiske forholdsregler bør træffes efter omhyggelig overvejelse af den individuelle patients underliggende risikofaktorer.
English: ILD and related events, including cases of pneumonitis, have been observed with pomalidomide.
Danish: ILD og relaterede hændelser, herunder tilfælde af pneumonitis, er blevet observeret med pomalidomid.
English: The effect of dexamethasone on warfarin is unknown.
Danish: Virkningen af dexamethason på warfarin kendes ikke.
English: If you forget to take Imnovid on a day when you should, take your next capsule as normal the next day.
Danish: Hvis du har glemt at tage Imnovid på en dag, hvor du skulle, skal du tage din næste kapsel som sædvanligt den næste dag.
English: Action should be taken to try to minimise all modifiable risk factors (e.g. smoking, hypertension, and hyperlipidaemia).
Danish: Det skal forsøges at minimere alle risikofaktorer, der kan modificeres (f.eks. rygning, hypertension og hyperlipidæmi).
English: If this happens to you, do not drive or operate tools or machinery.
Danish: Hvis dette forekommer, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: Maintain dose and treat with histamine (H2) blockers or equivalent.
Danish: Oprethold dosis og behandl med histamin- (H2-) blokker eller tilsvarende.
English: You may also experience an uneven heartbeat.
Danish: Du kan også opleve uregelmæssige hjerteslag.
English: The PFS advantage was more pronounced in patients who received only one prior line of therapy.
Danish: PFS-fordelen var mere tydelig hos patienter, der kun havde fået 1 tidligere behandlingslinje.
English: A female patient or a female partner of a male patient is considered of non-childbearing potential if she meets at least one of the following criteria:
Danish: En kvindelig patient eller en kvindelig partner til en mandlig patient betragtes som ikke at være i den fertile alder, hvis hun opfylder mindst et af følgende kriterier:
English: Some people feel tired, dizzy, faint, confused or less alert when taking Imnovid.
Danish: Nogle personer føler sig trætte, svimle, forvirrede eller mindre opmærksomme, når de tager Imnovid.
English: Not Known Hepatitis B reactivation
Danish: Ikke kendt Reaktivering af hepatitis B
English: Pomalidomide must not be taken during pregnancy, since a teratogenic effect is expected.
Danish: Pomalidomid må ikke tages under graviditet, da der forventes en teratogen virkning.
English: If you suffer from liver or kidney problems your doctor will check your condition very carefully whilst you are receiving this medicine.
Danish: Hvis du lider af lever- eller nyreproblemer, vil lægen kontrollere din tilstand meget omhyggeligt, så længe du får dette lægemiddel.
English: Doses were reduced and treatment was temporarily interrupted or stopped as needed to manage toxicity (see section
Danish: Doserne blev reduceret, og behandling blev midlertidigt afbrudt eller stoppet efter behov for at håndtere toksicitet (se pkt.
English: No metabolites were present at >10% relative to parent or total radioactivity in plasma.
Danish: Der var ingen metabolitter med >10 % i forhold til udgangsstoffet eller total radioaktivitet i plasma.
English: • Pregnancy test dates and results
Danish: • Datoerne for og resultaterne af graviditetstests
English: This requirement includes women of childbearing potential who practice absolute and continuous abstinence.
Danish: Dette krav omfatter også kvinder i den fertile alder, som praktiserer absolut og vedvarende seksuel afholdenhed.
English: Uterine examination on Gestation Day 13 showed a decrease in mean number of viable embryos and an increase in postimplantation loss at all dosage levels.
Danish: Uterine undersøgelser på gestationsdag 13 viste nedsat gennemsnitligt antal levedygtige embryoer og et øget postimplantationstab ved alle doseringsniveauer.
English: • The patient complies with the conditions of the Pregnancy Prevention Programme, including confirmation that she has an adequate level of understanding
Danish: • Patienten overholder betingelserne i ”Programmet til svangerskabsforebyggelse”, herunder bekræftelse af, at patienten har et passende forståelsesniveau
English: Staphylococcal infection was observed in 4 monkeys; 3 of these animals responded to antibiotic treatment and 1 died without treatment.
Danish: Stafylokok-infektion blev observeret hos 4 aber, 3 af disse dyr responderede på antibiotika, og 1 døde uden behandling.
English: Neutropenia did not lead to pomalidomide discontinuation in any patient and was infrequently serious.
Danish: Neutropeni førte ikke til seponering af pomalidomid hos nogen patienter og var sjældent alvorligt.
English: The doctor may also change the dose or stop the medicine because of your general health.
Danish: Lægen kan også ændre dosis eller stoppe behandlingen på grund af din almene helbredstilstand.
English: Pomalidomide has minor or moderate influence on the ability to drive and use machines.
Danish: Pomalidomid påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: The test should ensure the patient is not pregnant when she starts treatment with pomalidomide.
Danish: Testen skal sikre, at patienten ikke er gravid, når hun indleder behandlingen med pomalidomid.
English: • Brief background on pomalidomide and its licensed indication
Danish: • Kort baggrundsinformation angående pomalidomid og den godkendte indikation
English: Median OS time from Kaplan-Meier estimates has not been reached for the Pom + LD-Dex, but would be expected to be at least 48 weeks, which is the lower boundary of the 95% CI.
Danish: Den mediane OS-tid fra Kaplan-Meier-estimater er ikke nået for POM + LD-Dex, men den forventes at være mindst 48 uger, som er den nedre grænse for 95 % CI.
English: This is because this medicine is expected to harm the unborn baby.
Danish: Dette skyldes, at medicinen forventes at skade det ufødte barn.
English: Each pack contains 14 or 21 capsules.
Danish: Hver pakning indeholder 14 eller 21 kapsler.
English: The systemic exposure (AUC) of pomalidomide increases in an approximately linear and dose proportional manner.
Danish: Den systemiske eksponering (AUC) af pomalidomid øges omtrentlig linært og dosisproportionalt.
English: No data are available on administration of pomalidomide to paediatric patients (< 18 years of age).
Danish: Der foreligger ingen data for administration af pomalidomid til pædiatriske patienter (< 18 år).
English: You and your partner should use effective methods of contraception while taking this medicine.
Danish: Du og din partner skal anvende sikker prævention, mens du tager dette lægemiddel.
English: When treated males on this study were mated with untreated females, all uterine parameters were comparable to the controls.
Danish: Når de behandlede hanner i dette studie blev parret med ubehandlede hunner, var alle uterine parametre sammenlignelige med kontrollerne.
English: Note: CI=Confidence interval; IRAC=Independent Review Adjudication Committee; NE = Not Estimable.
Danish: Bemærk: CI=konfidensinterval, IRAC=Independent Review Adjudication Committee; NE = kan ikke estimeres (Not Estimable).
English: Such patients may be at higher risk of hypersensitivity reactions and should not receive pomalidomide.
Danish: Sådanne patienter kan have en større risiko for overfølsomhedsreaktioner og bør ikke få pomalidomid.
English: Imnovid contains the active substance ‘pomalidomide'.
Danish: Imnovid indeholder det aktive stof ‘pomalidomid'.
English: Pomalidomide should be interrupted pending investigation of these symptoms and if ILD is confirmed, appropriate treatment should be initiated.
Danish: Pomalidomid bør afbrydes, mens disse symptomer undersøges og hvis ILD bekræftes, skal passende behandling iværksættes.
English: The p-value is based on a stratified log-rank test.
Danish: P-værdien er baseret på en stratificeret log-rank-test.
English: • She acknowledges that she understands the hazards and necessary precautions associated with the use of pomalidomide.
Danish: • Kvinden bekræfter, at hun forstår risikoen og de nødvendige sikkerhedsforanstaltninger, som er forbundet med brugen af pomalidomid.
English: Based on the results of both PFS and OS endpoints, the Data Monitoring Committee established for this study recommended that the study be completed and patients in the HD-Dex arm be crossed over to the Pom + LD-Dex arm.
Danish: Baseret på resultater for de 2 endepunkter PFS og OS har dataovervågningskomitéen (Data Monitoring Committee), der er nedsat for dette studie, anbefalet, at studiet gennemføres, og at patienterne i HD-Dex-armen kan skifte til Pom + LD-Dex-armen.
English: Regardless of the subgroup evaluated, PFS was generally consistent with that observed in the ITT population for both treatment groups.
Danish: Uanset den evaluerede undergruppe var PFS normalt i overensstemmelse med den observerede PFS for ITT-populationen for begge behandlingsgrupper.
English: Pomalidomide is present in human semen.
Danish: Pomalidomid er til stede i human sæd.
English: Do not increase the number of capsules you take to make up for not taking Imnovid the previous day.
Danish: Du må ikke øge det antal kapsler, du tager, for at erstatte den kapsel, som du ikke tog den foregående dag.
English: • The recommended starting dose of bortezomib will be worked out by your doctor and based on your height and weight (1.3 mg/m2 body surface area).
Danish: • Den anbefalede startdosis af bortezomib vil blive beregnet af din læge på baggrund af din højde og vægt (1,3 mg/m2 legemsoverfladeareal).
English: **ANC - Absolute Neutrophil Count; ***CBC - Complete Blood Count.
Danish: **ANC - absolut neutrofiltal, ***CBC - komplet blodtælling.
English: • Need for effective contraception and definition of effective contraception
Danish: • Nødvendigheden af sikker kontraception og definition af sikker kontraception
English: Stop using pomalidomide if you develop these symptoms and contact your doctor or seek medical attention immediately.
Danish: Stop med at bruge pomalidomid, hvis du udvikler disse symptomer, og kontakt straks din læge, eller søg lægehjælp.
English: Prophylaxis with acetylsalicylic acid (and other anticoagulants in high risk patients) was mandatory for all patients in clinical studies.
Danish: Profylakse med acetylsalicylsyre (og andre antikoagulantia hos højrisikopatienter) var obligatorisk for alle patienter i kliniske studier.
English: • After completing each 3-week cycle, start a new one.
Danish: • Efter hver 3-ugers cyklus er gennemført, skal der startes en ny.
English: Hepatitis B virus status should be established before initiating treatment with pomalidomide.
Danish: Hepatitis B-virusstatus skal bestemmes før påbegyndelse af behandling med pomalidomid.
English: • if you are able to become pregnant, unless you follow all the necessary measures to prevent you from becoming pregnant (see “Pregnancy, contraception and breast-feeding - information for women and men”).
Danish: • hvis du kan blive gravid, med mindre du træffer alle nødvendige forholdsregler for at undgå at blive gravid (se ”Graviditet, prævention og amning - information til kvinder og mænd”).
English: If you become pregnant despite the prevention measures: • you must stop the treatment immediately and talk to your doctor straight away.
Danish: Hvis du bliver gravid trods svangerskabsforebyggelse: • skal du omgående stoppe behandlingen og straks kontakte lægen.
English: If adverse reactions occur after dose reductions to 1 mg, then the medicinal product should be discontinued.
Danish: Hvis der opstår bivirkninger efter dosisreduktion til 1 mg, bør lægemidlet seponeres.
English: The MAH should agree on the implementation of the patient card system in each Member State.
Danish: Indehaveren af markedsføringstilladelsen skal aftale implementeringen af patientkortsystemet i hvert enkelt medlemsland.
English: Details of the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Danish: Detaljerne i dette PPP skal aftales med den relevante nationale myndighed i hvert enkelt medlemsland og være på plads, inden præparatet markedsføres.
English: As a precaution, and taking into account special populations with potentially prolonged elimination time such as hepatic impairment, all male patients taking pomalidomide must meet the following conditions:
Danish: Som forholdsregel og under hensyntagen til særlige patientpopulationer med potentiel forlænget eliminationstid, såsom ved nedsat leverfunktion, skal alle mandlige patienter, som tager pomalidomid, opfylde følgende betingelser:
English: • Dizziness, tremor.
Danish: • Svimmelhed, tremor.
English: As a result of these tests, your doctor may change your dose of Imnovid or stop your treatment.
Danish: Ud fra disse prøver kan lægen ændre din dosis af Imnovid eller standse behandlingen.
English: The p-value is based on a stratified log-rank test with the same stratification factors as the above Cox model.
Danish: P-værdien er baseret på en stratificeret log-rank-test med samme stratifikationsfaktorer som for ovenstående Cox-model.
English: Following multiple doses, pomalidomide has an accumulation ratio of 27 to 31% on AUC.
Danish: Efter flere doser har pomalidomid en akkumulationsratio på 27 til 31 % på AUC.
English: Overall Survival (week)
Danish: Samlet overlevelse (uge)
English: Prescriptions for women of childbearing potential can be for a maximum duration of 4 weeks, and prescriptions for all other patients can be for a maximum duration of 12 weeks.
Danish: Ordinationer til kvinder i den fertile alder kan kun være af en maksimal varighed på 4 uger, og ordinationer til alle andre patienter kan være af en maksimal varighed på 12 uger.
English: Patients with known risk factors for thromboembolism - including prior thrombosis - should be closely monitored.
Danish: Patienter med kendte risikofaktorer for tromboemboli - herunder tidligere trombose - bør monitoreres nøje.
English: Pomalidomide must be discontinued permanently for angioedema.
Danish: Pomalidomid skal seponeres permanent for angioødem.
English: The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential.
Danish: Betingelserne i ”Programmet til svangerskabsforebyggelse” skal overholdes af alle patienter, medmindre der er pålidelige beviser for, at patienten ikke er i den fertile alder.
English: • you have a high total amount of tumour throughout the body, including your bone marrow.
Danish: • hvis du har en høj total tumorbyrde i hele kroppen, herunder i knoglemarven.
English: Upper respiratory tract infection and pneumonia were the most frequently occurring infections.
Danish: Øvre luftvejsinfektion og pneumoni var de hyppigst forekommende infektioner.
English: Therefore, erythropoietic agents, as well as other agents that may increase the risk of thromboembolic events, should be used with caution.
Danish: Derfor bør erytropoietiske stoffer samt andre stoffer, der kan øge risikoen for trombotiske hændelser, anvendes med forsigtighed.
English: If you forget to take Imnovid
Danish: Hvis du har glemt at tage Imnovid
English: Patients should be advised of the signs and symptoms of these reactions by their prescribers and should be told to seek medical attention immediately if they develop these symptoms.
Danish: Patienterne skal underrettes om tegn og symptomer på disse reaktioner af dem, der ordinerer medicinen, og skal instrueres i straks at søge lægehjælp, hvis de udvikler disse symptomer.
English: Pregnancy, contraception and breast-feeding - information for women and men The following must be followed as stated in the Imnovid Pregnancy Prevention Programme.
Danish: Graviditet, prævention og amning - information til kvinder og mænd Følgende skal overholdes som beskrevet i ”Programmet til svangerskabsforebyggelse” for Imnovid.
English: See section 4.2 for dosing information.
Danish: 4.2 for doseringsoplysninger.
English: • National specific requirements agreed with the National Competent Authority regarding: o Distribution of the product o To ensure that all appropriate measures have been performed prior to pomalidomide being dispensed
Danish: • Specifikke, nationale krav, som er aftalt med den relevante nationale myndighed angående: o Distribuering af præparatet o Sikkerhed for, at alle passende foranstaltninger er blevet iværksat, inden pomalidomid udleveres
English: Pomalidomide is structurally related to thalidomide.
Danish: Pomalidomid er strukturelt i familie med thalidomid.
English: • National or other applicable specific arrangements for a prescription for pomalidomide to be dispensed
Danish: • Nationale eller andre specifikke foranstaltninger for, at en ordination af pomalidomid kan udleveres
English: • by stimulating the immune system to attack the cancer cells
Danish: • ved at stimulere immunsystemet, så kræftcellerne angribes.
English: • Even if a woman of childbearing potential has amenorrhoea she must follow all the advice on effective contraception
Danish: • Selv hvis en kvinde i den fertile alder har amenorré, skal hun følge alle rådene om sikker kontraception
English: Population Pharmacokinetics (PK)
Danish: Populationsfarmakokinetik (PK)
English: If you notice any changes to your skin whilst taking Imnovid, tell your doctor as soon as possible.
Danish: Hvis du bemærker nogle hudændringer, mens du tager Imnovid, skal du så hurtigt som muligt fortælle det til lægen.
English: Pomalidomide has a mean apparent volume of distribution (Vd/F) between 62 and 138 L at steady state.
Danish: Pomalidomid har et gennemsnitligt tilsyneladende fordelingsvolumen (Vd/F) på mellem 62 og 138 l ved steady state.
English: • Flu-like symptoms (influenza).
Danish: • Influenzalignende symptomer (influenza).
English: Censored n (%)
Danish: Censureret n (%)
English: • by stopping the myeloma cells developing
Danish: • ved at stoppe myelomcellernes udvikling.
English: • certain antidepressants such as fluvoxamine.
Danish: • visse lægemidler mod depression, såsom fluvoxamin.