FrancophonIA/ELRC3.0 huggingface dataset:
English: 4.6 Fertility, pregnancy and lactation Women of childbearing potential / Contraception in males and females
Danish: 4.6 Fertilitet, graviditet og amning Kvinder i den fertile alder/kontraception hos mænd og kvinder
English: Summary of overall efficacy data are presented in Table 10 using a cut-off date of 26 Oct 2017.
Danish: En oversigt over samlede effektdata er vist i tabel 10 med afskæringsdatoen 26. okt 2017.
English: o Some days, you take all 3 medicines, some days just 2 or 1 medicines, and some days none at all.
Danish: o Nogle dage tager du alle 3 lægemidler, nogle dage kun 2 lægemidler eller 1 lægemiddel og nogle dage slet ikke nogen.
English: • After completing each 4-week cycle, start a new one.
Danish: • Efter hver 4-ugers cyklus er gennemført, skal der startes en ny.
English: Careful assessment of patients with an acute onset or unexplained worsening of pulmonary symptoms should be performed to exclude ILD.
Danish: Der bør udføres en nøje vurdering af patienter med akut opstået eller uforklarlig forværring af lungesymptomerne for at udelukke ILD.
English: During the treatment with Imnovid you have an increased risk of getting blood clots in your veins and arteries.
Danish: Under din behandling med Imnovid vil du have en øget risiko for at få blodpropper i dine vener og arterier.
English: If a patient is currently using combined oral contraception the patient should switch to one of the effective methods listed above.
Danish: Hvis en patient aktuelt anvender p-piller af kombinationstypen, bør patienten skifte til én af de ovenstående effektive metoder.
English: Increased cardiac anomalies were seen at all doses with significant increases at 250 mg/kg/day.
Danish: Flere hjerteanomalier blev set ved alle doseringer, med signifikant stigning ved 250 mg/kg/dag.
English: • Infections of the lungs (pneumonia and bronchitis).
Danish: • Lungeinfektioner (pneumoni og bronkitis).
English: Pomalidomide (4 mg)
Danish: Pomalidomid (4 mg)
English: Treatment must be initiated and monitored under the supervision of physicians experienced in the management of multiple myeloma.
Danish: Behandlingen skal indledes og monitoreres under supervision af læger med erfaring i behandling af myelomatose.
English: Pomalidomide (4 mg) Bortezomib (1.3 mg/m2) Dexamethasone (20 mg) * • •
Danish: Pomalidomid (4 mg) Bortezomib (1,3 mg/m2) Dexamethason (20 mg) * • •
English: In addition to the above adverse reactions identified from the pivotal clinical trials, the following Table 9 is derived from data gathered from post-marketing surveillance.
Danish: Foruden ovennævnte bivirkninger, der er identificeret i de pivotale kliniske studier, er oplysningerne i den følgende tabel 9 indsamlet fra overvågning efter markedsføring.
English: • you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet).
Danish: • hvis du har eller tidligere har haft neuropati (nerveskade, der forårsager prikken eller smerter i hænder eller fødder).
English: If the patient forgets to take a dose of pomalidomide on one day, then the patient should take the normal prescribed dose as scheduled on the next day.
Danish: Hvis patienten glemmer at tage en dosis pomalidomid en dag, skal patienten tage den normale, ordinerede dosis på det normale tidspunkt den efterfølgende dag.
English: Progression free survival (PFS), N Censored, n (%)
Danish: Progressionsfri overlevelse (PFS), N Censureret, n (%)
English: o Some days, you take both medicines, some days just 1 medicine, and some days none at all.
Danish: o Nogle dage tager du begge lægemidler, nogle dage kun 1 lægemiddel og nogle dage slet ingen.
English: Pomalidomide is partly metabolised by CYP1A2 and CYP3A4/5.
Danish: Pomalidomid metaboliseres delvist af CYP1A2 og CYP3A4/5.
English: Dizziness and confusion
Danish: Svimmelhed og forvirring
English: Ideally, pregnancy testing, issuing a prescription and dispensing should occur on the same day.
Danish: Ideelt bør udførelse af graviditetstest, ordinering og udlevering foregå samme dag.
English: • Decreased number of lymphocytes (one type of white blood cells) often caused by infection (lymphopenia).
Danish: • Nedsat antal lymfocytter (en type hvide blodlegemer), ofte forårsaget af infektion (lymfopeni).
English: In clinical studies, patients received prophylactic acetylsalicylic acid or alternative antithrombotic therapy.
Danish: I de kliniske studier fik patienterne profylaktisk acetylsalicylsyre eller alternativ antitrombotisk behandling.
English: The most frequently reported adverse reaction was peripheral sensory neuropathy (47.8%).
Danish: Den hyppigst rapporterede bivirkning var perifer sensorisk neuropati (47,8 %).
English: Women and men taking Imnovid must not become pregnant or father a child.
Danish: Kvinder, der tager Imnovid, må ikke blive gravide, og mænd må ikke blive fædre.
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide, including periodic monitoring for signs or symptoms of cardiac events.
Danish: Der bør udvises passende forsigtighed, når behandling med pomalidomid hos sådanne patienter overvejes, herunder periodisk overvågning for tegn og symptomer på hjertehændelser.
English: Your doctor may recommend you take additional treatments (e.g. warfarin) or lower the dose of Imnovid to reduce the chance that you get blood clots.
Danish: Din læge kan anbefale, at du tager ekstra medicin (f.eks. warfarin), eller lægen kan reducere dosis af Imnovid, for at nedsætte risikoen for, at du får blodpropper.
English: Pomalidomide binds directly to the protein cereblon (CRBN), which is part of an E3 ligase complex that includes deoxyribonucleic acid (DNA) damage-binding protein 1(DDB1), cullin 4 (CUL4), and regulator of cullins-1 (Roc1), and can inhibit the auto-ubiquitination of CRBN within the complex.
Danish: Pomalidomid binder direkte til proteinet cereblon (CRBN), som er en del af et E3-ligasekompleks, der omfatter deoxyribonukleinsyre (dna) damage-binding protein 1(DDB1), cullin 4 (CUL4) og regulator af cullins-1 (Roc1), og kan hæmme auto-ubiquitineringen af CRBN i komplekset.
English: In case of permanent discontinuation of any component of the treatment regimen, continuation of the remaining medicinal products is at the physician's discretion.
Danish: I tilfælde af permanent seponering af en eller flere af komponenterne af behandlingsprogrammet, fortsættes de resterede lægemidler efter lægens skøn.
English: The MAH shall agree the details of a controlled distribution system with the National Competent Authorities and must implement such programme nationally to ensure that:
Danish: Indehaveren af markedsføringstilladelsen skal aftale detaljerne omkring et kontrolleret distributionssystem med den relevante nationale myndighed og implementere et sådant program nationalt for at sikre at:
English: There is no relevant use of pomalidomide in children aged 0-17 years for the indication of multiple myeloma.
Danish: Det er ikke relevant at anvende pomalidomid hos den pædiatriske population i alderen 0-17 år til indikationen myelomatose.
English: Take the medicine pack with you.
Danish: Medbring lægemiddelpakningen.
English: 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Immunosuppressants, Other immunosuppressants, ATC code: L04AX06
Danish: Farmakoterapeutisk klassifikation: Immunsuppressiva, Andre immunsuppressiva, ATC-kode: L04AX06
English: A teratogenic effect of pomalidomide in humans is expected.
Danish: Der forventes en teratogen virkning af pomalidomid hos mennesker.
English: What is multiple myeloma
Danish: Hvad er myelomatose?
English: Coadministration with a high-fat and high-calorie meal slows the rate of absorption, decreasing mean plasma Cmax by approximately 27%, but has minimal effect on the overall extent of absorption with an 8% decrease in mean AUC.
Danish: Administration sammen med måltider med højt fedt- og kalorieindhold sænker absorptionsraten, nedsætter den gennemsnitlige plasma-Cmax med ca. 27 %, men har kun minimal virkning på den samlede absorptionsgrad med 8 % reduktion af gennemsnitligt AUC.
English: • if you are allergic to pomalidomide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for pomalidomid eller et af de øvrige indholdsstoffer i Imnovid (angivet i punkt 6).
English: The controlled distribution system includes the use of a patient card and/or equivalent tool for prescribing and /or dispensing controls, and the collection of detailed data relating to the indication in order to monitor the off-label use within the national territory.
Danish: Det kontrollerede distributionssystem omfatter anvendelse af et patientkort og/eller ækvivalent redskab for kontrol af ordinering og/eller udlevering samt indsamling af detaljerede data i relation til indikationen for nøje at overvåge off label-anvendelse i det pågældende land.
English: Cycle 1-8
Danish: Cyklus 1-8
English: Patients with serum total bilirubin > 1.5 x ULN (upper limit of normal range) were excluded from clinical studies.
Danish: Patienter med total serum bilirubin > 1,5 ULN (øvre normalgrænse) blev ekskluderet fra de kliniske studier.
English: Significant cardiac dysfunction
Danish: Signifikant hjertedysfunktion
English: The use of erythropoietic agents carries a risk of thrombotic events including thromboembolism.
Danish: Anvendelsen af erytropoietiske stoffer medfører en risiko for trombotiske hændelser, herunder tromboemboli.
English: The capsules are packaged in Polyvinyl chloride (PVC)/ polychlorotrifluoroethylene (PCTFE) blisters with push through aluminium foil.
Danish: Kapslerne er pakket i polyvinylchlorid (PVC) / polychlortrifluorethylen (PCTFE)-blisterpakker med gennembrydelig aluminiumsfolie.
English: • Sore or dry mouth.
Danish: • Ømhed eller tørhed i munden.
English: In vitro, CYP1A2 and CYP3A4 were identified as the primary enzymes involved in the CYP-mediated hydroxylation of pomalidomide, with additional minor contributions from CYP2C19 and CYP2D6.
Danish: In vitro blev CYP1A2 og CYP3A4 identificeret som de primære enzymer, der var involveret i den CYP-medierede hydroxylering af pomalidomid, med yderligere mindre bidrag fra CYP2C19 og CYP2D6.
English: Patients should be instructed to seek medical care if they develop symptoms such as shortness of breath, chest pain, arm or leg swelling.
Danish: Patienterne skal informeres om at søge læge, hvis de udvikler symptomer som stakåndethed, brystsmerter, hævede arme eller ben.
English: • The need to avoid foetal exposure due to teratogenicity of pomalidomide in animals and the expected teratogenic effect of pomalidomide in humans
Danish: • Nødvendigheden af at undgå føtal eksponering pga. pomalidomids teratogenicitet hos dyr og den forventede teratogene effekt af pomalidomid hos mennesker
English: • you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels.
Danish: • hvis du har haft et hjerteanfald, lider af hjertesvigt, har vejrtrækningsbesvær, eller hvis du ryger, har højt blodtryk eller forhøjet kolesterol.
English: In monkeys, pomalidomide was evaluated in repeat-dose studies of up to 9 months in duration.
Danish: Hos aber blev pomalidomid evalueret i studier med gentagne doser med en varighed på op til 9 måneder.
English: • Pain in the pelvis.
Danish: • Smerter i bækkenet.
English: This is because your medicine may cause a fall in the number of blood cells that help fight infection (white cells) and in the number of cells that help to stop bleeding (platelets).
Danish: Dette skyldes, at medicinen kan forårsage et nedsat antal blodlegemer, der hjælper med at bekæmpe infektion (hvide blodlegemer), og et nedsat antal blodplader, der hjælper med at stoppe blødningen.
English: Direct Healthcare Professional Communications (Prior to Launch)
Danish: Information, der stiles direkte til sundhedspersonale (inden præparatet markedsføres)
English: It is also a substrate for P-glycoprotein.
Danish: Det er også et substrat for Pglykoprotein.
English: • by stopping the formation of blood vessels supplying the cancer cells.
Danish: • ved at stoppe dannelsen af blodkar, som forsyner kræftcellerne.
English: Common Vertigo
Danish: Almindelig Vertigo
English: There have also been cases of hepatitis that resulted in discontinuation of pomalidomide.
Danish: Der har også været tilfælde af hepatitis, som førte til seponering af pomalidomid.
English: Resume at one dose level lower than previous dose at next cycle (adverse event must be resolved or improved to ≤ Grade 2 before restarting dosing).
Danish: Genoptag med et dosisniveau lavere end den tidligere dosis i den næste cyklus (bivirkningen skal have fortaget sig eller være bedret til ≤ grad 2, før doseringen genstartes).
English: Two sided 95% CIb
Danish: Tosidet 95 % CIb
English: Date of first authorisation: 05 August 2013 Date of latest renewal: 11 July 2018
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 05 august 2013 Dato for seneste fornyelse: 11/07/2018
English: Celgene Distribution B.V. Winthontlaan 6 N 3526 KV Utrecht Netherlands
Danish: Winthontlaan 6 N 3526 KV Utrecht Holland
English: Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver SOC og hyppighedsgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: However, if you are over 75, the recommended starting dose is 10 mg per day.
Danish: Hvis du imidlertid er over 75 år, er den anbefalede startdosis 10 mg pr. dag.
English: The predominant metabolic pathways of excreted radioactivity are hydroxylation with subsequent glucuronidation, or hydrolysis.
Danish: De primære metaboliseringsveje for udskillelse af radioaktivitet er hydroxylering med efterfølgende glukuronidering, eller hydrolyse.
English: Also some other medicines can affect the way Imnovid works.
Danish: Andre lægemidler kan også påvirke den måde, Imnovid virker på.
English: What Imnovid is used for Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma'.
Danish: Anvendelse Imnovid bruges til at behandle voksne med en type kræft, der kaldes ‘myelomatose'.
English: These cells grow out of control and accumulate in the bone marrow.
Danish: Disse celler vokser ukontrolleret og ophobes i knoglemarven.
English: Pomalidomide was found to impact negatively on fertility and be teratogenic in animals.
Danish: Det er fundet, at pomalidomid har en negativ virkning på fertiliteten, og at det er teratogent hos dyr.
English: Interrupt dose until muscle weakness ≤ Grade 1.
Danish: Afbryd dosis, indtil muskelsvaghed ≤ grad 1.
English: Approximately 30% of the patients experiencing peripheral neuropathy had a history of neuropathy at baseline.
Danish: Ca. 30 % af patienterne, der oplevede perifer neuropati, havde en anamnese med neuropati ved baseline.
English: E3 ubiquitin ligases are responsible for the poly-ubiquitination of a variety of substrate proteins, and may partially explain the pleiotropic cellular effects observed with pomalidomide treatment.
Danish: E3-ubiquitinligaser er ansvarlige for poly-ubiquitineringen af mange forskellige substratproteiner og kan muligvis delvist forklare de pleiotrope cellulære virkninger, der observeres ved behandling med pomalidomid.
English: Duration of the treatment with Imnovid You should continue the cycles of treatment until your doctor tells you to stop.
Danish: Du skal fortsætte med dine behandlingscyklusser, indtil lægen fortæller dig, at du skal stoppe.
English: Appropriate caution should be exercised when considering the treatment of such patients with pomalidomide.
Danish: Der bør udvises en passende forsigtighed, når behandling med pomalidomid hos sådanne patienter overvejes.
English: st relapse and approximately 73% of patients received bortezomib as prior treatment.
Danish: Ca. 40 % af patienter havde deres første relaps, og ca. 73 % af patienterne fik bortezomib som tidligere behandling.
English: • Infections of the nose, sinuses and throat, caused by bacteria or viruses.
Danish: • Infektioner i næsen, bihulerne og halsen, forårsaget af bakterier eller vira.
English: The prescriber must inform the patient about the expected teratogenic risk and the strict pregnancy prevention measures as specified in the Pregnancy Prevention Programme and provide patients with appropriate patient educational brochure, patient card and/or equivalent tool in accordance with the national implemented patient card system.
Danish: Den ordinerende læge skal informere patienten om den forventede teratogene risiko og om de strenge svangerskabsforebyggende forholdsregler som specificeret i ”Programmet til svangerskabsforebyggelse” og forsyne patienten med hensigtsmæssigt uddannelsesmateriale, patientkort og/eller lignende redskaber i overensstemmelse med det nationalt implementerede patientkortsystem.
English: Regular monitoring of liver function is recommended for the first 6 months of treatment with pomalidomide and as clinically indicated thereafter.
Danish: Det anbefales at overvåge leverfunktionen regelmæssigt i løbet af de første 6 måneders behandling med pomalidomid og derefter i henhold til klinisk indikation.
English: Evaluation of recovery animals indicated that all treatment-related findings were reversible after 8 weeks of dosing cessation, except for proliferation of intrahepatic bile ducts observed in 1 animal in the 1 mg/kg/day group.
Danish: Evaluering af dyr i bedring indikerede, at alle behandlingsrelaterede fund var reversible 8 uger efter doseringsophør undtagen proliferation af intrahepatiske galdeveje observeret hos 1 dyr i gruppen med 1 mg/kg/dag.
English: Dyspepsia = Grade 1-2
Danish: Dyspepsi = grad 1-2
English: • Verification that appropriate counselling has taken place
Danish: • Bekræftelse på, at patienten har fået relevant rådgivning
English: You must follow the Imnovid Pregnancy Prevention Programme.
Danish: Du skal følge ”Programmet til svangerskabsforebyggelse” for Imnovid.
English: Day IMN BOR DEX
Danish: Dag IMN BOR DEX
English: Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding.
Danish: Implantater og spiraler, der afgiver levonorgestrel, forbindes med en øget infektionsrisiko på opsætningstidspunktet og uregelmæssig vaginal blødning.
English: Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell').
Danish: Myelomatose er en kræfttype, der påvirker visse hvide blodlegemer (der kaldes ‘plasmaceller').
English: Pomalidomide also inhibits angiogenesis by blocking the migration and adhesion of endothelial cells.
Danish: Pomalidomid hæmmer også angiogenese ved at blokere migration og adhæsion af endotelceller.
English: • Severe, persistent or bloody diarrhoea (possibly with stomach pain or fever) caused by bacteria called Clostridium difficile.
Danish: • Alvorlig, vedvarende eller blodig diarré (muligvis med mavesmerter eller feber) forårsaget af bakterier, der kaldes Clostridium difficile.
English: Dosing is continued or modified based upon clinical and laboratory findings (see section 4.4).
Danish: Doseringen fortsættes eller justeres baseret på kliniske og laboratoriemæssige fund (se pkt.
English: Your doctor may need to reduce the dose of Imnovid, bortezomib or dexamethasone or stop one or more of these medicines based on the results of your blood tests, your general condition, other medicines you may be taking (e.g. ciprofloxacin, enoxacin and fluvoxamine) and if you experience side effects (especially rash or swelling) from treatment.
Danish: Det kan være nødvendigt, at lægen nedsætter dosis af Imnovid, bortezomib eller dexamethason eller stopper et eller flere af disse lægemidler ud fra resultaterne af dine blodprøver, din almentilstand, andre lægemidler, du evt. tager (f.eks. ciprofloxacin, enoxacin og fluvoxamin), eller hvis du får bivirkninger (især udslæt eller hævelse) af behandlingen.
English: Anticoagulation therapy (unless contraindicated) is recommended, (such as acetylsalicylic acid, warfarin, heparin or clopidogrel), especially in patients with additional thrombotic risk factors.
Danish: Antikoagulantia (medmindre det er kontraindiceret) anbefales (såsom acetylsalicylsyre, warfarin, heparin eller clopidogrel), især til patienter med yderligere risikofaktorer for trombose.
English: In particular, tell your doctor, pharmacist or nurse before taking Imnovid if you are taking any of the following medicines:
Danish: Fortæl især lægen, apotekspersonalet eller sundhedspersonalet, før du tager Imnovid, hvis du tager nogle af de følgende lægemidler:
English: Your doctor will advise if you should stop or continue breast-feeding.
Danish: Din læge vil rådgive dig, om du skal stoppe eller fortsætte amningen.
English: In vitro binding of pomalidomide enantiomers to proteins in human plasma ranges from 12% to 44% and is not concentration dependent.
Danish: In-vitro-binding af pomalidomid-enantiomerer til proteiner i humant plasma er i intervallet 1244 % og er ikke koncentrationsafhængig.
English: Use diuretics as needed and decrease dose by one dose level.
Danish: Anvend diuretika som nødvendigt og reducer dosis med et dosisniveau.
English: Frequencies are defined in accordance with current guidance, as: very common (≥ 1/10), common (≥ 1/100 to < 1/10); and uncommon (≥ 1/1,000 to < 1/100).
Danish: Hyppigheden defineres i henhold til gældende retningslinjer som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10) og ikke almindelig (≥ 1/1.000 til < 1/100).
English: Btz = bortezomib; CI = Confidence interval; CR = Complete response; DoR = Duration of response; HR = Hazard Ratio; LD-Dex = low-dose dexamethasone; OR = Odds ratio; ORR = Overall response rate; PFS = Progression free survival; POM = pomalidomide; PR = Partial Response; sCR = Stringent complete response VGPR = Very good partial response.
Danish: Btz = bortezomib, CI = konfidensinterval, CR = fuldstændigt respons, DoR = varighed af respons, HR = Hazard Ratio, LD-Dex = lavdosis dexamethason, OR = Odds ratio, ORR = samlet responsrate, PFS = progressionsfri overlevelse, POM = pomalidomid, PR = delvist respons, sCR = stringent fuldstændigt respons, VGPR = meget godt delvist respons a
English: • She understands the need to commence the treatment as soon as pomalidomide is dispensed following a negative pregnancy test
Danish: • Kvinden forstår nødvendigheden af at påbegynde behandlingen, så snart pomalidomid er blevet ordineret efter en negativ graviditetstest
English: Effect of other medicinal products on pomalidomide
Danish: Virkningen af andre lægemidler på pomalidomid
English: • Male patients unable to follow or comply with the required contraceptive measures (see section 4.4).
Danish: • Mandlige patienter, der ikke kan følge eller overholde de påkrævede præventionsmetoder (se pkt.
English: How much Imnovid to take with other medicines
Danish: Hvor meget Imnovid skal der tages sammen med anden medicin?
English: In the presence of pomalidomide in vitro, substrate proteins Aiolos and Ikaros are targeted for ubiquitination and subsequent degradation leading to direct cytotoxic and immunomodulatory effects.
Danish: Når pomalidomid er til stede in vitro, er substratproteinerne Aiolos og Ikaros mål for ubiquitinering og efterfølgende nedbrydning, hvilket fører til direkte cytotoksiske og immunmodulerende virkninger.
English: Interrupt dose until symptoms are controlled.
Danish: Afbryd dosis, indtil symptomerne kontrolleres.
English: Patients and physicians are advised to be observant for the signs and symptoms of thromboembolism.
Danish: Patienter og læger rådes til at være på udkig for tegn og symptomer på tromboemboli.
English: In vivo, pomalidomide therapy led to reduction in the levels of Ikaros in patients with relapsed lenalidomiderefractory multiple myeloma.
Danish: In vivo førte pomalidomidbehandlingen til en reduktion af niveauet af Ikaros hos patienter med relaps lenalidomid-refraktær myelomatose.
English: Kaplan-Meier Curve of Overall Survival (ITT Population)
Danish: Kaplan-Meier-kurve over samlet overlevelse (ITT-population)