FrancophonIA/ELRC3.0 huggingface dataset:
English: Insertion of copper-releasing intrauterine devices is not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with severe neutropenia or severe thrombocytopenia.
Danish: Spiraler, som afgiver kobber, bør ikke bruges på grund af den potentielle risiko for infektion på opsætningstidspunktet og blodtabet ved menstruation, hvilket kan indebære en risiko for patienter med svær neutropeni eller svær trombocytopeni.
English: • Decreased ability to move or feel (sensation) in your hands, arms, feet and legs because of nerve damage (peripheral sensorimotor neuropathy).
Danish: • Nedsat evne til at bevæge eller nedsat følelse i hænder, arme, fødder og ben som følge af nerveskader (perifer sensomotorisk neuropati).
English: ANC** < 0.5 x 109/l or febrile neutropenia (fever ≥38.5°C and ANC <1 x 109/l)
Danish: 9/l eller febril neutropeni (feber ≥ 38,5 °C og ANC < 1 x 109/l)
English: Markedly elevated levels of alanine aminotransferase and bilirubin have been observed in patients treated with pomalidomide (see section 4.8).
Danish: Markant forhøjede niveauer af alaninaminotransferase og bilirubin er blevet observeret hos patienter i behandling med pomalidomid (se pkt.
English: Hyperglycaemia ≥ Grade 3
Danish: Hyperglykæmi ≥ grad 3
English: Data cutoff: 26 Oct 2017
Danish: Dataafskæring: 26. okt 2017
English: • Urinary tract infection, which may cause a burning sensation when passing urine, or a need to pass urine more often.
Danish: • Urinvejsinfektion, hvilket kan forårsage en brændende fornemmelse, når du lader vandet, eller en hyppigere vandladningstrang.
English: This condition is called tumour lysis syndrome.
Danish: Denne tilstand kaldes tumorlysesyndrom.
English: Slight reduction in maternal body weight gain, significant reduction in triglycerides, and significant dec rease in absolute and relative spleen weights were observed at 100 and 250 mg/kg/day.
Danish: En let reduktion i maternal vægtøgning, signifikant reduktion i triglycerider og en signifikant reduktion i absolut og relativ miltvægt blev observeret ved 100 og 250 mg/kg/dag.
English: Patients > 75 years of age started treatment with 20 mg dexamethasone.
Danish: Patienter > 75 år startede behandling med 20 mg dexamethason.
English: Prophylactic antibiotics should be considered particularly in patients with neutropenia.
Danish: Det bør overvejes at give antibiotika profylaktisk, især til patienter med neutropeni.
English: Based on population pharmacokinetic analyses in healthy subjects and multiple myeloma patients, no significant influence of age (19-83 years) on oral clearance of pomalidomide was observed.
Danish: Baseret på farmakokinetiske populationsanalyser hos raske personer og patienter med myelomatose har alder (19-83 år) ingen signifikant indvirkning på pomalidomids orale clearance.
English: Pomalidomide doses as high as 50 mg as a single dose in healthy volunteers, and 10 mg as once-daily multiple doses in multiple myeloma patients have been studied without reported serious adverse reactions related to overdose.
Danish: Doser af pomalidomid så høje som 50 mg som enkeltdosis hos raske frivillige og 10 mg én gang dagligt som gentagne doser hos myelomatosepatienter er undersøgt uden rapporterede alvorlige bivirkninger med relation til overdosering.
English: • Bleeding within the skull.
Danish: • Blødning inde i kraniet.
English: Common Depression Insomnia
Danish: Almindelig Depression Insomni
English: • Look at the chart below to see what to take on each day of the 4-week cycle: o Each day, look down the chart and find the correct day to see which medicines to take.
Danish: • Diagrammet nedenfor viser, hvad du skal tage hver dag i en 4-ugers cyklus: o Hver dag skal du kigge i diagrammet og finde den korrekte dag for at se hvilke lægemidler, du skal tage.
English: In clinical studies, no dose adjustment was required in elderly (> 65 years) patients exposed to pomalidomide (see section 4.2).
Danish: I kliniske studier var dosisjustering ikke nødvendig hos ældre (> 65 år) patienter, der fik pomalidomid (se pkt.
English: Imnovid is expected to cause severe birth defects and may lead to the death of an unborn baby.
Danish: Imnovid forventes at forårsage svære medfødte misdannelser og kan medføre, at fostret dør.
English: Patients should be monitored for haematological adverse reactions, especially neutropenia.
Danish: Patienterne bør monitoreres for hæmatologiske bivirkninger, især neutropeni.
English: Do not use Imnovid if you notice any damage or signs of tampering to medicine packaging.
Danish: Brug ikke Imnovid, hvis du bemærker, at pakningen er beskadiget eller udviser tegn på at have været åbnet.
English: In rats, chronic administration of pomalidomide at doses of 50, 250, and 1000 mg/kg/day for 6 months was well tolerated.
Danish: Hos rotter var kronisk administration af pomalidomid med doser på 50, 250 og 1000 mg/kg/dag i 6 måneder veltolereret.
English: The pharmacokinetic parameters were modestly changed in hepatically impaired patients (defined by Child-Pugh criteria) compared to healthy subjects.
Danish: De farmakokinetiske parametre blev i beskedent omfang ændret hos patienter med nedsat leverfunktion (defineret i henhold til Child-Pugh-kriterier) sammenlignet med raske personer.
English: Approximately 70% of patients were refractory to lenalidomide (71.2% in Pom+Btz+LD-Dex, 68.7 % in Btz+LD-Dex).
Danish: Ca. 70 % af patienterne var refraktære over for lenalidomid (71,2 % i Pom+Btz+LD-Dex, 68,7 % i Btz+LD-Dex).
English: Very Common Decreased appetite
Danish: Meget almindelig Nedsat appetit
English: • Obligations of the health care professional in relation to the prescribing of pomalidomide o Need to provide comprehensive advice and counselling to patients o That patients should be capable of complying with the requirements for the safe use of pomalidomide o Need to provide patients with appropriate patient educational brochure and patient card
Danish: • Sundhedspersonalets forpligtelser i forbindelse med ordinering af pomalidomid o Nødvendigheden af at forsyne patienterne med forståelig vejledning og rådgivning o Patienterne skal være i stand til at overholde de krav, der stilles til sikker brug af pomalidomid o Nødvendigheden af at forsyne patienterne med en relevant informationsbrochure og patientkort
English: Because of the potential for adverse reactions in breastfed infants from pomalidomide, a decision must be made whether to discontinue breast-feeding or to discontinue the medicinal product, taking into account the benefit of breast-feeding for the child and the benefit of the therapy for the woman.
Danish: På grund af den potentielle risiko for bivirkninger fra pomalidomid hos ammede spædbørn, skal det besluttes, om amning skal ophøre eller behandling med Imnovid seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: If you are uncertain whether any of the conditions above apply to you, talk to your doctor, pharmacist or nurse before taking Imnovid.
Danish: Hvis du er i tvivl, om nogle af ovenstående betingelser gælder for dig, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før du tager Imnovid.
English: Fatigue, depressed level of consciousness, confusion, and dizziness have been reported with the use of pomalidomide.
Danish: Træthed, nedsat bevidsthed, forvirring og svimmelhed er rapporteret under brug af pomalidomid.
English: Median OS time for the HD-Dex arm was 34 weeks (95% CI: 23.4, 39.9).
Danish: Median OS-tid for HD-Dex-armen var 34 uger (95 % CI: 23,4, 39,9).
English: Very Common Pneumonia
Danish: Meget almindelig Pneumoni
English: Psychiatric disorders Common Confusional state
Danish: Psykiske forstyrrelser Almindelig Forvirret tilstand
English: For information on other medicinal products given in combination with Imnovid, refer to the respective current SmPC.
Danish: For information om andre lægemidler, der gives i kombination med Imnovid, henvises til det relevante gældende produktresumé.
English: The risk of venous thromboembolism continues for 4-6 weeks after discontinuing combined oral contraception.
Danish: Risikoen for venetrombose vedvarer i 4−6 uger efter ophør med p-piller af kombinationstypen.
English: Co-administration of pomalidomide with the strong CYP3A4/5 and P-gp inhibitor ketoconazole, or the strong CYP3A4/5 inducer carbamazepine, had no clinically relevant effect on exposure to pomalidomide.
Danish: Administration af pomalidomid sammen med den potente CYP3A4/5- og P-gp-hæmmer ketoconazol eller den potente CYP3A4/5-inducer carbamazepin havde ingen klinisk relevant virkning på eksponeringen for pomalidomid.
English: • The need to stop pomalidomide immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af omgående at ophøre med pomalidomid, hvis der er mistanke om graviditet
English: Patients receiving pomalidomide either in combination with bortezomib and dexamethasone or in combination with dexamethasone have developed venous thromboembolic events (predominantly deep vein thrombosis and pulmonary embolism) and arterial thrombotic events (myocardial infarction and cerebrovascular accident).
Danish: Patienter i behandling med pomalidomid enten i kombination med bortezomib og dexamethason eller i kombination med dexamethason har udviklet venøse tromboemboliske hændelser (hovedsageligt dyb venetrombose og lungeemboli) samt arterielle trombotiske hændelser (myokardieinfarkt og cerebrovaskulært anfald).
English: The 1-year event free rate was 52.6% (± 5.72%) for the Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm.
Danish: Den 1-års hændelsesfrie rate var 52,6 % (± 5,72 %) for Pom + LD-Dex-armen og 28,4 % (± 7,51 %) for HDDex-armen.
English: Common Hypotension Hypertension
Danish: Almindelig Hypotension Hypertension
English: • The need to contact their doctor immediately upon suspicion of pregnancy
Danish: • Nødvendigheden af omgående at kontakte lægen, hvis der er mistanke om graviditet
English: According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
Danish: I overensstemmelse med lokal praksis skal der udføres lægeligt superviserede graviditetstests på kvinder i den fertile alder. Testene skal have en minimumfølsomhed på 25 mIE/ml og foretages som beskrevet nedenfor.
English: Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Danish: Bivirkningerne havde tendens til at opstå hyppigere i de første 2 behandlingscyklusser med pomalidomid.
English: The p-value is based on a CMH test, stratified by age (<=75 vs >75), Prior number of antimyeloma regimens (1 vs >1), and Beta-2 microglobulin at screening (< 3.5 mg/L versus ≥ 3.5 mg/L - ≤ 5.5 mg/L versus > 5.5 mg/L).
Danish: P-værdien er baseret på en CMH-test, stratificeret ved alder (<=75 vs. >75), tidligere antal antimyelomprogrammer (1 vs. >1) og beta2.mikroglobulin ved screening (< 3,5 mg/l versus ≥ 3,5 mg/l, ≤ 5,5 mg/l versus > 5,5 mg/l).
English: Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Danish: Det bør overvejes at afbryde eller seponere pomalidomid for grad 2-3 hududslæt.
English: Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with the hepatitis B virus (HBV).
Danish: Der er i sjældne tilfælde blevet rapporteret om reaktivering af hepatitis B hos patienter, der fik pomalidomid i kombination med dexamethason, og som tidligere er blevet inficeret med hepatitis Bvirus (HBV).
English: • Swelling of the body, including swelling of the arms or legs.
Danish: • Hævelser i kroppen, herunder hævede arme og ben.
English: Overall Survival: ITT Population
Danish: Samlet overlevelse: ITT-population
English: Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
Danish: Tobaksrygning vides at inducere CYP1A2-isoformen, men administration af pomalidomid til rygere havde ingen klinisk relevant indvirkning på eksponeringen for pomalidomid sammenlignet med den eksponering for pomalidomid, der blev observeret hos ikke-rygere.
English: • Safety advice relevant to all patients o Description and management of thrombocytopenia including incidence rates from clinical studies o Description and management of cardiac failure o Disposal of unwanted medicine o Local country specific arrangements for a prescription for pomalidomide to be dispensed
Danish: • Råd om sikkerhed, som er relevante for alle patienter o Beskrivelse og håndtering af trombocytopeni, herunder incidensrater fra kliniske studier o Beskrivelse og håndtering af hjertesvigt o Bortskaffelse af uønsket medicin o Lokale, national-specifikke foranstaltninger for, at en ordination af pomalidomid kan udleveres
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Imnovid findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: PFS was evaluated in several relevant subgroups: gender, race, ECOG performance status, stratification factors (age, disease population, prior anti-myeloma therapies [2, > 2]), selected parameters of prognostic significance (baseline beta-2 microglobulin level, baseline albumin levels, baseline renal impairment, and cytogenetic risk), and exposure and refractoriness to prior anti-myeloma therapies.
Danish: PFS blev evalueret i flere relevante undergrupper: køn, race, ECOG-præstationsstatus, stratifikationsfaktorer (alder, sygdomspopulation, tidligere antimyelom-behandlinger [2, > 2], udvalgte parametre af prognostisk signifikans (beta-2-mikroglobulinniveau, albuminniveau og nedsat nyrefunktion ved baseline samt cytogenetisk risiko) samt eksponering og refraktær tendens ved tidligere anti-myelom-behandlinger.
English: The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Danish: Virkningen af steroider til kontraception kan muligvis være nedsat ved samtidig behandling med dexamethason (se pkt.
English: However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed.
Danish: Patienter med nedsat leverfunktion bør dog overvåges nøje for bivirkninger, og dosis af pomalidomid bør reduceres eller behandlingen afbrydes, såfremt det er nødvendigt.
English: Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex.
Danish: Odds ratio er for Pom+Btz+LD-Dex:Btz+LD-Dex.
English: • two other medicines - called ‘bortezomib' (a type of chemotherapy medicine) and ‘dexamethasone' (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide.
Danish: • to andre lægemidler - der kaldes ‘bortezomib' (en type kemoterapi) og ‘dexamethason' (et antiinflammatorisk lægemiddel), til personer, som har fået mindst én anden behandlingherunder lenalidomid.
English: Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.
Danish: Neutropeni var den hyppigst rapporterede grad 3 eller 4 hæmatologiske bivirkning hos patienter med relaps / refraktær myelomatose, efterfulgt af anæmi og trombocytopeni.
English: • Brochure for women patients of childbearing potential and their partners
Danish: • En brochure til kvindelige patienter i den fertile alder og deres partnere
English: Treatment with pomalidomide combined with dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Danish: Behandling med pomalidomid kombineret med dexamethason bør gives, indtil der opstår sygdomsprogression eller uacceptabel toksicitet.
English: At 250 mg/kg/day, fetal malformations included limb anomalies (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia); moderate dilation of the lateral ventricle in the brain; abnormal placement of the right subclavian artery; absent intermediate lobe in the lungs; low-set kidney; altered liver morphology; incompletely or not ossified pelvis; an increased average for supernumerary thoracic ribs and a reduced average for ossified tarsals.
Danish: Ved 250 mg/kg/dag omfattede de føtale misdannelser abnormiteter af lemmer (bøjede og/eller roterede for- og/eller bagben, ikke vedhæftede eller manglende tæer) og dermed forbundne skeletmisdannelser (ikke ossificerede metakarpalknogler, forkert placerede falanks og metakarpalknogler, manglende tæer, ikke ossificerede falanks samt korte, ikke ossificerede eller bøjede tibia), moderat dilation af den laterale ventrikel i hjernen, unormal placering af den højre subclavia-arterie, manglende intermediær lungelap, lavt placerede nyrer, ændret levermorfologi, ufuldstændigt eller ikke ossificeret bækken, et forhøjet gennemsnit for overtallige torakale ribben og et nedsat gennemsnit for ossificerede tarsalknogler.
English: Physicians should observe patients for signs of bleeding including epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding (see section 4.8).
Danish: Lægerne skal være på udkig efter tegn på blødning, herunder epistaxis, især ved samtidig anvendelse af lægemidler, der vides at øge risikoen for blødning (se pkt.
English: Peripheral neuropathy occurred in 12.3% of patients (1.0% Grade 3 or 4).
Danish: Perifer neuropati forekom hos 12,3 % af patienterne (1,0 % grad 3 eller 4).
English: The majority of patients were male (59%) and white (79%); the median age for the overall population was 64 years (min, max: 35, 87 years).
Danish: Størstedelen af patienterne var mænd (59 %) og hvide (79 %), medianalderen for den samlede population var 64 år (35-87 år).
English: Angioedema and severe cutaneous reactions including SJS, TEN and DRESS has been reported with the use of pomalidomide.
Danish: Der er blevet rapporteret angioødem og svære kutane reaktioner, herunder SJS, TEN og DRESS, ved brug af pomalidomid.
English: No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see section 4.4).
Danish: Ingen reaktioner med perifer neuropati blev rapporteret som alvorlige, og perifer neuropati førte til seponering hos 0,3 % af patienterne (se pkt.
English: The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm.
Danish: Den mediane behandlingsvarighed var 8,8 måneder (12 behandlingscyklusser) i armen med Pom+Btz+LD-Dex og 4,9 måneder (7 behandlingscyklusser) i armen med Btz+LD-Dex.
English: Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Danish: Pomalidomid har en direkte anti-myelom tumoricid aktivitet, immunmodulerende aktiviteter og hæmmer stromacellernes støtte til tumorcellevækst ved myelomatose.
English: Dexamethasone (20 mg) * • • * For patients > 75 years of age, see Special populations.
Danish: Bortezomib (1,3 mg/m2) Dexamethason (20 mg) * • • * For patienter > 75 år, se specielle populationer.
English: Interrupt pomalidomide treatment.
Danish: Afbryd behandlingen med pomalidomid.
English: • Itchy skin.
Danish: • Kløende hud.
English: • Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to infection of blood called sepsis or septic shock).
Danish: • Hurtig vejrtrækning, hurtig puls, feber og kulderystelser, udskillelse af meget lidt eller ingen urin, kvalme og opkastning, forvirring, bevidstløshed (skyldes en infektion af blodet, der kaldes sepsis eller septisk shock).
English: Progression Free Survival (weeks)
Danish: Progressionsfri overlevelse (uger)
English: In the 9-month study in monkeys with doses of 0.05, 0.1, and 1 mg/kg/day, morbidity and early euthanasia of 6 animals were observed at the dose of 1 mg/kg/day and were attributed to immunosuppressive effects (staphylococcal infection, decreased peripheral blood lymphocytes, chronic inflammation of the large intestine, histologic lymphoid depletion, and hypocellularity of bone marrow) at high exposures of pomalidomide (15-fold exposure ratio relative to a 4 mg clinical dose).
Danish: I 9-måneders studiet med aber med doser på 0,05, 0,1 og 1 mg/kg/dag blev der observeret morbiditet og tidlig eutanasi hos 6 dyr ved en dosis på 1 mg/kg/dag, og de blev tilskrevet immunsuppressive virkninger (stafylokok-infektion, nedsat antal lymfocytter i det perifere blod, kronisk inflammation i tyktarmen, histologisk lymfoid udtømning og hypocellularitet i knoglemarven) ved høje eksponeringer af pomalidomid (15 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
English: For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met:
Danish: Pomalidomid er kontraindiceret til kvinder i den fertile alder, medmindre alle følgende kriterier opfyldes:
English: (E133), and white ink.
Danish: (E133) samt hvidt blæk.
English: A total of 226 (74.8%) of the Pom + LD-Dex patients and 95 (62.1%) of the HD-Dex patients were alive as of the cutoff date (07 Sep 2012).
Danish: I alt 226 (74,8 %) af patienterne, der fik Pom + LD-Dex, og 95 (62,1 %) af patienterne, der fik HD-Dex, levede på afskæringsdatoen (7. september 2012).
English: Haemorrhagic disorders have been reported with pomalidomide, especially in patients with risk factors such as concomitant medicinal products that increase susceptibility to bleeding.
Danish: Blødningsforstyrrelser er blevet rapporteret med pomalidomid, især hos patienter med risikofaktorer, såsom samtidig administration af lægemidler, der øger tendensen til blødning.
English: The most commonly reported serious adverse reaction was pneumonia (11.5%).
Danish: Den mest almindeligt rapporterede alvorlige bivirkning var pneumoni (11,5 %).
English: • Imnovid, bortezomib and dexamethasone are taken in ‘treatment cycles'.
Danish: • Imnovid, bortezomib og dexamethason tages i 'behandlingscyklusser'.
English: Uncommon Alanine aminotransferase increased
Danish: Ikke almindelig Forhøjet alaninaminotransferase
English: Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.
Danish: Før og under behandlingen bør lægerne evaluere patienterne nøje med standardmetoder for cancerscreening for fremkomst af anden primær malignitet og påbegynde relevant behandling.
English: For each subsequent drop < 0.5 x 109/l
Danish: For hvert efterfølgende fald < 0,5 x 10
English: • He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Danish: • Han forstår, at hvis den kvindelige partner bliver gravid, mens han tager pomalidomid eller 7 dage efter, han er holdt op med at tage pomalidomid, skal han straks informere den behandlende læge, og at det anbefales, at den kvindelige partner bliver henvist til en læge med speciale eller erfaring i teratologi for evaluering og rådgivning.
English: Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours post-dose (approximately Tmax) after 4 days of once daily dosing at 2 mg.
Danish: Pomalidomid fordeles til sæden hos raske personer med en koncentration på ca. 67 % af plasmaniveauet 4 timer efter dosis (omtrentlig Tmax) efter dosering med 2 mg én gang dagligt i 4 dage.