FrancophonIA/ELRC3.0 huggingface dataset:
English: PFS is summarised in Table 11 for the ITT population.
Danish: PFS overlevelse er opsummeret i Tabel 11 for ITT-populationen.
English: Strong CYP1A2 inhibitors
Danish: Potente CYP1A2-hæmmere
English: • See the leaflet that comes with dexamethasone for further information on its use and effects.
Danish: • Se indlægssedlen, der følger med dexamethason, for yderligere oplysninger om brug og virkning af dexamethason.
English: Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg if > 75 years old.
Danish: Dexamethason bør seponeres, hvis patienten ikke kan tåle 10 mg, hvis ≤ 75 år, eller 8 mg, hvis > 75 år.
English: Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide.
Danish: Patienter med aktuel ≥ grad 2 perifer neuropati blev ekskluderet fra de kliniske studier med pomalidomid.
English: • Changes in the way things taste.
Danish: • Ændringer af smagssans.
English: Dexamethasone should be discontinued if the patient is unable to tolerate 8 mg if ≤ 75 years old or 4 mg if > 75 years old.
Danish: Dexamethason bør seponeres, hvis patienten ikke kan tåle 8 mg, hvis ≤ 75 år, eller 4 mg, hvis > 75 år.
English: • That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans
Danish: • At pomalidomid er teratogent hos dyr og forventes at have teratogen virkning hos mennesker
English: • She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in case of confirmed tubal sterilisation
Danish: • Kvinden forstår nødvendigheden af og accepterer at få foretaget en graviditetstest mindst hver 4. uge undtagen ved bekræftet æggeleder-sterilisation
English: If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Danish: Hvis pulveret med pomalidomid får kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
English: No adjustment of the starting dose of pomalidomide is required for patients with hepatic impairment as defined by the Child-Pugh criteria.
Danish: Justering af startdosis af pomalidomid er ikke nødvendig hos patienter med nedsat leverfunktion, defineret i henhold til Child-Pugh-kriterier.
English: Additionally, pomalidomide inhibits the proliferation of lenalidomide-resistant multiple myeloma cell lines and synergises with dexamethasone in both lenalidomide-sensitive and lenalidomide-resistant cell lines to induce tumour cell apoptosis.
Danish: Desuden hæmmer pomalidomid proliferation af lenalidomid-resistente myelomatose-cellelinjer og virker synergistisk med dexamethason på induktion af tumorcelle-apoptose i både lenalidomid-følsomme og lenalidomid-resistente cellelinjer.
English: o Educational Health Care Professional's kit o Educational brochures for patients o Patient cards o Summary of Product Characteristics (SmPC) and Package Leaflet and Labelling.
Danish: Informationspakken indeholder følgende: o Sæt med oplysningsmateriale til sundhedspersonale o Informationsbrochurer til patienter o Patientkort o Produktresumé (SmPC), indlægsseddel og etikettering.
English: • Pomalidomide in combination with dexamethasone
Danish: • Pomalidomid i kombination med dexamethason
English: Drug Reaction with Eosinophilia and Systemic Symptoms Toxic Epidermal Necrolysis Stevens-Johnson Syndrome
Danish: Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer Toksisk epidermal nekrolyse Stevens-Johnsons syndrom
English: Log-Rank Test Two sided P-Value d
Danish: Log-rank-test tosidet p-værdid
English: Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see section 5.2).
Danish: Nedsat leverfunktion har en beskeden indvirkning på pomalidomids farmakokinetik (se pkt.
English: Refer also to the bortezomib SmPC.
Danish: Se også produktresuméet for bortezomib.
English: Co-administration of multiple doses of up to 4 mg pomalidomide with 20 mg to 40 mg dexamethasone (a weak to moderate inducer of several CYP enzymes including CYP3A) to patients with multiple myeloma had no effect on the pharmacokinetics of pomalidomide compared with pomalidomide administered alone.
Danish: Samtidig administration af flere doser på op til 4 mg pomalidomid og 20-40 mg dexamethason (en svag til moderat inducer af flere CYP-enzymer, herunder CYP3A) til patienter med myelomatose havde ingen indvirkning på farmakokinetikken af pomalidomid sammenlignet med pomalidomid administreret alene.
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis.
Danish: Det blev fundet, at pomalidomid var teratogent hos både rotter og kaniner, når det blev administreret i perioden med major organogenese.
English: Febrile neutropenia (FN) was reported in 3.2-6.7% of patients and was serious in 1.8-4.0% of patients (see section 4.2 and 4.4).
Danish: Febril neutropeni (FN) blev rapporteret hos 3,2-6,7 % af patienterne og var alvorlig hos 1,8-4,0 % af patienterne (se pkt.
English: A medically supervised pregnancy test should be repeated at least every 4 weeks, including at least 4 weeks after the end of treatment, except in the case of confirmed tubal sterilisation.
Danish: En lægeligt superviseret graviditetstest skal gentages mindst hver 4. uge, inklusive mindst 4 uger efter afslutning af behandlingen undtagen ved bekræftet æggeleder-sterilisation.
English: • Requirements in the event of pregnancy o Instructions to stop pomalidomide immediately upon suspicion of pregnancy if female patients o Need to refer to physician specialised or experienced in dealing with teratology and its diagnosis for evaluation and advice o Local contact details for reporting of any suspected pregnancy o Pregnancy reporting form
Danish: • Krav i forbindelse med en opstået graviditet o Instruktion i omgående at ophøre med pomalidomid, hvis der er mistanke om graviditet hos kvindelige patienter o Nødvendigheden af at opsøge en læge med speciale eller erfaring i teratologi og diagnosticering af misdannelser til vurdering og rådgivning o Detaljerede lokale kontaktoplysninger til rapportering af ethvert tilfælde af mistænkt graviditet o Formular til rapportering af graviditet
English: The most commonly reported serious adverse reaction was pneumonia (9.3%).
Danish: Den mest almindeligt rapporterede alvorlige bivirkning var pneumoni (9,3 %).
English: 4.5 Interaction with other medicinal products and other forms of interaction Effect of pomalidomide on other medicinal products
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4).
Danish: Perifer neuropati forekom hos 55,4 % af patienterne (10,8 % grad 3, 0,7 % grad 4).
English: • Description of the PPP and categorisation of patients based on sex and childbearing potential o Algorithm for implementation of PPP o Definition of women of childbearing potential (WCBP) and actions the physician should take if unsure
Danish: • Beskrivelse af PPP og kategorisering af patienter på basis af køn og fertilitet o Algoritme til implementering af PPP o Definition af kvinder i den fertile alder og af de forholdsregler, som lægen skal tage i tvivlstilfælde
English: Clostridium difficile colitis Bronchitis
Danish: Septisk shock Clostridium difficile-kolitis Bronkitis
English: Pomalidomide is not anticipated to cause clinically relevant pharmacokinetic drug-drug interactions due to P450 isoenzyme inhibition or induction or transporter inhibition when co-administered with substrates of these enzymes or transporters.
Danish: Pomalidomid forventes ikke at forårsage klinisk relevante farmakokinetiske lægemiddelinteraktioner på grund af CYP-isoenzymhæmning eller -induktion eller transporterhæmning, når det administreres samtidigt med substrater for disse enzymer eller transportere.
English: Thrombocytopenia was Grade 3 or 4 in 20.7-27.3% of patients, led to pomalidomide discontinuation in 0.7% of patients and was serious in 0.4-1.7% of patients (see sections 4.2 and 4.4).
Danish: Trombocytopeni var grad 3 eller 4 hos 20,7-27,3 % af patienterne, førte til seponering af pomalidomid hos 0,7 % af patienterne og var alvorligt hos 0,4-1,7 % af patienterne (se pkt.
English: The capsules should not be opened, broken or chewed (see section 6.6).
Danish: Kapslerne må ikke åbnes, knækkes eller tygges (se pkt.
English: If pomalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Danish: Hvis pomalidomid får kontakt med slimhinder, skal de skylles grundigt med vand.
English: Some of these cases have progressed to acute hepatic failure, resulting in discontinuation of pomalidomide.
Danish: Nogle af disse tilfælde udviklede sig til akut leversvigt, og førte til seponering af pomalidomid.
English: Peripheral neuropathy adverse reactions were reported in 12.3% of patients and venous embolic or thrombotic (VTE) adverse reactions were reported in 3.3% of patients.
Danish: Bivirkninger relateret til perifer neuropati blev rapporteret hos 12,3 % af patienterne, og venøse emboliske eller trombotiske (VTE) bivirkninger blev rapporteret hos 3,3 % af patienterne.
English: The mean increases in exposure to pomalidomide in each of these impairment groups are not of a magnitude for which adjustments in schedule or dose are required (see section 4.2).
Danish: Den gennemsnitlige stigning i eksponering for pomalidomid hos hver af disse grupper med nedsat leverfunktion er ikke af en størrelsesorden, hvor det er nødvendigt at justere behandlingsprogrammet eller dosen (se pkt.
English: Do not use while pregnant or breast-feeding.
Danish: Må ikke bruges under graviditet eller amning.
English: • Pomalidomide in combination with bortezomib and dexamethasone In randomised study CC-4047-MM-007, 278 patients received pomalidomide, bortezomib and dexamethasone (Pom+Btz+Dex arm).
Danish: • Pomalidomid i kombination med bortezomib og dexamethason I det randomiserede studie CC-4047-MM-007 fik 278 patienter pomalidomid, bortezomib og dexamethason (Pom+Btz+Dex-armen).
English: How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma.
Danish: Du vil få Imnovid af en læge med erfaring i at behandle myelomatose.
English: Other ≥ Grade 3 dexamethasone-related adverse events
Danish: Andre ≥ grad 3 dexamethason-relaterede bivirkninger
English: Imnovid contains sodium
Danish: Imnovid indeholder natrium
English: • Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
Danish: • Vejrtrækningsbesvær (fra alvorlige brystinfektioner, lungebetændelse, hjertesvigt eller blodpropper).
English: Other ≥ Grade 3 pomalidomide-related adverse events
Danish: Andet ≥ grad 3 pomalidomid-relaterede bivirkninger
English: • See the leaflets that come with bortezomib and dexamethasone for further information on their use and effects.
Danish: • Se indlægssedlerne, der følger med bortezomib og dexamethason, for yderligere oplysninger om brug og virkning.
English: • Fever, chills, sore throat, cough, mouth ulcers or any other signs of infection (due to less white blood cells, which fight infection).
Danish: • Feber, kulderystelser, ondt i halsen, hoste, mundsår eller andre tegn på infektion (skyldes færre hvide blodlegemer, der bekæmper infektioner).
English: To initiate a new cycle of pomalidomide, the neutrophil count must be  1 x 109/l and the platelet count must be  50 x 109/l.
Danish: Dosisjustering eller dosisafbrydelse af pomalidomid For at påbegynde en ny cyklus af pomalidomid skal neutrofiltallet være  1 x 109/l, og trombocyttallet skal være  50 x 109/l.
English: For instructions on dose interruptions or reductions for bortezomib related adverse reactions, physicians should refer to bortezomib Summary of Product Characteristics (SmPC).
Danish: For instruktioner i dosisafbrydelser eller -reduktioner for bortezomib-relaterede bivirkninger, henvises lægerne til produktresuméet for bortezomib.
English: KaplanMeier curve for PFS for the ITT population is provided in Figure 1.
Danish: KaplanMeier-kurven for PFS for ITT-populationen kan ses i figur 1.
English: Hazard Ratio (Pom+LD-Dex:HD-Dex) 2-Sided 95% CI c
Danish: Hazard ratio (POM+LD-Dex:HD-Dex) tosidet 95 % CI c
English: Basal cell carcinoma of the skin, Squamous cell carcinoma of the skin
Danish: Ikke almindelig Basalcellekarcinom i huden, Planocellulært karcinom i huden
English: • Shortness of breath (dyspnoea).
Danish: • Åndenød (dyspnø).
English: All Adverse Reactions /Frequency
Danish: Alle bivirkninger /hyppighed
English: No adverse findings were noted up to 1000 mg/kg/day (175-fold exposure ratio relative to a 4 mg clinical dose).
Danish: Ingen uønskede fund blev bemærket ved op til 1000 mg/kg/dag (175 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
English: Mannitol (E421) Starch, pregelatinised Sodium stearyl fumarate
Danish: Mannitol (E421) Stivelse, prægelatineret Natriumstearylfumarat
English: Patients with a history of severe rash associated with lenalidomide or thalidomide should not receive pomalidomide (see section 4.4).
Danish: Patienter med tidligere svært udslæt i forbindelse med lenalidomid eller thalidomid må ikke få pomalidomid (se pkt.
English: In the Btz+LD-Dex arm, median PFS time was 7.1 months (95% CI: 5.88, 8.48).
Danish: I armen med Btz+LD-Dex var den mediane PFS-tid 7,1 måneder (95 % CI: 5,88;
English: In the rat embryofoetal developmental toxicity study, malformations of absence of urinary bladder, absence of thyroid gland, and fusion and misalignment of lumbar and thoracic vertebral elements (central and/or neural arches) were observed at all dosage levels (25, 250, and 1000 mg/kg/day).
Danish: I det embryoføtale studie af udviklingstoksicitet hos rotter blev der observeret misdannelser som manglende urinblære, manglende tyreoidea samt fusion og forkert placering af lumbale og torakale vertebrale elementer (centrale og/eller neurale buer) ved alle doseringsniveauer (25, 250 og 1000 mg/kg/dag).
English: Dizziness and confusional state have been reported with pomalidomide.
Danish: Der er blevet rapporteret svimmelhed og forvirret tilstand med pomalidomid.
English: Tell your doctor straightaway if you notice any of these symptoms.
Danish: Fortæl det straks til lægen, hvis du bemærker nogle af disse symptomer:
English: For information on bortezomib given in combination with Imnovid, refer to the respective current SmPC.
Danish: For information om bortezomib, der gives i kombination med Imnovid, henvises til det relevante gældende produktresumé.
English: As a precaution, all male patients taking pomalidomide should use condoms throughout treatment duration, during dose interruption and for 7 days after cessation of treatment if their partner is pregnant or of childbearing potential and has no contraception (see sections 4.3 and 4.4).
Danish: Som forholdsregel skal alle mandlige patienter, der er i behandling med pomalidomid, benytte kondom under hele behandlingen, under dosisafbrydelse og i 7 dage efter behandlingsophør, hvis deres partner er gravid eller i den fertile alder og ikke bruger kontraception (se pkt.
English: In order to assist patients in avoiding foetal exposure to pomalidomide, the Marketing Authorisation Holder will provide educational material to health care professionals to reinforce the warnings about the expected teratogenicity of pomalidomide, to provide advice on contraception before therapy is started, and to provide guidance on the need for pregnancy testing.
Danish: Undervisningsmaterialer, ordinations- og udleveringsrestriktioner For at støtte patienterne, så det undgås, at fostre udsættes for pomalidomid, vil indehaveren af markedsføringstilladelsen udlevere undervisningsmateriale til sundhedspersonale for at underbygge advarslerne vedrørende pomalidomids forventede teratogenicitet, for at rådgive om kontraception, inden behandlingen indledes, og for at rådgive om nødvendigheden af graviditetstests.
English: 31 August 2023
Danish: Endelig studierapport: 31. august 2023
English: In patients receiving combination therapy with pomalidomide in clinical studies, infection occurred in 55.0-80.2% of patients (24.0-30.9% Grade 3 or 4).
Danish: Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom infektion hos 55,0-80,2 % af patienterne (24,0-30,9 % grad 3 eller 4).
English: Dyspepsia ≥ Grade 3
Danish: Dyspepsi ≥ grad 3
English: Other serious adverse reactions reported included pyrexia (4.0%), lower respiratory tract infection (2.9%), pulmonary embolism (2.9%), influenza (2.9%), and acute kidney injury (2.9%).
Danish: Andre alvorlige rapporterede bivirkninger omfattede pyreksi (4,0 %), infektion i de nedre luftveje (2,9 %), lungeemboli (2,9 %), influenza (2,9 %) og akut nyreskade (2,9 %).
English: In a fertility and early embryonic development study in rats, pomalidomide was administered to males and females at dosages of 25, 250, and 1000 mg/kg/day.
Danish: I et studie af fertilitet og tidlig embryoudvikling hos rotter blev pomalidomid administreret til hanner og hunner i doser på 25, 250 og 1000 mg/kg/dag.
English: Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking pomalidomide and dexamethasone, combined oral contraceptive pills are not recommended (see also section 4.5).
Danish: På grund af den øgede risiko for venøs tromboemboli hos patienter med myelomatose, som tager pomalidomid og dexamethason, anbefales p-piller af kombinationstypen ikke (se også pkt.
English: Pomalidomide is contraindicated during pregnancy and in women of childbearing potential, except when all the conditions for pregnancy prevention have been met, see section 4.3 and section 4.4.
Danish: Pomalidomid er kontraindiceret under graviditeten og til kvinder i den fertile alder, undtagen hvor alle betingelserne for svangerskabsforebyggelse er opfyldt, se pkt.
English: • your doctor will arrange pregnancy tests before treatment, at least every 4 weeks during treatment, and at least 4 weeks after the treatment has finished.
Danish: • din læge vil sørge for, at der bliver udført graviditetstest før behandlingen, mindst hver 4. uge under behandlingen, og mindst 4 uger efter behandlingen er ophørt.
English: Thrombocytopenia Platelet count < 25 x 10
Danish: Trombocytopeni Trombocyttal < 25 x 109/l
English: Patients at greatest risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Danish: Patienter med stor tumorbyrde inden behandlingen har den største risiko for at få tumorlysesyndrom.
English: In studies, pomalidomide was found to be removed by haemodialysis.
Danish: I studier blev det fundet, at pomalidomid blev fjernet ved hæmodialyse.
English: Interstitial lung disease (ILD)
Danish: Interstitiel lungesygdom (ILD - interstitial lung disease)
English: Consider dose interruption or discontinuation of pomalidomide treatment.
Danish: Overvej dosisafbrydelse eller seponering af behandlingen med pomalidomid.
English: No dose adjustment of pomalidomide is required for patients with renal impairment.
Danish: Dosisjustering af pomalidomid er ikke nødvendig for patienter med nedsat nyrefunktion.
English: On haemodialysis days, patients should take their pomalidomide dose following haemodialysis.
Danish: På dage med hæmodialyse bør patienterne tage deres pomalidomiddosis efter hæmodialyse.
English: • Low blood levels of magnesium (hypomagnesaemia), which may cause tiredness, generalised weakness, muscle cramps, irritability and may result in low blood levels of calcium (hypocalcaemia), which may cause numbness and, or tingling of hands, feet, or lips, muscle cramps, muscle weakness, light-headedness, confusion.
Danish: • Lavt niveau af magnesium i blodet (hypomagnesiæmi), som kan forårsage træthed, en generel svaghedsfølelse, muskelkramper, irritabilitet og kan føre til et lavt niveau af calcium i blodet (hypocalcæmi), hvilket kan forårsage følelsesløshed og/eller en stikkende fornemmelse i hænder, fødder eller læber, muskelkramper, muskelsvaghed, ørhed, forvirring.
English: • Prior to launch, all doctors who intend to prescribe pomalidomide and all pharmacists who may dispense pomalidomide receive a Direct Healthcare Professional Communication as described below.
Danish: • Alle læger, som har til hensigt at ordinere pomalidomid, og alle farmaceuter, der eventuelt udleverer pomalidomid, modtager den nedenfor beskrevne information, der stiles direkte til sundhedspersonalet, inden præparatet markedsføres.
English: The recommended dose of dexamethasone is 20 mg orally once daily, on the days shown in Table 1.
Danish: Den anbefalede dosis af dexamethason er 20 mg oralt én gang dagligt på dagene vist i tabel 1.
English: • Pomalidomide in combination with dexamethasone In randomised study CC-4047-MM-003, 302 patients with relapsed and refractory multiple myeloma were exposed to 4 mg pomalidomide administered once daily for 21 days of each 28-day cycle in combination with a weekly low dose of dexamethasone.
Danish: • Pomalidomid i kombination med dexamethason I det randomiserede studie CC-4047-MM-003 blev 302 patienter med relaps og refraktær myelomatose eksponeret for 4 mg pomalidomid administreret én gang dagligt i 21 dage af hver 28dages cyklus i kombination med en ugentlig lav dosis af dexamethason.
English: Decrease dose by one dose level.
Danish: Reducer dosis med et dosisniveau.
English: 6.1 List of excipients Capsule contents
Danish: 6.1 Hjælpestoffer Kapselindhold
English: • Women of childbearing potential, unless all the conditions of the pregnancy prevention programme are met (see sections 4.4 and 4.6).
Danish: • Kvinder i den fertile alder, medmindre alle betingelserne i ”Programmet til svangerskabsforebyggelse” er opfyldt (se pkt.
English: Bortezomib (1.3 mg/m2/dose) was administered to patients in both study arms on Days 1, 4, 8 and 11 of a 21-day cycle for Cycles 1 to 8; and on Days 1 and 8 of a 21-day cycle for Cycles 9 and onwards.
Danish: Bortezomib (1,3 mg/m2/dosis) blev administreret til patienter i begge studiearme på dag 1, 4, 8 og 11 i en cyklus på 21-dage for cyklus 1 til 8 og på dag 1 og 8 i en cyklus på 21 dage for cyklus 9 og fremover.
English: • Swelling caused by fluid.
Danish: • Hævelse forårsaget af væske.
English: • Guidance on handling pomalidomide for patients, caregivers and family members
Danish: • Vejledning til patienter, omsorgspersoner og familiemedlemmer i håndtering af pomalidomid
English: The median is based on the Kaplan-Meier estimate.
Danish: Medianen er baseret på Kaplan-Meier-estimatet.
English: • Bleeding or bruising without a cause, including nosebleeds and bleeding from the bowels or stomach (due to effects on blood cells called ‘platelets').
Danish: • Blødning eller blå mærker uden årsag, herunder næseblod og blødning fra tarmen eller maven (skyldes virkningen på blodlegemer, der kaldes ‘blodplader').
English: Pomalidomide enhances T cell- and natural killer (NK) cell-mediated immunity and inhibits production of pro-inflammatory cytokines (e.g., TNF-α and IL-6) by monocytes.
Danish: Pomalidomid øger celle-medieret immunitet fra både T-celler og naturlige dræberceller (natural killer cells, NK-celler) og hæmmer monocytters produktion af proinflammatoriske cytokiner (f.eks. TNF-α og IL-6).
English: In patients receiving combination therapy with pomalidomide in clinical studies, thrombocytopenia occurred in 27.0-36.7% of patients.
Danish: Hos patienter, der fik kombinationsbehandling med pomalidomid i kliniske studier, forekom trombocytopeni hos 27,0-36,7 % af patienterne.
English: Ammonium hydroxide (E527)
Danish: Ammoniumhydroxid (E527)