FrancophonIA/ELRC3.0 huggingface dataset:
English: • If your partner becomes pregnant while you are taking Imnovid, tell your doctor straight away.
Danish: • Hvis din partner bliver gravid, mens du tager Imnovid, skal du straks fortælle det til lægen.
English: It is unknown whether pomalidomide is excreted in human milk.
Danish: Det er ukendt, om pomalidomid udskilles i human mælk.
English: If you take more Imnovid than you should, talk to a doctor or go to a hospital straight away.
Danish: Hvis du har taget for meget Imnovid, skal du straks tale med en læge eller tage på hospitalet.
English: Anticoagulation therapy (unless contraindicated) is recommended (see section 4.4).
Danish: Behandling med antikoagulantia anbefales (medmindre det er kontraindiceret) (se pkt.
English: 7 days after discontinuation of pomalidomide treatment
Danish: 7 dage efter ophør med pomalidomid
English: 14 hard capsules.
Danish: 14 hårde kapsler.
English: Treat with insulin or oral hypoglycaemic agents as needed.
Danish: Behandl med insulin eller orale antidiabetika efter behov.
English: Pomalidomide is extensively metabolised prior to excretion, with the resulting metabolites eliminated primarily in the urine.
Danish: Pomalidomid metaboliseres i udstrakt grad før udskillelse, og de resulterende metabolitter udskilles primært i urinen.
English: Pomalidomide is the major circulating component (approximately 70% of plasma radioactivity) in vivo in healthy subjects who received a single oral dose of [14C]-pomalidomide (2 mg).
Danish: Pomalidomid var den vigtigste cirkulerende komponent (ca. 70 % af radioaktiviteten i plasma) in vivo hos raske personer, der fik en enkelt oral dosis af [14C]-pomalidomid (2 mg).
English: Pomalidomide is eliminated with a median plasma half-life of approximately 9.5 hours in healthy subjects and approximately 7.5 hours in patients with multiple myeloma.
Danish: Pomalidomid elimineres med en median plasma-halveringstid på ca. 9,5 timer hos raske personer, og ca. 7,5 timer hos patienter med myelomatose.
English: At the end of the treatment you should return all unused capsules to the pharmacist.
Danish: Ved behandlingens afslutning skal du aflevere alle ubrugte kapsler på apoteket.
English: Exposure-adjusted rates were comparable across treatment arms.
Danish: Eksponeringsjusterede hyppigheder var sammenlignelige i behandlingsarmene.
English: Pomalidomide is also a substrate of P-glycoprotein in vitro.
Danish: Pomalidomid er også et substrat for P-glykoprotein in vitro.
English: • That pomalidomide may cause thrombocytopenia and the need for regular blood tests
Danish: • At pomalidomid kan forårsage trombocytopeni, og at regelmæssige blodprøver er nødvendige
English: Cycle 9 and onwards
Danish: Cyklus 9 og fremover
English: The 3 predominant metabolites in urine (formed via hydrolysis or hydroxylation with subsequent glucuronidation) account for approximately 23%, 17%, and 12%, respectively, of the dose in the urine.
Danish: De 3 hovedmetabolitter i urinen (der dannes via hydrolyse eller hydroxylering med efterfølgende glukuronidering) udgør ca. hhv. 23 %, 17 % og 12 % af dosis i urinen.
English: Overall survival is summarised in Table 12 for the ITT population.
Danish: Den samlede overlevelse er opsummeret i Tabel 12 for ITT-populationen.
English: Patients should not adjust the dose to make up for a missing dose on previous days.
Danish: Patienterne bør ikke justere dosis for at erstatte en tidligere glemt dosis.
English: If not established on effective contraception, the patient must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated.
Danish: Hvis patienten ikke benytter sikker kontraception, skal han/hun henvises til relevant uddannet sundhedspersonale for at få rådgivning om kontraception, således at kontraceptionen kan påbegyndes.
English: It is not known if Imnovid passes into human breast milk.
Danish: Det er ukendt, om Imnovid udskilles i human brystmælk.
English: Decrease by one dose level if symptoms persist.
Danish: Reducer med et dosisniveau, hvis symptomerne varer ved.
English: • Constipation, diarrhoea or nausea.
Danish: • Forstoppelse, diarré eller kvalme.
English: What Imnovid contains
Danish: Imnovid indeholder
English: If affected, patients should be instructed not to drive cars, use machines or perform hazardous tasks while being treated with pomalidomide.
Danish: Hvis patienten er påvirket, skal han/hun informeres om ikke at føre motorkøretøj eller udføre farlige opgaver under behandlingen med pomalidomid.
English: Pack size of 14 or 21 capsules.
Danish: Pakningsstørrelse på 14 eller 21 kapsler.
English: At 100 and 250 mg/kg/day, there were slight increases in post-implantation loss and slight decreases in fetal body weights.
Danish: Ved 100 og 250 mg/kg/dag var der let øget postimplantationstab og let reduceret føtal legemsvægt.
English: • That the patient should not donate blood during therapy (including during dose interruptions) and for
Danish: • At patienten ikke må være bloddonor under behandlingen (herunder under dosisafbrydelser) og i
English: 95% confidence interval about the median progression free survival time.
Danish: 95 % konfidensinterval for median progressionsfri overlevelsestid.
English: A dose modification may be required (see section 4.2).
Danish: Dosisjustering kan være nødvendig (se pkt.
English: A total of 455 patients were enrolled in the study: 302 in the Pom+LD-Dex arm and 153 in the HD-Dex arm.
Danish: I alt 455 patienter indgik i studiet: 302 i Pom+LD-Dex-armen og 153 i HD-Dex-armen.
English: This could lead to a condition where the tumours break down and cause unusual levels of chemicals in the blood which can lead to kidney failure.
Danish: Dette kan føre til en tilstand, hvor tumorerne nedbrydes og giver usædvanlige niveauer af salte i blodet, hvilket kan føre til nyreskade.
English: • Certain types of skin cancer (squamous cell carcinoma and basal cell carcinoma), which can cause changes in the appearance of your skin or growths on your skin.
Danish: • Visse typer hudkræft (planocellulært karcinom og basalcellekarcinom), som kan ændre din huds udseende eller forårsage vækster på din hud.
English: Oral pomalidomide dose
Danish: Oral pomalidomiddosis
English: Do not take Imnovid:
Danish: Tag ikke Imnovid:
English: • A fast and irregular heartbeat (atrial fibrillation).
Danish: • En hurtig og uregelmæssig puls (atrieflimmer).
English: The primary toxicities observed in monkeys were associated with the haematopoietic/lymphoreticular systems.
Danish: De primære toksiciteter observeret hos aber var forbundet med de hæmatopoietiske /lymforetikulære systemer.
English: What you need to know before you take Imnovid
Danish: Det skal du vide, før du begynder at tage Imnovid
English: If recovery from toxicities is prolonged beyond 14 days, then the dose of dexamethasone will be resumed at one dose level lower than the previous dose.
Danish: Hvis toksiciteterne varer længere end 14 dage, skal dexamethasondosis genoptages med et dosisniveau lavere end den tidligere dosis.
English: • To conduct a non-interventional post-authorisation registry of patients treated with pomalidomide for relapsed and refractory multiple myeloma to monitor the incidence of adverse drug reactions in the “real world situation” and to monitor the implementation and compliance of the Celgene PPP and controlled distribution system on a country basis in agreement with the relevant National Competent Authority (ie., monitoring of Patient Card completion).
Danish: • Udføre et registerstudie uden intervention efter udstedelse af markedsføringstilladelse af patienter behandlet med pomalidomid for relaps og refraktær myelomatose for at overvåge forekomsten af bivirkninger i "den virkelige verden" og for at overvåge implementeringen og overholdelsen af Celgenes PPP og det kontrollerede distributionssystem på landebasis efter aftale med den relevante nationale myndighed (dvs. overvågning af udfyldelsen af patientkort)
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and will provide you with this confirmation.
Danish: Hvis du kan blive gravid, vil din læge notere, at alle nødvendige forholdsregler er blevet truffet, og vil bekræfte dette over for dig, hver gang du får ordineret medicin.
English: Women of childbearing potential should use effective method of contraception.
Danish: Kvinder i den fertile alder skal anvende en sikker kontraceptionsmetode.
English: Fatal infections (Grade 5) occurred in 2.7-4.0% of patients.
Danish: Dødelige infektioner (grad 5) forekom hos 2,7-4,0 % af patienterne.
English: • Age ≥ 50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy or during breast-feeding does not rule out childbearing potential)
Danish: • Alder ≥ 50 år med naturlig amenorré i ≥ 1 år (amenorré som følge af cancerbehandling eller under amning udelukker ikke fertilitet)
English: • A fall in the number of red and white blood cells and platelets at the same time (pancytopenia), which will make you more prone to bleeding and bruising.
Danish: • Nedsat antal røde og hvide blodlegemer og blodplader på samme tid (pancytopeni), hvilket vil give dig en større tendens til at bløde og få blå mærker.
English: Based on in vitro data, pomalidomide is not an inhibitor or inducer of cytochrome P-450 isoenzymes, and does not inhibit any drug transporters that were studied.
Danish: Baseret på in vitro-data hæmmer eller inducerer pomalidomid ikke cytochrom P-450-isoenzymer og hæmmer ikke nogen af de undersøgte lægemiddeltransportere.
English: Interrupt pomalidomide treatment for remainder of cycle.
Danish: Afbryd behandlingen med pomalidomid i resten af cyklussen.
English: Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription and following a medically supervised negative pregnancy test result.
Danish: Udlevering af pomalidomid til kvinder i den fertile alder bør finde stede inden for 7 dage efter ordination og efter en lægeligt superviseret negativ graviditetstest.
English: Frequencies for Pom+Btz+Dex (any grade) 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: Hyppigheder for Pom+Btz+Dex (alle grader) 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: Pomalidomide is absorbed with a maximum plasma concentration (Cmax) occurring between 2 and 3 hours and is at least 73% absorbed following administration of single oral dose.
Danish: Pomalidomid absorberes med en maksimal plasmakoncentration (Cmax) efter 2-3 timer og med mindst 73 % af en enkelt oral dosis absorberet.
English: ANC return to ≥ 1 x 109/l
Danish: ANC vender tilbage til ≥ 1 x 109/l
English: Population pharmacokinetic analyses showed that the pomalidomide pharmacokinetic parameters were not remarkably affected in renally impaired patients (defined by creatinine clearance or estimated glomerular filtration rate [eGFR]) compared to patients with normal renal function (CrCl ≥60 mL/minute).
Danish: Populationsfarmakokinetiske analyser viste, at farmakokinetiske parametre for pomalidomid ikke i bemærkelsesværdig grad var påvirket hos patienter med nedsat nyrefunktion (defineret ved kreatininclearance eller estimeret glomerulær filtrationshastighed [eGFR]) sammenlignet med patienter med normal nyrefunktion (CrCl ≥ 60 ml/minut).
English: Very Common Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Danish: Meget almindelig Pneumoni (bakterie-, virus- og svampeinfektioner, herunder opportunistiske infektioner)
English: The recommended starting dose of bortezomib is 1.3 mg/m2 intravenous or subcutaneous once daily, on the days shown in Table 1.
Danish: Den anbefalede startdosis af bortezomib er 1,3 mg/m2 intravenøst eller subkutant én gang dagligt på dagene vist i tabel 1.
English: The mean changes in exposure to pomalidomide in each of these renal impairment groups are not of a magnitude that requires dosage adjustments.
Danish: De gennemsnitlige ændringer i eksponering over for pomalidomid hos hver af disse grupper med nedsat nyrefunktion er ikke af en størrelsesorden, der kræver dosisjusteringer.
English: • Patient confirmation form ensuring that patients receive the appropriate counselling concerning the treatment, contraceptive methods and pregnancy prevention appropriate for their sex and childbearing status
Danish: • Formular til patientbekræftelse, så der sikres, at patienterne får relevant rådgivning angående behandlingen, præventionsmetoder og svangerskabsforebyggelse i forhold til deres køn og fertilitetsstatus
English: • Abnormal liver test.
Danish: • Unormal leverprøve.
English: Patients with a prior history of serious allergic reactions associated with thalidomide or lenalidomide were excluded from clinical studies.
Danish: Patienter med tidligere alvorlige allergiske reaktioner under behandling med thalidomid eller lenalidomid blev ekskluderet fra de kliniske studier.
English: • Swelling of face, lips, tongue and throat, which may cause difficulty breathing (due to a serious type of allergic reaction called angioedema).
Danish: • Hævelse af ansigt, læber, tunge og hals, hvilket kan forårsage vejrtrækningsbesvær (skyldes en alvorlig form for allergisk reaktion, der kaldes angioødem).
English: The Direct Healthcare Professional Communication shall consist of two parts:
Danish: Den information, der stiles direkte til sundhedspersonale, skal bestå af to elementer:
English: Thalidomide is a known human teratogen that causes severe life-threatening birth defects.
Danish: Thalidomid er kendt som et teratogent stof hos mennesker og forårsager svære livstruende fødselsdefekter.
English: Clinically relevant drug-drug interactions are not anticipated when pomalidomide is coadministered with substrates of these pathways.
Danish: Klinisk relevante lægemiddelinteraktioner forventes ikke, når pomalidomid administreres sammen med substrater for disse metaboliseringsveje.
English: Stop taking Imnovid and see a doctor straight away if you notice any of the serious side effects listed above - you may need urgent medical treatment.
Danish: Hold op med at tage Imnovid og tag straks til lægen, hvis du bemærker en eller flere af de alvorlige bivirkninger anført ovenfor - du kan have behov for akut medicinsk behandling.
English: The MAH should agree the final text of the Direct Healthcare Professional Communication and the physician information pack contents with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Danish: Indehaveren af markedsføringstilladelsen skal aftale den endelige ordlyd af den information, der stiles direkte til sundhedspersonale, og indholdet af informationspakken til læger med den relevante nationale myndighed i hvert enkelt medlemsland og sikre, at materialet indeholder de nøgleelementer, der er beskrevet nedenfor.
English: Infections led to pomalidomide discontinuation in 2.0-2.9% of patients.
Danish: Infektioner førte til seponering af pomalidomid hos 2,0-2,9 % af patienterne.
English: Minimal or mild bile duct proliferation with associated increases in ALP and GGT were also observed at 1 mg/kg/day.
Danish: Minimal eller let galdevejsproliferation med relaterede forhøjelser i alkalisk fosfatase og GGT blev også observeret ved 1 mg/kg/dag.
English: The frequencies of adverse reactions are those reported in the pomalidomide plus dexamethasone arm of study CC-4047-MM-003 (n = 302).
Danish: Hyppighederne af bivirkninger er dem, der blev rapporteret i armen med pomalidomid plus dexamethason i studie CC-4047-MM-003 (n = 302).
English: • Maximum duration of prescription o 4 weeks for women with childbearing potential o 12 weeks for men and women without childbearing potential
Danish: • Maksimal ordinationsvarighed o 4 uger for kvinder i den fertile alder o 12 uger for mænd og kvinder uden for den fertile alder
English: • She should be capable of complying with effective contraceptive measures
Danish: • Kvinden skal være i stand til at benytte effektive præventionsmetoder
English: Stop dexamethasone dosing until the adverse event resolves to ≤ Grade 2.
Danish: Stop behandlingen med dexamethason, indtil bivirkningen er bedret til ≤ grad 2.
English: • The active substance is pomalidomide.
Danish: • Aktivt stof: pomalidomid.
English: Confusion or mood alteration ≥ Grade 2
Danish: Forvirring og humørsvingninger ≥ grad 2
English: Peripheral neuropathy led to discontinuation of bortezomib in approximately 12.9% of patients, pomalidomide in 1.8% and dexamethasone in 2.2 - 8.9% of patients, respectively.
Danish: Perifer neuropati førte til seponering af hhv. bortezomib hos ca. 12,9 % af patienterne, pomalidomid hos 1,8 % og dexamethason hos 2,2 - 8,9 % af patienterne.
English: CYP dependent metabolites account for approximately 43% of the total excreted radioactivity, while nonCYP dependent hydrolytic metabolites account for 25%, and excretion of unchanged pomalidomide accounted for 10% (2% in urine and 8% in faeces).
Danish: CYP-afhængige metabolitter udgør ca. 43 % af den totalt udskilte radioaktivitet, mens ikke-CYPafhængige hydrolytiske metabolitter udgør 25 %, og udskillelsen af uomdannet pomalidomid udgør 10 % (2 % i urin og 8 % i fæces).
English: • Look at the chart below to see what to take on each day of the 3-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 3-ugers cyklus: o Hver dag skal du kigge i diagrammet og finde den korrekte dag for at se hvilke lægemidler, du skal tage.
English: OR (95% CI) e, p-valuef DoR (months) Mediana time (95% CI) b HRc (95% CI)
Danish: OR (95 % CI) e, p-værdif DoR (måneder) Mediana-tid (95 % CI) b HRc (95 % CI)
English: 2 D bar code carrying the unique identifier
Danish: Der er anført en 2D-stregkode, som indeholder en entydig identifikator
English: • A core text as agreed by the CHMP.
Danish: • En kernetekst, som er godkendt af Udvalget for lægemidler til mennesker (CHMP).
English: • you have ever had an allergic reaction such as rash, itching, swelling, feeling dizzy or trouble breathing while taking related medicines called ‘thalidomide' or ‘lenalidomide'.
Danish: • hvis du tidligere har haft en allergisk reaktion, såsom udslæt, kløe, hævelse, svimmelhedsfølelse eller vejrtrækningsbesvær, mens du har taget beslægtede lægemidler, der hed enten ‘thalidomid' eller ‘lenalidomid'.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per capsule, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. kapsel, dvs. det er i det væsentlige "natriumfrit".
English: Dispensing of pomalidomide to women of childbearing potential should occur within 7 days of the prescription.
Danish: Udlevering af pomalidomid til kvinder i den fertile alder bør ske inden for 7 dage efter ordinering.
English: Patients should be instructed never to give this medicinal product to another person and to return any unused capsules to their pharmacist at the end of treatment.
Danish: Patienten skal instrueres i aldrig at overdrage dette lægemiddel til andre og i at aflevere eventuelt ikke anvendte kapsler på apoteket, når behandlingen er afsluttet.
English: Based on population PK analysis using a two-compartment model, healthy subjects and MM patients had comparable apparent clearance (CL/F) and apparent central volume of distribution (V2/F).
Danish: Baseret på en populationsfarmakokinetisk analyse under anvendelse af en to-kompartmentmodel havde raske personer og MM-patienter sammenlignelige tilsyneladende clearance-værdier (CL/F) og tilsyneladende centrale fordelingsvolumener (V2/F).
English: Common Depression
Danish: Almindelig Depression
English: Add H2 blocker or equivalent and resume at one dose level lower than previous dose.
Danish: Tilføj H2-blokker eller tilsvarende og genoptag med et dosisniveau lavere end den tidligere dosis.
English: • He understands the expected teratogenic risk if engaged in sexual activity with a pregnant woman or a woman of childbearing potential
Danish: • Han forstår den forventede teratogene risiko ved seksuelt samvær med en kvinde, som er gravid eller i den fertile alder.
English: Pomalidomide was not mutagenic in bacterial and mammalian mutation assays, and did not induce chromosomal aberrations in human peripheral blood lymphocytes or micronuclei formation in polychromatic erythrocytes in bone marrow of rats administered doses up to 2000 mg/kg/day.
Danish: Pomalidomid var ikke mutagent i bakterielle og mammale mutationsanalyser, og det inducerede ikke kromosomændringer i lymfocytter fra humant, perifert blod eller mikronuklei-dannelse i polykromatiske erytrocytter fra knoglemarven hos rotter, der fik doser på op til 2000 mg/kg/dag.
English: PFS (months) Mediana time (95% CI) b HR c (95% CI), p-valued ORR, n (%) sCR
Danish: PFS (måneder) Mediana-tid (95 % CI) b HR c (95 % CI), p-værdid ORR, n (%) sCR
English: The potential for such drug-drug interactions, including the potential impact of pomalidomide on the pharmacokinetics of combined oral contraceptives, has not been evaluated clinically (see section 4.4 Teratogenicity).
Danish: Muligheden for sådanne lægemiddelinteraktioner, herunder pomalidomids mulige påvirkning af farmakokinetikken af oral kontraception af kombinationstypen, er ikke blevet klinisk evalueret (se pkt.
English: Patients with significant cardiac dysfunction (congestive heart failure [NY Heart Association Class III or IV]; myocardial infarction within 12 months of starting study; unstable or poorly controlled angina pectoris) were excluded from clinical studies with pomalidomide.
Danish: Patienter med signifikant hjertedysfunktion (kronisk hjertesvigt [NYHA klasse III eller IV], myokardieinfarkt inden for 12 måneder før studiestart, ustabil eller dårligt kontrolleret angina pectoris) blev ekskluderet fra de kliniske studier med pomalidomid.
English: • If your partner is pregnant or able to become pregnant, you must use condoms for the whole time you are taking treatment and for 7 days after the end of treatment.
Danish: • Hvis din partner er eller kan blive gravid, skal du bruge kondom i al den tid, du får behandlingen, og i 7 dage efter behandlingsophør.
English: Neutropenia and thrombocytopenia tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
Danish: Neutropeni og trombocytopeni havde en tendens til at forekomme hyppigere i løbet af de første 2 behandlingscyklusser med pomalidomid.
English: Pomalidomide has a mean total body clearance (CL/F) of approximately 7-10 L/hr.
Danish: Pomalidomid har en gennemsnitlig total legemsclearance (CL/F) på ca. 7-10 l/t.
English: Stop taking Imnovid and see a doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Hold op med at tage Imnovid og kontakt straks lægen, hvis du bemærker en af de følgende alvorlige bivirkninger - du kan have behov for akut lægehjælp
English: In peripheral tissues, pomalidomide was preferentially taken up by tumors with apparent peripheral distribution clearance (Q/F) and apparent peripheral volume of distribution (V3/F) 3.7-fold and 8-fold higher, respectively, than that of healthy subjects.
Danish: I det perifere væv blev pomalidomid fortrinsvist optaget i tumorer med en tilsyneladende perifer fordelingsclearance (Q/F) og et tilsyneladende perifert fordelingsvolumen (V3/F), som er hhv. 3,7 og 8 gange større end for raske personer.
English: Pomalidomide crossed the placenta and was detected in foetal blood following administration to pregnant rabbits, see section 5.3.
Danish: Pomalidomid krydsede placenta og blev detekteret i fosterets blod efter administration til drægtige kaniner, se pkt.
English: Second primary malignancies, such as non-melanoma skin cancer, have been reported in patients receiving pomalidomide (see section 4.8).
Danish: Anden primær malignitet, såsom hudcancer, der ikke er melanoma, er blevet rapporteret hos patienter, der fik pomalidomid (se pkt.