FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pomalidomide in combination with bortezomib and dexamethasone The efficacy and safety of pomalidomide in combination with bortezomib and low -dose dexamethasone (Pom+Btz+LD-Dex) was compared with bortezomib and low-dose dexamethasone (Btz+LD-Dex) in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-007), in previously treated adult patients with multiple myeloma, who had received at least one prior regimen, including lenalidomide and have demonstrated disease progression on or after the last therapy.
Danish: • Pomalidomid i kombination med bortezomib og dexamethason Virkningen og sikkerheden af pomalidomid i kombination med bortezomib og lavdosis dexamethason (Pom+Btz+LD-Dex) blev sammenlignet med bortezomib og lavdosis dexamethason (Btz+LD-Dex) i et multicenter, randomiseret, open-label fase III-studie (CC-4047-MM-007) hos tidligere behandlede voksne patienter med myelomatose, som mindst havde fået et tidligere behandlingsprogram, der indbefattede lenalidomid, og har vist sygdomsprogression under eller efter den sidste behandling.
English: Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis (see section 5.3).
Danish: Det blev fundet, at pomalidomid var teratogent hos både rotter og kaniner, når det blev administreret i perioden med major organogenese (se pkt.
English: • For Cycles 9 and onwards: 10 mg once daily on Days 1, 2, 8 and 9 of each 21-day cycle.
Danish: • For cyklus 9 og fremover: 10 mg én gang dagligt på dag 1, 2, 8 og 9 i hver 21-dages behandlingscyklus.
English: All Adverse Reactions (ADRs) reported in clinical trial MM-007 in patients treated with pomalidomide in combination with bortezomib and dexamethasone.
Danish: Alle bivirkninger rapporteret i det kliniske studie MM-007 hos patienter behandlet med pomalidomid i kombination med bortezomib og dexamethason.
English: • Widespread rash, high body temperature, enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome, Toxic Epidermal Necrolysis or Stevens-Johnson Syndrome).
Danish: • Udbredt udslæt, høj legemstemperatur, forstørrede lymfeknuder og involvering af andre kropsorganer (lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer, som også kaldes DRESS eller lægemiddeloverfølsomhedssyndrom, toksisk epidermal nekrolyse eller Stevens-Johnsons syndrom).
English: • Inflammation of the liver (hepatitis) which can cause itchy skin, yellowing of the skin and the whites of the eyes (jaundice), pale coloured stools, dark coloured urine and abdominal pain.
Danish: • Betændelse i leveren (hepatitis), hvilket kan forårsage hudkløe, gulfarvning af huden og det hvide i øjnene (gulsot), bleg afføring, mørk urin og mavesmerter.
English: These immunosuppressive effects resulted in early euthanasia of 4 monkeys due to poor health condition (watery stool, inappetence, reduced food intake, and weight loss); histopathologic evaluation of these animals showed chronic inflammation of the large intestine and villous atrophy of the small intestine.
Danish: Disse immunsuppressive virkninger førte til tidlig eutanasi hos 4 aber på grund af en dårlig sundhedstilstand (vandig afføring, appetitløshed, nedsat fødeindtagelse og vægttab).
English: Progression Free Survival Time by IRAC Review Based on IMWG Criteria (Stratified Log Rank Test) (ITT Population)
Danish: Progressionsfri overlevelsestid ved IRAC-bedømmelse baseret på IMWG-kriterier (stratificeret log rank-test) (ITT-population)
English: • That if his partner becomes pregnant he should inform his treating doctor immediately
Danish: • At han skal informere den behandlende læge omgående, hvis hans partner bliver gravid
English: For male patients taking pomalidomide, pharmacokinetic data has demonstrated that pomalidomide is present in human semen during treatment.
Danish: Farmakokinetiske data har vist, at pomalidomid er til stede i sæden under behandlingen hos mandlige patienter, som tager pomalidomid.
English: • Pomalidomide in combination with dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 21 of repeated 28-day cycles.
Danish: • Pomalidomid i kombination med dexamethason Den anbefalede startdosis af Imnovid er 4 mg oralt én gang dagligt på dag 1 til 21 i gentagne cyklusser af 28-dages varighed.
English: • Numbness, itching, and a feeling of pins and needles on your skin (paraesthesia).
Danish: • Følelsesløshed, kløe og en følelse af stikken og prikken i huden (paræstesi).
English: Pomalidomide was detected in milk of lactating rats following administration to the mother.
Danish: Pomalidomid blev detekteret i mælken hos diegivende rotter, der havde fået pomalidomid.
English: However, dose interruption / resumption decisions are at physician's discretion per the current Summary of Product Characteristics (SmPC).
Danish: Beslutningerne om dosisafbrydelse/genoptagelse er imidlertid op til lægens skøn i henhold til det gældende produktresumé.
English: Respiratory tract infection Upper respiratory tract infection Nasopharyngitis Herpes zoster
Danish: Luftvejsinfektion Øvre luftvejsinfektion Nasofaryngitis Herpes zoster
English: • Documentation of childbearing potential status
Danish: • Dokumentation for fertilitetsstatus
English: Specifically, pomalidomide inhibits proliferation and induces apoptosis of haematopoietic tumour cells.
Danish: Pomalidomid hæmmer specifikt proliferation og inducerer apoptose af hæmatopoietiske tumorceller.
English: (E172), erythrosin (E127) and white ink.
Danish: erythrosin (E127) samt hvidt blæk.
English: • She understands the need for effective contraception, without interruption, at least 4 weeks before starting treatment, throughout the entire duration of treatment, and at least 4 weeks after the end of treatment
Danish: • Kvinden forstår nødvendigheden af en sikker, uafbrudt kontraception i mindst 4 uger, før behandlingen indledes, under hele behandlingsforløbet og i mindst 4 uger efter behandlingens afslutning
English: For the intention to treat (ITT) population, median PFS time by Independent Review Adjudication Committee (IRAC) review based on IMWG criteria was 15.7 weeks (95% CI: 13.0, 20.1) in the Pom + LD-Dex arm; the estimated 26-week event-free survival rate was 35.99% (±3.46%).
Danish: tid bedømt ved Independent Review Adjudication Committee (IRAC) baseret på IMWG-kriterier 15,7 uger (95 % CI: 13,0-20,1) i POM + LD-Dex-armen, og den estimerede 26-ugers hændelsesfrie overlevelsesrate var 35,99 % ±3,46 %.
English: Other serious adverse reactions reported included febrile neutropenia (4.0%), neutropenia (2.0%), thrombocytopenia (1.7%) and VTE adverse reactions (1.7 %).
Danish: Andre rapporterede alvorlige bivirkninger omfattede febril neutropeni (4,0 %), neutropeni (2,0 %), trombocytopeni (1,7 %) og VTE-bivirkninger (1,7 %).
English: • Pomalidomide in combination with bortezomib and dexamethasone The recommended starting dose of Imnovid is 4 mg orally once daily on Days 1 to 14 of repeated 21-day cycles.
Danish: • Pomalidomid i kombination med bortezomib og dexamethason Den anbefalede startdosis af Imnovid er 4 mg oralt én gang dagligt på dag 1 til 14 i gentagne cyklusser af 21-dages varighed.
English: • Hives (urticaria).
Danish: • Nældefeber (urticaria).
English: Common Febrile neutropenia
Danish: Almindelig Febril neutropeni
English: • The other ingredients are mannitol (E421), starch, pregelatinised, and sodium stearyl fumarate.
Danish: • Øvrige indholdsstoffer: mannitol (E421),stivelse; prægelatineret og natriumstearylfumarat.
English: Pomalidomide must be discontinued for exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected, and should not be resumed following discontinuation for these reactions.
Danish: Pomalidomid skal seponeres ved eksfoliativt eller bulløst udslæt, eller hvis der er mistanke om SJS, TEN eller DRESS.
English: Cardiac failure Atrial fibrillation Myocardial infarction
Danish: Almindelig Hjertesvigt Atrieflimmer Myokardieinfarkt
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50%.
Danish: Hvis potente CYP1A2-hæmmere (f.eks. ciprofloxacin, enoxacin og fluvoxamin) administreres sammen med pomalidomid, skal dosis af pomalidomid reduceres med 50 %.
English: > 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Danish: > 75 år Dag 1, 8, 15 og 22 i hver 28-dages behandlingscyklus
English: Imnovid 1 mg hard capsules Each hard capsule contains 1 mg of pomalidomide.
Danish: Imnovid 1 mg hårde kapsler Hver hård kapsel indeholder 1 mg pomalidomid.
English: • Heart attack (chest pain spreading to the arms, neck, jaw, feeling sweaty and breathless, feeling sick or vomiting).
Danish: • Hjerteanfald (brystsmerter, der spreder sig til arme, hals, kæbe, svedtendens og åndenød, kvalme eller opkastning).
English: ▪ Pregnancy test regime ▪ Advice on suitable tests ▪ Before commencing treatment ▪ During treatment based on method of contraception ▪ After finishing treatment o Need to stop pomalidomide immediately upon suspicion of pregnancy o Need to tell treating doctor immediately upon suspicion of pregnancy
Danish: o Nødvendigheden af sikker kontraception (også selvom kvinden har amenorré) og definition af sikker kontraception ▪ Graviditetstest-regime ▪ Rådgivning om passende test ▪ Før behandlingen påbegyndes ▪ Under behandlingen baserende på kontraceptionsmetoden ▪ Efter behandlingens afslutning o Nødvendigheden af omgående at seponere pomalidomid, hvis der er mistanke om graviditet o Nødvendigheden af omgående at informere lægen, hvis der er mistanke om graviditet
English: • The need to use condoms if sexual partner is pregnant or a WCBP and has no contraception (even if man has had vasectomy) o During pomalidomide treatment (including dose interruptions) o For 7 days following final dose
Danish: • Nødvendigheden af at bruge kondom, hvis partneren, som der er seksuelt samvær med, er gravid eller fertil og ikke anvender nogen former for kontraception (også selvom manden er vasektomeret) o Under behandlingen med pomalidomid (herunder dosisafbrydelser) o I 7 dage efter sidste dosis.
English: • Low red blood cells, which may cause anaemia leading to tiredness and weakness.
Danish: • Lavt antal røde blodlegemer, hvilket kan forårsage blodmangel (anæmi) og medføre træthed og svaghed.
English: • Pomalidomide in combination with dexamethasone The most commonly reported adverse reactions in clinical studies have been blood and lymphatic system disorders including anaemia (45.7%), neutropenia (45.3%) and thrombocytopenia (27%); in general disorders and administration site conditions including fatigue (28.3%), pyrexia (21%) and oedema peripheral (13%); and in infections and infestations including pneumonia (10.7%).
Danish: • Pomalidomid i kombination med dexamethason De mest almindeligt rapporterede bivirkninger i kliniske studier var inden for blod og lymfesystem, herunder anæmi (45,7 %), neutropeni (45,3 %) og trombocytopeni (27 %), inden for almene symptomer og reaktioner på administrationsstedet, herunder træthed (28,3 %), pyreksi (21 %) og perifert ødem (13 %), samt inden for infektioner og parasitære sygdomme, herunder pneumoni (10,7 %).
English: C] -pomalidomide (2 mg) to healthy subjects, approximately 73% and 15% of the radioactive dose was eliminated in urine and faeces, respectively, with approximately 2% and 8% of the dosed radiocarbon eliminated as pomalidomide in urine and faeces.
Danish: 15 % af den radioaktive dosis elimineret i hhv. urin og fæces, hvoraf ca. 2 % og 8 % af det doserede radioaktive kulstof blev elimineret som pomalidomid i urin og fæces.
English: The most commonly reported Grade 3 or 4 adverse reactions were blood and lymphatic system disorders including neutropenia (41.7%), thrombocytopenia (27.3%) and anaemia (14.0%).
Danish: De mest almindeligt rapporterede grad 3 eller 4 bivirkninger var forstyrrelser i blod og lymfesystem, herunder neutropeni (41,7 %), trombocytopeni (27,3 %) og anæmi (14,0 %).
English: Low-dose dexamethasone (20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old]) was administered to patients in both study arms on Days 1, 2, 4, 5, 8, 9, 11 and 12 of a 21-day cycle for Cycles 1 to 8; and on Days 1, 2, 8 and 9 of each subsequent 21-day cycle from Cycles 9 onwards.
Danish: Lavdosis dexamethason (20 mg/dag [≤ 75 år] eller 10 mg/dag [> 75 år]) blev administreret til patienterne i begge studiearme på dag 1, 2, 4, 5, 8, 9, 11 og 12 i en cyklus på 21 dage for cyklus 1 til 8 og på dag 1, 2, 8 og 9 i hver efterfølgende cyklus på 21 dage fra cyklus 9 og fremover.
English: Common Basal cell carcinoma
Danish: Almindelig Basalcellekarcinom
English: Unused medicinal product should be returned to the pharmacist at the end of treatment.
Danish: Ikke anvendt lægemiddel skal afleveres på apoteket efter afsluttet behandling.
English: • The printing ink contains: shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527) (white ink) and shellac, iron oxide black (E172), propylene glycol (E1520) and ammonium hydroxide (E527) (black ink).
Danish: • Prægeblækket indeholder: shellac, titandioxid (E171), simeticon, propylenglycol (E1520) og ammoniumhydroxid (E527) (hvidt blæk) og shellac, jernoxid, sort (E172), propylenglycol (E1520) og ammoniumhydroxid (E527) (sort blæk).
English: These pregnancy tests should be performed on the day of the prescribing visit or in the 3 days prior to the visit to the prescriber.
Danish: Disse graviditetstests skal udføres enten under selve den konsultation, hvor patienten får ordineret lenalidomid, eller inden for de sidste 3 dage inden konsultationen hos den ordinerende læge.
English: ≤ 75 years old Days 1, 8, 15 and 22 of each 28-day treatment cycle
Danish: ≤ 75 år Dag 1, 8, 15 og 22 i hver 28-dages behandlingscyklus
English: In addition, findings consistent with acute myelogenous leukemia led to euthanasia of 1 monkey; clinical observations and clinical pathology and/or bone marrow alterations observed in this animal were consistent with immunosuppression.
Danish: Kliniske observationer og klinisk patologi og/eller knoglemarvsændringer observeret hos dette dyr var i overensstemmelse med immunsuppression.
English: Dose reduction in this table is applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Danish: Dosisreduktionen i denne tabel gælder for pomalidomid i kombination med bortezomib og dexamethason og for pomalidomid i kombination med dexamethason.
English: The most commonly reported Grade 3 or 4 adverse reactions were in the blood and lymphatic system disorders including neutropenia (41.7%), anaemia (27%) and thrombocytopenia (20.7%); in infections and infestations including pneumonia (9%); and in general disorders and administration site conditions including fatigue (4.7%), pyrexia (3%) and oedema peripheral (1.3%).
Danish: De mest almindeligt rapporterede grad 3 eller 4 bivirkninger var inden for blod og lymfesystem, herunder neutropeni (41,7 %), anæmi (27 %) og trombocytopeni (20,7 %), inden for infektioner og parasitære sygdomme, herunder pneumoni (9 %), samt inden for almene symptomer og reaktioner på administrationsstedet, herunder træthed (4,7 %), pyreksi (3 %) og perifert ødem (1,3 %).
English: • The recommended starting dose of dexamethasone is 20 mg per day.
Danish: • Den anbefalede startdosis af dexamethason er 20 mg pr. dag.
English: If you take more Imnovid than you should
Danish: Hvis du har taget for meget Imnovid
English: If pomalidomide is taken during pregnancy, a teratogenic effect of pomalidomide in humans is expected (see section 4.4).
Danish: Det forventes det, at pomalidomid har en teratogen virkning hos mennesker, hvis det indtages under graviditet (se pkt.
English: • Pomalidomide in combination with dexamethasone No dose adjustment is required for pomalidomide.
Danish: • Pomalidomid i kombination med dexamethason Dosisjustering af pomalidomid er ikke nødvendig.
English: Co-administration of the strong CYP1A2 inhibitor fluvoxamine with pomalidomide in the presence of ketoconazole, increased mean exposure to pomalidomide by 107% with a 90% confidence interval [91% to 124%] compared to pomalidomide plus ketoconazole.
Danish: Administration af den potente CYP1A2-hæmmer fluvoxamin sammen med pomalidomid, når ketoconazol var til stede, øgede den gennemsnitlige eksponering for pomalidomid med 107 % (90 % konfidensinterval 91-124 %) sammenlignet med pomalidomid plus ketoconazol.
English: • Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
Danish: • Seksuelt samleje kun med en vasektomeret mandlig partner.
English: • Ovulation inhibitory progesterone-only pills (i.e. desogestrel)
Danish: • Mini-piller kun med ægløsningshæmmende progestogen (f.eks. desogestrel)
English: Hypokalaemia Hyperglycaemia Hypomagnaesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
Danish: Almindelig Hypokaliæmi Hyperglykæmi Hypomagnesiæmi Hypocalcæmi Hypofosfatæmi Hyperkaliæmi Hypercalcæmi
English: • The recommended dose of Imnovid is 4 mg per day.
Danish: • Den anbefalede dosis af Imnovid er 4 mg pr. dag.
English: In a second study to evaluate the contribution of a CYP1A2 inhibitor alone to metabolism changes, co-administration of fluvoxamine alone with pomalidomide increased mean exposure to pomalidomide by 125% with a 90% confidence interval [98% to 157%] compared to pomalidomide alone.
Danish: I et andet studie, der blev udført for udelukkende at evaluere metaboliske ændringer pga. CYP1A2-hæmning, øgede samtidig administration af fluvoxamin alene og pomalidomid den gennemsnitlige eksponering for pomalidomid med 125 % (90 % konfidensinterval 98- 157 %) sammenlignet med pomalidomid alene.
English: Imnovid with dexamethasone only
Danish: Imnovid kun sammen med dexamethason
English: Clostridium difficile colitis Respiratory tract infection Lower respiratory tract infection Lung infection
Danish: Septisk shock Clostridium difficile-kolitis Luftvejsinfektion Nedre luftvejsinfektion Lungeinfektion Influenza
English: Mean normalised AUC exposure to pomalidomide increased by 35.8% with a 90% CI [7.5% to 70.0%] in severe renal impairment patients requiring dialysis (CrCl <30mL/minute requiring dialysis) compared to patients with normal renal function.
Danish: Gennemsnitlig normaliseret AUC-eksponering over for pomalidomid var forøget med 35,8 % med et 90 % CI [7,5 % til 70,0 %] hos patienter med svært nedsat nyrefunktion, der var dialysekrævende (CrCl < 30 ml/minut, dialysekrævende), sammenlignet med patienter med normal nyrefunktion.
English: In patients who received 1 prior antimyeloma line, median PFS time was 20.73 months (95% CI: 15.11, 27.99) in the Pom + Btz + LD-Dex arm and 11.63 months (95% CI: 7.52, 15.74) in the Btz + LD-Dex arm. A 46% risk reduction was observed with Pom + Btz + LD-Dex treatment (HR = 0.54, 95% CI: 0.36,
Danish: Hos patienter, der havde fået 1 tidligere antimyelomlinje, var den mediane PFS-tid 20,73 måneder (95 % CI: 15,11; 27,99) i armen med Pom+Btz+LD-Dex og 11,63 måneder (95 % CI: 7,52; 15,74) i armen med Btz+LD-Dex.
English: Common Pancytopenia
Danish: Almindelig Pancytopeni
English: NE = Not Estimable.
Danish: Bemærk: CI=konfidensinterval, NE = kan ikke estimeres (Not Estimable).
English: • The recommended starting dose of dexamethasone is 40 mg per day.
Danish: • Den anbefalede startdosis af dexamethason er 40 mg pr. dag.
English: Dose modification instructions in this table are applicable to pomalidomide in combination with bortezomib and dexamethasone and to pomalidomide in combination with dexamethasone.
Danish: Instruktionerne i dosisjustering i denne tabel gælder for pomalidomid i kombination med bortezomib og dexamethason og for pomalidomid i kombination med dexamethason.
English: • Adverse event reporting forms
Danish: • Formularer til rapportering af bivirkninger
English: • Pomalidomide in combination with bortezomib and dexamethasone No dose adjustment is required for pomalidomide.
Danish: • Pomalidomid i kombination med bortezomib og dexamethason Dosisjustering af pomalidomid er ikke nødvendig.
English: It is important to note that patients with multiple myeloma treated with pomalidomide may develop additional types of cancer, therefore your doctor should carefully evaluate the benefit and risk when you are prescribed this medicine.
Danish: Det er vigtigt at bemærke, at patienter med myelomatose, der behandles med pomalidomid, kan udvikle andre typer kræft.
English: Mean normalised AUC exposure to pomalidomide was 98.2% with a 90% confidence interval [77.4% to 120.6%] in moderate renal impairment patients (eGFR ≥30 to ≤45 mL/minute/1.73 m2) compared to patients with normal renal function.
Danish: Gennemsnitlig normaliseret AUCeksponering over for pomalidomid var 98,2 % med et 90 % konfidensinterval [77,4 % til 120,6 %] hos patienter med moderat nedsat nyrefunktion (eGFR ≥ 30 til ≤ 45 ml/minut/1,73 m2) sammenlignet med patienter med normal nyrefunktion.
English: • High blood levels of potassium, which may cause abnormal heart rhythm.
Danish: • Forhøjet kalium i blodet, hvilket kan forårsage unormal hjerterytme.
English: • Pregnancy.
Danish: • Udslæt.
English: Name and address of the manufacturer responsible for batch release
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse
English: Instructions for dose reduction for dexamethasone related adverse reactions are outlined in Table 6 below.
Danish: Instruktioner i dosisreduktion for dexamethason-relaterede bivirkninger er anført i tabel 6 nedenfor.
English: Mean normalised AUC exposure to pomalidomide was 100.2% with a 90% confidence interval [79.7% to 127.0%] in severe renal impairment patients not requiring dialysis (CrCl <30 or eGFR <30 mL/minute/1.73 m2) compared to patients with normal renal function.
Danish: Gennemsnitlig normaliseret AUC-eksponering over for pomalidomid var 100,2 % med et 90 % konfidensinterval [79,7 % til 127,0 %] hos patienter med svært nedsat nyrefunktion, som ikke var dialysekrævende (CrCl < 30 eller eGFR < 30 ml/minut/1,73 m2), sammenlignet med patienter med normal nyrefunktion.
English: In rabbits, pomalidomide at dosages ranging from 10 to 250 mg/kg produced embryo-foetal developmental malforma tions.
Danish: Hos kaniner forårsagede pomalidomid embryoføtale udviklingsmæssige misdannelser ved doser i intervallet fra 10 til 250 mg/kg.
English: Pneumonia (bacterial, viral and fungal infections, including opportunistic infections)
Danish: Neutropenisk sepsis Pneumoni (bakterie-, virus- og svampeinfektioner, herunder opportunistiske infektioner) Bronkopneumoni Luftvejsinfektion Øvre luftvejsinfektion
English: Before and during the treatment with Imnovid you will have regular blood tests.
Danish: Du vil få taget blodprøver før behandlingen og regelmæssigt under behandlingen med Imnovid.
English: • Muscle spasm, muscle weakness.
Danish: • Muskelspasmer, muskelsvaghed.
English: Dexamethasone dose modification instructions Toxicity
Danish: Instruktioner i dosisjustering af dexamethason Toksicitet
English: Uncommon Cerebrovascular accident
Danish: Ikke almindelig Cerebrovaskulært anfald
English: > 75 years old Dose (Cycle 1-8: Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21-day cycle Cycle ≥ 9: Days 1, 2, 8, 9 of a 21-day cycle)
Danish: > 75 år Dosis (cyklus 1-8: Dag 1, 2, 4, 5, 8, 9, 11, 12 i en 21-dages cyklus Cyklus ≥ 9: Dag 1, 2, 8, 9 i en 21dages cyklus)
English: Rash Rash = Grade 2-3
Danish: Udslæt Udslæt = grad 2-3
English: Dose Level -1
Danish: Dosisniveau -1
English: • you must use effective methods of contraception for at least 4 weeks before starting treatment, for the whole time you are taking treatment, and until at least 4 weeks after stopping treatment.
Danish: • skal du bruge sikker prævention i mindst 4 uger før, behandlingen påbegyndes, i al den tid, du får behandlingen, og i mindst 4 uger efter behandlingsophør.
English: • The recommended starting dose of Imnovid is 4 mg per day.
Danish: • Den anbefalede startdosis af Imnovid er 4 mg pr. dag.