FrancophonIA/ELRC3.0 huggingface dataset:
English: A medically supervised pregnancy test should be performed during the consultation, when pomalidomide is prescribed, or in the 3 days prior to the visit to the prescriber once the patient had been using effective contraception for at least 4 weeks.
Danish: En lægeligt superviseret graviditetstest skal udføres enten under selve den konsultation, hvor patienten får ordineret pomalidomid, eller inden for de sidste 3 dage inden konsultationen hos den ordinerende læge.
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 21-dages cyklus)
English: Titanium dioxide (E171) Indigotine (E132) Brilliant blue FCF (E133) White ink
Danish: Titandioxid (E171) Indigotin (E132) Brilliant blue FCF (E133) Hvidt blæk
English: When Imnovid is used with dexamethasone, in people who have had at least two other treatments, it can stop multiple myeloma getting worse:
Danish: Fordelen ved at bruge Imnovid sammen med dexamethason Når Imnovid anvendes sammen med dexamethason hos personer, som har fået mindst to andre behandlinger, kan det forhindre, at myelomatosen forværres:
English: Very Common Neutropenia Thrombocytopenia Anaemia
Danish: Meget almindelig Neutropeni Trombocytopeni Anæmi
English: Propylene glycol (E1520) Ammonium hydroxide (E527)
Danish: Propylenglycol (E1520) Ammoniumhydroxid (E527)
English: Data cutoff: 07 Sep 2012
Danish: Dataafskæring: 7. september 2012
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups.
Danish: c Baseret på Cox proportionale hazards model, som sammenligner hazard-funktionerne relateret til behandlingsgrupperne, d P-værdien er baseret på en non-stratificeret log-rank-test.
English: Imnovid 2 mg hard capsules, Imnovid 3 mg hard capsules, Imnovid 4 mg hard capsules White ink
Danish: Imnovid 2 mg hårde kapsler, Imnovid 3 mg hårde kapsler, Imnovid 4 mg hårde kapsler Hvidt blæk
English: If strong inhibitors of CYP1A2 (e.g. ciprofloxacin, enoxacin and fluvoxamine) are co-administered with pomalidomide, reduce the dose of pomalidomide by 50% (see sections 4.5 and 5.2).
Danish: Hvis potente CYP1A2-hæmmere (f.eks. ciprofloxacin, enoxacin og fluvoxamin) administreres sammen med pomalidomid, skal dosis af pomalidomid reduceres med 50 % (se pkt.
English: The primary efficacy endpoint was progression free survival by International Myeloma Working Group (IMWG criteria).
Danish: Det primære effekt endepunkt var progressionsfri overlevelse i henhold til kriterierne fra International
English: Caution should be exercised when pomalidomide in combination with dexamethasone is used in patients previously infected with HBV, including patients who are anti-HBc positive but HBsAg negative.
Danish: For patienter, der testes positive for HBV-infektion, anbefales konsultation med en læge med ekspertise i behandlingen af hepatitis B. Der bør udvises forsigtighed, når pomalidomid anvendes i kombination med dexamethason til patienter, der tidligere er blevet inficeret med HBV, herunder patienter, som er anti-HBc-positive, men HBsAg-negative.
English: Pomalidomide dose modification instructions Toxicity
Danish: Instruktioner i dosisjustering af pomalidomid∞ Toksicitet
English: Propotion of Patients
Danish: Andel af patienter
English: Common Pulmonary embolism
Danish: Almindelig Lungeemboli
English: Haemorrhagic events have included epistaxis, intracranial haemorrhage and gastrointestinal haemorrhage.
Danish: Blødningshændelser har omfattet epistaxis, intrakraniel blødning og mave-tarm-blødning.
English: Iron oxide black (E172) Propylene glycol (E1520) Ammonium hydroxide (E527)
Danish: Jernoxid, sort (E172) Propylenglycol (E1520) Ammoniumhydroxid (E527)
English: Common Intracranial haemorrhage
Danish: Almindelig Intrakraniel blødning
English: Common Blood uric acid increased
Danish: Almindelig Forhøjet urinsyre i blodet
English: Repeat-dose toxicology studies
Danish: 5.3 Prækliniske sikkerhedsdata Toksicitetsstudier med gentagne doser
English: This includes vasectomised males who should wear a condom if engaged in sexual activity with a pregnant woman or a woman of childbearing potential as seminal fluid may still contain pomalidomide in the absence of spermatozoa.
Danish: som er gravid eller i den fertile alder, da sædvæsken stadig kan indeholde pomalidomid, selvom den ikke indeholder spermatozoer.
English: The efficacy and safety of pomalidomide in combination with dexamethasone were evaluated in a Phase III multi-centre, randomised, open-label study (CC-4047-MM-003), where pomalidomide plus low-dose dexamethasone therapy (Pom+LD-Dex) was compared to high-dose dexamethasone alone (HD-Dex) in previously treated adult patients with relapsed and refractory multiple myeloma, who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Danish: Virkningen og sikkerheden af pomalidomid i kombination med dexamethason blev evalueret i et multicenter, randomiseret, open-label fase III-studie (CC-4047-MM-003), hvor pomalidomid plus lavdosis-dexamethason (Pom+LD-Dex) blev sammenlignet med monoterapi med højdosis dexamethason (HD-Dex) hos tidligere behandlede voksne patienter med relaps og refraktær myelomatose.
English: Hypomagnesaemia Hypocalcaemia Hypophosphataemia Hyperkalaemia Hypercalcaemia
Danish: Almindelig Hypomagnesiæmi Hypocalcæmi Hypofosfatæmi Hyperkaliæmi Hypercalcæmi
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), brilliant blue FCF
Danish: • Kapselskallen indeholder: gelatine, titandioxid (E171), indigotin (E132), brilliant blue FCF
English: ADRs reported in clinical study MM-003 in patients treated with pomalidomide in combination with dexamethasone.
Danish: Bivirkninger rapporteret i det kliniske studie MM-003 hos patienter behandlet med pomalidomid i kombination med dexamethason Systemorganklasse/ foretrukken term
English: Uncommon Blood uric acid increased
Danish: Ikke almindelig Forhøjet urinsyre i blodet
English: Instructions on dose interruptions or reductions for low-dose dexamethasone related adverse reactions are outlined in Tables 4 and 5 below.
Danish: Dosisjustering eller dosisafbrydelse af dexamethason Instruktioner i dosisafbrydelser eller -reduktioner for lavdosis-dexamethason-relaterede bbivirkninger er anført i tabel 4 og 5 nedenfor.
English: Brochure for women patients with childbearing potential
Danish: Brochure til kvindelige patienter i den fertile alder
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.53 (0.37, 0.74) KM median: POM+LD-DEX=NE [48.1, NE] KM median: HD-DEX = 34.0[23.4, 39.9] Events: POM+LD-DEX=75/284 HD-DEX=56/139
Danish: KM median HD-DEX = 34,0 [23,4-39,9] Progression/død; POM+LD-DEX =75/284 HD-DEX = 56/139
English: Instructions for dose interruptions or reductions for pomalidomide related adverse reactions are outlined in Table 2 and 3.
Danish: Dosisjustering eller dosisafbrydelse af pomalidomid Instruktioner i dosisafbrydelser eller -reduktioner for pomalidomid relaterede bivirkninger er anført i tabel 2 og 3 nedenfor.
English: • if you are pregnant or think you may be pregnant or are planning to become pregnant - this is because Imnovid is expected to be harmful to an unborn child. (Men and women taking this medicine must read the section “Pregnancy, contraception and breast-feeding - information for women and men” below).
Danish: • hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid - da Imnovid forventes at være skadeligt for det ufødte barn.
English: Dose Level -2
Danish: Dosisniveau -2
English: Progression Free Survival Time (weeks) Median a
Danish: Døde n (%) Overlevelsestid (uger) Mediana
English: • Safety advice for women of childbearing potential o The need to avoid foetal exposure o Description of the PPP o Need for effective contraception (even if woman has amenorrhoea) and definition of effective contraception
Danish: • Råd om sikkerhed, som er relevante for kvinder i den fertile alder o Nødvendigheden af at undgå føtal eksponering o Beskrivelse af PPP
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules
Danish: Imnovid 1 mg hårde kapsler Imnovid 2 mg hårde kapsler Imnovid 3 mg hårde kapsler Imnovid 4 mg hårde kapsler
English: Oedema ≥ Grade 3
Danish: Ødem ≥ grad 3
English: Muscle weakness ≥ Grade 2
Danish: Muskelsvaghed ≥ grad 2
English: Common Hyperkalaemia Hyponatraemia
Danish: Almindelig Hyperkaliæmi Hyponatriæmi
English: • Prior to prescribing (where appropriate, and in agreement with the National Competent Authority, dispensing) all healthcare professionals who intend to prescribe (and dispense) pomalidomide are provided with a physician information pack containing the following:
Danish: • Alt sundhedspersonale, som har til hensigt at ordinere (og udlevere) pomalidomid, modtager en informationspakke til læger inden ordination (og hvor det er hensigtsmæssigt og efter aftale med den relevante nationale myndighed, inden udleveringen).
English: Any unused medicine should be returned to the pharmacist at the end of treatment.
Danish: Af hensyn til miljøet skal al ikke anvendt medicin afleveres på apoteket efter endt behandling.
English: muscle aches, palpitations, tingling or numbness, dyspnoea, mood changes.
Danish: Knogler, led, muskler og bindevæv
English: Instructions for dose modification for dexamethasone related adverse reactions are outlined in Table 4.
Danish: Dosisjustering eller dosisafbrydelse af dexamethason Instruktioner i dosisjustering for dexamethason-relaterede bivirkninger er anført i tabel 4.
English: Based on Cox proportional hazards model comparing the hazard functions associated with treatment groups, stratified by age (≤75 vs >75),diseases population (refractory to both lenalidomide and bortezomib vs not refractory to both active substances), and prior number of anti myeloma therapy (=2 vs >2).
Danish: >75), sygdomspopulation (refraktær over for både lenalidomid og bortezomib versus ikke refraktær over for begge aktive stoffer) og antal tidligere behandlinger mod myelom (=2 versus.
English: • some antifungals such as ketaconazole
Danish: • nogle lægemidler mod svampeinfektion, såsom ketoconazol
English: Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules pomalidomide
Danish: Imnovid 1 mg hårde kapsler Imnovid 2 mg hårde kapsler Imnovid 3 mg hårde kapsler Imnovid 4 mg hårde kapsler pomalidomid
English: Common Cataract
Danish: Almindelig Katarakt
English: Common Depressed level of consciousness
Danish: Almindelig Nedsat bevidsthed
English: Pneumonia
Danish: Tumorlysesyndrom
English: A total of 559 patients were enrolled and randomised in the study: 281 in the Pom+Btz+LD-Dex arm and 278 in the Btz+LD-Dex arm. 54% of patients were male with median age for the overall population of 68 years (min, max: 27, 89 years).
Danish: I alt 559 patienter indgik og blev randomiseret i studiet: 281 i armen med Pom+Btz+LD-Dex og 278 i armen med Btz+LD-Dex.
English: Imnovid 1 mg hard capsules White ink
Danish: Imnovid 1 mg hårde kapsler Hvidt blæk
English: POM+LD-DEX vs HD-DEX Logrank p-value = < 0.001 (2-sided) HR (95% CI) 0.45 (0.35, 0.59) Events: POM+LD-DEX=164/302 HD-DEX=103/153
Danish: Log-rank p-værdi=< 0,001 (tosidet) HR (95 % CI) 0,45 (0,35-0,59)
English: Bortezomib dose modification or interruption
Danish: Dosisjustering eller dosisafbrydelse af bortezomib
English: Acute kidney injury Chronic kidney injury Urinary retention
Danish: Almindelig Akut nyreskade Kronisk nyreskade Urinretention
English: • Tubal sterilisation
Danish: • Sterilisation ved lukning af æggelederne
English: Alanine aminotransferase increased Weight decreased
Danish: Forhøjet alaninaminotransferase Vægtreduktion
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132) and yellow iron oxide (E172) and white and black ink.
Danish: • Kapselskallen indeholder: gelatine, titandioxid (E171), indigotin (E132) og gul jernoxid (E172) samt hvidt og sort blæk.
English: Very Common Peripheral sensory neuropathy Dizziness
Danish: Meget almindelig Perifer sensorisk neuropati Svimmelhed
English: Upper respiratory tract infection Respiratory tract infection Lower respiratory tract infection Lung infection
Danish: Øvre luftvejsinfektion Luftvejsinfektion Nedre luftvejsinfektion Lungeinfektion Influenza
English: Medicine name Day IMN DEX
Danish: • IMN: Imnovid; DEX: Dexamethason Lægemiddelnavn Dag IMN DEX
English: Hepatobiliary disorders Uncommon Hyperbilirubinaemia
Danish: Lever og galdeveje Ikke almindelig Hyperbilirubinæmi
English: Common Diarrhoea Vomiting Abdominal pain Constipation
Danish: Almindelig Abdominalsmerter Øvre abdominalsmerter Stomatitis
English: Medicine name
Danish: Lægemiddelnavn
English: Hard capsule Imnovid 1 mg hard capsules
Danish: Hård kapsel Imnovid 1 mg hårde kapsler
English: However, dose interruption or resumption decisions are at the physician's discretion per Summary of Product Characteristics (SmPC).
Danish: Beslutninger om dosisafbrydelse eller dosisgenoptagelse sker efter lægens skøn i henhold til produktresuméet.
English: Uncommon Abdominal pain upper Stomatitis
Danish: Ikke almindelig Øvre abdominalsmerter Stomatitis
English: • Brochure for male patients
Danish: • En brochure til mænd
English: Cerebrovascular accident Intracranial haemorrhage
Danish: Ikke almindelig Cerebrovaskulært anfald Intrakraniel blødning
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) Erythrosin (E127) White ink
Danish: Titandioxid (E171) Indigotin (E132) Gul jernoxid (E172) Erythrosin (E127) Hvidt blæk
English: Upper respiratory tract infection Viral upper respiratory tract infection
Danish: Øvre luftvejsinfektion Viral øvre luftvejsinfektion
English: Imnovid 2 mg hard capsules: Dark blue opaque cap and orange opaque body, with “POML 2 mg” written on them.
Danish: Imnovid 2 mg hårde kapsler: Mørkeblå, uigennemsigtig hætte og orange uigennemsigtig kapselunderdel, præget med ”POML2 mg”.
English: Talk to your doctor, pharmacist or nurse before taking Imnovid if:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Imnovid:
English: Uncommon Hyperbilirubinaemia
Danish: Ikke almindelig Hyperbilirubinæmi
English: • Low blood levels of sodium, which may cause tiredness and confusion, muscle twitching, fits
Danish: • Nedsat natrium i blodet, hvilket kan forårsage træthed og forvirring, muskeltrækninger, epileptiske anfald og koma.
English: Depressed level of consciousness Peripheral sensory neuropathy Dizziness
Danish: Nedsat bevidsthed Perifer sensorisk neuropati Svimmelhed
English: Common Febrile neutropenia Leucopenia Lymphopenia
Danish: Almindelig Febril neutropeni Leukopeni Lymfopeni
English: Therefore, the NOAEL for these observed effects was < 25 mg/kg/day (AUC 24h was 39960 ng•h/mL (nanogram•hour/millilitres) at this lowest dose tested, and the exposure ratio was 99-fold relative to a 4 mg clinical dose).
Danish: 39.960 ng•t/ml (nanogram•time/ml) ved denne lavest testede dosis, og eksponeringsratio var 99 gange i forhold til en klinisk dosis på 4 mg).
English: Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 4 gelatin hard capsule.
Danish: Mørkeblå, uigennemsigtig overdel og gul, uigennemsigtig underdel, præget med ”POML” med hvidt blæk og ”1 mg” med sort blæk, størrelse 4, hård gelatinekapsel.
English: Very Common Muscular weakness Back pain
Danish: Meget almindelig Muskelsvaghed Rygsmerter
English: Women of childbearing potential must use at least one effective method of contraception for at least 4 weeks before therapy, during therapy, and until at least 4 weeks after pomalidomide therapy and even in case of dose interruption unless the patient commits to absolute and continuous abstinence confirmed on a monthly basis.
Danish: Kvinder i den fertile alder skal benytte mindst en sikker kontraception i mindst 4 uger før pomalidomid-behandlingen, under behandlingen, og i mindst 4 uger efter behandlingen.
English: • Each capsule contains 1 mg of pomalidomide.
Danish: • Hver kapsel indeholder 1 mg pomalidomid.
English: Common Rash Pruritus
Danish: Almindelig Udslæt Pruritus
English: • one other medicine - called ‘dexamethasone' in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib.
Danish: • ét andet lægemiddel - der kaldes ‘dexamethason', til personer, hvis myelomatose er forværret,
English: Very Common Diarrhoea Vomiting Nausea
Danish: Vaskulære sygdomme Almindelig Dyb venetrombose
English: Very Common Dyspnoea Cough
Danish: Meget almindelig Dyspnø
English: 6.6 Special precautions for disposal and other handling Capsules should not be opened or crushed.
Danish: Kapslerne må ikke åbnes eller knuses.
English: Imnovid 1 mg hard capsules
Danish: Imnovid 1 mg hårde kapsler
English: Imnovid 4 mg hard capsules: Dark blue opaque cap and blue opaque body, with “POML 4 mg” written on them.
Danish: Imnovid 4 mg hårde kapsler: Mørkeblå, uigennemsigtig hætte og blå uigennemsigtig kapselunderdel, præget med ”POML4 mg”.
English: Imnovid 1 mg hard capsule:
Danish: Imnovid 1 mg hård kapsel:
English: Haemorrhage
Danish: Forstoppelse
English: Very Common Insomnia
Danish: Psykiske forstyrrelser Meget almindelig Insomni
English: Imnovid 3 mg hard capsules: Dark blue opaque cap and green opaque body, with “POML 3 mg” written on them.
Danish: Imnovid 3 mg hårde kapsler: Mørkeblå, uigennemsigtig hætte og grøn uigennemsigtig kapselunderdel, præget med ”POML3 mg”.
English: Each hard capsule contains 1 mg of pomalidomide.
Danish: Hver hård kapsel indeholder 1 mg pomalidomid.
English: Pom+Btz+LD-Dex (N = 281)
Danish: Oversigt over samlede effekt data Pom+Btz+LD-Dex (N = 281)
English: • Levonorgestrel-releasing intrauterine system
Danish: • Spiral, som frigiver levonorgestrel
English: Common Febrile neutropenia Lymphopenia
Danish: Almindelig Febril neutropeni Lymfopeni
English: Imnovid 4 mg hard capsule:
Danish: Imnovid 4 mg hård kapsel:
English: • Each capsule contains 4 mg of pomalidomide.
Danish: • Hver kapsel indeholder 4 mg pomalidomid.
English: • Each capsule contains 3 mg of pomalidomide.
Danish: • Hver kapsel indeholder 3 mg pomalidomid.
English: Mean exposure to pomalidomide increased by 58% with a 90% confidence interval [13% to 119%] in moderately hepatically impaired patients compared to healthy subjects.
Danish: Sammenlignet med raske personer steg den gennemsnitlige eksponering for pomalidomid med 51 % (90 % konfidensinterval 9-110 %) hos patienter med let nedsat leverfunktion, med 58 % (90 % konfidensinterval 13-119 %) hos patienter med moderat nedsat leverfunktion og med 72 % (90 % konfidensinterval 24-138 %) hos patienter med svært nedsat leverfunktion.
English: Common Febrile neutropenia Leucopenia
Danish: Almindelig Febril neutropeni Leukopeni
English: Imnovid 1 mg hard capsules pomalidomide
Danish: Imnovid 1 mg hårde kapsler pomalidomid
English: Peripheral sensory neuropathy Peripheral sensorimotor neuropathy
Danish: Perifer sensorisk neuropati Perifer sensomotorisk neuropati
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White and black ink
Danish: Titandioxid (E171) Indigotin (E132) Gul jernoxid (E172) Hvidt og sort blæk
English: Imnovid 1 mg hard capsules Gelatin
Danish: Imnovid 1 mg hårde kapsler Gelatine
English: Common Weight decreased
Danish: Nedsat leverfunktion
English: Imnovid 4 mg hard capsules
Danish: Imnovid 4 mg hårde kapsler
English: Imnovid 2 mg hard capsule:
Danish: Imnovid 2 mg hård kapsel:
English: • Each capsule contains 2 mg of pomalidomide.
Danish: • Hver kapsel indeholder 2 mg pomalidomid.
English: Common Angioedema Urticaria
Danish: Almindelig Nyresvigt Urinretention
English: Peripheral sensory neuropathy Dizziness
Danish: (perifer sensorisk neuropati).
English: Imnovid 3 mg hard capsules
Danish: Imnovid 3 mg hårde kapsler
English: Imnovid 2 mg hard capsules
Danish: Imnovid 2 mg hårde kapsler
English: Each hard capsule contains 3 mg of pomalidomide.
Danish: Hver hård kapsel indeholder 3 mg pomalidomid.
English: Cardiac events, including congestive cardiac failure, pulmonary oedema and atrial fibrillation (see section 4.8), have been reported, mainly in patients with pre-existing cardiac disease or cardiac risk factors.
Danish: Der er blevet rapporteret hjertehændelser, herunder kongestivt hjertesvigt, lungeødem og atrieflimmer (se pkt.
English: Imnovid 4 mg hard capsules pomalidomide
Danish: Imnovid 4 mg hårde kapsler pomalidomid
English: Each hard capsule contains 2 mg of pomalidomide.
Danish: Hver hård kapsel indeholder 2 mg pomalidomid.
English: Each hard capsule contains 4 mg of pomalidomide.
Danish: Hver hård kapsel indeholder 4 mg pomalidomid.
English: Imnovid 3 mg hard capsule:
Danish: Imnovid 3 mg hård kapsel:
English: Imnovid 4 mg hard capsules Gelatin
Danish: Imnovid 4 mg hårde kapsler Gelatine
English: • The capsule shell contains: gelatin, titanium dioxide (E171), indigotine (E132), yellow iron oxide
Danish: • Kapselskallen indeholder: gelatine, titandioxid (E171), indigotin (E132), gul jernoxid (E172)
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Almindelig Pancytopeni
English: Imnovid 2 mg hard capsules pomalidomide
Danish: Imnovid 2 mg hårde kapsler pomalidomid
English: Imnovid 3 mg hard capsules Gelatin
Danish: Imnovid 3 mg hårde kapsler Gelatine
English: • Numbness, tingling or burning sensation to the skin, pains in hands or feet (peripheral sensory neuropathy).
Danish: • Følelsesløshed, stikkende eller brændende fornemmelse i huden, smerter i hænder eller fødder
English: Common Fall
Danish: Almindelig Faldtendens
English: Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 2 gelatin hard capsule.
Danish: Mørkeblå, uigennemsigtig overdel og orange, uigennemsigtig underdel, præget med ”POML 2 mg” med hvidt blæk, størrelse 2, hård gelatinekapsel.
English: Imnovid 2 mg hard capsules Gelatin
Danish: Imnovid 2 mg hårde kapsler Gelatine
English: Imnovid 3 mg hard capsules pomalidomide
Danish: Imnovid 3 mg hårde kapsler pomalidomid
English: Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 2 gelatin hard capsule.
Danish: Mørkeblå, uigennemsigtig overdel og grøn, uigennemsigtig underdel, præget med ”POML 3 mg” med hvidt blæk, størrelse 2, hård gelatinekapsel.
English: What Imnovid looks like and contents of the pack Imnovid 1 mg hard capsules: Dark blue opaque cap and yellow opaque body, with “POML 1 mg” written on them.
Danish: Imnovid 1 mg hårde kapsler: Mørkeblå, uigennemsigtig hætte og gul uigennemsigtig kapselunderdel, præget med ”POML1 mg”.
English: • The printing ink contains: white ink - shellac, titanium dioxide (E171), simeticone, propylene glycol (E1520) and ammonium hydroxide (E527).
Danish: • Prægeblækket indeholder: hvidt blæk - shellac, titandioxid (E171), simeticon, propylenglycol
English: Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 2 gelatin hard capsule.
Danish: Mørkeblå, uigennemsigtig overdel og blå, uigennemsigtig underdel, præget med ”POML 4 mg” med hvidt blæk, størrelse 2, hård gelatinekapsel.
English: Titanium dioxide (E171) Indigotine (E132) Yellow iron oxide (E172) White ink
Danish: Titandioxid (E171) Indigotin (E132) Gul jernoxid (E172) Hvidt blæk
English: Hepatobiliary disorders Uncommon Hepatitis
Danish: Almindelig Hyperurikæmi Ikke almindelig Tumorlysesyndrom
English: Very Common Bone pain Muscle spasms
Danish: Meget almindelig Knoglesmerter Muskelspasmer
English: NE Two sided 95% CIb [48.1, NE] Hazard Ratio (Pom+LD-Dex:HD-Dex) [Two sided 95% CIc] Log-Rank Test Two sided P-Value d
Danish: Hazard ratio (POM+LD-Dex:HD-Dex) [tosidet 95 % CIc]
English: • Imnovid and dexamethasone are taken in ‘treatment cycles'.
Danish: Imnovid og dexamethason tages i behandlingscyklusser.Hver cyklus varer 28 dage (4 uger).
English: Very Common Diarrhoea Nausea
Danish: Almindelig Diarré
English: What Imnovid is
Danish: Sådan virker Imnovid