natgillin/translations-raw huggingface dataset:
Den 1-års hændelsesfrie rate var 52,6 % (± 5,72 %) for Pom + LD-Dex-armen og 28,4 % (± 7,51 %) for HDDex-armen.
The 1-year event free rate was 52.6% (± 5.72%) for the Pom + LD-Dex arm and 28.4% (± 7.51%) for the HD-Dex arm.
Almindelig Hypotension Hypertension
Common Hypotension Hypertension
• Nødvendigheden af omgående at kontakte lægen, hvis der er mistanke om graviditet
• The need to contact their doctor immediately upon suspicion of pregnancy
I overensstemmelse med lokal praksis skal der udføres lægeligt superviserede graviditetstests på kvinder i den fertile alder. Testene skal have en minimumfølsomhed på 25 mIE/ml og foretages som beskrevet nedenfor.
According to local practice, medically supervised pregnancy tests with a minimum sensitivity of 25 mIU/mL must be performed for women of childbearing potential as outlined below.
Bivirkningerne havde tendens til at opstå hyppigere i de første 2 behandlingscyklusser med pomalidomid.
Adverse reactions tended to occur more frequently within the first 2 cycles of treatment with pomalidomide.
P-værdien er baseret på en CMH-test, stratificeret ved alder (<=75 vs. >75), tidligere antal antimyelomprogrammer (1 vs. >1) og beta2.mikroglobulin ved screening (< 3,5 mg/l versus ≥ 3,5 mg/l, ≤ 5,5 mg/l versus > 5,5 mg/l).
The p-value is based on a CMH test, stratified by age (<=75 vs >75), Prior number of antimyeloma regimens (1 vs >1), and Beta-2 microglobulin at screening (< 3.5 mg/L versus ≥ 3.5 mg/L - ≤ 5.5 mg/L versus > 5.5 mg/L).
Det bør overvejes at afbryde eller seponere pomalidomid for grad 2-3 hududslæt.
Pomalidomide interruption or discontinuation should be considered for Grade 2-3 skin rash.
Der er i sjældne tilfælde blevet rapporteret om reaktivering af hepatitis B hos patienter, der fik pomalidomid i kombination med dexamethason, og som tidligere er blevet inficeret med hepatitis Bvirus (HBV).
Reactivation of hepatitis B has been reported rarely in patients receiving pomalidomide in combination with dexamethasone who have previously been infected with the hepatitis B virus (HBV).
• Hævelser i kroppen, herunder hævede arme og ben.
• Swelling of the body, including swelling of the arms or legs.
Samlet overlevelse: ITT-population
Overall Survival: ITT Population
Tobaksrygning vides at inducere CYP1A2-isoformen, men administration af pomalidomid til rygere havde ingen klinisk relevant indvirkning på eksponeringen for pomalidomid sammenlignet med den eksponering for pomalidomid, der blev observeret hos ikke-rygere.
Administration of pomalidomide in smokers, with smoking tobacco known to induce the CYP1A2 isoform, had no clinically relevant effect on exposure to pomalidomide compared to that exposure to pomalidomide observed in non-smokers.
• Råd om sikkerhed, som er relevante for alle patienter o Beskrivelse og håndtering af trombocytopeni, herunder incidensrater fra kliniske studier o Beskrivelse og håndtering af hjertesvigt o Bortskaffelse af uønsket medicin o Lokale, national-specifikke foranstaltninger for, at en ordination af pomalidomid kan udleveres
• Safety advice relevant to all patients o Description and management of thrombocytopenia including incidence rates from clinical studies o Description and management of cardiac failure o Disposal of unwanted medicine o Local country specific arrangements for a prescription for pomalidomide to be dispensed
Yderligere oplysninger om Imnovid findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
PFS blev evalueret i flere relevante undergrupper: køn, race, ECOG-præstationsstatus, stratifikationsfaktorer (alder, sygdomspopulation, tidligere antimyelom-behandlinger [2, > 2], udvalgte parametre af prognostisk signifikans (beta-2-mikroglobulinniveau, albuminniveau og nedsat nyrefunktion ved baseline samt cytogenetisk risiko) samt eksponering og refraktær tendens ved tidligere anti-myelom-behandlinger.
PFS was evaluated in several relevant subgroups: gender, race, ECOG performance status, stratification factors (age, disease population, prior anti-myeloma therapies [2, > 2]), selected parameters of prognostic significance (baseline beta-2 microglobulin level, baseline albumin levels, baseline renal impairment, and cytogenetic risk), and exposure and refractoriness to prior anti-myeloma therapies.
Virkningen af steroider til kontraception kan muligvis være nedsat ved samtidig behandling med dexamethason (se pkt.
The efficacy of contraceptive steroids may be reduced during cotreatment with dexamethasone (see section 4.5).
Patienter med nedsat leverfunktion bør dog overvåges nøje for bivirkninger, og dosis af pomalidomid bør reduceres eller behandlingen afbrydes, såfremt det er nødvendigt.
However, patients with hepatic impairment should be carefully monitored for adverse reactions and dose reduction or interruption of pomalidomide should be used as needed.
Odds ratio er for Pom+Btz+LD-Dex:Btz+LD-Dex.
Odds ratio is for Pom+Btz+LD-Dex:Btz+LD-Dex.
• to andre lægemidler - der kaldes ‘bortezomib' (en type kemoterapi) og ‘dexamethason' (et antiinflammatorisk lægemiddel), til personer, som har fået mindst én anden behandlingherunder lenalidomid.
• two other medicines - called ‘bortezomib' (a type of chemotherapy medicine) and ‘dexamethasone' (an anti-inflammatory medicine) in people who have had at least one other treatment - including lenalidomide.
Neutropeni var den hyppigst rapporterede grad 3 eller 4 hæmatologiske bivirkning hos patienter med relaps / refraktær myelomatose, efterfulgt af anæmi og trombocytopeni.
Haematological events Neutropenia was the most frequently reported Grade 3 or 4 haematological adverse reaction in patients with relapsed/refractory multiple myeloma, followed by anaemia and thrombocytopenia.
• En brochure til kvindelige patienter i den fertile alder og deres partnere
• Brochure for women patients of childbearing potential and their partners
Behandling med pomalidomid kombineret med dexamethason bør gives, indtil der opstår sygdomsprogression eller uacceptabel toksicitet.
Treatment with pomalidomide combined with dexamethasone should be given until disease progression or until unacceptable toxicity occurs.
Ved 250 mg/kg/dag omfattede de føtale misdannelser abnormiteter af lemmer (bøjede og/eller roterede for- og/eller bagben, ikke vedhæftede eller manglende tæer) og dermed forbundne skeletmisdannelser (ikke ossificerede metakarpalknogler, forkert placerede falanks og metakarpalknogler, manglende tæer, ikke ossificerede falanks samt korte, ikke ossificerede eller bøjede tibia), moderat dilation af den laterale ventrikel i hjernen, unormal placering af den højre subclavia-arterie, manglende intermediær lungelap, lavt placerede nyrer, ændret levermorfologi, ufuldstændigt eller ikke ossificeret bækken, et forhøjet gennemsnit for overtallige torakale ribben og et nedsat gennemsnit for ossificerede tarsalknogler.
At 250 mg/kg/day, fetal malformations included limb anomalies (flexed and/or rotated fore- and/or hindlimbs, unattached or absent digit) and associated skeletal malformations (not ossified metacarpal, misaligned phalanx and metacarpal, absent digit, not ossified phalanx, and short not ossified or bent tibia); moderate dilation of the lateral ventricle in the brain; abnormal placement of the right subclavian artery; absent intermediate lobe in the lungs; low-set kidney; altered liver morphology; incompletely or not ossified pelvis; an increased average for supernumerary thoracic ribs and a reduced average for ossified tarsals.
Lægerne skal være på udkig efter tegn på blødning, herunder epistaxis, især ved samtidig anvendelse af lægemidler, der vides at øge risikoen for blødning (se pkt.
Physicians should observe patients for signs of bleeding including epistaxes, especially with use of concomitant medicinal products known to increase the risk of bleeding (see section 4.8).
Perifer neuropati forekom hos 12,3 % af patienterne (1,0 % grad 3 eller 4).
Peripheral neuropathy occurred in 12.3% of patients (1.0% Grade 3 or 4).
Størstedelen af patienterne var mænd (59 %) og hvide (79 %), medianalderen for den samlede population var 64 år (35-87 år).
The majority of patients were male (59%) and white (79%); the median age for the overall population was 64 years (min, max: 35, 87 years).
Der er blevet rapporteret angioødem og svære kutane reaktioner, herunder SJS, TEN og DRESS, ved brug af pomalidomid.
Angioedema and severe cutaneous reactions including SJS, TEN and DRESS has been reported with the use of pomalidomide.
Ingen reaktioner med perifer neuropati blev rapporteret som alvorlige, og perifer neuropati førte til seponering hos 0,3 % af patienterne (se pkt.
No peripheral neuropathy reactions were reported as serious, and peripheral neuropathy led to dose discontinuation in 0.3% of patients (see section 4.4).
Den mediane behandlingsvarighed var 8,8 måneder (12 behandlingscyklusser) i armen med Pom+Btz+LD-Dex og 4,9 måneder (7 behandlingscyklusser) i armen med Btz+LD-Dex.
The median duration of treatment was 8.8 months (12 treatment cycles) in the Pom+Btz+LD-Dex arm and 4.9 months (7 treament cycles) in the Btz+LD-Dex arm.
Pomalidomid har en direkte anti-myelom tumoricid aktivitet, immunmodulerende aktiviteter og hæmmer stromacellernes støtte til tumorcellevækst ved myelomatose.
Pomalidomide has direct anti-myeloma tumoricidal activity, immunomodulatory activities and inhibits stromal cell support for multiple myeloma tumour cell growth.
Bortezomib (1,3 mg/m2) Dexamethason (20 mg) * • • * For patienter > 75 år, se specielle populationer.
Dexamethasone (20 mg) * • • * For patients > 75 years of age, see Special populations.
Afbryd behandlingen med pomalidomid.
Interrupt pomalidomide treatment.
• Kløende hud.
• Itchy skin.
• Hurtig vejrtrækning, hurtig puls, feber og kulderystelser, udskillelse af meget lidt eller ingen urin, kvalme og opkastning, forvirring, bevidstløshed (skyldes en infektion af blodet, der kaldes sepsis eller septisk shock).
• Rapid breathing, rapid pulse, fever and chills, passing very little to no urine, nausea and vomiting, confusion, unconsciousness (due to infection of blood called sepsis or septic shock).
Progressionsfri overlevelse (uger)
Progression Free Survival (weeks)
I 9-måneders studiet med aber med doser på 0,05, 0,1 og 1 mg/kg/dag blev der observeret morbiditet og tidlig eutanasi hos 6 dyr ved en dosis på 1 mg/kg/dag, og de blev tilskrevet immunsuppressive virkninger (stafylokok-infektion, nedsat antal lymfocytter i det perifere blod, kronisk inflammation i tyktarmen, histologisk lymfoid udtømning og hypocellularitet i knoglemarven) ved høje eksponeringer af pomalidomid (15 gange eksponeringen i forhold til en klinisk dosis på 4 mg).
In the 9-month study in monkeys with doses of 0.05, 0.1, and 1 mg/kg/day, morbidity and early euthanasia of 6 animals were observed at the dose of 1 mg/kg/day and were attributed to immunosuppressive effects (staphylococcal infection, decreased peripheral blood lymphocytes, chronic inflammation of the large intestine, histologic lymphoid depletion, and hypocellularity of bone marrow) at high exposures of pomalidomide (15-fold exposure ratio relative to a 4 mg clinical dose).
Pomalidomid er kontraindiceret til kvinder i den fertile alder, medmindre alle følgende kriterier opfyldes:
For women of childbearing potential, pomalidomide is contraindicated unless all of the following are met:
(E133) samt hvidt blæk.
(E133), and white ink.
I alt 226 (74,8 %) af patienterne, der fik Pom + LD-Dex, og 95 (62,1 %) af patienterne, der fik HD-Dex, levede på afskæringsdatoen (7. september 2012).
A total of 226 (74.8%) of the Pom + LD-Dex patients and 95 (62.1%) of the HD-Dex patients were alive as of the cutoff date (07 Sep 2012).
Blødningsforstyrrelser er blevet rapporteret med pomalidomid, især hos patienter med risikofaktorer, såsom samtidig administration af lægemidler, der øger tendensen til blødning.
Haemorrhagic disorders have been reported with pomalidomide, especially in patients with risk factors such as concomitant medicinal products that increase susceptibility to bleeding.
Den mest almindeligt rapporterede alvorlige bivirkning var pneumoni (11,5 %).
The most commonly reported serious adverse reaction was pneumonia (11.5%).
• Imnovid, bortezomib og dexamethason tages i 'behandlingscyklusser'.
• Imnovid, bortezomib and dexamethasone are taken in ‘treatment cycles'.
Ikke almindelig Forhøjet alaninaminotransferase
Uncommon Alanine aminotransferase increased
Før og under behandlingen bør lægerne evaluere patienterne nøje med standardmetoder for cancerscreening for fremkomst af anden primær malignitet og påbegynde relevant behandling.
Physicians should carefully evaluate patients before and during treatment using standard cancer screening for occurrence of second primary malignancies and institute treatment as indicated.
For hvert efterfølgende fald < 0,5 x 10
For each subsequent drop < 0.5 x 109/l
• Han forstår, at hvis den kvindelige partner bliver gravid, mens han tager pomalidomid eller 7 dage efter, han er holdt op med at tage pomalidomid, skal han straks informere den behandlende læge, og at det anbefales, at den kvindelige partner bliver henvist til en læge med speciale eller erfaring i teratologi for evaluering og rådgivning.
• He understands that if his female partner becomes pregnant whilst he is taking pomalidomide or 7 days after he has stopped taking pomalidomide, he should inform his treating physician immediately and that it is recommended to refer the female partner to a physician specialised or experienced in teratology for evaluation and advice.
Pomalidomid fordeles til sæden hos raske personer med en koncentration på ca. 67 % af plasmaniveauet 4 timer efter dosis (omtrentlig Tmax) efter dosering med 2 mg én gang dagligt i 4 dage.
Pomalidomide is distributed in semen of healthy subjects at a concentration of approximately 67% of plasma level at 4 hours post-dose (approximately Tmax) after 4 days of once daily dosing at 2 mg.
PFS overlevelse er opsummeret i Tabel 11 for ITT-populationen.
PFS is summarised in Table 11 for the ITT population.
Potente CYP1A2-hæmmere
Strong CYP1A2 inhibitors
• Se indlægssedlen, der følger med dexamethason, for yderligere oplysninger om brug og virkning af dexamethason.
• See the leaflet that comes with dexamethasone for further information on its use and effects.
Dexamethason bør seponeres, hvis patienten ikke kan tåle 10 mg, hvis ≤ 75 år, eller 8 mg, hvis > 75 år.
Dexamethasone should be discontinued if the patient is unable to tolerate 10 mg if ≤ 75 years old or 8 mg if > 75 years old.
Patienter med aktuel ≥ grad 2 perifer neuropati blev ekskluderet fra de kliniske studier med pomalidomid.
Patients with ongoing ≥ Grade 2 peripheral neuropathy were excluded from clinical studies with pomalidomide.
• Ændringer af smagssans.
• Changes in the way things taste.
Dexamethason bør seponeres, hvis patienten ikke kan tåle 8 mg, hvis ≤ 75 år, eller 4 mg, hvis > 75 år.
Dexamethasone should be discontinued if the patient is unable to tolerate 8 mg if ≤ 75 years old or 4 mg if > 75 years old.
• At pomalidomid er teratogent hos dyr og forventes at have teratogen virkning hos mennesker
• That pomalidomide is teratogenic in animals and is expected to be teratogenic in humans
• Kvinden forstår nødvendigheden af og accepterer at få foretaget en graviditetstest mindst hver 4. uge undtagen ved bekræftet æggeleder-sterilisation
• She understands the need and accepts to undergo pregnancy testing at least every 4 weeks except in case of confirmed tubal sterilisation
Hvis pulveret med pomalidomid får kontakt med huden, skal huden straks vaskes grundigt med sæbe og vand.
If powder from pomalidomide makes contact with the skin, the skin should be washed immediately and thoroughly with soap and water.
Justering af startdosis af pomalidomid er ikke nødvendig hos patienter med nedsat leverfunktion, defineret i henhold til Child-Pugh-kriterier.
No adjustment of the starting dose of pomalidomide is required for patients with hepatic impairment as defined by the Child-Pugh criteria.
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.
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.
Informationspakken indeholder følgende: o Sæt med oplysningsmateriale til sundhedspersonale o Informationsbrochurer til patienter o Patientkort o Produktresumé (SmPC), indlægsseddel og etikettering.
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.
• Pomalidomid i kombination med dexamethason
• Pomalidomide in combination with dexamethasone
Lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer Toksisk epidermal nekrolyse Stevens-Johnsons syndrom
Drug Reaction with Eosinophilia and Systemic Symptoms Toxic Epidermal Necrolysis Stevens-Johnson Syndrome
Log-rank-test tosidet p-værdid
Log-Rank Test Two sided P-Value d
Nedsat leverfunktion har en beskeden indvirkning på pomalidomids farmakokinetik (se pkt.
Hepatic impairment has a modest effect on the pharmacokinetics of pomalidomide (see section 5.2).
Se også produktresuméet for bortezomib.
Refer also to the bortezomib SmPC.
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.
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.
Det blev fundet, at pomalidomid var teratogent hos både rotter og kaniner, når det blev administreret i perioden med major organogenese.
Pomalidomide was found to be teratogenic in both rats and rabbits when administered during the period of major organogenesis.
Febril neutropeni (FN) blev rapporteret hos 3,2-6,7 % af patienterne og var alvorlig hos 1,8-4,0 % af patienterne (se pkt.
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).
En lægeligt superviseret graviditetstest skal gentages mindst hver 4. uge, inklusive mindst 4 uger efter afslutning af behandlingen undtagen ved bekræftet æggeleder-sterilisation.
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.
• 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
• 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
Den mest almindeligt rapporterede alvorlige bivirkning var pneumoni (9,3 %).
The most commonly reported serious adverse reaction was pneumonia (9.3%).
4.5 Interaktion med andre lægemidler og andre former for interaktion
4.5 Interaction with other medicinal products and other forms of interaction Effect of pomalidomide on other medicinal products
Perifer neuropati forekom hos 55,4 % af patienterne (10,8 % grad 3, 0,7 % grad 4).
Peripheral neuropathy occurred in 55.4 % of patients (10.8% Grade 3; 0.7% Grade 4).
• 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
• 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
Septisk shock Clostridium difficile-kolitis Bronkitis
Clostridium difficile colitis Bronchitis
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.
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.
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.
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).
Kapslerne må ikke åbnes, knækkes eller tygges (se pkt.
The capsules should not be opened, broken or chewed (see section 6.6).
Hvis pomalidomid får kontakt med slimhinder, skal de skylles grundigt med vand.
If pomalidomide makes contact with the mucous membranes, they should be thoroughly flushed with water.
Nogle af disse tilfælde udviklede sig til akut leversvigt, og førte til seponering af pomalidomid.
Some of these cases have progressed to acute hepatic failure, resulting in discontinuation of pomalidomide.
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.
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.
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.
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).
Må ikke bruges under graviditet eller amning.
Do not use while pregnant or breast-feeding.
• 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).
• 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).
Du vil få Imnovid af en læge med erfaring i at behandle myelomatose.
How to take Imnovid Imnovid must be given to you by a doctor with experience in treating multiple myeloma.
Andre ≥ grad 3 dexamethason-relaterede bivirkninger
Other ≥ Grade 3 dexamethasone-related adverse events
Imnovid indeholder natrium
Imnovid contains sodium
• Vejrtrækningsbesvær (fra alvorlige brystinfektioner, lungebetændelse, hjertesvigt eller blodpropper).
• Shortness of breath (from serious chest infection, inflammation of the lung, heart failure or blood clot).
Andet ≥ grad 3 pomalidomid-relaterede bivirkninger
Other ≥ Grade 3 pomalidomide-related adverse events