FrancophonIA/ELRC3.0 huggingface dataset:
English: Adult population aged 65 years or older with AML with > 30% marrow blasts The most common serious adverse reactions (≥ 10%) noted from AZA-AML-001 within the azacitidine treatment arm included febrile neutropenia (25.0%), pneumonia (20.3%), and pyrexia (10.6%).
Danish: Voksenpopulation i alderen 65 år eller derover med AML med > 30 % knoglemarvsblaster De hyppigste alvorlige bivirkninger (≥ 10 %) registreret fra AZA-AML-001 i azacitidin-armen omfattede febril neutropeni (25,0 %), pneumoni (20,3 %) og pyreksi (10,6 %).
English: Do not use Azacitidine Celgene
Danish: Brug ikke Azacitidin Celgene
English: In all pre- specified subgroups age [(< 75 years & ≥ 75 years), gender, race, ECOG performance status (0 or 1 & 2) , baseline cytogenetic risk (intermediate & poor) , geographic region, WHO classification of AML (including AML with myelodysplasia-related changes), baseline WBC count (≤ 5 x10
Danish: I alle de præspecificerede undergrupper alder [(< 75 år og ≥ 75 år), køn, race, ECOG-præstationsstatus (0 eller 1 & 2), cytogenetisk risiko ved baseline (intermediær og ringe), geografisk region, WHOklassifikation af AML (herunder AML med myelodysplasi-relaterede ændringer), antallet af hvide blodlegemer ved baseline (≤ 5x10
English: Azacitidine Celgene is indicated for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation (HSCT) with:
Danish: Azacitidin Celgene er indiceret til behandling af voksne patienter, som ikke er egnede til hæmatopoietisk stamcelletransplantation (HSCT), og som lider af:
English: Azacitidine treatment led to a reduced need for red blood cell (RBC) and platelet transfusions.
Danish: Behandling med azacitidin førte til et reduceret behov for transfusioner med røde blodlegemer (RBC) og trombocytter.
English: Adult population aged 65 years or older with AML with > 30% marrow blasts The results presented below represent the intent-to-treat population studied in AZA-AML-001 (see section 4.1 for the approved indication).
Danish: Voksen population i alderen 65 år og derover med AML med > 30 % knoglemarvsblaster Resultaterne vist nedenfor udgør intent-to-treat-populationen undersøgt i AZA-AML-001 (se pkt.
English: Azacitidine Celgene 25 mg/mL powder for suspension for injection
Danish: Azacitidin Celgene 25 mg/ml pulver til injektionsvæske, suspension
English: Necrotising fasciitis, including fatal cases, have been reported in patients treated with azacitidine.
Danish: Nekrotiserende fasciitis, herunder med dødeligt udfald, er blevet rapporteret hos patienter i behandling med azacitidin.
English: Overall response rate (complete remission [CR] + complete remission with incomplete blood count recovery [CRi]) as determined by the IRC was 27.8% in the azacitidine group and 25.1% in the combined CCR group (p = 0.5384).
Danish: Den samlede responsrate (fuldstændig remission [CR] + fuldstændig remission med ufuldstændig genetablering af antal blodlegemer [CRi]) bedømt af IRC var 27,8 % i gruppen med azacitidin og 25,1 % i den kombinerede CCR-gruppe (p=0,5384).
English: Following subcutaneous administration of a single 75 mg/m dose, mean exposure values (AUC and Cmax) from subjects with mild, moderate and severe renal impairment were increased by 11-21%, 15-27%, and 41-66%, respectively, compared to normal renal function subjects.
Danish: Efter subkutan administration af en enkelt dosis på 75 mg/m var de gennemsnitlige eksponeringsværdier (AUC og Cmax) forhøjet med hhv. 11-21 %, 15-27 % og 41-66 % hos personer med let, moderat og svært nedsat nyrefunktion, sammenlignet med personer med normal nyrefunktion.
English: If the decrease in WBC or ANC or platelets is greater than 50 % from that prior to treatment, with no improvement in cell line differentiation, the next cycle of Azacitidine Celgene therapy should be delayed until the platelet count and the ANC have recovered.
Danish: Hvis reduktionen i WBC, ANC eller trombocytter er på mere end 50 % i forhold til reduktionen før behandlingen, og uden forbedring i cellelinjedifferentieringen, bør den næste behandlingscyklus med Azacitidin Celgene udsættes, indtil trombocyttallet og ANC er restitueret.
English: *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Following dose modifications, the cycle duration should return to 28 days.
Danish: *Restituering = Givne hæmatologiske parametre ≥ nadirtal+ (0,5 x [baseline-tal -nadirtal]) Efter dosisjusteringerne bør cyklusvarigheden atter være 28 dage.
English: The survival benefits of azacitidine were consistent regardless of the CCR treatment option (BSC alone, low-dose cytarabine plus BSC or standard induction chemotherapy plus BSC) utilised in the control arm.
Danish: Overlevelsesgevinsten ved azacitidin var konsekvent, uanset hvilken CCR-behandlingsoption (BSC alene, lavdosis cytarabin plus BSC eller standard induktionskemoterapi plus BSC), der blev anvendt i kontrolgruppen.
English: Method of administration Do not filter the suspension after reconstitution.
Danish: Administration Suspensionen må ikke filtreres efter rekonstitution.
English: If haematological toxicity is observed following Azacitidine Celgene treatment, the next cycle of the therapy should be delayed until the platelet count and the ANC have recovered.
Danish: Hvis der observeres hæmatologisk toksicitet efter behandlingen med Azacitidin Celgene, bør behandlingen udsættes, indtil trombocyttallet og ANC er restitueret.
English: What you need to know before you use Azacitidine Celgene
Danish: Det skal du vide, før du begynder at bruge Azacitidin Celgene
English: Azacitidine treatment improved peripheral blood counts and led to a reduced need for RBC and platelet transfusions.
Danish: Behandling med azacitidin forbedrede de perifere blodtal og førte til et nedsat behov for transfusion af røde blodlegemer og blodplader.
English: CCR consisted of BSC alone (n=45), low-dose cytarabine plus BSC (n=158), or standard intensive chemotherapy with cytarabine and anthracycline plus BSC (n=44).
Danish: CCR bestod af BSC alene (n=45), lavdosis-cytarabin plus BSC (n=158) eller standard intensiv kemoterapi med cytarabin og antracyklin plus BSC (n=44).
English: In patients who achieved CR or CRi, the median duration of remission was 10.4 months (95% CI = 7.2, 15.2) for the azacitidine subjects and 12.3 months (95% CI = 9.0, 17.0) for the CCR subjects.
Danish: Hos patienter, der opnåede CR eller CRi, var den mediane remissionsvarighed 10,4 måneder (95 % CI=7,2; 15,2) for azacitidin-gruppen og 12,3 måneder (95 % CI=9,0; 17,0) for CCR-gruppen.
English: In the ITT analysis of 488 patients (241 azacitidine and 247 CCR), azacitidine treatment was associated with a median survival of 10.4 months versus 6.5 months for those receiving CCR treatment, a difference of 3.8 months, with a stratified log-rank p-value of 0.1009 (two- sided).
Danish: I ITT-analysen med 488 patienter (241 azacitidin og 247 CCR) blev behandling med azacitidin forbundet med en median overlevelse på 10,4 måneder versus 6,5 måneder for patienter i behandling med CCR, en forskel på 3,8 måneder, med en stratificeret log-rank p-værdi på 0,1009 (to-sidet).
English: When Azacitidine Celgene is reconstituted using water for injections that has not been refrigerated, chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 25 °C for 45 minutes and at 2 °C to 8 °C for 8 hours.
Danish: Når Azacitidin Celgene rekonstitueres med vand til injektionsvæsker, som ikke er nedkølet, er der påvist kemisk og fysisk stabilitet under brug efter opbevaring af det rekonstituerede lægemiddel ved 25 °C i 45 minutter og ved 2 °C til 8 °C i 8 timer.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Azacitidin Celgene på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Reconstituted suspension For storage conditions after reconstitution of the medicinal product, see section 6.3.
Danish: Rekonstitueret suspension Opbevaringsforhold efter rekonstitution af lægemidlet, se pkt.
English: Area under the curve and maximum plasma concentration (Cmax) of subcutaneous admiminstration of azacitidine were approximately proportional within the 25 to 100 mg/m dose range.
Danish: Efter subkutan administration af azacitidin var arealet under kurven og den maksimale plasmakoncentration (Cmax) omtrent proportionale inden for dosisintervallet 25 til 100 mg/m
English: 9/l, and platelets ≥ 75.0 x 10
Danish: 9/l og trombocytter ≥ 75,0 x 10
English: Azacitidine Celgene 25 mg/mL powder for suspension for injection Azacitidine
Danish: Azacitidin Celgene 25 mg/ml pulver til injektionsvæske, suspension azacitidin
English: *Recovery = counts ≥ nadir count + (0.5 x [baseline count - nadir count]) Patients with reduced baseline blood counts (i.e. WBC < 3.0 x 10
Danish: *Restituering = Givne hæmatologiske parametre ≥ nadirtal + (0,5 x [baseline-tal - nadirtal]) Patienter med reducerede hæmatologiske parametre ved baseline (dvs. WBC < 3,0 x 10
English: Talk to your doctor, pharmacist or nurse before using Azacitidine Celgene:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger Azacitidin Celgene:
English: Number of vials required
Danish: Antal nødvendige hætteglas
English: 21 days (28 day treatment cycle), for a median of 6 cycles (range: 1 to 28), BSC- only patients for a median of 3 cycles (range: 1 to 20), low-dose cytarabine patients for a median of 4 cycles (range 1 to 25) and standard intensive chemotherapy patients for a median of 2 cycles (range: 1 to 3, induction cycle plus 1 or 2 consolidation cycles).
Danish: Azacitidin blev administreret med en dosis på 75 mg/m2/dag s.c. i 7 dage efterfulgt af en hvileperiode på 21 dage (28 dages behandlingscyklus) i mediant 6 cyklusser (interval 1 til 28), patienter, der kun fik BSC, fik mediant 3 cyklusser (interval 1 til 20), patienter med lavdosis-cytarabin mediant 4 cyklusser (interval 1 til 25) og patienter i behandling med standard intensiv kemoterapi mediant 2 cyklusser (interval 1 til 3, induktionscyklus plus 1 eller 2 konsolideringscyklusser).
English: Each pack contains one vial of Azacitidine Celgene.
Danish: Hver pakning indeholder et hætteglas med Azacitidin Celgene.
English: Reconstituted Azacitidine Celgene should be injected subcutaneously into the upper arm, thigh or abdomen.
Danish: Efter rekonstitution skal Azacitidin Celgene injiceres subkutant i overarmen, låret eller maven.
English: You should not breast-feed when using Azacitidine Celgene.
Danish: Du må ikke amme, mens du bruger Azacitidin Celgene.
English: Patients received the pre-selected regimen if not randomised to azacitidine.
Danish: Patienterne fik det tildelte behandlingsprogram, hvis de ikke blev randomiseret til azacitidin.
English: When Azacitidine Celgene is reconstituted using refrigerated (2 °C to 8 °C) water for injections, the chemical and physical in-use stability of the reconstituted medicinal product has been demonstrated at 2 °C to 8 °C for 22 hours.
Danish: Når Azacitidin Celgene rekonstitueres med nedkølet (2 °C til 8 °C) vand til injektionsvæsker, er der påvist kemisk og fysisk stabilitet under brug efter opbevaring af det rekonstituerede lægemiddel ved 2 °C til 8 °C i 22 timer.
English: • if you are allergic to azacitidine or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for azacitidin eller et af de øvrige indholdsstoffer i Azacitidin Celgene
English: In patients who were platelet transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of platelet transfusion independence was 10.8 months in the azacitidine group and 19.2 months in the CCR group.
Danish: Hos patienter, der var afhængige af transfusion af blodplader ved baseline, og som opnåede transfusionsuafhængighed i løbet af behandlingen, var den mediane varighed af transfusionsuafhængigheden af blodplader 10,8 måneder i azacitidin-gruppen, og 19,2 måneder i CCR-gruppen.
English: In the ITT analysis of 358 patients (179 azacitidine and 179 CCR), azacitidine treatment was associated with a median survival of 24.46 months versus 15.02 months for those receiving CCR treatment, a difference of 9.4 months, with a stratified log-rank p-value of 0.0001.
Danish: I ITT-analysen af 358 patienter (179 azacitidin og 179 CCR), var behandling med azacitidin associeret med en medianoverlevelse på 24,46 måneder kontra 15,02 måneder for de patienter, der fik CCRbehandling.
English: Of the patients in the azacitidine group who were platelet transfusion dependent at baseline, 40.6% (95% CI = 30.9, 50.8) of these patients became platelet transfusion independent during the treatment period, compared with 29.3% of (95% CI = 19.7, 40.4) patients in the combined CCR groups.
Danish: Ud af patienterne i azacitidin-gruppen, som var afhængige af transfusion af blodplader ved baseline, blev 40,6% (95 % CI=30,9; 50,8) uafhængige af transfusion af blodplader i løbet af behandlingsperioden, sammenlignet med 29,3% (95 % CI=19,7; 40,4) af patienterne i de kombinerede CCR-grupper.
English: 9/l or ANC < 1.5 x 10
Danish: 9/l, ANC ≥1,5 x 10
English: • Sore or runny nose or sinuses (sinusitis).
Danish: • Øm eller løbende næse eller bihuler (bihulebetændelse).
English: Of the patients in the azacitidine group who were RBC transfusion dependent at baseline, 38.5% (95% CI = 31.1, 46.2) of these patients became RBC transfusion independent during the treatment period, compared with 27.6% of (95% CI = 20.9, 35.1) patients in the combined CCR groups.
Danish: Ud af patienterne i azacitidin-gruppen, som var afhængige af transfusion af røde blodlegemer ved baseline, blev 38,5 % (95 % CI=31,1; 46,2) uafhængige af transfusion af røde blodlegemer i løbet af behandlingsperioden, sammenlignet med 27,6 % (95 % CI=20,9; 35,1) af patienterne i de kombinerede CCR-grupper.
English: As part of the inclusion criteria, patients were required to have an ECOG performance status of 0-2 and intermediate- or poor-risk cytogenetic abnormalities.
Danish: præstationsstatus på 0-2 og intermediær eller lav risiko for cytogenetiske anomalier.
English: In patients who were RBC transfusion dependent at baseline and achieved transfusion independence on treatment, the median duration of RBC transfusion independence was 13.9 months in the azacitidine group and was not reached in the CCR group.
Danish: Hos patienter, der var afhængige af transfusion af røde blodlegemer ved baseline, og som opnåede transfusionsuafhængighed i løbet af behandlingen, var den mediane varighed af transfusionsuafhængigheden af røde blodlegemer 13,9 måneder i azacitidin-gruppen, og det blev ikke opnået i CCR-gruppen.
English: Following Azacitidine Celgene treatment, if the decrease in WBC or ANC or platelets from that prior to treatment is ≤ 50 %, or greater than 50 % but with an improvement in any cell line differentiation, the next cycle should not be delayed and no dose adjustment made.
Danish: Hvis reduktionen i WBC, ANC eller trombocytter efter behandling med Azacitidin Celgene er ≤ 50 % i forhold til baseline, bør den næste cyklus ikke udsættes, og der bør ikke foretages en dosisjustering.
English: 9/l and/or absolute neutrophil count (ANC) ≤ 1 x 10
Danish: Neutrophil Count, ANC) ≤ 1 x 10 9/l.
English: What Azacitidine Celgene is and what it is used for What you need to know before you use Azacitidine Celgene How to use Azacitidine Celgene Possible side effects
Danish: Det skal du vide, før du begynder at bruge Azacitidin Celgene Sådan skal du bruge Azacitidin Celgene Bivirkninger
English: What Azacitidine Celgene contains
Danish: Azacitidin Celgene indeholder:
English: OTHER
Danish: Almindelig
English: Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Azacitidin Celgene Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Azacitidine Celgene is contraindicated in patients with advanced malignant hepatic tumours (see sections 4.3 and 4.4).
Danish: Azacitidin Celgene er kontraindiceret hos patienter med fremskredne, maligne levertumorer (se pkt.
English: If the Azacitidine Celgene suspension is prepared using water for injections that has been stored in the refrigerator (2 °C - 8 °C), the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 22 hours.
Danish: Hvis Azacitidin Celgene-suspensionen forberedes med vand til injektionsvæsker, der har været opbevaret i køleskab (2 °C - 8 °C), skal suspensionen sættes i køleskab (2 °C - 8 °C) straks efter forberedelsen, og opbevares i køleskab i maksimalt 22 timer.
English: Each vial contains 100 mg azacitidine.
Danish: Hvert hætteglas indeholder 100 mg azacitidin.
English: If the Azacitidine Celgene suspension is prepared using water for injections that has not been refrigerated, the suspension must be placed in the refrigerator (2 °C - 8 °C) immediately after it is prepared and kept refrigerated for up to a maximum of 8 hours.
Danish: Hvis Azacitidin Celgene-suspensionen forberedes med vand til injektionsvæsker, der ikke er nedkølet, skal suspensionen sættes i køleskab (2 °C - 8 °C) umiddelbart efter forberedelsen, og opbevares i køleskab i maksimalt 8 timer.
English: Elderly patients
Danish: Ældre personer
English: Platelets (x 10
Danish: Trombocytter (x 10 9/l)
English: How to use Azacitidine Celgene
Danish: Sådan skal du bruge Azacitidin Celgene
English: The recommended starting dose for the first treatment cycle, for all patients regardless of baseline haematology laboratory values, is 75 mg/m of body surface area, injected subcutaneously, daily for 7 days, followed by a rest period of 21 days (28-day treatment cycle).
Danish: Behandlingen injiceres subkutant dagligt i 7 dage, efterfulgt af en hvileperiode på 21 dage (28 dages behandlingscyklus).
English: 9/l.
Danish: 9/ eller
English: What Azacitidine Celgene is used for
Danish: Sådan bruges Azacitidin Celgene
English: These proteins encourage the growth of new cells.
Danish: Disse proteiner fremmer væksten af nye celler.
English: It was to be available as tablets to be taken by mouth.
Danish: Det skulle leveres som tabletter, der tages gennem munden.
English: What is Balimek?
Danish: Hvad er Balimek?
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse og har behov for mere information om din behandling, yderligere oplysninger om din behandling, kan du kontakte den læge, der behandler dig.
English: What was Balimek expected to be used for?
Danish: Hvad forventedes Balimek anvendt til?
English: Balimek is a medicine that contains the active substance binimetinib.
Danish: Balimek er et lægemiddel, der indeholder det aktive stof binimetinib.
English: The evidence provided was insufficient to show that Balimek fulfils an unmet medical need.
Danish: Evidensen var ikke tilstrækkelig til at vise, at Balimek opfylder et uopfyldt medicinsk behov.
English: Withdrawal of the marketing authorisation application for Balimek (binimetinib) EMA/41972/2018
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Balimek (binimetinib) EMA/41972/2018
English: On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.
Danish: Den 4. januar 2018 meddelte Pierre Fabre Médicament officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Balimek til behandling af melanom.
English: Considering this, along with data on the time patients lived overall and their quality of life, the CHMP considered that Balimek's effectiveness was questionable.
Danish: I betragtning af dette og sammenholdt med data for den tid, patienterne levede samlet set, og deres livskvalitet, fandt CHMP, at Balimeks virkning var tvivlsom.
English: The company had not responded to the last round of questions at the time of the withdrawal.
Danish: Virksomheden havde ikke svaret på den sidste spørgsmålsrunde, da ansøgningen blev trukket tilbage.
English: It was to be used in patients who had a specific genetic mutation (change) called NRAS Q61 mutation.
Danish: Det skulle anvendes hos patienter med en specifik genetisk mutation (forandring), der hedder NRAS Q61.
English: The active substance in Balimek, binimetinib, blocks proteins called MEK1 and MEK2.
Danish: Det aktive stof i Balimek, binimetinib, blokerer proteinerne MEK1 og MEK2.
English: The Committee also considered that although no medicine is approved specifically to treat patients with the NRAS Q61 mutation, there are effective treatments for melanoma in general.
Danish: Udvalget var også af den opfattelse, at selvom der ikke findes et godkendt lægemiddel specifikt til behandling af patienter med NRAS Q61-mutation, findes der effektiv behandling for melanom generelt.
English: The CHMP noted that patients treated with Balimek lived slightly longer without their disease getting worse compared with those receiving dacarbazine.
Danish: CHMP bemærkede, at patienter behandlet med Balimek levede lidt længere, uden at deres sygdom forværredes, sammenholdt med dem, der fik dacarbazin.
English: The company presented data from one main study comparing Balimek with dacarbazine (a cancer medicine used for treating melanoma).
Danish: Virksomheden fremlagde data fra en hovedundersøgelse, hvor Balimek sammenlignedes med dacarbazin (et andet kræftmiddel til behandling af melanom).
English: Moreover, the CHMP was concerned that Balimek was linked to worse side effects than dacarbazine.
Danish: Derudover var CHMP betænkelig ved, at Balimek var forbundet med værre bivirkninger end dacarbazin.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that the withdrawal is based on CHMP's opinion that the data supplied did not provide sufficient evidence to conclude that the medicine's benefits outweigh its risks.
Danish: I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at baggrunden for tilbagetrækningen er CHMP's udtalelse om, at de fremlagte data ikke giver tilstrækkelig evidens til at konkludere, at fordelene ved lægemidlet opvejer risiciene.
English: Withdrawal of the marketing authorisation application for Balimek (binimetinib)
Danish: Tilbagetrækning af ansøgningen om markedsføringstilladelse for Balimek (binimetinib)
English: Based on the data reviewed, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Balimek could not have been approved for the treatment of advanced melanoma in patients with the NRAS Q61 mutation.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Balimek ikke kunne være blevet godkendt til behandling af fremskredent melanom hos patienter med NRAS Q61-mutationen.
English: Balimek was expected to be used for treating melanoma (a type of skin cancer) that had spread or could not be removed by surgery.
Danish: Balimek skulle anvendes til behandling af melanom (en type hudkræft), der har spredt sig, eller som ikke kan fjernes ved operation.
English: The company informed the CHMP that there are no consequences for patients currently included in clinical trials using Balimek.
Danish: Virksomheden har oplyst CHMP om, at beslutningen ikke vil få konsekvenser for patienter, som i øjeblikket deltager i kliniske undersøgelser med Balimek.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Balimek did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Balimek ikke opvejede risiciene.