FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Danish: Det primære effektendepunkt var progressionsfri overlevelse baseret på en bedømmelse fra en uafhængig review-komite (IRC).
English: In patients with MCL, transient neutropenia that was reversible between cycles was observed, with no evidence of cumulative neutropenia.
Danish: Hos patienter med MCL blev der observeret forbigående neutropeni, som var reversibel mellem cyklusser og uden evidens for kumulativ neutropeni.
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Danish: Eksponering for bortezomib (dosisnormaliseret AUC og Cmax) var sammenlignelig for alle grupper (se pkt.
English: Do not give by other routes.
Danish: Må ikke gives via andre indgiftsveje.
English: Table 11: Efficacy results following the final survival update to VISTA study
Danish: Tabel 11: Effektresultater efter den endelige opdatering af overlevelse i VISTA-studiet
English: 2132JH HOOFDDORP NETHERLANDS
Danish: 2132 JH HOOFDDORP HOLLAND
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Danish: Bortezomib-medieret proteasomhæmning påvirker cancerceller på flere måder, inklusive - men ikke begrænset til - ændring af regulatorproteiner, som styrer cellecyklusprogression og aktiveringen af nuklear faktor kappa B (NF-κB).
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Danish: Granulocyt-kolonistimulerende faktorer kan administreres ved hæmatologisk toksicitet i henhold til lokal standardpraksis.
English: Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Danish: Hæmning af 26S-proteasom forhindrer denne målrettede proteolyse og påvirker multiple signaleringskaskader i cellen, hvilket til sidst resulterer i cancercelledød.
English: In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Danish: I BzmbTDx-gruppen var 12 % af patienterne cytogenetisk klassificeret som højrisiko versus 16 % af patienterne i TDx-gruppen.
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Danish: Håndtering af ortostatisk/postural hypotension kan omfatte justeringer af antihypertensiva, rehydrering eller indgift af mineralkortikosteroider og/eller sympatomimetika.
English: - Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Danish: - Når det er opløst, udtrækkes den relevante mængde af den rekonstituerede opløsning i henhold til beregnet dosis ud fra patientens legemsoverflade.
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Danish: Baseret på dosisændringer i fase II- og III-studier vedrørende myelomatose og erfaring efter markedsføring.
English: Treatment with Bortezomib SUN can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Danish: Behandlingen med Bortezomib SUN kan meget ofte forårsage et fald i antallet af røde og hvide blodlegemer samt blodplader i blodet.
English: Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy.
Danish: Baseret på de præsenterede data var det PRAC's holdning, at produktinformationen skal ændres for at opdatere punkt 4.8 i produktresuméet og de relevante afsnit i indlægssedlen med henblik på at tilføje følgende: chalazion, blefaritis og trombotisk mikroangiopati.
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Danish: Patienter, som havde fået 2 eller 3 tidligere behandlinger, havde en responsrate på 32 % (10/32), og patienter, som havde fået mere end 7 tidligere behandlinger, havde en responsrate på 31 % (21/67).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1102/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1102/001
English: Therefore, patients who experience constipation should be closely monitored.
Danish: Derfor skal patienter, som oplever forstoppelse, monitoreres omhyggeligt.
English: Intrathecal administration
Danish: Intratekal administration
English: Time to first response in CR + PR
Danish: Tid til første respons i CR+PR Median
English: The duration of a treatment cycle is 21 days (3 weeks).
Danish: Varigheden af en behandlingscyklus er 21 dage (3 uger).
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below.
Danish: Lægemiddelbivirkninger, identificeret med en forekomst på ≥ 1 %, tilsvarende eller højere forekomst i BzmbR-CAP-armen og med mindst en mulig eller sandsynlig årsagssammenhæng med komponenterne i BzmbR-CAP-armen, er anført i tabel 8 nedenfor.
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Danish: Uanset β2-mikroglobulintal ved baseline var alle effektparametre (tiden indtil progression og samlet overlevelse samt responsrate) signifikant forbedret i bortezomib-gruppen.
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Danish: Bortezomib blev kun administreret i blok 1 og 2 for at undgå potentiel overlappende toksicitet med co-administrerede lægemidler i blok 3.
English: There was no evidence of cumulative thrombocytopenia.
Danish: Der var ingen tegn på kumulativ trombocytopeni.
English: Therefore, patients must be cautious when driving or using machines and should be advised not to drive or operate machinery if they experience these symptoms (see section 4.8).
Danish: Patienterne skal derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner, og skal advares om ikke at føre motorkøretøj eller betjene maskiner, hvis de oplever disse symptomer (se pkt.
English: It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response.
Danish: Det anbefales, at patienterne får 2 cyklusser med Bortezomib SUN efter bekræftelse af et komplet respons.
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX32.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler, ATC-kode: L01XX32.
English: Bortezomib SUN dose.
Danish: Bortezomib SUN seponeres
English: If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Danish: Hvis du tidligere har haft en hepatitis B-infektion, vil din læge undersøge dig omhyggeligt for at se, om du har tegn på aktiv hepatitis B.
English: NF-kB is a transcription factor whose activation is required for many aspects of tumourigenesis, including cell growth and survival, angiogenesis, cell-cell interactions, and metastasis.
Danish: κB er en transskriptionsfaktor, hvis aktivering kræves til mange aspekter af tumorgenese, inklusive cellevækst og -overlevelse, angiogenese, celle-celle-interaktioner og metastase.
English: Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter) - blodprop i små blodkar (trombotisk mikroangiopati).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 22 July 2016
Danish: Dato for første markedsføringstilladelse : 22 juli 2016 Dato for seneste fornyelse:
English: rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: BSA-normalized clearance of bortezomib in paediatric patients was similar to that observed in adults.
Danish: BSAnormaliseret bortezomib-clearance hos pædiatriske patienter var den samme som den, der observeres hos voksne.
English: No clinical data are available for bortezomib with regard to exposure during pregnancy.
Danish: Der foreligger ingen kliniske data for bortezomib vedrørende eksponering under graviditet.
English: If bortezomib is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Danish: Hvis bortezomib anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun orienteres om de mulige risici for fostret.
English: Herpes zoster virus reactivation
Danish: Herpes zoster-virusreaktivering
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib SUN must be considered unless the benefit of treatment clearly outweighs the risk.
Danish: Hvis toksiciteten ikke forsvinder, eller hvis den forekommer igen ved den laveste dosis, skal seponering af Bortezomib SUN overvejes, medmindre fordelene ved behandlingen tydeligt opvejer risici.
English: In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Danish: Hos patienter er overdosering med mere end det dobbelte af den anbefalede dosis blevet forbundet med akut symptomatisk hypotension og trombocytopeni med dødelig udgang.
English: Overall, the literature results are suggestive of a possible causal association between bortezomib (and other proteasome inhibitors) and TMA.
Danish: Generelt antyder resultaterne fra litteraturen en mulig kausal sammenhæng mellem bortezomib (og andre proteasom-hæmmere) og TMA.
English: Experiments have demonstrated that bortezomib is cytotoxic to a variety of cancer cell types and that cancer cells are more sensitive to the pro-apoptotic effects of proteasome inhibition than normal cells.
Danish: Studier har påvist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for pro-apoptotiske virkninger af proteasomhæmning end normale celler.
English: A hazard ratio < 1 indicates an advantage for BzmbR-CAP. c Based on Kaplan-Meier product limit estimates.
Danish: En hazard-ratio < 1 angiver en fordel for BzmbR-CAP. c Baseret på Kaplan-Meier-estimater for produktgrænser.
English: It is not known whether bortezomib is excreted in human milk.
Danish: Det er ukendt, om bortezomib udskilles i human mælk.
English: There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
Danish: Der er ikke data, der tyder på, at dosisjustering er nødvendig hos patienter over 65 år med myelomatose eller mantle-celle-lymfom.
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Danish: Thalidomid er kontraindiceret under graviditet og til kvinder i den fertile alder, medmindre alle betingelserne i det svangerskabsforebyggende program for thalidomid overholdes.
English: The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Danish: Forekomsten af perifer neuropati øges tidligt i behandlingen og når et højdepunkt i cyklus 5.
English: The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Danish: Cmax var lavere efter subkutan administration (20,4 ng/ml) end efter intravenøs administration (223 ng/ml).
English: There have been fatal cases of inadvertent intrathecal administration of bortezomib.
Danish: Der er forekommet fatale tilfælde efter utilsigtet intratekal administration af bortezomib.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, the scientific conclusions of CHMP are as follows:
Danish: Under hensyntagen til PRAC's vurderingsrapport om PSUR'en/PSUR'erne for bortezomib er CHMP nået frem til følgende videnskabelige konklusioner:
English: This medicine is for intravenous or subcutaneous use.
Danish: Dette lægemiddel er til intravenøs eller subkutan anvendelse.
English: Reduction in serum Mprotein populationg n=667
Danish: Reduktion i serum M-protein populationg n=667
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Danish: - Tjek dosis og koncentration i sprøjten før brug (kontroller, at sprøjten er mærket som intravenøs administration).
English: Unopened vial 18 months.
Danish: Hætteglas inden anbrud 18 måneder.
English: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median duration Days (months) Time to response CR+PR(days)
Danish: 5 (2)b CR+nCR+PR 121 (38)b 56 (18)b 57 (45)d 29 (26)d 64 (34)b 27 (13)b CR+nCR+PR+M R Median varighed dage (måneder) Tiden indtil respons CR+PR (dage)
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Danish: h Inkluderer alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og LDH.
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm.
Danish: Antiviral profylakse blev administreret til 137 af 240 patienter (57 %) i BzmbR-CAP-armen.
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Danish: Hepatitis B-virus (HBV)-reaktivering og -infektion Mantle-celle-lymfom
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Danish: For prækliniske farmakologiske kardiovaskulære sikkerhedsstudier, se pkt.
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Danish: Dosering til behandling af progressiv myelomatose (patienter, som tidligere har fået mindst én behandling)
English: Of those, 121 cases reported chalazion, blepharitis, meibomianitis, and/or Meibomian gland dysfunction.
Danish: Af disse rapporterede 121 tilfælde om chalazion, blefaritis, meibomianitis og/eller dysfunktion af Meiboms kirtler.
English: The ubiquitin-proteasome pathway plays an essential role in regulating the turnover of specific proteins, thereby maintaining homeostasis within cells.
Danish: Ubiquitin-proteasom-pathway'en spiller en vigtig rolle i reguleringen af omsætningen af specifikke proteiner, som derved opretholder homeostasen i cellerne.
English: For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Danish: For patienter med et respons, som først blev dokumenteret ved cyklus 6, blev der givet to supplerende behandlingscyklusser.
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Danish: Perifer neuropati uanset grad og perifer neuropati ≥ grad 3 blev observeret hos henholdsvis 40 % og 8,5 % af patienterne.
English: TTP, days [95% CI]
Danish: TTP, dage [95 % CI]
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Danish: Dosisjusteringer i behandlingsforløbet og ved genoptagelse af kombinationsbehandling med melphalan og prednison
English: Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Danish: Patienter i behandling med orale antidiabetika, som behandles med bortezomib, kan have brug for nøje monitorering af deres blodsukkerniveau og justering af deres antidiabetikadosis.
English: Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Danish: Den mediane overlevelse i Bzmb+M+P-behandlingsgruppen var 56,4 måneder sammenlignet med 43,1 i M+P-behandlingsgruppen.
English: Both men and women receiving Bortezomib SUN must use effective contraception during and for up to 3 months after treatment.
Danish: Både mænd og kvinder, som er i behandling med Bortezomib SUN, skal anvende sikker prævention under og op til 3 måneder efter behandlingen.
English: Medianc(95% CI) (months) Response rate n: response-evaluable patients Overall complete response (CR+CRu)f n(%)
Danish: Medianc (95 % CI) (måneder) Responsrate n: respons-evaluerbare patienter Samlet komplet respons (CR+CRu)f n(%)
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide).
Danish: • instruktioner i ordinering og administration, herunder cyklussernes længde og antal cyklusser, for herved at minimere risikoen for lægmiddel- eller administrationsfejl, der kunne opstå grundet de to forskellige bortezomibkombinationsregimer i transplantationsinduktionsregi (Bortezomib SUN plus dexamethason og Bortezomib SUN plus dexamethason og thalidomid).
English: Grade 1 (asymptomatic; loss of deep tendon reflexes or paresthesia) with no pain or loss of function
Danish: Grad 1 (asymptomatisk tab af dybe senereflekser eller paræstesi) uden smerter eller funktionstab
English: • storage precautions for reconstituted solution
Danish: • regler for opbevaring af den rekonstituerede opløsning
English: DISPOSAL A vial is for single use only and the remaining solution must be discarded.
Danish: Et hætteglas er kun til engangsbrug, og resterende opløsning skal bortskaffes.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN
Danish: Grad ≥ 3 ikke-hæmatologisk toksicitet, som anses for relateret til Bortezomib SUN
English: As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Danish: Som et resultat af den forud planlagte interimanalyse blev dexamethason-gruppen standset på anbefaling fra datamonitoreringskomiteen, alle patienter som var randomiseret til dexamethason, og fik derefter tilbudt bortezomib uanset sygdommens status.
English: Combination therapy with dexamethasone
Danish: Kombination med dexamethason
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Danish: Disse bivirkninger er baseret på et integreret datasæt med 5.476 patienter, hvoraf 3.996 patienter blev behandlet med bortezomib ved 1,3 mg/m2 og er medtaget i tabel 7.
English: Special handling instructions
Danish: Særlige instruktioner for håndtering.
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Danish: Bærere af hepatitis B og patienter med en anamnese med hepatitis B skal nøje monitoreres for kliniske og laboratoriemæssige tegn på aktiv HBV-infektion under og efter rituximab-kombinationsbehandling med bortezomib.
English: Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving bortezomib in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered.
Danish: Tidlig og regelmæssig monitorering for symptomer på behandlingsrelateret neuropati og neurologisk evaluering skal overvejes hos patienter, der får bortezomib i kombination med lægemidler, der vides at være forbundet med neuropati (f.eks. thalidomid), og passende dosisreduktion eller behandlingsseponering skal overvejes.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.5 mg
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 3,5 mg
English: - When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Danish: - Når Bortezomib SUN gives sammen med thalidomid og dexamethason, er varigheden af en behandlingscyklus 28 dage (4 uger).
English: Pregnancy and breast-feeding You should not use Bortezomib SUN if you are pregnant, unless clearly necessary.
Danish: Graviditet og amning Du må ikke bruge Bortezomib SUN, hvis du er gravid, medmindre det er absolut nødvendigt.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Danish: Derfor frarådes det at anvende dette regime med samtidig administration af højdosis-cytarabin (2 g/m2 dagligt) ved kontinuerlig infusion over en periode på 24 timer.
English: Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Danish: Trombocyttransfusion til behandling af trombocytopeni skal overvejes, når det er klinisk relevant.
English: At 10 μM concentrations, bortezomib does not inhibit any of a wide variety of receptors and proteases screened and is more than 1,500-fold more selective for the proteasome than for its next preferable enzyme.
Danish: I koncentrationer på 10 µM hæmmer bortezomib ingen af en lang række screenede receptorer og proteaser og er mere end 1.500 gange så selektivt for proteasom end for det næste foretrukne enzym.
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Danish: Det primære effektendepunkt var TTP, og det sekundære effektendepunkt var OS og ORR (CR+PR), og kriterierne fra The European Group for Blood and Marrow Transplantation (EBMT) blev brugt.
English: The solution will be clear and colourless, with a final pH of 4 to 7.
Danish: Opløsningen vil blive klar og farveløs med en pH på 4 til 7.
English: Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Danish: Autonom neuropati kan relateres til bortezomib, eller bortezomib kan forværre en tilgrundliggende tilstand som f.eks. diabetisk eller amyloid neuropati.
English: EBMT criteria g All randomised patients with secretory disease
Danish: g Alle randomiserede patienter med sekretorisk sygdom.
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Danish: Patienter, der opnår respons eller stabiliseret sygdom efter 4 cyklusser med denne kombinationsbehandling, kan fortsætte behandlingen med samme kombination i højst 4 yderligere cyklusser.
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Danish: Fase II-studiet MMY-2036 (RETRIEVE), et åbent studie med en enkelt arm, blev udført for at bestemme virkning og sikkerhed af genbehandling med bortezomib.