FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Danish: Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, inklusive myelomatose.
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Danish: Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 i forhold til toksicitet og behandlingsseponering som følge af perifer neuropati BR-CAP (N=240)
English: Table 8: Adverse reactions in patients with mantle cell lymphoma treated with BR-CAP in a clinical trial
Danish: Tabel 8: Bivirkninger hos patienter med mantlecellelymfom, som blev behandlet med BR-CAP i et klinisk studie
English: What Bortezomib Fresenius Kabi contains - The active substance is bortezomib.
Danish: Bortezomib Fresenius Kabi indeholder: - Aktivt stof: Bortezomib.
English: Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Danish: Melphalan (9 mg/m2) og prednison (60 mg/m2) gives gennem munden på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus.
English: • storage precautions for reconstituted solution
Danish: • Regler for opbevaring af den rekonstituerede opløsning.
English: Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
Danish: Der anbefales seks bortezomib-cyklusser, men patienter med et respons, som først dokumenteres ved cyklus 6, kan gives yderligere to bortezomib-cyklusser.
English: Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Danish: 5.1, men der kan ikke gives nogle anbefalinger vedrørende dosering.
English: Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med bortezomib Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin.
English: The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Danish: Den samlede bedste responsrate (CR + PR) ved genbehandling af 130 patienter var 38,5 % (95 % CI: 30,1-47,4).
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Danish: Patienter ≥ 75 år tålte begge regimer, både BR-CAP og R-CHOP, dårligere (se pkt.
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 10
Danish: Patienterne havde IgG/IgA/let kæde myelom i henholdsvis 63 %/25 %/8 % tilfælde, mediant hæmoglobin på 105 g/l og mediant trombocyttal på 221,5 x 10
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Danish: På grund af risiko for alvorlige bivirkninger hos ammede børn, bør amning ophøre under behandling med bortezomib.
English: OR; 95% CI; P value a
Danish: OR; 95 % CI; Pværdi a
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m weekly and 1.3 mg/m twice-weekly.
Danish: Fra en uddybende effektanalyse rapporteredes en responsrate på 67,3 % (inklusive en CR-rate på 28,6 %) bestemt ud fra hæmatologisk respons (Mprotein) hos 49 evaluérbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m en gang ugentlig og 1,3 mg/m to gange ugentlig.
English: 9/l • Non-haematological toxicities should have resolved to grade 1 or baseline
Danish: 9/l • Ikke-hæmatologiske, toksiske hændelser skal være bedret til grad 1 eller baseline
English: Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Danish: Der er rapporteret sjældne tilfælde af leversvigt hos patienter, der er i samtidig behandling med bortezomib og andre lægemidler og med alvorlige tilgrundliggende helbredsproblemer.
English: - Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Danish: Injicer opløsningen som en 3-5 sek. intravenøs bolusinjektion gennem et perifert eller centralt intravenøst kateter ind i en vene.
English: Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Danish: Grad 1 med smerter eller Grad 2 (moderate symptomer; begrænser daglige gøremål, der kræver hjælpemidler; instrumentel ADL**)
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Danish: For yderligere oplysninger om melphalan og prednison henvises til produktresuméet for disse produkter.
English: • symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion,
Danish: • Symptomer på tumorlysesyndrom, som f.eks. muskelkramper, muskelsvaghed, forvirring,
English: Bortezomib is for single use only.
Danish: Bortezomib er kun til engangsbrug.
English: Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Danish: Bortezomib gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
English: Time to first response in CR + PR Median
Danish: Tid til første respons i CR + PR
English: Response Evaluable Population n=73
Danish: Population evaluérbar for respons n=73
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 det er nødvendigt at justere dosis hos patienter med myelomatose eller med mantlecellelymfom, som er ældre end 65 år.
English: (60 mg/m2) in patients with previously untreated multiple myeloma.
Danish: mg/m2) til patienter med tidligere ubehandlet myelomatose.
English: • to remind that patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Danish: • At minde patienter, der modtager bortezomib sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid med reference til produktresuméet for thalidomid med henblik på yderligere oplysninger.
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Danish: Derfor skal patienterne monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4-inhibitorer (f.eks. ketoconazol, ritonavir).
English: The incidence of herpes zoster among patients in the B+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Danish: Forekomsten af herpes zoster blandt patienter i B+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse.
English: Hepatitis B virus (HBV) reactivation and infection Mantle cell lymphoma
Danish: Hepatitis B-virus (HBV)-reaktivering og -infektion
English: • Bortezomib 3.5 mg can be administered both intravenously and subcutaneously
Danish: • At Bortezomib 3,5 mg kan administreres både intravenøst og subkutant.
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Danish: I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zoster-reaktivering større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (henholdsvis 14 % versus 4 %).
English: The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Danish: Varigheden af det samlede respons var 21,4 måneder længere i BRCAP-gruppen (median 36,5 måneder kontra 15,1 måneder i R-CHOP-gruppen).
English: Absorption Following intravenous bolus administration of a 1.0 mg/m and 1.3 mg/m dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Danish: Absorption Efter intravenøs bolusadministration af en dosis på 1,0 mg/m og 1,3 mg/m til 11 patienter med myelomatose og kreatininclearance-værdier på mere end 50 ml/min., var de gennemsnitlige maksimale plasmakoncentrationer efter første dosis af bortezomib henholdsvis 57 og 112 mg/ml.
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Danish: Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m doser to gange ugentlig til 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML).
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Danish: Median for investigatorbedømt PFS var 30,7 måneder i BR-CAP-gruppen og 16,1 måneder i RCHOP-gruppen (Hazard ratio [HR]=0,51; p < 0,001).
English: • Infection of the outermost layer of the eye and the inner surface of the eyelids
Danish: • Infektion i øjets yderste lag og i indersiden af øjenlåget (Konjunktivitis)
English: Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Danish: Notérbare forskelle mellem sikkerhedsprofilen for bortezomib administreret subkutant versus intravenøst som monoterapi
English: p-value d
Danish: p-værdi d
English: If you are given bortezomib for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Danish: Hvis du får bortezomib for myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du oplever nogle af nedenstående bivirkninger: - Muskelkramper, muskelsvaghed - Forvirring, synstab eller -forstyrrelser, blindhed, krampeanfald, hovedpine - Åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - Hoste og vejrtrækningsbesvær eller trykken for brystet.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Danish: forekom hos 6 % af patienterne i den subkutane behandlingsgruppe sammenlignet med 16 % i den intravenøse behandlingsgruppe (p=0,0264).
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib together with two other medicines; melphalan and prednisone.
Danish: Hvis du ikke er blevet behandlet for myelomatose tidligere, og du ikke er egnet til at få transplantation med blodstamceller, vil du få bortezomib samtidig med to andre lægemidler; melphalan og prednison.
English: The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Danish: Forekomsten af herpes zoster blandt patienter i BR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt.
English: Response rate population e n=668
Danish: Responserate Populatione n=668
English: 1 mg/m to 0.7 mg/m
Danish: 1 mg/m til 0,7 mg/m
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Danish: In vitro-studier viser, at bortezomib er en svag inhibitor af CYP-isozymerne 1A2, 2C9, 2C19, 2D6 og 3A4.
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med bortezomib i alle undergrupper af den pædiatriske population ved myelomatose og ved mantlecellelymfom (se pkt.
English: Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Danish: Bortezomib kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn.
English: A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Danish: I alt fik 74 vurderbare patienter administreret dexamethason sammen med bortezomib.
English: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy:
Danish: Dosisjustering under behandlingen af patienter med tidligere ubehandlet mantlecellelymfom Før påbegyndelse af en ny behandlingscyklus:
English: Bortezomib should not be given by other routes.
Danish: Bortezomib må ikke indgives via andre administrationsveje.
English: In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Danish: I fase III-studiet havde patienter, der fik bortezomib subkutant sammenlignet med intravenøs administration, en 13 % lavere samlet forekomst af bivirkninger der havde en grad 3 eller højere toksicitet, og en 5 % lavere forekomst af seponering af behandling med bortezomib.
English: If any discolouration or particulate matter is observed, the solution must be discarded.
Danish: Hvis der ses nogle partikler eller misfarvning, skal opløsningen bortskaffes.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Danish: CR=komplet respons; CRu=komplet respons ubekræftet; PR=partielt respons; CI=konfidensinterval, HR=hazard-ratio; OR=oddsratio; ITT= Intent to Treat
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1397/001
Danish: EU/1/19/1397/001
English: Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Danish: Bemærk: OR > 1 tyder på en fordel for B-indeholdende induktionsterapi.
English: You must read the package leaflets of all medicinal products to be taken in combination with bortezomib for information related to these medicines before starting treatment with bortezomib.
Danish: Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med bortezomib, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med bortezomib.
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify bortezomib as outlined in table 1.
Danish: For bortezomib-relateret neuropatisk smerte og/eller perifer neuropati, tilbageholdes og/eller modificeres bortezomib som beskrevet i tabel 1.
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BDx groups respectively; the majority of patients underwent one single transplant procedure.
Danish: 198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx- og BDx-gruppen fik autolog stamcelletransplantation.
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/μl (see section 4.2).
Danish: Behandlingen med bortezomib skal indstilles, når trombocyttallet er < 25.000/µl eller, ved kombinationsbehandling med melphalan og prednison, når trombocyttallet er ≤ 30.000/µl (se pkt.
English: SGOT (AST) levels
Danish: (SGOT) ASATniveau
English: Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Danish: Almindelig Vægttab Ikke almindelig Hyperbilirubinæmi*, abnorme proteinanalyser*, vægtstigning, abnorm blodprøve*, forhøjet C-reaktivt protein
English: c p-value d
Danish: c p-værdi d
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Danish: Studier af udviklingstoksicitet på rotter og kaniner har vist embryo/fosterdødelighed ved doser som var toksiske for moderdyret, men ingen direkte embryo/fostertoksicitet ved doser som ikke var toksiske for moderdyret.
English: Bortezomib must be reconstituted by a healthcare professional (see section 6.6).
Danish: Bortezomib skal rekonstitueres af sundhedspersonale (se pkt.
English: You must tell your doctor if you have any of the following:
Danish: Særligt skal du fortælle lægen, hvis du bruger medicin, som indeholder følgende aktive stoffer:
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Danish: Graden er bestemt i henhold til det amerikanske National Cancer Institute's Common Toxicity Criteria (CTCAE) version 4.0.
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Danish: B= bortezomib; Dx=dexamethason; T=thalidomid a Thalidomid-dosis øges kun til 100 mg fra uge 3 i cyklus 1, hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles.
English: • Inflammation of a vein, blood clots in your veins and lungs
Danish: • Betændelse i en vene, blodpropper i dine vener eller lunger
English: Bortezomib treatment must be withheld at the onset of any ≥ grade 3 bortezomib -related non-haematological toxicities (excluding neuropathy) or ≥ grade 3 haematological toxicities (see also section 4.4).
Danish: Behandling med bortezomib skal seponeres ved forekomst af enhver ≥ grad 3 bortezomib-relateret ikke-hæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
English: Patients with baseline grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Danish: Patienter med ≥ grad 2 perifer neuropati eller trombocyttal < 50.000/µl ved baseline indgik ikke.
English: (95% CI) p-value c
Danish: (95% CI) p-værdi c
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value a
Danish: Responsrate ved 8 cyklusser n (%) ORR (CR+PR) p-value a
English: - The other ingredients are mannitol (E421).
Danish: - Øvrigt indholdsstof: Mannitol (E421)
English: Bortezomib therapy should be withheld until symptoms of the toxicity have resolved to grade 2 or better.
Danish: Behandling med bortezomib skal indstilles indtil symptomerne på toksiciteten er bedret til Grad 2 eller bedre.
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m dose and 89 to 120 ng/ml for the 1.3 mg/m dose.
Danish: Ved efterfølgende doser lå de gennemsnitlige maksimale observerede plasmakoncentrationer på 67-106 ng/ml for en dosis på 1,0 mg/m og på 89-120 ng/ml for en dosis på 1,3 mg/m
English: Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Danish: Patienter, der får bortezomib i kombination med thalidomid, skal overholde det særlige program for svangerskabsforebyggelse for thalidomid.
English: During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Danish: Under kliniske studier er der rapporteret om hypoglykæmi og hyperglykæmi som henholdsvis ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika.
English: Patient demographic and baseline disease charateristics were similar between the treatment groups.
Danish: Patientdemografi og sygdomsegenskaber ved baseline var sammenlignelige mellem behandlingsgrupperne.
English: • storage precautions for reconstituted solution • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Danish: • Oplysning om potentielle risici ved administration - herunder overdosering og underdosering,
English: Mechanism of action
Danish: Virkningsmekanisme>
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see table 4).
Danish: Thalidomid administreres oralt i en dosis på 50 mg daglig på dag 1-14, og hvis det tåles, øges dosis til 100 mg daglig på dag 15-28, hvorefter dosis yderligere kan øges til 200 mg daglig fra cyklus 2 (se tabel 4).
English: When compared to patients with normal hepatic function, mild hepatic impairment did not alter dose-normalised bortezomib AUC.
Danish: Ved sammenligning med patienter med normal leverfunktion ændrede en let nedsættelse af leverfunktionen ikke bortezomibs AUC normaliseret i forhold til standarddosis.
English: 10 ml clear Type I glass vial with grey chlorobutyl rubber stopper and blue aluminium flip-off over seal, containing 3.5 mg bortezomib.
Danish: 10 ml klart type I-hætteglas med grå chlorbutyl gummiprop og blå aluminiumshætte med flip-off indeholdende 3,5 mg bortezomib.
English: Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Danish: Både BR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i BR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen.
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Danish: Tabel 1: Anbefalede* dosisjusteringer for bortezomibrelateret neuropati Sværhedsgrad af neuropati
English: The usual starting dose of bortezomib is 1.3 mg/m body surface area twice a week.
Danish: Den normale startdosis af bortezomib er 1,3 mg/m legemsoverflade to gange om ugen.
English: Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy
Danish: Bemærk: OR > 1 tyder på en fordel for bortzomib-indeholdende induktionsterapi
English: Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Danish: Tabel 16: Effektresultater fra studie LYM-3002 Effektmål
English: The total storage time for the reconstituted medicinal product should not exceed 96 hours (if stored at 25°C) and 8 days (if stored at 2-8 °C) prior to administration.
Danish: Den samlede opbevaringstid for det rekonstituerede lægemiddel må ikke overstige 96 timer (hvis opbevaret ved 25⁰C) og 8 dage (hvis opbevaret ved 2-8⁰C) inden administration.