FrancophonIA/ELRC3.0 huggingface dataset:
English: No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Danish: Der observeredes ikke nogen nye sikkerhedsproblemer, når bortezomib blev føjet til standard-kemoterapiregimet for pædiatrisk præ-B-celle ALL.
English: c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Danish: p < 0,0001. c Responspopulation omfatter patienter, som havde målbar sygdom ved baseline og fik mindst 1 dosis studiemedicin.
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Danish: Patientdemografi og baseline-sygdomsegenskaber var sammenlignelige behandlingsgrupperne imellem.
English: Previously untreated multiple myeloma
Danish: Tidligere ubehandlet myelomatose
English: Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Danish: Farmakologiske studier vedrørende kardiovaskulær sikkerhed med aber og hunde viser, at intravenøse doser på ca. 2-3 gange den anbefalede kliniske dosis på mg/m2-basis er forbundet med pulsstigninger, fald i kontraktilitet, hypotension og dødsfald.
English: Common Urinary tract infection*
Danish: Almindelig Urinvejsinfektion*
English: In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Danish: I prækliniske studier havde bortezomib ingen indvirkning på den embryonale/føtale udvikling hos rotter og kaniner ved den højeste tålte dosis hos mater.
English: Following a review of post-marketing cases and literature reports for the period covered by this PSUR, 158 cases of “Lid, lash and lacrimal infections, irritations and inflammations” were retrieved in patients who received bortezomib.
Danish: Efter en gennemgang af tilfælde efter markedsføringen og rapporter i litteraturen for den periode, som denne PSUR dækker, blev der fundet 158 tilfælde af “øjenlågs-, øjenvippe- og tåregangsinfektion, -irritation og -inflammation” hos patienter, som fik bortezomib.
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib SUN are provided with educational materials.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at læger og sundhedspersonale, der beskæftiger sig med ordination, udlevering, håndtering eller administration af Bortezomib SUN, forsynes med uddannelsespakken.
English: A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Danish: Der blev observeret en statistisk signifikant forbedring af overlevelsen i Bzmb+M+Pbehandlingsgruppen (HR=0,695; p=0,00043) til trods for efterfølgende behandlinger, inklusive regimer baseret på bortezomib.
English: - If several Bortezomib SUN doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Danish: - Hvis flere Bortezomib SUN-doser i en cyklus tilbageholdes (≥ 3 doser under indgift to gange om ugen eller ≥ 2 doser under indgift en gang om ugen)
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib SUN only after careful risk/benefit assessment.
Danish: Patienter med præeksisterende, svær neuropati må kun behandles med Bortezomib SUN efter en omhyggelig vurdering af risici og fordele.
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Danish: Tabel 12: Effektresultater fra studiet IFM-2005-01 Endepunkter
English: The median number of cycles received for both groups was 4 cycles.
Danish: Begge grupper fik i gennemsnit 4 cyklusser.
English: Patients in the BzmbTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Danish: Patienter i henholdsvis BzmbTDx- og TDx-gruppen havde en gennemsnitsalder på 57 versus 56 år, 99 % versus 98 % af patienterne var kaukasere, og 58 % versus 54 % var mænd.
English: Tel. +40 (264) 501 500
Danish: România Tel. +40 (264) 501 500
English: Bortezomib should not be used during pregnancy unless the clinical condition of the woman requires treatment with bortezomib.
Danish: Bortezomib bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med Bortezomib SUN.
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Danish: Bivirkningerne i tabel 7 ansås af investigatorerne for mindst at have en mulig eller sandsynlig årsagsmæssig sammenhæng med bortezomib.
English: In myeloma, bortezomib affects the ability of myeloma cells to interact with the bone marrow microenvironment.
Danish: I myelomer påvirker bortezomib myelomcellernes evne til at interagere med knoglemarvens mikromiljø.
English: Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm.
Danish: Antiviral profylakse blev administreret til 26 % af patienterne i Bzmb+M+P-gruppen.
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Danish: Patienter med risiko for tumorlysesyndrom er dem, der allerede har en høj tumorbyrde forud for behandlingen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Hvis den ikke anvendes omgående, er opbevaringstider og -betingelser før anvendelsen brugerens ansvar.
English: The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to bortezomib alone.
Danish: Forekomsten af disse hændelser var sammenlignelig i de to behandlingsarme, hvilket tyder på, at disse bivirkninger ikke udelukkende kan tilskrives bortezomib.
English: Special care is required when treating patients with any risk factors for seizures.
Danish: Der skal udvises særlig forsigtighed ved behandling af patienter med risikofaktorer for kramper.
English: Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Danish: Behandling med bortezomib er meget ofte forbundet med perifer neuropati, som er overvejende sensorisk.
English: An odds ratio (OR) > 1 indicates an advantage for BzmbR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH.
Danish: En oddsratio (OR) > 1 angiver en fordel for BzmbR-CAP. f Inkluderer alle CR+CRu, efter IRC, knoglemarv og LDH.
English: In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and
Danish: I tilfælde af overdosering skal patientens vitale tegn monitoreres, og der skal ydes relevant støttende behandling for at opretholde blodtrykket (f.eks. væske, pressorer og/eller inotropiske midler) og kropstemperaturen (se pkt.
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Danish: Den er specifikt designet til at hæmme chymotrypsinlignende aktivitet ved 26S-proteasom i pattedyrceller.
English: This suggests that bortezomib distributes widely to peripheral tissues.
Danish: Dette tyder på, at bortezomib i stor udstrækning distribueres til perifert væv.
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Danish: På baggrund af det begrænsede bidrag (7 %) fra CYP2D6 til metaboliseringen af bortezomib forventes det ikke, at CYP2D6-fænotypen, som metaboliserer dårligt, påvirker den samlede disponering for bortezomib.
English: There is no known specific antidote for bortezomib overdose.
Danish: Der findes ingen specifik antidot mod overdosering af bortezomib.
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Danish: Sekundære effektendepunkter omfattede post-transplantations-responsrater (CR+nCR, CR+nCR+VGPR+PR), progressionsfri overlevelse og samlet overlevelse.
English: However, the dose-normalised mean AUC values were increased by approximately 60% in patients with moderate or severe hepatic impairment.
Danish: De gennemsnitlige AUCværdier justeret i forhold til standarddosis øgedes dog med ca. 60 % hos patienter med moderat eller alvorligt nedsat leverfunktion.
English: Phase II
Danish: Fase II
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Danish: Frekvensen defineres som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Danish: Patienterne bør kontrolleres regelmæssigt for nye eller tiltagende neurologiske symptomer eller tegn, der kunne tyde på PML, som led i differentialdiagnosticeringen af lidelser i centralnervesystemet.
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Danish: Overvej dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 i de efterfølgende cyklusser afhængigt af patientens tolerabilitet.
English: A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Danish: En biologisk plausibilitet understøtter sammenhængen mellem bortezomib og chalazion/blefaritis: teoretisk set kan bortezomib-relateret myelosuppression bane vejen for virusinfektioner som f.eks. herpes zoster, hvilket fremmer chalazia.
English: A lower starting dose is recommended in patients with moderate or severe hepatic impairment, and those patients should be closely monitored (see section 4.2, Table 6).
Danish: Det anbefales at give en lavere startdosis til patienter med moderat eller alvorligt nedsat leverfunktion, og disse patienter bør monitoreres nøje (se tabel 6, pkt.
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Danish: Den mediane alder hos patienterne i studiet var 71 år, 50 % var mænd, 88 % var kaukasere, og medianen for Karnofsky performance status var en score på 80.
English: 56.4 mo
Danish: 56,4 mdr.
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Danish: Sekundære effektendepunkter inkluderede tid til progression (TTP), tid til næste antilymfombehandling (TNT), varighed af behandlingsfrit interval (TFI), samlet responsrate (ORR) og komplet responsrate (CR/CRu), samlet overlevelse (OS) og responsvarighed.
English: The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Danish: Fraktionen af bortezomib bundet til plasmaproteiner var ikke koncentrationsafhængig.
English: ** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; ***Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Danish: ** Instrumentel ADL: Dækker madlavning, indkøb af dagligvarer eller tøj, brug af telefon, håndtering af penge osv. *** Personlig ADL: Dækker badning, på- og afklædning, spisning, toiletbesøg, indtagelse af medicin og oppegående.
English: 1 year survival, [95% CI]
Danish: 1 års overlevelse, [95 % CI]
English: Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Danish: Sådanne ændringer kan være reversible ved seponering af bortezomib (se pkt.
English: - The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Danish: - Den rekonstituerede opløsning administreres subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
English: Once weekly Bortezomib SUN (cycles 5-9)
Danish: Bortezomib SUN en gang om ugen (cyklus 5-9)
English: One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression.
Danish: 130 patienter (≥ 18 år) med myelomatose, som tidligere havde haft mindst partielt respons på et bortezomib-holdigt regime, fik ny behandling ved progression.
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Danish: Den samlede forekomst af diarré, smerter i mave-tarm-kanalen og abdomen, asteniske tilstande, øvre luftvejsinfektioner og perifere neuropatier var 12-15 % lavere i den subkutane gruppe end i den intravenøse gruppe.
English: Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Danish: Mandlige og kvindelige fertile patienter skal anvende sikker kontraception under behandlingen og i 3 måneder efter behandlingen.
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: Perifer neuropati ≥ grad 3 forekom hos 6 % af patienterne i den subkutane behandlingsgruppe sammenlignet med 16 % i den intravenøse behandlingsgruppe (p=0,0264).
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Danish: Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
English: Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy.
Danish: Bemærk: OR > 1 tyder på en fordel for Bzmb-indeholdende induktionsterapi.
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Danish: Kinetikken ved proteasomhæmning blev vurderet in vitro, og det blev påvist, at bortezomib adskiller sig fra proteasom med et t1/2 på 20 minutter, hvilket påviser, at proteasomhæmning ved hjælp af bortezomib er reversibel.
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Danish: Kontroller, at den korrekte dosis anvendes til intravenøs administration (1 mg/ml).
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Danish: Patienter, der oplever ny eller forværret perifer neuropati, bør få foretaget en neurologisk evaluering og kan have brug for ændring af dosis, behandlingsplan eller ændring til den subkutane administrationsvej (se pkt.
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Danish: Der blev administreret et effektivt reinduktionskemoterapiregime med flere stoffer i 3 blokke.
English: Six Bortezomib SUN cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib SUN cycles may be given.
Danish: Seks Bortezomib SUN-cyklusser anbefales, men patienter med et respons, som først dokumenteres ved cyklus 6, kan gives yderligere to Bortezomib SUN-cyklusser.
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Danish: Baseret på en farmakokinetisk populationsanalyse øgedes bortezomibclearance ved stigende BSA (legemsoverfladeareal).
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Danish: Deborerede bortezomib-metabolitter er inaktive som 26S-proteasomhæmmere.
English: The concentration of the resulting solution will be 2.5 mg/ml.
Danish: Den færdige koncentration i opløsningen vil være 2,5 mg/ml.
English: Therefore, platelet counts should be monitored prior to each dose of bortezomib.
Danish: Trombocyttallet skal derfor monitoreres før hver bortezomib-dosis.
English: PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Danish: PRES er en sjælden, ofte reversibel, neurologisk lidelse, som udvikles hurtigt, og som kan optræde med blandt andet kramper, hypertension, hovedpine, sløvhed, konfusion, blindhed og andre visuelle og neurologiske forstyrrelser.
English: ≤ 1.0 x ULN
Danish: ≤ 1,0 x ULN > ULN
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Danish: Dexamethason blev administreret i kombination med bortezomib til 83 patienter i cyklus 1, mens yderligere 11 patienter fik dexamethason i løbet af efterfølgende bortezomib-behandlingscyklusser.
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Danish: Ud over perifer neuropati kan der forekomme autonom neuropati ved nogle bivirkninger, f.eks. postural hypotension og svær forstoppelse med ileus.
English: Haematological toxicity during a cycle - If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Danish: Hæmatologisk toksicitet i løbet af en cyklus: - Hvis der observeres langvarig grad 4neutropeni eller trombocytopeni, eller trombocytopeni med blødning i den foregående cyklus
English: Bortezomib is highly selective for the proteasome.
Danish: Bortezomib er meget selektivt for proteasom.
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Danish: Resultater fra in vitro-, ex vivo- og dyremodelforsøg med bortezomib tyder på, at bortezomib øger osteoblastdifferentieringen og -aktiviteten samt hæmmer osteoklastfunktionen.
English: An open label, randomised, Phase III non-inferiority study compared the efficacy and safety of the subcutaneous administration of bortezomib versus the intravenous administration.
Danish: Der er gennemført et åbent, randomiseret, fase III-non-inferiority-studie til sammenligning af effekt og sikkerhed af subkutan administration af bortezomib versus intravenøs administration.
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Danish: I bortezomibs koncentrationsinterval på 0,01-1,0 µg/ml var in vitro-proteinbindingen gennemsnitligt 82,9 % i humant plasma.
English: Reduce Bortezomib SUN to 0.7 mg/m2 in the first treatment cycle.
Danish: Reducer Bortezomib SUN til 0,7 mg/m2 i første behandlingscyklus.
English: Geometric mean (%CV) clearance was 7.79 (25%) l/hr/m2, volume of distribution at steady-state was 834 (39%) l/m2, and the elimination half-life was 100 (44%) hours.
Danish: Geometrisk middel (%CV) for clearance var 7,79 (25 %) l/t/m2, fordelingsvolumen ved steady state var 834 (39 %) l/m2 og eliminationshalveringstiden var 100 (44 %) timer.
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Danish: Død som følge af “progredierende sygdom” forekom hos 18 % i den subkutane gruppe og hos 9 % i den intravenøse gruppe.
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were 80.18%-122.80%.
Danish: Den geometriske gennemsnitsratio AUClast var 0,99, og 90-%-konfidensintervaller var 80,18 %
English: The majority of the patients in both groups completed treatment, 80% in the BzmbR-CAP group and 82% in the R-CHOP group.
Danish: Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80 % i BzmbR-CAP-gruppen og 82 % i R-CHOP-gruppen.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Danish: Gastrointestinal toksicitet, inklusive kvalme, diarré, opkastning og forstoppelse, er meget almindelig ved behandling med bortezomib.
English: - Non-haematological toxicities should have resolved to Grade 1 or baseline.
Danish: - Ikke-hæmatologisk toksicitet skal være bedret til grad 1 eller baseline-niveau.
English: If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib SUN you should tell your doctor: - if you think you have hepatitis infection now or have had it in the past.
Danish: Hvis du har mantle-celle-lymfom og får lægemidlet rituximab sammen med Bortezomib SUN, skal du fortælle det til din læge: - hvis du tror, du har en hepatitisinfektion nu, eller hvis du har haft det engang.
English: Other reported hepatic reactions include increases in liver enzymes, hyperbilirubinaemia, and hepatitis.
Danish: Andre rapporter om leverreaktioner omfatter øget leverenzymtal, hyperbilirubinæmi og hepatitis.
English: Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Danish: Den inkluderer desuden bivirkninger, som blev identificeret i BzmbR-CAP-armen, og som af investigatorerne blev anset for at have mindst en mulig eller sandsynlig årsagssammenhæng med bortezomib, baseret på historiske data i myelomatosestudierne.
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Danish: Den gennemsnitlige eliminationshalveringstid (t1/2) for bortezomib efter gentagne doser var mellem 40 og 193 timer.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Danish: Patienternes gennemsnitsalder i studiet var 57 år, 55 % var mænd, og 48 % af patienterne blev cytogenetisk klassificeret som højrisiko.
English: The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects.
Danish: "Matchet par"-analysen er en statistisk metode, hvor patienter i behandlingsgruppen (f.eks. bortezomib i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. bortezomib) gøres sammenlignelige med hensyn til confounding-faktorer, idet forsøgspersonerne sammensættes individuelt i par.
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Danish: Den samlede bedste responsrate (CR+PR) ved genbehandling af 130 patienter var 38,5 % (95 % CI: 30,1-47,4).
English: Deutschland tel. +49 (0) 214 403 99 192
Danish: Tel. +49 (0) 214 403 99 192
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Danish: Klinisk virkning ved subkutan administration af bortezomib hos patienter med recidiverende/refraktær myelomatose