natgillin/translations-raw huggingface dataset:
Desuden viste de sekundære endepunkt, som var relateret til respons og tid til hændelse, overensstemmende resultater for subkutan og intravenøs administration (tabel 15).
In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Behandlingen med VELCADE kan meget ofte forårsage et fald i antal af røde og hvide blodlegemer samt blodplader i blodet.
Treatment with VELCADE can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Man behøver ikke at tjekke pH-værdien af opløsningen.
You do not need to check the pH of the solution.
VELCADE blev kun administreret i blok 1 og 2 for at undgå potentiel overlappende toksicitet med co-administrerede lægemidler i blok 3.
VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Responspopulation omfatter patienter, som havde målbar sygdom ved baseline og fik mindst 1 dosis studiemedicin.
Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Ved multivarians analyse var responsraten uafhængig af myelomtype, performance status, kromosom 13 deletion-status og antallet eller typen af tidligere behandling.
By multivariate analysis, the response rate was independent of myeloma type, performance status, chromosome 13 deletion status, or the number or type of previous therapies.
• Hormonelle uregelmæssigheder, som kan påvirke salt- og vandoptagelsen
• Hormone abnormality which may affect salt and water absorption
Når VELCADE gives sammen med thalidomid og dexamethason, er varigheden af en behandlingscyklus 28 dage (4 uger).
When VELCADE is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
• Kan ikke tåle at drikke alkohol
• Inability to tolerate alcohol consumption
Din læge vil bestemme dosis ud fra din højde og vægt (areal af legemsoverflade).
Your doctor will work out your dose of VELCADE according to your height and weight (body surface area).
• lavt antal røde eller hvide blodlegemer
• low numbers of red or white blood cells
Et hætteglas er kun til engangsbrug og resterende opløsning skal bortskaffes.
A vial is for single use only and the remaining solution must be discarded.
Baseret på dyrestudier synes gennemtrængningen af bortezomib gennem blod/hjerne-barrieren at være begrænset, om overhovedet nogen og relevansen for mennesker er ukendt.
Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
• Infektion i øjets yderste lag og i indersiden af øjenlåget (conjunctivitis)
• Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
• Øget antal blodplader eller plasmaceller (en type hvide celler) i blodet
• Increase of platelets or plasma cells (a type of white cell) in the blood
• Ændret bevidsthedsniveau, forvirring
• Altered level of consciousness, confusion
De fleste patienter havde brug for behandling mod ortostatiske hypotension.
Most patients required treatment for their orthostatic hypotension.
OR; 95 % CI; P værdi
OR; 95% CI; P value
I de enkelte medlemslande skal indehaveren af markedsføringstilladelsen blive enig med den relevante nationale myndighed om format og indhold af uddannelsespakken.
In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
• Hvis flere VELCADE-doser i en cyklus tilbageholdes (≥ 3 doser under indgift to gange om ugen eller ≥ 2 doser under indgift en gang om ugen)
• If several VELCADE doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
På tidspunktet for en forudspecificeret interimanalyse var det primære endepunkt, tid til progression, opnået, og patienterne i M+P-gruppen blev tilbudt Vc+M+P-behandling.
At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Vc+M+P treatment.
VELCADE er kun til engangsbrug.
VELCADE is for single use only.
Graviditet og amning Du må ikke bruge VELCADE hvis du er gravid, medmindre det er absolut nødvendigt.
Pregnancy and breast-feeding You should not use VELCADE if you are pregnant, unless clearly necessary.
• Død
• Death
Det primære effektendepunkt var progressionsfri overlevelse baseret på en bedømmelse fra en uafhængig review-komité (IRC).
The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
BSAnormaliseret bortezomib-clearance hos pædiatriske patienter var den samme som den, der observeres hos voksne.
BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
VELCADE må ikke administreres intratekalt.
VELCADE should not be administered intrathecally.
Hvis du tidligere har haft hepatitis B-infektion, vil din læge undersøge dig omhyggeligt for at se, om du har tegn på aktiv hepatitis B.
If you have a history of hepatitis B infection you will be carefully checked by your doctor for signs of active hepatitis B.
Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 patienter) • Blodprop i små blodkar (trombotisk mikroangiopati)
Rare side effects (may affect up to 1 in 1,000 people) • Blood clot in small blood vessels (thrombotic microangiopathy)
Op til 6 cyklusser kan gives til patienter, der får i det mindste partielt respons efter 4 cyklusser
Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Eksponering for VELCADE (dosis-normaliseret AUC og Cmax) var sammenlignelig for alle grupper (se pkt.
Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Hvordan VELCADE gives
How VELCADE is given
Ældre patienter med MCL
Elderly MCL patients
Hvis toksiciteten ikke forsvinder, eller hvis den forekommer igen ved den laveste dosis, skal seponering af VELCADE overvejes, medmindre fordelene ved behandlingen tydeligt opvejer risici.
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of VELCADE must be considered unless the benefit of treatment clearly outweighs the risk.
Vc = VELCADE; M = melphalan, P = prednison
Vc=VELCADE; M=melphalan, P=prednisone
• moderate til svære problemer med leveren
• moderate to severe liver problems
I VcTDx-gruppen var 12 % af patienterne cytogenetisk klassificeret som højrisiko versus 16 % af patienterne i TDx-gruppen.
In the VcTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
VELCADE påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
VELCADE may have a moderate influence on the ability to drive and use machines.
CI = konfidensinterval
CI=Confidence Interval
Seks procent af patienterne fik en lokal reaktion på subkutan administration, for det meste rødmen.
Six percent of patients had an adverse local reaction to subcutaneous administration, mostly redness.
Frekvensen defineres som: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Hvis VELCADE anvendes under graviditeten, eller hvis patienten bliver gravid, mens hun får dette lægemiddel, skal hun orienteres om de mulige risici for fostret.
If VELCADE 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.
(CrCl = 20-39 ml/min/1,73 m 2, n = 9) og Alvorlig (CrCl < 20 ml/min/1,73 m 2, n = 3).
(CrCL=20-39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Lægemiddelbivirkninger, identificeret med en forekomst på ≥ 1 %, tilsvarende eller højere forekomst i VcR-CAP-armen og med mindst en mulig eller sandsynlig årsagssammenhæng med komponenterne i VcR-CAP-armen, er anført i tabel 8 nedenfor.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the VcR-CAP arm and with at least a possible or probable causal relationship to the components of the VcR-CAP arm, are listed in Table 8 below.
Hæmning af 26S-proteasom forhindrer denne målrettede proteolyse og påvirker multiple signalleringskaskader i cellen, hvilket til sidst resulterer i cancer-celle-død.
Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Patienter med præ-eksisterende, svær neuropati må kun behandles med VELCADE efter en omhyggelig vurdering af risici og fordele.
Patients with pre-existing severe neuropathy may be treated with VELCADE only after careful risk/benefit assessment.
Hvis du har brugt for meget VELCADE
If you are given too much VELCADE
• Reduktion i antallet af røde blodlegemer eller hvide blodlegemer (se ovenfor)
• Reduction in the number of red blood cells and or white blood cells (see above)
Hæmatologisk toksicitet i løbet af en cyklus:
Haematological toxicity during a cycle
Må ikke opbevares ved over 30 °C.
Do not store above 30ºC.
Både hos de patienter, som var refraktære over for den seneste behandling, og de, der ikke var refraktære, var den samlede overlevelse signifikant længere, og responsraten var signifikant højere i VELCADE-gruppen.
Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the VELCADE arm.
NFκB er en transkriptionsfaktor, hvis aktivering kræves til mange aspekter af tumorgenese, inklusive cellevækst og -overlevelse, angiogenese, celle-celle-interaktioner og metastase.
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.
9/l, og absolut neutrofiltal skal være ≥ 1,0 x 10
9/l and the absolute neutrophils count should be ≥ 1.0 x 10
• blødningsproblemer og/eller lavt antal blodplader i blodet
• bleeding problems and/or low number of platelets in your blood
(sædvanligvis på benene) eller store blå mærker under huden eller vævet.
(usually on the legs) to large bruise-like patches under the skin or tissue
Patienter i behandling med orale antidiabetika, som behandles med VELCADE, kan have brug for nøje monitorering af deres blodsukkerniveau og justering af deres antidiabetikadosis.
Patients on oral antidiabetic agents receiving VELCADE treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Tid til første respons i CR + PR Median
Time to first response in CR + PR Median
VELCADE en gang om ugen (cyklus 5-9)
Once weekly VELCADE (cycles 5-9)
Henviser til responsrate efter den anden transplantation hos forsøgspersoner, der blev transplanteret 2 gange (42/240 [18 % ] i VcDx-gruppen og 52/242 [21 %] i VDDx-gruppen).
Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx group and 52/242 [21%] in VDDx group).
Som et resultat af den forud planlagte interimanalyse blev dexamethason-gruppen standset på anbefaling fra datamonitoreringskomiteen, og alle patienter som var randomiseret til dexamethason, fik derefter tilbudt VELCADE uanset sygdommens status.
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 VELCADE, regardless of disease status.
• problemer med hjertet eller blodtrykket
• heart or blood pressure problems
Behandling med VELCADE er meget ofte forbundet med perifer neuropati, som er overvejende sensorisk.
Treatment with VELCADE is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Median c (95 % CI) (måneder) Responsrate n: respons-evaluerbare patienter 229 Samlet komplet respons (CR+CRu)
Median c(95% CI) (months) Response rate n: response-evaluable patients 229 Overall complete response (CR+CRu)
Patientdemografiske og baseline-sygdomsegenskaber var sammenlignelige behandlingsgrupperne imellem.
Patient demographic and baseline disease charateristics were similar between the treatment groups.
Studier har påvist, at bortezomib er cytotoksisk over for en række cancercelletyper, og at cancerceller er mere følsomme over for pro-apoptotiske virkninger af proteasom-hæmning end normale celler.
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.
Disse bivirkninger er baseret på et integreret datasæt med 5.476 patienter, hvoraf 3.996 patienter blev behandlet med VELCADE ved 1,3 mg/m2 og er medtaget i tabel 7.
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE at 1.3 mg/m2 and included in Table 7.
OR for responsrater baseret på Mantel-Haenszel skøn af den fælles oddsratio for stratificerede tabeller; p-værdier efter Cochran Mantel-Haenszel test.
OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by Cochran Mantel-Haenszel test.
• Blodprop i små blodkar (trombotisk mikroangiopati)
• Blood clot in small blood vessels (thrombotic microangiopathy)
• Hvis der observeres langvarig grad 4 neutropeni eller trombocytopeni, eller trombocytopeni med blødning i den foregående cyklus
• If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
• Højt eller lavt blodtryk
• High or low blood pressure
Der er forekommet fatale tilfælde af utilsigtet intratekal administration af VELCADE.
There have been fatal cases of inadvertent intrathecal administration of VELCADE.
• Unormal aflejring af protein i vigtige organer
• Abnormal protein deposits in your vital organs
• Den rekonstituerede opløsning administreres subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
• The reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Intention to treat-population n = 74
Intent to Treat Population n=74
Reducer VELCADE til 0,7 mg/m2 i første behandlingscyklus.
Reduce VELCADE to 0.7 mg/m2 in the first treatment cycle.
træthed, konfusion, blindhed eller andre synsproblemer.
tiredness, confusion, blindness or other vision problems.
• Hudreaktioner og hudsygdomme (som kan være alvorlige og livstruende), hudsår
• Skin reactions and disorders (which may be severe and life threatening), skin ulcers
En hazard ratio < 1 angiver en fordel for VcR-CAP.
A hazard ratio < 1 indicates an advantage for VcR-CAP.
Der blev observeret en statistisk signifikant forbedring af overlevelsen i Vc+M+Pbehandlingsgruppen (HR = 0,695; p = 0,00043) til trods for efterfølgende behandlinger, inklusive regimer baseret på VELCADE.
A statistically significant survival benefit in favour of the Vc+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including VELCADE-based regimens.
I koncentrationer på 10 µM hæmmer bortezomib ikke nogen 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.
At 10 M 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.
Posteriort reversibelt encefalopatisk syndrom (PRES) Der er indberettet PRES hos patienter, der fik VELCADE.
Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Forkortelser: ASAT = aspartat-aminotransferase, ULN = øvre grænse for normalområdet.
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Herpes zoster virusreaktivering
Herpes zoster virus reactivation
Forekomst af PN (%) Alle grader PN ≥ Grad 2 PN ≥ Grad 3 PN
Incidence of PN (%) All GradePN  Grade 2 PN  Grade 3 PN
• 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 (VELCADE plus dexamethason og VELCADE plus dexamethason og thalidomid).
• 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 (VELCADE plus dexamethasone, and VELCADE plus dexamethasone and thalidomide).
Den mediane overlevelse i Vc+M+P-behandlingsgruppen var 56,4 måneder sammenlignet med 43,1 i M+P-behandlingsgruppen.
Median survival for the Vc+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
• Tjek dosis og koncentration i sprøjten før brug (kontroller, at sprøjten er mærket som intravenøs administration).
• Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
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 VELCADE.
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 VELCADE.
Bivirkningerne i tabel 7 ansås af investigatorerne for mindst at have en mulig eller sandsynlig årsagsmæssig sammenhæng med VELCADE.
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to VELCADE.
Intent to Treat (ITT) population p-værdi fra den stratificerede log-rank test; analyse ud fra behandling udelukker opdeling på tidligere behandling; p < 0,0001
Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001
Ortostatisk/postural hypotension var ikke akut relateret til bolusinjektion af VELCADE.
Orthostatic/postural hypotension was not acutely related to bolus infusion of VELCADE.
Fase II-studiet MMY-2036 (RETRIEVE), et åbent studie med en enkelt arm, blev udført for at bestemme virkning og sikkerhed af genbehandling med VELCADE.
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with VELCADE.
• Cyster i ledkapslerne (synoviale cyster)
• Cysts in the lining of joints (synovial cysts)
Der skal gå mindst 72 timer mellem 2 doser VELCADE.
At least 72 hours should elapse between consecutive doses of VELCADE.
I prækliniske studier havde bortezomib ingen indvirkning på den embryonale/føtale udvikling hos rotter og kaniner ved den højest tålte dosis hos mater.
In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Antiviral profylakse blev administreret til 137 af 240 patienter (57 %) i VcR-CAP-armen.
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
9/l på en VELCADE-dosisdag (bortset fra dag 1)
9/l on a VELCADE dosing day (other than day 1)
• Overfølsomhed (allergisk reaktion)
• Hypersensitivity (allergic reaction)
"Matchet par"-analysen er en statistisk metode i hvilken patienter i behandlingsgruppen (f.eks. VELCADE i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. VELCADE) gøres sammenlignelige med hensyn til confounding faktorer ved individuelt at sammensætte forsøgspersonerne i par.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. VELCADE in combination with dexamethasone) and patients in the comparison group (e.g. VELCADE) are made comparable with respect to confounding factors by individually pairing study subjects.
Kinetikken ved proteasomhæmning blev vurderet in vitro, og det blev påvist, at bortezomib adskiller sig fra proteasom med et t½ på 20 minutter, hvilket påviser, at proteasomhæmning ved hjælp af bortezomib er reversibel.
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.
Du kan ligeledes få VELCADE sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason.
You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Trombocyttallet skal derfor monitoreres før hver VELCADE-dosis.
Therefore, platelet counts should be monitored prior to each dose of VELCADE.
• Budd-Chiaris syndrom (de kliniske symptomer på blokering af levervenerne)
• Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
Både mænd og kvinder, som er i behandling med VELCADE, skal anvende sikker prævention under og op til 3 måneder efter behandlingen.
Both men and women receiving VELCADE must use effective contraception during and for up to 3 months after treatment.
• Øget eller nedsat urinproduktion (pga. nyreskade), smerter ved vandladning og blod/protein i urinen, væskeophobning
• Increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention
• ≥ Grad 3 neutropeni med feber, grad 4 neutropeni, som varer mere end 7 dage, trombocyttal < 10 x 10 9 celler/l
• ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Det anbefales ligeledes, at responderende patienter, som ikke opnår fuldstændig remission, gennemgår i alt 8 behandlingscyklusser med VELCADE.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy.
Uanset β2-mikroglobulintal ved baseline var alle effektparametre (tiden indtil progression og samlet overlevelse samt responsrate) signifikant forbedrede i VELCADE-gruppen.
Regardless of 2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the VELCADE arm.
• Hvis toksiciteten ikke forsvinder efter, at VELCADE har været indstillet som defineret ovenfor, skal VELCADE seponeres.
• If, after VELCADE has been held, the toxicity does not resolve, as defined above, then VELCADE must be discontinued.
Klinisk virkning ved subkutan administration af VELCADE hos patienter med recidiverende/refraktær myelomatose
Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma
Forekomsten af alle grader af perifer neuropati efter intravenøs administration af VELCADE var lavere i de ældre studier med VELCADE administreret intravenøst end i studie MMY-3021.
The incidence of all grade peripheral neuropathy with VELCADE administered intravenously was lower in the historical studies with VELCADE administered intravenously than in study MMY-3021.