natgillin/translations-raw huggingface dataset:
VELCADE indeholder: - Aktivt stof: bortezomib. 
What VELCADE contains - The active substance is bortezomib.
Den samlede forekomst af hepatitis B-infektion var sammenlignelig hos patienter i VcRCAP-armen og patienter i R-CHOP-armen (henholdsvis 0,8 % vs 1,2 %). 
The overall incidence of hepatitis B infections was similar in patients treated with VcR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Kontroller at den korrekte dosis anvendes til intravenøs administration (1 mg/ml). 
Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Bemærk: OR > 1 tyder på en fordel for Vc-indeholdende induktionsterapi 
Note: An OR > 1 indicates an advantage for Vc-containing induction therapy
- sammen med lægemidlerne dexamethason eller dexamethason sammen med thalidomid til patienter, hvis sygdom ikke tidligere er blevet behandlet, og før de får højdosis-kemoterapi med transplantation af blodstamceller (induktionsbehandling). 
- in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
• Hurtigere hjerteslag, højt blodtryk, svedtendens 
• Increased heartbeat, high blood pressure, sweating,
En statistisk signifikant forskel i CR+nCR blev observeret til fordel for gruppen med VELCADE i kombination med dexamethason. 
A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Dag 8, 9, 10, 11 
Day 8, 9, 10, 11
Hos patienter med MCL (studie LYM-3002) var der en højere forekomst (56,7 % versus 5,8 %) af grad ≥ 3 trombocytopeni i VELCADE-armen (VcR-CAP) sammenlignet med non-VELCADE-armen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison [R-CHOP]). 
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the VELCADE treatment group (VcR-CAP) as compared to the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Dosisjustering af kombinationsbehandling for patienter med progressiv myelomatose Dosisjustering af VELCADE ved kombinationsbehandling skal følge retningslinjerne, der er beskrevet under monoterapi ovenfor. 
Dose adjustments for combination therapy for patients with progressive multiple myeloma For VELCADE dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Tabel 15: Effektresultater fra studie LYM-3002 
Table 15: Efficacy results from study LYM-3002
Mindst 6 måneder efter den tidligere behandling initieredes VELCADE med den senest tålte dosis på 1,3 mg/m2 (n = 93) eller ≤ 1,0 mg/m2 (n = 37); VELCADE blev administreret på dag 1, 4, 8 og 11 hver 3. uge i maksimalt 8 cyklusser enten som monoterapi eller i kombination med dexamethason i henhold til gældende standardbehandling. 
At least 6 months after prior therapy, VELCADE was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Du må ikke amme, mens du behandles med VELCADE. 
You should not breast-feed while using VELCADE.
Dette studie omfattede 222 patienter med recidiverende eller refraktær myelomatose, som blev randomiseret i forholdet 2:1 til at få 1,3 mg/m2 VELCADE enten som subkutan eller intravenøs administration i 8 cyklusser. 
222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of VELCADE by either the subcutaneous or intravenous route for 8 cycles.
Kombinationsbehandling med dexamethason 
Combination therapy with dexamethasone
Indehaver af markedsføringstilladelsen JANSSEN-CILAG INTERNATIONAL NV 
Marketing Authorisation Holder JANSSEN-CILAG INTERNATIONAL NV
Hver pakning VELCADE 1 mg pulver til injektionsvæske, opløsning, indeholder et hætteglas med grønt låg i en gennemsigtig blisterpakning. 
Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.
• Hikke, taleforstyrrelser 
• Hiccups, speech disorders
I studie MMY-3010 blev induktionsbehandling med VELCADE i kombination med thalidomid og dexamethason [VcTDx, n = 130] sammenlignet med thalidomid-dexamethason [TDx, n = 127]. 
In study MMY-3010 induction treatment withVELCADE combined with thalidomide and dexamethasone [VcTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
I studie LYM-3002 fik 78 % af patienterne i VcR-CAP-armen og 61 % af patienterne i R-CHOP-armen support med kolonistimulerende faktor. 
In study LYM-3002, colony stimulating factor support was given to 78% of patients in the VcR-CAP arm and 61% of patients in the R-CHOP arm.
10 ml hætteglas i type 1 glas med en grå bromobutyl-prop og en aluminiumsforsegling med kongeblåt låg, der indeholder 3,5 mg bortezomib. 
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
I studier med patienter med recidiverende myelomatose, som blev behandlet med VELCADE, og med patienter med tidligere ubehandlet MCL, som blev behandlet med VELCADE i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP), var en af de hyppigste hæmatologiske bivirkninger forbigående trombocytopeni. 
In studies in patients with relapsed multiple myeloma treated with VELCADE and in patients with previously untreated MCL treated with VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
• Leddegigt, herunder betændelsestilstand i leddene i fingre, tæer og kæben 
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
• Blodpropper i lungerne 
• Blood clots in your lungs
Kun til subkutan eller intravenøs anvendelse. 
Subcutaneous or Intravenous use only.
Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypotyroidisme 
Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Klinisk virkning hos tidligere ubehandlede myelomatosepatienter Et prospektivt, internationalt, randomiseret (1:1), åbent klinisk fase III-studie (MMY-3002 VISTA) med 682 patienter blev gennemført for at bestemme, om VELCADE (1,3 mg/m2 som intravenøs injektion) i kombination med melphalan (9 mg/m 2) og prednison (60 mg/m 2) medførte en forbedring i tid til progression (TTP) ved sammenligning med melphalan (9 mg/m2) og prednison (60 mg/m2) til patienter med tidligere ubehandlet myelomatose. 
Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Responsrate efter 8 cyklusser n (%) ORR (CR+PR) p-værdi 
Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
• I tilfælde af lokale reaktioner på injektionsstedet efter en subkutan injektion af VELCADE anbefales det enten at administrere en mindre koncentreret VELCADE opløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller skifte til intravenøs administration. 
• If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Der er hos patienter behandlet med VELCADE rapporteret meget sjældne tilfælde af John Cunningham-virus (JC-virus), der førte til PML og død. 
Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with VELCADE.
• diaré, forstoppelse, kvalme eller kaster op 
• diarrhoea, constipation, nausea or vomiting
• tidligere har haft problemer med følelsesløshed, følelse af prikken eller smerte i hænder eller fødder (neuropati) 
• numbness, tingling, or pain in the hands or feet (neuropathy) in the past
Både VcR-CAP og R-CHOP var mindre veltolereret hos patienter ≥ 75 år, og hyppigheden af alvorlige bivirkninger var i VcR-CAP-gruppen 68 % sammenlignet med 42 % i R-CHOP-gruppen. 
Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Vaginalblødning, genitale smerter*, erektil dysfunktion 
Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Bemærk: OR > 1 tyder på en fordel for Vc-indeholdende induktionsterapi. 
Note: An OR > 1 indicates an advantage for Vc-containing induction therapy.
• Hudkløe, buler i huden eller tør hud 
• Itching of the skin, lumps on the skin or dry skin
VDDx = vincristin, doxorubicin, dexamethason; VcDx = VELCADE, dexamethason; TDx = thalidomid, dexamethason; VcTDx = VELCADE, thalidomid, dexamethason; PN = perifer neuropati Bemærk: Perifer neuropati inkluderede de foretrukne termer: perifer neuropati, perifer motorisk neuropati, perifer sensorisk neuropati og polyneuropati. 
VDDx=vincristine, doxorubicin, dexamethasone; VcDx=VELCADE, dexamethasone; TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
• Herpes-virusinfektioner 
• Herpes virus infections
• Hævelser på kroppen, inklusive omkring øjnene og andre steder på kroppen 
• Swelling of body, to include around eyes and other parts of the body
• Bevægelsesforstyrrelser, lammelse, spjætten 
• Movement disorders, paralysis, twitching
• Trombocyttal skal være ≥ 75x 10 9 celler/l hos patienter med infiltreret knoglemarv eller sekvestration af milten. 
• Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Tabel 3: Dosisjusteringer under efterfølgende cyklusser med VELCADE i kombination med melphalan og prednison 
Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone
VELCADE bruges til behandling af myelomatose (kræft i knoglemarven) hos patienter over 18 år: - alene eller sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason til patienter, hvis sygdom forværres (er progressiv) efter mindst én forudgående behandling, og som ikke har haft gavn af eller mulighed for at få en transplantation af blodstamceller (knoglemarvstransplantation). 
VELCADE is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.
VcR-CAP = VELCADE, rituximab, cyclophosphamid, doxorubicin og prednison; R-CHOP = rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; PN = perifer neuropati Perifer neuropati inkluderede de foretrukne termer: perifer sensorisk neuropati, perifer neuropati, perifer motorisk neuropati og perifer sensomotorisk neuropati 
VcR-CAP=VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Dexamethason gives i en dosis på 40 mg gennem munden på dag 1, 2, 3, 4, 8, 9, 10 og 11 i den 28-dages VELCADE-behandlingscyklus, og thalidomid gives dagligt gennem munden i en dosis på 50 mg frem til dag 14 i den første cyklus, og hvis du tolererer thalidomiddosen, øges den til 100 mg på dag 15-28 og kan derefter øges igen til 200 mg dagligt fra og med den anden cyklus. 
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Patienterne i VcR-CAP-armen fik VELCADE (1,3 mg/m2 på dag 1, 4, 8, 11, hvileperiode dag 12-21), rituximab 
Patients in the VcR-CAP treatment arm received VELCADE (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21),
En statistisk signifikant forskel i CR+nCR blev observeret til fordel for gruppen, der fik VELCADE i kombination med dexamethason og thalidomid. 
A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
• Skader 
• Injuries
• Injicer opløsningen subkutant i en vinkel på 45-90°. 
• Inject the solution subcutaneously, under a 45-90°angle.
• Nedsat sexlyst 
• Decreased sex drive
• Forskellige typer udslæt 
• Different types of rash
≥ 2 tidligere behandlinger 
≥ 2 prior lines
Klinisk virkning ved tidligere ubehandlet mantle-celle-lymfom (MCL) Studie LYM-3002 var et åbent, randomiseret fase III-studie, som sammenlignede effekt og sikkerhed af kombinationen af VELCADE, rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP; n = 243) i forhold til rituximab, cyclophosphamid, doxorubicin, vincristin og prednison (R-CHOP; n = 244) hos voksne patienter med tidligere ubehandlet MCL (stadie II, III eller IV). 
Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
HBV-infektion med dødelig udgang forekom hos 0,8 % (n = 2) af patienterne i non-VELCADE-armen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4 % (n = 1) af patienterne i armen med VELCADE plus rituximab, cyclophosphamid, doxorubicin og prednison (VcR-CAP). 
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP).
Hvis PML diagnosticeres, skal VELCADE seponeres. 
Discontinue VELCADE if PML is diagnosed.
Hvis du får VELCADE sammen med thalidomid, skal du benytte effektiv prævention som angivet for thalidomid (se indlægssedlen for thalidomid). 
When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Responsrate efter 4 cyklusser n (%) ORR (CR+PR) p-værdi 
Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Brug ikke VELCADE: - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i VELCADE 
Do not use VELCADE - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
• Hensygnen eller tab af kropsmasse 
• Wasting, or loss of body mass
De bivirkninger, du kan opleve, hvis du får VELCADE sammen med andre lægemidler til behandling af mantle-celle-lymfom, er angivet nedenfor: 
If you are given VELCADE together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Nogle af disse sygdomme omfatter vejrtrækningsbesvær, kortåndethed, kortåndethed uden fysiske udfoldelser, 
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise,
Du kan få op til 8 cyklusser (24 ugers behandling). 
You might receive up to 8 cycles (24 weeks).
Opdatering af overlevelsesdata baseret på en median opfølgning på 60,1 måneder mdr.= måneder 
EBMT criteria All randomised patients with secretory disease * Survival update based on a median duration of follow-up at 60.1 months mo: months
Klinisk virkning ved recidiverende eller refraktær myelomatose Sikkerheden og effekten ved VELCADE (som intravenøs injektion) blev vurderet i to studier med den anbefalede dosis på 1,3 mg/m2: et randomiseret, komparativt fase III-studie (APEX) versus dexamethason (Dex) med 669 patienter med recidiverende eller refraktær myelomatose, som havde fået 1-3 tidligere behandlinger, og et fase II-studie med en enkelt gruppe med 202 patienter med recidiverende eller refraktær myelomatose, som havde fået mindst 2 tidligere behandlinger, og som i deres seneste behandlingsregime havde oplevet progression. 
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of VELCADE (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Neuropati*, perifer sensorisk neuropati, dysæstesi*, neuralgi* 
Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
dissemineret & oftalmisk), pneumoni*, herpes simplex*, svampeinfektion* 
Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Tid til næste behandling Hændelser n (%) Median (95 % CI) 
Time to next therapy Events n (%) Median (95% CI)
• Generel følelse af at være syg, smerter, svimmelhed, ør i hovedet, en følelse af afkræftelse eller bevidsthedstab 
• General ill feeling, pain, vertigo, light-headedness, a feeling of weakness or loss of consciousness
Effekten af nedsat leverfunktion på bortezomibs farmakokinetik i doseringsintervallet 0,5-1,3 mg/m blev vurderet i et fase I-studie i den første behandlingscyklus hos 61 patienter med primært solide tumorer og nedsat leverfunktion i varierende grad. 
The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m
N = 130 (ITTpopulation) 
N=130 (ITT population)
Patienter i VcDx-gruppen fik fire 21-dages cyklusser, hver bestående af VELCADE (1,3 mg/m2 administreret intravenøst to gange om ugen dag 1, 4, 8 og 11) og oralt dexamethason (40 mg/dag, dag 1 til 4 og dag 9 til 12 i cyklus 1 og 2 og dag 1 til 4 i cyklus 3 og 4). 
Patients in the VcDx group received four 21 day cycles, each consisting of VELCADE (1.3 mg/m2 administered intravenously twice weekly on days 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
på dag 1 og prednison 100 mg/m2 oralt på dag 1 til og med dag 5 af VELCADE-behandlingscyklussens 21 dage. 
IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day VELCADE treatment cycle.
• Koma 
• Coma
Tid til progressionHændelser n (%) Median a (95 % CI) 
Time to progression Events n (%) Median a (95% CI)
Det primære effektendepunkt for studiet var post-induktions- og post-transplantationsresponsrater(CR+nCR). 
The primary efficacy endpoints of the study were post-induction and post-transplant response rates (CR+nCR).
• Hæmoglobin ≥ 8 g/dl (4,96 mmol/l) 
• Haemoglobin ≥ 8 g/dL
• Betændelse i rygmarvsnerven 
• Inflammation of the spinal nerve
• Udstående øjne 
• Bulging eyes
RR (Post-induktion) *CR+nCR 
RR (Post-induction) *CR+nCR
Hvis der opstår lokale reaktioner på injektionsstedet efter en subkutan injektion af VELCADE, bør VELCADE enten gives subkutant i en lavere koncentration (VELCADE 3,5 mg rekonstitueres til 1 mg/ml i stedet for 2,5 mg/ml), eller der bør skiftes til intravenøs injektion. 
If local injection site reactions occur following VELCADE subcutaneous injection, either a less concentrated VELCADE solution (VELCADE 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
N = 127 (ITTpopulation) 
N=127 (ITT population)
Perifer neuropati ved kombinationsbehandlinger 
Peripheral neuropathy in combination regimens Multiple Myeloma
Tabel 6: Anbefalet justering af initialdosis for VELCADE hos patienter med nedsat leverfunktion Grad af leverfunktionsnedsættelse* 
Table 6: Recommended starting dose modification for VELCADE in patients with hepatic impairment
9/l eller 
9/l
Sjælden Leversvigt, hepatomegali, Budd-Chiaris syndrom, cytomegalovirus-hepatitis, leverblødning, kolelitiasis 
Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
*RR (Post-induktion) CR+nCR 
*RR (Post-induction) CR+nCR
Tilsvarende andele af patienterne havde kreatininclearance ≤ 30 ml/min (3 % i hver gruppe). 
≤ 30 ml/min (3% in each arm).
Når VELCADE gives i kombination med andre lægemidler, bør produktresuméerne for disse lægemidler kontrolleres før initiering af behandling med VELCADE. 
When VELCADE is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with VELCADE.
Kombinationsbehandling med melphalan og prednison VELCADE 1 mg pulver til injektionsvæske, opløsning indgives som intravenøs injektion kombineret med oral melphalan og oral prednison som vist i tabel 2. 
Combination therapy with melphalan and prednisone VELCADE 1 mg powder for solution for injection is administered via intravenous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Et lægemiddelinteraktionsstudie til vurdering af effekten af ketoconazol, en kraftig CYP3A4-hæmmer, på bortezomibs farmakokinetik (som intravenøs injektion) viste en gennemsnitlig stigning i bortezomibs AUC på 35 % (CI90 % (1,032 til 1,772)) baseret på data fra 12 patienter. 
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Bortezomib er en proteasom-hæmmer. 
Bortezomib is a proteasome inhibitor.
• Problemer med blodets størknen 
• Problems with blood clotting
VELCADE-kombinationsbehandling med pegyleret liposomal doxorubicin (studie DOXIL-MMY-3001) Der blev udført et randomiseret, parallelgruppe, åbent, fase III-multicenterstudie med 646 patienter for at sammenligne sikkerheden og effekten af VELCADE plus pegyleret liposomal doxorubicin versus VELCADE som monoterapi hos patienter med myelomatose, som tidligere har fået mindst 1 behandling, og som ikke progredierede under antracyklin-baseret behandling. 
VELCADE combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of VELCADE plus pegylated liposomal doxorubicin versus VELCADE monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
1, 4, 8 og 11 i en 21-dages behandlingscyklus. 
11 in a 21 day treatment cycle.