natgillin/translations-raw huggingface dataset:
Yderligere oplysninger om Bortezomib Accord findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Dosering til patienter med tidligere ubehandlet mantle-celle-lymfom (MCL) 
Posology for patients with previously untreated mantle cell lymphoma (MCL)
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-værdid 
CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med Bortezomib Accord, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med Bortezomib Accord. 
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Accord for information related to these medicines before starting treatment with Bortezomib Accord.
BzR-CAP R-CHOP 
BzR-CAP
(95 % CI) p-værdi c a Kaplan-Meier-estimat b Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region. 
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
• Trombocyttal skal være ≥ 75x 109 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
Det skal du vide, før du begynder at bruge Bortezomib Accord Brug ikke Bortezomib Accord: 
What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Bortezomib-behandling skal indstilles ved forekomst af ≥ grad 3 bortezomib-relateret ikke hæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt. 
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).
Patienter med moderat eller alvorligt nedsat leverfunktion skal starte med en reduceret dosis af Bortezomib Accord på 0,7 mg/m2 pr. injektion i den første behandlingscyklus; efterfølgende dosisøgning til 1,0 mg/m2 eller yderligere dosisreduktion til 0,5 mg/m2 kan overvejes, afhængigt af patientens tolerabilitet (se Tabel 6 samt pkt. 
Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Median OS var 30,8 måneder (95 % CI: 25,2-36,5 måneder) for patienter i monoterapi med bortezomib og 33,0 måneder (95 % CI: 28,9-37,1 måneder) for patienter i kombinationsbehandling med bortezomib plus pegyleret liposomal doxorubicin. 
The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Bortezomib Accord-behandlingen skal indstilles, indtil symptomerne på toksiciteten er vurderet til grad 1 eller baseline. 
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Bortezomib Accord vil blive givet af sundhedspersonale, som har erfaring med behandling med cytostatika. 
Bortezomib Accord will be administered by a health care professional experienced in the use of cytotoxic medicines.
- Aktivt stof: bortezomib. 
The active substance is bortezomib.
Kun intravenøs anvendelse. 
Intravenous use.
- Øvrige indholdsstoffer: Mannitol (E421). 
The other ingredient is mannitol (E421).
Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetes-patienter i behandling med orale hypoglykæmika. 
During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Patienterne i begge behandlingsarme fik i gennemsnit 6 cyklusser, hvor 14 % af patienterne i BzR-CAP-armen og 17 % af patienterne i R-CHOP-armen fik 2 supplerende cyklusser. 
A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
• Ikke-hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline 
• Non-haematological toxicities should have resolved to Grade 1 or baseline
For studiet LYM-3002, hvor bortezomib blev administreret sammen med rituximab, cyclophosphamid, doxorubicin og prednison (R-CAP), præsenteres forekomsten af perifer neuropati i kombinationregimerne i tabellen nedenfor: 
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Hvis du får Bortezomib Accord 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, hovedpiner - åndenød, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed, besvimelse - hoste og vejrtrækningsbesvær eller trykken for brystet. 
If you are given Bortezomib Accord 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,
Hvis du ikke tidligere er blevet behandlet for mantle-celle-lymfom, vil du få Bortezomib Accord intravenøst eller subkutant sammen med lægemidlerne rituximab, cyclophosphamid, doxorubicin og prednison. 
If you have not been treated before for mantle cell lymphoma, you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Patienter, som er egnede til stamcelletransplantation 
Patients eligible for stem cell transplantation
Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon Sjælden Hypotyroidisme 
Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Patienterne fik administreret intravenøse doser bortezomib på 0,7 til 1,3 mg/m2 to gange ugentlig. 
Patients were administered intravenous doses of 0.7 to 1.3 mg/m2 of bortezomib twice weekly.
Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi 
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy
Perifer neuropati ved kombinationsbehandlinger 
Peripheral neuropathy in combination regimens
Forjustering af Bortezomib Accord-dosis: Retningslinjerne for dosisændringer som beskrevet for monoterapi skal følges. 
For Bortezomib Accord dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Du vil derfor få taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer. 
Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Hvis du har brugt for meget Bortezomib Accord 
If you are given too much Bortezomib Accord
Hvis du ikke er blevet behandlet for myelomatose tidligere, og du er egnet til at få transplantation med blodstamceller, vil du få Bortezomib Accord intravenøst eller subkutant samtidig med lægemidlerne dexamethason, eller dexamethason og thalidomid, som induktionsbehandling. 
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Skift behandlingsplanen for Bortezomib Accord til 1,3 mg/m2 en gang om ugen 
Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Bemærk: OR > 1 tyder på en fordel for Bz-indeholdende induktionsterapi. 
Note: An OR > 1 indicates an advantage for Bz-containing induction therapy.
Bortezomib Accord-behandlingen seponeres, indtil toksicitetssymptomerne er forsvundet. 
Withhold Bortezomib Accord treatment until symptoms of toxicity have resolved.
Det er nødvendigt, at du får taget regelmæssige blodprøver før og under din behandling med Bortezomib Accord for at kontrollere niveauet af dine blodlegemer. 
You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Tabel 3: Dosisjusteringer under efterfølgende cyklusser med Bortezomib Accord i kombination med melphalan og prednison 
Table 3: Posology modifications during subsequent cycles of Bortezomib Accord therapy in combination with melphalan and prednisone
Følgende lægemidler administreres som intravenøse infusioner på dag 1 i hver 3-ugers behandlingscyklus med bortezomib: rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2. 
The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
n:ITT-patienter 
n: ITT patients
Den normale startdosis Bortezomib Accord er 1,3 mg/m2 legemsoverflade to gange om ugen. 
The usual starting dose of Bortezomib Accord is 1.3 mg/m2 body surface area twice a week.
• at kravene til rekonstitution af Bortezomib Accord 3,5 mg er forskellige ved intravenøs og subkutan anvendelse 
• different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
Pakningsstørrelser og yderligere oplysninger Bortezomib Accord indeholder: 
Contents of the pack and other information What Bortezomib Accord contains
Hos patienter med MCL (studie LYM-3002) var forekomsten af herpes zoster-infektion 6,7 % i BzRCAP-armen og 1,2 % i R-CHOP-armen (se pkt. 
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 1 mg 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 1 mg
I studie MMY-3010 blev induktionsbehandling med bortezomib i kombination med thalidomid og dexamethason [BzTDx, n=130] sammenlignet med thalidomid-dexamethason [TDx, n=127]. 
In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
I studier med patienter med recidiverende myelomatose, som blev behandlet med bortezomib, og med patienter med tidligere ubehandlet MCL, som blev behandlet med bortezomib i kombination med rituximab, cyclophosphamid, doxorubicin og prednison (BzR-CAP), var en af de hyppigste hæmatologiske bivirkninger forbigående trombocytopeni. 
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
ORR (CR+PR) p-værdia CR n (%) PR n (%) nCR n (%) 
ORR (CR+PR) p-valuea CR n (%) PR n (%) nCR n (%)
I studiet IFM-2005-01 blev bortezomib i kombination med dexamethason [BzDx, n=240] sammenlignet med vincristin-doxorubicin-dexamethason [VDDx, n=242]. 
In study IFM-2005-01 bortezomib combined with dexamethasone [BzDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
En statistisk signifikant forskel i CR+nCR) blev observeret til fordel for gruppen, der fik bortezomib i kombination med dexamethason og thalidomid. 
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Trombocyttallet var lavest på dag 11 i hver cyklus af bortezomib-behandlingen og var typisk vendt tilbage til baselineniveau ved den næste cyklus. 
Platelets were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle.
Genbehandling af patienter med recidiverende myelomatose 
Retreatment of patients with relapsed multiple myeloma
Dette studie omfattede 222 patienter med recidiverende eller refraktær myelomatose, som blev randomiseret i forholdet 2:1 til at få 1,3 mg/m2 bortezomib enten som subkutan eller intravenøs administration i 8 
222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Sindslidelser*, hallucinationer*, psykose*, konfusion*, rastløshed 
Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
cyklusser. 
8 cycles.
Det er yderst vigtigt, at der anvendes aseptisk teknik under håndteringen af Bortezomib Accord, da det ikke indeholder konserveringsmiddel. 
Aseptic technique must be strictly observed throughout the handling of Bortezomib Accord, since it contains no preservative.
Patienter med ≥ grad 2 perifer neuropati ved baseline eller trombocyttal < 50 x 109/l indgik ikke. 
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
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 bortezomib, rituximab, cyclophosphamid, doxorubicin og prednison (BzR-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 bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-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).
Der skal gå mindst 72 timer mellem 2 doser Bortezomib Accord. 
At least 72 hours should elapse between consecutive doses of Bortezomib Accord.
Hændelser n (%) Mediana 
Events n (%) Mediana
RR (Post-transplantation) 
RR (Post-transplant)
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON 3,5 mg 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON 3.5 mg
Bortezomib Accord pulver skal opløses, før det gives. 
Bortezomib Accord powder has to be dissolved before administration.
Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 efter toksicitet og behandlingsseponering som følge af perifer neuropati BzR-CAP (N=240) 
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Pancytopeni*, febril neutropeni, koagulopati*, leukocytose*, lymfadenopati, hæmolytisk anæmi# 
Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#
Der skal gå mindst 72 timer mellem 2 doser bortezomib. 
At least 72 hours should elapse between consecutive doses of bortezomib.
Tabel 6: Anbefalet justering af initialdosis for Bortezomib Accord hos patienter med nedsat leverfunktion 
Table 6: Recommended starting dose modification for Bortezomib Accord in patients with hepatic impairment
Bortezomib skal seponeres ved forekomst af ikke-hæmatologisk grad 3-toksicitet eller hæmatologisk grad 4-toksicitet med undtagelse af neuropati som beskrevet nedenfor (se pkt. 
Bortezomib treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Hos patienter med MCL (studie LYM-3002) var der en højere forekomst (56,7 % versus 5,8 %) af grad ≥ 3 trombocytopeni i bortezomib-armen (BzR-CAP) sammenlignet med non-bortezomib-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 bortezomib treatment group (BzR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
• I tilfælde af lokale reaktioner på injektionsstedet efter en subkutan injektion af Bortezomib Accord anbefales det enten at administrere en mindre koncentreret Bortezomib Accordopløsning (1 mg/ml i stedet for 2,5 mg/ml) subkutant eller skifte til intravenøs administration. 
• If local injection site reactions occur following Bortezomib Accord injection subcutaneously, either a less concentrated Bortezomib Accord solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Bortezomib Accord pulver til injektionsvæske, opløsning, er en hvid til gullig masse eller et hvidt til gulligt pulver. 
Bortezomib Accord powder for solution for injection is a white to off-white cake or powder.
Bortezomib-kombinationsbehandling med dexamethason 
Bortezomib combination treatment with dexamethasone
WESSLING Hungary Kft. Anonymus u. 6., Budapest, 1045, Ungarn 
Wessling Hungary Kft. Anonymus u. 6., Budapest, 1045, Hungary
VDDx=vincristin, doxorubicin, dexamethason; BzDx= bortezomib, dexamethason; TDx=thalidomid, dexamethason; BzTDx= bortezomib, 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; BzDx= bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzTDx= bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Der foreligger ingen studier af anvendelsen af bortezomib til ældre patienter med tidligere ubehandlet myelomatose, som er egnede til højdosis kemoterapi med hæmatopoietisk stamcelletransplantation. 
There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Hos patienter med fremskreden myelom var sværhedsgraden af trombocytopeni relateret til trombocyttallet før behandlingen: for trombocyttal ved baseline < 75 x 109/l havde 90 % af 21 patienter et tal på ≤ 25 x 109/l under studiet, herunder 14 % < 10 x 109/l. 
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/µl, 90% of 21 patients had a count ≤ 25,000/µl during the study, including 14% < 10,000/µl; in contrast, with a baseline platelet count > 75,000/µl, only 14% of 309 patients had a count ≤ 25,000/µl during the study.
Den samlede forekomst af hepatitis B-infektion var sammenlignelig hos patienter i BzRCAP-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 BzR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
BzR-CAP= bortezomib, rituximab, cyclophosphamid, doxorubicin og prednison; RCHOP=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 
BzR-CAP=Bortezomib, 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
Patienter i BzDx-gruppen fik fire 21-dages cyklusser, hver bestående af bortezomib (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 BzDx group received four 21 day cycles, each consisting of bortezomib (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).
• at eventuelle bivirkninger eller fejlmedicinering i forbindelse med administration af Bortezomib Accord bør indberettes. 
• to report any adverse event, or medication error experienced with the administration of Bortezomib Accord.
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 Bortezomib Accord-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 Bortezomib Accord 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.
I studie LYM-3002 fik 78 % af patienterne i BzR-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 BzR-CAP arm and 61% of patients in the R-CHOP arm.
Hvis du får Bortezomib Accord sammen med thalidomid, skal du benytte effektiv prævention som angivet for thalidomid (se indlægssedlen for thalidomid). 
When Bortezomib Accord is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
*RR (Post-transplantation) 
*RR (Post-transplant)
Patienterne havde IgG/IgA/lette kæder af myelomer i henholdsvis 63 %/25 %/8 % tilfælde, mediant hæmoglobin på 105 g/l og mediant trombocyttal på 
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
3,5 mg/hætteglas 
3.5 mg/vial
HBV-infektion med dødelig udgang forekom hos 0,8 % (n=2) af patienterne i non-bortezomib-armen (rituximab, cyclophosphamid, doxorubicin, vincristin og prednison; R-CHOP) og hos 0,4 % (n=1) af patienterne i armen med bortezomib plus rituximab, cyclophosphamid, doxorubicin og prednison (BzR-CAP). 
HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP).
Hepatitis B-virus (HBV)-reaktivering og -infektion Når rituximab anvendes i kombination med bortezomib, skal patienter, som har risiko for infektion med HBV, altid screenes for HBV, inden behandlingen startes. 
When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Tid til næste behandling 
Time to next therapy
Dosisjustering af Bortezomib Accord ved kombinationsbehandling skal følge retningslinjerne, der er beskrevet under monoterapi ovenfor. 
For Bortezomib Accord dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.