natgillin/translations-raw huggingface dataset:
Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Patientdemografiske og baseline-sygdomsegenskaber var sammenlignelige mellem behandlingsgrupperne. 
Patient demographic and baseline disease characteristics were similar between the treatment groups.
Tabel 11: Effektresultater efter den endelige opdatering af overlevelse i VISTA-studiet 
Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Behandling med bortezomib skal indstilles i op til 2 uger, indtil patienten har en ANC ≥ 750 celler/μl og et trombocyttal på ≥ 25.000 celler/μl. 
Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Der blev også noteret en højere incidens af infektioner med grad ≥ 3 neutropeni (24 % versus 19 % i blok 1 og 22 % versus 11 % i blok 2), øget ALAT (17 % versus 8 % i blok 2), hypokalcæmi (18 % versus 6 % i blok 1 og 21 % versus 12 % i blok 2) og hyponatræmi (12 % versus 5 % i blok 1 og 4 % versus 0 i blok 2). 
Higher incidences were also noted for infections with grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
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. 
Hepatitis B virus (HBV) reactivation and infection 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.
Nominel p-værdi baseret på den stratificerede log-rank-test justeret for stratifikationsfaktorer: β2mikroglobulin, albumin og region d p-værdi for responsrate (CR+PR) fra Cochran-Mantel-Haenszel chi-square-test justeret for stratifikationsfaktorer e 
Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran Mantel-Haenszel chi-square test adjusted for the stratification factors e
Bortezomib kan i moderat grad påvirke evnen til at føre motorkøretøj og betjene maskiner. 
Bortezomib may have a moderate influence on the ability to drive and use machines.
Den mediane gennemsnitsalder af patienterne i studiet var 57 år, 55 % var mænd, og 48 % af patienterne blev cytogenetisk klassificeret som højrisiko. 
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Ud over perifer neuropati kan der yderligere forekomme autonom neuropati ved nogle bivirkninger så som postural hypotension og svær forstoppelse med ileus. 
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.
Matched-pair-analysen er en statistisk metode, i hvilken patienter i behandlingsgruppen (f.eks. bortezomib i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. bortezomib) 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. 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.
I fase II-studiet kunne de patienter, som ikke havde en optimal respons til behandlingen med bortezomib alene, få højdosis dexamethason sammen med bortezomib. 
In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Klinisk effekt ved subkutan administration af bortezomib hos patienter med recidiverende/refraktær myelomatose 
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Grad 2 med smerter eller Grad 3 (svære symptomer; begrænset personlige pleje; personlig ADL***) 
Grade 2 with pain or grade 3 (severe symptoms; limiting self care ADL***)
Selvmordstanker*, tilpasningsforstyrrelser, delirium, nedsat libido 
Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Patienter, der ikke opnåede en optimalt respons (mindre end et komplet respons [CR]) på behandlingen med bortezomib alene efter 4 cyklusser, fik desuden dexamethason 20 mg dagligt dagen før og efter administration af bortezomib. 
Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Dosisjusteringer under behandling og efter re-initiering af kombinationsbehandling med melphalan og prednison 
Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
• Blå mærker, fald og skader 
• Bruises, falls and injuries
Denne interimanalyse viste en TTP-risikoreduktion på 45 % (95 % CI, 29-57 %, p < 0,0001) for patienter behandlet med kombinationsbehandlingen af bortezomib og pegyleret liposomal doxorubicin. 
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
P-værdi fra Cochran Mantel-Haenszel chi-square -test, med IPI og sygdomsstadie som stratifikationsfaktorer. 
g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
• Rådgivning om intravenøs og subkutan administration, herunder at der bør skiftes mellem injektionssteder ved s.c. anvendelse. 
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Der blev observeret en statistisk signifikant fordel (p < 0,001) for BR-CAP-gruppen i forhold til R-CHOP-gruppen for TTP (median 30,5 kontra 16,1 måneder), TNT (median 44,5 kontra 24,8 måneder) og TFI (median 40,6 kontra 20,5 måneder). 
A statistically significant benefit (p < 0.001) in favour of the BR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Aktivering af makrofager 
Macrophage activation
Når det er opløst, udtrækkes den relevante mængde af den rekonstituerede opløsning i henhold til beregnet dosis ud fra patientens legemsoverflade. 
- Once dissolved, withdraw the appropriate amount of the reconstituted solution according to calculated dose based upon the patient´s Body Surface Area.
Kontroller at den korrekte dosis anvendes til subkutan administration (2,5 mg/ml). 
Be sure that the correct dose is being given for the subcutaneous route of administration (2.5 mg/ml).
Efter en intravenøs bolus- eller subkutan injektion af en dosis på 1,3 mg/m hos patienter med myelomatose (n = 14 i den intravenøse gruppe, n = 17 i den subkutane gruppe) sås ækvivalente total systemisk eksponering efter gentagne doser (AUClast) for subkutan og intravenøs administration. 
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
De to behandlingsgrupper var sammenlignelige, hvad angår den samlede forekomst af alle grader af blødningshændelser (6,3 % i BR-CAP-gruppen og 5,0 % i R-CHOP-gruppen) såvel som blødningshændelser af grad 3 og højere (BR-CAP: 4 patienter [1,7 %]; R-CHOP: 3 patienter [1,2 %]). 
The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Bortezomib var positivt for klastogen aktivitet (strukturelle kromosomafvigelser) i in vitro-analysen af kromosomafvigelser ved hjælp af ovarieceller fra kinesiske hamstre (CHO-celler) i koncentrationer så lave som 3,125 μg/ml, som var den lavest undersøgte koncentration. 
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
• ≥ Grad 3 neutropeni med feber, grad 4 neutropeni, som varer længere end 7 dage, trombocyttal < 10.000 celler/μl 
Haematological toxicity - ≥ Grade 3 neutropenia with fever, grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Brug ikke bortezomib - hvis du er allergisk over for bortezomib, bor eller et af de øvrige indholdsstoffer i denne medicin (angivet i afsnit 6). 
Do not use bortezomib - 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.
Tabel 15: Resumé af effektanalyser sammenlignende subkutan og intravenøs administration af bortezomib 
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Baseret på dyrestudier synes bortezomibs penetration af blod/hjerne-barrieren at være begrænset, om overhovedet nogen. 
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.
Det anbefales at give en lavere startdosis til patienter med moderat eller alvorligt nedsat leverfunktion, og disse patienter bør monitoreres nøje (se pkt. 
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).
Patienter, der udviklede ortostatisk hypotension med bortezomib (som intravenøs injektion) viste ikke tegn på ortostatisk hypotension før behandlingen med bortezomib. 
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Hæmning af proteasomet resulterer i cellecyklusstop og apoptose. 
Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Thalidomid er et kendt teratogent lægemiddel, som medfører livstruende medfødte misdannelser hos mennesker. 
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects.
Bortezomib-kombinationsbehandling med pegyleret liposomal doxorubicin (studie DOXIL-MMY 
Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
• Besvær eller problemer med at sove, svedeture, angst, humørsvingninger, nedsat humør, 
• Difficulty or problems in sleeping, sweating, anxiety, mood swings, depressed mood,
Der skal udvises forsigtighed, ved behandling af patienter med tidligere synkope, der får lægemidler, som er kendt for at være forbundet med hypotension, eller patienter som er dehydrerede pga. tilbagevendende diarré eller opkastning. 
Caution is advised when treating patients with a history of syncope receiving medicinal products known to be associated with hypotension; or who are dehydrated due to recurrent diarrhoea or vomiting.
Bortezomib var ikke genotoksisk i in vitro-analyser af mutagenicitet (Ames' test) og in vivo-analyser af mikronukleus hos mus. 
Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Der er rapporteret akut udvikling eller forværring af kongestiv hjertesvigt og/eller ny forekomst af nedsat ejektionsfraktion fra venstre ventrikel ved behandling med bortezomib. 
Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Følgende bivirkninger (grad ≥ 3) blev observeret i højere grad i behandlingsregimet med bortezomib sammenlignet med et historisk kontrolstudie, hvor grundbehandlingen blev givet alene: i blok 1 perifer sensorisk neuropati (3 % versus 0 %); ileus (2,1 % versus 0 %), hypoxi (8 % versus 2 %). 
The following adverse reactions (grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Hvid til offwhite frysetørret pulver eller masse. 
White to off-white lyophilized powder or cake.
I et studie med patienter med tidligere ubehandlet mantlecellelymfom var henholdsvis 42,9 % og 10,4 % af de patienter, der fik bortezomib, i alderen 65-74 år og ≥ 75 år. 
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Inkluderer alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og LDH. 
h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
De væsentligste effektresultater er præsenteret i tabel 13. 
Main efficacy results are presented in table 13.
Der blev foretaget et farmakokinetisk studie hos patienter med varierende grad af nedsat nyrefunktion, som blev klassificeret i følgende grupper i henhold til deres kreatininclearance (CrCl): Normal (CrCl ≥ 60 ml/min/1,73 m2, n=12), Mild (CrCl=40-59 ml/min/1,73 m2, n=10), Moderat 
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Tabel 13: Effektresultater fra studie MMY-3010 Effektmål 
Table 13: Efficacy results from study MMY-3010 Endpoints
Estimatet af Hazard ratio er baseret på Cox' proportionelle risikomodel justeret for stratifikationsfaktorer: β2-mikroglobulin, albumin og region. 
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Demografiske og baseline-sygdomskarakteristika var generelt afbalanceret mellem de to behandlingsarme: Den mediane patientalder var 66 år, 74 % var mænd, 66 % var kaukasiere og 32 % asiatere, 69 % af patienterne havde et positivt knoglemarvsaspirat og/eller en positiv knoglemarvsbiopsi for MCL, 54 % af patienterne havde en IPI-score (International Prognostic Index) på ≥ 3, og 76 % var i sygdomsstadie IV. Behandlingens varighed (median=17 uger) og varigheden af opfølgningen (median=40 måneder) var sammenlignelige i de to behandlingsarme. 
The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
En oddsratio (OR) > 1 angiver en fordel for BR-CAP. 
An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Der skal vælges et nyt injektionssted mellem på hinanden følgende injektioner. 
Injection sites should be rotated for successive injections.
Se tabel 5 nedenfor vedrørende dosisjusteringer. 
For dose adjustments, see table 5 below.
Melphalan og prednison bør begge gives oralt på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus med bortezomib. 
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each bortezomib treatment cycle.
Dette studie inkluderede 222 patienter med recidiverende eller refraktær myelomatose, som blev randomiseret i forholdet 2:1 til at få 1,3 mg/m bortezomib enten som subkutan eller intravenøs administration i 8 cyklusser. 
This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, inklusive myelomatose. 
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 i forhold til toksicitet og behandlingsseponering som følge af perifer neuropati BR-CAP (N=240) 
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Tabel 8: Bivirkninger hos patienter med mantlecellelymfom, som blev behandlet med BR-CAP i et klinisk studie 
Table 8: Adverse reactions in patients with mantle cell lymphoma treated with BR-CAP in a clinical trial
Bortezomib Fresenius Kabi indeholder: - Aktivt stof: Bortezomib. 
What Bortezomib Fresenius Kabi contains - The active substance is bortezomib.
Melphalan (9 mg/m2) og prednison (60 mg/m2) gives gennem munden på dag 1, 2, 3 og 4 i den første uge af hver behandlingscyklus. 
Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
• Regler for opbevaring af den rekonstituerede opløsning. 
• storage precautions for reconstituted solution
Der anbefales seks bortezomib-cyklusser, men patienter med et respons, som først dokumenteres ved cyklus 6, kan gives yderligere to bortezomib-cyklusser. 
Six bortezomib cycles are recommended, although for patients with a response first documented at cycle 6, two additional bortezomib cycles may be given.
5.1, men der kan ikke gives nogle anbefalinger vedrørende dosering. 
Currently available data are described in section 5.1 but no recommendation on a posology can be made.
Brug af anden medicin sammen med bortezomib Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin, for nylig har taget anden medicin eller planlægger at tage anden medicin. 
Other medicines and bortezomib Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Den samlede bedste responsrate (CR + PR) ved genbehandling af 130 patienter var 38,5 % (95 % CI: 30,1-47,4). 
The overall best response rate (CR+PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1,
Patienter ≥ 75 år tålte begge regimer, både BR-CAP og R-CHOP, dårligere (se pkt. 
In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Patienterne havde IgG/IgA/let kæde myelom i henholdsvis 63 %/25 %/8 % tilfælde, mediant hæmoglobin på 105 g/l og mediant trombocyttal på 221,5 x 10 
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 10
På grund af risiko for alvorlige bivirkninger hos ammede børn, bør amning ophøre under behandling med bortezomib. 
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
OR; 95 % CI; Pværdi a 
OR; 95% CI; P value a
Fra en uddybende effektanalyse rapporteredes en responsrate på 67,3 % (inklusive en CR-rate på 28,6 %) bestemt ud fra hæmatologisk respons (Mprotein) hos 49 evaluérbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m en gang ugentlig og 1,3 mg/m to gange ugentlig. 
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m weekly and 1.3 mg/m twice-weekly.
9/l • Ikke-hæmatologiske, toksiske hændelser skal være bedret til grad 1 eller baseline 
9/l • Non-haematological toxicities should have resolved to grade 1 or baseline
Der er rapporteret sjældne tilfælde af leversvigt hos patienter, der er i samtidig behandling med bortezomib og andre lægemidler og med alvorlige tilgrundliggende helbredsproblemer. 
Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Injicer opløsningen som en 3-5 sek. intravenøs bolusinjektion gennem et perifert eller centralt intravenøst kateter ind i en vene. 
- Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Grad 1 med smerter eller Grad 2 (moderate symptomer; begrænser daglige gøremål, der kræver hjælpemidler; instrumentel ADL**) 
Grade 1 with pain or grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
For yderligere oplysninger om melphalan og prednison henvises til produktresuméet for disse produkter. 
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
• Symptomer på tumorlysesyndrom, som f.eks. muskelkramper, muskelsvaghed, forvirring, 
• symptoms of tumor lysis syndrome such as muscle cramping, muscle weakness, confusion,
Bortezomib er kun til engangsbrug. 
Bortezomib is for single use only.
Bortezomib gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling. 
Bortezomib is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Tid til første respons i CR + PR 
Time to first response in CR + PR Median
Population evaluérbar for respons n=73 
Response Evaluable Population n=73
Der er ikke data, der tyder på, at det er nødvendigt at justere dosis hos patienter med myelomatose eller med mantlecellelymfom, som er ældre end 65 år. 
There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma.
mg/m2) til patienter med tidligere ubehandlet myelomatose. 
(60 mg/m2) in patients with previously untreated multiple myeloma.
• At minde patienter, der modtager bortezomib sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid med reference til produktresuméet for thalidomid med henblik på yderligere oplysninger. 
• to remind that patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Derfor skal patienterne monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4-inhibitorer (f.eks. ketoconazol, ritonavir). 
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Forekomsten af herpes zoster blandt patienter i B+M+P-behandlingsgruppen var 17 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3 % hos patienter, der havde fået antiviral profylakse. 
The incidence of herpes zoster among patients in the B+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Hepatitis B-virus (HBV)-reaktivering og -infektion 
Hepatitis B virus (HBV) reactivation and infection Mantle cell lymphoma
• At Bortezomib 3,5 mg kan administreres både intravenøst og subkutant. 
• Bortezomib 3.5 mg can be administered both intravenously and subcutaneously