FrancophonIA/ELRC3.0 huggingface dataset:
English: 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%).
Danish: Følgende bivirkninger (grad ≥ 3) blev observeret med en hyppigere forekomst i behandlingsregimet med bortezomib sammenlignet med et historisk kontrolforsøg, hvor baggrundsregimet blev givet alene: I blok 1 perifer sensorisk neuropati (3% vs. 0%), ileus (2,1% vs. 0%), hypoksi (8% vs. 2%).
English: This medicine is for intravenous or subcutaneous use only.
Danish: Dette lægemiddel er kun beregnet til intravenøs eller subkutan anvendelse.
English: • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Danish: • Thrombocyttal skal være ≥ 75.000 celler/μl hos patienter med infiltreret knoglemarv eller sekvestration af milten
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Hospira
Danish: Ikke-hæmatologiske toksiciteter grad ≥ 3, som anses for at være relateret til Bortezomib Hospira
English: p-value g=0.007
Danish: p-værdi g=0,007
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Danish: Tabel 13: Effektresultater fra forsøg MMY-3010 Endepunkt
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Danish: Patienter, der udviklede ortostatisk hypotension efter behandling med bortezomib (som intravenøs injektion), viste ikke tegn på ortostatisk hypotension før behandlingen med bortezomib.
English: 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.
Danish: Denne interimanalyse viste en TTP-risikoreduktion på 45% (95% CI, 29-57%, p < 0,0001) for patienter behandlet med kombinationsbehandlingen bortezomib og pegyleret liposomal doxorubicin.
English: 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.
Danish: Bortezomib er positivt for klastogen aktivitet (strukturelle kromosomafvigelser) i in vitro-analysen af kromosomafvigelser med anvendelse af ovarieceller fra kinesiske hamstre (CHO) i koncentrationer så lave som 3,125 µg/ml, som er den laveste undersøgte koncentration.
English: Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Danish: Der er ikke udført dyreforsøg til fastlæggelse af bortezomibs effekter på fødslen og den postnatale udvikling (se pkt.
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Danish: Tabel 1: Anbefalede* doseringsændringer ved bortezomib-relateret neuropati Neuropatiens sværhedsgrad
English: Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Danish: Grad 1 med smerter eller grad 2 (moderate symptomer; begrænsning i daglige gøremål, der kræver hjælpemidler [instrumental ADL**])
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Danish: Forsøg af udviklingstoksiciteten på rotter og kaniner har vist embryo-/fosterdødelighed ved maternelt toksiske doser, men ingen direkte embryo-/fostertoksicitet ved doser mindre end de maternelt toksiske.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Danish: Patienternes medianalder i forsøget var 57 år, 55% var mænd, og 48% af patienterne blev cytogenetisk klassificeret som højrisiko.
English: • Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
Danish: • Følsomhed, følelsesløshed, prikken eller en brændende følelse i huden eller smerter i hænder eller fødder på grund af nerveskade
English: Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Danish: Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, blandt andet i myelomatose.
English: Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Danish: Samtidig anvendelse af bortezomib og potente CYP3A4-induktorer (f.eks. rifampicin, carbamazepin, phenytoin, phenobarbital og perikon) frarådes derfor, da effekten derved kan blive nedsat.
English: Therefore, platelet counts should be monitored prior to each dose of Bortezomib Hospira.
Danish: Thrombocyttallet skal derfor monitoreres før hver dosis Bortezomib Hospira.
English: A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
English: With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BR-CAP group) favoured the BR-CAP group, (estimated HR=0.80; p=0.173).
Danish: Med en medianopfølgning på 40 måneder var median-OS (56,3 måneder i R-CHOP-gruppen og ikke nået i BR-CAP-gruppen) højest i BR-CAP-gruppen (estimeret HR=0,80; p=0,173).
English: 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).
Danish: Der blev set en statistisk signifikant fordel (p < 0,001) ved BR-CAP-gruppen i forhold til R-CHOP-gruppen for TTP (medianværdi 30,5 vs. 16,1 måneder), TNT (medianværdi 44,5 vs. 24,8 måneder) og TFI (medianværdi 40,6 vs. 20,5 måneder).
English: Therefore, caution should be used during handling and preparation of Bortezomib Hospira.
Danish: Der skal derfor udvises forsigtighed under håndtering og klargøring af Bortezomib Hospira.
English: Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Danish: Fase II-forsøget MMY-2036 (RETRIEVE), et åbent forsøg med en enkelt behandlingsgruppe, blev gennemført for at fastlægge effekten og sikkerheden ved genbehandling med bortezomib.
English: Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Danish: Behandling med bortezomib forbindes almindeligvis med ortostatisk/postural hypotension.
English: Bortezomib Hospira reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Danish: Bortezomib Hospira rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
English: Bortezomib Hospira may have a moderate influence on the ability to drive and use machines.
Danish: Bortezomib Hospira påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Danish: Forsøgets primære effektendepunkt var responsraten efter induktion (CR+nCR).
English: • storage precautions for reconstituted solution
Danish: • Regler for opbevaring af den rekonstituerede opløsning
English: Instructions for reconstitution Bortezomib Hospira must be reconstituted by a healthcare professional.
Danish: Instruktioner til rekonstitution Bortezomib Hospira skal rekonstitueres af sundhedspersonale.
English: Progression Free Survival, months (95% CI)
Danish: Progressionsfri overlevelse, måneder (95% CI)
English: Once weekly Bortezomib Hospira (cycles 5-9)
Danish: Bortezomib Hospira én gang om ugen (cyklus 5-9)
English: • Sudden fall of blood pressure upon standing which may lead to fainting
Danish: • Pludseligt fald i blodtrykket, når du rejser dig op, som kan medføre, at du besvimer
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Danish: Forekomsten af alle grader af perifer neuropati efter intravenøs administration af bortezomib var lavere i de ældre forsøg med bortezomib administreret intravenøst end i forsøg MMY-3021.
English: 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 (CrCL = 20
Danish: Et farmakokinetisk forsøg er gennemført 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 (CrCl = 20-39
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section
Danish: Profylaktisk brug af granulocyt-kolonistimulerende faktorer skal overvejes i tilfælde af gentagne udsættelser af cyklusadministration (se pkt.
English: Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with Bortezomib Hospira.
Danish: Komplet blodtælling (CBC) med differentialtælling og inklusive thrombocyttal skal gennemføres hyppigt under behandlingen med Bortezomib Hospira.
English: • Non-haematological toxicities should have resolved to Grade 1 or baseline.
Danish: • Ikke-hæmatologiske toksiciteter skal være svundet til grad 1 eller baseline-niveau.
English: Therefore, patients who experience constipation should be closely monitored.
Danish: Patienter, der får obstipation, skal derfor monitoreres nøje.
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the RCHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Danish: Medianværdien af investigatorbedømt PFS var 30,7 måneder i BR-CAP-gruppen og 16,1 måneder i RCHOP-gruppen (hazard ratio [HR]=0,51; p < 0,001).
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Danish: Forkortelser: SGOT=serumglutamatoxaloacetat-transaminase;
English: EXP The reconstituted solution should be used immediately after preparation.
Danish: EXP Den rekonstituerede opløsning skal anvendes umiddelbart efter klargøring.
English: 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.
Danish: 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.
English: 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/m2 weekly and 1.3 mg/m2 twice-weekly.
Danish: I en eksploratorisk effektanalyse blev der indberettet en responsrate på 67,3% (inklusive en CR-rate på 28,6%), fastlagt ud fra hæmatologisk respons (M-protein), hos 49 evaluerbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m én gang ugentligt og 1,3 mg/m 2 2 gange ugentligt.
English: In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
Danish: In vitro-forsøg med humane levermikrosomer og humane cDNA-udtrykte cytokrom P450-isozymer tyder på, at bortezomib hovedsageligt metaboliseres ved oxidering via cytokrom P450-enzymerne 3A4, 2C19 og 1A2.
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Hospira dose.
Danish: • Et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne legemsoverfladearealet og derved fastsætte en passende dosering af Bortezomib Hospira
English: Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Danish: Patienterne skal anmodes om at søge læge, hvis de oplever symptomer som svimmelhed, uklarhed eller besvimelse.
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Danish: Reaktionerne svandt i løbet af gennemsnitligt 6 dage og udløste dosisjustering hos 2 patienter.
English: Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
Danish: Der er indberettet sjældne tilfælde af leverinsufficiens hos patienter, der fik bortezomib og andre lægemidler samtidig og havde alvorlige tilgrundliggende helbredsproblemer.
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Danish: Forsøg in vitro viser, at bortezomib er en svag hæmmer af cytochrom P450-isozymerne (CYP) 1A2, 2C9, 2C19, 2D6 og 3A4.
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Danish: Patienter med perifer neuropati ≥ grad 2 ved baseline eller thrombocyttal < 50,000/μl indgik ikke.
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Danish: Bortezomib er ikke genotoksisk i in vitro-analyser af mutagenicitet (Ames test) og in vivo-analyser af mikronukleus hos mus.
English: A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Danish: Thoraxrøntgen anbefales før behandling til anvendelse som udgangspunkt for potentielle lungeforandringer efter behandling.
English: Bortezomib Hospira 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.
Danish: Afbryd behandling med Bortezomib Hospira i op til 2 uger, indtil patienten har et ANC på ≥ 750 celler/μl og et thrombocyttal på ≥ 25.000 celler/μl.
English: 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%]).
Danish: 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 grad 3 og højere (BR-CAP: 4 patienter [1,7%]; R-CHOP: 3 patienter [1,2%]).
English: If you are given bortezomib 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,
Danish: Hvis du får bortezomib på grund af myelomatose eller mantle-celle-lymfom, skal du straks kontakte din læge, hvis du får en eller flere af nedenstående bivirkninger: - muskelkramper, muskelsvaghed - forvirring, synstab eller synsforstyrrelser, blindhed, krampeanfald, hovedpine - stakåndethed, hævede fødder eller ændringer i din hjerterytme, højt blodtryk, træthed,
English: At least 72 hours should elapse between consecutive doses of Bortezomib Hospira.
Danish: Der skal gå mindst 72 timer mellem 2 doser Bortezomib Hospira.
English: Six Bortezomib Hospira cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib Hospira cycles may be given.
Danish: 6 cyklusser med Bortezomib Hospira anbefales, men patienter med et respons, som først dokumenteres ved cyklus 6, kan få yderligere 2 cyklusser med Bortezomib Hospira.
English: Table 7: Adverse reactions in patients with multiple myeloma treated with Bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication System Organ Class
Danish: Tabel 7: Bivirkninger hos patienter med myelomatose, der er blevet behandlet med Bortezomib i kliniske forsøg og alle indberetninger af bivirkninger efter markedsføring, uanset indikation
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Hospira should be administered after the dialysis procedure (see section 5.2).
Danish: Da dialyse kan reducere koncentrationen af bortezomib, bør Bortezomib Hospira gives efter dialyse (se pkt.
English: Uncommon Hepatitis B, Infection*, Bronchopneumonia
Danish: Ikke almindelig Hepatitis B-infektion*, bronkopneumoni
English: Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Danish: Bemærkelsesværdige forskelle mellem sikkerhedsprofilen for bortezomib administreret subkutant vs. intravenøst som monoterapi
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Danish: Patienter, der får ny eller forværret perifer neuropati, bør få foretaget en neurologisk evaluering og kan have brug for ændring af dosis af bortezomib eller behandlingsplan eller skift til subkutan administration (se pkt.
English: 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.
Danish: Der skal udvises forsigtighed, ved behandling af patienter med tidligere synkope, der får lægemidler som vides at være forbundet med hypotension, eller patienter, som er dehydrerede på grund af tilbagevendende diarré eller opkastning.
English: Kaplan-Meier estimate.
Danish: Kaplan-Meier-estimat.
English: The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Danish: Nadir for det gennemsnitlige thrombocyttal var ca. 40% af værdien ved baseline i myelomatoseforsøgene med monoterapi og 50% i MCL-forsøget.
English: 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).
Danish: 2 gange om ugen dag 1, 4, 8 og 11) og oralt dexamethason (40 mg/dag på dag 1-4 og dag 9-12 i cyklus 1 og 2 og på dag 1-4 i cyklus 3 og 4).
English: Bortezomib Hospira should not be administered intrathecally.
Danish: Bortezomib Hospira må ikke administreres intratekalt.
English: 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.
Danish: Demografi og sygdomskarakteristika ved baseline var generelt velafbalanceret mellem de 2 behandlingsgrupper: Patienternes medianalder var 66 år, 74% var mænd, 66% var af kaukasisk oprindelse og 32% asiatiske, 69% af patienterne havde positivt knoglemarvsaspirat og/eller positiv knoglemarvsbiopsi for MCL, 54% af patienterne havde en IPI-score (International Prognostic Index) på ≥ 3, og 76% havde sygdom i stadie IV. Behandlingens varighed (medianværdi=17 uger) og varigheden af opfølgningen (medianværdi=40 måneder) var sammenligneligt i de 2 behandlingsgrupper.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see Pregnancy and breast-feeding in this section).
Danish: Hvis du får thalidomid, skal du være særlig opmærksom på kravene til graviditetsprøver og prævention (se under "Graviditet og amning" i dette afsnit).
English: 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.
Danish: Patienterne havde IgG/IgA/lette kæder af myelomer i henholdsvis 63%/25%/8% af tilfældene, medianhæmoglobin på 105 g/l og medianthrombocyttal på 221,5 x 10
English: • St. John's Wort (Hypericum perforatum), used for depression or other conditions
Danish: • perikon (Hypericum perforatum), naturmedicin, som bruges mod depression eller andre lidelser
English: B=bortezomib; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
Danish: B=bortezomib; Dx=dexamethason; T=thalidomid a Thalidomid-dosis øges til 100 mg fra uge 3 i cyklus 1, men kun hvis 50 mg tåles, og til 200 mg fra og med cyklus 2, hvis 100 mg tåles.
English: Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy.
Danish: Bemærk: Et OR på > 1 tyder på en fordel for induktionsterapi, der indeholder bortezomib.
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Danish: P-værdi fra Cochran-Mantel-Haenszel chi-kvadrattest med IPI og sygdomsstadie som stratifikationsfaktorer.
English: Electrocardiogram investigations
Danish: Elektrokardiogrammer
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
Danish: I fase III-forsøget med hidtil ubehandlede myelomatose-patienter var den samlede forekomst af reaktivering af herpes zoster større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (henholdsvis 14% og 4%).
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Danish: Forsøget opfyldte det primære mål, som var noninferioritet, hvad angår responsrate (CR+PR) efter 4 cyklusser med bortezomib som monoterapi for såvel subkutan som intravenøs administration, 42% i begge grupper.
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Danish: Patienter ≥ 75 år tolererede begge regimer dårligere, både BR-CAP og R-CHOP (se pkt.
English: Post-marketing adverse reactions not seen in clinical trials are also included.
Danish: Den omfatter også bivirkninger fremkommet efter markedsføring, som ikke er set i kliniske forsøg.
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Danish: Den gennemsnitlige totale clearance er 102 l/t og 112 l/t efter den første dosis for doser på henholdsvis 1,0 mg/m2 og 1,3 mg/m2, og den er inden for intervallet 15-32 l/t og 18-32 l/t efter de efterfølgende doser for doser på henholdsvis 1,0 mg/m2 og 1,3 mg/m
English: Caution should be exercised when Bortezomib Hospira is combined with CYP3A4or CYP2C19 substrates (see section 4.5).
Danish: Der skal udvises forsigtighed, hvis Bortezomib Hospira kombineres med CYP3A4- eller CYP2C19-substrater (se pkt.