natgillin/translations-raw huggingface dataset:
9/l på en dag med dosering af Bortezomib Hospira (bortset fra dag 1)
9/l on a Bortezomib Hospira dosing day (other than day 1)
"Matchede par"-analysen er en statistisk metode, hvor patienter i behandlingsgruppen (f.eks. bortezomib i kombination med dexamethason) og patienter i sammenligningsgruppen (f.eks. bortezomib) gøres sammenlignelige med hensyn til forvekslelige 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.
Responsrate Population e n=668
Response rate population e n=668
Tid indtil første respons i CR + PR Medianværdi
Time to first response in CR + PR Median
Du kan ligeledes få bortezomib sammen med lægemidlerne pegyleret liposomal doxorubicin eller dexamethason.
You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Omfatter alle radiologiske CR+CRu+PR efter IRC uanset verificering ved knoglemarv og LDH.
Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Ud over perifer neuropati kan der forekomme autonom neuropati ved nogle bivirkninger, f.eks. postural hypotension og svær obstipation 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.
Størstedelen af patienterne i begge grupper fuldførte behandlingen, 80% i BR-CAP-gruppen og 82% i R-CHOP-gruppen.
The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Det anbefales ligeledes, at responderende patienter, som ikke opnår komplet remission, gennemgår i alt 8 behandlingscyklusser med Bortezomib Hospira.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib Hospira therapy.
Den samlede forekomst af diarré, smerter i mave-tarm-kanalen og abdomen, asteniske tilstande, øvre luftvejsinfektioner og perifere neuropatier var 12-15% lavere i den subkutane gruppe end i den intravenøse gruppe.
The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
TTP, måneder (95% CI)
TTP, months (95% CI)
Dexamethason blev administreret i kombination med bortezomib til 83 patienter i cyklus 1, mens yderligere 11 patienter fik dexamethason i løbet af de efterfølgende cyklusser med genbehandling med bortezomib.
Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Bortezomib Hospira skal seponeres, hvis der opstår alvorlige reaktioner.
Bortezomib Hospira should be discontinued if serious reactions occur.
Estimatet af hazards ratio er baseret på en Cox proportional hazard-model 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.
Fraktionen af bortezomib bundet til plasmaproteiner er ikke koncentrationsafhængig.
The fraction of bortezomib bound to plasma proteins was not concentration-dependent.
Opløsningen vil være klar og farveløs med en endelig pH-værdi på 4-7.
The solution will be clear and colourless, with a final pH of 4 to 7.
Koncentrationen i den færdige opløsning vil være 1 mg/ml.
The concentration of the resulting solution will be 1 mg/ml.
CR = komplet respons; CRu = komplet respons ubekræftet; PR = partielt respons; CI = konfidensinterval, HR = hazard ratio; OR = odds ratio; ITT = intent to treat
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Koncentrationen i den færdige opløsning vil være 2,5 mg/ml.
The concentration of the resulting solution will be 2.5 mg/ml.
Behandlingen med bortezomib forbindes meget ofte med hæmatologisk toksicitet (thrombocytopeni, neutropeni og anæmi).
Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Meget almindelig Thrombocytopeni*, febril neutropeni, neutropeni*,
Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Kontrollér, 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).
Klinisk virkning ved subkutan administration af bortezomib til patienter med recidiverende/refraktær myelomatose
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
• Hårtab og unormal hårtekstur
• Hair loss and abnormal hair texture
I fase III-forsøget førte behandling med bortezomib til signifikant længere tid indtil progression, en signifikant længere overlevelse og en signifikant højere responsrate sammenlignet med behandling med dexamethason (se tabel 14) hos alle patienter samt hos patienter, som tidligere havde fået én behandling.
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Den geometriske gennemsnitlige (%CV) clearance er 7,79 (25%) l/t/m2, fordelingsvolumen ved steady state er 834 (39%) l/m2, og eliminationshalveringstiden er 100 (44%) timer.
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Patienter, der ikke opnåede optimalt respons (mindre end komplet respons [CR]) på behandling 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.
I tilfælde af overdosering skal patientens vitale funktioner monitoreres, og der skal ydes relevant, understøttende behandling for at opretholde blodtryk (f.eks. væske, pressorer og/eller inotrope midler) og legemstemperatur (se pkt.
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and 4.4).
• Hjerteproblemer, herunder hjerteanfald, angina pectoris
• Heart problems to include heart attack, angina
Dosisjustering til transplantationsegnede patienter
Patients eligible for stem cell transplantation
Tabel 15: Resumé af effektanalyser med sammenligning af subkutan og intravenøs administration af bortezomib
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Omfatter alle CR + CRu, efter IRC, knoglemarv og LDH.
Include all CR+CRu, by IRC, bone marrow and LDH.
Thrombocytopeni*, neutropeni*, anæmi*
Thrombocytopenia*, Neutropenia*, Anaemia*
• Søvnbesvær eller søvnproblemer
• Difficulty or problems in sleeping
Det anbefales, at patienterne monitoreres nøje for symptomer på neuropati, f.eks. brændende fornemmelse, hyperæstesi, hypæstesi, paræstesi, ubehag, neuropatiske smerter eller svækkelse.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Den rekonstituerede opløsning er klar og farveløs med en endelig pH-værdi på 4-7.
The reconstituted solution is clear and colourless, with a final pH of 4 to 7.
Der blev ikke observeret nogen nye sikkerhedsmæssige problemer, når bortezomib blev tilføjet til standardregimet med kemoterapi for pædiatrisk præ-B-celleALL.
No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone.
Bortezomib er særdeles selektivt for proteasomet.
Bortezomib is highly selective for the proteasome.
Gastrointestinal toksicitet, herunder kvalme, diaré, opkastning og obstipation, er meget almindelig ved behandling med bortezomib.
Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Den indeholder desuden bivirkninger, som blev identificeret i BR-CAP-gruppen, og som af investigatorerne blev anset for som et minimum at have en mulig eller sandsynlig kausal sammenhæng med bortezomib, baseret på historiske data i myelomatose-forsøgene.
Also included are adverse drug reactions identified in the BR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Analysen viste forbedret ORR (CR+PR) (odds ratio 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (hazard ratio 0,511; 95% CI 0,309-0,845; p=0,008), TTP (hazard ratio 0,385; 95% CI 0,212-0,698; p=0,001) for bortezomib kombineret med dexamethason sammenlignet med monoterapi med bortezomib.
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Medianvarigheden af komplet respons var 42,1 måneder i BR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
The median duration of complete response was 42.1 months in the BR-CAP group compared with 18 months in the RCHOP group.
Desuden er forekomsten af perifere neuropatier ≥ grad 3 10% lavere, og seponeringsraten på grund af perifer neuropati er 8% lavere i den subkutane gruppe end i den intravenøse gruppe.
In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
I fase II-forsøget kunne de patienter, som ikke havde optimalt respons på 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.
p-værdi g=0,275
p-value g=0.275
• Hvis thrombocyttallet er < 25.000 celler/μl eller ANC er < 750 celler/μl l på en dag med dosering af Bortezomib Hospira (bortset fra dag 1 i hver cyklus)
• If platelet counts < 25,000 cells/μL or ANC < 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
Medianalderen hos patienterne i forsøget var 71 år, 50% var mænd, 88% var af kaukasisk oprindelse, og medianscoren for Karnofsky performance status var 80.
The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
• Thrombocyttal skal være ≥ 100.000 celler/μl, og absolut neutrofiltal (ANC) skal være ≥ 1.500
• Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
• ritonavir, der bruges til behandling af hiv-infektion
• ritonavir, used to treat HIV infection
130 patienter (≥ 18 år) med myelomatose, som tidligere havde haft mindst partielt respons på et bortezomib-holdigt regime, fik ny behandling ved progression.
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib -containing regimen were retreated upon progression.
Der blev desuden noteret højere forekomst af infektioner med neutropeni grad ≥ 3 (24% vs. 19% i blok 1 og 22% vs. 11% i blok 2), forhøjet ALAT (17% vs. 8% i blok 2), hypokaliæmi (18% vs. 6% i blok 1 og 21% vs. 12% i blok 2) og hyponatriæmi (12% vs. 5% i blok 1 og 4% vs. 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).
Da bortezomib er et cytotoksisk stof, som hurtigt kan dræbe maligne plasmaceller, kan der opstå komplikationer i form af tumorlysesyndrom.
Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Hæmning af proteasomet fører til cellecyklusstop og apoptose.
Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Bortezomib Hospira indeholder det aktive stof bortezomib, som er en såkaldt proteasomhæmmer.
Bortezomib Hospira contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
I et forsøg med patienter med tidligere ubehandlet mantle-celle-lymfom 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.
Der er indberettet akut udvikling eller forværring af kronisk venstresidig hjerteinsufficiens 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.
Det er ukendt, om bortezomib udskilles i modermælk.
It is not known whether bortezomib is excreted in human milk.
Forekomsten af dødsfald efter behandlingen var 5% i den subkutane gruppe og 7% i den intravenøse gruppe.
The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
4 eller thrombocytopeni, eller der observeres thrombocytopeni med blødning i den foregående cyklus
• If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
CI = konfidensinterval; CR = komplet respons; nCR = næsten komplet respons; ITT = intent to treat; RR = responsrate;
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate;
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%).
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%).
Dette lægemiddel er kun beregnet til intravenøs eller subkutan anvendelse.
This medicine is for intravenous or subcutaneous use only.
• Thrombocyttal skal være ≥ 75.000 celler/μl 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
Ikke-hæmatologiske toksiciteter grad ≥ 3, som anses for at være relateret til Bortezomib Hospira
Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Hospira
p-værdi g=0,007
p-value g=0.007
Tabel 13: Effektresultater fra forsøg MMY-3010 Endepunkt
Table 13: Efficacy results from study MMY-3010 Endpoints
Patienter, der udviklede ortostatisk hypotension efter behandling 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.
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.
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.
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.
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.
Der er ikke udført dyreforsøg til fastlæggelse af bortezomibs effekter på fødslen og den postnatale udvikling (se pkt.
Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Tabel 1: Anbefalede* doseringsændringer ved bortezomib-relateret neuropati Neuropatiens sværhedsgrad
Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Grad 1 med smerter eller grad 2 (moderate symptomer; begrænsning i daglige gøremål, der kræver hjælpemidler [instrumental ADL**])
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
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.
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.
Patienternes medianalder i forsøget 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.
• Følsomhed, følelsesløshed, prikken eller en brændende følelse i huden eller smerter i hænder eller fødder på grund af nerveskade
• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, blandt andet i myelomatose.
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Samtidig anvendelse af bortezomib og potente CYP3A4-induktorer (f.eks. rifampicin, carbamazepin, phenytoin, phenobarbital og perikon) frarådes derfor, da effekten derved kan blive nedsat.
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.
Thrombocyttallet skal derfor monitoreres før hver dosis Bortezomib Hospira.
Therefore, platelet counts should be monitored prior to each dose of Bortezomib Hospira.
A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE
A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE
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).
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).
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).
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).
Der skal derfor udvises forsigtighed under håndtering og klargøring af Bortezomib Hospira.
Therefore, caution should be used during handling and preparation of Bortezomib Hospira.
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.
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib.
Behandling med bortezomib forbindes almindeligvis med ortostatisk/postural hypotension.
Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Bortezomib Hospira rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
Bortezomib Hospira reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Bortezomib Hospira påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
Bortezomib Hospira may have a moderate influence on the ability to drive and use machines.
Forsøgets primære effektendepunkt var responsraten efter induktion (CR+nCR).
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
• Regler for opbevaring af den rekonstituerede opløsning
• storage precautions for reconstituted solution
Instruktioner til rekonstitution Bortezomib Hospira skal rekonstitueres af sundhedspersonale.
Instructions for reconstitution Bortezomib Hospira must be reconstituted by a healthcare professional.
Progressionsfri overlevelse, måneder (95% CI)
Progression Free Survival, months (95% CI)
Bortezomib Hospira én gang om ugen (cyklus 5-9)
Once weekly Bortezomib Hospira (cycles 5-9)
• Pludseligt fald i blodtrykket, når du rejser dig op, som kan medføre, at du besvimer
• Sudden fall of blood pressure upon standing which may lead to fainting
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.
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.
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
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
Profylaktisk brug af granulocyt-kolonistimulerende faktorer skal overvejes i tilfælde af gentagne udsættelser af cyklusadministration (se pkt.
Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section
Komplet blodtælling (CBC) med differentialtælling og inklusive thrombocyttal skal gennemføres hyppigt under behandlingen med Bortezomib Hospira.
Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with Bortezomib Hospira.