natgillin/translations-raw huggingface dataset:
Behandlingen med bortezomib forbindes meget ofte med hæmatologisk toksicitet (trombocytopeni, neutropeni og anæmi).
Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Grafen over induktionstransplantationsregimerne skal indeholde følgende nøgleelementer:
Induction Transplant Regimens Graph shall contain the following key elements:
Den mediane varighed af komplet respons var 42,1 måneder i BzmbR-CAP-gruppen sammenlignet med 18 måneder i R-CHOP-gruppen.
The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Instruktioner for rekonstitution Bortezomib SUN skal rekonstitueres af sundhedspersonale.
Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Bortezomib forårsager reduktion af tumorvækst in vivo i mange prækliniske tumormodeller, inklusive i myelomatose.
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
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 SUN gives intravenøst eller subkutant på dag 1, 4, 8 og 11, fulgt af en ‘hvileperiode' uden behandling.
Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Disse virkninger er set hos patienter med myelomatose påvirket af en fremskreden osteolytisk sygdom, der har været behandlet med bortezomib.
These effects have been observed in patients with multiple myeloma affected by an advanced osteolytic disease and treated with bortezomib.
Udviklingstoksicitetsstudier på rotter og kaniner har vist embryo-/fosterdødelighed ved maternelt toksiske doser, men ingen direkte embryo-/fostertoksicitet ved ikke-maternelt toksiske doser.
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.
Der sås også hyppigere forekomst af infektioner med grad ≥ 3 neutropeni (24 % kontra 19 % i blok 1 og 22 % kontra 11 % i blok 2), forhøjet ALAT (17 % kontra 8 % i blok 2), hypokaliæmi (18 % kontra 6 % i blok 1 og 21 % kontra 12 % i blok 2) samt hyponatriæmi (12 % kontra 5 % i blok 1 og 4 % kontra 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).
Ikke-anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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 dehydreret 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.
In vitro -studier viser, at bortezomib er en svag hæmmer af cytochrom P450 (CYP)-isozymer 1A2, 2C9, 2C19, 2D6 og 3A4.
In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Den rekonstituerede opløsning skal inspiceres visuelt for partikler og misfarvning før anvendelse.
The reconstituted solution must be inspected visually for particulate matter and discolouration prior to administration.
Patienterne skal instrueres i at søge læge, hvis de oplever symptomer som svimmelhed, uklarhed eller besvimelse.
Patients should be instructed to seek medical advice if they experience symptoms of dizziness, light-headedness or fainting spells.
Med en median opfølgningsvarighed på 40 måneder var den mediane OS (56,3 måneder i R-CHOP-gruppen og ikke nået i BzmbR-CAP-gruppen) højest i BzmbR-CAPgruppen (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 BzmbR-CAP group) favoured the BzmbR-CAP group, (estimated HR=0.80; p=0.173).
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/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Bortezomib SUN rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
De væsentligste effektresultater er præsenteret i tabel 13.
Main efficacy results are presented in Table 13.
Studiet opfyldte det primære mål, som var non-inferiority, hvad angår responsrate (CR+PR) efter 4 cyklusser med bortezomib som monoterapi for såvel subkutan som intravenøs administration, 42 % i begge grupper.
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.
Der er ikke gennemført dyrestudier til bestemmelse af bortezomibs effekt 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).
De patienter, hvor PML blev diagnosticeret, havde tidligere fået eller fik samtidig immunsuppressiv behandling.
Patients diagnosed with PML had prior or concurrent immunosuppressive therapy.
HRb(95 % CI)=0,63 p-værdid < 0.001
HRb (95% CI)=0.63 p-valued < 0.001
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.
Grad 1 med smerter eller grad 2 (moderate symptomer, som begrænser daglige gøremål, der kræver hjælpemidler (instrumentel ADL**)
Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 efter toksicitet og behandlingsseponering som følge af perifer neuropati
Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
I så fald varer en behandlingscyklus 42 dage (6 uger).
In this case, the duration of a treatment cycle is 42 days (6 weeks).
For yderligere oplysninger om melphalan og prednison henvises til produktresumé for disse produkter.
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
In vitro-studier med humane levermikrosomer og cDNA-udtrykte cytokrom P450-isozymer indikerer, at bortezomib hovedsageligt metaboliseres ved oxidering via cytokrom P450-enzymer, 3A4, 2C19 og 1A2.
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.
• at Bortezomib SUN 3,5 mg kan administreres enten intravenøst eller subkutant
• Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
Dag 29 Pause
Day 29 Rest period
Da dialyse kan reducere koncentrationen af bortezomib, bør Bortezomib SUN gives efter dialyse (se pkt.
Since dialysis may reduce bortezomib concentrations, Bortezomib SUN should be administered after the dialysis procedure (see section 5.2).
Fra en uddybende effektanalyse rapporteredes en responsrate på 67,3 % (inklusive en CR-rate på 28,6 %) bestemt ud fra hæmatologisk respons (M-protein) hos 49 evaluerbare patienter, der fik de maksimale tilladte doser på 1,6 mg/m2 en gang ugentligt og 1,3 mg/m2 to gange ugentligt.
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.
Bemærkelsesværdige forskelle mellem sikkerhedsprofilen for bortezomib administreret subkutant versus intravenøst som monoterapi
Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent
Behandlingen med bortezomib forbindes almindeligvis med ortostatisk/postural hypotension.
Hypotension Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Læs indlægssedlerne for alle de lægemidler, som du skal tage sammen med Bortezomib SUN, for at få oplysninger om disse lægemidler, før du begynder på behandlingen med Bortezomib SUN.
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib SUN for information related to these medicines before starting treatment with Bortezomib SUN.
Særligt skal du fortælle lægen, hvis du bruger medicin, som indeholder et eller flere af følgende aktive stoffer: - ketoconazol, som bruges til behandling af svampeinfektioner - ritonavir, som bruges til behandling af hiv-infektion - rifampicin, et antibiotikum, som bruges til at behandle bakterieinfektioner - carbamazepin, phenytoin eller phenobarbital til behandling af epilepsi - perikon (Hypericum perforatum), naturmedicin, som bruges mod depression eller andre lidelser - tabletter til behandling af sukkersyge (diabetes)
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Population evaluerbar for respons n=73
Response Evaluable Population n=73
Bortezomib SUN kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn.
Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision.
I et studie 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.
Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyclus 2-4b
Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4b
Median for investigatorbedømt PFS var 30,7 måneder i BzmbR-CAP-gruppen og 16,1 måneder i RCHOP-gruppen (hazard-ratio [HR]=0,51; p < 0,001).
Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
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 cyklusser.
This study included 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.
MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Din læge vil bestemme dosis ud fra din højde og vægt (areal af legemsoverflade).
Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area).
Sjælden Selvmordstanker*, tilpasningsforstyrrelser, delirium, nedsat libido
Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
ORe (95 % CI)=1,428 p-værdig=0,275
ORe (95% CI)=1.428 p-valueg=0.275
To (1 %) af patienterne havde svære reaktioner.
Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
10 ml rørformet, farveløst type 1-hætteglas med grå bromobutylgummiprop og forseglet med en lysegrøn flip-off-aluminiumsforsegling, som indeholder 3,5 mg bortezomib.
10 ml Type 1 tubular colourless glass vial with a grey bromobutyl rubber stopper, sealed with a light green flip off aluminium seal containing 3.5 mg bortezomib.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER CYTOSTATIKUM.
OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
Der administreres fire behandlingscyklusser af denne kombination.
Four treatment cycles of this combination are administered.
d Baseret på log-rank-test stratificeret efter IPI-risiko og sygdomsstadie.
d Based on Log rank test stratified with IPI risk and stage of disease.
a Intent to Treat (ITT)-population b p-værdi fra den stratificerede log-rank-test; analyse ud fra behandling udelukker opdeling på tidligere behandling;
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
- Hvis toksiciteten ikke forsvinder, efter at Bortezomib SUN har været indstillet som defineret ovenfor, skal Bortezomib SUN seponeres.
- If, after Bortezomib SUN has been held, the toxicity does not resolve, as defined above, then Bortezomib SUN must be discontinued.
Tidligere ubehandlet mantle-celle-lymfom
Previously untreated mantle cell lymphoma
Akut diffus infiltrativ lunge- og perikardiesygdom.
Acute diffuse infiltrative pulmonary and pericardial disease.
I fase III-studiet med hidtil ubehandlede myelomatosepatienter var den samlede forekomst af herpes zosterreaktivering større hos patienter behandlet med bortezomib+melphalan+prednison sammenlignet med melphalan+prednison (14 % versus 4 %).
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).
Trombocyttransfusion skal overvejes, når det er klinisk relevant (se pkt.
Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Ældre patienter med MCL Henholdsvis 42,9 % og 10,4 % af patienterne i BzmbR-CAP-armen var i alderen 65-74 år og ≥ 75 år.
Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Bortezomib bør derfor ikke anvendes samtidig med potente CYP3A4-induktorer (f.eks. rifampicin, carbamazepin, phenytoin, phenobarbital og perikon), 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.
Patienter, der får bortezomib i kombination med thalidomid, skal overholde det særlige svangerskabsforebyggende program for thalidomid.
Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Du vil få 9 behandlingscyklusser (54 ugers behandling).
You will receive 9 cycles (54 weeks).
Lægen kan give dig medicin til at kontrollere diarréen med - træthed, svaghed - muskelsmerter, smerter i knogler.
Your doctor may give you another medicine to control diarrhoea - tiredness (fatigue), feeling weak - muscle pain, bone pain.
Bortezomib SUN må ikke administreres intratekalt.
Bortezomib SUN should not be administered intrathecally.
Bortezomibs farmakokinetik blev karakteriseret efter intravenøs bolus-administration af 1,3 mg/m2 to gange om ugen hos 104 pædiatriske patienter (2-16 år) med akut lymfoblastær leukæmi (ALL) eller akut myeloid leukæmi (AML).
Age The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Mantle-celle-lymfom
Mantle cell lymphoma
Reaktionerne gik over i løbet af 6 dage i gennemsnit og udløste dosisjustering hos to patienter.
Cases resolved in a median of 6 days, dose modification was required in two patients.
n: ITT-patienter
n: ITT patients
Samlet respons (CR+CRu+PR)h n(%)
Overall response (CR+CRu+PR)h n(%)
Forekomsten af herpes zoster blandt patienter i Bzmb+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 Bzmb+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Patienterne skal derfor monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4-hæmmere (f.eks. ketoconazol, ritonavir).
Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Posteren om rekonstitution skal indeholde følgende hovedpunkter:
The Reconstitution poster shall contain the following key elements:
Bortezomib SUN-behandlingen skal indstilles ved forekomst af ≥ grad 3 bortezomib-relateret ikkehæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
Bortezomib SUN 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).
Pause Dag Dag
Day Day Day Day
Patienter ≥ 75 år tolererede begge regimer dårligere, både BzmbR-CAP og R-CHOP (se pkt.
In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
b Hazard-ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
e Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon
Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Genbehandling af patienter med recidiverende myelomatose I et studie, hvor bortezomib-behandling blev gentaget hos 130 patienter med recidiverende myelomatose, som tidligere havde opnået mindst partielt respons med et regime, der omfattede bortezomib, var de hyppigste bivirkninger af alle grader, der indtraf hos mindst 25 % af patienterne, trombocytopeni (55 %), neuropati (40 %), anæmi (37 %), diarré (35 %) og obstipation (28 %).
Retreatment of patients with relapsed multiple myeloma In a study in which bortezomib retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a bortezomib-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og BzmbDx-gruppen fik autolog stamcelletransplantation.
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Administration Bortezomib SUN er tilgængelig til intravenøs eller subkutan administration.
Method of administration Bortezomib SUN is available for intravenous or subcutaneous administration.
- Ikke-hæmatologiske, toksiske hændelser skal være vurderet til grad 1 eller baseline Tabel 3: Dosisjusteringer under efterfølgende cyklusser med Bortezomib SUN i kombination med melphalan og prednison
- Non-haematological toxicities should have resolved to Grade 1 or baseline Table 3: Posology modifications during subsequent cycles of Bortezomib SUN therapy in combination with melphalan and prednisone
• for at minde patienter, der modtager Bortezomib SUN sammen med thalidomid, om, at de skal overholde det svangerskabsforebyggende program for thalidomid, og med reference til produktresuméet for thalidomid for yderligere oplysninger.
• to remind that patients receiving Bortezomib SUN in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Bemærkelsesværdige forskelle i MCL-patientpopulationen sammenlignet med patienter i myelomatosestudierne var en ≥ 5 % højere forekomst af hæmatologiske bivirkninger (neutropeni, trombocytopeni, leukopeni, anæmi, lymfopeni), perifer sensorisk neuropati, hypertension, pyreksi, pneumoni, stomatitis og hårsygdomme.
Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
19,9 mdr.
19.9 mo
a OR for responsrater baseret på Mantel-Haenszel-skøn af den fælles oddsratio for stratificerede tabeller; p-værdier efter
* Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
En periode på 6 uger anses for en behandlingscyklus.
A 6-week period is considered a treatment cycle.
Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis.
Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
I fase III-studiet til sammenligning af bortezomib administreret intravenøst versus subkutant var forekomsten af hændelser med ≥ grad 2 perifer neuropati 24 % i gruppen, der fik subkutane injektioner, og 41 % i gruppen, der fik intravenøse injektioner (p=0,0124).
In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Cochran-Mantel-Haenszel-test. b Henviser til responsrate efter den anden transplantation hos forsøgspersoner, der blev transplanteret 2 gange (42/240[18 %]
Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzmbDx group and 52/242 [21%] in VDDx group).
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning 1 hætteglas
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Hvis der ses nogle partikler eller misfarvning, skal opløsningen bortskaffes.
If any discolouration or particulate matter is observed, the solution should be discarded.
Når toksiciteten er forsvundet, gives Bortezomib SUN igen, og dosis reduceres til 0,7 mg/m2 en gang om ugen.
When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week.
Kun til subkutan eller intravenøs anvendelse.
Subcutaneous or intravenous use only.