FrancophonIA/ELRC3.0 huggingface dataset:
English: Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Danish: Bortezomib SUN rekonstitueret opløsning indgives subkutant i låret (højre eller venstre) eller abdomen (højre eller venstre side).
English: Main efficacy results are presented in Table 13.
Danish: De væsentligste effektresultater er præsenteret i tabel 13.
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: 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.
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 gennemført dyrestudier til bestemmelse af bortezomibs effekt på fødslen og den postnatale udvikling (se pkt.
English: Patients diagnosed with PML had prior or concurrent immunosuppressive therapy.
Danish: De patienter, hvor PML blev diagnosticeret, havde tidligere fået eller fik samtidig immunsuppressiv behandling.
English: HRb (95% CI)=0.63 p-valued < 0.001
Danish: HRb(95 % CI)=0,63 p-værdid < 0.001
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Danish: På grund af risiko for alvorlige bivirkninger hos ammede børn bør amning ophøre under behandling med bortezomib.
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, som begrænser daglige gøremål, der kræver hjælpemidler (instrumentel ADL**)
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Danish: Tabel 10: Forekomst af perifer neuropati i studie LYM-3002 efter toksicitet og behandlingsseponering som følge af perifer neuropati
English: In this case, the duration of a treatment cycle is 42 days (6 weeks).
Danish: I så fald varer en behandlingscyklus 42 dage (6 uger).
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Danish: For yderligere oplysninger om melphalan og prednison henvises til produktresumé for disse produkter.
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-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.
English: • Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
Danish: • at Bortezomib SUN 3,5 mg kan administreres enten intravenøst eller subkutant
English: Day 29 Rest period
Danish: Dag 29 Pause
English: Since dialysis may reduce bortezomib concentrations, Bortezomib SUN should be administered after the dialysis procedure (see section 5.2).
Danish: Da dialyse kan reducere koncentrationen af bortezomib, bør Bortezomib SUN gives efter dialyse (se pkt.
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: 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.
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 versus intravenøst som monoterapi
English: Hypotension Bortezomib treatment is commonly associated with orthostatic/postural hypotension.
Danish: Behandlingen med bortezomib forbindes almindeligvis med ortostatisk/postural hypotension.
English: 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.
Danish: 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.
English: 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
Danish: 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)
English: Response Evaluable Population n=73
Danish: Population evaluerbar for respons n=73
English: Bortezomib SUN might cause tiredness, dizziness, fainting, or blurred vision.
Danish: Bortezomib SUN kan forårsage træthed, svimmelhed, besvimelse og uklart/sløret syn.
English: 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.
Danish: 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.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4b
Danish: Dag 1, 2, 3, 4 Dag 8, 9, 10, 11Cyclus 2-4b
English: 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).
Danish: 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).
English: 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.
Danish: 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.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Danish: Rituximab 375 mg/m2, cyclophosphamid 750 mg/m2 og doxorubicin 50 mg/m2.
English: Your doctor will work out your dose of Bortezomib SUN according to your height and weight (body surface area).
Danish: Din læge vil bestemme dosis ud fra din højde og vægt (areal af legemsoverflade).
English: Suicidal ideation*, Adjustment disorder, Delirium, Libido decreased
Danish: Sjælden Selvmordstanker*, tilpasningsforstyrrelser, delirium, nedsat libido
English: ORe (95% CI)=1.428 p-valueg=0.275
Danish: ORe (95 % CI)=1,428 p-værdig=0,275
English: Two (1%) of the patients had severe reactions; 1 case of pruritus and 1 case of redness.
Danish: To (1 %) af patienterne havde svære reaktioner.
English: 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.
Danish: 10 ml rørformet, farveløst type 1-hætteglas med grå bromobutylgummiprop og forseglet med en lysegrøn flip-off-aluminiumsforsegling, som indeholder 3,5 mg bortezomib.
English: OTHER SPECIAL WARNING(S), IF NECESSARY CYTOTOXIC.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER CYTOSTATIKUM.
English: Four treatment cycles of this combination are administered.
Danish: Der administreres fire behandlingscyklusser af denne kombination.
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Danish: d Baseret på log-rank-test stratificeret efter IPI-risiko og sygdomsstadie.
English: 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 <
Danish: a Intent to Treat (ITT)-population b p-værdi fra den stratificerede log-rank-test; analyse ud fra behandling udelukker opdeling på tidligere behandling;
English: - If, after Bortezomib SUN has been held, the toxicity does not resolve, as defined above, then Bortezomib SUN must be discontinued.
Danish: - Hvis toksiciteten ikke forsvinder, efter at Bortezomib SUN har været indstillet som defineret ovenfor, skal Bortezomib SUN seponeres.
English: Previously untreated mantle cell lymphoma
Danish: Tidligere ubehandlet mantle-celle-lymfom
English: Acute diffuse infiltrative pulmonary and pericardial disease.
Danish: Akut diffus infiltrativ lunge- og perikardiesygdom.
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-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 %).
English: Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Danish: Trombocyttransfusion skal overvejes, når det er klinisk relevant (se pkt.
English: 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.
Danish: 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.
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: Bortezomib bør derfor ikke anvendes samtidig med potente CYP3A4-induktorer (f.eks. rifampicin, carbamazepin, phenytoin, phenobarbital og perikon), da effekten derved kan blive nedsat.
English: Patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide.
Danish: Patienter, der får bortezomib i kombination med thalidomid, skal overholde det særlige svangerskabsforebyggende program for thalidomid.
English: You will receive 9 cycles (54 weeks).
Danish: Du vil få 9 behandlingscyklusser (54 ugers behandling).
English: Your doctor may give you another medicine to control diarrhoea - tiredness (fatigue), feeling weak - muscle pain, bone pain.
Danish: Lægen kan give dig medicin til at kontrollere diarréen med - træthed, svaghed - muskelsmerter, smerter i knogler.
English: Bortezomib SUN should not be administered intrathecally.
Danish: Bortezomib SUN må ikke administreres intratekalt.
English: 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).
Danish: 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).
English: Mantle cell lymphoma
Danish: Mantle-celle-lymfom
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Danish: Reaktionerne gik over i løbet af 6 dage i gennemsnit og udløste dosisjustering hos to patienter.
English: n: ITT patients
Danish: n: ITT-patienter
English: Overall response (CR+CRu+PR)h n(%)
Danish: Samlet respons (CR+CRu+PR)h n(%)
English: 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.
Danish: 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.
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Danish: Patienterne skal derfor monitoreres omhyggeligt, når der gives bortezomib sammen med kraftige CYP3A4-hæmmere (f.eks. ketoconazol, ritonavir).
English: The Reconstitution poster shall contain the following key elements:
Danish: Posteren om rekonstitution skal indeholde følgende hovedpunkter:
English: 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).
Danish: Bortezomib SUN-behandlingen skal indstilles ved forekomst af ≥ grad 3 bortezomib-relateret ikkehæmatologisk toksicitet (undtagen neuropati) eller ≥ grad 3 hæmatologisk toksicitet (se også pkt.
English: Day Day Day Day
Danish: Pause Dag Dag
English: In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Danish: Patienter ≥ 75 år tolererede begge regimer dårligere, både BzmbR-CAP og R-CHOP (se pkt.
English: b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease.
Danish: b Hazard-ratio-estimat er baseret på en Cox-model stratificeret efter IPI-risiko og sygdomsstadie.
English: e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Danish: e Mantel-Haenszel-estimat af den fælles oddsratio for stratificerede tabeller er benyttet med IPI-risiko og sygdomsstadie som stratifkationsfaktorer.
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Danish: Cushings syndrom*, hypertyroidisme*, uhensigtsmæssig produktion af antidiuretikahormon
English: 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%).
Danish: 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 %).
English: 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.
Danish: 198 (82 %) og 208 (87 %) patienter i henholdsvis VDDx og BzmbDx-gruppen fik autolog stamcelletransplantation.
English: Method of administration Bortezomib SUN is available for intravenous or subcutaneous administration.
Danish: Administration Bortezomib SUN er tilgængelig til intravenøs eller subkutan administration.
English: - 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
Danish: - 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
English: • 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.
Danish: • 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.
English: 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.
Danish: 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.
English: 19.9 mo
Danish: 19,9 mdr.
English: * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
Danish: a OR for responsrater baseret på Mantel-Haenszel-skøn af den fælles oddsratio for stratificerede tabeller; p-værdier efter
English: A 6-week period is considered a treatment cycle.
Danish: En periode på 6 uger anses for en behandlingscyklus.
English: Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Danish: Der er i sjældne tilfælde rapporteret mulige immunkompleksmedierede reaktioner, f.eks. serumsyge, polyarthritis med udslæt og proliferativ glomerulonefritis.
English: 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).
Danish: 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).
English: 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).
Danish: Cochran-Mantel-Haenszel-test. b Henviser til responsrate efter den anden transplantation hos forsøgspersoner, der blev transplanteret 2 gange (42/240[18 %]
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning 1 hætteglas
English: If any discolouration or particulate matter is observed, the solution should be discarded.
Danish: Hvis der ses nogle partikler eller misfarvning, skal opløsningen bortskaffes.
English: When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week.
Danish: Når toksiciteten er forsvundet, gives Bortezomib SUN igen, og dosis reduceres til 0,7 mg/m2 en gang om ugen.
English: Subcutaneous or intravenous use only.
Danish: Kun til subkutan eller intravenøs anvendelse.
English: The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Danish: Forekomsten af herpes zoster blandt patienter i BzmbR-CAP-armen var 10,7 % hos patienter, der ikke havde fået antiviral profylakse, sammenlignet med 3,6 % hos patienter, der havde fået antiviral profylakse (se pkt.
English: The duration of overall response was 21.4 months longer in the BzmbR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Danish: Varigheden af det samlede respons var 21,4 måneder længere i BzmbR-CAP-gruppen (median 36,5 måneder kontra 15,1 måneder i RCHOP-gruppen).
English: - Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Danish: - Trombocyttal skal være ≥ 70 x 109/l, og absolut neutrofiltal skal være ≥ 1,0 x 109/l
English: Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy.
Danish: Der er rapporteret enkelte tilfælde af krampeanfald hos patienter, som ikke tidligere har oplevet sådanne anfald eller epilepsi.
English: Bzmb (1.3 mg/m2) Day 1, 4
Danish: Bzmb (1,3 mg/m2) Dag 1, 4
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio;
Danish: CR=komplet respons; CRu=komplet respons ubekræftet; PR=partielt respons; CI=konfidensinterval, HR=hazard-ratio; OR=oddsratio; ITT=Intent to Treat.
English: Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma
Danish: Tabel 5: Dosisjusteringer under behandlingen af patienter med tidligere ubehandlet mantle-cellelymfom
English: During clinical trials, hypoglycemia and hyperglycemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycemics.
Danish: Der er i kliniske studier rapporteret hypoglykæmi og hyperglykæmi som ikke almindelige og almindelige bivirkninger hos diabetespatienter i behandling med orale hypoglykæmika.
English: A Phase II, single arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi agent re induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Danish: Et fase II-forsøg med en enkelt arm vedrørende aktivitet, sikkerhed og farmakokinetik udført af Children's Oncology Group vurderede virkningen af at tilføje bortezomib til reinduktionskemoterapi med flere stoffer hos pædiatriske og unge voksne patienter med lymfoid malignitet (akut præ-B-celle lymfoblastær leukæmi [ALL], T-celle ALL og T-celle lymfoblastært lymfom [LL]).
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
Danish: • et redskab til beregning af dosis, hvor den ordinerende læge kan indlæse patientens højde og vægt for ud fra disse at beregne arealet af legemsoverfladen og derved fastsætte en passende dosering af Bortezomib SUN.
English: Marketing Authorisation Holder and Manufacturer Sun Pharmaceutical Industries Europe B.V. Polarisavenue 87
Danish: Indehaver af markedsføringstilladelsen og fremstiller Sun Pharmaceutical Industries Europe B.V.
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Danish: Studiets primære effektendepunkt var post-induktions-responsrate (CR+nCR).