FrancophonIA/ELRC3.0 huggingface dataset:
English: Neutropenia/Thrombocytopenia
Slovenian: Nevtropenija/trombocitopenija
English: Post-infusion medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
Slovenian: Za zmanjševanje tveganja za pozne infuzijske reakcije je treba bolnikom po infuziji aplicirati naslednja zdravila:
English: Based on the population PK analysis of daratumumab monotherapy (Analysis 1), daratumumab steady state is achieved approximately 5 months into the every 4-week dosing period (by the 21
Slovenian: Po podatkih analize populacijske farmakokinetike (1. analize) doseže daratumumab v monoterapiji stanje dinamičnega ravnovesja po približno 5 mesecih obdobja odmerjanja na vsake 4 tedne (do 21. infuzije).
English: Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Slovenian: Med manj pogostimi simptomi so bili piskajoče dihanje, alergijski rinitis, zvišana telesna temperatura, neprijeten občutek v prsnem košu, srbenje in hipotenzija (glejte poglavje 4.8).
English: Doses up to 24 mg/kg have been administered intravenously in a clinical study.
Slovenian: V klinični študiji so bolnikom intravensko aplicirali odmerke do 24 mg/kg.
English: • Gently invert the bag/container to mix the solution.
Slovenian: • Raztopino v vrečki/vsebniku premešajte z nežnim obračanjem.
English: Four individual population PK analyses were performed based on pre-existing renal function data in patients receiving daratumumab monotherapy, or various combination therapies (Analyses 1-4), and included a total of 441 patients with normal renal function (creatinine clearance [CRCL] ≥90 mL/min), 621 with mild renal impairment (CRCL <90 and ≥60 mL/min), 523 with moderate renal impairment (CRCL <60 and ≥30 mL/min), and 27 with severe renal impairment or end stage renal disease
Slovenian: Štiri ločene analize populacijske farmakokinetike so izvedli na podatkih prej pridobljenih izvidov ledvične funkcije pri bolnikih, ki so prejemali daratumumab v monoterapiji ali v različnih kombinacijah z drugimi zdravili (1.-4. analiza) pri skupno 441 bolnikih z normalno ledvično funkcijo (z očistkom kreatinina ≥90 ml/min), 621 bolnikih z blago okvaro ledvic (z očistkom kreatinina <90 ml/min in ≥ 60 ml/min), 523 bolnikih z zmerno okvaro levic (z očistkom kreatinina <60 ml/min in ≥30 ml/min) in pri 27 bolnikih s hudo okvaro ledvic ali s končno ledvično odpovedjo (z očistkom kreatinina <30 ml/min).
English: Bortezomib was administered by SC injection or IV injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28 day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles 5 and 6) following ASCT after Cycle 4.
Slovenian: Bortezomib so prejemali s subkutanimi ali intravenskimi injekcijami v odmerku 1,3 mg/m2 telesne površine dvakrat na teden dva tedna (na 1., 4., 8. in 11. dan) v več 28-dnevnih (4-tedenskih) krogih indukcijskega zdravljenja (1.-4. krog) in dveh konsolidacijskih krogih (5. in 6. krog), ki sta sledila avtologni presaditvi matičnih celic po 4. krogu.
English: The median patient age was 63.5 years (range, 31 to 84 years), 11% of patients were ≥75 years of age, 49% were male and 79% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 63,5 let (od 31 do 84 let), 11% je bilo starejših od 75 let, 49% je bilo moškega spola in 79% je bilo belcev.
English: • Withdraw the necessary amount of DARZALEX solution and dilute to the appropriate volume by adding to an infusion bag/container containing 0.9% Sodium Chloride.
Slovenian: • Izračunani volumen DARZALEX koncentrata za raztopino za infundiranje razredčite do ustreznega volumna tako, da ga dodate v infuzijsko vrečko/vsebnik z 0,9-odstotno raztopino natrijevega klorida.
English: Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Slovenian: Če se vam poslabša utrujenost, vam porumeni koža ali očesne beločnice, morate takoj obvestiti zdravnika.
English: At baseline, 76% of patients were refractory to the last line of treatment, 64% were refractory to both a PI and IMiD, 60% were refractory to alkylating agents, 36% were refractory to pomalidomide and 17% were refractory to carfilzomib.
Slovenian: Ob izhodišču je bilo na zadnjo linijo zdravljenja neodzivnih 76% bolnikov, na obe liniji zdravljenja (na zaviralec proteasoma (PI) in imunomodulirajoče zdravilo) je bilo neodzivnih 64% bolnikov, na alkilirajoča zdravila je bilo neodzivnih 60% bolnikov, na pomalidomid je bilo neodzivnih 36% bolnikov in na karfilzomib je bilo neodzivnih 17% bolnikov.
English: DARZALEX contains sodium
Slovenian: Zdravilo DARZALEX vsebuje natrij
English: * No Grade 4
Slovenian: Stopnja odsotne MRD
English: Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Slovenian: Preglednica 1: Razpored odmerjanja zdravila DARZALEX v kombinaciji z lenalidomidom (režim odmerjanja s 4-tedenskim krogom) in v monoterapiji
English: Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
Slovenian: Po podatkih štirih analiz populacijske farmakokinetike (1.-4. analize) je telesna masa statistično pomembna sospremenljivka za očistek daratumumaba in zato je odmerjanje na osnovi telesne mase primerna strategija odmerjanja za bolnike z diseminiranim plazmocitomom.
English: o A warning message for HCPs treating the patient at any time, including in conditions of emergency, that the patient is using DARZALEX (daratumumab), and that this treatment is associated with the Important Identified Risk of Interference for blood typing (minor antigen) (Positive Indirect Coombs' test), which might persist for up to 6 months after the last product's infusion, and a clear reference that the patient should continue to carry this card until 6 months after the treatment has ended; o Contact details of the DARZALEX (daratumumab) prescriber; o Reference to the need to consult the Package Leaflet (PL).
Slovenian: o Opozorilo zdravstvenim delavcem, ki kadarkoli (tudi v nujnih primerih) obravnava bolnika, da bolnik prejema zdravilo DARZALEX (daratumumab), ki je povezano s pomembnim znanim tveganjem vpliva na tipizacijo krvi (majhen antigen) (pozitiven indirektni Coombsov test) in, da ta vpliv lahko traja do 6 mesecev po prejetju zadnje infuzije zdravila.
English: The pharmacokinetics (PK) of daratumumab following intravenous administration of daratumumab monotherapy were evaluated in patients with relapsed and refractory multiple myeloma at dose levels from 0.1 mg/kg to 24 mg/kg.
Slovenian: Farmakokinetiko daratumumaba po intravenskem odmerjanju daratumumaba v monoterapiji so pri bolnikih s ponovljenim in neodzivnim diseminiranim plazmocitomom ocenjevali pri odmernih ravneh od 0,1 mg/kg do 24 mg/kg.
English: A subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab mediated cell lysis.
Slovenian: Z daratumumabom povzročena citoliza zmanjša število podskupin mieloičnih supresorskih celic (CD38+MDSC), regulatornih limfocitov T (CD38+Treg) in limfocitov B (CD38+Breg).
English: 500 mL 100 mL/hour 50 mL/hour every hour
Slovenian: 100 ml/uro vsako uro za 50 ml/uro
English: Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Slovenian: Pojavile so se hude reakcije, vključno z bronhospazmom, hipoksijo, dispnejo, hipertenzijo, laringealnim edemom in pljučnim edemom.
English: The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Slovenian: Mediana starost bolnikov je bila 64 let (od 44 do 76 let), 64% bolnikov je bilo moškega spola in 76% je bilo belcev.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih infuzijska reakcija zelo pogosti
English: Do not use DARZALEX if the above applies to you.
Slovenian: Če navedeno velja za vas, ne uporabljajte zdravila DARZALEX.
English: The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Slovenian: Mediana starost bolnikov je bila 64 let (od 30 do 88 let), 12% bolnikov je bilo starih ≥75 let.
English: Response assessment Day 100 posttransplant Stringent Complete Response (sCR) 157 (28.9%) CR or better (sCR+CR) Very Good Partial Response or better (sCR+CR+VGPR) MRD negativity c, d n(%)
Slovenian: Ocena odziva na 100. dan po presaditvi strog popolni odziv (sCR) popolni ali še boljši odziv (sCR+CR) 211 (38,9%) zelo dober delni ali še boljši odziv (sCR+CR+VGPR)
English: Efficacy was evaluated by PFS based on IMWG criteria.
Slovenian: Učinkovitost so vrednotili s trajanjem preživetja brez napredovanja bolezni po kriterijih IMWG.
English: Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
Slovenian: Hude infuzijske reakcije so vključevale bronhospazem, dispnejo, laringealni edem, pljučni edem, hipoksijo in hipertenzijo.
English: Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Slovenian: Daratumumab je humano monoklonsko protitelo vrste IgG1κ, ki je usmerjeno proti antigenu CD 38.
English: Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6.
Slovenian: V 5. in 6. krogu so deksametazon prejeli v odmerku 20 mg na 1., 2., 8., 9., 15. in 16. dan.
English: 9/L, and platelets > 50 x 10 9/L without transfusion).
Slovenian: 9/l brez transfuzije).
English: Infusion rate/dilution volume used upon re-initiation was that used for the last DARZALEX infusion prior to interruption due to ASCT.
Slovenian: Pri ponovni uvedbi so uporabili enako hitrost infundiranja in volumen razredčitve kot pri zadnji infuziji zdravila DARZALEX pred prekinitvijo zdravljenja zaradi avtologne presaditve matičnih celic.
English: The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Slovenian: Mediana starost bolnikov je bila 71 let (od 40 do 93 let), pri čemer je bilo 30% bolnikov starih ≥75 let.
English: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
Slovenian: Ena 5-mililitrska viala zdravila DARZALEX vsebuje 0,4 mmol (9,3 mg) natrija in ena 20-mililitrska viala zdravila DARZALEX vsebuje 1,6 mmol (37,3 mg) natrija.
English: DARZALEX is indicated:
Slovenian: Zdravilo DARZALEX je indicirano
English: • in combination with lenalidomide and dexamethasone or with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
Slovenian: • v kombinaciji z lenalidomidom in deksametazonom ali bortezomibom, melfalanom in prednizonom za zdravljenje odraslih bolnikov z novo odkritim diseminiranim plazmocitomom, ki niso primerni za avtologno presaditev matičnih celic.
English: All patients should be monitored throughout the infusion for IRRs.
Slovenian: Med infundiranjem je treba vse bolnike spremljati glede pojava infuzujskih reakcij.
English: Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
Slovenian: 100 mg metilprednizolona ali drugega enakovrednega zdravila z intravenskim odmerjanjem; po drugi infuziji se lahko odmerek kortikosteroida zmanjša (60 mg metilprednizolona peroralno ali intravensko).
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose dexamethasone at 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or BMI <18.5).
Slovenian: Bolniki so prejemali lenalidomid (25 mg enkrat na dan peroralno od 1. do 21. dne v več 28-dnevnih [4-tedenskih] krogih) skupaj z majhnimi odmerki deksametazona 40 mg/teden (ali zmanjšan odmerek 20 mg/teden pri bolnikih, ki so bili stari več kot 75 let ali so imeli ITM <18,5).
English: Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
Slovenian: Kombinirano zdravljenje z bortezomibom, melfalanom in prednizonom (VMP) pri bolnikih, ki niso primerni za avtologno presaditev matičnih celic:
English: Dosing schedule in combination with bortezomib, thalidomide and dexamethasone (4-week cycle regimens) for treatment of newly diagnosed patients eligible for autologous stem cell transplant (ASCT):
Slovenian: Razpored odmerjanja v kombinaciji z bortezomibom, talidomidom in deksametazonom 4-tedenski krog zdravljenja) za zdravljenje novo odkritih bolnikov, ki so primerni za avtologno presaditev matičnih celic:
English: Dosing schedule in combination with lenalidomide (4-week cycle regimen) and for monotherapy: The recommended dose is DARZALEX 16 mg/kg body weight administered as an intravenous infusion according to the following dosing schedule in Table 1.
Slovenian: Razpored odmerjanja v kombinaciji z bortezomibom (3-tedenski krog zdravljenja): Priporočeni odmerek zdravila DARZALEX je 16 mg/kg telesne mase z odmerjanjem v obliki intravenske infuzije po razporedu v preglednici 4.
English: Four individual population PK analyses were performed in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), and included a total of 1404 patients with normal hepatic function (total bilirubin [TB] and aspartate aminotransferase [AST] ≤ upper limit of normal [ULN]), 189 with mild hepatic impairment (TB 1.0 x to 1.5 x ULN or AST >ULN) and 8 patients with moderate (TB > 1.5 x to 3.0 x ULN; n=7), or severe (TB > 3.0 x ULN; n=1) hepatic impairment.
Slovenian: Štiri ločene analize populacijske farmakokinetike so izvedli pri bolnikih, ki so prejemali daratumumab v monoterapiji ali v različnih kombinacijah z drugimi zdravili (1.-4. analiza) pri skupno 1404 bolnikih z normalno jetrno funkcijo (z vrednostmi celokupnega bilirubina in aspartat aminotransferaze [AST] do največ zgornje meje normalnih vrednosti [ZMN]) in 189 bolnikih z blago okvaro jeter (z vrednostmi celokupnega bilirubina 1,0 do 1,5-kratnikom ZMN ali vrednostmi AST nad ZMN) ter pri 8 bolnikih z zmerno (z vrednostmi celokupnega bilirubina nad 1,5 do 3,0-kratnikom ZMN; n=7)
English: Median OS was not reached for either treatment group.With an overall median follow-up of 7.4 months (95% CI: 0.0, 14.9), the hazard ratio for OS was 0.77 (95% CI: 0.47, 1.26; p=0.2975).
Slovenian: S skupnim medianim trajanjem spremljanja 7,4 meseca (95-odstotni IZ: 0,0, 14,9) je bilo razmerje ogroženosti za celokupno preživetje 0,77 (95-odstotni IZ: 0,47, 1,26; p=0,2975).
English: Since the Kell Blood group system is also sensitive to DTT treatment, Kell-negative units should be supplied after ruling out or identifying alloantibodies using DTT-treated RBCs.
Slovenian: Tudi sistem krvnih skupin Kell je občutljiv na obdelavo z ditiotretiolom, zato je treba po izključitvi oziroma določitvi prisotnosti aloprotiteles na vzorcu eritrocitov, ki je bil obdelan z ditiotretiolom, uporabiti enote po Kellu negativne krvi.
English: DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
Slovenian: Izgled zdravila DARZALEX in vsebina pakiranja Zdravilo DARZALEX je koncentrat za raztopino za infundiranje in je brezbarvna do rumena tekočina.
English: Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Slovenian: Resni neželeni učinki so bili pljučnica, bronhitis, okužba zgornjih dihal, pljučni edem, gripa, zvišana telesna temperatura, dehidracija, driska in atrijska fibrilacija.
English: Lenalidomide (25 mg once daily orally on Days 1-21 of repeated 28-day [4-week] cycles) was given with low dose oral or intravenous dexamethasone 40 mg/week (or a reduced dose of 20 mg/week for patients >75 years or body mass index [BMI] <18.5).
Slovenian: Bolniki so prejemali lenalidomid (25 mg enkrat na dan peroralno od 1. do 21. dne v več 28-dnevnih [4-tedenskih] krogih) skupaj z majhnimi odmerki peroralnega ali intravenskega deksametazona v odmerku 40 mg/teden (ali zmanjšan odmerek 20 mg/teden pri bolnikih, ki so bili stari več kot 75 let ali so imeli indeks telesne mase [ITM] <18,5).
English: Manufacturer Janssen Biologics B.V. Einsteinweg 101
Slovenian: Proizvajalec Janssen Biologics B.V.
English: DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
Slovenian: Osebi, ki izvaja ta test, morate povedati, da prejemate zdravilo DARZALEX.
English: Pre-infusion medication
Slovenian: Premedikacija pred infuzijo
English: every three weeks (total of 16 doses)
Slovenian: 7. do 54. teden vsak tretji teden (skupno 16 odmerkov)
English: Tell your doctor or nurse straight away if you get any of the following signs of an infusion-related reaction during or in the 3 days after the infusion.
Slovenian: Če med infundiranjem ali v 3 dneh po infuziji opazite katerega od naslednjih znakov infuzijske reakcije, takoj obvestite zdravnika ali medicinsko sestro.
English: Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Slovenian: Kombinirano zdravljenje z bortezomibom, talidomidom in deksametazonom (VTd) pri bolnikih, ki so primerni za avtologno presaditev matičnih celic (autologous stem cell transplantation, ASCT):
English: On the days of DARZALEX infusion, 20 mg of the dexamethasone dose was administered as a pre-infusion medication.
Slovenian: V dneh, ko so bolniki prejemali infuzijo zdravila DARZALEX, so odmerek 20 mg deksametazona prejemali kot premedikacijo pred infuzijo.
English: • in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
Slovenian: • v kombinaciji z bortezomibom, talidomidom in deksametazonom za zdravljenje odraslih bolnikov z novo odkritim diseminiranim plazmocitomom, ki so primerni za avtologno presaditev matičnih celic.
English: Weeks 1 to 9
Slovenian: 1. do 9. teden enkrat tedensko (skupno 9 odmerkov)
English: What DARZALEX is used for
Slovenian: Za kaj uporabljamo zdravilo DARZALEX
English: Patients refractory to bortezomib were excluded from the study.
Slovenian: Bolnikov, ki so bili neodzivni na bortezomib, niso vključevali v študijo.
English: It is given as a drip into a vein (“intravenous infusion”) over several hours.
Slovenian: Zdravilo boste prejemali z “intravensko infuzijo”, kar pomeni, da vam bo več ur počasi teklo v veno.
English: Combination treatment with lenalidomide and dexamethasone in patients ineligible for autologous stem cell transplant:
Slovenian: Kombinirano zdravljenje z lenalidomidom in deksametazonom pri bolnikih, ki niso primerni za avtologno presaditev matičnih celic:
English: The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Slovenian: Mediana starost bolnikov je bila 73 let (od 45 do 90 let), pri čemer je bilo 44% bolnikov starih ≥75 let.
English: Part 1 compared induction and consolidation treatment with DARZALEX 16 mg/kg in combination with bortezomib, thalidomide and dexamethasone (D-VTd) to treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma eligible for ASCT.
Slovenian: V 1. delu so primerjali indukcijsko in konsolidacijsko zdravljenje z zdravilom DARZALEX 16 mg/kg v kombinaciji z bortezomibom, talidomidom in deksametazonom (D-VTd) z zdravljenjem z bortezomibom, talidomidom in deksametazonom (VTd) pri bolnikih z novo odkritim diseminiranim plazmocitomom, ki so bili primerni za avtologno presaditev matičnih celic.
English: D-VMP=daratumumab-bortezomib-melphalan-prednisone; VMP=bortezomib-melphalan-prednisone; MRD=minimal residual disease; CI=confidence interval
Slovenian: D-VTd=daratumumab-bortezomib-talidomid-deksametazon; VTd=bortezomib-talidomide-deksametazon; MRD=minimalna preostala bolezen (minimal residual disease); IZ=interval zaupanja.
English: • Visually inspect parenteral medicinal products for particulate matter and discolouration prior to administration.
Slovenian: • Pred odmerjanjem preverite izgled parenteralnega zdravila in se prepričajte, da ne vsebuje delcev in je ustrezne barve.
English: Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Slovenian: na osnovi populacije z namenom zdravljenja (Intent-to-treat) vrednost-p pri testu hi-kvadrat po Cochran Mantel-Haenszelu na osnovi pražne vrednosti 10 ne glede na odziv IMWG za stratificirane preglednice je uporabljena ocena skupnega razmerja obetov po Mantel-Haenszelu
English: The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Slovenian: Mediana starost bolnikov je bila 65 let (od 34 do 89 let), 11% bolnikov je bilo starih ≥75 let.
English: Table 4: DARZALEX dosing schedule in combination with bortezomib (3-week cycle dosing regimen)
Slovenian: Preglednica 4: Prilagojen razpored odmerjanja zdravila DARZALEX v kombinaciji z bortezomibom (režim odmerjanja s 3-tedenskim krogom)
English: Pharmacodynamic effects
Slovenian: Farmakodinamične lastnosti
English: Following the start of daratumumab treatment, none of the monotherapy patients and 2 of the 1051 combination therapy patients tested positive for anti-daratumumab antibodies; 1 of the combination therapy patients developed transient neutralising antibodies against daratumumab.
Slovenian: Po začetku zdravljenja z daratumumabom prisotnosti protiteles proti daratumumabu niso potrdili pri nobenem od bolnikov, ki je daratumumab prejemal v monoterapiji, prisotnost protiteles pa so potrdili pri 2 od 1051 bolnikov, ki so daratumumab prejemali v okviru kombiniranega zdravljenja.
English: Subsequent (Week 3 onwards, 16 mg/kg) infusions
Slovenian: Nadaljnje infuzije (od 3. tedna dalje, 16 mg/kg)
English: Hepatitis B virus reactivation, in some cases fatal, has been reported in patients treated with DARZALEX.
Slovenian: Pri bolnikih, ki so prejemali zdravilo DARZALEX, so poročali o reaktivaciji virusa hepatitisa B, v nekaterih primerih s smrtnim izidom.
English: Table 10: IRC assessed efficacy results for study MMY2002 Efficacy endpoint
Slovenian: Preglednica 10: Rezultati učinkovitosti v študiji MMY2002 na osnovi ocene neodvisnega odbora (IRC)
English: D-VTd=daratumumab-bortezomib-thalidomide-dexamethasone; VTd=bortezomib-thalidomide-dexamethasone; MRD=minimal residual disease; CI=confidence interval Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Slovenian: D-VMP=daratumumab-bortezomib-melfalan-prednizon; VMP=bortezomib-melfalan-prednizon; MRD=minimalna rezidualna bolezen; IZ=interval zaupanja na osnovi populacije z namenom zdravljenja (Intent-to-treat) vrednost-p pri testu hi-kvadrat po Cochran Mantel-Haenszelu na osnovi pražne vrednosti 10 za stratificirane preglednice je uporabljena ocena skupnega razmerja obetov po Mantel-Haenszelu: razmerje obetov > 1 pomeni prednost zdravljenja z D-VMP vrednost p pri Fisherjevem eksaktnem testu
English: The mean (SD) predose (trough) serum concentration at the end of weekly dosing was 573 (331.5) micrograms/mL.
Slovenian: Ob koncu odmerjanja enkrat tedensko je bila povprečna najnižja koncentracija učinkovine v serumu pred prejemom novega odmerka 573 mikrogramov/ml (s standardnim odklonom 331,5 mikrogramov/ml).
English: • constipation
Slovenian: • mrazenje
English: When dexamethasone is the background-regimen specific corticosteroid, the dexamethasone treatment dose will instead serve as pre-medication on DARZALEX infusion days (see section 5.1).
Slovenian: Kadar bolnik prejema deksametazon kot specifičen kortikosteroid v osnovni shemi zdravljenja, ta terapevtski odmerek deksametazona prejme namesto premedikacije na tiste dni, ko prejeme infuzijo zdravila DARZALEX (glejte poglavje 5.1) Pred prvo infuzijo zdravila DARZALEX naj bolnik deksametazon prejme intravensko, pred nadaljnjimi infuzijami pa ga lahko prejme peroralno.