FrancophonIA/ELRC3.0 huggingface dataset:
English: • If not used immediately, the diluted solution can be stored prior to administration for up to 24 hours at refrigerated conditions (2°C-8°C) and protected from light.
Icelandic: Ef lyfið er ekki tafarlaust notað má geyma þynntu lausnina fyrir lyfjagjöf í allt að 24 klst. í kæli (2°C-8°C) varið ljósi.
English: Efficacy was evaluated by the stringent Complete Response (sCR) rate at Day 100 post-transplant and Progression free survival (PFS).
Icelandic: Verkun var metin með tíðni strangrar algjörrar svörunar (sCR) á degi 100 eftir ígræðslu og lifun án versnunar sjúkdóms (PFS).
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).
Icelandic: Lenalidomid (25 mg einu sinni á dag til inntöku á dögum 1-21 í endurteknum 28-daga [4-vikna] meðferðarlotum) var gefið með lágskammta dexametasoni 40 mg/viku (eða minni skammtur 20 mg/viku fyrir sjúklinga >75 ára eða með BMI <18,5).
English: Based on four individual population PK analyses in patients receiving either daratumumab monotherapy or various combination therapies (Analyses 1-4), the exposure to daratumumab was similar between white (n=1371) and non-white subjects (n=242).
Icelandic: Miðað við fjórar sjálfstæðar þýðisgreiningar lyfjahvarfa hjá sjúklingum sem fengu annaðhvort daratumumab einlyfjameðferð eða mismunandi samsettar meðferðir (greiningar 1-4), var útsetning fyrir daratumumabi svipuð hjá einstaklingum af hvítum kynstofni (n=1.371) og kynstofni sem ekki er hvítur (n=242).
English: In patients with persistent very good partial response, where daratumumab interference is suspected, consider using a validated daratumumab-specific IFE assay to distinguish daratumumab from any remaining endogenous M protein in the patient's serum, to facilitate determination of a complete response.
Icelandic: Hjá sjúklingum með stöðuga mjög góða hlutasvörun, þar sem grunur er um daratumumab truflun, skal íhuga að nota gildaða daratumumab-sértæka mótefnalitun til að aðgreina daratumumab frá þeim innrænu M-próteinum sem geta verið eftir í sermi sjúklings, til að auðvelda ákvörðun algerrar svörunar.
English: Table 6 summarises the adverse drug reactions that occurred in patients receiving DARZALEX.
Icelandic: Tafla 6 sýnir aukaverkanir sem komu fram hjá sjúklingum sem fengu DARZALEX.
English: On DARZALEX infusion days, 20 mg of the dexamethasone dose was given as a pre-infusion medication and the remainder given the day after the infusion.
Icelandic: DARZALEX voru 20 mg af dexametason skammtinum gefin sem forlyf fyrir innrennsli og afgangurinn var gefinn daginn eftir innrennslið.
English: p-value from Cochran Mantel-Haenszel Chi-Squared test.
Icelandic: p-gildi úr Cochran Mantel-Haenszel kí-kvaðrata prófi.
English: Other medicines and DARZALEX
Icelandic: Notkun annarra lyfja samhliða DARZALEX
English: The median time to onset of a reaction was 1.8 hours (range: 0.1 to 5.4 hours).
Icelandic: Miðgildi tíma þar til viðbrögð komu fram var 1,8 klst. (bil: 0,1 til 5,4 klst.).
English: In Study MMY3006, the number of CD34+ cell yield was numerically lower in the D-VTd arm compared with the VTd arm (Median: D-VTd: 6.3 x 10
Icelandic: Í rannsókn MMY3006 voru heimtur CD34+ frumna tölulega lægri hjá D-VTd hópnum samanborið við VTd hópinn (miðgildi:
English: 95% CI (%) Odds ratio with 95% CI
Icelandic: 95% CI (%) Líkindahlutfall með 95% CI
English: The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Icelandic: Miðgildi aldurs sjúklinga var 64 ár (bil: 44 til 76 ára), 64% voru karlar og 76% voru af hvítum kynþætti.
English: No animal studies have been performed to evaluate the potential effects of daratumumab on reproduction or development.
Icelandic: Engar dýratilraunir hafa verið gerðar til að meta möguleg áhrif daratumumabs á æxlun eða þroska.
English: Therefore, body weight based dosing is an appropriate dosing strategy for the multiple myeloma patients.
Icelandic: Þess vegna er skömmtun byggð á líkamsþyngd viðeigandi við ákvörðun skammta fyrir sjúklinga með mergæxli.
English: Weeks 1 to 9
Icelandic: Vikur 1 til 9
English: A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Icelandic: 350 í D-VMP arminn og 356 í VMP arminn.
English: How to store DARZALEX
Icelandic: Hvernig geyma á DARZALEX
English: Very Common 45
Icelandic: Mjög algengar 45
English: The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Icelandic: Miðgildi aldurs sjúklinga var 64 ár (bil 30 til 88 ára) og 12% voru ≥75 ára.
English: Clearance also decreased with multiple doses, which may be related to tumour burden decreases.
Icelandic: Úthreinsun minnkar einnig við endurtekna skammta sem getur tengst minni æxlisbyrði.
English: DARZALEX is given as an infusion (drip) into a vein.
Icelandic: DARZALEX er gefið sem innrennsli (dreypi) í bláæð.
English: In the event of a planned transfusion blood transfusion centres should be notified of this interference with indirect antiglobulin tests (see section 4.5).
Icelandic: Ef blóðgjöf er fyrirhuguð á að láta blóðbanka vita af þessari truflun á óbein andglóbúlín próf (sjá kafla 4.5).
English: The majority were male (59%), 48% had an ECOG performance score of 0, 42% had an ECOG performance score of 1 and 10% had an ECOG performance score of 2.
Icelandic: Meirihlutinn voru karlar (59%), 48% voru með ECOG færniskor 0, 42% með ECOG færniskor 1 og 10% með ECOG færniskor 2.
English: This is because DARZALEX could cause hepatitis B virus to become active again.
Icelandic: Það er vegna þess að DARZALEX gæti valdið því að lifrarbólgu
English: every three weeks (total of 5 doses)
Icelandic: á þriggja vikna fresti (samtals 5 skammtar)
English: • Corticosteroid (long-acting or intermediate-acting) - Monotherapy:
Icelandic: Barksteri (langvirkur eða verkar í meðallagi langan tíma) Einlyfjameðferð:
English: Three additional population PK analyses (Analysis 2, Analysis 3 and Analysis 4) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Icelandic: Þrjár viðbótar þýðisgreiningar lyfjahvarfa (greining 2, greining 3 og greining 4) voru gerðar hjá sjúklingum með mergæxli sem fengu daratumumab í samsettum meðferðum.
English: Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness.
Icelandic: Innan hvers tíðniflokks eru aukaverkanir taldar upp í alvarleikaröð þegar við á.
English: Forty percent had International Staging System (ISS) Stage I, 45% had ISS Stage II and 15% had ISS Stage III disease.
Icelandic: á ISS stigi I, 45% á ISS stigi II og 15% á ISS stigi III.
English: No interaction studies have been performed.
Icelandic: Engar langvarandi eitrunarprófanir hafa verið gerðar.
English: Bortezomib is given twice weekly at Weeks 1, 2, 4 and 5 for the first 6-week cycle, followed by once weekly at Weeks 1, 2, 4 and 5 for eight more 6-week cycles.
Icelandic: Bortezomib er gefið tvisvar sinnum í viku í vikum 1, 2, 4 og 5 í fyrstu 6-vikna meðferðarlotunni og síðan einu sinni í viku í vikum 1, 2, 4 og 5 í átta 6-vikna meðferðarlotur til viðbótar.
English: To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following DARZALEX infusions.
Icelandic: Til að minnka hættuna á seinkuðum viðbrögðum tengdum innrennsli á að gefa öllum sjúklingum barkstera til inntöku eftir innrennsli með DARZALEX.
English: weekly (total of 9 doses)
Icelandic: vikulega (samtals 9 skammtar)
English: The overall response rate was 90% in the D-VMP group and 74% in theVMP group (VGPR rate:29% in D-VMP group and 26% in VMP group; CR: 22% in D-VMP group and 18% in VMP group; sCR rate: 20% in D-VMP group and 7% in VMP group).
Icelandic: Heildarsvörunarhlutfallið var 90% hjá D-VMP hópnum og 74% hjá VMP hópnum (VGPR hlutfall:
English: The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, dyspnoea, cough, neutropenia, thrombocytopenia, anaemia, oedema peripheral, asthenia, peripheral sensory neuropathy and upper respiratory tract infection.
Icelandic: Algengustu aukaverkanirnar (≥ 20%) voru viðbrögð tengd innrennsli, þreyta, ógleði, niðurgangur, hægðatregða, hiti, mæði, hósti, daufkyrningafæð, blóðflagnafæð, blóðleysi, útlimabjúgur, þróttleysi, útlægur skyntaugakvilli og sýkingar í efri öndunarvegi.
English: If the patient does not experience additional symptoms, infusion rate escalation may be resumed at increments and intervals as appropriate (Table 5).
Icelandic: Ef sjúklingurinn fær ekki frekari viðbrögð tengd innrennsli má stigauka innrennslishraðann með hléum eins og við á (tafla 5).
English: Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity (see section 4.4).
Icelandic: Skammti getur þurft að seinka til að blóðfrumufjöldi nái jafnvægi á ný ef fram koma eitrunaráhrif á blóðmynd (sjá kafla 4.4).
English: For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Icelandic: Varðandi upplýsingar um lyf sem gefin eru með DARZALEX, sjá viðkomandi samantekt á eiginleikum lyfs.
English: Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
Icelandic: Miðað við þessar fjórar þýðisgreiningar lyfjahvarfa (greiningar 1-4) var líkamsþyngd marktækt mikilvæg skýribreyta fyrir úthreinsun daratumumabs.
English: Gender did not affect exposure of daratumumab to a clinically relevant degree in the population PK analyses.
Icelandic: Kyn hafði ekki áhrif á útsetningu fyrir daratumumabi að klínískt mikilvægu marki í þýðisgreiningum lyfjahvarfa.
English: Sodium acetate trihydrate Sodium chloride Water for injections
Icelandic: Natríumklóríð Vatn fyrir stungulyf
English: Based on population PK analyses, no dosage adjustments are necessary for patients with hepatic impairment (see section 5.2).
Icelandic: Miðað við þýðisgreiningar lyfjahvarfa er ekki þörf á að aðlaga skammta hjá sjúklingum með skerta lifrarstarfsemi (sjá kafla 5.2).
English: • sore throat, cough
Icelandic: • særindi í hálsi, hósti
English: DARZALEX is supplied as a carton pack containing 1 glass vial.
Icelandic: DARZALEX er fáanlegt í öskju sem inniheldur 1 hettuglas úr gleri.
English: No clinically important differences in the exposure to daratumumab were observed between patients with hepatic impairment and those with normal hepatic function.
Icelandic: Enginn klínískt mikilvægur munur á útsetningu fyrir daratumumabi sást milli sjúklinga með skerta lifrarstarfsemi og þeirra sem voru með eðlilega lifrarstarfsemi.
English: However, baseline levels of NK cells did not show an association with clinical response.
Icelandic: Grunngildi náttúrulegra drápsfrumna sýndu þó ekki tengsl við klíníska svörun.
English: No dose reduction of DARZALEX is recommended.
Icelandic: Skammtaminnkun DARZALEX er ekki ráðlögð.
English: 9/L, leukocytes > 1.0 x 10
Icelandic: > 1,0 x 10
English: Manage patients according to current clinical guidelines.
Icelandic: Meðhöndla skal sjúklinga í samræmi við núgildandi klínískar leiðbeiningar.
English: Warnings and precautions Talk to your doctor or nurse before you are given DARZALEX:
Icelandic: Leitið ráða hjá lækninum eða hjúkrunarfræðingnum áður en þér er gefið DARZALEX.
English: First dose of the every-2-week dosing schedule is given at Week 9 First dose of the every-2-week dosing schedule is given at Week 1 upon re-initiation of treatment following ASCT
Icelandic: Fyrsti skammtur í 2-vikna skammtaáætluninni er gefinn í viku 1 þegar meðferð er hafin á ný eftir samgena stofnfrumuígræðslu
English: Based on in vitro studies, daratumumab may utilise multiple effector functions, resulting in immune mediated tumour cell death.
Icelandic: Miðað við rannsóknir in vitro getur verið að daratumumab nýti margþætta hrifilstarfsemi (effector functions) sem veldur ónæmismiðluðum dauða æxlisfrumna.
English: The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Icelandic: Miðgildi aldurs var 71 ár (bil: 40-93) og 30% sjúklinganna var ≥75 ára.
English: every two weeks (total of 4 doses)
Icelandic: á tveggja vikna fresti (samtals 4 skammtar)
English: For patients with evidence of positive HBV serology, monitor for clinical and laboratory signs of HBV reactivation during, and for at least six months following the end of DARZALEX treatment.
Icelandic: B þarf að fylgjast með klínískum teiknum og rannsóknarniðurstöðum um endurvirkjun lifrarbólguveiru B á meðan meðferð stendur og í að minnsta kosti 6 mánuði eftir að DARZALEX meðferð lýkur.
English: Toxicology data have been derived from studies with daratumumab in chimpanzees and with a surrogate anti-CD38 antibody in cynomolgus monkeys.
Icelandic: Upplýsingar um eiturverkanir eru fengnar úr rannsóknum með daratumumabi hjá simpönsum og með staðgengils and-CD38 mótefni hjá cyonmolgus öpum.
English: Very Common 19
Icelandic: Mjög algengar 19
English: Interference with Indirect Antiglobulin Test (Indirect Coombs Test) Daratumumab binds to CD38 on RBCs and interferes with compatibility testing, including antibody screening and cross matching (see section 4.4).
Icelandic: Truflun á óbeinu andglóbúlín prófi (óbeint Coombs próf) Daratumumab binst CD38 á rauðum blóðkornum og truflar prófanir á samrýmanleika, þ.m.t. mótefnaskimun og krossprófun (sjá kafla 4.4).
English: DARZALEX may increase neutropenia and thrombocytopenia induced by background therapy (see section 4.8).
Icelandic: DARZALEX getur aukið daufkyrningafæð og blóðflagnafæð sem bakgrunnsmeðferð getur valdið (sjá kafla 4.8).
English: Dose adjustments for bortezomib, thalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Icelandic: Skammtaaðlaganir fyrir bortezomib, talidomid og dexametason voru gerðar í samræmi við ávísunarleiðbeiningar frá framleiðanda.
English: Ringaskiddy, Co. Cork Ireland
Icelandic: Cork Írland
English: • medicines to help the airways in your lungs stay open (bronchodilators)
Icelandic: lyf sem hjálpa við að halda öndunarvegi í lungum opnum (berkjuvíkkandi lyf)
English: Consider administering low-dose oral methylprednisolone (≤ 20 mg) or equivalent the day after the DARZALEX infusion.
Icelandic: Íhuga skal að gefa lágan skammt af metylprednisólon (≤20 mg) eða jafngilt lyf daginn eftir innrennsli með DARZALEX.
English: DARZALEX 20 mg/mL concentrate for solution for infusion.
Icelandic: DARZALEX 20 mg/ml innrennslisþykkni, lausn.
English: Stringent complete response (sCR) Complete response (CR)
Icelandic: Ströng alger svörun (sCR) Alger svörun (CR)
English: Week 1 Infusion
Icelandic: Innrennsli í viku
English: What DARZALEX looks like and contents of the pack
Icelandic: Lýsing á útliti DARZALEX og pakkningastærðir
English: Combination therapy:
Icelandic: Samsett meðferð:
English: At baseline, 97% of patients were refractory to the last line of treatment, 95% were refractory to both, a proteasome inhibitor (PI) and immunomodulatory agent (IMiD), 77% were refractory to alkylating agents, 63% were refractory to pomalidomide and 48% of patients were refractory to carfilzomib.
Icelandic: 97% sjúklinga ekki svarað síðustu tegund meðferðar, 95% svöruðu hvorki próteasómhemli né ónæmistemprandi lyfi, 77% svöruðu ekki alkýlerandi lyfi, 63% svöruðu ekki meðferð með pomalidomidi og 48% sjúklinga svöruðu ekki meðferð með carfilzomibi.
English: First dose of the every-3-week dosing schedule is given at Week 10 First dose of the every-4-week dosing schedule is given at Week 25
Icelandic: Fyrsti skammtur í 3-vikna skammtaáætluninni er gefinn í viku 10 Fyrsti skammtur í 4-vikna skammtaáætluninni er gefinn í viku 25
English: Post-marketing adverse reaction
Icelandic: Aukaverkanir eftir markaðssetningu
English: Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Icelandic: Sjaldgæfari einkenni voru hvæsandi andardráttur, ofnæmisnefslímubólga, hiti, óþægindi fyrir brjósti, kláði og lágþrýstingur (sjá kafla 4.8).
English: The mean (standard deviation [SD]) estimated terminal half-life of daratumumab following the first 16 mg/kg dose was 9 (4.3) days.
Icelandic: Meðal (staðalfrávik) áætlaður helmingunartími daratumumabs eftir fyrsta 16 mg/kg skammtinn var 9 (4,3) sólarhringar.
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.
Icelandic: Bortezomib var gefið með inndælingu undir húð eða í bláæð í skömmtunum 1,3 mg/m líkamsyfirborðs tvisvar í viku í tvær vikur (dagar 1, 4, 8 og 11) af endurteknum 28 daga (4-vikna) innleiðslumeðferðarlotum (lotur 1-4) og tveimur upprætingarlotum (lotur 5 og 6) í kjölfar samgena stofnfrumuígræðslu eftir lotu
English: DARZALEX dosing schedule in combination with bortezomib, melphalan and prednisone ([VMP]; 6-week cycle dosing regimen)
Icelandic: Skammtaáætlun fyrir DARZALEX í samsettri meðferð með bortezomibi, melphalani og prednisoni ([VMP]; 6-vikna meðferðarlotur)
English: Very common (may affect more than 1 in 10 people):
Icelandic: Mjög algengar (geta komið fyrir hjá fleiri en 1 af 10 einstaklingum):
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.
Icelandic: Dragið upp nauðsynlegt magn af DARZALEX lausn og þynnið að viðeigandi rúmmáli með því að bæta því í innrennslispoka/ílát sem inniheldur 0,9% natríumklóríðlausn.
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL 1 vial, 400 mg/20 mL
Icelandic: Innrennslisþykkni, lausn 1 hettuglas, 100 mg/5 ml 1 hettuglas, 400 mg/20 ml
English: • high blood pressure
Icelandic: • hátt blóðsykursgildi
English: Management of infusion-related reactions
Icelandic: Meðferð við viðbrögðum tengdum innrennsli
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).
Icelandic: Með heildar miðgildi eftirfylgni 7,4 mánuði (95% CI: 0,0; 14,9), var áhættuhlutfallið fyrir heildarlifun 0,77 (95% CI: 0,47; 1,26; p=0,2975).
English: Stringent complete response (sCR) [n (%)] Complete response (CR) [n] Very good partial response (VGPR) [n (%)] Partial response (PR) [n (%)] Clinical Benefit Rate (ORR+MR) [n (%)]
Icelandic: 95% CI (%) Ströng alger svörun (sCR) [n (%)] Alger svörun (CR) [n] Mjög góð hlutasvörun (VGPR) [n (%)] Hlutasvörun (PR) [n (%)] Hlutfall klínísks ávinnings (Clinical Benefit Rate) (ORR+MR) [n (%)]
English: Paraesthesia Headache
Icelandic: Útlimabjúgur Hiti
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.
Icelandic: 76% sjúklinga ekki svarað síðustu tegund meðferðar, 64% svöruðu hvorki próteasómhemli né ónæmistemprandi lyfi, 60% svöruðu ekki alkýlerandi lyfi, 36% svöruðu ekki meðferð með pomalidomidi og 17% sjúklinga svöruðu ekki meðferð með carfilzomibi.
English: weekly (total of 6 doses)
Icelandic: vikulega (samtals 6 skammtar)
English: In order to improve the traceability of biological medicinal products, the tradename and the batch number of the administered product should be clearly recorded.
Icelandic: Til þess að bæta rekjanleika líffræðilegra lyfja skal heiti og lotunúmer lyfsins sem gefið er vera skráð með skýrum hætti.
English: Dyspnoea Pulmonary oedema
Icelandic: Mæði Lungnabjúgur
English: For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
Icelandic: Komi fram viðbrögð tengd innrennsli, af hvaða stigi/alvarleika sem er, á tafarlaust að stöðva meðferð með DARZALEX innrennsli og bregðast við einkennum.
English: Based on intent-to-treat population p-value from Cochran Mantel-Haenszel Chi-Squared test.
Icelandic: Byggt á þýði sem á að meðhöndla (intent-to-treat population) p-gildi úr Cochran Mantel-Haenszel kí-kvaðrata prófi.
English: In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Icelandic: Að auki tempraði daratumumab CD38 ensímvirkni, hamlaði cyclasa ensímvirkni og örvaði virkni hydrolasa.
English: In patients who develop reactivation of HBV while on DARZALEX, suspend treatment with DARZALEX and institute appropriate treatment.
Icelandic: B á meðan þeir eru á DARZALEX eiga að gera hlé á DARZALEX meðferð og hefja viðeigandi meðferð.
English: every two weeks (total of 8 doses)
Icelandic: á tveggja vikna fresti (samtals 8 skammtar)
English: In the 1 to 24 mg/kg cohorts, peak serum concentrations (Cmax) after the first dose increased in approximate proportion to dose and volume of distribution was consistent with initial distribution into the plasma compartment.
Icelandic: Í hópunum sem fengu 1 til 24 mg/kg jókst hámarksþéttni í sermi (Cmax) eftir fyrsta skammt u.þ.b. hlutfallslega við skammta og dreifingarrúmmál var í samræmi við upphafsdreifingu inni í plasmahólfið.
English: Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Icelandic: Hvert 20 ml hettuglas inniheldur 400 mg af daratumumabi (20 mg daratumumab í ml).
English: The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Icelandic: Miðgildi aldurs var 73 ár (bil: 45-90) og 44% sjúklinganna var ≥75 ára.
English: Discard any unused portion left in the vial.
Icelandic: Fargið allri ónotaðri lausn sem verður eftir í hettuglasinu.
English: Study MMY3006 is a 2 Part, open-label, randomized, active-controlled Phase 3 study.
Icelandic: Rannsókn MMY3006 er opin slembuð 3. stigs rannsókn með virkum samanburði, í tveimur hlutum.
English: • feeling short of breath or other breathing problems.
Icelandic: • mæði eða aðrir öndunarerfiðleikar.
English: No clinically important differences in exposure to daratumumab were observed between patients with renal impairment and those with normal renal function.
Icelandic: Enginn klínískt mikilvægur munur sást á útsetningu fyrir daratumumabi milli sjúklinga með skerta nýrnastarfsemi og þeirra sem voru með eðlilega nýrnastarfsemi.
English: The median patient age was 65 years (range 34 to 89 years) and 11% were ≥75 years.
Icelandic: Miðgildi aldurs sjúklinga var 65 ár (bil 34 til 89 ára) og 11% voru ≥75 ára.
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.
Icelandic: 1.404 sjúklinga með eðlilega lifrarstarfsemi (heildarbilirubin [TB] og aspartat amínótransferasi [AST] ≤ efri mörk eðlilegs gildis (ULN), 189 með vægt skerta lifrarstarfsemi (TB 1,0 x til 1,5 xULN eða AST >ULN) og 8 sjúklinga með í meðallagi (TB >1,5 x til 3,0 x ULN; n=7) eða verulega (TB >3,0 x ULN; n=1) skerta lifrarstarfsemi.
English: Daratumumab is an IgG1κ human monoclonal antibody (mAb) that binds to the CD38 protein expressed at a high level on the surface of multiple myeloma tumour cells, as well as other cell types and tissues at various levels.
Icelandic: Daratumumab er einstofna manna IgG1κ mótefni sem binst CD38 próteininu sem er tjáð í háum gildum á yfirborði mergæxlafrumna sem og annarra frumugerða og vefja í mismunandi gildum.