FrancophonIA/ELRC3.0 huggingface dataset:
English: Thirty-three percent (33%) of patients were refractory to an IMiD only, and 28% were refractory to lenalidomide.
Slovenian: Triintrideset odstotkov (33%) bolnikov je bilo neodzivnih samo na imunomodulirajoče zdravilo, 28% jih je bilo neodzivnih na lenalidomid.
English: o The guide for HCPs and Blood Banks, to advice about the risk of interference for blood typing and how to minimise it; o The Patient Alert Card.
Slovenian: o Vodnik za za zdravstvene delavce in krvno banko s podatki o tveganju glede vpliva na tipizacijo krvi in navodili, kako zmanjšati to tveganje; o Opozorilno kartico za bolnika.
English: This medicine contains 9.3 mg sodium (main component of cooking/table salt) in each 5 mL vial.
Slovenian: To zdravilo vsebuje 9,3 mg natrija (glavne sestavine kuhinjske soli) v eni 5-mililitrski viali.
English: After each infusion of DARZALEX you will be given medicines (such as corticosteroids) to lower the chance of infusion-related reactions.
Slovenian: Po vsaki infuziji zdravila DARZALEX boste prejeli zdravila (kot so kortikosteroidi) za zmanjševanje možnosti za infuzijske reakcije.
English: If you get infusion-related reactions, you may need other medicines, or the infusion may need to be slowed down or stopped.
Slovenian: Če pride do infuzijskih reakcij, boste morda potrebovali dodatna zdravila ali pa bo treba upočasniti ali povsem prekiniti infundiranje zdravila.
English: • then once every 2 weeks for 16 weeks
Slovenian: • naslednjih 16 tednov ga boste prejemali enkrat na 2 tedna,
English: Fertility No animal studies have been performed to determine potential effects on fertility in males or females.
Slovenian: Plodnost Na živalih niso izvajali študij za oceno morebitnega vpliva zdravila na plodnost samcev ali samic.
English: The MAH shall ensure that in each MS where DARZALEX (daratumumab) is marketed, all HCPs and patients who are expected to prescribe, dispense and receive this product have access to/are provided with the below.
Slovenian: Imetnik mora zagotoviti, da bodo v vseh državah članicah, kjer je zdravilo DARZALEX (daratumumab) na trgu, vsi zdravstveni delavci in bolniki, za katere se pričakuje, da bodo predpisovali, izdajali ali prejeli to zdravilo, imeli dostop oziroma prejeli:
English: CARTON (100 mg/400 mg) (WITH BLUE BOX)
Slovenian: ŠKATLA (100 mg/400 mg) (Z MODRIM OKENCEM)
English: This interference can impact the determination of complete response and of disease progression in some patients with IgG kappa myeloma protein.
Slovenian: Ta motnja lahko vpliva na določanje popolnega odgovora na zdravljenje in napredovanja bolezni pri nekaterih bolnikih z IgG1 kapa proteini diseminiranega plazmocitoma.
English: Fatal infections were primarily due to pneumonia and sepsis.
Slovenian: Do smrtnega izida zaradi okužbe je prišlo predvsem zaradi pljučnice in sepse.
English: • low number of red blood cells which carry oxygen in the blood (anaemia)
Slovenian: • zmanjšano število rdečih krvničk, ki prenašajo kisik po krvi (anemija ali slabokrvnost)
English: Key: D=daratumumab; Vd=bortezomib-dexamethasone; Rd=lenalidomide-dexamethasone; Pd=pomalidomidedexamethasone; VMP=bortezomib-melphalan-prednisone; VTd=bortezomib-thalidomide-dexamethasone.
Slovenian: Razlaga kratic: D=daratumumab; Vd=bortezomib-deksametazon; Rd=lenalidomid-deksametazon; Pd=pomalidomiddeksametazon; VMP=bortezomib-melfalan-prednizon; VTd=bortezomib-talidomid-deksametazon
English: This medicine contains 37.3 mg sodium (main component of cooking/table salt) in each 20 mL vial.
Slovenian: To zdravilo vsebuje 37,3 mg natrija (glavne sestavine kuhinjske soli) v eni 20-mililitrski viali.
English: DARZALEX can decrease white blood cell counts which help fight infections, and blood cells called platelets which help to clot blood.
Slovenian: Zdravilo DARZALEX lahko zmanjša število belih krvnih celic (levkocitov), ki sodelujejo pri obrambi telesa pred okužbami, in število krvnih ploščic, ki jih imenujemo trombociti in omogočajo strjevanje krvi.
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.
Slovenian: V kohorti bolnikov, ki so prejemali odmerke od 1 do 24 mg/kg, je vrednost najvišje koncentracije v serumu (Cmax) po prvem odmerku naraščala približno sorazmerno z velikostjo odmerka, volumen porazdelitve pa je bil skladen z začetno porazdelitvijo v predelek plazme.
English: How much is given
Slovenian: Koliko zdravila prejemate
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).
Slovenian: V primeru načrtovane transfuzije je treba transfuzijski center obvestiti o možnosti opisanega vpliva na rezultate indirektnih antiglobulinskih testov (glejte poglavje 4.5).
English: • Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre).
Slovenian: • Razredčeno raztopino injicirajte z intravensko infuzijo z uporabo infuzijskega kompleta z regulatorjem pretoka in linijskim sterilnim apirogenim polietersulfonskim (PES) filtrom, ki minimalno veže proteine (z velikostjo por 0,22 ali 0,2 mikrometra).
English: • swollen hands, ankles or feet
Slovenian: • otekanje rok, gležnjev ali stopal
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
Slovenian: V študiji MMY3006 je bilo absolutno število zbranih celic CD34+ (cell yield) v skupini D-VTd manjše kot v skupini VTd (mediana: v skupini D-VTd 6,3 x 10
English: Median durations of infusions were 4.2 h for Week 1-Day 1, 4.2 h for Week 1-Day 2, and 3.4 hours for the subsequent infusions.
Slovenian: Mediano trajanje infuzij na 1. dan 1. tedna je bilo 4,2 ure, na 2. dan 1.tedna 4,2 ure, pri nadaljnjih infuzijah pa 3,4 ure.
English: DARZALEX is for intravenous use.
Slovenian: Zdravilo DARZALEX je namenjeno intravenski uporabi.
English: For patients that experience any Grade IRRs, continue monitoring post-infusion until symptoms resolve.
Slovenian: Bolnike, pri katerih pride do infuzijske reakcije katere koli stopnje, je treba spremljati tudi v obdobju po infuziji vse dokler simptomi ne izzvenijo.
English: A subgroup analysis was performed on patients at least 70 years old, or those 65-69 years old with ECOG performance score of 2, or aged less than 65 years of age with significant comorbidity or ECOG performance score of 2 (D-VMP: n=273, VMP: n=270).
Slovenian: Analizo podatkov podskupine bolnikov so izvedli pri bolnikih, ki so bili stari najmanj 70 let in pri tistih, ki so bili stari 65-69 let in so imeli oceno ECOG 2, ter pri bolnikih, ki so bili stari manj kot 65 let in so imeli pomembno sočasno bolezen ali oceno stanja zmogljivosti ECOG 2 (D-VMP: n=273, VMP: n=270).
English: The dose of DARZALEX will depend on your body weight.
Slovenian: Odmerek zdravila DARZALEX je odvisen od vaše telesne mase.
English: Pneumonia was the most commonly reported severe (Grade 3 or 4) infection across studies.
Slovenian: V vseh študijah so med hudimi okužbami (3. ali 4. stopnje) najpogosteje poročali o pljučnici.
English: These observations suggest CD38 may become saturated at higher doses, after which the impact of target binding clearance is minimised and the clearance of daratumumab approximates the linear clearance of endogenous IgG1.
Slovenian: Ta opažanja kažejo, da pri večjih odmerkih morda pride do zasičenosti proteina CD38 in da je po tej točki pomen odstranjevanja po vezavi na tarčo (target binding clearance) majhen, očistek daratumumaba pa se približa linearnemu očistku endogenih IgG1.
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se obrnite na zdravnika ali medicinsko sestro.
English: Management of infusion-related reactions
Slovenian: Obvladovanje infuzijskih reakcij
English: The median duration of response was not reached (95% CI: 5.6 months, not estimable).
Slovenian: Mediana trajanja odziva ni bila dosežena (95-odstotni IZ: 5,6 meseca, zgornje meje ni mogoče oceniti).
English: What DARZALEX is and what it is used for What you need to know before you are given DARZALEX How DARZALEX is given
Slovenian: Kaj je zdravilo DARZALEX in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo DARZALEX Kako se uporablja zdravilo DARZALEX Možni neželeni učinki
English: If a planned dose of DARZALEX is missed, the dose should be administered as soon as possible and the dosing schedule should be adjusted accordingly, maintaining the treatment interval.
Slovenian: Če bolnik ne prejme načrtovanega odmerka zdravila DARZALEX, ga mora prejeti čimprej, nadaljnji razpored odmerjanja pa je treba prilagoditi tako, da se interval med odmerki ne spremeni.
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).
Slovenian: Celokupna stopnja odziva je bila v skupini D-VMP 90%, v skupini VMP pa 74% (stopnja zelo dobrega delnega odziva (VGPR) je bila v skupini D-VMP 29%, v skupini VMP pa 26%; stopnja popolnega odziva (CR): 22% v skupini D-VMP in 18% v skupini VMP; stopnja strogega popolnega odziva (sCR): 20% v skupini D-VMP in 7% v skupini VMP).
English: Resumption of DARZALEX treatment in patients whose HBV reactivation is adequately controlled should be discussed with physicians with expertise in managing HBV.
Slovenian: O nadaljevanju zdravljenja z zdravilom DARZALEX pri bolnikih, pri katerih je reaktivacija HBV ustrezno nadzorovana, se je treba posvetovati s specialistom za zdravljenje HBV.
English: At the end of weekly dosing for the recommended monotherapy schedule and dose of 16 mg/kg, the mean (SD) serum Cmax value was 915 (410.3) micrograms/mL, approximately 2.9-fold higher than following the first infusion.
Slovenian: Ob koncu priporočenenega razporeda odmerjanja enkrat tedensko v monoterapiji in odmerku 16 mg/kg je bila povprečna vrednost Cmax v serumu 915 mikrogramov/ml (s standardnim odklonom 410,3 mikrogramov/ml), kar je približno 2,9-krat več kot po prvi infuziji.
English: It is administered as an intravenous infusion following dilution with sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Apliciramo ga z intravensko infuzijo po redčenju z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za iniciranje.
English: 95% CI (%) Odds ratio with 95% CI MRD negativity in combination with CR or better c n(%)
Slovenian: c,d n (%) 95-odstotni IZ (%) razmerje obetov s 95-odstotnim IZ Stopnja odsotne MRD v kombinaciji s CR ali še boljšim odzivom c n(%)
English: The majority of patients (86%) received a prior PI, 55% of patients had received a prior IMiD, including 18% of patients who had received prior lenalidomide; and 44% of patients had received both a prior PI and IMiD.
Slovenian: Večina bolnikov (86%) je predhodno prejemala zaviralec proteasoma, 55% bolnikov je predhodno prejemalo imunomodulirajoče zdravilo, vključno z 18% bolnikov, ki so predhodno prejemali lenalidomid, 44% bolnikov pa je predhodno prejemalo tako zaviralec proteasoma kot imunomodulirajoče zdravilo.
English: What DARZALEX is and what it is used for
Slovenian: Kaj je zdravilo DARZALEX in za kaj ga uporabljamo
English: Clinical pharmacokinetic assessments of daratumumab in combination with lenalidomide, pomalidomide, thalidomide, bortezomib and dexamethasone indicated no clinically-relevant drug-drug interaction between daratumumab and these small molecule medicinal products.
Slovenian: Ocena klinične farmakokinetike daratumumaba v kombinaciji z lenalidomidom, pomalidomidom, talidomidom, bortezomibom in deksametazonom ni pokazala klinično pomembnih interakcij med daratumumabom in navedenimi učinkovinami iz skupine malih molekul.
English: Additionally, for patients with a history of chronic obstructive pulmonary disease, the use of post-infusion medications including short and long acting bronchodilators, and inhaled corticosteroids should be considered.
Slovenian: Pri bolnikih z anamnezo kronične obstruktivne pljučne bolezni je treba razmisliti tudi o uporabi dodatnih zdravil po infuziji, med drugim kratko in dolgo delujočih bronhodilatatorjev in inhalacijskih kortikosteroidov.
English: Eighteen percent (18%) of patients were refractory to a PI only, and 21% were refractory to bortezomib.
Slovenian: Osemnajst odstotkov (18%) bolnikov je bilo neodzivnih samo na zaviralec proteasoma, 21% pa jih je bilo neodzivnih na bortezomib.
English: The rates of engraftment and haematopoietic reconstitution was similar among the transplanted subjects in the D-VTd and VTd arms (D-VTd: 99.8%; VTd: 99.6%; as measured by the recovery of neutrophils > 0.5 x 10
Slovenian: Stopnji vsaditve in hematopoetske rekonstitucije po presaditvi sta bili podobni pri bolnikih v skupinah D-VTd in VTd (v skupini D-VTd: 99,8%; v skupini VTd: 99,6% glede na izmerjeno obnovitev števila nevtrofilcev na > 0,5 x 10
English: Discard any unused portion left in the vial.
Slovenian: Neporabljen preostanek zdravila v viali zavrzite.
English: All patients were ≤ 65 years: 43% were in the age group ≥ 60-65 years, 41% were in the age group ≥ 50-60 years and 16% below age of 50 years.
Slovenian: Vsi bolniki so bili stari ≤ 65 let: 43% jih je bilo v starostni skupini ≥ 60-65 let, 41% jih je bilo v starostni skupini ≥ 50-60 let, 16% bolnikov pa je bilo starih manj kot 50 let.
English: Thalidomide was administered orally at 100 mg daily during the six bortezomib cycles.
Slovenian: Talidomid so prejemali peroralno v odmerku 100 mg enkrat na dan v šestih krogih z bortezomibom.
English: Other common symptoms (affecting up to 1 in 10 people) are:
Slovenian: Drugi pogosti simptomi (pojavijo se pri največ 1 od 10 bolnikov) so:
English: • dizziness or lightheadedness (hypotension)
Slovenian: • omotičnost ali občutek slabosti pred omedlevico (hipotenzija)
English: Patients had IgG/IgA/Light chain myeloma in 64%/22%/10% of instances, 19% had ISS Stage I, 42% had ISS Stage II, 38% had ISS Stage III disease and 84% had standard risk cytogenetics.
Slovenian: Bolniki so imeli plazmocitom z IgG/IgA/lahkimi verigami v 64%/22%/10% primerov, po mednarodnem sistemu razvrščanja v stadije bolezni (ISS) jih je imelo 19% stadij I, 42% stadij II in 38% stadij III, 84% pa je imelo prisotne standardne neugodne citogenetske spremembe.
English: In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Slovenian: Poleg tega je daratumumab vplival tudi na encimsko aktivnost proteina CD38, in sicer je zaviral ciklazno encimsko aktivnost in stimuliral hidrolazno aktivnost.
English: Adverse reaction Frequency Incidence (%) Any Grade Grade 3-4
Slovenian: Pojavnost (%) vse stopnje stopnja
English: 1 vial, 400 mg/20 mL
Slovenian: 1 viala, 400 mg/20 ml
English: • medicines for inflammation (corticosteroids)
Slovenian: • zdravila proti vnetju (kortikosteroide),
English: Combination treatment with bortezomib:
Slovenian: Kombinirano zdravljenje z bortezomibom:
English: From a microbiological point of view, unless the method of opening/ dilution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če metoda odpiranja oziroma redčenja izključuje tveganje za kontaminacijo z mikrobi.
English: This is equivalent to 1.86% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 1,86% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: • bronchitis
Slovenian: • bronhitis
English: Before and after each infusion of DARZALEX, you will be given medicines which help to lower the chance of infusion-related reactions (see “Medicines given during treatment with DARZALEX” in section 3).
Slovenian: Pred vsako infuzijo zdravila DARZALEX in po njej boste prejeli zdravila, ki lahko zmanjšajo možnost infuzijske reakcije (glejte odstavek “Zdravila, ki jih boste prejemali med zdravljenjem z zdravilom DARZALEX” v poglavju 3).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov proizvajalca odgovornega za sproščanje serij
English: Prior therapies included bortezomib (99%), lenalidomide (99%), pomalidomide (63%) and carfilzomib (50%).
Slovenian: Predhodno zdravljenje je vključevalo bortezomib (99%), lenalidomid (99%), pomalidomid (63%) in karfilzomib (50%).
English: Melphalan at 9 mg/m2, and prednisone at 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9).
Slovenian: Melfalan v odmerku 9 mg/m2 in prednizon v odmerku 60 mg/m2 so bolniki prejemali peroralno na 1. do 4. dan devetih 6-tedenskih krogov zdravljenja (1.-9. krog).
English: Pre-infusion medications should be administered to reduce the risk of IRRs to all patients 1-3 hours prior to every infusion of DARZALEX as follows:
Slovenian: Za zmanjševanje tveganja za infuzijske reakcije je treba vsem bolnikom 1-3 ure pred vsako infuzijo zdravila DARZALEX aplicirati:
English: Changes in hepatic function are unlikely to have any effect on the elimination of daratumumab since IgG1 molecules such as daratumumab are not metabolised through hepatic pathways.
Slovenian: Po vsej verjetnosti razlike v delovanju jeter ne vplivajo na izločanje daratumumaba, saj se molekule IgG1, kot je daratumumab, ne presnavljajo s procesi v jetrih.
English: A dilution volume of 500 mL for the 16 mg/kg dose should be used only if there were no IRRs the previous week.
Slovenian: Zdravilo je mogoče uporabiti z volumnom razredčitve 500 ml za odmerek 16 mg/kg samo v primeru, da v prvem tednu pri bolniku ni prišlo do infuzijske reakcije.
English: • Do not store any unused portion of the infusion solution for reuse.
Slovenian: • Neporabljeni preostanek infuzijske raztopine morate zavreči.
English: Figure 2:
Slovenian: Preglednica 3:
English: Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56
Slovenian: Pri zdravljenju z daratumumabom so opažali zmanjšanje tako absolutnega števila kot odstotkov vseh celic NK (CD16+CD56+) in aktiviranih celic NK (CD16+CD56
English: To facilitate administration, the first prescribed 16 mg/kg dose at Week 1 may be split over two consecutive days i.e. 8 mg/kg on Day 1 and Day 2 respectively, see Table 5 below.
Slovenian: Za lažje odmerjanje se lahko prvi predpisani odmerek 16 mg/kg v 1. tednu razdeli na dva zaporedna dneva, 8 mg/kg na prvi dan in 8 mg/kg na drugi dan zdravljenja, glejte spodaj preglednico 5.
English: At baseline, 27% of patients were refractory to the last line of treatment.
Slovenian: Ob izhodišču je bilo 27% bolnikov neodzivnih na zadnjo linijo zdravljenja.
English: A total of 706 patients were randomised: 350 to the D-VMP arm and 356 to the VMP arm.
Slovenian: Skupno so randomizirali 706 bolnikov: 350 v skupino D-VMP in 356 v skupino VMP.
English: This is equivalent to 0.46% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 0,46% priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Schedule
Slovenian: Razpored
English: In clinical trials (monotherapy and combination treatments; N=2066) the incidence of any grade infusion-related reactions was 37% with the first (16 mg/kg, Week 1) infusion of DARZALEX, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions.
Slovenian: V kliničnih študijah (monoterapije in kombiniranega zdravljenja; N=2066) je bila pojavnost infuzijskih reakcij katere koli stopnje ob prvi infuziji zdravila DARZALEX (16 mg/kg, 1. teden) 37%, pri infuziji v 2. tednu 2%, in pri nadaljnjih infuzijah kumulativno 6%.
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.
Slovenian: Kadar obstaja sum vpliva daratumumaba je treba pri bolnikih z dolgotrajnim zelo dobrim delnim odzivom, razmisliti o uporabi validiranih analiz imunofiksacije, specifičnih za daratumumab, da bi lahko razlikovali daratumumab od katerega koli drugega endogenega M-proteina v bolnikovem serumu in s tem omogočili določanje popolnega odziva
English: DARZALEX is supplied as a carton pack containing 1 glass vial.
Slovenian: Zdravilo DARZALEX je pakirano v škatli, v kateri je 1 steklena viala.
English: The Guide for HCP and Blood Banks shall contain the following key elements:
Slovenian: Vodnik za za zdravstvene delavce in krvno banko mora vsebovati naslednje ključne elemente:
English: The incidence of any grade infusion-related reactions was 42%, with 36% of patients experiencing infusion-related reactions on Day 1 of Week 1, 4% on Day 2 of Week 1, and 8% with subsequent infusions.
Slovenian: Pojavnost infuzijskih reakcij katere koli stopnje je bila 42%, pri čemer je na 1. dan 1. tedna prišlo do infuzijske reakcije pri 36% bolnikov, na 2. dan 1. tedna pri 4% bolnikov, pri nadaljnjih infuzijah pa pri 8% bolnikov.
English: A total of 1085 patients were randomized: 543 to the D-VTd arm and 542 to the VTd arm.
Slovenian: Skupno so randomizirali 1085 bolnikov: 543 v skupino D-VTd in 542 v skupino VTd.
English: Driving and using machines You may feel tired after taking DARZALEX which may affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Med zdravljenjem z zdravilom DARZALEX boste morda utrujeni, kar lahko vpliva na vašo sposobnost za vožnjo in upravljanje strojev.
English: If not used immediately, in-use storage times and conditions are the responsibility of the user and should be no more than 24 hours at refrigerated conditions (2°C-8°C) protected from light, followed by 15 hours (including infusion time) at room temperature (15°C-25°C) and room light.
Slovenian: Če uporabnik zdravila ne uporabi takoj, je za čas in pogoje shranjevanja pripravljenega zdravila odgovoren sam. Čas shranjevanja v hladilniku (2°C-8°C) in zaščiteno pred svetlobo ne sme presegati 24 ur, zatem pa sme biti zdravilo 15 ur (vključno s časom infundiranja) pri sobni temperaturi (15°C-25°C) in sobni osvetlitvi.
English: Eighty percent of patients had received prior autologous stem cell transplantation (ASCT).
Slovenian: Osemdesetim odstotkom bolnikov so predhodno opravili avtologno presaditev krvotvornih matičnih celic.
English: Prophylaxis for herpes zoster virus reactivation Anti-viral prophylaxis should be considered for the prevention of herpes zoster virus reactivation.
Slovenian: Za preprečevanje reaktivacije virusa herpes zoster je treba razmisliti o profilaktični uporabi protivirusnih zdravil.
English: Terminal half-life increases with increasing dose and with repeated dosing.
Slovenian: Končni razpolovni čas izločanja se podaljšuje z velikostjo odmerka in s ponavljanjem odmerjanja.
English: The HCPs and Blood Banks educational materials, shall contain the following key elements:
Slovenian: Izobraževalna gradiva za zdravstvene delavce in krvno banko, ki vsebujejo naslednje ključne elemente:
English: For information concerning medicinal products given in combination with DARZALEX, see corresponding Summary of Product Characteristics.
Slovenian: Za podatke o zdravilih, ki jih bolnik prejema v kombinaciji z zdravilom DARZALEX, glejte ustrezen Povzetek glavnih značilnosti zdravila.
English: Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%).
Slovenian: Predhodno zdravljenje je vključevalo bortezomib (100%), lenalidomid (95%), pomalidomid (36%) in karfilzomib (19%).