natgillin/translations-raw huggingface dataset:
In Study GEN501, 42 patients with relapsed and refractory multiple myeloma received 16 mg/kg DARZALEX until disease progression.
V študiji GEN501 je 42 bolnikov s ponovljenim in neodzivnim diseminiranim plazmocitomom prejemalo zdravilo DARZALEX v odmerku 16 mg/kg do napredovanja bolezni.
Additionally the use of post-infusion medications (e.g. inhaled corticosteroids, short and long acting bronchodilators) should be considered for patients with a history of chronic obstructive pulmonary disease to manage respiratory complications should they occur (see section 4.2).
Pri bolnikih z anamnezo kronične obstruktivne pljučne bolezni je treba razmisliti o uporabi dodatnih zdravil za odmerjanje po infuziji (na primer inhalacijskih kortikosteroidov ter kratko in dolgo delujočih bronhodilatatorjev) za obvladovanje morebitnih respiratornih zapletov (glejte poglavje 4.2).
Symptoms predominantly included nasal congestion, cough, throat irritation, chills, vomiting and nausea.
Simptomi so večinoma vključevali kongestijo nosne sluznice, kašelj, draženje žrela, mrazenje, bruhanje in navzeo.
For IRRs of any grade/severity, immediately interrupt the DARZALEX infusion and manage symptoms.
V primeru infuzijske reakcije katerekoli stopnje ali izraženosti je treba infundiranje zdravila DARZALEX takoj prekiniti in ukrepati glede na simptome.
20 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 400 mg of daratumumab.
20 ml koncentrata v stekleni viali iz stekla tipa 1 z elastomernim zamaškom in aluminijasto zaporko s snemljivim pokrovčkom; 20 ml koncentrata vsebuje 400 mg daratumumaba.
Daratumumab interference mitigation methods include treating reagent RBCs with dithiothreitol (DTT) to disrupt daratumumab binding or other locally validated methods.
Med metode, s katerimi je mogoče zmanjšati vpliv daratumumaba, sodijo obdelava reagentnih eritrocitov z ditiotretiolom (DTT) (kar onemogoči vezavo daratumumaba), ali druge lokalno validirane metode.
DARZALEX 20 mg/mL concentrate for solution for infusion daratumumab
DARZALEX 20 mg/ml koncentrat za raztopino za infundiranje daratumumab
st infusion), and the mean (SD) ratio of Cmax at steady-state to Cmax after the first dose was 1.6 (0.5).
Povprečna vrednost razmerja med Cmax v stanju dinamičnega ravnovesja in Cmax po prvem odmerku je 1,6 (s standardnim odklonom 0,5).
Dose delay may be required to allow recovery of blood cell counts in the event of haematological toxicity (see section 4.4).
V primeru hematološke toksičnosti bo morda potrebno odmerjanje odložiti, da se krvna slika lahko izboljša (glejte poglavje 4.4).
5 mL concentrate in a Type 1 glass vial with an elastomeric closure and an aluminium seal with a flip-off button containing 100 mg of daratumumab.
5 ml koncentrata v stekleni viali iz stekla tipa 1 z elastomernim zamaškom in aluminijasto zaporko s snemljivim pokrovčkom; 5 ml koncentrata vsebuje 100 mg daratumumaba.
• in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
• v kombinaciji z lenalidomidom in deksametazonom ali bortezomibom in deksametazonom za zdravljenje odraslih bolnikov z diseminiranim plazmocitomom, ki so predhodno prejemali vsaj eno zdravljenje.
In this subgroup, median PFS was not reached in the DVMP group and was 17.9 months in the VMP group (HR=0.56; 95% CI: 0.42, 0.75); p<0.0001).
V tej podskupini bolnikov mediana PFS ni bila dosežena v skupini D-VMP, v skupini VMP pa je bila 17,9 meseca (razmerje ogroženosti=0,56; 95-odstotni IZ: 0,42, 0,75); p<0,0001).
To reduce the risk of delayed IRRs, oral corticosteroids should be administered to all patients following DARZALEX infusions.
Za zmanjševanje tveganja za pozne infuzijske reakcije je treba vsem bolnikom po infuziji zdravila DARZALEX dati peroralni kortikosteroid.
• sore throat, cough
• vnetje žrela ali grla, kašelj
Median OS was not reached for either treatment group.
Mediana trajanja celokupnega preživetja ni bila dosežena v nobeni od študijskih skupin.
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.
Večina bolnikov je bila moškega spola (59%), 48% bolnikov je imelo oceno ECOG 0, 42% jih je imelo oceno ECOG 1 in 10% jih je imelo oceno ECOG 2.
500 mL 50 mL/hour 50 mL/hour every hour
50 ml/uro vsako uro za 50 ml/uro
However, baseline levels of NK cells did not show an association with clinical response.
) v periferni krvi in kostnem mozgu, vendar ni kazalo, da bi bilo izhodiščno število celic NK povezano s kliničnim odzivom.
The mean (standard deviation [SD]) estimated terminal half-life of daratumumab following the first 16 mg/kg dose was 9 (4.3) days.
Povprečna vrednost ocenjenega končnega razpolovnega časa daratumumaba po prvem odmerku 16 mg/kg je bila 9 dni (s standardnim odklonom 4,3 dneva).
No clinically important differences in exposure to daratumumab were observed between patients with renal impairment and those with normal renal function.
Izpostavljenost daratumumabu se ni klinično pomembno razlikovala med bolniki z okvaro ledvic in tistimi z normalno ledvično funkcijo.
Based on four individual population PK analyses (1-4) in patients receiving daratumumab monotherapy or various combination therapies (Analyses 1-4), age (range: 31-93 years) had no clinically important effect on the PK of daratumumab, and the exposure of daratumumab was similar between younger (aged <65 years, n=518) and older (aged ≥65 to <75 years n=761; aged ≥75 years, n=334) patients.
Po podatkih štirih ločenih analiz populacijske farmakokinetike (1.-4. analize) pri bolnikih, ki so daratumumab prejemali v monoterapiji ali v različnih kombinacijah z drugimi zdravili (1.-4. analiza), starost (v okviru od 31 do 93 let) nima klinično pomembnega vpliva na farmakokinetiko daratumumaba, saj je bila izpostavljenost daratumumabu pri mlajših bolnikih (starih manj kot 65 let, n = 518) podobna kot pri starejših bolnikih (starih ≥65 do <75 let, n=761; oziroma starih ≥75 let, n=334).
Dose adjustments for bortezomib, thalidomide and dexamethasone were applied according to manufacturer's prescribing information.
Pri prilagajanju odmerkov bortezomiba, talidomida in deksametazona so upoštevali proizvajalčeve informacije za predpisovanje zdravila.
Four population PK analyses were performed to describe the PK characteristics of daratumumab and to evaluate the influence of covariates on the disposition of daratumumab in patients with multiple myeloma; Analysis 1 (n=223) in patients receiving DARZALEX monotherapy while Analysis 2 (n=694), Analysis 3 (n=352) and Analysis 4 (n=355) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Za opis farmakokinetičnih lastnosti daratumumaba in oceno vpliva sospremenljivk na razporejanje daratumumaba pri bolnikih z diseminiranim plazmocitomom so izvedli štiri analize populacijske farmakokinetike: 1. analizo (n=223) pri bolnikih, ki so prejemali zdravilo DARZALEX v monoterapiji, in 2. analizo (n=694), 3. analizo (n=352) in 4. analizo (n=355), ki so jih izvedli pri bolnikih z diseminiranim plazmocitomom, ki so prejemali daratumumab v kombinaciji z drugimi zdravili.
Consider consulting a hepatitis disease expert as clinically indicated.
Če je klinično indicirano se priporoča posvet s specialistom za zdravljenje hepatitisa B.
Following dilution the DARZALEX infusion should be intravenously administered at the initial infusion rate presented in Table 5 below.
Po redčenju zdravila DARZALEX je treba intravensko apliciranje začeti s hitrostjo infundiranja, ki je navedena v preglednici 5.
• Using aseptic technique, remove a volume of 0.9% Sodium Chloride from the infusion bag/container that is equal to the required volume of DARZALEX solution.
• V aseptičnih pogojih iz infuzijske vrečke/vsebnika odstranite volumen 0,9-odstotne raztopine natrijevega klorida, ki ustreza izračunanemu volumnu DARZALEX koncentrata za raztopino za infundiranje.
17.4 (17.4, NE)
NMO (NMO, NMO) 17,4 (17,4, NMO)
Neutropenia/Thrombocytopenia
Nevtropenija/trombocitopenija
Post-infusion medications should be administered to reduce the risk of delayed infusion-related reactions as follows:
Za zmanjševanje tveganja za pozne infuzijske reakcije je treba bolnikom po infuziji aplicirati naslednja zdravila:
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
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).
Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
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).
Doses up to 24 mg/kg have been administered intravenously in a clinical study.
V klinični študiji so bolnikom intravensko aplicirali odmerke do 24 mg/kg.
• Gently invert the bag/container to mix the solution.
• Raztopino v vrečki/vsebniku premešajte z nežnim obračanjem.
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
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).
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.
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.
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.
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.
• 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.
• 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.
Tell your doctor right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes.
Če se vam poslabša utrujenost, vam porumeni koža ali očesne beločnice, morate takoj obvestiti zdravnika.
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.
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.
DARZALEX contains sodium
Zdravilo DARZALEX vsebuje natrij
* No Grade 4
Stopnja odsotne MRD
Table 1: DARZALEX dosing schedule in combination with lenalidomide (4-week cycle dosing regimen) and monotherapy
Preglednica 1: Razpored odmerjanja zdravila DARZALEX v kombinaciji z lenalidomidom (režim odmerjanja s 4-tedenskim krogom) in v monoterapiji
Based on the four population PK analyses (Analyses 1-4) body weight was identified as a statistically significant covariate for daratumumab clearance.
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.
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).
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.
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.
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.
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.
Z daratumumabom povzročena citoliza zmanjša število podskupin mieloičnih supresorskih celic (CD38+MDSC), regulatornih limfocitov T (CD38+Treg) in limfocitov B (CD38+Breg).
500 mL 100 mL/hour 50 mL/hour every hour
100 ml/uro vsako uro za 50 ml/uro
Severe reactions have occurred, including bronchospasm, hypoxia, dyspnoea, hypertension, laryngeal oedema and pulmonary oedema.
Pojavile so se hude reakcije, vključno z bronhospazmom, hipoksijo, dispnejo, hipertenzijo, laringealnim edemom in pljučnim edemom.
The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Mediana starost bolnikov je bila 64 let (od 44 do 76 let), 64% bolnikov je bilo moškega spola in 76% je bilo belcev.
Injury, poisoning and procedural complications
Poškodbe in zastrupitve in zapleti pri posegih infuzijska reakcija zelo pogosti
Do not use DARZALEX if the above applies to you.
Če navedeno velja za vas, ne uporabljajte zdravila DARZALEX.
The median patient age was 64 years (range 30 to 88 years) and 12% were ≥75 years.
Mediana starost bolnikov je bila 64 let (od 30 do 88 let), 12% bolnikov je bilo starih ≥75 let.
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(%)
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)
Efficacy was evaluated by PFS based on IMWG criteria.
Učinkovitost so vrednotili s trajanjem preživetja brez napredovanja bolezni po kriterijih IMWG.
Severe infusion-related reactions included bronchospasm, dyspnoea, laryngeal oedema, pulmonary oedema, hypoxia, and hypertension.
Hude infuzijske reakcije so vključevale bronhospazem, dispnejo, laringealni edem, pljučni edem, hipoksijo in hipertenzijo.
Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Daratumumab je humano monoklonsko protitelo vrste IgG1κ, ki je usmerjeno proti antigenu CD 38.
Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6.
V 5. in 6. krogu so deksametazon prejeli v odmerku 20 mg na 1., 2., 8., 9., 15. in 16. dan.
9/L, and platelets > 50 x 10 9/L without transfusion).
9/l brez transfuzije).
Infusion rate/dilution volume used upon re-initiation was that used for the last DARZALEX infusion prior to interruption due to ASCT.
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.
The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Mediana starost bolnikov je bila 71 let (od 40 do 93 let), pri čemer je bilo 30% bolnikov starih ≥75 let.
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.
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.
DARZALEX is indicated:
Zdravilo DARZALEX je indicirano
• 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.
• 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.
All patients should be monitored throughout the infusion for IRRs.
Med infundiranjem je treba vse bolnike spremljati glede pojava infuzujskih reakcij.
Following the second infusion, the dose of corticosteroid may be reduced (oral or intravenous methylprednisolone 60 mg).
100 mg metilprednizolona ali drugega enakovrednega zdravila z intravenskim odmerjanjem; po drugi infuziji se lahko odmerek kortikosteroida zmanjša (60 mg metilprednizolona peroralno ali intravensko).
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).
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).
Combination treatment with bortezomib, melphalan and prednisone (VMP) in patients ineligible for autologous stem cell transplant:
Kombinirano zdravljenje z bortezomibom, melfalanom in prednizonom (VMP) pri bolnikih, ki niso primerni za avtologno presaditev matičnih celic:
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):
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:
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.
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.
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.
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)
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).
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).
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.
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.
DARZALEX is a concentrate for solution for infusion and is a colourless to yellow liquid.
Izgled zdravila DARZALEX in vsebina pakiranja Zdravilo DARZALEX je koncentrat za raztopino za infundiranje in je brezbarvna do rumena tekočina.
Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Resni neželeni učinki so bili pljučnica, bronhitis, okužba zgornjih dihal, pljučni edem, gripa, zvišana telesna temperatura, dehidracija, driska in atrijska fibrilacija.
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).
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).
Manufacturer Janssen Biologics B.V. Einsteinweg 101
Proizvajalec Janssen Biologics B.V.
DARZALEX can affect the results of this blood test. Tell the person doing the test that you are using DARZALEX.
Osebi, ki izvaja ta test, morate povedati, da prejemate zdravilo DARZALEX.
Pre-infusion medication
Premedikacija pred infuzijo
every three weeks (total of 16 doses)
7. do 54. teden vsak tretji teden (skupno 16 odmerkov)