natgillin/translations-raw huggingface dataset:
For Bortezomib Accord dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Za prilagodbe doziranja lijeka Bortezomib Accord potrebno je slijediti smjernice za promjenu doze opisane za monoterapiju.
Hypotension*, Orthostatic hypotension, Hypertension*
Hipotenzija*, ortostatska hipotenzija, hipertenzija *
BzR-CAP=Bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
BzR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin i prednizon; R-CHOP= rituksimab, ciklofosfamid, doksorubicin, vinkristin i prednizon; PN=periferna neuropatija Periferna neuropatija uključila je preporučene izraze: periferna senzorna neuropatija, periferna neuropatija, periferna motorna neuropatija i periferna senzorno-motorna neuropatija
** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
** Instrumentalni ADL: odnosi se na pripremu obroka, kupnju namirnica ili odjeće, korištenje telefona, rukovanje novcem,
Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
volumen distribucije u stanju dinamičke ravnoteže bio je 834 (39%) l/m2, i poluvijek eliminacije bio je 100 (44%) sati.
Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BzR-CAP)
Kombinirano liječenje s rituksimabom, ciklofosfamidom, doksorubicinom i prednizonom (BzR-CAP)
• advice on method of administration for both intravenous and subcutaneous use, including the need to rotate injection sites for subcutaneous use
• savjeti vezani uz put /način primjene za oba puta primjene, intravenski i supkutani, uključujući potrebu promjene mjesta injiciranja kod supkutanog puta primjene.
Week Bz (1.3 mg/m
Tjedan Bz (1,3 mg/m2)
Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*,C-reactive protein increased
Manje često Hiperbilirubinemija*, abnormalan nalaz proteina*, povećana težina, abnormalan krvni nalaz*, povišen C-reaktivni protein
Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions.
U rijetkim je slučajevima zabilježeno zatajenje jetre u bolesnika s ozbiljnim podležećim zdravstvenim stanjem koji su istodobno primali bortezomib i konkomitantne lijekove.
Patients in the BzR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 intravenous on day 1; cyclophosphamide 750 mg/m2 intravenous on day 1; doxorubicin 50 mg/m2 intravenous on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5
Bolesnici u skupini liječenoj sBzR-CAP primili su bortezomib (1,3 mg/m2; 1., 4., 8., 11. dan, dani perioda odmora 12-21), rituksimab 375 mg/m2 intravenski 1. dan; ciklofosfamid 750 mg/m2 intravenski 1. dan; doksorubicin 50 mg/m2 intravenski 1. dan i prednizon 100 mg/m2 peroralno 1. do 5. dan 21-dnevnog ciklusa liječenja bortezomibom.
3.5 mg/vial
3,5 mg/bočica
Hypertension*, Hypotension*, Orthostatic hypotension
Hipertenzija*, hipotenzija*, ortostatska hipotenzija
• storage precautions for reconstituted solution
• čuvanje i mjere opreza za rekonstituiranu otopinu
Pegylated liposomal doxorubicin is administered at 30 mg/m2 on day 4 of the Bortezomib Accord treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Accord injection.
Pegilirani liposomalni doksorubicin se primjenjuje u dozi od 30 mg/m2 na 4. dan ciklusa liječenja lijekom lijekom Bortezomib Accord, putem intravenske infuzije u trajanju od 1 sata, nakon primjene injekcije lijeka lijeka Bortezomib Accord.
The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the Bortezomib Accord containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Accord u usporedbi s ispitivanjem s povijesnom kontrolom u kojem je osnovni režim davan samostalno: u 1. bloku periferna senzorna neuropatija (3% naspram 0%); ileus (2,1% naspram 0%);
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Accord for information related to these medicines before starting treatment with Bortezomib Accord.
Za informacije o svim lijekovima koji se uzimaju zajedno s lijekom Bortezomib Accord, morate pročitati pripadajuću uputu o lijeku, prije započinjanja liječenja lijekom Bortezomib Accord.
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Klinička djelotvornost kod relapsa ili refraktornog multiplog mijeloma Sigurnost i djelotvornost primjene bortezomiba (primjenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1-3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
Table 1: Recommended* posology modifications for Bortezomib Accord -related neuropathy
Tablica 1: Preporučene* prilagodbe doziranja kod neuropatije povezane s lijekom lijekom Bortezomib Accord
What you need to know before you use Bortezomib Accord Do not use Bortezomib Accord
Što morate znati prije nego počnete primjenjivati Bortezomib Accord
Bortezomib Accord therapy should be withheld until symptoms of the toxicity have resolved to Grade 1 or baseline.
Liječenje lijekom Bortezomib Accord mora se prekinuti dok se simptomi toksičnosti ne povuku na 1. stupnja ili početnu težinu.
Therefore, you will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Stoga ćete prije i za vrijeme liječenja lijekom Bortezomib Accord morati ići na redovite kontrole krvi, kako bi se redovito provjerio broj krvnih stanica.
b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
ciklusa nadalje ako se podnosi doza od 100 mg. b Bolesnicima koji nakon 4 ciklusa postignu najmanje parcijalni odgovor, može se dati do 6 ciklusa
The other ingredient is mannitol (E421).
Pomoćna tvar je manitol (E421).
• If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib Accord dosing day (other than day 1)
Ako je broj trombocita ≤ 30 × 109/l ili apsolutni broj neutrofila (ABN) ≤ 0,75 × 109/l na dan primjene doze lijeka Bortezomib Accord (osim 1. dana)
Uncommon Cardiovascular disorder (inc cardiogenic shock) Vascular disorders Common
Manje često Kardiovaskularni poremećaj (uključujući kardiogeni šok)
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib Accord intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment.
Ukoliko se prethodno niste liječili od multiplog mijeloma i predviđeni ste za transplantaciju krvotvornih matičnih stanica, Bortezomib Accord ćete primiti intravenski ili supkutano, u kombinaciji s lijekovima deksametazonom, ili deksametazonom i talidomidom kao uvodno liječenje.
• different reconstitution requirements for intravenous or subcutaneous use
• različite zahtjeve za rekonstituciju za intravensku ili supkutanu primjenu lijeka
There were 140 patients with ALL or LL enrolled and evaluated for safety; median age was 10 years (range 1 to 26).
Ukupno je bilo uključeno i procijenjeno na sigurnost 140 bolesnika s ALL ili LL; medijan dobi bio je
The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Analiza je pokazala poboljšani ORR (CR+PR) (omjer izgleda 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (omjer hazarda 0,511; 95% CI 0,309-0,845;
Posology for patients with previously untreated mantle cell lymphoma (MCL)
Doziranje za bolesnike s prethodno neliječenim limfomom plaštenih stanica (MCL, od engl. mantle cell lymphoma)
In addition, when Bortezomib Accord is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Dodatno, kad se Bortezomib Accord primjenjuje u kombinaciji s ostalim kemoterapeuticima, u slučaju toksičnosti u obzir se moraju uzeti prikladne redukcije doza tih lijekova, u skladu s preporukama iz sažetka opisa svojstava lijeka.
Table 7:Adverse reactions in patients with Multiple Myeloma treated with Bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication
Tablica 7: Nuspojave u bolesnika s multiplim mijelomom liječenih bortezomibom u kliničkim ispitivanjima i nuspojave nakon stavljanja lijeka u promet neovisno o indikaciji
In addition, when bortezomib is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these medicinal products should be considered in the event of toxicities, according to the recommendations in the respective Summary of Product Characteristics.
Dodatno, kada se bortezomib daje u kombinaciji s drugim kemoterapeuticima, u slučaju toksičnosti u obzir se moraju uzeti prikladna smanjenja doza tih lijekova, sukladno preporukama u odgovarajućem sažetku opisa svojstava lijeka.
Oedema (inc peripheral), Chills, Injection site reaction*, Malaise*
Edem (uključujući periferni), zimica, reakcija na mjestu injekcije*, malaksalost*
Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
Kad se simptomi toksičnosti povuku, može se ponovno uvesti liječenje bortezomibom uz dozu smanjenu za 25% (1,3 mg/m2 smanjeno na 1,0 mg/m2; 1,0 mg/m2 smanjeno na
Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Neuropatije*, motorna neuropatija*, gubitak svijesti (uključujući sinkopu), encefalopatija*, periferna senzornomotorna neuropatija, omaglica*, disgeuzija*, autonomna neuropatija
ORR (CR+PR) p-valuea CR n (%) PR n (%) nCR n (%)
ORR (CR+PR) p-vrijednost CR n (%) PR n (%) nCR n (%)
Combination therapy with melphalan and prednisone
Kombinirano liječenje uz melfalan i prednizon
Progression free survival (IRC)a Events n (%)
Preživljenje bez progresije bolesti događaji n (%)
Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Nisu provedena ispitivanja utjecaja bortezomiba na plodnost (vidjeti dio 5.3).
Median duration Days (months) Time to response CR+PR (days)
CR+nCR+PR+M R Medijan trajanja dani (mjeseci) Vrijeme do odgovora CR+PR (dani)
M (9 mg/m P (60 mg/m2)
M (9 mg/m2) P (60 mg/m dan dan dan dan period odmora period odmora
Bortezomib Accord is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable.
Accord se primjenjuje u liječenju bolesnika s multiplim mijelomom (rak koštane srži) u bolesnika starijih od 18 godina: - samostalno ili zajedno sa lijekom pegiliranim liposomalnim doksorubicinom ili deksametazonom, u bolesnika kod kojih je došlo do pogoršanja bolesti (progresije) nakon posljednje terapije, te su prethodno prošli ili nisu predviđeni za transplantaciju krvotvornih matičnih stanica.
CR+nCR+PR % (95% CI)
CR+nCR CR+nCR+PR % (95% CI)
If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive Bortezomib Accord together with two other medicines; melphalan and prednisone.
Ukoliko se prethodno niste liječili od multiplog mijeloma i niste predviđeni za transplantaciju krvotvornih matičnih stanica, Bortezomib Accord ćete primiti u kombinaciji s druga dva lijeka;
You should not breast-feed while using Bortezomib Accord.
Ne smijete dojiti dok primate Bortezomib Accord.
If you are given Bortezomib Accord together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Ako Bortezomib Accord primate zajedno s drugim lijekovima za liječenje limfoma plaštenih stanica mogu
The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja lijekom Bortezomib Accord u trajanju od
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), postojala je viša incidencija (56,7% naspram 5,8%) trombocitopenije stupnja ≥ 3 u skupini liječenoj bortezomibom (BzR-CAP) u usporedbi sa skupinom koja nije liječena bortezomibom (rituksimab, ciklofosfamid, doksorubicin,
Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common
Vrlo često Periferna senzorna neuropatija, disestezija*, neuralgija*
• Increased heartbeat, high blood pressure, sweating,
• ubrzani otkucaji srca, visoki krvni tlak, znojenje, • poremećaj vida, zamagljen vid
tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
- kašalj i poteškoće s disanjem ili stezanje u prsnom košu.
Cochran Mantel-Haenszel test. b Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in BzDx group and 52/242 [21%] in VDDx group).
b Odnosi se na stope odgovora nakon druge transplantacije za ispitanike koji su prošl drugu transplantaciju (42/240 [18% ] u
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
(uključujući QT produljenje)*, abnormalan međunarodni normalizirani omjer (INR)*, snižen pH želuca, povećana agregacija trombocita, povišen troponin I, identifikacija virusa i serologija*, abnormalan nalaz urina*
This study included
Accord sadrži
By interfering with their function, bortezomib can kill cancer cells.
bortezomib može uništiti stanice raka.
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzTDx= bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by
CI= interval pouzdanosti; CR=kompletni odgovor; nCR=blizu kompletnog odgovora; ITT=populacija bolesnika uključenih u ispitivanje; RR=stopa odgovora; Bz=bortezomib; BzTDx=bortezomib, talidomid, deksametazon; TDx=talidomid, deksametazon; PR=parcijalni odgovor; OR=omjer izgleda; * Primarna mjera ishoda a OR za stope odgovora temeljeno na Mantel Haenszel procjeni zajedničkog omjera izlgleda za stratificirane tablice; p vrijednosti Cochran Mantel Haenszelovog testa.
If local injection site reactions occur following Bortezomib Accord subcutaneous injection, either a less concentrated Bortezomib Accord solution (Bortezomib Accord 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Ako se nakon supkutane injekcije lijeka Bortezomib Accord pojave reakcije na mjestu primjene, supkutano se može primijeniti otopina lijeka Bortezomib Accord manje koncentracije (Bortezomib Accord 3,5 mg pripremiti na 1 mg/ml umjesto na 2,5 mg/ml) ili se preporučuje prijeći na intravensku injekciju.
Intravenous administration:
Intravenska primjena:
Bortezomib treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Liječenje bortezomibom mora se prekinuti u slučaju nastupa bilo koje nehematološke toksičnosti ≥ stupnja 3 povezane s bortezomibom (isključujući neuropatiju) ili hematološke toksičnosti ≥ stupnja 3
Table 2: Recommended posology for Bortezomib Accord in combination with melphalan and prednisone
Tablica 2: Preporučeno doziranje lijekom lijeka Bortezomib Accord kada se primjenjuje u kombinaciji s melfalanom i prednizonom
Bz n=333a
Bz n=333
In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
U bolesnika s B-staničnom ALL s relapsom unutar 18 mjeseci od dijagnoze (n = 27) stopa kompletnog odgovora bila je 67% (95% CI: 46, 84); stopa četveromjesečnog preživljenja bez događaja bila je 44% (95% CI:
Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Fibrilacija srca (uključujući atrijsku), aritmija*, srčano zatajenje (uključujući lijevo i desno ventrikularno)*, ishemija miokarda,
Table 4: Posology for Bortezomib Accord combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Tablica 4: Doziranje za kombinirano liječenje lijekom Bortezomib Accord za bolesnike s prethodno neliječenim multiplim mijelomom za koje je transplantacija hematopoetskih matičnih stanica prikladna
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzDx= bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
CI= interval pouzdanosti; CR=kompletni odgovor; nCR=blizu kompletnog odgovora; ITT=Populacija bolesnika s namjerom liječenja; RR=stopa odgovora; Bz=bortezomib; BzDx=bortezomib, deksametazon; VDDx=vinkristin, doksorubicin, deksametazon; VGPR=vrlo dobar parcijalni odgovor; PR=parcijalni odgovor; OR=omjer izgleda.
Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Mišićni spazmi*, mišićno-koštana bol*, bol u ekstremitetima
*RR (Post-induction)
*RR (Postindukcijska)
When Bortezomib Accord is given alone, you will receive 4 doses of Bortezomib Accord intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a 10-day ‘rest period' without treatment.
Kada se Bortezomib Accord daje sam (kao monoterapija), primit ćete 4 doze lijeka Bortezomib Accord intravenski ilisupkutano 1., 4., 8. i 11. dana, nakon čega slijedi 10-dnevni ‘period odmora' bez primjene lijeka.
Events n (%) Mediana
Događaji n (%)
Bortezomib Accord as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation.
Accord je indiciran kao monoterapija ili u kombinaciji s pegiliranim liposomalnim doksorubicinom ili deksametazonom za liječenje odraslih bolesnika s progresivnim multiplim mijelomom koji su prethodno primili najmanje jednu liniju terapije, i već su prošli transplantaciju hematopoetskih matičnih stanica ili ona za njih nije bila prikladna.
Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#
Manje često Pancitopenija*, febrilna neutropenija, koagulopatija*, leukocitoza*, limfadenopatija, hemolitička anemija#
Bortezomib Accord is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Accord se primjenjuje intravenskom bolus injekcijom u trajanju od 3-5 sekundi kroz periferni ili centralni venski kateter, koji se potom mora isprati 0,9%-tnom (9 mg/ml) otopinom natrijevog klorida za injekciju.
Bortezomib treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Prilagodbe doze za vrijeme i kod ponovnog uvođenja monoterapije Liječenje bortezomibom mora se prekinuti po javljanju svake nehematološke toksičnosti 3. stupnja ili bilo kakve hematološke toksičnosti 4. stupnja, isključujući neuropatiju, kako je objašnjeno u daljnjem tekstu (vidjeti također dio 4.4).
a p-value is for the non-inferiority hypothesis that the subcutaneous arm retains at least 60% of the response rate in the intravenous arm. b 222 subjects were enrolled into the study; 221 subjects were treated with bortezomib c Hazards ratio estimate is based on a Cox model adjusted for stratification factors: ISS staging and number of prior lines.
b 222 ispitanika bilo je uključeno u ispitivanje; 221 ispitanik bio je liječen s bortezomibom c Procjena omjera hazarda temelji se na Coxovom modelu proporcionalnog rizika prilagođenom prema čimbenicima stratifikacije: ISS stupnjevanje i broj prethodnih linija.
a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
b p-vrijednost iz stratificiranog log-rank testa; analiza po liniji liječenja isključuje stratifikaciju po prethodnim liječenjima; p < 0,0001
Combination therapy with dexamethasone and thalidomide
Kombinirano liječenje uz deksametazon i talidomid
administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
17-dnevni period odmora od 12. do 28. dana), deksametazon (40 mg primijenjeno peroralno 1. do 4. i 8. do 11. dan), i talidomid (primijenjen peroralno 50 mg na dan 1.-14. dan, doza povišena na 100 mg 15.-28. dana a nakon toga na 200 mg na dan).
- in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment).
- zajedno s lijekom deksametazonom ili deksametazonom zajedno s talidomidom za bolesnike koji prethodno nisu bili liječeni, te prije nego što prime liječenje visokim dozama kemoterapije u kombinaciji s transplantacijom matičnih krvotvornih stanica (uvodno liječenje).