FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial
Croatian: Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s BzmbR-CAP u kliničkom ispitivanju
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Croatian: Za nuspojave u Tablici 7 ispitivači su smatrali da postoji barem mogućnost ili vjerojatnost uzročnoposljedične povezanosti s bortezomibom.
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Croatian: Omjer hazardab (95 % CI) p-vrijednostc a Kaplan-Meierova analiza.
English: A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Croatian: Preporučuje se napraviti rendgenogram pluća prije liječenja, da posluži kao početni nalaz u slučaju mogućih plućnih promjena nakon liječenja.
English: There have been isolated cases of QT-interval prolongation in clinical studies, causality has not been established.
Croatian: U kliničkim ispitivanjima prijavljeni su izolirani slučajevi produljenja QT intervala, ali uzročno posljedična povezanost nije ustanovljena.
English: Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Croatian: Progresivna multifokalna leukoencefalopatija (PML) Vrlo rijetko su bili zabilježeni slučajevi John Cunningham (JC) virusne infekcije nepoznate uzročnosti, koji su rezultirali progresivnom multifokalnom leukoencefalopatijom (PML) i smrću kod bolesnika liječenih bortezomibom.
English: Patients on oral antidiabetic agents receiving bortezomib treatment may require close monitoring of their blood glucose levels and adjustment of the dose of their antidiabetics.
Croatian: U bolesnika na terapiji oralnim antidijabeticima koji se liječe bortezomibom može biti potrebno pomno praćenje razine glukoze u krvi i prilagodba doze antidijabetika.
English: Uncommon Fall, Contusion Rare
Croatian: Manje često Pad, kontuzija Rijetko
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzmbR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzmbR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Croatian: Dvije liječene skupine imale su sličnu ukupnu incidenciju događaja krvarenja svih stupnjeva (6,3 % u BzmbR-CAP skupini i 5,0 % u R-CHOP skupini), kao i stupnja 3 i višeg za događaje krvarenja (BzmbR-CAP: 4 bolesnika [1,7 %]; R-CHOP: 3 bolesnika [1,2 %]).
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Croatian: Ove nuspojave temelje se na integriranom setu podataka od 5476 bolesnika od kojih je 3996 bilo liječeno bortezomibom u dozi 1,3 mg/m2 te je uvršteno u Tablicu
English: In myeloma, bortezomib affects the ability of myeloma cells to interact with the bone marrow microenvironment.
Croatian: Kod mijeloma, bortezomib utječe na sposobnost interakcije stanica mijeloma s mikrookolišem koštane srži.
English: Therefore, the concomitant use of bortezomib with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's Wort) is not recommended, as efficacy may be reduced.
Croatian: Stoga se ne preporučuje istodobna primjena bortezomiba i jakih induktora enzima CYP3A4 (npr. rifampicina, karbamazepina, fenitoina, fenobarbitala i Gospine trave), jer djelotvornost može biti smanjena.
English: Bortezomib is metabolised by liver enzymes.
Croatian: Bortezomib metaboliziraju enzimi jetre.
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Croatian: Deksametazon je bio primijenjen u kombinaciji s bortezomibom u 83 bolesnika u 1. ciklusu te u dodatnih 11 bolesnika koji su deksametazon primili tijekom ponovnog liječenja bortezomibom.
English: ORe (95% CI)=1.428 p-valueg=0.275
Croatian: ORe (95 % CI)=1,428 p-vrijednostg=0,275
English: Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Croatian: Autonomna neuropatija može biti povezana s bortezomibom ili bortezomib može pogoršati postojeće stanje kao što su dijabetička neuropatija ili neuropatija kod amiloidoze.
English: In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy.
Croatian: U ispitivanju faze III, liječenje bortezomibom značajno je produljilo vrijeme do progresije bolesti i dovelo do značajno produljenog preživljenja te značajno veće stope odgovora u usporedbi s liječenjem deksametazonom (vidjeti Tablicu 14) u svih bolesnika, kao i u bolesnika koji su prethodno primili 1 liniju terapije.
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Croatian: Bolesnici koji su razvili ortostatsku hipotenziju za vrijeme liječenja bortezomibom (injiciran intravenski) nisu imali znakove ortostatske hipotenzije prije liječenja bortezomibom.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Croatian: Medijan dobi bolesnika u ispitivanju bio je 57 godina, 55 % bili su muškarci i 48 % bolesnika imalo je citogenetiku visokog rizika.
English: In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Croatian: ≥ 75 godina oba su režima, BzmbR-CAP i R-CHOP, podnosili lošije (vidjeti dio 4.8).
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors.
Croatian: Bolesnike treba pomno pratiti kada primaju bortezomib u kombinaciji s jakim inhibitorima enzima CYP3A4.
English: The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Croatian: Medijan TTP-a bio je 6,5 mjeseci za bolesnike na monoterapiji bortezomibom u usporedbi s 9,3 mjeseci za bolesnike na kombiniranoj terapiji bortezomibom plus pegilirani liposomalni doksorubicin.
English: Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy.
Croatian: Temljem predstavljenih podataka, stajalište je PRAC-a da je informacije o lijeku potrebno izmijeniti kako bi se ažurirali dio 4.8 sažetka opisa svojstava lijeka i relevantni dijelovi upute o lijeku kako bi se uvrstilo sljedeće: halacion, blefaritis i trombotička mikroangiopatija.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration (see section 4.2).
Croatian: Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih zakašnjelih primjena ciklusa (vidjeti dio 4.2).
English: Animal studies to determine the effects of bortezomib on parturition and post-natal development were not conducted (see section 5.3).
Croatian: Nisu provedena ispitivanja na životinjama koja bi utvrdila učinak bortezomiba na porod i postnatalni razvoj (vidjeti dio 5.3).
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib 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%).
Croatian: (stupnja ≥ 3) zabilježene su u većoj incidenciji kod režima liječenja koji sadrži bortezomib 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%); hipoksija (8% naspram 2%).
English: Special care is required when treating patients with any risk factors for seizures.
Croatian: Poseban nadzor je potreban u liječenju bolesnika s nekim od čimbenika rizika za nastanak epileptičkih napadaja.
English: A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib.
Croatian: Ukupno je 74 bolesnika koje se moglo procijeniti, primilo deksametazon u kombinaciji s bortezomibom.
English: Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with bortezomib, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Croatian: Reaktivacija virusa hepatitisa B (HBV) i infekcija Kada se rituksimab koristi u kombinaciji s bortezomibom u bolesnika koji imaju rizik od infekcije s HBVom, prije početka liječenja uvijek se mora provoditi probir na HBV.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Croatian: Tablica 15: Sažetak analize djelotvornosti usporedbe supkutane i intravenske primjene bortezomiba
English: Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma.
Croatian: Bortezomib smanjuje rast tumora in vivo u mnogim nekliničkim modelima tumora, uključujući multipli mijelom.
English: • Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously
Croatian: • Bortezomib SUN 3,5 mg može biti primijenjen intravenski i supkutano
English: * Based on posology modifications in Phase II and III multiple myeloma studies and post-marketing experience.
Croatian: * Prema prilagodbama doziranja u ispitivanjima liječenja multiplog mijeloma faze II i III i iskustvima nakon stavljanja lijeka u promet.
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Croatian: Medijan od 6 dana bio je potreban za prolazak nuspojave, a kod dvoje bolesnika bila je potrebna promjena doze.
English: Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Croatian: Zbog mogućnosti ozbiljnih nuspojava u dojene djece, za vrijeme liječenja bortezomibom potrebno je prekinuti dojenje.
English: The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Croatian: Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u BzmbR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
English: Prophylactic use of granulocyte colony stimulating factors should be considered in case of repeated delays in cycle administration.
Croatian: Profilaktička primjena faktora stimulacije kolonija granulocita mora se uzeti u obzir kod ponovljenih zakašnjelih primjena ciklusa.
English: Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Croatian: Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzmbR-CAP i RCHOP, stopa ozbiljnih nuspojava u BzmbR-CAP skupini bila je 68 %, u usporedbi s 42 % u R-CHOP skupini.
English: Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Croatian: Tablica 16: Rezultati djelotvornosti iz ispitivanja LYM-3002 Ishod djelotvornosti
English: Therefore, platelet counts should be monitored prior to each dose of bortezomib.
Croatian: Stoga, broj trombocita potrebno je odrediti prije svake doze bortezomiba.
English: MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
Croatian: International Prognostic Index, IPI) ≥ 3, i 76 % imalo je stadij IV bolesti.
English: You will receive 9 cycles (54 weeks).
Croatian: Primit ćete 9 ciklusa (54
English: • advice on how to reduce the risk of mix-up of IV and SC reconstituted syringes
Croatian: • uputstva kako smanjiti rizik zamjene i.v. i s.c. pripremljenih štrcaljki
English: Grade ≥ 3 non-haematological toxicities
Croatian: ≥ 3. stupanj nehematoloških toksičnosti
English: In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Croatian: Tijekom kliničkog ispitivanja, dvoje bolesnika (od 2) koji su primali visoku dozu citarabina (2 g/m2 na dan) kontinuiranom infuzijom u trajanju od 24 sata s daunorubicinom i bortezomibom zbog relapsa akutne mijeloične leukemije umrla su od ARDS-a na početku liječenja, a ispitivanje je bilo prekinuto.
English: Bortezomib is a proteasome inhibitor.
Croatian: Bortezomib je inhibitor proteasoma.
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group.
Croatian: Statistički značajna razlika CR+nCR bila je uočena u korist skupine s bortezomibom u kombinaciji s deksametazonom i talidomidom.
English: > ULN
Croatian: > GGN
English: Bortezomib may have a moderate influence on the ability to drive and use machines.
Croatian: Bortezomib može umjereno utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
English: Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: Rekonstituirana otopina Bortezomib SUN-a primjenjuje se supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: As a result of a pre-planned interim analysis, the dexamethasone arm was halted at the recommendation of the data monitoring committee and all patients randomised to dexamethasone were then offered bortezomib, regardless of disease status.
Croatian: Kao posljedica unaprijed planirane privremene analize, skupini koja je primala deksametazon liječenje je zaustavljeno na preporuku radne skupine koja je pratila ispitivanja i svim je bolesnicima nakon toga ponuđeno liječenje bortezomibom bez obzira na stanje bolesti.
English: - Inject the solution subcutaneously, under a 45-90°angle.
Croatian: - Primijenite injekciju supkutano, pod kutem od 45 - 90°.
English: Patients in the BzmbTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Croatian: Medijan dobi bolesnika u BzmbTDx odnosno TDx skupini, bio je 57 naspram 56 godina, 99 % naspram 98 % bolesnika bili su bijele rase, a 58 % naspram 54 % bili su muškarci.
English: Common Hypertension*, Hypotension*, Orthostatic hypotension
Croatian: Hipertenzija*, hipotenzija*, ortostatska hipotenzija
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Croatian: Izloženost bortezomibu povećana je u bolesnika s umjereno ili teško oštećenom jetrom; te bolesnike treba liječiti smanjenim dozama bortezomiba i pomno ih pratiti na znakove toksičnosti (vidjeti dijelove 4.2 i 5.2).
English: The incidence of herpes zoster among patients in the BzmbR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Croatian: Incidencija herpes zostera među bolesnicima u BzmbR-CAP skupini bila je 10,7 % za bolesnike kojima nije bila primijenjena antivirusna profilaksa u uspredbi s 3,6 % za bolesnike kojima je primijenjena antivirusna profilaksa (vidjeti dio 4.4).
English: The following medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Croatian: Sljedeći lijekovi daju se 1. dana svakog ciklusa liječenja Bortezomib SUN-om u trajanju od 21 dan kao infuzije u venu:
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Croatian: Klinička djelotvornost uz supkutanu primjenu bortezomiba u bolesnika s relapsnim/refraktornim multiplim mijelomom
English: Bortezomib is highly selective for the proteasome.
Croatian: Bortezomib je visoko selektivan za proteasome.
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Croatian: Bolesnici s osnovnom periferenom neuropatijom stupnja ≥ 2 ili s brojem trombocita < 50 000/µl bili su isključeni.
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Croatian: Rituksimab 375 mg/m2, ciklofosfamid 750 mg/m2 i doksorubicin 50 mg/m2.
English: Incidence of PN (%) All GradePN ≥ Grade 2 PN ≥ Grade 3 PN Discontinuation due to PN (%)
Croatian: Svi stupnjevi PN ≥ Stupanj 2 PN ≥ Stupanj 3 PN
English: 19.9 mo
Croatian: 19,9 mjeseci
English: Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Croatian: Bortezomib SUN primjenjuje se u venu ili potkožno 1., 4., 8. i 11. dan, nakon čega slijedi „period odmora” bez liječenja.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Croatian: U bolesnika s umjerenim ili teškim oštećenjem jetre liječenje bortezomibom treba započeti smanjenom dozom od 0,7 mg/m2 po injekciji tijekom prvog ciklusa liječenja, a naknadno povećanje doze na 1,0 mg/m2 ili daljnje smanjenje doze na 0,5 mg/m2 može se razmotriti na temelju podnošljivosti liječenja za bolesnika (vidjeti Tablicu 6 i dijelove 4.4 i 5.2).
English: • different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use
Croatian: • različite zahtjeve za rekonstituciju za intravensku (i.v.) ili supkutanu (s.c.) primjenu lijeka
English: g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Croatian: g P-vrijednost Cochran Mantel-Haenszelovog hi-kvadrat testa, s IPI i stadijem bolesti kao stratifikacijskim faktorima.
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Croatian: Tablica 13: Rezultati djelotvornosti iz ispitivanja MMY-3010 Mjere ishoda
English: Overall response (CR+CRu+PR)h n(%)
Croatian: Ukupni odgovor (CR+CRu+PR)h n(%)
English: In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections - ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Croatian: Posebno naglasite svome liječniku ako koristite lijek koji u svom sastavu ima sljedeće tvari: - ketokonazol, za liječenje gljivičnih infekcija - ritonavir, uzima se za liječenje HIV infekcije - rifampicin, antibiotik za liječenje bakterijskih infekcija - karbamazepin, fenitoin ili fenobarbital za liječenje epilepsije - gospinu travu (Hypericum perforatum) koja se primjenjuje kod depresije ili drugih stanja
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Croatian: Uz perifernu neuropatiju, nekim nuspojavama može pridonijeti i autonomna neuropatija, kao što je posturalna hipotenzija i teški zatvor s ileusom.
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio;
Croatian: CR=Kompletni odgovor; CRu=Nepotvrđeni kompletni odgovor; PR=Djelomični odgovor; CI=Interval pouzdanosti, HR=Omjer hazarda; OR=Omjer izgleda; ITT=Populacija namijenjena za liječenje
English: It is recommended that patients receive 2 cycles of Bortezomib SUN following a confirmation of a complete response.
Croatian: Preporučuje se da bolesnici prime još 2 ciklusa liječenja Bortezomib SUN-om nakon potvrđenog kompletnog odgovora.
English: - swelling of body, to include eyes and other parts of the body - shivering - redness and pain at injection site - general ill feeling - weight loss - weight increase.
Croatian: - oticanje tijela, uključujući oči i druge dijelove tijela - drhtanje - crvenilo i bol na mjestu primjene injekcije - opći osjećaj bolesti - gubitak težine - povećanje težine.
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Croatian: Medijan dobi bolesnika u ispitivanju bio je 71 godina, 50 % bili su muškarci, 88 % bili su bijele rase a medijan rezultata funkcionalnog stanja po Karnofskom za bolesnike je bio 80.
English: Once weekly Bortezomib SUN (cycles 5-9)
Croatian: Bortezomib SUN jednom tjedno (5. - 9. ciklus)
English: Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Croatian: 2. stupanj s bolovima ili 3. stupanj (teški simptomi; ograničavaju aktivnosti samozbrinjavanja u svakodnevnom životu***)
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Croatian: Provedeno je farmakokinetičko ispitivanje u bolesnika s različitim stupnjevima oštećenja bubrega koji su bili podijeljeni prema vrijednostima klirensa kreatinina (CrCL) u sljedeće skupine: Normalno (CrCL ≥ 60 ml/min/1,73 m2, n=12), blago (CrCL=40 - 59 ml/min/1,73 m2, n=10), umjereno (CrCL=20 - 39 ml/min/1,73 m2, n=9) i teško (CrCL < 20 ml/min/1,73 m2, n=3).
English: Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Croatian: Bortezomib SUN sadrži djelatnu tvar bortezomib, koja se naziva „inhibitor proteasoma”.
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib SUN are provided with educational materials.
Croatian: Nositelj odobrenja će osigurati dostupnost edukacijskog materijala svim zdravstvenim radnicima koji su uključeni u postupak propisivanja, doziranje, pripremu i primjenu Bortezomib SUN-a.
English: When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Croatian: Kada se Bortezomib SUN daje zajedno s talidomidom, morate slijediti program namijenjen prevenciji trudnoće za talidomid (vidjeti uputu o lijeku za talidomid).
English: The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Croatian: Potrebno je razmotriti omjer koristi i rizika prije nastavka liječenja bortezomibom.
English: OR; 95% CI; P valuea
Croatian: OR; 95 % CI; P
English: Response Evaluable Population n=73
Croatian: Populacija procjenjiva na odgovor n=73
English: - The other ingredient is mannitol (E421).
Croatian: - Pomoćna tvar je manitol (E421).