FrancophonIA/ELRC3.0 huggingface dataset:
English: • If several Bortezomib Accord doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Croatian: Ako se prekine primijena nekoliko doza lijeka Bortezomib Accord u jednom ciklusu (≥ 3 doze tijekom primjene dva puta tjedno ili ≥ 2 doze tijekom primjene jedanput na tjedan)
English: Bortezomib Accord might cause tiredness, dizziness, fainting, or blurred vision.
Croatian: Bortezomib Accord može uzrokovati umor, omaglicu, nesvjesticu ili zamagljen vid.
English: What Bortezomib Accord looks like and contents of the pack
Croatian: Kako Bortezomib Accord izgleda i sadržaj pakiranja
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered Bz+M+P treatment.
Croatian: U vrijeme unaprijed planirane privremene analize postigla se primarna mjera ishoda, vrijeme do progresije te je bolesnicima u M+P kraku studije bilo ponuđeno liječenje Bz+M+P.
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Croatian: Doziranje pri liječenju progresivnog multiplog mijeloma (bolesnici koji su prethodno primili barem jednu liniju liječenja) Monoterapija
English: Bortezomib Accord contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Croatian: Bortezomib Accord sadrži djelatnu tvar bortezomib, koja se naziva ‘inhibitor proteasoma'.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Croatian: Medijan preživljenja svih uključenih bolesnika bio je 17 mjeseci (raspon <1
English: The median duration of complete response was 42.1 months in the BzR-CAP group compared with 18 months in the R-CHOP group.
Croatian: Medijan trajanja kompletnog odgovora bio je 42,1 mjesec u BzR-CAP skupini u usporedbi s 18 mjeseci u R-CHOP skupini.
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild, moderate,
Croatian: * Prema klasifikaciji Radne skupine za poremećaj funkcije organa Nacionalnog instituta za rak za kategorizaciju oštećenja jetre (blago, umjereno, teško).
English: It is recommended that patients receive 2 cycles of bortezomib following a confirmation of a complete response.
Croatian: Preporučuje se da bolesnici prime još 2 ciklusa liječenja bortezomibom nakon potvrđenog kompletnog odgovora.
English: Overall complete response (CR+CRu)f n(%)
Croatian: Ukupni kompletni odgovor (CR+CRu)f n(%)
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BzR-CAPgroup and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (BzR-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 BzR-CAP skupini i 5,0% u R-CHOP skupini) kao i stupnja 3 i višeg za događaje krvarenja (BzR-CAP: 4 bolesnika [1.7%]; R-CHOP: 3 bolesnika [1,2%]).
English: Bortezomib Accord was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Croatian: Accord je bio primijenjen samo u 1. i 2.bloku zbog izbjegavanja mogućeg preklapanja toksičnosti s istodobno primijenjenim lijekovima u bloku 3.
English: Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the RCHOP group.
Croatian: Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzR-CAP i R-CHOP, stopa ozbiljnih nuspojava u BzR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Croatian: Tablica 15: Sažetak analize djelotvornosti usporedbe supkutane i intravenske primjene bortezomiba bortezomib intravenska skupina bortezomib supkutana skupina
English: Antiviral prophylaxis was administered to 26% of the patients in the Bz+M+P arm.
Croatian: Antivirusna profilaksa se primijenila u 26% bolesnika u skupini koja je primala Bz+M+P.
English: The duration of overall response was 21.4 months longer in the BzR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Croatian: Trajanje ukupnog odgovora bilo je 21,4 mjeseca duže u BzR-CAP skupini (medijan 36,5 mjeseci naspram 15,1 mjeseci u R-CHOP skupini).
English: Mannitol (E421).
Croatian: manitol (E421).
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: In patients developing PRES, bortezomib should be discontinued.
Croatian: U bolesnika u kojih se razvije PRES, mora se prekinuti primjena bortezomiba.
English: Bortezomib Accord should not be administered intrathecally.
Croatian: Bortezomib Accord se ne smije primijeniti intratekalno.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Croatian: pojavila se kod 6% bolesnika u skupini liječenoj supkutano, u usporedbi sa 16% u skupini liječenoj intravenski (p=0,0264).
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib Accord
Croatian: Nehematološke toksičnosti stupnja ≥ 3 za koje se smatra da su povezane s lijekom Bortezomib Accord
English: Vision abnormal*
Croatian: Abnormalan vid*
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Croatian: ● prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Very Common Pneumonia* Common
Croatian: Vrlo često Pneumonija*
English: The incidence of herpes zoster among patients in the BzR-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 BzR-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: - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Croatian: - ako ste alergični na bortezomib, bor ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: HRb (95% CI)=0.63 (0.50; 0.79) p-valued < 0.001
Croatian: HRb (95% CI)=0,63 (0,50; 0,79) p-vrijednostd < 0,001
English: If you are given Bortezomib Accord for multiple myeloma or mantle cell lymphoma, tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure,
Croatian: Ako Bortezomib Accord primate za multipli mijelom ili limfom plaštenih stanica, odmah obavijestite svog liječnika ako primijetite bilo koji od sljedećih simptoma: - grčenje mišića, slabost mišića - smetenost, gubitak vida ili smetnje vida, sljepoću, napadaje, glavobolje
English: • to remind that patients receiving Bortezomib Accord in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Croatian: • kako bi se podsjetilo bolesnike koji primaju Bortezomib Accord u kombinaciji s talidomidom da se moraju pridržavati talidomidskog programa prevencije trudnoće, s upućivanjem na SPC za talidomid za dodatne informacije.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV
Croatian: Demografski podaci i karakteristike bolesti na početku ispitivanja općenito su bile dobro izbalansirane unutar dvije liječene skupine: medijan dobi bolesnika bio je 66 godina, 74% su bili muškarci, 66% su bili bijele rase, a 32% azijskog porijekla, 69% bolesnika imalo je pozitivan aspirat koštane srži i/ili pozitivnu biopsiju koštane srži na limfom plaštenih stanica, 54% bolesnika imalo je skor Internacionalnog indeksa prognoze (od engl.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord 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 lijekom Bortezomib Accord 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: Bortezomib therapy should be withheld when the platelet count is < 25,000/µl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/µl (see section 4.2).
Croatian: Liječenje bortezomibom mora se prekinuti kad je broj trombocita < 25 000/µl, a u slučaju kombinacije s melfalanom i prednizonom kad je broj trombocita ≤ 30 000/µl (vidjeti dio 4.2).
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BzR-CAP in a clinical trial
Croatian: Tablica 8: Nuspojave u bolesnika s limfomom plaštenih stanica liječenih s BzR-CAP u kliničkom ispitivanju
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Croatian: Incidencija periferene neuropatije svih stupnjeva uz intravensku primjenu bortezomiba bila je niža u prethodnim ispitivanjima s bortezomibom primjenjenim intravenski, nego u ispitivanju MMY-3021.
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/µl, 90% of 21 patients had a count ≤ 25,000/µl during the study, including 14% < 10,000/µl; in contrast, with a baseline platelet count > 75,000/µl, only 14% of 309 patients had a count ≤ 25,000/µl during the study.
Croatian: U bolesnika s uznapredovalim mijelomom, težina trombocitopenije bila je povezana s brojem trombocita prije liječenja: kod početnog broja trombocita < 75 000/µl, 90% od 21 bolesnika imalo je ≤ 25 000/µl trombocita za vrijeme ispitivanja, uključujući njih 14% s < 10 000/µl; nasuprot tome, kod početnog broja trombocita > 75 000/µl, samo 14% od 309 bolesnika imalo je ≤ 25 000/µl trombocita za vrijeme ispitivanja.
English: • Shingles (localised including around the eyes or spread across the body)
Croatian: • herpes zoster (lokalizirano, uključujući područje oko očiju ili prošireno po cijelom tijelu)
English: The majority of the patients in both groups completed treatment, 80% in the BzR-CAP group and 82% in the R-CHOP group.
Croatian: Većina bolesnika u obje skupine završilo je liječenje, 80% u BzR-CAP skupini i 82%
English: • Infection or inflammation of the stomach and intestines
Croatian: • infekcija ili upala želuca i crijeva
English: Patients in the BzTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2
Croatian: Bolesnici u BzDx skupini primili su četiri 21 dnevna ciklusa, od kojih je svaki uključivao bortezomib (1,3 mg/m2
English: Contents of the pack and other information What Bortezomib Accord contains
Croatian: Sadržaj pakiranja i druge informacije Što Bortezomib
English: When Bortezomib Accord is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Croatian: Kada se Bortezomib Accord daje zajedno s talidomidom, morate slijediti program namijenjen prevenciji trudnoće za talidomid (vidjeti uputu o lijeku za talidomid).
English: • Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l
Croatian: Broj trombocita mora biti ≥ 70 x 109/l, a apsolutni broj neutrofila mora biti ≥ 1,0 x 109/l.
English: In the absence of any direct comparison between bortezomib and bortezomib in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Croatian: Radi nepostojanja bilo kakve izravne usporedbe između bortezomiba i bortezomiba u kombinaciji s deksametazonom u bolesnika s progresivnim multiplim mijelomom, provedena je statistička analiza odgovarajućih parova, radi usporedbe rezultata nerandomizirane skupine bortezomiba u kombinaciji s deksametazonom (otvoreno ispitivanje faze II, MMY-2045), s rezultatima koji su dobiveni u skupini na monoterapiji bortezomibom iz različitih ispitivanja faze III (M34101-039 [APEX] i DOXIL MMY-3001), u istoj indikaciji.
English: Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median haemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Croatian: IgG/IgA/lakih lanaca u 63%/25%/8% slučajeva, medijan hemoglobina od 105 g/l, i medijan broja trombocita od 221,5 x 109/l.
English: Hyperbilirubinaemia*, Protein analyses abnormal*, Weight decreased, Weight increased
Croatian: Hiperbilirubinemija*, abnormalan nalaz analize proteina*, smanjena težina, povećana težina
English: • If prolonged Grade 4 neutropenia or thrombocytopenia, or thrombocytopenia with bleeding is observed in the previous cycle
Croatian: Ako se primijetilo produljeno trajanje neutropenije 4. stupnja ili trombocitopenije ili trombocitopenija s krvarenjem u prethodnom ciklusu
English: If you have mantle cell lymphoma and are given the medicine rituximab with Bortezomib Accord you should tell your doctor:
Croatian: Ako imate limfom plaštenih stanica i uz Bortezomib Accord primate lijek rituksimab morate obavijestiti svog liječnika:
English: c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Croatian: Populacija s terapijskim odgovorom uključuje bolesnike koji su imali mjerljivu bolesti na početku liječenja i primili su najmanje 1 dozu ispitivanog lijeka.
English: ORe (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Croatian: ORe (95% CI)=1,428 (0,749; 2,722) p-vrijednost g=0,275
English: Bortezomib Accord is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
Croatian: Accord se primjenjuje supkutano u bedro (desno ili lijevo) ili abdomen (desnu ili lijevu stranu).
English: OR; 95% CI; P valuea
Croatian: OR; 95% CI; P vrijednosta
English: Change Bortezomib Accord treatment schedule to 1.3 mg/m2 once per week
Croatian: Promijeniti raspored primjene lijeka lijeka Bortezomib Accord na 1,3 mg/m2 jedanput tjedno
English: Bortezomib Accord powder for solution for injection is a white to off-white cake or powder.
Croatian: Bortezomib Accord prašak za otopinu za injekciju je bijeli do gotovo bijeli kolačić ili prašak.
English: 169d b
Croatian: 169d
English: ORe (95% CI)=1.688 (1.148; 2.481) p-valueg=0.007
Croatian: ORe (95% CI)=1,688 (1,148; 2,481) p-vrijednostg=0,007
English: Combination therapy with pegylated liposomal doxorubicin
Croatian: Kombinirano liječenje s pegiliranim liposomalnim doksorubicinom
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML).
Croatian: Farmakokinetika bortezomiba bila je okarakterizirana nakon primjene intravenske bolusne injekcije dva puta tjedno u dozi od 1,3 mg/m2 u 104 pedijatrijska bolesnika (u dobi od 2-16 godina) s akutnom limfoblastičnom leukemijom (ALL) ili akutnom mijeloidnom leukemijom (AML).
English: Dex n=119a
Croatian: Dex n=119
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
English: • a dose-calculation tool that enables prescribers to input a patient's height and weight in order to calculate the body surface area (BSA) and thereby to determine the appropriate Bortezomib Accord dose.
Croatian: • instrument za izračun doze koji omogućava propisivaču lijeka da na osnovu unosa podataka o visini i težni bolesnika izračuna tjelesnu površinu (engl. body surface area, BSA), te tako odredi potrebnu dozu lijeka Bortezomib Accord.
English: > 1.0 x −1.5 x ULN Any
Croatian: > 1,0x−1,5x GGN bilo koja
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Croatian: Omjer hazardab (95% CI) p-vrijednost a Kaplan-Meierova analiza.
English: You will have to take regular blood tests before and during your treatment with Bortezomib Accord, to check your blood cell counts regularly.
Croatian: Imati ćete redovne kontrole krvi prije i tijekom liječenja lijekom Bortezomib Accord, kako bi se redovito provjerio broj krvnih stanica.
English: For bortezomib-related neuropathic pain and/or peripheral neuropathy, hold and/or modify Bortezomib Accord as outlined in Table 1.
Croatian: Kod neuropatske boli povezane s bortezomibom i/ili periferne neuropatije, pričekajte s primjenom i/ili prilagodite dozu lijeka Bortezomib Accord kako je prikazano u Tablici 1.
English: The MAH shall ensure thatall healthcare professionals involved in the prescribing, dispensing, handling or administration of Bortezomib Accord are provided with educational material.
Croatian: Nositelj odobrenja će osigurati dostupnost edukacijskog materijala svim zdravstvenim radnicima koji su uključeni u postupak propisivanja, doziranje, pripremu i primjenu lijeka Bortezomib Accord.
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
Croatian: • Broj trombocita mora biti ≥ 100 000 stanica/μL i apsolutni broj neutrofila mora biti ≥ 1500 stanica/μL
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Croatian: U bolesnika s limfomom plaštenih stanica (ispitivanje LYM-3002), incidencija infekcije virusom herpes zoster bila je 6,7% u BzR-CAP skupini i 1,2% u R-CHOP skupini (vidjeti dio 4.8).
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Croatian: Kinetika inhibicije proteasoma ocjenjivala se in vitro i pokazalo se da se bortezomib razdvaja od proteasoma uz t½ od 20 minuta,
English: No clinical data are available for bortezomib with regard to exposure during pregnancy.
Croatian: Trudnoća Nema dostupnih kliničkih podataka o izloženosti bortezomibu tijekom trudnoće.
English: Absorption Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Croatian: Apsorpcija Nakon intravenske primjene bolus doze od 1,0 mg/m2 odnosno 1,3 mg/m2 u 11 bolesnika s multiplim mijelomom čije su vrijednosti klirensa kreatinina bile više od 50 ml/min, srednje vrijednosti maksimalne koncentracije bortezomiba u plazmi nakon prve doze iznosile su 57 odnosno 112 ng/ml.
English: The overall incidence of hepatitis B infections was similar in patients treated with BzR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Croatian: Ukupna incidencija infekcija hepatitisom B bila je slična u bolesnika liječenih s BzR-CAP i liječenih s R-CHOP (0,8% odnosno 12%).
English: • Feeling sick (nausea) or vomiting, loss of appetite
Croatian: • vrućica • mučnina ili povraćanje, gubitak apetita
English: Patients in the BzTDx 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 BzTDx odnosno TDx skupini, bio je 57 naspram 56 godina, 99% naspram 98% bolesnika bili su bijele rase, a 58% naspram
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Croatian: neutropenija stupnja 4 koja traje duže od 7 dana, broj trombocita < 10 000 stanica/μL
English: Mantle cell lymphoma (MCL)
Croatian: Limfom plaštenih stanica (MCL)
English: Male patients and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Croatian: Muškarci i žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja i do
English: In trials in which bortezomib was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Croatian: U ispitivanjima u kojima je bortezomib bio primijenjen kao uvodno liječenje u kombinaciji s deksametazonom (ispitivanje IFM-2005-01), i deksametazonom-talidomidom (ispitivanje MMY-3010), incidencija periferne neuropatije u kombiniranim režimima prikazana je u tablici dolje:
English: • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Croatian: • Isperite periferni ili centralni venski kateter sterilnom 0,9%-tnom otopinom natrijevog klorida (9 mg/ml).
English: In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Croatian: U ispitivanju faze III uspoređena je intravenska primjena bortezomiba u odnosu na supkutanu primjenu, incidencija periferne neuropatije stupnja ≥ 2 bila je 24% u skupini sa supkutanom primjenom injekcije i 41% u intravenskoj skupini (p=0,0124).