FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Slovenian: Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi (CR+nCR).
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Slovenian: Razvrstitev po 4. različici enotnih meril toksičnosti za vrednotenje neželenih učinkov Nacionalnega onkološkega inštituta (NCI Common Toxicity Criteria CTCAE v 4.0).
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, albumin, and region.
Slovenian: Ocena razmerja tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-micikllobulin, albumin in regija.
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Slovenian: Pri bolnikih v skupini B+M+P so opazili statistično značilno izboljšanje preživetja (HR (Hazard Ratio - razmerje tveganja) = 0,695; p = 0,00043), kljub kasnejšim terapijam, vključno s terapijo z bortezomibom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z bortezomibom za vse skupine pediatrične populacije za indikacijo diseminirani plazmocitom in limfom plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: A. PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: Bortezomib therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Slovenian: Zdravljenje z bortezomibom je treba prekiniti za največ 2 tedna, dokler nima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl.
English: Bortezomib is for single use only.
Slovenian: Bortezomib je samo za enkratno uporabo.
English: If you have mantle cell lymphoma and are given the medicine rituximab with bortezomib you must tell your doctor:
Slovenian: Če imate limfom plaščnih celic in prejemate rituksimab skupaj z bortezomibom, zdravniku povejte če:
English: Withhold bortezomib treatment until symptoms of toxicity have resolved.
Slovenian: prekinite zdravljenje z bortezomibom, dokler ne minejo znaki toksičnosti.
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Slovenian: Preglednica 10: Pojavnost periferne nevropatije v študiji LYM-3002 glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije BR-CAP (n = 240)
English: Melphalan (9 mg/m 2) and prednisone (60 mg/m 2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Slovenian: Melfalan (9 mg/m2) in prednizon (60 mg/m2) se dajeta peroralno na 1., 2., 3., in 4. dan prvega tedna vsakega cikla zdravljenja.
English: For these dose cohorts, the combined 1-year survival rate was 88.1%.
Slovenian: Skupna stopnja 1-letnega preživetja za skupini bolnikov, ki sta prejemali ta dva odmerka, je bila 88,1 %.
English: TTP, days [95% CI]
Slovenian: TTP,dnevi ([95 % CI])
English: (95% CI) p-value c a Kaplan-Meier estimate b
Slovenian: (95% CI) p-vrednost c a Ocena po metodi Kaplan-Meier.
English: Uncommon Autonomic nervous system imbalance
Slovenian: Občasni neravnovesje v delovanju avtonomnega živčevja
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.
Slovenian: Progresivna multifokalna levkoencefalopatija (PML) Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z JC virusom (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
English: - Flush the peripheral or intravenous catheter with sterile, sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: • Izperite periferni ali intravenski kateter s sterilno raztopino 9 mg/ml (0,9 %) natrijevega klorida.
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Slovenian: Bolniki, s predhodno zdravljeno amiloidozo lahkih verig (AL amiloidoza) V odprti, ne-randomizirani študiji faze I/II so ugotavljali varnost in učinkovitost bortezomiba pri bolnikih, s predhodno zdravljeno AL amiloidozo.
English: 1 mg/m to 0.7 mg/m
Slovenian: 1 mg/m na 0,7 mg/m
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Slovenian: • nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
English: You might receive up to 8 cycles (24 weeks).
Slovenian: Lahko boste prejeli do največ 8 ciklov zdravljenja (24 tednov).
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%).
Slovenian: V shemi zdravljenja z dodanim bortezomibom so se naslednji neželeni učinki (stopnje ≥ 3) pojavili pogosteje kot v predhodni kontrolni študiji, kjer so bolniki prejemali samo osnovno shemo zdravljenja: v 1. sklopu periferna senzorična nevropatija (3 % proti 0 %), ileus (2,1 % proti 0 %), hipoksija (8 % proti 2 %).
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Slovenian: h Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the BR-CAP group and 5.0% in the R-CHOP group) as well as grade 3 and higher bleeding events (BR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Slovenian: V obeh skupinah pa je bila podobna celokupna pojavnost krvavitev vseh stopenj (6,3 % v BR-CAP in 5,0 % v R-CHOP) in krvavitev stopnje 3 ali več (BR-CAP: 4 bolniki [1,7 %]; R-CHOP: 3
English: - Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Slovenian: • Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferno ali centralno intravensko cevko v veno.
English: (95% CI)=1.688
Slovenian: (95% CI) = 1,688 p-vrednost g
English: M (9 mg/m P (60 mg/m
Slovenian: M (9 mg/m P (60 mg/m dan dan dan dan
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Slovenian: Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini BR-CAP 6,7 % in v skupini R-CHOP 1,2 % (glejte poglavje 4.8).
English: In addition, the incidence of grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Slovenian: Dodatno je bila pri subkutani skupini incidenca perifernih nevropatij stopnje 3 ali več za 10 % manjša in za 8 % manjša pogostnost prekinitve zdravljenja zaradi perifernih nevropatij, v primerjavi s skupino, ki je zdravilo prejemala intravensko.
English: Pregnancy and breast-feeding You must not use this medicine if you are pregnant, unless clearly necessary.
Slovenian: Nosečnost in dojenje Če ste noseči zdravila Bortezomib Fresenius Kabi ne smete prejeti, razen, če je nujno potrebno.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BTDx and TDx groups, respectively.
Slovenian: Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81%) bolnikih v skupini BTDx in 78 (61%) bolnikih v skupini TDx.
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.
Slovenian: Pogostnost vseh stopenj periferne nevropatije pri dajanju bortezomiba intravensko je bila v že prej opravljenih študijah manjša kot v študiji MMY-3021.
English: Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m reduced to 1.0 mg/m 2; 1.0 mg/m reduced to 0.7 mg/m 2).
Slovenian: Ko znaki toksičnosti minejo, lahko zdravljenje z bortezomibom ponovno uvedete, vendar s 25 % manjšim odmerkom (1,3 mg/m zmanjšano na 1,0 mg/m 2; 1,0 mg/m zmanjšano na 0,7 mg/m telesne površine).
English: (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Slovenian: 59 ml/min/1,73 m 2, n = 10), zmerna okvara ledvic (CrCL = 20-39 ml/min/1,73 m 2, n = 9), resna okvara ledvic (CrCL < 20 ml/min/1,73 m2, n = 3).
English: Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: d Log- rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
English: The incidence of herpes zoster among patients in the BR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Slovenian: Pogostnost virusa herpes zoster v skupini BR-CAP je bila 10,7 % pri bolnikih, ki niso prejemali protivirusnih zdravil, pri bolnikih, ki so prejemali protivirusna zdravila pa 3,6 % (glejte poglavje 4.4).
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each bortezomib treatment cycle.
Slovenian: Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega cikla zdravljenja z bortezomibom.
English: Inhibition of the proteasome results in cell cycle arrest and apoptosis.
Slovenian: Zavora proteasoma povzroči ustavitev celičnega cikla in apoptozo.
English: Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Slovenian: Bolniki, ki prejemajo kombinirano zdravljenje in po 4 ciklih zdravljenja dosežejo odgovor ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne cikle.
English: Patients in the BTDx 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.
Slovenian: V skupini BTDx oziroma TDx je bila mediana starost bolnikov 57 let oziroma 56 let, 99 % oziroma 98 % je bilo belcev, moških je bilo 58 % oziroma 54 %.
English: Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BR-CAP arm and with at least a possible or probable causal relationship to the components of the BR-CAP arm, are listed in table 8 below.
Slovenian: V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1%, ki je bila podobna ali večja v skupini BR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BR-CAP.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Slovenian: Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba Bortezomib intravensko Bortezomib subkutano
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BDx, n=240] was compared to vincristine-doxorubicin-dexamethasone [VDDx, n=242].
Slovenian: V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BDx, n = 240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n = 242].
English: • Irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion) and red and swollen eyelids, discharge from the eyes, abnormal vision, bleeding of the eye
Slovenian: • draženje ali vnetje oči, prekomerno solzne oči, boleče oči, suhe oči, okužbe oči, zatrdlina na veki (halazij), rdeče in otekle veke, izcedek iz oči, motnje vida, krvavitve v očesu
English: Table 16: Efficacy results from study LYM-3002 Efficacy endpoint
Slovenian: Preglednica 16: Rezultati učinkovitosti zdravila v študiji LYM-3002
English: If you are given bortezomib 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, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Slovenian: Če prejemate bortezomib za zdravljenje diseminiranega plazmocitoma ali limfoma plaščnih celic, takoj obvestite svojega zdravnika, če se pri vas pojavi kateri koli od naslednjih simptomov: - mišični krči, mišična šibkost - zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli - težko dihanje, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost,
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Slovenian: Mediana PFS po oceni raziskovalca je bila 30,7 mesecev v skupini BR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR] = 0,51; p < 0,001).
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 dose.
Slovenian: • Model izračuna odmerka, s katerim lahko zdravnik, ki predpisuje zdravilo, izračuna telesno površino na podlagi izbire bolnikove višine in telesne mase, ter tako določil ustrezen odmerek bortezomiba.
English: Fertility Fertility studies were not conducted with bortezomib (see section 5.3).
Slovenian: Plodnost Študije plodnosti pri uporabi bortezomiba niso bile izvedene (glejte poglavje 5.3).
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m dose and 89 to 120 ng/ml for the 1.3 mg/m dose.
Slovenian: Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu 67 do 106 ng/ml pri odmerku 1,0 mg/m in 89 do 120 ng/ml pri odmerku 1,3 mg/m
English: Median OS was 90.7 months for the BR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Slovenian: V skupini BR-CAP je bilo mediano OS 90,7 mesecev v primerjavi s 55,7 meseci v skupini R-CHOP (HR=0,66; p=0,001).
English: B=bortezomib; Dex=dexamethasone
Slovenian: B = bortezomib; Dex = deksametazon
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BR-CAP arm and 61% of patients in the R-CHOP arm.
Slovenian: V študiji LYM-3002 je podporno zdravljenje s kolonijami spodbujajočih faktorjev prejelo 78 % bolnikov v skupini BR-CAP in 61 % bolnikov v skupini R-CHOP.
English: • Injection sites must be rotated for successive injections.
Slovenian: • Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
English: • to remind that patients receiving bortezomib in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
Slovenian: • Bolnike, ki prejemajo bortezomib v kombinaciji s talidomidom je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti za talidomid, s sklicem na povzetek glavnih značilnosti zdravila za talidomid za pridobitev dodatnih informacij.
English: In the BR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Slovenian: V skupini BR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini RCHOP pa 2,9% bolnikov.
English: Hepatitis B virus (HBV) reactivation and infection Mantle cell lymphoma
Slovenian: Reaktivacija in okužba z virusom hepatitisa B (HBV) Limfom plaščnih celic
English: • different reconstitution requirements for bortezomib 3.5 mg IV or SC use
Slovenian: • Različne zahteve za rekonstitucijo bortezomiba 3,5 mg pri i.v.
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m
Slovenian: Po najmanj 6 mesecih po predhodnem zdravljenju, so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m
English: You may also be given bortezomib together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Slovenian: Lahko pa boste bortezomib prejeli skupaj z zdraviloma pegilirani liposomski doksorubicin ali deksametazon.
English: In the Phase II study, patients who did not obtain an optimal response to therapy with bortezomib alone were able to receive high-dose dexamethasone in conjunction with bortezomib.
Slovenian: Bolniki v študiji faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom v monoterapiji, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Slovenian: Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALLAcute Lymphoblastic Leukemia) ali z akutno mieloično levkemijo (AML - Acute Myeloid Leukemia).
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with Bortezomib+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Slovenian: V študiji faze III, pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih zdravljenih z zdravili bortezomib+melfalan+prednizon pogostejša, kot pri bolnikih zdravljenih z melfalanom+prednizonom (14 % v primerjavi s 4 %).
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BR-CAP arm.
Slovenian: V BR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Slovenian: Redki meningitis (vključno z bakterijskim), okužba z virusom Epstein- Barr, genitalni herpes, tonzilitis, mastoiditis, post virusni sindrom utrujenosti
English: - Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
Slovenian: • Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za intravensko dajanje).
English: You must not breast-feed while using bortezomib.
Slovenian: Med uporabo bortezomiba ne smete dojiti.
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Slovenian: Pri bolnikih, ki so prejemali bortezomib so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot je pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
English: Bortezomib should not be administered intrathecally.
Slovenian: Bortezomiba se ne sme dajati intratekalno.
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.
Slovenian: V 1. ciklu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih ciklih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
English: If any discolouration or particulate matter is observed, the solution must be discarded.
Slovenian: Če opazite kakršno koli spremembo barve ali delce v raztopini, jo morate zavreči.
English: 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).
Slovenian: Zdravljenje z bortezomibom je treba prekiniti ob pojavu katere koli z uporabo bortezomiba povezane ne-hematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
English: 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 < 0.0001
Slovenian: b p-vrednost iz stratificiranega testa log-rank; v analizi po vrsti terapije ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy 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).
Slovenian: Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z bortezomibom morate prekiniti ob pojavu katere koli nehematološke toksičnosti 3. stopnje ali katere koli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
English: Grade ≥ 3 non-haematological toxicities considered to be related to bortezomib
Slovenian: Ne-hematološka toksičnost stopnje ≥ 3 povezana z uporabo bortezomiba
English: * Survival update based on a median duration of follow-up at 60.1 months mo: months
Slovenian: * Preživetje na osnovi podatkov po 60,1 mesecih spremljanja.
English: Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m per day)
Slovenian: Zato ta režim dajanja s sočasnim velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m na dan) ni priporočljiv.
English: T 100 mg a
Slovenian: T 100 mg a na dan na dan
English: The MAH shall ensure that all healthcare professionals involved in the prescribing, dispensing, handling or administration of bortezomib are provided with educational material.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo vsi zdravstveni delavci, ki bodo predpisovali, izdajali ali uporabljali zdravilo, prejeli izobraževalno gradivo.
English: Table 2: Recommended posology for bortezomib in combination with melphalan and prednisone Twice weekly bortezomib (cycles 1-4) Week B (1.3 mg/m
Slovenian: Preglednica 2: Priporočeno odmerjanje bortezomiba v kombinaciji z melfalanom in prednizonom Odmerjanje bortezomiba dvakrat na teden (cikli 1-4)