natgillin/translations-raw huggingface dataset:
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 
Še posebej morate svojega zdravnika obvestiti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin: - ketokonazol, ki se uporablja za zdravljenje glivičnih okužb - ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV - rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb
Therefore, platelet counts should be monitored prior to each dose of bortezomib. 
Zato je treba pred dajanjem vsakega odmerka bortezomiba določiti število trombocitov.
Inhibition of the proteasome results in cell cycle arrest and apoptosis. 
Zavora proteasoma povzroči ustavitev celičnega ciklusa in apoptozo.
In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2. 
In vitro študije na človeških jetrnih mikrosomih in izocimih citokroma P450 z izraženo človeško cDNA kažejo, da se bortezomib v prvi vrsti oksidativno presnovi z encimi citokroma P450, 3A4, 2C19 in 1A2.
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. 
Pogostnost vseh stopenj periferne nevropatije pri dajanju bortezomiba intravensko je bila v že prej opravljenih študijah nižja kot v študiji MMY-3021.
A hazard ratio < 1 indicates an advantage for BzmbR-CAP. c Based on Kaplan-Meier product limit estimates. 
Razmerje tveganja < 1 predstavlja prednost za skupino BzmbR-CAP. c Ocena po metodi Kaplan-Meier.
Bortezomib causes reduction of tumour growth in vivo in many preclinical tumour models, including multiple myeloma. 
Bortezomib je povzročil zmanjšanje rasti tumorja in vivo v mnogih predkliničnih tumorskih modelih, vključno z modelom diseminiranega plazmocitoma.
1.2 Before administration, visually inspect the solution for particulate matter and discolouration. 
1.2 Pred dajanjem vizualno preverite, ali raztopina vsebuje delce in ali je barva spremenjena.
Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients. 
Za zdravljenje diseminiranega plazmocitoma je bortezomib prejelo skupno 3.974 bolnikov.
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. 
Čeprav so bolniki, stari ≥ 75 let, slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP, je bila stopnja resnih neželenih učinkov v skupini BzmbR-CAP 68 % v primerjavi z 42 % v skupini R
Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion 
Cushingov sindrom*, hipertiroidizem*, motnje izločanja antidiuretičnega hormona
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. 
TTP je bila 6,5 meseca pri bolnikih, ki so prejemali samo bortezomib, v primerjavi z 9,3 meseca pri tistih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2. 
375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2doksorubicina.
Overall response (CR+CRu+PR)h n(%) 
Celokupni odziv (CR+CRu+PR)h n(%)
In this case, the duration of a treatment cycle is 42 days (6 weeks). 
V tem primeru traja en krog 42 dni (6 tednov).
A total of 74 evaluable patients were administered dexamethasone in combination with bortezomib. 
Odziv na zdravljenje so ocenili pri skupaj 74 bolnikih, ki so prejeli deksametazon v kombinaciji z bortezomibom.
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. 
Absorpcija Po intravenski aplikaciji bolusnega odmerka 1,0 mg/m2 in 1,3 mg/m2 11 bolnikom z diseminiranim plazmocitomom in očistkom kreatinina, večjim kot 50 ml/min, sta bili povprečni vrednosti najvišjih plazemskih koncentracij bortezomiba po prvem odmerku 57 in 112 ng/ml.
Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice. 
Bortezomib se ni izkazal za genotoksičnega v in vitro preskusu mutagenosti (Amesov preskus) in v in vivo mikronukleusnem preskusu pri miših.
visual loss or disturbances and shortness of breath - memory loss, trouble thinking, difficulty with walking or loss of vision. 
izguba ali motnje vida ali težko dihate, - če doživite izgubo spomina, imate težave z mišljenjem, s hojo ali se vam poslabša vid.
Subcutaneous or intravenous use only. 
Samo za subkutano ali intravensko uporabo.
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). 
Pogostnost virusa herpes zoster v skupini BzmbR-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).
Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy. 
Opomba: OR > 1 kaže na prednost uvajalnega zdravljenja z Bzmb.
Cycles 1 to 4 
krog 2 do 4b
Reduce Bortezomib SUN to 1.0 mg/m2 
zmanjšajte odmerek zdravila Bortezomib SUN na 1,0 mg/m2
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user. 
Če se ne porabi takoj, je za čas in pogoje shranjevanja zdravila po rekonstituciji odgovoren uporabnik.
Patients eligible for stem cell transplantation 
Bolniki, primerni za presaditev krvotvornih matičnih celic
Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib SUN 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). 
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z zdravilom Bortezomib SUN 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).
Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy 
Stopnja 4 (posledice, ki ogrožajo življenje;potrebno je nujno ukrepanje ) in/ali močna avtonomna nevropatija ukinite zdravljenje z zdravilo Bortezomib SUN
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). 
V študiji faze III pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom je bila splošna pojavnost reaktivacije virusa herpes zoster pri bolnikih, zdravljenih z bortezomibom+melfalanom+prednizonom, pogostejša kot pri bolnikih, zdravljenih z melfalanom+prednizonom (14 % v primerjavi s 4 %).
Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib. 
Bolniki, pri katerih se pojavi ortostatska hipotenzija med zdravljenjem z bortezomibom (intravensko), pred uporabo bortezomiba niso imeli nobenih znakov ortostatske hipotenzije.
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. 
V 1. krogu zdravljenja je skupaj z bortezomibom prejemalo deksametazon 83 bolnikov, v nadaljnjih krogih zdravljenja z bortezomibom pa še dodatnih 11 bolnikov.
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). 
Pri bolnikih, ki so prejemali bortezomib, so redko poročali o akutni difuzni infiltracijski pljučni bolezni neznane etiologije, kot so pnevmonitis, intersticijska pljučnica, infiltracija pljuč in sindrom akutne respiratorne stiske (SARS) (glejte poglavje 4.8).
One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively. 
Eno avtologno presaditev krvotvornih matičnih celic so opravili pri 105 (81 %) bolnikih v skupini BzmbTDx in pri 78 (61 %) bolnikih v skupini TDx.
Median follow-up was 16.3 months. 
Po vmesni analizi so še naprej spremljali preživetje; mediana je bila 16,3 meseca.
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. 
Bolniki v preskušanju faze II, ki niso dosegli optimalnega odziva na zdravljenje z bortezomibom v monoterapiji, so poleg bortezomiba lahko prejemali tudi deksametazon v velikih odmerkih.
HRb (95% CI)=0.63 p-valued < 0.001 
HRb (95 % CI)=0,63
In the BzmbR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group. 
V skupini BzmbR-CAP je prejelo infuzijo trombocitov 22,5 % bolnikov, v skupini R-CHOP pa 2,9 % bolnikov.
* Survival update based on a median duration of follow-up at 60.1 months mo: months 
* preživetje na osnovi podatkov po 60,1 mesecih spremljanja CI=interval zaupanja
In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242]. 
V študiji IFM-2005-01 so primerjali kombinacijo bortezomiba in deksametazona [BzmbDx, n=240] s kombinacijo vinkristin-doksorubicin-deksametazon VDDx, n=242].
b Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2-microglobulin, 
b Ocena razmerja tveganja na podlagi Coxovega proporcionalnega modela, prilagojena na podlagi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
When compared to patients with normal hepatic function, mild hepatic impairment did not alter dosenormalised bortezomib AUC. 
Ob primerjavi z bolniki z normalnim delovanjem jeter pri bolnikih z blago jetrno okvaro ni bilo sprememb v povprečnem, na odmerek normaliziranem AUC bortezomiba.
Bzmb=Bortezomib SUN; M=melphalan, P=prednisone 
Bzmb=bortezomib; Dex=deksametazon
12.8 mo 
12,8 meseca
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. 
V kliničnem preskušanju sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z visokim odmerkom citarabina v 24-urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in bortezomibom, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Injury, poisoning and procedural complications 
Poškodbe, zastrupitve in Občasni padci, kontuzije
Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly. 
Morebitne reakcije, povzročene z imunskimi kompleksi Občasno so poročali o reakcijah, morda povzročenih z imunskimi kompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations. 
Pri bolnikih z diseminiranim plazmocitomom se po intravenski bolusni ali subkutani injekciji pri odmerku 1,3 mg/m2 (n=14 pri intravenski in n=17 pri subkutani skupini) je bila skupna sistemska izpostavljenost po ponovljenem odmerku (AUClast) ekvivalentna pri subkutanem in intravenskem dajanju.
You do not need to check the pH of the solution. 
Vrednosti pH raztopine ni treba preverjati.
In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose. 
Pri ponovljenih odmerkih so bile povprečne vrednosti najvišjih plazemskih koncentracij v razponu od 67 do 106 ng/ml pri odmerku 1,0 mg/m2 in od 89 do 120 ng/ml pri odmerku 1,3 mg/m2.
When toxicity resolves re-initiate Bortezomib SUN treatment and reduce dose to 0.7 mg/m2 once per week. 
Nato ponovno uvedite zdravljenje z zdravilom Bortezomib SUN in zmanjšajte odmerek na 0,7 mg/m2 enkrat na teden.
Adverse drug reactions identified as those with a ≥ 1% incidence, similar or higher incidence in the BzmbR-CAP arm and with at least a possible or probable causal relationship to the components of the BzmbR-CAP arm, are listed in Table 8 below. 
V preglednici 8 so navedeni ugotovljeni neželeni učinki s pogostnostjo ≥ 1 %, ki je bila podobna ali večja v skupini BzmbR-CAP in z najmanj verjetno ali možno vzročno povezanostjo s komponentami v skupini BzmbR-CAP.
Bortezomib SUN 3.5 mg powder for solution for injection IS FOR SUBCUTANEOUS OR INTRAVENOUS USE. 
Zdravilo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je ZA SUBKUTANO ALI INTRAVENSKO UPORABO.
Day 1, 2, 3, 4 Day 8, 9, 10, 11 
Dx 40 mg dan 1, 2, 3, 4 dan 8, 9, 10, 11
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. 
Ker se lahko zmanjša učinkovitost, se sočasna uporaba bortezomiba z močnimi induktorji encima CYP3A4 (npr. rifampicinom, karbamazepinom, fenitoinom, fenobarbitalom in šentjanževko) ne priporoča.
You will receive 4 cycles (12 weeks). 
Prejeli boste 4 kroge zdravljenja (12 tednov).
There is no evidence to suggest that dose adjustments are necessary in patients over 65 years of age with multiple myeloma or with mantle cell lymphoma. 
Ni dokazov, da je pri bolnikih, starejših od 65 let, z diseminiranim plazmocitomom ali limfomom plaščnih celic, potrebna prilagoditev odmerka.
- If several Bortezomib SUN doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration) 
Bortezomib SUN v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
Bortezomib SUN therapy should be withheld until symptoms of the toxicity have resolved to Grade 2 or better. 
Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti, dokler se simptomi toksičnosti ne povrnejo na 2. stopnjo ali še izboljšajo.
Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate. 
Če je klinično ustrezno, je treba za zdravljenje trombocitopenije razmisliti o transfuziji trombocitov.
Common Hypertension*, Hypotension*, Orthostatic hypotension 
Pogosti hipertenzija*, hipotenzija*, ortostatska hipotenzija
Bortezomib SUN 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). 
Zdravljenje z zdravilom Bortezomib SUN je treba prekiniti ob pojavu katere koli z uporabo bortezomiba povezane nehematološke toksičnosti stopnje ≥ 3 (razen nevropatije) ali hematološke toksičnosti stopnje ≥ 3 (glejte tudi poglavje 4.4).
Age 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 leukemia (ALL) or acute myeloid leukemia (AML). 
Farmakokinetiko bortozomiba so ovrednotili po intravenski aplikaciji bolusnega odmerka 1,3 mg/m2 dvakrat na teden 104 pediatričnim bolnikom (starim 2-16 let) z akutno limfoblastno levkemijo (ALL
RECONSTITUTION FOR SUBCUTANEOUS INJECTION 
REKONSTITUCIJA ZA SUBKUTANO INJICIRANJE
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. 
Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z virusom JC (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
The Reconstitution poster shall contain the following key elements: 
Plakat z navodili za rekonstitucijo mora vsebovati naslednje ključne elemente:
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
Time to progression Events n (%) Mediana (95% CI) 
Čas do napredovanja bolezni dogodki n (%) medianaa (95 % CI)
Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure. 
Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82 %) bolnikih v skupini VDDx in 208 (87 %) bolnikih v skupini BzmbDx.
Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib SUN treatment cycle. 
Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom Bortezomib SUN.
Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded. 
Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
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. 
Takoj obvestite svojega zdravnika, če opazite katerega 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,
If you are given Bortezomib SUN together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below: 
Če prejemate zdravilo Bortezomib SUN skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
Platelet transfusion should be considered when clinically appropriate (see section 4.2). 
Če je klinično ustrezno, je treba razmisliti o transfuziji trombocitov (glejte poglavje 4.2).
All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively. 
Periferno nevropatijo (vseh stopenj) so opazili pri 40 %, periferno nevropatijo stopnje ≥ 3 pa pri 8,5 % bolnikov.
If any discolouration or particulate matter is observed, the solution should be discarded. 
Če opazite kakršno koli spremembo barve ali delce v raztopini, jo morate zavreči.
Efficacy results are presented in Table 11: 
Podatki o učinkovitosti so navedeni v preglednici 11:
The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment. 
Tveganje za pojav sindroma razpada tumorja je večje pri bolnikih z večjo maso tumorja pred začetkom zdravljenja.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib SUN therapy. 
da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z zdravilom.
Common Vision abnormal* 
Pogosti nenormalen vid *
Grade ≥ 3 non-haematological toxicities 
Nehematološka toksičnost stopnje ≥ 3
The median number of cycles received for both groups was 4 cycles. 
Mediano število krogov zdravljenja je bilo 4 v obeh skupinah.
Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign* 
Redki maligne neoplazme, plazmocitna levkemija, karcinom ledvičnih celic, masa, fungoidna mikoza, benigne neoplazme*
Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm. 
V BzmbR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib 
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba Skupina z intravenskim injiciranjem
Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown. 
Na podlagi rezultatov raziskav na živalih je prehajanje bortezomiba preko hematoencefalne bariere omejeno oz. zanemarljivo.
- Injection sites should be rotated for successive injections. 
- Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
Subcutaneous use: Add 1.4 ml 0.9% sodium chloride to make 2.5 mg/ml final concentration. 
Subkutana uporaba: dodajte 1,4 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics. 
Za dodatne informacije o melfalanu in prednizonu glejte ustrezna Povzetka glavnih značilnosti zdravila.
Time related events 
Časovno pogojeni
When Bortezomib SUN is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib SUN. 
Kadar se zdravilo Bortezomib SUN uporablja v kombinaciji z drugimi zdravili, je treba prebrati povzetke glavnih značilnosti teh zdravil pred začetkom zdravljenja z zdravilom Bortezomib SUN.
Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2). 
Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja ali preiti na subkutano dajanje (glejte poglavje 4.2).
Adverse reactions are listed below by system organ class and frequency grouping. 
Neželeni učinki v spodnji preglednici so navedeni po organskih sistemih in po pogostnosti.
Sun Pharmaceutical Industries Europe B.V. 
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
Bortezomib SUN is for single use only. 
Zdravilo Bortezomib SUN je samo za enkratno uporabo.
e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors. 
e Uporabljena je Mantel-Haenszelova ocena razmerja obetov za stratificirane preglednice, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.