natgillin/translations-raw huggingface dataset:
In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia. 
V študijah zdravljenja z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma in pri bolnikih z nezdravljenim MCL, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzmbR-CAP), je bil eden od najpogostejših toksičnih učinkov na hematološki sistem prehodna trombocitopenija.
- Platelet counts should be ≥ 70 x 109/l and the absolute neutrophils count should be ≥ 1.0 x 109/l 
Neutrophil Count) mora biti ≥ 1,0 x 109/l.
T 50 mg 
T 50 mg na dan na dan
Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib SUN dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above. 
Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila Bortezomib SUN pri kombiniranem zdravljenju upoštevajte navodila za samostojno zdravljenje, opisana zgoraj.
Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors. 
Presnovka, ki nastaneta po odcepitvi bora, ne delujeta kot zaviralca 26S-proteasoma.
Intent to Treat Populationb n=74 
Populacija bolnikov, ki naj bi jo zdravili (ITT)b n=74
You may experience a reduction in the number of: - platelets, which may make you be more prone to bruising, or to bleeding without obvious injury (e.g., bleeding from your bowels, stomach, mouth and gum or bleeding in the brain or bleeding from the liver) - red blood cells, which can cause anaemia, with symptoms such as tiredness and paleness - white blood cells may make you more prone to infections or flu-like symptoms. 
- krvnih ploščic, zaradi česar ste lahko bolj dovzetni za podplutbe ali krvavitve brez očitnih poškodb (npr.: krvavitve v črevesju, želodcu, ustih in dlesnih ali krvavitve v možganih ali jetrih); - rdečih krvnih celic, kar lahko vodi v anemijo, s simptomi, kot sta utrujenost in bledica; - belih krvnih celic, zato boste bolj dovzetni za okužbe ali gripi podobne simptome.
b Hazard ratio estimate is based on a Cox's model stratified by IPI risk and stage of disease. 
b Ocena razmerja tveganja na podlagi Coxovega modela, stratificirana z IPI-tveganjem in stadijem bolezni.
Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy. 
Bortezomib v kombinaciji s pegiliranim liposomskim doksorubicinom (študija DOXIL-MMY-3001) Pri 646 bolnikih je bila opravljena randomizirana, odprta, multicentrična študija faze III pri vzporednih skupinah, v kateri so primerjali varnost in učinkovitost kombinirane terapije z bortezomibom in pegiliranim liposomskim doksorubicinom z monoterapijo z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto terapije in pri katerih bolezen ni napredovala med prejemanjem antraciklinske terapije.
No new safety concerns were observed during the study, and in particular bortezomib did not exacerbate target organ damage (heart, kidney and liver). 
Uporaba bortezomiba ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
Notable differences in the safety profile of bortezomib administered subcutaneously versus intravenously as single agent 
Pomembne razlike v varnostnem profilu uporabe bortezomiba v monoterapiji subkutano oz.
Aseptic technique must be strictly observed throughout the handling of Bortezomib SUN, since it contains no preservative. 
MED RAVNANJEM Z ZDRAVILOM BORTEZOMIB SUN MORATE VES ČAS STROGO UPOŠTEVATI ASEPTIČNO PRIPRAVO, SAJ ZDRAVILO NE VSEBUJE KONZERVANSA.
Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment. 
Varnost in učinkovitost bortezomiba (injicirano intravensko) v priporočenem odmerku 1,3 mg/m2 so ovrednotili v dveh preskušanjih: v randomiziranem, primerjalnem (primerjava z deksametazonom (Dex)) preskušanju faze III (APEX) pri 669 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli 1 do 3 vrste terapije ter v enodelnem preskušanju druge faze pri 202 bolnikih z relapsom ali z diseminiranim plazmocitomom, odpornim na zdravljenje, ki so pred tem že prejeli najmanj 2 vrsti terapije in je bolezen ob zadnji vrsti terapije napredovala.
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester). 
Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline).
(listed in section 6) - if you have certain severe lung or heart problems. 
- če imate določene hude težave s pljuči ali srcem.
These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up. 
To so lahko znaki resne okužbe možganov.
Week Bzmb (1.3 mg/m2) Day 1, 4 
Teden Bzmb (1,3 mg/m2) dan 1, 4
The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia. 
Med zdravljenjem z bortezomibom so najpogosteje poročali o navzei, diareji, zaprtosti, bruhanju, utrujenosti, pireksiji, trombocitopeniji, anemiji, nevtropeniji, periferni nevropatiji (vključno s senzorično nevropatijo), glavobolu, paresteziji, zmanjšanem apetitu, dispneji, izpuščaju, virusu herpes zostru in mialgiji.
No clinical data are available for bortezomib with regard to exposure during pregnancy. 
Nosečnost Za bortezomib ni na voljo kliničnih podatkov nosečnic, ki so bile izpostavljene zdravilu.
Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3. 
Bolniki so prejeli zdravilo bortezomib le v 1. in 2. sklopu zdravljenja, da so izognili prekrivanju toksičnih učinkov z drugimi, sočasno danimi zdravili v 3. sklopu zdravljenja.
How to use Bortezomib SUN 
Kako uporabljati zdravilo Bortezomib SUN
Bortezomib SUN will be administered by a health care professional experienced in the use of cytotoxic medicines. 
Zdravilo Bortezomib SUN vam bo injiciral zdravstveni delavec, izkušen v uporabi citotoksičnih zdravil.
Medianc(95% CI) (months) Response rate n: response-evaluable patients Overall complete response (CR+CRu)f n(%) 
medianac(95 % CI) (meseci) Stopnja odziva n: odziv preiskovanih bolnikov
Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis 
Redki odpoved jeter, hepatomegalija, Budd-Chiarijev sindrom, citomegalovirusni hepatitis, krvavitev v jetrih, holelitiaza
Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2). 
< 25.000/μl ali če se bolnik zdravi z bortezomibom v kombinaciji z melfalanom in prednizonom ter je število trombocitov ≤ 30.000/μl (glejte poglavje 4.2).
This 3-week period is considered a treatment cycle. 
To 3-tedensko obdobje predstavlja en krog zdravljenja.
24.0 mo 
24,0 meseca
Bortezomib SUN dose should be reduced by 1 dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2) 
Odmerek zdravila Bortezomib SUN je treba zmanjšati za 1 stopnjo (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2)
PHARMACEUTICAL FORM Powder for solution for injection. 
Prašek za raztopino za injiciranje.
- In cycles 1 to 4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 
- V krogih od 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25.,
Neutrophils were lowest at Day 11 of each cycle of bortezomib treatment and typically recovered to baseline by the next cycle. 
Število trombocitov je bilo najmanjše 11. dan vsakega kroga zdravljenja z bortezomibom in se je do naslednjega kroga zdravljenja navadno povrnilo na začetno vrednost.
Common Weight decreased Uncommon Hyperbilirubinaemia*, Protein analyses abnormal*, Weight increased, Blood test abnormal*, C-reactive protein increased 
Občasni hiperbilirubinemija*, nenormalni izvidi analiz proteinov*, zvečana telesna masa, nenormalni izvidi krvnih preiskav*, zvišana koncentracija C-reaktivnega proteina
Table 5: Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma 
Preglednica 5: Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic Toksičnost
Both in patients who were refractory to their last prior therapy and those who were not refractory, overall survival was significantly longer and response rate was significantly higher on the bortezomib arm. 
Tako pri bolnikih s plazmocitomom, odpornim na zdravljenje, po prejšnji vrsti zdravljenja, kot pri tistih, ki so se odzvali na zdravljenje, je bilo celokupno preživetje v skupini, ki je prejemala bortezomib, statistično značilno daljše in odziv na zdravljenje je bil statistično značilno boljši.
In B-ALL patients with relapse 18 36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85). 
Pri bolnikih z B-celično ALL in relapsom po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odgovorov 79% (95% CI: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73% (95% CI: 54, 85).
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. 
Reaktivacija in okužba z virusom hepatitisa B (HBV) Pri bolnikih s tveganjem za okužbo s HBV je treba pred uporabo rituksimaba v kombinaciji z bortezomibom vedno opraviti presejalni test za HBV. Prenašalce virusa hepatitisa B in bolnike, ki so že bili okuženi z virusom hepatitisa B, je treba med zdravljenjem in v nadaljevanju zdravljenja z rituksimabom v kombinaciji z bortezomibom skrbno spremljati glede kliničnih in laboratorijskih znakov aktivne okužbe s HBV.
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib SUN plus dexamethasone, and Bortezomib SUN plus dexamethasone and thalidomide). 
• Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo
Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency 
Redki periferni embolizem, limfedem, bledica, eritromelalgija, vazodilatacija, sprememba barve ven, venska insuficienca
A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone and thalidomide group. 
Pri CR+nCR so opazili statistično značilno razliko v prid kombinaciji bortezomiba z deksametazonom in talidomidom.
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors. 
Sočasno jemanje zdravil Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4, je treba skrbno spremljati.
> 1.5 x - 3 x ULN Any 
> 1,5-3x ULN katera koli
In Cycles 1-4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32. 
V krogih 1 do 4 se zdravilo Bortezomib SUN daje dvakrat na teden, 1., 4., 8., 11., 22., 25., 29. in 32. dan.
In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzmbR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]). 
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost trombocitopenije stopnje 3 ali več v skupini, ki je prejemala bortezomib (BzmbR-CAP), večja (56,7 % proti 5,8 %), v primerjavi s skupino, ki bortezomiba ni prejemala (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon [R-CHOP]).
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio. 
CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbDx=bortezomib in deksametazon; VDDx=vinkristin, doksorubicin in deksametazon; VGPR=zelo dober delni odziv; PR=delni odziv; OR=razmerje obetov.
Uncommon Cardiac tamponade#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia 
Občasni tamponada srca#, srčno-pljučni zastoj*, srčna fibrilacija (vključno z atrijsko), srčno popuščanje (vključno z levim in desnim prekatom)*, aritmija*, tahikardija*, palpitacije, angina pektoris, perikarditis (vključno s perikardialnim izlivom)*, kardiomiopatija*, disfunkcija prekata*, bradikardija
Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV). 
V randomizirani, odprti študiji faze III, LYM-3002, so pri odraslih bolnikih s predhodno nezdravljenim MCL (stopnje II, III ali IV) primerjali učinkovitost in varnost bortezomiba v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (BzmbR-CAP; n=243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n=244).
You might receive up to 8 cycles (24 weeks). 
Lahko boste prejeli do največ 8 krogov zdravljenja (24 tednov).
Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response 
CR=popolni odziv; nCR=skoraj popolni odziv PR=delni odziv; MR=minimalni odziv
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted Bortezomib SUN (both IV and SC use) required for different body surface areas. 
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila Bortezomib SUN (za i.v.
Dosage adjustments for transplant eligible patients 
Prilagoditev odmerjanja pri bolnikih, primernih za presaditev krvotvornih matičnih celic
Some of these include difficulty breathing, shortness of breath, shortness of breath without exercise, 
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje, ki postane plitvo, oteženo ali preneha, sopenje
Therefore, caution should be used during handling and preparation. 
Splošni previdnostni ukrepi Bortezomib je citotoksično zdravilo, zato je med pripravo in ravnanjem z njim potrebna previdnost.
You might receive up to 6 cycles (24 weeks). 
Lahko boste prejeli do 6 krogov zdravljenja (24 tednov).
In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib. 
V študiji faze III so imeli bolniki, ki so prejemali bortezomib subkutano, za 13 % manjšo celokupno incidenco neželenih učinkov zaradi uporabe zdravila s stopnjo toksičnosti 3 ali več in za 5 % manjšo pogostnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali bortezomib intravensko.
Hair disorder* 
Stopnja jetrne okvare*
Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma 
Klinična učinkovitost subkutanega dajanja bortezomiba bolnikom pri relapsu/diseminiranem plazmocitomu, odpornem na zdravljenje
Seizures have been uncommonly reported in patients without previous history of seizures or epilepsy. 
Pri bolnikih, ki pred zdravljenjem niso imeli epileptičnih napadov ali epilepsije, so občasno poročali o epileptičnih napadih.
Bortezomib SUN is given intravenously or subcutaneously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment. 
Zdravilo Bortezomib SUN boste prejeli intravensko na 1., 4., 8. in 11. dan, temu pa bo sledil premor brez zdravljenja.
It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells. 
Izdelan je specifično za zaviranje kimotripsinske aktivnosti 26S
Table 6: Recommended starting dose modification for Bortezomib SUN in patients with hepatic impairment Grade of hepatic impairment* 
Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila Bortezomib SUN pri bolnikih z boleznijo jeter
Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* 
Zelo pogosti periferna senzorična nevropatija, disestezija*, nevralgija*
Also included are adverse drug reactions identified in the BzmbR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies. 
Vključeni so tudi neželeni učinki, ugotovljeni v skupini BzmbR-CAP, ki so na podlagi podatkov študij diseminiranega plazmocitoma in po mnenju raziskovalcev najmanj verjetno ali možno povezani z uporabo bortezomiba.
Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with BzmbR-CAP in a clinical trial 
Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BzmbR-CAP v kliničnih preskušanjih Organski sistem Pogostnost Neželeni učinek
Reduce Bortezomib SUN to 0.7 mg/m2 in the first treatment cycle. 
Zmanjšati odmerek zdravila Bortezomib SUN v prvem krogu zdravljenja na 0,7 mg/m2.
At least 72 hours should elapse between consecutive doses of Bortezomib SUN. 
Med zaporednimi odmerki zdravila Bortezomib SUN mora preteči vsaj 72 ur.
Bzmb (1.3 mg/m2) Day 1, 4 
Bzmb (1,3 mg/m2) dan 1, 4
In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly. 
Pri analizi učinkovitosti, merjene s hematološkim odzivom (M-protein), pri 49 bolnikih, pri katerih je bila mogoča ocena in so prejemali največje dovoljene odmerke 1,6 mg/m2 na teden in 1,3 mg/m2 dvakrat na teden, je bila stopnja odziva 67,3 % (vključno z deležem CR 28,6 %).
Bortezomib SUN is for intravenous or subcutaneous use. 
Zdravilo Bortezomib SUN je namenjeno za intravensko ali subkutano uporabo.
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bzmb=bortezomib; BzmbTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; 
CI= interval zaupanja; CR= popoln odziv; nCR= skoraj popoln odziv; ITT=populacija, ki so jo nameravali zdraviti; RR=stopnja odziva; Bzmb=bortezomib; BzmbTDx=bortezomib, talidomid in deksametazon; TDx=talidomid in deksametazon; PR=delni odziv; OR=razmerje obetov
Uncommon Angioedema#, Hypersensitivity* Rare 
Občasni angioedem#, preobčutljivost*
• Bortezomib SUN 3.5 mg can be administered both intravenously and subcutaneously 
• Zdravilo Bortezomib SUN 3,5 mg se lahko daje intravensko in subkutano.
BzmbR-CAP=bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy 
BzmbR-CAP=bortezomib, rituksimab, ciklofosfamid, doksorubicin in prednizon; R-CHOP= rituksimab ciklofosfamid, doksorubicin, vinkristin in prednizon; PN=periferna nevropatija
13.1 mo 
13,1 meseca
* Primary endpoint a OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by 
* Primarna ocena učinkovitosti a OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti Cochran Mantel-Haenszelovega testa.
Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration 
Redki bolezni mod*, prostatitis, bolezni dojk pri ženskah, občutljivost epididimisa, epididimitis, bolečina v medenici, razjede vulve
Common Muscle spasms*, Musculoskeletal pain*, Pain in extremity 
Pogosti mišični krči*, mišično-skeletna bolečina*, bolečine v udih
Injection under the skin is in either the thighs or the abdomen. 
Pri podkožnem dajanju se zdravilo injicira v stegna ali trebuh.
The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83). 
Delež popolnih odgovorov pri prvih bolnikih s T-celično ALL (n = 22) je bil 68% (95% CI: 45, 86), delež 4-mesečnega preživetja bolnikov brez dogodkov pa 67% (95%
Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome 
Redki respiratorna odpoved, sindrom akutne dihalne stiske, apneja, pnevmotoraks, atelektaza, pljučna hipertenzija, hemoptiza, hiperventilacija, ortopneja, pnevmonitis, respiratorna alkaloza, tahipneja, pljučna fibroza, bolezni bronhijev*, hipokapnija*, intersticijska bolezen pljuč, infiltracija pljuč, stiskanje v grlu, suho grlo, zvečana sekrecija iz zgornjih dihal, draženje žrela, sindrom kašlja zgornjih dihalnih poti (UACS - Upper-airway cough syndrome)
Early and regular monitoring for symptoms of treatment-emergent neuropathy with neurological evaluation should be considered in patients receiving bortezomib in combination with medicinal products known to be associated with neuropathy (e.g. thalidomide) and appropriate dose reduction or treatment discontinuation should be considered. 
(npr. talidomid), je potrebno zgodnje in redno spremljanje pojava simptomov (z zdravljenjem povezane) nevropatije, opraviti nevrološko oceno ter ustrezno zmanjšati odmerek ali razmisliti o ukinitvi zdravljenja.
Rest period Rest period 
premor premor