natgillin/translations-raw huggingface dataset:
Patients with moderate or severe hepatic impairment should be started on Bortezomib SUN at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2). 
Na podlagi bolnikovega prenašanja zdravljenja je treba pretehtati možnost povečanja odmerka na 1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2 (glejte preglednico 6 ter poglavji 4.4 in 5.2).
Refer to the Summary of Product Characteristics of thalidomide for additional information. 
Za dodatne podatke glejte povzetek glavnih značilnosti zdravila za talidomid.
and 32. 
29. in 32. dan.
Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction* Uncommon Cardiovascular disorder (inc cardiogenic shock) 
Pogosti fibrilacija srca (vključno z atrijsko), aritmija*, srčno popuščanje (vključno s popuščanjem levega in desnega prekata)*, ishemija miokarda, moteno delovanje prekatov*
- If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib SUN dosing day (other than day 1) 
≤ 30 x 109/l ali ANC ≤ 0,75 x 109/l
- Platelet counts should be ≥ 75,000 cells/μl in patients with bone marrow infiltration or splenic sequestration 
- Pri bolnikih z infiltracijo kostnega mozga ali sekvestracijo vranice mora biti število trombocitov ≥ 75.000 celic/μl.
Change Bortezomib SUN treatment schedule to 1.3 mg/m2 once per week 
Bortezomib SUN na odmerek 1,3 mg/m2 enkrat na teden
Nine treatment cycles of this combination therapy are administered. 
Zdravljenje s to kombinacijo traja devet krogov.
The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80. 
Mediana starosti bolnikov v študiji je bila 71 let, 50 % sodelujočih je bilo moških, 88 % belcev.
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01 
Preglednica 9: Pojavnost periferne nevropatije med uvajalnim zdravljenjem glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije
A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients. 
Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek rifampicina, močnega inhibitorja encima CYP2C19, na farmakokinetiko bortezomiba (danega intravensko), je na podlagi podatkov 6 bolnikov pokazala povprečno zmanjšanje AUC bortezomiba za 45 %.
Method of administration Bortezomib SUN is available for intravenous or subcutaneous administration. 
Zdravilo Bortezomib SUN se daje intravensko ali subkutano.
Bortezomib SUN in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. 
Zdravilo Bortezomib SUN je v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom indicirano za zdravljenje odraslih bolnikov z limfomom plaščnih celic, ki še niso prejemali zdravljenja in pri katerih presaditev krvotvornih matičnih celic ni mogoča.
Time to next therapy Events n (%) Mediana (95% CI) 
Čas do naslednjega zdravljenja dogodki n (%) Medianaa
Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. 
Talidomid je učinkovina z znanim teratogenim učinkom pri ljudeh.
If you have not been treated before for multiple myeloma, and you are suitable for blood stem cell transplantation you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines dexamethasone, or dexamethasone and thalidomide, as induction treatment: - When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. 
Če pri vas diseminiranega plazmocitoma še niso zdravili in je presaditev krvotvornih matičnih celic za vas primerna, boste kot uvajalno zdravljenje prejeli zdravilo Bortezomib SUN v veno ali v podkožje v kombinaciji z deksametazonom ali z deksametazonom in talidomidom:
Seizures 
- fistula
Do not drive or operate tools or machines if you experience such side effects; even if you do not, you should still be cautious. 
Če imate naštete neželene učinke, ne vozite in ne upravljajte orodij ali strojev.
Bortezomib SUN must be reconstituted by a healthcare professional (see section 6.6). 
mora rekonstituirati zdravstveno osebje (glejte poglavje 6.6).
Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing 
Občasni pljučni embolizem, plevralni izliv, pljučni edem (vključno z akutnim), pljučna alveolarna krvavitev#, bronhospazem, kronična obstruktivna pljučna bolezen*, hipoksemija*, kongestija dihal*, hipoksija, plevritis*, kolcanje, izcedek iz nosu, disfonija, piskanje v pljučih
Bortezomib SUN reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left). 
Subkutano injiciranje Rekonstituirano raztopino zdravila Bortezomib SUN injiciramo subkutano v stegno (desno ali levo)
Patients in the BzmbR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 IV on day 1; cyclophosphamide 750 mg/m2 IV on day 1; doxorubicin 50 mg/m2 IV on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5 of the 21 day bortezomib treatment cycle. 
Bolniki v skupini BzmbR-CAP so prejeli bortezomib (1,3 mg/m2 na 1., 4., 8., in 11. dan, sledil je premor od 12. do 21. dne), 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida, 50 mg/m2 doksorubicina i.v.
Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability. 
1,0 mg/m2 ali zmanjšanja odmerka na 0,5 mg/m2.
- Non-haematological toxicities should have resolved to Grade 1 or baseline. 
- Nehematološke toksičnosti se morajo povrniti na 1. stopnjo ali stanje pred začetkom zdravljenja.
Thrombocytopenia*, Febrile neutropenia, Neutropenia*, Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia* 
Zelo pogosti trombocitopenija*, febrilna nevtropenija, nevtropenija*, levkopenija*, anemija*, limfopenija*
The benefit/risk ratio should be considered prior to continuing bortezomib therapy. 
Pred nadaljevanjem zdravljenja z bortezomibom je treba oceniti razmerje med koristjo in tveganjem.
Prednisone is given orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of the Bortezomib SUN treatment cycle. 
Prednizon boste jemali peroralno v odmerku 100 mg/m2 na 1., 2., 3., 4. in 5. dan kroga zdravljenja z zdravilom Bortezomib SUN.
For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics. 
Za dodatne informacije o deksametazonu glejte povzetek glavnih značilnosti tega zdravila.
Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with bortezomib at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2). 
Zato je treba te bolnike zdraviti z manjšimi odmerki bortezomiba in pri njih skrbno spremljati morebitni pojav toksičnosti (glejte poglavji 4.2 in 5.2).
Thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards. 
Če boste odmerek dobro prenašali, se lahko poveča na 100 mg na dan od 15. do 28. dneva in od drugega kroga zdravljenja naprej še na 200 mg na dan.
EBMT criteria g All randomised patients with secretory disease 
fCR = popolni odgovor; PR = delni odgovor, EBMT kriteriji g Vsi randomizirani bolniki s sekrecijsko boleznijo
Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance 
Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična nevropatija, omotica*, disgevzija*,
When Bortezomib SUN is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications. 
Pri sočasni uporabi Bortezomib SUN z drugimi zdravili glejte povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
Each 10 ml vial of Bortezomib SUN must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. 
Vsako 10 ml vialo zdravila Bortezomib SUN morate previdno rekonstituirati s 1,4 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
Each 10 ml vial of Bortezomib SUN must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper. 
Vsako 10 ml vialo zdravila Bortezomib SUN morate previdno rekonstituirati s 3,5 ml 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje.
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. 
309 bolnikov, ki so imeli začetno število trombocitov > 75.000/μl, jih je samo 14 % imelo med preskušanjem število trombocitov ≤ 25.000/μl.
Based on the data presented, the PRAC was of the view that the product information should be varied to update Section 4.8 the SmPC and relevant section of the package leaflet to add the following: chalazion, blepharitis and Thrombotic Microangiopathy. 
Na osnovi pregledanih podatkov, je PRAC mnenja, da so spremembe v informacijah o zdravilu v poglavju 4.8 povzetka glavnih značilnosti zdravila in ustreznem poglavju navodila za uporabo utemeljene.
In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below: 
skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia *, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance 
Redki hipermagneziemija*, acidoza, motnje ravnovesja elektrolitov*, čezmerno nabiranje tekočine, hipokloremija*, hipovolemija, hiperkloremija*, hiperfosfatemija*, presnovne motnje, pomanjkanje vitaminov B-kompleksa, pomanjkanje vitamina B12,
NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection bortezomib 
Navodilo za uporabo Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje bortezomib
Incidence Adverse reaction 
Občasni anafilaktična reakcija
Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment. 
V povezavi z zdravljenjem z bortezomibom so poročali o gastrointestinalni in intracerebralni krvavitvi.
In the same drug-drug interaction study assessing the effect of dexamethasone, a weaker CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 7 patients. 
V študiji medsebojnega delovanja zdravil, ki je ocenjevala učinek omeprazola, močnega induktorja encima CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), na podlagi podatkov 17 bolnikov, ni bilo pomembnega vpliva na farmakokinetiko bortezomiba.
Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved. 
SUN, dokler ne minejo znaki toksičnosti.
breathing that becomes shallow, difficult or stops, wheezing - hiccups, speech disorders - increased or decreased urine production (due to kidney damage), painful passing of urine or blood/proteins in the urine, fluid retention - altered levels of consciousness, confusion, memory impairment or loss - hypersensitivity - hearing loss, deafness or ringing in the ears, ear discomfort - hormone abnormality which may affect salt and water absorption - overactive thyroid gland - inability to produce enough insulin or resistance to normal levels of insulin - irritated or inflamed eyes, excessively wet eyes, painful eyes, dry eyes, eye infections, lump in the eyelid (chalazion), red and swollen eyelids, discharge from the eyes, abnormal vision, 
- preobčutljivost - poslabšanje sluha, gluhost ali zvonjenje v ušesih, nelagodje v ušesu - hormonske motnje, ki lahko vplivajo na absorpcijo soli in vode - preveč aktivna žleza ščitnica - nezmožnost tvorbe insulina ali odpornost na normalne koncentracije insulina - draženje ali vnetje oči, čezmerno solzenje, boleče oči, suhe oči, okužbe oči, zatrdlina na veki
Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria 
Občasni akutna odpoved ledvic, kronična odpoved ledvic*, okužba sečil*, znaki in simptomi bolezni sečil*, hematurija*, retenca urina, težave pri uriniranju*,
• advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use 
in s.c. in, da je pri s.c. uporabi potrebno menjati mesta injiciranja.
Bortezomib SUN in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. 
Zdravilo Bortezomib SUN je v kombinaciji z melfalanom in prednizonom indicirano za zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih pred presaditvijo krvotvornih matičnih celic kemoterapija v velikih odmerkih ni primerna.
Uncommon Fall, Contusion Rare 
- nenormalen, zamegljen vid
If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib SUN must be considered unless the benefit of treatment clearly outweighs the risk. 
morate premisliti o ukinitvi zdravila Bortezomib SUN, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
How to store Bortezomib SUN 
Način dajanja zdravila Bortezomib SUN
Pneumonia* 
Syndrome)
You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib SUN for information related to these medicines before starting treatment with Bortezomib SUN. 
Preden začnete zdravljenje z zdravilom Bortezomib SUN, preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom Bortezomib SUN.
Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with bortezomib. 
Med zdravljenjem z bortezomibom je treba pogosto spremljati število krvnih celic z diferencialno krvno sliko, vključno s številom trombocitov.
VDDx=vincristine, doxorubicin, dexamethasone; BzmbDx=bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzmbTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy. 
VDDx=vinkristin, doksorubicin, deksametazon; BzmbDx=bortezomib, deksametazon; TDx=talidomid, deksametazon;
Renal complications are frequent in patients with multiple myeloma. 
Pri bolnikih z diseminiranim plazmocitomom so pogosti ledvični zapleti.
Pulmonary disorders 
Diseminirani plazmocitom
The vial is contained in a transparent blister pack consisting of a tray with a lid. Each pack contains 1 single-use vial. 
Ena škatla vsebuje eno vialo za enkratno uporabo.
Common Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection* Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection* 
Občasni okužba*, bakterijske okužbe*, virusne okužbe*, sepsa (vključno s septičnim šokom)*, bronhopnevmonija, okužba s herpesvirusom*, herpetični meningoencefalitis#, bakteriemija (vključno s stafilokokno), hordeol, gripa, celulitis, z uporabo katetra povezana okužba, okužba
Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma. 
Za potrditev varnosti in učinkovitosti uvajalnega zdravljenja z bortezomibom v kombinacijah z dvema ali tremi kemoterapevtskimi učinkovinami, pred presaditvijo krvotvornih matičnih celic pri bolnikih s še nezdravljenim diseminiranim plazmocitomom so izvedli dve randomizirani, odprti, multicentrični preskušanji faze III (IFM-2005-01, MMY-3010).
Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality* 
Zelo pogosti zmanjšan apetit Pogosti dehidracija, hipokaliemija*, hiponatriemija*, nenormalne koncentracije glukoze v krvi*, hipokalciemija*, encimske motnje*
Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention 
hipomagneziemija*, hipofosfatemija*, hiperkaliemija*, hiperkalciemija*, hipernatriemija*, nenormalne koncentracije sečne kisline*, sladkorna bolezen*, zastajanje tekočine
Very common side effects (may affect more than 1 in 10 people) - sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage - reduction in the number of red blood cells and/or white blood cells (see above) - fever - feeling sick (nausea) or vomiting, loss of appetite - constipation with or without bloating (can be severe) - diarrhoea: if this happens, it is important that you drink more water than usual. 
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) - občutljivost, odrevenelost, mravljinci ali pekoč občutek na koži ali bolečine v dlaneh in stopalih zaradi poškodbe živca - zmanjšanje števila rdečih krvnih celic in/ali belih krvnih celic (glejte zgoraj)
Ear haemorrhage, Vestibular neuronitis, Ear disorder NOS 
Redki ušesna krvavitev, vestibularni nevronitis, ušesne bolezni n.d.n.
If you have not been treated before for mantle cell lymphoma you will receive Bortezomib SUN intravenously or subcutaneously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone. 
Limfom plaščnih celic, ki še ni bil zdravljen Če vam limfoma plaščnih celic še niso zdravili, boste zdravilo Bortezomib SUN prejeli v veno, skupaj z rituksimabom, ciklofosamidom, doksorubicinom in prednizonom.
Bortezomib SUN in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. 
Zdravilo Bortezomib SUN je v kombinaciji z deksametazonom ali deksametazonom in talidomidom indicirano za indukcijsko zdravljenje odraslih bolnikov, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih.
Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below. 
1,3 mg/m2 telesne površine, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (BzmbR-CAP), v primerjavi z 242 bolniki, zdravljenimi z rituksimabom,
Class 
Izmed
Mild 
Viala
Once the symptoms of the toxicity have resolved, Bortezomib SUN treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2). 
vendar s 25 % manjšim odmerkom (1,3 mg/m2 zmanjšano na 1,0 mg/m2; 1,0 mg/m2 zmanjšano na
Hypothyroidism 
Hipotenzija
Posology modification 
Prilagoditev odmerjanja
bleeding of the eye - swelling of your lymph glands - joint or muscle stiffness, sense of heaviness, pain in your groin - hair loss and abnormal hair texture - allergic reactions - redness or pain at the injection site - mouth pain - infections or inflammation of the mouth, mouth ulcers, oesophagus, stomach and intestines, 
- bolečine v trebuhu, napenjanje - oteženo požiranje - okužba ali vnetje trebuha in črevesja - bolečina v želodcu - vnetje ust ali ustnic, bolečina v žrelu
restlessness or agitation, changes in your mental status, disorientation 
- težave s spanjem, znojenje, tesnoba, nihanje razpoloženja, depresivno razpoloženje, nemir ali vznemirjenost, spremembe v duševnem stanju, dezorientiranost
Bortezomib is eliminated more rapidly following the first dose compared to subsequent doses. 
V primerjavi s ponovljenimi odmerki se bortezomib po prvem odmerku hitreje izloči iz telesa.
Common Renal impairment* 
Pogosti okvara ledvic*
sometimes associated with pain or bleeding, poor movement of the intestines (including blockage), abdominal or oesophageal discomfort, difficulty swallowing, vomiting of blood - skin infections - bacterial and viral infections - tooth infection - inflammation of the pancreas, obstruction of the bile duct - genital pain, problem having an erection - weight increase - thirst - hepatitis - injection site or injection device related disorders - skin reactions and disorders (which may be severe and life threatening), skin ulcers - bruises, falls and injuries - inflammation or haemorrhage of the blood vessels that can appear as small red or purple dots 
- pordelost ali bolečina na mestu injiciranja - bolečine v ustih - okužbe ali vnetja v ustih, razjede v ustih, požiralniku, želodcu in črevesju, ki jih včasih spremlja bolečina ali krvavitev, počasno gibanje črevesja (vključno z zaporo), nelagodje v trebuhu ali požiralniku, oteženo požiranje, bruhanje krvi - okužbe kože - bakterijske in virusne okužbe - okužba zob - vnetje trebušne slinavke, zapora žolčevoda - bolečina v spolovilih, motnje pri doseganju erekcije - zvečanje telesne mase - žeja - vnetje jeter (hepatitis)
• Reconstitution, dosing and administration booklet 
• Izobraževalno knjižico z navodili za rekonstitucijo, odmerjanje in način uporabe
1 prior line of therapy 
1 predhodna vrsta zdravljenja
- If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl, Bortezomib SUN may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2). 
≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo Bortezomib SUN v odmerku, ki je za eno stopnjo manjši od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na 0,7 mg/m2).