natgillin/translations-raw huggingface dataset:
Incidence Adverse reaction block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest 
Redki atrijska undulacija, miokardni infarkt*, atrioventrikularni blok*, srčnožilne bolezni (vključno s kardiogenim šokom), Torsade de pointes, nestabilna angina pektoris,
Distribution The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma. 
Po enkratnem ali večkratnem intravenskem dajanju odmerkov 1,0 mg/m2 ali 1,3 mg/m2 bolnikom z diseminiranim plazmocitomom je bil povprečni volumen porazdelitve (Vd) od 1,659 l do 3,294 l. To nakazuje, da se bortezomib v veliki meri porazdeljuje v periferna tkiva.
The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria. 
Po kriterijih Evropske skupine za transplantacijo kostnega mozga (EBMT - European Group for Blood and Marrow Transplantation) je bil primarni opazovani dogodek glede učinkovitosti TTP, sekundarna opazovana dogodka pa OS in
When Bortezomib SUN is given in combination with other medicinal products, refer to the Summary of Product Characteristics of these products for instructions for administration. 
Pri sočasni uporabi zdravila Bortezomib SUN z drugimi zdravili glejte povzetke glavnih značilnosti teh zdravil za navodila za odmerjanje.
Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)* 
krvavitev*, tromboflebitis (vključno s površinskim), cirkulatorni kolaps (vključno s hipovolemičnim šokom), flebitis, pordelost*, hematom (vključno s perirenalnim)*, slaba periferna prekrvavitev*, vaskulitis, hiperemija (vključno z očesno)*
Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst 
fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega sistema in vezivnega tkiva*, sinovialna cista
Common Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness) 
Občasni vertigo*, okvara sluha (vse do in vključno z gluhostjo)
Bortezomib SUN as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. 
4.1 Terapevtske indikacije Zdravilo Bortezomib SUN je indicirano za zdravljenje diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali deksametazonom pri odraslih bolnikih, ki so prejeli najmanj eno predhodno vrsto zdravljenja in so jim že presadili krvotvorne matične celice ali presaditev pri njih ni mogoča.
You may also be given Bortezomib SUN together with the medicines pegylated liposomal doxorubicin or dexamethasone: - When Bortezomib SUN is given together with pegylated liposomal doxorubicin, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. 
- Če boste prejeli zdravilo Bortezomib SUN skupaj s pegiliranim liposomskim doksorubicinom, vam bodo zdravilo Bortezomib SUN injicirali v veno ali v podkožje v 21-dnevnem krogu zdravljenja in pegilirani liposomski doksorubicin v odmerku 30 mg/m2 v obliki enourne intravenske infuzije na 4. dan 21-dnevnega kroga zdravljenja, po injekciji zdravila Bortezomib SUN.
Dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib SUN 21-day treatment cycle. 
Bolnik jemlje 20 mg deksametazona peroralno na 1., 2., 4., 5., 8., 9., 11. in 12. dan 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN.
- mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable. 
v kombinaciji z deksametazonom ali z deksametazonom in talidomidom pri bolnikih, pri katerih bolezni še nismo zdravili ter pred kemoterapijo v velikih odmerkih in presaditvijo krvotvornih matičnih celic (uvajalno zdravljenje); - limfoma plaščnih celic (redka oblika raka, ki prizadene bezgavke) pri bolnikih, starih 18 let in več, v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom, pri bolnikih, pri katerih bolezni še nismo zdravili in pri katerih presaditev krvotvornih matičnih celic ni primerna.
Uncommon side effects (may affect up to 1 in 100 people) - heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate - failing of your kidneys - inflammation of a vein, blood clots in your veins and lungs - problems with blood clotting - insufficient circulation - inflammation of the lining around your heart or fluid around your heart - infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis - bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina - cerebrovascular disorders - paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation 
- vnetje srčne ovojnice ali nabiranje tekočine okoli srca - okužbe, vključno z okužbo sečil, gripa, okužba s herpes virusom, ušesne okužbe in celulitis - krvavo blato, krvavitve iz sluznic, npr. v ustih, nožnici - možganskožilne bolezni - paraliza, krči, padci, motnje gibanja, nenormalen, spremenjen ali zmanjšan občutek (otip, sluh,
Overall survival* Events (deaths) n (%) Mediana (95% CI) 
Preživetje brez napredovanja bolezni dogodki n (%) medianaa (95 % CI)
There have been fatal cases of inadvertent intrathecal administration of bortezomib. 
Intratekalna uporaba Nenamerno intratekalno dajanje bortezomiba se je končalo s smrtnimi primeri.
Injection into a vein is rapid, taking 3 to 5 seconds. 
traja od 3 do 5 sekund.
The matched-pair analysis is a statistical method in which patients in the treatment group (e.g. bortezomib in combination with dexamethasone) and patients in the comparison group (e.g. bortezomib) are made comparable with respect to confounding factors by individually pairing study subjects. 
(npr. bortezomib v kombinaciji z deksametazonom) in bolnike v primerjalni skupini (npr. samo bortezomib) po parih tako, da na podlagi nerandomiziranih podatkov izločimo moteče dejavnike, ki lahko vplivajo na oceno učinkov zdravljenja.
Posology for previously untreated multiple myeloma patients eligible for haematopoietic stem cell transplantation (induction therapy) 
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in so primerni za presaditev krvotvornih matičnih celic (uvajalno zdravljenje)
SGOT (AST) levels Modification of starting dose 
Koncentracija SGOT (AST)
Antiviral prophylaxis was administered to 26% of the patients in the Bzmb+M+P arm. 
Diseminirani plazmocitom V Bzmb+M+P kraku študije je protivirusna zdravila prejelo 26 % bolnikov.
Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)#, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration 
hiperviskozni sindrom, bolezni trombocitov n.d.n., trombotična mikroangiopatija (vključno s trombocitopenično purpuro)#, bolezni krvi n.d.n.,
Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder* 
krvavitev iz dlesni, gastroezofagealna refluksna bolezen*, kolitis (vključno s kolitisom, povzročenim s clostridium difficile)*, ishemični kolitis#, vnetje prebavil*, disfagija, sindrom razdražljivega črevesja, bolezni prebavil n.d.n., obložen jezik, motnje črevesne motilitete*, motnje v delovanju žlez slinavk*
chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse - movement disorders, paralysis, twitching - vertigo - hearing loss, deafness - disorders that affect your lungs, preventing your body from getting enough oxygen. 
bolečino ali tiščanje v prsih in/ali omotico/omedlevico, hudo srbenje kože ali dvignjene bulice na koži, otekanje obraza, ustnic, jezika in/ali grla, kar lahko povzroči oteženo požiranje, kolaps
Elderly 
huda
Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder 
sindrom palmarno-plantarne eritrodisestezije, podkožne krvavitve, livedo retikularis, zatrdlina kože, papule,
Bortezomib subcutaneous arm 
Redki draženje sečnega mehurja
No new safety concerns were observed when bortezomib was added to the standard paediatric pre B cell ALL chemotherapy backbone. 
Pri dodatku zdravila bortezomib standardni pediatrični pre B-celični ALL osnovni kemoterapevtski shemi niso opazili novih vplivov na varnost.
Bortezomib SUN is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle. 
Priporočeni odmerek je 1,3 mg/m2 telesne površine, dvakrat na teden dva tedna, na 1., 4., 8. in 11. dan v 21-dnevnem krogu zdravljenja.
Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal* 
intervala)*, nenormalno mednarodno umerjeno razmerje*, znižan pH v želodcu, zvečana agregacija trombocitov, zvišana koncentracija troponina I,
Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction Rare 
Občasni krvavitev iz nožnice, bolečina v spolovilih*, erektilna disfunkcija
NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection 
Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje
Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment. 
Med zdravljenjem z bortezomibom se zelo pogosto pojavijo toksični učinki na prebavila, kot so navzea, driska, bruhanje in zaprtost.
If local injection site reactions occur following Bortezomib SUN subcutaneous injection, either a less concentrated Bortezomib SUN solution (bortezomib 3.5 mg to be reconstituted to 1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended. 
Bortezomib SUN (1 mg/ml namesto 2,5 mg/ml) ali preidete na intravensko dajanje zdravila.
PR n (%) nCR n(%) 
ORR (CR+PR) p-vrednosta CR n (%) PR n (%) nCR n(%)
GENERAL CLASSIFICATION FOR SUPPLY 
Prilagoditev začetnega odmerka blaga
• different reconstitution requirements for intravenous (IV) or subcutaneous (SC) use 
• Informacijo o različnem postopku rekonstitucije pri intravenskem (i.v.)
Common Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion#, Blepharitis#, Eye inflammation*, Diplopia, Dry eye*, Eye irritation*, Eye pain, Lacrimation increased, Eye discharge 
Občasni krvavitve v očesu*, okužba veke*, halazij#, blefaritis#, vnetje očesa*, diplopija, suhe oči*, draženje očesa*, bolečina v očesu, povečano solzenje, izcedek iz očesa
Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'. 
Kaj je zdravilo Bortezomib SUN in za kaj ga uporabljamo Zdravilo Bortezomib SUN vsebuje zdravilno učinkovino bortezomib, ki je zaviralec proteasomov.
breathing that becomes shallow, difficult or stops, wheezing - blood clots in your lungs - yellow discoloration of the eyes and skin (jaundice) - lump in the eyelid (chalazion), red and swollen eyelids. 
Nekatere vključujejo oteženo dihanje, zasoplost, zasoplost brez telesnega napora, dihanje, ki postane plitvo, oteženo ali preneha, sopenje - krvni strdki v pljučih - rumeno obarvanje beločnic ali kože (zlatenica) - zatrdlina na veki (halazij), rdeče in otekle veke.
Name and address of the manufacturer responsible for batch release 
A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ Ime in naslov izdelovalca, odgovornega za sproščanje serije Sun Pharmaceutical Industries Europe B.V.
Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia 
sindrom možganskega debla, možgansko-žilne bolezni, lezija živčnih korenov, psihomotorna hiperaktivnost, kompresija hrbtenjače, kognitivna motnja n.d.n., motorične motnje, bolezni živčevja n.d.n., radikulitis, slinjenje, hipotonija
In the Phase III study, treatment with bortezomib led to a significantly longer time to progression, a significantly prolonged survival and a significantly higher response rate, compared to treatment with dexamethasone (see Table 14), in all patients as well as in patients who have received 1 prior line of therapy. 
Pri vseh bolnikih, kot tudi pri bolnikih, ki so pred tem že prejeli eno vrsto terapije, je preskušanje zdravljenja z bortezomibom vodilo do statistično značilno daljšega časa do napredovanja bolezni, statistično značilno podaljšanega preživetja in statistično značilno boljšega odziva na zdravljenje v primerjavi z zdravljenjem z deksametazonom (glejte preglednico 14).
Dose adjustments during treatment for patients with previously untreated mantle cell lymphoma Prior to initiating a new cycle of therapy: 
Prilagajanje odmerkov med zdravljenjem pri bolnikih s predhodno nezdravljenim limfomom plaščnih celic
Common Sleep disorders and disturbances* Nervous system disorders Very Common 
Pogosti motnje razpoloženja*, anksiozne motnje*, motnje spanja*
Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, 
levkocitoza*, limfadenopatija, hemolitična anemija#
Rare cases of hepatic failure have been reported in patients receiving bortezomib and concomitant medicinal products and with serious underlying medical conditions. 
Pri bolnikih z obstoječimi resnimi boleznimi, ki so bortezomib prejemali sočasno z drugimi zdravili, so poročali o redkih primerih odpovedi jeter.
What Bortezomib SUN is and what it is used for 
Zdravilo Bortezomib SUN se uporablja za zdravljenje:
Common Dyspnoea*, Cough*, Hiccups Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute) 
Občasni sindrom akutne dihalne stiske, pljučna embolija, pnevmonitis, pljučna hipertenzija, pljučni edem (vključno z akutnim)
- When Bortezomib SUN is given together with dexamethasone, you will receive Bortezomib SUN intravenously or subcutaneously as a 21-day treatment cycle. 
Bortezomib SUN injicirali v veno ali v podkožje v 21-dnevnem krogu zdravljenja.
Common Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#, Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#, Acne*, Blister*, Pigmentation disorder* 
Občasni multiformni eritem, urtikarija, akutna febrilna nevtrofilna dermatoza, toksični kožni izpuščaj, toksična epidermalna nekroliza#, Stevens-Johnsonov sindrom#, dermatitis*,
4.2 mo 
4,2 meseca
• that Bortezomib SUN is to be given only by IV or SC injections; no other route of administration is allowed 
• Zdravilo Bortezomib SUN se lahko injicira samo i.v.
Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 21-day treatment cycle. 
Bolnik jemlje 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3.5 mg 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT
PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances. 
letargijo, zmedenostjo, slepoto in drugimi motnjami vida ter nevrološkimi motnjami.
Table 2: Recommended posology for Bortezomib SUN in combination with melphalan and prednisone Twice weekly Bortezomib SUN (cycles 1-4) 
Bortezomib SUN v kombinaciji z deksametazonon in zdravilo Bortezomib SUN v kombinaciji z deksametazonom in talidomidom).
At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care. 
Po najmanj 6 mesecih po predhodnem zdravljenju so bortezomib uvedli v odmerku, ki ga je bolnik pri predhodnem zdravljenju še prenašal, 1,3 mg/m2 (n=93) ali ≤ 1,0 mg/m2 (n=37).
in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation. 
Odmerjanje pri bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in niso primerni za presaditev krvotvornih matičnih celic
Bortezomib SUN powder has to be dissolved before administration. 
Zdravilo Bortezomib SUN je v obliki praška, ki ga je treba raztopiti pred injiciranjem.
Decreased appetite Common Hypokalaemia*, Blood glucose abnormal*, Hyponatraemia*, Diabetes mellitus*, Fluid retention Uncommon Tumour lysis syndrome 
Zelo pogosti zmanjšan apetit Pogosti hipokaliemija*, nenormalne koncentracije glukoze v krvi*, hiponatriemija*, sladkorna bolezen*, zastajanje
One hundred and thirty patients (≥ 18 years of age) with multiple myeloma who previously had at least partial response on a bortezomib-containing regimen were retreated upon progression. 
Bolnike, ki so predhodno imeli vsaj delni odziv na režim zdravljenja z bortezomibom, so ponovno zdravili po napredovanju bolezni.
In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the BzmbR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8). 
Pri bolnikih z MCL (študija LYM-3002) je bila pojavnost okužbe z virusom herpes zoster v skupini
rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Macrophage activation 
Redki aktivacija makrofagov n.d.n.
België/Belgique/Belgien/България/Česká republika/ 
Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/
Common Oedema (inc peripheral), Chills, Pain*, Malaise* Uncommon General physical health deterioration*, Face oedema*, Injection site reaction*, Mucosal disorder*, Chest pain, Gait disturbance, Feeling cold, Extravasation*, Catheter related complication*, Change in thirst*, Chest discomfort, Feeling of body temperature change*, Injection site pain* 
Občasni poslabšanje splošnega zdravstvenega stanja*, edem obraza*, reakcija na mestu injiciranja*, bolezni sluznice*, bolečina v prsih, motnje hoje, občutek mrazenja, ekstravazacija*, s katetrom povezani zapleti*,
Common Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence 
Pogosti krvavitev v prebavilih (vključno s sluznico)*, dispepsija, stomatitis*, abdominalna distenzija, bolečina v žrelu in grlu*, bolečina v trebuhu (vključno z bolečino v prebavilih in vranici)*, bolezni ust*, flatulenca
However, the reconstituted solution is stable for 8 hours at 25°C stored in the original vial and/or a syringe, with a total storage time for the reconstituted medicine not exceeding 8 hours prior to administration. 
Rekonstituirana raztopina je stabilna 8 ur pri 25 °C, shranjena v originalni viali in/ali injekcijski brizgi.
Pregnancy 
premor
*RR (Post-induction) CR+nCR 
*CR+nCR CR+nCR+VGPR+PR
A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response. 
Razmerje tveganja, manjše kot 1, kaže prednost zdravljenja z VMP. c Nominalna p-vrednost na podlagi stratificiranega log-rank testa, prilagojena na podlagi stratifikacijskih dejavnikov: β2
- Non-haematological toxicities should have resolved to Grade 1 or baseline Table 3: Posology modifications during subsequent cycles of Bortezomib SUN therapy in combination with melphalan and prednisone 
Preglednica 2: Priporočeno odmerjanje zdravila Bortezomib SUN v kombinaciji z melfalanom in prednizonom
c Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product. 
e Populacijo, pri kateri je prišlo do odziva, predstavljajo bolniki, pri katerih so lahko ovrednotili bolezen pred začetkom zdravljenja.
Dexamethasone 40 mg is given orally on days-1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib SUN 28-day treatment cycle. 
Bolnik jemlje 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan kroga zdravljenja z zdravilom Bortezomib SUN.
Limited information on bortezomib retreatment in relapsed multiple myeloma is available. 
Na voljo je malo podatkov o ponovnem zdravljenju z bortezomibom pri bolnikih s ponovitvijo diseminiranega plazmocitoma.
- swelling of body, to include eyes and other parts of the body - shivering - redness and pain at injection site - general ill feeling - weight loss - weight increase. 
- srbenje kože - pordelost kože - izpuščaj - mišični krči - okužba sečil - bolečine v udih - otekanje telesa, vključno z očmi in drugimi deli telesa
Your doctor may change the dose and total number of treatment cycles, depending on your response to the treatment on the occurrence of certain side effects and on your underlying conditions (e.g. liver problems). 
Glede na vaš odziv na zdravljenje, pojavnost določenih neželenih učinkov in morebitne druge bolezni
Bladder irritation 
avtonomna nevropatija
Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness 
Občasni duševne motnje*, halucinacije*, psihotične motnje*,
Phase II study MMY-2036 (RETRIEVE), single arm, open-label study was conducted to determine the efficacy and safety of retreatment with bortezomib. 
Za ugotavljanje učinkovitosti in varnosti ponovnega zdravljenja z bortezomibom so izvedli odprto, enokračno, študijo faze II MMY-2036 (RETRIEVE) pri stotridesetih bolnikih (starih ≥ 18 let) z diseminiranim plazmocitomom.