FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone Prior to initiating a new cycle of therapy:
Slovenian: Prilagajanje odmerka med zdravljenjem in ob ponovni uvedbi kombiniranega zdravljenja z melfalanom in prednizonom
English: BTDx=bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Slovenian: VDDx = vinkristin, doksorubicin, deksametazon; BDx = bortezomib, deksametazon; TDx = talidomid, deksametazon; BTDx = bortezomib, talidomid, deksametazon; PN = periferna nevropatija Opomba: periferna nevropatija vključuje priporočene termine: periferna nevropatija, periferna motorična nevropatija, periferna senzorična nevropatija in polinevropatija.
English: During clinical trials, hypoglycaemia and hyperglycaemia were uncommonly and commonly reported in diabetic patients receiving oral hypoglycaemics.
Slovenian: Med kliničnimi preskušanji so pri bolnikih z diabetesom, ki prejemajo peroralne antidiabetike, občasno poročali o hipoglikemiji in pogosto o hiperglikemiji.
English: Patients in the BTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2 administered twice weekly days
Slovenian: Bolniki v skupini BR-CAP so prejeli bortezomib (1,3 mg/m2 na
English: Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Slovenian: Redki akutni pankreatitis, peritonitis*, edem jezika*, ascites, ezofagitis, heilitis, inkontinenca blata, atonija analnega sfinktra, fekalom*, razjede in perforacije v prebavilih*, hipertrofija dlesni, megakolon, izcedek iz rektuma, orofaringealni mehurji*, bolečina v ustnicah, periodontitis, analna fisura, spremembe pri odvajanju blata, proktalgija, nenormalno blato
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Slovenian: Po odmerku 1,0 mg/m je srednji celotni očistek telesa po prvem odmerku znašal 102 l/h in 112 l/h po odmerku 1,3 mg/m 2.
English: • advice on method of administration for both IV and SC use, including the need to rotate injection sites for SC use
Slovenian: in s.c. in da je pri s.c. uporabi potrebno menjati mesta injiciranja.
English: Injection sites should be rotated for successive injections.
Slovenian: Za uspešna injiciranja je treba mesta injiciranja menjati.
English: Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001 Response population includes patients who had measurable disease at baseline and received at least 1 dose of study medicinal product.
Slovenian: a populacija z namenom zdravljenja (ITT - Intent To Treat) b vrednost p iz stratificiranega testa log-rang; v analizi po vrsti zdravljenja ni bila vključena stratifikacija po terapevtski anamnezi, p < 0,0001 c Populacija, pri kateri so ovrednotili odziv na zdravljenje, vključuje bolnike, ki so imeli merljivo bolezen na začetku in so prejeli najmanj en odmerek preskušanega zdravila d vrednost p iz Cochran-Mantel-Haenszelovega hi-kvadrat testa, korigiranega s faktorji stratifikacije; v analizi po vrsti zdravljenja ni bila vključena stratifikacija po terapevtski anamnezi * CR+PR+MR; **CR=CR, (IF-); nCR=CR (IF+)
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether bortezomib (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m2) and prednisone (60 mg/m2) in patients with previously untreated multiple myeloma.
Slovenian: mg/m2) in prednizonom (60 mg/m2) vodi v podaljšanje časa do napredovanja bolezni (TTP - Time To Progression) v primerjavi z zdravljenjem samo z melfalanom (9 mg/m2) in prednizonom (60 mg/m pri bolnikih s predhodno nezdravljenim diseminiranim plazmocitomom, so izvedli prospektivno, mednarodno, randomizirano (1:1), odprto klinično preskušanje faze III (MMY-3002 VISTA) s 682 bolniki.
English: 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 (BR-CAP;
Slovenian: V randomiziranem, odprtem preskušanju 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 (BR-CAP; n = 243) z zdravljenjem z rituksimabom, ciklofosfamidom, doksorubicinom, vinkristinom in prednizonom (R-CHOP; n = 244).
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma For Bortezomib Hospira dosage adjustments for combination therapy follow dose modification guidelines described under monotherapy above.
Slovenian: Prilagoditev odmerjanja pri kombiniranem zdravljenju bolnikov z diseminiranim plazmocitomom Za prilagoditev odmerjanja zdravila Bortezomib Hospira pri kombiniranem zdravljenju upoštevajte navodila za samostojno zdravljenje, opisana zgoraj pri zdravljenju v obliki monoterapije.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.
Slovenian: Če opazite kateregakoli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Bortezomib Hospira is for intravenous or subcutaneous use.
Slovenian: Zdravilo Bortezomib Hospira je namenjeno za intravensko ali subkutano uporabo.
English: 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.
Slovenian: Pri 646 bolnikih je bilo izvedeno randomizirano, odprto, multicentrično preskušanje faze III pri vzporednih skupinah, v katerem so primerjali varnost in učinkovitost kombiniranega zdravljenja z bortezomibom in pegiliranim liposomskim doksorubicinom z monoterapijo z bortezomibom pri bolnikih z diseminiranim plazmocitomom, ki so že prejeli najmanj eno vrsto zdravljenja in pri katerih bolezen ni napredovala med prejemanjem antraciklinskega zdravljenja.
English: After reconstitution, each ml solution contains 1 mg bortezomib.
Slovenian: Po rekonstituciji 1 ml raztopine vsebuje 1 mg bortezomiba.
English: RR (Post-transplant) CR+nCR
Slovenian: *RR (po presaditvi) CR+nCR
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each Bortezomib Hospira treatment cycle.
Slovenian: Bolnik jemlje 100 mg/m2 prednizona peroralno na 1., 2., 3., 4. in 5. dan vsakega cikla zdravljenja z zdravilom Bortezomib Hospira.
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia (inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Slovenian: Redki smrt (vključno z nenadno), odpoved več organov, krvavitev na mestu injiciranja*, kila (vključno s hiatusno)*, slabše celjenje*, vnetje, flebitis na mestu injiciranja*, občutljivost, razjede, razdražljivost, bolečina v prsih, ki ni srčnega izvora, bolečina na mestu katetra, občutek tujka
English: Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Slovenian: Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*, nemir
English: Day 1 Day 2 Day 3 Day rest period rest period
Slovenian: Dan 1 Dan 2 Dan 3 Dan 4 -- -- premor -- -- -- -- premor
English: Lymphadenopathy, Haemolytic anaemia
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Slovenian: Prednizon boste jemali peroralno v odmerku 100 mg/m2 na 1., 2., 3., 4. in 5. dan cikla zdravljenja z bortezomibom.
English: * Based on NCI Organ Dysfunction Working Group classification for categorising hepatic impairment (mild,
Slovenian: * Na osnovi klasifikacije okvar jeter (blaga, zmerna, huda) delovne skupine za disfunkcije organov nacionalnega onkološkega inštituta ZDA (National Cancer Institute Organ Dysfunction Working Group).
English: Withhold Bortezomib Hospira treatment until symptoms of toxicity have resolved.
Slovenian: Prekinitev zdravljenja z zdravilom Bortezomib Hospira, dokler ne minejo znaki toksičnosti.
English: Bortezomib Hospira 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.
Slovenian: Zdravilo Bortezomib Hospira 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.
English: Combination with dexamethasone
Slovenian: Bortezomib v kombinaciji z deksametazonom
English: In addition, when Bortezomib Hospira is given in combination with other chemotherapeutic medicinal products, appropriate dose reductions for these products should be considered in the event of toxicities according to the recommendations in the Summary of Product Characteristics.
Slovenian: Kadar dajemo zdravilo Bortezomib Hospira v kombinaciji z drugimi kemoterapevtiki, je v primeru pojava toksičnosti potrebno razmisliti o zmanjšanju odmerka teh zdravil, skladno z njihovimi Povzetki glavnih značilnosti zdravil.
English: The 1 mg, 2.5 mg, 3 mg and 3.5 mg vial can be administered subcutaneously, as described below.
Slovenian: Kot navedeno spodaj, se lahko dajejo subkutano 1 mg, 2,5 mg, 3 mg in 3,5 mg viale.
English: There are no studies on the use of bortezomib in elderly patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation.
Slovenian: Preskušanj glede uporabe bortezomiba pri starejših bolnikih, pri katerih diseminirani plazmocitom še ni bil zdravljen in pri katerih je pred presaditvijo krvotvornih matičnih celic primerna kemoterapija v velikih odmerkih, niso izvedli.
English: b Up to 6 cycles may be given to patients who achieve at least a partial response after 4 cycles
Slovenian: Bolniki, ki dosežejo vsaj delni odziv po 4 ciklih, lahko prejmejo do 6 ciklov zdravljenja.
English: What Bortezomib Hospira contains
Slovenian: Kaj vsebuje zdravilo Bortezomib Hospira
English: Discontinue Bortezomib Hospira
Slovenian: Shranjevanje zdravila Bortezomib Hospira
English: When Bortezomib Hospira is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Slovenian: Pri sočasni uporabi zdravila Bortezomib Hospira z drugimi zdravili glejte Povzetke glavnih značilnosti teh zdravil za dodatne kontraindikacije.
English: 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).
Slovenian: Glede na vaš odziv na zdravljenje, pojavnost določenih neželenih učinkov in morebitne druge bolezni (npr. težave z jetri) lahko zdravnik spremeni odmerek in število ciklov zdravljenja.
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Slovenian: #, Stevens-Johnsonov sindrom #, dermatitis*, bolezni las*, petehije, ekhimoza, spremembe na koži, purpura, kožna novotvorba*, luskavica, hiperhidroza, nočno znojenje, dekubitusna razjeda #, akne*, izpuščaj*, motnje pigmentacije*
English: In Cycles 1-4, Bortezomib Hospira is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Slovenian: V ciklih 1-4 se zdravilo Bortezomib Hospira daje dvakrat na teden, na 1., 4., 8., 11., 22., 25., 29. in 32. dan, v ciklih 5-9 pa enkrat na teden, na 1., 8., 22. in 29. dan.
English: After reconstitution, each ml solution contains 2.5 mg bortezomib.
Slovenian: Po rekonstituciji 1 ml raztopine vsebuje 2,5 mg bortezomiba.
English: Bortezomib Hospira 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.
Slovenian: Zdravilo Bortezomib Hospira je indicirano za zdravljenje napredovalega diseminiranega plazmocitoma v monoterapiji ali v kombinaciji s pegiliranim liposomskim doksorubicinom ali z 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 primerna.
English: It is recommended that patients receive 2 cycles of Bortezomib Hospira following a confirmation of a complete response.
Slovenian: Priporočamo, da bolniki po potrjenem popolnem odzivu prejmejo še 2 cikla zdravljenja z zdravilom Bortezomib Hospira.
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Slovenian: Bortezomib Hospira 2,5 mg prašek za raztopino za injiciranje Ena viala vsebuje 2,5 mg bortezomiba (v obliki estra manitola in borove kisline).
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Slovenian: Redki rabdiomioliza, sindrom temporomandibularnega sklepa, fistula, izliv v sklep, bolečina v čeljusti, bolezni kosti, okužbe in vnetja mišično-skeletnega in vezivnega tkiva*, sinovialna cista
English: Bortezomib Hospira 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.
Slovenian: Zdravilo Bortezomib Hospira 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.
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Hospira treatment cycle.
Slovenian: Bolnik jemlje 40 mg deksametazona peroralno na 1., 2., 3., 4., 8., 9., 10. in 11. dan cikla zdravljenja z zdravilom Bortezomib Hospira.
English: Then, Bortezomib Hospira may be reinitiated with one dose level reduction (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to
Slovenian: Nato lahko ponovno uvedete zdravilo Bortezomib Hospira v odmerku, ki je eno stopnjo nižji od prejšnjega (z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m na 0,7 mg/m2).
English: • Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Slovenian: • okužbe, vključno s pljučnico, okužba dihal, bronhitis, glivične okužbe, produktiven kašelj,
English: Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Slovenian: Bolezni živčevja Zelo pogosti periferna senzorična nevropatija, disestezija*, nevralgija* Pogosti nevropatije*, motorična nevropatija*, izguba zavesti (vključno s sinkopo), encefalopatija*, periferna senzorična in motorična nevropatija, omotica*, disgevzija*, avtonomna nevropatija
English: If you have not been treated before for multiple myeloma, and you are not suitable for blood stem cell transplantation you will receive bortezomib intravenously or subcutaneously together with two other medicines; melphalan and prednisone.
Slovenian: Diseminirani plazmocitom, ki še ni bil zdravljen Če vam diseminiranega plazmocitoma še niso zdravili in presaditev krvotvornih matičnih celic za vas ni primerna, boste bortezomib prejeli v veno ali v podkožje skupaj z zdraviloma melfalan in prednizon.
English: Musculoskeletal pain*
Slovenian: • mišični krči
English: B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Slovenian: IZ = interval zaupanja; CR = popoln odziv; nCR = skoraj popoln odziv; ITT = populacija z namenom zdravljenja; RR = stopnja odziva; B = bortezomib; BDx = bortezomib in deksametazon; VDDx = vinkristin, doksorubicin in deksametazon; VGPR = zelo dober delni odziv; PR = delni oodziv; OR = razmerje obetov.
English: 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.
Slovenian: Bolniki, primerni za presaditev krvotvornih matičnih celic 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).
English: Muscle spasms*, Musculoskeletal pain*, Pain in extremity
Slovenian: Pogosti mišični krči*, mišično-skeletna bolečina*, bolečine v udih
English: Dyspnoea*, Cough*, Hiccups
Slovenian: Pogosti dispneja*, kašelj*, kolcanje
English: 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:
Slovenian: Pojavnost periferne nevropatije pri kombiniranem zdravljenju v preskušanju LYM-3002 z bortezomibom, skupaj z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (R-CAP), je navedena v spodnji preglednici:
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Slovenian: Bortezomib Hospira 3,5 mg prašek za raztopino za injiciranje Ena viala vsebuje 3,5 mg bortezomiba (v obliki estra manitola in borove kisline)
English: Complete blood counts (CBC) with differential and including platelet counts should be frequently monitored throughout treatment with Bortezomib Hospira.
Slovenian: Med zdravljenjem z zdravilom Bortezomib Hospira je treba pogosto spremljati število krvnih celic z diferencialno krvno sliko, vključno s številom trombocitov.
English: Adverse reaction Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest Vascular disorders Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Slovenian: Redki atrijska undulacija, miokardni infarkt*, atrioventrikularni blok*, srčno-žilne bolezni (vključno s kardiogenim šokom), torsade de pointes, nestabilna angina pektoris, bolezni srčnih zaklopk*, insuficienca koronarnih arterij, sinusni zastoj
English: You must read the package leaflets of all medicinal products to be taken in combination with Bortezomib Hospira for information related to these medicines before starting treatment with Bortezomib Hospira.
Slovenian: Preden začnete zdravljenje z zdravilom Bortezomib Hospira, preberite tudi navodila za uporabo zdravil, ki jih jemljete skupaj z zdravilom Bortezomib Hospira.
English: Bortezomib Hospira 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje Ena viala vsebuje 1 mg bortezomiba (v obliki estra manitola in borove kisline).
English: Six Bortezomib Hospira cycles are recommended, although for patients with a response first documented at cycle 6, two additional Bortezomib Hospira cycles may be given.
Slovenian: Priporočamo, da bolniki, ki dosežejo odziv šele v 6. ciklu, prejmejo dva dodatna cikla zdravljenja z zdravilom Bortezomib Hospira.
English: Seizures
Slovenian: premor
English: Bortezomib Hospira 3 mg powder for solution for injection Each vial contains 3 mg bortezomib (as a mannitol boronic ester).
Slovenian: Bortezomib Hospira 3 mg prašek za raztopino za injiciranje Ena viala vsebuje 3 mg bortezomiba (v obliki estra manitola in borove kisline).
English: Hazard ratio b (95% CI)
Slovenian: 15,0 mesecev razmerje ogroženosti b (95 % IZ)
English: Bortezomib Hospira 1 mg powder for solution for injection bortezomib
Slovenian: Bortezomib Hospira 1 mg prašek za raztopino za injiciranje bortezomib
English: Uncommon Dysacusis (inc tinnitus)*, Hearing impaired (up to and inc deafness),
Slovenian: Občasni disakuza (vključno s tinitusom) *, okvara sluha (vse do in vključno z gluhostjo), neprijeten občutek v ušesu*
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Slovenian: Med zdravljenjem z bortezomibom se zelo pogosto pojavijo toksični učinki na prebavila, kot so slabost, diareja, bruhanje in zaprtje.
English: Bortezomib Hospira 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.
Slovenian: Zdravilo Bortezomib Hospira 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.
English: Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Slovenian: Ena viala vsebuje 2,5 mg bortezomiba (v obliki estra manitola in borove kisline).
English: Peripheral neuropathy in combination regimens
Slovenian: Periferna nevropatija pri kombiniranem zdravljenju Diseminirani plazmocitom
English: Bortezomib Hospira 3 mg powder for solution for injection
Slovenian: Bortezomib Hospira 3 mg prašek za raztopino za injiciranje
English: • If platelet counts < 25,000 cells/μL or ANC < 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
Slovenian: • Če je na dan odmerjanja zdravila Bortezomib Hospira (razen 1. dneva vsakega cikla zdravljenja) število trombocitov < 25.000 celic/μl ali ANC < 750 celic/μl
English: Very Common Hair disorder* Common
Slovenian: Pogosti okvara ledvic*