FrancophonIA/ELRC3.0 huggingface dataset:
English: Pregnancy and breast-feeding You should not use bortezomib if you are pregnant, unless clearly necessary.
Slovenian: Nosečnost in dojenje Če ste noseči, bortezomiba ne smete prejeti, razen če je nujno potrebno.
English: n: ITT patients
Slovenian: n: bolniki (ITT)
English: Inhibition of the 26S proteasome prevents this targeted proteolysis and affects multiple signalling cascades within the cell, ultimately resulting in cancer cell death.
Slovenian: Zaviranje 26S proteasoma to ciljano proteolizo preprečuje in vpliva na več signalnih kaskad v celici, kar končno vodi do smrti rakave celice.
English: Your doctor will work out your dose of bortezomib according to your height and weight (body surface area).
Slovenian: Zdravnik bo določil odmerek bortezomiba na osnovi vaše telesne višine in mase (telesne površine).
English: If the toxicity is not resolved or if it recurs at the lowest dose, discontinuation of Bortezomib Hospira must be considered unless the benefit of treatment clearly outweighs the risk.
Slovenian: Če toksičnost ne mine ali če se ponovi tudi pri najmanjšem odmerku, morate razmisliti o ukinitvi zdravila Bortezomib Hospira, razen če koristi zdravljenja odtehtajo s tem povezano tveganje.
English: It is recommended that patients with at least partial response receive 2 additional cycles.
Slovenian: Priporočamo, da bolniki z najmanj delnim odzivom prejmejo 2 dodatna cikla zdravljenja.
English: Neuropathic pain and/or peripheral neuropathy
Slovenian: Nevropatska bolečina in/ali periferna nevropatija
English: The majority of the patients in both groups completed treatment, 80% in the BR-CAP group and 82% in the R-CHOP group.
Slovenian: Večina bolnikov v obeh skupinah je zdravljenje zaključila, 80 % v skupini BR-CAP in 82 % v skupini R-CHOP.
English: • carbamazepine, phenytoin or phenobarbital used to treat epilepsy
Slovenian: • karbamazepin, fenitoin ali fenobarbital, ki se uporabljajo za zdravljenje epilepsije
English: Cases resolved in a median of 6 days, dose modification was required in two patients.
Slovenian: Primere so rešili v mediano 6 dneh, dvema bolnikoma so morali prilagoditi odmerek zdravila.
English: Kaplan-Meier estimate.
Slovenian: c Ocena po metodi Kaplan-Meier.
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Slovenian: Primarni opazovani dogodek učinkovitosti je bilo preživetje brez napredovanja bolezni, ki ga je ocenil neodvisni odbor za pregled (IRC - Independent Review Committee).
English: tiredness, confusion, blindness or other vision problems.
Slovenian: zmedenostjo, slepoto ali drugimi težavami z vidom
English: ** Instrumental ADL: refers to preparing meals, shopping for groceries or clothes, using telephone, managing money, etc; *** Self care ADL: refers to bathing, dressing and undressing, feeding self, using the toilet, taking medicinal products, and not bedridden.
Slovenian: ** Instrumentalna ADL: zajema pripravo obrokov, nakup živil ali oblačil, uporabo telefona, upravljanje z denarjem, itd; *** Fizična ADL: zajema kopanje, oblačenje in slačenje, hranjenje, uporabo stranišča, jemanje zdravil, ne zajema pa bolnikov priklenjenih na posteljo zaradi bolezni
English: At the time of a pre-specified interim analysis, the primary endpoint, time to progression, was met and patients in the M+P arm were offered B+M+P treatment.
Slovenian: Ob predhodno določeni vmesni analizi je bil dosežen primarni cilj (čas do napredovanja bolezni) in bolnikom v M+P kraku preskušanja so ponudili zdravljenje z B+M+P.
English: • rifampicin, an antibiotic used to treat bacterial infections
Slovenian: • rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Slovenian: Sekundarni opazovani dogodki so vključevali čas do napredovanja bolezni (TTP), čas do naslednjega zdravljenja limfoma (TNT), trajanje obdobja brez zdravljenja (TFI), celokupno stopnjo odziva (ORR) in stopnjo popolnega odziva (CR/CRu), celokupno preživetje (OS) in trajanje odziva.
English: OR e (95% CI)=1.688
Slovenian: OR e (95 % IZ) = 1,688 (1,148;
English: No information on possible sequelae or rates of peripheral neuropathy resolution were available in this study.
Slovenian: Podatkov o možnih posledicah ali ozdravitvah periferne nevropatije v tem preskušanju ni na voljo.
English: For single use only
Slovenian: za enkratno uporabo
English: No clinical data are available for bortezomib with regard to exposure during pregnancy.
Slovenian: Za bortezomib ni na voljo kliničnih podatkov glede izpostavljenosti zdravilu med nosečnostjo.
English: 1-year Overall Survival (%) (95% CI)
Slovenian: 1-letno celokupno preživetje (%) (95 % IZ)
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Slovenian: Odmerjanje pri zdravljenju napredovalega diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli vsaj eno vrsto terapije)
English: Your doctor may give you another medicine to control diarrhoea
Slovenian: Zdravnik vam bo lahko dal tudi zdravilo za obvladovanje driske.
English: This minimises the effects of observed confounders when estimating treatment effects using non-randomised data.
Slovenian: To pri oceni učinkov zdravljenja na osnovi nerandomiziranih podatkov zmanjša učinke opaženih motečih dejavnikov.
English: Bortezomib Hospira should not be used during pregnancy unless the clinical condition of the woman requires treatment with Bortezomib Hospira.
Slovenian: Zdravila Bortezomib Hospira se med nosečnostjo ne sme uporabljati, razen če klinično stanje ženske zahteva zdravljenje z zdravilom Bortezomib Hospira.
English: In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
Slovenian: V nekliničnih študijah bortezomib ni imel nobenih učinkov na embrionalni/fetalni razvoj pri podganah in kuncih pri največjih odmerkih, ki so jih samice še lahko prenašale.
English: Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
Slovenian: V razponu koncentracij bortezomiba od 0,01 do 1,0 μg/ml je bila in vitro vezava na beljakovine v človeški plazmi povprečno 82,9 %.
English: Most patients required treatment for their orthostatic hypotension.
Slovenian: Pri večini bolnikov je bilo potrebno zdravljenje ortostatske hipotenzije.
English: Injection under the skin is in either the thighs or the abdomen.
Slovenian: Injiciranje pod kožo je možno na stegnih ali trebuhu.
English: p-value is for the non-inferiority hypothesis that the SC arm retains at least 60% of the response rate in the IV arm.
Slovenian: a Vrednost p podpira hipotezo, da s.c. krak zadrži najmanj 60 % stopnje odziva i.v.
English: • bleeding problems and/or low number of platelets in your blood
Slovenian: • imate težave s strjevanjem krvi in/ali majhno število krvnih ploščic,
English: Regardless of β2-microglobulin levels at baseline, all efficacy parameters (time to progression and overall survival, as well as response rate) were significantly improved on the bortezomib arm.
Slovenian: Ne glede na koncentracijo β2- mikroglobulina ob začetku zdravljenja, so se tudi vsi parametri učinkovitosti (čas do napredovanja bolezni in celokupno preživetje, kot tudi odziv na zdravljenje) v delu preskušanja z bortezomibom statistično pomembno izboljšali.
English: When bortezomib is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
Slovenian: Če boste prejeli bortezomib skupaj z talidomidom in deksametazonom, traja en cikel zdravljenja 28 dni (4 tedne).
English: the combined 1-year survival rate was 88.1%.
Slovenian: Skupna stopnja 1-letnega preživetja za skupini bolnikov, ki sta prejemali ta dva odmerka, je bila 88,1 %.
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Slovenian: Pojavnost smrti med zdravljenjem je bila v subkutani skupini 5 % in v intravenski skupini 7 %.
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Slovenian: Preglednica 12: Rezultati učinkovitosti v preskušanju IFM-2005-01 Opazovani dogodki
English: Patients whose levels of paraprotein continue to decrease after 8 cycles can also continue for as long as treatment is tolerated and they continue to respond.
Slovenian: Bolniki, pri katerih se koncentracija paraproteinov po 8 ciklih še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
English: Bortezomib might cause tiredness, dizziness, fainting, or blurred vision.
Slovenian: Bortezomib lahko povzroči utrujenost, omotičnost, omedlevico ali zamegljen vid.
English: p-value g=0.275
Slovenian: vrednost p g = 0,275
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Slovenian: • nevtropenija z zvišano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
English: In addition to peripheral neuropathy, there may be a contribution of autonomic neuropathy to some adverse reactions such as postural hypotension and severe constipation with ileus.
Slovenian: Poleg periferne nevropatije lahko avtonomna nevropatija prispeva k nastanku nekaterih neželenih učinkov, npr. posturalne hipotenzije in hudega zaprtja z ileusom.
English: Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, bor ali katerokoli pomožno snov, navedeno v poglavju 6.1.
English: • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Slovenian: • Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferni ali centralni intravenski kateter v veno.
English: • ritonavir, used to treat HIV infection
Slovenian: • ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV
English: Bortezomib should not be used in children and adolescents because it is not known how the medicine will affect them.
Slovenian: Otroci in mladostniki Bortezomib se pri otrocih in mladostnikih ne sme uporabljati, ker njegov vpliva nanje ni znan.
English: The resulting solution is then either injected into a vein or under the skin.
Slovenian: Nastalo raztopino se nato injicira v veno ali pod kožo.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Slovenian: • Možna tveganja napak pri dajanju zdravila, vključno z informacijami o prevelikem odmerjanju, premajhnem odmerjanju in, da se je nenamerno intratekalno dajanje zdravila končalo s smrtnimi primeri.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske značilnosti in značilnosti bolezni od začetku preskušanja: mediana starost bolnikov je bila 66 let, 74 % je bilo moških, 66 % je bilo belcev in 32 % azijcev, 69 % bolnikov je imelo pozitivno aspiracijo kostnega mozga in/ali pozitivno biopsijo kostnega mozga za MCL, 54 % bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (IPI - International Prognostic Index) ≥ 3 in 76 % bolnikov je bilo v IV. stadiju bolezni.
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Slovenian: In vitro, ex vivo in podatki iz živalskih modelov kažejo, da bortezomib spodbuja diferenciacijo in aktivnost osteoblastov ter zavira delovanje osteoklastov.
English: Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Slovenian: Sekundarni opazovani dogodki učinkovitosti so vključevali čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
English: ≥ 1,500 cells/μL
Slovenian: ≥ 75.000 celic/μl.
English: Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with bortezomib alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after bortezomib administration.
Slovenian: Bolniki, ki niso dosegli optimalnega odziva (manj kot popoln odziv [CR]) na zdravljenje z bortezomibom samim po 4 ciklih zdravljenja, so lahko prejeli 20 mg deksametazona na dan dajanja in po dajanju bortezomiba.
English: A statistically significant benefit (p < 0.001) in favour of the BR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Slovenian: Opazili so statistično pomembno korist (p < 0,001) v skupini BR-CAP v primerjavi s skupino R-CHOP za TTP (mediana 30,5 proti 16,1 mesecev), TNT (mediana 44,5 proti 24,8 mesecev) in TFI (mediana 40,6 proti 20,5 mesecev).
English: Overall response (CR+CRu+PR)
Slovenian: Celokupen odziv (CR+CRu+PR)
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be
Slovenian: • mora biti število trombocitov ≥ 100.000 celic/μl in celokupno število nevtrofilcev (ANC
English: Median survival for the B+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Slovenian: Mediano preživetje v skupini B+M+P je bilo 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
English: The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Slovenian: Mediani čas trajanja zdravljenja je bil 24 tednov in mediano število ciklov zdravljenja je bilo 6,0 v obeh skupinah.
English: Since dialysis may reduce bortezomib concentrations, Bortezomib Hospira should be administered after the dialysis procedure (see section 5.2).
Slovenian: Ker dializa lahko zmanjša koncentracijo bortezomiba, je treba zdravilo Bortezomib Hospira injicirati po zaključku dializnega postopka (glejte poglavje 5.2).
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Slovenian: Zaviranje proteasoma z bortezomibom vpliva na rakave celice na več načinov, vključno s spremembo regulatornih proteinov, ki nadzorujejo napredovanje celičnega ciklusa in aktivacijo nuklearnega faktorja kapa B (NF-kB).
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Slovenian: Ti neželeni učinki so navedeni na podlagi celotnega nabora podatkov 5.476 bolnikov, od katerih je bilo 3.996 bolnikov zdravljenih z bortezomibom v odmerku 1,3 mg/m2 telesne površine in so vključeni v preglednico 7.
English: An odds ratio (OR) > 1 indicates an advantage for BR-CAP.
Slovenian: Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino BR-CAP.
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Slovenian: Sekundarni opazovani dogodki učinkovitosti so vključevali stopnjo odziva po presaditvi (CR+nCR, CR+nCR+VGPR+PR), čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
English: The usual starting dose of bortezomib is 1.3 mg/m2 body surface area twice a week.
Slovenian: Običajni začetni odmerek bortezomiba je 1,3 mg/m2 telesne površine dvakrat na teden.
English: Post-marketing adverse reactions not seen in clinical trials are also included.
Slovenian: Vključeni so tudi neželeni učinki iz obdobja trženja, ki se v kliničnih preskušanjih niso pojavili.
English: Additional adverse drug reactions identified associated with the use of the combination therapy (BR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Slovenian: Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BR-CAP), sta bila okužba z virusom hepatitisa B (< 1 %) in ishemija miokarda (1,3 %).
English: This 21-day period (3 weeks) corresponds to one treatment cycle.
Slovenian: To 21-dnevno obdobje (3 tedni) je en cikel zdravljenja.
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Slovenian: Geometrijska sredina (% CV) očistka je bila 7,79 l/h/m2 (25 %), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39 %), razpolovni čas izločanja pa 100 ur (44 %).
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Slovenian: Mediana starost bolnikov v preskušanju je bila 57 let, 55 % je bilo moških in 48 % bolnikov je imelo citogenetiko visokega tveganja.
English: This interim analysis showed a TTP risk reduction of 45 % (95 % CI; 29-57 %, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Slovenian: Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45 % (95 % IZ; 29-57 %, p < 0,0001) pri bolnikih, ki so prejemali kombinirano zdravljenje z bortezomibom in pegiliranim liposomskim doksorubicinom.
English: p-value g=0.007
Slovenian: vrednost p g = 0,007
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Slovenian: Bolniki, stari ≥ 75 let, so oba režima zdravljenja, BR-CAP in R-CHOP, slabše prenašali (glejte poglavje 4.8).
English: B= bortezomib M=melphalan, P=prednisone
Slovenian: B = bortezomib; M = melfalan, P = prednizon
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Slovenian: Večja je bila tudi pojavnost okužb z nevtropenijo stopnje ≥ 3 (24 % proti 19 % v 1. sklopu in 22 % proti 11 % v 2. sklopu), povečane koncentracije ALT (17 % proti 8 % v 2. sklopu), hipokaliemije (18 % proti 6 % v 1. sklopu in 21 % proti 12 % v 2. sklopu) in hiponatriemije (12 % proti 5 % v 1. sklopu in 4 % proti 0 v 2. sklopu).
English: The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Slovenian: Pojavnost periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. ciklu zdravljenja.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib Hospira therapy.
Slovenian: Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 ciklov zdravljenja z zdravilom Bortezomid Hospira.
English: > 3 x ULN
Slovenian: > 3 x ULN katerakoli
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511;95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Slovenian: Analiza je pokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95 % IZ 2,045-6,947; p < 0,001), PFS (razmerje ogroženosti 0,511; 95 % IZ 0,309-0,845; p = 0,008), TTP (razmerje ogroženosti 0,385; 95 % IZ 0,212-0,698; p = 0,001) pri zdravljenju z bortezomibom v kombinaciji z deksametazonom v primerjavi z zdravljenjem z bortezomibom samim.
English: Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Slovenian: d Log-rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Slovenian: Periferna nevropatija stopnje ≥ 3 se je pojavila pri 6 % bolnikov v skupini s subkutanim dajanjem v primerjavi s 16 % bolnikov v skupini, ki je prejemala bortezomib intravensko (p = 0,0264).
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Slovenian: Tveganje za pojav sindroma tumorske lize je večje pri bolnikih z visoko tumorsko obremenitvijo pred začetkom zdravljenja.
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Slovenian: Celokupna pojavnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z BR-CAP ali s R-CHOP (0,8 % v primerjavi z 1,2 %).
English: Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: β2 -microglobulin, albumin, and region.
Slovenian: b Ocena stopnje tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
English: Overall complete response (CR+CRu)
Slovenian: Celokupen popoln odziv (CR+CRu)
English: • If several Bortezomib Hospira doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
Slovenian: • Če je več odmerkov zdravila Bortezomib Hospira v enem ciklu zdravljenja izpuščenih (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
English: Table 8 Adverse reactions in patients with Mantle cell lymphoma treated with BR-CAP in a clinical trial.
Slovenian: Preglednica 8: Neželeni učinki pri bolnikih z limfomom plaščnih celic, zdravljenih z BR-CAP v kliničnem preskušanju.
English: If Bortezomib Hospira is used during pregnancy, or if the patient becomes pregnant while receiving this medicinal product, the patient should be informed of potential for hazard to the foetus.
Slovenian: Če se zdravilo Bortezomib Hospira uporablja med nosečnostjo ali če bolnica med jemanjem tega zdravila zanosi, jo morate obvestiti o potencialnem tveganju za plod.
English: What Bortezomib Hospira is and what it is used for What you need to know before you use Bortezomib Hospira How to use Bortezomib Hospira Possible side effects
Slovenian: Kaj je zdravilo Bortezomib Hospira in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib Hospira Kako uporabljati zdravilo Bortezomib Hospira Možni neželeni učinki
English: Developmental toxicity studies in the rat and rabbit have shown embryo-fetal lethality at maternally toxic doses, but no direct embryo-foetal toxicity below maternally toxic doses.
Slovenian: Raziskave razvojne toksičnosti pri podganah in kuncih so pokazale embriofetalno smrtnost pri odmerkih, toksičnih za matere, pri odmerkih, manjših od toksičnih za mater pa neposredne embriofetalne toksičnosti ni bilo.
English: Patients with pre-existing severe neuropathy may be treated with Bortezomib Hospira only after careful risk/benefit assessment.
Slovenian: Bolnike z obstoječo hudo nevropatijo lahko zdravite z zdravilom Bortezomib Hospira šele po skrbnem pretehtanju razmerja med tveganjem in koristjo.