natgillin/translations-raw huggingface dataset:
It is not known whether bortezomib is excreted in human milk.
Ni znano, ali se bortezomib izloča v materino mleko.
Efficacy results are presented in Table 16:
Rezultati učinkovitosti so podani v preglednici 16:
A pre-treatment chest radiograph is recommended to serve as a baseline for potential post-treatment pulmonary changes.
Pred zdravljenjem je priporočljivo opraviti rentgensko slikanje prsnega koša za oceno potencialnih pljučnih sprememb po zdravljenju.
Grade 2 with pain or Grade 3 (severe symptoms; limiting self care ADL***)
Stopnja 2 z bolečino ali stopnja 3 (hudi simptomi; omejene fizične ADL***)
Most adverse reactions are mild to moderate in nature and are observed throughout treatment.
Ti neželeni učinki so po jakosti večinoma blagi do zmerni in jih opažamo ves čas zdravljenja.
However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Poročali so tudi o primerih resne motorične nevropatije (z ali brez senzorične periferne nevropatije).
Rare side effects (may affect up to 1 in 1,000 people) - blood clot in small blood vessels (thrombotic microangiopathy)
Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) - krvni strdek v malih krvnih žilah (trombotična mikroangiopatija)
1 year survival, [95% CI]
1-letno preživetje, [95 % CI]
Response Evaluable Population n=73
Populacija za ovrednotenje odziva n=73
Discuss with your doctor when it is safe to restart breast-feeding after finishing your treatment.
Ko zaključite zdravljenje, se z zdravnikom pogovorite o tem, kdaj je varno ponovno začeti z dojenjem.
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.
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 kappa B (NF-kB).
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.
Mediani čas trajanja zdravljenja je bil 24 tednov in mediano število krogov zdravljenja je bilo 6,0 v obeh skupinah.
Caution should be exercised when bortezomib is combined with CYP3A4 or CYP2C19 substrates (see section 4.5).
Še posebna previdnost je potrebna, kadar se daje bortezomib v kombinaciji s substrati encima CYP3A4 ali CYP2C19 (glejte poglavje 4.5).
Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Mediana starost bolnikov v študiji je bila 57 let, 55 % je bilo moških in 48 % bolnikov je imelo citogenetiko visokega tveganja.
The solution will be clear and colourless, with a final pH of 4 to 7.
Nastala bo bistra in brezbarvna raztopina s končnim pH v območju med 4 in 7.
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- Confirm the dose and concentration in the syringe prior to use (check that the syringe is marked as intravenous administration).
- Pred dajanjem zdravila preverite odmerek in koncentracijo v brizgi (prepričajte se, da je na brizgi oznaka za intravensko dajanje).
Based on this review, chalazion/blepharitis is considered associated with the use of bortezomib.
Na osnovi tega pregleda halazij/blefaritis povezujejo z uporabo bortezomiba.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
You will receive 9 cycles (54 weeks).
Prejeli boste 9 krogov zdravljenja (54 tednov).
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.
Geometrični povprečni očistek (%CV) je bil 7,79 l/h/m2 (25%), volumen porazdelitve v dinamičnem ravnovesju 834 l/m2 (39%), razpolovni čas izločanja pa 100 ur (44%).
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with bortezomib.
Zaradi morebitnih resnih neželenih učinkov na dojene otroke je treba med zdravljenjem z bortezomibom dojenje prekiniti.
Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Redki anafilaktični šok, amiloidoza, z imunskim kompleksom tipa III povzročene reakcije
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.
Poleg periferne nevropatije lahko avtonomna nevropatija prispeva k nastanku nekaterih neželenih učinkov, npr. posturalne hipotenzije in hude zaprtosti z ileusom.
It is not necessary to protect the reconstituted medicinal product from light.
Rekonstituiranega zdravila ni treba zaščititi pred svetlobo.
Autonomic neuropathy may be related to bortezomib or bortezomib may aggravate an underlying condition such as diabetic or amyloidotic neuropathy.
Avtonomna nevropatija je lahko povezana z bortezomibom oz. bortezomib lahko poslabša osnovno bolezen, npr. diabetično ali amiloidno nevropatijo.
Additional adverse drug reactions identified associated with the use of the combination therapy (BzmbR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (BzmbR-CAP), sta bila okužba z virusom hepatitisa B (< 1 %) in ishemija miokarda (1,3 %).
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Preobčutljivost za učinkovino, bor ali katero koli pomožno snov, navedeno v poglavju 6.1.
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.
Ne glede na koncentracijo β2mikroglobulina 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 značilno izboljšali.
Cardiovascular safety pharmacology studies in monkeys and dogs show that intravenous doses approximately two to three times the recommended clinical dose on a mg/m2 basis are associated with increases in heart rate, decreases in contractility, hypotension and death.
Farmakološka preskušanja kardiovaskularne varnosti zdravila pri opicah in psih kažejo povezavo med intravenskimi odmerki, ki so bili dva- do trikrat višji od priporočenega kliničnega odmerka (v mg/m2), ter povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
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.
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.
This 21-day period (3 weeks) corresponds to one treatment cycle.
To 21-dnevno obdobje (3 tedni) je en krog zdravljenja.
Posterior Reversible Encephalopathy Syndrome (PRES)
Sindrom reverzibilne posteriorne levkoencefalopatije (PRES - Posterior Reversible Encephalopathy
Special care is required when treating patients with any risk factors for seizures.
Pri zdravljenju bolnikov z dejavniki tveganja za epileptične napade, je potrebna posebna previdnost.
In non-clinical studies, bortezomib had no effects on embryonal/foetal development in rats and rabbits at the highest maternally tolerated doses.
V nekliničnih raziskavah bortezomib ni imel nobenih učinkov na embrionalni/fetalni razvoj pri podganah in kuncih pri največjih odmerkih, ki so jih samice še lahko prenašale.
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.
Raziskave razvojne toksičnosti pri podganah in kuncih so pokazale embriofetalno smrtnost pri odmerkih, toksičnih za samice, vendar ni bilo neposredne embriofetalne toksičnosti pri odmerkih, manjših od tistih, ki so bili toksični za mater.
The reported efficacy data are considered inconclusive (see section 4.2).
Poročani podatki ne dovoljujejo dokončnih zaključkov o učinkovitosti (glejte poglavje
Please tell your doctor, or pharmacist if you are taking, have recently taken or might take any other medicines.
Druga zdravila in zdravilo Bortezomib SUN Obvestite svojega zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste začeli jemati katero koli drugo zdravilo.
The incidence of peripheral neuropathy increases early in the treatment and has been observed to peak during cycle 5.
Incidenca periferne nevropatije se poveča v začetku zdravljenja in doseže najvišjo vrednost v 5. krogu zdravljenja.
Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Analiza populacijske farmakokinetike je pokazala, da se očistek bortezomiba zveča z zvečanjem telesne površine (BSA - Body Surface Area).
Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX32.
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe, druga zdravila z delovanjem na novotvorbe; oznaka ATC: L01XX32.
A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Biološka verjetnost podpira povezavo med bortezomibom in halazijem/blefaritisom; teoretično lahko z bortezomibom povezana mielosupresija spodbudi nastanek virusnih okužb, kot je okužba z virusom herpes zoster, in s tem pospeši nastanek halazija.
A group of dialysis patients who were dosed after dialysis was also included in the study (n=8).
V študijo je bila vključena tudi skupina bolnikov na dializi, ki so prejemali zdravilo po dializi (n=8).
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Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
(AUC in Cmax normalizirana glede na odmerek) je bila primerljiva med vsemi skupinami (glejte poglavje 4.2).
Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Uporaba talidomida je med nosečnostjo in pri ženskah v rodni dobi kontraindicirana, razen če so izpolnjeni vsi pogoji programa preprečevanja nosečnosti za talidomid (Thalidomide Pregnancy Prevention Programme).
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.
Vmesna analiza je pokazala zmanjšanje tveganja za TTP za 45 % (95 % CI; od 29 do 57 %, p < 0,0001) pri bolnikih, ki so prejemali kombinirano terapijo z bortezomibom in pegiliranim liposomskim doksorubicinom.
- When Bortezomib SUN is given together with thalidomide and dexamethasone, the duration of a treatment cycle is 28 days (4 weeks).
- Če uporabljate zdravilo Bortezomib SUN skupaj s talidomidom in deksametazonom, traja en krog zdravljenja 28 dni (4 tedne).
If a diagnosis of PML is suspected, patients should be referred to a specialist in PML and appropriate diagnostic measures for PML should be initiated.
V primeru suma na PML je treba bolnika napotiti k specialistu in opraviti ustrezne diagnostične teste.
Grounds for the variation to the terms of the marketing authorisation(s) On the basis of the scientific conclusions for bortezomib the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing bortezomib is unchanged subject to the proposed changes to the product information.
Podlaga za priporočilo spremembe pogojev dovoljenj(-a) za promet z zdravilom Na podlagi znanstvenih zaključkov za bortezomib odbor CHMP meni, da je razmerje med koristjo in tveganjem zdravil, ki vsebujejo bortezomib ugodno ob upoštevanju predlaganih sprememb v informacijah o zdravilu.
56.4 mo
56,4 meseca
Thalidomide causes birth defects and foetal death.
Talidomid povzroča prirojene poškodbe in smrt ploda.
h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
h Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in LDL.
- Inject the solution subcutaneously, under a 45-90°angle.
- Raztopino injicirajte subkutano, pod kotom 45-90°.
Median survival for the Bzmb+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Mediana preživetja v skupini Bzmb+M+P je bila 56,4 meseca, v skupini M+P pa 43,1 meseca.
Patients had IgG/IgA/Light chain myeloma in 63%/25%/8% instances, a median hemoglobin of 105 g/l, and a median platelet count of 221.5 x 109/l.
Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63 %/25 %/8 % primerov, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x 109/l.
A minority of patients with orthostatic hypotension experienced syncopal events.
Manjši del bolnikov z ortostatsko hipotenzijo je imelo sinkope.
Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Odmerjanje pri zdravljenju diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli vsaj eno vrsto terapije)
In the event of an overdose, the patient's vital signs should be monitored and appropriate supportive care given to maintain blood pressure (such as fluids, pressors, and/or inotropic agents) and body temperature (see sections 4.2 and
V primeru prevelikega odmerka bortezomiba je treba spremljati bolnikove vitalne znake in uvesti ustrezne podporne ukrepe za vzdrževanje krvnega tlaka (npr.: tekočine, učinkovine, ki zvišujejo krvni tlak, in/ali inotropne učinkovine) in telesne temperature
If the reconstituted solution is not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Če se rekonstituirana raztopina ne porabi takoj, je za čas in pogoje shranjevanja zdravila po rekonstituciji odgovoren uporabnik.
Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Bolnike z motenim delovanjem ledvic je treba skrbno spremljati (glejte poglavji 4.2 in 5.2).
10 ml Type 1 tubular colourless glass vial with a grey bromobutyl rubber stopper, sealed with a light green flip off aluminium seal containing 3.5 mg bortezomib.
10 ml cevasta viala iz brezbarvnega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom, zaprta s svetlo zeleno dvižno aluminijasto zaporko, ki vsebuje 3,5 mg bortezomiba.
Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Sekundarna ocena učinkovitosti je zajemala stopnje odziva po presaditvi (CR+nCR, CR+nCR+VGPR+PR), čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
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).
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
Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Na podlagi majhnega deleža (7 %) encima CYP2D6 pri presnovi bortezomiba ni pričakovati, da bi fenotip slabe presnove s CYP2D6 vplival na skupno izločanje bortezomiba.
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Po ponavljajočih se odmerkih je bil razpon razpolovnih časov (t1/2) bortezomiba 40-193 ur.
Antiviral prophylaxis should be considered.
Razmisliti je treba o protivirusnem zdravljenju.
Uncommon side effects (may affect up to 1 in 100 people) - hepatitis - severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing,
Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) - vnetje jeter (hepatitis) - znaki hude alergijske reakcije (anafilaktična reakcija), ki lahko vključujejo oteženo dihanje,
When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Pri sočasni uporabi s talidomidom je potrebna posebna pozornost pri preverjanju nosečnosti in ukrepih za preprečevanje nosečnosti (glejte poglavje 4.6).
The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Primarna ocena učinkovitosti je bila stopnja odziva po uvedbi (Cr+nCR).
TTP, days [95% CI]
TTP, meseci (95 % CI)
Patients with mild hepatic impairment do not require a dose adjustment and should be treated per the recommended dose.
Pri bolnikih z blago jetrno okvaro ni treba prilagajati odmerka, treba jih je zdraviti s priporočenim odmerkom.
Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Za neželene učinke, navedene v preglednici 7, so raziskovalci menili, da imajo vsaj možno do verjetno vzročno povezavo z bortezomibom.
- Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
- Raztopino injicirajte v obliki 3-5 sekund trajajoče bolusne intravenske injekcije skozi periferno ali centralno intravensko cevko v veno.
The following medicinal products are given on day 1 of each Bortezomib SUN 21-day treatment cycle as intravenous infusions:
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom Bortezomib SUN v obliki intravenske infuzije:
Other reported hepatic reactions include increases in liver enzymes, hyperbilirubinaemia, and hepatitis.
Poročali so tudi o povišanju vrednosti jetrnih encimov, hiperbilirubinemiji in hepatitisu.
• Induction Transplant Regimens Graph The Reconstitution, dosing and administration booklet shall contain the following key elements:
• Diagram režima uvajanja pred transplantacijo Izobraževalna knjižica z navodili za rekonstitucijo, odmerjanje in načinom uporabe mora vsebovati naslednje ključne elemente:
- Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
- Izperite periferni ali intravenski kateter s sterilno raztopino 9 mg/ml (0,9 %) natrijevega klorida.
Male and female patients of childbearing potential must use effective contraceptive measures during and for 3 months following treatment.
Moški in ženske v rodni dobi morajo uporabljati ustrezno kontracepcijsko metodo med zdravljenjem in še 3 mesece po njem.
All these target organs have shown partial to full recovery following discontinuation of treatment.
Po ukinitvi zdravljenja so ugotavljali delno do popolno okrevanje vseh navedenih tarčnih organov.
19.9 mo
19,9 meseca
What Bortezomib SUN is and what it is used for What you need to know before you are given Bortezomib SUN How to use Bortezomib SUN
Kaj je zdravilo Bortezomib SUN in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bortezomib SUN Kako uporabljati zdravilo Bortezomib SUN
The European Medicines Agency has waived the obligation to submit the results of studies with bortezomib in all subsets of the paediatric population in multiple myeloma and in mantle cell lymphoma (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov z bortezomibom za vse skupine pediatrične populacije za indikacijo diseminiranega plazmocitoma in limfoma plaščnih celic (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The concentration of the resulting solution will be 1 mg/ml.
Koncentracija dobljene raztopine je 1 mg/ml.
Median PFS by investigator assessment was 30.7 months in the BzmbR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Mediana PFS po oceni raziskovalca je bila 30,7 meseca v skupini BzmbR-CAP in 16,1 meseca v skupini R-CHOP (razmerje tveganja [HR]=0,51; p < 0,001).
Instructions for reconstitution Bortezomib SUN must be reconstituted by a healthcare professional.
Navodila za rekonstitucijo Zdravilo Bortezomib SUN mora rekonstituirati zdravstveno osebje.
Patients achieving a response or a stable disease after 4 cycles of this combination therapy can continue to receive the same combination for a maximum of 4 additional cycles.
Bolniki, ki prejemajo kombinirano zdravljenje in po 4 krogih zdravljenja dosežejo odziv ali so stabilni, lahko prejmejo enako zdravljenje še največ 4 dodatne kroge.
It is recommended that patients be carefully monitored for symptoms of neuropathy such as a burning sensation, hyperesthesia, hypoesthesia, paraesthesia, discomfort, neuropathic pain or weakness.
Priporočamo, da bolnike skrbno spremljate in ugotavljate simptome nevropatije, npr. pekoč občutek, hiperestezijo, hipestezijo, parestezijo, neprijeten občutek, nevropatično bolečino ali oslabelost.
d Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
d Log-rank test, prilagojen na podlagi stratifikacijskih faktorjev: ISS-razvrstitvi in številu predhodnih zdravljenj.
In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Bolniki, stari ≥ 75 let, so slabše prenašali oba režima zdravljenja, BzmbR-CAP in R-CHOP (glejte poglavje 4.8).
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.
Bolniki, ki niso dosegli optimalnega odziva (manj kot popolni odziv [CR]) na zdravljenje z bortezomibom v monoterapiji po 4 krogih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju bortezomiba.
Secondary efficacy endpoints included Progression Free Survival and Overall Survival.
Sekundarna ocena učinkovitosti je vključevala rezultate časa preživetja brez napredovanja bolezni in celokupni čas preživetja.
Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Bortezomib je citotoksična učinkovina in lahko hitro uniči maligne plazemske in MCL-celice, zato lahko povzroči zaplete sindroma razpada tumorja.
A statistically significant survival benefit in favour of the Bzmb+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Pri bolnikih v skupini Bzmb+M+P so opazili statistično značilno izboljšanje preživetja (HR (Hazard Ratio - razmerje tveganja)=0,695; p=0,00043), kljub poznejšim terapijam, vključno s terapijo z bortezomibom.
By interfering with their function, bortezomib can kill cancer cells.
Z zaviranjem njihovega delovanja lahko bortezomib uniči rakave celice.
The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Pri 130 bolnikih je bila celokupna stopnja odgovora (CR+PR) 38,5% (95% CI: 30,1; 47,4).
Table 13: Efficacy results from study MMY-3010 Endpoints
Preglednica 13: rezultati učinkovitosti študije MMY-3010 Ocena učinkovitosti
Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Preverite in zagotovite pravilni odmerek za intravensko dajanje zdravila (1 mg/ml).