natgillin/translations-raw huggingface dataset:
• Decreased sex drive
• zmanjšana želja po spolnosti
• Severe allergic reaction (anaphylactic reaction) signs of which may include difficulty breathing,
• znaki hude alergijske reakcije (anafilaktična reakcija), ki lahko vključujejo oteženo dihanje,
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.
Bolniki, pri katerih se koncentracija paraproteinov po 8. krogih še znižuje, lahko z zdravljenjem nadaljujejo, dokler zdravljenje dobro prenašajo in se odzivajo nanj.
• If, after VELCADE has been held, the toxicity does not resolve, as defined above, then VELCADE must be discontinued.
• Če po prekinitvi zdravljenja z zdravilom VELCADE toksičnost ne mine kot je opisano zgoraj, je treba zdravljenje z zdravilom VELCADE ukiniti.
It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Izdelan je specifično za zaviranje kimotripsinske aktivnosti 26S proteasoma v sesalskih celicah.
Because of the potential for serious adverse reactions in breast-fed infants, breast-feeding should be discontinued during treatment with VELCADE.
Zaradi morebitnih resnih neželenih učinkov na dojene otroke je treba med zdravljenjem z zdravilom VELCADE dojenje prekiniti.
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 4.4).
V primeru prevelikega odmerka zdravila Velcade 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 (glejte poglavji 4.2 in 4.4).
Over a bortezomib concentration range of 0.01 to 1.0 μg/ml, the in vitro protein binding averaged 82.9% in human plasma.
V razponu koncentracij bortezomiba od 0,01 do 1,0 μg/ml je bila in vitro vezava na beljakovine povprečno 82,9% v človeški plazmi.
Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Odmerjanje pri zdravljenju napredujočega diseminiranega plazmocitoma (bolniki, ki so pred tem že prejeli vsaj eno vrsto terapije)
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).
The reconstituted solution should be used immediately after preparation.
Rekonstituirano raztopino je treba porabiti takoj po pripravi.
In addition, secondary response-related and time to event related efficacy endpoints showed consistent results for subcutaneous and intravenous administration (Table 15).
Sekundarna stopnja odziva in čas do z dogodkom povezane učinkovitosti sta pokazali trdne rezultate za subkutano on intravensko uporabo (preglednica 15).
The similar incidences of these events in both treatment arms, indicated that these adverse drug reactions are not attributable to VELCADE alone.
Podobna pojavnost teh neželenih učinkov v obeh zdravljenih skupinah kaže, da ju ni možno pripisati samo uporabi zdravila VELCADE.
The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Incidenca smrti med zdravljenjem je bila v subkutani skupini 5% in v intravenski skupini 7%.
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.
It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of VELCADE therapy.
Priporočamo tudi, da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z zdravilom VELCADE.
Table 13: Efficacy results from study MMY-3010
Preglednica 13: rezultati učinkovitosti študije MMY-3010
• Bacterial and viral infections
• bakterijske in virusne okužbe
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS OF THE MARKETING AUTHORISATION(S)
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA SPREMEMBO POGOJEV DOVOLJENJA ZA PROMET Z ZDRAVILOM
The observed final median difference in the OS between the 2 treatment groups was 35 months.
Dejanska končna razlika med medianama OS obeh skupin je bila 35 mesecev.
Therefore, this specific regimen with concomitant administration with high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours is not recommended.
Zato ta režim dajanja s sočasnim velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) ni priporočljiv.
• Increase of platelets or plasma cells (a type of white cell) in the blood
• povečanje števila krvnih ploščic ali plazemskih celic v krvi (vrsta belih krvnih celic)
• If several VELCADE doses in a cycle are withheld (≥ 3 doses during twice weekly administration or ≥ 2 doses during weekly administration)
• Če preskočite več odmerkov zdravila VELCADE v enem krogu zdravljenja (≥ 3 odmerke pri odmerjanju dvakrat na teden ali ≥ 2 odmerka pri odmerjanju enkrat na teden)
Uncommon Cerebrovascular accident
Občasni cerebrovaskularni dogodek
Table 11: Efficacy results following the final survival update to VISTA study Efficacy endpoint
Preglednica 11: Rezultati učinkovitosti zdravila po posodobljenih podatkih o končnem preživetju iz študije VISTA
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).
Periferna nevropatija ≥ 3. stopnje se je pojavila pri 6% bolnikov v skupini s subkutanim dajanjem v primerjavi s 16% bolnikov v skupini, ki je prejemala zdravilo intravensko (p = 0,0264).
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.
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.
In particular, tell your doctor if you are using medicines containing any of the following active substances: - ketoconazole, used to treat fungal infections ritonavir, used to treat HIV infection - rifampicin, an antibiotic used to treat bacterial infections - carbamazepine, phenytoin or phenobarbital used to treat epilepsy - St. John's Wort (Hypericum perforatum), used for depression or other conditions - oral antidiabetics
Še posebno morate svojega zdravnika obvestiti, če jemljete zdravila, ki vsebujejo katero izmed naslednjih učinkovin: - ketokonazol, ki se uporablja za zdravljenje glivičnih okužb - ritonavir, ki se uporablja za zdravljenje okužbe z virusom HIV - rifampicin, antibiotik, ki se uporablja za zdravljenje bakterijskih okužb - karbamazepin, fenitoin ali fenobarbital, ki se uporabljajo za zdravljenje epilepsije - šentjanževko (Hypericum perforatum), ki se uporablja pri depresiji ali drugih stanjih - peroralne antidiabetike
Your doctor will work out your dose of VELCADE according to your height and weight (body surface area).
Zdravnik bo določil odmerek na osnovi vaše telesne višine in mase (telesne površine).
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 hudega zaprtja z ileusom.
• Ringing in the ears, ear discomfort
• zvonjenje v ušesih, nelagodje v ušesu
Regardless of
katera koli
OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by Cochran Mantel-Haenszel test.
OR za stopnje odziva na osnovi Mantel-Haenszelove ocene razmerja verjetnosti za stratificirane preglednice; p-vrednosti Cochran Mantel-Haenszelovega testa.
Vc=VELCADE; Dx=dexamethasone; T=thalidomide
Vc = VELCADE; Dx = deksametazon; T = talidomid
Since patients with neutropenia are at increased risk of infections, they should be monitored for signs and symptoms of infection and treated promptly.
Bolniki z nevtropenijo so izpostavljeni zvečanemu tveganju za okužbe, zato jih je treba spremljati glede pojava znakov in simptomov okužbe in jih takoj zdraviti.
• ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
• nevtropenija z zvečano telesno temperaturo stopnje ≥ 3, nevtropenija 4. stopnje, ki traja več kot 7 dni, število trombocitov < 10.000 celic/μl
Neuropathic pain and/or peripheral neuropathy
Nevropatična bolečina in/ali periferna nevropatija
b (95% CI)=0.63 (0.50; 0.79) p-value d < 0.001
b (95% CI) = 0,63 (0,50; 0,79) p-vrednost d < 0,001
VIAL VELCADE 1 mg
VIALA VELCADE 1 mg
Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Preobčutljivost na učinkovino, bor ali katero koli pomožno snov, navedeno v poglavju 6.1.
It is recommended that patients with at least partial response receive 2 additional cycles.
Priporočamo, da bolniki z najmanj delnim odgovorom prejmejo 2 dodatna kroga zdravljenja.
VELCADE is for single use only.
Zdravilo VELCADE je samo za enkratno uporabo.
Discontinuation due to PN (%)
prekinitev zdravljenja zaradi PN (%)
Once weekly VELCADE (cycles 5-9)
Odmerjanje zdravila VELCADE enkrat na teden (krogi 5-9)
The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:
Naslednja zdravila boste prejeli 1. dan vsakega 21-dnevnega kroga zdravljenja z zdravilom VELCADE v obliki intravenske infuzije:
Hazard ratio estimate is based on a Cox proportional-hazard model adjusted for stratification factors: 2-microglobulin, albumin, and region.
Ocena razmerja tveganja na osnovi Coxovega proporcionalnega modela, prilagojena na osnovi stratifikacijskih dejavnikov: β2-mikroglobulin, albumin in regija.
Log rank test adjusted for stratification factors: ISS staging and number of prior lines.
Log- rank test prilagojen na osnovi stratifikacijaskih faktorjev: ISS razvrstitvi in številu predhodnih zdravljenj.
MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
bolnikov je imelo vrednost mednarodnega prognostičnega indeksa (International Prognostic Index-IPI) ≥ 3 in 76% bolnikov je bilo v IV. stadiju bolezni.
These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE 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 zdravilom VELCADE z odmerkom 1,3 mg/m2 telesne površine in so vključeni v preglednico 7.
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 velikega tveganja.
A statistically significant benefit (p < 0.001) in favour of the VcR-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).
Opazili so statistično značilno korist (p < 0,001) v skupini VcR-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).
Do not use VELCADE - if you are allergic to bortezomib, boron or to any of the other ingredients of this medicine (listed in section 6) - if you have certain severe lung or heart problems.
Ne uporabljajte zdravila VELCADE - če ste alergični na bortezomib, bor ali katero koli sestavino tega zdravila (navedeno v poglavju
Additional adverse drug reactions identified associated with the use of the combination therapy (VcR-CAP) were hepatitis B infection (< 1%) and myocardial ischaemia (1.3%).
Dodatno ugotovljena neželena učinka, povezana z uporabo kombiniranega zdravljenja (VcR-CAP), sta bila okužba z virusom hepatitisa B (< 1%) in ishemija miokarda (1,3%).
The overall incidence of hepatitis B infections was similar in patients treated with VcR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Celokupna pogostnost okužbe z virusom hepatitisa B je bila podobna pri bolnikih, zdravljenih z VcR-CAP ali s R-CHOP (0,8% v primerjavi z 1,2%).
• instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (VELCADE plus dexamethasone, and VELCADE plus dexamethasone and thalidomide).
• Navodila za predpisovanje in odmerjanje, vključno z dolžino in številom krogov zdravljenja z namenom zmanjšati tveganje za napake pri izdajanju in uporabi zdravila, ki bi jih lahko povzročile različne kombinacije režima uvajanja bortezomiba pred transplantacijo (zdravilo VELCADE v kombinaciji z deksametazonon in zdravilo VELCADE v kombinaciji z deksametazonom in talidomidom).
Median survival for the Vc+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Mediana preživetja v skupini Vc+M+P je bila 56,4 mesecev, v skupini M+P pa 43,1 mesecev.
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).
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 10
Bolniki so imeli plazmocitom IgG/IgA/lahke verige v 63%/25%/8%, mediano koncentracijo hemoglobina 105 g/l in mediano število trombocitov 221,5 x10
Include all CR+CRu, by IRC, bone marrow and LDH.
Vključuje vse CR+CRu, IRC, kostni mozeg in LDH.
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 VELCADE in combination with dexamethasone over VELCADE monotherapy.
Analiza je dokazala izboljšan ORR (CR+PR) (razmerje obetov 3,769; 95% CI 2,045-6,947; p < 0,001), PFS (stopnja tveganja 0,511; 95% CI 0,309-0,845; p = 0,008), TTP (stopnja tveganja 0,385; 95% CI 0,212-0,698; p = 0,001) pri zdravljenju z zdravilom VELCADE v kombinaciji z deksametazonom v primerjavi z zdravljenjem z zdravilom VELCADE v monoterapiji.
• potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
• Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju, premajhnem odmerjanju in, da se je nenamerno intratekalno dajanje zdravila končalo s smrtnimi primeri.
The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Po ponavljajočih odmerkih je bil razpon razpolovnih časov (t1/2) bortezomiba 40-193 ur.
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 doseženi vsi pogoji programa preprečevanja nosečnosti za talidomid (Thalidomide Pregnancy Prevention Programme).
• Platelet counts should be ≥ 70 x 10
• Število trombocitov mora biti ≥ 70 x 10
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
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
What VELCADE looks like and contents of the pack VELCADE powder for solution for injection is a white to off-white cake or powder.
Izgled zdravila VELCADE in vsebina pakiranja VELCADE prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
• Sudden fall of blood pressure upon standing which may lead to fainting
• nenaden padec krvnega tlaka pri vstajanju, kar lahko vodi do omedlevice
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 večji od priporočenega kliničnega odmerka (v mg/m in povišanjem srčne frekvence, zmanjšanjem kontraktilnosti srca, hipotenzijo in smrtjo.
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.
• Weight loss, loss of taste
• hujšanje, izguba okusa
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 in še 3 mesece po zdravljenju.
An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
Razmerje obetov (odds ratio-OR) > 1 predstavlja prednost za skupino VcR-CAP.
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 statistically significant survival benefit in favour of the Vc+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including VELCADE-based regimens.
Pri bolnikih v skupini Vc+M+P so opazili statistično značilno izboljšanje preživetja (HR (Hazard Ratio - razmerje tveganja) = 0,695; p = 0,00043), kljub kasnejšim terapijam, vključno s terapijo z zdravilom VELCADE.
AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Okrajšave: SGOT = serumska glutamat-oksaloacetat transaminaza AST = aspartat-aminotransferaza; ULN - upper limit of the normal range = zgornja meja razpona normalnih vrednosti.
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 odgovora po presaditvi (CR+nCR, CR+nCR+VGPR+PR), čas preživetja brez napredovanja bolezni in celokupni čas preživetja.
This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of VELCADE 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 zdravilom VELCADE in pegiliranim liposomskim doksorubicinom.
• to remind that patients receiving VELCADE in combination with thalidomide should adhere to the pregnancy prevention programme of thalidomide, with reference to the SmPC of thalidomide for additional information.
• Bolnike, ki prejemajo zdravilo VELCADE v kombinaciji s talidomidom je treba opozoriti, da morajo upoštevati program preprečevanja nosečnosti kot je predpisan za talidomid, s sklicem na SmPC za talidomid za pridobitev dodatnih informacij.
Therefore, patients who experience constipation should be closely monitored.
Zato je treba bolnike z zaprtjem skrbno spremljati.
• Herpes virus infections
• okužbe s herpes virusom
• Low blood pressure, sudden fall of blood pressure on standing which may lead to fainting
• nizek krvni tlak, nenaden padec krvnega tlaka pri vstajanju, kar lahko povzroči omedlevico
Incidence of PN (%) All GradePN  Grade 2 PN  Grade 3 PN
pojavnost PN (%) vse stopnje PN ≥ stopnja 2 PN ≥ stopnja 3 PN prekinitev zdravljenja zaradi PN (%)
Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Vključuje vse radiološke diagnostične metode CR+CRu+PR po IRC, ne glede na preverjanje kostnega mozga in LDL.
The solution should be injected subcutaneously, at a 45-90° angle.
Raztopino morate injicirati subkutano, pod kotom 45-90 °.
VELCADE 3.5 mg reconstituted solution is administered subcutaneously through the thighs (right or left) or abdomen (right or left).
VELCADE 3,5 mg rekonstituirano raztopino dajte subkutano v stegno (desno ali levo) ali trebuh (desno ali levo).
- The other ingredients are mannitol (E421) and nitrogen.
- Drugi sestavini zdravila sta sta manitol (E421) in dušik.
Patients who developed orthostatic hypotension on VELCADE (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with VELCADE.
Bolniki, pri katerih se pojavi ortostatska hipotenzija ob zdravilu VELCADE (intravensko), niso imeli nobenih znakov ortostatske hipotenzije pred zdravljenjem z zdravilom VELCADE.
Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01
Preglednica 9: Pojavnost periferne nevropatije med uvajalnim zdravljenjem glede na stopnjo toksičnosti in prekinitev zdravljenja zaradi periferne nevropatije IFM-2005-01
If you have mantle cell lymphoma and are given the medicine rituximab with VELCADE you should tell your doctor:
Če imate limfom plaščnih celic in prejemate rituksimab skupaj z zdravilom VELCADE, zdravniku povejte če:
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.
The incidence of all grade peripheral neuropathy with VELCADE administered intravenously was lower in the historical studies with VELCADE administered intravenously than in study MMY-3021.
Pogostnost vseh stopenj periferne nevropatije pri dajanju zdravila VELCADE intravensko je bila v že prej opravljenih študijah manjša kot v študiji MMY-3021.
Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Incidenca smrti zaradi napredovanja bolezni je bila v subkutani skupini 18% in v intravenski skupini
Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of VELCADE
Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja zdravila VELCADE
19.9 mo
19,9 mesecev
Patients who did not obtain an optimal response (less than Complete Response [CR]) to therapy with VELCADE alone after 4 cycles were allowed to receive dexamethasone 20 mg daily on the day of and after VELCADE administration.
Bolniki, ki niso dosegli optimalnega odgovora (manj kot popolni odgovor [CR]) na zdravljenje z zdravilom VELCADE v monoterapiji po 4 krogih zdravljenja, so prejeli 20 mg deksametazona na dan brez zdravila in po dajanju zdravila VELCADE.
Day 8, 9, 10, 11
dan 8, 9, 10, 11
Phase II
faza II
The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Primarna ocena učinkovitosti je bilo preživetje brez napredovanja bolezni, ki ga je ocenil neodvisni odbor za pregled (Independent Review Committee - IRC).
Subcutaneous or Intravenous use only.
Samo za subkutano ali intravensko uporabo.
• Sensitivity, numbness, tingling or burning sensation of the skin, or pain in the hands or feet, due to nerve damage
• povečana občutljivost, odrevenelost, mravljinci ali pekoč občutek na koži ali bolečine v dlaneh in stopalih, zaradi poškodbe živca
• 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.