natgillin/translations-raw huggingface dataset:
• Heartburn, bloating, belching, wind, stomach pain, bleeding from your bowels or stomach
• zgaga, napenjanje, spahovanje, vetrovi, bolečine v trebuhu, krvavitev v črevesju ali želodcu
Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Občasni duševne motnje*, halucinacije*, psihotične motnje*, zmedenost*, nemir
Hazard ratio (95% CI) p-value Response rate population e n=668
43,1 mesecev stopnja tveganja (95% CI) p-vrednost Stopnja odziva populacija e n = 668
Table 6: Recommended starting dose modification for VELCADE in patients with hepatic impairment
Preglednica 6: Priporočena prilagoditev začetnega odmerka zdravila VELCADE pri bolnikih z boleznijo jeter Stopnja jetrne okvare*
• Infection of the outermost layer of the eye and the inner surface of the eyelids (conjunctivitis)
• okužba veznice očesa in vek (konjuktivitis)
Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Bolnike, ki prejemajo bortezomib v kombinaciji z močnimi inhibitorji encima CYP3A4 je treba skrbno spremljati.
• Arthritis, including inflammation of the joints in the fingers, toes, and the jaw
• vnetje sklepa (artritis), vključno z vnetjem sklepov prstov na roki in nogi ter čeljusti
For patients with a response first documented at cycle 6, two additional treatment cycles were given.
Bolniki, ki so dosegli odgovor šele v 6. krogu, so prejeli dva dodatna kroga zdravljenja.
Efficacy results are presented in Table 15:
Rezultati učinkovitosti so podani v preglednici 15:
A drug-drug interaction study assessing the effect of ketoconazole, a potent CYP3A4 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 35% (CI90% [1.032 to 1.772]) based on data from 12 patients.
Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na famakokinetiko bortezomiba (danega intravensko), je na osnovi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35% (CI90% (1.032 do 1.772)).
N=130 (ITT population)
n = 130 (ITT populacija)
Patients were administered intravenous doses of 0.7 to 1.3 mg/m 2 of VELCADE twice weekly.
Bolniki so dvakrat na teden prejemali intravenske odmerke zdravila VELCADE v odmerku od 0,7 do 1,3 mg/m2.
Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Kot del diferencialne diagnoze težav CŽS je treba pri bolnikih redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
CR = popolni odgovor; CRu = nepotrjen popolni odgovor; PR = delni odgovor; CI = interval zaupanja, HR = razmerje tveganja; OR = razmerje verjetnosti; ITT = populacija, ki so jo nameravali zdraviti
Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Med zdravljenjem z zdravilom VELCADE so občasno poročali o resnih neželenih učinkih: srčno popuščanje, sindrom razpada tumorja, pljučna hipertenzija, sindrom reverzne posteriorne encefalopatije, akutna difuzna infiltracijska pljučna stanja in redko o avtonomni nevropatiji.
1.3 The reconstituted product is preservative free and should be used immediately after preparation.
Rekonstituirana raztopina ne vsebuje konzervansov in jo je treba porabiti takoj po raztapljanju.
VDDx=vincristine, doxorubicin, dexamethasone; VcDx=VELCADE, dexamethasone; TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
VDDx = vinkristin, doksorubicin, deksametazon; VcDx = VELCADE, deksametazon; TDx = talidomid, deksametazon; VcTDx = VELCADE, talidomid, deksametazon; PN = periferna nevropatija Opomba: periferna nevropatija vključuje priporočene termine: periferna nevropatija, periferna motorična nevropatija, periferna senzorična nevropatija, in polinevropatija.
The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Pri bolnikih z blago do zmerno okvaro ledvic (očistek kreatinina [CrCL] > 20 ml/min/1,73 m farmakokinetika bortezomiba ni spremenjena, zato pri njih ni potrebno prilagajati odmerka.
Instructions for reconstitution VELCADE must be reconstituted by a healthcare professional.
Navodila za rekonstitucijo raztopine Zdravilo VELCADE mora rekonstituirati zdravstveno osebje.
VELCADE treatment is commonly associated with orthostatic/postural hypotension.
Zdravljenje z zdravilom VELCADE je pogosto povezano z ortostatsko hipotenzijo oz. posturalno hipotenzijo.
Dyspnoea*, Epistaxis, Upper/lower respiratory tract infection*, Cough*
Pogosti dispneja*, epistaksa, okužba zgornjih/spodnjih dihal*, kašelj*
N=127 (ITT population)
n = 127 (ITT populacija)
P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI tveganjem in stopnjo bolezni.
Uncommon Fall, Contusion Rare
Občasni padci, kontuzije
You will have to take regular blood tests before and during your treatment with VELCADE, to check your blood cell counts regularly.
Pred in med zdravljenjem z zdravilom VELCADE vam bodo redno pregledovali kri, in tako spremljali število krvnih celic.
Only the 3.5 mg vial can be administered subcutaneously, as described below.
Kot navedeno spodaj, se lahko daje subkutano le 3,5 mg viala.
Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2 onwards if 100 mg is tolerated.
V 3. tednu 1. kroga se lahko odmerek talidomida poveča na 100 mg samo, če bolnik dobro prenaša odmerek 50 mg in na 200 mg v 2. krogu, če bolnik dobro prenaša odmerek 100 mg.
#, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
#, bakteriemija (vključno s stafilokokno), hordeol, gripa, celulitis, z uporabo katetra povezana okužba, okužba kože*, ušesne okužbe*, okužba s stafilokoki, okužbe zob*
This medicine is for intravenous use only.
To zdravilo se daje samo v veno (intravensko).
• Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
• paraliza, krči, padci, motnje gibanja, nenormalen, spremenjen ali zmanjšan občutek (otip, sluh,
Platelet transfusion for the treatment of thrombocytopenia should be considered when clinically appropriate.
Če je klinično ustrezno je treba za zdravljenje trombocitopenije razmisliti o transfuziji trombocitov.
VELCADE intravenous arm
VELCADE intravensko VELCADE subkutano
In a clinical trial, two patients (out of 2) given high-dose cytarabine (2 g/m2 per day) by continuous infusion over 24 hours with daunorubicin and VELCADE for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
V kliničnem preskušanju, sta dva bolnika (od dveh), pri katerih so akutno mielogeno levkemijo zdravili z velikim odmerkom citarabina v 24 urni kontinuirani infuziji (2 g/m2 na dan) skupaj z daunorubicinom in zdravilom VELCADE, umrla zaradi SARS na začetku zdravljenja in študijo so zaključili.
Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2doksorubicina.
No new safety concerns were observed during the study, and in particular VELCADE did not exacerbate target organ damage (heart, kidney and liver).
Uporaba zdravila VELCADE ni povečala poškodb tarčnih organov (srce, ledvice, jetra).
The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Stopnja geometrične sredine AUCzadnji je bila 0,99 in 90% intervali zaupanja 80,18%-122,80%.
• Heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate
• popuščanje srca, srčni infarkt, bolečina v prsih, občutek nelagodja v prsih, pospešen ali upočasnjen srčni utrip
[95% CI] Best response
1-letno preživetje,% [95% CI] Najboljši odziv
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. pH raztopine ni treba preverjati.
A Phase II, single-arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi-agent re-induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
V farmakokinetični študiji varnosti in učinkovitosti faze II, z enim krakom, ki jo je izvedla Skupina za otroško onkologijo (COG - Children's Oncology Group) so ocenili delovanje bortezomiba, ki so ga dodali k ponovno uvedeni indukcijski kemoterapiji z več zdravili pri pediatričnih in mladih odraslih bolnikih z limfatičnimi malignomi (s pre-B-celično akutno limfoblastno levkemijo [ALL], T-celično ALL in T-celičnim limfoblastnim limfomom [LL]).
Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone
Preglednica 3: Prilagajanje odmerkov med kasnejšimi krogi zdravljenja z zdravilom VELCADE v kombinaciji z melfalanom in prednizonom
• If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from
• Če toksičnost mine oz. ima bolnik ANC ≥ 750 celic/μl in število trombocitov ≥ 25.000 celic/μl, lahko ponovno uvedete zdravilo VELCADE v odmerku, ki je eno stopnjo manjši od prejšnjega(z 1,3 mg/m2 na 1 mg/m2 ali z 1 mg/m2 na
Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
Pogosti motnje razpoloženja*, anksiozne motnje*, motnje spanja*
Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Občasni okužba*, bakterijske okužbe*, virusne okužbe*, sepsa (vključno s septičnim šokom)*, bronhopnevmonija, okužba s herpesvirusom*, herpetični meningoencefalitis
In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/l, 90% of 21 patients had a count ≤ 25,000/l during the study, including 14% < 10,000/l; in contrast, with a baseline platelet count > 75,000/l, only 14% of 309 patients had a count ≤ 25,000/l during the study.
Pri bolnikih, z napredujočim plazmocitomom, je bila resnost trombocitopenije povezana s številom trombocitov pred zdravljenjem (90% od 21 bolnikov, ki so imeli začetno število trombocitov < 75.000/l, je med preskušanjem imelo število trombocitov ≤ 25.000/l (vključno s 14% bolnikov, ki so imeli število trombocitov < 10.000/l).
In B-ALL patients with relapse 18-36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Pri bolnikih z B-celično ALL in relapsom po 18-36 mesecev po diagnozi (n = 33) je bil delež popolnih odgovorov 79% (95% CI: 61, 91) in delež 4-mesečnega preživetja bolnikov brez dogodkov 73% (95% CI: 54, 85).
The Reconstitution, dosing and administration booklet shall contain the following key elements:
Izobraževalna knjižica z navodili za rekonstitucijo, odmerjanje in načinom uporabe mora vsebovati naslednje ključne elemente:
In the Phase III study patients who received VELCADE subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of VELCADE.
V študiji faze III so imeli bolniki, ki so prejemali zdravilo VELCADE subkutano za 13% manjšo celokupno incidenco neželenih učinkov zaradi uporabe zdravila, s stopnjo toksičnosti 3 ali več in za 5% manjšo pogostnost prekinitve zdravljenja v primerjavi z bolniki, ki so prejemali zdravilo VELCADE intravensko.
OUTER CARTON, VELCADE 1 mg
ŠKATLA, VELCADE 1 mg
• Tooth infection
• okužba zob
Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Občasni multiformni eritem, urtikarija, akutna febrilna nevtrofilna dermatoza, toksični kožni izpuščaj, toksična epidermalna nekroliza
CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcDx=VELCADE, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
CI = interval zaupanja; CR = popoln odgovor; nCR = skoraj popoln odgovor; ITT = populacija, ki so jo nameravali zdraviti; RR = stopnja odgovora; Vc = VELCADE; VcDx = VELCADE in deksametazon; VDDx = vinkristin, doksorubicin in deksametazon; VGPR = zelo dober delni odgovor; PR = delni odgovor; OR = razmerje verjetnosti.
• A sore mouth or lip, dry mouth, mouth ulcers or throat pain
• vnetje ust ali ustnic, suha usta, razjede v ustih ali bolečine v grlu
PRES is a rare, often reversible, rapidly evolving neurological condition, which can present with seizure, hypertension, headache, lethargy, confusion, blindness, and other visual and neurological disturbances.
Pri bolnikih, ki so prejemali zdravilo VELCADE so poročali o PRES. PRES je redka, pogosto reverzibilna nevrološka motnja, ki se razvije hitro in se lahko kaže z epileptičnimi napadi, hipertenzijo, glavoboli, letargijo, zmedenostjo, slepoto in drugimi motnjami vida ter nevrološkimi motnjami.
The CR rate in first-relapsed T-cell ALL patients (n = 22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Delež popolnih odgovorov pri prvih bolnikih s T-celično ALL (n = 22) je bil 68% (95% CI: 45, 86), delež 4-mesečnega preživetja bolnikov brez dogodkov pa 67% (95% CI: 42, 83).
The mean platelet count nadir measured was approximately 40% of baseline in the single-agent multiple myeloma studies and 50% in the MCL study.
Povprečna vrednost najnižjega izmerjenega števila trombocitov je v študijah diseminiranega plazmocitoma z uporabo ene učinkovine znašala približno 40% in v študiji MCL 50% začetne vrednosti.
You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Lahko pa boste zdravilo VELCADE prejeli skupaj z zdraviloma pegilirani liposomski doksorubicin ali deksametazon.
A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Bolnike so glede na vrednost očistka kreatinina (CrCL) razdelili v naslednje skupine: normalno delovanje ledvic (CrCL ≥ 60 ml/min/1,73 m2, n = 12), blaga okvara ledvic
Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
Stopnja odziva v 8. krogu n (%) ORR (CR+PR) p-vrednost
Median c(95% CI) (months) Response rate n: response-evaluable patients 229 Overall complete response (CR+CRu)
mediana c(95% CI) (meseci) Stopnja odziva n: odgovor preiskovanih bolnikov
• If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
• Če se po subkutanem injiciranju zdravila VELCADE na mestu injiciranja pojavijo lokalne reakcije, se priporoča, da subkutano injicirate manj koncentrirano raztopino zdravila VELCADE (1 mg/ml namesto 2,5 mg/ml) ali pa preidete na intravensko dajanje zdravila.
Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Občasno so poročali o reakcijah povzročenih z imunskimi kompleksi, kot so serumska bolezen, poliartritis z izpuščajem in proliferativni glomerulonefritis.
• Skin infections
• okužbe kože
Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Stopnja odziva v 4. krogu n (%) ORR (CR+PR) p-vrednost
Dose adjustments during treatment and re-initiation of treatment for monotherapy VELCADE treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Prilagoditev odmerjanja med zdravljenjem in pri ponovni uvedbi zdravljenja v obliki monoterapije Zdravljenje z zdravilom VELCADE morate prekiniti ob pojavu katere koli nehematološke toksičnosti 3. stopnje ali katere koli hematološke toksičnosti 4. stopnje, z izjemo nevropatije, kot je opisano v nadaljevanju (glejte tudi poglavje 4.4).
• General ill feeling
• splošno slabo počutje
Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Občasni pancitopenija*, febrilna nevtropenija, koagulopatija*, levkocitoza*, limfadenopatija, hemolitična anemija
Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO celic) je bil bortezomib v koncentraciji le 3,125 μg/ml, ki je bila najnižja ovrednotena koncentracija, pozitiven na klastogeno aktivnost (strukturne kromosomske aberacije).
• dosing instructions and examples: how to calculate the body surface area of a patient and the volume of reconstituted VELCADE (both IV and SC use) required for different body surface areas.
• Navodila za odmerjanje s primeri: kako se izračuna telesna površina bolnika in volumen rekonstituiranega zdravila VELCADE (za i.v.
Adverse reactions are listed below by system organ class and frequency grouping.
Neželeni učinki so v spodnji preglednici navedeni po organskih sistemih in po pogostnosti.
1.3 mg/m 2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m 2 and 1.3 mg/m 2, respectively.
Po ponovljenih odmerkih je bil razpon 15 do 32 l/h za odmerek 1,0 mg/m2 in 18 do 32 l/h za odmerek 1,3 mg/m
42.9% and 10.4% of patients in the VcR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
V skupini VcR-CAP je bilo 42,9% bolnikov starih 65-74 let in 10,4% bolnikov, starih ≥ 75 let.
Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
10 ml, steklena viala, steklo tipa I, s sivim zamaškom iz bromobutilne gume in aluminijasto zaporko z modrim pokrovčkom, ki vsebuje 3,5mg bortezomiba.
11 in a 21 day treatment cycle.
28 dnevnem krogu zdravljenja.
This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent VELCADE for both the subcutaneous and intravenous routes, 42% in both groups.
V študiji je bil dosežen primarni cilj, 42% stopnja odziva (CR+PR) po 4 krogih zdravljenja z zdravilom VELCADE v monoterapiji pri subkutani in intravenski uporabi.
• Hiccups, speech disorders
• kolcanje, motnje govora
For VELCADE-related neuropathic pain and/or peripheral neuropathy, hold and/or modify VELCADE as outlined in Table 1.
V primeru nevropatske bolečine in/ali periferne nevropatije povezane z zdravilom VELCADE zakasnite in/ali prilagodite odmerek zdravila VELCADE, kot je opisano v preglednici 1.
• Non-haematological toxicities should have resolved to Grade 1 or baseline.
• Ne-hematološke toksičnosti se morajo povrniti na 1. stopnjo ali na stanje pred začetkom zdravljenja.
VELCADE therapy should be withheld when the platelet count is < 25,000/l or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/l (see section 4.2).
Zdravljenje je treba prekiniti, kadar se bolnik zdravi z zdravilom VELCADE in je število trombocitov < 25.000/l, ali če se bolnik zdravi z zdravilom VELCADE v kombinaciji z melfalanom in prednizonom in je število trombocitov < 30.000/l (glejte poglavje 4.2).
In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to VELCADE were in the range 65-74 years and ≥ 75 years of age, respectively.
V študiji z zdravilom VELCADE pri bolnikih, pri katerih limfom plaščnih celic še ni bil zdravljen, je bilo 42,9% bolnikov starih 65-74 let in 10,4% bolnikov starih ≥ 75 let.
#, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
#, srčno-pljučni zastoj*, srčna fibrilacija (vključno z atrijsko), srčno popuščanje (vključno z levim in desnim prekatom)*, aritmija*, tahikardija*, palpitacije, angina pektoris, perikarditis (vključno s perikardialnim izlivom)*, kardiomiopatija*, disfunkcija prekata*, bradikardija
Injection under the skin is in either the thighs or the abdomen.
V podkožje se injicira v stegno ali v trebuh.
Haematological toxicity during a cycle
Hematološka toksičnost med zdravljenjem
In study MMY-3010 induction treatment withVELCADE combined with thalidomide and dexamethasone [VcTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
V študiji MMY-3010 so primerjali uvajalno zdravljenje z zdravilom VELCADE v kombinaciji s talidomidom in deksametazonom [VcTDx, n = 130] s kombinacijo talidomid-deksametazon [TDx, n = 127].
VELCADE combination treatment with dexamethasone In the absence of any direct comparison between VELCADE and VELCADE in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of VELCADE in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the VELCADE monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Zato je bila opravljena statistična analiza izenačenih parov, ki je primerjala rezultate nerandomizirane skupine zdravljene z zdravilom VELCADE v kombinaciji z deksametazonom (odprta študija faze II; MMY-2045) z rezultati zdravljenja z zdravilom VELCADE v različnih študijah faze III (M34101-039 [APEX] in DOXIL MMY-3001) za enako indikacijo.
At least 72 hours should elapse between consecutive doses of VELCADE.
Med zaporednimi odmerki zdravila VELCADE mora preteči vsaj 72 ur.
Each carton of VELCADE 1 mg powder for solution for injection contains a glass vial with a green cap, in a transparent blister pack.
Ena škatla zdravila VELCADE 1 mg prašek za raztopino za injiciranje vsebuje stekleno vialo z zelenim pokrovčkom v prozorni zavarjeni vrečki.
Combination therapy with melphalan and prednisone VELCADE 1 mg powder for solution for injection is administered via intravenous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Kombinirano zdravljenje z melfalanom in prednizonom Zdravilo VELCADE 1 mg prašek za raztopino za injiciranje se daje intravensko v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
Therefore, platelet counts should be monitored prior to each dose of VELCADE.
Zato je treba pred dajanjem vsakega odmerka zdravila VELCADE določiti število trombocitov.