FrancophonIA/ELRC3.0 huggingface dataset:
English: Progressive multifocal leukoencephalopathy (PML) Very rare cases with unknown causality of John Cunningham (JC) virus infection, resulting in PML and death, have been reported in patients treated with bortezomib.
Slovenian: Pri bolnikih, zdravljenih z bortezomibom, so poročali o zelo redkih primerih okužbe z virusom JC (John Cunningham virus), z neznano vzročno povezavo, ki je vodila v PML in smrt.
English: The Reconstitution poster shall contain the following key elements:
Slovenian: Plakat z navodili za rekonstitucijo mora vsebovati naslednje ključne elemente:
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3. 6.5 Vrsta ovojnine in vsebina
English: Time to progression Events n (%) Mediana (95% CI)
Slovenian: Čas do napredovanja bolezni dogodki n (%) medianaa (95 % CI)
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and BzmbDx groups respectively; the majority of patients underwent one single transplant procedure.
Slovenian: Avtologno presaditev krvotvornih matičnih celic so opravili pri 198 (82 %) bolnikih v skupini VDDx in 208 (87 %) bolnikih v skupini BzmbDx.
English: Melphalan and prednisone should both be given orally on days 1, 2, 3 and 4 of the first week of each Bortezomib SUN treatment cycle.
Slovenian: Melfalan in prednizon je treba dati peroralno na 1., 2., 3. in 4. dan v prvem tednu vsakega kroga zdravljenja z zdravilom Bortezomib SUN.
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Slovenian: Bolniki, ki so imeli na začetku študije stopnjo periferne nevropatije ≥ 2 ali število trombocitov < 50,000/µl, so bili izključeni.
English: Tell your doctor straight away if you notice any of the following symptoms: - muscle cramping, muscle weakness - confusion, visual loss or disturbances, blindness, seizures, headaches - shortness of breath, swelling of your feet or changes in your heart beat, high blood pressure, tiredness, fainting - coughing and breathing difficulties or tightness in the chest.
Slovenian: Takoj obvestite svojega zdravnika, če opazite katerega koli od naslednjih simptomov: - mišični krči, mišična šibkost - zmedenost, izguba ali motnje vida, slepota, epileptični napadi, glavoboli - težko dihanje, otekanje nog ali spremembe srčnega utripa, visok krvni tlak, utrujenost,
English: If you are given Bortezomib SUN together with other medicines for the treatment of mantle cell lymphoma the side effects you may get are listed below:
Slovenian: Če prejemate zdravilo Bortezomib SUN skupaj z drugimi zdravili za zdravljenje limfoma plaščnih celic, se lahko pri vas pojavijo naslednji neželeni učinki:
English: N=127 (ITT population)
Slovenian: n=127 (ITT
English: Platelet transfusion should be considered when clinically appropriate (see section 4.2).
Slovenian: Če je klinično ustrezno, je treba razmisliti o transfuziji trombocitov (glejte poglavje 4.2).
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Slovenian: Periferno nevropatijo (vseh stopenj) so opazili pri 40 %, periferno nevropatijo stopnje ≥ 3 pa pri 8,5 % bolnikov.
English: If any discolouration or particulate matter is observed, the solution should be discarded.
Slovenian: Če opazite kakršno koli spremembo barve ali delce v raztopini, jo morate zavreči.
English: Efficacy results are presented in Table 11:
Slovenian: Podatki o učinkovitosti so navedeni v preglednici 11:
English: The patients at risk of tumour lysis syndrome are those with high tumour burden prior to treatment.
Slovenian: Tveganje za pojav sindroma razpada tumorja je večje pri bolnikih z večjo maso tumorja pred začetkom zdravljenja.
English: It is also recommended that responding patients who do not achieve a complete remission receive a total of 8 cycles of Bortezomib SUN therapy.
Slovenian: da odzivni bolniki, ki ne dosežejo popolne remisije, prejmejo skupno 8 krogov zdravljenja z zdravilom.
English: Common Vision abnormal*
Slovenian: Pogosti nenormalen vid *
English: Grade ≥ 3 non-haematological toxicities
Slovenian: Nehematološka toksičnost stopnje ≥ 3
English: The median number of cycles received for both groups was 4 cycles.
Slovenian: Mediano število krogov zdravljenja je bilo 4 v obeh skupinah.
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Slovenian: Redki maligne neoplazme, plazmocitna levkemija, karcinom ledvičnih celic, masa, fungoidna mikoza, benigne neoplazme*
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm.
Slovenian: V BzmbR-CAP kraku študije je protivirusna zdravila prejelo 137 od 240 bolnikov (57 %).
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib
Slovenian: Preglednica 15: Povzetek analize učinkovitosti subkutanega in intravenskega dajanja bortezomiba Skupina z intravenskim injiciranjem
English: Based on animal studies, the penetration of bortezomib through the blood-brain barrier appears to be limited, if any and the relevance to humans is unknown.
Slovenian: Na podlagi rezultatov raziskav na živalih je prehajanje bortezomiba preko hematoencefalne bariere omejeno oz. zanemarljivo.
English: - Injection sites should be rotated for successive injections.
Slovenian: - Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
English: Subcutaneous use: Add 1.4 ml 0.9% sodium chloride to make 2.5 mg/ml final concentration.
Slovenian: Subkutana uporaba: dodajte 1,4 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 2,5 mg/ml.
English: For additional information concerning melphalan and prednisone, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o melfalanu in prednizonu glejte ustrezna Povzetka glavnih značilnosti zdravila.
English: Time related events
Slovenian: Časovno pogojeni
English: When Bortezomib SUN is given in combination with other medicinal products, the Summary of Product Characteristics of these other medicinal products must be consulted prior to initiation of treatment with Bortezomib SUN.
Slovenian: Kadar se zdravilo Bortezomib SUN uporablja v kombinaciji z drugimi zdravili, je treba prebrati povzetke glavnih značilnosti teh zdravil pred začetkom zdravljenja z zdravilom Bortezomib SUN.
English: Patients experiencing new or worsening peripheral neuropathy should undergo neurological evaluation and may require a change in the dose, schedule or route of administration to subcutaneous (see section 4.2).
Slovenian: Pri bolnikih, pri katerih se periferna nevropatija pojavi prvič ali se obstoječa periferna nevropatija poslabša, je treba napraviti nevrološko oceno in po potrebi prilagoditi odmerek ali shemo odmerjanja ali preiti na subkutano dajanje (glejte poglavje 4.2).
English: Adverse reactions are listed below by system organ class and frequency grouping.
Slovenian: Neželeni učinki v spodnji preglednici so navedeni po organskih sistemih in po pogostnosti.
English: Sun Pharmaceutical Industries Europe B.V.
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Sun Pharmaceutical Industries Europe B.V.
English: Bortezomib SUN is for single use only.
Slovenian: Zdravilo Bortezomib SUN je samo za enkratno uporabo.
English: e Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Slovenian: e Uporabljena je Mantel-Haenszelova ocena razmerja obetov za stratificirane preglednice, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.
English: In the Phase III study comparing bortezomib administered intravenously versus subcutaneously, the incidence of Grade ≥ 2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Slovenian: V študiji faze III z bortezomibom, ki je primerjala intravensko in subkutano dajanje zdravila, je bila pogostnost dogodkov periferne nevropatije 2. stopnje v skupini, ki je prejemala zdravilo subkutano, 24 %, v skupini, ki je prejemala zdravilo intravensko, pa 41 % (p=0,0124).
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;
English: PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection 1 vial
Slovenian: prašek za raztopino za injiciranje 1 viala
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzmbR-CAP).
Slovenian: Do okužbe s HBV s smrtnim izidom je prišlo pri 0,8 % (n=2) bolnikov v skupini, ki ni prejemala bortezomiba (rituksimab, ciklofosfamid, doksorubicin, vinkristin in prednizon; skupina R-CHOP), in pri 0,4 % (n=1) bolnikov v skupini, ki je prejemala bortezomib v kombinaciji z rituksimabom, ciklofosfamidom, doksorubicinom in prednizonom (skupina BzmbR-CAP).
English: Bortezomib is a proteasome inhibitor.
Slovenian: Mehanizem delovanja Bortezomib je zaviralec proteasoma.
English: Main efficacy results are presented in Table 13.
Slovenian: Glavni rezultati so zbrani v preglednici 13.
English: N=130 (ITT population)
Slovenian: n=130 (ITT
English: What Bortezomib SUN contains - The active substance is bortezomib.
Slovenian: Kaj vsebuje zdravilo Bortezomib SUN - Učinkovina je bortezomib.
English: Neuropathic pain and/or peripheral neuropathy Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Slovenian: Nevropatična bolečina in/ali periferna nevropatija Bolnike, ki imajo nevropatično bolečino in/ali periferno nevropatijo v povezavi z jemanjem bortezomiba, zdravite v skladu s preglednico 1 (glejte poglavje 4.4).
English: For Bortezomib SUN dosage adjustments, dose modification guidelines described for monotherapy should be followed.
Slovenian: Za prilagoditev odmerjanja zdravila Bortezomib SUN je treba upoštevati navodila za odmerjanje, opisana pri samostojnem zdravljenju.
English: g P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Slovenian: g Vrednost p iz Cochran Mantel-Haenszelovega hi-kvadrat testa, skupaj s stratifikacijskima dejavnikoma IPI-tveganjem in stadijem bolezni.
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Slovenian: Za dodatne informacije o pegiliranem liposomskem doksorubicinu glejte povzetek glavnih značilnosti tega zdravila.
English: Bortezomib is metabolised by liver enzymes.
Slovenian: Bortezomib se presnavlja z jetrnimi encimi.
English: 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.
Slovenian: V in vitro preskusu kromosomskih aberacij z uporabo ovarijskih celic kitajskega hrčka (CHO-celic) je bil bortezomib v koncentraciji samo 3,125 μg/ml, ki je bila najnižja ovrednotena koncentracija,
English: 20.7 mo
Slovenian: 20,7 meseca
English: LIST OF EXCIPIENTS Excipient: mannitol (E421)
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožna snov: manitol (E421).
English: ORe (95% CI)=1.688 p-valueg=0.007
Slovenian: ORe (95 % CI)=1,688
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Slovenian: Vpliv hude okvare ledvic na farmakokinetiko bortezomiba pri bolnikih, ki se še ne zdravijo z dializo (CrCL< 20 ml/min/1,73 m2), ni znan.
English: This study met its primary objective of non-inferiority for response rate (CR+PR) after 4 cycles of single agent bortezomib for both the subcutaneous and intravenous routes, 42% in both groups.
Slovenian: V študiji je bil dosežen primarni cilj neinferiornosti, 42 % stopnja odziva (CR+PR) po 4 krogih zdravljenja z bortezomibom v monoterapiji pri subkutani in intravenski uporabi.
English: 4.63 (2.61, 8.22); < 0.001a 3.46 (1.90, 6.27); < 0.001a
Slovenian: 4,63 (2,61; 8,22); < 0,001a
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
Slovenian: Bolniki v obeh skupinah so na splošno imeli podobne demografske in bolezenske značilnosti: mediana starost bolnikov je bila 66 let, 74 % je bilo moških, 66 % je bilo belcev in 32 % azijcev,
English: • different reconstitution requirements for Bortezomib SUN 3.5 mg IV or SC use
Slovenian: • Različne zahteve za rekonstitucijo zdravila Bortezomib SUN 3,5 mg pri i.v.
English: The effect of hepatic impairment on the pharmacokinetics of bortezomib was assessed in a Phase I study during the first treatment cycle, including 61 patients primarily with solid tumors and varying degrees of hepatic impairment at bortezomib doses ranging from 0.5 to 1.3 mg/m2.
Slovenian: Vpliv jetrne okvare na farmakokinetiko bortezomiba v odmerkih od 0,5 do 1,3 mg/m2 so ocenjevali v študiji faze I med prvim ciklom zdravljenja, ki je vključevala 61 bolnikov s primarno solidnimi tumorji in različnimi stopnjami jetrne okvare.
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Slovenian: Redki meningitis (vključno z bakterijskim), okužba z virusom Epstein-Barr, genitalni herpes, tonzilitis, mastoiditis,
English: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Slovenian: V študiji z bortezomibom 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.
English: • potential risks of administration errors including overdosing, underdosing and that inadvertent intrathecal administration has resulted in death
Slovenian: • Možna tveganja napak pri uporabi zdravila, vključno z informacijami o prevelikem odmerjanju,
English: 1-year Overall Survival (%)e
Slovenian: 1-letno celokupno preživetje (%)e (95 % CI)
English: There is no known specific antidote for bortezomib overdose.
Slovenian: Specifični antidot za bortezomib ni znan.
English: Main efficacy results are presented in Table 12.
Slovenian: Glavni rezultati so zbrani v preglednici 12.
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100);
Slovenian: Pogostnost neželenih učinkov je opredeljena, kot sledi: zelo pogosti (≥ 1/10); pogosti (≥ 1/100 do
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Slovenian: Glede na lokalne smernice se za hematološke toksičnosti lahko daje granulocitne kolonije spodbujajoče faktorje.
English: Treatment with Bortezomib SUN can very commonly cause a decrease in the numbers of red and white blood cells and platelets in your blood.
Slovenian: - težave s kašljem in dihanjem ali tiščanje v prsih Zdravljenje z zdravilom Bortezomib SUN lahko zelo pogosto povzroči zmanjšanje števila rdečih in belih krvnih celic ter krvnih ploščic.
English: RECONSTITUTION FOR INTRAVENOUS INJECTION
Slovenian: REKONSTITUCIJA ZA INTRAVENSKO INJICIRANJE
English: Bortezomib SUN should not be administered intrathecally.
Slovenian: Zdravila Bortezomib SUN se ne sme dajati intratekalno.
English: When Bortezomib SUN is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Slovenian: Če jemljete zdravilo Bortezomib SUN v kombinaciji s talidomidom, morate upoštevati program za preprečevanje nosečnosti, ki velja za talidomid (glejte navodilo za uporabo talidomida).
English: This 4-week period is considered a treatment cycle.
Slovenian: To 4-tedensko obdobje predstavlja en krog zdravljenja.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for bortezomib, the scientific conclusions of CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za bortezmib, je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: Combination therapy with melphalan and prednisone Bortezomib SUN is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Slovenian: Zdravilo Bortezomib SUN se daje intravensko ali subkutano v kombinaciji s peroralnim melfalanom in prednizonom, kot je prikazano v preglednici 2.
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Slovenian: Opazili so statistično značilno razliko v CR+nCR v prid skupine, ki je prejemala bortezomib in deksametazon.
English: Injection sites should be rotated for successive injections.
Slovenian: Mesta injiciranja je treba med zaporednimi injiciranji menjavati.
English: What Bortezomib SUN looks like and contents of the pack Bortezomib SUN 3.5 mg powder for solution for injection is a white to off-white powder or cake.
Slovenian: Izgled zdravila Bortezomib SUN in vsebina pakiranja Bortezomib SUN 3,5 mg prašek za raztopino za injiciranje je bela do belkasta pogača ali prašek.
English: Brain imaging, preferably Magnetic Resonance Imaging (MRI), is used to confirm the diagnosis.
Slovenian: Diagnozo potrdimo s slikovnimi preiskavami možganov, najbolje z magnetnoresonančnim slikanjem (MRIMagnetic Resonance Imaging).
English: You will have to take regular blood tests before and during your treatment with Bortezomib SUN, to check your blood cell counts regularly.
Slovenian: Pred in med zdravljenjem z zdravilom Bortezomib SUN vam bodo redno pregledovali kri in tako spremljali število krvnih celic.
English: Intravenous use: Add 3.5 ml 0.9% sodium chloride to make 1 mg/ml final concentration.
Slovenian: Intravenska uporaba: dodajte 3,5 ml sterilne 0,9 % raztopine natrijevega klorida za končno koncentracijo 1 mg/ml.
English: Grade ≥ 3 non-haematological toxicities considered to be related to Bortezomib SUN
Slovenian: Nehematološka toksičnost stopnje ≥ 3, povezana z uporabo zdravila Bortezomib SUN
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla
English: Response parameters as well as TTP remained significantly better for bortezomib independently of age.
Slovenian: Parametri odziva na zdravljenje, kot tudi čas do napredovanja bolezni (time to progression, TTP) so bili, neodvisno od starosti, pri zdravljenju z bortezomibom statistično značilno boljši.
English: d Based on Log rank test stratified with IPI risk and stage of disease.
Slovenian: d Na podlagi log-rank testa, stratificiranega z IPI-tveganjem in stadijem bolezni.
English: 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.
Slovenian: Študija medsebojnega delovanja zdravil, ki je ocenjevala učinek ketokonazola, močnega inhibitorja CYP3A4, na farmakokinetiko bortezomiba (danega intravensko), je na podlagi podatkov 12 bolnikov pokazala povprečen dvig AUC bortezomiba za 35 % (CI 90 % (1.032 do 1.772)).
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Slovenian: Bolniki v obeh skupinah so imeli podobne demografske in bolezenske značilnosti.
English: Elderly MCL patients 42.9% and 10.4% of patients in the BzmbR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Slovenian: V skupini BzmbR-CAP je bilo 42,9 % bolnikov starih 65-74 let in 10,4 % bolnikov starih ≥ 75 let.
English: The following information is intended for healthcare professionals only: Only the 3.5 mg vial can be administered subcutaneously, as described below.
Slovenian: Kot je navedeno spodaj, se lahko daje subkutano samo 3,5 mg viala.
English: The following medicinal products are administered on day 1 of each Bortezomib SUN 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Slovenian: Zdravila, ki se dajejo v obliki intravenske infuzije na 1. dan vsakega 3-tedenskega kroga zdravljenja z zdravilom Bortezomib SUN, so: 375 mg/m2 rituksimaba, 750 mg/m2 ciklofosfamida in 50 mg/m2 doksorubicina.
English: 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.
Slovenian: Kot del diferencialne diagnoze težav CŽS je pri bolnikih treba redno spremljati pojav novih ali poslabšanje nevroloških simptomov ali znakov, ki bi lahko nakazovali na PML.
English: Acute development or exacerbation of congestive heart failure, and/or new onset of decreased left ventricular ejection fraction has been reported during bortezomib treatment.
Slovenian: Med zdravljenjem z bortezomibom so poročali o akutnem razvoju ali poslabšanju kongestivnega srčnega popuščanja in/ali novim pojavom zmanjšanja iztisne frakcije levega prekata.
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Slovenian: Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
English: 1.4 mo
Slovenian: 1,4 meseca
English: 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]).
Slovenian: 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
English: This study included 222 patients with relapsed/refractory multiple myeloma, who were randomised in a 2:1 ratio to receive 1.3 mg/m2 of bortezomib by either the subcutaneous or intravenous route for 8 cycles.
Slovenian: V študijo je bilo vključenih 222 bolnikov z relapsom/diseminiranim plazmocitomom, odpornim na zdravljenje, randomiziranih 2:1 na bortezomib v odmerku 1,3 mg/m2 telesne površine subkutano ali intravensko 8 krogov zdravljenja.