FrancophonIA/ELRC3.0 huggingface dataset:
English: • Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Maltese: • Aħsel il-kateter periferali jew fil-vina b'soluzzjoni sterile, 9 mg/ml (0.9%) ta' sodium chloride.
English: What VELCADE contains - The active substance is bortezomib.
Maltese: X'fih VELCADE - Is-sustanza attiva hi bortezomib.
English: Herpes zoster (inc disseminated & ophthalmic), Pneumonia*, Herpes simplex*, Fungal infection*
Maltese: Herpes zoster (anke mifrux u oftalmiku), Pnewmonja*, Herpes simplex*, Infezzjoni fungali*
English: NOS=not otherwise specified * Grouping of more than one MedDRA preferred term.
Maltese: NOS = mhux speċifikat mod ieħor (not otherwise specified) * Aggruppament ta' aktar minn terminu wieħed ta' MedDRA huwa preferut
English: Multiple Myeloma
Maltese: Majeloma Multipla
English: • If platelet counts < 25,000 cells/μL.
Maltese: • Jekk l-għadd tal-plejtlits ikun < 25,000 ċellula/μL.
English: Uncommon Angioedema
Maltese: Mhux Komuni Anġjoedema
English: OR for response rates based on Mantel-Haenszel estimate of the common odds ratio for stratified tables; p-values by Cochran Mantel-Haenszel test.
Maltese: OR għal rati ta' rispons bażati fuq stima ta' Mantel-Haenszel tal-odds ratio komuni għal tabelli stratifikati; valuri p skont it-test ta' Cochran Mantel-Haenszel test.
English: Antiviral prophylaxis was administered to 26% of the patients in the Vc+M+P arm.
Maltese: Profilassi antivirali ngħatat lil 26 % tal-pazjenti fil-parti tal-istudju dwar Vc+M+P.
English: • Hypersensitivity
Maltese: • Sensittività eċċessiva
English: 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).
Maltese: Benefiċċju statistikament sinifikanti (p < 0.001) favur il-grupp ta' trattament ta' VcR-CAP fuq il-grupp ta' R-CHOP ġie osservat għal TTP (medjan 30.5 versus 16.1 xhur), TNT (medjan 44.5 versus 24.8 xhur) u TFI (medjan 40.6 versus 20.5 xhur).
English: • Abnormal vision, blurred vision
Maltese: • Vista mhux normali, vista mċajpra
English: OUTER CARTON, VELCADE 3.5 mg
Maltese: KARTUNA TA' BARRA, VELCADE 3.5 mg
English: PL-02-135 Warszawa Tel.: + 48 22 237 60 00
Maltese: Warszawa Tel.: + 48 22 237 60 00
English: VIAL VELCADE 3.5 mg FLAG LABEL
Maltese: KUNJETT VELCADE 3.5 mg TIKKETTA BIL-BANDIERA
English: Date of latest renewal: 10 January 2014
Maltese: Data tal-aħħar tiġdid: 26 t'April 2014
English: OTHER
Maltese: last
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the VcTDx and TDx groups, respectively.
Maltese: Trapjanti ta' ċelluli steminali awtologi ġew mogħtija lil 105 (81%) u 78 (61%) pazjent fil-gruppi VcTDx u TDx, rispettivament.
English: Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Maltese: Melphalan (9 mg/m 2) u prednisone (60 mg/m 2) jingħataw it-tnejn li huma mill-ħalq fil-jiem 1, 2, 3 u
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone group.
Maltese: Differenza statistikament sinifikanti fis-CR+nCR kienet osservata favur il-grupp ta' VELCADE kkombinat ma' dexamethasone.
English: Refers to response rate after second transplant for subjects who received a second transplant (42/240 [18% ] in VcDx group and 52/242 [21%] in VDDx group).
Maltese: Jirreferi għar-rata ta' rispons wara t-tieni trapjant għal individwi li rċevew it-tieni trapjant (42/240 [18%] fil-grupp ta' VcDx u 53/242 [21%] fil-grupp ta' VDDx)
English: Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Maltese: Grad 1 bl-uġigħ jew Grad 2 sintomi moderati: li jirristrinġu l-Attivitajiet strumentali tal-Ħajja ta' Kuljum (ADL - Activities of Daily Living))**
English: TTP, months (95% CI)
Maltese: TTP, xhur (95% CI)
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Maltese: last kien ta' 0.99 u l-intervalli ta' kunfidenza ta' 90% kienu 80.
English: 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
Maltese: Il-pazjenti kellhom IgG/IgA/majeloma ta' katina ħafifa f'instanzi ta' 63 %/25 %/ 8%, emoglobina medjana ta' 105 g/l, u għadd medjan ta' plejtlits ta' 221.5 x 10
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Maltese: Neoplażmi malinni, Lewkemja plażmaċitika, Karċinoma taċ-ċellula renali, Piż, Fungojdi mikosi, Neoplażma beninni*
English: For dose adjustments, see Table 5 below.
Maltese: Għal aġġustamenti fid-doża, ara Tabella 5 taħt.
English: Very Common Thrombocytopenia*, Neutropenia*, Anaemia* Common
Maltese: Komuni Ħafna Tromboċitopenija*, Newtropenija*, Anemija* Komuni
English: Patients in the VcTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Maltese: Pazjenti fil-gruppi ta' trattament ta' VcTDx u TDx rispettivament kellhom età medjana tal-pazjenti fl-istudju kienet ta' 57 sena kontra 56 sena, 99 % tal-pazjenti kienu Kawkasi, u 58 % kontra 54 % kienu rġiel.
English: • General ill feeling
Maltese: • Telf mis-sensi
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Maltese: Meninġite (anke batterika), Infezzjoni tal-virus EpsteinBarr, Herpes ġenitali, Tonsillite, Mastojdite, Sindromu ta' għeja wara l-virus
English: OUTER CARTON, VELCADE 1 mg
Maltese: KARTUNA TA' BARRA, VELCADE 1 mg
English: • Inability to produce enough insulin or resistance to normal levels of insulin
Maltese: • Inkapaċità li jiġi prodott biżżejjed insulin jew reżistenza għal-livelli normali ta' insulina
English: Week Vc (1.3 mg/m
Maltese: Ġimgħa Vc (1.3 mg/m
English: You may also be given VELCADE together with the medicines pegylated liposomal doxorubicin or dexamethasone.
Maltese: Tista' tingħata VELCADE flimkien mal-mediċini pegylated liposomal doxorubicin jew dexamethasone.
English: In the VcTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Maltese: Fil-grupp ta' VcTDx 12 % tal-pazjenti kienu ċitoġenetikament ikklassifikati bħala ta' riskju għoli meta mqabbel ma' 16 % tal-pazjenti fil-grupp ta' TDx.
English: The two treatment groups were similar with regard to the overall incidence of all-grade bleeding events (6.3% in the VcR-CAP group and 5.0% in the R-CHOP group) as well as Grade 3 and higher bleeding events (VcR-CAP: 4 patients [1.7%]; R-CHOP: 3 patients [1.2%]).
Maltese: Iż-żewġ gruppi ta' trattament kienu jixxiebhu f'dik li hija inċidenza totali ta' każijiet ta' fsada tal-gradi kollha (6.3% fil-grupp ta' VcR-CAP u 5.0% fil-grupp ta' R-CHOP) kif ukoll każijiet ta' fsada ta' Grad 3 jew aktar (VcR-CAP: 4 pazjenti [1.7%]; R-CHOP: 3 pazjenti [1.2%]).
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Maltese: Studji in vitro jindikaw li bortezomib huwa inibitur dgħajjef għall-isożimi 1A2, 2C9, 2C19, 2D6 u 3A4 taċ-ċitokromju P450 (CYP).
English: 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.
Maltese: Skont il-kontribuzzjoni limitata (7 %) ta' CYP2D6 għallmetaboliżmu ta' bortezomib, il-metabolizzatur batut b'fenotip CYP2D6 mhux mistenni li jaffettwa ddispożizzjoni ġlobali ta' bortezomib.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Maltese: AST = aspartate aminotransferase;
English: • Hepatitis
Maltese: • Epatite
English: 1 mg/m 2 to 0.7 mg/m
Maltese: 1 mg/m 2, jew minn 1 mg/m 2 għal 0.7 mg/m
English: The incidence of herpes zoster among patients in the Vc+M+P treatment group was 17% for patients not administered antiviral prophylaxis compared to 3% for patients administered antiviral prophylaxis.
Maltese: L-inċidenza ta' herpes zoster fost pazjenti fil-grupp tat-trattament b'Vc+M+P kienet ta' 17 % għal pazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3 % għal pazjenti li ngħataw profilassi antivirali.
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Maltese: Jum1, 2, 3, 4 Jum 8, 9, 10, 11Ċikli 2 to 4
English: In the VcR-CAP group, 22.5% of patients received platelet transfusions compared to 2.9% of patients in the R-CHOP group.
Maltese: Fil-grupp ta' VcR-CAP, 22.5% tal-pazjenti rċivew trasfużjonijiet tal-plejtlets meta mqabbla ma' 2.9% tal-pazjenti fil-grupp ta' R-CHOP.
English: Median age of the patients in the study was 57 years, 55% were male and 48% of patients had high-risk cytogenetics.
Maltese: L-età medjana tal-pazjenti fl-istudju kienet ta' 57 sena, 55% kienu rġiel u 48% talpazjenti kellhom ċitoġenetiċi ta' riskju għoli.
English: Secondary endpoints included, time to progression (TTP), time to next anti-lymphoma treatment (TNT), duration of treatment free interval (TFI), overall response rate (ORR) and complete response (CR/CRu) rate, overall survival (OS) and response duration.
Maltese: Punti finali sekondarji kienu jinkludu, iż-żmien għall-progressjoni (TTP- time to progression), iż-żmien għat-trattament li jmiss kontra l-limfoma (TNT - time to next anti-lymphoma treatment), it-tul ta' żmien tal-perjodu mingħajr trattament (TFI - duration of treatment free interval), ir-rata totali ta' rispons (ORR - overall response rate) u r-rata ta' rispons sħiħ (CR/CRu - complete response), is-sopravivenza globali (OSoverall survival) u t-tul ta' żmien ta' rispons.
English: Progression free survival (IRC) Events n (%)
Maltese: Sopravivenza ħielsa mill-progressjoni (IRC) Każijiet n (%)
English: rituximab 375 mg/m 2 IV on day 1; cyclophosphamide 750 mg/m 2 IV on day 1; doxorubicin 50 mg/m
Maltese: cyclophosphamide 750 mg/m 2 IV fil-jum 1; doxorubicin 50 mg/m 2 IV fil-jum 1; u prednisone
English: 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.
Maltese: Kien osservat benefiċċju ta' sopravivenza sinifikanti b'mod statistiku favur il-grupp ta' trattament Vc+M+P (HR=0.695; p=0.00043) minkejja terapiji sussegwenti li kienu jinkludu programmi ta' trattament ibbażati fuq VELCADE.
English: > 1.0 x 1.5 x ULN Any
Maltese: > 1.0x 1.5x ULN
English: Table 8: Adverse reactions in patients with Mantle Cell Lymphoma treated with VcR-CAP in a clinical trial System Organ Class
Maltese: Tabella 8: Reazzjonijiet avversi f'pazjenti b'Limfoma taċ-Ċellula Mantle ttrattati b'VcR-CAP fi prova klinika Klassi tas-Sistemi u tal-Organi
English: • Paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Maltese: • Paraliżi, aċċessjonijiet, waqgħat, disturbi marbuta mal-moviment, sensazzjoni abnormali,
English: Uncommon Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia
Maltese: Mhux Komuni Panċitopenija*, Newtropenija bid-deni, Koagulopatija*, Lewkoċitosi*, Limfodenopatija, Anemija emolitika
English: Name and address of the manufacturer responsible for batch release Janssen Pharmaceutica NV
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott Janssen Pharmaceutica NV
English: Retreatment of patients with relapsed multiple myeloma In a study in which VELCADE retreatment was administered in 130 patients with relapsed multiple myeloma, who previously had at least partial response on a VELCADE-containing regimen, the most common all-grade adverse events occurring in at least 25% of patients were thrombocytopenia (55%), neuropathy (40%), anaemia (37%), diarrhoea (35%), and constipation (28%).
Maltese: Fi studju li fih trattamenti konsekuttivi b'VELCADE ngħataw lil 130 pazjent b'majeloma multipla li rkadiet, li qabel kellhom tal-anqas rispons parzjali bi programm ta' trattament li kien fih VELCADE, l-aktar każijiet avversi ta' kull grad li seħħew f'tal-anqas 25% tal-poazjenti kienu tromboċitopenija (55 %), newropatija (40 %), anemija (37 %), dijarea (35 %) u stitikezza (28 %).
English: Caution should be exercised when bortezomib is combined with CYP3A4- or CYP2C19 substrates (see section 4.5).
Maltese: Għandha jkun hemm kawtela meta bortezomib jintuża ma' substrati ta' CYP3A4 jew CYP2C19 (ara sezzjoni 4.5).
English: VELCADE was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Maltese: VELCADE ingħata biss fi Blokki 1 u 2 biex jiġu evitati tossiċitajiet li possibbli jikkonċidu parzjalment ma' ta' mediċini mogħtija flimkien miegħu fi Blokk 3.
English: ● Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: Intent to Treat (ITT) population p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p < 0.0001
Maltese: valur-p mit-test log-rank stratifikat, analiżi skont il-linja ta' terapija teskludi l-istratifikazzjoni għall-istorja terapewtika; p<0.0001
English: ≥ 2 prior lines
Maltese: 2 linji filpassat
English: Testicular disorder*, Prostatitis, Breast disorder female, Epididymal tenderness, Epididymitis, Pelvic pain, Vulval ulceration
Maltese: Disturb testikolari*, Prostatite, Disturb fis-sider tal-mara, Tenerezza epididimali, Epididimite, Uġigħ fil-ġenb, Ulċerazzjoni vulvali
English: 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.
Maltese: F'pazjenti b'majeloma avvanzata sseverità tat-tromboċitopenija kienet marbuta mal-għadd tal-plejtlits qabel it-trattament: għal għadd mil-linja bażi tal-plejtlits < 75,000/l, 90 % ta' 21 pazjent kellhom għadd  25,000/l waqt l-istudju, inkluż 14 % < 10,000/l; b'kuntrast, b'għadd mil-linja bażi > 75,000/l, 14 % biss minn 309 pazjenti kellhom għadd  25,000/l waqt l-istudju.
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura)
Maltese: Koagulazzjoni intravaskulari mifruxa, Tromboċitosi*, Sindromu ta' Iperviskosità, Disturb fil-plejtlits NOS, Mikroanġiopatija trombotika (inkl purpura tromboċitopenika)
English: The concentration of the resulting solution will be 2.5 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni li tinkiseb tkun ta' 2.5 mg/ml.
English: A statistically significant difference in CR+nCR was observed in favour of the VELCADE combined with dexamethasone and thalidomide group.
Maltese: Differenza statistikament sinifikanti f'CR+nCR kienet osservata favur il-grupp ta' VELCADE kkombinat ma' dexamethasone u thalidomide.
English: Peripheral neuropathy in combination regimens Multiple Myeloma
Maltese: Newropatija periferali fi programmi ta' trattament ta' kombinazzjoni Majeloma Multipla
English: RR (Post-induction) *CR+nCR
Maltese: RR (Wara l-induzzjoni) *CR+nCR
English: In patients with MCL (study LYM-3002), the incidence of herpes zoster infection was 6.7% in the VcR-CAP arm and 1.2% in the R-CHOP arm (see section 4.8).
Maltese: F'pazjenti b'MCL (studju LYM-3002), l-inċidenza ta' infezzjoni b'herpes zoster kienet 6.7% filfergħa ta' VcR-CAP u 1.2% fil-fergħa ta' R-CHOP (ara sezzjoni 4.8).
English: The incidence of herpes zoster among patients in the VcR-CAP arm was 10.7% for patients not administered antiviral prophylaxis compared to 3.6% for patients administered antiviral prophylaxis (see section 4.4).
Maltese: 7% għall-pazjenti li ma ngħatawx profilassi antivirali meta mqabbel ma' 3.6% għall-pazjenti li ngħataw profilassi antivirali (ara sezzjoni 4.4).
English: Based on Kaplan-Meier product limit estimates.
Maltese: Abbażi tal-Istimi Kaplan-Meier tal-limitu tal-prodott.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the VELCADE containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Maltese: Irreazzjonijiet avversi li ġejjin (Grad ≥ 3) kienu osservati b'inċidenza ogħla bl-iskeda ta' trattament li kien fiha VELCADE meta mqabbla ma' studju storiku ta' kontroll fejn l-iskeda ewlenija ingħatat waħedha: fi Blokk 1 newropatija tas-sensi periferali (3% versus 0%); ilju (2.1% versus 0%); ipoksja (8% versus 2%).
English: Hazard ratio (95% CI) p-value
Maltese: Proporzjon ta' periklu (95% CI) Valur p
English: Median OS was 90.7 months for the VcR-CAP group compared with 55.7 months for the R-CHOP group (HR=0.66; p=0.001).
Maltese: Il-medjan ta' OS kien 90.7 xhur għall-grupp ta' VcR-CAP meta mqabbel ma' 55.7 xhur għall-grupp ta' R-CHOP (HR=0.66; p=0.001).
English: Uncommon Cushing's syndrome*, Hyperthyroidism*, Inappropriate antidiuretic hormone secretion
Maltese: Mhux Komuni Sindromu ta' Cushing*, Ipertajroidiżmu*, Tnixxija mhux adattata tal-ormon antidijuretiku
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Maltese: Mewt minn “Mard progressiv” kien ta' 18 % fil-grupp ta' taħt il-ġilda u 9 % fil-grupp ġol-vina.
English: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the VcR-CAP arm and 61% of patients in the R-CHOP arm.
Maltese: Fl-istudju LYM-3002, sostenn b'fattur stimulanti tal-kolonja ngħata lil 78% tal-pazjenti fil-fergħa ta' VcR-CAP u lil 61% tal-pazjenti fil-fergħa R-CHOP.
English: 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.
Maltese: TDx=thalidomide, dexamethasone; VcTDx=VELCADE, thalidomide, dexamethasone; PN=peripheral neuropathy Nota: Newropatija periferali kien jinkludi t-termini ppreferuti: newropatija periferali, newropatija motorea periferali, newropatija sensorjali periferali, u polinewropatija.
English: 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%).
Maltese: Reazzjonijiet avversi addizjonali għall-mediċina li kienu identifikatiu assoċjati mal-użu tat-terapija ta' kombinazzjoni (VcR-CAP) kienu infezzjoni bl-epatite B (< 1%) u iskemija mijokardijaka (1.3%).
English: Once weekly VELCADE (cycles 5-9)
Maltese: VELCADE darba fil-ġimgħa (ċikli 5-9)
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Maltese: Peress li din il-mediċina tingħata mit-tabib jew l-infermier tiegħek, mhux probabbli li ser tingħata żżejjed.
English: 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).
Maltese: L-inċidenza totali ta' infezzjonijiet bl-epatite B kienet tixxiebah f'pazjenti ttrattati b'VcR-CAP jew b'R-CHOP (0.8% vs 1.2% rispettivament).
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Maltese: Jum1, 2, 3, 4 Jum 8, 9, 10, 11
English: Other medicines and VELCADE
Maltese: Mediċini oħra u VELCADE
English: Mantle cell lymphoma
Maltese: Limfoma taċ-ċellula mantle
English: The mean distribution volume (Vd) of bortezomib ranged from 1,659 l to 3,294 l following single- or repeated-dose intravenous administration of 1.0 mg/m2 or 1.3 mg/m2 to patients with multiple myeloma.
Maltese: d) ta' bortezomib kien mifrux minn 1,659 l sa 3,294 l wara li ngħatat doża waħda jew doża ripetuta ġol-vina ta' 1.0 mg/m2 jew 1.3 mg/m2 lil pazjenti b'majeloma multipla.
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the VELCADE treatment group (VcR-CAP) as compared to the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Maltese: F'pazjenti b'MCL (studju LYM-3002), kien hemm inċidenza ogħla (56.7% versus 5.8%) ta' tromboċitopenija ta' Grad ≥ 3 fil-grupp ta' trattament b'VELCADE (VcR-CAP) meta mqabbla malgrupp li ma kienx ittrattat b'VELCADE (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP]).
English: In trials in which VELCADE was administered as induction treatment in combination with dexamethasone (study IFM-2005-01), and dexamethasone-thalidomide (study MMY-3010), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fil-provi li fihom VELCADE ngħata bħala trattament ta' induzzjoni f'kombinazzjoni ma' dexamethasome (studju IFM-2005-01), u dexamethasone-thalidomide (studju MMY-3010), l inċidenza ta' newropatija periferali fil-programmi ta' trattament ikkombinat qed jiġu ppreżentati fittabella t'hawn isfel:
English: • Budd-Chiari syndrome (the clinical symptoms caused by blockage of the hepatic veins)
Maltese: • Sindromu ta' Budd-Chiari (is-sintomi kliniċi kkaġunati minn imblukkar tal-vini tal-fwied)
English: Table 2: Recommended posology for VELCADE in combination with melphalan and prednisone
Maltese: Tabella 2: Pożologija rrakkommandata għal VELCADE flimkien ma' melphalan u prednisone
English: Clinical efficacy in previously untreated multiple myeloma A prospective Phase III, international, randomised (1:1), open-label clinical study (MMY-3002 VISTA) of 682 patients was conducted to determine whether VELCADE (1.3 mg/m2 injected intravenously) in combination with melphalan (9 mg/m 2) and prednisone (60 mg/m 2) resulted in improvement in time to progression (TTP) when compared to melphalan (9 mg/m 2) and prednisone
Maltese: III li fih il-pazjenti ntgħażlu b'mod każwali (1:1), open-label, (MMY-3002-VISTA) ta' 682 pazjent kien magħmul biex jiġi dderminat jekk VELCADE (1.3 mg/m 2 injettat fil-vina) flimkien ma' melphalan (9 mg/m 2) u prednisone (60 mg/m 2) jirriżultawx f'titjib fiż-żmien ta' progressjoni (TTP) meta mqabbel ma' melphalan (9 mg/m 2) u prednisone
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 VELCADE.
Maltese: Lewkoenċefalopatija progressiva u multifokali (PML) Każijiet rari ħafna fejn mhux magħruf il-kawża għal infezjoni bil-virus John Cunningham (JC), li irriżultaw f'PML u mewt, ġew irrappurtati f'pazjenti li ġew trattati b'VELCADE.
English: Fertility Fertility studies were not conducted with VELCADE (see section 5.3).
Maltese: Fertilità Ma sarux studji dwar il-fertilità b'VELCADE (ara sezzjoni 5.3).
English: The median age of the patients in the study was 71 years, 50% were male, 88% were Caucasian and the median Karnofsky performance status score for the patients was 80.
Maltese: L-età medjana tal-pazjenti fl-istudju kien ta' 71 sena, 50% kienu rġiel, 88 % kienu Kawkasi u l-istat ta' punteġġ medjan ta' prestazzjoni ta' Karnofsky għall-pazjenti kien ta' 80.
English: In the Phase III study in patients with previously untreated multiple myeloma, the overall incidence of herpes zoster reactivation was more common in patients treated with VELCADE+Melphalan+Prednisone compared with Melphalan+Prednisone (14% versus 4% respectively).
Maltese: III f'pazjenti b'majeloma multipla li qatt ma kienet ittrattata qabel, l-inċidenza globali ta' riattivazzjoni ta' herpes zoster kien aktar komuni f'pazjenti ttrattati b'VELCADE+Melphalan+Prednisolone meta mqabbel ma' Melphalan+Prednisolone (14 % kontra 4 % rispettivament).