FrancophonIA/ELRC3.0 huggingface dataset:
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Maltese: Dawn ir-reazzjonijiet avversi kienu bażati fuq tagħrif integrat ta' 5,476 pazjent li minnhom 3,996 pazjent kienu trattati b'bortezomib b'1.3 mg/m2 u inklużi f'Tabella 7.
English: Bortezomib Accord 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Accord 1 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 1 mg ta' bortezomib (bħala mannitol boronic ester).
English: Patients in the BzR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21), rituximab 375 mg/m2 intravenous on day 1; cyclophosphamide 750 mg/m2 intravenous on day 1; doxorubicin 50 mg/m2 intravenous on day 1; and prednisone 100 mg/m2 orally on day 1 through day 5
Maltese: cyclophosphamide 750 mg/m2 ġol-vini fil-jum 1; doxorubicin 50 mg/m2 ġol-vini fil-jum 1; u prednisone 100 mg/m2 mill-ħalq minn jum 1sa jum 5 taċ-ċiklu ta' trattament ta' 21 jum b'bortezomib.
English: Setting (Bortezomib Accord plus dexamethasone, and Bortezomib Accord plus dexamethasone and thalidomide).
Maltese: pazjent u l-volum ta' Bortezomib Accord rikostitwit (kemm użu ġol-vina u taħt il-ġilda)
English: Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Maltese: Emorraġija gastrointestinali (anke tal-mukosa)*, Dispepsja, Stomatite*, Distensjoni addominali, Uġigħ orofarinġeali*, Uġigħ ta' żaqq (li jinkludi uġigħ gastrointestinali u tal milsa)*, Disturb orali*, Gass
English: Posology for patients with previously untreated mantle cell lymphoma (MCL)
Maltese: Effikaċja klinika f'limfoma taċ-ċellula mantle (MCL-mantle cell lymphoma) li qatt ma kienet ittrattata qabel
English: Dose adjustments for combination therapy for patients with progressive multiple myeloma
Maltese: Aġġustamenti fid-doża għal terapija ta' kombinazzjoni għal pazjenti b'majeloma multipla progressiva
English: • SmPC
Maltese: • Mewt
English: BzR-CAP=Bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Maltese: R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone; PN=newropatija periferali
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.
Maltese: e Qed tintuża l-istima Mantel-Haenszel tal-proporzjon ta' probabbiltà komuni għal tabelli stratifikati, bir-riskju IPI u listadju tal-marda bħala fatturi ta' stratifikazzjoni.
English: A statistically significant difference in CR+nCR was observed in favour of the bortezomib combined with dexamethasone group.
Maltese: Differenza statistikament sinifikanti fis-CR+nCR kienet osservata favur il-grupp ta'
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each bortezomib treatment cycle.
Maltese: Prednisone jingħata mill-ħalq b'doża ta' 100 mg/m2 fil-jiem 1, 2, 3, 4 u 5 ta' kull waħda miċ-ċikli ta'
English: CYTOTOXIC
Maltese: KIF JINTREMA
English: Disseminated intravascular coagulation, Thrombocytosis*, Hyperviscosity syndrome, Platelet disorder NOS, Thrombotic microangiopathy (inc thrombocytopenic purpura) #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Maltese: Koagulazzjoni intravaskulari mifruxa, Tromboċitosi*, Sindromu ta' Iperviskosità, Disturb fil-plejtlits NOS,
English: Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Accord 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Accord irid ikun rikostitwit b'attenzjoni bi 1.4 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Maltese: Petpita atrijali, Infart mijokardjali*, Imblokk atrijoventrikulari*, Disturb kardjovaskulari (li jinkludi xokk kardjoġeniku), Torsade de pointes, Anġina mhux stabbli,
English: The chemical and physical in-use stability of the reconstituted solution of 2.5 mg/ml has been demonstrated for 8 hours at 20°C-25°C stored in the original vial and/or a syringe.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu tas-soluzzjoni rrikostitwita ta' 2.5 mg/ml intweriet għal 8 sigħat f'temperatura ta' 20°C-25°C maħżuna fil-kunjett oriġinali u/jew ġo siringa.
English: Events n (%) Mediana (95% CI)
Maltese: 3 snin OS rata % ta' OS (95% CI)
English: Eye swelling*, Vision abnormal*, Conjunctivitis*
Maltese: Nefħa fl-għajnejn*, Vista mhix normali*, Konġunktivite*
English: Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Maltese: Newropatija awtonomika, Puplesija kranjali*, Paralisi*, Paresi*, Presinkope, Sindromu tal-istemma tal-moħħ, Disturb ċerebrovaskulari, Ġerħa fl-għerq tan-nerv, Iperattività psikomotorili, Kompressjoni fil-korda dorsali, Disturb fl għarfien NOS, Disfunzjoni motorili, Disturb fis-sistema nervuża
English: Bortezomib Accord in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Maltese: Bortezomib Accord flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għat-trattament ta' pazjenti adulti b'limfoma taċ-ċellula mantle li qatt ma kienet ittrattata qabel li mhumiex addattati għal trapjant taċ-ċellula steminali ematopojetika.
English: In patients with MCL (study LYM-3002), there was a higher incidence (56.7% versus 5.8%) of Grade ≥ 3 thrombocytopenia in the bortezomib treatment group (BzR-CAP) as compared to the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]).
Maltese: tromboċitopenija ta' Grad ≥ 3 fil-grupp ta' trattament b'bortezomib (BzR-CAP) meta mqabbla malgrupp li ma kienx ittrattat b'bortezomib (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP]).
English: The following medicinal products are given on day 1 of each Bortezomib Accord 21-day treatment cycle as intravenous infusions:
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jum 1 ta' kull wieħed miċ-ċiklu ta' trattament ta' 21 jum ta' Bortezomib Accord bħala infużjonijiet fil-vina:
English: Pancytopenia*, Febrile neutropenia, Coagulopathy*, Leukocytosis*, Lymphadenopathy, Haemolytic anaemia#
Maltese: Lewkoċitosi*, Limfodenopatija, Anemija emolitika #
English: Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome#, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Maltese: Disturbi fil-bilanċ u fil-koordinazzjoni ċerebellari*, Telf ta' memorja (li jeskludi dimenzja)*, Enċefalopatija*, Sindromu enċefalopatiku riversibbli fuq wara #, Newrotossiċita, Disturbi pupletiċi*, Newralġja post herpetika, Disturb fid-diskors*,
English: Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Maltese: Proporzjon Internazzjonali normalizzat abnormali*, Tnaqqis fil-pH tal-istonku, Aggregazzjoni ta' plejtlits ogħla, Żieda f'Troponin I, Identifikazzjoni u seroloġija tal-vajrus*, Valuri tal-analiżi tal-awrina abnormali*
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Accord treatment cycle.
Maltese: Dexamethasone 40 mg jingħata mill-ħalq fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' 21
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Maltese: permezz tal-kriterji tal-Grupp Ewropew dwar Trapjanti ta' Demm u Mudullun (EBMT-European Group for Blood and Bone Marrow Transplantation).
English: Other medicines and Bortezomib Accord
Maltese: Mediċini oħra u Bortezomib Accord
English: Bortezomib Accord 3.5 mg powder for solution for injection Each 10 ml vial of Bortezomib Accord must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Bortezomib Accord 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 10 ml ta' Bortezomib Accord irid ikun rikostitwit b'attenzjoni bi 3.5 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: • In cycles 5 to 9, Bortezomib Accord is administered once weekly on days 1, 8, 22 and 29.
Maltese: Fiċ-ċikli minn 5 sa 9, Bortezomib Accord jingħata darba fil-ġimgħa fil-jiem 1, 8, 22 u 29.
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Bz= bortezomib; BzDx= bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Maltese: VDDx=vincristine, doxorubicin, dexamethasone; VGPR= rispons parzjali tajjeb ħafna; PR= rispons parzjali; OR= proporzjon ta' probabbilta.
English: In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Maltese: CYP2C19, fuq il-farmakokinetiċi ta' bortezomib (injettat ġol-vina), ma kienx hemm effett sinifikanti fuq il-farmakokinetika ta' bortezomib abbażi ta' dejta minn 17-il-pazjent.
English: Bortezomib Accord 1 mg powder for solution for injection Type 1 glass 6 ml-vial with a grey chlorobutyl stopper and an aluminium seal, with a blue cap containing 1 mg bortezomib.
Maltese: Kunjett ta' 6 ml ta' ħġieg ta' tip 1, b'tapp griż tal-gomma chlorobutyl u siġill tal-aluminju b'għatu blu li fih 1 mg bortezomib.
English: Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m2 reduced to 1.0 mg/m2; 1.0 mg/m2 reduced to 0.7 mg/m2).
Maltese: Meta s-sintomi tat-tossiċità jkunu marru, it-trattament b'bortezomib jista' jerġa' jibda jingħata b'doża mnaqqsa b'25% (1.3 mg/m2 imnaqqsa għal 1.0 mg/m2;
English: Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Maltese: Sindromu ta' eritrodisestesija ta' Palmar-Plantar, Emorraġija taħt il-ġilda, Livedo reticularis, Ebusija tal-ġilda, Papule, Reazzjoni ta' fotosensittività, Seborrea, Għaraq kiesaħ, Disturb tal-ġilda NOS, Eritrosi, Ulċera tal-ġilda, Disturbi tad dwiefer
English: A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
Maltese: Proporzjon ta' riskju anqas minn 1 jindika vantaġġ għall-VMP c Valur-p nominali bbażat fuq it-test log-rank stratifikat aġġustat għal fatturi ta' stratifikazzjoni: β2-mikroglobulina, albumina, u reġjun.
English: Table 4: Posology for Bortezomib Accord combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Maltese: Tabella 4: Pożoloġija għal terapija kombinata b'Bortezomib Accord għal pazjenti b'majeloma multipla li ma kienux ġew ittrattati qabel eliġibbli għal trapjant b'ċelluli steminali ematopojetiċi
English: Table 7:Adverse reactions in patients with Multiple Myeloma treated with Bortezomib in clinical trials, and all post-marketing adverse reactions regardless of indication
Maltese: Tabella 7: Reazzjonijiet avversi f'pazjenti b'Majeloma multipla trattati b'bortezomib fi provi kliniċi, u r-reazzjonijiet avversi kollha ta' wara t-tqegħid fis-suq irrispettivament millindikazzjoni
English: 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 bortezomib for relapsed acute myelogenous leukaemia died of ARDS early in the course of therapy, and the study was terminated.
Maltese: Fi prova klinika, żewġ pazjenti (minn 2) li ngħataw doża qawwija ta' cytarabine (2 g/m2 kuljum) b'infużjoni kontinwa matul 24 siegħa b'daunorubicin u bortezomib għal episodju ġdid ta' lewkimja akuta majloġenuża mietu minħabba ARDS fil-bidu tat-terapija, u l-istudju twaqqaf.
English: Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic#, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Maltese: Gastrite*, Emorraġija ġenġivali, Mard ta' refluss gastroesofaġeali*, Kolite (li jinkludi clostridium difficile)*, Kolite iskemika#,Infjammazzjoni gastrointestinali*, Disfaġja,
English: Bortezomib Accord 1 mg powder for solution for injection bortezomib
Maltese: • li Bortezomib Accord 1 mg huwa biss għal użu ġol-vina
English: Very Common Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia* Common
Maltese: Komuni ħafna Newropatija tas-sensazzjoni periferali, Disastesija*, Nevralġija*
English: Events n (%) Mediana
Maltese: Każijiet n (%)
English: Patients with previously treated light-chain (AL) Amyloidosis An open label non randomised Phase I/II study was conducted to determine the safety and efficacy of bortezomib in patients with previously treated light-chain (AL) Amyloidosis.
Maltese: Pazjenti li qabel kienu ttrattati għal Amilojdożi (AL) tal-katina ħafifa Sar studju open label u mhux każwali ta' Fażi I/II sabiex jiġu stabbiliti s-sigurtà u l-effikaċja ta' bortezomib f'pazjenti li qabel kienu ttrattati għal Amilojdożi (AL) tal-katina ħafifa.
English: Note: An OR > 1 indicates an advantage for Bz-containing induction therapy
Maltese: Nota: OR > 1 jindika vantaġġ għal terapija t'induzzjoni li jkun fiha Bz.
English: Twice weekly Bortezomib Accord (cycles 1-4) Week Bz (1.3 mg/m
Maltese: Bortezomib Accord darbtejn fil-ġimgħa (ċikli 1-4)
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Maltese: (CR+nCR, CR+nCR+VGPR+PR), is-Sopravivenza Mingħajr Progressjoni u s-Sopravivenza Globali.
English: • different reconstitution requirements for Bortezomib Accord 3.5 mg intravenous or subcutaneous use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ta' Bortezomib Accord 3.5 mg ġol-vina jew taħt il-ġilda
English: administered twice weekly days 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Maltese: Pazjenti fil-grupp BzTDx kellhom sitt ċikli ta' 4 ġimgħat, li kull wieħed minnhom kien jikkonsisti minn bortezomib (1.3 mg/m2 li ngħata darbtejn fil-ġimgħa fil-jiem 1, 4, 8 u 11, segwit b'perjodu ta' serħan ta' 17-il jum minn jum 12 sa jum 28), dexamethasone (40 mg li ngħata oralment fil-jiem 1 sa 4 u l-jiem 8 sa 11) u thalidomide (mogħti mill-ħalq f'doża ta' 50 mg kuljum fil-jiem 1-14,
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fl-istudju LYM-3002 fejn bortezomib ingħata flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (R-CAP), l-inċidenza ta' newropatija periferali fl-iskedi ta' għoti ta'
English: Patients who developed orthostatic hypotension on bortezomib (injected intravenously) did not have evidence of orthostatic hypotension prior to treatment with bortezomib.
Maltese: Pazjenti li żviluppaw ipotensjoni ortostatika b'bortezomib (injettat ġol-vina) ma kellhomx ipotensjoni ortostatika qabel ma kienu bdew it-trattament b'bortezomib.
English: Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Maltese: Iperkalċemija*, Ipernatremija*, Aċidu Uriku abnormali*, Dijabete mellitus*, Żamma ta' fluwidu
English: or ANC < 750 cells/μL on a Bortezomib Accord dosing day (other than Day 1 of each cycle)
Maltese: < 750 ċellula/μL f'ġurnata ta' għoti ta' doża ta' Bortezomib Accord (ħlief fil-Jum 1 ta'
English: d d d d
Maltese: TA' EĊĊIPJENTI
English: Bortezomib Accord is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lymph nodes) in patients 18 years or older in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, for patients whose disease has not been previously treated and for whom blood stem cell transplantation is unsuitable.
Maltese: Bortezomib Accord jintuża għat-trattament ta' limfoma taċ-ċellula ta' mantle (tip ta' kanċer li jaffettwa l-glandoli limfatiċi) f'pazjenti li għandhom 18-il sena u aktar b'kombinazzjoni mal-mediċini rituximab, cyclophosphamide, doxorubicin u prednisone, għall-pazjenti li l-marda tagħhom qatt ma kienet ittrattata qabel u li trapjant taċ-ċelluli steminali tad-demm ma jkunx tajjeb għalihom.
English: Table 15: Summary of efficacy analyses comparing subcutaneous and intravenous administrations of bortezomib bortezomib intravenous arm bortezomib subcutaneous arm
Maltese: Dawn l-effetti ġew osservati f'pazjenti b'majeloma multipla li għandhom marda osteolitika avvanzata u li huma ttrattati b'bortezomib.
English: The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: It-TTP medjan kien ta' 6.5 xhur għall-monoterapija ta' bortezomib meta mqabbel ma' 9.3 xhur għall-pazjenti fuq terapija kkombinata ta' bortezomib flimkien ma' pegylated liposomal doxorubicin.
English: 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).
Maltese: (95% CI: 45, 86 ) u r-rata ta' sopravivenza ta' 4 xhur mingħajr avvenimenti kienet 67% (95% CI: 42,
English: Bortezomib Accord 3.5 mg powder for solution for injection Type 1 glass 10 ml-vial with a grey chlorobutyl rubber stopper and an aluminium seal, with a red cap containing 3.5 mg bortezomib.
Maltese: Kunjett ta' 10 ml ta' ħġieg ta' tip 1, b'tapp griż tal-gomma chlorobutyl u siġill tal-aluminju b'għatu aħmar li fih 3.5 mg bortezomib
English: The reconstituted solution is stable for 3 days at 20°C-25°C stored in the original vial and/or a syringe.
Maltese: Is-soluzzjoni rrikostitwita hija stabbli għal 3 ijiem f'temperatura ta' 20°C-25°C meta maħżuna filkunjett oriġinali u/jew ġo siringa.
English: CR=Complete Response; nCR=near Complete response
Maltese: CR=Rispons Sħiħ; nCR=rispons kważi Sħiħ
English: • Muscle spasms
Maltese: • Kanċer tal-ġilda
English: TTP-Time to Progression
Maltese: Żmien għall-progressjoni
English: Serious adverse reactions uncommonly reported during treatment with bortezomib include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Maltese: enċefalopatija riversibbli fuq in-naħa ta' wara, disturbi pulmonari akuti diffużi u infiltrattivi, u b'mod rari newropatija awtonomika.
English: It is specifically designed to inhibit the chymotrypsin-like activity of the 26S proteasome in mammalian cells.
Maltese: Huwa msawwar apposta biex jinibixxi l-attività li tixbah dik ta' chymotrypsin minn 26S proteasome f'ċelluli mammiferi. 26S proteasome hija proteina komposta kbira li tiddegrada proteini ubikwitinati.
English: Hazard ratiob (95% CI) p-value c
Maltese: Medjanc(95% CI) (xhur)
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Maltese: Falliment epatiku, Epatomegalija, Sindromu ta' Budd-Chiari,
English: In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
Maltese: Studji in vitro b'mikromożomi ta' fwied uman u isożimi P450 ċitokromiċi espressi minn cDNA uman jindikaw li bortezomib huwa primarjament metabolizzat bl-ossiġnu permezz ta' isożimi
English: Grade ≥ 3 non-haematological toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/µl or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/µl (see section 4.2).
Maltese: Terapija b'bortezomib għandha titwaqqaf meta l-għadd ta' plejtlits ikun < 25,000/µl jew, fil-każ ta' għoti flimkien ma' melphalan u prednisone, meta l-għadd tal-plejtlits ikun ta' ≤ 30,000/µl (ara sezzjoni 4.2).
English: Table 16: Efficacy results from study LYM-3002
Maltese: Riżultati ta' effikaċja mill-istudju LYM-3002 Punt finali ta' effikaċja
English: Carriers of hepatitis B and patients with a history of hepatitis B must be closely monitored for clinical and laboratory signs of active HBV infection during and following rituximab combination treatment with bortezomib.
Maltese: infezzjoni attiva b'HBV waqt u wara trattament b'rituximab flimkien ma' bortezomib.
English: Patients in the BzTDx group received six 4-week cycles, each consisting of bortezomib (1.3 mg/m2
Maltese: Il-pazjenti fil-fergħa ta' trattament b'BzR-CAP irċivew bortezomib (1.3 mg/m2;
English: 1.3 mg/m2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m2 and 1.3 mg/m2, respectively.
Maltese: Tneħħijiet totali medji mill-ġisem kienu 102 u 112 l/siegħa wara l ewwel doża għad-dożi ta' 1.0 mg/m2 u 1.3 mg/m2, rispettivament, u fuq medda minn 15 sa 32 l/siegħa u 18 sa 32 l/siegħa għad-dożi sussegwenti ta' 1.0 mg/m2 u 1.3 mg/m2, rispettivament.
English: Renal impairment*
Maltese: Sopravivenza totali*