FrancophonIA/ELRC3.0 huggingface dataset:
English: The overall incidence of hepatitis B infections was similar in patients treated with BR-CAP or with R-CHOP (0.8% vs 1.2% respectively).
Maltese: L-inċidenza totali ta' infezzjonijiet bl-epatite B kienet tixxiebaħ f'pazjenti ttrattati b'BR-CAP jew b'R-CHOP 0.8 % vs 1.2 % rispettivament).
English: There was a trend towards prolonged overall survival favouring the BR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BR-CAP group.
Maltese: Ir-rata stmata ta' sopravivenza għal 4 snin kienet 53.9% fil-grupp ta' R-CHOP u 64.4% fil-grupp ta' BRCAP.
English: Mantle cell lymphoma (MCL) The safety profile of bortezomib in 240 MCL patients treated with bortezomib at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP) versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Maltese: Il-profil ta' sigurtà ta' bortezomib f'240 pazjent b'MCL ittrattati b'bortezomib bid-doża ta' 1.3 mg/m flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisolone (BR-CAP), kontra il-242 pazjent ittrattati b'rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP] kien relattivament konsistenti ma' dak osservat b'majeloma multipla bid-differenzi prinċipali deskritti taħt.
English: Metabolism and nutrition disorders
Maltese: Disturbi filmetaboliżmuu nnutrizzjoni
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Maltese: Meninġite (anke batterika), Infezzjoni tal-virus Epstein-Barr, Herpes ġenitali,
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 bortezomib+melphalan+prednisone compared with melphalan+prednisone (14% versus 4% respectively).
Maltese: Fl-istudju ta' Fażi 3 f'pazjenti b'majeloma multipla li qatt ma kienet ittrattata qabel,, l-inċidenza globali ta' riattivazzjoni ta' herpes zoster kien aktar komuni f'pazjenti kkurati bi bortezomib+ melphalan+prednisone meta mqabbel ma' melphalan+prednisone (14 % kontra 4 % rispettivament).
English: Caution should be exercised when Bortezomib Hospira is combined with CYP3A4or CYP2C19 substrates (see section 4.5).
Maltese: Għandha jkun hemm kawtela meta bortezomib jintuża ma' sottostrati ta' CYP3A4 jew CYP2C19 (ara sezzjoni 4.5).
English: Day 1 -- -- Day 4 Day 8 Day rest period
Maltese: Jum 1 -- -- Jum 4 Jum 8 Jum perjodu ta' mistrieħ
English: BR-CAP= bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy
Maltese: R-CHOP=rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone; PN=newropatija periferali (peripheral neuropathy).
English: Hypersensitivity to the active substance, to boron or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal boron jew għal kwalunkwe eċċipjent elenkat fissezzjoni 6.1.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib 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: Ir-reazzjonijiet avversi li ġejjin (Grad ≥3) kienu osservati b'inċidenza ogħla bl-iskeda ta' trattament li kien fiha bortezomib meta mqabbla ma' studju storiku ta' kontroll fejn l-iskeda ewlenija ngħatat waħedha: f'newropatija sensorjali periferali ta' Blokk 1 (3 % kontra 0 %); ilju (2.1 % kontra 0 %) ipoksja (8 % kontra 2 %).
English: Mean total body clearances were 102 and 112 l/h following the first dose for doses of 1.0 mg/m2 and 1.3 mg/m 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 lewwel 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: 1 mg/m 2, or from 1 mg/m 2 to 0.7 mg/m 2).
Maltese: mg/m 2, jew minn 1 mg/m 2 għal 0.7 mg/m
English: In patients aged ≥ 75 years, both regimens, BR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Maltese: F'pazjenti li kellhom  75 sena, iż-żewġ skedi ta' trattament BR-CAP kif ukoll R-CHOP kienu ttollerati inqas (ara sezzjoni 4.8).
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving bortezomib (see section 4.8).
Maltese: Kien hemm rapporti rari ta' mard pulmonari akut infiltrat b'mod diffuż b'etjoloġija mhix magħrufa bħal pulmonite, pnewmonja interstitjali, infiltrazzjoni tal-pulmun, sindromu ta' għeja respiratorja akuta (ARDS) f'pazjenti li kienu qed jieħdu bortezomib (ara sezzjoni 4.8).
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: Il-volum medju ta' distribuzzjoni (Vd) 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: 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: Il-punt aħħari ta' effikaċja prinċipali kien TTP waqt li punti aħħarin ta' effikaċja sekondarji kienu OS u ORR (CR+PR), permezz tal-kriterji tal-Grupp Ewropew dwar Trapjanti ta' Demm u mudullun (EBMT-European Group for Blood and Bone Marrow Transplantation).
English: Note: Bortezomib Hospira is a cytotoxic agent.
Maltese: Nota: Bortezomib Hospira huwa sustanza ċitotossika.
English: Geometric mean (%CV) clearance was 7.79 (25%) L/hr/m2, volume of distribution at steady-state was 834 (39%) L/m2, and the elimination half-life was 100 (44%) hours.
Maltese: L/siegħa/m2, il-volum ta' distribuzzjoni fl-istat fiss kien ta'834 (39%) L/m2, u l-half-life ta' eliminazzjoni kien ta' 100 (44%) siegħa.
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells, the complications of tumour lysis syndrome may occur.
Maltese: Billi bortezomib huwa sustanza ċitotossika u jista' joqtol malajr iċ-ċelluli malinni tal-plażma, jista' jkun hemm komplikazzjonijiet tas-sindromu tad-diżintegrazzjoni tat-tumur.
English: Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Newropatiji*, Newropatija sensorjali periferika, Disestesija*, Newralġja*
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Maltese: Dexamethasone 40 mg jingħata fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' 28 jum ta' bortezomib u thalidomide jingħata mill-ħalq kuljum f'doża ta' 50 mg sa jum 14 tal-ewwel ċiklu, u jekk ittollerat id-doża ta' thalidomide tiżdied għal 100 mg fil-jiem 15-28 u tista' tiżdied aktar għal 200 mg kuljum wara dan mit-tieni ċiklu 'l quddiem.
English: Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Maltese: Sindrome ta' għeja respiratorja akuta, Emboliżmu fil-pulmun, Pnewmonite, Pressjoni għolja fil-pulmun, Edema fil-pulmun (inkluż akuta)
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Reduction in serum M-protein population g n=667
Maltese: f n (%) Valur-p Tnaqqis tal-proteina M fis-serum popolazzjoni g n=667
English: The incidence of herpes zoster among patients in the BR-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
English: CR=Complete Response; CRu=Complete Response unconfirmed; PR=Partial Response; CI=Confidence Interval, HR=Hazard Ratio; OR=Odds Ratio; ITT=Intent to Treat
Maltese: PR=Rispons Parzjali (Partial Respoonse), CI=Intervall ta' Kunfidenza (Confidence Interval); HR=Proporzjon ta' Periklu (Hazard ratio); OR= Proporzjon ta' Probabbiltà (Odds Ratio);
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BDx group.
Maltese: It-tul medjan ta' trattament kien ta' 13-il ġimgħa għall-grupp VDDx u 11-il ġimgħa għall-grupp BDx.
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Maltese: Aplasja, malformazzjoni gastrointestinali, Iktijosi
English: Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upperairway cough syndrome
Maltese: Falliment respiratorju, Sindromu ta' distress respiratorju akut, Apnea, Pnewmotoraċi, Atelektasi, Pressjoni fil-pulmun, Emoptisi, Iperventilazzjoni, Ortopnea, Pnewmonite, Alkalosi respiratorja, Takipnea, Fibrosi pulmonari, Disturb bronkjali*, Ipokapnija*, Mard tal-pulmun interstizzjali, Infiltrazzjoni tal-pulmun, Griżmejn issikkati, Griżmejn xotti, Aktar tnixxija fil-passaġġ tal
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 paediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Maltese: Il-farmakokinetika ta' bortezomib ġiet ikkaraterrizata wara għoti ta' injezzjoni f'daqqa ta' dożi ta' 1.3 mg/m2 darbtejn fil-ġimgħa fil-vina lil 104 pazjenti pedjatriċi (2-16-il sena) b'lewkimja limfoblastika akuta (ALL - acute lymphoblastic lewkemia) jew lewkimja mijelojde akuta (AMLacute myeloid leukemia).
English: Bortezomib Hospira contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Maltese: Bortezomib Hospira fih is-sustanza attiva bortezomib, hekk imsejjaħ ‘impeditur ta' proteasome'.
English: The most commonly reported adverse reactions during treatment with bortezomib are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni waqt it-trattament bi bortezomib huma nawsja, dijarea, stitikezza, rimettar, għeja, deni, tromboċitopenija, anemija, newtropenija, newropatija periferali (inkluż tas-sensi), uġigħ ta' ras, parestesija, nuqqas t'aptit, qtugħ ta' nifs, raxx, herpes zoster u mijalġja.
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anaemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Maltese: Differenzi li setgħu jiġu nnutati fil-popolazzjoni ta' pazjenti b'MCL meta mqabbla ma' pazjenti fl-istudji ta' majeloma multipla kienu inċidenza ta' ≥ 5 % ogħla fir-reazzjonijiet ematoloġiċi avversi (newtropenija, tromboċitopenija, lewkopenija, anemija, limfopenija), newtropenija tas-sensazzjoni periferika, pressjoni għolja, deni, pulmonite, stomatite u disturbi fix-xagħar.
English: Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Maltese: Ipermagnesemja*, Aċidosi, Żbilanċ fl-elettroliti*, Mifqugħ bil-fluwidu, Ipokloremija*, Ipovolemija, Iperkloremija*, Iperfosfatemija*, Disturb metaboliku, Nuqqas fil-kompless ta' vitamina B, Nuqqas ta' vitamina B12, Gotta, Żieda fl-aptit, Intolleranza għal alkoħol
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer
Maltese: #, Dermatite*, Disturb fix-xagħar*, Petekije, Eċċimosi, Ġerħa fuq il-ġilda, Purpura, Massa tal-ġilda*, Psorijasi, Iperidrosi, Għorieq bil-lejl, Ulċera dekubitè
English: CR+nCR+PR 121 (38)b 56 (18)
Maltese: CR CR+nCR 41 (13) CR+nCR+PR 121 (38) CR+nCR+ PR+MR Tul medjan Jiem (xhur)
English: #, Hypersensitivity*
Maltese: Anġjoedema#, Sensittività eċċessiva*
English: Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Maltese: Eritema multiforme, Urtikarja, Dermatosi newtrofilika akuta bid-deni, Infafet tossiċi fuq il-ġilda, Nekrosi epidermali tossika
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 MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Maltese: Il-karatteristiċi demografiċi u fil-linja bażi tal-marda kienu b'mod ġenerali bbilanċjati tajjeb bejn iż-żewġ fergħat ta' trattament: il-medjan tal-età tal-pazjenti kienet ta' 66 sena, 74 % kienu rġiel, 66 % kienu Kawkasiċi u 32 % Ażjatiċi, 69 % tal-pazjenti kellhom materjal miġbud mill-mudullun talgħadam pożittiv u/jew bijopsija tal-mudullun tal-għadam pożittiva għal MCL, 54 % tal-pazjenti kellhom punteġġ ta' Indiċi Internazzjonali ta' Pronjożi (IPI - International Prognostic Index) ta' ≥ 3, u 76 % kellhom marda tal-Istadju IV.
English: Week B (1.3 mg/m
Maltese: Ġimgħa B (1.3 mg/m
English: Dyspnoea*, Cough*, Hiccups
Maltese: Dispnea*, Sogħla*, Sulluzzu
English: Uncommon Angioedema
Maltese: Reazzjoni anafilattika
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Maltese: #, Infjammazzjoni gastrointestinali*, Disfaġja, Sindromu ta' imsaren irritabbli, Axxite, Esofaġite, Disturb gastrointestinali
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).
Maltese: III li qabbel bortezomib mogħti ġol-vina kontra dak li ngħata taħt il-ġilda, linċidenza ta' każijiet ta' newropatija periferali ta' Grad  2 kien ta' 24 % għall-grupp li ngħata linjezzjoni taħt il-ġilda u 41 % għall-grupp li ngħata l-injezzjoni ġol-vina (p=0.0124).
English: Discontinue Bortezomib Hospira
Maltese: Mediċini oħra u Bortezomib Hospira
English: 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 (CrCL = 20
Maltese: Normali (CrCL ≥60 ml/min/1.73 m2, n=12), Ħafif (CrCL=40-59 ml/min/1.73 m2, n=10), Moderat
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered medicinal product in Block 3.
Maltese: Bortezomib ngħata biss fi blokki 1 u 2 biex jiġu evitati tossiċitajiet li possibbli jikkonċidu parzjalment ma' ta' prodotti mediċinali mogħtija flimkien miegħu fi Blokk 3.
English: Day 22
Maltese: Tabella 10:
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Maltese: • Newtropenija bid-deni  Grad 3, newtropenija ta' Grad 4 li ddum aktar minn 7 ijiem, u għadd ta' ċelluli ta' < 10,000 ċellula/μL
English: A statistically significant survival benefit in favour of the B+M+P treatment group was observed (HR=0.695; p=0.00043) despite subsequent therapies including bortezomib-based regimens.
Maltese: B+M+P (HR=0.695; p=0.00043) minkejja terapiji sussegwenti li kienu jinkludu programmi ta' kura bbażati fuq Bortezomib Hospira.
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: Ir-rata ta' CR f'pazjenti b'ALL taċ-ċelluli T li rkadew għall-ewwel darba (n=22) kienet 68 % (95% CI: 45, 86) u r-rata ta' sopravivenza ta' 4 xhur mingħajr każijiet kienet ta' 67 % (95% CI: 42, 83).
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Maltese: Falliment epatiku, Epatomegalija, Sindromu ta' Budd-Chiari, Epatite minħabba ċ-Ċitomeaglovirus, Emorraġija epatika, Kolelitijasi
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Hospira treatment cycle.
Maltese: Dexamethasone jingħata mill-ħalq f'doża ta' 40 mg fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' Bortezomib Hospira.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Hospira at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m 2 or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment moderat jew qawwi tal-fwied għandhom jinbdew fuq Bortezomib Hospira bid-doża mnaqqsa ta' 0.7 mg/m2 f'kull injezzjoni waqt l-ewwel ċiklu ta' kura, u sussegwentement tista' tiġi kkunsidrata żieda sa doża ta' 1.0 mg/m jew aktar tnaqqis sa doża ta' 0.5 mg/m 2 fuq bażi tat-tollerabiltà tal-pazjent (ara Tabella 2 u sezzjonijiet 4.4 u 5.2).
English: When bortezomib is given together with pegylated liposomal doxorubicin, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the bortezomib 21-day treatment cycle as an intravenous infusion after the bortezomib injection.
Maltese: Meta bortezomib jingħata flimkien ma' pegylated liposomal doxorubicin, inti ser tirċievi bortezomib ġol-vina f'ċiklu ta' trattament ta' 21 jum u pegylated liposomal doxorubicin 30 mg/m2 jingħata f'jum 4 taċ-ċiklu ta' trattament ta' 21 jum ta' bortezomib bħala infużjoni ġol-vina wara l-injezzjoni bi bortezomib.
English: B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Maltese: VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial responserispons parzjali tajjeb ħafna; PR=partial response - rispons parzjali, HR=hazard ratio - proporzjon ta' periklu; NE=not estimable - ma jistax jiġi stmat; OR=odds ratio - proporzjon ta' odds; * Primary endpoint - L-ewwel punt aħħari
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Maltese: Valur p mit-test chi-squared ta' Cochran Mantel-Haenszel, bir-riskju IPI tal-marda bħala fatturi ta' stratifikazzjoni.
English: ≥ 2 prior lines
Maltese: 2 linji fil-passat
English: Each carton of 2.5 mg, 3 mg or 3.5 mg Bortezomib Hospira contains a glass 10 ml vial with a rubber stopper and an aluminium seal.
Maltese: Kull kartuna ta' 2.5 mg, 3 mg jew 3.5 mg Bortezomib Hospira fih kunjett tal-ħġieġ ta' 10 ml b'tapp tal-lastku u siġill tal-aluminju.
English: Macrophage activation
Maltese: Attivazzjoni ta' makrofagi
English: OR=odds ratio
Maltese: • Uġigħ fir-rectum
English: Peripheral neuropathy in combination regimens
Maltese: Newropatija periferali fi programmi ta' kura ta' kombinazzjoni Majeloma Multipla
English: The duration of overall response was 21.4 months longer in the BR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Maltese: It-tul ta' żmien ta' rispons totali kien ta' 21.4 xhur itwal fil-grupp BR-CAP (medjan 36.5 xhur kontra 15.1 xahar fil-grupp ta' R-CHOP).
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Maltese: Infezzjoni*, Infezzjonijiet batteriċi*, Infezzjonijiet virali*, Sepsis (li jinkludi wkoll xokk settiku)*, Bronkopnewmonja, Infezzjoni tal-virus ta' Herpes*, Meningoenċefalite ħerpetika
English: In B-ALL patients with relapse within 18 months of diagnosis (n = 27) the CR rate was 67% (95% CI: 46, 84); the 4-month event free survival rate was 44% (95% CI: 26, 62).
Maltese: F'pazjenti b'ALL taċ-ċelluli B li rkadew fi żmien 18-il xahar mid-dijanjosi (n=27) ir-rata ta' CR kienet ta' 67% (95% CI: 46, 84); ir-rata ta' sopravivenza ta' 4 xhur mingħajr każijiet kienet ta' 44% (95% CI: 26, 62).
English: Vision abnormal*
Maltese: Sensittività eċċessiva*
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BR-CAP) Bortezomib Hospira is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m2 body surface area twice weekly for two weeks on days 1, 4, 8 and 11, followed by a 10-day rest period on days 12-21.
Maltese: Terapija ta' kombinazzjoni ma' rituximab, cyclophosphamide, doxorubiċin u prednisone (BR-CAP) Bortezomib Hospira jingħata permezz ta' injezzjoni fil-vini jew taħt il-ġilda bid-doża rrakomandata ta' 1.3 mg/m2 ta' erja superfiċjali tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8, u 11 segwiti minn perjodu ta' mistrieħ ta' 10 ijiem fil-jiem 12-21.
English: #, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Maltese: #, Newrotossiċita, Disturbi ta' Puplesija*, Newralġja post herpetika, Disturb fid-diskors*, Sindromu ta' irrikwitezza fir-riġlejn, Emigranja, Xjatika, Disturb fl-attenzjoni, Abnormalita fir-riflessi*, Parosmija
English: Mantle cell lymphoma
Maltese: Limfoma taċ-ċellula ‘mantle'
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the bortezomib monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: 2-36.5 xhur) għall-pazjenti b'monoterapija ta' bortezomib u 33.0 xahar (95 % CI; 28.9-37.1 xahar) għall-pazjenti li qed jieħdu terapija kombinata ta' bortezomib flimkien ma' doxorubicin liposomali pegilat.
English: In Cycles 5-9, Bortezomib Hospira is administered once weekly on days 1, 8, 22 and 29.
Maltese: Fiċ-Ċikli 5-9, Bortezomib Hospira jingħata darba fil-ġimgħa fil-jiem 1, 8, 22 u 29.
English: T 100 mg a
Maltese: T 100 mg