FrancophonIA/ELRC3.0 huggingface dataset:
English: - Inject the solution subcutaneously, under a 45-90°angle.
Maltese: - Injetta s-soluzzjoni taħt il-ġilda f'angolu ta' 45-90o.
English: In study MMY-3010 induction treatment with bortezomib combined with thalidomide and dexamethasone [BzmbTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Maltese: Fl-istudju MMY-3010 it-trattament ta' induzzjoni b'bortezomib flimkien ma' thalidomide u dexamethasone [BzmbTDx, n=130] kien imqabbel ma' dak ta' thalidomide-dexamethasone [TDx, n=127].
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, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Maltese: Differenzi ta' rilevanza li setgħu jiġu nnutati fil-popolazzjoni ta' pazjenti b'MCL meta mqabbla ma' pazjenti fl-istudji dwar majeloma multipla kienu inċidenza ta' ≥ 5% ogħla fir-reazzjonijiet ematoloġiċi avversi (newtropenija, tromboċitopenija, lewkopenija, anemija, limfopenija), newropatija periferali tas-sensi, pressjoni għolja, deni, pulmonite, stomatite u disturbi fix-xagħar.
English: In patients aged ≥ 75 years, both regimens, BzmbR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Maltese: F'pazjenti li kellhom ≥ 75 sena, iż-żewġ korsijiet ta' trattament, BzmbR-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 interstizjali, infiltrazzjoni tal-pulmun, sindrome ta' għeja respiratorja akuta (ARDS) f'pazjenti li kienu qed jirċievu bortezomib (ara sezzjoni 4.8).
English: Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Newropatiji*, Newropatija sensorjali periferika, Disestesija*, Nevralġija*,
English: Incidence Adverse reaction Common Pruritus*, Dermatitis*, Rash*
Maltese: Prurite*, Dermatite*, Raxx*
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 tal-effikaċja primarja kien TTP filwaqt li l-punti aħħarin tal-effikaċja sekondarji kienu OS u ORR (CR+PR), bl-użu tal-kriterji tal-Grupp Ewropew dwar Trapjanti ta' Demm u Mudullun (EBMT-European Group for Blood and Bone Marrow Transplantation).
English: There was a trend towards prolonged overall survival favouring the BzmbR-CAP group; the estimated 4-year survival rate was 53.9% in the R-CHOP group and 64.4% in the BzmbR-CAP group.
Maltese: Kien hemm tendenza lejn sopravivenza totali mdewma li tiffavorixxi lgrupp ta' BzmbR-CAP; ir-rata stmata ta' sopravivenza għal 4 snin kienet 53.9% fil-grupp ta' RCHOP u 64.4% fil-grupp ta' BzmbR-CAP.
English: In Cycles 1-4, Bortezomib SUN is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Maltese: F'Ċikli 1-4, Bortezomib SUN jingħata darbtejn fil-ġimgħa f'jiem 1, 4, 8, 11, 22, 25, 29 u 32.
English: Overall survival* Events (deaths) n (%) Mediana (95% CI)
Maltese: Sopravivenza totali* Każijiet (imwiet) n (%) Medjana (95% CI)
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Maltese: Emorraġija gastrointestinali u intraċerebrali, ġew irrappurtati b'rabta mat-trattament b'bortezomib.
English: Bortezomib is metabolised by liver enzymes.
Maltese: Bortezomib huwa mmetabolizzat permezz ta' enzimi tal-fwied.
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 trattament b'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: In study LYM-3002, colony stimulating factor support was given to 78% of patients in the BzmbR-CAP arm and 61% of patients in the R-CHOP arm.
Maltese: Fl-istudju LYM-3002, sostenn b'fattur stimulanti tal-kolonji ngħata lil 78% tal-pazjenti fil-parti tal-istudju dwar BzmbR-CAP u lil 61% tal-pazjenti fil-parti tal-istudju dwar R-CHOP.
English: Best response
Maltese: MANIFATTUR RESPONSABBLI
English: Age 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 ikkaratterizzata 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 leukemia) jew lewkimja mijelojde akuta (AMLacute myeloid leukemia).
English: 24.0 mo
Maltese: 24.0 xahar
English: 14.0 mo
Maltese: 14.0 xahar
English: Mediana (95% CI)
Maltese: Medjanc (95% CI) (xhur)
English: Intravenous use: Add 3.5 ml 0.9% sodium chloride to make 1 mg/ml final concentration.
Maltese: Żid 3.5 ml ta' 0.9% sodium chloride sabiex tagħmel konċentrazzjoni finali ta' 1 mg/ml.
English: In patients with advanced myeloma the severity of thrombocytopenia was related to pre-treatment platelet count: for baseline platelet counts < 75,000/μl, 90% of 21 patients had a count ≤ 25,000/μl during the study, including 14% < 10,000/μl; in contrast, with a baseline platelet count > 75,000/μl, only 14% of 309 patients had a count ≤ 25,000/μl during the study.
Maltese: F'pazjenti b'majeloma avvanzata s-severità tat-tromboċitopenija kienet marbuta mal-għadd tal-plejtlits qabel it-trattament: għal għadd mil-linja bażi tal-plejtlits < 75,000/µl, 90% ta' 21 pazjent kellhom għadd ≤ 25,000/µl waqt l-istudju, inkluż 14% < 10,000/µl; b'kuntrast, b'għadd mil-linja bażi > 75,000/µl, 14% biss minn 309 pazjenti kellhom għadd ≤ 25,000/µl waqt l-istudju.
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Maltese: Fatturi stimulanti tal-kolonji ta' granuloċiti jistgħu jingħataw għal tossiċità ematoloġika skont ilprattika lokali standard.
English: Herpes zoster virus reactivation
Maltese: Attivazzjoni mill-ġdid tal-virus tal-Herpes zoster
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Maltese: Xokk anafilattiku, Amilojdożi, Reazzjoni ta' Tip III permezz tal-kumpless immuni
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 avvenimenti kienet 67% (95% CI: 42, 83).
English: Note: Bortezomib SUN is a cytotoxic agent.
Maltese: Nota: Bortezomib SUN huwa sustanza ċitotossika.
English: The overall incidence of diarrhoea, gastrointestinal and abdominal pain, asthenic conditions, upper respiratory tract infections and peripheral neuropathies were 12%-15% lower in the subcutaneous group than in the intravenous group.
Maltese: Linċidenza globali ta' dijarea, uġigħ gastrointestinali u ta' żaqq, kondizzjonijiet asteniċi, infezzjonijiet marbuta mal-passaġġ respiratorju u newropatiji periferali kienu 12%-15% inqas fil-grupp li ngħata taħt il-ġilda milli fil-grupp ta' ġol-vini.
English: Common Vertigo*
Maltese: Vertiġini*
English: - The other ingredient is mannitol (E421).
Maltese: - Is-sustanza l-ohra hija mannitol (E421).
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 sustanza mhux attiva elenkata fis-sezzjoni 6.1.
English: Response Evaluable Population n=73
Maltese: Popolazzjoni ta' Rispons li seta' jiġi Evalwat n=73
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-vini 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-vini (p=0.0124).
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Maltese: Il-punt aħħari tal-effikaċja primarja kien sopravivenza ħielsa mill-progressjoni abbażi ta' stima talKumitat ta' Reviżjoni Indipendenti (IRC - Independent Review Committee).
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Maltese: Bortezomib ma kienx ġenotossiku meta kien ittestjat in vitro għal bidliet ġenetiċi (assaġġ ta' Ames) uin vivo f'eżami mikronukleju fil-ġrieden.
English: You might receive up to 8 cycles (24 weeks).
Maltese: Inti tista' tirċievi sa 8 ċikli (24 ġimgħa).
English: a Intent to Treat (ITT) population b p-value from the stratified log-rank test; analysis by line of therapy excludes stratification for therapeutic history; p <
Maltese: b valur-p mit-test log-rank stratifikat, analiżi skont il-linja ta' terapija teskludi l-istratifikazzjoni għall-istorja terapewtika;
English: Once the symptoms of the toxicity have resolved, Bortezomib SUN 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 SUN jista' jerġa' jibda jingħata b'doża mnaqqsa b'25% (1.3 mg/m2 imnaqqsa għal 1.0 mg/m2; 1.0 mg/m2 imnaqqsa għal 0.7 mg/m2).
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.
Maltese: Lewkoenċefalopatija progressiva u multifokali (PML) Każijiet rari ħafna fejn ma tkunx magħrufa l-kawża għal infezzjoni bil-virus John Cunningham (JC), li irriżultaw f'PML u mewt, ġew irrappurtati f'pazjenti li ġew ittrattati b'bortezomib.
English: Patients in the BzmbTDx group received six 4-week cycles, each consisting of bortezmib (1.3 mg/m2 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 BzmbTDx kellhom sitt ċikli ta' 4 ġimgħat, li kull wieħed minnhom kien jikkonsisti minn bortezomib (1.3 mg/m2 li ngħata darbtejn fil-ġimgħa f'jiem 1, 4, 8 u 11, segwit minn perjodu ta' serħan ta' 17-il jum minn jum 12 sa jum 28), dexamethasone (40 mg li ngħata oralment f'jiem 1 sa 4 u l-jiem 8 sa 11) u thalidomide (mogħti mill-ħalq f'doża ta' 50 mg kuljum f'jiem 1-14, li tiżdied għal 100 mg f'jiem 15-28 u minn hemm sa 200 mg kul jum).
English: - Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Maltese: - Injetta s-soluzzjoni bħala injezzjoni bolus ta' bejn 3 u 5 sekondi minn ġo kateter periferali jew ċentrali ġol-vini.
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Maltese: Studju ta' interazzjoni bejn mediċina u oħra li evalwa l-effett ta' rifampicin, induttur qawwi ta' CYP3A4, fuq il-farmakokinetika ta' bortezomib (injettat ġol-vini), wera tnaqqis medju ta' 45% flAUC ta' bortezomib ibbażat minn dejta minn 6 pazjenti.
English: 18.3 mo
Maltese: 18.3 xahar
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of bortezomib in dual and triple combinations with other chemotherapeutic agents, as induction therapy prior to stem cell transplantation in patients with previously untreated multiple myeloma.
Maltese: III, open-label (IFM-2005-01, MMY-3010) saru biex juru s-sigurtà u l-effikaċja ta' bortezomib f'kombinazzjonijiet doppji u tripli ma' sustanzi kimoterapewtiċi oħra, bħala terapija ta' induzzjoni qabel it-trapjant ta' ċelluli staminali f'pazjenti b'majeloma multipla li ma ġietx ittrattata qabel.
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 ta' ċitokrom P450 espressi minn cDNA uman, jindikaw li bortezomib huwa primarjament metabolizzat b'mod ossidattiv permezz ta' isożimi ta' ċitokrom P450, 3A4, 2C19, u 1A2.
English: Bortezomib SUN therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μl and a platelet count ≥ 25,000 cells/μl.
Maltese: Terapija b'Bortezomib SUN m'għandhiex tingħata sa ġimagħtejn sakemm il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL.
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 kienet ta' 71 sena, 50% kienu rġiel, 88% kienu Kawkasi u l-medjan tal-punteġġ tal-istat ta' prestazzjoni ta' Karnofsky għall-pazjenti kien ta' 80.
English: You will receive 9 cycles (54 weeks).
Maltese: Se tirċievi 9 ċikli (54 ġimgħa).
English: Contraception in males and females
Maltese: Avvenimenti relatati maż żmien
English: At least 6 months after prior therapy, bortezomib was started at the last tolerated dose of 1.3 mg/m2 (n=93) or ≤ 1.0 mg/m2 (n=37) and given on days 1, 4, 8 and 11 every 3 weeks for maximum of 8 cycles either as single agent or in combination with dexamethasone in accordance with the standard of care.
Maltese: Tal-anqas 6 xhur wara t-terapija ta' qabel, bortezomib inbeda fl-aħħar doża ttolerata ta' 1.3 mg/m2 (n=93) jew ≤ 1.0 mg/m2 (n=37)u mogħti f'jiem 1, 4, 8 u 11 kull 3 ġimgħat għal massimu ta' 8 ċikli jew bħala mediċina waħidha jew f'kombinazzjoni b'dexamethasome b'mod konformi mal-istandard tat-trattament.
English: The duration of overall response was 21.4 months longer in the BzmbR-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 ta' BzmbR-CAP (medjan 36.5 xhur kontra 15.1 xhur fil-grupp ta' R-CHOP).
English: Be sure that the correct dose is being given for the intravenous route of administration (1 mg/ml).
Maltese: Kun ċert li d-doża korretta tkun qed tingħata għar-rotta tal-għoti ġol-vini (1 mg/ml).
English: Reduce Bortezomib SUN to 1.0 mg/m2
Maltese: Bortezomib SUN 3.5 mg
English: Bortezomib was administered only in Blocks 1 and 2 to avoid potential overlapping toxicities with coadministered drugs in Block 3.
Maltese: Bortezomib 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: In B-ALL patients with relapse 18 36 months from diagnosis (n = 33) the CR rate was 79% (95% CI: 61, 91) and the 4-month event free survival rate was 73% (95% CI: 54, 85).
Maltese: F'pazjenti b'ALL taċ-ċelluli B ilpazjenti li rkadew fi żmien 18-il xahar sa 36 xahar mid-dijanjosi (n = 33) ir-rata ta' CR kienet 79% (95% CI: 61, 91) u r-rata ta' sopravivenza ta' 4 xhur mingħajr avvenimenti kienet 73% (95% CI: 54, 85).
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/μl were excluded.
Maltese: Pazjenti b'newropatija periferali fil-linja bażi ta' Grad ≥ 2 jew b'għadd ta' plejtlits ta' < 50,000/µl kienu esklużi.
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m2 weekly and 1.3 mg/m2 twice-weekly.
Maltese: F'analiżi tal-effikaċja esploratorja, rata ta' rispons ta' 67.3% (li tinkludi rata CR ta' 28.6%) kif imkejla minn rispons ematoloġiku (proteina M), ġiet irrappurtata f'49 pazjent li setgħu jiġu evalwati li kienu ttrattati bid-dożi massimi permessi ta' b'1.6 mg/m2 fil-ġimgħa u 1.3 mg/m2 darbtejn fil-ġimgħa.
English: Bzmb=bortezomib; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Maltese: CR = Rispons Komplet (Complete Response); nCR= viċin ir-Rispons Kompleta (near Complete Response) PR = Rispons Parzjali (Partial Response);
English: Haematological toxicity - ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μl
Maltese: Tossiċità ematoloġika - Newtropenija bid-deni ≥ Grad 3, newtropenija ta' Grad 4 li ddum aktar minn 7 ijiem, u għadd taċ-ċelluli ta' < 10,000 ċellula/μL
English: 1.4 mo
Maltese: 1.4 xahar
English: Bortezomib is a proteasome inhibitor.
Maltese: Bortezomib huwa inibitur tal-proteasome.
English: Potentially immunocomplex-mediated reactions Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Maltese: Reazzjonijiet potenzjali medjati mill-immunokumpless Ġew irrappurtati b'mod mhux komuni reazzjonijiet li potenzjalment huma medjati millimmunokumpless, bħalma huma reazzjoni tat-tip tal-mard tas-serum, poliartrite b'raxx u glomerulonefrite proliferattiva.
English: Batch
Maltese: LUŻU
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.
Maltese: Il-prodotti mediċinali li ġejjin jingħataw f'jum 1 ta' kull waħda miċ-ċikli ta' trattament ta' 3 ġimgħat ta' Bortezomib SUN bħala infużjonijiet ġol-vini: rituximab b'doża ta' 375 mg/m2, cyclophosphamide b'doża ta' 750 mg/m2 u doxorubicin b'doża ta' 50 mg/m2.
English: Pegylated liposomal doxorubicin 30 mg/m2 is given on day 4 of the Bortezomib SUN 21-day treatment cycle as an intravenous infusion after the Bortezomib SUN injection.
Maltese: Pegylated liposomal doxorubicin 30 mg/m2 jingħata f'jum 4 taċ-ċiklu ta' trattament ta' 21 jum ta' Bortezomib SUN bħala infużjoni ġol-vini wara l-injezzjoni ta' Bortezomib SUN.
English: Hazard ratiob (95% CI) p-valuec
Maltese: Proporzjon ta' periklub (95% CI) valur-pc
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, Upper-airway cough syndrome
Maltese: Insuffiċjenza respiratorju, Sindrome ta' distress respiratorju akut, Apnea, Pnewmotoraks, Atelektasi, Pressjoni għolja fl-arterji pulmonari, Emoptisi, Iperventilazzjoni, Ortopnea, Pnewmonite, Alkalosi respiratorja, Takipnea, Fibrosi pulmonari, Disturb bronkjali*, Ipokapnija*, Mard tal-pulmun interstizjali, Infiltrazzjoni tal-pulmun, Griżmejn issikkati, Griżmejn xotti, Aktar tnixxija fil-passaġġ tal-arja, Irritazzjoni talgriżmejn, Sindrome tas-sogħla tal-passaġġ ta' fuq
English: Bilirubin level
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Uncommon Pulmonary embolism, Pleural effusion, Pulmonary oedema (inc acute), Pulmonary alveolar haemorrhage#, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Maltese: Emboliżmu pulmonarju, Effużjoni plewrali, Edema pulmonari (li tista' tkun akuta), Bronkospażmu, Emorraġija alveolari pulmonari#, Mard pulmonari kroniku u ostruttiv (COPD)*, Ipoksemija*, Konġestjoni fil-passaġġ respiratorju*, Ipoksja, Plewrisi*, Sulluzzu, Rinorea, Disfonja, Tħarħir
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Maltese: Aplasija, Malformazzjoni gastrointestinali, Iktijożi,
English: Week
Maltese: Età
English: Common Rash*, Pruritus*, Erythema, Dry skin Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis#, Stevens-Johnson syndrome#, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer#, Acne*, Blister*, Pigmentation disorder*
Maltese: Eritema multiforme, Urtikarja, Dermatożi newtrofilika akuta bid-deni, Infafet tossiċi fuq il-ġilda, Nekrożi epidermali tossika#, Sindrome ta' Stevens-Johnson#, Dermatite*, Disturb fix-xagħar*, Petekije, Ekkimożi, Ġerħa fuq il-ġilda, Purpura, Massa fil-ġilda*, Psorjasi, Iperidrożi, Għaraq bil-lejl, Ulċera dekubitè#, Akne*, Infafet, Disturb fil-pigmentazzjoni*
English: Note: An OR > 1 indicates an advantage for Bzmb-containing induction therapy.
Maltese: Nota: OR > 1 jindika vantaġġ għal terapija ta' induzzjoni li jkun fiha Bzmb.
English: AST=aspartate aminotransferase; ULN=upper limit of the normal range.
Maltese: ULN = l-ogħla limitu tal-medda normali.
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to 120 ng/ml for the 1.3 mg/m2 dose.
Maltese: Fid-dożi ta' wara, il-medja ta' konċentrazzjonijiet massimi osservati fil-plażma kienu fuq medda minn 67 sa 106 ng/ml għal doża ta' 1.0 mg/ m2 u minn 89 sa 120 ng/ml għal doża ta' 1.3 mg/m2.
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BzmbDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Maltese: Fl-istudju IFM-2005-01 bortezomib flimkien ma' dexamethasone [BzmbDx, n=240] ġie mqabbel ma' vincristine-doxorubicin-dexamethasone [VDDx, n=242].
English: CR+nCR+VGPR+PR % (95% CI) RR (Post-transplant)b CR+nCR
Maltese: CR+nCR+VGPR+PR % (95% CI) RR (Wara t-trapjant)
English: Common Vision abnormal*
Maltese: Sensittività eċċessiva*
English: Seizures
Maltese: Ipotirojdiżmu
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Maltese: Aġġustamenti fid-doża waqt it-trattament u trattament li jinbeda mill-ġdid għal terapija kombinata b' melphalan u prednisolone
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Maltese: Ir-rata tal-aħjar rispons globali (CR + PR), għal trattament mill-ġdid lil 130 pazjent kien 38.5% (95% CI: