FrancophonIA/ELRC3.0 huggingface dataset:
English: In studies in patients with relapsed multiple myeloma treated with bortezomib and in patients with previously untreated MCL treated with bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Maltese: Fi studji f'pazjenti b'majeloma multipla li rkadiet li ġiet trattata bi bortezomib u f'pazjenti b'MCL li qatt ma kienet trattata qabel li ġiet ittrattata bi bortezomib flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone (BR-CAP), waħda mill-aktar tossiċitajiet ematoloġiċi komuni kienet tromboċitopenija temporanja.
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the Bortezomib Hospira treatment cycle as a 1 hour intravenous infusion administered after the Bortezomib Hospira injection.
Maltese: Pegyalted liposomal doxorubicin għandu jingħata f'doża ta' 30 mg/m2 f'jum 4 taċ-ċiklu ta' tratament ta' Bortezomib Hospira bħala infużjoni ta' siegħa ġol-vina mogħtija wara l-injezzjoni ta' Bortezomin Hospira.
English: Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Maltese: Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni
English: When Bortezomib Hospira is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Maltese: Meta Bortezomib Hospira jingħata f'kombinazzjoni ma' prodotti mediċinali oħra, irreferi għasSommarju tal-Karatteristiċi tal-Prodott għal kontraindikazzjonijiet addizzjonali.
English: • Platelet counts should be ≥ 75,000 cells/μL in patients with bone marrow infiltration or splenic sequestration
Maltese: • L-għadd ta' plejtlits għandu jkun  75,000 ċellula/μL f'pazjentli għandhom infiltrazzjoni fil-mudullun jew sekwestru tal-frixa
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Maltese: (CR+nCR, CR+nCR+VGPR+PR), is-Sopravivenza Mingħajr Progressjoni u s-Sopravivenza Globali.
English: Preparation of the 2.5 mg vial: carefully add 2.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 2.5 mg: b'attenzjoni żid 2.5 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Subcutaneous use: Add 1.2 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 1.2 ml 0.9% Sodium Chloride biex tagħmel konċentrazzjoni finali ta' 2.5 mg/ml.
English: Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 0.4 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 Hospira 1 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 5 mL ta' Bortezomib Hospira 1 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 0.4 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: Bortezomib Hospira 2.5 mg powder for solution for injection bortezomib
Maltese: Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni
English: 1.1 Preparation of the 1mg vial: carefully add 1mlof sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: 1.1. Preparazzjoni tal-kunjett ta' 1 mg: b'attenzjoni żid 1 mL ta' 9 mg/mL (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Bortezomib exposure is increased in patients with moderate or severe hepatic impairment; these patients should be treated with Bortezomib Hospira at reduced doses and closely monitored for toxicities (see sections 4.2 and 5.2).
Maltese: Esponiment għal bortezomib jiżdied f'pazjenti b'indeboliment moderat jew qawwi tal-fwied; dawn il-pazjenti għandhom jiġu kkurati b'dożi mnaqqsa ta' Bortezomib Hospira u mmonitorjati mill-qrib għal tossiċitajiet (ara sezzjonijiet 4.2 u 5.2).
English: Combination therapy with pegylated liposomal doxorubicin 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 in a 21-day treatment cycle.
Maltese: Terapija ta' kombinazzjoni ma' pegyalted liposomal doxorubiċin Bortezomib Hospira jingħata bħala injezzjoni ġol-vina jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 ta' erja superfiċjali tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8, u 11, f'ċiklu ta' trattament ta' 21 jum.
English: Preparation of the 3 mg vial: carefully add 3 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 3 mg: b'attenzjoni żid 3 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Combination therapy with dexamethasone and thalidomide 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 in a 28-day treatment cycle.
Maltese: Terapija ta' kombinazzjoni ma' dexamethasome u thalidomide Bortezomib Hospira jingħata permezz ta' injezzjoni ġol-vina jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 erja superfiċjali tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8 u 11, f'ċiklu ta' trattament ta' 28jum.
English: Bortezomib Hospira 1 mg powder for solution for injection Bortezomib Hospira 2.5 mg powder for solution for injection Bortezomib Hospira 3 mg powder for solution for injection Bortezomib Hospira 3.5 mg powder for solution for injection bortezomib
Maltese: L-MAH irid jiżgura li, il-professjonisti kollha tas-saħħa involuti fil-preskrizzjoni, tqassim, limmaniġġar jew l-amministrazzjoni ta' Bortezomib Hospira 3.5 mg huma pprovduti b'materjal edukattiv
English: Bortezomib Hospira 3 mg powder for solution for injection bortezomib
Maltese: It-terapija bi Bortezomib Hospira m'għandhiex tingħata
English: Very Common Pneumonia* Common
Maltese: Vista' mhux normali*
English: Intravenous use: Add 3 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Maltese: Żid 3 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta'1 mg/ml.
English: Median c (95% CI) (months)
Maltese: (95% CI) (xhur)
English: • Respiratory infections, bronchitis, coughing with phlegm, flu like illness
Maltese: • Infezzjonijiert respiratorji, bronkite, sogħla bil-bili, mard jixbaħ l-influwenza
English: Dose adjustments during treatment and re-initiation of treatment for monotherapy Bortezomib Hospira treatment must be withheld at the onset of any Grade 3 non-haematological or any Grade 4 haematological toxicities, excluding neuropathy as discussed below (see also section 4.4).
Maltese: It-trattament bi Bortezomib Hospira għandu jitwaqqaf mal-bidu ta' kwalunkwe tossiċitajiet mhux ematoloġiċi (minbarra newropatija) ta'  Grad 3 marbuta ma' bortezomib jew tossiċitajiet ematoloġiċi ta'  Grad 3 (ara wkoll sezzjoni 4.4).
English: Adverse reaction Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest Vascular disorders Common Hypotension*, Orthostatic hypotension, Hypertension* Uncommon Cerebrovascular accident
Maltese: Petpita atrijali, Infart mijokardjali*, Imblokk atrijoventrikulari*, Disturb kardjovaskulari (li jinkludi xokk kardjoġeniku), Torsade de pointes, Anġina mhux stabbli, Disturbi tal-valv kardijaku*, Insuffiċjenza tal-arterja koronarja, Arrest tas-sinus
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Maltese: Il-kura kienet mogħtija għal massimu ta' 9 ċikli (bejn wieħed u ieħor 54 ġimgħa) u twaqqfet qabel fejn kien hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Maltese: Tossiċità gastro-intestinali, li tinkludi nawsja, dijarea, rimettar u stitikezza huma komuni ħafna waqt kura b'Bortezomib Hospira.
English: Posology for treatment of progressive multiple myeloma (patients who have received at least one prior therapy)
Maltese: Pożoloġija għal trattament ta' majeloma multipla progressiva (pazjenti li rċevew tal-anqas terapija waħda qabel)
English: Dexamethasone was administered in combination with bortezomib to 83 patients in Cycle 1 with an additional 11 patients receiving dexamethasone during the course of bortezomib retreatment cycles.
Maltese: Dexamethasome kien mogħti f'kombinazzjoni ma' bortezomib lil 83 pazjent f'Ċiklu 1 bi 11-il pazjenti addizzjonali jirċievu dexamethasome waqt il-kors ta' ċiklu ta' trattament bi bortezomib.
English: A hazard ratio less than 1 indicates an advantage for VMP Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors
Maltese: Irrispettivament milllivelli ta' mikroglobulina 2 fil-linja bażi, il-parametri kollha ta' effikaċja (żmien ta' progressjoni, sopravvivenza ġenerali, kif ukoll rata ta' rispons) tjiebu b'mod sinifikanti fil-parti ta' bortezomib talistudju.
English: When toxicity resolves re-initiate Bortezomib Hospira treatment and reduce dose to 0.7 mg/m2 once per week.
Maltese: Meta t-tossiċità tgħaddi erġa' ibda l-kura b'Bortezomib Hospira u naqqas id-doża għal 0.7 mg/m2 darba fil-ġimgħa.
English: Bortezomib Hospira 1 mg powder for solution for injection Each 5 ml vial of Bortezomib Hospira 1 mg powder for solution for injection must be carefully reconstituted with 1 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 Hospira 1 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett ta' 5 mL ta' Bortezomib Hospira 1 mg trab għal soluzzjoni għall-injezzjoni jrid ikun rikostitwit b'attenzjoni bi 1 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: Bortezomib Hospira 1 mg powder for solution for injection bortezomib
Maltese: Tużax Bortezomib Hospira - jekk inti allerġiku għal bortezomib, boron jew għal xi sustanza oħra ta' din il-mediċina
English: Subcutaneous use: Add 1 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 1 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta' 2.5 mg/ml.
English: Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness)
Maltese: Disakusi (li jinkludi tinnite)*, Is-smigħ imxekkel (sa anke truxija), Dwejjaq fil-widnejn*
English: UNIQUE IDENTIFIER -HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: 1, 4, 8, and 11), and oral dexamethasone (40 mg/day on days 1 to 4 and days 9 to 12, in Cycles 1 and 2, and on days 1 to 4 in Cycles 3 and 4).
Maltese: Pazjenti fil-grupp BDx kellhom 4 ċikli ta' 21 jum, kull wieħed minnhom jikkonsisti minn Bortezomib Hospira (1.3 mg/m2 mogħti ġol-vina darbtejn kuljum fil-jiem 1, 4. 8 u 11) u dexamethasone orali (40 mg/jum fil-jiem 1 sa 4 u fil-jiem 9 sa 12, fiċ-Ċikli 1 u 2, u fil-jiem 1 sa 4 fiċ-Ċikli 3 u 4).
English: Preparation of the 2.5 mg vial: carefully add 1 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Hospira powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: Preparazzjoni tal-kunjett ta' 2.5 mg: b'attenzjoni żid 1 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Hospira billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Previously untreated mantle cell lymphoma
Maltese: Effikaċja klinika f'limfoma taċ-ċellula ‘mantle' (MCL-mantle cell lymphoma) li qatt ma kienet ittrattata qabel
English: Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Maltese: Panċitopenija*, Newtropenija bid-deni, Koagulopatija*, Lewkoċitosi*, Limfodenopatija, Anemija emolitika
English: Bortezomib Hospira 1 mg powder for solution for injection Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Hospira 1 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 1 mg ta' bortezomib (bħala mannitol boronic ester).
English: Bortezomib 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 jintuża għat-trattament ta' limfoma taċ-ċellula ‘mantle' (tip ta' kanċer li jaffettwa lglandoli limfatiċi) f'pazjenti ta' 18-il sena jew aktar f'kombinazzjoni mal-mediċini rituximab, cyclophosphamide, doxorubicin u prednisone, għal pazjenti li l-marda tagħhom ma kinetx ittratta qabel u li trapjant ta' ċelluli steminali tad-demm ma jkunx tajjeb għalihom.
English: TTP, days [95% CI] 1 year survival, % [95% CI]
Maltese: Sopravivenza ta' sena waħda, % [95% CI] L-aħjar rispons n=315
English: Urinary tract infection*
Maltese: Kolite (unkluż Clostridium difficile)*
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Maltese: Il-ġestjoni tal-ipotensjoni ortostatika/tal-qagħda tista' tinkludi bdil fid-doża ta' prodotti mediċinali kontra l-ipertensjoni, reidratazzjoni jew il-għoti ta' mineralokortikosterojdi u/jew simpatomimetiċi.
English: Also included are adverse drug reactions identified in the BR-CAP arm that were considered by investigators to have at least a possible or probable causal relationship to bortezomib based on historical data in the multiple myeloma studies.
Maltese: Inklużi wkoll huma reazzjonijiet avversi għall-mediċina identifikati fil-fergħa ta' BR-CAP li kienu meqjusa mill-investigaturi li tal-anqas kien hemm il-possibbiltà jew probabbiltà li dawn kienu kkawżati minn bortezomib abbażi tad-dejta storika fl-istudji ta' majeloma multipla.
English: Intravenous use: Add 1 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Maltese: Żid 1 mL ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta'1 mg/mL.
English: Bladder irritation
Maltese: Disturbi vaskulari
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of bortezomib (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Maltese: III fejn il-pazjenti ġew magħżula b'mod każwali, (APEX) kontra dexamethasone (Dex), ta' 669 pazjent b'majeloma multipla refrattorja jew b'episodju ġdid tagħha li ħadu bejn 1 u 3 linji ta' terapija fil-passat, u studju ta' Fażi
English: Table 4: Posology for Bortezomib Hospira combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation B+Dx
Maltese: Tabella 4: Pożoloġija għal terapija kombinata b'Bortezomib Hospira għal pazjenti b'majeloma multipla li ma kienux ġew ittrattati qabel eliġibbli għal trapjant b'ċelluli steminali ematopojetiċi
English: Bortezomib Hospira treatment must be withheld at the onset of any ≥ Grade 3 bortezomib-related non-haematological toxicities (excluding neuropathy) or ≥ Grade 3 haematological toxicities (see also section 4.4).
Maltese: Il-kura b'Bortezomib Hospira trid tieqaf mill-bidu jekk ikun hemm xi tossiċitajiet mhux ematoloġiċi ta' Grad 3 jew kwalunkwe tossiċitajiet ematoloġiċi ta' Grad 4, ħlief għan-newropatija kif imfisser hawn taħt (ara wkoll sezzjoni 4.4).
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia (inc hiatus)*, Impaired healing*, Inflammation, Injection site phlebitis*, Tenderness, Ulcer, Irritability, Non-cardiac chest pain, Catheter site pain, Sensation of foreign body
Maltese: Mewt (ankef'daqqa), Falliment f'ħafna organi, Emorraġija fis-sit talinjezzjoni*, Ftuq (li jinkludi ħijatus)*, Fejqan indebolit*, Infjammazzjoni*, Flebitè fis-sit ta' injezzjoni, Tenerezza, Ulċera, Irritabilità, Uġigħ tas-sider mhux tal-qalb, Uġigħ fis-sit tal-katiter, Sensazzjoni ta' korp barrani
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 majloġenuża akuta mietu minħabba ARDS fil-bidu tat-terapija, u l-istudju twaqqaf.
English: # , Acne*, Blister*,
Maltese: #, Sindromu ta' Stevens
English: The following medicinal products are administered on day 1 of each Bortezomib Hospira 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m 2, cyclophosphamide at 750 mg/m 2 and doxorubicin at 50 mg/m
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jum 1 ta' kull waħda miċ-ċikli ta' trattament ta' 3 ġimgħat ta' Bortezomib Hospira bħala infużjonijiet fil-vina: rituximab b'doża ta' 375 mg/m cyclophosphamide b'doża ta' 750 mg/m2 u doxorubicin b'doża ta' 50 mg/m 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: Pigmentation disorder*
Maltese: Panċitopenija*
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: Fi studju dwar interazzjoni bejn mediċini, fejn ġie studjat l-effett ta' omeprazole, inibitur potenti ta' 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: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Maltese: Id-demografiċi tal-pazjenti u l-karatteristiċi tal-mard fil-linja bażi kienu simili bejn il-gruppi ta' trattament.
English: • Muscle pain, bone pain
Maltese: • Spażmi fil muskoli
English: The incidence of all grade peripheral neuropathy with bortezomib administered intravenously was lower in the historical studies with bortezomib administered intravenously than in study MMY-3021.
Maltese: L-inċidenza ta' newropatija periferali ta' kull grad bi bortezomib li ngħata ġol-vina kien inqas fl-istudji storiċi bi bortezomib mogħti ġol-vina milli fl-istudju MMY-3021.
English: • Inject the solution subcutaneously, under a 45-90°angle.
Maltese: Is-soluzzjoni għandha tiġi injettata taħt il-ġilda, b'angolu ta' 45-90°.
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 ikkurati 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 Hospira f'pazjenti li qabel kienu kkurati għal Amilojdożi (AL) tal-katina ħafifa.
English: Based on Log rank test stratified with IPI risk and stage of disease.
Maltese: Abbażi tat-test log-rank stratifikat bir-riskju IPI u l-istadju tal-marda.
English: Renal impairment
Maltese: Reazzjonjiet epatiċi
English: The full EPAR for Vedrop can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vedrop contains the active substance tocofersolan.
Maltese: Vedrop fih is-sustanza attiva tocofersolan.
English: The recommended daily dose is 0.34 ml per kilogram body weight.
Maltese: Id-doża rakkomandata ta' kuljum hija ta' 0.34 ml għal kull kilogramma tal-piż tal-ġisem.
English: Other information about Vedrop
Maltese: Informazzjoni oħra dwar Vedrop
English: Vedrop tocofersolan
Maltese: Sommarju tal-EPAR għall-pubbliku tocofersolan
English: The active substance in Vedrop, tocofersolan, is vitamin E that has been made water soluble by attaching it to a chemical called polyethylene glycol.
Maltese: Is-sustanza attiva f'Vedrop, tocofersolan, hija vitamina E li saret solubbli fl-ilma billi tweħħlet ma' kimika li tissejjaħ polyethylene glycol.
English: Why is Vedrop approved?
Maltese: Għaliex ġie approvat Vedrop?
English: It has a number of actions in the body, including protecting the nervous system from damage.
Maltese: Din għandha numru ta' azzjonijiet fil-ġisem, inkluż li tipproteġi s-sistema nervuża mill-ħsara.
English: Vedrop is a medicine used to treat or prevent vitamin E deficiency (low vitamin E levels).
Maltese: Vedrop huwa mediċina li tintuża biex tikkura jew tipprevjeni defiċjenza tal-vitamina E (livelli baxxi talvitamina E).
English: What are the risks associated with Vedrop?
Maltese: X'inhuma r-riskji assoċjati ma' Vedrop?
English: To support the use of Vedrop, the company presented information from the scientific literature, including the results of three studies in a total of 92 children and adolescents with chronic cholestasis who were given tocofersolan for about two years.
Maltese: Sabiex tappoġġja l-użu ta' Vedrop, il-kumpanija ppreżentat informazzjoni mil-letteratura xjentifika, inkluż ir-riżultati ta' tliet studji f'total ta' 92 tifel u tifla u adolexxent b'kolestażi kronika li ngħataw tocofersolan għal madwar sentejn.
English: What information is still awaited for Vedrop?
Maltese: Liema informazzjoni għadha mistennija għal Vedrop?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vedrop on 24 July 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vedrop fl-24 ta' Lulju 2009.
English: This is a summary of the European public assessment report (EPAR) for Vedrop.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta