FrancophonIA/ELRC3.0 huggingface dataset:
English: Pancreatitis acute, Peritonitis*, Tongue oedema*, Ascites, Oesophagitis, Cheilitis, Faecal incontinence, Anal sphincter atony, Faecaloma*, Gastrointestinal ulceration and perforation*, Gingival hypertrophy, Megacolon, Rectal discharge, Oropharyngeal blistering*, Lip pain, Periodontitis, Anal fissure, Change of bowel habit, Proctalgia, Abnormal faeces
Maltese: Pankreatite akuta, Peritonite*, Edema tal-ilsien*, Axxite, Kajlite, Esofagite, Kejlite, Inkontinenza tal-ippurgar, Atonija fl-isfinkter anali, Fekaloma*, Ulċerazzjoni u perforazzjoni gastrointestinali*, Ipertrofija ġenġivali, Megakolon, Tnixxija rektali, Infafet Orofarinġeali*, Uġigħ fix-xofftejn,
English: Up to 8 cycles of this combination therapy can be administered as long as patients have not progressed and tolerate treatment.
Maltese: Sa 8 ċikli ta' din it-terapija ta' kombinazzjoni jistgħu jiġu amministrati kemm-il darba l-kundizzjoni fil-pazjent ma progressatx u t-trattament jiġi ttollerat.
English: OR; 95% CI; P valuea
Maltese: VDDx jew; 95% CI; valur P
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Maltese: It-trattament b'bortezomib b'mod komuni ħafna tiġi assoċjata ma' tossiċitajiet ematoloġiċi (tromboċitopenija, newtropenija u anemija).
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Maltese: Emorraġija gastrointestinali u intraċerebrali, ġiet irrappurtata b'rabta mat-trattament b'bortezomib.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001)
Maltese: Trattament ta' kombinazzjoni ta' bortezomib ma' pegylated liposomal doxorubicin (studju DOXILMMY-3001)
English: Very Common Musculoskeletal pain* Common
Maltese: Komuni ħafna Uġigħ muskoloskeletriku*
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzDx group.
Maltese: It-tul medjan ta' trattament kien ta' 13-il ġimgħa għallgrupp VDDx u 11-il ġimgħa għall-grupp VcDx.
English: The duration of overall response was 21.4 months longer in the BzR-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' BzR-CAP (medjan 36.5 xhur versus 15.1 xhur fil-grupp ta' R-CHOP).
English: Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Maltese: Mhux komuni Disturb mentali*, Alluċinazzjoni*, Disturb psikotiku*, Konfużjoni*, Irrikwitezza
English: Intravenous use.
Maltese: Anonymus u.
English: Patients with moderate or severe hepatic impairment should be started on Bortezomib Accord 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/m2 or further dose reduction to 0.5 mg/m2 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 Accord bid-doża mnaqqsa ta' 0.7 mg/m2 f'kull injezzjoni waqt l-ewwel ċiklu ta' trattament, u sussegwentement tista' tiġi kkunsidrata żieda sa doża ta' 1.0 mg/m2 jew aktar tnaqqis sa doża ta' 0.5 mg/m2 fuq bażi tat-tollerabiltà tal-pazjent (ara Tabella 6 u sezzjonijiet 4.4 u 5.2).
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, Ipokloremja*, Ipovolemja, Iperkloremja*, Iperfosfatemja*, Disturb metaboliku, Nuqqas fil-kompless ta' vitamina B, Nuqqas ta' vitamina B12, Gotta, Żieda fl-aptit,
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the Bortezomib Accord 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 mill-ħalq fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' 28 jum ta' Bortezomib Accord u thalidomide għandu 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 mit-tieni ċiklu 'l quddiem.
English: 4.63 (2.61, 8.22); < 0.001a a
Maltese: 1.34 (0.87, 2.05); 0.179b
English: 8 cycles.
Maltese: Tabella 8 taħt.
English: The following medicinal products are administered on day 1 of each bortezomib 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 fil-jum 1 ta' kull waħda miċ-ċikli ta' trattament ta' 3 ġimgħat ta' bortezomib bħala infużjonijiet fil-vina: rituximab b'doża ta' 375 mg/m2, cyclophosphamide b'doża ta' 750 mg/m2 u doxorubicin b'doża ta' 50 mg/m2.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib Accord treatment cycle.
Maltese: Dexamethasone għandu jiġi amministrat mill-ħalq f'doża ta' 20 mg fil-jiem 1, 2, 4, 5, 8, 9, 11, u 12 tat-trattament taċ-ċiklu ta' Bortezomib Accord.
English: VDDx=vincristine, doxorubicin, dexamethasone; BzDx= bortezomib, dexamethasone; TDx=thalidomide, dexamethasone; BzTDx= bortezomib, thalidomide, dexamethasone; PN=peripheral neuropathy Note: Peripheral neuropathy included the preferred terms: neuropathy peripheral, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.
Maltese: TDx=thalidomide, dexamethasone; BzTDx= bortezomib, thalidomide, dexamethasone; PN= newropatija periferali
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Maltese: inkluż, imma mhux limitat, għall-bdil tal-proteini regolatorji, li jikkontrollaw iċ-ċiklu tal-progressjoni taċ-ċellula u l-attivazzjoni tal-fattur nukleari kappa B (NF-kB).
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Maltese: Newropatija periferali ta' Grad ≥3 seħħ f'6 % tal-pazjenti fil-grupp li ngħata t-trattament taħt il-ġilda meta mqabbel ma' 16 % fil-grupp li ngħata t-trattament ġol-vina (p=0.0264).
English: How to store Bortezomib Accord Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: When Bortezomib Accord is given together with dexamethasone, you will receive Bortezomib Accord intravenously or subcutaneously as a 21-day treatment cycle and dexamethasone 20 mg is given orally on days 1, 2, 4, 5, 8, 9, 11, and 12, of the Bortezomib Accord, 21-day treatment cycle.
Maltese: Meta Bortezomib Accord jingħata flimkien ma' dexamethasone, inti ser tirċievi Bortezomib Accord ġol-vina jew taħt il-ġilda f'ċiklu ta' trattament ta' 21 jum u dexamethasone 20 mg jingħata mill-ħalq fil-jiem 1, 2, 4, 5, 8, 9 11 u 12 taċ-ċiklu ta' trattament ta' 21 jum ta' Bortezomib Accord.
English: Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Maltese: Insuffiċjenza kardijaka (inkluż ventrikulari tax-xellug u tallemin)*, Iskemija mijokardijaka, Funzjoni ħażina tal ventrikulu*
English: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to bortezomib were in the range 65-74 years and ≥ 75 years of age, respectively.
Maltese: 4% tal pazjenti esposti għal bortezomib kienu fil-firxa ta' età bejn 65-74 sena u ≥ 75 sena, rispettivament.
English: In study IFM-2005-01 bortezomib combined with dexamethasone [BzDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Maltese: Fl-istudju IFM-2005-01 bortezomib flimkien ma' dexamethasone [BzDx, n=240] ġie mqabbel ma' vincristine-doxorubicin-dexamethasone [VDDx, n=242].
English: Severity of neuropathy
Maltese: Severità tan-newropatija
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: L-inċidenza 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-vina.
English: Then, Bortezomib Accord may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from 1 mg/m2 to 0.7 mg/m2).
Maltese: Imbagħad Bortezomib Accord jista' jerġa' jinbeda bi tnaqqis ta' livell 1 tad-doża (minn 1.3 mg/m2 għal 1 mg/m2, jew minn 1 mg/m2 għal 0.7 mg/m2).
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy
Maltese: Inċidenza ta' newropatija periferali fl-istudju LYM-3002 skont it-tossiċità u l-waqfien tat trattament minħabba newropatija periferali
English: Bortezomib Accord 1 mg powder for solution for injection Each carton of Bortezomib Accord 1 mg powder for solution for injection contains a glass 6 ml vial with a grey chlorobutyl rubber stopper and aluminium seal, with a blue cap, containing 1 mg of bortezomib.
Maltese: Bortezomib Accord 1 mg trab għal soluzzjoni għall-injezzjoni Kull kartuna ta' Bortezomib Accord 1 mg trab għal soluzzjoni għall-injezzjoni fiha kunjett tal-ħġieġ ta' 6 ml b'tapp griż tal-gomma chlorobutyl u siġill tal-aluminju, b'tapp blu, li fih 1 mg ta' bortezomib.
English: Bortezomib Accord 3.5 mg powder for solution for injection Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Accord 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 3.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: Combination therapy with pegylated liposomal doxorubicin
Maltese: ANNESS I SOMMARJU TAL-KARATTERISTIĊI
English: Cerebrovascular accident#, Deep vein thrombosis*, Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
Maltese: Mhux komuni Aċċident ċerebrovaskulari #, Trombożi profonda tal-vini*, Emorraġija*, Tromboflebite (anke superfiċjali), Kollass ċirkolatorju (li jinkludi xokk ipovolemiku), Flebite, Fwawar, Ematoma (li jinkludi perirenal)*, Ċirkolazzjoni periferali batuta*, Vaskulite, Iperemija (li tinkludi okulari)
English: Very Common Pneumonia* Common
Maltese: Komuni ħafna Pulmonite*
English: Rare side effects (may affect up to 1 in 1,000 people)
Maltese: Effetti sekondarji rari (li jistgħu jaffettwaw sa persuna 1 f'1,000)
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-bortezomib treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP) and 0.4% (n=1) of patients receiving bortezomib in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (BzR-CAP).
Maltese: Infezzjoni b'HBV b'riżultati fatali seħħet f'0.8% (n=2) tal-pazjenti fil-grupp li ma kienx ittrattat b'bortezomib (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone;
English: • Diarrhoea
Maltese: • Diżidratazzjoni
English: Incidence of death from “Progressive disease” was 18% in the subcutaneous group and 9% in the intravenous group.
Maltese: Mewt minn “Mard progressiv” kien ta' 18 %
English: 1.1 Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the Bortezomib Accord 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 1.0 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab Bortezomib Accord billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: A drug-drug interaction study assessing the effect of melphalan-prednisone on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC increase of 17% based on data from 21 patients.
Maltese: Studju dwar interazzjoni bejn mediċini li evalwa l-effett ta' melphalan-prednisone fuq ilfarmakokinetiċi ta' bortezomib (injettat ġol-vina) wera żieda medja fl-AUC ta' 17 % abbażi ta' dejta minn 21 pazjent.
English: *RR (Post-transplant)
Maltese: *RR (Wara t-trapjant)
English: Concomitant medicinal products
Maltese: EFFETTIV TAL-PRODOTT MEDIĊINALI
English: In vitro studies indicate that bortezomib is a weak inhibitor of the cytochrome P450 (CYP) isozymes 1A2, 2C9, 2C19, 2D6 and 3A4.
Maltese: P450 ċitokromiċi, 3A4, 2C19, u 1A2.
English: In the Phase III study patients who received bortezomib subcutaneously compared to intravenous administration had 13% lower overall incidence of treatment emergent adverse reactions that were Grade 3 or higher in toxicity, and a 5% lower incidence of discontinuation of bortezomib.
Maltese: III, pazjenti li ħadu bortezomib taħt il-ġilda meta paragunati ma' dawk li ħaduħ ġolvina kellhom inċidenza globali ta' 13% inqas ta' reazzjonijiet avversi emerġenti li kienu ta' grad 3 jew ogħla fit-tossiċità, u inċidenza inqas ta' 5% ta' waqfien b'bortezomib.
English: Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BzR-CAP)
Maltese: BzR-CAP=Bortezomib, rituximab, cyclophosphamide, doxorubicin, u prednisone;
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: Patients in the BzDx group received four 21 day cycles, each consisting of bortezomib (1.3 mg/m2 administered intravenously twice weekly on days 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: 21 jum, kull wieħed minnhom jikkonsisti minn bortezomib (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
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to bortezomib.
Maltese: L-effetti mhux mixtieqa f'Tabella 7 tqiesu mill-investigaturi li kienu possibbilment jew probabbilment ikkawżati minn bortezomib.
English: 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: Raxx*, Ħakk*, Eritema, Ġilda xotta Mhux komuni Eritema multiforme, Urtikarja, Dermatosi newtrofilika akuta bid-deni, Infafet tossiċi fuq il-ġilda, Nekrosi epidermali tossika#, Sindromu ta' Stevens-Johnson#, Dermatite*, Disturb fix-xagħar*, Petekije, Eċċimosi, Ġerħa fuq il-ġilda, Purpura, Għoqda fil-ġilda*, Psorijasi, Iperidrosi, Għorieq bil-lejl,
English: Dex n=336a Bz n=132a
Maltese: Dex n=336a
English: Bz= Bortezomib Accord; Dx=dexamethasone; T=thalidomide a Thalidomide dose is increased to 100 mg from week 3 of Cycle 1 only if 50 mg is tolerated and to 200 mg from cycle 2
Maltese: Bz= Bortezomib Accord; Dx=dexamethasone; T=thalidomide a Id-doża ta' thalidomide tiżdied għal 100 mg minn ġimgħa 3 ta' Ċiklu 1 biss kemm-il darba d-doża ta' 50 mg tkun ittolerata u għal 200 mg minn ċiklu 2 'il quddiem jekk id-doża ta' 100 mg hija ttolerata.
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 il pazjenti 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,
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: Apnea, Pnewmotoraks, Atelektasi, Pressjoni għolja fl-arterji pulmonari, Emoptisi, Iperventilazzjoni, Ortopnea, Pnewmonite, Alkalosi respiratorja, Takipnea, Fibrosi pulmonari, Disturb bronkjali*, Ipokapnija*, Mard tal-pulmun interstizzjali, Infiltrazzjoni tal-pulmun, Griżmejn issikkati,
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Maltese: Il-pazjenti rċivew medjan ta' 6 ċikli fiż-żewġ fergħat ta' trattament b'14% tal-individwi fil-grupp ta' BzR-CAP u 17% tal-pazjenti fil-grupp ta' R-CHOP jirċievu 2 ċikli addizzjonali.
English: Posterior reversible encephalopathy syndrome (PRES) There have been reports of PRES in patients receiving bortezomib.
Maltese: Sindromu ta' enċefalopatija posterjuri riversibbli (PRES - Posterior Reversible Encephalopathy Syndrome)
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Maltese: Billi bortezomib huwa sustanza ċitotossika u jista' joqtol malajr iċ-ċelluli malinni tal-plażma u ċ ċelluli ta' MCL, jista' jkun hemm komplikazzjonijiet tas-sindromu tal-lisi tat-tumur.
English: • In cycles 1 to 4, Bortezomib Accord is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29
Maltese: Fiċ-ċikli minn 1 sa 4, Bortezomib Accord jingħata darbtejn fil-ġimgħa fil-jiem 1, 4, 8, 11, 22,
English: Events (deaths) n (%) Mediana
Maltese: Każijiet (imwiet) n (%)
English: In Cycles 5-9, Bortezomib Accord is administered once weekly on days 1, 8, 22 and 29.
Maltese: Fiċ-Ċikli 5-9, Bortezomib Accord jingħata darba fil-ġimgħa fil-jiem 1, 8, 22 u 29.
English: Table 1: Recommended* posology modifications for Bortezomib Accord -related neuropathy
Maltese: Tabella 1: Bidliet rakkomandati* fil-pożoloġija għal newropatija marbuta ma' Bortezomib Accord
English: Bortezomib Accord 3.5 mg powder for solution for injection bortezomib
Maltese: Bortezomib Accord 3.5 mg trab għal soluzzjoni għall-injezzjoni bortezomib
English: Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Komuni ħafna Newropatiji*, Newropatija sensorjali periferika, Disestesija*,
English: Dyspnoea*, Cough*, Hiccups
Maltese: fuq/taħt*, Sogħla*
English: • If platelet counts ≤ 30 x 109/l or ANC ≤ 0.75 x 109/l on a Bortezomib Accord dosing day (other than day 1)
Maltese: • Jekk l-għadd tal-plejtlits ikun ≤30 × 109/l jew l-ANC ikun ≤0.75 x 109/l fil-jum meta jkun jmiss doża ta' Bortezomib Accord
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, bit-tikketta tingħaraf (IFM2005-01, MMY-3010) saru biex juru s-sigurtà u l-effikaċja ta' bortezomib f'kombinazzjonijiet doppji u tripliċi ma' sustanzi kimoterapewtiċi oħra, bħala terapija ta' induzzjoni qabel it-trapjant ta' ċelluli steminali f'pazjenti b'majeloma multipla li ma ġietx trattata qabel.
English: From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the reconstituted solution should be used immediately after preparation.
Maltese: Minn perspettiva mikrobijoloġika, sakemm il-metodu ta' ftuħ/rikostituzzjoni/dilwizzjoni ma jipprekludix ir-riskju ta' kontaminazzjoni mikrobjali, is-soluzzjoni rikostitwita għandha tintuża minnufih wara l-preparazzjoni.
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Maltese: Tossiċità gastrointestinali Tossiċità gastro-intestinali, li tinkludi nawsja, dijarea, rimettar u stitikezza huma komuni ħafna waqt trattament b'bortezomib.
English: 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: Mhux komuni Emboliżmu pulmonarju, Effużjoni plewrali, Edema pulmonari (li tista' tkun akuta), Bronkospażmu, Emorraġija alveolari pulmonari#, Mard pulmonary kroniku u ostruttiv
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: CYP3A4, fuq il-farmakokinetiċi ta' bortezomib (injettat ġol-vina), wera żieda medja ta' 35 % fil-AUC
English: Gastrointestinal haemorrhage (inc mucosal)*, Abdominal distension, Dyspepsia, Oropharyngeal pain*, Gastritis*, Oral ulceration*, Abdominal discomfort, Dysphagia, Gastrointestinal inflammation*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*
Maltese: Emorraġija gastrointestinali (inkluż mill-mukuża)*, Nefħa fladdome, Dispepsja, Uġigħ orofarinġali*, Gastrite*, Ulċeri filħalq*, Skumdità fl-addome, Disfaġja, Infjammazzjoni gastrointestinali*, Uġigħ fl-addome (inkluż uġigħ gastrointestinali u tal-milsa)*, Disturb orali*
English: An odds ratio (OR) > 1 indicates an advantage for BzR-CAP. f Include all CR+CRu, by IRC, bone marrow and LDH.
Maltese: Proporzjon ta' probabbiltà (OR) > 1 jindika vantaġġ għal BzR-CAP.
English: ORe (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Maltese: 749; 2.722) valur pg=0.275
English: disease.
Maltese: trattament.
English: Peripheral neuropathy in combination regimens
Maltese: Newropatija periferali fi programmi ta' trattament ta' kombinazzjoni
English: 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 (BzR-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: 242 pazjent ittrattati b'rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP] kien relattivament konsistenti ma' dak osservat f'pazjenti b'majeloma multipla bid differenzi prinċipali deskritti taħt.
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: 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: Antiviral prophylaxis is recommended in patients being treated with bortezomib.
Maltese: Profilassi antivirali hija rrakkomandata f'pazjenti li qed jiġu ttrattati b'bortezomib.