FrancophonIA/ELRC3.0 huggingface dataset:
English: • Muscle pain, bone pain
Maltese: • Spażmi fil-muskoli
English: Common Dyspnoea*, Cough*, Hiccups Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Maltese: Mhux komuni Sindrome ta' għeja respiratorja akuta, Emboliżmu fil-pulmun, Pnewmonite, Pressjoni għolja fil-pulmuni, Edima fil-pulmun (inkluż akuta)
English: The median duration of treatment was 24.0 weeks and the median number of treatment cycles received was 6.0, and was consistent across treatment groups.
Maltese: It-tul ta' żmien medjan ta' trattament kien ta' 24 ġimgħa u n-numru medjan ta' ċikli ta' trattament li ngħataw kien ta' 6.0, u dan kien konsistenti fil-gruppi kollha ta' trattament.
English: • Diarrhoea: if this happens, it is important that you drink more water than usual.
Maltese: • Dijarea; jekk jiġri hekk, importanti li tixrob iktar ilma mis-soltu.
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache* Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Maltese: Mhux komuni Rogħda, Newropatija sensomotorili periferali, Diskinesja*, Disturbi fil-bilanċ u fil-koordinazzjoni ċerebellari*, Telf ta' memorja (li jeskludi dimenzja)*, Enċefalopatija*, Sindromu enċefalopatiku riversibbli fuq wara
English: Progression Free Survival, months (95% CI)
Maltese: Sopravivenza Mingħajr Progressjoni, xhur (95% CI)
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously as a 21-day treatment cycle and dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 21-day treatment cycle.
Maltese: Meta VELCADE jingħata flimkien ma' dexamethasone, inti ser tirċievi VELCADE ġol-vina bħala ċiklu tat-trattament ta' 21 jum u dexamethasone 40 mg jingħata mill-ħalq fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' 21 jum ta' VELCADE.
English: 1.3 mg/m 2, respectively, and ranged from 15 to 32 l/h and 18 to 32 l/h following subsequent doses for doses of 1.0 mg/m 2 and 1.3 mg/m 2, respectively.
Maltese: Tneħħijiet totali medji mill-ġisem kienu 102 u 112 l/siegħa wara lewwel doża għad-dożi ta' 1.0 mg/m 2 u 1.3 mg/m 2, rispettivament, u fuq medda minn 15 sa 32 l/siegħa u 18 sa 32 l/siegħa għad-dożi sussegwenti ta' 1.0 mg/m 2 u 1.3 mg/m 2, rispettivament.
English: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Maltese: Wara li jiġi rrikostitwit, 1 ml tas-soluzzjoni għall-injezzjoni taħt il-ġilda jkun fih 2.5 mg 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: 2-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 mill-livelli 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' VELCADE tal-istudju.
English: Clinical efficacy with subcutaneous administration of VELCADE in patients with relapsed/refractory multiple myeloma
Maltese: fis-sistema immuni Mhux komuni Reazzjoni anafilattika Disturbi fil-metaboliżmu u n-nutrizzjoni
English: In Cycles 1-4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Maltese: Fiċ-Ċikli 1-4, VELCADE jingħata darbtejn filġimgħa fil-jiem 1, 4, 8, 11, 22, 25, 29 u 32. Fiċ-Ċikli 5-9, VELCADE jingħata darba fil-ġimgħa filjiem 1, 8, 22 u 29.
English: Macrophage activation
Maltese: Attivazzjoni ta' makrofaġi
English: • If platelet counts ≤ 30 x 10
Maltese: • Jekk l-għadd tal-plejtlits ikun 30  10
English: Intrathecal administration has resulted in death.
Maltese: Tinjettax minn rotot oħra.
English: • Muscle spasms
Maltese: • Disturbi marbuta mas-sider
English: The mean elimination half-life (t1/2) of bortezomib upon multiple dosing ranged from 40-193 hours.
Maltese: L/m2, u l-half-life ta' eliminazzjoni kienet 100 (44%) siegħa.
English: • Cysts in the lining of joints (synovial cysts)
Maltese: • Ċisti fir-rita tal-ġogi (ċisti sinovjali)
English: Each 10 ml vial of VELCADE must be carefully reconstituted with 3.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Kull kunjett ta' 10 ml ta' VELCADE irid ikun rikostitwit b'attenzjoni bi 3.5 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
English: • VELCADE 3.5 mg can be administered both intravenously and subcutaneously while VELCADE 1 mg can be administered only intravenously
Maltese: • Velcade 3.5 mg jista' jingħata kemm ġol-vina u anke taħt il-ġilda filwaqt li Velcade 1 mg jista' jingħata biss ġol-vina
English: In addition, the incidence of Grade 3 or higher peripheral neuropathies was 10% lower, and the discontinuation rate due to peripheral neuropathies 8% lower for the subcutaneous group as compared to the intravenous group.
Maltese: Barra minn hekk, l-inċidenza ta' newropatiji periferali ta' grupp 3 jew ogħla kien 10 % inqas, u r-rata ta' waqfien minħabba newropatiji periferali kien ta' 8 % inqas għall-grupp ta' taħt il-ġilda meta mqabbel mal-grupp ġol-vina.
English: • Infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis
Maltese: • Infezzjonijiet li jinkludu infezzjonijiet fl-apparat awrinarju, influwenza, infezzjonijiet bil-virus ta'herpes, infezzjonijiet fil-widnejn u ċellulite
English: • Tiredness, feeling weak • Fever
Maltese: • Żieda fl-aptit
English: Serious adverse reactions uncommonly reported during treatment with VELCADE include cardiac failure, tumour lysis syndrome, pulmonary hypertension, posterior reversible encephalopathy syndrome, acute diffuse infiltrative pulmonary disorders and rarely autonomic neuropathy.
Maltese: Reazzjonijiet avversi serji rrappurtati b'mod mhux komuni waqt trattament b'VELCADE jinkludu insuffiċjenza tal-qalb, sindromu ta' lisi tat-tumur, pressjoni għolja fil-pulmun, sindromu ta' enċefalopatija riversibbli fuq in-naħa ta' wara, disturbi pulmonari akuti diffużi u infiltrattivi diffużi, u b'mod rari newropatija awtonomika.
English: • Shivering
Maltese: • Fwawar
English: Patients should be closely monitored when given bortezomib in combination with potent CYP3A4-inhibitors.
Maltese: Għalhekk il-pazjenti għandhom jiġu mmonitorjati bir-reqqa meta jingħataw bortezomib flimkien ma' inibituri potenti CYP3A4
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: 67.3% (inkluża rata ta' 28.6 % għal CR) hekk kif imkejla mir-rispons ematoloġiku (proteina-M) kienet irrappurtata.
English: • Thirst
Maltese: • Tertir
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: A biological plausibility supports the association between bortezomib and chalazion/blepharitis; theoretically, bortezomib-related myelosuppression may facilitate viral infections such as herpes zoster thereby promoting chalazia.
Maltese: Raġuni bijoloġika ssostni l-assoċjazzjoni bejn bortezomib u keleżjon/blefarite; teoretikament, majelosoppressjoni marbuta ma' bortezomib tista' tiffaċilita infezzjonijiet virali bħal erpte zoster u b'hekk tippromwovi keleżja.
English: For additional information concerning pegylated liposomal doxorubicin, see the corresponding Summary of Product Characteristics.
Maltese: Għal informazzjoni addizzjonali rigward pegylated liposomal doxorubicin, ara s-Sommarju tal-Karatteristiċi tal-Prodott korrispondenti.
English: or ANC < 750 cells/μL on a VELCADE dosing day (other than Day 1 of each cycle)
Maltese: jew l-ANC ikun < 750 ċellula/μL f'ġurnata ta' għoti ta' doża ta' VELCADE (ħlief fil-Jum 1 ta' kull ċiklu)
English: VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation.
Maltese: VELCADE flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone huwa indikat għattrattament ta' pazjenti adulti b'limfoma taċ-ċellula mantle li qatt ma kienet ittrattata qabel li mhumiex addattati għal trapjant taċ-ċellula steminali ematopojetika.
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 (anke f'daqqa), Falliment ta' diversi organi, Emorraġija fis-sit tal-injezzjoni*, Ftuq*, Flebite fis-sit tal-injezzjoni*, Fejqan indebolit, Infjammazzjoni*, Flebite fis-sit ta' injezzjoni, Tenerezza, Ulċera, Irritabilità, Uġigħ tas-sider mhux tal-qalb, Uġigħ fis-sit tal-katiter, Sensazzjoni ta' korp barrani
English: Common Dysacusis (inc tinnitus)* Uncommon Vertigo*, Hearing impaired (up to and inc deafness) Cardiac disorders Common Cardiac fibrillation (inc atrial), Arrhythmia*, Cardiac failure (inc left and right ventricular)*, Myocardial ischaemia, Ventricular dysfunction*
Maltese: Fibrillazzjoni kardijaka (inkluż tal-atriju), Arritmija*, Insuffiċjenza kardijaka (inkluż ventrikulari tax-xellug u tallemin)*, Iskemija mijokardijaka, Funzjoni ħażina talventrikulu*
English: The following medicinal products are given on day 1 of each VELCADE 21-day treatment cycle as intravenous infusions:
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jum 1 ta' kull wieħed miċ-ċiklu ta' trattament ta' 21 jum ta' VELCADE bħala infużjonijiet fil-vina:
English: • Feeling dizzy
Maltese: • Effużjoni tal-ġog
English: VELCADE therapy should be withheld when the platelet count is < 25,000/l or, in the case of combination with melphalan and prednisone, when the platelet count is ≤ 30,000/l (see section 4.2).
Maltese: Terapija b'VELCADE għandha titwaqqaf meta l-għadd ta' plejtlits ikun < 25,000/l jew, fil-każ ta' għoti flimkien ma' melphalan u prednisone, meta l-għadd tal-plejtlits ikun ta' ≤ 30,000/l (ara sezzjoni 4.2).
English: The incidence of all grade peripheral neuropathy with VELCADE administered intravenously was lower in the historical studies with VELCADE administered intravenously than in study MMY-3021.
Maltese: L-inċidenza ta' newropatija periferali ta' kull grad b'VELCADE li ngħata ġol-vina kien inqas fl-istudji storiċi b'VELCADE mogħti ġol-vina milli fl-istudju MMY-3021.
English: The safety and efficacy of VELCADE in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Maltese: Is-sigurtà u l-effikaċja ta' VELCADE fit-tfal li għadhom m'għalqux 18-il sena għadhom ma ġewx determinati s'issa (ara sezzjonijiet 5.1 u 5.2).
English: Subcutaneous reconstitution: After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.
Maltese: Wara r-rikostituzzjoni, 1 ml ta' soluzzjoni għal injezzjoni ġol-vina fih 2.5 mg bortezomib
English: Patients who experience bortezomib-related neuropathic pain and/or peripheral neuropathy are to be managed as presented in Table 1 (see section 4.4).
Maltese: Pazjenti li jkollhom uġigħ newropatiku u/jew newropatija periferali relatati ma' bortezomib għandhom ikunu ttrattati skont Tabella 1 (ara sezzjoni 4.4).
English: An effective re-induction multi-agent chemotherapy regimen was administered in 3 blocks.
Maltese: Skeda effettiva ta' kimoterapija ta' induzzjoni mill-ġdid b'ħafna sustanzi ngħatat fi 3 blokok.
English: Clinical efficacy in relapsed or refractory multiple myeloma The safety and efficacy of VELCADE (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: VELCADE 3.5 mg powder for solution for injection
Maltese: VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni
English: • If local injection site reactions occur following VELCADE injection subcutaneously, either a less concentrated VELCADE solution (1 mg/ml instead of 2.5 mg/ml) may be administered subcutaneously or a switch to intravenous injection is recommended.
Maltese: • Jekk reazzjonijiet fis-sit lokali tal-injezzjoni jseħħu wara injezzjoni taħt il-ġilda b'VELCADE, huwa rakkomandat li jew tingħata soluzzjoni għal taħt il-ġilda inqas konċentrata ta' VELCADE (1 mg/ml minflok ta' 2.5 mg/ml) jew inkella li taqleb għall-injezzjoni ġol-vina.
English: Proteasomes play an important role in controlling cell function and growth.
Maltese: Il-proteasomes għandhom rwol important fil-kontroll tal-funzjoni u t-tkabbir taċ-ċellula.
English: The primary efficacy endpoint of the study was post-induction response rate (CR+nCR).
Maltese: Il-punt aħħari ta' effikaċja primarja tal-istudju kienet ir-rata ta' rispons (CR+nCR) ta' wara l-induzzjoni.
English: For additional information concerning dexamethasone, see the corresponding Summary of Product Characteristics.
Maltese: Għal informazzjoni addizzjonali rigward dexamethasone, ara s-Sommarju tal-Karatteristiċi tal-Prodott korrispondenti.
English: • Bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina
Maltese: • Artrite, li tinkludi infjammazzjoni tal-ġogi fis-swaba' tal-idejn, tas-saqajn u x-xedaq
English: The major metabolic pathway is deboronation to form two deboronated metabolites that subsequently undergo hydroxylation to several metabolites.
Maltese: Il-mogħdija metabolika maġġuri hija d-deboronazzjoni biex jiġu ffurmati żewġ metaboliti deboronizzati li wara jgħaddu minn proċess ta' idrossilazzjoni għal għadd ta' metaboliti.
English: Bilirubin level
Maltese: Livell tal-bilirubin
English: > 1 prior line of therapy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: In patients, overdose more than twice the recommended dose has been associated with the acute onset of symptomatic hypotension and thrombocytopenia with fatal outcomes.
Maltese: Fil-pazjenti, doża eċċessiva iktar minn darbtejn mid-doża rrakkomandata ġiet marbuta ma' episodju akut ta' ipotensjoni sintomatika u tromboċitopenija b'riżultati fatali.
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 VELCADE in patients with previously treated light-chain (AL) Amyloidosis.
Maltese: Pazjenti li qabel kienu ttrattati għal Amilojdożi (AL) tal-katina ħafifa Sar studju open label u mhux każwali ta' Fażi I/II sabiex jiġu stabbiliti s-sigurtà u l-effikaċja ta' VELCADE f'pazjenti li qabel kienu ttrattati għal Amilojdożi (AL) tal-katina ħafifa.
English: Renal impairment*
Maltese: Indeboliment tal-kliewi*
English: Thalidomide is contraindicated during pregnancy and in women of childbearing potential unless all the conditions of the thalidomide pregnancy prevention programme are met.
Maltese: Thalidomide huwa kontraindikat fit-tqala u f'nisa li jista' jkollhom ittfal għajr meta l-kundizzjonijiet tal-programm ta' prevenzjoni ta' tqala ta' thalidomide jkunu sodisfatti.
English: • Changes in or abnormal bowel function
Maltese: • Bidliet fi jew funzjoni tal-imsaren mhux normali
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Constipation Common
Maltese: Komuni ħafna Newropatija tas-sensazzjoni periferali, Disastesija*, Nevralġija* Komuni
English: In studies in patients with relapsed multiple myeloma treated with VELCADE and in patients with previously untreated MCL treated with VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP), one of the most common haematologic toxicity was transient thrombocytopenia.
Maltese: Fi studji f'pazjenti b'majeloma multipla li rkadiet li ġiet ittrattata b'VELCADE u f'pazjenti b'MCL li qatt ma kienet ittrattata qabel li ġiet ittrattata b'VELCADE flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (VcR-CAP), waħda mill-iktar tossiċitajiet ematoloġiċi komuni kienet tromboċitopenija temporanja.
English: 4.2 mo
Maltese: 4.2 xahar
English: • Mouth ulcers
Maltese: • Vista mċajpra
English: Grade 4 (life-threatening consequences; urgent intervention indicated) and/or severe autonomic neuropathy
Maltese: Grad 4 (konsegwenzi li jistgħu jkunu ta' thedida għall-ħajja; intervent urġenti indikat) u/jew newropatija awtonomika
English: Consider dose escalation to 1.0 mg/m2 or further dose reduction to 0.5 mg/m2 in subsequent cycles based on patient tolerability.
Maltese: Ikkunsidra żieda sa doża ta' 1.0 mg/m2 jew aktar tnaqqis sa doża ta' 0.5 mg/m2 f'ċikli sussegwenti fuq bażi tat-tolleranza tal-pazjent.
English: 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 onwards if 100 mg is tolerated.
Maltese: 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: • Death
Maltese: • Deni
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 VELCADE 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 VELCADE għal episodju ġdid ta' lewkimja akuta majloġenuża mietu minħabba ARDS fil-bidu tat-terapija, u l-istudju twaqqaf.
English: VELCADE 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: VELCADE jintuża għat-trattament ta' limfoma taċ-ċellula ta' mantle (tip ta' kanċer li jaffettwa lglandoli limfatiċi) f'pazjenti li għandhom 18-il sena u aktar b'kombinazzjoni mal-mediċini rituximab, cyclophosphamide, doxorubicin u prednisone, għall-pazjenti li l-marda tagħhom qatt ma kienet ittrattata qabel u li trapjant taċ-ċelluli steminali tad-demm ma jkunx tajjeb għalihom.
English: Uncommon Dysacusis (inc tinnitus)*,Hearing impaired (up to and inc deafness), Ear discomfort*
Maltese: Disakusi (inkluż tinnitus)* Mhux komuni Vertiġini*, Indeboliment fis-smigħ (sa anke truxija)
English: • Inflammation of the pancreas, obstruction of the bile duct
Maltese: • Infezzjonijiet respiratorji, bronkite, sogħla bil-bili, mard jixbah l-influwenza
English: Combination therapy with pegylated liposomal doxorubicin VELCADE 1 mg powder for solution for injection is administered via intravenous 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 b'pegylated liposomal doxorubicin VELCADE 1 mg trab għal soluzzjoni għall-injezzjoni jingħata bħala injezzjoni ġol-vina fid-doża rakkomandata ta' 1.3 mg/m erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8 u 11 f'ċiklu ta' trattament ta' 21 jum.
English: Combination therapy with pegylated liposomal doxorubicin VELCADE 3.5 mg powder for solution for injection 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 b'pegylated liposomal doxorubicin VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni jingħata bħala injezzjoni ġol-vina jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8 u 11 f'ċiklu ta' trattament ta' 21 jum.
English: In study IFM-2005-01 VELCADE combined with dexamethasone [VcDx, n=240] was compared to vincristine- doxorubicin-dexamethasone [VDDx, n=242].
Maltese: VELCADE flimkien ma' dexamethasone [VcDx, n=240] ġie mqabbel ma' vincristine-doxorubicin-dexamethasone [VDDx, n=242].
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) VELCADE 3.5 mg powder for solution for injection 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' dexamethasome u thalidomide VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni jingħata permezz ta' injezzjoni ġol-vina jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8 u 11 f'ċiklu ta' trattament ta' 21 jum.
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: In this case, the duration of a treatment cycle is 42 days (6 weeks).
Maltese: F'dan il-każ iż-żmien ta' ċiklu ta' trattament huwa ta' 42 jum (6 ġimgħat).
English: • Intestinal ulcers
Maltese: • Infezzjonijiet tal-ġilda
English: Time to response CR+PR (days)
Maltese: Żmien għal rispons CR+PR (jiem)
English: Discontinuation due to PN (%)
Maltese: Waqfien minħabba PN (%)
English: Regardless of
Maltese: ½ ta'
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: • Itching of skin
Maltese: • Żieda fil-piż
English: VELCADE 1 mg powder for solution for injection
Maltese: VELCADE 1 mg trab għal soluzzjoni għall-injezzjoni
English: Eye swelling*, Vision abnormal*, Conjunctivitis* Uncommon Eye haemorrhage*, Eyelid infection*, Chalazion Blepharitis
Maltese: Mhux Komuni Disakusi (li jinkludi tinnite)*, Is-smigħ imxekkel (sa anke truxija), Dwejjaq fil-widnejn*
English: Combination therapy with melphalan and prednisone VELCADE 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection in combination with oral melphalan and oral prednisone as shown in Table 2.
Maltese: Terapja ta' kombinazzjoni b'melphalan u prednisolone VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni jingħata bħala injezzjoni ġol-vina jew taħt ilġilda flimkien ma' melphalan mill-ħalq u prednisone mill-ħalq kif muri f'Tabella 2.