FrancophonIA/ELRC3.0 huggingface dataset:
English: Common Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances* Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Maltese: Disturb mentali*, Alluċinazzjoni*, Disturb psikotiku*, Konfużjoni*, Irrikwitezza
English: Table 1: Recommended* posology modifications for bortezomib-related neuropathy Severity of neuropathy
Maltese: Tabella 1: Bidliet rakkomandati* fil-pożoloġija għal newropatija marbuta ma' bortezomib
English: 19.2 mo
Maltese: 19.2 xahar
English: Patients should be monitored at regular intervals for any new or worsening neurological symptoms or signs that may be suggestive of PML as part of the differential diagnosis of CNS problems.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati f'intervalli regolari għal kwalunkwe sintomi newroloġiċi ġodda jew li jiggravaw jew sinjali li jistgħu jissuġġerixxu PML bħala parti mid-dijanjosi differenzjali tal-problemi tas-CNS.
English: The following adverse reactions (Grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Maltese: (3% versus 0%); ilju (2.1% versus 0%); ipoksja (8% versus 2%).
English: Data from in vitro, ex-vivo, and animal models with bortezomib suggest that it increases osteoblast differentiation and activity and inhibits osteoclast function.
Maltese: Dejta minn mudelli in-vitro, ex-vivo u mudelli ta' annimali b'bortezomib tissuġġerixxi li huwa jżid iddifferenzjal u l-attività tal-osteoblasts u jimpedixxi l-funzjoni tal-osteoklasts.
English: What Bortezomib SUN contains - The active substance is bortezomib.
Maltese: X'fih Bortezomib SUN - Is-sustanza attiva hi bortezomib.
English: Common Dehydration, Hypokalaemia*, Hyponatraemia*, Blood glucose abnormal*, Hypocalcaemia*, Enzyme abnormality*
Maltese: Deidratazzjoni, Ipokalemija*, Iponatremija*, Livell anormali ta' zokkor fid-demm*, Ipokalċemija*, Anormalità fl-enzimi*
English: The pharmacokinetics of bortezomib are not influenced in patients with mild to moderate renal impairment (Creatinine Clearance [CrCL] > 20 ml/min/1.73 m2); therefore, dose adjustments are not necessary for these patients.
Maltese: Il-farmakokinetika ta' bortezomib mhijiex influwenzata f'pazjenti b'indeboliment tal-kliewi ħafif sa moderat (Tneħħija tal-Kreatinina [CrCL] > 20 ml/min/1.73 m2); għalhekk, aġġustamenti tad-doża mhumiex meħtieġa għal dawn il-pazjenti.
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 talKaratteristiċi tal-Prodott korrispondenti.
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 rakkomandata ġiet marbuta ma' episodju akut ta' ipotensjoni sintomatika u tromboċitopenija b'riżultati fatali.
English: Serious adverse reactions uncommonly reported during treatment with bortezomib 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'bortezomib jinkludu insuffiċjenza tal-qalb, sindrome tal-lisi tat-tumur, pressjoni għolja fil-pulmun, sindrome ta' enċefalopatija riversibbli fuq in-naħa ta' wara, disturbi pulmonari akuti diffużi u infiltrattivi, u b'mod rari newropatija awtonomika.
English: Common 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* Uncommon Colitis (inc clostridium difficile)* Hepatobiliary disorders Common Hepatotoxicity (inc liver disorder) Uncommon Hepatic failure
Maltese: Emorraġija gastrointestinali (inkluż mill-mukuża)*, Nefħa fl-addome, Dispepsija, Uġigħ orofarinġali*, Gastrite*, Ulċeri fil-ħalq*, Skumdità fl-addome, Disfaġja, Infjammazzjoni gastrointestinali*, Uġigħ fladdome (inkluż uġigħ gastrointestinali u tal-milsa)*, Disturb orali*
English: Table 9: Incidence of peripheral neuropathy during induction treatment by toxicity and treatment discontinuation due to peripheral neuropathy IFM-2005-01
Maltese: Inċidenza ta' newropatija periferali (PN - peripheral neuropathy) waqt it-trattament ta' induzzjoni skont it-tossiċità u l-waqfien tat-trattament minħabba newropatija periferali
English: Bortezomib intravenous arm
Maltese: Injezzjoni ġol-vini
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Maltese: Id-Dosing Slide Rule għandu jkun fiha l-elementi ewlenien li ġejjin:
English: ADMINISTRATION
Maltese: LISTA
English: Common Dyspnoea*, Cough*, Hiccups Uncommon Acute respiratory distress syndrome, Pulmonary embolism, Pneumonitis, Pulmonary hypertension, Pulmonary oedema (inc acute)
Maltese: Sindrome ta' għeja respiratorja akuta, Emboliżmu filpulmun, Pnewmonite, Pressjoni għolja fil-pulmun, Edema fil-pulmun (inkluż akuta)
English: Combination therapy with pegylated liposomal doxorubicin Bortezomib SUN 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 kombinata b'pegylated liposomal doxorubicin Bortezomib SUN jingħata permezz ta' injezzjoni ġol-vini jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 ta' erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn f'jiem 1, 4, 8, u 11 f'ċiklu ta' trattament ta' 21 jum.
English: 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: Thalidomide jingħata mill-ħalq kuljum f'doża ta' 50 mg sa jum14 tal-ewwel ċiklu, u jekk ikun ittollerat, id-doża ta' thalidomide tiżdied għal 100 mg f'jiem 15-28 u tista' tiżdied aktar għal 200 mg kuljum mit-tieni ċiklu 'l quddiem.
English: A hazard ratio less than 1 indicates an advantage for VMP c Nominal p-value based on the stratified log-rank test adjusted for stratification factors: β2-microglobulin, albumin, and region d p-value for Response Rate (CR+PR) from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors e Response population includes patients who had measurable disease at baseline f CR=Complete Response; PR=Partial Response.
Maltese: Irrispettivament mill-livelli ta' mikroglobulina β2 fil-linja bażi, il-parametri kollha tal-effikaċja (żmien ta' progressjoni, sopravivenza globali, kif ukoll rata ta' rispons) tjiebu b'mod sinifikanti fil-parti talistudju dwar bortezomib.
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 lewkimja akuta majloġenuża li rkadiet, mietu minħabba ARDS fil-bidu tat-terapija, u l-istudju twaqqaf.
English: Neuropathic pain and/or peripheral neuropathy 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: Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Maltese: Għalkemm f'pazjenti li kellhom ≥ 75 sena, kemm BzmbRCAP kif ukoll R-CHOP kienu ttollerati anqas, ir-rata ta' każijiet avversi serji fil-gruppi ta' BzmbRCAP kienet 68%, meta mqabbla ma' 42% fil-grupp ta' R-CHOP.
English: Incidence Adverse reaction block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Maltese: Tħaxwix atrijali, Infart mijokardijali*, Imblokk atrijoventrikulari*, Disturb kardjovaskulari (li jinkludi xokk kardjoġeniku), Torsade de pointes, Anġina instabbli, Disturbi tal-valv kardijaku*, Insuffiċjenza talarterja koronarja, Waqfien tas-sinus
English: chest pain or chest tightness, and/or feeling dizzy/faint, severe itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and /or throat, which may cause difficulty in swallowing, collapse - breast disorders - vaginal tears - genital swelling - inability to tolerate alcohol consumption - wasting, or loss of body mass - increased appetite - fistula - joint effusion - cysts in the lining of joints (synovial cysts) - fracture - breakdown of muscle fibers leading to other complications - swelling of the liver, bleeding from the liver - cancer of the kidney - psoriasis like skin condition - cancer of the skin - paleness of the skin - increase of platelets or plasma cells (a type of white cell) in the blood - blood clot in small blood vessels (thrombotic microangiopathy) - abnormal reaction to blood transfusions - partial or total loss of vision - decreased sex drive - drooling - bulging eyes - sensitivity to light - rapid breathing - rectal pain - gallstones - hernia - injuries - brittle or weak nails - abnormal protein deposits in your vital organs - coma - intestinal ulcers - multi-organ failure - death.
Maltese: Xi wħud minn dawn jinkludu diffikultà biex tieħu n-nifs, nifsijiet qosra, nifsijiet qosra mingħajr ma tkun għamilt eżerċizzju, nifsijiet li ma jkunux fondi, isiru diffiċli jew bil-waqfiet, tħarħir - sulluzzu, disturbi marbuta mad-diskors - żieda jew tnaqqis fl-ammont tal-awrina li tipproduċi (minħabba ħsara fil-kliewi), tweġġa' biex tagħmel l-awrina jew demm/proteina fl-awrina, żamma ta' fluwidu - livelli mibdula ta' koxjenza, konfużjoni, indeboliment tal-memorja jew telf ta' memorja - sensittività eċċessiva - telf tas-smigħ, nuqqas tas-smigħ jew żanżin fil-widnejn, skumdità fil-widnejn - anormalitajiet ormonali li jistgħu jaffettwaw l-assorbiment tal-melħ u l-ilma - glandola tat-tirojde attiva żżejjed - inkapaċità li tiġi prodotta biżżejjed insulina jew reżistenza għal-livelli normali ta' insulina - għajnejn irritati jew infjammati, għajnejn imdemmgħin wisq, uġigħ fl-għajnejn, għajnejn xotti,
English: Each 10 ml vial of Bortezomib SUN must be carefully reconstituted with 1.4 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: Kull kunjett ta' 10 ml ta' Bortezomib SUN irid ikun rikostitwit bi 1.4 ml ta' soluzzjoni ta' 9 mg/ml (0.9%) ta' sodium chloride għall-injezzjoni, billi tintuża siringa tad-daqs xieraq, mingħajr ma jitneħħa t-tapp tal-kunjett.
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-parteċipanti ġew magħżula b'mod każwali, (APEX) kontra dexamethasone (Dex), ta' 669 pazjent b'majeloma multipla refrattorja jew li tirkadi li ħadu bejn 1 u 3 linji ta' terapija fil-passat, u studju ta' Fażi
English: Atrial flutter, Myocardial infarction*, Atrioventricular
Maltese: Emorraġija vaġinali, Uġigħ fil-parti ġenitali*, Disfunzjoni fl-erezzjoni
English: Treatment with bortezomib is very commonly associated with peripheral neuropathy, which is predominantly sensory.
Maltese: It-trattament b'bortezomib ħafna drabi jiġi assoċjat ma' newropatija periferali, l-iktar dik sensorjali.
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Maltese: Il-medjan ta' sopravivenza tal-pazjenti kollha rreġistrati kienet ta' 17-il xahar (medda < 1 sa 36+ xahar).
English: An effective reinduction multiagent chemotherapy regimen was administered in 3 blocks.
Maltese: Skeda effettiva ta' kimoterapija ta' induzzjoni mill-ġdid b'ħafna sustanzi ngħatat fi 3 blokok.
English: Hepatic impairment
Maltese: Reazzjonjiet epatiċi
English: Uncommon side effects (may affect up to 1 in 100 people) - heart failure, heart attack, chest pain, chest discomfort, increased or reduced heart rate - failing of your kidneys - inflammation of a vein, blood clots in your veins and lungs - problems with blood clotting - insufficient circulation - inflammation of the lining around your heart or fluid around your heart - infections including urinary tract infections, the flu, herpes virus infections, ear infection and cellulitis - bloody stools, or bleeding from mucosal membranes, e.g., mouth, vagina - cerebrovascular disorders - paralysis, seizures, falling, movement disorders, abnormal or change in, or reduced sensation
Maltese: Effetti sekondarji mhux komuni (li jistgħu jaffettwaw sa persuna 1 f'100) - insuffiċjenza tal-qalb, attakk ta' qalb, uġigħ fis-sider, skumdità fis-sider, żieda jew tnaqqis fir rata ta' taħbit tal-qalb - insuffiċjenza tal-kliewi - infjammazzjoni ta' vina, emboli tad-demm fil-vini u l-pulmun - problemi fit-tagħqid tad-demm - ċirkolazzjoni insuffiċjenti - infjammazzjoni fir-riti ta' madwar qalbek jew fluwidu madwar il-qalb tiegħek - infezzjonijiet li jinkludu infezzjonijiet fl-apparat urinarju, influwenza, infezzjonijiet bil-virus tal-herpes, infezzjonijiet fil-widnejn u ċellulite - ippurgar bid-demm, jew emorraġija madwar ir-riti mukużi, eż., il-ħalq, vaġina - disturbi ċerebrovaskulari - paralisi, aċċessjonijiet, waqgħat, disturbi marbuta mal-moviment, sensazzjoni mhux normali,
English: The median TTP was 6.5 months for the bortezomib monotherapy patients compared with 9.3 months for the bortezomib plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: It-TTP medjan kien ta' 6.5 xhur għall-monoterapija b'bortezomib meta mqabbel ma' 9.3 xhur għall-pazjenti fuq terapija kkombinata ta' bortezomib flimkien ma' pegylated liposomal doxorubicin.
English: Bzmb=Bortezomib SUN; 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 onwards if 100 mg is tolerated.
Maltese: 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 ttollerata.
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BzmbR-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 partijiet tal-istudju dwar ta' trattament b'14% tal-individwi fil-grupp ta' BzmbR-CAP u 17% tal-pazjenti fil-grupp ta' R-CHOP jirċievu 2 ċikli addizzjonali.
English: Common Neuropathies*, Motor neuropathy*, Loss of consciousness (inc syncope), Encephalopathy*, Peripheral sensorimotor neuropathy, Dizziness*, Dysgeusia*, Autonomic neuropathy Uncommon Autonomic nervous system imbalance
Maltese: Newropatiji*, Newropatija motorja*, Telf ta' koxjenza (inkluż sinkope), Enċefalopatija*, Newropatija sensomotorja periferali, Sturdament*, Tibdil fis-sens tattogħma*, Newropatija awtonomika
English: Any
Maltese: U
English: Bortezomib is highly selective for the proteasome.
Maltese: Bortezomib huwa selettiv ħafna għall-proteasome.
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the BzmbDx group.
Maltese: It-tul medjan tat-trattament kien ta' 13-il ġimgħa għall-grupp ta' VDDx u 11-il ġimgħa għall-grupp ta' BzmbDx.
English: When Bortezomib SUN is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Maltese: Meta Bortezomib SUN jingħata f'kombinazzjoni ma' prodotti mediċinali oħra, irreferi għasSommarju tal-Karatteristiċi tal-Prodott għal kontraindikazzjonijiet addizzjonali.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Bortezomib SUN 3.5 mg powder for solution for injection bortezomib
Maltese: It-terapija b'Bortezomib SUN m'għandhiex tingħata
English: h Include all radiological CR+CRu+PR by IRC regardless the verification by bone marrow and LDH.
Maltese: f Jinkludi is-CR + CRu kollha, mill-IRC, mill-mudullun tal-għadam u LDH.
English: B. PACKAGE LEAFLET
Maltese: Kriterji EBMT
English: Patient demographic and baseline disease characteristics were similar between the treatment groups.
Maltese: Id-demografika tal-pazjenti u l-karatteristiċi tal-mard fillinja bażi kienu simili bejn il-gruppi ta' trattament.
English: Each 10 ml vial of Bortezomib SUN 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' Bortezomib SUN 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: In addition, following a search of the worldwide medical and scientific literature carried out for the period covered by this PSUSA and a number of papers reporting safety information, 35 cases of Thrombotic Microangiopathy (TMA) were retrieved.
Maltese: Barra minn dan, wara riċerka tal-letteratura medika u xjentifika minn madwar id-dinja li saret għallperjodu li tkopri din il-PSUSA u ta' numru ta' publikazzjonijiet li jirrappurtaw informazzjoni dwar sigurtà, instilet 35 każ ta' Mikroanġiopatija Trombotika (TMA, Thrombotic Microangiopathy).
English: Reduce Bortezomib SUN to 0.7 mg/m2 in the first treatment cycle.
Maltese: Naqqas id-doża ta' Bortezomib SUN għal 0.7 mg/m2 fl-ewwel ċiklu ta' trattament.
English: NAME OF THE MEDICINAL PRODUCT Bortezomib SUN 3.5 mg powder for solution for injection bortezomib
Maltese: IL-PRODOTT MEDIĊINALI Bortezomib SUN 3.5 mg trab għal soluzzjoni għall-injezzjoni
English: Intrathecal administration has resulted in death.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: SGOT (AST) levels Modification of starting dose
Maltese: Livell tal-bilirubina Livelli ta' SGOT (AST)
English: Prednisone is administered orally at 100 mg/m2 on days 1, 2, 3, 4 and 5 of each Bortezomib SUN treatment cycle.
Maltese: Prednisone jingħata mill-ħalq b'doża ta' 100 mg/m2 f'jiem 1, 2, 3, 4 u 5 ta' kull wieħed miċ-ċikli ta'
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 (BzmbR-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'bortezomib u f'pazjenti b'MCL li qatt ma kienu ttrattati qabel li ġew ittrattati b'bortezomib flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (BzmbR-CAP), waħda mill-iktar tossiċitajiet ematoloġiċi komuni kienet tromboċitopenija temporanja.
English: Bortezomib therapy should be withheld when the platelet count is < 25,000/μl or in combination with melphalan and prednisone when the platelet count is ≤ 30,000/μl (see section 4.2).
Maltese: It-terapija b'bortezomib għandha titwaqqaf meta l-għadd ta' plejtlits ikun < 25,000/µl jew, fil-każ ta' għoti flimkien ma' melphalan u prednisone, meta l-għadd tal-plejtlits ikun ta' ≤ 30,000/µl (ara sezzjoni 4.2).
English: The incidence of death on treatment was 5% in the subcutaneous treatment group and 7% in the intravenous treatment group.
Maltese: L-inċidenza ta' mewt mat-trattament seħħ f'5% tal-individwi fil-grupp li ngħata trattament taħt ilġilda u 7% tal-indvidwi li ngħata trattament ġol-vini.
English: Death (inc sudden), Multi-organ failure, Injection site haemorrhage*, Hernia(inc hiatus)*, Impaired healing*,
Maltese: Herpes zoster (anki mifrux u oftalmiku), Pnewmonja*, Herpes simplex*, Infezzjoni fungali*
English: Withhold Bortezomib SUN treatment until symptoms of toxicity have resolved.
Maltese: Waqqaf it-trattament b'Bortezomib SUN sakemm is-sintomi tat-tossiċità jgħaddu.
English: Combination therapy with dexamethasone and thalidomide Bortezomib SUN 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 kombinata ma' dexamethasome u thalidomide Bortezomib SUN jingħata permezz ta' injezzjoni ġol-vini jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m2 ta' erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn f'jiem 1, 4, 8, u 11 f'ċiklu ta' trattament ta' 28 jum.
English: At least 72 hours should elapse between consecutive doses of Bortezomib SUN. Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the Bortezomib SUN treatment cycle.
Maltese: Dexamethasone għandu jingħata mill-ħalq f'doża ta' 20 mg f'jiem 1, 2, 4, 5, 8, 9, 11, u 12 ta' ċiklu ta' trattament ta' Bortezomib SUN.
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: grupp 3 jew ogħla kien 10% inqas, u r-rata ta' waqfien minħabba newropatiji periferali kienet ta' 8% inqas għall-grupp ta' taħt il-ġilda meta mqabbel mal-grupp ġol-vini.
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Maltese: L-injezzjoni ġo vina ssir malajr, u tieħu minn 3 sa 5 sekondi.
English: Treatment was administered for a maximum of 9 cycles (approximately 54 weeks) and was discontinued early for disease progression or unacceptable toxicity.
Maltese: It-trattament ingħata għal massimu ta' 9 ċikli (bejn wieħed u ieħor 54 ġimgħa) u twaqqaf qabel fejn kien hemm progressjoni tal-marda jew tossiċità mhux aċċettabbli.
English: However, cases of severe motor neuropathy with or without sensory peripheral neuropathy have been reported.
Maltese: Madankollu, ġew irrappurtati każijiet ta' newropatija motoreja severa b'newropatija sensorjali periferali jew mingħajrha.
English: The median duration of complete response was 42.1 months in the BzmbR-CAP group compared with 18 months in the R-CHOP group.
Maltese: Il-medjan tat-tul ta' żmien ta' rispons sħiħ kien ta' 42.1 xhur filgrupp ta' BzmbR-CAP meta mqabbel ma' 18-il xahar fil-grupp ta' R-CHOP.
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 ħlief jekk il-kundizzjonijiet kollha tal-programm ta' prevenzjoni tat-tqala ta' thalidomide ikunu ssodisfati.