FrancophonIA/ELRC3.0 huggingface dataset:
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 Hospira.
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12 of the Bortezomib Hospira treatment cycle.
Maltese: Dexamethasone jingħata mill-ħalq f'doża ta' 20 mg fil-jiem 1, 2, 3, 4, 5 8, 9, 11 u 12 taċ-ċiklu ta' trattament ta' Bortezomib Hospira.
English: #, 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: #, Trombożi fil-vini profondi*, Emorraġija*, Tromboflebite (anke superfiċjali), Kollass ċirkolatorju (li jinkludi xokk ipovolemiku), Flebite, Fwawar*, Ematoma (li jinkludi perirenal)*, Ċirkolazzjoni periferali batuta*, Vaskulite, Iperimja (li jinkludi dak okulari)*
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: Bortezomib Hospira reconstituted solution is administered as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter followed by a flush with sodium chloride 9 mg/ml (0.9%) solution for injection.
Maltese: Is-soluzzjoni rikostitwita ta' Bortezomib Hospira tingħata bħala injezzjoni f'daqqa ġol-vina fi 3-5 sekondi minn kateter periferali jew ċentrali ġol-vina segwita bi flaxx ta' soluzzjoni ta' 9 mg/ml (0.9%) għall-injezzjoni ta' sodium chloride.
English: Median PFS by investigator assessment was 30.7 months in the BR-CAP group and 16.1 months in the RCHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Maltese: Il-medjan ta' PFS skont il-valutazzjoni mill-investigatur kienet ta' 30.7 xhur fil-grupp ta' BR-CAP u 16.1 xahar fil-grupp ta' R-CHOP (Proporzjon ta' periklu [HR]=0.51).
English: Sleep disorders and disturbances*
Maltese: Disakusi (inkluż tinnite)*
English: Note: An OR > 1 indicates an advantage for bortezomib-containing induction therapy.
Maltese: Nota: OR > 1 jindika vantaġġ għal terapija t'induzzjoni li jkun fihabortezomib.
English: Skin reaction, Jessner's lymphocytic infiltration, Palmar-plantar erythrodysaesthesia syndrome, Haemorrhage subcutaneous, Livedo reticularis, Skin induration, Papule, Photosensitivity reaction, Seborrhoea, Cold sweat, Skin disorder NOS, Erythrosis, Skin ulcer, Nail disorder
Maltese: Reazzjoni tal-ġilda, Infiltrazzjoni limfoċitika ta' Jessner, Sindrome eritrodisestesija ta' Palmar-plantar, Emorraġija taħt il-ġilda, Livedo reticularis, Ebusija tal-ġilda, Papule, Reazzjoni ta' fotosensittività, Seborrea, Għaraq kiesaħ NOS, Disturbi tal-ġilda NOS, Eritrosi, Ulċera tal-ġilda, Disturb tad-dwiefer
English: When bortezomib is given together with dexamethasone, you will receive bortezomib 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, 21-day treatment cycle.
Maltese: Meta bortezomib jingħata flimkien ma' dexamethasone, inti ser tirċievi bortezomib ġol-vina 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.
English: #, Bronchospasm, Chronic obstructive pulmonary disease*, Hypoxaemia*, Respiratory tract congestion*, Hypoxia, Pleurisy*, Hiccups, Rhinorrhoea, Dysphonia, Wheezing
Maltese: #, Bronkospażmu, Mard pulmonarju kroniku u ostruttiv (COPD, Chronic obstructive pulmonary disease)*, Ipoksemija*, Konġestjoni fil-passaġġ respiratorju*, Ipoksemija, Konġestjoni fil-passaġġ respiratorju*, Ipoksja, Plewrisi*, Sulluzzu, Rinorea, Disfonja, Tħarħir
English: In subsequent doses, mean maximum observed plasma concentrations ranged from 67 to 106 ng/ml for the 1.0 mg/m2 dose and 89 to
Maltese: Fid-dożi ta' wara, il-medja ta' konċentrazzjonijiet massimi fil-plażma kienu fuq medda minn 67 sa 106 ng/ml għal doża ta' 1.0 mg/ m2 u minn 89 sa 120 ng/ml għal doża ta' 1.3 mg/m
English: • In cycles 1 to 4, bortezomib is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Maltese: Fiċ-ċikli minn 1 sa 4, bortezomib jingħata darbtejn fil-ġimgħa fil-jiem 1, 4, 8, 11, 22, 25, 29 u 32.
English: • carbamazepine, phenytoin or phenobarbital used to treat epilepsy
Maltese: (e.ż., rifampicin, carbamazepine, phenytoin, phenobarbital u St.
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Maltese: It-trattament bi bortezomib ħafna drabi jiġi assoċjat ma' tossiċitajiet ematoloġiċi (tromboċitopenija, newtropenija, anemija).
English: With a median duration of follow-up of 40 months, median OS (56.3 months in the R-CHOP group, and not reached in the BR-CAP group) favoured the BR-CAP group, (estimated HR=0.80; p=0.173).
Maltese: B'tul medjan ta' żmien ta' insegwiment ta' 40 xahar, il-medjan ta' OS (56.3 xhur fil-grupp ta' R-CHOP, u ma ntlaħaqx fil-grupp ta' BR-CAP) iffavorixxa l-grupp ta' BR-CAP, stima ta' HR=0.80;p=0.173).
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 każijiet kienet ta' 73 % (95% CI: 54, 85).
English: Bortezomib Hospira dose should be reduced by 1 dose level (from 1.3 mg/m to 1 mg/m 2, or from 1 mg/m 2 to
Maltese: Imbaghad, Bortezomib Hospira 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
English: 1, 4, 8, and 11, followed by a 17-day rest period from day 12 to day 28), dexamethasone (40 mg administered orally on days 1 to 4 and days 8 to 11), and thalidomide (administered orally at 50 mg daily on days 1-14, increased to 100 mg on days 15-28 and thereafter to 200 mg daily).
Maltese: Pazjenti fil-grupp BTDx kellhom sitt ċikli ta' 4 ġimgħat, li kull wieħed minnhom kien jikkonsisti minn bortezomib (1.3 mg/m2 li ngħata darbtejn fil-ġimgħa fil-jiem 1, 4, 8 u 11, segwit b'perjodu ta' serħan ta' 17-il jum minn jum 12 sa jum 28), dexamethasone (40 mg li ngħata oralment fil-jiem 1 sa 4 u ljiem 8 sa 11) u thalidomide (mogħti mill-ħalq f'doża ta' 50 mg kuljum fil-jiem 1-14, li tiżdied għal 100 mg fil-jiem 15-28 u minn hemm sa 200 mg kull jum).
English: Based on a population pharmacokinetic analysis, clearance of bortezomib increased with increasing body surface area (BSA).
Maltese: Abbażi ta' analiżi farmakokinetika tal-popolazzjoni, it-tneħħija ta' bortezomib żdiedet ma' żieda fis-superfiċje tal-erja tal-ġisem (BSA - body surface area).
English: Bortezomib Hospira 2.5 mg powder for solution for injection Each vial contains 2.5 mg bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Hospira 2.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 2.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CAP), the incidence of peripheral neuropathy in the combination regimens is presented in the table below:
Maltese: Fl-istudju LYM-3002 fejn bortezomib ingħata flimkien ma' rituximab, cyclophosphamide, doxorubicin u prednisone (R-CAP), l-inċidenza ta' newropatija periferika fl-iskedi ta' għoti ta' kombinazzjoni ta' mediċina hija ppreżentata fit-tabella taħt:
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 Hospira taħt il-ġilda meta paragunati ma' dawk li ħaduħ ġol-vina 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 Hospira.
English: Type I glass 5 ml siliconised vial with a rubber stopper and an aluminium seal containing 1 mg bortezomib.
Maltese: Kunjett ta' 5 ml silikonizzat tal-ħġieġ ta' tip I, b'tapp tal-lastku u siġill tal-aluminju li fih 1 mg bortezomib.
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 (BR-CAP).
Maltese: Infezzjoni b'HBV b'riżultati fatali seħħet f'0.8 % (n=2) tal-pazjenti fil-grupp li ma kienx ittrattat bi bortezomib (rituximab, cyclophosphamide, doxorubicin, vincristine u prednisone;
English: • If platelet counts < 25,000 cells/μL or ANC < 750 cells/μL on a Bortezomib Hospira dosing day (other than Day 1 of each cycle)
Maltese: • Jekk l-għadd ta' plejtlits ikun < 25,000 ċellula/μL jew lANC ikun <750 ċellula/μL f'ġurnata ta' għoti ta' doża ta' Bortezomib Hospira (ħlief f'Jum 1 ta' kull ċiklu)
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with bortezomib at 1.3 mg/m2 and included in Table 7.
Maltese: Dawn ir-reazzjonijiet avversi kienu bażati fuq tagħrif integrat ta' 5,476 pazjent li minnhom 3,996 pazjent kienu trattati bi bortezomib b'1.3 mg/m2 u inklużi f'tabella 7.
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Maltese: Meta thalidomide jintuża attenzjoni partikolari għal testijiet ta' tqala u rekwiżiti ta' prevenzjoni huma meħtieġa (ara sezzjoni 4.6).
English: Following an intravenous bolus or subcutaneous injection of a 1.3 mg/m2 dose to patients with multiple myeloma (n=14 in the intravenous group, n=17 in the subcutaneous group), the total systemic exposure after repeat dose administration (AUClast) was equivalent for subcutaneous and intravenous administrations.
Maltese: Wara bolus intravenuż jew injezzjoni ġol-vina b'doża ta' 1.3 mg/m2 lill-pazjenti b'majeloma multipla (n=14 fil-grupp ta' ġol-vina, n=17 fil-grupp ta' taħt il-ġilda), l-esponiment sistemiku totali wara l-għoti ta' doża ripetuta (AUClast) kienet ekwivalenti għall-għotjiet ta' taħt il-ġilda u ta' ġol-vina.
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with bortezomib treatment.
Maltese: Emorraġija gastrointestinali u intraċerebrali ġiet irrappurtata b'rabta mat-trattament bi bortezomib.
English: • If toxicity resolves i.e. patient has an ANC ≥ 750cells/μL and a platelet count ≥ 25,000 cells/μL, Bortezomib Hospira 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/m
Maltese: • Jekk it-tossiċità tgħaddi i.e. il-pazjent ikollu ANC ta'  750 ċellula/μL u għadd ta' plejtlits ta'  25,000 ċellula/μL, Bortezomib Hospira jista' jerġa' jibda jingħata mill-ġdid biddoża mnaqqsa b'livell wieħed ta' doża (minn 1.3 mg/m2 għal 1
English: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Maltese: It-trab lijofilizzat jinħall kompletament f'inqas minn 2 minuti.
English: Name and address of the manufacturers responsible for batch release Hospira UK Ltd.
Maltese: Il-Manifattur Hospira UK Ltd.
English: Cerebral haemorrhage*, Haemorrhage intracranial (inc subarachnoid)*, Brain oedema, Transient ischaemic attack, Coma, Autonomic nervous system imbalance, Autonomic neuropathy, Cranial palsy*, Paralysis*, Paresis*, Presyncope, Brain stem syndrome, Cerebrovascular disorder, Nerve root lesion, Psychomotor hyperactivity, Spinal cord compression, Cognitive disorder NOS, Motor dysfunction, Nervous system disorder NOS, Radiculitis, Drooling, Hypotonia
Maltese: Emorraġija ċerebrali*, Emorraġija intrakranjali (li jinkludi issottoaraknojde)*, Edema tal-moħħ, Attakk iskemiku għaddien, Koma, Żbilanċ fis-sistema awtonomika nervuża, Newropatija awtonomika, Puplesija kranjali*, Paralisi*, Paresi*, Presinkope, Sindromu tal-istemma tal-moħħ, Disturb ċerebrovaskulari, Ġerħa fl-għerq tan-nerv, Iperattività psikomotorili, Kompressjoni fil-korda dorsali, Disturb fl-għarfien NOS, Disfunzjoni motorili, Disturb fis-sistema nervuża
English: Special handling instructions.
Maltese: Informazzjoni għall-pazjent
English: The benefit/risk ratio should be considered prior to continuing Bortezomib Hospira therapy.
Maltese: Għandha tingħata kunsiderazzjoni tal-proporzjon tal-benefiċċju/riskju qabel ma titkompla t-terapija b'Bortezomib Hospira.
English: Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Maltese: Rogħda, Newropatija sensomotorili periferali, Diskinesja*, Disturbi fil-bilanċ u fil-koordinazzjoni ċerebellari*, Telf ta' memorja (li ma jinkludix demenzja)*, Enċefalopatija*, Sindromu enċefalopatiku Riversibbli
English: Pulmonary disorders
Maltese: Pulmonite*
English: Patients who had received 2 to 3 prior therapeutic regimens had a response rate of 32% (10/32) and patients who received greater than 7 prior therapeutic regimens had a response rate of 31% (21/67).
Maltese: Pazjenti li kienu ħadu minn 2 sa 3 terapiji qabel kellhom rata ta' rispons ta' 32 % (10/32) u pazjenti li kellhom iktar minn 7 terapiji minn qabel kellhom rata ta' rispons ta' 31 % (21/67).
English: Bortezomib Hospira 3.5 mg powder for solution for injection Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
Maltese: Bortezomib Hospira 3.5 mg trab għal soluzzjoni għall-injezzjoni Kull kunjett fih 3.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: The safety and efficacy of bortezomib 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' Bortezomib Hospira fit-tfal li għadhom m'għalqux 18-il sena ma ġewx determinati s'issa (ara sezzjonijiet 5.1 u 5.2).
English: Uncommon Cardiovascular disorder (inc cardiogenic shock)
Maltese: Disturb kardjovaskulari (inkluż xokk kardjoġeniku)
English: When bortezomib is given together with dexamethasone, you will receive bortezomib intravenously or subcutaneously 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 Bortezomib 21-day treatment cycle.
Maltese: Meta bortezomib jingħata flimkien ma' dexamethasone, inti ser tirċievi bortezomib ġol-vina bħala ċiklu ta' 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' bortezomib.
English: Neuropathic pain and/or peripheral neuropathy
Maltese: Uġigħ newropatiku u/jew newropatija periferali
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* Uncommon Colitis (inc clostridium difficile)*
Maltese: Emorraġija gastrointestinali (inkluż mill-mukuża)*, Nefħa fladdome, Dispepsja, Uġigħ orofarinġeali*, Gastrite*, Ulċeri filħalq*, Skumdità fl-addome, Disfaġja, Infjammazzjoni gastrointestinali*, Uġigħ fl-addome (inkluż uġigħ gastrointestinali u tal-milsa)*, Disturb orali*
English: Thalidomide is administered orally at 50 mg daily on days 1-14 and if tolerated the dose is increased to 100 mg on days 15-28, and thereafter may be further increased to 200 mg daily from cycle 2 (see Table 4).
Maltese: Thalidomide jingħata mill-ħalq f'doża ta' 50 mg kuljum fil-jiem 1-14 u jekk ikun ittollerat id-doża għandha tiżdied għal 100 mg wara dan fil-jiem 15-28, u wara dan tista' tiżdied aktar għal 200 mg kuljum minn ċiklu 2 (ara Tabella 4).
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: Bortezomib Hospira 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: Bortezomib Hospira f'kombinazzjoni ma' rituximab, cyclophosphamide, doxorubicin u prednisolone hu indikat għal trattament ta' pazjenti adulti li qabel kellhom limfoma taċ-ċellula ‘mantle' li ma kinetx trattata qabel li mhumiex eleġibbli għal trapjant ta' ċellul steminali ematopojetiċi.
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the BR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Maltese: Ilpazjenti rċivew medjan ta' 6 ċikli fiż-żewġ fergħat ta' trattament b'14 % tal-individwi fil-grupp ta' BR-CAP u 17 % tal-pazjenti fil-grupp ta' R-CHOP jirċievu 2 ċikli addizzjonali.
English: • Inject the solution as a 3-5 second bolus intravenous injection through a peripheral or central intravenous catheter into a vein.
Maltese: Injetta s-soluzzjoni bħala injezzjoni bolus ta' bejn 3 u 5 sekondi minn ġo kateter periferali jew ċentrali fil-vina.
English: • to report any adverse event, or medication error experienced with the administration of Bortezomib Hospira 1 mg, 2.5 mg, 3 mg and 3.5 mg.
Maltese: • sabiex jiġi rapportat kull każ avvers jew errur fil-medikazzjoni li ġie esperjenzat bl-għoti ta' Velcade 1 mg, 2.5 mg, 3 mg u 3.5 mg
English: Antiviral prophylaxis is recommended in patients being treated with Bortezomib Hospira.
Maltese: Profilassi antivirali hija rakkomandata f'pazjenti li qed jiġu kkurati b'Bortezomib Hospira.
English: Common Renal impairment* Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakisuria
Maltese: Falliment akut tal-kliewi, Falliment kroniku tal-kliewi *, Infezzjoni filpassaġġ awrinarju*, Sinjali u sintomi tal-passaġġ awrinarju*, Ematurja*, Żamma awrinarja, Disturb ta' mikturizzjoni*, Proteinurja, Azotemija, Oligurja*, Pollakijurja
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 ilfarmakokinetika ta' bortezomib (injettat ġol-vina) wera żieda medja fl-AUC ta' 17 % abbażi ta' dejta minn 21 pazjent.
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the bortezomib treatment cycle.
Maltese: Prednisone jingħata mill-ħalq bid-doża ta' 100 mg/m 2 fil-jiem 1, 2, 3, 4 u 5 taċ-ċiklu ta'
English: B=bortezomib; BTDx=bortezomib, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response;
Maltese: TDx=thalidomide, dexamethasone; PR=partial response - rispons parzjali, OR=odds ratio - proporzjon ta' odds; * Primary endpoint - L-ewwel punt aħħari
English: Tumour lysis syndrome
Maltese: Sindromu ta'diżintegrazzjoni tat-tumur
English: • Cough
Maltese: Qawwi
English: Table 2: Recommended posology for Bortezomib Hospira in combination with melphalan and prednisone Twice weekly Bortezomib Hospira (cycles 1-4)
Maltese: Tabella 2: Pożologija rrakkommandata għal Bortezomib Hospira flimkien ma' melphalan u prednisone
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*, Axite, Esofaġitè, Kajlite, Inkontinenza tal-ippurgar, Atonija fl-isfinkter anali, Fekaloma*, Ulċerazzjoni u perforazzjoni gastrointestinali*, Ipertrofija ġenġivali, Megakolon, Tnixxija rektali, Infafet Orofarinġeali*, Uġigħ fix-xofftejn, Perjodontite, Fissura anali, Bidla fid-drawwa ta' meta tipporga, Proctalġja, Ippurgar mhux normali
English: Progression-free survival Events n (%)
Maltese: Żmien għall-progressjoniKażijiet n (%)
English: Include all CR+CRu, by IRC, bone marrow and LDH.
Maltese: Jinkludi is-CT+CRU kollha, mill IRC, mill-mudullun tal-għadam u LDH
English: Bortezomib was positive for clastogenic activity (structural chromosomal aberrations) in the in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells at concentrations as low as 3.125 μg/ml, which was the lowest concentration evaluated.
Maltese: Bortezomib kien pożittiv għall-attività klastoġenika (aberrazzjonijiet fl-istruttura tal-kromożomi) fl-analiżi in vitro għal aberrazzjonijiet kromosomali b'ċelluli tal-ovarju tal-ħamster Ċiniż (CHO) anke b'konċentrazzjonijiet ta' 3.125 μg/ml, li kienet l-iċken konċentrazzjoni li kienet evalwata.
English: • Movement disorders, paralysis, twitching
Maltese: • Disturbi fiċ-ċaqlieq, paraliżi, ħbid involontarju tal-muskoli
English: Overall, bortezomib was administered for the treatment of multiple myeloma in 3,974 patients.
Maltese: B'mod globali, bortezomib ġie mgħoti lil 3974 pazjent għal kura ta' majeloma multipla.
English: Rhabdomyolysis, Temporomandibular joint syndrome, Fistula, Joint effusion, Pain in jaw, Bone disorder, Musculoskeletal and connective tissue infections and inflammations*, Synovial cyst
Maltese: Rabdomijolisi, Sindromu tal-ġog temporomandibulari, Fistula, Effużjoni talġog, Uġigħ fix-xedaq, Disturb tal-għadam, Infezzjonijiet u infjammazzjonijiet muskuloskeletriċi u tat-tessut konnettiv*, Ċista sinovjali
English: Four treatment cycles of this combination therapy are administered.
Maltese: Erba' ċikli ta' trattament ta' din it-terapija ta' kombinazzjoni jistgħu jingħataw.
English: Bortezomib combination treatment with pegylated liposomal doxorubicin (study DOXIL-MMY-3001) A Phase III randomised, parallel-group, open-label, multicentre study was conducted in 646 patients comparing the safety and efficacy of bortezomib plus pegylated liposomal doxorubicin versus bortezomib monotherapy in patients with multiple myeloma who had received at least 1 prior therapy and who did not progress while receiving anthracycline-based therapy.
Maltese: III fi gruppi paralleli, bit-tikketta tingħaraf, u multiċentriku sar fuq 646 pazjent li qabbel is-sigurtà u l-effikaċja ta' bortezomib ma' pegylated liposomal doxorubicin kontra monoterapija bi bortezomib f'pazjenti b'majeloma multipla li kienu rċevew tal-anqas terapija waħda qabel u li ma progrssawx waqt li kienu qed jieħdu terapija abbażi ta' anthracycline.
English: • instructions for prescribing and administration including the cycles' length and number of cycles, to minimise the risk of medication and dispensing errors potentially induced by the existence of the two different bortezomib combination regimens in the Transplant Induction Setting (Bortezomib plus dexamethasone, and Bortezomib plus dexamethasone and thalidomide).
Maltese: • istruzzjonijiet għal preskrizzjoni u l-għoti li jinkludu t-tul u l-għadd ta' ċikli, sabiex jiġi minimizzat ir-riskju ta' erruri ta' mediċina u tal-għoti potenzjalment indotti bl-eżistenza ta' żewġ programmi ta' kura differenti ta' kombinazzjoni bi borezomib fl-Ambjent ta' Induzzzjoni ta' Trapjant (Bortezomib flimkien ma' dexamethasone, u Bortezomib flimkien ma' dexamethasone u thalidomide).