FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients in the VcDx group received four 21 day cycles, each consisting of VELCADE (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: Pazjenti fil-grupp VcDx kellhom 4 ċikli ta' 21 jum, kull wieħed minnhom jikkonsisti minn VELCADE (1.3 mg/m 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, fiċĊikli 1 u 2, u fil-jiem 1 sa 4 fiċ-Ċikli 3 u 4).
English: The kinetics of proteasome inhibition were evaluated in vitro, and bortezomib was shown to dissociate from the proteasome with a t½ of 20 minutes, thus demonstrating that proteasome inhibition by bortezomib is reversible.
Maltese: 20 minuta, u b'hekk wera li l-inibizzjoni tal-proteasome minn bortezomib hija riversibbli.
English: • If, after VELCADE has been held, the toxicity does not resolve, as defined above, then VELCADE must be discontinued.
Maltese: • Jekk, wara li ma jkunx ingħata VELCADE, it-tossiċità ma tgħaddix, kif iddefinit fuq, allura VELCADE għandu jitwaqqaf.
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: Dissolution of the lyophilised powder is completed in less than 2 minutes.
Maltese: It-trab lajofilizzat idub f'inqas minn 2 minuti.
English: #, Blood disorder NOS, Haemorrhagic diathesis, Lymphocytic infiltration
Maltese: #, Disturb tad-demm NOS, Dijatesi emorraġika, Infiltrazzjoni limfoċitika
English: Neuropathic pain and/or peripheral neuropathy
Maltese: Disturbi fil-metaboliżmu u nnutrizzjon
English: Type 1 glass 10 ml-vial with a grey bromobutyl stopper and an aluminium seal, with a royal blue cap containing 3.5 mg bortezomib.
Maltese: Kunjett ta' 10 ml ta' ħġieg ta' tip 1, b'tapp griż tal-bromobutyl u siġill tal-aluminju b'għatu blu jgħajjat li fih 3.5 mg bortezomib
English: The 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 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: The benefit/risk ratio should be considered prior to continuing VELCADE therapy.
Maltese: Għandha tingħata kunsiderazzjoni tal-proporzjon tal-benefiċċju/riskju qabel ma titkompla t-terapija b'VELCADE.
English: Potentially immunocomplex-mediated reactions, such as serum-sickness-type reaction, polyarthritis with rash and proliferative glomerulonephritis have been reported uncommonly.
Maltese: Reazzjonijiet potenzjali medjati mill-immunokumpless Ġew irrappurtati b'mod mhux komuni reazzjonijiet li potenzjalment huma medjati mill-immunokumpless, bħalma huma reazzjoni tat-tip tal-mard tas-serum, poliartrite b'raxx u glomerulonefrite proliferattiva.
English: Very Common Thrombocytopenia*, Febrile neutropenia, Neutropenia*,
Maltese: Komuni ħafna Tromboċitopenija*, Newtropenija bid-deni, Newtropenija*,
English: Such changes may be reversible upon discontinuation of bortezomib (see section 4.8).
Maltese: Ġew irrappurtati każijiet b'mod mhux komuni ta' imblukkar tal-musrana (ara sezzjoni 4.8).
English: The observed final median difference in the OS between the 2 treatment groups was 35 months.
Maltese: Il-medjan tad-differenza finali osservat fl-OS bejn iż-żewġ gruppi ta' trattament kien ta' 35 xahar.
English: Hepatic enzyme abnormality*
Maltese: • Diffikultà biex tibla'
English: The median TTP was 6.5 months for the VELCADE monotherapy patients compared with 9.3 months for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: It-TTP medjan kien ta' 6.5 xhur għall-monoterapija ta' VELCADE meta mqabbel ma' 9.3 xhur għall-pazjenti fuq terapija kkombinata ta' VELCADE flimkien ma' pegylated liposomal doxorubicin.
English: BSA-normalized clearance of bortezomib in pediatric patients was similar to that observed in adults.
Maltese: It-tneħħija ta' bortezomib bil-BSA normalizzat f'pazjenti pedjatriċi kienet tixbah lil dik osservata fl-adulti.
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 kien mogħti 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: When VELCADE is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Maltese: Meta VELCADE jingħata f'kombinazzjoni ma' prodotti mediċinali oħra, irreferi għas-Sommarju talKaratteristiċi tal-Prodott għal kontraindikazzjonijiet addizzjonali.
English: Two randomised, open-label, multicenter Phase III trials (IFM-2005-01, MMY-3010) were conducted to demonstrate the safety and efficacy of VELCADE 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 (IFM-2005-01, MMY-3010) saru biex juru s-sigurtà u l-effikaċja ta' VELCADE 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: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (VcR-CAP) 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, followed by a 10-day rest period on days 12-21.
Maltese: Terapija ta' kombinazzjoni ma' rituximab, cyclophosphamide, doxorubicin u prednisone (VcR-CAP) VELCADE 1 mg trab għal soluzzjoni għall-injezzjoni jingħata permezz ta' injezzjoni fil-vini bid-doża rrakkomandata ta' 1.3 mg/m2 ta' erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimgħatejn filjiem 1, 4, 8, u 11, segwit minn perjodu ta' mistireħ ta' 10 ijiem fil-jiem 12-21.
English: The median OS was 30.8 months (95% CI; 25.2-36.5 months) for the VELCADE monotherapy patients and 33.0 months (95% CI; 28.9-37.1 months) for the VELCADE plus pegylated liposomal doxorubicin combination therapy patients.
Maltese: 2-36.5 xhur) għall-pazjenti b'monoterapija ta' VELCADE u 33.0 xahar (95% CI; 28.9-37.1 xahar) għall-pazjenti li qed jieħdu terapija kombinata ta' VELCADE flimkien ma' doxorubicin liposomali pegilat.
English: Patient demographic and baseline disease charateristics were similar between the treatment groups.
Maltese: Id-demografiċi tal-pazjenti u l-karatteristiċi tal-mard fil-linja bażi kienu simili bejn il-gruppi ta' trattament.
English: Very Common Nausea and vomiting symptoms*, Diarrhoea*, Stomatitis*, Constipation
Maltese: Komuni ħafna Sintomi ta' nawsja u rimettar*, Dijarea*, Stomatite*, Stitikezza Komuni
English: Gastrointestinal haemorrhage (inc mucosal)*, Dyspepsia, Stomatitis*, Abdominal distension, Oropharyngeal pain*, Abdominal pain (inc gastrointestinal and splenic pain)*, Oral disorder*, Flatulence
Maltese: Emorraġija gastrointestinali (anke tal-mukosa)*, Dispepsja, Stomatite*, Distensjoni addominali, Uġigħ orofarinġeali*, Uġigħ ta' żaqq (li jinkludi uġigħ gastrointestinali u talmilsa)*, Disturb orali*, Gass
English: Grade of hepatic impairment*
Maltese: Infezzjoni fl-apparat tal-awrina*
English: VELCADE is given intravenously on days 1, 4, 8 and 11, followed by a ‘rest period' without treatment.
Maltese: VELCADE jingħata minn ġol-vina fil-jiem 1, 4, 8 u 11, segwit minn ‘perjodu ta' mistrieħ' mingħajr trattament.
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 jek jiġi tolerat 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: Antiviral prophylaxis is recommended in patients being treated with VELCADE.
Maltese: Profilassi antivirali hija rrakkomandata f'pazjenti li qed jiġu ttrattati b'VELCADE.
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcTDx=VELCADE, thalidomide, dexamethasone; TDx=thalidomide, dexamethasone; PR=partial response; OR=odds ratio * Primary endpoint
Maltese: TDx=thalidomide, dexamethasone; PR=partial response - rispons parzjali, OR=odds ratio - proporzjon ta' odds; TTP=Time to Progression - Żmien ta' progressjoni * Primary endpoint - L-ewwel punt aħħari
English: Orthostatic/postural hypotension was not acutely related to bolus infusion of VELCADE.
Maltese: L-ipotensjoni ortostatika/talqagħda ma kinitx relatata b'mod akut ma' infużjoni f'daqqa ta' VELCADE.
English: • Rectal pain
Maltese: • Uġigħ fir-rectum
English: • Genital swelling
Maltese: • Sfurija tal-ġilda
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; Vc=VELCADE; VcDx=VELCADE, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Maltese: ITT=intent to treat - maħsub għal trattament; RR=response rate - rata ta rispons; Vc=VELCADE; VcTDx=VELCADE, thalidomide, dexamethasone;
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, Perjodontite, Fissura anali, Bidla fid-drawwa ta' meta tipporga, Proktalġja, Ippurgar mhux normali
English: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: 1.1 Preparazzjoni tal-kunjett ta' 3.5 mg: b'attenzjoni żid 3.5 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab VELCADE billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Uncommon Vaginal haemorrhage, Genital pain*, Erectile dysfunction, Rare
Maltese: Mhux komuni Emorraġija vaġinali, Uġigħ fil-parti ġenitali*, Impotenza Rari
English: • If toxicity resolves i.e. patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL, VELCADE may be reinitiated at a dose reduced by one dose level (from 1.3 mg/m2 to 1 mg/m2, or from
Maltese: • Jekk it-tossiċità tgħaddi i.e. il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL, VELCADE jista' jerġa' jinbeda mill-ġdid bid-doża mnaqqsa b'livell wieħed ta' doża (minn 1.3 mg/m2 għal 1 mg/m2, jew minn
English: Limited information on VELCADE retreatment in relapsed multiple myeloma is available.
Maltese: Informazzjoni ristretta disponibbli dwar it-trattament mill-ġdid b'VELCADE f'majeloma multipla li rkadiet.
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 tal-ġog, Uġigħ fix-xedaq, Disturb talgħadam, Infezzjonijiet u infjammazzjonijiet muskuloskeletriċi u tat-tessut konnettiv*, Ċista sinovjali
English: Instructions for reconstitution
Maltese: Investigazzjonijiet Komuni
English: Patients in the VcR-CAP treatment arm received VELCADE (1.3 mg/m2; on days 1, 4, 8, 11, rest period days 12-21),
Maltese: Il-pazjenti fil-fergħa ta' trattament b'VcR-CAP irċivew VELCADE (1.3 mg/m fil-jiem 1, 4, 8, 11, perjodu ta' waqfien jiem 12-21), rituximab 375 mg/m2 IV fil-jum 1;
English: CR+nCR+ PR+MR
Maltese: CR+nCR+ PR+MR Tul medjan Jiem (xhur)
English: Rash*, Pruritus*, Erythema, Dry skin
Maltese: Prurite*, Dermatite*, Raxx*
English: #, Dermatitis*, Hair disorder*, Petechiae, Ecchymosis, Skin lesion, Purpura, Skin mass*, Psoriasis, Hyperhidrosis, Night sweats, Decubitus ulcer Acne*, Blister*, Pigmentation disorder*
Maltese: Disturb fix-xagħar*, Petekije, Eċċimosi, Ġerħa fuq il-ġilda, Purpura, Għoqda fil-ġilda*, Psorijasi, Iperidrosi, Għorieq bil-lejl, Ulċera dekubitè
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Maltese: Indipendenti (IRC - Independent Review Committee) (dejta radjuloġika biss).
English: Uncommon Renal failure acute, Renal failure chronic*, Urinary tract infection*, Urinary tract signs and symptoms*, Haematuria*, Urinary retention, Micturition disorder*, Proteinuria, Azotaemia, Oliguria*, Pollakiuria
Maltese: Mhux komuni Falliment akut tal-kliewi, Falliment kroniku tal-kliewi*, Infezzjoni fil-passaġġ awrinarju*, Sinjali u sintomi talpassaġġ awrinarju*, Ematurja*, Żamma awrinarja, Disturb ta' mikturizzjoni*, Proteinurja, Azotemija, Oligurja*, Pollakijurja
English: VELCADE 1 mg powder for solution for injection bortezomib
Maltese: VELCADE 1 mg trab għal soluzzjoni għall-injezzjoni Bortezomib
English: VELCADE 1 mg powder for solution for injection Bortezomib
Maltese: VELCADE 1 mg trab għal soluzzjoni għall-injezzjoni bortezomib
English: Uncommon Tumour lysis syndrome, Failure to thrive*, Hypomagnesaemia*, Hypophosphataemia*, Hyperkalaemia*, Hypercalcaemia*, Hypernatraemia*, Uric acid abnormal*, Diabetes mellitus*, Fluid retention
Maltese: Mhux komuni Sindromu ta' lisi tat-tumur, Falliment biex tkampa*, Ipomagnesemja*, Ipofosfatemija*, Iperkalemja*, Iperkalċemija*, Ipernatremija*, Aċidu Uriku abnormali*, Dijabete mellitus*, Żamma ta' fluwidu
English: Haemorrhage*, Thrombophlebitis (inc superficial), Circulatory collapse (inc hypovolaemic shock), Phlebitis, Flushing*, Haematoma (inc perirenal)*, Poor peripheral circulation*, Vasculitis, Hyperaemia (inc ocular)*
Maltese: #, 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: Blood gases abnormal*, Electrocardiogram abnormalities (inc QT prolongation)*, International normalised ratio abnormal*, Gastric pH decreased, Platelet aggregation increased, Troponin I increased, Virus identification and serology*, Urine analysis abnormal*
Maltese: Gassijiet fid-demm abnormali*, Abnormalità flelettrokardjogramma (li jinkludi żieda fit-titwil ta' QT)*, Proporzjon Internazzjonali normalizzat abnormali*, Tnaqqis fil-pH tal-istonku, Aggregazzjoni ta' plejtlits ogħla, Żieda f'Troponin I, Identifikazzjoni u seroloġija tal-vajrus*, Valuri tal-analiżi tal-awrina abnormali*
English: Progression-free survival Events n (%)
Maltese: Sopravivenza mingħajr progressjoni Każijiet n (%)
English: - The other ingredients are mannitol (E421) and nitrogen.
Maltese: - Is-sustanzi l-oħra huma mannitol (E 421) u nitrogen.
English: Pegylated liposomal doxorubicin is administered at 30 mg/m² on day 4 of the VELCADE treatment cycle as a 1 hour intravenous infusion administered after the VELCADE injection.
Maltese: Pegylated liposomal doxorubicin 30 mg/m2 jingħata f'jum 4 taċ-ċiklu ta' trattament ta' 21 jum ta' VELCADE bħala infużjoni ġol-vina wara l-injezzjoni b'VELCADE.
English: Management of orthostatic/postural hypotension may include adjustment of antihypertensive medicinal products, rehydration or administration of mineralocorticosteroids and/or sympathomimetics.
Maltese: It-trattament tal-ipotensjoni ortostatika/tal-qagħda jista' jinkludi bdil fid-doża ta' prodotti mediċinali kontra l-ipertensjoni, reidratazzjoni jew il-għoti ta' mineralokortikosterojdi u/jew simpatomimetiċi.
English: Phase III
Maltese: PN  Grad 3
English: TTP, days [95% CI] 1 year survival,
Maltese: TTP, jiem [95% CI]
English: When VELCADE is given together with pegylated liposomal doxorubicin, you will receive VELCADE intravenously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the VELCADE 21-day treatment cycle as an intravenous infusion after the VELCADE injection.
Maltese: Meta VELCADE jingħata flimkien ma' pegylated liposomal doxorubicin, inti ser tirċievi VELCADE ġol-vina jew taħt il-ġilda bħala ċiklu ta' trattament ta' 21 jum u pegylated liposomal doxorubicin 30 mg/m għandu jingħata f'jum 4 taċ-ċiklu ta' trattament ta' 21 jum ta' VELCADE bħala infużjoni ġolvina wara l-injezzjoni ta'VELCADE.
English: Dose adjustments during treatment and re-initiation of treatment for combination therapy with melphalan and prednisone
Maltese: Aġġustamenti fid-doża waqt it-trattament u trattament li jinbeda mill-ġdid għal terapija mħallta b'melphalan u prednisolone
English: • Hernia
Maltese: • Fratturi
English: These adverse reactions are based on an integrated data set of 5,476 patients of whom 3,996 were treated with VELCADE 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 b'VELCADE b'1.3 mg/m2 u inklużi f'Tabella 7.
English: If you have not been treated before for mantle cell lymphoma you will receive VELCADE intravenously together with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone.
Maltese: VcR-CAP=VELCADE, rituximab, cyclophosphamide, doxorubicin, u prednisone;
English: The median survival of all patients enrolled was 17 months (range < 1 to 36+ months).
Maltese: Il-medja ta' sopravvivenza tal-pazjenti kollha kienet ta' 17-il xahar (medda <1 sa 36+ xahar).
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a syringe of the appropriate size without removing the vial stopper.
Maltese: 1.1 Preparazzjoni tal-kunjett ta' 3.5 mg: b'attenzjoni żid 1.4 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab VELCADE billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: • Vaginal tears
Maltese: • Tiċrit vaġinali
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE treatment cycle.
Maltese: Dexamethasone jingħata mill-ħalq f'doża ta' 40 mg fil-jiem 1, 2, 3, 4, 8, 9, 10, u 11 taċ-ċiklu ta' trattament ta' VELCADE.
English: Common Hypersensitivity* Uncommon Anaphylactic reaction
Maltese: Sensittività eċċessiva* Mhux komuni Reazzjoni anafilattika
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: Uncommon 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
English: 8 cycles of VELCADE therapy.
Maltese: trattament b'VELCADE.
English: Response Evaluable Population n=73
Maltese: Popolazzjoni ta' Rispons li seta' jiġi Valutat n=73
English: Mantel-Haenszel estimate of the common odds ratio for stratified tables is used, with IPI risk and stage of disease as stratification factors.
Maltese: Qed tintuża l-istima Mantel-Haenszel tal-proporzjon ta' probabbiltà komuni għal tabelli stratifikati, bir-riskju IPI u l-istadju tal-marda bħala fatturi ta' stratifikazzjoni.
English: IV on day 1; and prednisone 100 mg/m 2 orally on day 1 through day 5 of the 21 day VELCADE
Maltese: 100 mg/m2 mill-ħalq minn jum 1sa jum 5 taċ-ċiklu ta' trattament ta' 21 jum b'VELCADE.
English: When VELCADE is given together with dexamethasone, you will receive VELCADE intravenously 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 VELCADE, 21-day treatment cycle.
Maltese: Meta VELCADE jingħata flimkien ma' dexamethasone, inti ser tirċievi VELCADE 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 taċċiklu ta' trattament ta' 21 jum ta' VELCADE.
English: • Infections, including pneumonia, respiratory infections, bronchitis, fungal infections, coughing with phlegm, flu like illness
Maltese: • Infezzjonijiet, li jinkludi pnewmonja, infezzjonijiet fl-apparat tan-nifs, bronkite, infezzjonijiet fungali, sogħla bil-bili, mard qisu bħal influwenza
English: • Lump in the eyelid (chalazion), red and swollen eyelids
Maltese: • Sfurija tal-għajnejn u l-ġilda (suffejra)
English: Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Maltese: Għalkemm f'pazjenti li kellhom ≥ 75 sena, kemm VcR-CAP kif ukoll R-CHOP kienu ttollerati anqas, ir-rata ta' każijiet avversi serji fil-gruppi ta' VcR-CAP kienet 68%, meta mqabbla ma' 42% fil-grupp ta' R-CHOP.
English: Each 5 ml vial of VELCADE must be carefully reconstituted with 1 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a 1 ml syringe, without removing the vial stopper.
Maltese: Kull kunjett ta' 5 ml ta' VELCADE irid ikun rikostitwit b'attenzjoni b'1 ml ta' 9 mg/ml (0.9%) soluzzjoni ta' sodium chloride għall-injezzjoni, billi tintuża siringa ta' 1 ml, mingħajr ma jitneħħa ttapp tal-kunjett.
English: When VELCADE is given in combination with thalidomide you must follow the pregnancy prevention programme for thalidomide (see package leaflet for thalidomide).
Maltese: Thalidomide huwa kontraindikat waqt it-tqala u f'nisa li jista' jkollhom it-tfal għajr meta l-kundizzjonijiet tal-programm ta' prevenzjoni ta' tqala ta' thalidomide jkunu sodisfatti.
English: • Facial blushing or tiny broken capillaries
Maltese: • Tħossok stordut
English: • Hiccups, speech disorders
Maltese: • Sulluzzu, disturbi marbuta mad-diskors
English: Patients with baseline Grade ≥ 2 peripheral neuropathy or platelet counts < 50,000/µl were excluded.
Maltese: Pazjenti bi grad ta' linja bażi ta' newropatija periferali ta' ≥ 2 jew b'għadd ta' plejtlits ta' <50,000/µl kienu esklużi.
English: Table 4: Posology for VELCADE combination therapy for patients with previously untreated multiple myeloma eligible for haematopoietic stem cell transplantation
Maltese: Tabella 4: Pożoloġija għal terapija kombinata b'Velcade għal pazjenti b'majeloma multipla li ma kienux ġew ittrattati qabel eliġibbli għal trapjant b'ċelluli steminali ematopojetiċi
English: Each 10 ml vial of VELCADE 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' VELCADE irid ikun rikostitwit b'attenzjoni 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.