FrancophonIA/ELRC3.0 huggingface dataset:
English: Very Common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Komuni ħafna Newropatiji*, Newropatija sensorjali periferika, Disestesija*, Newralġja*,
English: Grade ≥ 3 peripheral neuropathy occurred in 6% of patients in the subcutaneous treatment group, compared with 16% in the intravenous treatment group (p=0.0264).
Maltese: Newropatija periferali ta' Grad 3 seħħ f'6 % tal-pazjenti fil-grupp li ngħata t-trattament taħt il-ġilda meta mqabbel ma' 16 % fil-grupp li ngħata t-trattament ġol-vina (p=0.0264).
English: 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 intravenus 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 sistemika totali wara l-għoti ta' doża ripetuta (AUC
English: • Inflammation of the spinal nerve
Maltese: • Infjammazzjoni fin-nerv tal-ispina
English: A drug-drug interaction study assessing the effect of rifampicin, a potent CYP3A4 inducer, on the pharmacokinetics of bortezomib (injected intravenously), showed a mean bortezomib AUC reduction of 45% based on data from 6 patients.
Maltese: Studju ta' interazzjoni bejn il-mediċini li jistima l-effett ta' rifampicin, induttur qawwi ta' CYP3A4, fuq il-farmakokinetiċi ta' bortezomib (injettat ġol-vina), wera tnaqqis medju ta' 45% fl-AUC ta' bortezomib ibbażat minn dejta minn 6 pazjenti.
English: HBV infection with fatal outcomes occurred in 0.8% (n=2) of patients in the non-VELCADE treatment group (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; R-CHOP ) and 0.4% (n=1) of patients receiving VELCADE in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP).
Maltese: Infezzjoni b'HBV b'riżultati fatali seħħet f'0.8% (n=2) tal-pazjenti fil-grupp li ma kienx ittrattat b'VELCADE (rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone;
English: The duration of overall response was 21.4 months longer in the VcR-CAP group (median 36.5 months versus 15.1 months in the R-CHOP group).
Maltese: It-tul ta' żmien ta' rispons totali kien ta' 21.4 xhur itwal fil-grupp ta' VcR-CAP (medjan 36.5 xhur versus 15.1 xhur fil-grupp ta' R-CHOP).
English: Intravenous use: Add 3.5 ml 0.9% Sodium Chloride to make 1 mg/ml final concentration.
Maltese: Żid 3.5 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta'1 mg/ml.
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 ssottoarachnojdi)*, 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 fissistema nervuża
English: • Altered levels of consciousness, confusion, memory impairment or loss
Maltese: • Livelli mibdula ta' kuxjenza, konfużjoni, indeboliment tal-memorja jew telf ta' memorja
English: Mood disorders and disturbances*, Anxiety disorder*, Sleep disorders and disturbances*
Maltese: Disturbi u disturbanzi fl-imġieba*, Disturb tal-ansjetà*, Disturbi u disturbanzi fl-irqad*
English: #, Deep vein thrombosis*,
Maltese: #, Newrotossiċita,
English: Hepatitis B Virus (HBV) reactivation and infection When rituximab is used in combination with VELCADE, HBV screening must always be performed in patients at risk of infection with HBV before initiation of treatment.
Maltese: Riattivazzjoni u infezzjoni bil-Virus tal-Epatite B (HBV - Hepatitis B Virus) Meta rituximab jintuża flimkien ma' VELCADE, għandu dejjem isir ittestjar għal HBV f'pazjenti b'riskju ta' infezzjoni b'HBV qabel il-bidu tat-trattament.
English: Anaphylactic shock, Amyloidosis, Type III immune complex mediated reaction
Maltese: Xokk anafilattiku, Amilojdosi, Reazzjoni ta' Tip III permezz tal-kumpless immuni
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 ilpazjenti li rkadew fi żmien 18-il xahar sa 36 xahar mid-dijanjosi (n = 33) ir-rata ta' CR kienet 79% (95% CI: 61, 91) u r-rata ta' sopravivenza ta' 4 xhur mingħajr avvenimenti kienet 73% (95% CI: 54, 85).
English: Skin reaction, Jessner's lymphocytic infiltration, Palmarplantar 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, Sindromu ta' eritrodisestesija ta' Palmar-Plantar, Emorraġija taħt il-ġilda, Livedo reticularis, Ebusija tal-ġilda, Papule, Reazzjoni ta' fotosensittività, Seborrea, Għaraq kiesaħ, Disturb tal-ġilda NOS, Eritrosi, Ulċera tal-ġilda, Disturbi tad-dwiefer
English: 1.1 Preparation of the 1 mg vial: carefully add 1.0 ml of sterile, 9 mg/ml (0.9%) sodium chloride solution for injection to the vial containing the VELCADE powder by using a 1 ml syringe without removing the vial stopper.
Maltese: 1.1 Preparazzjoni tal-kunjett ta' 1 mg: b'attenzjoni żid 1.0 ml ta' 9 mg/ml (0.9%) ta' soluzzjoni sterili ta' sodium chloride għall-injezzjoni fil-kunjett li fih it-trab VELCADE billi tuża siringa ta' 1 ml mingħajr ma tneħħi t-tapp tal-kunjett.
English: Dexamethasone 40 mg is given orally on days 1, 2, 3, 4, 8, 9, 10 and 11 of the VELCADE 28-day treatment cycle and thalidomide is given orally daily at 50 mg up to day 14 of the first cycle, and if tolerated the thalidomide dose is increased to 100 mg on days 15-28 and may be further increased to 200 mg daily from the second cycle onwards.
Maltese: Dexamethasone 40 mg jingħata mill-ħalq fil-jiem 1, 2, 3, 4, 8, 9, 10 u 11 taċ-ċiklu ta' trattament ta' 28 jum ta' VELCADE u thalidomide għandu jingħata mill-ħalq kuljum f'doża ta' 50 mg sa jum 14 talewwel ċiklu, u jekk ittollerat id-doża ta' thalidomide tiżdied għal 100 mg fil-jiem 15-28 u tista' tiżdied aktar għal 200 mg kuljum mit-tieni ċiklu 'l quddiem.
English: Uncommon Infection*, Bacterial infections*, Viral infections*, Sepsis (inc septic shock)*, Bronchopneumonia, Herpes virus infection*, Meningoencephalitis herpetic
Maltese: Mhux komuni Infezzjoni*, Infezzjonijiet batteriċi*, Infezzjonijiet virali*, Sepsis (li jinkludi wkoll xokk settiku)*, Bronkopnewmonja, Infezzjoni tal-virus ta' Herpes*, Meningoenċefalite ħerpetika
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 120 ng/ml for the 1.3 mg/m2 dose.
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: VELCADE combination treatment with dexamethasone In the absence of any direct comparison between VELCADE and VELCADE in combination with dexamethasone in patients with progressive multiple myeloma, a statistical matched-pair analysis was conducted to compare results from the non randomised arm of VELCADE in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the VELCADE monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Maltese: Trattament ta' kombinazzjoni ta' VELCADE ma' dexamethasone Fin-nuqqas ta' tqabbil dirett bejn VELCADE u VELCADE f'kombinazzjoni ma' dexamethasone f'pazjenti b'majeloma multipla progressiva, saret analiżi statistika ta' tqabbil bejn pari sabiex jitqabblu riżultati mill-grupp mhux magħżul b'mod każwali ta' VELCADE flimkien ma' dexamethasone (listudju b'tikketta tingħaraf ta' Fażi II MMY-2045), ma' riżultati miksuba fil-gruppi ta' monoterapija ta' VELCADE minn studji differenti b'għażla każwali ta' Fażi
English: Gastrointestinal and intracerebral haemorrhage, have been reported in association with VELCADE treatment.
Maltese: Emorraġija gastrointestinali u intraċerebrali, ġiet irrappurtata b'rabta mat-trattament b'VELCADE.
English: In each Member State, the Marketing Authorisation Holder (MAH) shall agree the content and format of the educational material with the national competent authority.
Maltese: F'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħd fis-Suq (MAH) għandu jaqbel fuq il-kontenut u l-format tal-materjal edukattiv ma' kull awtorità nazzjonali kompetenti.
English: Then, VELCADE 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
Maltese: VELCADE jista' jerġa' jinbeda bi tnaqqis ta' livell 1 tad-doża (minn 1.3 mg/m2 għal 1 mg/m jew minn 1 mg/m2 għal 0.7 mg/m2).
English: Clinical efficacy in previously untreated mantle cell lymphoma (MCL) Study LYM-3002 was a Phase III, randomised, open-label study comparing the efficacy and safety of the combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP; n=243) to that of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; n=244) in adult patients with previously untreated MCL (Stage II, III or IV).
Maltese: III, open-label fejn il-pazjenti ntgħażlu b'mod każwali, li qabbel l-effikaċja u s-sigurtà tal-kombinazzjoni ta' VELCADE, rituximab, cyclophosphamide, doxorubicin, u prednisone (VcR-CAP; n=243) ma' dik ta' rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone (R-CHOP; n=244) f'pazjenti adulti b'MCL (Stadju II, III jew IV) li qatt ma kienet ittrattata qabel.
English: P-value from the Cochran Mantel-Haenszel chi-square test, with IPI and stage of disease as stratification factors.
Maltese: Valur p mit-test chi-squared ta' Cochran Mantel-Haenszel, bir-riskju IPI u l-istadju tal-marda bħala fatturi ta' stratifikazzjoni.
English: Median duration of follow up is 11.8 months
Maltese: Żmien medjan ta' follow hu 11.8 xhur
English: Mantle Cell Lymphoma (MCL) The safety profile of VELCADE in 240 MCL patients treated with VELCADE at 1.3 mg/m2 in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (VcR-CAP), versus 242 patients treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP] was relatively consistent to that observed in patients with multiple myeloma with main differences described below.
Maltese: Il-profil ta' sigurtà ta' VELCADE f'240 pazjent b'MCL ittrattati b'VELCADE bid-doża ta' 1.3 mg/m flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (VcR-CAP), versus 242 pazjent ittrattati b'rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone [R-CHOP] kien relattivament konsistenti ma' dak osservat f'pazjenti b'majeloma multipla biddifferenzi prinċipali deskritti taħt.
English: • Genital pain, problem having an erection
Maltese: • Uġigħ ġenitali, problemi biex ikollok erezzjoni
English: Peripheral embolism, Lymphoedema, Pallor, Erythromelalgia, Vasodilatation, Vein discolouration, Venous insufficiency
Maltese: Emboliżmu periferali, Limfoedema, Musfarija, Eritromelalġja, Twessigħ ta' vażi tad-demm, Tibdil fil-kulur tal-vini, Insuffiċjenza fil-vini
English: Each carton of VELCADE 3.5 mg powder for solution for injection contains a glass 10 ml vial with a royal blue cap, in a transparent blister pack.
Maltese: Kull kartuna ta' VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni fih kunjett tal-ħġieġ ta' 10 ml b'tapp blu jgħajjat, f'pakkett b'folja trasparenti.
English: Elderly MCL patients
Maltese: Pazjenti anzjani b'MCL
English: • ≥ Grade 3 neutropenia with fever, Grade 4 neutropenia lasting more than 7 days, a platelet count < 10,000 cells/μL
Maltese: • newtropenija bid-deni ≥ Grad 3, newtropenija ta' Grad 4 li ddum aktar minn 7 ijiem, u għadd taċ-ċelluli ta' < 10,000 ċellula/μL
English: Hypermagnesaemia*, Acidosis, Electrolyte imbalance*, Fluid overload, Hypochloraemia*, Hypovolaemia, Hyperchloraemia*, Hyperphosphataemia*, Metabolic disorder, Vitamin B complex deficiency, Vitamin B12 deficiency, Gout, Increased appetite, Alcohol intolerance
Maltese: Ipermagnesemja*,Aċidosi, Żbilanċ fl-elettroliti*, Mifqugħ bil-fluwidu, Ipokloremja*, Ipovolemja, Iperkloremja*, Iperfosfatemja*, Disturb metaboliku, Nuqqas fil-kompless ta' vitamina B, Nuqqas ta' vitamina B
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 (VELCADE plus dexamethasone, and VELCADE plus dexamethasone and thalidomide).
Maltese: • istruzzjonijiet dwar il-preskrizzjoni u l-għoti li jinkludu t-tul taċ-ċikli u l-għadd ta' ċikli, sabiex jiġi minimizzat ir-riskju ta' medikazzjoni u erruri ta' għoti indotti potenzjalment bl-eżistenza ta' żewġ programmi ta' trattament differenti b'bortezomib fil-kumbinazzjoni fl-Ambjent ta' Trapjant Indott (Transplant Inductive Setting) (VELCADE flimkien ma' dexamethasone, u VELCADE flimkien ma' dexamethasone u thalidomide);
English: Injection into a vein is rapid, taking 3 to 5 seconds.
Maltese: Linjezzjoni ġo vina ssir malajr, u tieħu minn 3 sa 5 sekondi.
English: Hazard ratio (95% CI)
Maltese: Medjan (95% CI)
English: In study LYM-3002 in which VELCADE 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 VELCADE ingħata flimkien ma' rituximab, cyclophosphamide, doxorubicin, u prednisone (R-CAP), l-inċidenza ta' newropatija periferali fl-iskedi ta' għoti ta' kombinazzjoni ta' mediċini, hija ppreżentata fit-tabella taħt:
English: VELCADE treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Maltese: It-trattament b'VELCADE b'mod komuni ħafna tiġi assoċjata ma' tossiċitajiet ematoloġiċi (tromboċitopenija, newtropenija u anemija).
English: • Breast disorders
Maltese: • Disturbi ċerebrovaskulari
English: In the Phase III study patients who received VELCADE 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 VELCADE.
Maltese: III, pazjenti li ħadu VELCADE taħt il-ġilda meta paragunati ma' dawk li ħaduħ ġolvina kellhom inċidenza globali ta' 13% inqas ta' reazzjonijiet avversi emerġenti li kienu ta' grad 3 jew ogħla fit-tossiċità, u inċidenza inqas ta' 5% ta' waqfien b'VELCADE.
English: Patients with moderate or severe hepatic impairment should be started on VELCADE at a reduced dose of 0.7 mg/m2 per injection during the first treatment cycle, and a subsequent dose escalation to 1.0 mg/m or further dose reduction to 0.5 mg/m 2 may be considered based on patient tolerability (see Table 6 and sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment moderat jew qawwi tal-fwied għandhom jinbdew fuq VELCADE bid-doża mnaqqsa ta' 0.7 mg/m2 f'kull injezzjoni waqt l-ewwel ċiklu ta' trattament, u sussegwentement tista' tiġi kkunsidrata żieda sa doża ta' 1.0 mg/m jew aktar tnaqqis sa doża ta' 0.5 mg/m 2 fuq bażi tat-tollerabiltà tal-pazjent (ara Tabella 6 u sezzjonijiet 4.4 u 5.2).
English: VELCADE therapy should be withheld for up to 2 weeks until the patient has an ANC ≥ 750 cells/μL and a platelet count ≥ 25,000 cells/μL.
Maltese: Terapija b'VELCADE m'għandhiex tingħata sa ġimagħtejn sakemm il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL.
English: VELCADE 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 VELCADE plus pegylated liposomal doxorubicin versus VELCADE 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 paralelli, bit-tikketta tingħaraf, u multiċentriku sar fuq 646 pazjent li qabbel is-sigurtà u l-effikaċja ta' VELCADE ma' pegylated liposomal doxorubicin kontra monoterapija b'VELCADE f'pazjenti b'majeloma multipla li kienu rċevew tal-anqas terapija waħda qabel u li ma' progressawx waqt li kienu qed jieħdu terapija abbażi ta' anthracycline.
English: You might receive up to 6 cycles (24 weeks).
Maltese: Tista' tirċievi sa 6 ċikli (24 ġimgħa).
English: Hepatic failure, Hepatomegaly, Budd-Chiari syndrome, Cytomegalovirus hepatitis, Hepatic haemorrhage, Cholelithiasis
Maltese: Falliment epatiku, Epatomegalija, Sindromu ta' BuddChiari, Epatite minħabba ċ-Ċitomeaglovirus, Emorraġija epatika, Kolelitijasi
English: Up to 8 cycles of this combination therapy can be administered as long as patients have not progressed and tolerate treatment.
Maltese: Sa 8 ċikli ta' din it-terapija ta' kombinazzjoni jistgħu jiġu amministrati kemm-il darba l-kundizzjoni fil-pazjent ma progressatx u trattament jiġi t-tollerat.
English: You might receive up to 8 cycles (24 weeks).
Maltese: Tista tirċievi sa 8 ċikli (24 ġimgħa).
English: Day 29 rest period
Maltese: Jum 29 perjodu ta' mistrieħ
English: #, Bacteraemia (inc staphylococcal), Hordeolum, Influenza, Cellulitis, Device related infection, Skin infection*, Ear infection*, Staphylococcal infection, Tooth infection*
Maltese: #, Bakteremja (anke ta' staphylococcus), Hordeolum, Influwenza, Ċellulite, Infezzjoni marbut malapparat, Infezzjoni tal-ġilda*, Infezzjoni tal-widna*, Infezzjoni ta' Staphylococcus *, Infezzjoni tas-snien*
English: Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving VELCADE.
Maltese: Sindromu ta' Enċefalopatija Posterjuri Riversibbli (PRES - Posterior Reversible Encephalopathy Syndrome)
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy VcR-CAP (N=240)
Maltese: Inċidenza ta' newropatija periferali fl-istudju LYM-3002 skont it-tossiċità u l-waqfien tattrattament minħabba newropatija periferali
English: Because bortezomib is a cytotoxic agent and can rapidly kill malignant plasma cells and MCL cells, the complications of tumour lysis syndrome may occur.
Maltese: Billi bortezomib huwa sustanza ċitotossika u jista' joqtol malajr iċ-ċelluli malinni tal-plażma u ċċelluli ta' MCL, jista' jkun hemm komplikazzjonijiet tas-sindromu tal-lisi tat-tumur.
English: (95% CI)=1.428 (0.749; 2.722) p-value g=0.275
Maltese: 749; 2.722) valur p g=0.275
English: Incidence
Maltese: • Ftuq
English: When thalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see section 4.6).
Maltese: Meta jintuża thalidomide attenzjoni partikolari għal testijiet ta' tqala u rekwiżiti ta' prevenzjoni hija meħtieġa (ara sezzjoni 4.6).
English: • Hiccups
Maltese: • puplesiji
English: A median of 6 cycles was received by patients in both treatment arms with 14% of subjects in the VcR-CAP group and 17% of patients in the R-CHOP group receiving 2 additional cycles.
Maltese: Il-pazjenti rċivew medjan ta' 6 ċikli fiż-żewġ fergħat ta' trattament b'14% tal-individwi fil-grupp ta' VcR-CAP u 17% tal-pazjenti fil-grupp ta' R-CHOP jirċievu 2 ċikli addizzjonali.
English: Table 16: Efficacy results from study LYM-3002
Maltese: Riżultati ta' effikaċja mill-istudju LYM-3002
English: • Herpes virus infections
Maltese: • Infezzjonijiet bil-virus tal-herpes
English: 0.7 mg/m2).
Maltese: 1.0 mg/m2 imnaqqsa għal 0.7 mg/m2).
English: Uncommon Pancreatitis (inc chronic)*, Haematemesis, Lip swelling*, Gastrointestinal obstruction (inc small intestinal obstruction, ileus)*, Abdominal discomfort, Oral ulceration*, Enteritis*, Gastritis*, Gingival bleeding, Gastrooesophageal reflux disease*, Colitis (inc clostridium difficile)*, Colitis ischaemic
Maltese: Mhux komuni Pankreatite (anke kronika)*, Ematemesi, Nefħa taxxofftejn*, Imblukkar gastrointestinali (inkluż imblukkar talmusrana ż-żgħira, ileus)*, Dwejjaq addominali, Postumetti*, Enterite*, Gastrite*, Emorraġija ġenġivali, Mard ta' refluss gastroesofaġeali*, Kolite (li jinkludi clostridium difficile)*, Kolite iskemika
English: • Movement disorders, paralysis, twitching
Maltese: • Disturbi fiċ-ċaqlieq, paraliżi, ġbid involontarju tal-muskoli
English: Very Common Pneumonia* Common Sepsis (inc septic shock)*, Herpes zoster (inc disseminated & ophthalmic), Herpes virus infection*, Bacterial infections*, Upper/lower respiratory tract infection*, Fungal infection*, Herpes simplex* Uncommon Hepatitis B, Infection*, Bronchopneumonia
Maltese: Sepsi (inkluż xokk settiku)*, Herpes zoster (inkluż mifrux u talgħajn), Infezzjoni bil-virus tal-herpes*, Infezzjonijiet bilbatterji*, Infezzjoni fil-passaġġ tan-naħa ta' fuq/ta' taħt tannifs*, Infezzjoni bil-fungu*, Herpes simplex* Mhux komuni Epatite B, Infezzjoni*, Bronkopnewmonja
English: This leaflet was last revised in
Maltese: Punt finali ta' effikaċja
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 ilfarmakokinetici ta' bortezomib (injettat ġol-vina) wera żieda medja fl-AUC ta' 17 % abbażi ta' dejta minn 21 pazjent.
English: Bortezomib mediated proteasome inhibition affects cancer cells in a number of ways, including, but not limited to, altering regulatory proteins, which control cell cycle progression and nuclear factor kappa B (NF-kB) activation.
Maltese: L-inibizzjoni tal-proteasome permezz ta' bortezomib jaffettwa ċ-ċelluli tal-kanċer b'diversi modi, inkluż, imma mhux limitat, għall-bdil tal-proteini regolatorji, li jikkontrollaw iċ-ċiklu tal-progressjoni taċ-ċellula u l-attivazzjoni tal-fattur nukleari kappa B (NF-kB).
English: VELCADE 3.5 mg powder for solution for injection Bortezomib
Maltese: VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni bortezomib
English: VELCADE 3.5 mg powder for solution for injection bortezomib
Maltese: VELCADE 3.5 mg trab għal soluzzjoni għall-injezzjoni Bortezomib
English: Dexamethasone is administered orally at 20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 of the VELCADE treatment cycle.
Maltese: Dexamethasone għandu jiġi amministrat mill-ħalq f'doża ta' 20 mg fil-jiem 1, 2, 4, 5, 8, 9, 11, u 12 tat-trattament taċ-ċiklu ta' VELCADE.
English: • Cough
Maltese: • Mewt
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) flanaliżi 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.