FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacokinetics of bortezomib were characterized following twice weekly intravenous bolus administration of 1.3 mg/m2 doses to 104 pediatric patients (2-16 years old) with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
Maltese: Il-farmakokinetika ta' bortezomib ġiet ikkaratterizzata wara għoti ta' injezzjoni f'daqqa ta' dożi ta' 1.3 mg/m2 darbtejn fil-ġimgħa fil-vina lil 104 pazjenti pedjatriċi (2-16-il sena) b'lewkimja limfoblastika akuta (ALL - acute lymphoblastic leukemia) jew lewkimja mijelojde akuta (AML - acute myeloid leukemia).
English: Undesirable effects in Table 7 were considered by the investigators to have at least a possible or probable causal relationship to VELCADE.
Maltese: L-effetti mhux mixtieqa f'Tabella 7 tqiesu mill-investigaturi li kienu possibbilment jew probabbilment ikkawżati minn VELCADE.
English: Bortezomib was not genotoxic when tested in the in vitro mutagenicity assay (Ames assay) and in vivo micronucleus assay in mice.
Maltese: Bortezomib ma kienx ġenotossiku meta kien ittestjat in vitro għal bidliet ġenetiċi (assaġġ ta' Ames) u in vivo f'eżami mikronukleju fil-ġrieden.
English: The majority of the patients in both groups completed treatment, 80% in the VcR-CAP group and 82% in the R-CHOP group.
Maltese: Il-maġġoranza tal-pazjenti fiżżewġ gruppi temmew it-trattament, 80% fil-grupp ta' VcR-CAP u 82% fil-grupp ta' R-CHOP.
English: Median PFS by investigator assessment was 30.7 months in the VcR-CAP group and 16.1 months in the R-CHOP group (Hazard Ratio [HR]=0.51; p < 0.001).
Maltese: Il-medjan ta' PFS skont il-valutazzjoni mill-investigatur kienet 30.7 xhur fil-grupp ta' VcR-CAP u 16.1 xhur fil-grupp ta' R-CHOP (Proporzjon ta' periklu [HR]=0.51; p < 0.001).
English: 1-year Overall Survival (%) (95% CI)
Maltese: Sopravivenza Globali ta' sena (%) (95% CI)
English: Secondary efficacy endpoints included post-transplant response rates (CR+nCR, CR+nCR+VGPR+PR), Progression Free Survival and Overall Survival.
Maltese: Punti aħħarin ta' effikaċja sekondarji kienu jinkludu r-rati ta' rispons ta' wara t-trapjant (CR+nCR, CR+nCR+VGPR+PR), is-Sopravivenza Mingħajr Progressjoni u s-Sopravivenza Globali.
English: VcR-CAP=VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone; R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; PN=peripheral neuropathy Peripheral neuropathy included the preferred terms: peripheral sensory neuropathy, neuropathy peripheral, peripheral motor neuropathy, and peripheral sensorimotor neuropathy
Maltese: R-CHOP= rituximab, cyclophosphamide, doxorubicin, vincristine, u prednisone; PN=newropatija periferali (peripheral neuropathy) Newropatija periferali kienet tinkludi t-termini ppreferuti: newropatija tas-sensazzjoni periferali, newropatija periferali, newropatija motorja periferali, u newropatija sensimotorja periferali
English: Therefore, patients should be closely monitored when given bortezomib in combination with potent CYP3A4 inhibitors (e.g. ketoconazole, ritonavir).
Maltese: Għalhekk il-pazjenti għandhom jiġu mmonitorjati bir-reqqa meta jingħataw bortezomib flimkien ma' inibituri potenti CYP3A4 (eż., ketoconazole, ritonavir).
English: • Benign cysts
Maltese: • Ċisti beninni
English: Overall, VELCADE was administered for the treatment of multiple myeloma in 3,974 patients.
Maltese: B'kollox, VELCADE ġie mgħoti lil 3,974 pazjent għal trattament ta' majeloma multipla.
English: *RR (Post-induction) CR+nCR
Maltese: *RR (Wara l-induzzjoni) CR+nCR
English: Include all CR+CRu, by IRC, bone marrow and LDH.
Maltese: Jinkludi is-CR + Cru kollha, mill-IRC, mill-mudullun tal-għadam u LDH.
English: Very Common Musculoskeletal pain* Common
Maltese: Komuni ħafna Uġigħ muskoloskeletriku* Komuni
English: 42.9% and 10.4% of patients in the VcR-CAP arm were in the range 65-74 years and ≥ 75 years of age, respectively.
Maltese: 4% tal-pazjenti fil-fergħa ta' VcR-CAP kienu fil-firxa ta' età bejn 65-74 sena u ≥ 75 sena, rispettivament.
English: Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
Maltese: Kull kunjett fih 1 mg ta' bortezomib (bħala mannitol boronic ester).
English: In study MMY-3010 induction treatment withVELCADE combined with thalidomide and dexamethasone [VcTDx, n=130] was compared to thalidomide-dexamethasone [TDx, n=127].
Maltese: Fl-istudju MMY-3010 it-trattament ta' induzzjoni b'VELCADE flimkien ma' thalidomide u dexamethasone [VcTDx, n=130] kien imqabbel ma' dak ta' thalidomide-dexamethasone [TDx, n=127].
English: Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
Maltese: Kull kunjett fih 3.5 mg ta' bortezomib (bħala mannitol boronic ester).
English: It is unknown if the pharmacokinetics of bortezomib are influenced in patients with severe renal impairment not undergoing dialysis (CrCL < 20 ml/min/1.73 m2).
Maltese: Mhuwiex magħruf jekk il-farmakokinetika ta' bortezomib hijiex influwenzata f'pazjenti b'indeboliment qawwi tal-kliewi li mhumiex qegħdin fuq id-dijalisi (CrCL < 20 ml/min/1.73 m2).
English: Acute diffuse infiltrative pulmonary and pericardial disease.
Maltese: Mard pulmonari u perikardjali akut diffuż u infiltrattiv.
English: Respiratory failure, Acute respiratory distress syndrome, Apnoea, Pneumothorax, Atelectasis, Pulmonary hypertension, Haemoptysis, Hyperventilation, Orthopnoea, Pneumonitis, Respiratory alkalosis, Tachypnoea, Pulmonary fibrosis, Bronchial disorder*, Hypocapnia*, Interstitial lung disease, Lung infiltration, Throat tightness, Dry throat, Increased upper airway secretion, Throat irritation, Upper-airway cough syndrome
Maltese: Falliment respiratorju, Sindromu ta' distress respiratorju akut, Apnea, Pnewmotoraks, Atelektasi, Pressjoni għolja flarterji pulmonari, Emoptisi, Iperventilazzjoni, Ortopnea, Pnewmonite, Alkalosi respiratorja, Takipnea, Fibrosi pulmonari, Disturb bronkjali*, Ipokapnija*, Mard talpulmun interstizzjali, Infiltrazzjoni tal-pulmun, Griżmejn issikkati, Griżmejn xotti, Aktar tnixxija fil-passaġġ tal-arja, Irritazzjoni tal-griżmejn, Sindromu tas-sogħla tal-passaġġ ta' fuq
English: Reduce VELCADE to 1.0 mg/m or
Maltese: Naqqas VELCADE għal 1.0 mg/m jew
English: infestations
Maltese: Disturbi
English: • different reconstitution requirements for VELCADE 3.5 mg IV or SC use
Maltese: • ħtiġijiet ta' rikostituzzjoni differenti għall-użu ta' Velcade 3.5 mg IV jew SC
English: In patients aged ≥ 75 years, both regimens, VcR-CAP as well as R-CHOP, were less tolerated (see section 4.8).
Maltese: F'pazjenti li kellhom ≥ 75 sena, iż-żewġ skedi ta' trattament, VcR-CAP kif ukoll R-CHOP, kienu ttollerati inqas (ara sezzjoni 4.8).
English: Subcutaneous use: Add 1.4 ml 0.9% Sodium Chloride to make 2.5 mg/ml final concentration.
Maltese: Żid 1.4 ml ta' 0.9% Sodium Chloride sabiex tagħmel konċentrazzjoni finali ta' 2.5 mg/ml.
English: Hepatitis B Virus (HBV) reactivation and infection Mantle cell lymphoma
Maltese: Riattivazzjoni tal-Virus tal-Epatite B u infezzjoni bil-Virus tal-Epatite B (HBV - Hepatitis B Virus) Limfoma taċ-ċellula mantle
English: A Phase II, single-arm activity, safety, and pharmacokinetic trial conducted by the Children's Oncology Group assessed the activity of the addition of bortezomib to multi-agent re-induction chemotherapy in paediatric and young adult patients with lymphoid malignancies (pre-B cell acute lymphoblastic leukemia [ALL], T-cell ALL, and T-cell lymphoblastic lymphoma [LL]).
Maltese: II, b'fergħa waħda ta'attività, sigurtà u farmakokinetika li saret mill-Grupp ta' Onkoloġija tat-Tfal (Children's Oncology Group) ivvalutat l-attività taż-żieda ta' bortezomib ma' kimoterapija ta' induzzjoni mill-ġdid b'ħafna sustanzi f'pazjenti pedjatriċi u pazjenti adulti żgħar b'tumuri malinni tal-limfojd (lewkimja limfoblastika akuta ta' qabel iċ-ċelluli B [ALL] ALL taċċelluli T, u b'limfoma limfoblastika taċ-ċelluli T [LL]).
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: The Cmax after subcutaneous administration (20.4 ng/ml) was lower than intravenous (223 ng/ml).
Maltese: max wara l għoti ta' taħt il-ġilda (20.4 ng/ml) kien aktar baxx minn ta' ġol-vina (223 ng/ml).
English: Autologous stem cell transplants were received by 198 (82%) patients and 208 (87%) patients in the VDDx and VcDx groups respectively; the majority of patients underwent one single transplant procedure.
Maltese: Trapjanti ta' ċelluli steminali awtologi ġew mogħtija f'198 (83%) u 208 (87%) tal-pazjenti fil-gruppi VDDx u VcDx rispettivament;
English: Date of first authorisation: 26 April 2004
Maltese: Data tal-ewwel awtorizzazzjoni: 26 t'April 2004
English: The concentration of the resulting solution will be 1 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni li tinkiseb tkun ta' 1 mg/ml.
English: Twice weekly VELCADE (cycles 1-4)
Maltese: VELCADE darbtejn fil-ġimgħa (ċikli 1-4)
English: Notable differences in the MCL patient population as compared to patients in the multiple myeloma studies were a ≥ 5% higher incidence of the haematological adverse reactions (neutropenia, thrombocytopenia, leukopenia, anemia, lymphopenia), peripheral sensory neuropathy, hypertension, pyrexia, pneumonia, stomatitis, and hair disorders.
Maltese: Differenzi li setgħu jiġu nnutati fil-popolazzjoni ta' pazjenti b'MCL meta mqabbla ma' pazjenti fl-istudji ta' majeloma multipla kienu inċidenza ta' ≥ 5% ogħla fir-reazzjonijiet ematoloġiċi avversi (newtropenija, tromboċitopenija, lewkopenija, anemija, limfopenija), newropatija tassensazzjoni periferali, pressjoni għolja, deni, pulmonite, stomatite u disturbi fix-xagħar.
English: • In cycles 5 to 9, VELCADE is administered once weekly on days 1, 8, 22 and 29.
Maltese: • Fiċ-ċikli minn 5 sa 9, VELCADE jingħata darba fil-ġimgħa fil-jiem 1, 8, 22 u 29.
English: A hazard ratio < 1 indicates an advantage for VcR-CAP.
Maltese: Proporzjon ta' periklu ta' < 1 jindika vantaġġ għal VcR-CAP.
English: Time to progression Events n (%) Median a (95% CI)
Maltese: Żmien għall-progressjoni Każijiet n (%) Medjan a (95% CI)
English: Overall survival* Events (deaths) n (%) Median (95% CI)
Maltese: Sopravivenza totali* Każijiet (imwiet) n (%) Medjan (95% CI)
English: Following intravenous bolus administration of a 1.0 mg/m2 and 1.3 mg/m2 dose to 11 patients with multiple myeloma and creatinine clearance values greater than 50 ml/min, the mean first-dose maximum plasma concentrations of bortezomib were 57 and 112 ng/ml, respectively.
Maltese: Assorbiment Wara li ngħataw dożi f'daqqa fil-vina ta' 1.0 mg/m2 u 1.3 mg/m2 lil 11-il pazjent b'majeloma multipla u b'valuri ta' tneħħija tal-kreatinina ikbar minn 50 ml/min, il-medja ta' konċentrazzjonijiet massimi ta' bortezomib fil-plażma wara l-ewwel doża kienu ta' 57 u 112 ng/ml, rispettivament.
English: The most commonly reported adverse reactions during treatment with VELCADE are nausea, diarrhoea, constipation, vomiting, fatigue, pyrexia, thrombocytopenia, anaemia, neutropenia, peripheral neuropathy (including sensory), headache, paraesthesia, decreased appetite, dyspnoea, rash, herpes zoster and myalgia.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni waqt trattament b'VELCADE huma nawsja, dijarea, stitikezza, rimettar, għeja, deni, tromboċitopenija, anemija, newtropenija, newropatija periferali (inkluż tas-sensi), uġigħ ta' ras, parestesija, nuqqas t'aptit, qtugħ ta' nifs, raxx, herpes zoster u mijalġja.
English: The demographic and baseline disease characteristics were generally well balanced between the two treatment arms: median patient age was 66 years, 74% were male, 66% were Caucasian and 32% Asian, 69% of patients had a positive bone marrow aspirate and/or a positive bone marrow biopsy for MCL, 54% of patients had an International Prognostic Index (IPI) score of ≥ 3, and 76% had Stage IV disease.
Maltese: Il-karatteristiċi demografiċi u fil-linja bażi tal-marda kienu b'mod ġenerali bbilanċjati tajjeb bejn iżżewġ fergħat ta' trattament: il-medjan tal-età tal-pazjenti kienet 66 sena, 74% kienu rġiel, 66% kienu Kawkasiċi u 32% Ażjatiċi, 69% tal-pazjenti kellhom materjal miġbud mill-mudullun tal-għadam pożittiv u/jew bijopsija tal-mudullun tal-għadam pożittiva għal MCL, 54% tal-pazjenti kellhom punteġġ ta' Indiċi Internazzjonali ta' Pronjożi (IPI - International Prognostic Index) ta' ≥ 3, u 76% kellhom marda tal-Istadju IV.
English: Response Rate at 8 cycles n (%) ORR (CR+PR) p-value
Maltese: Rata ta' Rispons wara 8 ċikli n (%) ORR (CR+PR)
English: Leukopenia*, Anaemia*, Lymphopenia* Uncommon Pancytopenia*
Maltese: Lewkopenija*, Anemija*, Limfopenija* Mhux komuni Panċitopenija*
English: OR; 95% CI; P value
Maltese: TDx jew; 95% CI; VALUR P
English: Bortezomib is a cytotoxic agent.
Maltese: Bortezomib hija sustanza ċitotossika.
English: • In cycles 1 to 4, VELCADE is administered twice weekly on days 1, 4, 8, 11, 22, 25, 29 and 32.
Maltese: • Fiċ-ċikli minn 1 sa 4, VELCADE jingħata darbtejn fil-ġimgħa fil-jiem 1, 4, 8, 11, 22, 25, 29 u
English: There have been fatal cases of inadvertent intrathecal administration of VELCADE.
Maltese: VELCADE bħala infużjoni ta' siegħa ġol-vina amministrata wara l-injezzjoni ta' VELCADE.
English: Exposure of VELCADE (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Maltese: max normalizzati għad-doża) kien komparabbli fost il-gruppi kollha (ara sezzjoni 4.2).
English: Uncommon Mental disorder*, Hallucination*, Psychotic disorder*, Confusion*, Restlessness
Maltese: Mhux komuni Disturb mentali*, Alluċinazzjoni*, Disturb psikotiku*, Konfużjoni*, Irrikwitezza
English: #, Neurotoxicity, Seizure disorders*, Post herpetic neuralgia, Speech disorder*, Restless legs syndrome, Migraine, Sciatica, Disturbance in attention, Reflexes abnormal*, Parosmia
Maltese: Disturbi pupletiċi*, Newralġja post herpetika, Disturb fiddiskors*, Sindromu ta' irrikwitezza fir-riġlejn, Emigranja, Xjatika, Disturb fl-attenzjoni, Abnormalita fir-riflessi*, Parosmija
English: In vitro studies with human liver microsomes and human cDNA-expressed cytochrome P450 isozymes indicate that bortezomib is primarily oxidatively metabolised via cytochrome P450 enzymes, 3A4, 2C19, and 1A2.
Maltese: Studji in vitro b'mikromożomi ta' fwied uman u isożimi P450 ċitokromiċi espressi minn cDNA uman jindikaw li bortezomib huwa primarjament metabolizzat bl-ossiġnu permezz ta' isożimi P450 ċitokromiċi, 3A4, 2C19, u 1A2.
English: • Fungal infections
Maltese: • Ċirkolazzjoni insuffiċjenti
English: Median survival for the Vc+M+P treatment group was 56.4 months compared to 43.1 for the M+P treatment group.
Maltese: Is-sopravivenza medjana fil-grupp ta' trattament Vc+M+P kienet ta' 56.4 xhur ikkumparat ma' 43.1 fil-grupp ta' trattament M+P.
English: Efficacy results are presented in Table 15:
Maltese: Tabella 15:
English: • seizures
Maltese: • Korrimenti
English: The primary efficacy endpoint was TTP while the secondary efficacy endpoints were OS and ORR (CR+PR), using the European Group for Blood and Marrow Transplantation (EBMT) criteria.
Maltese: Il-punt aħħari ta' effikaċja prinċipali kien TTP waqt li punti aħħarin ta' effikaċja sekondarji kienu OS u ORR (CR+PR), permezz tal-kriterji tal-Grupp Ewropew dwar Trapjanti ta' Demm u Mudullun (EBMT-European Group for Blood and Bone Marrow Transplantation).
English: Patients in the VcTDx group received six 4-week cycles, each consisting of VELCADE (1.3 mg/m administered twice weekly days 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 VcTDx kellhom sitt ċikli ta' 4 ġimgħat, li kull wieħed minnhom kien jikkonsisti minn VELCADE (1.3 mg/m 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 l-jiem 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 kul jum).
English: This survival was greater than the six-to-nine month median survival anticipated by consultant clinical investigators for a similar patient population.
Maltese: Din is-sopravvivenza kienet ikbar mill-medja ta' sopravvivenza ta' bejn 6 u 9 xhur antiċipata mill-investigaturi kliniċi konsulenti għal popolazzjoni simili ta' pazjenti.
English: #, Gastrointestinal inflammation*, Dysphagia, Irritable bowel syndrome, Gastrointestinal disorder NOS, Tongue coated, Gastrointestinal motility disorder*, Salivary gland disorder*
Maltese: #,Infjammazzjoni gastrointestinali*, Disfaġja, Sindromu ta' imsaren irritabbli, Disturb gastrointestinali
English: Aplasia, Gastrointestinal malformation, Ichthyosis
Maltese: Aplasja, Malformazzjoni gastrointestinali, Iktijosi,
English: Prednisone is given orally at 100 mg/m 2 on days 1, 2, 3, 4 and 5 of the VELCADE treatment cycle.
Maltese: Prednisone jingħata mill-ħalq bid-doża ta' 100 mg/m2 fil-jiem 1, 2, 3, 4 u 5 taċ-ċiklu ta' trattament b'VELCADE.
English: Uncommon Erythema multiforme, Urticaria, Acute febrile neutrophilic dermatosis, Toxic skin eruption, Toxic epidermal necrolysis Stevens-Johnson syndrome
Maltese: Mhux komuni Eritema multiforme, Urtikarja, Dermatosi newtrofilika akuta bid-deni, Infafet tossiċi fuq il-ġilda, Nekrosi epidermali tossika
English: There have been rare reports of acute diffuse infiltrative pulmonary disease of unknown aetiology such as pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS) in patients receiving VELCADE (see section 4.8).
Maltese: Kien hemm rapporti rari ta' mard pulmonari akut infiltrat b'mod diffuż b'etjoloġija mhix magħrufa bħal pulmonite, pnewmonja interstitjali, infiltrazzjoni tal-pulmun, sindromu ta' għeja respiratorja akuta (ARDS) f'pazjenti li kienu qed jieħdu VELCADE (ara sezzjoni 4.8).
English: In the Phase III study comparing VELCADE administered intravenously versus subcutaneously, the incidence of Grade  2 peripheral neuropathy events was 24% for the subcutaneous injection group and 41% for the intravenous injection group (p=0.0124).
Maltese: III li qabbel VELCADE mogħti ġol-vina kontra dak li ngħata taħt il-ġilda, linċidenza ta' każijiet ta' newropatija periferali ta' Grad  2 kien ta' 24 % għall-grupp li ngħata linjezzjoni taħt il-ġilda u 41 % għall-grupp li ngħata l-injezzjoni ġol-vina (p=0.0124).
English: The median duration of treatment was 13 weeks for the VDDx group and 11 weeks for the VcDx group.
Maltese: It-tul medjan ta' trattament kien ta' 13-il ġimgħa għallgrupp VDDx u 11-il ġimgħa għall-grupp VcDx.
English: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value
Maltese: Rata ta' Rispons wara 4 ċikli n (%) ORR (CR+PR)
English: Table 3: Posology modifications during subsequent cycles of VELCADE therapy in combination with melphalan and prednisone
Maltese: Tabella 3: Modifikazzjonijiet fil-pożoloġija waqt ċikli sussegwenti ta' terapija b'VELCADE flimkien ma' melphalan u prednisolone
English: P-2740-262 PORTO SALVO Tel: +351 214 368 600
Maltese: P-2740-262 PORTO SALVO
English: Vc=VELCADE; Dex=dexamethasone CR=Complete Response; nCR=near Complete response PR=Partial Response; MR=Minimal response
Maltese: CR = Rispons Kompleta (Complete Response); nCR= viċin ir-Rispons Kompleta (near Complete Response) PR = Rispons Parzjali (Partial Response);
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 Severità tan-newropatija
English: Frequencies are defined as: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: <1/10); mhux komuni (1/1,000 sa <1/100); rari (1/10,000 sa <1/1,000); rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: • Platelet counts should be ≥ 100,000 cells/μL and the absolute neutrophils count (ANC) should be ≥ 1,500 cells/μL
Maltese: absolute neutrophils count) għandu jkun ≥ 1,500 ċellula/μL
English: VELCADE 3.5 mg 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' VELCADE 3.5 mg 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: #, Cardio-pulmonary arrest*, Cardiac fibrillation (inc atrial), Cardiac failure (inc left and right ventricular)*, Arrhythmia*, Tachycardia*, Palpitations, Angina pectoris, Pericarditis (inc pericardial effusion)*, Cardiomyopathy*, Ventricular dysfunction*, Bradycardia
Maltese: Fibrilazzjoni kardijaka (anke atriali), Insuffiċjenza kardijaku (li jinkludi l-ventrikulu tax-xellug u l-lemin)*, Arritmija*, Takikardja*, Palpitazzjonijiet, Anġina pektoris, Perikardite (li jinkludi effużjoni perikardjali)*, Kardijomijopatija*, Disfunzjoni ventrikulari*, Bradikardja
English: N=240 (ITT population) N=242 (ITT population)
Maltese: N=242 (popolazzjoni ITT)
English: A pharmacokinetic study was conducted in patients with various degrees of renal impairment who were classified according to their creatinine clearance values (CrCL) into the following groups: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate
Maltese: Normali (CrCL ≥60 ml/min/1.73 m2, n=12), Ħafif (CrCL=40-59 ml/min/1.73 m2, n=10), Moderat
English: (60 mg/m2) in patients with previously untreated multiple myeloma.
Maltese: (60 mg/m2) f'pazjenti b'majeloma multipla li qatt ma kienet ittrattata qabel.
English: Granulocyte colony stimulating factors may be administered for haematologic toxicity according to local standard practice.
Maltese: Fatturi stimulanti tal-kolonja ta' granuloċiti jistgħu jingħataw għal tossiċità ematoloġika skont ilprattika lokali standard.
English: Atrial flutter, Myocardial infarction*, Atrioventricular block*, Cardiovascular disorder (inc cardiogenic shock), Torsade de pointes, Angina unstable, Cardiac valve disorders*, Coronary artery insufficiency, Sinus arrest
Maltese: Petpita atrijali, Infart mijokardjali*, Imblokk atrijoventrikulari*, Disturb kardjovaskulari (li jinkludi xokk kardjoġeniku), Torsade de pointes, Anġina mhux stabbli, Disturbi tal-valv kardijaku*, Insuffiċjenza tal-arterja koronarja, Arrest tas-sinus
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 filgrupp ta' ġol-vina.
English: Seizures
Maltese: Kwalunkwe
English: Patients with renal impairment should be monitored closely (see sections 4.2 and 5.2).
Maltese: Pazjenti b'indeboliment tal-kliewi għandhom jiġu mmonitorjati bir-reqqa (ara sezzjonijiet 4.2 u 5.2).
English: Note: An OR > 1 indicates an advantage for Vc-containing induction therapy
Maltese: Nota: OR > 1 jindika vantaġġ għal terapija t'induzzjoni li jkun fiha Vc.
English: In a study in previously untreated mantle cell lymphoma patients, 42.9% and 10.4% of patients exposed to VELCADE were in the range 65-74 years and ≥ 75 years of age, respectively.
Maltese: 4% talpazjenti esposti għal VELCADE kienu fil-firxa ta' età bejn 65-74 sena u ≥ 75 sena, rispettivament.
English: • Inability to tolerate alcohol consumption
Maltese: • Ma tħossokx kapaċi li tittolera konsum t'alkoħol
English: A total of 218 patients were evaluable for response.
Maltese: Total ta' 218-il pazjent setgħu jiġu valutati għal rispons.