FrancophonIA/ELRC3.0 huggingface dataset:
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 bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-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' bortezomib, 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: (95% CI)=1.688
Maltese: (95% CI)=1.688 (1.148; 2.481) valur p g=0.007
English: Table 10: Incidence of peripheral neuropathy in study LYM-3002 by toxicity and treatment discontinuation due to peripheral neuropathy BR-CAP (N=240)
Maltese: Inċidenza ta' newropatija periferali fl-istudju LYM-3002 skont it-tossiċità u l-waqfien tattrattament minħabba newropatija periferali
English: The following medicinal products are administered on day 1 of each bortezomib 3 week treatment cycle as intravenous infusions: rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m and doxorubicin at 50 mg/m Prednisone is administered orally at 100 mg/m on days 1, 2, 3, 4 and 5 of each bortezomib treatment cycle.
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jum 1 ta' kull waħda miċ-ċikli ta' trattament ta' 3 ġimgħat ta' bortezomib bħala infużjonijiet fil-vina: rituximab b'doża ta' 375 mg/m2, cyclophosphamide b'doża ta' 750 mg/m u doxorubicin b'doża ta' 50 mg/m Prednisone jingħata mill-ħalq b'doża ta' 100 mg/m fil-jiem 1, 2, 3, 4 u 5 ta' kull waħda miċ-ċikli ta'
English: How to store Bortezomib Fresenius Kabi
Maltese: Kif jingħata Bortezomib Fresenius Kabi
English: 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 paralelli, 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' progressawx waqt li kienu qed jieħdu terapija abbażi ta' anthracycline.
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.
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 jew taħt il-ġilda 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: Adverse reaction ischaemic
Maltese: Inċidenza Reazzjoni avversa
English: Bortezomib treatment is very commonly associated with haematological toxicities (thrombocytopenia, neutropenia and anaemia).
Maltese: It-trattament bi bortezomib b'mod komuni ħafna tiġi assoċjata ma' tossiċitajiet ematoloġiċi (tromboċitopenija, newtropenija u anemija).
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
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)*,
English: Nervous system disorders Very common Neuropathies*, Peripheral sensory neuropathy, Dysaesthesia*, Neuralgia*
Maltese: Komuni ħafna Newropatiji*, Newropatija sensorjali periferika, Disestesija*, Nevralġija*,
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: Il-pazjenti 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: Response Rate at 4 cycles n (%) ORR (CR+PR) p-value a
Maltese: ORR (CR+PR) Valur p a
English: In study LYM-3002 in which bortezomib was administered with rituximab, cyclophosphamide, doxorubicin, and prednisone (BR-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 (BR-CAP), l-inċidenza ta' newropatija periferali fl-iskedi ta' għoti ta' kombinazzjoni ta' mediċini, hija ppreżentata fit-tabella taħt:
English: A hazard ratio < 1 indicates an advantage for BR-CAP.
Maltese: Proporzjon ta' periklu ta' < 1 jindika vantaġġ għal VcR-CAP.
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: Hypothyroidism
Maltese: Ċitotossiku
English: - The other ingredients are mannitol (E421).
Maltese: - Is-sustanzi l-oħra huma mannitol (E 421) u nitrogen.
English: Cytotoxic
Maltese: KIF JINTREMA
English: Uncommon Autonomic nervous system imbalance
Maltese: Disturbi fis-sistema nervuża
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 fiha bortezomib.
English: 2 years
Maltese: Jum 22
English: #, Neurotoxicity,
Maltese: #, Dermatite*,
English: g 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: Adverse reaction 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: • 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 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) (bortezomib flimkien ma' dexamethasone, u Bortezomib flimkien ma' dexamethasone u thalidomide);
English: Table 8: Adverse reactions in patients with mantle cell lymphoma treated with BR-CAP in a clinical trial
Maltese: Tabella 8: Reazzjonijiet avversi f'pazjenti b'limfoma taċ-ċellula mantle ttrattati b'BR-CAP fi prova klinika Klassi tas-Sistemi u tal-Organi
English: Bortezomib intravenous arm
Maltese: Waqqaf bortezomib
English: Haematological toxicity - ≥ 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: 1.1 Preparation of the 3.5 mg vial: carefully add 3.5 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib 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 bortezomib billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Table 3: Posology modifications during subsequent cycles of bortezomib therapy in combination with melphalan and prednisone Toxicity
Maltese: Tabella 2: Pożologija rrakkommandata għal bortezomib flimkien ma' melphalan u prednisone
English: Patients with moderate or severe hepatic impairment should be started on bortezomib at a reduced dose of 0.7 mg/m 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 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 bortezomib bid-doża mnaqqsa ta' 0.7 mg/m 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 fuq bażi tat-tollerabiltà tal-pazjent (ara Tabella 6 u sezzjonijiet 4.4 u 5.2).
English: Group.
Maltese: Globali.
English: Dexamethasone is administered orally at 40 mg on days 1, 2, 3, 4, 8, 9, 10 and 11 of the bortezomib 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' bortezomib.
English: Bortezomib 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 bi bortezomib m'għandhiex tingħata sa ġimagħtejn sakemm il-pazjent ikollu ANC ta' ≥ 750 ċellula/μL u għadd tal-plejtlits ta' ≥ 25,000 ċellula/μL.
English: Once the symptoms of the toxicity have resolved, bortezomib treatment may be re-initiated at a 25% reduced dose (1.3 mg/m reduced to 1.0 mg/m 2; 1.0 mg/m reduced to 0.7 mg/m 2).
Maltese: Imbagħad bortezomib jista' jerġa' jinbeda bi tnaqqis ta' livell 1 tad-doża (minn 1.3 mg/m għal 1 mg/m jew minn 1 mg/m għal 0.7 mg/m2).
English: Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection
Maltese: Bortezomib Fresenius Kabi 3.5 mg trab għal soluzzjoni għall-injezzjoni
English: Reduce bortezomib to 1.0 mg/m or
Maltese: Naqqas bortezomib Fresenius Kabi għal 1.0 mg/m jew
English: The CR rate in first-relapsed T-cell ALL patients (n=22) was 68% (95% CI: 45, 86) and the 4-month event free survival rate was 67% (95% CI: 42, 83).
Maltese: (95% CI: 45, 86 ) u r-rata ta' sopravivenza ta' 4 xhur mingħajr avvenimenti kienet 67% (95% CI: 42, 83).
English: Each carton of Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection contains a 10 ml clear glass-vial with grey rubber stopper and aluminium blue flip-off over seal, containing 3.5 mg bortezomib.
Maltese: Kull kartuna ta' Bortezomib 3.5 mg trab għal soluzzjoni għall-injezzjoni fih kunjett tal-ħġieġ ta' 10 ml b'tapp griż tal-lastku u siġill blu jgħajjat tal-aluminju li jista' jinqala',li fih 3.5 mg bortezomib..
English: When bortezomib is given together with pegylated liposomal doxorubicin, you will receive bortezomib intravenously or subcutaneously as a 21-day treatment cycle and pegylated liposomal doxorubicin 30 mg/m is given on day 4 of the bortezomib 21-day treatment cycle as an intravenous infusion after the bortezomib injection.
Maltese: Meta bortezomib jingħata flimkien ma' pegylated liposomal doxorubicin, inti ser tirċievi bortezomib Fresenius Kabi 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' bortezomib bħala infużjoni ġol- vina wara l-injezzjoni ta'bortezomib Fresenius Kabi.
English: Bortezomib combination treatment with dexamethasone In the absence of any direct comparison between bortezomib and bortezomib 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 bortezomib in combination with dexamethasone (Phase II open-label study MMY-2045), with results obtained in the bortezomib monotherapy arms from different Phase III randomised studies (M34101-039 [APEX] and DOXIL MMY-3001) in the same indication.
Maltese: Trattament ta' kombinazzjoni ta' bortezomib ma' dexamethasone Fin-nuqqas ta' tqabbil dirett bejn bortezomib u bortezomib 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' bortezomib flimkien ma' dexamethasone (listudju b'tikketta tingħaraf ta' Fażi
English: OR; 95% CI; P value a
Maltese: TDx jew; 95% CI; VALUR P
English: The benefit/risk ratio should be considered prior to continuing bortezomib therapy.
Maltese: Għandha tingħata kunsiderazzjoni tal-proporzjon tal-benefiċċju/riskju qabel ma titkompla t-terapija bi bortezomib.
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 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 bi bortezomib.
English: 1.1 Preparation of the 3.5 mg vial: carefully add 1.4 ml of sterile, sodium chloride 9 mg/ml (0.9%) solution for injection to the vial containing the bortezomib 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 bortezomib billi tuża siringa tad-daqs xieraq mingħajr ma tneħħi t-tapp tal-kunjett.
English: Uncommon Tremor, Peripheral sensorimotor neuropathy, Dyskinesia*, Cerebellar coordination and balance disturbances*, Memory loss (exc dementia)*, Encephalopathy*, Posterior Reversible Encephalopathy Syndrome
Maltese: Mhux komuni Rogħda, Newropatija sensomotorili periferali, Diskinesja*, Disturbi fil-bilanċ u fil-koordinazzjoni ċerebellari*, Telf ta' memorja (li jeskludi dimenzja)*, Enċefalopatija*, Sindromu enċefalopatiku riversibbli fuq wara
English: Posology for patients with previously untreated mantle cell lymphoma (MCL) Combination therapy with rituximab, cyclophosphamide, doxorubicin and prednisone (BR-CAP) Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m 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) Bortezomib Fresenius Kabi 1 mg trab għal soluzzjoni għall-injezzjoni jingħata permezz ta' injezzjoni fil-vini bid-doża rrakkomandata ta' 1.3 mg/m ta' erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimgħatejn fil- jiem 1, 4, 8, u 11, segwit minn perjodu ta' mistireħ ta' 10 ijiem fil-jiem 12-21.
English: Combination therapy with pegylated liposomal doxorubicin Bortezomib Fresenius Kabi 3.5 mg powder for solution for injection is administered via intravenous or subcutaneous injection at the recommended dose of 1.3 mg/m body surface area twice weekly for two weeks on days 1, 4, 8, and 11 in a 21-day treatment cycle.
Maltese: Terapija ta' kombinazzjoni b'pegylated liposomal doxorubicin Bortezomib Fresenius Kabi 3.5 mg trab għal soluzzjoni għall-injezzjoni jingħata bħala injezzjoni ġol-vina jew taħt il-ġilda fid-doża rakkomandata ta' 1.3 mg/m erja tas-superfiċje tal-ġisem darbtejn fil-ġimgħa għal ġimagħtejn fil-jiem 1, 4, 8 u 11 f'ċiklu ta' trattament ta' 21 jum.
English: IV on day 1; and prednisone 100 mg/m orally on day 1 through day 5 of the 21 day bortezomib treatment cycle.
Maltese: 100 mg/m mill-ħalq minn jum 1sa jum 5 taċ-ċiklu ta' trattament ta' 21 jum bi bortezomib.
English: 1-year Overall Survival (%)
Maltese: Sopravivenza Globali ta' sena (%)
English: Patients in the BR-CAP treatment arm received bortezomib (1.3 mg/m2; on days 1, 4, 8, 11, rest period days
Maltese: Il-pazjenti fil-fergħa ta' trattament b'VcR-CAP irċivew bortezomib (1.3 mg/m fil-jiem 1, 4, 8, 11, perjodu ta' waqfien jiem 12-21), rituximab 375 mg/m
English: 1 year survival, % [95% CI]
Maltese: Sopravivenza ta' sena waħda, % [95% CI]
English: CI=confidence interval; CR=complete response; nCR=near complete response; ITT=intent to treat; RR=response rate; B=bortezomib; BDx=bortezomib, dexamethasone; VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial response; PR=partial response; OR=odds ratio.
Maltese: VDDx=vincristine, doxorubicin, dexamethasone; VGPR=very good partial responserispons parzjali tajjeb ħafna; PR=partial response - rispons parzjali, NE=not estimable - ma jistax jiġi stmat; OR=odds ratio - proporzjon ta' odds; * Primary endpoint - L-ewwel punt aħħari a
English: Note: An OR > 1 indicates an advantage for B-containing induction therapy.
Maltese: Nota: OR > 1 jindika vantaġġ għal terapija t'induzzjoni li jkun fiha B.
English: Motor neuropathy*, Loss of consciousness (inc syncope), Dizziness*, Dysgeusia*, Lethargy, Headache*
Maltese: Newropatija motorili*, Telf ta' kuxjenza (li jinkludi sinkope), Sturdament*, Disgewsja*, Letarġija, Uġigħ ta' ras*,
English: Gastrointestinal toxicity, including nausea, diarrhoea, vomiting and constipation are very common with bortezomib treatment.
Maltese: Tossiċità gastro-intestinali, li tinkludi nawsja, dijarea, rimettar u stitikezza huma komuni ħafna waqt trattament bi bortezomib.
English: In a drug-drug interaction study assessing the effect of omeprazole, a potent CYP2C19 inhibitor, on the pharmacokinetics of bortezomib (injected intravenously), there was no significant effect on the pharmacokinetics of bortezomib based on data from 17 patients.
Maltese: Pazjenti li żviluppaw ipotensjoni ortostatika bi bortezomib (injettat ġol-vina) ma kellhomx ipotensjoni ortostatika qabel ma kienu bdew it-trattament bi bortezomib.
English: Intravenous injection
Maltese: Infezzjonijiet u infestazzjonijiet
English: The following medicinal products are given on day 1 of each bortezomib 21-day treatment cycle as intravenous infusions:
Maltese: Il-prodotti mediċinali li ġejjin jingħataw fil-jum 1 ta' kull wieħed miċ-ċiklu ta' trattament ta' 21 jum ta' bortezomib bħala infużjonijiet fil-vina:
English: Although in patients aged ≥ 75 years, both BR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Maltese: Għalkemm f'pazjenti li kellhom ≥ 75 sena, kemm BR-CAP kif ukoll R-CHOP kienu ttollerati anqas, ir-rata ta' każijiet avversi serji fil-gruppi ta' BR-CAP kienet 68%, meta mqabbla ma' 42% fil-grupp ta' R-CHOP.
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.>
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: 0.7 mg/m2).
Maltese: 1.0 mg/m imnaqqsa għal 0.7 mg/m2).
English: A hazard ratio less than 1 indicates an advantage for VMP
Maltese: Proporzjon ta' riskju anqas minn 1 jindika vantaġġ għallVMP
English: Each 10 ml vial of bortezomib must be carefully reconstituted with 1.4 ml of sodium chloride 9 mg/ml (0.9%) solution for injection, by using a syringe of the appropriate size, without removing the vial stopper.
Maltese: Kull kunjett ta' 10 ml ta' bortezomib 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.
English: When bortezomib is given in combination with other medicinal products, refer to their Summaries of Product Characteristics for additional contraindications.
Maltese: Meta bortezomib jingħata f'kombinazzjoni ma' prodotti mediċinali oħra, irreferi għas-Sommarju talKaratteristiċi tal-Prodott għal kontraindikazzjonijiet addizzjonali.
English: The following adverse reactions (grade ≥ 3) were observed at a higher incidence in the bortezomib containing treatment regimen as compared with a historical control study in which the backbone regimen was given alone: in Block 1 peripheral sensory neuropathy (3% versus 0%); ileus (2.1% versus 0%); hypoxia (8% versus 2%).
Maltese: (3% versus 0%); ilju (2.1% versus 0%); ipoksja (8% versus 2%).
English: The chemical and physical in-use stability of the reconstituted solution has been demonstrated at concentrations of 1 mg/ml and 2.5 mg/ml for 96 hours at 25°C and 8 days at 2-8°C, when stored in the original vial and/or a syringe.
Maltese: L-istabilità kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita ġiet murija f'konċentrazzjonijiet ta' 1 mg/ml u 2.5 mg/ml għal 96 siegħa f'temperatura ta' 25°C u 8 ijiem f'temperatura ta' 2-8°C, meta miżmum fil-kunjett oriġinali u/jew siringa.
English: Bortezomib must be reconstituted by a healthcare professional (see section 6.6).
Maltese: Bortezomib għandu jiġi rrikostitwit minn professjonist fil-qasam tal-kura tas-saħħa (ara sezzjoni 6.6).
English: Events n (%)
Maltese: Każijiet n (%)
English: B=bortezomib; Dex=dexamethasone
Maltese: TDx=thalidomide, dexamethasone;
English: In an exploratory efficacy analysis, a 67.3% response rate (including a 28.6% CR rate) as measured by hematologic response (M-protein) was reported in 49 evaluable patients treated with the maximum allowed doses of 1.6 mg/m weekly and 1.3 mg/m twice-weekly.
Maltese: 67.3% (inkluża rata ta' 28.6 % għal CR) hekk kif imkejla mir-rispons ematoloġiku (proteina-M) kienet irrappurtata.
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: • Inject the solution subcutaneously, under a 45-90°angle.
Maltese: • Injetta s-soluzzjoni taħt il-ġilda f'angolu ta' 45-90
English: Clinical efficacy with subcutaneous administration of bortezomib in patients with relapsed/refractory multiple myeloma
Maltese: fis-sistema immuni Mhux komuni Reazzjoni anafilattika Disturbi fil-metaboliżmu u n-nutrizzjoni