FrancophonIA/ELRC3.0 huggingface dataset:
English: It is also not recommended in combination with systemic cancer therapies other than LHRH analogues.
Maltese: Bħala konklużjoni, il-PRAC ma rrakkomandax il-kombinazzjoni ta' radium-223 ma' terapiji kontra l-kanċer sistemiċi oħrajn ħlief analogi ta' LHRH.
English: The review of Xofigo was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) after data from a clinical study suggested that patients given Xofigo in combination with Zytiga and prednisone/prednisolone could be at risk of dying earlier and had more fractures than patients given placebo (a dummy treatment) with Zytiga and prednisone/prednisolone.
Maltese: Abiraterone huwa magħruf li jżid ir-riskju ta' ksur, kif ukoll prednisone/prednisolone u effett sinerġistiku tal-kombinazzjoni tripla ma jistax jiġi eskluż.
English: Ringaskiddy, Co. Cork Ireland
Maltese: Ringaskiddy, Co. Cork l-Irlanda
English: Maximum rate
Maltese: Rata massima
English: There is a theoretical risk of haemolysis.
Maltese: Hemm riskju teoretiku ta' emoliżi.
English: DARZALEX 16 mg/kg N=106
Maltese: DARZALEX 16-il mg/kg N=106
English: DARZALEX is indicated:
Maltese: DARZALEX huwa indikat:
English: 9/L, leukocytes > 1.0 x 10
Maltese: 9/L, lewkoċiti > 1.0 x 10
English: 16 mg/kg
Maltese: 16-il mg/kg
English: Weeks 7 to 54
Maltese: Ġimgħat 7 sa 54
English: • Antipyretics (oral paracetamol 650 to 1,000 mg)
Maltese: • Mediċini kontra d-deni (paracetamol 650 sa 1,000 mg mill-ħalq)
English: DARZALEX contains sodium
Maltese: DARZALEX fih sodium
English: Sodium acetate trihydrate Sodium chloride Water for injections
Maltese: Sodium acetate trihydrate Sodium chloride Ilma għall-injezzjonijiet
English: Table 9: Efficacy results from Study MMY3006 D-VTd (n=543) VTd (n=542)
Maltese: Riżultati ta' effikaċja mill-Istudju MMY3006 D-VTd (n=543) VTd (n=542)
English: • medicines for inflammation (corticosteroids)
Maltese: • mediċini għall-infjammazzjoni (kortikosterojdi)
English: Hepatitis B virus (HBV) Reactivation
Maltese: Riattivazzjoni tal-virus tal-Epatite B (HBV)
English: Very Common 32
Maltese: Komuni Ħafna 32
English: Weeks 9 to 16
Maltese: Ġimgħat 9 sa 16
English: Dexamethasone 20 mg was administered on Days 1, 2, 8, 9, 15, 16 in Cycles 5 and 6.
Maltese: Dexamethasone 20 mg ingħata fil-Jiem 1, 2, 8, 9, 15, 16 f'Ċikli 5 u 6.
English: Combination treatment with lenalidomide:
Maltese: Trattament flimkien ma' lenalidomide:
English: • The active substance is daratumumab.
Maltese: • Is-sustanza attiva hija daratumumab.
English: Combination treatment with bortezomib:
Maltese: Trattament flimkien ma' bortezomib:
English: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
Maltese: Kull kunjett ta' 5 mL u 20 mL ta' DARZALEX fih 0.4 mmol u 1.6 mmol (9.3 mg u 37.3 mg) ta' sodium, rispettivament.
English: The median age was 58 (range: 22 to 65) years.
Maltese: Il-medjan tal-età kien 58 (firxa: 22 sa 65) sena.
English: Decreases in absolute counts and percentages of total NK cells (CD16+CD56+) and activated (CD16+CD56
Maltese: Tnaqqis fl-għadd assolut u l-perċetwali tat-total taċ-ċelluli NK (CD16+CD56+) u ċelluli NK attivati (CD16+CD56
English: Date of first authorisation: 20 May 2016 Date of latest renewal: 24 April 2017
Maltese: Data tal-aħħar tiġdid: 24 ta' April 2017
English: p-value from Cochran Mantel-Haenszel Chi-Squared test.
Maltese: Valur p mit-test Chi-Squared ta' Cochran Mantel-Haenszel.
English: Excipients: glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride, water for injections.
Maltese: Eċċipjenti: glacial acetic acid, mannitol, polysorbate 20, sodium acetate trihydrate, sodium chloride, ilma għall-injezzjonijiet.
English: Neutropenia/Thrombocytopenia
Maltese: Newtropenija/Tromboċitopenija
English: Atrial fibrillation Common
Maltese: Fibrillazzjoni tal-atriju Komuni
English: Prior therapies included bortezomib (100%), lenalidomide (95%), pomalidomide (36%) and carfilzomib (19%).
Maltese: Terapiji preċedenti kienu jinkludu bortezomib (100%), lenalidomide (95%), pomalidomide (36%) u carfilzomib (19%).
English: Prior therapies included bortezomib (99%), lenalidomide (99%), pomalidomide (63%) and carfilzomib (50%).
Maltese: Terapiji preċedenti kienu jinkludu bortezomib (99%), lenalidomide (99%), pomalidomide (63%) u carfilzomib (50%).
English: Analysis 2 included 694 patients (n=326 for lenalidomide-dexamethasone; n=246 for bortezomib-dexamethasone; n=99 for pomalidomidedexamethasone; n=11 for bortezomib-melphalan-prednisone; and n=12 for bortezomib-thalidomidedexamethasone), Analysis 3 included 352 patients (bortezomib-melphalan-prednisone) and Analysis 4 included 355 patients (lenalidomide-dexamethasone).
Maltese: Analysis 2 kienet tinkludi 694 pazjent (n=326 għal lenalidomide-dexamethasone; n=246 għal bortezomib-dexamethasone; n=99 għal pomalidomidedexamethasone; n=11 għal bortezomib-melphalan-prednisone; u n=12 għal bortezomib-thalidomidedexamethasone) u Analiżi 3 kienet tinkludi 352 pazjent (bortezomib-melphalan-prednisone) u Analiżi 4 kienet tinkludi 355 pazjent (lenalidomide-dexamethasone).
English: Methylprednisolone 100 mg, or equivalent, administered intravenously.
Maltese: Methylprednisolone 100 mg, jew l-ekwivalenti, mogħti mill-vini.
English: Weeks 10 to 24
Maltese: Ġimgħat 10 sa 24
English: p-value from Fisher's exact test.
Maltese: Valur p mit-test preċiż ta' Fisher.
English: MRD negativity rate (95% CI)
Maltese: Rata negattiva ta' MRD (95% CI)
English: Week 1 Day 2 (8 mg/kg)
Maltese: Ġimgħa 1 Jum 2 (8 mg/kg)
English: Weeks 1 to 8
Maltese: Ġimgħat 1 sa 8
English: The overall response rate was 90% in the D-VMP group and 74% in theVMP group (VGPR rate:29% in D-VMP group and 26% in VMP group; CR: 22% in D-VMP group and 18% in VMP group; sCR rate: 20% in D-VMP group and 7% in VMP group).
Maltese: Ir-rata ta' rispons totali kienet 90% fil-grupp ta' D-VMP u 74% fil-grupp ta' VMP (rata ta' VGPR: 29% fil-grupp ta' D-VMP u 26% fil-grupp ta' VMP; CR: 22% fil-grupp ta' D-VMP u 18% fil-grupp ta' VMP; ir-rata ta' sCR: 20% fil-grupp ta' D-VMP u 7% fil-grupp ta' VMP).
English: No chronic toxicity testing has been conducted.
Maltese: Ma sarux testijiet dwar tossiċità kronika.
English: Weeks 1 to 9
Maltese: Ġimgħat 1 sa 9
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) and very rare (< 1/10,000).
Maltese: Il-frekwenzi huma ddefiniti bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000) u rari ħafna (< 1/10,000).
English: Weeks 1 to 6
Maltese: Ġimgħat 1 sa 6
English: Otherwise, use a dilution volume of 1,000 mL.
Maltese: Inkella, kompli uża volum ta' dilwizzjoni ta' 1,000 mL.
English: Very Common 45
Maltese: Komuni Ħafna 45
English: Interference with Serum Protein Electrophoresis and Immunofixation Tests Daratumumab may be detected on serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for monitoring disease monoclonal immunoglobulins (M protein).
Maltese: Interferenza b'Testijiet ta' Elettroforesi ta' Proteini fis-Serum u Immunofissazzjoni Daratumumab jista' jiġi rilevat f'assaġġi ta' elettroforesi ta' proteini fis-serum (SPE) u immunofissazzjoni (IFE) użati għal monitoraġġ ta' immunoglobulini (proteina M) monoklonali morda.
English: Table 2:
Maltese: Tabella 7:
English: Tel.: +36 1 884 2858 janssenhu@its.jnj.com
Maltese: +36 1 884 2858 janssenhu@its.jnj.com
English: The majority were white (92%), male (52%), 34% had an Eastern Cooperative Oncology Group (ECOG) performance score of 0, 49.5% had an ECOG performance score of 1 and 17% had an ECOG performance score of ≥2.
Maltese: Il-biċċa lkbira kienu bojod (92%), irġiel (52%), 34% kellhom punteġġ ta' eżekuzzjoni tal-Koperattiva talGrupp ta' Onkoloġija tal-Lvant (ECOG, Eastern Cooperative Oncology Group) ta' 0, 49.5% kellhom puneġġ ta' eżekuzzjoni ECOG ta' 1 u 17% kellhom puneġġ ta' eżekuzzjoni ECOG ta' ≥2.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC24
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, kodiċi ATC:
English: CARTON (100 mg/400 mg) (WITH BLUE BOX)
Maltese: KARTUNA (100 mg/400 mg) (BIL-KAXXA Ċ-ĊELESTI)
English: Figure 2:
Maltese: Figura 2: Kurva
English: This corresponds to 0.46% and 1.86% of the WHO recommended maximum daily intake of 2 g sodium for an adult, respectively.
Maltese: Dan jikkorrispondi għal 0.46% u 1.86% tat-teħid massimu kuljum ta' 2 g sodium irrakkomandat mill-WHO għal adult, rispettivament.
English: Infusion bags/containers must be made of polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) or polyolefin blend (PP+PE).
Maltese: Ilboroż/kontenituri tal-infużjoni għandhom ikunu magħmula mill-polyvinylchloride (PVC), polypropylene (PP), polyethylene (PE) jew minn taħlita ta' polyolefin (PP+PE).
English: The mean (SD) central volume of distribution is 56.98 (18.07) mL/kg.
Maltese: Il-medja (SD) tal-volum ta' distribuzzjoni ċentrali huwa 56.98 (18.07) mL/kg.
English: 1 vial, 400 mg/20 mL
Maltese: Kunjett 1, 400 mg/20 mL
English: DARZALEX is given as an infusion (drip) into a vein.
Maltese: DARZALEX jiġi mogħti bħala infużjoni (dripp) ġo vina.
English: See below “Recommended concomitant medications”, “Management of infusion-related reactions” and section 4.4.
Maltese: Ara taħt “Mediċini rrakkomandati flimkien miegħu”, “Immaniġġjar ta' reazzjonijiet marbuta mal-infużjoni” u sezzjoni 4.4.
English: Weeks 9 to 24
Maltese: Ġimgħat 9 sa 24
English: • Antihistamine (oral or intravenous diphenhydramine 25 to 50 mg or equivalent).
Maltese: • Antiistamina (diphenhydramine 25 sa 50 mg jew l-ekwivalenti mill-ħalq jew mill-vini).
English: Terminal half-life increases with increasing dose and with repeated dosing.
Maltese: Il-half-life terminali tiżdied ma' żieda fid-doża u ma' dożi ripetuti.
English: Store in a refrigerator (2 °C-8 °C).
Maltese: Aħżen fi friġġ (2°C-8°C).
English: A total of 498 patients were randomised; 251 to the DVd arm and 247 to the Vd arm.
Maltese: Total ta' 498 pazjent intagħżlu b'mod arbitrarju; 251 għall-fergħa ta' DVd u 247 għall-fergħa ta' Vd.
English: CARTON (100 mg/400 mg) FOR 1 VIAL COMPONENT AS INTERMEDIATE PACK/COMPONENT OF AN INITIATION PACK (WITHOUT BLUE BOX)
Maltese: KARTUNA (100 mg/400 mg) GĦAL KUNJETT 1 BĦALA PAKKETT INTERMEDJU/KOMPONENT TAL-PAKKETT TAL-BIDU (MINGĦAJR IL-KAXXA ĊĊELESTI)
English: System Organ Class
Maltese: Klassi tas-Sistemi u tal
English: The majority were white (85%), female (54%), 25% had an ECOG performance score of 0, 50% had an ECOG performance score of 1 and 25% had an ECOG performance score of 2.
Maltese: Il-maġġoranza kienu bojod (85%), nisa (54%), 25% kellhom punteġġ ta' eżekuzzjoni ECOG ta' 0, 50% kellhom punteġġ ta' eżekuzzjoni ta' ECOG ta' 1 u 25% kellhom punteġġ ta' eżekuzzjoni ta' ECOG ta' 2.
English: 6/kg) and among those who completed mobilization, more patients in the D-VTd group received plerixafor compared to those in the VTd arm (D-VTd: 21.7%; VTd: 7.9%).
Maltese: 6/kg) u fost dawk li temmew mobilizzazzjoni, aktar pazjenti fil-grupp ta' D-VTd rċivew plerixafor meta mqabbel ma' dawk fil-grupp ta' VTd (D-VTd: 21.7%; VTd: 7.9%).
English: Name and address of the manufacturers of the biological active substance
Maltese: Isem u indirizz tal-manifatturi tas-sustanza bioloġika attiva
English: • irregular heart beat (atrial fibrillation)
Maltese: • taħbit irregolari tal-qalb (fibrillazzjoni tal-atriju)
English: * No Grade 4
Maltese: Gradi 3-4
English: The most frequent adverse reactions (≥ 20%) were infusion reactions, fatigue, nausea, diarrhoea, constipation, pyrexia, dyspnoea, cough, neutropenia, thrombocytopenia, anaemia, oedema peripheral, asthenia, peripheral sensory neuropathy and upper respiratory tract infection.
Maltese: L-aktar reazzjonijiet avversi frekwenti (≥ 20%) kienu reazzjonijiet għall-infużjoni, għeja, nawsja, dijarea, stitikezza, deni, qtugħ ta' nifs, sogħla, newtropenija, tromboċitopenija, anemija, edima periferali, astenja, newropatija tas-sensazzjoni periferali u infezzjoni fin-naħa ta' fuq tal-apparat tannifs.
English: Combination therapy:
Maltese: Terapija ta' kombinazzjoni:
English: Very Common 25
Maltese: Ħafna 25
English: The median age was 71 (range: 40-93) years, with 30% of the patients ≥75 years of age.
Maltese: Il-medjan tal-età kien 71 (firxa: 40-93) sena, bi 30% tal-pazjenti ≥75 sena.
English: In Study MMY3006, the number of CD34+ cell yield was numerically lower in the D-VTd arm compared with the VTd arm (Median: D-VTd: 6.3 x 10
Maltese: Fl-istudju MMY3006, in-numru ta' ċelluli CD34+ li ġew magħmula kien numerikament inqas filgrupp D-VTd meta mqabbel mal-grupp ta' VTd (Medjan: D-VTd: 6.3 x 10
English: Relapsed/refractory patient studies: DVd: 21%, Vd: 19%; DRd: 27%, Rd: 23%; DPd: 28% Newly diagnosed patient studies: D-VMP: 23%, VMP: 15%; DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
Maltese: DRd: 32%, Rd: 23%; D-VTd: 22%, VTd: 20%.
English: Very Common 26
Maltese: Komuni ħafna 26
English: Overall response rate (ORR) in MMY2002 was similar regardless of type of prior anti-myeloma therapy.
Maltese: Ir-rata ta' rispons totali (ORR - overall response rate) f'MMY2002 kienet simili irrelevanti mitterapija preċedenti ta' kontra l-majeloma.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCEAND MANUFACTURE RESPONSIBLE FOR BATCH RELEASE
Maltese: TAS-SUSTANZA BIOLOĠIKA ATTIVA U MANIFATTUR RESPONSABBLI
English: Very Common 40
Maltese: Komuni Ħafna 40
English: The median patient age was 64 years (range, 44 to 76 years), 64% were male and 76% were Caucasian.
Maltese: Il-medjan tal-età talpazjenti kien 64 sena (firxa, 44 sa 76 sena), 64% kienu rġiel u 76% kienu Kawkasiċi.
English: In clinical trials (monotherapy and combination treatments; N=2066) the incidence of any grade infusion-related reactions was 37% with the first (16 mg/kg, Week 1) infusion of DARZALEX, 2% with the Week 2 infusion, and cumulatively 6% with subsequent infusions.
Maltese: Fi provi kliniċi (trattamenti b'monoterapija u b'kombinazzjoni ta' mediċini; N=2066) l-inċidenza ta' reazzjonijiet ta' kwalunkwe grad marbuta mal-infużjoni kienet ta' 37% bl-ewwel infużjoni (16-il mg/kg, Ġimgħa 1) ta' DARZALEX, 2% bl-infużjoni ta' Ġimgħa 2, u b'mod kumulattiv 6% b'infużjonijiet sussegwenti.
English: • The other ingredients are glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride and water for injections (see “DARZALEX contains sodium” in section 2).
Maltese: • Is-sustanzi l-oħra huma glacial acetic acid, mannitol (E421), polysorbate 20, sodium acetate trihydrate, sodium chloride u ilma għall-injezzjonijiet (ara “DARZALEX fih sodium” f'sezzjoni 2).
English: Less common symptoms were wheezing, allergic rhinitis, pyrexia, chest discomfort, pruritus and hypotension (see section 4.8).
Maltese: Sintomi inqas komuni kienu tħarħir, rinite allerġika, deni, skumdità fis-sider, prurite u pressjoni baxxa (ara sezzjoni 4.8).
English: Glacial acetic acid Mannitol (E421) Polysorbate 20
Maltese: Glacial acetic acid Mannitol
English: All patients were ≤ 65 years: 43% were in the age group ≥ 60-65 years, 41% were in the age group ≥ 50-60 years and 16% below age of 50 years.
Maltese: Il-pazjenti kollha kellhom ≤ 65 sena: 43% kienu fil-grupp ta'età ≥ 60-65 sena, 41% kienu fil-grupp ta' età ≥ 50-60 sena u 16% kellhom inqas minn 50 sena.
English: A total of 1085 patients were randomized: 543 to the D-VTd arm and 542 to the VTd arm.
Maltese: Total ta' 1085 pazjent intagħżlu b'mod arbitrarju: 543 għall-grupp ta' D-VTd u 542 għall-grupp ta' VTd.
English: DARZALEX therapy should be discontinued immediately and permanently (see sections 4.2 and 4.3).
Maltese: It-terapija b'DARZALEX għandha titwaqqaf immedjamaent u b'mod permanenti (ara sezzjonijiet 4.2 u 4.3).
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Combination treatment with bortezomib, thalidomide and dexamethasone (VTd) in patients eligible for autologous stem cell transplant (ASCT):
Maltese: Trattament ta' kombinazzjoni b'bortezomib, thalidomide u dexamethasone (VTd) f'pazjenti eliġibbli għal trapjant taċ-ċelluli stem (ASCT, autologous stem cell transplant):
English: DARZALEX 20 mg/mL concentrate for solution for infusion.
Maltese: DARZALEX 20 mg/mL konċentrat għal soluzzjoni għall-infużjoni.
English: Other medicines and DARZALEX
Maltese: Mediċini oħra u DARZALEX
English: Based on threshold of 10
Maltese: Abbażi ta' limitu ta' 10
English: Week and subsequent infusions were approximately 7, 4 and 3 hours respectively.
Maltese: Ġimgħa u tal-infużjonijiet sussegwenti kien madwar 7, 4 u 3 sigħat rispettivament.
English: Dexamethasone (oral or intravenous) was administered at 40 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23 of Cycles 1 and 2, and at 40 mg on Days 1-2 and 20 mg on subsequent dosing days (Days 8, 9, 15, 16) of Cycles 3-4.
Maltese: Dexamethasone (mill-ħalq jew minn ġol-vini) ingħata b'doża ta' 40 mg fil-Jiem 1, 2, 8, 9, 15, 16, 22 u 23 taċ-Ċikli 1 u 2, u bid-doża ta' 40 mg fil-Jiem 1-2 u 20 mg fil-jiem sussegwenti ta' għoti tad-doża (Jiem 8, 9, 15, 16) taċ-Ċikli 3-4.
English: • medicines for an allergic reaction (anti-histamines)
Maltese: • mediċini għal reazzjoni allerġika (antiistamini)
English: Very Common 16
Maltese: Komuni Ħafna 16
English: Option 2 (Split dose infusion) Week 1 Day 1 (8 mg/kg)
Maltese: Għażla 2 (Infużjoni ta' doża maqsuma) Ġimgħa 1 Jum 1 (8 mg/kg)
English: Linear mixed PK-PD analyses indicated no large increase in mean QTcF interval (i.e. greater than 20 ms) at daratumumab Cmax.
Maltese: Analiżi PK-PD lineari mħallta ma indikat l-ebda żieda kbira fl-intervall medju ta' QTcF (i.e. akbar minn 20 ms) f'daratumumab Cmax.
English: Serious adverse reactions were pneumonia, bronchitis, upper respiratory tract infection, pulmonary oedema, influenza, pyrexia, dehydration, diarrhoea and atrial fibrillation.
Maltese: Reazzjonijiet avversi serji kienu pulmonite, bronkite, infezzjoni fin-naħa ta' fuq tal-apparat tannifs, edima fil-pulmuni, influwenza, deni, deidratazzjoni, dijarea u fibrillazzjoni tal-atriju.
English: Median PFS was not reached in the D-VMP arm and was 19.3 months in the VMP arm (HR=0.46; 95% CI: 0.36, 0.60; p<0.0001).
Maltese: Il-medjan ta' PFS ma ntlaħaqx fil-fergħa ta' D-VMP u kien ta' 19.3 xhur fil-fergħa ta' VMP (HR=0.46; 95% CI: 0.36, 0.60; p<0.0001).
English: • Administer the diluted solution by intravenous infusion using an infusion set fitted with a flow regulator and with an in-line, sterile, non-pyrogenic, low protein-binding polyethersulfone (PES) filter (pore size 0.22 or 0.2 micrometre).
Maltese: • Agħti s-soluzzjoni ddilwita permezz ta' infużjoni bl-użu ta' sett tal-infużjoni mgħammar b'regulatur tal-fluss u b'filter fil-pajp, sterili, mhux piroġeniku, li jintrabat ftit mal-proteini magħmul minn polyethersulfone (PES) (daqs tal-por 0.22 jew 0.2 mikrometru).
English: Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Maltese: IgG1κ uman kontra l-antiġen CD38, magħmul f'linja ta' ċelluli mammiferi (Ovarju tal-Ħamster Ċiniż [CHO - Chinese Hamster Ovary]) bl-użu tat-teknoloġija rikombinanti tad-DNA.
English: Key: D=daratumumab; Vd=bortezomib-dexamethasone; Rd=lenalidomide-dexamethasone; Pd=pomalidomidedexamethasone; VMP=bortezomib-melphalan-prednisone; VTd=bortezomib-thalidomide-dexamethasone.
Maltese: D-VMP=daratumumab-bortezomib-melphalan-prednisone; VMP=bortezomib-melphalan-prednisone;
English: Melphalan at 9 mg/m2, and prednisone at 60 mg/m2 were orally administered on Days 1 to 4 of the nine 6-week cycles (Cycles 1-9).
Maltese: Melphalan bid-doża ta' 9 mg/m2, u prednisone bid-doża ta' 60 mg/m2 ingħataw mill-ħalq fil-Jiem 1 sa 4 tad-disa' ċikli ta' 6 ġimgħat (Ċikli 1-9).
English: Concentrate for solution for infusion Initiation pack: 11 vials (6 x 5 mL vials + 5 x 20 mL vials)
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Pakkett tal-bidu: 11-il kunjett (6 kunjetti x 5 mL + 5 kunjetti x 20 mL)
English: In addition, daratumumab modulated CD38 enzymatic activity, inhibiting the cyclase enzyme activity and stimulating the hydrolase activity.
Maltese: Barra dan, daratumumab immodula l-attivita enzimatika ta' CD38, bl-inibizzjoni tal-attivita tal-enzima cyclase u l-istimulu tal-attività tal-hydrolase.
English: Interference with determination of Complete Response Daratumumab is a human IgG kappa monoclonal antibody that can be detected on both, the serum protein electrophoresis (SPE) and immunofixation (IFE) assays used for the clinical monitoring of endogenous M-protein (see section 4.5).
Maltese: IgG kappa uman li jista' jiġi rilevat kemm f'analiżi ta' elettroforesi ta' proteini fis-serum (SPE, serum protein electrophoresis) u f'immunofissazzjoni (IFE, immunofixation) użati fil-monitoraġġ kliniku ta' proteina M endoġena (ara sezzjoni 4.5).
English: Oedema peripheral Pyrexia
Maltese: Edima periferali
English: Bortezomib was administered by SC injection or IV injection at a dose of 1.3 mg/m2 body surface area twice weekly for two weeks (Days 1, 4, 8, and 11) of repeated 28 day (4-week) induction treatment cycles (Cycles 1-4) and two consolidation cycles (Cycles 5 and 6) following ASCT after Cycle 4.
Maltese: Bortezomib ingħata permezz ta' injezzjoni SC jew IV b'doża ta' 1.3 mg/m2 erja tas-superfiċje talġisem darbtejn fil-ġimgħa għal ġimagħtejn (Jiem 1, 4, 8, u 11) ta' ċikli ripetuti kull 28 jum (4 ġimgħat) ta' induzzjoni tat-trattament (Ċikli 1-4) u żewġ ċikli ta' konsolidazzjoni (Ċikli 5 u 6) wara ASCT wara Ċiklu 4.
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL 1 vial, 400 mg/20 mL
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1, 100 mg/5 mL Kunjett 1, 400 mg/20 mL
English: Concentrate for solution for infusion 1 vial, 100 mg/5 mL
Maltese: Konċentrat għal soluzzjoni għall-infużjoni Kunjett 1, 100 mg/5 mL
English: The median patient age was 63.5 years (range, 31 to 84 years), 11% of patients were ≥75 years of age, 49% were male and 79% were Caucasian.
Maltese: Il-medjan tal-età talpazjenti kienet 63.5 sena (firxa, 31 sa 84 sena), 11% tal-pazjenti kellhom età ≥75 sena, 49% kienu rġiel u 79% kienu Kawkasiċi.
English: The data reflects exposure to DARZALEX (16 mg/kg) in 2066 patients with multiple myeloma including 1910 patients who received DARZALEX in combination with background regimens and 156 patients who received DARZALEX as monotherapy.
Maltese: Id-dejta tirrifletti esponiment għal DARZALEX (16-il mg/kg) f'2066 pazjent b'majeloma multipla inkluż 1910 pazjenti li rċivew DARZALEX jew flimkien ma' skedi fl-isfond u 156 pazjent li rċivew DARZALEX bħala monoterapija.
English: DARZALEX can cause serious infusion related reactions (IRRs), including anaphylactic reactions (see section 4.8).
Maltese: DARZALEX jista' jikkawża reazzjonijiet marbuta mal-infużjoni (IRRs, infusion related reactions) serji, inklużi reazzjonijiet anaflattiċi (ara sezzjoni 4.8).
English: Three additional population PK analyses (Analysis 2, Analysis 3 and Analysis 4) were conducted in patients with multiple myeloma that received daratumumab combination therapies.
Maltese: Tliet analiżi PK addizzjonali ta' popolazzjoni (Analiżi 2, Analiżi 3 u Analiżi 4) saru f'pazjenti b'majeloma multipla li rċivew terapiji ta' kombinazzjoni b'daratumumab.
English: DARZALEX may increase neutropenia and thrombocytopenia induced by background therapy (see section 4.8).
Maltese: DARZALEX jista' jżid in-newtropenija u t-tromboċitopenija kkaġunati mit-terapija fl-isfond (ara sezzjoni 4.8).
English: Indicates grouping of terms
Maltese: Tindika l-ġabra ta' termini fi gruppi
English: The median age was 73 (range: 45-90) years, with 44% of the patients ≥75 years of age.
Maltese: Il-medjan tal-età kien 73 (firxa: 45-90) sena, b'44% tal-pazjenti b'età ≥75 sena.