FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaesthesiologists should be vigilant for methaemoglobinaemia in patients receiving dapsone therapy and for BIS (Bispectral Index) interference with Methylthioninium chloride Proveblue administration.
Maltese: L-anestesjologi għandhom joqgħodu attenti għall-metemoglobinemija f'pazjenti li jkunu qegħdin jingħataw kura b'dapsone u għall-interferenza BIS (Bispectral Index) mal-għoti ta' Methylthioninium chloride Proveblue.
English: Each carton contains a tray with 5 ampoules of 10 ml in blister.
Maltese: Kull kartuna fiha trej b'5 fjali ta' 10 ml f'pakkett ta' folji.
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride.
Maltese: Kull fjala ta' 10 ml fiha 50 mg methylthioninium chloride.
English: • Patients with nitrite-induced methaemoglobinaemia during treatment of cyanide poisoning
Maltese: • Pazjenti b'metemoglobinemija indotta min nitrite waqt it-trattament ta 'avvelenament b'cyanide
English: Each 10 ml ampoule contains 50 mg methylthioninium chloride Each 2 ml ampoule contains 10 mg methylthioninium chloride
Maltese: Kull fjal ta' 10 ml fiha 50 mg methylthioninium chloride Kull fjal ta' 2 ml fiha 10 mg methylthioninium chloride
English: Some evidence of carcinogenic activity of methylthioniniul chloride has been shown in male mice and male rats.
Maltese: Intweriet xi evidenza ta' attività karċinoġenika ta' methylthioniniul chloride fil-ġrieden maskili u filfirien maskili.
English: The recommended dose is 0.3-0.5 mg/kg body weight, i.e. 0.06 to 0.1 ml/kg body weight, given over a period of 5 minutes.
Maltese: Id-doża rakkomandata hija ta' 0.3-0.5 mg/kg piż tal-ġisem, jiġifieri 0.06 to 0.1 ml/kg piż tal-ġisem, mogħtija fuq perjodu ta' 5 minuti.
English: A repeat dose (1 to 2 mg/kg body weight, i.e. 0.2-0.4 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range.
Maltese: Doża ripetuta (1 sa 2 mg/kg piż tal-ġisem, jiġifieri 0.2-0.4 ml/kg piż tal-ġisem) tista' tingħata siegħa wara l-ewwel doża f'każ ta' sintomi persistenti jew rikorrenti jew jekk il-livelli ta' metemoglobina jibqgħu sostanzjalment ogħla mill-medda klinika normali.
English: When used in combination with these medicines methylthioninium chloride may cause serotonin syndrome, which can be potentially life-threatening.
Maltese: Meta użat flimkien ma' dawn il-mediċini Methylthioninium chloride jista' jikkaġuna s-sindrome ta' serotonin, li jista' jkun ta' theddida għall-ħajja.
English: The adverse reactions listed in the table below occur in adults, children and adolescents (aged 0 to 17 years old) after intravenous administration.
Maltese: Ir-reazzjonijiet avversi elenkati fit-tabella hawn taħt iseħħu fl-adulti, fit-tfal u fl-adolexxenti (minn 0 sa 17-il sena) wara l-għoti minn ġol-vini.
English: Methylthioninium chloride Proveblue may be diluted in 50 ml glucose 50 mg/ml (5%) solution for injection to avoid local pain, in particular in paediatric population.
Maltese: Methylthioninium chloride Proveblue jista' jkun dilwit f'soluzzjoni għal injezzjoni ta' 50 ml glukożju 50 mg/ml (5%) sabiex ikun evitat l-uġigħ lokali, b'mod partikolari fil-popolazzjoni pedjatrika.
English: The majority of the dose is excreted in the urine, usually in the form of leucomethylthioninium chloride.
Maltese: Il-parti l-kbira tad-doża titneħħa fl-awrina, normalment fil-forma ta' leucomethylthioninium chloride.
English: Methylthioninium chloride Proveblue can exacerbate dapsone-induced haemolytic anemia because of the formation of the dapsone reactive metabolite hydroxylamine which oxidises haemoglobin.
Maltese: Methylthioninium chloride Proveblue jista' jaggrava l-anemija emolitika indotta mid-dapsone minħabba l-formazzjoni tal-metabolit reattiv tad-dapsone hydroxylamine li jossida l-emoglobina.
English: Cumulative doses of Methylthioninium chloride may lead to dyspnoea and tachypnoea, presumably related to reduced oxygen availability caused by methaemoglobinaemia, chest pain, tremor, cyanosis and haemolytic anaemia.
Maltese: Dożi kumulattivi ta' Methylthioninium chloride jistgħu jwasslu għal dispneja u takipneja, li x'aktarx huma relatati mat-tnaqqis tad-disponibbiltà tal-ossiġnu kkawżat mill-metemoglobinemija, uġigħ fissider, rogħda, ċijanosi u anemija emolitika.
English: One-month repeated dose toxicity in dogs showed no macroscopic toxic effects.
Maltese: It-tossiċità ta' doża ripetuta ta' xahar fil-klieb ma uriet l-ebda effett tossiku makroskopiku.
English: Each carton contains a tray with 5 or 20 ampoules of 2 ml in blister.
Maltese: Kull kartuna fiha trej b'5 jew 20 fjali ta' 2 ml.
English: You must not be given Methylthioninium chloride Proveblue: - if you are allergic to methylthioninium chloride or other thiazine dyes - if your body does not produce enough of the enzyme G6PD (glucose-6-phosphate dehydrogenase) - if your body does not produce enough of the enzyme NADPH (nicotinamide adenine dinucleotide phosphate) reductase - if your blood disorder has been caused by nitrite during treatment of cyanide poisoning - if your blood disorder has been caused by chlorate poisoning.
Maltese: M'għandekx tingħata Methylthioninium chloride Proveblue: - jekk inti allerġiku/a għal methylthioninium chloride jew kuluri thiazine oħrajn - jekk ġismek ma jipproduċix biżżejjed enzima G6PD (glucose-6-phosphate dehydrogenase) - jekk ġismek ma jipproduċix biżżejjed enzima NADPH (nicotinamide adenine dinucleotide phosphate) reductase - jekk id-disturb fid-demm tiegħek kien ikkawżat min nitrite waqt it-trattament ta 'avvelenament b'cyanide - jekk id-disturb fid-demm tiegħek kien ikkawżat minn avvelenament tal-klorat.
English: If you are given more Methylthioninium chloride Proveblue than you should As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too much or too little, however, tell your doctor if you notice one of the following adverse reactions: - feeling sick, - stomach pain, - chest pain, - dizziness, - headache, - sweating, - confusion, - an increase in methaemoglobin (an abnormal form of haemoglobin in the blood), - high blood pressure, - shortness of breath, - abnormally fast beating of the heart, - tremor, - skin discolouration.
Maltese: Jekk tingħata Methylthioninium chloride Proveblue aktar milli suppost Minħabba li din il-mediċina tingħatalek waqt li tkun l-isptar, mhuwiex probabbli li tingħata żżejjed jew in-nieqes, madankollu, kellem lit-tabib tiegħek jekk tinnota xi reazzjoni avversa minn dawn li ġejjin: - tħossok ma tiflaħx, - uġigħ fl-istonku, - uġigħ fis-sider, - sturdament, - uġigħ ta' ras, - għaraq, - konfużjoni, - żieda fil-metemoglobina (forma mhux normali ta' emoglobina fid-demm), - pressjoni għolja tad-demm, - qtugħ ta' nifs, - taħbit mgħaġġel mhux normali tal-qalb, - rogħda, - bidla fil-kulur tal-ġilda.
English: Adverse reactions are the same as in adults (except hyperbilirubinaemia, reported in infants only).
Maltese: Ir-reazzjonijiet avversi huma l-istess bħal fl-adulti (minbarra l-iperbilirubinemija, irrapportata fit-trabi biss).
English: A repeat dose (0.3 to 0.5 mg/kg body weight, i.e. 0.06-0.1 ml/kg body weight) may be given one hour after the first dose in cases of persistent or recurrent symptoms or if methaemoglobin levels remain significantly higher than the normal clinical range (see section 4.4 for important safety information).
Maltese: Doża ripetuta (0.3 sa 0.5 mg/kg piż tal-ġisem, jiġifieri 0.06-0.1 ml/kg piż tal-ġisem) tista' tingħata siegħa wara l-ewwel doża f'każ ta' sintomi persistenti jew rikorrenti jew jekk il-livelli ta' metemoglobina jibqgħu sostanzjalment ogħla mill-medda klinika normali (ara sezzjoni 4.4 għal tagħrif importanti dwar is-sigurtà).
English: Alternative treatment options should be considered.
Maltese: Għandhom jiġu kkunsidrati għażliet alternattivi ta' kura.
English: It is recommended not to exceed a cumulative dose for the course of treatment of 4 mg/kg in patients with dapsone-induced methaemoglobinaemia.
Maltese: Huwa rrakkomandat li ma tinqabiżx doża kumulattiva għall-kors tat-trattament ta' 4 mg/kg f'pazjenti b'metemoglobinemija indotta mid-dapsone.
English: Infants above 3 months, children and adolescents: Same posology as for adults.
Maltese: Trabi ta' aktar minn 3 xhur, tfal u adolexxenti:
English: Each ml of solution contains 5 mg methylthioninium chloride.
Maltese: U KWANTITATTIVA Kull ml tas-soluzzjoni fih 5 mg methylthioninium chloride.
English: There is no experience in patients with severe hepatic impairment.
Maltese: M'hemmx esperjenza f'pazjenti b'indeboliment epatiku sever.
English: What Methylthioninium chloride Proveblue is and what it is used for What you need to know before you are given Methylthioninium chloride Proveblue How Methylthioninium chloride Proveblue is given Possible side effects
Maltese: X'għandek tkun taf qabel ma tingħata Methylthioninium chloride Proveblue Kif għandu jingħata Methylthioninium chloride Proveblue Effetti sekondarji possibbli
English: Warnings and precautions Talk to your doctor or nurse before you are given Methylthioninium chloride Proveblue - if you have moderate or severe renal disease; lower doses (< 1 mg/kg) may be needed - if your blood disorder has been caused by a chemical called aniline, which is contained in dyes; lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3 of this package leaflet) - if your blood disorder has been caused by a medicine called dapsone (used to treat leprosy and other skin conditions); lower doses may be needed and total cumulative dose should not exceed 4 mg/kg (see section 3)
Maltese: Twissijiet u prekawzjonijiet Kellem lit-tabib jew l-infermier tiegħek qabel tuża Methylthioninium chloride Proveblue - jekk għandek mard tal-kliewi moderat jew sever; jistgħu jkunu meħtieġa dożi aktar baxxi (< 1 mg/kg) - jekk id-disturb fid-demm tiegħek kien ikkawżat minn kimika li tissejjaħ anilina, li tinsab filkuluri; jistgħu jkunu meħtieġa dożi aktar baxxi u d-doża kumulattiva totali m'għandhiex taqbeż l-4 mg/kg (ara sezzjoni 3 ta' dan il-fuljett ta' tagħrif)
English: Solution for injection 5 ampoules of 10 ml
Maltese: Soluzzjoni għal injezzjoni 5 fjali ta' 10 ml 50 mg/10 ml
English: The administration of methylthioninium chloride Proveblue has the potential to transiently increase the exposure of drugs primarily cleared by renal transport involving the OCT2/MATE pathway, including cimetidine, metformin and acyclovir.
Maltese: L-għoti ta' methylthioninium chloride Proveblue għandu l-potenzjal li jżid b'mod għaddien l-esponiment għal mediċini mneħħija prinċipalment bi trasport mill-kliewi permezz tal-passaġġ OCT2/MATE, li jinkludi cimetidine, metformin u acyclovir.
English: Hyperbilirubinaemia has been observed in infants after administration of 20 mg/kg methylthioninium chloride.
Maltese: L-iperbilirubinemija ġiet osservata fi trabi wara l-għoti ta' 20 mg/kg ta' methylthioninium chloride.
English: Individuals without methaemoglobinaemia
Maltese: Individwi mingħajr metemoglobinemija
English: The efficacy of methylthioninium chloride for the treatment of methaemoglobinaemia in peadiatric population was demonstrated in two retrospective studies and one open randomised clinical trial.
Maltese: L-effikaċja ta' methylthioninium chloride għall-kura tal-metemoglobinemija fil-popolazzjoni pedjatrika ntweriet f'żewġ studji retrospettivi u fi prova klinika miftuħa u fortuwita.
English: Caution should be exercised in the course of treatment with methylthioninium chloride as this may exacerbate Heinz body formation and haemolytic anaemia.
Maltese: Waqt il-kors tal-kura b'methylthioninium chloride għandha tingħata attenzjoni minħabba li dan jista' jaggrava l-formazzjoni ta' korpi ta' Heinz u anemija emolitika.
English: Death occurred in 2 infants after administration of 20 mg/kg methylthioninium chloride.
Maltese: Żewġt itrabi mietu wara li ngħataw 20 mg/kg ta' methylthioninium chloride.
English: Such medicines include:
Maltese: Kategorija farmakoterapewtika:
English: Type I glass ampoules.
Maltese: L-istess pożoloġija tal-adulti.
English: In rats and rabbits, teratogenic effects have been reported, with foetal and maternal toxicity.
Maltese: Fil-firien u fil-fniek, ġew irrapportati effetti teratoġeniċi, b'tossiċità għall-fetu u għall-omm.
English: Aphasia
Maltese: Ipoksja
English: Methylthioninium chloride Proveblue 5 mg/ml solution for injection
Maltese: IL-PRODOTT MEDIĊINALI Methylthioninium chloride Proveblue 5 mg/ml soluzzjoni għal injezzjoni
English: Indeed, driving can be affected due to confusional state, dizziness and possibly eye disturbances.
Maltese: Fil-fatt, issewqan jista' jiġi affettwat minħabba stat ta' konfużjoni, sturdament u l-possibbiltà ta' disturbi flgħajnejn.
English: Both infants had complex medical circumstances and methylthioninium chloride was only partially responsible.
Maltese: Iż-żewġt itrabi kellhom ċirkostanzi mediċi kumplessi u methylthioninium chloride kien biss parzjalment responsabbli.
English: If symptoms of serotonin syndrome occur, discontinue use of methylthioninium chloride, and initiate supportive treatment.
Maltese: Jekk is-sintomi tas-sindrome ta' serotonin jitfaċċaw, waqqaf l-użu ta' methylthionium chloride, u ibda trattament t'appoġġ.
English: Methylthioninium chloride Proveblue will be given to you or your child (0-17 years old) to treat problems with your blood resulting from exposure to some medicines or chemicals that can cause a disease called methaemoglobinaemia.
Maltese: Kura għas-sintomi akuti ta' metemoglobinemija indotta minn prodotti mediċinali u kimiċi. Methylthioninium chloride Proveblue huwa indikat fl-adulti, fit-tfal u fl-adolexxenti (ta' bejn iż-0 u s17-il sena).
English: Extreme caution should be exercised when administering to newborns and infants below the age of 3 months due to lower concentrations of NADPH-methaemoglobin reductase necessary for reducing methaemoglobin to haemoglobin, making these infants more susceptible to methaemoglobinaemia produced by high doses of methylthioninium chloride.
Maltese: Agħti parir lil pazjenti biex jieħdu miżuri ta' protezzjoni kontra l-esponiment mid-dawl, peress li lfotosensittivita tista' sseħħ wara l-għoti ta' methylthioninium chloride.
English: Name and address of the manufacturers responsible for batch release
Maltese: Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott
English: • Selective serotonin reuptake inhibitors (SSRIs) such as citalopram, escitalopram, fluoxetine,
Maltese: • Inibituri selettivi ta' teħid mill-ġdid tas-serotonina (selective serotonin reuptake inhibitors
English: The maximum recommended cumulative dose for the course of treatment is 7 mg/kg.
Maltese: Id-doża kumulattiva massima rakkomandata għall-kors tat-trattament hija ta' 7 mg/kg.
English: Lietuva Provepharm SAS
Maltese: Magyarország Mediwings Pharma
English: In patients with aniline-induced methaemoglobinaemia, repeated doses of methylthioninium chloride may be required.
Maltese: F'pazjenti b'metemoglobinemija indotta mill-anilina, jistgħu jkunu meħtieġa dożi ripetuti ta' methylthioninium chloride.
English: Infants 3 months old or younger
Maltese: Adulti, tfal ikbar minn 3 xhur u anzjani
English: Methylthioninium chloride should be used with caution in patients with moderate to severe renal disease since there is limited data available and methylthioninium chloride is predominantly renally eliminated.
Maltese: Methylthioninium chloride għandu jintuża b'attenzjoni f'pazjenti b'mard renali moderat sa sever minħabba li hemm ftit dejta disponibbli u methylthioninium chloride jitneħħa prinċipalment millkliewi.
English: It has also been shown to inhibit the growth of cultured two-cell mouse embryos and the production of progesterone in cultured human luteal cells.
Maltese: Intwera wkoll li jinibixxi t-tkabbir ta' embrijuni tal-ġrieden ikkulturati ta' żewġ ċelloli u lproduzzjoni ta' proġesteron f'ċelloli luteali tal-bniedem ikkolturati.
English: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spain
Maltese: World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, 08039 Barcelona, Spanja
English: Grading based on NCI Common Toxicity Criteria CTCAE v 4.0.
Maltese: Il gradazzjoni hi bażata fuq l-NCI Komuni Toxicity Criteria CTCAE v 4.0.
English: Uncommon Colitis (inc clostridium difficile)*
Maltese: Mhux komuni Kolite (inkluż clostridium difficile)*
English: The active substance is bortezomib.
Maltese: -Is-sustanza attiva hi bortezomib.
English: CI=Confidence Interval
Maltese: CI=Intervall ta' Kunfidenza
English: Pruritus*, Dermatitis*, Rash*
Maltese: Prurite*, Dermatite*, Raxx*
English: Table 12: Efficacy results from study IFM-2005-01
Maltese: Tabella 12: Riżultati ta' effikaċja minn studju IFM-2005-01 Punti aħħarin
English: Bz n=315c n=312c Bz n=128 Dex n=110 Bz n=187 Dex n=202 Bz n=193
Maltese: Bzn=128 Dex n=110 Bzn=187 Dex n=202 Bzn=193
English: ORe (95% CI)=1.688 (1.148; 2.481) p-valueg=0.007
Maltese: ORe (95% CI)=1.688 (1.148; 2.481) valur p g=0.007
English: Date of first authorisation: 20 July 2015
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Lulju 2015
English: Normal (CrCL ≥ 60 ml/min/1.73 m2, n=12), Mild (CrCL=40-59 ml/min/1.73 m2, n=10), Moderate (CrCL=20-39 ml/min/1.73 m2, n=9), and Severe (CrCL < 20 ml/min/1.73 m2, n=3).
Maltese: ≥60 ml/min/1.73 m2, n=12), Ħafif (CrCL=40-59 ml/min/1.73 m2, n=10), Moderat (CrCL=20-39 ml/min/1.73 m2, n=9), u Qawwi (CrCL < 20 ml/min/1.73 m2, n=3).
English: ≥ 2 prior lines
Maltese: ≥2 linji fil-passat
English: HRb (95% CI)=0.63 (0.50; 0.79) p-valued < 0.001
Maltese: HRb (95% CI)=0.63 (0.50; 0.79)
English: Reduction in serum M-protein populationg n=667
Maltese: Tnaqqis tal-proteina M fis-serum popolazzjonig n=667
English: Reduce Bortezomib Accord to 1.0 mg/m2
Maltese: Naqqas Bortezomib Accord għal 1.0 mg/m2
English: Combination with dexamethasone
Maltese: Dex=dexamethasone
English: SC or IV
Maltese: SC jew IV
English: ORR (CR+PR) p-valuea
Maltese: ORR (CR+PR) Valur pa
English: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) p-valued
Maltese: CRf n (%) PRf n (%) nCR n (%) CR+PRf n (%) Valur-pd
English: The primary efficacy endpoint was progression-free survival based on Independent Review Committee (IRC) assessment.
Maltese: Il-punt finali ta' effikaċja primarja kien sopravivenza ħielsa mill-progressjoni abbażi ta' stima talKumitat ta' Reviżjoni Indipendenti (IRC - Independent Review Committee).
English: d p-value from the Cochran-Mantel-Haenszel chi-square test adjusted for the stratification factors; analysis by line of therapy excludes stratification for therapeutic history * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
Maltese: d valur-p mit-test chi-square Cochran Mantel-Haenszel aġġustat għal fatturi ta' stratifikazzjoni; analiżi skont il-linja tat terapija teskludi stratifikazzjoni għall-istorja terapewtika * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
English: CR+nCR+PR 121 (38)
Maltese: CR+nCR+PR 121 (38) b
English: Intent to Treat Populationb n=74
Maltese: Trattamentb n=74
English: 3.5 mg/vial
Maltese: 3.5 mg/kunjett
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m2.
Maltese: Rituximab bid-doża ta' 375 mg/m2, cyclophosphamide bid-doża ta' 750 mg/m2 u doxorubicin bid-doża ta' 50 mg/m2.
English: The analysis demonstrated improved ORR (CR+PR) (odds ratio 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (hazard ratio 0.511; 95% CI 0.309-0.845; p=0.008), TTP (hazard ratio 0.385; 95% CI 0.212-0.698; p=0.001) for bortezomib in combination with dexamethasone over bortezomib monotherapy.
Maltese: (proporzjon farradi 3.769; 95% CI 2.045-6.947; p < 0.001), PFS (proporzjon ta' periklu 0.511; 95% CI 0.309-0.845; p=0.008), TTP (proporzjon ta' periklu 0.385; 95% CI 0.212-0.698; p=0.001) għal bortezomib f'kombinazzjoni ma' dexamethasone fuq il-monoterapija b'bortezomib.
English: Day 29 rest period
Maltese: Jum 29 perjodu ta'
English: Melphalan (9 mg/m2) and prednisone (60 mg/m2) are both given orally on days 1, 2, 3 and 4 of the first week of each cycle.
Maltese: Melphalan (9 mg/m2) u prednisone (60 mg/m2) jingħataw it-tnejn li huma mill-ħalq fil-jiem 1, 2, 3 u
English: Bz n=200a
Maltese: Bzn=200
English: Table 13: Efficacy results from study MMY-3010
Maltese: Tabella 13: Riżultati t'effikaċja minn studju MMY-3010 Punti aħħarin
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzTDx and TDx groups, respectively.
Maltese: Trapjanti ta' ċelluli steminali awtologi ġew mogħtija lil 105 (81%) u 78 (61%) pazjent fil-gruppi BzTDx u TDx, rispettivament.
English: 0.7 mg/m2).
Maltese: għal 0.7 mg/m2).
English: Bortezomib Accord contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Maltese: Bortezomib Accord fih is-sustanza attiva bortezomib, hekk imsejjaħ ‘impeditur ta' proteasome'.
English: Overall complete response (CR+CRu)f n(%)
Maltese: Total ta' rispons sħiħ (CR+CRu)f n(%)
English: CR n (%) PR n (%) nCR n (%)
Maltese: CR n (%) PR n (%)
English: Hepatitis B virus (HBV) reactivation and infection
Maltese: Riattivazzjoni u infezzjoni bil-virus tal-Epatite B (HBV - Hepatitis B Virus)
English: The AUClast geometric mean ratio was 0.99 and 90% confidence intervals were
Maltese: Il-proporzjon ġeometriku medju AUClast kien ta' 0.99 u l-intervalli ta' kunfidenza ta' 90% kienu 80.
English: ORR (CR+PR) p-valuea CR n (%) PR n (%) nCR n (%)
Maltese: ORR (CR+PR) Valur pa CR n (%) PR n (%) nCR n (%)
English: A statistically significant benefit (p < 0.001) in favour of the BzR-CAP treatment group over the R-CHOP group was observed for TTP (median 30.5 versus 16.1 months), TNT (median 44.5 versus 24.8 months) and TFI (median 40.6 versus 20.5 months).
Maltese: Benefiċċju statistikament sinifikanti (p < 0.001) favur il-grupp ta' trattament ta' BzR-CAP fuq il-grupp ta' R-CHOP ġie osservat għal TTP (medjan 30.5 versus 16.1 xhur), TNT (medjan 44.5 versus 24.8 xhur) u TFI (medjan 40.6 versus 20.5 xhur).
English: • Pneumonia • Loss of appetite
Maltese: • Pulmonite • Telf ta' aptit
English: N=127 (ITT population)
Maltese: N=127 popolazzjoni ITT)
English: > 1.0 x −1.5 x ULN Any
Maltese: > 1.0x−1.5x ULN
English: TTP, months
Maltese: TTP, xhur
English: 2 years (for Bortezomib Accord 1 mg) 3 years (for Bortezomib Accord 3.5 mg)
Maltese: Sentejn (għal Bortezomib Accord 1 mg) 3 snin (għal Bortezomib Accord 3.5 mg)
English: 1-year Overall Survival (%)e
Maltese: Sopravivenza Globali ta' sena (%)e
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzR-CAP arm.
Maltese: Profilassi antivirali ngħatat lill-137 minn 240 pazjent (57%) fil-fergħa ta' BzR-CAP.
English: CR+nCR+PR % (95% CI)
Maltese: CR+nCR CR+nCR +PR % (95% CI)
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Maltese: Valur-pc a Stima Kaplan-Meier.
English: Neoplasm malignant, Leukaemia plasmacytic, Renal cell carcinoma, Mass, Mycosis fungoides, Neoplasm benign*
Maltese: Neoplażmi malinni, Lewkemja plażmaċitika, Karċinoma taċċellula renali, Piż, Fungojdi mikosi, Neoplażma beninni*
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4
Maltese: Jum1, 2, 3, 4 Jum 8, 9, 10, 11Ċikli 2 sa 4b
English: In the BzTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Maltese: Fil-grupp ta' BzTDx 12 % tal-pazjenti kienu ċitoġenetikament ikklassifikati bħala ta' riskju għoli meta mqabbel ma' 16 % tal-pazjenti fil-grupp ta' TDx.
English: Once weekly Bortezomib Accord (cycles 5-9)
Maltese: Bortezomib Accord darba fil-ġimgħa (ċikli 5-9)
English: Based on the limited contribution (7%) of CYP2D6 to the metabolism of bortezomib, the CYP2D6 poor metaboliser phenotype is not expected to affect the overall disposition of bortezomib.
Maltese: Skont il-kontribuzzjoni limitata (7 %) ta' CYP2DG għallmetaboliżmu ta' bortezomib, il-metabolizzatur batut b'fenotip CYP2D6 mhux mistenni li jaffettwa d dispożizzjoni ġenerali ta' bortezomib.
English: Meningitis (inc bacterial), Epstein-Barr virus infection, Genital herpes, Tonsillitis, Mastoiditis, Post viral fatigue syndrome
Maltese: Meninġite (anke batterika), Infezzjoni tal-virus Epstein-Barr, Herpes ġenitali, Tonsillite, Mastojdite, Sindromu ta' għeja wara l-virus