FrancophonIA/ELRC3.0 huggingface dataset:
English: Hexacima will be given to your child by a doctor or nurse trained in the use of vaccines and who are equipped to deal with any uncommon severe allergic reaction to the injection (see section 4 Possible side effects).
Maltese: Hexacima tingħata lit-tifel/tifla tiegħek minn tabib jew infermier li huma mħarrġa fl-użu ta' vaċċini u li huma mgħammra biex jittrattaw ma' kull reazzjoni allerġika severa mhux komuni għall-injezzjoni (ara sezzjoni 4 ‘Effetti sekondarji possibbli).
English: Apnoea in very premature infants (≤ 28 weeks of gestation) (see section 4.4)
Maltese: Disturbi Respiratorji, toraċiċi u medjastinali Apnea fi trabi prematuri ħafna (≤ 28 ġimgħa ta' tqala) (ara sezzjoni 4.4).
English: Hexacima can be considered for the booster.
Maltese: Hexacima jista jkun ikkunsidrat għal dan il buster.
English: Anti-PRP (≥ 1.0 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth ( Mexico) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration (pre-dose 1) <8 EU/ml, then the post-booster antibody concentration should be ≥8 EU/ml.
Maltese: 9 snin wara serje primarja li tikkonsisti minn doża waħda tal-vaċċin tal-epatite B mogħtija mat-twelid segwit minn serje infantili ta' 3 dożi fit-2,4 u 6 xahar ta' età mingħajr ma tingħata buster wara l-età ta' sena fejn 49.3% ta' dawk li ħadu l-vaċċin kellhom antikorpi ≥ 10 mIU/ml b'konċentrazzjonijiet medji ġeometriċi ta' 13.3 (95% CI: 8.82 - 20.0) mIU/ml.
English: • Haemophilus influenzae type b infections (often just called Hib) are serious bacterial infections and can cause meningitis (inflammation of the outer covering of the brain), which can lead to brain damage, deafness, epilepsy, or partial blindness.
Maltese: • Infezzjonijiet ta' Haemophilus influenzae tip b (ta' spiss msejħa Hib) huma infezzjonijiet batteriċi serji li jistgħu jikkawżaw meninġite (infjammazzjoni tal-kopertura ta' fuq barra tal-moħħ), ji jista jasal għal ħsara fil-moħħ, truxija, epilessija, u għama parzjali.
English: Hexacima suspension for injection in pre-filled syringe Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Maltese: Hexacima, suspensjoni għall-injezzjoni f'siringa mimlija għal-lest Vaċċin ikkonjugat (adsorbit) ta' Difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA),
English: Hexacima does not protect against infectious diseases caused by other types of Haemophilus influenzae or against meningitis of other origins.
Maltese: Hexacima ma jipproteġix kontra mard infettiv ikkawżat minn tipi oħra ta' Haemophilus influenzae jew kontra meninġite li ġejja minn oriġini oħra.
English: Poliovirus (Inactivated)4 Type 1 (Mahoney)
Maltese: Tip 1 (Mahoney)
English: 20.0) mIU/ml.
Maltese: 1886 - 7225) mIU/ml wara l-vaċċinazzjoni.
English: Anti-PRP (≥ 0.15 µg/ml) * Generally accepted surrogates (PT, FHA) or correlates of protection (other components) N = Number of individuals analysed (per protocol set) ** 3, 5 months without hepatitis B vaccination at birth (Finland, Sweden) † 6, 10, 14 weeks with and without hepatitis B vaccination at birth (Republic of South Africa) †† 2, 3, 4 months without hepatitis B vaccination at birth (Finland) ‡ 2, 4, 6 months without hepatitis B vaccination at birth (Argentina, Mexico, Peru) and with hepatitis B vaccination at birth (Costa Rica and Colombia) ‡‡ Seroconversion: minimum 4-fold increase compared to pre-vaccination level (pre-dose 1) § Vaccine response: If pre-vaccination antibody concentration <8 EU/ml, then the post-vaccination antibody concentration should be ≥8 EU/ml.
Maltese: †† 2, 3, 4 xhur mingħajr vaċċinazzjoni epatite B fit-twelid (il-Finlandja) ‡ 2, 4, 6 xhur mingħajr vaċċinazzjoni epatite B fit-twelid (Arġentina , il-Messiku , il-Peru) u bl-epatite B
English: • Pertussis (often called whooping cough) is a highly infectious illness that affects the airways.
Maltese: • Pertussi (ħafna drabi msejħa sogħla konvulsiva) hija marda infettiva ħafna, li taffettwa il-passaġġi tan-nifs.
English: Hexacima (DTaP-IPV-HB-Hib) is a vaccine used to protect against infectious diseases.
Maltese: X'inhu Hexacima u għalxiex jintuża Hexacima (DTaP-IPV-HB-Hib) huwa vaċċin li jintuża biex jipproteġi kontra mard infettiv.
English: Nervous system disorders - Brachial neuritis and Guillain-Barré Syndrome have been reported after administration of a tetanus toxoid containing vaccine - Peripheral neuropathy (polyradiculoneuritis, facial paralysis), optic neuritis, central nervous system demyelination (multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine - Encephalopathy/encephalitis
Maltese: - Newropatija periferali (poliradikulonewrite, paraliżi tal-wiċċ), newrite ottika, demijelinazzjoni tassistema nervuża ċentrali (sklerożi multipla) kienu rrappurtati wara l-għoti tal-vaċċin b'antiġen ta'
English: titers ≥ 0.15 µg/ml were observed in 73.0% of individuals, anti-PT vaccine response in 97.9% of individuals and anti-FHA vaccine response in 98.6% of individuals.
Maltese: FHA rispons tal-vaċċin fil 98.6 % tal -individwi.
English: Package leaflet: Information for the user Hexacima suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Maltese: Vaċċin ikkonjugat (adsorbit) ta' Difterite, tetnu, pertussi (komponent aċellulari), epatite B (rDNA),
English: Hexacima suspension for injection
Maltese: U KONTENUT Suspensjoni għall-injezzjoni
English: Table 1: Seroprotection/Seroconversion rates* one month after primary vaccination with 2 or 3 doses of Hexacima
Maltese: Tabella 1: Rati ta' Seroprotezzjoni/Serokonverżjoni* xahar wara tilqim b' żewg jew tlett dożi primarji ta' Hexacima
English: Reporting of suspected adverse reactions
Maltese: Rapportaġ ta' reazzjonijiet avversi
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed) DTaP-IPV-HB-Hib
Maltese: poljomelite (inattivat) u Haemophilus influenzae tip b DTaP-IPV-HB-Hib
English: Hexacima is available in pack containing 1 or 10 pre-filled syringes without attached needle.
Maltese: Hexacima huwa disponibbli f'pakkett li fih 1 jew 10 siringi mimlija lesti mingħajr labra mwaħħla.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One dose
Maltese: GĦAMLA KWALITATTIVA
English: Ireland sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 600
Maltese: Ireland sanofi-aventis Ireland T/A SANOFI
English: When a dose of hepatitis B vaccine is given at birth, the sequential infant primary vaccination hexavalent/pentavalent/hexavalent schedule with Hexacima and a pentavalent DTaP-IPV/Hib vaccine can be used in accordance with official recommendations.
Maltese: Meta doża ta' epatite B tingħata fit-twelid, l-iskeda ħexavalenti/pentavalenti/ħexavalenti b'Hexacima u vaċċin pentavalenti DTaP-IPV/Hib tal-vaċċinazzjoni primarja sekwenzjali tat-trabi tista' tintuża skont irrakkomandazzjonijiet uffiċjali.
English: • Inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis), facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis), inflammatory disease of brain and spinal cord (central nervous system demyelination, multiple sclerosis) have been reported after administration of a hepatitis B antigen containing vaccine.
Maltese: • Infjammazzjoni temorpanju tan-nervituri li jikkawża uġigħ, paraliżi u diżordni tas-sensittività (Is sindromu ta' Guillain-Barré) u uġigħ mifrux fid-driegħ u l-ispalla (newrite brakjali) kienu rrappurtati wara l-għoti ta' vaċċin li fih it-tetnu • Infjammmazzjoni ta' diversi nervi li jikawżaw disturbi sensorji jew dgħjufija fir-riġlejn
English: Hexacima may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.
Maltese: Hexacima jista jintuża bħala buster f'dawk in-nies li qabel ingħataw tilqim ieħor hexavalenti jew tilqim pentavalenti DTaP-IPV/Hib assoċjat ma tilqim ta epatite B monovalenti.
English: • has had an allergic reaction - to the active substances, - to any of the excipients listed in section 6, - to glutaraldehyde, formaldehyde, neomycin, streptomycin or polymyxin B, as these substances are used during the manufacturing process.
Maltese: - għal xi sustanza mhux attiva elenkata f'sezzjoni 6, - għal glutaraldehyde, formaldehyde, neomycin, streptomycin jew polymyxin B peress li dawn is-sustanzi jintuzaw fil-proċess tal-manifattura.
English: • has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough, cold or flu).
Maltese: • għandu deni moderat jew għoli jew mard akut (e.ż. deni, uġigħ fil-griżmejn, sogħla, riħ jew influenza).
English: Since the Hib capsular polysaccharide antigen is excreted in the urine, a positive urine test can be observed within 1 to 2 weeks following vaccination.
Maltese: Peress li l-antiġen kapsulari polisakkarid ta' Hib jiġi eliminat fl-awrina, test pożittiv fl-awrina jista' jiġi osservat fi żmien 1sa 2 ġimgħat wara t-tilqima.
English: Pack size of 10.
Maltese: Τηλ: +30.
English: Studies on long-term persistence of vaccine induced antibodies following varying infant / toddler primary series and following Hepatitis B vaccine given at birth or not have shown maintenance of levels above the recognized protective levels or antibody thresholds for the vaccine antigens (see Table 3).
Maltese: Studji fit-tul dwar il-persistenza tal-antikorpi kkawżati mill-vaċċin wara serje primarja li tvarja bejn tarbija/tifel ċkejken u wara l-għoti mat-twelid jew le tal-vaċċin kontra l-epatite B wrew manteniment tallivelli 'l fuq mill-livelli rikonoxxuti ta' protezzjoni jew limitu bażiku ta' antikorpi meħtieġa kontra lantiġeni tal-vaċċin (ara Tabella 3)
English: All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth.
Maltese: Kull skeda ta' tilqim inkluż il WHO Programm Mwassa' dwar l-Immunizzazzjoni (EPI) għal 6, 10 ġimgħat, 14-il ġimgħa ta' età tista' tintuża kemm jekk ingħatat doża ta' tilqim ta' epatite B fit-twelid jew le.
English: In individuals with chronic renal failure, an impaired hepatitis B response is observed and administration of additional doses of hepatitis B vaccine should be considered according to the antibody level against hepatitis B virus surface antigen (anti-HBsAg).
Maltese: F'individwi b'insuffiċjenza tal-kliewi kronika, rispons indebolit minħabba epatite B ġie osservat u l-għoti ta' dożi addizzjonali tat-tilqima għall-epatite B għandhom jiġu kkunsidrati skont il-livell ta' antikorpi kontra l-antiġeni tal-wiċċ tal-virus ta' epatite B (anti-HbsAg).
English: Extensive limb swelling†
Maltese: UŻATI JEW SKART MINN DAWN
English: • Uncommon side effects (may affect up to 1 in 100 people) are: - allergic reaction - lump (nodule) at the injection site - high fever (temperature 39.6°C or higher)
Maltese: • Reazzjonijiet mhux komuni (jistgħu jaffettwaw sa persuna 1 f'100 persuna) huma: - reazzjoni allerġika
English: If Guillain-Barré syndrome or brachial neuritis has occurred following receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks, such as whether or not the primary vaccination has been completed.
Maltese: Jekk ikun hemm is-sindromu ta' Guillain-Barré jew newrite brankjali wara t-teħid ta' vaċċin li jkun fih tossojdi tat-tetnu, id-deċiżjoni sabiex tingħata tilqima li fiha tossojdi tat-tetnu għandha tkun ibbażata fuq konsiderazzjoni attenta tal-benefiċċji potenzjali u r-riskji possibbli, bħal jekk l-immunizzazzjoni primarja tkunx tlestiet jew le.
English: Str. Fabricii nr 124
Maltese: Fabricii nr 124
English: Day -- -
Maltese: Jum -- -
English: Cycles 1 to 4
Maltese: Ċikli 1 sa 4
English: Ranbaxy (Poland) Sp. Z o. o. ul.
Maltese: Ranbaxy (Poland) Sp. Z o. o.
English: CI=Confidence Interval
Maltese: CI = Intervall ta' Kunfidenza (Confidence Interval)
English: ≥ 2 prior lines
Maltese: ≥ 2 linji
English: 2132JH HOOFDDORP NETHERLANDS
Maltese: 2132 JH HOOFDDORP L-OLANDA
English: Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
Maltese: Sun Pharma Laboratorios, S.L. Rambla de Catalunya 53-55 08007 Barcelona España tel. +34 93 342 78 90
English: Day 8, 11
Maltese: Jum 8, 11
English: OR; 95% CI; P valuea
Maltese: OR; 95% CI; valur Pa
English: Day 22
Maltese: Jum 22
English: Table 8 has been generated using Version 16 of the MedDRA.
Maltese: Tabella 8 ġiet iġġenerata bl-użu tal-Verżjoni 16 ta' MedDRA.
English: System Organ Class
Maltese: Sistema tal-Klassifikatal-Organi
English: HRb (95% CI)=0.63 p-valued < 0.001
Maltese: HRb (95% CI)=0.63 valur-pd < 0.001
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/Ολλανδία/ Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Maltese: L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
English: Table 12: Efficacy results from study IFM-2005-01 Endpoints
Maltese: Tabella 12: Riżultati tal-effikaċja minn studju IFM-2005-01 Punti aħħarin
English: Combination therapy with dexamethasone
Maltese: Dex=dexamethasone
English: • Dosing Slide Rule
Maltese: • Slide rule tad-dożaġġ
English: Posterior Reversible Encephalopathy Syndrome (PRES)
Maltese: Sindrome ta' Enċefalopatija Posterjuri Riversibbli (PRES - Posterior Reversible Encephalopathy Syndrome)
English: a Based on Independent Review Committee (IRC) assessment (radiological data only).
Maltese: Indipendenti (IRC - Independent Review Committee) (dejta radjuloġika biss).
English: ORe (95% CI)=1.428 p-valueg=0.275
Maltese: ORe (95% CI)=1.428 valur pg=0.275
English: Table 13: Efficacy results from study MMY-3010 Endpoints
Maltese: Tabella 13: Riżultati tal-effikaċja minn studju MMY-3010 Punti aħħarin
English: MARKETING AUTHORISATION NUMBER EU/1/16/1102/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/16/1102/001
English: Response rate populatione n=668
Maltese: Rata ta' rispons popolazzjonie n = 668
English: TTP, days [95% CI]
Maltese: TTP, jiem [95% CI]
English: LIST OF EXCIPIENTS Excipient: mannitol (E421)
Maltese: TA' EĊĊIPJENTI Eċċipjent: mannitol (E421)
English: Hazard ratiob (95% CI) p-valuec a Kaplan-Meier estimate.
Maltese: Proporzjon ta' periklub (95% CI) valur-pc a Stima Kaplan-Meier.
English: Antiviral prophylaxis should be considered.
Maltese: Għandha tiġi meqjusa profilassi antivirali.
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 biddoża ta' 50 mg/m2.
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Maltese: Metaboliti deboronati permezz ta' bortezomib mhumiex attivi bħala inibituri ta' proteasome 26S.
English: - Flush the peripheral or intravenous catheter with sterile, 9 mg/ml (0.9%) sodium chloride solution.
Maltese: - Aħsel il-kateter periferali jew ġol-vini b'soluzzjoni sterili, 9 mg/ml (0.9%) ta' sodium chloride.
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Maltese: SGOT = glutamic oxaloacetic transaminase fis-serum (serum glutamic oxaloacetic transaminase) AST = aspartate aminotransferase;
English: Bzmb (1.3 mg/m2) Day 1, 4
Maltese: Bzmb (1.3 mg/m2) Jum 1, 4
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11Cycles 2 to 4b
Maltese: Jum 1, 2, 3, 4 Jum 8, 9, 10, 11Ċikli 2 sa 4b
English: Exposure of bortezomib (dose-normalised AUC and Cmax) was comparable among all the groups (see section 4.2).
Maltese: L-esponiment ta' bortezomib (AUC u Cmax normalizzati għad-doża) kien komparabbli fost il-gruppi kollha (ara sezzjoni 4.2).
English: Patients in the BzmbTDx and TDx groups respectively had a median age of 57 versus 56 years, 99% versus 98% patients were Caucasians, and 58% versus 54% were males.
Maltese: Pazjenti fil-gruppi ta' trattament ta' BzmbTDx u TDx rispettivament kellhom età medjana ta' 57 sena kontra 56 sena, 99% kontra 98% tal-pazjenti kienu Kawkasi, u 58% kontra 54% kienu rġiel.
English: Day 29 Rest period
Maltese: Jum 29 Perjodu ta'
English: Higher incidences were also noted for infections with Grade ≥ 3 neutropenia (24% versus 19% in Block 1 and 22% versus 11% in Block 2), increased ALT (17% versus 8% in Block 2), hypokalaemia (18% versus 6% in Block 1 and 21% versus 12% in Block 2) and hyponatraemia (12% versus 5% in Block 1 and 4% versus 0 in Block 2).
Maltese: Inċidenzi ogħla ġew ukoll innutati għal infezzjonijiet b'newtropenija bi Grad ≥ 3 (24% versus 19% fi Blokk 1 u 22% versus 11% fi Blokk 2), żieda fl-ALT (17% versus 8% fi Blokk 2), ipokalimja (18% versus 6% fi Blokk 1 u 21% versus 12% fi Blokk 2) u iponatrimja (12% versus 5% fi Blokk 1 u 4% versus 0 fi Blokk 2).
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+) NA=not applicable, NE=not estimated TTP-Time to Progression
Maltese: d valur-p mit-test chi-square Cochran Mantel-Haenszel aġġustat għal fatturi stratifikati; analiżi skont il-linja tat-terapija teskludi stratifikazzjoni għall-istorja terapewtika * CR+PR+MR **CR=CR, (IF-); nCR=CR (IF+)
English: * Grouping of more than one MedDRA preferred term.
Maltese: * Ġabra flimkien ta' iktar minn terminu wieħed ippreferut ta' MedDRA.
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: L-analiżi wriet titjib fl-ORR (CR+PR) (proporzjon tal-odds 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: CR+PRf n (%) p-valued
Maltese: CR+PRf n (%) valur-pd
English: > 1.0 x - 1.5 x ULN Any
Maltese: > 1.0 x - 1.5 x ULN
English: Mannitol (E421)
Maltese: Mannitol (E421), nitrogen
English: Day 1, 2, 3, 4 Day 8, 9, 10, 11
Maltese: Jum 1, 2, 3, 4 Jum 8, 9, 10, 11
English: All grade peripheral neuropathy and grade ≥ 3 peripheral neuropathy were observed in 40% and 8.5% of patients, respectively.
Maltese: Newropatija periferali ta' kull grad u newropatija periferali ta' grad ≥ 3 kienu osservati f'40% u 8.5% tal-pazjenti, rispettivament.
English: The reported efficacy data are considered inconclusive (see section 4.2).
Maltese: Id-dejta dwar effikaċja rrappurtata hija meqjusa inkonklużiva (ara sezzjoni 4.2).
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 mill-ħalq f'jiem 1, 2, 3 u 4 tal-ewwel ġimgħa ta' kull ċiklu.
English: Reduction in serum Mprotein populationg n=667
Maltese: Tnaqqis tal-proteina M fisserum popolazzjonig n=667
English: Bzmb=Bortezomib SUN; M=melphalan, P=prednisone
Maltese: M=melphalan, P=prednisone
English: ORe (95% CI)=1.688 p-valueg=0.007
Maltese: ORe (95% CI)=1.688 valur pg=0.
English: The median OS was 30.8 months (95% CI;
Maltese: L-OS medjan kien ta' 30.8 xhur (95% CI; 25.
English: One single autologous stem cell transplant was received by 105 (81%) patients and 78 (61%) patients in the BzmbTDx and TDx groups, respectively.
Maltese: Trapjant wieħed ta' ċelluli staminali awtologi ġie riċevut minn 105 (81%) u 78 (61%) pazjent filgruppi ta' BzmbTDx u TDx, rispettivament.
English: A statistically significant benefit (p < 0.001) in favour of the BzmbR-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' BzmbR-CAP fuq il-grupp ta' RCHOP ġie osservat għal TTP (medjan 30.5 kontra 16.1 xhur), TNT (medjan 44.5 versus 24.8 xhur) u TFI (medjan 40.6 versus 20.5 xhur).
English: The concentration of the resulting solution will be 2.5 mg/ml.
Maltese: Il-konċentrazzjoni tas-soluzzjoni li tinkiseb se tkun ta' 2.5 mg/ml.
English: > 1.5 x - 3 x ULN Any
Maltese: > 1.5 x - 3 x ULN
English: 12.8 mo
Maltese: 12.8 xahar
English: This interim analysis showed a TTP risk reduction of 45% (95% CI; 29-57%, p < 0.0001) for patients treated with combination therapy of bortezomib and pegylated liposomal doxorubicin.
Maltese: Din l-analiżi interim uriet tnaqqis fir-riskju ta' TTP ta' 45% (95% CI; 29-57%, p < 0.0001) għal pazjenti ttrattati b'terapija kombinata ta' bortezomib u pegylated liposomal doxorubicin.
English: In the BzmbTDx group 12% of patients were cytogenetically classified as high risk versus 16% of patients in the TDx group.
Maltese: Fil-grupp ta' BzmbTDx, 12% tal-pazjenti kienu ċitoġenetikament ikklassifikati bħala ta' riskju għoli meta mqabbla ma' 16% tal-pazjenti fil-grupp ta' TDx.
English: Bortezomib SUN dose.
Maltese: Waqqaf Bortezomib SUN
English: Gastrointestinal disorders Very Common
Maltese: Disturbi gastrointestinali Komuni ħafna
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the BzmbR-CAP arm.
Maltese: Profilassi antivirali ngħatat lill-137 minn 240 pazjent (57%) fil-parti tal-istudju dwar BzmbR-CAP.
English: Bortezomib SUN contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Maltese: Bortezomib SUN fih is-sustanza attiva bortezomib, hekk imsejjaħ ‘impeditur ta' proteasome'.
English: - If platelet counts < 25,000 cells/μl.
Maltese: - Jekk l-għadd tal-plejtlits ikun < 25,000 ċellula/μL.
English: 56.4 mo
Maltese: 56.4 xahar
English: For preclinical cardiovascular safety pharmacology studies, see section 5.3.
Maltese: Għal studji prekliniċi kardjovaskulari ta' sigurtà farmakoloġika, ara sezzjoni 5.3.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 22 July 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 ta' Lulju, 2016
English: Unopened vial 18 months.
Maltese: Kunjett mhux miftuħ 18 xhur.
English: Similar proportions of patients had creatinine clearance ≤30 ml/min (3% in each arm).
Maltese: Proporzjonijiet simili ta' pazjenti kellhom tneħħija ta' kreatinina ta' ≤ 30 ml/min (3% f'kull parti talistudju)
English: Once weekly Bortezomib SUN (cycles 5-9)
Maltese: Bortezomib SUN darba fil-ġimgħa (ċikli 5-9)
English: Week Bzmb (1.3 mg/m2) Day 1, 4
Maltese: Ġimgħa Bzmb (1.3 mg/m2) Jum 1, 4
English: Ranbaxy Italia S.p.A. Viale Giulio Richard, 1 20143 Milano Italia tel. +39 02 33 49 07 93
Maltese: Viale Giulio Richard, 1 20143 Milano Italia tel.
English: N=127 (ITT population)
Maltese: N=127 (popolazzjoni ITT)
English: Grade 1 with pain or Grade 2 (moderate symptoms; limiting instrumental Activities of Daily Living (ADL)**)
Maltese: Grad 1 bl-uġigħ jew Grad 2 (sintomi moderati: li jirrestrinġu l-Attivitajiet strumentali tal-Ħajja ta' Kuljum (ADL - Activities of Daily Living**))