FrancophonIA/ELRC3.0 huggingface dataset:
English: • congenital choroid plexus cyst;
Maltese: · Ciclosporin u kortikosterojdi.
English: Concomitant administration of telmisartan and CellCept resulted in an approximately 30% decrease of MPA concentrations.
Maltese: Għoti flimkien ta' telmisartan u CellCept wassal għal tnaqqis ta' madwar 30% fil-konċentrazzjonijiet ta' MPA.
English: See also further information in this section under “Warnings and precautions” and “Pregnancy and breast-feeding”.
Maltese: Ara wkoll aktar informazzjoni f'din is-sezzjoni taħt “Twissijiet u prekawzjonijiet” u “Tqala u treddigħ”.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 250 mg mycophenolate mofetil.
Maltese: Kull kapsula fiha 250 mg mycophenolate mofetil.
English: This will be given as 1 g in the morning and then 1 g in the evening.
Maltese: Din se tingħata bħala 1 g filgħodu u wara 1 g filgħaxija.
English: Drugs which interfere with MPA's enterohepatic cycle (e.g. cholestyramine, antibiotics) should be used with caution due to their potential to reduce the plasma level and efficacy of CellCept (see also section 4.5).
Maltese: Mediċini li jinterferixxu maċ ċiklu enteroepatiku ta' MPA (eż. cholestyramine, antibijotiċi) għandhom jintużaw b'attenzjoni minħabba l-potenzjal tagħhom li jnaqqsu l-livelli fil-plażma u l-effikaċja ta' CellCept (ara wkoll sezzjoni 4.5).
English: WARNING
Maltese: Astenja
English: Take 3 tablets in the morning and then 3 tablets in the evening.
Maltese: Ħu 3 pilloli filgħodu u wara 3 pilloli filgħaxija.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, polysorbate
Maltese: Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal mycophenolate mofetil,
English: In contrast, there was an increase of approximately 20% in tacrolimus AUC when multiple doses of CellCept (1.5 g BID) were administered to hepatic transplant patients taking tacrolimus.
Maltese: B'kuntrast, kien hemm żieda ta' madwar 20% fl-AUC ta' tacrolimus meta dożi multipli ta' CellCept (1.5 g BID) ingħataw lil pazjenti bi trapjant tal-fwied li kienu qed jieħdu tacrolimus.
English: No pharmacokinetic data are available during hepatic transplant rejection.
Maltese: M'hemm l-ebda data farmakokinetika disponibbli waqt tiċħid ta' trapjant epatiku.
English: Other medicines and CellCept:
Maltese: Tiħux CellCept: ·
English: (body surface area - measured as square metres or “m2”).
Maltese: (doża ta' 3 g kuljum).
English: Do not store above 30 °C.
Maltese: Aħżen f'temperatura ta' 15 - 30°C.
English: Write the date of expiration of the reconstituted suspension on the bottle label.
Maltese: Id-data ta' skadenza tas-suspensjoni rikostitwita hija ta' xahrejn
English: Because MPAG plasma concentrations are increased in the presence of renal impairment, as are aciclovir concentrations, the potential exists for mycophenolate mofetil and aciclovir, or its prodrugs, e.g. valaciclovir, to compete for tubular secretion and further increases in concentrations of both substances may occur.
Maltese: Peress li fil-preżenza ta' indeboliment renali lkonċentrazzjonijiet fil-plażma ta' MPAG u ta' aciclovir jiżdiedu, hemm il-potenzjal li mycophenolate mofetil u aciclovir, jew il-prodrugs tiegħu eż. valaciclovir, jikkompetu għat-tneħħija mit-tubi talkliewi u dan iwassal għal aktar żieda fil-konċentrazzjoni taż-żewġ sustanzi.
English: Reconstitute the content of each vial by injecting 14 mL of glucose intravenous infusion 5%.
Maltese: infużjoni għal ġol-vini ta' 5% glucose.
English: Gingival hyperplasia
Maltese: Ipertrofija tal-ġilda
English: Uncommon Uncommon Uncommon
Maltese: Komuni Ħafna Komuni Ħafna Komuni
English: In this leaflet the shorter name CellCept is used.
Maltese: Ma jidhirx li huwa meħtieġ aġġustament fid-doża ta' CellCept.
English: Facial malformations such as cleft lip, cleft palate, micrognathia and hypertelorism of the orbits;
Maltese: atreżja tal-kanal estern tas-smigħ (widna tan-nofs); · Malformazzjonijiet fil-wiċċ bħal xoffa mixquqa, palat mixquq, mikrognatija u iperteloriżmu tal orbiti; ·
English: Pseudolymphoma
Maltese: Psewdolimfoma
English: Oral administration of radiolabelled mycophenolate mofetil results in complete recovery of the administered dose with 93% of the administered dose recovered in the urine and 6% recovered in the faeces.
Maltese: mycophenolate mofetil radjutikkettat iwassal għal irkupru komplut tad-doża mogħtija bi 93% tad-doża mogħtija rkuprata fl-awrina u 6% irkuprata fl-ippurgar.
English: If neutropenia develops, dosing with CellCept should be interrupted or the dose reduced (see section 4.4).
Maltese: CellCept huwa kontraindikat f'nisa li qed ireddgħu (ara sezzjoni 4.3).
English: (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), red iron oxide (E172).
Maltese: · il-kisja tal-pillola: hydroxypropyl methylcellulose, hydroxypropyl cellulose, titanium dioxide (E171), polyethylene glycol 400, indigo carmine aluminium lake (E132), iron oxide aħmar (E172).
English: Powder for concentrate for solution for infusion.
Maltese: Tilqim kontra linfluwenza jista' jkun utli.
English: There have been published reports of bronchiectasis in adults and children who received CellCept in combination with other immunosuppressants.
Maltese: Kien hemm rapporti ppubblikati ta' bronkjektasi f'adulti u tfal li rċevew CellCept flimkien ma' immunosoppressanti oħra.
English: diarrhea, constipation, feeling sick (nausea), indigestion, loss of appetite, flatulence.
Maltese: komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità
English: Counselling of patients: This section will emphasise the importance of a thorough, informative and ongoing dialogue between patient and healthcare professional about the pregnancy risks associated with mycophenolate mofetil and the relevant minimisation strategies including alternative treatment choices, if applicable.
Maltese: Din is-sezzjoni se tenfasizza l-importanza ta' djalogu komplut, informattiv u kontinwu bejn il-pazjent u l-professjonist tal-kura tas-saħħa dwar ir-riskji tat-tqala assoċjati ma' mycophenolate mofetil u l-istrateġiji ta' minimizzazzjoni rilevanti, inklużi għażliet ta' trattament alternattiv, jekk applikabbli.
English: PHARMACEUTICAL FORM AND CONTENTS 50 Tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: • Malformations of the fingers (e.g. polydactyly, syndactyly);
Maltese: · Malformazzjonijiet tas-swaba' (eż. swaba' żejda, swaba' mwaħħla flimkien);
English: Additional risk minimisation measures
Maltese: • Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: Congenital heart disease such as atrial and ventricular septal defects;
Maltese: Mard konġenitali tal-qalb bħal difetti fis-septum tal-atriju u tal-ventriklu;
English: • Powder for oral suspension: do not store above 30°C.
Maltese: Trab għal suspensjoni orali: taħżinx f'temperatura 'l fuq minn 30°C. ·
English: However, hepatic disease with predominantly biliary damage, such as primary biliary cirrhosis, may show a different effect.
Maltese: Iżda, mard epatiku bi ħsara predominanti tal-biljari, bħal ċirrożi biljari primarja, jista' juri effett differenti.
English: The full name of your medicine is CellCept 1 g/5 ml powder for oral suspension.
Maltese: Informazzjoni għall-utent CellCept 1 g/5 ml trab għal suspensjoni orali
English: No data are available for hepatic transplant patients with severe chronic renal impairment.
Maltese: M'hemm l-ebda data disponibbli għal pazjenti bi trapjant epatiku b'indeboliment renali kroniku sever.
English: If you have ever had a problem with your digestive system such as a stomach ulcer If you have a rare problem with your metabolism called “phenylketonuria” which runs in families
Maltese: Jekk għandek problema rari li tintiret bil-metaboliżmu tiegħek li tissejjaħ “phenylketonuria” ·
English: There are no data on CellCept with phosphate binders other than sevelamer.
Maltese: Il-ġlieda kontra l-infezzjonijiet CellCept inaqqas id-difiżi tal-ġisem tiegħek.
English: • shortness of breath, cough, which can be due to bronchiectasis (a condition in which the lung airways are abnormally dilated) or pulmonary fibrosis (scarring of the lung).
Maltese: · qtugħ ta' nifs, sogħla, li jistgħu jkunu kkawżati minn bronkjektasi (kondizzjoni fejn ilpassaġġi tan-nifs tal-pulmun ikunu dilatati b'mod mhux normali) jew fibrożi pulmonari (ċikatriċi fil-pulmun).
English: CellCept 500 mg powder for concentrate for solution for infusion
Maltese: CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni:
English: • isavuconazole - used to treat fungal infections
Maltese: · rifampicin - antibijotiku użat għall-prevenzjoni u t-trattament ta' infezzjonijiet bħat-tuberkulożi
English: Dose adjustment of CellCept does not appear to be necessary.
Maltese: CellCept inaqqas id-difiżi tal-ġisem tiegħek.
English: HOW TO STORE CELLCEPT
Maltese: Qabel ma tibda tieħu CellCept
English: Talk to your doctor if you develop a persistent cough or breathlessness fluid on the lungs or inside the chest, sinus problems.
Maltese: Huwa rakkomandat li pazjenti li jiżviluppaw sintomi pulmonari persistenti, bħal sogħla u qtugħ ta' nifs, jiġu investigati.
English: • If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid or any of the other ingredients in this medicine (listed in Section 6)
Maltese: Jekk inti allerġiku (tbati minn sensittività eċċessiva) għal mycophenolate mofetil, mycophenolic acid, jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6) ·
English: Elderly patients receiving CellCept as part of a combination immunosuppressive regimen may be at increased risk of certain infections (including cytomegalovirus tissue invasive disease) and possibly gastrointestinal haemorrhage and pulmonary oedema, compared to younger individuals.
Maltese: Pazjenti anzjani li qed jirċievu CellCept bħala parti minn kors immunosoppressiv kombinat, jistgħu jkunu f'riskju akbar ta' ċertu infezzjonijiet (inkluż mard b'cytomegalovirus invasiv fit-tessut) u possibbilment emorraġija gastrointestinali u edima fil-pulmun meta mqabbla ma' individwi iżgħar.
English: You will have the medicine for at least 4 days.
Maltese: Se tieħu l-mediċina għal tal-inqas 4 ijiem. ·
English: Changes to CellCept therapy should only be undertaken under appropriate supervision in transplant recipients in order to minimise the risk of graft rejection (see section 4.8).
Maltese: F'pazjenti li rċevew trapjant, bidliet fit-terapija ta' CellCept għandhom isiru biss taħt superviżjoni xierqa sabiex jitnaqqas ir-riskju ta' tiċħid tal-organu trapjantat (ara sezzjoni 4.8).
English: Gastrointestinal effects were observed in the dog at systemic exposure levels equivalent to or less than the clinical exposure at the recommended dose.
Maltese: Effetti gastrointestinali kienu osservati fil-kelb f'livelli ta' esponiment sistemiku ekwivalenti għal jew inqas mill-esponiment kliniku fid-doża rakkomandata.
English: Cardiac disorders Tachycardia
Maltese: Disturbi fil-qalb Takikardija
English: Nervous system problems such as: feeling dizzy, drowsy or numb, tremor, muscle spasms, convulsions, feeling anxious or depressed, changes in your mood or thoughts.
Maltese: Problemi fis-sistema nervuża bħal: · tħossok imħeddel jew imtarrax, · tregħid, spażmi tal-muskoli, konvulżjonijiet,
English: PVC/aluminium foil blister strips
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Flatulence
Maltese: Iperkalimja
English: Swallow your capsules whole with a glass of water Do not break or crush them
Maltese: Twissijiet speċjali u prekawzjonijiet għall-użu Neoplażmi
English: Sodium less than 1 mmol (23 mg) per dose
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment
English: NAME OF THE MEDICINAL PRODUCT CellCept 500 mg powder for concentrate for solution for infusion mycophenolate mofetil
Maltese: TAL-PRODOTT MEDIĊINALI CellCept 500 mg trab għal konċentrat għal soluzzjoni għall-infużjoni mycophenolate mofetil
English: Dyspnea
Maltese: Vaċċini
English: EMA/669530/2015 EMEA/V/C/003739
Maltese: EMEA/V/C/003739
English: It contains the active substance cabergoline.
Maltese: Fih is-sustanza attiva cabergoline.
English: The full EPAR for Velactis can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Velactis.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Velactis.
English: Velactis is used to:
Maltese: Velactis jintuża għal:
English: In an initial field study with 917 cows, Velactis was given to cows free of subclinical mastitis (inflammation of the udder without visible clinical signs) and in the absence of antimicrobial treatment, showed a 5.5% reduction of new udder infections during the dry period compared to cows treated with placebo (the dummy treatment).
Maltese: Fl-istudju inizjali fuq il-post b'917-il baqra, Velactis ingħata lil baqar li ma kellhomx mastite subklinika (infjammazzjoni tal-beżżula mingħajr sinjali kliniċi viżibbli) u fin-nuqqas ta' kura antimikrobika, wera tnaqqis ta' 5.5% ta' infezzjonijiet ġodda tal-beżżula waqt il-perjodu xott meta mqabbel ma' baqar ikkurati bi plaċebo (il-kura finta).
English: • reduce discomfort.
Maltese: • tnaqqis ta' skumdità.
English: In a second field study involving 263 dairy cows the percentage of Velactis-treated cows with milk leakages during a 14-day period after drying-off was 3.9% compared with 17.6% for the cows treated with placebo.
Maltese: Fit-tieni studju fuq il-post li jinvolvi 263 baqra tal-ħalib, il-perċentwal ta' baqar ikkurati b'Velactis bi tnixxijiet tal-ħalib matul il-perjodu ta' 14-il jum wara l-ixxuttar kien ta' 3.9% meta mqabbel ma' 17.6% għall-baqar ikkurati bi plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the EU for Velactis on 9 December 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Velactis fid9 ta' Diċembru 2015.
English: • reduce milk leakage at drying off (the point at which the cow is no longer milked),
Maltese: • tnaqqis tat-tnixxija tal-ħalib fl-ixxuttar (il-punt meta l-baqra ma tibqax tinħaleb),
English: Why is Velactis approved?
Maltese: Għaliex ġie approvat Velactis?
English: Velactis is given as a single injection into the muscle within four hours of the last milking on the day of drying off. Velactis is available as a solution for injection in multidose vials of 5 ml, 25 ml or 50 ml.
Maltese: Velactis huma disponibbli bħala soluzzjoni għall-injezzjoni f'kunjetti b'ħafna dożi ta' 5 ml, 25 ml jew 50 ml.
English: A third field study involved 228 dairy cows.
Maltese: It-tielet studju fuq il-post involva 228 baqra tal-ħalib.
English: • reduce the risk of new infections of the udder during the dry period,
Maltese: • tnaqqis ta' riskju ta' infezzjonijiet ġodda tal-beżżula waqt il-perjodu xott,
English: Velactis reduced the incidence of milk leakage to 2% compared to 10.7% in the cows treated with placebo.
Maltese: Velactis naqqas l-inċidenza ta' tnixxija tal-ħalib għal 2% meta mqabbel ma' 10.
English: What are the risks associated with Velactis?
Maltese: X'inhuma r-riskji assoċjati ma' Velactis?
English: It is 4 days (8 milkings) after calving when the dry period length is less than 32 days.
Maltese: Huwa ta' 4 ijiem (8 taħlibiet) wara t-twellid meta t-tul tal-perjodu xott huwa anqas minn 32 jum.
English: Milk production is stimulated by a hormone, prolactin, released from specialised cells in the pituitary gland (a small gland attached to the brain).
Maltese: Il-produzzjoni tal-ħalib hija stimulata b'ormon, prolactin, li jiġi rilaxxat minn ċelloli speċjalizzati filglandola pitwitarja (glandola żgħira mwaħħla mal-moħħ).
English: By blocking prolactin release in this way, milk production is reduced.
Maltese: Permezz talimblokkar b'dan il-mod ta' prolactin, il-produzzjoni tal-ħalib titnaqqas.
English: Cabergoline has a long-lasting action on receptors in these cells (called D2 receptors) that block release of the hormone.
Maltese: Cabergoline għandu azzjoni fit-tul fuq irriċetturi f'dawn iċ-ċelloli (li jissejħu riċetturi D2) li jimblokkaw ir-rilaxx tal-ormon.
English: The most common side effects with Velactis (which may affect up to 1 in 10 cows) are slight injection site reactions (mostly swellings) after injection of the product which may persist for at least 7 days.
Maltese: L-effetti sekondarji l-aktar komuni b'Velactis (li jistgħu jaffettwaw aktar 1 minn kull 10) huma reazzjonijiet ħfief fis-sit fejn issir l-injezzjoni (il-biċċa l-kbira nefħiet) wara l-injezzjoni tal-prodott li jistgħu jippersistu għal tal-inqas 7 ijiem.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Velactis' benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) tal-Aġenzija ddeċieda li l-benefiċċji ta' Velactis huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: Other information about Velactis?
Maltese: Kif jintuża Velactis?
English: People who are hypersensitive (allergic) to cabergoline should avoid contact with Velactis.
Maltese: Persuni li huma ipersensittivi (allerġiċi) għal cabergoline għandhom jevitaw il-kuntatt ma' Velactis.
English: The withdrawal period for milk from dairy cows treated with Velactis is ‘zero' days, which means there is no mandatory waiting time after calving, if the dry period length is 32 days or more.
Maltese: Il-perjodu ta' tiżmim għal ħalib minn baqar tal-ħalib ikkurati b'Velactis huwa ta' ‘żero' jiem, li jfisser li ma hemm l-ebda żmien obbligatorju ta' stennija wara t-twellid, jekk it-tul tal-perjodu xott huwa ta' 32 jum jew aktar.
English: How does Velactis work?
Maltese: Kif jaħdem Velactis?
English: Velactis is a medicine used in the herd management programme of dairy cows as an aid to reduce milk production in dairy cows at the start of the dry period (the period when the cow is not milked before calving and start of the next lactation).
Maltese: Velactis huwa mediċina użata fil-programm tal-ġestjoni tal-merħla ta' baqar tal-ħalib bħala għajnuna biex titnaqqas il-produzzjoni tal-ħalib mill-baqar tal-ħalib fil-bidu tal-perjodu xott (il-perjodu meta lbaqra mhijiex maħluba qabel twelled u l-bidu tat-treddigħ li jmiss).
English: Kaplan-Meier estimate.
Maltese: Stima Kaplan-Meier.
English: SGOT (AST) levels
Maltese: Livelli SGOT (AST)
English: • Haemoglobin ≥ 8 g/dL
Maltese: • L-emoglobina ≥ 8 g/dL
English: n: ITT patients
Maltese: n: pazjenti ITT
English: • Abnormal protein deposits in your vital organs
Maltese: • Depożiti abnormali ta' proteina fl-organi vitali tiegħek
English: • Different types of rash
Maltese: • Tipi differenti ta' raxx
English: (CrCL=20-39 ml/min/1.73 m 2, n=9), and Severe (CrCL < 20 ml/min/1.73 m 2, n=3).
Maltese: (CrCL=20-39 ml/min/1.73 m 2, n=9), u Qawwi (CrCL < 20 ml/min/1.73 m 2, n=3).
English: Abbreviations: SGOT=serum glutamic oxaloacetic transaminase;
Maltese: SGOT = glutamic oxaloacetic transaminase fis-serum (serum glutamic oxaloacetic transaminase);
English: Vc=VELCADE; Dx=dexamethasone; T=thalidomide
Maltese: Dx=dexamethasone; T=thalidomide
English: Progressive multiple myeloma
Maltese: Majeloma multipla progressiva
English: Based on Independent Review Committee (IRC) assessment (radiological data only).
Maltese: Indipendenti (IRC - Independent Review Committee).
English: • Hypersensitivity (allergic reaction)
Maltese: • Sensittività eċċessiva (reazzjoni allerġika)
English: Combination with dexamethasone
Maltese: Dex = dexamethasone
English: Leukopenia*, Lymphopenia*
Maltese: Lewkopenija*, Limfopenija*
English: • Multi-organ failure
Maltese: • Falliment f'diversi organi
English: Overall response (CR+CRu+PR)
Maltese: Rispons totali (CR+CRu+PR)
English: b (95% CI)=0.63 (0.50; 0.79) p-value d < 0.001
Maltese: b (95% CI)=0.63 (0.50; 0.79) valur p d < 0.001
English: Day 1, 2, 3, 4
Maltese: Jum1, 2, 3, 4
English: #, Hypersensitivity*
Maltese: #, Sensittività eċċessiva*
English: Table 13: Efficacy results from study MMY-3010
Maltese: Tabella 13: Riżultati t'effikaċja minn studju MMY-3010
English: Reduction in serum M-protein population g n=667
Maltese: Tnaqqis tal-proteina M fis-serum popolazzjoni g n=667
English: Table 12: Efficacy results from study IFM-2005-01
Maltese: Tabella 12: Riżultati ta' effikaċja minn studju IFM-2005-01
English: Median a (95% CI)
Maltese: Medjan a (95% CI)
English: Day 1, 4
Maltese: Jum 1, 4
English: Deboronated-bortezomib metabolites are inactive as 26S proteasome inhibitors.
Maltese: Metaboliti deboronati permezz ta' bortezomib mhumiex attivi bħala inibituri proteasome 26S.
English: Incidence of PN (%) All GradePN  Grade 2 PN  Grade 3 PN
Maltese: Inċidenza ta' PN (%) PN Gradi kollha  PN Grad 2  PN Grad 3
English: VIAL VELCADE 1 mg
Maltese: KUNJETT VELCADE 1 mg
English: Uncommon Fall, Contusion Rare
Maltese: Mhux Komuni Waqgħa, Kontużjoni Rari
English: e (95% CI)=1.688 (1.148; 2.481) p-value g=0.007
Maltese: e (95% CI)=1.688 (1.148; 2.481) valur p g=0.007
English: Vertigo*
Maltese: Vertiġini*
English: • Pneumonia
Maltese: • Pulmonite
English: Intent to Treat Population n=74
Maltese: Popolazzjoni Maħsuba għal Trattament n=74
English: An odds ratio (OR) > 1 indicates an advantage for VcR-CAP.
Maltese: Proporzjon ta' probabbiltà (OR - odds ratio) > 1 jindika vantaġġ għal VcR-CAP.
English: VELCADE contains the active substance bortezomib, a so-called ‘proteasome inhibitor'.
Maltese: VELCADE fih is-sustanza attiva bortezomib, hekk imsejjaħ ‘impeditur ta' proteasome'.
English: Manufacturer Janssen Pharmaceutica NV Turnhoutseweg 30
Maltese: Il-Manifattur Janssen Pharmaceutica NV, Turnhoutseweg 30
English: Rituximab at 375 mg/m2, cyclophosphamide at 750 mg/m2 and doxorubicin at 50 mg/m
Maltese: Rituximab bid-doża ta' 375 mg/m2, cyclophosphamide bid-doża ta' 750 mg/m2 u doxorubicin bid-doża ta' 50 mg/m
English: Day 8, 9, 10, 11
Maltese: 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: NA=not applicable, NE=not estimated TTP-Time to Progression
Maltese: NA = Mhux Applikabbli (not applicable), MS = Ma saritx stima TTP-Ħin għal Progressjoni (Time to Progression)
English: The overall best response rate (CR + PR), to retreatment in 130 patients was 38.5% (95% CI: 30.1, 47.4).
Maltese: Ir-rata tal-aħjar rispons globali (CR + PR), għal trattament mill-ġdid lil 130 pazjent kien 38.5% (95% CI: 30.1, 47.4).
English: Herpes zoster virus reactivation
Maltese: Riattivazzjoni tal-virus ta' Herpes zoster
English: Antiviral prophylaxis was administered to 137 of 240 patients (57%) in the VcR-CAP arm.
Maltese: Profilassi antivirali ngħatat lill-137 minn 240 pazjent (57%) fil-fergħa ta' VcR-CAP.
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 VELCADE and pegylated liposomal doxorubicin.
Maltese: Dan l-analiżi interim wera tnaqqis fir-riskju ta' TTP ta' 45 % (95 % CI; 29-57 %, p < 0.0001) għal pazjenti trattati b'terapija ta' kombinazzjoni ta' VELCADE u pegylated liposomal doxorubicin.
English: • Coma
Maltese: • Koma
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 VELCADE in combination with dexamethasone over VELCADE monotherapy.
Maltese: 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 VELCADE f'kombinazzjoni ma' dexamethasone fuq il-monoterapija b'VELCADE.
English: Note: VELCADE is a cytotoxic agent.
Maltese: Nota: VELCADE huwa sustanza ċitotossika.
English: 1 mg/m to 0.7 mg/m
Maltese: 1 mg/m għal 0.7 mg/m