FrancophonIA/ELRC3.0 huggingface dataset:
English: Page 6 (back)
Maltese: Paġna 6 (wara)
English: Cyclosporine A: Concomitant treatment with cyclosporine A 100 mg twice daily, a combined CYP3A4 and OATP inhibitor, did not alter the steady-state exposure to macitentan and its active metabolite to a clinically relevant extent.
Maltese: CYP3A4 u OATP, ma bidlitx l-esponiment fi stat fiss għal macitentan u għall-metabolit attiv tiegħu b'ammont klinikament rilevanti.
English: Treatment of juvenile rats from postnatal Day 4 to Day 114 caused reduced body weight gain leading to secondary effects on development (slight delay of descensus testis, reversible reduction of long-bone length, prolonged estrous cycle).
Maltese: Kura ta' firien minorenni minn Jum 4 sa Jum 114 wara t-twelid ikkawżat tnaqqis fiż-żieda fil-piż tal ġisem li wassal għal effetti sekondarji fuq l-iżvilupp (ittardjar żgħir ta' descensus testis, tnaqqis riversibbli tat-tul tal-għadam it-twil, ċiklu estrus imtawwal).
English: If you have anaemia (a reduced number of red blood cells), you may have the following signs:
Maltese: Jekk għandek anemija (numru mnaqqas ta' ċelluli ħomor tad-demm), jista' jkollok is-sinjali li ġejjin:
English: Breastfeeding
Maltese: Tromboċitopenija
English: Lactose monohydrate
Maltese: IL-PRODOTT MEDIĊINALI
English: Treatment with macitentan 10 mg at Month 6 resulted in a placebo-corrected mean increase in 6MWD of 22 meters (97.5% CI: 3 to 41; p = 0.0078).
Maltese: (CI ta' 97.5%: 3 sa 41; p = 0.0078).
English: • Prescribing checklists;
Maltese: • Biex tipprovdi kartuna tal-pazjent lill-pazjenti;
English: Macitentan has been administered as a single dose of up to 600 mg to healthy subjects.
Maltese: Macitentan ingħata bħala doża waħda sa 600 mg lill-individwi f'saħħithom.
English: What you need to know before you take Opsumit 3.
Maltese: X'għandek tkun taf qabel ma tieħu Opsumit 3.
English: It is recommended that haemoglobin concentrations be measured prior to initiation of treatment and tests repeated during treatment as clinically indicated.
Maltese: Huwa rrakkomandat li l-konċentrazzjonijiet talemoglobina jiġu mkejla qabel tinbeda l-kura u li t-testijiet jkunu ripetuti matul il-kura kif indikat klinikament.
English: Thereafter, plasma concentrations of macitentan and its active metabolite decrease slowly, with an apparent elimination half-life of approximately 16 hours and 48 hours, respectively.
Maltese: b'half-life apparenti tal-eliminazzjoni ta' madwar 16-il siegħa u 48 siegħa, rispettivament.
English: EN
Maltese: ISEM
English: Exposure to macitentan and its active metabolite was increased by 1.3- and 1.6-fold, respectively, in patients with severe renal impairment.
Maltese: L-esponiment għal macitentan u għall-metabolit attiv tiegħu żdied b'1.3 u b'1.6 darbiet,
English: This corresponds to over 180 literature reports (Randomized Clinical Trials (RCTs); Reviews, Monographs (Martindale etc.).
Maltese: Dan jikkorrespondi għal aktar minn 180 rapport tal-litteratura (Provi Kliniċi Randomizzati (RCTs); Reviżjonijiet, Monografi (Martindale eċċ.).
English: The application for Dexamethasone Alapis has therefore been made in accordance with Article 10a of Directive 2001/83/EC, as amended.
Maltese: Għaldaqstant, l-applikazzjoni għal Dexamethasone Alapis saret skont l-Artikolu 10a tad-Direttiva 2001/83/KE, kif emendata.
English: • Treatment of non-endocrine corticosteroid responsive conditions
Maltese: • Kura ta' kundizzjonijiet risponsivi kortikosterojdi mhux endokrinali
English: Overall summary of the scientific evaluation of Dexamethasone Alapis
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Dexamethasone Alapis
English: Although the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)” states: “In those cases where the test product is an oral solution which is intended to be bioequivalent to another immediate release oral dosage form, bioequivalence studies are required”, the application of a BCS-based biowaiver to bridge data from different pharmaceutical forms was considered to have been adequately justified from a scientific point of view, by provision of parallel artificial membrane permeability assay (PAMPA) data, literature and dissolution data, demonstrating that Dexamethasone drug substance has biopharmaceutical characteristics of BCS Class I/III, and that the excipients have no adverse affects on bioavailability.
Maltese: Għalkemm il-“Linja gwida dwar l-investigazzjoni tal-bioekwivalenza (CPMP/PWP/EWP/1401/98 Rev 1/Corr)” tiddikjara: “F'dawk il-każijiet fejn il-prodott tat-test ikun soluzzjoni orali li tkun titqies li hija bioekwivalenti għal forma ta' dożaġġ orali oħra ta' rilaxx immedjat, ikun hemm bżonn ta' studji ta' bioekwivalenza”, l-applikazzjoni ta' biorinunzja bbażata fuq BCS sabiex titqabbel id-dejta minn għamliet farmaċewtiċi differenti tqieset li ġiet iġġustifikata b'mod adegwat minn lat xjentifiku, bilprovvediment ta' dejta, litteratura u dejta tad-dissoluzzjoni ta' assaġġ tal-permeabilità tal-membrana artifiċjali parallela (PAMPA), li turi li s-sustanza mediċinali Dexamethasone għandha karatteristika biofarmaċewtika ta' Klassi I/III tal-BCS, u li s-sustanzi mhux attivi ma għandhom ebda effetti avversi fuq il-biodisponibilità.
English: Most of the literature provided by the Applicant concerned the administration of an oral solid dosage form, i.e. tablet.
Maltese: Ħafna mil-litteratura pprovduta mill-Applikant, kellha x'taqsam mal-amministrazzjoni ta' forma ta' dożaġġ solidu orali, jiġifieri pillola.
English: According to the Appendix II of the “Guideline on the investigation of bioequivalence (CPMP/PWP/EWP/1401/98 Rev 1/Corr)”, applying for a BCS-based biowaiver is restricted to highly soluble drug substances with known human absorption and considered not to have a narrow therapeutic index.
Maltese: Skont l-Appendiċi II tal-“Linja gwida dwar l-investigazzjoni tal-bijoekwivalenza (CPMP/PWP/EWP/1401/98 Rev 1/Corr)”, l-applikazzjoni għal biorinunzja bbażata fuq BCS hija ristretta għal sustanzi mediċinali solubbli ħafna b'assorbiment uman magħruf u meqjusin li ma għandhomx indiċi terapewtiċi dejjaq.
English: Dexamethasone has a biological half life of 36 - 54 hours and therefore is suitable in conditions where continuous glucocorticoid action is required.
Maltese: Dexamethasone għandu half life bijoloġiku ta' 36 - 54 siegħa u għaldaqstant huwa adegwat f'kundizzjonijiet fejn tkun meħtieġa azzjoni glukokortikojde.
English: The bibliography provided was considered sufficient to support the well established use of dexamethasone substance in different tablet formulations.
Maltese: Il-biblijografija pprovduta tqieset suffiċjenti biex tappoġġa l-użu stabbilit sew tas-sustanza dexamethasone f'formulazzjonijiet ta' pilloli differenti.
English: Therefore, a huge volume of efficacy and safety data exists for the dexamethasone pharmaceutical substance.
Maltese: Għaldaqstant, jeżisti volum kbir ta' dejta tal-effikaċja u s-sigurtà għas-sustanza farmaċewtika dexamethasone.
English: Elixirs are sweetened hydro-alcoholic oral solutions that are specially formulated for oral use in infants and children (Strickley, 2004).
Maltese: Elixirs huma soluzzjonijiet orali idro-alkoħoliċi mogħtija ħlewwa li huma fformulati b'mod speċjali għall-użu mit-trabi u mit-tfal (Strickley, 2004).
English: The BCS-based biowaiver approach is meant to reduce in vivo bioequivalence studies.
Maltese: L-approċċ tal-biorinunzja bbażata fuq BCS huwa maħsub sabiex inaqqas l-istudji ta' bioekwivalenza in vivo.
English: From the literature data provided by the Applicant, it was shown that there were no significant differences between the bioavailabilities of immediate release tablet formulations and elixir formulations of dexamethasone (irrespective of the elixir formulation used).
Maltese: Mid-dejta tal-litteratura pprovduta mill-Applikant, intwera li ma kien hemm ebda differenzi sinifikanti bejn il-biodisponibilitajiet ta' formolazzjonijiet ta' pilloli ta' rilaxx immedjat u formolazzjonijiet ta' elixir ta' dexamethasone (irrispettivament mill-formolazzjoni ta' elixir użata).
English: Additional bridging data (or its absence fully justified) between the bibliographic data and the proposed pharmaceutical product were therefore requested to the Applicant during the decentralised and the CMD(h) referral procedures.
Maltese: Għalhekk intalbet mingħand l-applikant dejta ta' tqabbil addizzjonali (jew ġustifikazzjoni għan-nuqqas għal kollox tagħha) bejn id-dejta biblijografika u l-prodott farmaċewtiku propost matul il-proċeduri ta' riferiment deċentralizzati u tas-CMD(h).
English: • Prevention of nausea and vomiting and treatment of cancer with oncolytics that have a serious emetic effect.
Maltese: • Prevenzjoni ta' dardir u rimettar u kura ta' kanċer b'onolitiċi li għandhom effett emetiku serju.
English: Data on the solubility and on the absorption and permeability of dexamethasone were provided by the Applicant during the decentralised and the CMD(h) referral procedure to show that Dexamethasone Alapis met all criteria for a BCS-based biowaiver.
Maltese: Dejta dwar is-solubilità u dwar l-assorbiment u l-permeabilità ta' dexamethasone ġew ipprovduti millApplikant matul il-proċedura ta' riferiment tas-CMD(h) biex jintwera li Dexamethasone Alapis issodisfa l-kriterji kollha għal biorinunzja bbażata fuq BCS.
English: Literature data available on the various routes of administration for the same treatment show that dexamethasone is equally effective via any administration route.
Maltese: Id-dejta mil-litteratura disponibbli fuq ir-rotot varji ta' amministrazzjoni għall-istess kura juru li dexamethasone huwa ugwalment effettiv permezz ta' kwalunkwe rotta amministrattiva.
English: Because it has only minimal mineral corticoid properties, the drug is inadequate as a monotherapy for the management of adrenocortical insufficiency.
Maltese: Minħabba li għandha biss karatteristiċi kortikojdi minerali minimi, il-mediċina mhijiex adegwata bħala monoterapija għall-ġestjoni ta' insuffiċjenza adrenokortikali.
English: This active substance is considered to have a ‘well-established use' within the European Community for at least 10 years, with recognised efficacy and an acceptable level of safety in the use in certain endocrine and non-endocrine disorders, in certain cases of cerebral oedema and for diagnostic testing of adrenocortical hyperfunction.
Maltese: Din is-sustanza attiva hija meqjusa li għandha “użu stabbilit sew” fi ħdan il-Komunità Ewropea għal mill-inqas 10 snin, b'effikaċja rikonoxxuta u livelli aċċettabbli ta' sigurtà fl-użu f'ċerti disturbi endokrinali u mhux endokrinali, f'ċerti każijiet ta' edema ċerebrali u għal ittestjar dijanjostiku ta' iperfunzjoni adrenokortikali.
English: The CHMP assessed the dossier and the available data, including the issues raised by the objecting CMS.
Maltese: Is-CHMP ivvaluta d-dossier u d-dejta disponibbli, inkluż il-kwistjonijiet imqajma mill-CMS oġġezzjonatur.
English: As a justification for not providing bioequivalence study to bridge the data submitted on the tablet formulation and the oral solution formulation applied for, the Applicant applied for a BCS (Biopharmaceutics Classification System)-based biowaiver.
Maltese: Bħala ġustifikazzjoni għala ma pprovdiex studju ta' bijoekwivalenza għat-tqabbil tad-dejta ppreżentata fuq il-formolazzjoni tal-pillola u l-formolazzjoni tas-soluzzjoni orali li saret applikazzjoni għaliha, lApplikant applika għal biorinunzja bbażata fuq BCS (Sistema ta' Klassifikazzjoni ta' Biofarmaċewtiċi).
English: Whereas, - the Applicant has provided sufficient literature data to demonstrate well-established use of dexamethasone, - efficacy and safety of dexamethasone has been adequately shown in the indications applied for - adequate bridging data between the tablet formulation and the oral solution formulation have been provided by the Applicant, the CHMP has recommended the granting of the marketing authorisation(s) for which the summary of product characteristics, labelling and package leaflet remain as per the final versions achieved during the Coordination group procedure as mentioned in Annex III of this Opinion.
Maltese: Billi, - l-Applikant ipprovda biżżejjed dejta mil-litteratura sabiex juri użu stabbilit sew ta' dexamethasone, - l-effikaċja u s-sigurtà ta' dexamethasone intwerew b'mod adegwat fl-indikazzjonijiet li saru applikazzjonijiet għalihom - ingħatat dejta ta' tqabbil adegwata bejn il-formolazzjoni tal-pilloli u l-formolazzjoni tas-soluzzjoni orali mill-Applikant, is-CHMP irrakkomanda l-għoti tal-awtorizzazzjoni(jiet) għat-tqegħid fis-suq li għalihom, is-sommarju tal-karatteristiċi tal-prodott, it-tikketta u l-fuljett ta' tagħrif jibqgħu skont il-verżjonijiet finali miksubin matul il-proċedura tal-Grupp ta' Koordinazzjoni msemmija fl-Anness
English: Therefore, from a pharmaceutical perspective, elixirs are a type of oral solutions and are expected to behave in vivo as such.
Maltese: Għaldaqstant, minn perspettiva farmaċewtika, elixirs huma tip ta' soluzzjonijiet orali u huma mistennija li jġibu ruħhom in vivo bħala tali.
English: It also showed that dexamethasone had a broad therapeutic index.
Maltese: Uriet ukoll li dexamethasone kellu indiċi terapewtiku wiesa'.
English: In addition, the limited number of published studies that used a solution formulation used a similar posology to the tablet formulation.
Maltese: Barra minn hekk, innumru limitat ta' studji ppubblikati li użaw formolazzjoni ta' soluzzjoni użaw pożoloġija simili għallformolazzjoni ta' pilloli.
English: It is used principally as an anti-inflammatory or immunosuppressant agent.
Maltese: Jintuża prinċipalment bħala sustanza anti-infjammatorja jew bħala sustanza immunosuppressanti.
English: In vivo bioequivalence studies may be exempted if an assumption of equivalence in in vivo performance can be justified by satisfactory in vitro data.
Maltese: Studji ta' bioekwivalenza in vivo jistgħu jkunu eżentati jekk assunzjoni ta' ekwivalenza fi prestazzjoni in vivo tkun tista' tiġi ġġustifikata b'dejta in vitro sodisfaċenti.
English: The objecting Concerned Member State raised a potential serious risk to public health as it considered that the literature data on dexamethasone tablets that had been submitted could not be extrapolated to dexamethasone oral solution without adequate bridging data and therefore the efficacy and safety of Dexamethasone Alapis could not be demonstrated in the application.
Maltese: L-Istat Membru konċernat li oġġezzjona qajjem riskju serju potenzjali għas-saħħa pubblika minħabba li qies li d-dejta tal-litteratura fuq pilloli ta' dexamethasone li kienet ġiet sottomessa, ma setgħetx tiġi estrapolata għal soluzzjoni orali ta' dexamethasone mingħajr dejta ta' tqabbil adegwata u għaldaqstant, l-effikaċja u s-sigurtà ta' Dexamethasone Alapis ma setgħux jintwerew fl-applikazzjoni.
English: From the literature submitted during the decentralised procedure, it was shown that dexamethasone has been widely used in clinical practice for a number of indications for more than 40 years.
Maltese: Mil-litteratura ppreżentata matul il-proċedura deċentralizzata, intwera li dexamethasone intuża b'mod mifrux fi prattika klinika għal għadd ta' indikazzjonijiet għal aktar minn 40 sena.
English: A referral was thus triggered at the CMD(h) and the Applicant was asked to provide detailed literature and critical assessment of the efficacy and safety of dexamethasone oral solution in the indications applied for.
Maltese: B'hekk ingħata bidu għal riferiment fis-CMD(h) u l-Applikant intalab jipprovdi litteratura dettaljata u valutazzjoni kritika tal-effikaċja u s-sigurtà ta' dexamethasone soluzzjoni orali fl-indikazzjonijiet li saret applikazzjoni għalihom.
English: In addition, a few literature reports (CTs) on the efficacy and safety of dexamethasone in oral solution/syrup have been submitted in the following indications applied for:
Maltese: Barra minn hekk, ftit rapporti tal-litteratura (CTs) dwar l-effikaċja u ssigurtà ta' dexamethasone f'soluzzjoni orali/xiropp ġew sottomessi fl-indikazzjonijiet li ġejjin li saret applikazzjoni għalihom:
English: The National Competent Authorities of Member States, coordinated by the Reference Member State, shall ensure that the following conditions are fulfilled by the MAH:
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu sodisfatti mill-MAH:
English: Annex III Conditions for lifting the suspension of the Marketing Authorisations
Maltese: Anness III Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq
English: Conditions for lifting the suspension of the Marketing Authorisations
Maltese: Kundizzjonijiet għat-tneħħija tas-sospensjoni tal-Awtorizzazzjonijiet għat-Tqegħid fis-Suq
English: Ref. EMEA/CHMP/502946/2008
Maltese: EMEA/549010/2008
English: International non-proprietary name (INN): ramelteon
Maltese: Denominazzjoni Komuni Internazzjonali (DKI): ramelteon
English: Ramelteon is a medicine that contains the active substance ramelteon.
Maltese: Ramelteon huwa mediċina li fih s-sustanza attiva ramelteon.
English: It was to be available as tablets.
Maltese: Hija disponibbli f'pilloli.
English: Most of the studies were carried out in sleep laboratories, but the three main studies were carried out in the ‘natural setting' (at home) in a total of 2,807 patients.
Maltese: Il-maġġoranza ta' l-istudji saru f'laboratorji ta' l-irqad, iżda t-tliet studji prinċipali saru fid jar f''ambjent naturali' f'total ta' 2,807 pazjent.
English: What is Ramelteon?
Maltese: X'inhu Ramelteon?
English: On 19 September 2008, Takeda Global Research & Development Centre (Europe) Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ramelteon, for the treatment of primary insomnia in adult patients.
Maltese: Fid-19 ta' Settembru 2008, Takeda Global Research & Development Centre (Europe) Ltd. uffiċjalment għarrfet lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq ta' Ramelteon, għat-trattament ta' insomnija primarja f'pazjenti adulti.
English: The effectiveness of Ramelteon was compared with that of placebo (a dummy treatment) in a total of about 5,400 patients.
Maltese: L-effikaċja ta' Ramelteon ġiet kumparata ma' dik ta' plaċebo (trattament fint) f'total ta' 5,4000 pazjent.
English: The active substance in Ramelteon, ramelteon, is a melatonin-receptor agonist.
Maltese: Is-sustanza attiva f'Ramelteon, ramelteon huwa agonist riċettur-melatonin.
English: Ramelteon was expected to be used to treat primary insomnia (difficulty falling and staying asleep, and poor quality of sleep) in patients aged 18 years or over.
Maltese: Ramelteon kien mistenni sabiex jintuża għat-trattament ta' insomnja primarja (problemi sabiex wieħed jorqod u jibqa' rieqed, u l-kwalità baxxa ta' rqad) f'pazjenti ta' 18 -il sena u aktar.
English: only one of the three studies carried out in the natural setting was there a difference in the time taken to fall asleep between patients taking Ramelteon and those taking placebo.
Maltese: Barra minn dan, fi studju wieħed minn tlieta li saru f'ambjent naturali kien hemm differenza fil-ħin li wieħed imur jorqod fost pazienti li jieħdu Ramelteon u dawk li jieħdu placebo.
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Ramelteon for the treatment of primary insomnia in adult patients.
Maltese: Abbażi ta' l-analiżi tad-dejta u r-rispons tal-kumpanija għal-lista ta' mistoqsijiet, fi żmien l-irtar, ilCHMP kien ta opinjoni negattiva u ma rrakomandax li tingħata l-awtorizzazzjoni għat-tqegħid fis-suq għal Ramelteon għat-trattament ta' pazjenti fuq trattament ta' insomnja primarja f'pazjenti adulti.
English: The effects of Ramelteon were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Ramelteon ġew l-ewwel ittestjati f'mudelli esperimentali qabel ma ġew studjati fuq ilbnedmin.
English: ‘Primary' means that the insomnia does not have any identified cause, including other medical, mental or environmental causes.
Maltese: 'Primarja' tfisser li l-insomnja ma tkunx ġiet identifikata kawża medika, mentali jew ambjentali, għan-nuqqas ta' rqad.
English: What was Ramelteon expected to be used for?
Maltese: Kif kien mistenni li jaħdem Ramelteon?
English: This means that it works by attaching itself to the receptors that melatonin normally attaches to. Melatonin is a naturally occurring hormone that is involved in co-ordinating the body's sleep cycle by acting on receptors in specific areas of the brain.
Maltese: Melatonin huwa ormon naturali li għandu x'jaqsam mal-ko-ordinazzjoni taċ-ċiklu ta' l-irqad tal-ġisem billi jaġixxi fuq riċetturi f'partijiet speċifiċi tal-moħħ.
English: How is Ramelteon expected to work?
Maltese: Għal xiex kien mistenni li jintuża Ramelteon?
English: Questions and answers on the withdrawal of the marketing application for Ramelteon
Maltese: Mistoqsija u Tweġiba dwar l-irtirar ta' l-applikazzjoni għat-tqegħid fis-suq għal Ramelteon
English: Ramelteon was expected to work in the same way as melatonin in promoting sleep.
Maltese: Ramelteon kien mistenni li jaħdem bl-istess mod ta' kif melatonin iżid l-irqad.
English: Educational materials
Maltese: Materjali edukattivi
English: Anaemia*
Maltese: Anemija*
English: To provide data from the observational US-based registry (PROCEED, Study P10-3)
Maltese: Jipprovdi dejta mir-reġistru ta' osservazzjoni bbażat fl-Istati Uniti (PROCEED, Studju P10-3)
English: NL-6229 EV, Maastricht The Netherlands
Maltese: NL-6229 EV, Maastricht Il-Pajjiżi l-Baxxi
English: This procedure usually takes 3-4 hours.
Maltese: Normalment, din il-proċedura tieħu bejn 3 u 4 sigħat.
English: Control (N=171)
Maltese: Kontroll (N=171)
English: Overall survival Median, months (95% CI) Hazard ratio (95% CI)
Maltese: Sopravivenza ġenerali Medja, xhur (95% CI) Proporzjon ta' periklu (95% CI)
English: Dispersion for infusion.
Maltese: Dispersjoni għal infużjoni.
English: c p-value based on a log-rank test.
Maltese: c Il-valur p ibbażat fuq test log-rank.
English: Control (N=33)
Maltese: Kontroll (N=33)
English: Control (N=45)
Maltese: Kontroll (N=45)
English: Some patients developed infection, including sepsis.
Maltese: Uħud mill-pazjenti żviluppaw infezzjoni, inkluż sepsis.
English: Thirty-five percent of patients had undergone radical prostatectomy, 54% had received local radiotherapy, and 82% had received combined androgen blockade.
Maltese: 54% irċivew radjoterapija lokali, u 82% irċivew imblokk androġenu kkombinat.
English: The median age was 71, 90% of the patients were Caucasian, and all had a life expectancy of at least 6 months.
Maltese: L-età medja kienet ta' 71, 90% tal-pazjenti kienu Kawkasi, u kollha kellhom għomor ta' mill-inqas 6 xhur.
English: Neither endpoint met statistical significance.
Maltese: ebda wieħed mill-punti finali ma laħaq importanza statistika.
English: The most frequently occurring serious infections in the Provenge group were catheter sepsis (0.7%), staphylococcal bacteraemia (0.7%), sepsis (0.7%), staphylococcal sepsis (0.5%), and pneumonia (0.5%).
Maltese: Provenge kienu sepsis tal-katiter (0.7%), batteremija stafilokokkali (0.7%), sepsis (0.7%), sepsis stafilokokkali (0.5%), u pulmonite (0.5%).
English: Abbreviations: CI = confidence interval.
Maltese: CI = intervall ta' kunfidenza.
English: • approximately 45 mg potassium per infusion.
Maltese: • madwar 45 mg potassju f'kull infużjoni.
English: In the pivotal randomised controlled study (D9902B, IMPACT, see section 5.1) Provenge was discontinued in 1.5% of patients due to adverse reactions.
Maltese: Fl-istudju kkontrollat aleatorju pivotali (D9902B, IMPACT, ara s-sezzjoni 5.1) Provenge twaqqaf f'1.5% tal-pazjenti minħabba reazzjonijiet avversi.