FrancophonIA/ELRC3.0 huggingface dataset:
English: A subject is classified as “positive” or “negative” based on the brain amyloid plaque load (BAPL) score (Table 2) which is derived from RCTU scores in the four brain regions (Table 1).
Maltese: Individwu huwa kklassifikat bħala "pożittiv" jew "negattiv" skont il-punteġġ ta' tagħbija ta' plakka ta' amyloid tal-moħħ (BAPL-brainamyloid plaque load) (Tabella 2) li hi derivata minn punteġġi RCTU fl-erba' reġjuni tal-moħħ (Tabella 1).
English: Colourless 15 mL Type I glass vial, sealed with a chlorobutyl stopper and aluminium seal.
Maltese: Kunjett tal-ħġieġ tat-Tip I bla kulur ta' 15 mL, issiġillat b'tapp tal-chlorobutyl u siġill tal-aluminju.
English: No animal studies have been conducted to investigate the reproductive effects in florbetaben (18F) (see section 5.3).
Maltese: Studji fuq l-annimali saru biex jiġu investigati l-effetti riproduttivi ta' florbetaben (18F) (ara sezzjoni 5.3).
English: Table 4: Estimated radiation absorbed doses from intravenous injection of Neuraceq to Caucasian subjects
Maltese: Tabella 4: Stima ta' dożi ta' radjazzjoni assorbiti minn injezzjoni ġol-vina ta' Neuraceq lil individwi
English: Rule for assessment
Maltese: INternal Dose Assessment)
English: Alliance Medical Radiopharmacy Ltd., UK BV Cyclotron VU, the Netherlands Cis Bio International, Nancy, France Cis Bio International, Nîmes, France Cis Bio International, Paris, France Cis Bio International, Rennes, France Cis Bio International, Pessac, France Life Radiopharma Berlin GmbH, Germany Advanced Accelerator Applications Germany GmbH, Germany Life Radiopharma Warszawa Sp. z o.o., Poland Life Radiopharma Bonn GmbH, Germany IBA Molecular Italy S.R.L., Monza, Italy IBA Molecular Italy S.R.L., Rome, Italy IBA Molecular Italy S.R.L., Udine, Italy Curium Pharma Spain, S.A., Seville, Spain Curium Pharma Spain, S.A., Madrid, Spain Seibersdorf Labor GmbH, Austria BetaPlus Pharma SA, Brussels, Belgium Institut Radiofarmacia Aplicada Barcelona-IRAB, Barcelona, Spain
Maltese: Cis Bio International, Nancy, Franza Cis Bio International, Nîmes, Franza Cis Bio International, Paris, Franza Cis Bio International, Rennes, Franza Cis Bio International, Pessac, Franza Life Radiopharma Berlin GmbH, Il-Ġermanja Advanced Accelerator Applications Germany GmbH, Il-Ġermanja Life Radiopharma Warszawa Sp. z o.o., Il-Polonja Life Radiopharma Bonn GmbH, Il-Ġermanja IBA Molecular Italy S.R.L., Monza, L-Italja IBA Molecular Italy S.R.L., Rome, L-Italja IBA Molecular Italy S.R.L., Udine, L-Italja Curium Pharma
English: Comparing the results of PET scan reading with the histopathology assessment collected for all subjects (same as used for the original pivotal study and its post-hoc analysis), the majority read sensitivity and specificity were 100% (95%CI: 89.4-100%) and 71.4% (95%CI: 52.1-90.8%), respectively.
Maltese: Meta tqabblu r-riżultati miġbura tal-qari tal-iskenn PET mal ħistopatoloġija għall-individwi kollha (l-istess bħalma ntuża fl-istudju ewlieni u l-analiżi post-hoc), issensittività u l-ispeċifiċità maġġura moqrija kienu ta' 100% (95% CI: 89.4-100%) u 71.4% (95%CI:
English: Each mL of solution for injection contains 300 MBq of florbetaben (18F) at the date and time of calibration.
Maltese: Kull mL ta' soluzzjoni għall-injezzjoni fih 300 MBq ta' florbetaben (18F) fid-data u l-ħin ta' kalibrazzjoni.
English: Each of these brain regions, the lateral temporal, frontal, posterior cingulate, precuneus, and parietal lobes should be systematically visually assessed and scored according to the regional cortical tracer uptake (RCTU) score (Table 1).
Maltese: Kull wieħed minn dawn ir-reġjuni, il-lobi temporali laterali, ċingulat posterjuri u lobi parjetali għandhom jiġu analizzati viżwalment b'mod sistematiku u jingħataw punti skont it-teħid ta' intraċċatur fil-kortiċi reġjonali (RCTU-regional cortical tracer uptake) (Tabella 1).
English: This medicinal product contains up to 33 mg sodium per dose, equivalent to 1.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 33 mg sodium f'kull doża, ekwivalenti għal 1.6 % tal-ammont massimu rakkomandat mill-WHO ta 2 g sodium li għandu jittieħed kuljum minn adult.
English: In a post-hoc analysis sensitivity and specificity of the majority read of the visual subject-level PET reading vs histopathology in a larger population (74 patients) was 97.9% (95% CI: 93.8 - 100%) and 88.9% (95% CI: 77-100%).
Maltese: 97.9 % (95% CI: 93.8-100%) u 88.9 % (95%CI: 77-100%).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: The volume of Neuraceq to be injected can be from 0.5 to 10 mL in order to provide the target activity of 300 MBq at the time of intravenous administration.
Maltese: Il-volum ta' Neuraceq li jrid jiġi injettat jista' jkun minn 0.5 sa 10 mL, sabiex jipprovdi l-attività mixtieqa ta' 300 MBq fil-ħin talgħoti ġol-vina.
English: Studies on reproduction toxicity have not been performed.
Maltese: Studji fuq tossiċità riproduttiva ma twettqux.
English: In completed clinical trials, uptake of florbetaben (18F) in 7 predefined cortical areas of the brain (frontal, parietal, lateral and medial temporal, occipital, caudate, posterior cingulate/precuneus cortex, and anterior cingulate gyrus) and cerebellar cortex was measured quantitatively using standardised uptake values (SUV).
Maltese: Fi provi kliniċi kompluti, it-teħid ta' florbetaben (18F) f'7 żoni kortikali tal-moħħ indikati minn qabel (frontali, parijetali, temporali laterali u medjali, oċċipitali, kawdate, kortiċi singulat posterjuri/prekuneju, u l-ġirus singulat anterjuri) u l-kortiċi ċerebellari kienu mkejjla b'mod kwantitattiv permezz ta' valuri ta' teħid standardizzat.
English: 2 (Moderate tracer uptake)
Maltese: (Teħid moderat ta' intraċċatur)
English: Injection site pain Injection/application site erythema
Maltese: Uġigħ fis-sit tal-injezzjoni Injezzjoni / eritema fissitt'applikazzjoni
English: Kidneys
Maltese: Dijarea
English: Sensitivity of florbetaben (18F) scan to show the MCI conversion rate to AD in 19 converters was 100%, specificity in 26 non-converters was 61.5% (95% CI: 42.8-80.2%) and positive likelihood ratio was 2.60 (1.60-4.23).
Maltese: 42.8-80.2 %) u l-proporzjon ta' probabilità pożittiva kienet ta' 2.60-(1.60-4.23).
English: It might be helpful to estimate the effective dose that was applied.
Maltese: Jaf tkun t'għajnuna li tiġi stmata d-doża effettiva li ġiet applikata.
English: The requirement for submission of periodic safety update report for this medicinal product are set out in the line of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2011/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il portal elettroniku Ewropew tal-mediċini.
English: Florbetaben (18F) is eliminated from plasma of AD patients with a mean biological half-life of about 1 hour.
Maltese: Florbetaben (18F) jiġi eliminat mill-plażma ta' pazjenti b'AD b'half-life bijoloġiku medju ta' madwar siegħa.
English: This is equivalent to 1.6% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 1.6 % tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: Contents of the pack and other information
Maltese: Il-kontenut tal-pakkett u informazzjoni oħra
English: Hypotension Flushing Haematoma
Maltese: applikazzjoni awtomatizzata awtorizzata.
English: Neuraceq 300 MBq/mL solution for injection
Maltese: Neuraceq 300 MBq/ml soluzzjoni għall-injezzjoni
English: The reader should compare the cortical grey matter signal intensity to the maximum white matter signal intensity.
Maltese: L-ispeċjalista għandu jikkompara l-intensità tas-sinjal fil-materja kortikali griża mal-intensità massima tas-sinjal fil-materja l-bajda.
English: A brain scan is usually taken 90 minutes after Neuraceq is given.
Maltese: Skenn tal-moħħ ġeneralment tittieħed fi żmien 90 minuta wara li jingħata Neuraceq.
English: The images should be viewed in a systematic manner (Figure 1) starting at the level of cerebellum and scrolling up through the lateral temporal and frontal lobes, then to the area of the posterior cingulate cortex and precuneus, and finally to the parietal lobe.
Maltese: L-immaġini għandhom jiġu analizzati sistematikament (Figura 1) billi wieħed jibda fil-livell taċ-ċerebellum u jiskrollja 'l fuq lejn il-lobi temporali laterali u frontali, imbagħad għaż-żona tal-kortiċi posterjuri singulat u prekuneju, u fl-aħħar fil-lobu parjetali.
English: Intravenous use
Maltese: Materjal radjuattiv
English: Neuraceq images should only be interpreted by readers trained in the interpretation of PET images with florbetaben (18F).
Maltese: Immaġini b'Neuraceq għandhom jiġu interpretati biss minn persuni mħarrġa fl-interpretazzjoni ta' immaġini PET bi florbetaben (18F).
English: Florbetaben (18F) is excreted primarily through the hepatobiliary system and patients with hepatic impairment have the potential of increased radiation exposure (see section 4.2).
Maltese: Florbetaben (18F) jiġi eliminat prinċipalment mis-sistema tal-fwied u l-marrara u pazjenti b'indeboliment tal-fwied għandhom il-potenzjal ta' esponiment ogħla ta' radjazzjoni (ara sezzjoni 4.2).
English: In addition, binding of florbetaben (18F) to β-amyloid plaques in post-mortem AD brain sections was demonstrated by autoradiography and supported by immunohistochemistry or Bielschowsky stain.
Maltese: Il-korrelazzjoni kwantitattiva in vivo ma kinetx stmata f'pazjenti moribondi bejn it-teħid ta' florbetaben (18F) fil-materja l-griża tal-kortiċi u d-depożizzjoni ta' β-amyloid f'kampjuni tal-awtopsja.
English: - This medicine contains up to 33 mg sodium (main component of cooking/table salt) in each dose.
Maltese: - Din il-mediċina fiha 33 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir / li jintuża mal ikel) f'kull doża.
English: The estimated absorbed radiation doses to organs are listed in Table 3, providing data from Caucasian healthy volunteers (n=17).
Maltese: L-istima tad-dożi ta' radjazzjoni assorbiti fl-organi huma elenkati f'Tabella 3 billi jipprovdu tagħrif minn voluntieri Kawkasi b'saħħithom (n=17).
English: Residual activity in the midsagittal sinus can be sometimes observed likely due to the presence of tracer in the blood pool.
Maltese: Attività residwali fis-sinus saġittali tan-nofs tista' xi kultant tiġi osservata, probabbli dovuta għallpreżenza ta' intraċċatur fid-demm miġbur.
English: The activity of florbetaben (18F) has to be measured with an activimeter (dose calibrator) immediately prior to injection.
Maltese: L-attività ta' florbetaben (18F) trid tiġi mkejjla b'attivimetru (kalibratur tad-doża) immedjatament qabel l-injezzjoni.
English: Talk to your nuclear medicine doctor before you are given Neuraceq if you: - have kidney problems - have liver problems - are pregnant or think you may be pregnant - are breast-feeding
Maltese: Kellem lit-tabib tal-mediċina nukleari tiegħek qabel ma tingħata Neuraceq jekk inti: - għandek problemi tal-kliewi - għandek problemi tal-fwied - tqila jew taħseb li tista' tkun tqila
English: The design of this study does not allow estimating the risk of MCI progression to clinical AD.
Maltese: Il-mod kif ġie ddisinjat l-istudju ma jippermettix stima ta' riskju ta' progressjoni ta' MCI għal AD klinika.
English: The results were lower than the results obtained in the pivotal trial: a sensitivity range between 77.5% to 90% and specificity range between 62.5-85.7%.
Maltese: Ir-riżultati kienu aktar baxxi mir-riżultati miksuba fil-prova ewlenija: medda tas-sensittività kienet bejn 77.5% sa 90 % u l-ispeċifiċità kienet mifruxa bejn62.5 - 85.
English: Ovaries
Maltese: Szeligi
English: Ascorbic acid
Maltese: Ascorbic acid Ethanol anidru Macrogol 400
English: Radioactive material.
Maltese: din il-mediċina.
English: When in doubt, it is important to consult your nuclear medicine doctor who will supervise the procedure.
Maltese: Meta tkun f'dubju, huwa importanti li tikkonsulta t-tabib tal-mediċina nukleari tiegħek li ser jissorvelja l-proċedura.
English: Dosimetry calculations were adapted to the adult model (with a body weight of 70 kg).
Maltese: Il-kalkulazzjonijiet dożimetriċi kienu adattati għall-mudell adult (b'piż korporali ta' 70 kg)
English: Cortical SUV ratios (SUVRs, relative to cerebellar cortex) are higher in AD patients compared with those of healthy volunteer subjects.
Maltese: Proporzjonijiet ta' SUV kortikali (SUVRs, relattivi għal kortiċi ċerebellari) huma ogħla f'pazjenti b'AD meta mqabbla ma' individwi volontieri b'saħħithom.
English: Toxic skin eruption Rash
Maltese: Eruzzjoni tossika fuq il-ġilda Raxx
English: Mechanism of action Florbetaben (18F) binds to β-amyloid neuritic plaques in the brain.
Maltese: florbetaben (18F) fid-data u l-ħin ta' kalibrazzjoni.
English: Diarrhoea Nausea
Maltese: Effetti farmakodinamiċi
English: Neuralgia Headache Burning sensation Tremor
Maltese: Fertilità Ma sarux studji ta' fertilità
English: Method of preparation The package must be checked before use and the activity measured using an activimeter.
Maltese: Metodu ta' preparazzjoni Il-pakkett għandu jiġi ċċekkjat qabel l-użu u l-attività mkejla permezz ta' attivimetru.
English: For the limitations of use in patients with mild cognitive impairment (MCI), see section 5.1.
Maltese: Għal-limitazzjoniiet dwar l-użu f'pazjenti b'indeboliment konjittiv ħafif (MCI-mild cognitive impairment), ara sezzjoni 5.1
English: A negative scan indicates sparse or no plaques, which is not consistent with a diagnosis of AD. For the limitations in the interpretation of a positive scan see sections 4.4 and 5.1.
Maltese: Għal-limitazzjonijiet fl-interpretazzjoni ta' skenn pożittiva ara sezzjonijiet 4.4 u 5
English: Uncommon (may affect up to 1 in 100 people): - Burning sensation, headache, neuralgia (intense, typically intermittent pain along the course of a nerve), tremor (an involuntary quivering movement) - Vessels: flushing (sudden reddening of the face and/or neck), haematoma (a bruise, a black and blue mark), hypotension (low blood pressure) - Stomach: diarrhea, nausea (feeling sick) - Liver: abnormal liver function - Skin: hyperhidrosis (excessive sweat), rash, toxic skin eruption (acute skin affections with measles-type erythema of the skin, potentially including blisters and ulcerations) - Muscles and bones: limb discomfort, pain in extremity - Injection site conditions: injection site irritation, pain and discomfort around the injection site,
Maltese: - Sensazzjoni ta' ħruq, uġigħ ta' ras, nevralġija (uġigħ qawwi, ġeneralment intermittenti tul in nerv), rogħda (moviment ta' ċaqlieq involontarju) - Vażi: fwawar (ħmura f'daqqa fuq il-wiċċ u/jew l-għonq), ematoma (tbenġila, marka sewda u blu), ipotensjoni (pressjoni baxxa)
English: Neuraceq is not intended for use in children and adolescents below the age of 18 years old.
Maltese: Neuraceq mhux maħsub għall-użu fi tfal u adolexxenti li għadhom m'għalqux it-18-il sena.
English: Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.
Maltese: Din il-mediċina hi intiża għal adulti biss.
English: Hepatobiliary disorders
Maltese: TAL-PRODOTT MEDIĊINALI
English: You must stop breast-feeding for 24 hours after the injection.
Maltese: Għandek tieqaf tredda' għal 24 siegħa wara l-injezzjoni.
English: Resuming breast-feeding should be in agreement with the nuclear medicine doctor who will supervise the procedure.
Maltese: - Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tal-mediċina nukleari tiegħek li ser jissorvelja l proċedura.
English: The table below shows the dosimetry as calculated using the OLINDA (Organ Level INternal Dose Assessment) software.
Maltese: It-tabella t'hawn taħt turi d-dożimetrija kif ikkalkulata permezz tas-softwer OLINDA (Organ Level
English: Image interpretation errors in the estimation of brain β-amyloid neuritic plaque density, including false negatives and false positives, have been observed.
Maltese: Kien hemm żbalji fl-interpretazzjoni tal-immaġini fl-istima tad-densità tal-plakka newritika ta' β-amyloid fil moħħ, li jinkludu negattivi foloz u pożittivi foloz.
English: The efficacy of florbetaben (18F) for predicting development of AD or monitoring response to therapy has not been established (see section 5.1).
Maltese: L-effikaċja ta' florbetaben (18F) li jipprevedi l-iżvilupp ta' AD jew jimmonitorja rispons għat-terapija ma ġiex stabbilit (ara sezzjoni 5.1).
English: How Neuraceq is stored
Maltese: X'fih Neuraceq
English: Quality - Module 3
Maltese: Kwalità - Modulu 3
English: Renal Dialysis
Maltese: Dijaliżi Renali
English: Labelling
Maltese: Funzjonali
English: Pulmonary Arterial Hypertension
Maltese: Pressjoni Arterjali Pulmonari Għolja
English: Flolan has been included in the list of products for Summary of Product Characteristics (SmPC) harmonisation in accordance with Article 30(2) of Directive 2001/83/EC.
Maltese: Flolan ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tas-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) skont l-Artikolu 30(2) tad-Direttiva 2001/83/KE.
English: Flolan is authorised in the following member states: Austria, Belgium, Czech Republic, Denmark, Estonia, France, Ireland, Italy, Luxembourg, Malta, The Netherlands, Spain and United Kingdom and in Norway.
Maltese: Flolan huwa awtorizzat fl-istati membri li ġejjin: l-Awstrija, il-Belġju, ir-Repubblika Ċeka, id-Danimarka, lEstonja, Franza, l-Irlanda, l-Italja, il-Lussemburgu, Malta, il-Pajjiżi l-Baxxi, Spanja u r-Renju Unit u finNorveġja.
English: Flolan is indicated for,
Maltese: Flolan huwa indikat għal,
English: It is a potent inhibitor of platelet aggregation and also a potent vasodilator.
Maltese: Huwa inibitur qawwi ta' aggregazzjoni ta' pjastrini u anki vasodilatatur potenti.
English: Mean systemic arterial pressure was not significantly different between the two groups (-4.33 vs. -3.05 mm Hg).
Maltese: Il-pressjoni arterjali sistemika medja ma kinitx differenti b'mod sinifikanti bejn iż-żewġ gruppi (-4.33 vs. -3.05 mm Hg).
English: However, more patients in both treatment groups (28/51 [55%] with epoprostenol and 35/48 [73%] with conventional therapy alone) showed no change in functional class, and 2/51 (4%) with epoprostenol and 13/48 (27%) with conventional therapy alone worsened.
Maltese: Madankollu, aktar pazjenti fiż-żewġ gruppi ta' trattament (28/51 [55%] b'epoprostenol u 35/48 [73%] bit-terapija konvenzjonali waħedha) ma wrew ebda bidla fil-klassifika funzjonali, u 2/51 (4%) b'epoprostenol u 13/48 (27%) bit-terapija konvenzjonali waħedha qalbu għallagħar.
English: Section 4.6 - Fertility, Pregnancy and lactation The CHMP agreed that there is limited amount of data from the use of epoprostenol in pregnant women (Schaefer 2007, Reprotox 2010).
Maltese: Is-CHMP qabel li hemm ammont limitat ta' dejta mill-użu ta' epoprostenol f'nisa tqal (Schaefer 2007, Reprotox 2010).
English: Flolan is indicated for Pulmonary Arterial Hypertension (PAH) and Renal Dialysis.
Maltese: Flolan huwa indikat għall-Pressjoni Arterjali Pulmonari Għolja (PAH) u d-Dijaliżi Renali.
English: 1.45 mm Hg), mean right atrial pressure (-2.26 vs. 0.59 mm Hg), total pulmonary resistance (-4.52 vs. 1.41 Wood U), pulmonary vascular resistance (-3.60 vs. 1.27 Wood U), and systemic vascular resistance (-4.31 vs. 0.18 Wood U) were statistically different between patients who received epoprostenol chronically and those who did not.
Maltese: 12 L/min/m2), il-volum ta' ppumpjar tad-demm (6.01 vs. -1.32 mL/taħbita), saturazzjoni tal-ossiġenu arterjali (1.62 vs. -0.85%), pressjoni medja tal-arterja pulmonari (-5.39 vs. 1.45 mm Hg), pressjoni atrijali leminija medja (-2.26 vs. 0.59 mm Hg), reżistenza pulmonari totali (-4.52 vs. 1.41 Wood U), reżistenza vaskulari pulmonari (-3.60 vs. 1.27 Wood U), u reżistenza vaskulari sistemika (-4.31 vs. 0.18 Wood U) kien statistikament differenti bejn il-pazjenti li rċievew epoprostenol b'mod kroniku u dawk li ma rċievewhx.
English: The labelling has been updated according to the latest QRD v8 template.
Maltese: It-tikkettar ġie aġġornat skont l-aħħar mudell tal-QRD v8.
English: Whereas
Maltese: Tikkettar
English: The combined baseline 6-minute walk test median values for the conventional therapy group and epoprostenol plus conventional therapy group was 266 meters and 301 meters, respectively.
Maltese: Il-valuri medjani kkombinati tal-linja bażi tat-test ta' mixi għal 6 minuti għallgrupp tat-terpaija konvenzjonali u l-grupp ta' epoprostenol flimkien mat-terapija konvenzjonali kienu ta' 266 metru u 301 metru, rispettivament.
English: Two major prospectively controlled studies (19 and 27), and 5 emergency studies were conducted to investigate bleeding during dialysis.
Maltese: Saru żewġ studji kbar prospettivament ikkontrollati (19 u 27), u 5 studji ta' emerġenza biex jinvestigaw il-fsad matul id-dijaliżi.
English: In emergency studies, 16 patients received 24 epoprostenol dialyses.
Maltese: Fl-istudji ta' emerġenza, 16-il pazjent irċievew 24 dijaliżi b'epoprostenol.
English: Statistically significant improvement was observed in exercise capacity (p=0.001), as measured by the 6 minutes walking test (6MWT) in patients receiving continuous intravenous epoprostenol plus conventional therapy (N=52) for 8 or 12 weeks compared to those receiving conventional therapy alone (N=54) (combined week 8 and 12 change from baseline - median: 49 vs. -4 meters; mean: 55 vs. -4 meters).
Maltese: Ġie osservat titjib statistikament sinifikanti fil-kapaċità ta' eżerċizzju (p=0.001), hekk kif din tkejlet mittest ta' mixi għal 6 minuti (6MWT) fil-pazjenti li rċievew epoprostenol kontinwu fil-vina flimkien matterapija konvenzjonali (N=52) għal 8 jew 12-il ġimgħa meta mqabbla ma' dawk li rċievew it-terapija konvenzjonali waħedha (N=54) (bidla kombinata fuq 8 u 12-il ġimgħa mil-linja bażi - medja:
English: Patients at Very High Risk of Haemorrhage were assessed in major controlled studies; 12 patients at very high risk of haemorrhage received 35 epoprostenol dialyses and 11 patients received 28 heparin dialyses.
Maltese: Il-pazjenti b'Riskju Għoli Ħafna ta' Emorraġija ġew ivvalutati fi studji kkontrollati kbar; 12-il pazjent b'riskju għoli ħafna ta' emorraġija rċievew 35 dijaliżi b'epoprostenol u 11-il pazjent irċievew 28 dijaliżi b'heparin.
English: Eight of 40 (20%) patients receiving conventional therapy alone died, whereas none of the 41 patients receiving epoprostenol died (p=0.003).
Maltese: Tmienja minn 40 (20%) pazjent li rċievew terapija konvenzjonali waħedha mietu, filwaqt li ma miet l-ebda wieħed mill-41 pazjent li rċievew epoprostenol (p=0.003).
English: Chronic continuous infusions of epoprostenol in patients with idiopathic or heritable pulmonary arterial hypertension (PAH) were studied in two prospective, open, randomised trials of 8 and 12 weeks' duration (N=25 and N=81, respectively) comparing epoprostenol plus conventional therapy to conventional therapy alone.
Maltese: Infużjonijiet kroniċi kontinwi ta' epoprostenol f'pazjenti bi pressjoni arterjali pulmonari għolja (PAH) ġew studjati f'żewġ prospettivi, provi kliniċi miftuħa u aleatorji b'dewmien ta' 8 u 12-il ġimgħa (N=25 u N=81, rispettivament) li fihom, epoprostenol flimkien mat-terapija konvenzjonali tqabblu mat-terapija konvenzjonali waħedha.
English: However, 9 of 27 epoprostenol dialyses were unsuccessful following multiple attempts.
Maltese: Madankollu, 9 mis-27 dijaliżi b'epoprostenol ma rnexxewx wara bosta tentattivi.
English: Following the discussion on the efficacy and safety data the CHMP agreed in the final indications for Flolan for pulmonary arterial hypertension and renal dialysis as per the wording below:
Maltese: Wara d-diskussjoni dwar id-dejta tal-effikaċja u s-sikurezza, fl-indikazzjonijiet finali għal Flolan għal pressjoni arterjali pulmonari għolja u dijaliżi renali, is-CHMP qabel dwar it-test ipprovdut hawn taħt: