FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 24-month carcinogenicity study in the rat, abiraterone acetate increased the incidence of interstitial cell neoplasms in the testes.
Maltese: Fi studju ta' karċinoġeniċità ta' 24 xahar fil-far, abiraterone acetate żied linċidenza ta' neoplażmi fiċ-ċelluli interstizzjali, fit-testikoli.
English: In clinical trials, the risk for hepatotoxicity was mitigated by exclusion of patients with baseline hepatitis or significant abnormalities of liver function tests.
Maltese: Fi provi kliniċi, ir-riskju ta' tossiċità tal-fwied tnaqqas permezz tal-esklużjoni ta' pazjenti li fil-linja bażi kellhom epatite jew anormalitajiet sinifikanti fit-testijiet tal-funzjoni tal-fwied.
English: Study 301 (patients who had received prior chemotherapy) Study 301 enrolled patients who had received prior docetaxel.
Maltese: Studju 301 (pazjenti li kienu kienu ħadu kura bil-kimoterapija qabel)
English: AST > 20 x ULN were not re-treated.
Maltese: Pazjenti li l-livelli tal-ALT jew tal-AST tagħhom żdiedu > 20 x l-ULN ma reġgħux ingħataw il-kura.
English: The Eastern Cooperative Oncology Group (ECOG) performance status was 0 for 76% of patients, and 1 for 24% of patients in both arms.
Maltese: L-istat ta' prestazzjoni tal-Koperattiva tal-Grupp ta' Onkoloġija tal-Lvant (ECOG) kien ta' 0 għal 76% tal-pazjenti, u 1 għal 24% tal-pazjenti fiż-żewġ fergħat.
English: High fat levels in your blood, chest pain, irregular heart beat (atrial fibrillation), heart failure, rapid heart rate, severe infections called sepsis, bone fractures, indigestion, blood in urine, rash.
Maltese: Livelli għoljin ta' xaħam fid-demm tiegħek, uġigħ fis-sider, qalb tħabbat irregolari (fibrillazzjoni talatriju), insuffiċjenza tal-qalb, rata mgħaġġla ta' taħbit tal-qalb, infezzjonijiet severi msejħa sepsis, ksur fl-għadam, indiġestjoni, demm fl-awrina, raxx.
English: p value is from a log-rank test stratified by ECOG PS score (0/1 or 2) and visceral lesion (absent or present).
Maltese: Il-valur p huwa minn test log-rank stratifikat permezz tal-punteġġ PS ECOG (0/1 jew 2) u leżjoni fil-vixxri (nieqsa jew preżenti).
English: respectively.
Maltese: Uġigħ
English: Overall survival was longer for ZYTIGA than placebo with a 25% reduction in risk of death (HR = 0.752; 95% CI: [0.606; 0.934], p = 0.0097), but OS was not mature and interim results did not meet the pre-specified stopping boundary for statistical significance (see Table 4).
Maltese: Is-sopravivenza globali kienet itwal għal ZYTIGA milli għall-plaċebo bi tnaqqis ta' 25% fir-risku ta' mewt (HR=0.752; 95% CI: [0.606; 0.934], p=0.0097),
English: Abnormal liver function tests developing in patients participating in clinical trials were vigorously managed by requiring treatment interruption and permitting re-treatment only after return of liver function tests to the patient's baseline (see section 4.2).
Maltese: Istma l-funzjoni tal-qalb skont kif indikat b'mod kliniku, ibda immaniġġar xieraq u qis jekk għandekx twaqqaf din il-kura jekk hemm tnaqqis sinifikanti b'mod kliniku fil-funzjoni tal-qalb (ara s-sezzjoni 4.2).
English: Table 5: Study 302: Radiographic progression-free survival of patients treated with either ZYTIGA or placebo in combination with prednisone or prednisolone plus LHRH analogues or prior orchiectomy (At second interim analysis of OS-Investigator Review)
Maltese: Studju 302: Sopravivenza ħielsa minn progressjoni radjugrafika tal-marda f'pazjenti ikkurati jew b'ZYTIGA jew inkella bi plaċebo flimkien ma' prednisone jew prednisolone u analogi ta' LHRH jew tneħħija qabel ta' testikola u l-korda tal-isperma (Fit-tieni analiżi interim ta' OS -Eżaminata mill-Ġdid millInvestigatur)
English: Caution is recommended in patients concomitantly treated with medicinal products known to be associated with myopathy/rhabdomyolysis.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji ssuspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: What ZYTIGA looks like and contents of the pack - ZYTIGA tablets are white to off-white, oval shaped (15.9 mm long x 9.5 mm wide), with
Maltese: Id-dehra ta' ZYTIGA u l-kontenuti tal-pakkett - Il-pilloli ZYTIGA huma minn bojod sa offwajt, għandhom forma ovali, (twal 15.
English: - This medicine also contains approximately 27 mg of sodium in a four tablet daily dose.
Maltese: - Din il-mediċina fiha madwar 27 mg ta' sodium fiż-żewġ pilloli tad-doża ta' kuljum.
English: Primary Survival Analysis Deaths (%) Median survival (months) (95% CI) p-value
Maltese: Analiżi ta' Sopravivenza Primarja Mwiet (%) Medjan ta' sopravivenza (xhur) (95% CI) Valur p Proporzjon ta' periklu (95% CI)
English: Day
Maltese: TIKKETTAR
English: Start date:
Maltese: Figura 6:
English: Control patients received placebo and low dose prednisone or prednisolone 5 mg twice daily.
Maltese: Pazjenti ta' kontroll irċivew plaċebo u doża baxxa ta' prednisone jew prednisolone 5 mg darbtejn kuljum.
English: Eleven percent of patients enrolled had an ECOG performance score of 2; 70% had radiographic evidence of disease progression with or without PSA progression; 70% had received one prior cytotoxic chemotherapy and 30% received two.
Maltese: Ħdax fil-mija tal-pazjenti li ddaħħlu fl-istudju kellhom punteġġ ta' kapaċità ECOG ta' 2; 70% kellhom evidenza radjugrafika ta' żvilupp tal-marda bi żvilupp fil-PSA jew mingħajru; 70% kienu rċivew kimoterapija ċitotossika waħda u 30% kienu rċivew tnejn.
English: QT prolongation has been observed in patients experiencing hypokalaemia in association with ZYTIGA treatment.
Maltese: Ukoll, ċertu mediċini jistgħu jżidu jew inaqqsu l-effetti ta' ZYTIGA.
English: 15 September 2016 EMA/616984/2016 EMEA/H/C/000471
Maltese: EMA/616984/2016
English: The active substance in Abilify, aripiprazole, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Abilify, l-aripiprażol, hija mediċina antipsikotika.
English: What was the conclusion of the CHMP?
Maltese: X'kienet il-konklużjoni tas-CHMP?
English: Abilify contains the active substance aripiprazole.
Maltese: Abilify fih is-sustanza attiva aripiprażolu.
English: What is Abilify?
Maltese: X'inhu Abilify?
English: What are the consequences for patients in clinical trials?
Maltese: X'inhuma l-konsegwenzi għall-pazjenti involuti fi provi kliniċi?
English: On 15 September 2016, the Committee for Medicinal Products for Human Use (CHMP) concluded the review of an application to extend the use of Abilify in schizophrenia to adolescents aged 13 and 14 years.
Maltese: Fil-15 ta' Settembru 2016, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) ikkonkluda l-analiżi ta' applikazzjoni biex jiġi estiż l-użu ta' Abilify fl-iskiżofrenja għall-adoloxxenti ta' 13 u 14-il sena.
English: Although the relapse rate with Abilify in 13 and 14 year olds was similar to the rate in older children (21% and 19% respectively), the number of patients in the main study was too small to draw firm conclusions in the younger group.
Maltese: Għalkemm ir-rata ta' ritorn tas-sintomi b'Abilify fil-pazjenti ta' 13 u 14-il sena kienet simili għar-rata fi tfal akbar (21 % u 19 % rispettivament), in-numru ta' pazjenti fl-istudju ewlieni kien wisq żgħir biex ikunu jistgħu jintlaħqu konklużjonijiet fil-grupp ta' pazjenti iżgħar fl-età.
English: Abilify is a medicine for treating schizophrenia and bipolar disorder.
Maltese: Abilify huwa mediċina għall-kura tal-iskiżofrenja u d-disturb bipolari.
English: The CHMP therefore concluded that Abilify could not be approved for schizophrenia in 13 and 14 year olds on the basis of these data.
Maltese: Għalhekk is-CHMP ikkonkluda li Abilify ma setax jiġi approvat għall-iskiżofrenja f'pazjenti ta' 13 u 14-il sena abbażi ta' din id-data.
English: However, the CHMP noted that schizophrenia is rare in younger patients and that including the data in Abilify's product information could help the healthcare professionals who manage them.
Maltese: Madanakollu, is-CHMP innota li l-iskiżofrenja hija rari f'pazjenti iżgħar fl-età u li l-inklużjoni tad-data flinformazzjoni tal-prodott ta' Abilify tista' tgħin lill-professjonisti tal-kura tas-saħħa li jirregolawha.
English: The company presented data from a main study in which 146 adolescents with schizophrenia whose symptoms were stable received either Abilify or placebo (a dummy treatment) for one year.
Maltese: Il-kumpanija ppreżentat data minn studju ewlieni li fih 146 adoloxxent bl-iskiżofrenja u li s-sintomi tagħhom kienu stabbli rċevew jewAbilify jew inkella plaċebo (kura finta) għal sena.
English: What was Abilify expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Abilify?
English: More information about Abilify is available on EMA's website.
Maltese: Aktar tagħrif dwar Abilify huwa disponibbli fuq is-sit elettroniku tal-EMA.
English: Its exact mechanism of action is unknown, but it is believed to work through several different receptors in the brain, where it partially mimics or blocks the action of the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Maltese: Il-mod kif taħdem din il-mediċina mhux magħruf, iżda ħafna jemmnu li taħdem permezz ta' riċetturi differenti fil-moħħ, fejn parzjalment timita jew timblokka l-azzjoni tan-newrotrażmettituri dopamina u 5-idrossitriptamina (magħruf ukoll bħala serotonina).
English: Application to extend use of Abilify in schizophrenia to 13 and 14 year olds EMA/616984/2016
Maltese: Applikazzjoni għall-estensjoni tal-użu ta' Abilify fl iskiżofrenja għall-adoloxxenti ta' 13-il sena u 14-il sena
English: Because these neurotransmitters are involved in schizophrenia and bipolar disorder, aripiprazole can help to normalise their activity in the brain, reducing psychotic or manic symptoms and preventing them from returning.
Maltese: Peress li d-dopamina u l-5-idrossitriptamina huma involuti fl-iskiżofrenja u d-disturb bipolari, l-aripiprażol tista' tgħin biex iġġib lura għan-normal l-attività tagħhom fil-moħħ, billi tnaqqas is-sintomi psikotiċi jew is-sintomi ta' manija u ma tħallihomx jirritornaw.
English: There are no consequences of the outcome of this application on patients currently in or who may be joining clinical trials with Abilify.
Maltese: M'hemm l-ebda konsegwenza tal-eżitu ta' din l-applikazzjoni fuq pazjenti li bħalissa huma involuti jew se jkunu involuti fi provi kliniċi b'Abilify.
English: There are no consequences on the use of Abilify in bipolar disorder or its currently approved use in patients with schizophrenia aged 15 years and over.
Maltese: Fil-kura tal-iskiżofrenja bħalissa huwa approvat biss għall-pazjenti ta' 15-il sena u akbar.
English: Further information on Poteligeo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Poteligeo was shown to be more effective than a comparator medicine, vorinostat, in a study of 372 adults with either mycosis fungoides or Sezary syndrome.
Maltese: Poteligeo intwera li hu aktar effettiv minn mediċina komparatur, vorinostat, fi studju ta' 372 adult b'fungojde mikożi jew bis-sindrome ta' Sezary.
English: Effects are clinically relevant considering that patients have limited treatment options.
Maltese: L-effetti huma klinikament rilevanti meta jitqies li l-pazjenti għandhom għażliet ta' kura limitati.
English: Both mycosis fungoides and Sezary syndrome belong to a group of rare cancers (cutaneous T-cell lymphomas), and Poteligeo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 14 October 2016.
Maltese: Kemm fungojde mikożi kif ukoll is-sindromu ta' Sezary jappartjenu għal grupp ta' kanċer rari (limfoma taċ-ċelluli T tal-ġilda), u Poteligeo ġie kklassifikat bħala "mediċina orfni" (mediċina użata f'mard rari) fl14 ta' Ottubru 2016.
English: The active substance in Poteligeo, mogamulizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to a receptor (target) called CCR4.
Maltese: Is-sustanza attiva f'Poteligeo, mogamulizumab, hija antikorp monoklonali (tip ta' proteina) li tfasslet biex teħel ma' riċettur (mira) imsejjaħ CCR4.
English: The most commonly reported serious reactions are pneumonia (infection of the lungs), fever, infusion-related reactions and cellulitis (inflammation of the deep skin tissue).
Maltese: L-iktar reazzjonijiet serji rrappurtati b'mod komuni huma pnewmonja (infezzjoni tal-pulmun), deni, reazzjonijiet relatati mal-infużjoni u ċellulite (infjammazzjoni tat-tessut tal-ġilda fonda).
English: The medicine is given as an infusion (drip) into a vein lasting at least 1 hour.
Maltese: Il-mediċina tingħata bħala infużjoni (dripp) ġo vina li ddum tal-inqas siegħa.
English: CCR4 is found on the surface of white blood cells, including the cancerous cells in mycosis fungoides or Sezary syndrome.
Maltese: CCR4 jinstab fuq il-wiċċ ta' ċelluli bojod tad-demm, inklużi ċ-ċelloli kanċeroġeni f'mikożi fungali jew is-sindromu ta' Sezary.
English: Other information about Poteligeo
Maltese: Informazzjoni oħra dwar Poteligeo:
English: Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation Poteligeo fih is-sustanza attiva mogamulizumab.
English: Patients should be monitored during and after the infusion for certain side effects related to the infusion.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati waqt u wara l-infużjoni għal ċerti effetti sekondarji relatati mal-infużjoni.
English: As for all medicines, data on the use of Poteligeo are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Poteligeo hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Poteligeo, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet irrappurtati b'Poteligeo, ara l-fuljett ta' tagħrif.
English: What are the risks associated with Poteligeo?
Maltese: X'inhuma r-riskji assoċjati ma' Poteligeo?
English: Poteligeo contains the active substance mogamulizumab.
Maltese: Aktar informazzjoni dwar Poteligeo tinstab fis-sit elettroniku tal-Aġenzija:
English: The most common side effects with Poteligeo (seen in more than 1 patient in 10) are infusion-related reactions and rash.
Maltese: L-effett sekondarju l-aktar komuni b'Poteligeo (li deher f'iktar minn pazjent 1 minn kull 10) huma reazzjonijiet relatati mal-infużjoni u raxx.
English: To reduce this risk, patients may be given other medicines such as an antipyretic (medicine that reduces fever) and an antihistamine (for treating allergic reactions) before or during treatment with Poteligeo.
Maltese: Biex jitnaqqas dan ir-riskju, il-pazjenti jistgħu jingħataw mediċini oħra bħal antipiretiċi (mediċina li tnaqqas id-deni) u antistamina (għall-kura ta' reazzjonijiet allerġiċi) qabel jew waqt il-kura b'Poteligeo.
English: How does Poteligeo work?
Maltese: Kif jintuża Poteligeo?
English: Why is Poteligeo authorised in the EU?
Maltese: Għaliex Poteligeo huwa awtorizzat fl-UE?
English: Poteligeo can only be obtained with a prescription and treatment should be supervised by a doctor who has experience in the treatment of cancer and in a place where equipment for resuscitation is available in case of rare and severe allergic reaction to the medicine.
Maltese: Poteligeo jista' jinkiseb biss b'riċetta tat-tabib u l-kura għandha tiġi sorveljata minn tabib li għandu esperjenza fil-kura tal-kanċer u f'post fejn tagħmir għar-risuxxitazzjoni huwa disponibbli f'każ ta' reazzjoni allerġika rari u serja għall-mediċina.
English: The European Medicines Agency therefore decided that Poteligeo's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Għaldaqstant, lAġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Poteligeo huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: How is Poteligeo used?
Maltese: Poteligeo?
English: This summary was last updated in 03-2017.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'03-2017.
English: This may take up to 5 weeks.
Maltese: Dan jista' jieħu sa 5 ġimgħat.
English: The full EPAR for Pergoveris can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: EPAR summary for the public follitropin alfa / lutropin alfa
Maltese: Sommarju tal-EPAR għall-pubbliku follitropina alfa / lutropina alfa
English: Other information about Pergoveris
Maltese: Informazzjoni oħra dwar Pergoveris
English: • tumours of the hypothalamus or pituitary gland,
Maltese: • tumuri tal-glandola ipotalama jew pitwitarja,
English: The medicine contains the active substances follitropin alfa and lutropin alfa.
Maltese: Il-mediċina fiha s-sustanzi attivi follitropina alfa u lutropina alfa.
English: By replacing the missing hormones, Pergoveris allows women with FSH and LH deficiency to develop a follicle, which will release an egg after an injection of the hormone human chorionic gonadotrophin (hCG).
Maltese: Permezz tassostituzzjoni tal-ormoni neqsin, Pergoveris jippermetti lin-nisa li għandhom defiċenzja ta' FSH u LH li jiżviluppaw follikola, li tirrilaxxa bajda wara injezzjoni tal-ormon gonadotrofin korjonik uman (chorionic gonadotrophin) (hCG).
English: The active substances in Pergoveris, follitropin alfa and lutropin alfa, are copies of the natural hormones FSH and LH.
Maltese: Is-sustanzi attivi f'Pergoveris, il-follitropina alfa u l-lutropina alfa, huma kopji tal-ormoni naturali FSH u LH.
English: The most common side effects reported with Pergoveris (seen in more than 1 patient in 10) are headache, ovarian cysts and injection site reactions (e.g. pain, itching, redness, bruising, swelling or irritation at the site of injection).
Maltese: L-effetti seondarji l-iktar komuni rrapportati b'Pergoveris (li dehru f'aktar minn pazjenta 1 minn 10) huma wġigħ ta' ras, ċesti fl-ovarji u reazzjonijiet fis-sit tal-injezzjoni (eż. wġigħ, ħakk, ħmura, tbenġil, nefħa jew irritazzjoni fis-sit tal-injezzjoni).
English: This is a summary of the European public assessment report (EPAR) for Pergoveris.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Pergoveris.
English: Why is Pergoveris approved?
Maltese: Għaliex ġie approvat Pergoveris?
English: Treatment can cause overstimulation of the ovaries (known as ovarian hyperstimulation syndrome, OHSS), which can lead to serious medical problems.
Maltese: Il-kura tista' tistimula l-ovarji aktar milli suppost (magħruf bħala sindromu tal-iperstimulazzjoni ovarja, OHSS), li tista' twassal għal problemi mediċi serji.
English: The recommended starting dose is 150 International Units (IU) of follitropin alfa and 75 IU of lutropin alfa once a day, but this should be tailored to the patient's response.
Maltese: Id-doża tal-bidu rakkomandata hija 159 Unitajiet Internazzjonali (IU) ta' follitropina alfa u 75 IU ta' lutropina alfa darba kuljum, iżda din għandha titfassal apposta għar-rispons tal-pazjenta.
English: Both active substances have already been authorised in the European Union (EU), follitropin alfa as GONAL-f and lutropin alfa as Luveris.
Maltese: Iż-żewġ sustanzi attivi diġà ġew awtorizzati fl-Unjoni Ewropea (UE), il-follitropina alfa bħala GONAL-f u l-lutropina alfa bħala Luveris.
English: Therefore, the company presented information from studies carried out during the development of Luveris to support the use of Pergoveris.
Maltese: Dan mhux intiż biex jipprovdi konsultazzjoni prattika dwar lużu ta' Pergoveris.
English: These studies confirmed that Pergoveris produced similar blood levels of follitropin alfa and lutropin alfa as when the two medicines are given separately.
Maltese: Dawn l-istudji kkonfermaw li Pergoveris ipproduċa livelli simili tad-demm tal-follitropina alfa u llutropina alfa bħal meta ż-żewġ mediċini jingħataw separatament.
English: Thromboembolism (clots in the blood vessels) may occur very rarely, usually associated with severe OHSS.
Maltese: Rari ħafna jista' jseħħ tromboemboliżmu (problemi ta' emboli tad-demm fil-vini), normalment assoċjat ma' OHSS serju.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pergoveris on 25 June 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Pergoveris valida fl-Unjoni Ewropea kollha fil-25 ta' Ġunju 2007.
English: What are the risks associated with Pergoveris?
Maltese: X'inhuma r-riskji assoċjati ma' Pergoveris?
English: The first injection must be given under direct supervision of a doctor who has experience in the treatment of fertility problems, but the patient can inject herself if she wants to, provided she has been properly trained and has access to expert advice.
Maltese: L-ewwel injezzjoni għandha tingħata taħt is-sorveljanza diretta ta' tabib li jkollu esperjenza fil-kura ta' problemi ta' fertilità, iżda l-pazjenta tista' tinjetta lilha nfisha jekk tkun trid, sakemm tkun tħarrġet b'mod xieraq u jkollha aċċess għal parir espert.
English: Mild or moderate OHSS is common, while severe OHSS is uncommon.
Maltese: OHSS ħafif jew moderat huwa komuni, filwaqt li OHSS serju mhuwiex komuni.
English: For the full list of all side effects and restrictions with Pergoveris, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Pergoveris, ara l-fuljett ta' tagħrif.
English: If necessary, the dose of follitropin alfa can be increased by adding it as a separate medicine, with 7 to 14 days between each dose increase.
Maltese: Jekk ikun hemm bżonn, id-doża ta' follitropina alfa tista' tiżdied billi din tiġi miżjuda bħala mediċina separata, b'7 sa 14-il jum bejn kull żieda fid-doża.
English: Pergoveris is for adult women who have low levels of two hormones that stimulate the ovariesfollicle-stimulating hormone (FSH) and luteinising hormone (LH).
Maltese: Pergoveris huwa għal nisa adulti li jkollhom livelli baxxi ta' żewġ ormoni li jistimulaw l-ovarji - ormon li jistimula l-follikoli (FSH) u ormon lutejinazzanti
English: In these studies, the combination of follitropin alfa and lutropin alfa at the same doses as in Pergoveris produced active follicles.
Maltese: F'dawn l-istudji, il-kombinazzjoni talfollitropina alfa u l-lutropina alfa fl-istess dożi bħal f'Pergoveris ipproduċiet follikoli attivi.
English: Ref.: EMEA/644240/2009 EMEA/H/C/396
Maltese: EMEA/644240/2009 EMEA/H/C/396
English: Xigris drotrecogin alfa (activated) EPAR summary for the public
Maltese: Xigris drotrecogin alfa (attivat) Sommarju tal-EPAR għall-pubbliku
English: • in the PROWESS study, Xigris was compared with placebo (dummy treatment) in 1,690 patients;
Maltese: • fl-istudju PROWESS, Xigris tqabbel ma' plaċebo (trattament finta) f'1,690 pazjent;
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xigris to Eli Lilly Nederland B.V. on 22 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xigris lil Eli Lilly Nederland B.V. fit-22 ta' Awwissu 2002.
English: Xigris should be started within 48 hours, and preferably within 24 hours, after the start of organ failure.
Maltese: Xigris għandu jibda fi żmien 48 siegħa, u preferibbilment fi żmien 24 siegħa, wara li organu ma jibqax jaħdem sew.
English: • in the ENHANCE study, over 2,000 patients received Xigris;
Maltese: • fl-istudju ENHANCE, aktar minn 2,000 pazjent irċievew Xigris;
English: This summary was last updated in 10-2009.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi: 10-2009.
English: If you want more information on the basis for the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CHMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: It contains the active substance drotrecogin alfa (activated).
Maltese: Xigris fih is-sustanza attiva drotrecogin alfa (attivata).
English: Why has Xigris been approved?
Maltese: Għal xiex ġie approvat Xigris?