FrancophonIA/ELRC3.0 huggingface dataset:
English: Of the control arm patients, 64% crossed over to receive an investigational autologous cellular immunotherapy manufactured from cells cryopreserved at the time the control was manufactured; patients were not randomised to subsequent autologous cellular immunotherapy.
Maltese: Mill pazjenti tal-grupp ta' kontroll, 64% biddlu biex jirċievu immunoterapija ċellolari awtologa ta' investigazzjoni manifatturata minn ċelloli ċiroppreservati fiż-żmien li fih ġie mmanifatturat ilkontroll; il-pazjenti ma tqassmux b'mod aleatorju għal immunoterapija ċellolari awtologa sussegwenti.
English: Store the bag in the insulated container to maintain the correct storage temperature (2°C-8°C) until infusion.
Maltese: Aħżen il-borża fil-kontenitur insulat biex iżżomm it-temperatura ta' ħżin ix-xierqa (2°C-8°C) salinfużjoni.
English: Patients should be informed of the possibility of late onset reactions and instructed to contact their physician if symptoms of dyspnoea, bronchospasm, dizziness, rash, or pyrexia occur.
Maltese: Il-pazjenti għandhom jiġu mgħarrfa bil-possibilità ta' reazzjonijiet li jfeġġu tard u jintalbu jikkuntattjaw lit-tabib tagħhom jekk iseħħu sintomi ta' dispnea, bronkospażmi, sturdament, raxx, jew piressija.
English: You can help by reporting any side effects you may get.
Maltese: Effetti sekondarji possibbli ta' Provenge
English: • You are immunocompromised (your immune system's ability to fight infections is reduced) or taking any immunosuppressant medicines (such as those used to treat or prevent organ rejection and certain medicines used to treat rheumatoid arthritis, multiple sclerosis, Crohn's disease, and ulcerative colitis)
Maltese: • Għandek sistema immuni dgħajfa (l-abilità tas-sistema immuni tiegħek sabiex tiġġieled linfezzjonijiet tkun imnaqqsa) jew jekk tieħu xi mediċini immunosuppressanti (bħal dawk użati biex jiġi kkurat jew evitat ir-rifjut ta' organu u ċerti mediċini użati biex jiġu kkurati lartrite rewmatojde, sklerożi multipla, il-marda ta' Crohn, u kolite ulċerattiva)
English: Peripheral blood mononuclear cells collected from the patients are cultured with PAP-GM-CSF, a fusion protein consisting of PAP linked to granulocyte-macrophage colony-stimulating factor (GM-CSF) an immune cell activator.
Maltese: Ċelloli mononukleari tad-demm periferali miġbura mill-pazjenti huma kkulturati b'PAP-GM-CSF, proteina tal-fużjoni li tikkonsisti f'PAP marbuta ma' fattur li jistimola l-kolonja tal-granuloċita-makrofagu (GM-CSF) attivatur taċ-ċelloli immuni.
English: The control was nonactivated autologous peripheral blood mononuclear cells.
Maltese: Il-kontroll kien ċelloli mononukleari tad-demm periferali awtologu mhux attivati.
English: Premedication
Maltese: Ipoestesija
English: Stroke
Maltese: Tilqim
English: It should not be given to children or adolescents under the age of 18 years.
Maltese: Ma għandux jingħata lil tfal jew adolexxenti ta' taħt it-18-il sena.
English: The patients enrolled in these trials had failed surgical or medical castration (e.g. luteinising hormone-releasing hormone [LHRH] agonist or gonadotropin-releasing hormone [GnRh] antagonist) therapies and had metastatic disease in the soft tissue and/or bone.
Maltese: Il-pazjenti rreġistrati f'dawn il-provi kliniċi ma rawx suċċess b'terapiji ta' kastrazzjoni kirurġika jew medika (eż. agonista tal-ormon li jnixxi ormon luteinizzanti [LHRH] jew antagonista tal-ormon li jnixxi gonadotropina [GnRh]) u kellhom mard metastatiku fit-tessut artab u/jew fl-għadam.
English: Visit 2 - Provenge infusion
Maltese: IMPORTANTI - Tagħtix infużjoni ta' Provenge jekk
English: Forty-eight percent of patients were receiving bisphosphonates and 18% had received prior chemotherapy, including docetaxel.
Maltese: Tmienja u erbgħin fil-mija tal-pazjenti kienu qed jirċievu bisfosfonati u 18% kienu rċivew kemoterapija qabel, inkluż docetaxel.
English: Autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (Sipuleucel-T)
Maltese: Ċelloli mononukleari tad-demm periferali awtologu attivati b'PAP-GM-CSF
English: Cases in which Provenge cannot be infused
Maltese: Każijiet li fihom Provenge ma jistax jiġi infuż
English: Immunocompromised patients and patients taking systemic immunosuppressive therapy were excluded from controlled clinical trials.
Maltese: Il-pazjenti immunokompromessi u l-pazjenti li jkunu qegħdin jieħdu kura immunosuppressiva sistemika ġew esklużi mill-provi kliniċi kkontrollati.
English: NAME OF THE MEDICINAL PRODUCT PROVENGE 50 x 106 CD54+ cells/250 mL dispersion for infusion.
Maltese: TAL-PRODOTT MEDIĊINALI PROVENGE 50 x 106 CD54+ ċelloli/250 mL dispersjoni għal infużjoni.
English: Educational material for Healthcare professionals 3.
Maltese: Materjal edukattiv għall-Professjonisti fil-kura tas-saħħa
English: Provenge should be infused intravenously over a period of approximately 60 minutes.
Maltese: Provenge għandu jiġi jingħata b'infużjoni ġol-vina fuq perjodu ta' bejn wieħed u ieħor 60 minuta.
English: Adverse reactions associated with leukapheresis
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Provenge treatment checklists
Maltese: TAL-PRODOTT MEDIĊINALI
English: In post-marketing experience of greater than 5,000 patients treated, this incidence is approximately 19% (see section 4.2).
Maltese: aktar minn 5,000 pazjent ikkurati, din l-inċidenza hija ta' madwar 19% (ara s-sezzjoni 4.2).
English: Do not
Maltese: FEJN MA
English: One bag containins autologous peripheral blood mononuclear cells activated with PAP-GM-CSF, including a minimum of 50 x 106 autologous CD54+ cells.
Maltese: Borża waħda fiha ċelloli mononukleari tad-demm periferali awtologu attivati bil-PAP-GM-CSF, inkluż minimu ta' 50 x 106 ċellola CD54+ awtologa.
English: Patients should be carefully evaluated to determine whether it is medically appropriate to discontinue immunosuppressive agents prior to treatment with Provenge (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu evalwati bir-reqqa biex jiġi stabbilit jekk huwiex medikament xieraq li jitwaqqfu l-aġenti immunosuppressivi qabel tingħata kura bi Provenge (ara s-sezzjoni 4.4).
English: The nature of Provenge is such that conventional studies on pharmacokinetics, absorption, distribution, metabolism, and elimination are not applicable.
Maltese: L-għamla ta' Provenge hija tali li l-istudji konvenzjonali fuq il-farmakokinetika, l-assorbiment, id-distribuzzjoni, il-metaboliżmu u l-eliminazzjoni mhumiex applikabbli.
English: Hyperhidrosis Pruritus Urticaria
Maltese: Fibrillazzjoni atrijali
English: In controlled clinical trials, 23.8% of patients treated with Provenge required opioids (a single dose of pethidine) on the day of infusion for infusion reactions (see sections 4.4 and 4.8).
Maltese: Fi provi kliniċi kkontrollati, 23.8% tal-pazjenti kkurati bi Provenge kienu jeħtieġu opjojdi (doża waħda ta' petidina) fil-jum tal-infużjoni għal reazzjonijiet għall-infużjoni (ara s-sezzjonijiet 4.4 u 4.8).
English: Some serious infections and sepsis were related to the use of central venous catheters (CVCs).
Maltese: Ċerti infezzjonijiet serji u sepsis kienu relatati mal-użu ta' katiters ġol-vini ċentrali (CVCs).
English: To establish and keep an observational EU-based registry of men with mCRPC to evaluate overall survival, the risk of ischemic stroke or myocardial infarction following treatment with Provenge and other identified and potential risks (observational study P13-1)
Maltese: Jistabbilixxi u jżomm reġistru ta' osservazzjoni bbażat fl-UE ta' rġiel b'mCRPC biex jevalwa s sopravivenza globali, ir-riskju ta' puplesija iskemika jew infart mijokardijaku wara l-kura bi Provenge u riskji oħra identifikati u riskji potenzjali (studju ta'
English: One bag contains autologous peripheral blood mononuclear cells activated with PAP-GM-CSF (prostatic acid phosphatase-granulocyte macrophage-colony stimulating factor), including a minimum of 50 x 106 autologous CD54+ cells
Maltese: Borża waħda fiha ċelloli mononukleari tad-demm periferali awtologu attivati bil-PAP-GM-SF (fattur li jistimula l-kolonja tal-makrofagu tal-phosphatase-granulocyte tal-aċidu prostatiku), inkluż minimu ta' 50 x 106 ċellola CD54+ awtologa.
English: CD54 is an adhesion and costimulatory molecule essential in the formation of the immunological synapse between an APC and a T cell.
Maltese: CD54 hija molekula tal-adeżjoni u kostimolanti essenzjali fis-sawra tas-sinapsi immunoloġika bejn
English: Prior to infusion, it must be confirmed that the patient's identity matches the essential unique patient information on the Provenge bag and on the Final Product Disposition Notification form (see sections 4.2 and 6.6).
Maltese: Qabel l-infużjoni, għandu jiġi kkonfermat li l-identità tal-pazjent taqbel mal informazzjoni essenzjali unika tal-pazjent fuq il-borża ta' Provenge u fuq il-formola ta' Notifika Finali għad-Dispożizzjoni tal-Prodott (ara s-sezzjonijiet 4.2 u 6.6).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Serious infections including sepsis have been observed in patients treated with Provenge.
Maltese: F'pazjenti kkurati bi Provenge ġew osservati infezzjonijiet serji inkluża sepsis.
English: PSA doubling time, the number of patients who develop metastatic disease, subsequent therapies received after diagnosis of metastatic disease, and efficacy parameters following subsequent therapies, including PSA progression, PSA progression-free survival, time to next line therapy, and overall survival.
Maltese: L-istudju għandu jipprovdi sommarju tal-karatteristiċi tal-pazjent fil linja bażi inkluż PSA u ż-żmien għall-irduppjar talPSA, in-numru ta' pazjenti li jiżviluppaw mard metastatiku, terapiji sussegwenti mogħtija wara ddijanjożi ta' mard metastatiku, u l-parametri tal effikaċja wara terapiji sussegwenti, li jinkludu l progressjoni tal-PSA, sopravivenza mingħajr progessjoni tal-PSA, iż-żmien għat-terapija li tmiss, u s-sopravivenza globali.
English: Provenge is designed to stimulate the immune system.
Maltese: Provenge huwa maħluq biex jistimula s-sistema immuni.
English: The most commonly reported adverse reactions are chills, fatigue, pyrexia, nausea, arthralgia, headache, and vomiting.
Maltese: L-iktar reazzjonijiet avversi rrapportati b'mod komuni huma dehxiet ta' bard, għeja, piressija, dardir, artralġija, uġigħ ta' ras u rimettar.
English: The IMPACT study was a randomised, double-blind, controlled, multicentre trial in patients with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer.
Maltese: L-istudju IMPACT kien prova aleatorja, bi blindaġġ doppju, ikkontrollata, multiċentrika f'pazjenti b'kanċer tal-prostata metastatiku asintomatiku jew minimament sintomatiku li hu reżistenti għallkastrazzjoni.
English: Acute infusion reactions
Maltese: Reazzjonijiet akuti għall-infużjoni
English: In controlled clinical trials, 23.8% of patients in the Provenge group required opioids (a single dose of pethidine) on the day of infusion for infusion reactions compared with 2.4% of patients in control group (see sections 4.2 and 4.4).
Maltese: Fi provi kliniċi kkontrollati, 23.8% tal-pazjenti fil-grupp ta' Provenge kienu jeħtieġu opjojdi (doża waħda ta' petidina) fil-jum tal-infużjoni għal reazzjonijiet għall-infużjoni meta mqabbel ma' 2.4% tal pazjenti fi grupp ikkontrollat (ara s-sezzjonijiet 4.2 u 4.4).
English: Hypertension Hypotension
Maltese: Artralġija
English: Arthralgia Myalgia Muscle spasms*
Maltese: Spażmi tal-muskoli*
English: As part of lot release, each product is assessed for activation of antigen presenting cells (APCs) by virtue of increased surface CD54 expression after culture with PAP-GM-CSF.
Maltese: Bħala parti mill-ħruġ tal-lott, kull prodott jiġi vvalutat għall-attivazzjoni ta' ċelloli li jippreżentaw antiġeni (APCs) permezz ta' espressjoni ta' CD54 tal-wiċċ miżjuda wara l-kultura b'PAP-GM-CSF.
English: Patients should be observed for at least 30 minutes following each infusion.
Maltese: Il-pazjenti għandhom jiġu osservati għal tal-inqas 30 minuta wara kull infużjoni.
English: Study D9901 was a randomised, double-blind, controlled, multicentre trial in patients with metastatic castrate resistant prostate cancer and no cancer-related pain.
Maltese: L-istudju D9901 kien prova aleatorja, bi blindaġġ doppju, ikkontrollata, b'aktar minn ċentru wieħed f'pazjenti b'kanċer tal-prostata metastatiku reżistenti għall-kastrazzjoni u mingħajr uġigħ relatat malkanċer.
English: Embolic and thrombotic events Provenge should be used with caution in patients with a history of embolic and thrombotic disorders.
Maltese: Avvenimenti emboliċi u trombotiċi Provenge għandu jintuża b'kawtela f'pazjenti li fl-imgħoddi kellhom disturbi emboliċi u trombotiċi.
English: Provenge is indicated for treatment of asymptomatic or minimally symptomatic metastatic (nonvisceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated.
Maltese: 4.1 Indikazzjonijiet terapewtiċi Provenge huwa indikat għall-kura tal-kanċer tal-prostata metastatiku (mhux vixxerali) reżistenti għall kastrazzjoni li hu asintomatiku jew minimament sintomatiku f'irġiel adulti li fihom il-kimoterapija għadha ma ġietx indikata klinikament.
English: In the post-marketing setting, serious acute infusion reactions involving hypotension and syncope have been reported.
Maltese: Wara t-tqegħid fis-suq, ġew irrapportati reazzjonijiet akuti severi għall-infużjoni li involvew pressjoni baxxa u sinkope.
English: There was a correlation between cellular or antibody responses to PAP or PAP-GM-CSF in the Provenge group and improved survival.
Maltese: Kien hemm korrelazzjoni bejn risponsi ċellulari jew tal-antikorp għal PAP jew PAP-GMCSF fil-grupp ta' Provenge u sopravivenza aħjar.
English: Therefore, patient leukapheresis material and Provenge may carry the risk of transmitting infectious viruses (HIV 1 and 2, hepatitis B and C) to healthcare professionals handling the product.
Maltese: Għaldaqstant, il-materjal tal-lewkafereżi talpazjent u Provenge jistgħu jġorru r-riskju li jgħaddu vajrusis infettużi (HIV 1 u 2, epatite B u Ċ) lil professjonisti fil-qasam tas-saħħa li jmissu l-prodott.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata, speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u rriskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: T cell proliferative and γIFN ELISPOT responses to PAP and
Maltese: Dan jinkludi mediċini miksuba mingħajr riċetta tat-tabib u mediċini erbali.
English: To conduct study P12-1 to evaluate characteristics predictive of a positive imaging study for distant metastases in patients with castrate-resistant prostate cancer.
Maltese: Iwettaq studju P12-1 biex jevalwa l-karatteristiċi mbassra minn studju ta' immaġini pożittiva għal metastasi distanti f'pazjenti b'kanċer tal-prostata
English: • Training completion form as agreed with the national competent authority
Maltese: • Il-formola ta' dispożizzjoni li tivverifika li l-prodott ġie APPROVAT ġiet ipprovduta
English: Summary of Product Characteristics (SmPC) 2.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (SmPC)
English: • high temperature, chills, breathing difficulties
Maltese: • temperatura għolja, dehxiet ta' bard, diffikultajiet fit-teħid tan-nifs
English: Provenge 50 x 106 CD54+ cells/250 mL dispersion for infusion
Maltese: Informazzjoni għall-pazjent Provenge 50 x 106 ċelloli CD54+/250 mL dispersjoni għal infużjoni
English: Visit 1 - Blood cell collection (leukapheresis)
Maltese: [HIV] - 1 u 2, ilvajrus limfotropiku taċ-ċellola-T umana
English: • tiredness
Maltese: Piressija
English: • shortness of breath, wheezing, dizziness, rash, or fever.
Maltese: • qtugħ ta' nifs, tħarħir, sturdament, raxx, jew deni.
English: Final study report by 31 December 2020
Maltese: Rapport tal-istudju finali sal31 ta' Diċembru 2020
English: Influenza-like illness Chest discomfort
Maltese: Disturbi fis-sistema nervuża Komuni ħafna
English: A third study, D9902A, similar in design to study D9901, was terminated prior to completion of planned accrual based on the time to disease progression results in study D9901.
Maltese: It-tielet studju, D9902A, simili fl-għamla għall-istudju D9901, twaqqaf qabel it-tlestija ppjanata fuq il-bażi tar-riżultati taż-żmien għall-progressjoni tal-marda fl-istudju D9901.
English: Patients with positive serology tests for human immunodeficiency virus [HIV] 1 and 2, human T cell lymphotropic virus [HTLV] 1, and hepatitis B and C were excluded from controlled clinical trials.
Maltese: Għaldaqstant, il-materjal tal-lewkafereżi tal-pazjent u Provenge jistgħu jġorru rriskju li jgħaddu vajrusis infettużi (vajrus tal-immunodefiċjenza tal-bniedem [HIV] 1 u 2, epatite B u Ċ) lil professjonisti fil-qasam tas-saħħa li jmissu l-prodott.
English: • Provenge is infused over a period of approximately 60 minutes through a large bore needle appropriate for transfusion of red blood cells.
Maltese: • Provenge huwa infuż fuq perjodu ta' madwar 60 minuta permezz ta' labra b'kanna kbira xierqa għat-trasfużjoni ta' ċelloli ħomor tad-demm.
English: If the infusion of Provenge must be interrupted, it should not be resumed if the infusion bag has been held at room temperature (25°C) for more than 3 hours (see section 6.3).
Maltese: Jekk trid titwaqqaf l-infużjoni ta' Provenge, din ma għandhiex tiġi ssoktata jekk il-borża ta' infużjoni tkun inżammet f'temperatura ambjentali (25°C) għal iktar minn 3 sigħat (ara s-sezzjoni 6.3).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INSULATED POLYURETHANE CONTAINER
Maltese: Wara t-tneħħija mill-kontenitur insulat
English: 0.331 c
Maltese: 0.586b (0.388, 0.884)
English: Tell your doctor after your Provenge treament if you get any symptoms of an infection, for example, a fever or high temperature above 38°C, chills, a fast heartbeat, fast breathing, dizziness on standing up, confusion or feeling/being sick.
Maltese: pereżempju, deni jew temperatura għolja iktar minn 38°C, dehxiet ta' bard, taħbit tal-qalb mgħaġġel, teħid tan-nifs mgħaġġel, sturdament meta tqum bil-wieqfa, konfużjoni jew tħossok/tkun ma tiflaħx.
English: Fertility Effect on male fertility is not known.
Maltese: Fertilità L-effett fuq il-fertilità tal-irġiel mhuwiex magħruf.
English: Citrate is generally the preferred anticoagulant used during leukapheresis and can result in hypocalcaemia.
Maltese: Ġeneralment, iċ-ċitrat huwa l-antikoagulant ippreferut użat matul il-lewkafereżi u jista' jirriżulta f'ipokalkemija.
English: • You are on a controlled sodium/potassium diet or you have reduced kidney function.
Maltese: • Qed issegwi dieta b'ammont ikkontrollat ta' kemm tieħu sodju/potassju jew għandek funzjoni tal-kliewiimnaqqsa.
English: Conventional toxicology, carcinogenicity, mutagenicity, and reproductive toxicity studies have not been performed.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Ma sarux studji konvenzjonali fuq it-tossikoloġija, il-karċinoġenità, il-mutaġeniċità, u t-tossiċità riproduttiva.
English: Provenge has not been investigated in patients with hepatic impairment.
Maltese: Provenge ma ġiex investigat f'pazjenti b'indeboliment renali.
English: If not used immediately, in-use storage times and conditions should not exceed 3 hours at room temperature (25°C).
Maltese: sigħat fit-temperatura ambjentali(25°C).
English: What Provenge looks like and contents of the pack Provenge is a slightly cloudy dispersion of cream-to-pink colour and is supplied in a plastic bag with 3 sample ports.
Maltese: Provenge huwa sospensjoni ftit imċajpra kulur il-krema sa roża u huwa pprovdut f'borża tal-plastik bi
English: No data are available for these patients.
Maltese: Data ta' Ska {JJ xahar SSSS}, Ħin ta' Ska.
English: The doses of paracetamol and antihistamine given should be in accordance with local practice.
Maltese: Id-dożi ta' paracetamol u antiħistamina mogħtija għandhom ikunu konformi mal-prattika lokali.
English: Cerebrovascular accident Transient ischaemic attack Tremor
Maltese: Aċċident ċerebrovaskulari Attakk iskemiku għaddieni Tregħid
English: Pharmaceutical Form Route of Administration
Maltese: Forma farmaċewtika
English: Strength
Maltese: Saħħa
English: EU number
Maltese: Numru tal-EMA
English: It is available as tablets (375 mg).
Maltese: Jiġi f'pilloli (375 mg).
English: The full EPAR for Incivo 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: Incivo is a medicine that contains the active substance telaprevir.
Maltese: Incivo huwa mediċina li fiha s-sustanza attiva telaprevir.
English: The active substance in Incivo, telaprevir, is a protease inhibitor.
Maltese: Is-sustanza attiva f'Incivo, it-telaprevir, hija inibitur tal-proteażi.
English: This is a summary of the European public assessment report (EPAR) for Incivo.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Incivo.
English: The most common side effects with Incivo (seen in more than 1 patient in 10) are anaemia (low red blood cell counts), nausea (feeling sick), diarrhoea, vomiting, haemorrhoids (piles), proctalgia (anal pain), pruritus (itching) and rash.
Maltese: L-effetti sekondarji l-aktar komuni b'Incivo (li dehru f'aktar minn pazjent 1 minn kull 10) kienu anemija (għadd baxx taċ-ċelloli ħomor tad-demm), nawżja (tħossok ma tiflaħx), dijarea, rimettar, murliti, proktalġja (uġigħ anali), prurite (ħakk) u raxx.
English: Incivo was investigated in three main studies in patients infected with hepatitis C. The first study involved 1,095 previously untreated patients, and the second study involved 663 patients who had already been treated with peginterferon alfa and ribavirin but were still infected.
Maltese: Fl-ewwel studju ħadu sehem 1,095 pazjent li ma kinux ingħataw kura preċedenti, u fit-tieni studju ħadu sehem 663 pazjent li kienu diġà rċevew kura bil-peginterferonu alfa u bir-ribavirina u li xorta baqgħu infettati.
English: How does Incivo work?
Maltese: Kif jaħdem Incivo?
English: What measures are being taken to ensure the safe use of Incivo?
Maltese: X'miżuri qed jittieħdu biex jiġi assigurat l-użu sigur ta' Incivo?
English: In the second study, 88% of patients receiving Incivo for three months tested negative for hepatitis C compared with 24% of patients receiving placebo.
Maltese: Fit-tieni studju, 88% talpazjenti li ngħataw Incivo tul tliet xhur kellhom riżultat negattiv għall-epatite Ċ apparagun ma' 24% tal-pazjenti li kienu qegħdin jingħataw plaċebo.
English: In the first study, when Incivo was given for three months, 75% of patients tested negative for hepatitis C compared with 44% of patients receiving placebo.
Maltese: Fl-ewwel studju, meta Incivo ingħata tul tliet xhur, 75% tal-pazjenti kellhom riżultat negattiv għallepatite Ċ apparagun ma' 44% tal-pazjenti li kienu qegħdin jingħataw plaċebo.
English: Incivo is used to treat chronic (long term) hepatitis C (a disease of the liver due to infection with the hepatitis C virus) in combination with two other medicines, peginterferon alfa and ribavirin.
Maltese: Incivo jintuża fil-kura tal-epatite Ċ (marda tal-fwied minħabba infezzjoni bil-virus tal-epatite Ċ) kronika (fit-tul) flimkien ma' żewġ mediċini oħra, il-peginterferonu alfa u r-ribavirina.