FrancophonIA/ELRC3.0 huggingface dataset:
English: Two hundred seventeen (217) patients 65 years and older received belatacept across one Phase 2 and two Phase 3 renal studies.
Maltese: Mitejn u sbatax (217)-il pazjent ta' 65 sena u aktar irċivew belatacept fi studju wieħed ta' Fażi 2 u żewġ studji tal-kliewi ta' Fażi 3.
English: Common renal tubular necrosis, renal vein thrombosis*, renal artery stenosis, glycosuria, hydronephrosis, vesicoureteric reflux, urinary incontinence, urinary retention, nocturia
Maltese: Ħafna proteinurja, żieda fil-krejatinina tad-demm, diżurja, ematurja Komuni nekrożi tubulari tal-kliewi, trombożi tal-vini tal-kliewi*, stenożi tal-arterja talkliewi, glajkosurja, idronefrożi, rifluss vesikoureteriku, inkontinenza urinarja, żamma urinarja, nokturja
English: The overall proportion of patients with death or graft loss was lower in belatacept-treated patients (MI: 11.4%, LI: 11.9%) as compared to ciclosporin-treated patients (17.6%) in Study 1.
Maltese: 4%, LI: 11.9%) meta mqabbel ma' pazjenti kkurati b'ciclosporin (17.6%) fi Studju 1.
English: Tests may show:
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Muscle pain, muscle weakness, bone pain, joint swelling, abnormal cartilage between bones of the spine, sudden inability to bend joint, muscle spasms, arthritis Blockage of kidney blood vessels, enlarged kidney due to blockage of urine flow out of the kidney, backflow of urine from the bladder into the kidney tubes, inability to hold urine, incomplete emptying of the bladder, urinating at night, sugar in the urine Increase in body weight, decrease in body weight Cataract, increased blood congestion in the eye, blurred vision Shaking or tremors, dizziness, fainting or passing out, ear pain, buzzing, ringing or other persistent noise in the ears
Maltese: Fluwidu fil-pulmuni, tħarħir, uġigħ fis-sider, uġigħ fil-gerżuma Infezzjoni tad-demm jew tat-tessut, infezzjonijiet respiratorji, pulmonite, influwenza, infjammazzjoni tas-sinus, imnieħer inixxi, griżmejn xotti, uġigħ fir-reġjun tal-ħalq/griżmejn, infezzjonijiet tal-virus tal-ħerpes, ħruq ta' Sant'Antnin u infezzjonijiet virali oħrajn, feriti fil-ħalq, ‘thrush', infezzjoni fil-kliewi, infezzjonijiet fungali tal-ġilda, infezzjonijiet fungali tad-dwiefer u infezzjonijiet fungali oħra, infezzjoni tal-ġilda, infezzjoni tat-tessut artab, infezzjoni fil-ferita, infezzjoni limitata għal żona waħda, fejqan bil-mod, tbenġil imdemmi, akkumulazzjoni ta' fluwidu tal-limfa madwar il-kilwa ttrapjantata
English: These studies compared two dose regimens of belatacept (MI and LI) with ciclosporin in recipients of standard criteria (Study 1) or extended criteria (Study 2) donor organs.
Maltese: Dawn l-istudji pparagunaw żewġ korsijiet ta' dożi ta' belatacept (MI u LI) ma' ciclosporin f'pazjenti li rċivew organi minn donaturi ta' kriterji standard (Studju 1) jew kriterji estiżi (Studju 2).
English: Any malignant neoplasm Non-melanoma skin cancer Malignant neoplasms excluding nonmelanoma skin cancers
Maltese: Kanċer tal-ġilda mhux melanoma Neoplażmi malinni għajr kanċers tal-ġilda mhux melanoma PTLD
English: Study 2 excluded recipients with a current PRA ≥ 30%, re-transplanted patients, and in case of a positive T-cell lymphocytotoxic cross match.
Maltese: Studju 2 eskluda riċevituri b'PRA attwali ≥ 30%, pazjenti bi trapjant mill-ġdid, u fil-każ ta' ċellola T pożittiva, tqabbil limfoċitotossiku trasversali.
English: Infusion-related reactions Anaphylaxis has been reported post marketing(see section 4.4).
Maltese: Reazzjonijiet relatati mal-infużjoni Ġiet irrappurtata anafilassi wara t-tqegħid fis-suq (ara sezzjoni 4.4).
English: In a clinical study, approximately 90% saturation of CD86 receptors on the surface of antigenpresenting cells in the peripheral blood was observed following the initial administration of belatacept.
Maltese: Fi studju kliniku, kienet osservata saturazzjoni ta' madwar 90% tar-riċetturi ta' CD86 fuq il-wiċċ taċċelluli li jippreżentaw antiġens fid-demm periferali wara l-għoti inizjali ta' belatacept.
English: After reconstitution, each ml of concentrate contains 25 mg belatacept.
Maltese: Wara r-rikostituzzjoni, kull ml ta' konċentrat ikun fih 25 mg ta' belatacept.
English: Cases of PTLD varied by serostatus.
Maltese: Il-każijiet ta' PTLD varjaw skont is-serostatus.
English: Respiratory, thoracic and mediastinal disorders Very Common dyspnoea, cough Common pulmonary oedema, wheezing, hypocapnea, orthopnoea, epistaxis, oropharyngeal pain
Maltese: klawdikazzjoni intermittenti, fwawar Disturbi respiratorji, toraċiċi u medjastinali Komuni Ħafna dispneja, sogħla Komuni edema pulmonari, tħarħir, ipokapnea, ortopnea, epistassi, uġigħ orofarinġeali
English: Concomitant use with other immunosuppressive agents Belatacept has been administered with the following immunosuppressive agents in clinical studies: basiliximab, an MPA and corticosteroids.
Maltese: L-użu fl-istess ħin ma' sustanzi immunosuppressivi oħrajn Fi studji kliniċi belatacept ingħata mas-sustanzi immunosuppressivi li ġejjin: basiliximab, MPA u kortikosterojdi.
English: Of the 1209 randomized and transplanted patients in the two Phase 3 studies (see section 5.1), 761 patients continued after Year 3 in a long-term extension period for up to an additional 4 years and continued to receive the study drug according to their original treatment assignment.
Maltese: Mill-1209 pazjenti randomizzati u trapjantati fiż-żewġ studji ta' Fażi 3 (ara sezzjoni 5.1), 761 pazjent komplew wara
English: GFRb ml/min/1.73 m2 Year 1
Maltese: Fi Studju 2 sa Sena 3, il-GFR medja kkalkulata kienet ta' 11 ml/min/1.73
English: Because of the risk of a high total burden of immunosuppression, belatacept should only be used in these patients after consideration of alternative therapy (see section 4.4).
Maltese: Minħabba r-riskju ta' piż totali għoli ta' immunosuppressjoni, belatacept għandu jintuża biss f'dawn il-pazjenti wara kunsiderazzjoni ta' terapija alternattiva (ara sezzjoni 4.4).
English: Serious infections can include Tuberculosis Cytomegalovirus (CMV), a virus that can cause serious tissue and blood infections Shingles Other herpes virus infections.
Maltese: Infezzjonijiet serji jistgħu jinkludu Tuberkolożi Ċitomegalovirus (CMV), virus li jista' jikkawża infezzjonijiet serji fit-tessuti u d-demm Ħruq ta' Sant'Antnin Infezzjonijiet oħra mill-virus tal-herpes.
English: Study 1 and 2: Phase 3 studies in renal transplant recipients The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Maltese: Studju 1 u 2: Studji ta' Fażi 3 f'pazjenti li rċivew trapjant tal-kliewi Is-sigurtà u l-effikaċja ta' belatacept bħala parti minn kors immunosoppressiv wara trapjant tal-kliewi ġew evalwati f'żewġ studji li fihom il-pazjenti ntgħażlu b'mod każwali, tat-tip partially-blinded, multiċentriċi, ta' 3 snin bil-punt tat-tmiem primarju speċifikat wara f'Sena 1.
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Maltese: NULOJIX 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni belatacept
English: More patients discontinued in the ciclosporin group (32.4%) versus each belatacept group (17.4% and 18.1% in MI and LI groups, respectively) during the long-term extension period.
Maltese: Aktar pazjenti waqfu fil-grupp ta' ciclosporin (32.4 %) meta mqabbel ma' kull grupp ta' belatacept (17.4 % u 18.1 % fil-gruppi
English: Graft thrombosis
Maltese: Fażi tal-bidu
English: Anaphylaxis has been reported during post marketing surveillance (see section 4.8).
Maltese: Matul is-sorveljanza ta' wara t-tqegħid fis-suq, ġiet irrappurtata anafilassi (ara sezzjoni 4.8).
English: NULOJIX should be administered in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.
Maltese: NULOJIX għandu jingħata flimkien ma' induzzjoni għal basiliximab, mycophenolate mofetil, u kortikosterojdi.
English: Belatacept appears not to have any relevant direct effects on cytokine levels in liver transplant recipients or in healthy volunteers.
Maltese: Belatacept jidher li ma għandu lebda effetti diretti rilevanti fuq il-livelli ta' cytokine f'persuni li jirċievu trapjant tal-fwied jew f'voluntiera b'saħħithom.
English: Eye disorders Common cataract, ocular hyperaemia, vision blurred
Maltese: Disturbi fl-għajnejn Komuni katarretti, iperemija okulari, vista mċajpra
English: Guillian-Barré syndrome (a condition that causes muscle weakness or paralysis) EBV (Epstein-Barr virus) lymphoproliferative disease Blood clotting in veins, inflamed veins, periodic leg cramps Abnormal arteries, scarring of the arteries, clotting in the arteries, narrowing of the arteries, temporary redness of the face/skin, swelling of the face Stones in the gallbladder, fluid filled pocket in the liver, fatty liver Skin disease with thickened patches of red skin, often with silvery scales, abnormal hair growth, excessive hair breakage, nails breaking, ulcer on the penis Abnormal balance of minerals in the body causing bone problems, bone inflammation, abnormal weakening of the bone leading to bone problems, inflammation of the lining of the joints, rare bone condition
Maltese: Fluss tad-demm batut lejn il-qalb, taħbit tal-qalb imblokkat, valv tal-qalb tal-aorta mblokkat, valv tal-qalb tal-aorta anormali, rata tal-qalb rapida b'mod anormali Problemi f'daqqa fit-teħid tan-nifs li jwasslu għal ħsara fil-pulmun, żieda fil-pressjoni tad-demm fil-pulmuni, infjammazzjoni tal-pulmuni, sogħla bid-demm, anormalità tal-pulmuni u tubi tal-arja li jwasslu l-arja 'l ġewwa jew 'il barra mill-pulmuni, fluwidu fil-borża madwar il-pulmuni, teħid tan-nifs li jieqaf temporanjament matul l-irqad, ħoss anormali waqt li wieħed jitkellem Herpes ġenitali
English: NAME OF THE MEDICINAL PRODUCT NULOJIX 250 mg powder for concentrate for solution for infusion
Maltese: NULOJIX 250 mg trab għall-konċentrat għal soluzzjoni għall-infużjoni
English: Uncommon hypogammaglobulinaemia, seasonal allergy Endocrine disorders
Maltese: Mhux Komuni ipogammaglobulinamija, allerġija staġjonali
English: Special caution should be exercised in patients with a history of allergic reactions to belatacept or to any of the excipients.
Maltese: Fl-istudji kliniċi ġew irrapportati reazzjonijiet allerġiċi relatati mal-użu ta' belatacept.
English: The Year 3 frequency of malignant neoplasms, excluding non-melanoma skin cancers, was similar in the belatacept LI and ciclosporin groups and higher in the belatacept MI group.
Maltese: Il-frekwenza ta' Sena 3 ta' neoplażmi malinni, għajr kanċer tal-ġilda mhux melanoma, kienet simili fil-gruppi ta' belacept LI u ciclosporin u ogħla fil-grupp ta' belatacept MI. PTLD seħħet b'rata ogħla fiż-żewġ gruppi ta' kura ta' belatacept meta mqabbel ma' ciclosporin (ara sezzjoni 4.4).
English: Uncommon cholelithiasis, hepatic cyst, hepatic steatosis Skin and subcutaneous tissue disorders Common acne, pruritis, alopecia, skin lesion, rash, night sweats, hyperhidrosis
Maltese: Mhux Komuni kolelitjażi, ċista epatika, steatożi epatika Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Komuni akne, prurite, alopeċja, leżjonijiet tal-ġilda, raxx, għaraq matul il-lejl, iperidrożi
English: In postmarketing experience, use of belatacept in conjunction with basiliximab induction, mycophenolate mofetil and corticosteroid taper to 5 mg/day by Week 6 post-transplant was associated with an increased rate of acute rejection, particularly Grade III rejection.
Maltese: Flesperjenza ta' wara t-tqegħid fis-suq, l-użu ta' belatacept flimkien ma' induzzjoni ta' basiliximab, mycophenolate mofetil u t-twaqqif gradwali ta' kortikosterojdi għal 5 mg/jum sa ġimgħa 6 wara ttrapjant ġie assoċjat ma' żieda fir-rata ta' rifjut akut, partikularment rifjut ta' Grad III.
English: Lung cancer, rectal cancer, breast cancer, a form of cancer in the bones, musles, or fat tissue, tumor of the skin and intestinal tract caused by a herpes virus and seen in patients with a weakened immune system, prostate cancer, cancer of the cervix, throat cancer, cancer of the lymph nodes, cancer of the bone marrow, cancer of the kidney, kidney tubes, or bladder Fungal infection of brain, inflammation of the brain, serious brain infection called PML (progressive multifocal leukoencephalopathy)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) huma: kanċer tal-pulmun, kanċer rektali, kanċer tas-sider, forma ta' kanċer fl-għadam, muskoli, jew tessut xaħmi, tumur tal-ġilda u tal-passaġġ intestinali kkawżat minn virus tal-ħerpes u li jidher f'pazjenti b'sistema immuni mdgħajfa, kanċer tal-prostata, kanċer tal-għonq tal-utru, kanċer talgerżuma, kanċer tan-nodi tal-limfa, kanċer tal-mudullun tal-għadam, kanċer tal-kliewi, tubi talkliewi, bużżieqa tal-awrina
English: Activated T cells are the predominant mediators of immunologic response to the transplanted kidney.
Maltese: Iċċelluli T attivati huma l-medjaturi prinċipali tar-rispons immunoloġiku għall-kilwa trapjantata.
English: The accumulation index for belatacept at steady state is 1.1.
Maltese: L-indiċi ta' akkumulazzjoni għal belatacept fl-istat fiss huwa ta' 1.1.
English: This will avoid aggregate formation (see section 6.2).
Maltese: Dan jevita l-formazzjoni ta' frak (ara sezzjoni 6.2).
English: NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Maltese: NULOJIX ma ġiex studjat fi tfal u adoloxxenti taħt it-18-il sena, u għalhekk mhuwiex irrakkomandat f'dan il-grupp ta' etajiet.
English: In Study 2, 9/33 belatacept and 5/29 ciclosporin acute rejections were Banff 97 grade ≥ IIb by Year 3.
Maltese: Fi Studju 1, 11/39 rifjut akut b'belatacept u 3/21 rifjut akut b'ciclosporin kienu grad Banff 97 ≥ IIb sa Sena 3. Fi Studju 2, 9/33 rifjut akut b'belatacept u 5/29 rifjut akut b'ciclosporin kienu grad Banff 97 ≥ IIb sa Sena 3. AR ġie kkurat aktar ta' sikwit b'terapija li tnaqqas il-limfoċiti (fattur ta' riskju għal PTLD; ara sezzjoni 4.4) fil-grupp li ħa belatacept milli fil-grupp li ħa ciclosporin.
English: Among Study 2 patients who were EBV seronegative at the time of transplant (for whom use of belatacept is not recommended), there were three cases of PTLD in the belatacept LI group, and none in the belatacept MI and ciclosporin groups.
Maltese: Fost il-pazjenti ta' Studju 2 li kienu seronegattivi għall-EBV fil-ħin tat-trapjant (li għalihom ma kienx irrakkomandat l-użu ta' belatacept), kien hemm tliet każijiet ta' PTLD fil-grupp ta' belatacept LI, u l-ebda każ fil-gruppi ta' belatacept MI u ciclosporin.
English: Table 4: Infections occurring by treatment group (%)
Maltese: Tabella 4: Infezzjonijiet li seħħew skont il-grupp ta' kura (%)
English: The increased incidence of lymphomas and mammary tumours observed in mice treated with abatacept may have been associated with decreased control of murine leukaemia virus and mouse mammary tumour virus, respectively, in the presence of long-term immunomodulation.
Maltese: Il-profil ta' reazzjonijiet avversi assoċjat ma' sustanzi immunosuppressivi huwa spiss diffiċli biex jiġi stabbilit minħabba l-marda bażika u l-użu fl-istess ħin ta' prodotti mediċinali multipli.
English: However, immunogenicity rate normalised for duration of exposure was consistent at 2.0 to 2.1 per 100 patient years among the three studies.
Maltese: Madankollu, ir-rata tal-immunoġeniċità innormalizzat għaliex it-tul tal-espożizzjoni kien konsistenti f'minn 2.0 sa 2.1 għal kull 100 sena ta' pazjenti fost ittliet studji.
English: Package leaflet: Information for the user NULOJIX 250 mg powder for concentrate for solution for infusion belatacept
Maltese: Informazzjoni għall-utent NULOJIX 250 mg trab għall-konċentrat għal soluzzjoni għal infużjoni belatacept
English: The full EPAR and risk management plan summary for Exviera 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: Other information about Exviera
Maltese: Informazzjoni oħra dwar Exviera
English: This is a summary of the European public assessment report (EPAR) for Exviera.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Exviera.
English: Why is Exviera approved?
Maltese: Għaliex ġie approvat Exviera?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exviera on 15 January 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Exviera fil-15 ta' Jannar 2015.
English: The active substance in Exviera, dasabuvir, works by blocking the action of an enzyme in the hepatitis C virus called ‘NS5B RNA-dependent polymerase', which the virus needs to multiply.
Maltese: Is-sustanza attiva f'Exviera, id-dasabuvir, taħdem billi timblokka l-azzjoni ta' enzima fil-virus talepatite Ċ imsejħa ‘NS5B polimerażi dipendenti fuq RNA', li l-virus għandu bżonn biex jimmultiplika.
English: Several varieties (genotypes) of hepatitis C virus exist and Exviera is recommended for use in patients with virus of genotypes 1a and 1b.
Maltese: Jeżistu diversi varjetajiet (ġenotipi) tal-virus tal-epatite Ċ u Exviera huwa rrakkomandat għall-użu f'pazjenti bil-virus tal-ġenotipi 1a u 1b.
English: What are the risks associated with Exviera?
Maltese: X'inhuma r-riskji assoċjati ma' Exviera?
English: In a seventh study, patients with liver scarring but stable liver function (compensated cirrhosis) who had genotype 1b infection were treated with Exviera and Viekirax without ribavirin and 100% of patients (60 out of 60 patients) had their blood cleared of the virus.
Maltese: Fis-seba' studju, pazjenti b'ċikatriċi tal-fwied iżda b'funzjoni stabbli tal-fwied (ċirrożi kkumpensata) li kellhom l-infezzjoni tal-ġenotip 1b ġew ikkurati b'Exviera u Viekirax mingħajr ribavirin u 100% tal-pazjenti (60 minn 60 pazjent) tneħħielhom il-virus mid-demm.
English: Exviera is available as 250 mg tablets, and the recommended dose is two tablets a day, one in the morning and one in the evening for 8, 12 or 24 weeks.
Maltese: Exviera jiġi bħala pilloli ta' 250 mg, u d-doża rrakkomandata hija żewġ pilloli kuljum, waħda filgħodu u waħda filgħaxija għal 8 ġimgħat, 12-il ġimgħa jew 24 ġimgħa.
English: Exviera is always used in combination with another medicine, Viekirax, which contains the active substances ombitasvir, paritaprevir and ritonavir.
Maltese: Exviera dejjem jintuża flimkien ma' mediċina oħra, Viekirax, li fiha s-sustanzi attivi ombitasvir, paritaprevir u ritonavir.
English: In 6 initial main studies involving around 2,300 patients infected with hepatitis C virus genotypes 1a or 1b, Exviera in combination with Viekirax was effective in clearing the virus from the blood.
Maltese: F'6 studji ewlenin tal-bidu li involvew madwar 2,300 pazjent infettati bil-virus tal-epatite Ċ tal-ġenotipi 1a jew 1b, Exviera flimkien ma' Viekirax kien effettiv fit-tneħħija tal-virus mid-demm.
English: In patients with liver scarring, Exviera treatment in combination with Viekirax and ribavirin resulted in a clearance rate of between 93% and 100% after 24 weeks of treatment.
Maltese: F'pazjenti b'ċikatriċi tal-fwied, kura b'Exviera flimkien ma' Viekirax u ribavirin irriżultat f'rata ta' tneħħija ta' bejn 93% u 100% wara 24 ġimgħa ta' kura.
English: The most common side effects with Exviera when used with Viekirax and ribavirin (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), nausea, pruritus (itching), asthenia (weakness) and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Exviera meta użat ma' Viekirax u ribavirin (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma insomnija (diffikultà fl-irqad), nawżja, prurite (ħakk), astenija (dgħjufija) u għeja.
English: Between 96% and 100% of patients without liver scarring had their blood cleared of the virus after 12 weeks of treatment (with or without ribavirin).
Maltese: Bejn 96% u 100% tal-pazjenti mingħajr ċikatriċi tal-fwied tneħħilhom il-virus mid-demm wara 12-il ġimgħa ta' kura (b'ribavirin jew mingħajru).
English: Exviera is an antiviral medicine used in combination with other medicines to treat adults with chronic (long-term) hepatitis C, an infectious disease of the liver caused by the hepatitis C virus.
Maltese: Exviera huwa mediċina antivirali li tintuża flimkien ma' mediċini oħrajn biex tikkura adulti b'epatite Ċ kronika (fit-tul), marda infettiva tal-fwied ikkawżata mill-virus tal-epatite Ċ.
English: Some patients taking Exviera are also treated with another antiviral medicine, ribavirin, in addition to Viekirax.
Maltese: Xi pazjenti li jieħdu Exviera jiġu kkurati wkoll b'mediċna antivirali oħra, ribavirin, apparti Viekirax.
English: The clearance rate was particularly high in patients infected with genotype 1b.
Maltese: Ir-rata ta' tneħħija kienet partikolarment għolja f'pazjenti infettati bil-ġenotip 1b.
English: The combination of medicines used and the duration of treatment will depend on which genotype of hepatitis C virus the patient is infected with, the nature of the liver problems they have (for example, if they have liver cirrhosis (scarring) or their liver is not working properly) and whether they have received previous treatment.
Maltese: Il-kombinazzjoni ta' mediċini li jintużaw u t-tul tal-kura se jiddependu mill-ġenotip tal-virus tal-epatite Ċ li bih il-pazjent huwa infettat, n-natura tal-problemi tal
English: Regarding its safety, although there were some cases of raised liver enzymes in patients treated with Exviera in combination with Viekirax and ribavirin, side effects seen with this combination were generally well tolerated.
Maltese: Fir-rigward tas-sigurtà, għalkemm kien hemm każijiet ta' enzimi fil-fwied għoljin f'pazjenti kkurati b'Exviera flimkien ma' Viekirax u ribavirin, l-effetti sekondarji li dehru b'din il-kombinazzjoni kienu ġeneralment ittollerati sew.
English: The company that markets Exviera will carry out a study in patients who previously have had liver cancer to evaluate the risk of liver cancer returning after treatment with direct-acting antivirals such as
Maltese: Il-kumpanija li tqiegħed Exviera fis-suq se twettaq studju fuq pazjenti li fil-passat kellhom kanċer filfwied sabiex tevalwa r-riskju li l-kanċer fil-fwied jirritorna wara kura b'antivirali b'azzjoni diretta bħal Exviera.
English: The European Medicines Agency noted that Exviera used in combination with Viekirax is effective in clearing the hepatitis C virus genotypes 1a and 1b from the blood with and without ribavirin.
Maltese: L-Aġenzija Ewropea għall-Mediċini nnotat li Exviera, meta użat flimkien ma' Viekirax huwa effettiv biex ineħħi l-virus tal-epatite Ċ tal-ġenotipi 1a u 1b mid-demm bir-ribavirin u mingħajru.
English: How does Exviera work?
Maltese: X'inhuma l-benefiċċji ta' Exviera li ħarġu mill-istudji?
English: Exviera.
Maltese: Kif jintuża Exviera?
English: EMA/32008/2016 EMEA/H/C/000348
Maltese: EMA/172925/2016 EMA/H/C/000348
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom f'ċirkostanzi ta' theddida għal ħajja.
English: The full EPAR for Nonafact 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: Other information about Nonafact
Maltese: Informazzjoni oħra dwar Nonafact
English: This is a summary of the European public assessment report (EPAR) for Nonafact.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Nonafact.
English: Nonafact human coagulation factor IX
Maltese: Nonafact fattur IX ta' koagulazzjoni tal-bniedem