FrancophonIA/ELRC3.0 huggingface dataset:
English: As reported in the literature, the PD-1/PD-L1 pathway plays a central role in preserving pregnancy by maintaining maternal immune tolerance to the foetus, and in mouse allogeneic pregnancy models disruption of PD-L1 signalling was shown to result in an increase in foetal loss.
Maltese: Kif irrappurtat fil-letteratura, il-passaġġ ta' PD1/PDL1 għandu rwol ċentrali biex jippreserva t-tqala billi jżomm tolleranza immuni materna għall-fetu, u f'mudelli ta' tqala alloġeniċi tal-ġurdien, it-tfixkil ta' sinjalazzjoni ta' PDL1 intwera li jirriżulta f'żieda fit-telf tal-fetu.
English: • infections of the upper respiratory tract
Maltese: • infezzjonijiet tal-parti ta' fuq tal-passaġġ respiratorju
English: Initiate 2 to 4 mg/kg/day prednisone or equivalent followed by a taper
Maltese: Ibda 2 sa 4 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali
English: The safety of IMFINZI (10 mg/kg) has been evaluated in the PACIFIC Study (n = 475) in patients with locally advanced, unresectable NSCLC who had completed treatment with at least 2 cycles of concurrent chemoradiation within 1 to 42 days prior to initiation of the study.
Maltese: Is-sigurtà ta' IMFINZI (10 mg/kg) ġiet evalwata fl-Istudju PACIFIC (n = 475) f'pazjenti b'NSCLC lokalment avvanzat, li ma jistax jitenħħa b'kirurġija li jkunu temmew kura b'mill-inqas 2 ċikli ta' kemoradjazzjoni konkurrenti fi żmien jum sa 42 jum qabel il-bidu tal-istudju.
English: All Patients
Maltese: TA' EĊĊIPJENTI
English: Cardiac disorders Myocarditis
Maltese: Disturbi fil-qalb Mijokardite
English: It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed.
Maltese: Huwa rrakkomandat li tkompli bil-kura għal pazjenti li huma klinikament stabbli b'evidenza inizjali ta' progressjoni tal-marda sakemm il-progressjoni tal-marda tiġi kkonfermata.
English: May consider pre-medications for prophylaxis of subsequent infusion reactions
Maltese: Tista' tikkunsidra premedikazzjonijiet għal profilassi ta' reazzjonijiet tal-infużjoni sussegwenti
English: Immune-mediated pneumonitis/interstitial lung disease
Maltese: Pulmonite medjata missistema immuni/marda tal-pulmun interstizjali
English: k includes colitis, enteritis, enterocolitis, and proctitis.
Maltese: k tinkludi kolite, enterite, enterokolite u proktite.
English: The PK of durvalumab was studied in 1902 patients with solid tumours with doses ranging from 0.1 to 20 mg/kg administered intravenously once every two, three or four weeks.
Maltese: Il-PK ta' durvalumab ġiet studjata f'1902 pazjenti b'tumuri solidi b'dożi li jvarjaw minn 0.1 sa 20 mg/kg mogħtija ġol-vini darba kull ġimagħtejn, tliet jew erba' ġimgħat.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated nephritis occurred in 3 (0.2%) patients, including Grade 3 in 1 (< 0.1%) patient.
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, nefrite medjata mis-sistema immuni seħħet fi 3 (0.2%) pazjenti, inkluż Grad 3 f'pazjent 1 (<0.
English: For non-immune-mediated adverse reactions, consider withholding IMFINZI for Grade 2 and 3 adverse reactions until ≤ Grade 1 or baseline.
Maltese: Għal reazzjonijiet avversi mhux medjati mill-immunità, ikkunsidra s-sospensjoni ta' IMFINZI għal reazzjonijiet avversi ta' Grad 2 u 3 sakemm ≤ Grad 1 jew linja bażi.
English: Randomisation was stratified by gender, age (< 65 years vs. ≥ 65 years) and smoking status (smoker vs. non-smoker).
Maltese: Ir-randomizzazzjoni ġiet stratifikata permezz tas-sess, l-età (< 65 sena kontra ≤ 65 sena) u l-istatus tattipjip (min ipejjep kontra min ma jpejjipx).
English: Immune-mediated rash or dermatitis
Maltese: Raxx jew dermatite medjata mis-sistema immuni
English: Immune-mediated type 1 diabetes mellitus
Maltese: Dijabete mellitus tattip 1 medjata mis-sistema immuni
English: Patients had completed at least 2 cycles of definitive platinum-based chemotherapy with radiation therapy within 1 to 42 days prior to initiation of the study and had a ECOG performance status of 0 or 1.
Maltese: Il-pazjenti kienu temmew tal-inqas 2 ċikli ta' kimoterapija bbażata fuq il-platinu definittiva b'terapija ta' radjazzjoni fi żmien 1 sa 42 jum qabel il-bidu tal-istudju u kellom status tal-prestazzjoni ECOG ta' 0 jew 1.
English: Initiate 1 to 2 mg/kg/day prednisone or equivalent followed by a taper
Maltese: Ibda 1 sa 2 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali
English: Sixteen of the 31 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day).
Maltese: Dan il-pazjent 1 irċieva kura b'kortikosterojdi ta' doża għolja (tal-inqas 40 mg prednisone jew ekwivalenti kuljum) u IMFINZI ma twaqqafx.
English: One ml of concentrate contains 50 mg of durvalumab.
Maltese: ml wieħed tal-konċentrat fih 50 mg ta' durvalumab.
English: IMFINZI should be permanently discontinued for recurrent Grade 3 or 4 (severe or life-threatening) immune-mediated adverse reactions.
Maltese: IMFINZI għandu jitwaqqaf b'mod permanenti għal reazzjonijiet avversi medjati mill-immunità rikorrenti ta' Grad 3 jew 4 (severi jew ta' theddida għall-ħajja).
English: IMFINZI will be given to you in a hospital or clinic and the healthcare professional will be responsible for its storage.
Maltese: Wara dan, IMFINZI jista' jitkompla abbażi ta' ġudizzjoni kliniku.
English: Negligible levels of durvalumab was found in milk of cynomolgous monkey on Day 28 after birth.
Maltese: Instabu livelli negliġibbli ta' durvalumab fil-ħalib tax-xadina cynomolgous f'Jum 28 wara t-twelid.
English: PD-L1 can be induced by inflammatory signals (e.g., IFN-gamma) and can be expressed on both tumour cells and tumour-associated immune cells in tumour microenvironment.
Maltese: PDL1 tista' tiġi indotta permezz ta' sinjali infjammatorji (eż., IFNgamma) u tisa' tiġi espressa kemm fuq iċ-ċelluli tat-tumur kif ukoll ċelluli immuni assoċjati mat-tumur f'mikroambjent tat-tumur.
English: Immune-mediated hypothyroidism and hyperthyroidism (including thyroiditis) should be managed as recommended in section 4.2.
Maltese: Ipotirojdiżmu u ipertirojdiżmu medjat mis-sistema immuni (inkluż tirojdite) għandhom jiġu mmaniġġjati kif irrakkomandat f'sezzjoni 4.2.
English: Immune-mediated nephritis
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Resolution occurred for 27 patients in the IMFINZI treated group vs 6 in placebo.
Maltese: Ir-riżoluzzjoni seħħet għal 27 pazjent fil-grupp ikkurat b'IMFINZI kontra 6 f'talplaċebo.
English: The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' IMFINZI fit-tfal u adolexxenti taħt it-18-il sena għadhom ma ġewx determinati s'issa.
English: However, systemic corticosteroids or other immunosuppressants can be used after starting durvalumab to treat immune-related adverse reactions (see section 4.4).
Maltese: Madankollu, il-kortikosterojdi sistemiċi jew immunosoppressanti oħra jistgħu jintużaw wara l-bidu ta' durvalumab biex jiġu kkurati reazzjonijiet avversi relatati mas-sistema immuni (ara sezzjoni 4.4).
English: 1 to 4 mg/kg/day prednisone or equivalent followed by a taper
Maltese: 1 sa 4 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali
English: Myositis
Maltese: Pożoloġija
English: Radiation pneumonitis is frequently observed in patients receiving radiation therapy to the lung and the clinical presentation of pneumonitis and radiation pneumonitis is very similar.
Maltese: Pulmonite minn radjazzjoni spiss tiġi osservata f'pazjenti li jirċievu terapija bir-radjazzjoni għallpulmun u l-preżentazzjoni klinika tal-pulmonite u ta' pulmonite minn radjazzjoni hija simili ħafna.
English: How you are given IMFINZI
Maltese: Kif tingħata IMFINZI
English: • decreased secretion of hormones produced by the adrenal glands that can cause tiredness
Maltese: • sekrezzjoni mnaqqsa tal-ormoni prodotti mill-glandoli adrenali li tista' tikkawża għeja
English: • a condition in which the muscles become weak and there is a rapid fatigue of the muscles (myasthenia gravis).
Maltese: • kundizzjoni li fiha l-muskoli jsiru dgħajfa u jkun hemm għeja f'daqqa tal-muskoli (mijastenja gravi).
English: Initiate 1 to 4 mg/kg/day prednisone or equivalent followed by a taper
Maltese: Ibda 1 sa 4 mg/kg/jum prednisone jew ekwivalenti segwit bi tnaqqis gradwali
English: See Table 3 and Figures 1 and 2.
Maltese: Irriżoluzzjoni seħħet f'pazjent 1.
English: In the combined safety database with IMFINZI monotherapy, immune-mediated hypopituitarism occurred in 1 (< 0.1%) patient (Grade 3).
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, ipopitwitariżmu medjata missistema immuni seħħet f'pazjent 1 (< 0.1%) (Grad 3).
English: • skin rash or itchiness
Maltese: • Tħawwadx il-kunjett.
English: Immune-mediated rash
Maltese: Raxx medjat mis-sistema immuni
English: Immune-mediated hypothyroidism
Maltese: Nefrite medjata mis-sistema immuni
English: Initiate treatment with insulin as clinically indicated
Maltese: Ibda kura bl-insulina kif indikat klinikament
English: If no improvement within 3 to 5 days despite corticosteroids, promptly start additional immunosuppressive therapy.
Maltese: Jekk ma jkun hemm ebda titjib 3 sa 5 ijiem minkejja l-kortikosterojdi, ibda terapija b'immunosoppressjoni addizzjonali minnufih.
English: Immune-mediated pneumonitis
Maltese: IL-PRODOTT MEDIĊINALI
English: Immune-mediated pneumonitis occurred more frequently in patients in the PACIFIC Study who had completed treatment with concurrent chemoradiation within 1 to 42 days prior to initiation of the study (10.7%), than in the other patients in the combined safety database (2.0%).
Maltese: Pulmonite medjata mis-sistema immuni seħħet aktar ta' spiss f'pazjenti fl-Istudju PACIFIC li temmew il-kura b'kimoradjazzjoni konkurrenti fi żmien 1 sa 42 jum qabel il-bidu tal-istudju (10.7%), milli filpazjenti l-oħra fid-dejtabejż dwar is-sigurtà kombinata (2.0%).
English: Available toxicological data in cynomolgus monkeys have shown low levels of durvalumab in breast milk on Day 28 after birth (see section 5.3).
Maltese: Dejta minn pazjenti b'indeboliment tal-kliewi sever hija limitata wisq sabiex jinstiltu konklużjonijiet dwar din il-popolazzjoni (ara sezzjoni 5.2).
English: The LC13 and C30 were assessed at baseline, every 4 weeks for the first 8 weeks, followed by every 8 weeks until completion of the treatment period or discontinuation of IMFINZI due to toxicity or disease progression.
Maltese: Il-LC13 u s-C30 ġew ivvalutati fil-linja bażi, kull 4 ġimgħat għall-ewwel 8 ġimgħat, segwiti minn kull 8 ġimgħat sakemm tlesta l-perjodu tal-kura jew it-twaqqif ta' IMFINZI minħabba tossiċità jew progressjoni tal-marda.
English: f includes hyperthyroidism, autoimmune thyroiditis, thyroiditis, thyroiditis subacute and Basedow's disease.
Maltese: f tinkludi ipertirojdiżmu, tirojdite awtoimmuni, tirojdite, tirojdite subakuta u marda ta' Basedow.
English: Immune-mediated colitis
Maltese: Kolite medjata mis-sistema immuni
English: Immune-mediated colitis or diarrhoea, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Maltese: Seħħet kolite medjata mis-sistema immuni, definita bħala li teħtieġ l-użu ta' kortikosterojdi sistemiċi u b'ebda etjoloġija alternata ċara f'pazjenti li rċivew IMFINZI (ara sezzjoni 4.8).
English: • has responded or stabilised after initial treatment with chemotherapy and radiotherapy.
Maltese: • ikun irrisponda jew stabilizza wara kura inizjali b'kimoterapija jew radjoterapija.
English: For myasthenia gravis, if there are signs of muscular weakness or respiratory insufficiency, IMFINZI should be permanently discontinued.
Maltese: Għal mijastenija gravi, jekk ikun hemm sinjali ta' dgħufija muskolari jew insuffiċjenza respiratorja, IMFINZI għandu jitwaqqaf b'mod permanenti.
English: Immune-mediated rash or dermatitis, defined as requiring use of systemic corticosteroids and with no clear alternate etiology, occurred in patients receiving IMFINZI (see section 4.8).
Maltese: Seħħ raxx jew dermatite medjata mis-sistema immuni, definita bħala li teħtieġ l-użu ta' kortikosterojdi sistemiċi u b'ebda etjoloġija alternata ċara f'pazjenti li rċivew IMFINZI (ara sezzjoni 4.8).
English: The effect of moderate hepatic impairment (bilirubin > 1.5 to 3 x ULN and any AST) or severe hepatic impairment (bilirubin > 3.0 x ULN and any AST) on the pharmacokinetics of durvalumab is unknown; however, as IgG monoclonal antibodies are not primarily cleared via hepatic pathways, a change in hepatic function is not expected to influence durvalumab exposure.
Maltese: Studji f'annimali b'durvalumab mhux biżżejjed biex juru xi effetti tossiċi fuq is-sistema riproduttiva (ara 5.3). IgG1 tal-bniedem hija magħrufa li taqbeż il-barriera tal-plaċenta u l-qsim tal-plaċenta ta' durvalumab ġie kkonfermat fi studji tal-annimali.
English: Patients should be monitored for clinical signs and symptoms of hypophysitis or hypopituitarism.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' ipofiżite jew ipopitwitariżmu.
English: One vial of 10 mL of concentrate contains 500 mg of durvalumab.
Maltese: Kunjett wieħed ta' 10 ml tal-konċentrat fih 500 mg ta' durvalumab.
English: For suspected immune-mediated adverse reactions, adequate evaluation should be performed to confirm etiology or exclude alternate etiologies.
Maltese: Għal reazzjonijiet avversi medjati mis-sistema immuni suspettati, għandha ssir evalwazzjoni adegwata sabiex tikkonferma l-etjoloġija jew teskludi etjoloġiji alternattivi.
English: Hypothyroidism and hyperthyroidism
Maltese: Ipotirojdiżmu u ipertirojdiżmu
English: • if you are allergic to durvalumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”).
Maltese: • jekk inti allerġiku għal durvalumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6 “Kontenut tal-pakkett u informazzjoni oħra”).
English: In the combined safety database with IMFINZI monotherapy, immune-mediated type 1 diabetes mellitus occurred in 1 (< 0.1%) patient (Grade 3).
Maltese: Fid-dejtabejż dwar is-sigurtà kombinata b'monoterapija b'IMFINZI, dijabete mellitus tat-tip 1 medjata mis-sistema immuni seħħet f'pazjent 1 (< 0.1%) (Grad 3).
English: IMFINZI was discontinued in 4 patients.
Maltese: IMFINZI twaqqaf f'4 pazjenti.
English: More information about the medicine can be found on the EMA website: ema.europa.eu/medicines/human/EPAR/lartruvo.
Maltese: ema.europa.eu/medicines/human/EPAR/lartruvo.
English: 26 April 2019 EMA/237662/2019 Rev.11
Maltese: 19 ta' Lulju 2019 EMA/423345/2019
English: • The study did not meet its primary objective to prolong survival in the overall population (stratified hazard ratio [HR]: 1.05; median 20.4 for Lartruvo plus doxorubicin versus 19.8 months for placebo plus doxorubicin) or in the leiomyosarcoma sub-population (HR: 0.95; median 21.6 months for Lartruvo plus doxorubicin versus 21.9 months for placebo plus doxorubicin).
Maltese: • L-istudju ma laħaqx l-objettiv primarju tiegħu li jtawwal is-sopravivenza fil-popolazzjoni ġenerali (proporzjoni ta' periklu stratifikat [HR]: 1.05; medja ta' 20.4 xhur għal Lartruvo flimkien ma' doxorubicin meta mqabbel ma' 19.8 xhur għall-plaċebo flimkien ma' doxorubicin) jew fissubpopolazzjoni ta' lejomijosarkoma (HR: 0.95; medja ta' 21.6 xhur għal Lartruvo flimkien ma' doxorubicin meta mqabbel ma' 21.9 xhur għall-plaċebo flimkien ma' doxorubicin).
English: • Lartruvo was approved to treat a rare type of cancer called soft tissue sarcoma.
Maltese: • Lartruvo ġie approvat biex jikkura tip ta' kanċer rari msejjaħ sarkoma tat-tessuti rotob.
English: • Additionally, no benefit was shown in terms of prolonging progression-free survival in the overall population (HR: 1.23; median 5.4 months for Lartruvo plus doxorubicin versus 6.8 months for placebo plus doxorubicin), which was one of the secondary objectives of the study.
Maltese: • Barra minn hekk, ma ntwera l-ebda benefiċċju f'termini ta' estensjoni tas-sopravivenza mingħajr progressjoni fil-popolazzjoni ġenerali (HR: 1.23; medja ta' 5.4 xhur għal Lartruvo flimkien ma' doxorubicin meta mqabbel ma' 6.8 xhur għall-plaċebo flimkien ma' doxorubicin), li kien wieħed mill-objettivi sekondarji tal-istudju.
English: Lartruvo is a cancer medicine that was authorised in the EU on 9 November 2016 to treat adults with advanced soft tissue sarcoma, a type of cancer that affects tissues of the body such as muscles, blood vessels and fat tissue.
Maltese: Lartruvo huwa mediċina kontra l-kanċer li ġiet awtorizzata fl-UE fid-9 ta' Novembru 2016 biex tikkura adulti b'sarkoma tat-tessuti rotob avvanzata, tip ta' kanċer li jaffettwa t-tessuti tal-ġisem bħallmuskoli, il-vażijiet u t-tessut tax-xaħam.
English: Lartruvo was authorised in November 2016 to treat advanced soft tissue sarcoma, a condition for which there is paucity of suitable medicines.
Maltese: Lartruvo ġie awtorizzat f'Novembru 2016 biex jikkura sarkoma tat-tessuti rotob avvanzata, kundizzjoni li għaliha hemm nuqqas ta' mediċini adegwati.
English: The medicine was therefore granted a conditional marketing authorisation on condition that the company provided additional data from the ANNOUNCE study.
Maltese: Għaldaqstant, il-mediċina ngħatatawtorizzazzjoni kondizzjonali għat-tqegħid fis-suqbilkundizzjoni li l-kumpanija tipprovdi data addizzjonali mill-istudju ANNOUNCE.
English: The medicine was therefore granted a marketing authorisation on condition that the company provided additional data from the ANNOUNCE study in order to confirm the benefits and safety of the medicine.
Maltese: Għaldaqstant, il-mediċina ngħatat awtorizzazzjoni għat-tqegħid fis-suq bil-kundizzjoni li l-kumpanija tipprovdi data addizzjonali mill-istudju ANNOUNCE sabiex tikkonferma l-benefiċċji u ssikurezza tal-mediċina.
English: Lartruvo was for use together with doxorubicin (another cancer medicine) in patients who could not undergo surgery or radiotherapy (treatment with radiation) and who had not been previously treated with doxorubicin.
Maltese: Lartruvo kellu jintuża flimkien ma' doxorubicin (mediċina oħra kontra l-kanċer) f'pazjenti li ma setgħux jiġu operati jew jingħataw radjoterapija (kura bir-radjazzjoni) u li ma kinux ġew ikkurati qabel b'doxorubicin.
English: EMA recommends withdrawal of marketing authorisation for cancer medicine Lartruvo
Maltese: L-EMA tirrakkomanda l-irtirar tal-awtorizzazzjoni għat tqegħid fis-suq għall-mediċina kontra l-kanċer Lartruvo
English: The review of Lartruvo was initiated on 31 January 2019 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-rieżami ta' Lartruvo nbeda fil-31 ta' Jannar 2019 fuq talba tal-Kummissjoni Ewropea, skont lArtikolu 20 tar-Regolament (KE) Nru 726/2004.
English: • The phase 3 study ANNOUNCE of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma did not confirm the clinical benefit of Lartruvo.
Maltese: • L-ebda tħassib ġdid dwar is-sikurezza ma ġie identifikat matul l-istudju.
English: 18 October 2019
Maltese: 18 ta' Ottubru 2019
English: Further information on Translarna's current uses can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/translarna.
Maltese: Aktar informazzjoni dwar l-użu attwali ta' Translarna tinstab fis-sit web talAġenzija: ema.europa.eu/medicines/human/EPAR/translarna.
English: Refusal of a change to the marketing authorisation for Translarna (ataluren)
Maltese: Translarna (ataluren)
English: The company that had applied for the change to Translarna's authorisation is PTC Therapeutics International Limited.
Maltese: Il-kumpanija li kienet applikat għal bidla fl-awtorizzazzjoni ta' Translarna hija PTC Therapeutics International Limited.
English: EMA/565599/2019
Maltese: Rifjut ta' bidla fl-awtorizzazzjoni għat-tqegħid fis-suq għal Translarna (ataluren) EMA/565599/2019
English: The company then compared the results with historical data from patients with Duchenne muscular dystrophy recorded in the database of the CINRG (Cooperative International Neuromuscular Research Group).
Maltese: Ilkumpanija mbagħad qabblet ir-riżultati ma' data storika minn pazjenti b'distrofija muskolari Duchenne rreġistrata fil-bażi tad-data tas-CINRG (Grupp ta' Riċerka Newromuskolari Internazzjonali Kooperattiv).
English: In addition, the company presented the results of a study involving 94 patients with nonsense mutation Duchenne muscular dystrophy, 44 of whom were no longer able to walk.
Maltese: Barra minn hekk, il-kumpanija ppreżentat ir-riżultati ta' studju li involva 94 pazjent b'mutazzjoni nonsens ta' distrofija muskolari Duchenne, li 44 minnhom ma kinux għadhom kapaċi jimxu.
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene that prematurely stop the production of dystrophin, leading to a shortened dystrophin protein that does not function properly.
Maltese: Translarna huwa għal użu f'pazjenti li l-marda tagħhom hija minħabba l-preżenza ta' ċerti difetti (imsejħa mutazzjonijiet nonsens) fil-ġene distrofin li jwaqqfu b'mod prematur il-produzzjoni ta' distrofin, li twassal għal proteina distrofin imqassra li ma taħdimx sew.
English: It had issued its initial opinion on 27 June 2019.
Maltese: Din kienet ħarġet l-opinjoni inizjali tagħha fis-27 ta' Ġunju 2019.
English: The additional data from the study could also not confirm the benefit of Translarna in patients no longer able to walk because there were problems with the way data from the CINRG database, which was used to indirectly compare the effects of Translarna, were selected and analysed.
Maltese: Id-data addizzjonali mill-istudju lanqas ma setgħet tikkonferma l-benefiċċju ta' Translarna f'pazjenti li ma għadhomx jistgħu jimxu minħabba li kien hemm problemi fil-mod kif id-data mill-bażi tad-data tasCINRG, li ntużat indirettament biex jitqabblu l-effetti ta' Translarna, ġiet magħżula u analizzata.
English: What did the company present to support its application?
Maltese: Liema kienu r-raġunijiet ewlenin għar-rifjut tal-bidla fl-awtorizzazzjoni għat-tqegħid fis-suq?
English: Does this refusal affect patients in clinical trials?
Maltese: Dan ir-rifjut jaffettwa lill-pazjenti fi provi kliniċi?
English: Translarna is a medicine used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Maltese: Translarna huwa mediċina li tintuża biex tikkura pazjenti minn età ta' sentejn 'il fuq b'distrofija muskolari Duchenne u li jistgħu jimxu.
English: If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.
Maltese: Jekk inti qed tieħu sehem fi prova klinika u teħtieġ aktar informazzjoni dwar il-kura tiegħek, kellem littabib tal-prova klinika tiegħek.
English: The company provided data to show that the body handles the medicine in a similar way in patients who are able to walk and those who cannot.
Maltese: Il-kumpanija pprovdiet data biex turi li l-ġisem jittratta l-mediċina b'mod simili f'pazjenti li jistgħu jimxu u dawk li ma jistgħux.
English: The company informed the Agency that there are no consequences for patients who are receiving Translarna in clinical trials.
Maltese: Il-kumpanija informat lill-Aġenzija li ma kien hemm l-ebda konsegwenza għal pazjenti li qed jirċievu Translarna fi provi kliniċi.
English: The company applied for an extension of indication to add the treatment of patients with Duchenne muscular dystrophy who can no longer walk.
Maltese: Il-kumpanija applikat għal estensjoni tal-indikazzjoni biex tiżdied il-kura tal-pazjenti b'distrofija muskolari Duchenne li ma għadhomx kapaċi jimxu.
English: (See section 4.4)
Maltese: (Ara sezzjoni 4.4)
English: Overall Survival Probability
Maltese: Probabbiltà ta' Sopravvivenza Globali
English: Secondary malignancy (including reports of AML and MDS)
Maltese: Malinn sekondarju (inkluż rapporti ta'AML u MDS)
English: Les Laboratoires Servier Industrie 905 Route de Saran 45520 Gidy
Maltese: Les Laboratoires Servier Industrie 905 route de Saran 45520
English: Reduce the dose by 20%.
Maltese: Naqqas id-doża b'20%.
English: ATC code: L01DB11
Maltese: L01DB11