FrancophonIA/ELRC3.0 huggingface dataset:
English: When the full volume of Kymriah has been infused, the infusion bag should be rinsed with 10 to 30 mL sodium chloride 9 mg/mL (0.9%) solution for injection by back priming to ensure as many cells as possible are infused into the patient.
Maltese: Meta ssir l-infużjoni tal-volum sħiħ ta' Kymriah, il-borża bl-infużjoni għandha titlaħlaħ b'10 sa 30 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride billi jintuża l-proċess ta' back priming sabiex tiżgura li saret infużjoni tal-akbar ammont ta' ċelluli possibbli fil-pazjent.
English: The efficacy of Kymriah was evaluated through the primary endpoint of best overall response rate (ORR), which includes complete response (CR) and partial response (PR) as determined by Independent Review Committee (IRC) assessment as well as secondary endpoints including duration of response (Table 6).
Maltese: L-effikaċja ta' Kymriah kienet evalwata permezz ta' endpoint primarju tal-aħjar rata ta' rispons sħiħ (ORR), li kienet tinkudi rispons sħiħ (CR) u rispons parzjali (PR) kif iddeterminat minn evalwazzjoni tal-Kumitat ta' Reviżjoni Indipendenti (IRC) kif ukoll fuq endpoints sekondarji li jinkludu kemm dam ir-rispons (Tabella 6).
English: Pruritus Erythema Night sweats Petechiae Hyperhidrosis
Maltese: Instabbiltà emodinamika minkejja lfluwidi fil-vina u l-għajnuna b'vażopressur
English: Ischaemic cerebral infarction
Maltese: Evalwazzjoni klinika qabel l-infużjoni
English: Health-related quality of life (HRQoL) was evaluated by PedsQL™ and EQ-5D questionnaires completed by patients aged 8 years and above (n=58).
Maltese: Saret evalwazzjoni b'rabta mas-saħħa u l-kwalità tal-ħajja (HRQoL) permezz tal-kwestjonarji PedsQL™ u EQ-5D mimlija minn pazjenti ta' 8 snin u aktar (n=58).
English: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV.
Maltese: Bħalissa m'hemmx esperjenza bil-manifattura ta' Kymriah għal pazjenti ttestjati pożittivament għallHBV, għall-HCV u għall-HIV.
English: There is no apparent relationship between dose and AUC0-28d or Cmax.
Maltese: Ma jidhirx li hemm relazzjoni bejn id-doża u l-AUC0-28d jew is-Cmax.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion and to rinse it after infusion.
Maltese: Għandha tintuża 9 mg/mL (0.9%) soluzzjoni għall-injezzjoni bis-sodium chloride sabiex jitħejja t-tubu qabel ma sseħħ l-infużjoni u sabiex jitlaħlaħ wara.
English: • If no clinical improvement within 12 to 18 hours of the first tocilizumab dose, or worsening at any time, administer methylprednisolone 2 mg/kg as an initial dose, then 2 mg/kg per day until vasopressors and high-flow oxygen are no longer needed, then taper.
Maltese: • Jekk m'hemmx titjib kliniku fi żmien 12 sa 18il siegħa mill-ewwel doża ta' tocilizumab, jew ilpazjent imur għall-agħar fi kwalunkwe ħin, agħti 2 mg/kg methylprednisolone bħala doża inizjali, u wara 2 mg/kg kuljum sakemm il-vażopressuri u lossiġnu b'livell għoli ta' fluss ma jibqgħux aktar meħtieġa, u wara naqqas bil-mod il-mod.
English: A summary of cellular kinetic parameters of tisagenlecleucel in paediatric and young adult B-cell ALL patients is provided in Table 7 below.
Maltese: Sommarju tal-parametri tal-kinetika ċellulari ta' tisagenlecleucel f'pazjenti pedjatriċi u adulti żgħażagħ b'ALL taċ-ċellula B jinsab f'Tabella 7 hawn taħt.
English: 103/111 patients (93%) received lymphodepleting chemotherapy prior to Kymriah infusion.
Maltese: It-tip u d-dewmien tat-terapija ta' tranżizzjoni tħallew fid-diskrezzjoni tattabib. 103/111-il pazjent (93%) ingħataw kimoterapija ta' limfodeplezzjoni qabel l-infużjoni ta' Kymriah.
English: Febrile neutropenia was frequently observed in patients after Kymriah infusion (see section 4.8) and may be concurrent with cytokine release syndrome.
Maltese: Spiss kien hemm newtropenija febbrili f'pazjenti wara li ngħataw infużjoni ta' Kymriah (ara sezzjoni 4.8) u tista' tkun fl-istess waqt tas-sindrome ta' rilaxx taċ-ċitokini.
English: Table 4 Study B2202: Efficacy results in paediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (ALL)
Maltese: Riżultati dwar l-effikaċja f'pazjenti pedjatriċi u adulti żgħażagħ b'lewkimja limfoblastika akuta (ALL) b'rikaduta/refrattorja taċ-ċellula B
English: • Headache
Maltese: • Fwawar
English: Rash includes rash, rash maculo-papular, rash papular and rash pruritic.
Maltese: Ma kenux identifikati riskji ta' dan it-tip skont dawn l-istudji.
English: Pulmonary oedema Pleural effusion Tachypnoea
Maltese: Dispnean) Edima pulmonari Effużjoni plewrali Tachypnoea
English: Active central nervous system (CNS) leukaemia or lymphoma
Maltese: Lewkimja jew limfoma tas-sistema nervuża ċentrali (CNS) attiva
English: Headachee) Encephalopathyf) Dizziness
Maltese: Disturbi psikjatriċi Thewdinc) Ansjetà
English: Additional organ system adverse reactions, including transient cardiac insufficiency and arrhythmia, renal insufficiency, elevated aspartate aminotransferase (AST), elevated alanine aminotransferase (ALT) and elevated bilirubin have been observed.
Maltese: Kienu osservati reazzjonijiet avversi oħrajn fis-sistema tal-organi, fosthom insuffiċjenza kardijaka tranżitorja u arritmija, insuffiċjenza renali, livell għoli ta' aspartat aminotransferażi (AST), livell għoli ta' alanina aminotransferażi (ALT) u livell għoli ta' bilirubina.
English: Final report of study results: December 2038
Maltese: Diċembru 2038
English: Kymriah contains human blood cells.
Maltese: Kymriah fih ċelluli tad-demm umani.
English: Non-clinical safety assessment of Kymriah addressed the safety concerns of potential uncontrolled cell growth of transduced T cells in vitro and in vivo as well as dose-related toxicity, biodistribution and persistence.
Maltese: Evalwazzjoni dwar is-sigurtà mhux klinika ta' Kymriah indirizzat it-tħassib dwar is-sigurtà b'rabta ma' tkabbir potenzjali mhux ikkontrollat ta' ċelluli taċ-ċelluli T ta' trasduzzjoni in vitro u in vivo kif ukoll dwar tossiċità b'rabta mal-mediċina, il-bijodistribuzzjoni u l-persistenza.
English: In addition the applicant should submit the final CSR including 5 years of follow-up.
Maltese: Barra minn hekk l-applikant għandu jissottometti s-CSR finali li jinkludi follow-up ta' 5 snin.
English: The concentration of CAR-positive viable T cells is dependent on indication and patient body weight (for B-cell acute lymphoblastic leukaemia [ALL]).
Maltese: Il-konċentrazzjoni taċ-ċelluli T vijabbli pożittivi għal CAR hi dipendenti fuq l-indikazzjoni u l-piż talġisem tal-pazjent (għal lewkimja limfoblastika akuta [ALL] taċ-ċellula B).
English: The overall incidence (all grades) was 65% (unspecified 49%, viral 32%, bacterial 24% and fungal 15%) (see section 4.4).
Maltese: L-inċidenza ġenerali (il-gradi kollha) kienet ta' 65% (mhux speċifikata 49%, virali 32%, batterika 24% u fungali 15%) (ara sezzjoni 4.4). 43% tal-pazjenti esperjenzaw infezzjoni ta' xi tip fi żmien 8 ġimgħat wara l-infużjoni ta' Kymriah.
English: Cytokine release syndrome
Maltese: • Sinjali u sintomi ta' emboli
English: Pregnancy after Kymriah therapy should be discussed with the treating physician.
Maltese: Għandha ssir diskussjoni dwar it-tqala wara li tingħata terapija b'Kymriah mat-tabib kuranti.
English: A summary of cellular kinetic parameters of tisagenlecleucel in DLBCL patients is provided in Table 8 below.
Maltese: Sommarju tal-parametri tal-kinetika ċellulari ta' tisagenlecleucel f'pazjenti b'DLBCL jinsab f'Tabella 8 hawn taħt.
English: • You will be given a pregnancy test before treatment starts.
Maltese: • Se jingħatalek test tat-tqala qabel ma jibda t-trattament.
English: Kymriah must be administered in a qualified treatment centre.
Maltese: Kymriah għandha tingħata f'ċentru għat-trattament ikkwalifikat.
English: Patients should be monitored for neurological events.
Maltese: Il-pazjenti għandhom ikunu mmonitorati għal episodji newroloġiċi.
English: In patients achieving complete remission following Kymriah, resulting low immunoglobulin levels can increase the risk for infections.
Maltese: F'pazjenti li jiksbu remissjoni sħiħa wara Kymriah, li twassal għal livelli baxxi ta' immunoglobulina jista' jiżdied ir-riskju ta' infezzjonijiet.
English: Hyperbilirubinaemia
Maltese: Qabel il-medikazzjoni
English: Anti-IL-6 based therapy such as tocilizumab has been administered for moderate or severe cytokine release syndrome associated with Kymriah and a minimum of four doses of tocilizumab must be on site and available for administration prior to Kymriah infusion.
Maltese: Terapija msejsa fuq anti-IL-6 fosthom tocilizumab ingħatat għal sindrome ta' rilaxx taċ-ċitokini moderati jew gravi assoċjati ma' Kymriah u mill-inqas erba' dożi ta' tocilizumab għandu jkun fuq il-post u disponibbli sabiex tingħata qabel l-infużjoni ta' Kymriah.
English: The pivotal study (B2202) is a multicentre, single-arm phase II study in paediatric and young adult patients with r/r B-cell acute lymphoblastic leukaemia.
Maltese: L-istudju pivotali (B2202) hu studju multiċentriku, bi grupp wieħed ta' pazjenti f'fażi
English: Following infusion of Kymriah into paediatric and young adult r/r B-cell ALL and r/r DLBCL patients, Kymriah typically exhibited an initial rapid expansion followed by a slower bi-exponential decline.
Maltese: Dan jista' jinterferixxi mal-mod kif jaħdmu l-organi varji tal-ġisem, b'mod speċjali tal-kliewi, il-qalb u s-sistema nervuża (sindrome ta' liżi tat-tumur).
English: If the patient experienced a previous Grade 4 haemorrhagic cystitis with cyclophosphamide, or demonstrated a chemorefractory state to a cyclophosphamide-containing regimen administered shortly before lymphodepleting chemotherapy, then the following should be used: - Bendamustine (90 mg/m2 intravenous daily for 2 days).
Maltese: Jekk il-pazjent kellu ċistite emorraġika fi Grad 4 b'cyclophosphamide, jew wera stat kimorefrattorju għal reġim li fih cyclophosphamide mogħti minnufih qabel il-kimoterapija ta' limfodeplezzjoni, allura għandu jintuża dan li ġej: - Bendamustine (90 mg/m2 fil-vina kuljum għal jumejn).
English: Coagulopathy
Maltese: FARMAĊEWTIKU
English: • Do not donate blood, organs, tissues or cells for transplants.
Maltese: • Tagħtix demm, organi, tessuti jew ċelluli għal trapjanti.
English: • Paediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse.
Maltese: • Pazjenti pedjatriċi u adulti żgħażagħ li għandhom sa 25 sena b'lewkimja limfoblastika akuta (ALL) taċ-ċellula B li hi refrattorja, b'rikaduta wara trapjant jew bit-tieni rikaduta jew b'rikaduta aktar tard.
English: • Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Maltese: • Pazjenti adulti b'limfoma kbira mifruxa taċ-ċellula B (DLBCL) b'rikaduta jew refrattorja wara żewġ jew aktar linji ta' terapija sistemika.
English: • Dizziness
Maltese: Dijarrea
English: Content (concentration) Package size
Maltese: Kontenut (konċentrazzjo ni)
English: EMA/746670/2017 EMEA/H/C/002020
Maltese: EMA/746670/2017 EMA/H/C/002020
English: Bydureon exenatide
Maltese: Bydureon eksenatid
English: The full EPAR for Bydureon 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 Bydureon
Maltese: Informazzjoni oħra dwar Bydureon
English: The active substance in Bydureon, exenatide, is an ‘incretin mimetic'.
Maltese: Is-sustanza attiva f'Bydureon, l-eksenatid, hija ‘inkretina mimetika'.
English: This is a summary of the European public assessment report (EPAR) for Bydureon.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Bydureon.
English: Most side effects are mild to moderate in intensity.
Maltese: Ħafna mill-effetti sekondarji kienu minn ħfief sa moderati fl-intensità.
English: Bydureon contains the active substance exenatide.
Maltese: Bydureon fih is-sustanza attiva l-eksenatid.
English: The average reduction with Bydureon plus dapagliflozin was 2.0 points after 28 weeks, compared with an average reduction of 1.6 points with Bydureon alone and 1.4 points with dapagliflozin alone.
Maltese: It-tnaqqis medju b'Bydureon flimken ma' dapagliflozin kien ta' 2.0 punti perċentwali wara 28 ġimgħa, meta mqabbel ma' tnaqqis medju ta' 1.6 punti perċentwali b'Bydureon waħdu u 1.4 punti b'dapagliflozin waħdu.
English: The average reduction with Bydureon was 1.5 points after 26 weeks, compared with an average reduction of 1.3 points with insulin glargine.
Maltese: It-tnaqqis medju b'Bydureon kien ta' 1.5 punti perċentwali wara 26 ġimgħa, meta mqabbel ma' tnaqqis medju ta' 1.3 punti perċentwali bl-insulina glargina.
English: In the sixth study (in 464 patients), Bydureon given together with insulin glargine with or without metformin was compared with placebo (dummy treatment) also given with insulin glargine with or without metformin.
Maltese: Fis-sitt studju (f'464 pazjent), Bydureon mogħti flimkien mal-insulina glargina mal-metformina jew mingħajrha tqabbel ma' plaċebo (kura finta) mogħtija wkoll mal-insulina glargina mal-metformina jew mingħajrha.
English: The first two studies (in a total of 555 patients) compared Bydureon with another medicine also containing exenatide but given twice daily, both given as add-on treatment to oral diabetes medicines or diet and exercise alone.
Maltese: L-ewwel żewġ studji (f'total ta' 555 pazjent) qabblu Bydureon ma' mediċina li fiha wkoll l-eksenatid iżda li tingħata darbtejn kuljum, it-tnejn mogħtija bħala kura miżjuda ma' mediċini tad-dijabete orali jew ma' dieta u eżerċizzju weħidhom.
English: What are the risks associated with Bydureon?
Maltese: X'inhuma r-riskji assoċjati ma' Bydureon?
English: Why is Bydureon approved?
Maltese: Għaliex ġie approvat Bydureon?
English: The average reduction with Bydureon was 1.0 point after 28 weeks, compared with an average reduction of 0.2 points with placebo.
Maltese: It-tnaqqis medju b'Bydureon kien ta' 1.0 punti perċentwali wara 28 ġimgħa, meta mqabbel ma' tnaqqis medju ta' 0.2 punti perċentwali ma' plaċebo.
English: When adding Bydureon to a sulphonylurea, the doctor may need to reduce the dose of the sulphonylurea because there is a risk of hypoglycaemia (low blood sugar levels).
Maltese: Meta Bydureon jiżdied ma' xi sulfonilurea, it-tabib jista' jkollu bżonn inaqqas id-doża tas-sulfonilurea minħabba li hemm riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Bydureon reduced HbA1c levels by an average of 1.4 points after 26 weeks of treatment, compared with an average reduction of 0.8 and 1.1 points with sitagliptin and pioglitazone respectively.
Maltese: Bydureon naqqas il-livelli ta' HbA1c b'medja ta' 1.4 punti perċentwali wara 26 ġimgħa ta' kura, meta mqabbel ma' tnaqqis medju ta' 0.8 u ta' 1.1 punti perċentwali b'sitagliptina jew pjoglitażon rispettivament.
English: At the start of the study, the patients' HbA1c levels were around 9.3%.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c tal-pazjenti kienu madwar 9.3 %.
English: Bydureon was effective at controlling blood glucose in six main studies involving nearly 2700 patients with type 2 diabetes.
Maltese: Bydureon kien effettiv fil-kontroll tal-glukożju fid-demm f'sitt studji ewlenin li involvew kważi 2700 pazjent bid-dijabete tat-tip 2.
English: In the second study, the average reduction was 1.6 points after 24 weeks of treatment with Bydureon, compared with an average reduction of 0.9 points with exenatide given twice daily.
Maltese: Fit-tieni studju, it-tnaqqis medju kien ta' 1.6 punti perċentwali wara 24 ġimgħa ta' kura b'Bydureon, meta mqabbel ma' tnaqqis medju ta' 0.9 punti perċentwali bl-eksenatid mogħtija darbtejn kuljum.
English: For the full list of side effects and restrictions with Bydureon, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Bydureon, ara l-fuljett ta' tagħrif.
English: The fourth study (in 456 patients) compared Bydureon with insulin glargine (a long-acting insulin) as add-on treatment to metformin with or without a sulphonylurea.
Maltese: Ir-raba' studju (f'456 pazjent) qabbel Bydureon mal-insulina glargina (insulina li taħdem fit-tul) bħala kura miżjuda ma' metformina bi jew mingħajr sulfonilurea.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bydureon on 17 June 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Bydureon fis-17 ta' Ġunju 2011.
English: At the start of the study, the patients' HbA1c levels were around 8.3%.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c talpazjenti kienu madwar 8.3 %.
English: Adding Bydureon to metformin or pioglitazone does not cause hypoglycaemia.
Maltese: Dan iwassal għal glukożju żejjed fiddemm.
English: All patients were also taking metformin.
Maltese: Il-pazjenti kollha kienu qed jieħdu wkoll metformina.
English: At the start of the studies, the patients' HbA1c levels were around 8.4%.
Maltese: Fil-bidu tal-istudji, il-livelli ta' HbA1c tal-pazjenti kienu madwar 8.4%.
English: The third study (in 514 patients) compared Bydureon with sitagliptin or pioglitazone as add-on treatment to metformin.
Maltese: It-tielet studju (f'514-il pazjent) qabbel Bydureon ma' sitagliptina jew pjoglitażon bħala kura miżjuda ma' metformina.
English: At the start of the study, the patients' HbA1c levels were around 8.5%.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c tal-pazjenti kienu madwar 8.5 %.
English: In the first study, Bydureon reduced HbA1c levels by an average of 1.9 percentage points after 30 weeks of treatment, compared with an average reduction of 1.5 points with exenatide given twice daily.
Maltese: Fl-ewwel studju, Bydureon naqqas il-livelli ta' HbA1c b'medja ta' 1.9 punti perċentwali wara 30 ġimgħa ta' kura, meta mqabbel ma' tnaqqis medju ta' 1.5 punti perċentwali bl-eksenatid mogħtija darbtejn kulljum.
English: Bydureon is a diabetes medicine used together with other diabetes medicines including long-acting insulin to treat adults with type 2 diabetes whose blood glucose (sugar) levels are not adequately controlled with the other medicines.
Maltese: Bydureon huwa mediċina tad-dijabete li tintuża flimkien ma' mediċini oħra tad-dijabete inkluża linsulina li taħdem fit-tul biex tikkura adulti b'dijabete tat-tip 2 li l-livelli tal-glukożju (taz-zokkor) fiddemm tagħhom ma jkunux ikkontrollati b'mod adegwat b'mediċini oħra.
English: Bydureon is available as a powder and solvent that are mixed together to make a prolonged-release suspension for injection providing 2 mg of exenatide.
Maltese: Bydureon jiġi bħala trab u solvent li jitħalltu flimkien biex jagħmlu sospensjoni b'rilaxx fit-tul għal injezzjoni li tipprovdi 2 mg ta' eksenatid.
English: The most common side effects with Bydureon are nausea (feeling sick) and diarrhoea.
Maltese: L-effetti sekondarji l-aktar komuni b'Bydureon huma nawżja (tħossok ma tiflaħx) u dijarea.
English: In addition, reactions at the site of injection (itching and redness), low blood sugar levels (when used with a sulphonylurea) and headache occur.
Maltese: Barra minn hekk, kien hemm reazzjonijiet fis-sit tal-injezzjoni (ħakk u ħmura), livelli baxxi taz-zokkor fid-demm (meta użat ma' sulfonilurea) u wġigħ ta' ras.
English: In the fifth study (in 695 patients), Bydureon given with dapagliflozin was compared with Bydureon alone and dapagliflozin alone.
Maltese: Dan jispjega kif l-Aġenzija vvalutat il-mediċina biex tirrakkomanda l-awtorizzazzjoni tagħha fl-UE u l-kondizzjonijiet ta' użu tagħha.
English: The European Medicines Agency noted that the benefits of Bydureon, such as its effect on reducing the levels of HbA1c, compare well with those of comparator medicines and that its side effects are manageable.
Maltese: L-Aġenzija Ewropea għall-Mediċini nnotat li l-benefiċċji ta' Bydureon, bħall-effett tiegħu fuq it-tnaqqis tal-livelli ta' HbA1c, jikkomparaw tajjeb ma' dawk tal-mediċini komparaturi u li l-effetti sekondarji tiegħu huma maniġġabbli.
English: Patients using both Bydureon and insulin should inject the medicines separately.
Maltese: Il-pazjenti li jużaw kemm Bydureon kif ukoll l-insulina għandhom jinjettaw il-mediċini separatament.
English: Prolonged-release means that the active substance is released slowly after being injected.
Maltese: Rilaxx fit-tul ifisser li s-sustanza attiva tiġi rilaxxata bil-mod wara li tiġi injettata.
English: How does Bydureon work?
Maltese: Kif jintuża Bydureon?
English: Rinvoq (upadacitinib)
Maltese: Rinvoq (upadaċitinib)
English: It is available as 15 mg tablets.
Maltese: Dan jiġi bħala pilloli ta' 15 mg.
English: Further information on Rinvoq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rinvoq.
Maltese: ema.europa.eu/medicines/human/EPAR/rinvoq.
English: Upadacitinib, the active substance in Rinvoq, is an immunosuppressant.
Maltese: L-upadaċitinib, is-sustanza attiva f'Rinvoq, huwa immunosoppressant.
English: The patients were being treated with conventional disease-modifying anti-rheumatic medicines (chloroquine, hydroxychloroquine, leflunomide or sulfasalazine, often combined with methotrexate).
Maltese: Il-pazjenti kienu qed jiġu kkurati b'mediċini konvenzjonali antirewmatiċi li jimmodifikaw il-marda (chloroquine, hydroxychloroquine, leflunomide jew sulfasalazine, ħafna drabi flimkien ma' methotrexate).
English: Other information about Rinvoq
Maltese: Informazzjoni oħra dwar Rinvoq
English: It found that 45% of patients treated with methotrexate plus Rinvoq had low disease activity after 12 weeks compared with 29% of patients treated with methotrexate plus adalimumab (a biological diseasemodifying anti-rheumatic medicine) and 14% of patients receiving methotrexate plus placebo.
Maltese: Dan sab li 45 % tal-pazjenti kkurati b'methotrexate flimkien ma' Rinvoq kellhom attività tal-marda baxxa wara 12-il ġimgħa meta mqabbla ma' 29 % tal-pazjenti kkurati b'methotrexate flimkien ma' adalimumab (mediċina bijoloġika antirewmatika li timmodifika l-marda) u 14 % tal-pazjenti li rċevew methotrexate flimkien ma' plaċebo.
English: The most important serious side effects are serious infections.
Maltese: L-effetti sekondarji serji l-aktar importanti huma infezzjonijiet serji.
English: These studies involved rating disease activity in 28 joints in the body on a standard scale.
Maltese: Dawn l-istudji involvew attività ta' klassifikazzjoni tal-marda fi 28 ġog fil-ġisem fuq skala standard.
English: It found that of patients treated with Rinvoq, 48% had low disease activity after 12 weeks compared with 17% of patients receiving placebo (a dummy treatment).
Maltese: Dan sab li minn pazjenti kkurati b'Rinvoq, 48 % kellhom attività tal-marda baxxa wara 12-il ġimgħa meta mqabbla ma' 17 % tal-pazjenti li rċivew il-plaċebo (kura finta).
English: What are the risks associated with Rinvoq?
Maltese: X'inhuma r-riskji assoċjati ma' Rinvoq?
English: Five studies involving a total of nearly 4,400 patients found Rinvoq effective in reducing symptoms in patients with moderate to severe rheumatoid arthritis.
Maltese: Ħames studji li jinvolvu total ta' kważi 4,400 pazjent sabu li Rinvoq huwa effettiv fit-tnaqqis tassintomi f'pazjenti b'artrite rewmatojde moderata sa severa.
English: Rinvoq contains the active substance upadacitinib.
Maltese: Rinvoq fih is-sustanza attiva upadaċitinib.
English: The most common side effects with Rinvoq (which may affect more than 1 in 10 people) are upper respiratory tract infections (nose and throat infections).
Maltese: L-effetti sekondarji l-aktar komuni b'Rinvoq (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma infezzjonijiet fl-apparat respiratorju ta' fuq (infezzjonijiet fl-imnieħer u fil-griżmejn).
English: Of the patients who also received Rinvoq, 43% had low disease activity compared with 14% of patients receiving placebo.
Maltese: Mill-pazjenti li rċevew ukoll Rinvoq, 43 % kellhom attività tal-marda baxxa meta mqabbla ma' 14 % tal-pazjenti li rċivew il-plaċebo.