FrancophonIA/ELRC3.0 huggingface dataset:
English: A suppression of foetal intrauterine growth as well as cervical ribs occurred at doses (40 mg/kg/day or more), showing maternal toxicity.
Maltese: Soppressjoni tat-tkabbir intrauterin fil-fetu kif ukoll kustilji ċervikali seħħew b'dożi (40 mg/kg/jum jew aktar), indikazzjoni ta' tossiċità materna.
English: Placebo N = 107
Maltese: N = 107
English: One patient had mesenteric vein thrombosis reported as a TEAE in the lusutrombopag 4 mg group; two patients had mesenteric vein thrombosis reported as a TEAE in the placebo group (see section 4.4).
Maltese: Pazjent wieħed kellu trombożi fil-vina mesenterika rrappurtata bħala TEAE fil-grupp ta' lusutrombopag 4 mg, żewġ pazjenti kellhom trombożi fil-vina mesenterika rrappurtata bħala TEAE fil-grupp tal-plaċebo (ara sezzjoni 4.4).
English: Due to limited information available, the safety and efficacy of Mulpleo in patients with severe hepatic impairment (Child-Pugh class C) have not been established (see sections 4.4 and 5.1).
Maltese: Minħabba li l-informazzjoni disponibbli hija limitata, is-sigurtà u l-effikaċja ta' Mulpleo f'pazjenti b'indeboliment epatiku sever (Child-Pugh Klassi C) għadhom ma ġewx determinati (ara sezzjonijiet 4.4 u 5.1).
English: Mulpleo is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures (see section 5.1).
Maltese: Mulpleo huwa indikat għat-trattament ta' tromboċitopenija severa f'pazjenti adulti b'marda kronika fil-fwied li jkunu għaddejjin minn proċeduri mediċi invażivi (ara sezzjoni 5.1).
English: Tel: +44 (0)20 3053 4190 contact@shionogi.eu
Maltese: 3053 4190 contact@shionogi.eu
English: In the placebo group, 94/107 subjects (87.9%) received the study drug for 7 days.
Maltese: Fil-grupp tal-plaċebo, 94/107 individwi (87.9%) irċevew il-mediċina tal-istudju għal
English: A population pharmacokinetic analysis using plasma lusutrombopag concentrations from clinical studies with lusutrombopag did not identify a clinically meaningful effect of renal function on the pharmacokinetics of lusutrombopag.
Maltese: Analiżi farmakokinetika talpopolazzjoni bl-użu ta' konċentrazzjonijiet fil-plażma ta' lusutrombopag mill-istudji kliniċi b'lusutrombopag ma identifikawx effett klinikament sinifikanti tal-funzjoni renali fuq ilfarmakokinetika ta' lusutrombopag.
English: The differences in pharmacokinetics of a single 0.75 mg dose of lusutrombopag were relatively small in both subjects with mild hepatic impairment and subjects with moderate hepatic impairment, compared with the healthy matched control group.
Maltese: Id-differenzi fil farmakokinetika ta' doża waħda ta' 0.75 mg ta' lusutrombopag kienu relattivament żgħar fiż-żewġ individwi b'indeboliment epatiku ħafif u f'individwi b'indeboliment epatiku moderat, meta mqabbla mal-grupp ta' kontroll ta' individwi b'saħħithom li ġie pparagunat.
English: In the phase 2b study one patient had portal vein thrombosis reported as a treatment-emergent adverse event (TEAE) in the lusutrombopag 2 mg and 4 mg groups.
Maltese: Fl-istudju ta' fażi 2b, pazjent wieħed kellu trombożi fil-vina portali rrappurtata bħala avveniment avvers li jiżviluppa bħala konsegwenza tat-trattament (TEAE, treatment-emergent adverse event) filgruppi ta' lusutrombopag 2 mg u 4 mg.
English: In the human mass balance study using [14C]-lusutrombopag, unchanged lusutrombopag (97% of radioactivity in plasma) was the major circulating component, and the metabolites, such as deshexyl, β-oxidated carboxylic acid, taurine conjugate of β-oxidated carboxylic acid, and acyl glucuronide, were detected with less than 2.6% of radioactivity in plasma.
Maltese: Fl-istudju dwar il-bilanċ tal-massa tal-bniedem bl-użu ta' [14C]-lusutrombopag, lusutrombopag mhux mibdul (97% tar-radjuattività fil-plażma) kien il-komponent maġġuri li jiċċirkola, u l-metaboliti,
English: Patients with chronic liver disease have a risk of portal vein thrombosis and mesenteric vein thrombosis.
Maltese: Pazjenti b'marda tal-fwied kronika jkollhom riskju ta' trombożi tal-vina portali u trombożi tal-vina mesenterika.
English: The p value and confidence interval were calculated using the Wald method.
Maltese: Il-valur p u l-intervall ta' kunfidenza kienu kkalkulati permezz talmetodu Wald.
English: There were no effects on pregnancy, parturition, lactation in F0 dams and postnatal development in F1 pups at doses up to 12.5 mg/kg/day (89 times the human clinical exposures in adults based on AUC).
Maltese: Ma ġew innotati ebda effetti fuq it-tqala, twelid u t-treddigħ f'nisa F0 u żvilupp wara t-twelid fi frieħ F1 b'dożi li jaslu sa 12.5 mg/kg/jum (89 aktar l-esponimenti kliniċi tal bniedem fl-adulti abbażi tal-AUC).
English: • Blood clot in the liver (portal vein thrombosis)
Maltese: • Emboli tad-demm ġol-fwied (trombożi fil-vina portali)
English: Mulpleo should be used with contraception (see sub-section Pregnancy and section 5.3).
Maltese: Mulpleo għandu jintuża flimkien ma' kontraċezzjoni (ara s-sotto-sezzjoni Tqala u sezzjoni 5.3).
English: In order to allow an overall comparison of the results across Studies M0631 and M0634, as presented in Table 2 to Table 5, data from study M0631 was reanalysed according to the primary endpoint for study M0634.
Maltese: Sabiex ikun jista' jsir paragun b'mod globali tar-riżultati fi Studji M0631 u M0634, kif ippreżentati f'Tabella 2 sa Tabella 5, id-data minn studju M0631 kienet analizzata mill-ġdid skont il-punt aħħari primarju għal studju M0634.
English: Overdose may induce an excessive increase of platelet counts, and it may subsequently provoke a medically susceptible state to cause thrombosis and thromboembolism.
Maltese: Doża eċċessiva tista' tikkaġuna żieda eċċessiva fl-għadd tal-plejtlits, u tista' sussegwentement tipprovoka stat medikament suxxettibbli li jikkawża trombożi u tromboemboliżmu.
English: In the pre- and postnatal development study in rats at doses up to 40 mg/kg/day, there were adverse effects of lusutrombopag on postnatal development at 40 mg/kg/day as follow: prolongation of gestation period in dams, low viability before weaning, delayed postnatal growth such as delayed negative geotaxis or delayed eyelid opening, low pup body weight, low female fertility index, a tendency to low number of corpora lutea or implantations, and a tendency to increased preimplantation loss rate and an abnormal clinical sign such as prominent annular rings on tail after weaning.
Maltese: dewmien tal-perjodu ta' ġestazzjoni fin-nisa, vijabilità baxxa qabel il-ftim, żvilupp ta' wara t-twelid imdewwem bħal ġeotassi negattivi mdewma jew ftuħ ta' tebqet il-għajnejn imdewwem, piż tal-ġisem tal-ferħ baxx, indiċi tal-fertilità baxx fin-nisa, tendenza ta' rata baxxa ta' corpora lutea jew ta'
English: The duration of the increase in platelet count to ≥ 50,000/µL in Studies M0631 and M0634 and the pooled (Studies M0631 and M0634) lusutrombopag group was significantly greater than compared with placebo (Table 5).
Maltese: lusutrombopag (Studji M0631 u M0634) kien akbar b'mod sinifikanti milli mqabbel mal-plaċebo (Tabella 5).
English: ≥ 50,000/μL with an increase of ≥ 20,000/μL from baseline) during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 4).
Maltese: Il-proporzjon ta' individwi li ssodisfaw il-kriterju ta' dawk li juru rispons (definit bħala żieda fl-għadd tal-plejtlits għal ≥ 50,000/μL b'żieda ta' ≥ 20,000/μL mil-linja bażi) kien akbar b'mod sinifikanti fil gruppi ta' lusutrombopag fl-istudji individwali u fil-grupp miġbur ta' lusutrombopag (Studji M0631 u M0634) meta mqabbel mal-plaċebo (Tabella 4).
English: Missed dose
Maltese: Doża rakkomandata:
English: The ranges of observed Cmax and AUC0-τ overlapped among the patients with Child-Pugh class A, B, and C. Cmax and AUC0-τ of all patients with Child-Pugh class C did not exceed the maximum values from Child-Pugh class A and class B. Due to the limited information available, lusutrombopag should not be used in Child-Pugh class C patients unless the expected benefit outweighs the expected risks.
Maltese: Child-Pugh klassi A u klassi B. Minħabba informazzjoni limitata disponibbli, lusutrombopag m'għandux jintuża f'pazjenti b'Child-Pugh klassi C ħlief jekk il-benefiċċju mistenni jiżboq ir-riskji mistennija.
English: In patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy the risk for thrombosis or thromboembolism may increase.
Maltese: F'pazjenti bi trombożi jew tromboemboliżmu, bi storja medika ta' trombożi jew tromboemboliżmu, b'nuqqas ta' fluss ta' demm epatopetali fil-parti prinċipali tal-vina portali, jew f'pazjenti b'koagulopatija konġenitali r-riskju ta' trombożi jew tromboemboliżmu jista' jiżdied.
English: Eight lusutrombopag-treated subjects and 2 placebo-treated subjects received less than 7 days of treatment as they met the criterion for a responder prior to Day 7.
Maltese: Tmien individwi ttrattati b'lusutrombopag u żewġ (2) individwi ttrattati bi plaċebo rċevew inqas minn 7 ijiem ta' trattament peress li ssodisfaw il-kriterju għal pazjenti li juru rispons qabel Jum 7.
English: The pharmacokinetic parameters in patients with chronic liver disease are shown in Table 6.
Maltese: Il-parametri farmakokinetiċi f'pazjenti b'mard tal-fwied kroniku huma murija f'Tabella 6.
English: You may be monitored for side effects associated with excessive platelets such as blood clots (see section 2, ‘Warnings and precautions', and section 4, ‘Possible side effects').
Maltese: Inti ser tkun immonitorjat għal effetti sekondarji assoċjati ma' żieda eċċesiva ta' plejtlits bħal emboli fid-demm (ara sezzjoni 2, ‘Twissijiet u prekawzjonijiet', u sezzjoni 4, ‘Effetti sekondarji possibbli').
English: Lusutrombopag was not genotoxic when tested in a bacterial reverse mutation test, a chromosomal aberration test with cultured Chinese hamster lung cells, or an in vivo micronucleus test with mouse bone marrow cells.
Maltese: Lusutrombopag ma kienx ġenotossiku meta kien ittestjat f'test tal-mutazzjoni invertita batterjali, f'test tal-aberrazzjoni kromożomali b'ċelluli tal-pulmun kkultivati tal-ħamster Ċiniż, jew f'test tal mikronukleu in vivo fuq ċelluli tal-mudullun tal-ġrieden.
English: There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.
Maltese: Hemm informazzjoni limitata dwar l-użu ta' lusutrombopag f'pazjenti li qabel kienu esposti għal lusutrombopag.
English: The recommended dose is 3 mg lusutrombopag once daily for 7 days.
Maltese: Id-doża rakkomandata hija ta' 3 mg lusutrombopag darba kuljum għal 7 ijiem.
English: The principal toxicity findings associated with lusutrombopag administration included prolongation of PT and APTT (rats), increased activities of plasma ALT and AST (rats and dogs), adrenal toxicity (rats and dogs), skin and forestomach lesions (rats) and renal toxicity (rats).
Maltese: Is-sejbiet prinċipali tat-tossiċità assoċjati mal-għoti ta' lusutrombopag kienu jinkludu d-dewmien ta' PT u APTT (firien), żieda fl-attivitajiet ta' ALT u AST fil-plażma (firien u klieb), tossiċità adrenali (firien u klieb) leżjonijiet fuq il-ġilda u fil-parti ta' quddiem tal-istonku (firien) u tossiċità renali
English: Randomisation was stratified by platelet count at screening/baseline and primary invasive procedure.
Maltese: L-għażla b'mod każwali kienet stratifikata skont l-għadd tal-plejtlits matul l-iskrinjar/linja bażi u proċedura medika invażiva primarja.
English: No effects on foetal viability embryo-foetal development were noted in rabbits at doses up to 1000 mg/kg/day (161 times the human clinical exposures in adults based on AUC).
Maltese: Ma ġew innotati ebda effetti fuq il-vijabilità tal-fetu jew l-iżvilupp embrijofetali fil-fniek b'dożi li jaslu sa 1000 mg/kg/jum (161 aktar l-esponimenti kliniċi tal-bniedem fl-adulti abbażi tal-AUC).
English: In the clinical drug-drug interaction study, co-administration of cyclosporine, a P-gp and BCRP dual inhibitor, increased the Cmax and AUCinf values of lusutrombopag by approximately 20% compared with lusutrombopag administration alone.
Maltese: cyclosporine, inibitur doppju ta' P-gp u BCRP, żied il-valuri ta' Cmax u AUCinf ta' lusutrombopag b'madwar 20% meta mqabbel mal-għoti ta' lusutrombopag waħdu.
English: 0% 67.5% 23.9% (number of subjects)
Maltese: Tel: +44 (0)20
English: Adverse reactions with 3 mg of lusutrombopag once daily for up to 7 days in randomised, doubleblind, placebo-controlled trials in thrombocytopenic patients with chronic liver disease undergoing an invasive procedure (M0626, M0631 and M0634; N=171) are listed in Table 1 by MedDRA System Organ Class.
Maltese: Lista tabulata tar-reazzjonijiet avversi Reazzjonijiet avversi bi 3 mg ta' lusutrombopag darba kuljum għal sa 7 ijiem fi provi fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo li saru fuq pazjenti tromboċitopeniċi b'marda tal-fwied kronika li jkunu għaddejjin minn proċedura medika invażiva (M0626, M0631 u
English: Phase 3 Study M0634
Maltese: Studju M0634 ta' Fażi 3
English: Mulpleo contains the active substance lusutrombopag, which belongs to a group of medicines called thrombopoietin receptor agonists.
Maltese: Mulpleo fih is-sustanza attiva lusutrombopag, li tappartjeni għal grupp ta' mediċini msejħa agonisti tar-riċetturi ta' thrombopoietin.
English: Lusutrombopag acts on the haematopoietic stem cells and on the transmembrane domain of human TPO receptors expressed in megakaryocytes, to stimulate the megakaryocyte to proliferate and differentiate via the similar signal transduction pathway for up-regulating production used by endogenous TPO, thus leading to thrombocytopoiesis.
Maltese: Għandha tkun eżercitata l-kawtela fir-rigward ta' avvenimenti tromboemboliċi wara l-proċeduri mediċi invażivi kif ukoll wara t-trattament irrispettivament mill-għadd tal-plejtlits.
English: No dosage adjustment is necessary for patients with mild (Child-Pugh class A) to moderate (Child-Pugh class B) hepatic impairment.
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'indeboliment epatiku minn ħafif (Child-Pugh Klassi A) sa moderat (Child-Pugh
English: The time course of platelet counts in lusutrombopag-treated subjects without platelet transfusion and placebo-treated subjects with platelet transfusion in Studies M0631 and M0634 is presented in Figure 1.
Maltese: It-tul ta' żmien għall-għadd tal-plejtlits f'individwi ttrattati b'lusutrombopag mingħajr trasfużjoni talplejtlits u individwi ttrattati bi plaċebo bi trasfużjoni tal-plejtlits fi Studji M0631 u M0634 hu ppreżentat f'Figura 1.
English: Each box contains 7 film-coated tablets.
Maltese: Kull kaxxa fiha 7 pilloli miksija b'rita.
English: Meanwhile, the short thoracolumbar supernumerary ribs were observed at doses without maternal toxicity.
Maltese: Sadanittant, in-numru iktar minnormal ta' kustilji torakolumbari qosra kien osservat b'dożi mingħajr tossiċità materna.
English: On the basis of the results, the no observed adverse effect level (NOAEL) was estimated to be near 4 mg/kg/day in the embryo-foetal development study in rats (23 times the human clinical exposures in adults based on AUC).
Maltese: 4 mg/kg/jum fl-istudju tal-iżvilupp embrijofetali fil-firien (23 darba aktar l-esponimenti kliniċi talbniedem fl-adulti abbażi tal-AUC).
English: Proportion of subjects who required no platelet transfusion during the study (Day 1 through Day 35) The proportion of subjects who required no platelet transfusion during the study was significantly greater in the lusutrombopag groups in the individual studies and the pooled (Studies M0631 and M0634) lusutrombopag group compared with placebo (Table 3).
Maltese: Il-proporzjon ta' individwi li ma kienu jeħtieġu l-ebda trasfużjoni tal-plejtlits matul l-istudju kien akbar b'mod sinifikanti fil-gruppi ta' lusutrombopag fl-istudji individwali u fil-grupp miġbur ta' lusutrombopag (Studji M0631 u M0634) meta mqabbel mal-plaċebo (Tabella 3).
English: Two Phase 3, randomised, double-blind, placebo-controlled studies were conducted to evaluate lusutrombopag versus placebo in thrombocytopenic (platelet count < 50,000/µL) subjects with chronic liver disease (Child-Pugh class A and B), undergoing elective invasive procedures (excluding laparotomy, thoracotomy, craniotomy, open-heart surgery, organ resection, or partial organ resection) in Japan (M0631 (L-PLUS 1)) and multiple countries (M0634 (L-PLUS 2)).
Maltese: Żewġ studji ta' Fażi 3, fejn il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollati bil-plaċebo, ġew imwettqa biex jiġu evalwati lusutrombopag kontra plaċebo f'individwi tromboċitopeniċi (għadd tal-plejtlits < 50,000/µL) b'marda tal-fwied kronika (Child-Pugh klassi A u B), li jkunu għaddejjin minn proċeduri mediċi invażivi mhux obbligatorji (esklużi laparotomija, torakotomija, kranjotomija,
English: Each film-coated tablet contains 3 mg lusutrombopag.
Maltese: Kull pillola miksija b'rita fiha 3 mg ta' lusutrombopag.
English: Placebo N =48
Maltese: N =48
English: Lusutrombopag is a substrate of P-gp and BCRP, but is not a substrate of OATP1B1, OATP1B3 or OCT1.
Maltese: Lusutrombopag huwa substrat ta' P-gp u BCRP, iżda mhux substrat ta' OATP1B1, OATP1B3 jew
English: In rats, there were adverse effects of lusutrombopag on foetal intrauterine growth and skeletal morphology as follows: a suppression of foetal intrauterine growth (low foetal body weight and a decrease in the number of ossified sternebrae) at 80 mg/kg/day, and an high incidence of short cervical supernumerary ribs at 40 mg/kg/day or more, and an high incidence of short thoracolumbar supernumerary rib at 4 mg/kg/day or more.
Maltese: (piż tal-ġisem baxx tal-fetu u tnaqqis fin-numru ta' sternebrae ossifikati) b'doża ta' 80 mg/kg/jum, u inċidenza għolja ta' numru iktar min-normal ta' kustilji ċervikali qosra b'doża ta' 40 mg/kg/jum jew aktar, u inċidenza għolja ta' numru iktar min-normal ta' kustilji torakolumbari qosra b'doża ta'
English: Lusutrombopag is not considered to affect the pharmacokinetics of co-administered medicinal products that are substrates of these enzymes or transporters.
Maltese: Lusutrombopag mhux ikkunsidrat li jaffettwa l-farmakokinetika ta' prodotti mediċinali li jingħataw flimkien li huma sottostrati ta' dawn l-enzimi jew trasportaturi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Shionogi
Maltese: KONDIZZJONIJIET U REKWIŻITI OĦRA TAL-AWTORIZZAZZJONI
English: The proportion of subjects who required no platelet transfusion prior to the primary invasive procedure and no rescue therapy for bleeding from randomisation through 7 days after the primary invasive procedure was statistically significantly greater in the lusutrombopag group compared with placebo group for the individual study and pooled analyses (Table 2).
Maltese: Il-proporzjon ta' individwi li ma kienu jeħtieġu l-ebda trasfużjoni talplejtlits qabel il-proċedura medika invażiva primarja u l-ebda terapija ta' salvataġġ għal ħruġ ta' demm mill-għażla b'mod każwali sa 7 ijiem wara l-proċedura medika invażiva primarja kien akbar b'mod statistikament sinifikanti fil-grupp ta' lusutrombopag meta mqabbel mal-grupp tal-plaċebo għallistudju individwali u l-analiżi miġbura (Tabella 2).
English: Studies in animals have shown lusutrombopag is secreted in the milk of lactating rats (see section 5.3).
Maltese: Dan il-prodott mediċinali jista' jkun ta' theddida għall-ambjent (ara sezzjoni 5.5).
English: The pharmacokinetics of lusutrombopag was similar in both healthy subjects and the chronic liver disease population.
Maltese: Il-farmakokinetika ta' lusutrombopag kienet simili kemm fl-individwi b'saħħithom u kif ukoll fil-popolazzjoni tal-marda tal-fwied kronika.
English: Table 1 Adverse reactions System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: The full EPAR for Nexium Control can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ għal Nexium Control jista' jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Nexium Control is a medicine that contains the active substance esomeprazole.
Maltese: Nexium Control huwa mediċina li fiha s-sustanza attiva esomeprazole.
English: This is a summary of the European public assessment report (EPAR) for Nexium Control.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Nexium Control.
English: The active substance in Nexium Control, esomeprazole, is a proton pump inhibitor.
Maltese: Is-sustanza attiva f'Nexium Control, esomeprazole, hija inibitur tal-pompa tal-protons.
English: Nexium Control has been compared with placebo (a dummy treatment) in two main studies involving 718 adult patients with reflux symptoms including heartburn.
Maltese: Nexium Control tqabbel ma' plaċebo (kura finta) f'żewġ studji ewlenin li involvew lil 718-il pazjent adult b'sintomi ta' rifluss inkluż ħruq ta' stonku.
English: Nexium Control is similar to a ‘reference medicine' already authorized in the European Union (EU) containing the same active substance, called Nexium.
Maltese: Nexium Control huwa simili għal 'mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li fiha l-istess sustanza attiva, imsejħa Nexium.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nexium Control on 26 August 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Nexium Control fis-26 ta' Awwissu 2013.
English: In the first study, around 34% of patients taking a 20 mg dose of Nexium Control (41 out of 121) had no more heartburn symptoms, compared with around 14% of patients taking placebo (17 out of 124).
Maltese: Fl-ewwel studju, madwar 34% tal-pazjenti li kienu qed jieħdu doża ta' 20 mg ta' Nexium Control (41 minn 121) ma kellhom ebda sintomu ta' ħruq ta' stonku, meta mqabbel ma' madwar 14% tal-pazjenti li kienu qed jieħdu plaċebo (17 minn 124).
English: Headache, abdominal pain, diarrhoea and nausea are among the most common side effects with Nexium Control (which may affect up to 1 in 10 patients).
Maltese: Uġigħ ta' ras, uġigħ addominali, dijarrea u dardir huma fost l-aktar effetti sekondarji komuni b'Nexium Control (li jistgħu jaffettwaw sa pazjent 1 minn kull 10).
English: Why is Nexium Control approved?
Maltese: Għal xiex ġie approvat Nexium Control?
English: In the second study, around 42% of patients taking Nexium Control (47 out of 113) had no more heartburn symptoms, compared with around 12% of patients taking placebo (14 out of 118).
Maltese: Fit-tieni studju, madwar 42% tal-pazjenti li kienu qed jieħdu doża ta' 20 mg ta' Nexium Control (47 minn 113) ma kellhom ebda sintomu ta' ħruq ta' stonku, meta mqabbel ma' madwar 12% tal-pazjenti li kienu qed jieħdu plaċebo (14 minn 118).
English: A risk management plan has been developed to ensure that Nexium Control is used as safely as possible.
Maltese: Pjan ta' ġestjoni tar-riskju ġie żviluppat biex jassigura li Nexium Control jintuża bl-aktar mod sigur possibbli.
English: The CHMP concluded that the medicine's effects were already well established, as esomeprazole-containing medicines have been authorised in EU countries since 2000, and that its short-term benefits had been demonstrated in studies where most patients' symptoms cleared up in 2 weeks.
Maltese: Is-CHMP ikkonkluda li leffetti tal-mediċina diġà kienu ġew stabbiliti sew, minħabba li mediċini li fihom esomeprazole ilhom awtorizzati fil-pajjiżi tal-UE sa mis-sena 2000, u li l-benefiċċji fuq perjodu ta' żmien qasir tagħha intwerew fi studji fejn ħafna mis-sintomi tal-pazjenti għebu fi żmien ġimagħtejn.
English: Nexium Control must not be used together with another medicine called nelfinavir (used to treat HIV infection).
Maltese: Nexium Control ma għandux jintuża flimkien ma' mediċina oħra msejħa nelfinavir (użata fil-kura ta' infezzjoni tal-HIV).