FrancophonIA/ELRC3.0 huggingface dataset:
English: Cimetidine used to relieve the symptoms of stomach and duodenal ulcers, oesophageal reflux disease and the Zollinger-Ellison syndrome
Maltese: ulċeri fl-istonku u duwodenali, itaffi lmarda tar-rifluss esofagali u jtaffi ssindrome ta' Zollinger-Ellison
English: As generally recommended in such situations, if vomiting occurs less than 30 minutes following administration of AMGLIDIA, a new dose can be given.
Maltese: Kif ikun ġeneralment rakkomandat f'tali sitwazzjonijiet, jekk ikun hemm rimettar inqas minn 30 minuta wara li jkun ingħata AMGLIDIA, tista' tingħata doża ġdida.
English: The average dose reported in the literature (clinical trials and case reports) is of approximately 0.5 mg/kg/day.
Maltese: Id-doża medja rrappurtata fil-letteratura (provi kliniċi u rapporti tal-każijiet) hija ta' madwar 0.5 mg/kg/jum.
English: H2-receptor antagonists used for reducing stomach acid (such as ranitidine) to relieve the symptoms of stomach and duodenal ulcers, oesophageal reflux disease and the Zollinger-Ellison syndrome
Maltese: Antagonisti tar-riċettur H2 użati biex jitnaqqas l-aċidu fl-istonku (bħal pereżempju ranitidine) biex itaffu s-sintomi ta' ulċeri fl-istonku u duwodenali, itaffu lmarda tar-rifluss esofagali u jtaffu ssindrome ta' Zollinger-Ellison
English: The following adverse reactions have been observed in a clinical study (Neogli study).
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew osservati fi studju kliniku (l-istudju Neogli).
English: Contains sodium and benzoate, see leaflet for further information.
Maltese: Fih is-sodium u l-benzoate, ara l-fuljett għal aktar informazzjoni.
English: Medicines
Maltese: Mediċini
English: Throughout the transfer period, administer bolus insulin or insulin pump boluses with meals as required to maintain reasonable glycemic control.
Maltese: Matul il-perjodu ta' trasferiment, agħti insulina bolus jew bolusis bil-pompa tal insulina mal-ikel kif meħtieġ biex iżżomm kontroll gliċemiku raġonevoli.
English: From week 2 onward, if capillary blood glucose is ≥7 mmol/L increase AMGLIDIA by 0.2 mg/kg/day and reduce insulin.
Maltese: Minn ġimgħa 2 'il quddiem, jekk il-glucose fid-demm kapillari jkun ≥7 mmol/L, żid AMGLIDIA b'0.2 mg/kg/jum u naqqas l-insulina.
English: Interactions of AMGLIDIA with other medicines are presented in the table below:
Maltese: L-interazzjonijiet ta' AMGLIDIA ma' mediċini oħra huma elenkati fit-tabella hawn taħt:
English: After oral administration, glibenclamide is absorbed rapidly and induces its effect within 2.5 hours with a duration of up to 15 hours, although the elimination half-life is 5 to 10 hours.
Maltese: Wara li jingħata mill-ħalq, glibenclamide jiġi assorbit malajr u jinduċi l-effett tiegħu fi żmien 2.5 sigħat b'dewmien sa 15-il siegħa, għalkemm l-eliminazzjoni tal-half-life hi 5 sa 10 sigħat.
English: The exposures were respectively similar for the two glibenclamide oral suspensions, and greater than those observed after administration of crushed Daonil tablets.
Maltese: L-esponimenti kienu rispettivament simili għaż-żewġ glibenclamide suspensjonijiet orali, u ikbar minn dawk osservati wara l-għoti ta' Daonil pilloli mfarrka.
English: The elimination half-lives were similar for the two suspensions (almost 8 hours) and a little shorter than those observed with the crushed Daonil tablets.
Maltese: Il-half-lives tal-eliminazzjoni kienu simili għaż-żewġ suspensjonijiet (kważi 8 sigħat) u ftit iqsar minn dawk osservati b'Daonil pilloli mfarrka.
English: Phenothiazine derivatives Weakening of the blood-glucoselowering effect
Maltese: Derivattivi talphenothiazine
English: A large international long-term term study of treatment for neonatal diabetes due to KCNJ11 mutations is ongoing and results were reported in 81 patients of the 90 patients originally included with a median [interquartile range] follow-up duration of 10.2 years [9.3-10.8 years].
Maltese: Għaddej studju internazzjonali kbir fuq terminu twil dwar it-trattament ta' dijabete fit-trabi tat-twelid minħabba mutazzjonijiet KCNJ11 u ġew irrappurtati riżultati f'81 pazjent mid-90 pazjent li oriġinarjament ġew inklużi b'dewmien ta' segwitu medjan [medda interkwartili] ta' 10.2 snin [9.3
English: White, odourless suspension.
Maltese: Suspensjoni bajda, bla riħa.
English: Calcium channel blockers (such as nifedipine used to treat high blood pressure)
Maltese: Imblokkaturi tal-kanali tal-kalċju (bħal pereżempju nifedipine użat għat-trattament tal-pressjoni tad-demm għolja.
English: Effect of interaction
Maltese: Effett tal-interazzjoni
English: Diuretics
Maltese: infezzjonijiet
English: Animal studies do not indicate a teratogenic potential.
Maltese: Studji fl-annimali ma jindikawx potenzjal teratoġeniku.
English: Increase ciclosporin plasma concentration
Maltese: Tiżdied il-konċentrazzjoni tal-plażma ta' ciclosporin
English: Beta-receptor blockers Potentiation of the blood-glucose lowering
Maltese: Imblokkaturi tar reċetturi beta
English: Hypoglycaemia can occur under treatment with hypoglycaemic sulphonamides.
Maltese: Kull siringa hi inkluża fi preżentazzjoni speċifika.
English: ACE inhibitors
Maltese: Inibituri ACE
English: • Amglidia is available in four different boxes corresponding to four different presentations (four different strengths): One box for the 0.6 mg/mL strength with one 1mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 0.6 mg/mL strength with one 5 mL syringe: yellow colour for outer carton and reverse type yellow colour for label One box for the 6 mg/mL strength with one syringe of 1 mL: purple colour for outer carton and reverse type purple colour for label One box for the 6 mg/mL strength with one syringe of 5 mL: purple colour for outer carton and reverse type purple colour for label
Maltese: Kaxxa waħda għall-qawwa ta' 6 mg/mL b'siringa waħda ta' 1mL: kartuna ta' barra vjola u vjola tat-tip invertit għat-tikketta
English: Large doses of laxatives (such as macrogol) Increased blood sugar levels MAO inhibitors (such as iproniazide) used to treat depression
Maltese: Inibituri MAO (bħal pereżempju iproniazide) użati għat-trattament ta'
English: Transfer to sulfonylureas occurred in childhood with a median [IQR] at transfer of 4.8 years [1.7 - 11.4 years].
Maltese: It-trasferiment għal sulfonylureas seħħ fit-tfulija b'[IQR] medjan fi trasferiment ta' 4.8 snin
English: To avoid exceeding sodium benzoate acceptable daily dose, AMGLIDIA daily dose should not exceed 1 mL/kg/day.
Maltese: Biex jiġi evitat li tinqabeż id-doża aċċettabbli ta' kuljum ta' sodium benzoate , id-doża ta' kuljum ta' AMGLIDIA m'għandhiex taqbeż 1 mL/kg/jum.
English: Skin and subcutaneous tissue disorders
Maltese: Telf tal-kulur tas-snien
English: Ciclosporin used to prevent rejection of the transplanted organ
Maltese: Ciclosporin użat għall-prevenzjoni tar-rifjut tal-organu trapjantat
English: Oral glucose tolerance tests and intravenous glucose tolerance tests revealed good insulin response to glucose and maintained incretin effect after ten years.
Maltese: Ittestijiet tat-tolleranza tal-glucose orali u t-testijiet tat-tolleranza tal-glucose ġol-vini wrew rispons tajjeb tal-insulina għall-glucose u żammew effett ta' incretin wara għaxar snin.
English: One bottle of 30 ml suspension and one oral syringe of 1 mL packed in an individual bag and one syringe adaptor.
Maltese: Flixkun wieħed bi 30 ml suspensjoni u siringa orali waħda ta' 1 mL ippakkjata f'borża individwali u adapter wieħed tas-siringa.
English: Diarrhea, nausea and vomiting
Maltese: Dijarea, dardir u rimettar
English: Glibenclamide, a second-generation, short half-life sulphonylurea, is a hypoglycaemic agent that reduces blood-glucose by stimulating insulin release by the pancreas; this effect depends on the presence of active beta-cells or beta-cells made active by glibenclamide in the pancreatic islets in certain cases of neonatal diabetes.
Maltese: Effetti farmakodinamiċi Glibenclamide, sulphonylurea tat-tieni ġenerazzjoni, b'half-life qasira hu aġent ipogliċemiku li jnaqqas iz-zokkor fid-demm billi jistimula r-rilaxx tal-insulina mill-frixa; dan l-effett jiddependi mill preżenza ta' ċelloli beta attivi jew ta' ċelloli beta li jsiru attivi bi glibenclamide fil-gżejjer pankreatiċi f'ċerti każijiet ta' dijabete fit-trabi tat-twelid.
English: The starting dose of AMGLIDIA is 0.2 mg of glibenclamide for each kilogram (kg) of body weight daily, divided in two doses of 0.1 mg/kg.
Maltese: Id-dożi ta' kuljum varjaw minn 0.1 sa 0.8 mg/kg għal glibenclamide pilloli (doża medjana, 0.3 mg/kg)
English: One bottle of 30 ml suspension and one oral syringe of 5 mL packed in an individual bag and one syringe adaptor.
Maltese: Flixkun wieħed bi 30 ml suspensjoni u siringa orali waħda ta' 5 mL ippakkjata f'borża individwali u adapter wieħed tas-siringa.
English: If you stop giving AMGLIDIA
Maltese: AMGLIDIA suspensjoni..
English: Dose adjustment is required in patients with mild to moderate renal impairment (refer to section 4.2).
Maltese: Hemm ħtieġa ta' aġġustament tad-doża f'pazjenti b'insuffiċjenza tal-kliewi ħafifa sa moderata (irreferi għal sezzjoni 4.2).
English: Increase liver enzymes
Maltese: insuffiċjenza fit-testosterone)
English: • If the patient is prescribed a different presentation, the prescriber should highlight to the patient the packaging differences between the different presentations (focus on colour differentiation, warning statements on carton, thickness and length of the provided syringe).
Maltese: • Jekk il-pazjent tingħatalu riċetta tat-tabib bi preżentazzjoni differenti, il-preskrivent għandu jenfasizza lill-pazjent id-differenzi fl-ippakkjar bejn il-presentazzjonijiet differenti (fokus fuq id-differenzjazzjoni tal-kulur, id-dikjarazzjonijiet ta' twissija fuq il-kaxxa, il-ħxuna u t-tul tassiringa provduta).
English: Biliary excretion of the metabolites increases in the event of kidney failure, proportionally to the severity of the change in renal function.
Maltese: L-eliminazzjoni biljari tal-metaboliti tiżdied f'każ li jkun hemm falliment tal-kliewi, proporzjonalment għas-severità tal-bidla fil-funzjoni tal-kliewi.
English: Barbiturates
Maltese: Barbituriċi
English: Published data from 11 glibenclamide-treated mothers indicate that glibenclamide is not excreted in human milk and hypoglycemia in the breast-fed newborns was not reported.
Maltese: Data ppubblikata minn 11-il omm ittrattata bi glibenclamide tindika li glibenclamide ma jitneħħiex fil ħalib tal-bniedem u l-ipogliċemija fi trabi tat-twelid imreddgħin ma ġietx irrappurtata.
English: Under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine, and reserpine, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.
Maltese: clonidine, guanethidine u reserpine, is-sinjali tal-kontroregolazzjoni adrenerġika għall-ipogliċemija jistgħu jitnaqqsu jew jgħibu.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Pregnancy and breast-feeding
Maltese: Disturbi fil-metaboliżmu u n nutrizzjoni
English: Reduction of AMGLIDIA dose should be anticipated by the treating physician and certainly if the glucose values are going below 4 mmol/L (72 mg/dL).
Maltese: It-tnaqqis tad-doża ta' AMGLIDIA għandu jiġi antiċipat mit-tabib li jkun qed jikkura u ċertament jekk il-valuri tal-glucose jkunu qed jinżlu taħt 4 mmol (72 mg/dL).
English: Tell your doctor or pharmacist if you notice any of the following side effects: - Skin rash: itching, nettle rash (urticarial), allergic skin reaction, blistering of the skin, skin inflammation.
Maltese: - Raxx fil-ġilda, ħakk, ħorriqija (urtikarjali), reazzjoni allerġika fil-ġilda, infafet fuq il-ġilda,
English: AMGLIDIA has moderate influence on the ability to drive and use machines since glibenclamide may increase the risk of hypoglycaemia.
Maltese: AMGLIDIA għandu influwenza moderata fuq il-ħila li ssuq u tħaddem magni billi glibenclamide jista' jżid ir-riskju ta' ipogliċemija.
English: Tooth discoloration
Maltese: Rimettar Dispepsja
English: Hypoglycaemia may occur when taking other medicinal products.
Maltese: Jista' jkun hemm ipogliċemija meta jittieħdu prodotti mediċinali oħra.
English: The 1 mL oral syringe is thin and small while the 5 mL syringe is thick and long.
Maltese: Is-siringa orali ta' 1 mL hi rqiqa u żgħira waqt li s-siringa ta' 5 mL hi ħoxna u twila.
English: There is a risk of hypoglycaemia.
Maltese: Hemm riskju ta' ipogliċemija.
English: Weakening of the blood-glucose
Maltese: Tisħiħ jew indeboliment tal-effett tat tnaqqis tal-glucose fid-demm
English: - Transient visual disturbances.
Maltese: Mhux applikabbli.
English: Potentiation of the blood-glucose
Maltese: Livelli miżjudin tal-glucose fid-demm
English: As the dose is increased, it is usually possible to reduce and then stop the insulin dose.
Maltese: Hekk kif tiżdied id-doża, normalment ikun possibbli li d-doża tal-insulina titnaqqas imbagħad titwaqqaf.
English: Inpatient treatment introduction
Maltese: TAL-PRODOTT MEDIĊINALI
English: tiotropium, indacaterol.
Maltese: eż. tiotropium, indacaterol.
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street
Maltese: Glaxo Operations UK Ltd (tinnegozja bħala Glaxo Wellcome Operations) Priory Street
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Maltese: Glaxo Wellcome Production Żona Industrijali Nru 2, 23 Rue Lavoisier, 27000 Evreux, Franza
English: Interaction with CYP2D6 inhibitors/CYP2D6 polymorphism
Maltese: Interazzjoni ma' inibituri ta' CYP2D6/CYP2D6 polymorphism
English: • inflammation of the lungs (bronchitis)
Maltese: • infajmmazzjoni tal-pulmun (bronkite)
English: Trelegy vs.
Maltese: Tqabbil Trelegy vs.
English: Systemic corticosteroid effects
Maltese: Effetti tal-kortikosterojdi sistemiċi
English: Table 2 - Lung function endpoint in IMPACT
Maltese: Tabella 2 - End-point tal-funzjoni tal-pulmun f'IMPACT
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 15 ta' Novembru 2018
English: Umeclidinium is a substrate of cytochrome P450 2D6 (CYP2D6).
Maltese: Umeclidinium huwa substrat taċ-ċitokromu P450 2D6 (CYP2D6).
English: Fluticasone furoate, umeclidinium and vilanterol are substrates of the P-glycoprotein transporter (P-gp).
Maltese: Fluticasone furoate, umeclidinium u vilanterol huma substrati tat-trasportatur tal-glikoproteina P (P-gp).
English: Treatment difference 95% CI
Maltese: Differenza fil-kura 95% CI Tqabbil Trelegy vs.
English: Treatment difference (95% CI) Comparison with BUD/FOR
Maltese: Differenza fil-kura (95% CI) Tqabbil ma' BUD/FOR
English: The inhaler is a multi-component device composed of polypropylene, high density polyethylene, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate and stainless steel.
Maltese: L-inalatur huwa strument multi-komponenti magħmul minn polypropylene, polyethylene ta' densità għolja, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate u azzar inossidabbli.
English: Interaction with CYP3A4 inhibitor
Maltese: Interazzjoni ma' inibitur ta' CYP3A4
English: See section 4 ‘Possible side effects' for information on symptoms to look out for while you are using this medicine.
Maltese: Ara sezzjoni 4, “Effetti sekondarji possibbli” għal informazzjoni dwar sintomi li inti għandek toqgħod attent/a għalihom waqt li tkun qed tuża din il-mediċina.
English: Comparison Trelegy vs. UMEC/VI
Maltese: FF/VI and FF/UMEC/VI vs.
English: BUD/FOR (N=899)
Maltese: (N=899)
English: Supraventricular tachyarrhythmia Tachycardia
Maltese: Takiarritmija supraventikulari Takikardija
English: The pharmacologic effects of beta2-adrenergic agonists, including vilanterol, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Maltese: L-effetti farmakoloġiċi tal-agonisti beta2 adrenerġiċi, inkluż vilanterol, huma tal-anqas parzjalment attribwibbli lillistimulazzjoni tal-adenylate cyclase ġoċ-ċelloli, l-enzima li tikkatalizza l-konverżjoni ta' adenosine triphosphate (ATP, adenosine triphosphate) fi 3',5'-adenosine monophosphate ċikliku (AMP ċikliku).
English: Co-administration increased mean fluticasone furoate AUC(0-24) and Cmax by 36% and 33%, respectively.
Maltese: L-għoti flimkien żied l-AUC(024) u s-Cmax medji ta' fluticasone furoate b'36% u 33%, rispettivament.
English: The most frequently reported adverse reactions with Trelegy Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktkar mod frekwenti b'Trelegy Ellipta kienu nażofarinġite (7%), uġigħ ta' ras (5%) u infezzjoni fl-apparat respiratorju ta' fuq (2%).
English: EU/1/17/1236/002
Maltese: EU/1/17/1236/001 EU/1/17/1236/002
English: An overdose will likely produce signs, symptoms or adverse effects associated with the individual components' pharmacological actions (e.g. Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, dry mouth, visual accommodation disturbances, tachycardia, arrhythmias, tremor, headache, palpitations, nausea, hyperglycaemia and hypokalaemia).
Maltese: Doża eċċessiva aktarx se tipproduċi sinjali, sintomi jew reazzjonijiet avversi assoċjati mal-azzjonijiet farmakoloġiċi tal-komponenti individwali (eż. sindrome ta' Cushing, karatteristiċi ta' Cushing, soppressjoni adrenali, tnaqqis fid-densità minerali tal-għadam, ħalq xott, disturbi tal-akkomodazzjoni viżwali, takikardija, arritmiji, rogħda, uġigħ ta' ras, palpitazzjonijiet, nawsja, ipergliċemija u ipokalimja).
English: What Trelegy Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Maltese: Is-sustanzi attivi huma fluticasone furoate, umeclidinium bromide u vilanterol.
English: The primary metabolic route for fluticasone furoate is hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Maltese: Ir-rotta metabolika primarja għal fluticasone furoate hija idroliżi tal-grupp ta' S-fluoromethyl carbothioate f'metaboliti b'attività kortikosterojdi konsiderevolment imnaqqsa.
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax by 65% and 22%, respectively.
Maltese: L-għoti flimkien żied l-AUC(0-t) u s-Cmax medji ta' vilanterol b'65 % u 22 %, rispettivament.
English: The other ingredients are lactose monohydrate (see section 2 under ‘Trelegy Ellipta contains lactose') and magnesium stearate.
Maltese: L-ingredjenti l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt ‘Trelegy Ellipta fih lactose') u magnesium stearate.
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Trelegy Ellipta (92/55/22 micrograms) with fluticasone furoate/vilanterol 92/22 micrograms (FF/VI) and umeclidinium/vilanterol 55/22 micrograms (UMEC/VI).
Maltese: IMPACT (CTT116855) kien studju ta' 52 ġimgħa (N=10,355), li qabbel Trelegy Ellipta (92/55/22 mikrogramma) ma' fluticasone furoate/vilanterol 92/22 mikrogramma (FF/VI) u umeclidinium/vilanterol 55/22 mikrogramma (UMEC/VI).
English: A repeat dose study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and ketoconazole (400 milligrams, a strong CYP3A4 inhibitor).
Maltese: Sar studju b'dożi ripetuti f'individwi b'saħħithom bil-kombinazzjoni ta' fluticasone furoate/vilanterol (184/22 mikrogramma) u ketoconazole (400 milligramma, inibitur qawwi ta' CYP3A4).
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita billi tintuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Maltese: L-effetti tal-età fuq il-farmakokinetika ta' fluticasone furoate, umeclidinium u/vilanterol ġew ivvalutati flanaliżi farmakokinetika tal-popolazzjoni.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44
Maltese: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: The fluticasone furoate/vilanterol component of Trelegy Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Maltese: Il-komponent fluticasone furoate/vilanterol ta' Trelegy Ellipta ġie vvalutat f'pazjenti bis-severitajiet kollha ta' indebboliment tal-fwied (Child-Pugh A, B jew C).
English: Trelegy Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Trelegy Ellipta jintuża għall-kura ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti.
English: Trough FEV1 (L) at Week 24, LS mean change from baseline (SE)a
Maltese: FEV1 minimu (L) f'Ġimgħa 24, bidla medja ta' LS mil-linja bażi (SE)
English: Respiratory, thoracic & mediastinal disorders
Maltese: Disturbi respiratorji , toraċiċi u medjastinali
English: The incidence of pneumonia with Trelegy Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Maltese: L-inċidenza ta' pulmonite b'Trelegy Ellipta hija kumparabbli ma' dik osservata fil-fergħa fluticasone furoate/vilanterol (FF/VI) 100/25 tal-istudji kliniċi ta' FF/VI fis-COPD.
English: The absolute bioavailability of inhaled vilanterol was 27%, with negligible contribution from oral absorption.
Maltese: Il-bijodisponibilità assoluta ta' vilanterol li jittieħed man-nifs kienet ta' 27 %, b'kontribuzzjoni negliġibbli mill-assorbiment orali.
English: Fluticasone furoate/umeclidinium/vilanterol is a combination of inhaled synthetic corticosteroid, long-acting muscarinic receptor antagonist and long-acting beta2-adrenergic agonist (ICS/LAMA/LABA).
Maltese: Fluticasone furoate/umeclidinium/vilanterol huwa kombinazzjoni ta' kortikosterojde sintetiku, riċettur muskariniku li jaġixxi fit-tul u agonist beta2-adrenerġiku li jaġixxi fit-tul li jitteħdu bin-nifs (ICS/LAMA/LABA).
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Trelegy Ellipta, 5 of 4,134 patients (1.7 per 1,000 patient-years) receiving fluticasone furoate/vilanterol, and 5 of 2,070 patients (2.9 per 1,000 patient-years) receiving umeclidinium/vilanterol.
Maltese: Pulmonite fatali seħħet fi 12 minn 4,151 pazjent (3.5 għal kull 1,000 snin ta' pazjent) li rċivew Trelegy Ellipta, 5 minn 4,134 pazjent (1.7 għal kull 1,000 snin ta' pazjent) li rċivew fluticasone furoate/vilanterol, u 5 minn 2,070 pazjent (2.9 għal kull 1,000 snin ta' pazjent) li rċivew umeclidinium/vilanterol.
English: Use Trelegy Ellipta regularly
Maltese: Uża Trelegy Ellipta regolarment
English: In FULFIL, Trelegy Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Maltese: F'FULFIL, Trelegy Ellipta tejjeb is-sintomi ta' kuljum ta' COPD kif ivvalutat mill-punteġġ totali ta' E-RS: COPD, meta mqabbel ma' BUD/FOR (tnaqqis ta' ≥2 unitajiet mil-linja bażi).
English: In IMPACT, Trelegy Ellipta significantly improved (p<0.001) lung function when compared with FF/VI and UMEC/VI over a 52-week period (See Table 2).
Maltese: F'IMPACT, Trelegy Ellipta tejjeb sinifikament (p<0.001) il-funzjoni tal-pulmun meta mqabbel ma' FF/VI u UMEC/VI fuq perjodu ta' 52 ġimgħa (Ara Tabella 2).