FrancophonIA/ELRC3.0 huggingface dataset:
English: Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Maltese: Jekk seħħet espożizzjoni għall-AIIRAs mit-tieni trimestru tat-tqala, huwa rrakkomandat kontroll bl-ultrasound tal-funzjoni renali u tal-kranju.
English: Renal impairment and kidney transplantation: when Irbesartan Zentiva is used in patients with impaired renal function, a periodic monitoring of potassium and creatinine serum levels is recommended.
Maltese: Indeboliment renali u trapjant tal-kliewi: meta Irbesartan Zentiva jintuża f'pazjenti b'indeboliment renali, hija irrikmandata osservanza perjodika tal-livelli tal-potassju u tal-krejatinina fis-serum.
English: Plasma protein binding is approximately 96%, with negligible binding to cellular blood components.
Maltese: L-irbit mal-proteini tal-plażma kien madwar 96%, b'irbit negliġibbli ma' komponenti ċellulari tad-demm.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Maltese: Taħżinx f'temperatura'l fuq minn 30°C.
English: Potassium supplements and potassium-sparing diuretics: based on experience with the use of other medicinal products that affect the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e.g. heparin) may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Maltese: Supplimenti tal-potassium u dijuretiċi potassium-sparing: ibbażat fuq l-esperjenza bl-użu ta' prodotti mediċinali oħra li jaffettwaw lis-sistema ta' renin-angiotensin, l-użu konkomitanti ta' dijuretiċi potassium-sparing, supplimenti tal-potassium, sostituti tal-melħ li fihom il-potassium jew prodotti mediċinali oħra li jżidu il-livelli tal-potassium fis-serum (eż. ħeparina) jistgħu jwasslu għal żidiet tal-potassium fis-serum u, għalhekk, mhumiex irrikmandati (ara sezzjoni 4.4).
English: CHINOIN PRIVATE CO. LTD. Lévai u.5.
Maltese: Ma jgħoddx f'dan il-każ.
English: The demonstration of renal benefit of Irbesartan Zentiva in hypertensive type 2 diabetic patients is based on studies where irbesartan was used in addition to other antihypertensive agents, as needed, to reach target blood pressure (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: Il-benefiċċju renali muri b'Irbesartan Zentiva f'pazjenti b'dijabete ta' tip 2 li għandhom pressjoni għolja huwa bbażat fuq studji fejn irbesartan intuża flimkien ma' mediċini oħra ta' kontra lpressjoni għolja kif meħtieġ, biex jintlaħaq il-livell mixtieq ta' pressjoni (ara sezzjoni jiet 4.3, 4.4, 4.5 u 5.1).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg tablets irbesartan NAME OF THE MARKETING AUTHORISATION HOLDER Zentiva k.s.
Maltese: Informazzjoni għall-utent Irbesartan Zentiva 75 mg pilloli miksijin b'rita irbesartan
English: There is no clinically important effect on serum uric acid or urinary uric acid secretion.
Maltese: M'hemmx effett ta' importanza klinika fil-livelli tal-uric acid fis-serum jew fil-ħruġ tal-uric acid 'mal-awrina.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 300 mg film-coated tablets.
Maltese: Informazzjoni għall-utent Irbesartan Zentiva 300 mg pilloli irbesartan
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 150 mg tablets.
Maltese: Irbesartan Zentiva 150 mg pilloli.
English: Diabetes Mellitus (IRMA 2)” shows that irbesartan 300 mg delays progression to overt proteinuria in patients with microalbuminuria.
Maltese: L-istudju ta' “L-effetti ta' Irbesartan fuq il-Mikroalbuminuria fil-Pazjenti bi Pressjoni Għolja b'Tip 2 ta' Diabete Mellitus (IRMA)” juri li irbesartan 300 mg jittardja il-progressjoni għal proteinuria li tidher f'pazjenti b'mikroalbuminuria.
English: However, there was no difference in the half-life and accumulation of irbesartan.
Maltese: Madanakollu, ma kienx hemm differenza fil-half-life u lakkumulazzjoni t'irbesartan.
English: Investigations:
Maltese: Sími:
English: NAME OF THE MEDICINAL PRODUCT Irbesartan Zentiva 75 mg film-coated tablets.
Maltese: Informazzjoni għall-utent Irbesartan Zentiva 75 mg pilloli irbesartan
English: The marketing authorisation holder should demonstrate therapeutic equivalence based on a clinical and bioanalytical study performed in compliance with GCP requirements.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu juri ekwivalenza terapewtika bbażata fuq studju kliniku u bijoanalitiku li jsir f'konformità mar-rekwiżiti tal-GCP.
English: New clinical and bioanalytical studies are performed and submitted to the relevant national competent authorities.
Maltese: Isiru studji kliniċi u bijoanalitiċi ġodda u dawn jiġu sottomessi lill-awtoritajiet nazzjonali kompetenti.
English: Prior to the lifting of the suspension of the marketing authorisations, the national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Maltese: Qabel it-tneħħija tas-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq, l-awtoritajiet nazzjonali kompetenti, ikkoordinati mill-Istat Membru ta' Referenza, għandhom jiżguraw li l-kundizzjonijiet li ġejjin jiġu ssodisfati mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq:
English: Ratio vs VI
Maltese: Proporzjon vs VI
English: Multipack: 90 (3 packs of 30) doses
Maltese: Pakkett multiplu: 90 (3 pakketti ta' 30) doża
English: Pneumonia*
Maltese: Pulmonite*
English: Treatment Dose of FF/VI*(micrograms)
Maltese: Doża tal-kura ta' FF/VI*(mikrogrammi)
English: 92/22 micrograms
Maltese: 92/22 mikrogramma
English: Interaction with CYP3A4 inhibitors
Maltese: Interazzjoni ma' inibituri ta' CYP3A4
English: Interaction with beta-blockers
Maltese: Interazzjoni ma' imblokkaturi beta
English: 14 doses 30 doses
Maltese: 14-il doża 30 doża
English: Extrasystoles Palpitations Tachycardia
Maltese: Extrasistoli Palpitazzjonijiet Takikardija
English: Sympathomimetic medicinal products
Maltese: Prodotti mediċinali simpatomimetiċi
English: Systemic corticosteroid effects
Maltese: Effetti sistemiċi tal-kortikosterojdi
English: 184/22 micrograms
Maltese: 184/22 mikrogramma
English: COPD (Chronic Obstructive Pulmonary Disease)
Maltese: COPD (Mard Kroniku Ostruttiv tal-Pulmuni)
English: HZC102970 and HZC102871 integrated
Maltese: HZC102970 u HZC102871 integrati
English: Tray
Maltese: Trej
English: All-cause mortality was: fluticasone furoate/vilanterol, 6.0%; placebo, 6.7%; fluticasone furoate, 6.1%; vilanterol, 6.4%.
Maltese: Il-mortalità minn kull kawża kienet: fluticasone furoate/vilanterol, 6.0%; plaċebo, 6.7%; fluticasone furoate, 6.1%; vilanterol, 6.4%.
English: • inflammation of the lungs (bronchitis)
Maltese: • infjammazzjoni fil-pulmuni (bronkite)
English: Table 1 - Results of primary and key secondary endpoints in HZA106827 and HZA106829
Maltese: Tabella 1 - Riżultati tal-endpoints primarji u tal-endpoints sekondarji prinċipali fl-istudji HZA106827 u HZA106829
English: Absolute difference in number per year vs VI (95% CI)
Maltese: Differenza assoluta fin numru għal kull sena vs VI (95% CI)
English: Vision blurred (see section 4.4)
Maltese: Vista mċajpra (ara sezzjoni 4.4)
English: Hypersensitivity reactions including anaphylaxis, angioedema, rash, and urticaria.
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż anafilassi, anġjoedema, raxx u ħakk
English: Fluticasone furoate and vilanterol are both substrates of P-glycoprotein (P-gp).
Maltese: Fluticasone furoate u vilanterol, it-tnejn huma substrati tal-glikoproteina P (P-gp).
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 stainless steel.
English: Studies versus salmeterol/fluticasone propionate combinations
Maltese: Studji kontra l-kombinazzjonijiet ta' salmeterol/fluticasone propionate
English: Symptoms and signs
Maltese: Sintomi u sinjali
English: United Kingdom GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
Maltese: GlaxoSmithKline UK Tel: + 44 (0)800 221441 customercontactuk@gsk.com
English: 184/22, 85.7 in the FF/VI 92/22 and 42.3 in the VI 22 group.
Maltese: 7 fl-FF/VI 92/22 u 42.3 fil-grupp VI 22.
English: FF/VI 184/22 Once Daily vs FP 500 Twice Daily
Maltese: FF/VI 184/22 Darba Kuljum vs FP 500
English: 14 doses
Maltese: 14-il doża
English: INFORMATION IN BRAILLE relvar ellipta 92:22
Maltese: relvar ellipta 92:22
English: Three phase III randomised, double-blind studies (HZA106827, HZA106829 and HZA106837) of different durations evaluated the safety and efficacy of fluticasone furoate/vilanterol in adult and adolescent patients with persistent asthma.
Maltese: III (HZA106827, HZA106829 u HZA106837) ta' tul differenti evalwaw is-sigurtà u l-effikaċja ta' fluticasone furoate/vilanterol f'pazjenti adulti u adolexxenti li kellhom ażżma persistenti.
English: PHARMACEUTICAL FORM AND CONTENTS 30 doses
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 30 doża
English: The COPD clinical development programme included a 12-week (HZC113107), two 6-month (HZC112206, HZC112207), two one-year (HZC102970, HZC102871), and one >1 year study (SUMMIT).
Maltese: (HZC113107), żewġ studji randomizzati u kkontrollati ta' 6 xhur (HZC112206, HZC112207), żewġ studji randomizzati u kkontrollati ta' sena (HZC102970, HZC102871), u studju (SUMMIT) randomizzat u kkontrollat ta' sena waħda >1.
English: Elderly patients (> 65 years old)
Maltese: Pazjenti anzjani (>65 sena)
English: Lactose monohydrate
Maltese: Lactose monohydrate Magnesium stearate
English: - The other ingredients are lactose monohydrate (See section 2) and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate (Ara taqsima 2) u magnesium stearate.
English: Time to first exacerbation: Hazard ratio (95% CI) % risk reduction p-value p<0.001
Maltese: Proporzjon ta' periklu (95% CI) % ta' tnaqqis tar-riskju valur p p<0.001
English: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland GlaxoSmithKline (Ireland) Limited logo
Maltese: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, L-Irlanda GlaxoSmithKline (Ireland) Limited logo
English: FF/VI 184/22 Once Daily vs FF 184 Once Daily
Maltese: FF/VI 184/22 Darba Kuljum vs FF 184 Darba Kuljum
English: Adverse reaction(s)
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Date of latest renewal: 26 July 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Novembru 2013 Data ta' l-aħħar tiġdid: 26 ta 'Lulju 2018
English: The adjusted mean treatment difference of 22 mL (95% CI: -18, 63mL) between the groups was not statistically significant (p=0.282).
Maltese: Id-differenza medja aġġustata fil-kuri ta' 22 mL (95% CI: -18, 63mL) bejn il-gruppi ma kinitx statistikament sinifikanti (p=0.282).
English: Finally, the exposure-adjusted cases of fatal pneumonia were 8.8 for FF/VI 184/22 versus 1.5 for FF/VI 92/22 and 0 for VI 22.
Maltese: Finalment, il każijiet aġġustati għall-espożizzjoni ta' pulmonite fatali kienu 8.8 għal FF/VI 184/22 meta mqabbla ma' 1.5 għal FF/VI 92/22 u 0 għal VI 22.
English: In the COPD clinical development programme a total of 6,237 subjects were included in an integrated assessment of adverse reactions.
Maltese: Fil-programm ta' żvilupp kliniku dwar COPD, total ta' 6,237 kienu inklużi f'valutazzjoni integrata tar-reazzjonijiet avversi.
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations), Priory Street,
Maltese: Glaxo Operations UK Limited (li tinnegozja bħala Glaxo Wellcome Operations), Priory Street,
English: Headache Tremor
Maltese: Tqala u Treddigħ
English: Co-administration increased mean vilanterol AUC(0-t) and Cmax 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: FF/VI 92/22 Once Daily vs FF 92 Once Daily
Maltese: FF/VI 92/22 Darba Kuljum vs FF 92 Darba Kuljum
English: Interaction with P-glycoprotein inhibitors
Maltese: Interazzjoni ma' inibituri tal-glikoproteina P
English: The following convention has been used for the classification of frequencies: 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).
Maltese: Intużat il konvenzjoni li ġejja ntużat għall-klassifikazzjoni tal-frekwenzi: 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).
English: Animal studies showed no effect of fluticasone furoate/vilanterol trifenatate on fertility (see section 5.3).
Maltese: Studji f'annimali ma wrew l-ebda effett ta' fluticasone furoate/vilanterol trifenatate fuq il-fertilità (ara sezzjoni 5.3).
English: België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Maltese: GlaxoSmithKline Pharmaceuticals s.a./n.v. Belgique/Belgien
English: 95% CI p-value % reduction (95% CI)
Maltese: 95% CI valur p % ta' tnaqqis 95% CI
English: Relvar Ellipta is indicated for the symptomatic treatment of adults with COPD with a FEV1<70% predicted normal (post-bronchodilator) with an exacerbation history despite regular bronchodilator therapy.
Maltese: Relvar Ellipta hu indikat għat-trattament sintomatiku ta' persuni adulti b'COPD b'FEV1 ta' <70% imbassar normali (wara bronkodilatur) bi storja ta' taħrix minkejja terapija regolari bi bronkodilatur.
English: In a placebo-controlled study (SUMMIT) in subjects with moderate COPD (mean percent postbronchodilator screening FEV1 of 60%, SD 6%), and a history of, or an increased risk of cardiovascular disease, the incidence of pneumonia with FF/VI, FF, VI and placebo was: adverse events (6%, 5%, 4%, 5%); serious adverse events (3%, 4%, 3%, 3%); adjudicated on treatment deaths due to pneumonia (0.3%, 0.2%, 0.1%, 0.2%); the exposure adjusted rates (per 1000 treatment years) were: adverse events (39.5, 42.4, 27.7, 38.4); serious adverse events (22.4, 25.1, 16.4, 22.2); adjudicated on-treatment deaths due to pneumonia (1.8, 1.5, 0.9, 1.4) respectively.
Maltese: avvenimenti avversi serji (3%, 4%, 3%, 3%); imwiet aġġudikati waqt il-kura minħabba l-pulmonite (0.3%, 0.2%, 0.1%, 0.2%); ir-rati aġġustati għall-esponiment (għal kull 1000 sena ta' kura) kienu: avvenimenti avversi (39.5, 42.4, 27.7, 38.4); avvenimenti avversi serji (22.4, 25.1, 16.4, 22.2); imwiet aġġudikati waqt ilkura minħabba l-pulmonite (1.8, 1.5, 0.9, 1.4) rispettivament.
English: These differences are unlikely to be of clinical relevance.
Maltese: Dawn id-differenzi mhumiex probabbli li jkunu ta' rilevanza klinika.
English: Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Maltese: GlaxoSmithKline Pharmaceuticals s.a./n.v.
English: Overall, across the two studies combined 2009 (62%) patients had cardiovascular history/risk factors at screening.
Maltese: B'mod ġenerali, fiż-żewġ studji kombinati, 2009 (62%) pazjenti kellhom storja/fatturi ta' riskju kardjovaskulari fl-iskrinjar.
English: The pharmacologic effects of beta2-adrenoceptor agonist active substances, including vilanterol trifenatate, are at least in part attributable to stimulation of intracellular adenylate cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3',5'-adenosine monophosphate (cyclic AMP).
Maltese: L-effetti farmakoloġiċi tal-mediċini agonisti tal-adrenoriċetturi beta2 sustanzi attivi, inkluż vilanterol trifenatate, huma tal-anqas parzjalment attribwibbli lill-istimulazzjoni tal-adenylate cyclase ġoċ-ċelloli, lenzima li tikkatalizza l-konverżjoni ta' adenosine triphosphate (ATP) 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(0-24) u s-Cmax medji ta' fluticasone furoate b'36% u 33%,
English: Exposure-adjusted all-cause mortality per 100 patients/year (%/yr) was: fluticasone furoate/vilanterol, 3.1 %/yr; placebo, 3.5 %/yr; fluticasone furoate, 3.2 %/yr; and vilanterol, 3.4 %/yr.
Maltese: (% kull sena) kienet: fluticasone furoate/vilanterol, 3.1 % kull sena; placebo, 3.5 % kull sena; fluticasone furoate, 3.2% kull sena; u vilanterol, 3.4 % kull sena.
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Maltese: UNIQUE IDENTIFIER - 2D BARCODE 18.
English: Dose-normalised fluticasone furoate systemic exposure was similar in subjects with moderate and severe hepatic impairment (Child-Pugh B or C).
Maltese: L-esponiment sistemiku għal fluticasone furoate normalizzat għad-doża kien simili f'individwi b'indeboliment tal-fwied moderat u sever (Child-Pugh B jew C).
English: Following intravenous dosing, both fluticasone furoate and vilanterol are extensively distributed with average volumes of distribution at steady state of 661 L and 165 L, respectively.
Maltese: Wara għoti fil-vini, kemm fluticasone furoate kif ukoll vilanterol jiġu distribwiti estensivament b'volumi medji ta' distribuzzjoni fl-istat fiss ta' 661 L u 165 L, rispettivament.
English: At screening, the mean pre-bronchodilator FEV1 was 42.6% and 43.6% predicted, and the mean reversibility was 15.9% and 12.0% in HZC112206 and HZC112207, respectively.
Maltese: Fl-iskrinjar, il-FEV1 medju qabel il-bronkodilatur kien ta' 42.6% u 43.6% imbassar, u r-riversibbiltà medja kienet ta' 15.9% u 12.0% fl-istudji HZC112206 u HZC112207, rispettivament.
English: Two different strengths of Relvar Ellipta are available: fluticasone furoate 92 micrograms/vilanterol 22 micrograms and fluticasone furoate 184 micrograms/vilanterol 22 micrograms.
Maltese: Huma disponibbli żewġ qawwiet differenti ta' Relvar Ellipta: fluticasone furoate 92 mikrogramma/vilanterol 22 mikrogramma u fluticasone furoate 184 mikrogramma/vilanterol 22 mikrogramma.
English: Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g. eosinophils, macrophages, lymphocytes) and mediators (e.g. cytokines and chemokines involved in inflammation).
Maltese: Il-kortikosterojdi ntwerew li għandhom firxa wiesgħa ta' azzjonijiet fuq diversi tipi ta' ċelloli (eż. eosinofili, makrofaġi, limfoċiti) u medjaturi (eż. ċitokini u kemokini involuti fl-infjammazzjonijiet).
English: Fluticasone furoate is primarily metabolised through hydrolysis of the S-fluoromethyl carbothioate group to metabolites with significantly reduced corticosteroid activity.
Maltese: Fluticasone furoate huwa metabolizzat prinċipalment permezz ta' idrolisi tal-grupp ta' S-fluoromethyl carbothioate f'metaboliti b'attività kortikosterojdi konsiderevolment imnaqqsa.
English: • inflammation of the sinuses
Maltese: • infjammazzjoni fis-sinusijiet
English: Very common Rare
Maltese: Rari Komuni
English: In vitro plasma protein binding in human plasma of fluticasone furoate and vilanterol was high, on average >99.6% and 93.9%, respectively.
Maltese: It-twaħħil mal-proteini tal-plażma in vitro, ta' fluticasone furoate u vilanterol fil-plażma umana kien għoli, b'medja ta' >99.6% u 93.9%, rispettivament.
English: Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, decrease in bone mineral density, growth retardation in children and adolescents, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Maltese: Effetti sistemiċi possibbli jinkludu s-sindrome ta' Cushing, karatteristiċi Cushingoid, soppressjoni adrenali, tnaqqis fid-densità minerali tal-għadam, ittardjar tat-tkabbir fit-tfal u l-adolexxenti, katarretti u glawkoma u b'mod aktar rari, firxa ta' effetti psikoloġiċi jew tal-imġiba li jinkludu attività eċċessiva psikomotorili, disturbi fl-irqad, ansjetà, depressjoni jew aggressività (partikolarment fit-tfal).
English: Asthma Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product (long-acting beta2-agonist and inhaled corticosteroid) is appropriate:
Maltese: Relvar Ellipta hu indikat għat-trattament regolari tal-ażżma f'persuni adulti u adolexxenti minn 12-il sena 'l fuq fejn l-użu ta' prodott mediċinali kombinat (agonisti beta2 li jaħdmu fit-tul u kortikosterojd li jittieħed man-nifs) ikun adattat:
English: INFORMATION IN BRAILLE relvar ellipta 184:22
Maltese: Relvar Ellipta 184:
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Maltese: M'hemmx evidenza klinika konklussiva għal differenzi bejn klassi u oħra fid-daqs tar-riskju tal-pulmonite fost il-prodotti kortikosterojdi li jittieħdu man-nifs.
English: Adverse reactions are listed by system organ class and frequency.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi u l-frekwenza.
English: Relvar Ellipta contains lactose
Maltese: Relvar Ellipta fih il-lactose
English: For severe pneumonia the corresponding number of events per 1000 patient years were 33.6, 35.5, and 7.6 respectively, while for serious pneumonia the corresponding events per 1000 patient years were 35.1 for FF/VI 184/22, 42.9 with FF/VI 92/22, 12.1 with VI 22.
Maltese: Għal pulmonite severa, l-għadd korrespondenti ta' episodji għal kull 1000 sena ta' pazjenti kienu 33.6, 35.5 u 7.6 rispettivament, filwaqt li għal pulmonite severa, l-episodji korrespondenti għal kull 1000 pazjent snin kienu 35.1 għal FF/VI 184/22, 42.9 b'FF/VI 92/22, 12.1 b'VI 22.
English: A repeat dose CYP3A4 drug interaction study was performed in healthy subjects with the fluticasone furoate/vilanterol combination (184/22 micrograms) and the strong CYP3A4 inhibitor ketoconazole (400mg).
Maltese: Sar studju b'dożi ripetuti dwar l-interazzjoni tal-mediċini fuq CYP3A4 f'individwi b'saħħithom bil kombinazzjoni ta' fluticasone furoate/vilanterol (184/22 mikrogramma ) u l-inibitur qawwi ta' CYP3A4 ketoconazole (400mg).
English: • tremor
Maltese: • influwenza
English: Mortality risk with fluticasone furoate/vilanterol was not significantly different compared with placebo (HR 0.88; 95% CI: 0.74 to 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 to 1.15; p=0.681) or vilanterol (HR 0.91; 95% CI: 0.77 to 1.09; p=0.299).
Maltese: Ir-riskju tal-mortalità bi fluticasone furoate/vilanterol ma kienx ferm differenti meta mqabbel mal-plaċebo (HR 0.88; 95% CI: 0.74 sa 1.04; p=0.137), fluticasone furoate (HR 0.96; 95% CI: 0.81 sa 1.15; p=0.681) jew vilanterol (HR 0.91; 95% CI: 0.77 sa 1.09; p=0.299).
English: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 dk-info@gsk.com
Maltese: GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
English: Relvar Ellipta contains two active substances: fluticasone furoate and vilanterol.
Maltese: Relvar Ellipta fih żewġ sustanzi attivi: fluticasone furoate u vilanterol.
English: • irregular heartbeat
Maltese: • taħbita tal-qalb irregolari
English: Adults aged 18 years and over
Maltese: Adulti minn 18-il sena 'l fuq
English: The use of concurrent inhaled long-acting bronchodilators (beta2-agonist and anticholinergic), ipratropium/salbutamol combination products, oral beta2-agonists, and theophylline preparations were not allowed during the treatment period.
Maltese: prodotti kombinati ta' ipratropium/salbutamol, agonisti beta2 orali, u preparazzjonijiet tat-theophylline ma kinux permessi matul il-perjodu tal-kura.
English: A 24 week randomised, double-blind placebo controlled study (FFA112059) evaluated the safety and efficacy of FF 92 micrograms once daily [n= 114] and FP 250 micrograms twice daily [n=114] versus placebo [n=115] in adult and adolescent patients with persistent asthma.
Maltese: Studju double-blind, randomizzat, ta' 24 ġimgħa, ikkontrollat bil-plaċebo (FFA112059) evalwa s-sigurtà u leffikaċja ta' FF 92 mikrogramma darba kuljum [n= 114] u FP 250 mikrogramma darbtejn kuljum [n=114] kontra plaċebo [n=115] f'pazjenti adulti u adolexxenti li kellhom ażżma persistenti.