FrancophonIA/ELRC3.0 huggingface dataset:
English: Insomnia, irritability, tachycardia (rapid heartbeat) and headaches have been reported as side effects with eleutherococcus root medicines, although their frequency is not known.
Maltese: L-insomnija, l-irritabilità, it-takikardja (taħbit tal-qalb mgħaġġel) u l-uġigħ ta' ras ġew irrapportati bħala effetti sekondarji tal-mediċini li fihom l-għerq tal-elewterokokku, għalkemm il-frekwenza tagħhom mhijiex magħrufa.
English: Eleutherococcus root is the common name for the root of the plant Eleutherococcus senticosus (Rupr.
Maltese: L-għerq tal-elewterokokku huwa l-isem komuni għall-għerq tal-pjanta Eleutherococcus senticosus (Rupr. et Maxim.)
English: Eleutherococcus root
Maltese: Għerq tal-elewterokokku
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Maltese: Għal informazzjoni dettaljata dwar l-istudji vvalutati mill-HMPC, ara r-rapport ta' valutazzjoni talHMPC.
English: What are the HMPC conclusions on its medicinal uses?
Maltese: X'inhuma l-konklużjonijiet tal-HMPC dwar l-użijiet mediċinali tiegħu?
English: Further information on the HMPC assessment of eleutherococcus root medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar il-valutazzjoni tal-HMPC tal-mediċini li fihom l-għerq tal-elewterokokku, inklużi d-dettalji tal-konklużjonijiet tal-Kumitat, tinsab taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: Moreover, the intended use does not require medical supervision.
Maltese: Barra minn hekk, l-użu maħsub ma jeħtieġx superviżjoni medika.
English: Further information on the risks associated with eleutherococcus root medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom l-għerq tal-elewterokokku, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: What are the risks associated with eleutherococcus root medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom l-għerq tal-elewterokokku?
English: They are also obtained by using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol or water) to form a liquid extract or tincture (an alcoholic extract).
Maltese: Dawn jinkisbu wkoll bl-użu ta' teknika għall-estrazzjoni ta' komponenti mill-materjali talpjanta billi jinħallu f'solvent (bħall-etanol jew bħall-ilma) sabiex jifforma estratt likwidu jew tintura (estratt tal-alkoħol).
English: How are eleutherococcus root medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini li fihom l-għerq tal-elewterokokku?
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of eleutherococcus root.
Maltese: Dan huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għall-Prodotti tal-Ħxejjex Mediċinali (HMPC) dwar l-użu mediċinali tal-għerq tal-elewterokokku.
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini tal-ħxejjex hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod għal mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: What is eleutherococcus root?
Maltese: X'inhu l-għerq tal-elewterokokku?
English: Eleutherococcus root should only be used in adults and adolescents over the age of 12 years and should not be taken for more than 2 months.
Maltese: L-għerq tal-elewterokokku għandu jintuża biss fl-adulti u fl-adolexxenti li għandhom 'il fuq minn 12il sena u ma għandux jittieħed għal aktar minn xahrejn.
English: Other information about eleutherococcus root medicines
Maltese: Aktar informazzjoni dwar il-mediċini li fihom l-għerq tal-elewterokokku
English: Any applications for the licensing of medicines containing eleutherococcus root have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom l-għerq tal-elewterokokku għandha titressaq lill-awtoritajiet nazzjonali responsabbli għall-prodotti mediċinali, li ser jivvalutaw lapplikazzjoni għall-mediċina tal-ħxejjex u jqisu l-konklużjonijiet xjentifiċi tal-HMPC.
English: In its assessment, the HMPC also considered numerous clinical studies with eleutherococcus root.
Maltese: Fil-valutazzjoni tiegħu, l-HMPC ikkunsidra għadd ta' studji kliniċi bl-għerq tal-elewterokokku.
English: 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
Maltese: (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu
English: This summary was last updated in 04-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 04-2009.
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan Hydrochlorothiazide BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Irbesartan Hydrochlorothiazide BMS lil Bristol-Myers Squibb Pharma EEIG fid-19 ta' Jannar 2007.
English: It is available as oval tablets (peach: 150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; pink: 300 mg irbesartan and 25 mg hydrochlorothiazide).
Maltese: Huwa disponibbli f'pilloli ovali (lewn il-ħawħ: 150 mg jew 300 mg irbesartan u 12.5 mg idroklorotijażide; roża: 300 mg irbesartan u 25 mg idroklorotijażide).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) IRBESARTAN HYDROCHLOROTHIAZIDE BMS Sommarju tal-EPAR għall-pubbliku
English: The most common side effects with Irbesartan Hydrochlorothiazide BMS (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Maltese: L-effetti sekondarji l-aktar komuni b'Irbesartan Hydrochlorothiazide BMS (li dehru f'bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, disturbi urinarji, għeja kbira u żieda fillivelli tan-nitroġenu urejku tad-demm (blood urea nitrogen, BUN, prodott ta' skart mill-proteini), talkreatinina (prodott ta' skart mill-muskoli) u kreatina kinażi (creatine kinase, enzima li tinsab filmuskoli).
English: This document is a summary of the European Public Assessment Report (EPAR).
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Maltese: Jekk tixtieq aktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CHMP, aqra dDiskussjoni Xjentifika (parti wkoll mill-EPAR).
English: Irbesartan on its own has been approved in the EU since 1997 under the names Karvea and Aprovel.
Maltese: Irbesartan waħdu ilu approvat fl-UE bl-ismijiet ta' Karvea u Aprovel mill-1997.
English: Irbesartan Hydrochlorothiazide BMS contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: Irbesartan Hydrochlorothiazide BMS fih żewġ sustanzi attivi, irbesartan u idroklorotijażide.
English: Further studies were also carried out with doses of 300 mg irbesartan in combination with 25 mg hydrochlorothiazide.
Maltese: Mhuwiex rakkomandat dożaġġ ogħla minn 300 mg irbesartan jew 25 mg idroklorotijażide darba kuljum.
English: Irbesartan Hydrochlorothiazide BMS may be added to other treatments for hypertension.
Maltese: Irbesartan Hydrochlorothiazide BMS jista' jintuża flimkien ma' trattamenti għall-ipertensjoni.
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II hija vażokostrittur qawwi (sustanza li ddejjaq l-arterji u l-vini - vasoconstrictor).
English: Other information about Irbesartan Hydrochlorothiazide BMS:
Maltese: Aktar tagħrif dwar Irbesartan Hydrochlorothiazide BMS:
English: Irbesartan Hydrochlorothiazide BMS should not be used in people who may be hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Maltese: Irbesartan Hydrochlorothiazide BMS ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għall-idroklorotijażide, għas-sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
English: What is Irbesartan Hydrochlorothiazide BMS?
Maltese: X'inhu Irbesartan Hydrochlorothiazide BMS?
English: Irbesartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Irbesartan hu tip ta' 'antagonista tar-riċetturi tal-anġjotensina II' li tfisser li jimblokka l-azzjoni talormon fil-ġisem imsejjaħ anġjotensina II.
English: What is the risk associated with Irbesartan Hydrochlorothiazide BMS?
Maltese: X'inhuma r-riskji assoċjati ma' Irbesartan Hydrochlorothiazide BMS?
English: For the full list of all side effects reported with Irbesartan Hydrochlorothiazide BMS, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Irbesartan Hydrochlorothiazide BMS, ara l-Fuljett ta' Tagħrif.
English: Irbesartan Hydrochlorothiazide BMS must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Maltese: Irbesartan Hydrochlorothiazide BMS ma għandux jintuża wkoll minn pazjenti li jbatu minn problemi gravi fil-fwied, kliewi jew problemi biljari, persuni li jkollhom livelli wisq baxxi ta' potassju fid-demm, jew livelli wisq għoljin ta' kalċju fid-demm.
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of Irbesartan Hydrochlorothiazide BMS.
Maltese: Ilkumpanija li tipproduċi Karvezide qablet li t-tagħrif xjentifiku tagħha jista' jintuża għal Irbesartan Hydrochlorothiazide BMS.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan Hydrochlorothiazide BMS's benefits are greater than its risks for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Irbesartan Hydrochlorothiazide BMS huma ogħla mir-riskji tiegħu fit-trattament tal-ipertensjoni essenzjali f'pazjenti adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata adegwatament b'irbesartan jew bl-idroklorotijażide meħudin waħedhom.
English: By Q3 2024
Maltese: Sa Q3 2024
English: 55 micrograms
Maltese: 55 mikrogramma
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti
English: Reproductive toxicity
Maltese: Tossiċità riproduttiva
English: See section 4.
Maltese: Ara sezzjoni 4.
English: 4.3 Contraindications
Maltese: 4.3 Kontraindikazzjonijiet
English: Paradoxical bronchospasm
Maltese: Bronkospażmu paradossali
English: Adults
Maltese: Adulti
English: System Organ Class
Maltese: Sistema tal-Klassifika talOrgani
English: A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Maltese: Menarini Industrie Farmaceutiche Riunite s.r.l.
English: Date of first authorisation: 20th March 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Marzu 2017
English: INFORMATION IN BRAILLE
Maltese: INFORMAZZJONI BIL-BRAILLE
English: Gastrointestinal disorders
Maltese: Disturbi gastrointestinali
English: Versus Placebo mcg = micrograms 1.least squares mean (95% confidence interval)
Maltese: Plaċebo mcg = mikrogramma 1. least squares mean (intervall ta' kunfidenza ta' 95%)
English: For instructions for handling, see section 4.2.
Maltese: Għal struzzjonijiet dwar l-immaniġġjar, ara sezzjoni 4.2.
English: 6.2 Incompatibilities
Maltese: .2 Inkompatibbiltajiet
English: Summary of the safety profile
Maltese: Sommarju tal-profil tas-sigurtà
English: Excipients: lactose and magnesium stearate.
Maltese: Eċċipjenti: lactose u magnesium stearate.
English: Distribution
Maltese: Distribuzzjoni
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 magħmul minn diversi komponenti magħmul minn polypropylene, polyethylene ta' densità għolja, polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate u stainless steel.
English: Antimuscarinic activity
Maltese: Attività antimuskarinika
English: The active substance is umeclidinium bromide.
Maltese: Is-sustanza attiva hija umeclidinium bromide.
English: Deutschland BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
Maltese: BERLIN-CHEMIE AG Tel: +49 (0) 30 67070
English: 30 doses
Maltese: 30 doża
English: Glaxo Wellcome Production Zone Industrielle No.2, 23 Rue Lavoisier, 27000 Evreux, France
Maltese: 23 Rue Lavoisier, 27000 Evreux, Franza
English: Multipack: 90 (3 inhalers of 30) doses
Maltese: Pakkett multiplu: 90 (3 inalaturi ta' 30) doża
English: Umeclidinium bromide is a substrate of cytochrome P450 2D6 (CYP2D6).
Maltese: Umeclidinium bromide huwa substrat taċ-ċitokromju P450 2D6 (CYP2D6).
English: Atrial fibrillation Rhythm idioventricular Supraventricular tachycardia Supraventricular extrasystoles Tachycardia
Maltese: Ritmu idjoventrikulari Takikardja supraventrikulari Extrasistoli supraventrikulari Takikardja
English: 7 doses 30 doses
Maltese: 7 dożi 30 doża
English: Pharmacodynamic effects
Maltese: Effetti farmakodinamiċi
English: Umeclidinium bromide is a substrate of P-glycoprotein (P-gp) transporter.
Maltese: Umeclidinium bromide huwa substrat tat-trasportatur ta' P-glycoprotein (P-gp).
English: Renal impairment
Maltese: Indeboliment renali
English: 7 doses
Maltese: 7 dożi
English: Fertility
Maltese: Fertilità
English: Absorption
Maltese: Assorbiment
English: Cardiac electrophysiology
Maltese: Elettrofiżjoloġija kardijaka
English: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Maltese: 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) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Vistor hf. Sími: + 354 535 7000
Maltese: Sími: + 354 535 7000
English: Rare side effects
Maltese: Effetti sekondarji rari
English: Elimination
Maltese: Eliminazzjoni
English: Glaxo Operations UK Ltd. (trading as Glaxo Wellcome Operations) Priory Street
Maltese: (li tinnegozja bħala Glaxo Wellcome Operations) Priory Street
English: Tabulated summary of adverse reactions
Maltese: Sommarju tabulat ta' reazzjonijiet avversi
English: Possible side effects
Maltese: Effetti sekondarji possibbli
English: In vitro studies showed that umeclidinium bromide is principally metabolised by cytochrome P450 2D6 (CYP2D6) and is a substrate for the P-glycoprotein (P-gp) transporter.
Maltese: Studji in vitro wrew li prinċipalment umeclidinium bromide jiġi metabolizzat miċ ċikotromju P450 2D6 (CYP2D6) u huwa substrat għat-trasportatur ta' P-glycoprotein (P-gp).
English: 2D barcode carrying the unique identifier included.
Maltese: Barcode 2D li għandha l-identifikatur uniku inkluż.
English: Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
Maltese: FranceLaboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 diam@gsk.com
English: For the full list of excipients, see section 6.1.
Maltese: Għal-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10);
Maltese: Il-frekwenza ta' reazzjonijiet avversi hija definita permezz tal-konvenzjoni li ġejja: komuni ħafna (≥1/10);
English: An updated RMP should be submitted:
Maltese: RMP aġġornat għandu jiġi ppreżentat:
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP)
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ
English: Adverse reactions
Maltese: Reazzjonijiet avversi
English: Inhalation use.
Maltese: Mhux applikabbli.
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Metabolic and transporter based interactions
Maltese: Interazzjonijiet metaboliċi u bbażati fuq it-trasportaturi
English: Use Rolufta Ellipta regularly
Maltese: Uża Rolufta Ellipta regolarment
English: The mean annual rate of exacerbations was 0.91 and 1.07 for FF/UMEC/VI and FF/VI respectively (Rate Ratio: 0.85; 95% CI: 0.80, 0.90; p<0.001).
Maltese: Ir-rata annwali medja ta' aggravar kienet 0.91 u 1.07 għal FF/UMEC/VI u FF/VI rispettivament (Proporzjon tarRata: 0.85; 95% CI: 0.80, 0.90; p<0.001).
English: Component of a multipack can't be sold separately.
Maltese: Komponent ta' pakkett multiplu, ma jistax jinbiegħ separatament.
English: Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: Headache Dysgeusia Dizziness
Maltese: Dysguesia Sturdament
English: Cardiovascular effects
Maltese: Effetti kardjovaskulari
English: Table 1: Trough FEV1 (ml) at Week 12 and Week 24 (primary endpoint) Treatment with Rolufta Ellipta 55 mcg
Maltese: Tabella 1: Il-livell minimu tal-FEV1 (ml) fil-Ġimgħa 12 u fil-Ġimgħa 24 (endpoint primarju) Kura b' Rolufta Ellipta55 mcg
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Service Limited logo
Maltese: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, L-Irlanda GlaxoSmithKline Trading Service Limited logo
English: Excipients
Maltese: Eċċipjenti
English: In a randomised, double-blind, 52-week study (CTT116855, IMPACT) of 10,355 adult patients with symptomatic COPD and a history of 1 or more moderate or severe exacerbations within the prior 12 months, treatment with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 micrograms) once daily as a single inhaler was compared with fluticasone furoate/vilanterol (FF/VI 99/22 micrograms) once daily as a single inhaler.
Maltese: Fi studju ta' 52 ġimgħa, randomizzat, double-blind (CTT116855, IMPACT) ta' 10,355 pazjent adult b'COPD sintomatiku u bi storja ta' aggravar 1 jew aktar moderat jew sever fit-12-il xahar ta' qabel, ittrattament b'fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 99/55/22 mikrogramma) darba kuljum bħala inalatur wieħed tqabbel ma' fluticasone furoate/vilanterol (FF/VI 99/22 mikrogramma) darba kuljum bħala inalatur wieħed.
English: Tel.: + 48 (0)22 576 9000
Maltese: GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
English: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, Ireland GlaxoSmithKline Trading Services Limited logo
Maltese: GlaxoSmithKline Trading Services Limited, Currabinny, Carrigaline, County Cork, L-Irlanda GlaxoSmithKline Trading Services Limited logo
English: The other ingredients are lactose monohydrate (see section 2 under ‘Rolufta Ellipta contains lactose') and magnesium stearate.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt ‘Rolufta Ellipta fih lactose') u magnesium stearate.
English: In vitro plasma protein binding in human plasma was on average 89%.
Maltese: In vitro, l-irbit mal-proteina tal-plasma fil-plasma tal-bniedem kien medja ta' 89%.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi u medjastinali
English: Umeclidinium bromide plasma elimination half-life following inhaled dosing for 10 days averaged 19 hours, with 3% to 4% active substance excreted unchanged in urine at steady-state.
Maltese: Il-half life tal-eliminazzjoni ta' umeclidinium bromide mill-plasma wara doża man-nifs għal 10 ijiem kellha medja ta' 19-il siegħa, b'3% sa 4% tas-sustanza attiva eliminata mhux mibdula fl-awrina fi stat stabbli.
English: The primary metabolic routes for umeclidinium bromide are oxidative (hydroxylation, O-dealkylation) followed by conjugation (glucuronidation, etc), resulting in a range of metabolites with either reduced pharmacological activity or for which the pharmacological activity has not been established.
Maltese: Ir-rotot metaboliċi prinċipali għal umeclidinium bromide huma ossidattivi (idroksilazzjoni, O-dealkylation) segwiti minn konjugazzjoni (glukuronidazzjoni, eċċ), li jwasslu għal firxa ta' metaboliti li jew għandhom attività farmakoloġika mnaqqsa jew li l-attività farmakoloġika tagħhom ma ġietx stabbilita.
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists including umeclidinium bromide.
Maltese: Effetti kardjovaskulari, bħal arritmiji kardijaċi eż. fibrillazzjoni atrijali u takikardja, jistgħu jidhru wara lgħoti ta' antagonisti tar-riċettur muskariniku inkluż umeclidinium bromide.
English: Improvements in lung function were supported with reductions in use of salbutamol over Weeks 1-12 (-0.4 puffs per day (95% CI: -0.7, -0.2; p<0.001) and -0.3 puffs per day (95% CI: -0.5, -0.1; p=0.003)) compared to placebo plus FF/VI but improvements in SGRQ at week 12 were not statistically significant (200109) or clinically relevant (200109 and 200110).
Maltese: puffs kuljum (95% CI: -0.7, -0.2; p<0.001) u -0.3 puffs kuljum (95% CI: -0.5, -0.1; p=0.003) meta mqabbel ma' plaċebo flimkien ma' FF/VI, iżda t-titjib fl-SGRQ fil-ġimgħa 12 ma kienx statistikament sinifikanti (200109) jew klinikament rilevanti (200109 u 200110).
English: Common
Maltese: Komuni
English: Glaxo Operations UK Limited (trading as Glaxo Wellcome Operations) Priory Street
Maltese: Glaxo Operations UK Limited (li tinnegozja bħala Glaxo Wellcome Operations)
English: GlaxoSmithKline Trading Services Limited logo
Maltese: GlaxoSmithKline Trading Services Limited
English: Hepatic impairment
Maltese: Indeboliment epatiku
English: How to use Rolufta Ellipta 4.
Maltese: Kif għandek tuża Rolufta Ellipta 4.
English: Systemic exposure to the metabolites is low.
Maltese: L-espożizzjoni sistemika għall-metaboliti hija baxxa.
English: Common side effects
Maltese: Effetti sekondarji komuni
English: Rolufta Ellipta is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Rolufta Ellipta huwa indikat bħala kura ta' manteniment bi bronkodilatur biex itaffi s-sintomi f'pazjenti adulti b'mard kroniku ostruttiv tal-pulmun (COPD).
English: 5.2 Pharmacokinetic properties
Maltese: 5.2 Tagħrif farmakokinetiku
English: Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
Maltese: Sensittività eċċessiva għas-sustanza(i) attiva(i) jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1
English: 1 inhaler of 30 doses.
Maltese: 1 inalatur ta' 30 doża.
English: The effect of the moderate P-gp inhibitor verapamil (240 mg once daily) on the steady-state pharmacokinetics of umeclidinium bromide was assessed in healthy volunteers.
Maltese: L-effett tal-inibitur moderat ta' P-gp verapamil (240 mg darba kuljum) fuq il-farmakokinetika ta' umeclidinium bromide fi stat stabbli kien evalwat f'voluntiera b'saħħithom.