FrancophonIA/ELRC3.0 huggingface dataset:
English: Reproductive system and breast disorders Priapism, erection increased and prolonged erection Frequency: not known
Maltese: .8. Effetti mhux mixtieqa Disturbi fis-sistema riproduttiva u s-sider Prijapiżmu, erezzjoni miżjuda u erezzjoni fit-tul Frekwenza: mhux magħrufa
English: During treatment, boys and adolescents may unexpectedly experience prolonged erections.
Maltese: Waqt il-kura, it-tfal subien u l-adoloxxenti jistgħu jesperjenzaw b'mod mhux mistenni erezzjonijiet fittul.
English: Common side effects (seen between 1 and 10 patients in 100) have been reported with ginger, mostly affecting the stomach and gut: stomach upset, eructation (belching), dyspepsia (heartburn) and nausea (feeling sick).
Maltese: Effetti sekondarji komuni (li jidhru f'bejn pazjent 1 u 10 minn kull 100) ġew irrapportati bil-ġinġer, laktar fosthom jaffettwaw l-istonku u l-imsaren: tqallib tal-istonku, tifwiq, dispepsija (ħruq ta' stonku) u dardir (tħossok ma tiflaħx).
English: Moreover, these intended uses do not require medical supervision.
Maltese: Barra minn hekk, dan l-użu intenzjonat ma jeħtieġx superviżjoni medika.
English: Herbal medicines containing ginger are usually available in solid forms and are taken by mouth.
Maltese: Mediċini erbali li fihom il-ġinġer normalment huma disponibbli f'forom solidi u jittieħdu mill-ħalq.
English: The exact way ginger acts on the stomach and gut is not fully known, but it is thought to work by blocking certain receptors for the hormone 5HT3, known as serotonin, which are involved in the contraction of the smooth muscles inside the stomach and gut.
Maltese: Il-mod eżatt kif il-ġinġer jaġixxi fuq l-istonku u fuq l-imsaren mhuwiex magħruf eżattament, iżda huwa maħsub li jaħdem billi jimblokka lil ċerti riċetturi għall-ormon 5HT3, magħrufin bħala serotonin, li huma involuti fil-ġbid tal-muskoli lixxi ġewwa l-istonku u l-imsaren.
English: What is ginger?
Maltese: X'inhu ġinġer?
English: Further information on the HMPC assessment of ginger, 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: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Ginger is the common name for the whole or cut rhizome (underground stems) of the plant Zingiber officinale.
Maltese: Il-ġinper huwa l-isem komuni għar-riżoma sħiħa jew maqtugħa (għeruq ta' taħt l-art) tal-pjanta Zingiber officinale.
English: What are the risks associated with ginger medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini tal-ġinġer?
English: Further information on the risks associated with ginger 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 mal-mediċini tal-ġinġer, inklużi l-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab ‘Id-dokumenti kollha' fis-sit elettroniku talAġenzija:
English: The herbal preparation is obtained by drying and powdering the rhizome.
Maltese: Il-preparazzjoni erbali tinkiseb bit-tnixxif u bit-tifrik tar-riżoma.
English: The HMPC concluded that ginger can be used in adults to prevent nausea and vomiting in motion sickness.
Maltese: L-HMPC ikkonkluda li l-ġinġer jista' jintuża fl-adulti sabiex jimpedixxi dardir u rimettar f'mard relatat mal-moviment.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of ginger.
Maltese: Dan id-dokument huwa sommarju tal-konklużjonijiet xjentifiċi li wasal għalihom il-Kumitat għallProdotti Mediċinali Erbali (HMPC) dwar l-użu mediċinali tal-ġinġer.
English: Any applications for the licensing of medicines containing ginger have to be submitted to the national authorities responsible for medicinal products, which will assess the herbal medicine and take into account the scientific conclusions of the HMPC.
Maltese: Kwalunkwe applikazzjoni għal-liċenzjar ta' mediċini li fihom il-ġinġer għandha titressaq lill-awtoritajiet nazzjonali responsabbli mill-prodotti mediċinali li ser jivvalutaw il-mediċina erbali u jqisu lkonklużjonijiet xjentifiċi tal-HMPC.
English: EMA/HMPC/296580/2012
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom
English: The HMPC conclusions on the use of ginger medicines for the treatment of symptoms of motion sickness and of mild complaints affecting the stomach or gut are based on their ‘traditional use' in these indications.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-ġinġer għall-prevenzjoni ta' dardir u rimettar f'mard relatat mal-moviment huma bbażati fuq l-'użu stabbilit sew' tagħhom f'din l-indikazzjoni.
English: Other information about ginger medicines
Maltese: Aktar informazzjoni dwar il-mediċini tal-ġinġer
English: EU/1/17/1208/001 EU/1/17/1208/002 EU/1/17/1208/003 EU/1/17/1208/004 EU/1/17/1208/005
Maltese: EU/1/17/1208/001 EU/1/17/1208/002 EU/1/17/1208/003 EU/1/17/1208/004
English: Chiesi Bulgaria EOOD
Maltese: Chiesi Bulgaria EOOD Teл.:
English: EU/1/17/1208/004 EU/1/17/1208/005
Maltese: EU/1/17/1208/004
English: Similar effects were seen when comparing Trimbow with the extemporary triple combination.
Maltese: Effetti simili kienu osservati meta Trimbow kien imqabbel mal-kombinazzjoni tripla estemporanja.
English: Compared with tiotropium, Trimbow significantly improved IC by 39 mL (p = 0.025) and 60 mL (p = 0.001) after 26 and 52 weeks of treatment respectively.
Maltese: Meta mqabbel ma' tiotropium, Trimbow tejjeb l-IC b'mod sinifikanti b'39 mL (p = 0.025) u 60 mL (p = 0.001) wara 26 u 52 ġimgħa ta' trattament rispettivament.
English: Trimbow is available in three container sizes:
Maltese: Trimbow huwa disponibbli f'kontenituri ta' tliet daqsijiet:
English: The use of Trimbow with the AeroChamber Plus spacer in COPD patients increased the lung delivery of beclometasone 17-monopropionate, formoterol and glycopyrronium (maximum plasma concentration increased by 15%, 58% and 60% respectively).
Maltese: beclometasone 17-monopropionate, formoterol u glycopyrronium (il-konċentrazzjoni massima fil plażma żdiedet bi 15%, 58% u 60% rispettivament).
English: Compared with tiotropium, Trimbow also reduced the rate of severe exacerbations (i.e. excluding moderate exacerbations) by 32% (rate: 0.067 versus 0.098 events per patient/year; p = 0.017).
Maltese: Trimbow naqqas ukoll ir-rata ta' episodji ta' aggravar sever (jiġifieri episodji ta' aggravar moderat kienu esklużi) bi 32% (rata: 0.067 kontra 0.098 avveniment għal kull pazjent/sena; p = 0.017).
English: Trimbow contains beclometasone dipropionate, formoterol and glycopyrronium in a solution formulation resulting in an aerosol with extrafine particles with an average mass median aerodynamic diameter (MMAD) of around 1.1 micrometres and co-deposition of the three components.
Maltese: Trimbow fih beclometasone dipropionate, formoterol u glycopyrronium f'formulazzjoni ta' soluzzjoni li twassal għal aerosol b'partiċelli fini ħafna b'dijametru aerodinamiku medjan tal-massa (MMADmass median aerodynamic diameter) medju ta' madwar 1.1 mikrometri u ko-depożizzjoni tat-tliet komponenti.
English: There is a risk of worsening shortness of breath and wheezing immediately after using Trimbow and this is known as paradoxical bronchospasm (may affect up to 1 in 1,000 people).
Maltese: Hemm riskju ta' aggravar tal-qtugħ ta' nifs u tħarħir immedjatament wara li tuża Trimbow u dan huwa magħruf bħala bronkospażmu paradossali (jista' jaffettwa sa persuna waħda minn kull 1,000 persuna).
English: Trimbow can reduce exacerbations (flare-ups) of COPD symptoms.
Maltese: Trimbow jista' jnaqqas aggravar (irkadar) tas-sintomi ta' COPD.
English: 1 Adverse reactions reported in the SmPC of at least one of the individual components, but not observed as adverse reactions in the clinical development of Trimbow
Maltese: 1 Reazzjonijiet avversi rrappurtati fl-SmPC ta' mill-inqas wieħed mill-komponenti ndividwali, iżda mhux osservati bħala reazzjonijiet avversi fl-iżvilupp kliniku ta' Trimbow
English: Study TRINITY compared Trimbow with tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily; in addition, effects were compared with an extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (2,691 randomised patients).
Maltese: Studju TRINITY qabbel Trimbow ma' tiotropium 18-il mikrogramma trab li jittieħed man-nifs, kapsula iebsa, inalazzjoni waħda darba kuljum; barra dan, l-effetti tqabblu ma' kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum flimkien ma' tiotropium 18-il mikrogramma trab li jittieħed man-nifs, kapsula iebsa, inalazzjoni waħda darba kuljum (2,691 pazjent li ntgħażlu b'mod każwali).
English: Related to Trimbow
Maltese: Relatat ma' Trimbow
English: Content of the pack and other information What Trimbow contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Trimbow
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 23% (rate: 0.41 versus 0.53 events per patient/year; p = 0.005).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, Trimbow naqqas ir-rata ta' episodji ta' aggravar moderat/sever fuq medda ta' 52 ġimgħa bi 23% (rata: 0.41 kontra 0.53 avveniment għal kull pazjent/sena; p = 0.005).
English: Trimbow contains a small amount of ethanol.
Maltese: Trimbow fih ammont żgħir ta' ethanol.
English: Teл.
Maltese: xaharejn.
English: Study TRILOGY compared Trimbow with a fixed combination of beclometasone dipropionate and formoterol 100/6 micrograms two inhalations twice daily (1,368 randomised patients).
Maltese: Studju TRILOGY qabbel Trimbow ma' kombinazzjoni fissa ta' beclometasone dipropionate u formoterol 100/6 mikrogrammi żewġ inalazzjonijiet darbtejn kuljum (1,368 pazjent li ntgħażlu b'mod każwali).
English: In repeat dose inhalation studies with Trimbow in rats and dogs of up to 13 weeks duration, the main observed alterations were related to effects on the immune system (probably due to systemic corticosteroid effects of beclometasone dipropionate and its active metabolite beclometasone17-monopropionate) and on the cardiovascular system (probably related to the beta2-adrenergic activity of formoterol and the anti-muscarinic activity of glycopyrronium).
Maltese: il-bidliet ewlenin osservati kienu relatati ma' effetti fuq is-sistema immuni (probabbilment minħabba l-effetti sistemiċi tal-kortikosterojdi ta' beclometasone dipropionate u l-metabolit attiv tiegħu beclometasone-17-monopropionate) u fuq is-sistema kardjovaskulari (probabbilment relatati malattività beta2-adrenerġika ta' formoterol u l-attività anti-muskarinika ta' glycopyrronium).
English: Trimbow 87/5/9 micrograms pressurised inhalation beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium Inhalation use
Maltese: Trimbow 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: In addition, compared with both a fixed combination of beclometasone dipropionate and formoterol and with tiotropium, Trimbow significantly prolonged the time to first exacerbation (hazard ratio 0.80 and 0.84 respectively; p = 0.020 and 0.015 respectively), with no differences between Trimbow and the extemporary triple combination made of beclometasone dipropionate and formoterol fixed combination plus tiotropium (hazard ratio 1.06).
Maltese: (proporzjon ta' periklu 0.80 u 0.84 rispettivament; p = 0.020 u 0.015 rispettivament), bl-ebda differenzi bejn Trimbow u l-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (proporzjon ta' periklu 1.06).
English: Using Trimbow together with:
Maltese: Tużax Trimbow:
English: TRIBUTE was a 52-week activecontrolled study comparing Trimbow with a fixed combination of indacaterol/glycopyrronium 85/43 micrograms inhalation powder, hard capsule, one inhalation once daily (1,532 randomised patients).
Maltese: TRIBUTE kien studju kkontrollat b'mod attiv ta' 52 ġimgħa li qabbel Trimbow ma' taħlita fissa ta' trab li jittieħed man-nifs ta' indacaterol/glycopyrronium 85/43 mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,532 pazjent randomised).
English: Trimbow significantly improved dyspnoea (measured as the Transition Dyspnoea Index - TDI - focal score) after 26 weeks of treatment compared with baseline (by 1.71 units; p < 0.001), but the adjusted mean difference versus a fixed combination of beclometasone dipropionate and formoterol was not statistically significant (0.21 units; p = 0.160).
Maltese: Trimbow tejjeb il-qtugħ ta' nifs (imkejjel bħala punteġġ fokali tal-Indiċi ta' Transizzjoni ta' Qtugħ ta' Nifs - TDI [Transition Dyspnoea Index]) b'mod sinifikanti wara 26 ġimgħa ta' trattament meta mqabbel mal-linja bażi (b'1.71 unità; p < 0.001), iżda d-differenza medja aġġustata kontra kombinazzjoni fissa ta' beclometasone dipropionate u formoterol ma kinitx statistikament sinifikanti
English: For beclometasone dipropionate, this results in a more potent effect than formulations with a non-extrafine particle size distribution (100 micrograms of beclometasone dipropionate extrafine in Trimbow are equivalent to 250 micrograms of beclometasone dipropionate in a non-extrafine formulation).
Maltese: Għal beclometasone dipropionate, dan iwassal għal effett aktar qawwi minn formulazzjonijiet b'distribuzzjoni tad-daqs tal-partiċelli mhux fini ħafna (100 mikrogramma ta' beclometasone dipropionate fin ħafna f'Trimbow huma ekwivalenti għal 250 mikrogramma ta' beclometasone dipropionate f'formulazzjoni mhux fina ħafna).
English: Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trimbow with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium.
Maltese: Data farmakokinetika b'doża waħda (ara sezzjoni 5.2) uriet li meta mqabbel ma' użu ta' rutina mingħajr apparat spacer, l-użu ta' Trimbow flimkien mal-apparat spacer AeroChamber Plus, żied lesponiment sistemiku totali (AUC0-t) għal glycopyrronium.
English: Trimbow 87/5/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Maltese: Trimbow 87/5/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: Compared with a fixed combination of indacaterol and glycopyrronium, Trimbow improved average pre-dose FEV1 over the 52-week treatment period by 22 mL (p=0.018).
Maltese: Meta mqabbel ma' kombinazzjoni fissa ta' indacaterol u glycopyrronium, Trimbow tejjeb il-medja ta' FEV1 ta' qabel id-doża matul il-perjodu ta' trattament ta' 52 ġimgħa bi 22 mL (p=0.018).
English: TRISTAR was a 26-week active-controlled open label study comparing Trimbow with an extemporary combination made of a fixed combination of fluticasone/vilanterol 92/22 micrograms inhalation powder, one inhalation once daily plus tiotropium 18 micrograms inhalation powder, hard capsule, one inhalation once daily (1,157 randomised patients).
Maltese: fluticasone/vilanterol 92/22 mikrogramma, inalazzjoni waħda darba kuljum flimkien ma' trab li jittieħed man-nifs ta' tiotropium 18-il mikrogramma, kapsula iebsa, inalazzjoni waħda darba kuljum (1,157 pazjent randomised).
English: Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval (QTc > 450 milliseconds for males, or > 470 milliseconds for females), either congenital or induced by medicinal products as these patients were excluded from clinical trials with Trimbow.
Maltese: Għandu jkun hemm kawtela wkoll meta jiġu ttrattati pazjenti b'titwil magħruf jew issuspettat tal intervall QTc (QTc > 450 millisekonda għall-irġiel, jew > 470 millisekonda għan-nisa), li jista' jkun konġenitali jew ikkaġunat minn prodotti mediċinali għax dawn il-pazjenti kienu esklużi minn provi kliniċi bi Trimbow.
English: Trimbow is not indicated for the treatment of acute episodes of bronchospasm, or to treat an acute COPD exacerbation (i.e. as a rescue therapy).
Maltese: Trimbow mhux indikat għat-trattament ta' episodji akuti ta' bronkospażmu, jew biex jittratta aggravar akut ta' COPD (jiġifieri bħala terapija ta' salvataġġ).
English: Trimbow was also statistically significantly superior to a fixed combination of beclometasone dipropionate and formoterol, to tiotropium and to a fixed combination of indacaterol and glycopyrronium in terms of improvement in quality of life (measured by the Saint George Respiratory Questionnaire - SGRQ - total score).
Maltese: Trimbow kien ukoll superjuri b'mod statistikament sinifikanti għall-kombinazzjoni fissa ta' beclometasone dipropionate u formoterol, għal tiotropium u għall-kombinazzjoni fissa ta' indacaterol u glycopyrronium f'termini ta' titjib fil-kwalità tal-ħajja (imkejjel permezz tal-punteġġ totali tal
English: No differences were observed when comparing Trimbow and the extemporary triple combination made of a fixed combination of beclometasone dipropionate and formoterol plus tiotropium (difference of 3 mL in pre-dose FEV1 after 52 weeks of treatment).
Maltese: Ma kienu osservati l-ebda differenzi meta Trimbow kien imqabbel mal-kombinazzjoni tripla estemporanja magħmula minn kombinazzjoni fissa ta' beclometasone dipropionate u formoterol flimkien ma' tiotropium (differenza ta' 3 mL f'FEV1 qabel id-doża wara 52 ġimgħa ta' trattament).
English: Other medicines and Trimbow
Maltese: Mediċini oħra u Trimbow
English: The study compared data obtained after treatment with a single dose of Trimbow (4 inhalations of 100/6/25 micrograms, a non-marketed formulation containing twice the approved strength of glycopyrronium) or a single dose of the extemporary combination of beclometasone dipropionate/formoterol (4 inhalations of 100/6 micrograms) plus glycopyrronium (4 inhalations of 25 micrograms).
Maltese: L-istudju qabbel data miksuba wara trattament b'doża waħda ta' Trimbow (4 inalazzjonijiet ta' 100/6/25 mikrogramma, formulazzjoni li ma tqegħditx fis-suq li fiha qawwa ta' glycopyrronium id-doppju ta' dak approvat) jew doża waħda tal-kombinazzjoni estemporanja ta' beclometasone dipropionate/formoterol (4 inalazzjonijiet ta' 100/6 mikrogrammi) flimkien ma' glycopyrronium (4 inalazzjonijiet ta' 25 mikrogramma).
English: The most frequently reported adverse reactions with Trimbow were oral candidiasis (which occurred in 0.8% of the exposed subjects), which is normally associated with inhaled corticosteroids; muscle spasms (0.4%), which can be attributed to the long-acting beta2-agonist component; dry mouth (0.4%), which is a typical anticholinergic effect.
Maltese: Sommarju tal-profil tas-sigurtà Ir-reazzjonijiet avversi rrappurtati l-aktar frekwenti bi Trimbow kienu kandidjasi tal-ħalq (li seħħet f'0.8% tal-individwi esposti), li normalment hija assoċjata ma' kortikosterojdi li jittieħdu man-nifs; spażmi fil-muskoli (0.4%), li jistgħu jiġu attribwiti għall-komponent agonist tar-riċetturi beta2 li jaħdem fit-tul; ħalq xott (0.4%), li huwa effett antikolinerġiku tipiku.
English: Simulations performed with a pharmacokinetic model showed that even when covariates had extreme values (body weight less than 40 kg and concomitant glomerular filtration rate below 27 mL/min/1.73 m²), exposure to Trimbow active substances remains in approximately a 2.5-fold range compared to the exposure in a typical patient with median covariate values.
Maltese: Simulazzjonijiet imwettqa b'mudell farmakokinetiku wrew li anke meta kovarjabbli kellhom valuri estremi (piż tal-ġisem inqas minn 40 kg u rata ta' filtrazzjoni glomerulari taħt 27 mL/min/1.73 m² fl-istess waqt), esponiment għas sustanzi attivi ta' Trimbow jibqa' fil-firxa ta' madwar 2.5 darbiet meta mqabbel mal-esponiment f'pazjent tipiku b'valuri medjana ta' kovarjabbli.
English: Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution
Maltese: Trimbow 87 mikrogramma/5 mikrogrammi/9 mikrogrammi, sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni
English: Compared with a fixed combination of beclometasone dipropionate and formoterol, Trimbow significantly improved 2-hour post dose FEV1 by 117 mL after 26 weeks of treatment and by 103 mL after 52 weeks of treatment (p < 0.001).
Maltese: FEV1 sagħtejn wara doża b'mod sinifikanti b'117 mL wara 26 ġimgħa ta' trattament u b'103 mL wara 52 ġimgħa ta' trattament (p < 0.001).
English: It is preferable to avoid the use of Trimbow during labour due to the inhibitory effects of formoterol on uterine contractions.
Maltese: Huwa preferibbli li jiġi evitat l-użu ta' Trimbow waqt il-ħlas minħabba l-effetti inibitorji ta' formoterol fuq il-kontrazzjonijiet tal-utru.
English: An overdose of Trimbow may produce signs and symptoms due to the individual component's actions, including those seen with overdose of other beta2-agonists or anticholinergics and consistent with the known inhaled corticosteroid class effects (see section 4.4).
Maltese: Doża eċċessiva ta' Trimbow tista' tipproduċi sinjali u sintomi minħabba azzjonijiet tal-komponenti individwali, inklużi dawk osservati b'doża eċċessiva ta' agonisti tar-riċetturi beta2 jew antikolinerġiċi oħra u konsistenti mal-effetti magħrufa tal-klassi tal-kortikosterojdi li jittieħdu man-nifs (ara sezzjoni 4.4).
English: Trimbow should be used with caution in patients with cardiac arrhythmias, especially third degree atrioventricular block and tachyarrhythmias (accelerated and/or irregular heart beat), idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease (particularly acute myocardial infarction, ischaemic heart disease, congestive heart failure), occlusive vascular diseases (particularly arteriosclerosis), arterial hypertension and aneurysm.
Maltese: Trimbow għandu jintuża b'kawtela f'pazjenti b'arritmiji kardijaċi, speċjalment imblokk atrijoventrikulari tat-tielet grad u takiarritmiji (taħbit tal-qalb mgħaġġel u/jew irregolari), stenosi idjopatika subvalvulari tal-aorta, kardjomijopatija ipertrofika ostruttiva, mard sever tal-qalb
English: In addition, two Phase IIIb studies were conducted to support the clinical efficacy and safety of Trimbow.
Maltese: IIIb biex isostnu l-effikaċja klinika u s-sigurtà ta' Trimbow.
English: Compared with tiotropium, Trimbow reduced the rate of moderate/severe exacerbations over 52 weeks by 20% (rate: 0.46 versus 0.57 events per patient/year; p = 0.003).
Maltese: tiotropium (rata ta' episjodi ta' aggravar moderat/sever: 0.46 kontra 0.45 avveniment għal kull pazjent/sena).
English: The long-term co-administration of Trimbow with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended (see section 4.4).
Maltese: L-għoti fit-tul ta' Trimbow flimkien ma' prodotti mediċinali oħra li fihom antikolinerġiċi ma ġiex studjat u għalhekk mhux rakkomandat (ara sezzjoni 4.4).
English: Package leaflet: Information for the user Trimbow 87 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
Maltese: Trimbow 87 mikrogramma/5 mikrogrammi/9 mikrogrammi sustanza taħt pressjoni għolja li tittieħed man-nifs, soluzzjoni beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium
English: It is important to use Trimbow every day.
Maltese: Huwa importanti li tuża Trimbow kuljum.
English: Trimbow comes in a pressurised container (coated aluminium), with a metering valve.
Maltese: Trimbow huwa disponibbli f'kontenitur għal kontenut taħt pressjoni għolja (aluminju miksi), b'valv tal-kejl.