FrancophonIA/ELRC3.0 huggingface dataset:
English: The applicant Pfizer Limited has submitted an application for a decentralised procedure for Dectomax 5 mg/ml pour-on solution for cattle.
Maltese: L-applikant Pfizer Limited issottometta applikazzjoni għal proċedura deċentralizzata għal Dectomax 5 mg/ml soluzzjoni li titferragħ għall-ifrat.
English: Two Concerned Member States (the Netherlands and France) considered that the authorisation of Dectomax 5 mg/ml pour-on solution for cattle may present a potential serious risk to the environment.
Maltese: Żewġ Stati Membri Kkonċernati (il-Pajjiżi l-Baxxi u Franza) qiesu li l-awtorizzazzjoni ta' Dectomax 5 mg/ml soluzzjoni li titferragħ għall-ifrat tista' tippreżenta riskju potenzjali serju għall-ambjent.
English: Pharmaceutical form
Maltese: Medical
English: As the risk for Daphnia could not be ruled out by PEC refinements Tier B assessment should be performed according VICH Guideline 38 be performed for which a Daphnia magna reproduction study is required.
Maltese: Peress li r-riskju għal Daphnia ma jistax jiġi eliminat permezz ta' rfinar tal-PEC, għandha ssir valutazzjoni tal-Livell B skont il-Linja Gwida 38 tal-VICH li għaliha jenħtieġ studju tar-riproduzzjoni tadDaphnia magna.
English: Further PEC refinement considering that peak excretion of total residues occurred on day 21 after administration and accounted for 2.3% of the administered dose, as well as based on sediment partitioning lead to a PECsw-refined-direct of 0.00037 µg/l, resulting in a RQ for Daphnia (3.7) still higher than 1.
Maltese: Irfinar ulterjuri tal-PEC li jikkunsidra li l-eskrezzjoni massima tar-residwi totali seħħet fil-jum 21 wara lamministrazzjoni u ammontat għal 2.3% tad-doża amministrata, kif ukoll fuq il-bażi tad-diviżjoni tannaqal iwassal għal PECsw-irfinati-diretti ta' 0.00037 µg/l, u dan jirriżulta f'RQ għal Daphnia (3.7) li xorta jibqa' ogħla minn 1.
English: Several studies and published literature on the toxicity to dung fauna were available.
Maltese: Għad-dispożizzjoni kien hemm bosta studji u riċensjoni ppubblikata dwar it-tossiċità għall-fawna taddemel.
English: Consequently the matter was referred to the CVMP.
Maltese: Għaldaqstant il-kwistjoni ġiet riferuta lis-CVMP.
English: The reference product for this generic application was Dectomax 5 mg/ml pour-on solution for cattle.
Maltese: Il-prodott ta' referenza għal din l-applikazzjoni ġenerika kien Dectomax 5 mg/ml soluzzjoni li titferragħ għall-ifrat.
English: Name
Maltese: Svezja
English: The product is indicated for treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Maltese: Il-prodott huwa indikat għat-trattament ta' dud nematode gastrointestinali, dud nematode tal-pulmun, loa loa, mard tal-ipoderma, qamel li jerda' u li jigdem, ‘mange mites' u haematobia irritans fl-ifrat.
English: • On the basis of environmental risk assessment data submitted with the application it was considered that in order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation risk mitigation measures should be applied; the CVMP concluded that the objections raised by the Netherlands and France should not prevent the granting of a marketing authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names (see annex I) as the overall benefit-risk balance for the product is positive subject to the recommended changes in the product information set out in annex III.
Maltese: • Fuq il-bażi tal-valutazzjoni tad-dejta dwar ir-riskju ambjentali mressqa mal-applikazzjoni, tqies li biex jiġu identifikati r-riskji għall-organiżmi akwatiċi u l-fawna tad-demel kif ukoll kwalunkwe inċertezza li jifdal rigward il-bijoakkumulazzjoni, għandhom jiġu applikati miżuri ta' mitigazzjoni tar-riskji; is-CVMP ikkonkluda li l-oġġezzjonijiet imqajma mill-Pajjiżi l-Baxxi u Franza ma għandhomx jipprevjenu l-għoti ta' awtorizzazzjoni għat-tqegħid fis-suq għal Prontax 5 mg/ml soluzzjoni li titferragħ għall-ifrat u ismijiet assoċjati (ara anness I) peress li l-bilanċ ġenerali bejn il-benefiċċji u r-riskji għall-prodott huwa pożittiv soġġett għall-bidliet rakkomandati fit-tagħrif dwar il-prodott stabbiliti fl-anness III.
English: In terms of environmental safety, in addition to the fact that the current data package does not allow to rule out bioaccumulation of doramectin, a risk to the aquatic compartment has been identified based on available toxicity data (acute toxicity for Daphnia magna) as well as a risk to dung fauna exposed to residue-containing dung out when the product is used in accordance with the recommended posology.
Maltese: F'termini ta' sikurezza ambjentali, minbarra l-fatt li l-pakkett ta' dejta attwali ma jeliminax ilpossibbiltà tal-bijoakkumulazzjoni tad-doramektina, ġie identifikat riskju għall-kompartiment akwatiku fuq il-bażi ta' dejta disponibbli dwar it-tossicità (tossicità akuta ghal Daphnia magna) kif ukoll riskju għall-fawna tad-demel esposta għal demel li fih residwu meta l-prodott jintuża skont il-pożoloġija rakkomandata.
English: The product is intended for the treatment of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.
Maltese: Il-prodott huwa maħsub għattrattament ta' dud nematode gastrointestinali, dud nematode tal-pulmun, loa loa, mard tal-ipoderma, qamel li jerda' u li jigdem, ‘mange mites' u haematobia irritans fl-ifrat.
English: It is a macrocyclic lactone and is closely related to ivermectin.
Maltese: Huwa latton makroċikliku relatat mill-qrib mal-ivermektina.
English: The supplementary data provided did not allow ruling out a medium to longterm risk to dung insects.
Maltese: Id-dejta supplimentari pprovduta ma ppermettietx li jiġi eliminat riskju medju sa fittul għall-insetti tad-demel.
English: Dectomax 5 mg/ml Pour-On Solution for Cattle
Maltese: Raġunijiet għall-emendar tat-tagħrif dwar il-prodott
English: According to the VICH Guideline 38 Phase II, a Tier B assessment is required.
Maltese: Skont il-Linja Gwida 38 tal-VICH, jenħtieġ issir valutazzjoni tal-Fażi II, Livell B.
English: In order to address the identified risks for aquatic organisms and dung fauna as well as any remaining uncertainty regarding bioaccumulation the following risk mitigation measures are recommended: The following text is proposed in section 4.5 of the SPC(special precautions for use): Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
Maltese: Sabiex jiġu indirizzati r-riskji identifikati għall-organiżmi akwatiċi u l-fawna tad-demel kif ukoll kwalunwke inċertezza rigward il-bijoakkumulazzjoni, huma rakkomandati l-miżuri ta' mitigazzjoni tarriskji li ġejjin:
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street
Maltese: Glaxo Operations UK Ltd (tinnegozja bħala Glaxo Wellcome Operations)
English: For further instructions on handling the device, see section 6.6.
Maltese: Għal aktar istruzzjonijiet dwar l-immaniġġjar tal-apparat, ara sezzjoni 6.6.
English: The most frequently reported adverse reactions with Temybric Ellipta were nasopharyngitis (7%), headache (5%) and upper respiratory tract infection (2%).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktkar mod frekwenti b'Temybric Ellipta kienu nażofarinġite (7%), uġigħ ta' ras (5%) u infezzjoni fl-apparat respiratorju ta' fuq (2%).
English: Hertfordshire SG12 0DJ UK
Maltese: Hertfordshire SG12 0DJ Ir-Renju Unit
English: Treatment difference 95% CI
Maltese: Differenza fil-kura (95% CI)
English: EU/1/19/1378/002
Maltese: EU/1/19/1378/001 EU/1/19/1378/002
English: Comparison Temybric vs. UMEC/VI
Maltese: FF/VI and FF/UMEC/VI vs.
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: fluticasone furoate/vilanterol (184/22 mikrogramma) u ketoconazole (400 milligramma, inibitur qawwi ta' CYP3A4).
English: The fluticasone furoate/vilanterol component of Temybric Ellipta was assessed in patients with all severities of hepatic impairment (Child-Pugh A, B or C).
Maltese: Il-komponent fluticasone furoate/vilanterol ta' Temybric Ellipta ġie vvalutat f'pazjenti bis-severitajiet kollha ta' indebboliment tal-fwied (Child-Pugh A, B jew C).
English: IMPACT (CTT116855) was a 52-week study (N=10,355) that compared Temybric 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 Temybric Ellipta (92/55/22 mikrogramma) ma' fluticasone furoate/vilanterol 92/22 mikrogramma (FF/VI) u umeclidinium/vilanterol 55/22 mikrogramma (UMEC/VI).
English: The other ingredients are lactose monohydrate (see section 2 under ‘Temybric Ellipta contains lactose') and magnesium stearate.
Maltese: L-ingredjenti l-oħra huma lactose monohydrate (ara sezzjoni 2 taħt ‘Temybric Ellipta fih lactose') u magnesium stearate.
English: What Temybric Ellipta contains The active substances are fluticasone furoate, umeclidinium bromide and vilanterol.
Maltese: Is-sustanzi attivi huma fluticasone furoate, umeclidinium bromide u vilanterol.
English: Use Temybric Ellipta regularly
Maltese: Uża Temybric Ellipta regolarment
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%,
English: GSK Services Sp. z o.o.
Maltese: Laboratori Guidotti S.p.A.
English: INFORMATION IN BRAILLE temybric ellipta
Maltese: INFORMAZZJONI BIL-BRAILLE temybric ellipta
English: Temybric Ellipta is indicated as a maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting β2-agonist or a combination of a long-acting β2-agonist and a long-acting muscarinic antagonist (for effects on symptom control and prevention of exacerbations see section 5.1).
Maltese: Temybric Ellipta huwa indikat bħala kura ta' manteniment f'pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD, chronic obstructive pulmonary disease) moderat sa sever li ma jiġux ikkurati b'mod adegwat b'kombinazzjoni ta' kortikosterojde li jittieħed man-nifs u agonista-β2 li jaġixxi fit-tul jew kombinazzjoni ta' agonista-β2 li jaġixxi fit-tul u agonista-β2 li jaġixxi fit-tul muskariniku (għall-effetti dwar il-kontroll tas-sintomi u prevenzjoni ta' taħrix ara sezzjoni 5.1).
English: Temybric Ellipta is used to treat chronic obstructive pulmonary disease (COPD) in adults.
Maltese: Temybric Ellipta jintuża għall-kura ta' mard kroniku ostruttiv tal-pulmuni (COPD) fl-adulti.
English: Treatment with Temybric Ellipta significantly reduced the annual rate of severe exacerbations by 34% compared with UMEC/VI (95% CI: 22, 44; p<0.001).
Maltese: Il-kura bi Temybric Ellipta naqqset sinifikament ir-rata annwali ta' taħrix sever b'34 % meta mqabbel ma' UMEC/VI (95% CI: 22, 44; p<0.001).
English: Trough FEV1 (L) at Week 52, LS mean change from baseline (SE) a
Maltese: FEV1 minimu (L) f'Ġimgħa 52, bidla medja ta' LS mil-linja bażi (SE) a
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BUNDLE LABEL (WITH BLUE BOX- MULTIPACK)
Maltese: TIKKETTA TAL-PAKKETT (BIL-KAXXA BLU- PAKKETT MULTIPLU)
English: Fatal pneumonia occurred in 12 of 4,151 patients (3.5 per 1,000 patientyears) receiving Temybric 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 Temybric 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: Česká republika GlaxoSmithKline, s.r.o.
Maltese: Slovenská republika GlaxoSmithKline Slovakia s. r. o.
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Temybric Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Maltese: FULFIL (CTT116853) kien studju ta' 24 ġimgħa (N=1,810), b'estensjoni sa 52 ġimgħa f'subsett ta' individwi (n=430), li qabbel Temybric Ellipta (92/55/22 mikrogramma) ma' budesonide/formoterol 400/12il mikrogramma (BUD/FOR) mogħti darbtejn kuljum.
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)a
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Temybric Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Maltese: F'FULFIL il-proporzjon ta' rispondenti skont TDI (definit skont tal-inqas unità 1) kien sinifikament ogħla (p<0.001) għal Temybric Ellipta meta mqabbel ma' BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
English: The effects of age on the pharmacokinetics of fluticasone furoate, umeclidinium and vilanterol were evaluated in the population pharmacokinetic analysis.
Maltese: Anzjani L-effetti tal-età fuq il-farmakokinetika ta' fluticasone furoate, umeclidinium u/vilanterol ġew ivvalutati fl analiżi farmakokinetika tal-popolazzjoni.
English: Temybric Ellipta significantly improved (p<0.001) Health Related Quality of Life (as measured by the St George's Respiratory Questionnaire [SGRQ] total score) in both FULFIL (week 24) when compared with BUD/FOR (-2.2 units; 95% CI: -3.5, -1.0) and IMPACT (week 52) when compared with FF/VI (-1.8 units; 95% CI: -2.4, -1.1) and UMEC/VI (-1.8 units; 95% CI: -2.6, -1.0).
Maltese: George's [SGRQ]) kemm f'FULFIL (ġimgħa 24) meta mqabbel ma' BUD/FOR (-2.2 unitajiet; 95% CI: -3.5, -1.0) u IMPACT (ġimgħa 52) meta mqabbel ma' FF/VI (-1.8 unitajiet; 95% CI: -2.4, -1.1) u UMEC/VI (-1.8 unitajiet; 95% CI: -2.6, -1.0).
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: polyoxymethylene, polybutylene terephthalate, acrylonitrile butadiene styrene, polycarbonate u azzar inossidabbli.
English: Temybric Ellipta contains lactose
Maltese: Temybric Ellipta fih lactose
English: Following intravenous administration of vilanterol to healthy volunteers, the mean volume of distribution at steady state was 165 litres.
Maltese: Vilanterol Wara għoti ġol-vini ta' vilanterol lil voluntiera b'saħħithom, il-volum medju ta' distribuzzjoni fl-istat fiss kien ta' 165 litru.
English: Cardiovascular effects, such as cardiac arrhythmias, e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium and vilanterol, respectively.
Maltese: L-effetti kardjovaskulari, bħal arritmiji kardijaċi, eż. fibrillazzjoni atrijali u takikardija, jistgħu jidhru wara lgħoti ta' riċetturi muskariniċi antagonisti u simpatomimetiċi, inkluż umeclidinium u vilanterol,
English: In IMPACT, over 52 weeks, Temybric Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Maltese: F'IMPACT, matul 52 ġimgħa, Temybric Ellipta naqqas sinifikament ir-rata annwali ta' taħrix moderat/sever bi 15 % (95% CI:10, 20) meta mqabbel ma' FF/VI (rata; 0.91 vs 1.07 avvenimenti għal kull sena ta' pazjent) u b'25% (95% CI: 19, 30) meta mqabbel ma' UMEC/VI (rata; 0.91 vs 1.21 avvenimenti għal kull sena ta'
English: Study 200812 was a 24-week, non-inferiority study (N=1,055) that compared Temybric Ellipta (92/55/22 micrograms) with FF/VI (92/22 micrograms) + UMEC (55 micrograms), co-administered once daily as a multi-inhaler therapy in patients with a history of moderate or severe exacerbations within the prior 12 months.
Maltese: Studju 200812 kien studju ta' 24 ġimgħa, ta' non-inferjorità (N=1,055) li qabbel Temybric Ellipta (92/55/22 mikrogramma) ma' FF/VI (92/22 mikrogramma) + UMEC (55 mikrogramma), mogħti flimien darba kuljum bħala terapija ta' ħafna inalaturi f'pazjenti bi storja ta' taħrix moderat jew sever fi żmien 12
English: The incidence of pneumonia with Temybric Ellipta is comparable with that observed in the fluticasone furoate/vilanterol (FF/VI) 100/25 arm of FF/VI clinical studies in COPD.
Maltese: dik osservata fil-fergħa fluticasone furoate/vilanterol (FF/VI) 100/25 tal-istudji kliniċi ta' FF/VI fis-COPD.
English: Laboratori Guidotti S.p.A. Tel: + 39 050 971011
Maltese: Tel: + 39 050 971011
English: The absolute bioavailability of inhaled umeclidinium was on average 13%, with negligible contribution from oral absorption.
Maltese: Il-bijodisponibilità assoluta ta' umeclidinium li jittieħed man nifs kienet bħala medja 13 %, b'kontribuzzjoni negliġibbli mill-assorbiment orali.
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Temybric Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Maltese: 001) għal pazjenti kkurati bi Temybric Ellipta (42%) meta mqabbel ma' FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) u UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
English: In IMPACT, Temybric 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: 001) il-funzjoni tal-pulmun meta mqabbel ma' FF/VI u UMEC/VI fuq perjodu ta' 52 ġimgħa (Ara Tabella 2).
English: In FULFIL, based upon data up to 24 weeks, Temybric Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Maltese: F'FULFIL, abbażi ta' dejta sa 24 ġimgħa, Temybric Ellipta naqqas sinifikament (p=0.002) ir-rata annwali ta' taħrix moderat/sever b'35 % (95% CI: 14, 51) meta mqabbel ma' BUD/FOR.
English: In IMPACT, Temybric Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Maltese: F'IMPACT, Temybric Ellipta naqqas sinifikament in-numru medju ta' qawmien billejl minħabba COPD meta mqabbel ma' FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) u ma' UMEC/VI (-0.10; 95%
English: How to use Temybric Ellipta 4.
Maltese: Kif għandek tuża Temybric Ellipta 4.
English: Lung Function
Maltese: DARBA KULJUM
English: Temybric Ellipta
Maltese: Tużax Temybric Ellipta:
English: 1 inhaler of 14 doses
Maltese: INDIVIDWALI 14-il doża
English: In FULFIL, Temybric Ellipta improved daily symptoms of COPD as assessed by E-RS: COPD total score, compared with BUD/FOR (≥2 unit decrease from baseline).
Maltese: E-RS: COPD, meta mqabbel ma' BUD/FOR (tnaqqis ta' ≥2 unitajiet mil-linja bażi).
English: FEV1=forced expiratory volume in 1 second; L=litres; LS=least squares; SE= standard error, N=number in the intent-totreat population; CI= confidence interval, a Statistically significant treatment difference for FF/UMEC/VI vs. BUD/FOR also observed at the other assessment timepoints (weeks 2, 4 and 12).
Maltese: LS=l-inqas kaxxi; SE= errur standard, N=numru fl-intenzjoni li jikkura l-popolazzjoni; CI= interval ta' kunfidenza; a Differenzi fil-kura statistikament sinifikanti għal FF/UMEC/VI vs.
English: The proportion of responders during weeks 21-24 was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (47% and 37% respectively; OR 1.59; 95% CI: 1.30, 1.94).
Maltese: 001) għal pazjenti kkurati bi Temybric meta mqabbel ma' BUD/FOR (47% u 37% rispettivament; OR 1.59; 95% CI: 1.30, 1.94).
English: 14 doses 30 doses
Maltese: 14-il doża
English: In FULFIL, bronchodilatory effects with Temybric Ellipta were evident on the first day of treatment and were maintained over the 24-week treatment period (mean changes from baseline in FEV1 were 90-222 mL on day 1 and 160-339 mL at week 24).
Maltese: F'FULFIL, l-effetti bronkodilatorji bi Temybric Ellipta kienu evidenti fl-ewwel jum ta' kura u nżammu matul il-perjodu ta' kura ta' 24 ġimgħa (il-bidliet medji mil-linja bażi f'FEV1 kienu 90-222 mL f'jum 1 u 160-339 mL f'ġimgħa 24).
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Maltese: Temybric Ellipta 92 /55 /22 mcg trab li jittieħed man-nifs fluticasone furoate/umeclidinium/vilanterol
English: Rhinitis
Maltese: Dessikant
English: In IMPACT, the proportion of responders was also significantly higher (p<0.001) for Temybric Ellipta (36%) compared with FF/VI (29%; OR 1.36; 95% CI: 1.19, 1.55) and UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
Maltese: (29%; OR 1.36; 95% CI: 1.19, 1.55) u UMEC/VI (30%; OR 1.33; 95% CI: 1.13, 1.57).
English: LIST OF EXCIPIENTS Also contains lactose and magnesium stearate.
Maltese: TA' EĊĊIPJENTI Fih ukoll lattożju u magnesium stearate.
English: • If the dose counter does not count down as you hear the “click”, the inhaler will not deliver medicine.
Maltese: • Jekk il-kontatur tad-dożi ma jnaqqasx b'1 malli tisma' l-“klikk”, l-inalatur ma jagħtikx il mediċina.
English: Viral respiratory tract infection
Maltese: Pulmonite Infezzjoni tal-apparat respiratorju ta' fuq
English: The efficacy of Temybric Ellipta (92/55/22 micrograms), administered as a once-daily treatment, has been evaluated in patients with a clinical diagnosis of COPD in two, active-controlled studies and in a single, noninferiority study.
Maltese: L-effikaċja ta' Temybric Ellipta (92/55/22 mikrogramma) mogħti bħala kura ta' darba kuljum ġiet ivvalutata f'pazjenti b'dijanjożi klinika ta' COPD f'żewġ studji kkontrollati attivi u fi studju wieħed mhux ta' inferjorità.
English: In a total of 1810 patients with advanced COPD (mean post-bronchodilator screening FEV1 45% of predicted, standard deviation (SD) 13%), 65% of whom had experienced a moderate/severe COPD exacerbation in the year prior to study entry (study CTT116853), there was a higher incidence of pneumonia events reported up to 24 weeks in patients receiving Temybric Ellipta (20 patients, 2%) than in patients receiving budesonide/formoterol (7 patients, <1%).
Maltese: moderat/sever fis-sena preċedenti qabel id-dħul fl-istudju (studju CTT116853), kien hemm inċidenza ogħla ta' avvenimenti ta' pulmonite rrappurtati sa 24 ġimgħa f'pazjenti li kienu qed jirċievu Temybric Ellipta (20 pazjent, 2 %) milli f'pazjenti li kienu qed jirċievu budesonide/formoterol (7 pazjenti, <1 %).
English: In a 52-week study, with a total of 10,355 patients with COPD and a history of moderate or severe exacerbations within the prior 12 months (mean post-bronchodilator screening FEV1 46% of predicted, SD 15%) (study CTT116855), the incidence of pneumonia was 8% (317 patients) for Temybric Ellipta (n = 4,151), 7% (292 subjects) for fluticasone furoate/vilanterol (n = 4,134), and 5% (97 subjects) for umeclidinium/vilanterol (n = 2,070).
Maltese: 12-il xahar ta' qabel (skrinjar wara l-bronkodilatur medju FEV1 ta' 46 % tal-previst, SD 15%) (studju CTT116855), l-inċidenza ta' pulmonite kienet 8 % (317-il pazjent) għal Temybric Ellipta (n = 4,151), 7%
English: Temybric Ellipta contains three active substances called fluticasone furoate, umeclidinium and vilanterol.
Maltese: Temybric Ellipta fih tliet sustanzi attivi li jissejħu fluticasone furoate, umeclidinium u vilanterol.
English: Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Maltese: Temybric Ellipta 92 mikrogramma/55 mikrogramma/22 mikrogramma trab li jittieħed man-nifs, lest minn qabel fluticasone furoate/umeclidinium/vilanterol