FrancophonIA/ELRC3.0 huggingface dataset:
English: In a thorough QT study in 73 healthy volunteers, a single inhaled dose of glycopyrronium 352 micrograms (8 times the therapeutic dose) did not prolong the QTc interval and slightly reduced heart rate (maximal effect -5.9 bpm; average effect over 24 hours -2.8 bpm) when compared to placebo.
Maltese: Fi studju profond tal-QT fost 73 voluntier b'saħħithom, doża waħda meħuda man-nifs ta' 352 mikrogramma glycopyrronium (8 darbiet id-doża terapewtika) ma tawlitx l-intervall tal-QTc u naqqset kemm kemm ir-rata tal-qalb (effett massimali -5.9 bpm, effett medju tul 24 siegħa -2.8 bpm) imqabbel mal-plaċebo.
English: Tovanor Breezhaler is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Tovanor Breezhaler hu indikat bħala trattament bronkodilatatur ta' manutenzjoni biex iserraħ lil pazjenti adulti minn sintomi ta' mard pulmonari ostruttiv kroniku (COPD).
English: This medicine contains lactose.
Maltese: Din il-mediċina fiha l-lactose.
English: The effect on heart rate and QTc interval of 150 micrograms glycopyrronium bromide (equivalent to 120 micrograms glycopyrronium) administered intravenously was investigated in young healthy subjects.
Maltese: L-effett fuq ir-rata tat-taħbit tal-qalb u l-intervall tal-QTc wara li ngħataw mill-vina 150 mikrogramma glycopyrronium bromide (ekwivalenti għal 120 mikrogramma glycopyrronium) kien investigat f'suġġetti żgħażagħ b'saħħithom.
English: Patients with unstable ischaemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable atrial fibrillation), a history of long QT syndrome or whose QTc (Fridericia method) was prolonged (>450 ms for males or >470 ms for females) were excluded from the clinical trials, and therefore the experience in these patient groups is limited.
Maltese: Pazjenti b'mard tal-qalb iskemiku instabbli, insuffiċjenza tal-ventrikolu tax-xellug, storja ta' infart mijokardijaku, arritmija (mhux inkluża fibrillazzjoni atrijali kronika stabbli), storja ta' QT twil jew li lQTc tagħhom (metodu ta' Fridericia) kien imtawwal (>450 ms għall-irġiel jew >470 ms għan-nisa) kienu esklużi mill-provi kliniċi, u għalhekk l-esperjenza f'dawn il-gruppi ta' pazjenti hija limitata.
English: Gastrointestinal effects including gastroenteritis and dyspepsia were also observed.
Maltese: Kienu osservati wkoll effetti gastrointestinali fosthom gastroenterite u dispepsja.
English: Tovanor Breezhaler once daily statistically significantly reduced the use of rescue medication (salbutamol) by 0.46 puffs per day (p=0.005) over 26 weeks and by 0.37 puffs per day (p=0.039) over 52 weeks, compared to placebo for the 6- and 12-month studies, respectively.
Maltese: Tovanor Breezhaler darba kuljum naqqas b'mod statistikament sinifikanti l-użu ta' mediċini ta' salvataġġ (salbutamol) b'0.46 pumpjaturi kuljum (p=0.005) tul 26 ġimgħa u b'0.37 pumpjaturi kuljum (p=0.039) tul 52 ġimgħa, imqabbel mal-plaċebo tul l-istudji li damu 6 u 12-il xahar, rispettivament.
English: No specific side effects have been reported when Tovanor Breezhaler has been used together with other medicines used to treat COPD such as reliever inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline) and/or oral and inhaled steroids (e.g. prednisolone).
Maltese: Ma ġewx irrappurtati effetti sekondarji speċifiċi meta Tovanor Breezhaler intuża flimkien ma' mediċini oħrajn użati biex jittrattaw COPD bħalma huma inalaturi ta' serħan (eż. salbutamol), methylxanthines (eż. theophylline) u/jew sterojdi orali u meħuda mal-imnfisejn (eż. prednisolone).
English: • Tiredness
Maltese: • Titrix
English: Each blister strip contains either 6 or 10 hard capsules.
Maltese: Kull strixxa ta' folji fiha 6 jew 10 kapsuli iebsin.
English: Tovanor Breezhaler can be used at the recommended dose in elderly patients (75 years of age and older) (see section 4.8).
Maltese: Tovanor Breezhaler jista' jintuża skont id-doża rrakkomandata f'pazjenti anzjani (minn 75 sena 'l fuq) (ara sezzjoni 4.8).
English: • Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)
Maltese: • Diffikultà biex tieħu n-nifs b'tisfir jew sogħla (sinjali ta' bronkospażmi paradossali)
English: In the 12-month study, the improvement versus placebo for tiotropium was 83 ml (p<0.001).
Maltese: Fl-istudju li dam 12-il xahar, it-titjib għal tiotropium kontra l-plaċebo kien ta' 83 ml (p<0.
English: Multipack: 96 (4 packs of 24 x 1) capsules + 4 inhalers.
Maltese: Pakkett b'ħafna: 96 (4 pakketti ta' 24 x 1) kapsula + 4 inhalers.
English: In COPD patients both systemic exposure and total urinary excretion of glycopyrronium at pharmacokinetic steady state increased about dose-proportionally over the dose range of 44 to 176 micrograms.
Maltese: F'pazjenti b'COPD kemm l-espożizzjoni sistemika u l-eskrezzjoni totali mal-awrina ta' glycopyrronium fi stat farmakokinetiku fiss żdiedet proporzjonalment skont id-doża fuq il-medda taddożi mogħtija minn 44 sa 176 mikrogramma.
English: Multipack: 90 (3 packs of 30 x 1) capsules + 3 inhalers.
Maltese: Pakkett b'ħafna: 90 (3 pakketti ta' 30 x 1) kapsula + 3 inhalers.
English: For patients receiving tiotropium, 61.0% responded with a 4 point or greater improvement in SGRQ (p=0.004 compared to placebo).
Maltese: Għal pazjenti mogħtija tiotropium, 61.0% rrispondew b'titjib ta' 4 punti jew aktar f'SGRQ (p=0.004 mqabbel mal-plaċebo).
English: Steady-state exposure to glycopyrronium (AUC over the 24-hour dosing interval) was about 1.4- to 1.7-fold higher than after the first dose.
Maltese: L-espożizzjoni għal glycopyrronium fi stat fiss (l-AUC wara intervall mill-aħħar doża ta' 24 siegħa) kien ta' madwar 1.4 sa 1.7 drabi ogħla minn dik wara l-ewwel doża.
English: The clinical Phase III development programme included two phase III studies: a 6-month placebo-controlled study and a 12-month placebo and active-controlled (open label tiotropium 18 micrograms once daily) study, both in patients with clinical diagnosis of moderate to severe COPD.
Maltese: III: studju ta' 6 xhur ikkontrollat bi plaċebo u studju ta' 12-il xahar bi plaċebo u kkontrollat bl-attiv (18-il mikrogramma tiotropium open label darba kuljum), it-tnejn li huma fost pazjenti b'dijanjosi klinika ta' COPD minn moderata għal gravi.
English: Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms glycopyrronium).
Maltese: Kull kapsula fiha 63 mikrogramma ta' glycopyrronium bromide (ekwivalenti għal 50 mikrogramma ta' glycopyrronium).
English: The most common anticholinergic adverse reaction was dry mouth (2.4%).
Maltese: L-aktar reazzjoni avversa antikolinerġika komuni kienet ħalq xott (2.4%).
English: This includes medicines similar to Tovanor Breezhaler used for your lung disease, such as ipratropium, oxitropium or tiotropium (so called anticholinergics).
Maltese: Dan jinkludi mediċini simili għal Tovanor Breezhaler użati għall-mard li għandek tal-pulmun, bħal ipratropium, oxitropium jew tiotropium (imsejħa wkoll antikolinerġiċi).
English: Renal elimination of parent drug accounts for about 60 to 70% of total clearance of systemically available glycopyrronium whereas non-renal clearance processes account for about 30 to 40%.
Maltese: L-eliminazzjoni tal-mediċina ewlenija mill-kliewi kien ta' madwar 60 u 70% tat-tneħħija totali ta' glycopyrronium disponibbli sistemikament filwaqt li l-proċessi tat-tneħħija mhux mill-kliewi kienu ta' madwar 30 sa 40%.
English: Date of first authorisation: 28 September 2012 Date of latest renewal: 26 July 2017
Maltese: Data tal-aħħar tiġdid: 26 Lulju 2017
English: No change in mean heart rate or QTc interval was observed with Tovanor Breezhaler in doses up to 176 micrograms in COPD patients.
Maltese: Ma kienx hemm bidla fir-rata tat-taħbit tal-qalb jew fl-intervall tal-QTc b'Tovanor Breezhaler b'dożi sa 176 mikrogramma f'pazjenti b'COPD.
English: In a clinical study in healthy volunteers, cimetidine, an inhibitor of organic cation transport which is thought to contribute to the renal excretion of glycopyrronium, increased total exposure (AUC) to glycopyrronium by 22% and decreased renal clearance by 23%.
Maltese: Fi studju klinku fost voluntiera b'saħħithom, cimetidine, inibitur tat-trasport ta' cations organiċi li hu maħsub li għandhom sehem fl-eskrezzjoni ta' glycopyrronium mill-kliewi, żied l-espożizzjoni totali (AUC) għal glycopyrronium bi 22% u naqqas it-tneħħija tiegħu mill-kliewi bi 23%.
English: In clinical studies with Tovanor Breezhaler, paradoxical bronchospasm was not observed.
Maltese: Fi studji kliniċi b'Tovanor Breezhaler, ma kienx hemm spażmi paradossali tal-bronki.
English: 30 x 1 capsules + 1 inhaler.
Maltese: 30 x 1 kapsula + inhaler wieħed.
English: Throat irritation
Maltese: Griżmejn irritati
English: The following pack sizes are available: Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.
Maltese: Pakketti li fihom 6x1, 10x1, 12x1 jew 30x1 kapsula iebsa, flimkien ma' inhaler wieħed.
English: If signs suggesting allergic reactions occur, in particular, angioedema (including difficulties in breathing or swallowing, swelling of the tongue, lips, and face), urticaria or skin rash, treatment should be discontinued immediately and alternative therapy instituted.
Maltese: Jekk ikun hemm sinjali li jissuġġerixxu reazzjonijiet allerġiċi, b'mod partikulari, anġjoedima (li tinkludi diffikultajiet biex tieħu n-nifs jew biex tibla', nefħa fl-ilsien, fix-xufftejn u filwiċċ), urtikarja jew raxx fil-ġilda, it-trattament għandu jitwaqqaf minnufih u kull terapija alternattiva mibdija.
English: Each delivered dose (the dose that leaves the mouthpiece of the inhaler) contains 55 micrograms of glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Maltese: Kull doża meħuda (id-doża li tħalli l-bokkin tal-inhaler) fiha 55 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 44 mikrogramma ta' glycopyrronium.
English: In the 6-month study, Tovanor Breezhaler increased FEV1 after the first dose with an improvement of 93 ml within 5 minutes and 144 ml within 15 minutes of dosing, compared to placebo (both p<0.001).
Maltese: Fl-istudju li dam 6 xhur, Tovanor Breezhaler żied l-FEV1 wara l-ewwel doża b'titjib ta' 93 ml fi żmien 5 minuti u ta' 144 ml fi żmien 15-il minuta mid-doża, imqabbel mal-plaċebo (it-tnejn p<0.001).
English: Carcinogenicity studies in transgenic mice using oral administration and in rats using inhalation administration revealed no evidence of carcinogenicity at systemic exposures (AUC) of approximately 53-fold higher in mice and 75-fold higher in rats than the maximum recommended dose of 44 micrograms once daily for humans.
Maltese: Studji dwar il-karċinoġeniċità fi ġrieden transġeniċi li ħadu dożi mill-ħalq u f'firien li ħadu dożi man-nifs ma wrew l-ebda evidenza ta' karċinoġeniċità f'espożizzjonijiet sistemiċi (AUC) ta' madwar 53 darba ogħla fil-ġrieden u ta' 75 darba ogħla fil-firien mid-doża massima rrakkomandata ta' 44 mikrogramma darba kuljum għall-bnedmin.
English: Gastrointestinal disorders Dry mouth
Maltese: Disturbi gastrointestinali
English: The magnitude of the effect was dependent on the degree of reversibility of airflow limitation at baseline (tested by administration of a short-acting muscarinic antagonist bronchodilator): Patients with the lowest degree of reversibility at baseline (<5%) generally exhibited a lower bronchodilator response than patients with a higher degree of reversibility at baseline (≥5%).
Maltese: Il-qawwa tal-effett kienet tiddependi mill-grad ta' riversibbiltà tallimitazzjoni tal-mogħdija tal-arja fil-linja bażi (ippruvat bl-għoti ta' bronkodilatatur tal-antagonist muskariniku li jaħdem għal ftit żmien): Pazjenti bl-anqas grad ta' riversibbiltà fil-linja bażi (<5%) ġeneralment urew rispons aktar baxx tal-bronkodilatatur minn pazjenti bi grad ogħla ta' riversibbiltà fil-linja bażi (≥5%).
English: These include sympathomimetic bronchodilators, methylxanthines, and oral and inhaled steroids.
Maltese: Dawn jinkludu bronkodilataturi simpatomimetiċi, methylxanthines, u sterojdi orali u meħuda mill-imnifsejn.
English: What Tovanor Breezhaler contains - The active substance is glycopyrronium bromide.
Maltese: X'fih Tovanor Breezhaler - Is-sustanza attiva hi glycopyrronium bromide.
English: Multipacks containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.
Maltese: Pakketti multipli li fihom 90 (3 pakketti ta' 30x1) kapsula iebsa u 3 inhalers.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' Lapp lactase jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Chec k
Maltese: • Ħakk
English: Each capsule contains 63 micrograms of glycopyrronium bromide equivalent to 50 micrograms of glycopyrronium.
Maltese: Kull kapsula fiha 63 mikrogramma ta' glycopyrronium bromide ekwivalenti għal 50 mikrogramma ta' glycopyrronium.
English: Some elderly patients above 75 years of age experienced headache (frequency common) and urinary tract infection (frequency common).
Maltese: Xi pazjenti anzjani 'l fuq minn 75 sena kellhom uġigħ ta' ras (frekwenza komuni) u infezzjoni filpassaġġ tal-awrina (frekwenza komuni).
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of allergic reaction)
Maltese: • Raxx, ħakk, ħorriqija, diffikultà biex tieħu n-nifs jew biex tibla', sturdament (sinjali li jistgħu jkunu ta' reazzjoni allerġika)
English: Show the pack of Tovanor Breezhaler.
Maltese: Uri l-pakkett ta' Tovanor Breezhaler.
English: What Tovanor Breezhaler looks like and contents of the pack Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules are transparent and orange and contain a white powder.
Maltese: Kif jidher Tovanor Breezhaler u l-kontenut tal-pakkett Il-kapsuli iebsin ta' Tovanor Breezhaler 44 mikrogramma trab li jittieħed man-nifs, huma trasparenti u oranġjo u fihom trab abjad.
English: Insufficient pharmacokinetic data is available for other ethnicities or races.
Maltese: M'hemmx biżżejjed dejta farmakokinetika dwar etniċitajiet jew razez oħrajn.
English: Musculoskeletal chest pain
Maltese: Uġigħ muskoluskelettriku tas-sider
English: The long duration of action can be partly attributed to sustained concentrations of active substance in the lung as reflected by the prolonged terminal elimination half-life of glycopyrronium after inhalation via the Tovanor Breezhaler inhaler in contrast to the half life after intravenous administration (see section 5.2).
Maltese: Jista' jkun li parti mir-raġuni għala l-prodott mediċinali jibqa' jaħdem fit-tul hi minħabba lkonċentrazzjonijiet sostenibbli tas-sustanza attiva fil-pulmun kif jidher mill-eliminazzjoni terminali mtawla tal-half-life ta' glycopyrronium wara li jittieħed man-nifs bl-inhaler Tovanor Breezhaler għallkuntrarju tal-half-life wara l-għoti mill-vina (ara sezzjoni 5.2).
English: Peak exposures (Cmax) about 50-fold higher than after inhalation of glycopyrronium 44 micrograms at steady state were achieved and did not result in tachycardia or QTc prolongation.
Maltese: Espożizzjonijiet massimi (Cmax) ta' madwar 50 darba ogħla meta mqabbla ma' 44 mikrogramma glycopyrronium mannifs fi stat fiss intlaħqu u ma wasslux għal takikardija jew għal titwil tal-QTc.
English: Glucuronide and/or sulfate conjugates of glycopyrronium were found in urine of humans after repeated inhalation, accounting for about 3% of the dose.
Maltese: Instab li kien hemm glucuronide u/jew konjugati tas-sulfat ta' glycopyrronium fl-awrina tal-bnedmin wara teħid ripetut tal-mediċina man-nifs, li jammontaw għal madwar 3% tad-doża.
English: The safety profile is further characterised by other symptoms related to the anticholinergic effects, including signs of urinary retention, which were uncommon.
Maltese: Il-profil ta' sigurtà hu kkaratterizzat b'aktar sintomi oħrajn marbutin mal-effetti antikolinerġiċi, inkluż sinjali ta' retenzjoni tal-awrina, li mhux komuni.
English: Multipack: 150 (15 packs of 10 x 1) capsules + 15 inhalers.
Maltese: Pakkett b'ħafna: 150 (15-il pakkett ta' 10 x 1) kapsula + 15-il inhaler.
English: 3) Seen more frequently for glycopyrronium than placebo in elderly >75 years only.
Maltese: 3) Deher aktar ta' spiss bi glycopyrronium milli bil-plaċebo f'pazjenti anzjani ta' >75 sena biss.
English: In a pooled analysis of the 6and 12-month pivotal studies a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 1 point or greater improvement in the TDI focal score at week 26 compared to placebo (58.4% and 46.4% respectively, p<0.001).
Maltese: Flanaliżi miġbura taż-żewġ studji pivitali, dak ta' 6 xhur u l-ieħor ta' 12-il xahar, kien hemm perċentwali ogħla b'mod statistikament sinifikanti ta' pazjenti li qed jingħataw Tovanor Breezhaler li rrispondew b'titjib ta' punt 1 jew aktar fl-iskor fokali ta' TDI fis-26 ġimgħa mqabbel mal-plaċebo (58.4% u 46.4% rispettivament, p<0.001).
English: Although no formal drug interaction studies have been performed, Tovanor Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.
Maltese: Minkejja li ma saru l-ebda studji formali dwar l-interazzjoni tal-mediċina, Tovanor Breezhaler intuża flimkien ma' prodotti mediċinali oħrajn użati normalment waqt it-trattament ta' COPD mingħajr evidenza klinika ta' interazzjonijiet bejn il-mediċini.
English: The capsules must be administered only using the Tovanor Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Tovanor Breezhaler (ara sezzjoni 6.6).
English: This belongs to a group of medicines called bronchodilators.
Maltese: Din tappartjeni għal grupp ta' mediċini msejħin bronkodilataturi.
English: The delivered dose (the dose that leaves the mouthpiece of the inhaler) is equivalent to 44 micrograms of glycopyrronium.
Maltese: Id-doża li tittieħed (id-doża li tħalli l-bokkin tal-inhaler) hija ekwivalenti għal 44 mikrogramma ta' glycopyrronium.
English: At 12 weeks (primary endpoint), Tovanor Breezhaler increased trough FEV1 by 72 ml in patients with the lowest degree of reversibility (<5%) and by 113 ml in those patients with a higher degree of reversibility at baseline (≥5%) compared to placebo (both p<0.05).
Maltese: Wara 12-il ġimgħa (punt ta' tmiem primarju), Tovanor Breezhaler żied il-FEV1 minimu bi 72 ml fil-pazjenti bl-inqas livell ta' riversibbiltà (<5%) u b'113-il ml f'dawk il-pazjenti li kellhom grad ogħla ta' riversibbiltà fil-linja bażi (≥5%) meta mqabbel mal-plaċebo (it-tnejn p<0.05).
English: Step 1c:
Maltese: Stadju 1e:
English: A slight reduction in heart rate (mean difference over 24 h -2 bpm when compared to placebo), which is a known effect of low exposures to anticholinergic compounds in young healthy subjects, was observed.
Maltese: Kien hemm tnaqqis ħafif fir-rata tal-qalb (differenza medja tul 24 siegħa -2 bpm imqabbel mal-plaċebo), meqjus bħala effett magħruf ta' espożizzjonijiet baxxi għall-komponenti antikolinerġiċi f'suġġetti żgħażagħ b'saħħithom.
English: Adverse reactions related to local tolerability included throat irritation, nasopharyngitis, rhinitis and sinusitis.
Maltese: Ir-reazzjonijiet avversi b'rabta mat-tolleranza lokali kienu jinkludu griżmejn irritati, nażofarinġite, rinite u sinusite.
English: Transparent orange capsules containing a white powder, with the product code “GPL50” printed in black above and the company logo ( ) printed in black below a black bar.
Maltese: Kapsuli trasparenti oranġjo li fihom trab abjad, bil-kodiċi tal-prodott “GPL50” stampata bl-iswed fuq u bil-marka tal-kumpanija ( ) stampata bl-iswed taħt linja sewda.
English: A moderate mean increase in total systemic exposure (AUClast) of up to 1.4-fold was seen in subjects with mild and moderate renal impairment and up to 2.2-fold in subjects with severe renal impairment and end-stage renal disease.
Maltese: Kien hemm żieda moderata fil-medja tal-espożizzjoni sistemika totali (AUClast) sa 1.4 drabi f'suġġetti b'indeboliment tal-kliewi ħafif u moderat u sa 2.2 drabi f'suġġetti b'indeboliment tal-kliewi gravi u li jinsabu fl-aħħar stadju tal-mard tal-kliewi.
English: Effects attributable to the muscarinic receptor antagonist properties of glycopyrronium bromide included mild to moderate increases in heart rate in dogs, lens opacities in rats and, reversible changes associated with reduced glandular secretions in rats and dogs.
Maltese: Effetti attribwiti għall-proprjetatjiet tar-riċettur muskariniku antagonist ta' glycopyrronium bromide kienu jinkludu żidiet bejn ħfief u moderati fir-rata tat-taħbit tal-qalb tal-klieb, opaċitajiet tal-lenti filfirien u, tibdiliet riversibbli assoċjati ma' tnaqqis fis-sekrezzjonijiet mill-glandoli fil-firien u l-klieb.
English: In the 12-month study, Tovanor Breezhaler produced statistically significant improvements in FEV1 compared to tiotropium in the first 4 hours after dosing on day 1 and at week 26, and numerically greater values for FEV1 in the first 4 hours after dosing than tiotropium at week 12 and week 52.
Maltese: Fl-istudju li dam 12-il ġimgħa, Tovanor Breezhaler ipproduċa titjib sinjifikanti statistikament fl-FEV1, imqabbel ma' tiotropium fl-ewwel 4 sigħat mid-doża fl-ewwel jum u fis26 ġimgħa, u valuri numerikament akbar għal FEV1, fl-ewwel 4 sigħat mid-doża milli għal tiotropium fit-12-il ġimgħa u fit-52 ġimgħa.
English: Tovanor Breezhaler 44 micrograms once daily can be safely used in all age and body weight groups.
Maltese: 44 mikrogramma Tovanor Breezhaler darba kuljum jistgħu jintużaw bla periklu minn nies ta' kull età u piż.
English: Cystitis
Maltese: Ipoestesija
English: Tovanor Breezhaler 44 micrograms inhalation powder, hard capsules
Maltese: IL-PRODOTT MEDIĊINALI Tovanor Breezhaler 44 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa
English: In a pooled analysis of the first 6 months of treatment in the 6- and 12-month studies, compared to placebo Tovanor Breezhaler statistically significantly prolonged time to first moderate or severe exacerbation and reduced the rate of moderate or severe COPD exacerbations (0.53 exacerbations/year versus 0.77exacerbations /year, p<0.001).
Maltese: F'analiżi miġbura tal-ewwel 6 xhur ta' kura fl-istudji ta' 6 xhur u 12-il xahar, imqabbel mal-plaċebo Tovanor Breezhaler tawwal b'mod statistikament sinifikanti ż-żmien għall-ewwel taħrix ħafif jew gravi u naqqas ir-rata ta' taħrix moderat jew gravi ta' COPD (taħrix ta' 0.53 fis-sena kontra taħrix ta' 0.77 fis-sena, p<0.001).
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, anticholinergics, ATC code: R03BB06
Maltese: Għal istruzzjonijiet fuq l-użu tal-prodott mediċinali qabel jingħata, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: Tovanor Breezhaler is a single-dose inhaler.
Maltese: • Tużax il-kapsuli Tovanor Breezhaler ma' xi inhaler ieħor.
English: In patients with severe renal impairment (estimated glomerular filtration rate below 30 ml/min/1.73 m2), including those with end-stage renal disease requiring dialysis, Tovanor Breezhaler should be used only if the expected benefit outweighs the potential risk (see section 5.2).
Maltese: F'pazjenti b'indeboliment tal-kliewi gravi (rata ta' filtrazzjoni glomerulari stmata taħt it-30 ml/min/1.73 m2), inkluż dawk li jinsabu fl-aħħar stadju talmarda tagħhom tal-kliewi u li jeħtieġu dijaliżi, Tovanor Breezhaler għandu jintuża biss jekk ilbenefiċċji mistennija jegħlbu r-riskju li jista' jkun hemm (ara sezzjoni 5.2).
English: A pooled analysis of the 6- and 12-month pivotal studies found a statistically significantly higher percentage of patients receiving Tovanor Breezhaler responded with a 4 point or greater improvement in SGRQ compared to placebo at week 26 (57.8% and 47.6% respectively, p<0.001).
Maltese: Fl-analiżi miġbura taż-żewġ studji pivitali, dak ta' 6 xhur u l-ieħor ta' 12-il xahar, instab li kien hemm perċentwali ogħla b'mod statistikament sinifikanti ta' pazjenti li qed jingħataw Tovanor Breezhaler li rrispondew b'titjib ta' punt 4 jew aktar f'SGRQ fis-26 ġimgħa mqabbel mal-plaċebo (57.8% u 47.