FrancophonIA/ELRC3.0 huggingface dataset:
English: Why has Optimark been approved?
Maltese: Għaliex ġie approvat Optimark?
English: The CHMP decided that Optimark's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Optimark huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Optimark been studied?
Maltese: Kif ġie studjat Optimark?
English: How is Optimark used?
Maltese: X'inhu Optimark?
English: 90 (3 x 30) tablets
Maltese: 90 (3 x 30) pillola
English: MA (EU) number Invented name Strength Pharmaceutical form
Maltese: Numru ta' l-EU Isem ivvintat Qawwa Għamla farmaċewtika
English: White suspension.
Maltese: Suspensjoni bajda.
English: Treatment difference (95% confidence intervals, p-value)
Maltese: Differenza fit-trattament (intervalli ta' kunfidenza ta' 95 %, valur p)
English: Figure 2d
Maltese: Figura 2d
English: 120 actuations
Maltese: 120 attwazzjoni
English: ASTRAZENECA DUNKERQUE PRODUCTION 224 avenue de la Dordogne 59640 DUNKERQUE
Maltese: ASTRAZENECA DUNKERQUE PRODUCTION 224 avenue de la Dordogne 59640
English: Multipack: 360 actuations (3 packs of 120 actuations)
Maltese: Pakkett multiplu: 360 attwazzjoni (3 pakketti ta' 120 attwazzjoni).
English: Date pouch opened:__________
Maltese: Data tal-ftuħ tal-pawċ:__________
English: Table 1Adverse reactions by frequency and system organ class (SOC)
Maltese: Tabella 1 Reazzjonijiet avversi skont il-frekwenza u s-sistema tal-klassifika tal-organi (SOC)
English: Figure 2a 120 puffs
Maltese: Figura 2a 120 nefħa
English: OUTER CARTON, MULTIPACK - WITH BLUE BOX
Maltese: KARTUNA TA' ĠEWWA, PAKKETT MULTIPLU - MINGĦAJR KAXXA BLU
English: EU/1/18/1339/002 360 actuations (3 packs of 120 actuations)
Maltese: EU/1/18/1339/002 360 attwazzjoni (3 pakketti ta' 120 attwazzjoni)
English: Cardiac arrhythmias (atrial fibrillation, supraventricular tachycardia, and extrasystoles)
Maltese: Aritmiji kardijaċi (fibrillazzjoni atrijali, takikardija supraventrikulari, u estrasistoli)
English: COPD exacerbations:
Maltese: Aggravamenti ta' COPD:
English: Effect of a spacer
Maltese: Effett ta' spacer
English: You may need medical attention.
Maltese: Jista' jkollok bżonn attenzjoni medika.
English: In-vitro glycopyrronium is a substrate for the renal transporters OCT2 and MATE1/2K.
Maltese: Glycopyrronium in vitro huwa substrat għat-trasportaturi tal-kliewi OCT2 u MATE1/2K.
English: The most common adverse reactions reported in the clinical development program (comprised of 1,588 patients receiving Bevespi Aerosphere) were headache (1.9%), nausea (1.4%), muscle spasms (1.4%), and dizziness (1.3%).
Maltese: L-aktar reazzjonijiet avversi rrapportati fil-programm tal-iżvilupp kliniku (li inkluda1,588 pazjent li rċevew Bevespi Aerosphere) kienu uġigħ ta' ras (1.9 %), nawsja (1.4 %), spażmi fil-muskoli (1.4 %) u sturdament (1.3 %).
English: Figure 2c 100 puffs
Maltese: Figura 2c 100 nefħa
English: SAC-TDI / TDI Focal Score
Maltese: Punteġġ Fokali SACTDI / TDI
English: CYP2D6 was found to be the predominant enzyme involved in the metabolism of glycopyrronium.
Maltese: CYP2D6 instab li huwa l-enzima predominanti involuta fil-metaboliżmu ta' glycopyrronium.
English: Figure 2b 110 puffs
Maltese: Figura 2b 110 nefħa
English: Do not expose to temperatures higher than 50
Maltese: Tesponix għal temperaturi ogħla minn 50
English: Do not expose to temperatures higher than 50°C.
Maltese: Tesponix għal temperaturi 'l fuq minn 50 C.
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita billi tintuża l-konvenzjoni li ġejja: komuni ħafna (≤1/10); komuni (≤1/100 sa <1/10); mhux komuni (≤1/1,000 sa <1/100); rari (≤1/10,000 sa <1/1,000); rari ħafna (<1/10,000) mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Peak FEV1 (ml)
Maltese: FEV1 massimu (ml)
English: Date of first authorisation: 18 December 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 18 ta' Diċembru 2018
English: Bevespi Aerosphere is a pressurised inhalation, suspension.
Maltese: Aerosphere huwa inalazzjoni taħt pressjoni, sospensjoni.
English: Linear pharmacokinetics were observed for glycopyrronium (dose range: 14.4 to 115.2 mcg) and formoterol (dose range: 2.4 to 19.2 mcg) after oral inhalation.
Maltese: Farmakokinetika lineari kienet osservata għal glycopyrronium (firxa tad-doża: 14.4 sa 115.2 mcg) u formoterol (firxa tad-doża:
English: Over the concentration range of 10-500 nmol/L, plasma protein binding of formoterol ranged from 46% to 58%.
Maltese: Fil-firxa ta' konċentrazzjoni ta' 10-500 nmol/L, it-twaħħil ta' formoterol mal-proteini tal-plażma varja minn 46 % sa 58 %.
English: Figure 18
Maltese: Figura 18
English: Estimated glomerular filtration rate (eGFR) varied from 30-196 mL/min, representing a range of moderate to no renal impairment.
Maltese: Ir-rata ta' filtrazzjoni glomerulari stmata (eGFR) varjat minn 30 sa 196 mL/min, li tirrappreżenta medda tal-ebda indeboliment tal-kliewi sa indeboliment moderat.
English: AstraZeneca Dunkerque Production 224 Avenue de la Dordogne Dunkerque
Maltese: AstraZeneca Dunkerque Production 224
English: Figure 16
Maltese: Figura 16
English: This means that there are 110 puffs of medicine left in the pressurised container (See Figure 2b).
Maltese: Dan ifisser li jkun għad fadal 110 nefħiet ta' mediċina fil-kontenitur taħt pressjoni (Ara Figura 2b).
English: CARTON - SINGLE INHALER
Maltese: KARTUNA - INALATUR SINGOLU
English: Bevespi Aerosphere (N=551) vs glycopyrronium (N=474)
Maltese: Aerosphere (N=551) vs glycopyrronium (N=474)
English: The typical clearance (CL/F) of glycopyrronium was 124 L/h.
Maltese: It-tneħħija tipika (CL/F) ta' glycopyrronium kienet ta' 124 L/h.
English: Glycopyrronium has similar affinity to the subtypes of muscarinic receptors M1 to M5.
Maltese: Glycopyrronium għandu affinità simili għas-sottotipi tar-riċetturi muskariniċi M1 sa M5.
English: Bevespi Aerosphere is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD) (see section 5.1).
Maltese: Aerosphere huwa indikat bħala trattament ta' manteniment bi bronkodilatur għas-serħan missintomi f'pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD) (ara sezzjoni 5.1).
English: The systemic exposure (AUC0-12) in subjects with COPD with moderate-severe renal impairment (eGFR of 30-45 mL/min) is approximately 30% higher for glycopyrronium compared to subjects with COPD with normal renal function (eGFR of >90 mL/min).
Maltese: L-esponiment sistemiku (AUC0-12) f'individwi b'COPD b'indeboliment tal-kliewi moderat sa sever (eGFR ta' 3045 mL/min) huwa madwar 30 % ogħla għal glycopyrronium meta mqabbel ma' individwi b'COPD b'funzjoni tal-kliewi normali (eGFR ta' >90 mL/min).
English: INHALER LABEL (PRESSURISED CONTAINER)
Maltese: TIKKETTA TAL-INALATUR (KONTENITUR TAĦT PRESSJONI)
English: The toxicity observed in studies with the combination of glycopyrronium and formoterol in dogs were associated with the pharmacological actions of formoterol, including effects mainly on the cardiovascular system, consisting of hyperaemia, tachycardia, arrhythmias and myocardial lesions.
Maltese: It-tossiċitajiet osservati fi studji bil-kombinazzjoni ta' glycopyrronium u formoterol fil-klieb kienu assoċjata mal-azzjonijiet farmakoloġiċi ta' formoterol, inklużi effetti prinċipalment fuq is-sistema kardjovaskolari, li jikkonsistu f'iperimija, takikardija, aritmiji u leżjonijiet mijokardijaċi.
English: Bevespi Aerosphere contains two bronchodilators: glycopyrronium a long-acting muscarinic antagonist (also referred to as an anticholinergic) and formoterol a long-acting β2-adrenergic agonist with a rapid onset of action.
Maltese: Aerosphere fih żewġ bronkodilaturi: glycopyrronium huwa antagonista muskariniku b'azzjoni fit-tul (magħruf ukoll bħala antikolinerġiku) u formoterol huwa agonista adrenerġiku β2 b'azzjoni fittul b'bidu rapidu ta' azzjoni.
English: Other antimuscarinics and sympatomimetics
Maltese: Antimuskariniċi u simpatomimetiċi oħra
English: In that study, 62% of the radiolabelled formoterol was excreted in the urine while 24% was eliminated in the faeces.
Maltese: F'dak l-istudju, 62 % ta' formoterol radjutikkettat ġie eliminat fl-awrina, filwaqt li 24 % kien eliminat fl-ippurgar.
English: • any medicines that work in the same way as Bevespi Aerosphere, such as medicines containing active substances such as tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol, or indacaterol.
Maltese: Aerosphere, bħal mediċini li fihom sustanzi attivi bħal tiotropium, ipratropium, aclidinium, umeclidinium, salmeterol, vilanterol, olodaterol jew indacaterol.
English: Figure 15
Maltese: Figura 15
English: This will release a puff of medicine from the mouthpiece (See Figure 5).
Maltese: Dan se jirrilaxxa nefħa tal-mediċina mill-biċċa tal-ħalq (Ara Figura 5).
English: The safety profile is characterised by anticholinergic and β2-adrenergic class effects related to the individual components of the combination.
Maltese: Il-profil tas-sigurtà huwa kkaratterizzat minn effetti ta' klassi antikolinerġiċi u adrenerġiċi β2 marbuta mal-komponenti individwali tal-kombinazzjoni.
English: Figure 13
Maltese: Figura 13
English: Over the concentration range of 2-500 nmol/L, plasma protein binding of glycopyrronium ranged from 43% to 54%.
Maltese: Fil-firxa ta' konċentrazzjoni ta' 2-500 nmol/L, it-twaħħil ta' glycopyrronium malproteini tal-plażma varja minn 43 % sa 54 %.
English: For inhalation use.
Maltese: Mhux applikabbli.
English: • The pointer points between 100 and 120 after you use 10 more puffs.
Maltese: • Il-vleġġa tindika bejn 100 u 120 wara li tkun użajt 10 nefħiet oħra.
English: The largest mean (90% upper confidence bound) differences from placebo in baseline- and individually corrected QT was 3.1 (4.7) ms for Bevespi Aerosphere (14.4 /10 micrograms) and 7.6 (9.2) ms for glycopyrronium/formoterol with eight times the recommended dose of glycopyrronium and four times the recommended dose of formoterol.
Maltese: L-akbar differenzi medji (limitu ta' kunfidenza ta' fuq ta' 90 %) minn plaċebo fil-QT korrett għal-linja bażi u b'mod individwali kienu 3.1 (4.7) ms għal Bevespi Aerosphere (14.4/10 mikrogrammi) u 7.6 (9.2) ms għal glycopyrronium/formoterol b'doża tmien darbiet aktar minn dik irrakkomandata ta' glycopyrronium u erba' darbiet aktar id-doża rakkomandata ta' formoterol.
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 glycopyrronium or formoterol.
Maltese: Effetti kardjovaskulari, bħal aritmiji kardijaċi, eż. fibrillazzjoni atrijali u takkikardija, jistgħu jiġu osservati wara l-għoti ta' riċetturi muskariniċi antagonisti u simpatikomimetiċi, inklużi glycopyrronium jew formoterol.
English: In clinical studies, paradoxical bronchospasm was not observed with Bevespi Aerosphere at its recommended dose.
Maltese: Fi studji kliniċi, ma ġiex osservat bronkospażmu paradossali b'Bevespi Aerosphere fid-doża rakkomandata tiegħu.
English: In three Phase III, 24-week studies (PINNACLE 1, PINNACLE 2 and PINNACLE 4) Bevespi Aerosphere provided improvements over placebo in lung function (as measured by morning pre-dose trough forced expiratory volume in 1 second [FEV1]), with a demonstrated onset of action at 5 minutes following administration of the first dose on Day 1 (improvement over placebo by 187 mL, 186 mL and 179 mL in PINNACLE 1, PINNACLE 2 and PINNACLE 4, respectively [p <0.001]).
Maltese: [FEV1]), b'bidu muri ta' azzjoni ta' 5 minuti wara l-għoti tal-ewwel doża fl-Ewwel Jum (titjib meta mqabbel ma' plaċebo b'187 mL, 186 mL u 179 mL f'PINNACLE 1, PINNACLE 2 u PINNACLE 4, rispettivament p <0.
English: The estimated glycopyrronium Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 741 L, and 2990 L, respectively, via population pharmacokinetic analysis.
Maltese: (volum talkompartiment periferali) huma 741 L, u 2990 L, rispettivament, permezz tal-analiżi farmakokinetika tal-popolazzjoni.
English: Although no formal in-vivo drug interaction studies have been performed with Bevespi Aerosphere, studies indicate no clinical evidence of interactions when used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids.
Maltese: Għalkemm ma sar l-ebda studju formali in vivo tal-interazzjoni mediċinali b'Bevespi Aerosphere, studji ma jindikaw l-ebda evidenza klinika ta' interazzjonijiet meta jintuża flimkien ma' prodotti mediċinali tas-COPD oħra inklużi bronkodilaturi adrenerġiċi β2 b'azzjoni fil-qosor, methylxanthines, u sterojdi orali u li jittieħdu man-nifs.
English: The effect of cimetidine, a probe inhibitor of OCT2 and MATE1, on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.
Maltese: L-effett ta' cimetidine, inibitur probe ta' OCT2 u MATE1, fuq id-dispożizzjoni ta' glycopyrronium inalat wera żieda limitata fl-esponiment sistemiku (AUC0-t) totali tiegħu bi 22 % u ftit tnaqqis fit-tneħħija millkliewi bi 23 % minħabba l-għoti flimkien ta' cimetidine.
English: Common conditions adverse reaction relates to formoterol adverse reaction relates to glycopyrronium
Maltese: Komuni reazzjoni avversa relatata ma' formoterol reazzjoni avversa relatata ma' glycopyrronium
English: The estimated formoterol Vc/F (volume of the central compartment), and Vp1/F (volume of the peripheral compartment) are 1030 L, and 647 L, respectively, via population pharmacokinetic analysis.
Maltese: (volum tal-kompartiment periferali) huma 1030 L, u 647 L, rispettivament, permezz tal-analiżi farmakokinetika talpopolazzjoni.
English: Carton containing 1 inhaler with 120 actuations.
Maltese: Kartuna li fiha 1 inalatur b'120 attwazzjoni.
English: Compatibility with the Aerochamber Plus Flow-Vu spacer device has been demonstrated (see section 5.2).
Maltese: Il-kompatibbiltà mal-apparat tal ispacer Aerochamber Plus Flow-Vu ntweriet (ara sezzjoni 5.2).
English: Figure 11
Maltese: Figura 11
English: In-vitro studies indicate the glycopyrronium does not inhibit any subtype of cytochrome P450 and that there is no induction of CYP1A2, 2B6, or 3A4.
Maltese: Studji in vitro jindikaw li glycopyrronium ma jinibixxi l-ebda sottotip ta' ċitikromu P450 u li m'hemm l-ebda induzzjoni ta' CYP1A2, 2B6, jew 3A4.
English: Bevespi Aerosphere is available in packs containing 1 inhaler with 120 puffs and in multipacks comprising 3 inhalers, each containing 120 puffs.
Maltese: Aerosphere jiġi f'pakketti li fihom 1 inalatur b'120 nefħa u f'pakketti multipli li fihom 3 inalaturi, b'120 nefħa kull wieħed.
English: The mean bronchodilator effect derived from serial FEV1 measurements at Day 1 and Week 12 from PINNACLE 1 are shown in Figure 1.
Maltese: Leffett medju tal-bronkodilatur derivat mill-kejl FEV1 serjali fl-Ewwel Jum u wara 12-il Ġimgħa minn PINNACLE 1 huwa muri fil-Figura 1.
English: Aerosphere (N=551) vs placebo (N=235)
Maltese: Aerosphere (N=551) vs plaċebo (N=235)
English: • medicines which can prolong ‘QT interval' (a change in the electrical activity of the heart).
Maltese: • mediċini li jistgħu jtawlu l-“intervall QT” (bidla fl-attività elettrika tal-qalb).
English: Pointer
Maltese: TIKKETTAR
English: Symptomatic outcomes
Maltese: Riżultati sintomatiċi
English: No significant effects attributable to glycopyrronium were seen.
Maltese: Ma ġew osservati l-ebda effetti sinifikanti attribwibbli għal glycopyrronium.
English: The parts of your Bevespi Aerosphere inhaler (See Figure 1):
Maltese: Il-partijiet tal-inalatur tiegħek ta' Bevespi Aerosphere (Ara Figura 1):
English: A population pharmacokinetic analysis of formoterol was performed based on data collected in a total of 437 subjects with COPD.
Maltese: Twettqet analiżi farmakokinetika tal-popolazzjoni b'formoterol abbażi tad-data miġbura f'total ta' 437 individwu b'COPD.
English: These include medicines for the treatment of: o depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), o bacterial infections (such as erythromycin, clarithromycin, telithromycin), o allergic reactions (anti-histamines).
Maltese: Dawn jinkludu mediċini għat-trattament ta': o dipressjoni (bħal inibituri ta' monoamine oxidase jew antidipressanti triċikliċi), o infezzjonijiet batteriċi (bħal erythromycin, clarithromycin, telithromycin), o reazzjonijiet allerġiċi (antiistamini).
English: Repeat steps 2 to 7 to take your second puff of Bevespi Aerosphere.
Maltese: Irrepeti l-passi 2 sa 7 biex tieħu t-tieni nefħa tiegħek ta' Bevespi
English: • Repeat the priming steps 3 more times (See Figure 4 and Figure 5).
Maltese: • Irrepeti l-passi ta' tħejjija għal 3 darbiet oħra (Ara Figura 4 u Figura 5).
English: The number in the dose indicator display window will change after every 20 puffs.
Maltese: In-numru fit-tieqa tal-wiri tal-indikatur tad-doża se tinbidel wara kull 20 nefħa.
English: This corresponds to a metered dose of glycopyrronium bromide 10.4 micrograms equivalent to 8.3 micrograms of glycopyrronium, and formoterol fumarate dihydrate 5.8 micrograms.
Maltese: 4 mikrogrammi ta' glycopyrronium bromide ekwivalenti għal 8.3 mikrogrammi ta' glycopyrronium, u 5.8 mikrogrammi ta' formoterol fumarate dihydrate.
English: Bevespi Aerosphere is not indicated for the treatment of acute episodes of bronchospasm, i.e. as a rescue therapy.
Maltese: Aerosphere mhuwiex indikat għat-trattament ta' episodji akuti ta' bronkospażmu, jiġifieri bħala terapija ta' salvataġġ.
English: The primary metabolism of formoterol is by direct glucuronidation and by O-demethylation followed by conjugation to inactive metabolites.
Maltese: Il-metaboliżmu primarju ta' formoterol huwa permezz ta' glukuronidazzjoni diretta u permezz ta' demetilizzazzjoni-O segwiti minn konjugazzjoni ma' metaboliti inattivi.
English: Aerosphere (N=526) vs placebo (N=219)
Maltese: Aerosphere (N=526) vs plaċebo (N=219)
English: Bevespi Aerosphere (N=551) vs formoterol fumarate (N=480)
Maltese: Aerosphere (N=551) vs formoterol fumarate (N=480)
English: In-vitro studies indicate that formoterol does not inhibit the CYP450 enzymes at therapeutically relevant concentrations.
Maltese: Studji in vitro jindikaw li formoterol ma jinibixxix l-enzimi CYP450 f'konċentrazzjonijiet terapewtikament rilevanti.
English: Aerosphere (N=510) vs placebo (N=223)
Maltese: Aerosphere (N=510) vs plaċebo (N=223)
English: Bevespi Aerosphere also showed improvements in peak FEV1 within 2 hours post-dose over 24 weeks relative to placebo, glycopyrronium and formoterol (p<0.0001) [see Table 2].
Maltese: Aerosphere wera titjib fl-FEV1 minimu fuq perjodu ta' 24 ġimgħa b'rabta ma' plaċebo, glycopyrronium u formoterol (p<0.0001) [ara t-Tabella 2].
English: Bevespi Aerosphere (N=526) vs formoterol fumarate (N=449)
Maltese: Aerosphere (N=526) vs formoterol fumarate (N=449)
English: After IV administration of a 0.2 mg dose of radiolabelled glycopyrronium, 85% of the dose was recovered in urine 48 hours post dose and some of radioactivity was also recovered in bile.
Maltese: Wara l-għoti minn ġol-vina ta' doża ta' 0.2 mg ta' glycopyrronium radjutikkettat, 85 % tad-doża kienet irkuprata fl-awrina 48 siegħa wara d-doża u xi parti mir-radjuattività kienet irkuprata wkoll fil-bili.
English: Do not press down too hard on the pressurised container.
Maltese: Ittaqqabx il-kontenitur taħt pressjoni.
English: • you have thyroid gland problems (called ‘thyrotoxicosis')
Maltese: • għandek problemi fil-glandola tat-tirojde (imsejħa “tirotossikożi”)
English: Bevespi Aerosphere (N=510) vs formoterol fumarate (N=437)
Maltese: Aerosphere (N=510) vs formoterol fumarate (N=437)
English: Immune system disorders Hypersensitivity reactions including rash and pruritus
Maltese: Reazzjonijiet ta' sensittività eċċessiva inkluż raxx u ħakk
English: Norflurane 1,2-distearoyl-sn-glycero-3-phosphocholine and calcium chloride.
Maltese: Norflurane, 1,2-distearoyl-sn-glycero-3-phosphocholine u calcium chloride.
English: - you are allergic to glycopyrronium, formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Maltese: - inti allerġiku għal glycopyrronium, formoterol fumarate dihydrate jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: The use of Bevespi Aerosphere with the Aerochamber Plus Flow-Vu spacer in COPD patients increased the total systemic exposure to glycopyrronium (as measured by AUC0-12) by 16% while formoterol exposure was unchanged.
Maltese: Aerosphere mal-ispacer Aerochamber Plus Flow-Vu f'pazjenti b'COPD, żied lesponiment sistemiku totali għal glycopyrronium (kif imkejjel mill-AUC0-12) b'16 % filwaqt li lesponiment għal formoterol baqa' l-istess.
English: Each single actuation (delivered dose, ex-actuator) contains glycopyrronium bromide 9 micrograms equivalent to 7.2 micrograms of glycopyrronium, and 5 micrograms of formoterol fumarate dihydrate.
Maltese: Kull attwazzjoni unika (doża mogħtija, ex-azzjonaturi) fiha 9 mikrogrammi ta' glycopyrronium bromide ekwivalenti għal 7.2 mikrogrammi ta' glycopyrronium, u 5 mikrogrammi ta' formoterol fumarate dihydrate.
English: This means that there are 120 puffs of medicine left in the pressurised container (See Figure 2a).
Maltese: Dan ifisser li jkun għad fadal 120 nefħa ta' mediċina fil-kontenitur taħt pressjoni (Ara Figura 2a).
English: If there is any built-up medicine, repeat Steps 3 to 5 in the section.
Maltese: Jekk għad hemm xi akkumulu tal-mediċina, irrepeti lPassi 3 sa 5 fis-sezzjoni.
English: In animal studies formoterol and glycopyrronium, individually, have caused adverse effects in reproduction studies at very high doses/systemic exposure levels (see section 5.3).
Maltese: Fi studji f'annimali formoterol u glycopyrronium, individwalment, ikkawżaw effetti avversi fl-istudji dwar ir-riproduzzjoni f'dożi/livelli ta' esponiment sistemiku għoljin ħafna (ara sezzjoni 5.3).
English: This means that there are 100 puffs of medicine left in the pressurised container (See Figure 2c).
Maltese: Dan ifisser li jkun għad fadal 100 nefħa ta' mediċina fil-kontenitur taħt pressjoni (Ara Figura 2c).
English: Headache Dizziness
Maltese: DATA TA' SKADENZA
English: Multipack containing 3 inhalers each with 120 actuations.
Maltese: Pakkett multiplu li fih 3 inalaturi b'kull wieħed fih 120 attwazzjoni.
English: In PINNACLE 2, the results were similar to those observed in PINNACLE 1.
Maltese: F'PINNACLE 2, ir-riżultati kienu simili għal dawk osservati f'PINNACLE 1.
English: Bevespi Aerosphere contains two active substances called glycopyrronium and formoterol fumarate dihydrate.
Maltese: X'fih Bevespi Aerosphere Is-sustanzi attivi huma glycopyrronium u formoterol fumarate dihydrate.
English: Co-administration of Bevespi Aerosphere with other anticholinergic and/or long-acting β2-adrenergic agonist containing medicinal products has not been studied and is not recommended as it may potentiate known inhaled muscarinic antagonist or beta2-adrenergic agonist adverse reactions (see section 4.4 and section 4.9).
Maltese: Aerosphere ma' agonista antikolinerġiku u/jew adrenerġiku β2 b'azzjoni fit-tul ieħor li fih prodotti mediċinali ma ġiex studjat u mhuwiex irrakkomandat peress li jista' jżid issaħħa ta' reazzjonijiet avversi magħrufa ta' antagonista muskariniku jew agonista adrenerġiku beta2 li jittieħdu man-nifs (ara sezzjoni 4.4 u sezzjoni 4.9).
English: • The pointer points to 100 after you take 10 more puffs.
Maltese: • Il-vleġġa tindika 100 wara li tieħu 10 nefħiet oħra.
English: Breathlessness:
Maltese: Twissija:
English: INHALER LABEL (ACTUATOR)
Maltese: TIKKETTA TAL-INALATUR (AZZJONATUR)