FrancophonIA/ELRC3.0 huggingface dataset:
English: The magnitude of response was generally greater than seen with active comparators (Table 2).
Maltese: Ilqawwa tar-rispons kienet ġeneralment aktar minn dik li dehret b'komparaturi attivi (Tabella 2).
English: Pierce the capsule:
Maltese: Daħħal il-kapsula:
English: Indacaterol once a day
Maltese: Indacaterol darba kuljum
English: Oropharyngeal pain including throat irritation
Maltese: Uġigħ orofarinġeali li jinkludi irritazzjoni tal-griżmejn
English: 300 microgram, tiotropium and placebo;
Maltese: b: 150 u 300 mikrogramma indacaterol, tiotropium u plaċebo;
English: Each capsule contains indacaterol maleate equivalent to 300 microgram indacaterol.
Maltese: Kull kapsula fiha l-indacaterol maleate ekwivalenti għal 300 mikrogramma indacaterol.
English: 10 capsules + 1 inhaler 30 capsules + 1 inhaler
Maltese: 10 kapsuli + inhaler wieħed 30 kapsula + inhaler wieħed
English: Multipack: 90 (3 packs of 30 capsules and 1 inhaler).
Maltese: Pakkett b'ħafna: 90 (tliet pakketti ta' 30 kapsula u inhaler wieħed).
English: Hold breath:
Maltese: Attenzjoni:
English: Percentage of patients who achieved MCID SGRQ†
Maltese: Perċentwali ta' pazjenti li kellhom MCID SGRQ†
English: 47 b 41 c
Maltese: 45 a 47 b c
English: OUTER CARTON OF UNIT PACK
Maltese: KARTUNA INTERMEDJA TAL-PAKKETTI
English: These include: o steroids (e.g. prednisolone), o diuretics (water tablets) used for high blood pressure such as hydrochlorothiazide, o medicines for breathing problems such as theophylline.
Maltese: Dawn jinkludu: o sterojdi (eż. prednisolone), o dijuretiċi (pilloli tal-pipì) użati għall-pressjoni għolja tad-demm bħallhydrochlorothiazide, o mediċini minħabba problemi tan-nifs bħat-theophylline.
English: Metabolic and transporter based interactions
Maltese: Interazzjonijiet metaboliċi u oħrajn dipendenti fuq it-trasportaturi
English: The capsules contain lactose.
Maltese: Il-kapsuli fihom il-lactose.
English: Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Oslif Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2-adrenergic agonists.
Maltese: Minkejja li wara li jingħata Oslif Breezhaler skont id-dożi rrakkomandati normalment ma jidher l-ebda effett relevanti klinikament fuq is-sistema kardjovaskulari, l-istess kif jiġri fil-każ ta' agonisti beta2adrenerġiċi oħrajn, l-indacaterol għandu jintuża b'kawtela f'pazjenti b'disturbi kardjovaskulari (mard tal-arterja koronarja, infart mijokardijaku akut, arritmija kardijaka, pressjoni għolja), f'pazjenti b'disturbi konvulżivi jew tirotossikożi, u f'pazjenti li jirrispondu b'mod mhux tas-soltu għall-agonisti beta2-adrenerġiċi.
English: Oslif Breezhaler, administered once a day at doses of 150 and 300 microgram consistently provided clinically significant improvements in lung function (as measured by the forced expiratory volume in one second, FEV1) over 24 hours across a number of clinical pharmacodynamic and efficacy studies.
Maltese: Oslif Breezhaler, mogħti darba kuljum f'dożi ta' 150 u 300 mikrogramma għen sabiex b'mod konsistenti jkun hemm titjib sinifikanti klinikament fil-funzjoni tal-pulmun (kif imkejjel skont ilvolum espiratorju furzat f'sekonda, l-FEV1) għal 24 siegħa fuq firxa ta' studji kliniċi dwar ilfarmakodinamiċità u l-effikaċja.
English: Capsule chamber
Maltese: Toqba tal-kapsula
English: Oslif Breezhaler is not indicated for the treatment of acute episodes of bronchospasm, i.e. as rescue therapy.
Maltese: Oslif Breezhaler mhuwiex indikat sabiex jikkura episodji gravi ta' spażmi fil-bronki, jiġifieri bħala terapija ta' salvataġġ.
English: In vitro investigations further indicated that indacaterol is a low affinity substrate for the efflux pump P-gp.
Maltese: Investigazzjonijiet in vitro komplew juru li lindacaterol huwa substrat b'affinità baxxa għall-pompa ta' effluss P-gp.
English: In vitro studies have shown that indacaterol, a long-acting beta2-adrenergic agonist, has more than 24-fold greater agonist activity at beta2-receptors compared to beta1-receptors and 20-fold greater agonist activity compared to beta3receptors.
Maltese: Studji in vitro wrew li l-indacaterol, agonist beta2adrenerġiku li jibqa' attiv fit-tul, għandu attività agonista għar-riċetturi-beta2 iżjed minn 24 darba aktar meta mqabbla mar-riċetturi-beta1 u attività agonista 20 darba aktar meta mqabbla mar-riċetturi-beta3.
English: - Each Oslif Breezhaler 300 microgram capsule contains 300 microgram indacaterol as indacaterol maleate.
Maltese: - Kull kapsula Oslif Breezhaler ta' 300 mikrogramma fiha 300 mikrogramma indacaterol bħala indacaterol maleate.
English: What Oslif Breezhaler contains - Each Oslif Breezhaler 150 microgram capsule contains 150 microgram indacaterol as indacaterol maleate.
Maltese: X'fih Oslif Breezhaler - Kull kapsula Oslif Breezhaler ta' 150 mikrogramma fiha 150 mikrogramma indacaterol bħala indacaterol maleate.
English: Systemic exposures (AUC) in rats and mice at the no-observed adverse effect levels in these studies were at least 7- and 49-fold higher, respectively, than in humans treated with Oslif Breezhaler once a day at a dose of 300 microgram.
Maltese: Lespożizzjonijiet sistemiċi (AUC) fil-firien u l-ġrieden fuq livelli ta' effett avvers mhux osservat f'dawn l-istudji kienu mill-inqas 7 u 49 darba aktar, rispettivament, milli fil-bnedmin ikkurati b'Oslif Breezhaler b'doża ta' 300 mikrogramma darba kuljum.
English: Mean peak improvements in FEV1 relative to baseline were 250-330 ml at steady state.
Maltese: It-titjib fil-medja tal-quċċata fl-FEV1 relattiv għal-linja bażi kienu ta' 250-330 ml f'kundizzjoni stabbli.
English: During clinical studies, clinically notable changes in blood glucose were generally more frequent by 1-2% on Oslif Breezhaler at the recommended doses than on placebo.
Maltese: Waqt studji kliniċi, it-tibdil notevoli klinikament fil-livell tal-glukosju fid-demm kien ġeneralment bejn 1% u 2% aktar frekwenti meta ngħata Oslif Breezhaler skont id-dożi rrakkomandati milli meta ngħata l-plaċebo.
English: Multipack: 300 (30 packs of 10 capsules and 1 inhaler).
Maltese: Pakkett b'ħafna: 300 (tletin pakkett ta' 10 kapsuli u inhaler wieħed).
English: Pharmacokinetic data were obtained from a number of clinical studies, from healthy volunteers and COPD patients.
Maltese: L-informazzjoni farmakokinetika nġabret minn firxa ta' studji kliniċi fost voluntiera b'saħħithom u pazjenti bis-COPD.
English: 6.5 Nature and contents of container
Maltese: 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula
English: Rhinorrhoea
Maltese: Rinorrea
English: Clinically relevant effects on prolongation of the QTc-interval have not been observed in clinical studies of Oslif Breezhaler at recommended therapeutic doses (see section 5.1).
Maltese: Studji kliniċi dwar Oslif Breezhaler ma wrewx effetti relevanti klinikament fuq it-titwil tal-intervall QTc meta mogħti skont id-dożi terapewtiċi rrakkomandati (ara sezzjoni 5.1).
English: Do not swallow Oslif Breezhaler capsules.
Maltese: Tiblax il-kapsuli Oslif Breezhaler.
English: Prepare capsule:
Maltese: Taqqab il-kapsula:
English: Metabolism and nutrition disorders Diabetes mellitus and hyperglycaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Dijabete mellitus u ipergliċemija
English: Oslif Breezhaler, administered once a day at doses of 150 microgram and 300 microgram, showed clinically meaningful improvements in lung function.
Maltese: Oslif Breezhaler, mogħti darba kuljum f'dożi ta' 150 mikrogramma u 300 mikrogramma, wera titjib sinifikanti klinikament fil-funzjoni tal-pulmun.
English: The mean age of patients was 64 years, with 48% of patients aged 65 years or older, and the majority (80%) was Caucasian.
Maltese: L-età medja tal-pazjenti kienet ta' 64 sena, bi 48% tal-pazjenti li kellhom 65 sena jew aktar, u l-biċċa l-kbira (80%) kienu Kawkażjatiċi.
English: Insert capsule: Place the capsule into the capsule chamber.
Maltese: Jista' jkun li l-kapsula tkun weħlet fit-toqba tal-kapsula.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakovigilanza dettaljati fil-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Oslif Breezhaler huwa indikat biex jissokta bil-kura bronkodilatatorja f'każ li jinstaddu l-passaġġi talarja f'pazjenti adulti li jbatu mill-marda pulmonari ostruttiva kronika (COPD).
English: The chances of the capsule shattering will be increased if the capsule is accidentally pierced more than once (step 6).
Maltese: Il-probabbiltajiet li l-kapsula titfarrak jiżdiedu jekk il-kapsula tittaqqab bi żball għal aktar minn darba (stadju 6).
English: Oslif Breezhaler inhaler
Maltese: Inhaler Oslif Breezhaler
English: Carton containing 30 capsules and one Oslif Breezhaler inhaler.
Maltese: Kartuna li fiha 30 kapsula u inhaler wieħed Oslif Breezhaler.
English: Open inhaler:
Maltese: Iftaħ l-inhaler:
English: An additional adverse reaction was tremor (common).
Maltese: Reazzjoni avversa oħra kienet ittregħid (komuni).
English: • Open the mouthpiece again, and remove the empty capsule by tipping it out of the capsule chamber.
Maltese: • Erġa' iftaħ il-bokkin, u oħroġ il-kapsula mbattla billi taqlagħha mit-toqba tal kapsula.
English: Show the pack of Oslif Breezhaler.
Maltese: Uri l-pakkett ta' Oslif Breezhaler.
English: Mass balance was complete with ≥90% of the dose recovered in the excreta.
Maltese: Il-bilanċ tal-massa kien sħiħ b'≥90% tad-doża mgħoddija fl-ekskreta.
English: In vitro investigations indicated that UGT1A1 is the only UGT isoform that metabolised indacaterol to the phenolic O-glucuronide.
Maltese: Investigazzjonijiet in vitro wrew li l-UGT1A1 huwa l-uniku iżoform UGT li mmetabolizza lindacaterol mal-O-glukuronid fenoliku.
English: Adverse reactions in Table 1 are listed according to MedDRA system organ class in the COPD safety database.
Maltese: Ir-reazzjonijiet avversi f'Tabella 1 tniżżlu skont id-databażi dwar is-sigurtà għas-COPD fis-sistema tal-klassifika tal-organi ta' MedDRA.
English: • Hold your breath for at least 5-10 seconds or as long as you comfortably can while taking the inhaler out of your mouth.
Maltese: • Żomm in-nifs għal mill-inqas 5-10 sekondi jew sakemm jirnexxilek tissaporti filwaqt li toħroġ l-inhaler minn ħalqek.
English: 46 b 40 c
Maltese: 40 c
English: Infections and infestations Upper respiratory tract infection
Maltese: Infezzjonijiet u infestazzjonijiet Nażofarinġite
English: There was a rapid onset of action within 5 minutes after inhalation, with an increase in FEV1 relative to baseline of 110-160 ml, comparable to the effect of the fast-acting beta2-agonist salbutamol 200 microgram and statistically significantly faster compared to salmeterol/fluticasone 50/500 microgram.
Maltese: Wara 5 minuti li l-mediċina ttieħdet man-nifs bdiet taħdem minnufih, b'żieda fl-FEV1 relattiv għal-linja bażi ta' 110-160 ml, u dan meta mqabbel mal-effett ta' 200 mikrogramma salbutamol li huwa agonist-beta2 li jaħdem malajr, u statistikament jaħdem aktar malajr meta jitqabbel ma' 50/500 mikrogramma salmeterol/fluticasone.
English: Oslif Breezhaler contains the active substance indacaterol which belongs to a group of medicines called bronchodilators.
Maltese: Oslif Breezhaler fih is-sustanza attiva indacaterol li tagħmel parti minn grupp ta' mediċini msejħa bronkodilataturi.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 240 microgram indacaterol.
Maltese: Id-doża mgħoddija meta tinġibed mill-bokkin tal-inhaler hi ta' indacaterol maleate ekwivalenti għal 240 mikrogramma indacaterol.
English: Available pharmacokinetic/toxicological data in animals have shown excretion of indacaterol/metabolites in milk (see section 5.3).
Maltese: Dejta farmakokinetika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' indacaterol/metaboliti fil-ħalib tas-sider (ara sezzjoni 5.3). Ir-riskju gћat-tarbija li qed titredda' mhux eskluż.
English: Carton containing 10 capsules and one Oslif Breezhaler inhaler.
Maltese: Kartuna li fiha 10 kapsuli u inhaler wieħed Oslif Breezhaler.
English: The mean accumulation ratio of indacaterol, i.e. AUC over the 24-h dosing interval on Day 14 compared to Day 1, was in the range of 2.9 to 3.5 for once-daily inhaled doses between 150 microgram and 600 microgram.
Maltese: Il-proporzjon medju talakkumulazzjoni tal-indacaterol, jiġifieri l-AUC wara intervall fl-għoti tad-doża ta' 24 siegħa fl-14il ġurnata meta mqabbel mal-ewwel ġurnata, kien ta' bejn 2.9 u 3.5 għal dożi ta' bejn 150 mikrogramma u ta' 600 mikrogramma meħudin man-nifs darba kuljum.
English: The capsules must be administered only using the Oslif Breezhaler inhaler (see section 6.6).
Maltese: Il-kapsuli għandhom jittieħdu biss billi jintuża l-inhaler Oslif Breezhaler (ara sezzjoni 6.6).
English: In vitro investigations have indicated that indacaterol has negligible potential to cause metabolic interactions with medicinal products at the systemic exposure levels achieved in clinical practice.
Maltese: Investigazzjonijiet in vitro wrew li fuq livelli ta' espożizzjoni sistemika miksuba waqt prattika klinika, l-indacaterol għandu ftit li xejn potenzjal li jikkawża interazzjonijiet metaboliċi ma' prodotti mediċinali.
English: Note:
Maltese: FTAKAR:
English: In particular, please tell your doctor if you are using: medicines for breathing problems that are similar to Oslif Breezhaler (i.e. medicines such as salmeterol and formoterol).
Maltese: B'mod speċjali, jekk jogħġbok għid lit-tabib tiegħek jekk qed tuża: mediċini minħabba problemi tan-nifs li jixbhu lil Oslif Breezhaler (jiġifieri mediċini bħalma huma salmeterol u formoterol).
English: Transparent (uncoloured) capsules containing a white powder, with “IDL 300” printed in blue above a blue bar and company logo ( ) printed in blue below the blue bar.
Maltese: Kapsuli trasparenti ( mingħajr kulur) li fihom trab abjad, b'“IDL 300” stampata bil-blu fuq linja blu u bil-marka tal-kumpanija ( ) stampata bl-iswed taħt il-linja l-blu.
English: Reports of hypersensitivity have been received from post-approval marketing experience in association with the use of Oslif Breezhaler.
Maltese: Waslu rapporti ta' sensittività eċċessiva mill-esperjenza ta' wara l-approvazzjoni tas-suq rigward lużu ta' Oslif Breezhaler.
English: The delivered dose leaving the mouthpiece of the inhaler is indacaterol maleate equivalent to 120 microgram indacaterol.
Maltese: Id-doża mgħoddija meta tinġibed mill-bokkin tal-inhaler hi ta' indacaterol maleate ekwivalenti għal 120 mikrogramma indacaterol.
English: Oslif Breezhaler 150 microgram inhalation powder, hard capsules Oslif Breezhaler 300 microgram inhalation powder, hard capsules indacaterol
Maltese: Id-doża rrakkomandata hija ta' kapsula waħda kuljum ta' 150 mikrogramma, fejn il-kontenut jittieħed man-nifs billi jintuża l-inhaler Oslif Breezhaler.
English: In addition, beta-adrenergic agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of QT interval and ST segment depression, although the clinical significance of these observations is unknown.
Maltese: Barra minn hekk, kien irrappurtat li l-agonisti beta-adrenerġiċi jipproduċu tibdiliet elettrokardjogrammi (ECG), bħalma huma l-iċċattjar tal-mewġa T, it-titwil tal-intervall QT u ddepressjoni tas-segment ST, minkejja li l-effett kliniku ta' dawn l-osservazzjonijiet mhuwiex magħruf.
English: At the 12-week primary endpoint (24-hour trough FEV1), the 150 microgram dose resulted in a 130-180 ml increase compared to placebo (p<0.001) and a 60 ml increase compared to salmeterol 50 microgram twice a day (p<0.001).
Maltese: Fl-endpoint primarju tat-12-il ġimgħa (fl-aktar punt baxx tal-FEV1 tul 24 siegħa), id-doża ta' 150 mikrogramma wasslet għal żieda ta' 130-180 ml meta mqabbla mal-plaċebo (p<0.
English: Lung function
Maltese: Funzjoni tal-pulmun
English: Formoterol twice a day
Maltese: Formoterol darbtejn kuljum
English: 47 b a
Maltese: 38 a b
English: Carton containing 10 capsules and 1 inhaler.
Maltese: Kartuna li fiha 10 kapsuli u inhaler wieħed.
English: Renal clearance of indacaterol was, on average, between 0.46 and 1.20 litres/hour.
Maltese: Il-medja tat-tneħħija tal-indacaterol mill-kliewi kienet ta' bejn 0.46 u ta' 1.20 litri/siegħa.
English: INNER LID OF OUTER CARTON OF UNIT PACK AND OF INTERMEDIATE CARTON OF MULTIPACK
Maltese: L-GĦATU MINN ĠEWWA TAL-KARTUNA TA' BARRA TAL-PAKKETT B'WIEĦED U TAL-KARTUNA INTERMEDJA TAL-PAKKETTI
English: In Phase III clinical studies, healthcare providers observed during clinic visits that on average 17-20% of patients experienced a sporadic cough that occurred usually within 15 seconds following inhalation and typically lasted for 5 seconds (about 10 seconds in current smokers).
Maltese: III, professjonisti mill-qasam tas-saħħa osservaw waqt il-viżti li bħala medja bejn 17-20% tal-pazjenti kellhom sogħla sporadika li normalment seħħet sa 15-il sekonda wara li ttieħdet il-mediċina man-nifs u normalment damet 5 sekondi (madwar 10 sekondi f'dawk li dak iżżmien kienu jpejpu).
English: Systemic exposure to indacaterol increased with increasing dose (150 microgram to 600 microgram) in a dose proportional manner.
Maltese: Malli żdiedet id-doża (minn 150 mikrogramma għal 600 mikrogramma) żdiedet l-espożizzjoni sistematika għall-indacaterol b'mod proporzjonali skont id-doża.
English: Your Oslif Breezhaler pack: Each Oslif Breezhaler pack contains: one Oslif Breezhaler inhaler one or more blister containing Oslif Breezhaler capsules to be used in the inhaler.
Maltese: Tużax il-kapsuli Oslif Breezhaler ma' xi inhaler ieħor, u tużax l-inhaler Oslif Breezhaler biex tieħu xi mediċina oħra maħżuna f'kapsuli.
English: Tiotropium once a day
Maltese: Tiotropium darba kuljum
English: Indacaterol has not been shown to cause interactions with medicinal products administered concomitantly.
Maltese: Ma dehrex li l-indacaterol jikkawża interazzjonijiet meta ngħata flimkien ma' prodotti mediċinali.
English: Other medicines and Oslif Breezhaler
Maltese: Kif taħżen Oslif Breezhaler
English: • Close the inhaler.
Maltese: • Agħlaq l-inhaler.
English: Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the human heart, there are also beta2-adrenergic receptors in the human heart comprising 10-50% of the total adrenergic receptors.
Maltese: Minkejja li r-riċetturi-beta2 huma r-riċetturi adrenerġiċi predominanti fil-muskolu lixx tal-bronki u rriċetturi-beta1 huma r-riċetturi predominanti fil-qalb tal-bniedem, hemm ukoll riċetturi beta2adrenerġiċi fil-qalb tal-bniedem li jiffurmaw bejn 10 u 50% tar-riċetturi adrenerġiċi kollha.
English: 57 b a
Maltese: 53 a b b
English: As demonstrated in 605 patients with COPD in a 26-week, double-blind, placebo-controlled Phase III study, there was no clinically relevant difference in the development of arrhythmic events monitored over 24 hours, at baseline and up to 3 times during the 26-week treatment period, between patients receiving recommended doses of Oslif Breezhaler treatment and those patients who received placebo or treatment with tiotropium.
Maltese: III li dam 26 ġimgħa, ikkontrollat bi plaċebo, ma kienx hemm differenza relevanti klinikament fejn jidħol l-iżvilupp ta' episodji arritmiċi kif osservati tul 24 siegħa, la fil-linja bażi u lanqas sa tliet darbiet aktar waqt is26 ġimgħa li matulhom ingħatat il-kura, bejn il-pazjenti mogħtija l-kura skont id-dożi rrakkomandati b'Oslif Breezhaler u dawk mogħtija l-plaċebo jew il-kura bit-tiotropium.
English: Carton containing 30 capsules and 1 inhaler.
Maltese: Kartuna li fiha 30 kapsula u inhaler wieħed.
English: Therefore, long-acting beta2-adrenergic agonists such as Oslif Breezhaler should be used with caution in patients with known or suspected prolongation of the QT interval or treated with medicinal products affecting the QT interval.
Maltese: Għaldaqstant, l-agonisti beta2-adrenerġiċi li jibqgħu attivi fit-tul bħalma hu Oslif Breezhaler għandu jintuża b'kawtela f'pazjenti b'titwil tal-intervall QT magħruf jew issuspettat jew ittrattati bi prodotti mediċinali li jaffettwaw l-intervall QT.
English: There are no data available for use of Oslif Breezhaler in patients with severe hepatic impairment.
Maltese: Ma teżisti l-ebda informazzjoni dwar l-użu ta' Oslif Breezhaler f'pazjenti b'indeboliment epatiku gravi.
English: • cough
Maltese: Qiegħ
English: • if you get symptoms of an allergic reaction such as rash, itching, hives, difficulty breathing or swallowing, dizziness (uncommon).
Maltese: • jekk ikollok sintomi ta' reazzjoni allerġika bħal raxx, ħakk, urtikarja, diffikultà biex tieħu nifs jew biex tibla', sturdament (mhux komuni).
English: Oslif Breezhaler should not be used in conjunction with other long-acting beta2-adrenergic agonists or medicinal products containing long-acting beta2-adrenergic agonists.
Maltese: Oslif Breezhaler m'għandux jintuża flimkien ma' agonisti beta2-adrenerġiċi oħrajn li jibqgħu attivi fittul jew ma' prodotti mediċinali li fihom agonisti beta2-adrenerġiċi li jibqgħu attivi fit-tul.
English: In COPD patients, single doses of 10 times the maximum recommended therapeutic dose were associated with a moderate increase in pulse rate, systolic blood pressure and QTc interval.
Maltese: F'pazjenti b'COPD, dożi singoli 10 darbiet aktar mill-ogħla doża terapewtika rrakkomandata kienu assoċjati ma' żieda moderata fir-ritmu tal-polz, fil-pressjoni sistolika tad-demm u fl-intervall QTc.
English: Indacaterol serum concentrations increased with repeated once-daily administration.
Maltese: Il-konċentrazzjonijiet tas-serum tal-indacaterol żdiedu wara li ngħatat ta' doża waħda kuljum ripetutament.
English: Nasopharyngitis
Maltese: FARMAĊEWTIKU
English: Long-acting beta2-adrenergic agonists may increase the risk of asthma-related serious adverse events, including asthma-related deaths, when used for the treatment of asthma.
Maltese: L-agonisti beta2-adrenerġiċi li jibqgħu attivi fit-tul jistgħu jżidu r-riskju ta' episodji avversi serji relatati mal-ażma inkluż imwiet minħabba ażma, meta jintużaw għat-trattament tal-ażma.
English: • swollen hands, ankles and feet (oedema)
Maltese: • idejn, għaksijiet u saqajn minfuħin (edima)
English: Oslif Breezhaler 150 microgram inhalation powder, hard capsules indacaterol
Maltese: Oslif Breezhaler 150 mikrogramma trab li jittieħed man-nifs, kapsuli iebsa indacaterol
English: Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassiumsparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore caution is required (see section 4.4).
Maltese: Meta mal-kura għall-ipokalimja jingħataw derivattivi ta' methylxanthine, sterojdi, jew dijuretiċi li ma jħallux il-potassju joħroġ fl-awrina jista' jwassal biex tiżdied il-qawwa tal-effett ipokalimiku talagonisti beta2-adrenerġiċi, għaldaqstant meħtieġa b'kawtela (ara sezzjoni 4.4).
English: Increased cyclic AMP levels cause relaxation of bronchial smooth muscle.
Maltese: Żieda fil-livelli tal-AMP ċikliku tikkawża rilassament tal-muskolu lixx tal-bronki.