FrancophonIA/ELRC3.0 huggingface dataset:
English: If liver transferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, anorexia, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in total bilirubin > 2x ULN, treatment should be stopped and re-introduction of Thelin is not to be considered.
Maltese: Jekk elevazzjonijiet tat-transferases tal-fwied huma akkompanjati b'sintomi kliniċi ta' ħsara fil-fwied (bħal dardir, rimettar, anoressja, deni, uġigħ ta' żaqq, suffejra, jew letarġija jew għeja mhux tas-soltu) u żieda fil-bilirubina totali ta' > 2x ULN, il-kura għandha titwaqqaf u l-introduzzjoni mill-ġdid ta' Thelin m'għandhiex tkun ikkunsidrata.
English: For your own safety, it is very important that you have regular blood tests.
Maltese: Għas-sigurtà tiegħek, huwa importanti ħafna li jsirulek testijiet tad-demm regolari.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 5 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-tqegħid fis-Suq jobbliga ruħu li jwettaq studji u attivitajiet oħra ta' Farmakoviġilanza kif dettaljat fil pjan ta' Farmakoviġilanza, kif miftiehem f'versjoni 5 tal- Pjan ta' mmaniġġjar tar-riskju (RMP) kif preżentat f'Modulu 1.8.2 ta' l-applikazzjoni għat-tqegħid fis-suq u kull tiġdid tal RMP miftiehem mas-CHMP.
English: Based on results of the population pharmacokinetic analysis and pooled pharmacokinetic data over several studies, it was found that gender, race, and age do not clinically significantly affect the pharmacokinetics of sitaxentan sodium.
Maltese: Ibbażat fuq riżultati ta' analiżi farmakokinetika tal-popolazzjoni u informazzjoni farmakokinetika miġbura minn bosta studji, instab li s-sess, ir-razza, u l-età ma jaffettwawx, b'mod klinikament sinifikanti, il-farmakokinetiċi ta' sitaxentan sodium.
English: Sub-maximal exercise capacity: This was assessed by measuring distance walked in 6 minutes (6-minute walk test) at 12 weeks for STRIDE-1 and 18 weeks for STRIDE-2 and STRIDE-4.
Maltese: Il-kapaċità għall-eżerċizzju taħt il-massimu kienet assessjata billi tkejlet id-distanza li l-pazjent mexa f'6 minuti (test ta' mixja ta' 6 minuti) wara 12-il ġimgħa għal STRIDE-1 u wara 18-il ġimgħa għal STRIDE-2 u STRIDE_4.
English: Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x Upper Limit of Normal (ULN)) or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment (see section 4.3).
Maltese: Thelin huwa kontra-indikat f'pazjenti li diġà ikollhom l-aminotransferases tal-fwied għoljin qabel ma nbdiet il-kura (> 3 x l-Limitu ta' Fuq tan-Normal (ULN - Upper Limit of Normal) jew bilirubin għoli (tat-tip dirett) > 2 x ULN qabel ma nbdiet il-kura (ara taqsima 4.3).
English: Haemodynamic parameters: These were assessed in STRIDE-1 for both functional class II and III patients.
Maltese: Parametri emodinamiċi kienu assessjati fi STRIDE-1 fuq pazjenti kemm fi klassi funzjonali
English: • unusual tiredness
Maltese: • ma tistax torqod
English: Thelin was not carcinogenic when administered to rats for 97-99 weeks or when administered to p53(+/-) transgenic mice for 6 months.
Maltese: Thelin ma kienx karċinoġeniku meta ngħata lil firien għal 97-99 ġimgħa jew meta ngħata lil ġrieden transġeniċi p53(+/-) għal 6 xhur.
English: HOW TO STORE THELIN
Maltese: QABEL MA TIEĦU THELIN
English: 10 August 2006
Maltese: 10 t'Awwissu, 2006
English: If AST and/or ALT are > 3 x ULN prior to initiation of therapy, or direct bilirubin is > 2 x ULN, use of sitaxentan is contraindicated (see section 4.3)
Maltese: Jekk AST u/jew ALT huma > 3 x ULN qabel ma nbdiet il-kura, jew bilirubin tat-tip dirett huwa > 2 x ULN, użu ta' sitaxentan huwa kontra-indikat (ara sezzjoni 4.3).
English: This may lead to hepatic failure, which can be fatal, and highlights the need for regular monitoring of transaminases and bilirubin.
Maltese: Din tista' twassal għal falliment tal-fwied, li jista' jkun fatali, u tenfasizza il-bżonn ta' monitoraġġ regolari ta' transaminases u bilirubin.
English: Nifedipine (substrate of CYP3A4/5): The clearance of nifedipine was not clinically significantly changed when given concomitantly with Thelin.
Maltese: Nifedipine (sottostrat ta' CYP3A4/5):
English: • flushed
Maltese: • sturdament
English: Ketoconazole (substrate and inhibitor of CYP3A4/5): Co-administration with Thelin did not cause a clinically significant change in the clearance of either sitaxentan sodium or ketoconazole.
Maltese: Ketoconazole (sottostrat u inibitur ta' CYP3A4/5):
English: Plasma concentrations of drugs principally metabolized by CYP2C9 may be increased during sitaxentan sodium co-administration.
Maltese: Konċentrazzjonijiet fil-plażma ta' mediċini li huma metabolizzati prinċipalment minn CYP2C9, jistgħu jiżdiedu meta jingħataw flimkien ma' sitaxentan sodium.
English: The overall mean decrease in haemoglobin concentration for Thelin -treated patients was 0.5 g/dl (change to end of treatment).
Maltese: It-tnaqqis totali medju fil-konċentrazzjoni ta' l-emoglobina f'pazjenti ttrattati b'Thelin kien ta' 0.5 g/dl (g/dl (bidla sa tmiem il-kura).
English: Treatment with Thelin was associated with a dose-related decrease in haemoglobin (see section 4.8).
Maltese: Il-kura b'Thelin kienet assoċjata ma' tnaqqis fl-emoglobina marbuta mad-doża (ara taqsima 4.8).
English: Thelin is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Maltese: Thelin mhuwiex rakkomandat biex jingħata lit-tfal u l-adoloxxenti ta' taħt it-18-il sena minħabba nnuqqas ta' informazzjoni dwar is-sigurtà u l-effikaċja.
English: • Physician information about Thelin
Maltese: X'INHU THELIN
English: Insomnia, dizziness
Maltese: Disodium edetate
English: • feeling tired
Maltese: Tqala u Treddigħ
English: Pharmacovigilance Plan or risk minimisation activities
Maltese: Farmakoviġilanza, jew attivitajiet li jnaqqsu r-riskju.
English: In PAH patients, peak plasma concentrations are generally achieved within 1-4 hours.
Maltese: F'pazjenti bil-PAH, konċentrazzjonijiet massimi fil-plażma jintlaħqu fi żmien 1-4 sigħat.
English: No data are available with Thelin in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
Maltese: M'hemm l-ebda informazzjoni disponibbli dwar Thelin f'pazjenti bi pressjoni għolja pulmonari assoċjata ma' mard veno-okklusiv pulmonari.
English: • feeling and/or being sick, difficulty in passing stools, stomach ache, indigestion and diarrhoea
Maltese: • tħossok u/jew tkun ma tiflaħx, issibha diffiċli biex tipporga, uġigħ fl-istonku, indiġestjoni u dijarea
English: Each film-coated tablet contains 100 mg sitaxentan sodium.
Maltese: Kull pillola fiha 100 mg ta' sitaxentan sodium
English: Compared with placebo treatment, Thelin resulted in statistically significant improvement in pulmonary vascular resistance (PVR) and cardiac index (CI) after 12 weeks of treatment (see below).
Maltese: Meta mqabbel mal-kura bil-plaċebo, Thelin irriżulta f'ameljorament statistikament sinifikanti, f'reżistenza vaskulari pulmonari (PVR) u fl-indiċi tal-qalb (CI)wara 12-il ġimgħa ta' kura.
English: Sitaxentan sodium was detected in the plasma of breast fed pups from female rats treated with sitaxentan sodium, indicating that sitaxentan sodium was present in the breast milk.
Maltese: Sitaxentan sodium instab fil-plażma ta' frieħ imredda' minn firien nisa kkurati b'sitaxentan sodium, li jindika li sitaxentan sodium kien preżenti fil-ħalib ta' l-omm.
English: Film-coated tablet Capsule shaped yellow-to-orange film-coated tablets, debossed with T-100 on one side.
Maltese: Pilloli miksija b'rita, f'forma ta' kapsuli, ta' lewn safrani jagħti fl-oranġjo, b'T-100 imnaqqxa fuq naħa waħda.
English: In these studies, the study medicine was added to patients' current therapy, which could have included a combination of digoxin, anticoagulants, diuretics, oxygen, and vasodilators (eg, calcium channel blockers, ACE inhibitors).
Maltese: F'dawn l-istudji, il-mediċina li kienet qed tiġi studjata żdiedet mal-kura attwali tal-pazjenti, li setgħet kienet tinkludi kumbinazzjoni ta' digoxin, antikoagulanti, dijuretiċi, ossiġnu u vasodilaturi (eż. imblukkaturi tal-kanali tal-kalċju, inibituri tal-ACE).
English: Drugs which inhibit Organic Anion Transporting Polypeptides (OATP) The extent of interaction with potent OATP inhibitors (e.g. some statins, proteinase inhibitors, tuberculostatics) is unknown.
Maltese: Inibituri ta' Organic Anion Transporting Polypeptides (OATP):
English: Safety of Thelin has been evaluated in clinical trials of more than 1200 patients with PAH, as well as post-marketing safety data.
Maltese: Is-sigurta' ta' Thelin ġiet evalwata fi studji kliniċi ta' iktar minn 1200 pazjent bi PAH, kif ukoll b'informazzjoni dwar is-sigurta' wara t-tqegħid fis-suq.
English: The extent of interaction with other OATP inhibitors (some HMG CoA reductase inhibitors eg, atorvastatin, protease inhibitors eg, ritonavir, tuberculostatics eg, rifamycin) is unknown but could result in raised plasma levels of sitaxentan.
Maltese: Il-firxa ta' l-interazzjoni ma' inibituri oħra ta' OATP (xi inibituri tal-HMG CoA reductase eż. atorvastatin, inibituri tal-protinase eż. ritonavir, tuberculostatics eż. rifamycin) mhijiex magħrufa, imma din tista' tirriżulta f'livelli għoljin ta' sitaxentan sodium fil-plażma.
English: ET-1 actions are mediated through endothelin A receptors (ETA), present on smooth muscle cells, and endothelin B receptors (ETB), present on endothelial cells.
Maltese: L-effetti ta' ET-1 isiru permezz ta' riċetturi ta' endothelin A (ETA), li jinsabu fuq iċ-ċelluli talmuskoli lixxi, u riċetturi ta' endothelin B (ETB) li jinsabu fuq iċ-ċelluli endoteljali.
English: Treatment must not be initiated in women of child-bearing potential unless they practice reliable contraception, due to possible teratogenicity.
Maltese: Mhux magħruf kemm din ilpossibilta hija klinikament sinifikanti.
English: The Sitaxentan population also included patients (N = 53) who had discontinued another endothelin receptor antagonist due to liver function abnormalities.
Maltese: Il-popolazzjoni ta' Sitaxentan kienet tinkludi wkoll pazjenti (N = 53) li minħabba anormalitajiet filfunzjoni tal-fwied, kienu waqqfu antagonist tar-riċetturi endothelin ieħor.
English: Thelin should be used with caution if you are taking or begin to take Vitamin K antagonists (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione).
Maltese: Thelin għandu jintuża b'attenzjoni jekk qed tieħu jew tibda tieħu antagonisti tal-Vitamina K (eż. warfarin, acenocoumarol, fenprocoumon jew fluindione).
English: Fluconazole (inhibitor of CYP2C19, CYP2C9 and CYP3A4/5): Co-administration of Thelin and fluconazole had no effect on the clearance of sitaxentan sodium.
Maltese: Fluconazole (inibitur ta' CYP2C19 u CYP2C9, u CYP3A4/5):
English: In an open-label hypertension study, 10 patients received 480 mg twice daily (approximately a 10-fold increase in daily dose compared to the MRHD) for up to 2 weeks.
Maltese: Fi studju open-label dwar il-pressjoni għolja, 10 pazjenti ngħataw 480 mg darbtejn kuljum (żieda ta' madwar 10 darbiet fid-doża ta' kuljum meta mqabbla mal-MRHD) għal mhux aktar minn ġimgħatejn.
English: There was no change in Cmax or AUC for the active metabolite, n-desmethylsildenafil.
Maltese: Ma kien hemm l-ebda bidla f'Cmax jew f'AUC għall-metabolit attiv, n-desmethylsildenafil.
English: Thelin is contraindicated in patients with elevated liver aminotransferases prior to initiation of treatment (> 3 x ULN), or with elevated direct bilirubin > 2 x ULN prior to initiation of treatment, see section
Maltese: Thelin huwa kontraindikat f'pazjenti b'livelli għoljin ta' l-aminotransferases tal-fwied qabel ma tkun inbdiet il-kura (>3 x ULN), jew bilirubin għoli (tat-tip dirett) > 2 x ULN qabel ma nbdiet il-kura.
English: What Thelin tablets look like and contents of the pack Thelin 100 mg film-coated tablets are yellow-to-orange, capsule-shaped tablets, marked with T-100 on one side.
Maltese: Kif inhuma l-pilloli Thelin u l-kontenut tal-pakkett Thelin 100 mg pilloli miksija b'rita huma ta' lewn isfar jagħti fl-oranġjo, f'forma ta' kapsula, immarkati b'T-100 fuq naħa waħda minnhom.
English: o Contraindication in patients with elevated direct bilirubin > 2 x ULN prior to initiation of treatment.
Maltese: o Kontra-indikazzjoni f'pazjenti bil-bilirubin għoli (tat-tip dirett) > 2 x ULN qabel ma nbdiet il-kura.
English: Effects of Thelin on other medicinal products
Maltese: Effetti ta' Thelin fuq prodotti mediċinali oħrajn
English: Transfer to a therapy that is recommended at the severe stage of the disease (eg, epoprostenol) should be considered if the clinical condition deteriorates (see section 4.2).
Maltese: It-trasferiment għat-terapija li hi rrakkomandata fl-istadju serju talmarda (eż. epoprostenol) għandu jiġi kkunsidrat jekk il-kundizzjoni klinika tmur għall-agħar (ara taqsima 4.2).
English: Steady state in volunteers is reached within about 6 days.
Maltese: L-istat fiss fil-voluntieri jintlaħaq bejn wieħed u ieħor fi żmien 6 ijiem.
English: • If you are taking or begin to take anticoagulants (e.g. warfarin, acenocoumarol, fenprocoumon or fluindione) to prevent blood clots.
Maltese: • Jekk int qed tieħu jew ser tibda tieħu mediċini anti-koagulanti (e.g. warfarin, acenocoumarol,
English: In repeated-dose toxicity studies, dose-related liver changes (weight, centrilobular hypertrophy, occasionally necrosis), induction of hepatic drug metabolising enzymes and slightly decreased erythron parameters were seen in mice, rats and dogs.
Maltese: Fi studji dwar it-tossiċità b'doża ripetuta, bidliet fil-fwied marbuta mad-doża (piż, ipertrofija ċentrilobulari, kultant nekrosi), induzzjoni ta' enzimi tal-fwied li jimmetabolizzaw il-mediċini u parametri erythron ftit imnaqqsa ntwerew fil-ġrieden, firien u klieb.
English: • pain in the stomach (abdominal pain)
Maltese: • uġigħ fl-istonku (uġigħ addominali)
English: No clinical interaction study was performed with a substrate of CYP 2C8.
Maltese: Ma sar l-ebda studju dwar interazzjonijiet kliniċi ma' s-sottostrat ta' CYP 2C8.
English: This specific group had a higher risk (19%; N = 10/53) of developing elevations in ALT and/or AST > 3 x ULN indicating that appropriate care should be exercised when initiating sitaxentan in this patient population.
Maltese: Dan il-grupp speċifiku kellu riskju ogħla (19%; N = 10/53) li jiżviluppa żidiet f'ALT u/jew AST > 3 x ULN, u dan jindika li trid tingħata attenzjoni meta jinbeda sitaxentan f'din il popolazzjoni ta' pazjenti.
English: Muscle cramp
Maltese: GĦALL-HRUĠ TALLOTT
English: • Repeat steps 8, 9, 10 and 11.
Maltese: • Irrepeti l-istadji 8, 9, 10 u 11.
English: Treatment Dose (microgram)
Maltese: Doża (f'mikrogrammi)
English: Each capsule contains 24.6 mg lactose.
Maltese: Kull kapsula fiha 24.6 mg lactose.
English: 1.0 b a n/e a
Maltese: 1.2 a n/e
English: Each capsule contains 24.8 mg lactose.
Maltese: Kull kapsula fiha 24.8 mg lactose.
English: • itching/rash
Maltese: • ħakk/raxx
English: The most common adverse reactions at the recommended doses were nasopharyngitis (14.3%), upper respiratory tract infection (14.2%), cough (8.2%), headache (3.7%) and muscle spasms (3.5%).
Maltese: L-aktar reazzjonijiet avversi komuni meta mogħtija skont id-dożi rrakkomandati kienu nażofarinġite (14.3%), infezzjoni fin-naħa ta' fuq tal-passaġġ respiratorju (14.2%), sogħla (8.2%), uġigħ ta' ras (3.7%) u spażmi fil-muskoli (3.5%).
English: The oxidative metabolites were found in incubations with recombinant CYP1A1, CYP2D6, and CYP3A4.
Maltese: Il-metaboliti ossidattivi nstabu f'inkubazzjonijiet b'CYP1A1, CYP2D6, u CYP3A4 rrikombinanti.
English: Date of first authorisation: 30 November 2009 Date of latest renewal: 18 September 2014
Maltese: Data tal-aħħar tiġdid: 18 Settembru 2014
English: PA/Alu/PVC - Alu blister containing 10 hard capsules.
Maltese: Folji PA/Alu/PVC - Alu, li fihom 10 kapsuli iebsa.
English: Study design with a: indacaterol 150 microgram, salmeterol and placebo;
Maltese: a: 150 mikrogramma indacaterol, salmeterol u plaċebo;
English: 54 c a
Maltese: 54 a c
English: Treatment comparison compared to placebo showed a ratio of rates of 0.68 (95% CI [ 0.47, 0.98]; p-value 0.036) and 0.74 (95% CI [0.56, 0.96]; pvalue 0.026) for 150 microgram and 300 microgram, respectively.
Maltese: Meta tqabblet il-kura malplaċebo il-proporzjon tar-rati kienet ta' 0.68 (95% CI [0.47, 0.98], valur-p 0.036) u ta' 0.74 (95% CI [0.56, 0.96]; valur-p 0.026) għal 150 mikrogramma u 300 mikrogramma, rispettivament.
English: The frequency of notable QTcF intervals [i.e. >450 ms (males) and >470 ms (females)] and reports of hypokalaemia were similar to placebo.
Maltese: Il-frekwenza ta' intervalli QTcF notevoli [jiġifieri >450 ms (fl-irġiel) u >470 ms (fin-nisa)] u ta' rapporti ta' ipokalimja kienu jixbhu lil dawk tal-plaċebo.
English: A double-blind, placebo- and active (moxifloxacin)-controlled study for 2 weeks in 404 healthy volunteers demonstrated maximum mean (90% confidence intervals) prolongations of the QTcF interval (in milliseconds) of 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) following multiple doses of 150 microgram, 300 microgram and 600 microgram, respectively.
Maltese: Studju double-blind ikkontrollat bi plaċebo u b'(moxifloxacin) attiv li dam għaddej ġimagħtejn fost 404 voluntiera b'saħħithom wera li l-ogħla medja (intervalli ta' kunfidenza ta' 90%) tat-titwil talintervall QTcF (f'millisekondi) kienet ta' 2.66 (0.55, 4.77) 2.98 (1.02, 4.93) u 3.34 (0.86. 5.82) wara li ngħataw bosta dożi ta' 150 mikrogramma, 300 mikrogramma u 600 mikrogramma, rispettivament.
English: • if you get irregular heart beat (uncommon).
Maltese: • iekk ikollok qalbek tħabbat b'mod irregolari (mhux komuni).
English: c: indacaterol 300 microgram, formoterol and placebo MCID = minimal clinically important difference (≥1 point change in TDI, ≥4 point change in SGRQ) n/e= not evaluated at six months
Maltese: 300 mikrogramma indacaterol, formoterol u plaċebo MCID = differenza ftit li xejn importanti klinikament (bidla ta' ≥punt fit-TDI, bidla ta' ≥4 punti flSGRQ) n/e= mhux evalwata wara sitt xhur
English: Within each system organ class, adverse reactions are ranked by frequency in descending order according to 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), not known (cannot be estimated from the available data).
Maltese: 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: Table 2 Symptom relief at 6 months treatment duration
Maltese: Tabella 2 Serħan mis-sintomi wara perjodu ta' 6 xhur kura
English: Approximately 41% of patients had severe COPD.
Maltese: Madwar 41% tal-pazjenti kellhom COPD gravi.
English: Button
Maltese: Buttuna
English: The pharmacological effects of beta2-adrenoceptor agonists are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyses the conversion of adenosine triphosphate (ATP) to cyclic-3', 5'-adenosine monophosphate (cyclic monophosphate).
Maltese: L-effetti farmakoloġiċi tal-agonisti beta2-adrenoriċetturi huma sa ċertu punt attribwiti lillistimulazzjoni tal-adenyl cyclase intraċellulari, l-enżima li tikkatalizza l-bidla tal-adenosina trifosfat (ATP) f'adenosina monofosfat-3', 5' ċikliku (monofosfat ċikliku).
English: Limited treatment experience is available in individuals of African descent.
Maltese: Teżisti esperjenza limitata disponibbli dwar il-kura fost individwi ta' dixxendenza Afrikana.
English: Paradoxical bronchospasm
Maltese: Spażmi paradossali fil-bronki
English: Musculoskeletal and connective tissue disorders Muscle spasm
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Spażmi fil-muskoli
English: Both doses resulted in an increase of 40-50 ml over open-label tiotropium 18 microgram once a day (150 microgram, p=0.004; 300 microgram, p=0.01).
Maltese: Iż-żewġ dożi wasslu għal żieda ta' 40-50 ml waqt prova openlabel li matulha ngħataw 18-il mikrogramma tiotropium darba kuljum (150 mikrogramma, p=0.004; 300 mikrogramma, p=0.01).
English: Indacaterol is a chiral molecule with R-configuration.
Maltese: L-indacaterol huwa molekulu kirali b'konfigurazzjoni-R.
English: 60 capsules + 2 inhalers
Maltese: 60 kapsula + 2 inhalers
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant exposures (see section 5.3).
Maltese: Studji f'annimali ma urewx effetti diretti jew indiretti tossiċi fuq is-sistema riproduttiva waqt espożizzjonijiet relevanti klinikament (ara sessjoni 5.3).
English: 0.4 b
Maltese: 0.3 a 0.4
English: Systemic exposure results from a composite of pulmonary and gastrointestinal absorption; about 75% of systemic exposure was from pulmonary absorption and about 25% from gastrointestinal absorption.
Maltese: L-espożizzjoni sistemika hija riżultat tar-rabta bejn l-assorbiment pulmunarju u dak gastrointestinali; madwar 75% tal-esponiment sistemiku kien minn assorbiment pulmonari u madwar 25% kien minn assorbiment gastrointestinali.
English: 90 capsules + 3 inhalers
Maltese: 90 kapsula + 3 inhalers
English: Inhibition of the key contributors of indacaterol clearance, CYP3A4 and P-glycoprotein (P-gp) raises the systemic exposure of indacaterol by up to two-fold.
Maltese: L-inibizzjoni tal-kontributuri ewlenin fit-tneħħija tal-indacaterol, is-CYP3A4 u l-P-glikoproteina (Pgp) tgħolli sa darbtejn l-espożizzjoni sistemika tal-indacaterol.
English: Pharmacotherapeutic group: Drugs for obstructive airways diseases, selective beta-2-adrenoreceptor agonists, ATC code: R03AC18
Maltese: Mediċini kontra mard ta' ostruzzjoni tal-passaġġi tal-arja, agonisti selettivi beta-2-adrenoriċettur, Kodiċi ATC:
English: An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia.
Maltese: Doża eċċessiva ta' indacaterol tista' twassal sabiex l-effetti tipiċi tal-istimulanti beta2-adrenerġiċi jkunu esaġerati, jiġifieri takikardija, tregħid, palpitazzjonijiet, uġigħ ta' ras, dardir, rimettar, sturdament, arritmija ventrikulari, aċidożi metabolika, ipokalimja u ipergliċemija.
English: Each capsule contains indacaterol maleate equivalent to 150 microgram indacaterol.
Maltese: Kull kapsula fiha l-indacaterol maleate ekwivalenti għal 150 mikrogramma indacaterol.
English: 53 b 55 c
Maltese: 55 c b
English: Salmeterol twice a day
Maltese: Salmeterol darbtejn kuljum
English: 51 c a
Maltese: 51 c
English: Absolute bioavailability of indacaterol after an inhaled dose was on average 43% to 45%.
Maltese: Il-bijodisponibbiltà assoluta tal-indacaterol wara li ttieħdet id-doża mannifs kienet ta' bejn wieħed u ieħor bejn 43% u 45%.
English: The 300 microgram dose resulted in a 170-180 ml increase compared to placebo (p<0.001) and a 100 ml increase compared to formoterol 12 microgram twice a day (p<0.001).
Maltese: Id-doża ta' 300 mikrogramm wasslet għal żieda ta' 170-180 ml meta mqabbla mal-plaċebo (p<0.001) u għal żieda ta' 100 ml meta mqabbla ma' 12-il mikrogramma formoterol darbtejn kuljum (p<0.
English: Percentage of patients who achieved MCID TDI†
Maltese: Perċentwali ta' pazjenti li kellhom MCID TDI†
English: Of these patients, 2,611 were on treatment with 150 microgram once daily and 1,157 on treatment with 300 microgram once daily.
Maltese: Minn dawn il-pazjenti, 2,611 ingħataw kura b'150 mikrogramma darba kuljum u 1,157 ingħataw kura bi 300 mikrogramma darba kuljum.
English: For instructions on use of the medicinal product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq il-prodott mediċinali qabel jingħata, ara sezzjoni 6.6.
English: 300 capsules + 30 inhalers
Maltese: 300 kapsula + 30 inhaler