FrancophonIA/ELRC3.0 huggingface dataset:
English: • Patients should be carefully monitored for signs and symptoms of hypersensitivity reactions including monitoring of blood pressure and pulse during and for at least 30 minutes following each infusion of Rienso.
Maltese: • Il-pazjenti għandhom jiġu mmonitorjati b'attenzjoni għal sinjali u sintomi ta' reazzjonijiet ta' sensittività eċċessiva inkluż monitoraġġ tal-pressjoni u tal-polz matul u għal mill-inqas 30 minuta wara kull infużjoni ta' Rienso.
English: Within this PSUR, a further literature review has been provided by the MAH identifying 9 relevant publications addressing ferumoxytol and MRI.
Maltese: Tnejn minn dawn ir-rapporti kienu inklużi mill-MAH bħala informazzjoni kritika ttardjata f'dan il-PSUR.
English: Periodic monitoring of laboratory parameters of iron storage, such as serum ferritin and transferrin saturation, enables recognition of iron accumulation.
Maltese: Sorveljanza perjodika ta' parametri tal-laboratorju ta' ħażna ta' ħadid, bħal ferritin u saturazzjoni ta' transferrin fis-serum, tippermetti r-rikonoxximent ta' akkumulazzjoni ta' ħadid.
English: If you are breast-feeding, ask your doctor for advice before you are given Rienso.
Maltese: M'hemmx dejta disponibbli minn provi kliniċi dwar doża eċċessiva ta' Rienso fil-bnedmin.
English: The pharmacokinetic (PK) behaviour of Rienso has been examined in healthy subjects and in patients with CKD stage 5D on haemodialysis.
Maltese: L-imġieba farmakokinetika (PK) ta' Rienso ġiet eżaminata f'individwi f'saħħithom u f'pazjenti b'CKD ta' stadju 5D fuq emodijalisi.
English: Post-Marketing Data from Dialysis Clinics in the United States
Maltese: Dejta ta' Wara t-Tqegħid fis-Suq minn Kliniki tad-Dijalisi fl-Istati Uniti
English: Lip swelling Swollen tongue
Maltese: Żieda fid-dmugħ Vista mċajpra
English: Please see the iron overload section 4.4 and for dosing guidance, see section 4.2.
Maltese: Jekk jogħġbok ara sezzjoni 4.4 dwar ammont żejjed ta' ħadid u għal gwida dwar id-dożaġġ, ara sezzjoni 4.2.
English: Prior to the use of Rienso in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Qabel l-użu ta' Rienso f'kull Stat Membru id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH - Marketing Authorisation Holder) għandu jaqbel dwar il-kontenut u d-disinn tal-programm edukattiv, inkluż mezzi ta' komunikazzjoni, modalitajiet ta' distribuzzjoni, u kwalunkwe aspetti oħra tal-programm, mal-Awtorità Kompetenti Nazzjonali.
English: Hypotension
Maltese: Iperkalimja
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton Label (1, 2, 6 or 10 vial pack)
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Tikketta tal-Kartuna (pakkett b'kunjett 1, 2, 6 jew 10 kunjetti)
English: Mean haemoglobin increased (0.5-0.9 g/dl) post-treatment and stabilised in the range of 11-11.7 g/dl over the 10 month post-dose period; no new safety signals were identified with repeat dosing.
Maltese: L-emoglobina medja żdiedet (0.5-0.9 g/dl) wara l-kura u stabbilizzat fil-firxa ta' 11-11.
English: In 5 out of these 6 cases, ferumoxytol was administered via IV injection (either quick or slow IV push), for the remaining case the method of administration is unknown.
Maltese: F'5 minn dawn is-6 każijiet, ferumoxytol ingħata permezz ta' injezzjoni IV (IV push mgħaġġla jew bil-mod), għall-każ li jifdal il-metodu tal-għoti mhux magħruf.
English: Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into haemoglobin.
Maltese: Wara dan il-ħadid jidħol fil-ħażna intraċellulari ta' ħadid (eż., ferritin) jew ikun ittrasferit għal transferrin fil-plażma għal trasport lejn iċ-ċelluli prekursuri eritrojdi għall-inkorporazzjoni fl-emoglobina.
English: congestive heart failure, palpitations, blood vessel dilation, changes in your pulse rate including weak/absent pulse, heart stops beating, heart and breathing stop, blue discolouration of skin and/or mucous membranes due to lack of oxygen in the blood (cyanosis) - fainting/loss of consciousness/unresponsiveness - sudden swelling up of skin or mucous membranes (angioedema), skin rash - wheezing (bronchospasm), cough, upper airway swelling, difficulty breathing (change to
Maltese: ossiġnu fid-demm (ċjanożi) - ħass ħażin/telfa tas-sensi/nuqqas ta' rispons - nefħa f'daqqa waħda tal-ġilda jew tal-membrani mukużi (anġjoedima), raxx tal-ġilda - tħarħir (bronkospażmu), sogħla, nefħa tal-passaġġi tal-arja ta' fuq, diffikultà biex tieħu nifs
English: The healthcare professional checklist shall contain the following messages:
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi talProdott, sezzjoni 4.2).
English: Adverse reactions reported in these patients were similar in character and frequency to those observed in the other clinical trials.
Maltese: Reazzjonijiet avversi rrappurtati f'dawn il-pazjenti kienu simili fil-karattru u lfrekwenza għal dawk osservati fil-provi kliniċi l-oħra.
English: Rienso should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Maltese: Rienso għandu jingħata biss meta staff imħarreġ biex jevalwa u jimmaniġġja r-reazzjonijiet anafilattiċi jkun disponibbli immedjatament, f'ambjent fejn faċilitajiet kompleti ta' risuxxitazzjoni jistgħu jiġi assigurati.
English: On the basis of the scientific conclusions for Rienso, the CHMP is of the opinion that the benefit-risk balance of the medicinal product containing the active substance ferumoxytol is favourable subject to the proposed changes to the product information.
Maltese: Abbażi ta' konklużjonijiet xjentifiċi għal Rienso is-CHMP huwa tal-opinjoni li l-bilanċ bejn benefiċċju u riskju ta' prodott mediċinali li fih is-sustanza attiva ferumoxytol huwa favorevoli soġġett għall-bidliet proposti lill-informazzjoni tal-prodott.
English: The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy (see section 4.3).
Maltese: Ir-riskju jkun ikbar għal pazjenti b'allerġiji magħrufa li jinkludu allerġiji għal mediċini, li inklużi pazjenti bi storja ta' ażżma severa, ekżema jew allerġija atopika oħra (ara sezzjoni 4.3).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Rienso 30 mg/ml infusion
Maltese: U MNEJN GĦANDU JINGĦATA Rienso 30 mg/ml infużjoni
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, local tolerance and immunotoxicity.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, tolleranza lokali u immunotossiċità ma juri l-ebda periklu speċjali għall-bnedmin.
English: Uncommon side effects (may affect up to 1 in 100 people): - dizziness - low blood pressure - feeling weak or tired - feeling drowsy or sleepy - flushing, hot flush - feeling hot, fever - sweating (including night sweats) - chills - high blood pressure (sudden increase in blood pressure) - skin rash, itching, darkening of an area of skin or nails, bruising, hives - burning sensation of skin - shortness of breath - diarrhoea - constipation - stomach pain/discomfort - stomach distension or bloating - nausea, vomiting
Maltese: L-effetti sekondarji serji li ġejjin kienu irrappurtati eżatt wara li ngħata Rienso: - reazzjonijiet allerġiċi (anafilattiċi/reazzjonijiet simili għal dawk anafilattici, sensitività eċċesiva) ta' periklu għal ħajja u fatali - kumplikazzjonijiet kardjovaskulari (li jaffetwaw il-qalb u kanali tad-demm) inkluż attakk tal qalb, insuffiċjenza konġestiva tal-qalb, palpitazzjonijiet, dilazzjoni tal-kanali tad-demm, bidliet fir-rata tal-polz tiegħek inkluż polz dgħajjef/nieqes, il-qalb tieqaf tħabbat, waqfien tal-qalb u tan-nifs, tibdil ta' lewn blu tal-ġilda u/jew tal-membrani mukużi kkawżat minn nuqqas ta'
English: Dizziness Dysgeusia Headache Somnolence Burning sensation
Maltese: Il-professjonisti dwar il-kura tassaħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Luxembourg/Luxemburg Takeda Belgium Tél./Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Maltese: Luxembourg/Luxemburg Takeda Belgium Tél./Tel:
English: No change in dosage is recommended from Table 1.
Maltese: Mhux irrakkomandata bidla fid-dożaġġ minn dik murija f'Tabella 1.
English: Proportion of Hgb
Maltese: GĦAMLA KWALITATTIVA
English: The treatment you will receive can be 1 or 2 vials of Rienso (510 mg each) by infusion and each dose will be infused into a vein.
Maltese: Il-kura li se tirċievi tista' tkun ta' kunjett wieħed jew 2 ta' Rienso (510 mg kull waħda) permezz ta' infużjoni u kull doża se tingħata bħala infużjoni ġewwa vina.
English: Overall conclusion and Benefit -risk balance
Maltese: Konklużjoni ġenerali u l-Bilanċ tal-benefiċċju-riskju
English: Leflunomide Actavis is available as 10 mg, 20 mg and 100 mg film-coated tablets.
Maltese: Leflunomide Actavis jiġi bħala pilloli miksijin b'rita ta' 10 mg, 20 mg u 100 mg.
English: Leflunomide Actavis contains leflunomide, a pyrimidine synthesis inhibitor belonging to the DMARD (disease-modifying antirheumatic drug) class of drugs, which are chemically and pharmacologically very heterogeneous.
Maltese: Leflunomide Actavis fih leflunomide, inibitur tas-sinteżi ta' pyrimidine li jappartjeni għall-klassi ta' mediċini DMARD (mediċini kontra r-rewmatiżmu li jimmodifikaw il-marda), li huma kimikament u farmakoloġikament eteroġeniċi ħafna.
English: The single pivotal bioequivalence study 125-07 was conducted in May 2008 at the Cetero Research facilities in Houston.
Maltese: L-istudju ta' bijoekwivalenza pivotali uniku 125-07 twettaq f'Mejju 2008 fil-faċilitajiet ta' Cetero Research fi Houston.
English: Overall summary of the scientific evaluation of Leflunomide Actavis (see Annex I)
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika ta' Leflunomide Actavis (ara Anness I)
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Actavis and associated names.
Maltese: • Il-Kumitat ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għal Leflunomide Actavis u ismijiet assoċjati.
English: It is indicated for the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Maltese: Huwa indikat għall-kura ta' adulti b'artrite rewmatojde u b'artrite psorjatika attiva moderata għal severa.
English: The Committee, as a consequence, recommended the suspension of the marketing authorisations for Leflunomide Actavis and associated names, pursuant to Article 116 of Directive 2001/83/EC; as a. the risk-benefit balance cannot be considered favourable and b. the particulars supporting the application as provided in Article 10 of Directive 2001/83/EC cannot be considered correct
Maltese: B'konsegwenza ta' dan, il-Kumitat irrakkomanda s-sospensjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq għal Leflunomide Actavis u ismijiet assoċjati skont l-Artikolu 116 tad-Direttiva 2001/83/KE; minħabba li a. il-bilanċ tal-benefiċċju-riskju ma jistax jitqies bħala favorevoli u b. id-dettalji li jappoġġjaw l-applikazzjoni kif previst fl-Artikolu 10 tad-Direttiva 2001/83/KE ma jistgħux jitqiesu bħala korretti
English: As no data has been submitted by the MAH in response to the CHMP List of Questions, the CHMP retained serious doubts due to the findings of the inspection of the Cetero Research facilities in Houston (Texas, USA), regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study submitted in support of the marketing authorisation.
Maltese: Minħabba li ma ġiet sottomessa ebda dejta mill-MAH bi tweġiba għal-lista ta' Mistoqsijiet tas-CHMP, isCHMP kien għad fadallu dubji serji minħabba s-sejbiet tal-ispezzjoni tal-faċilitajiet ta' Cetero Research fi Houston (Texas, USA), dwar l-affidabbiltà u l-korrettezza tad-dejta mill-istudju pivotali kritiku ta' bijoekwivalenza sottomessa b'appoġġ għall-awtorizzazzjoni għat-tqegħid fis-suq.
English: Therefore, given the serious doubts regarding the reliability and the correctness of the data from the critical pivotal bioequivalence study 125-07, submitted in support of the marketing authorisation, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence Leflunomide Actavis to its EU reference product, the CHMP was unable to conclude on the bioequivalence of Leflunomide Actavis.
Maltese: Għalhekk, minħabba d-dubji serji rigward l-affidabbiltà u l-korrettezza tad-dejta mill-istudju pivotali kritiku ta' bijoekwivalenza 125-07, sottomessa b'appoġġ għall-awtorizzazzjoni għat-tqegħid fis-suq, u fin-nuqqas ta' studju affidabbli ta' bijoekwivalenza speċifikament imfassal biex jistabbilixxi l-bijoekwivalenza ta' Leflunomide Actavis malprodott ta' referenza tiegħu tal-UE, is-CHMP ma setax jikkonkludi dwar il-bijoekwivalenza ta' Leflunomide Actavis.
English: Therefore, and in the absence of a reliable bioequivalence study specifically designed to establish the bioequivalence of Leflunomide Actavis to its EU reference product, the benefit-risk balance of Leflunomide Actavis cannot be considered to be favourable.
Maltese: Għalhekk, u fin-nuqqas ta' studju affidabbli ta' bijoekwivalenza speċifikament imfassal biex jistabbilixxi l-bijoekwivalenza ta' Leflunomide Actavis mal-prodott ta' referenza tiegħu tal-UE, il-bilanċ tal-benefiċċju-riskju ta' Leflunomide Actavis ma jistax jiġi kkunsidrat bħala favorevoli.
English: EU/1/14/964/001 1 inhaler with 60 doses EU/1/14/964/002 3 inhalers each with 60 doses EU/1/14/964/003 1 inhaler with 30 doses
Maltese: EU/1/14/964/001 1 inalatur b'60 doża EU/1/14/964/002 3 inalaturi kull wieħed b'60 doża EU/1/14/964/003 1 inalatur bi 30 doża
English: Protective Cap
Maltese: Għatu protettiv
English: Manufacturer: Industrias Farmacéuticas Almirall, S.A.
Maltese: Industrias Farmacéuticas Almirall, S.A.
English: How to store Duaklir Genuair 6.
Maltese: Kif taħżen Duaklir Genuair 6.
English: The most frequently reported adverse reactions with Duaklir Genuair were nasopharyngitis (7.9%) and headache (6.8%).
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni b'Duaklir Genuair kienu nażofarinġite (7.9%) u wġigħ ta' ras (6.8%).
English: A total of 1222 patients were treated with Duaklir Genuair 340 micrograms /12 micrograms.
Maltese: Total ta' 1222 pazjent ikkurati b'Duaklir Genuair 340 mikrogramma/12-il mikrogramma.
English: Duaklir Genuair is indicated as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Maltese: Duaklir Genuair huwa indikat bħala trattament ta' manteniment bi bronkodilatatur sabiex itaffi s-sintomi fil-pazjenti adulti b'mard pulmonari ostruttiv kroniku (COPD).
English: Following repeated inhalations of Duaklir Genuair 340/12 micrograms, the systemic exposure of aclidinium and formoterol, as measured by AUC, is similar in Japanese and Caucasian patients.
Maltese: Wara inalazzjonijiet ripetuti ta' Duaklir Genuair 340/12-il mikrogramma, l-esponiment sistemiku ta' aclidinium u formoterol, kif imkejjel mill-AUC, huwa simili f'pazjenti Ġappuniżi u Kawkasi.
English: Following inhalation of a single dose of Duaklir Genuair 340/12 micrograms, aclidinium and formoterol were rapidly absorbed into plasma, reaching peak plasma concentrations within 5 minutes of inhalation in healthy subjects and within 24 minutes of inhalation in patients with COPD.
Maltese: Wara inalazzjoni ta' doża unika ta' Duaklir Genuair 340/12 -il mikrogramma, aclidinium u formoterol ġew assorbiti b'mod rapidu fil-plażma, u laħqu l-ogħla konċentrazzjonijiet fil-plażma fi żmien 5 minuti mill-inalazzjoni fl-individwi b'saħħithom u fi żmien 24 minuta mill-inalazzjoni f'pazjenti b'COPD.
English: After 4 weeks of treatment, Duaklir Genuair improved the number of steps per day compared to placebo (731 steps/day; 95% CI=279, 1181; p=0.0016) and reduced the percentage of inactive patients (<6000 steps per day) [40.8% compared to 54.5%; p<0.0001].
Maltese: Wara 4 ġimgħat ta' kura, Duaklir Genuair tejjeb in-numru ta' passi kuljum meta mqabbel mal-plaċebo (731 pass/jum; 95% CI=279, 1181; p=0.0016) u naqqas il-perċentwal ta' pazjenti mhux attivi (<6000 pass kuljum) [40.8% meta mqabbel ma' 54.5%; p<0.0001].
English: Duaklir Genuair 340 mcg/12 mcg inhalation powder aclidinium/formoterol fumarate dihydrate
Maltese: Duaklir Genuair 340 mcg/12 mcg trab li jittieħed man-nifs aclidinium/formoterol fumarate dihydrate
English: Although no formal in vivo drug interaction studies have been performed with Duaklir Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Maltese: Għad li ma sar l-ebda studju formali in vivo tal-interazzjoni tal-mediċina b'Duaklir Genuair, intuża b'mod konkomitanti ma' prodotti mediċinali tas-COPD oħrajn inklużi bronkodilataturi adrenerġiċi β2 b'azzjoni fuq żmien qasir, methylxanthines, u sterojdi orali u li jittieħdu man-nifs mingħajr prova klinika ta' interazzjonijiet tal-mediċina.
English: Duaklir Genuair contains lactose
Maltese: Kontenut tal-lactose
English: Common (may affect up to 1 in 10 people) - Combination of sore throat and runny nose - these may be signs of nasopharyngitis - Headache - Painful and/or frequent urination - these may be signs of a urinary tract infection - Cough - Diarrhoea - A blocked, runny or stuffy nose and/or pain or a feeling of pressure in the cheeks or forehead these may be symptoms of sinusitis - Dizziness - Muscle cramps - Nausea (feeling sick) - Difficulty sleeping - Dry mouth - Muscle pain - Abscess (infection) in the tissues at the base of a tooth - Increased blood levels of a protein found in muscle called creatine phosphokinase - Shaking/tremor - Anxiety
Maltese: nażofarinġite - Uġigħ ta' ras - Uġigħ biex tagħmel l-awrina jew tkun tagħmel l-awrina b'mod frekwenti - dawn jistgħu jkunu sinjali ta' infezzjoni fl-apparat urinarju - Sogħla - Dijarea - Imnieħer imblokkat, inixxi jew misdud u/jew uġigħ jew sensazzjoni ta' pressjoni fil-ħaddejn jew fuq il-moħħ - dawn jistgħu jkunu sintomi ta' sinusite - Sturdament - Bugħawwieġ fil-muskoli - Nawseja (tħossok imdardar) - Diffikultà biex torqod - Ħalq xott - Uġigħ fil-muskoli - Axxesi (infezzjoni) fit-tessuti fil-bażi ta' sinna - Żieda fil-livelli fid-demm ta' proteina misjuba f'muskolu msejħa creatine phosphokinase - Rogħda/tertir - Ansjetà
English: 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: In the pooled analysis of these two studies, Duaklir Genuair showed greater improvements in SGRQ total score compared to formoterol (-1.7 units; p=0.018) or aclidinium (-0.79 units, p=0.273).
Maltese: Fl-analiżi miġbura ta' dawn iż-żewġ studji, Duaklir Genuair wera titjib akbar fil-punteġġ totali ta' SGRQ meta mqabbel ma' formoterol (-1.7 unità; p=0.018) jew aclidinium (-0.79 unità, p=0.273).
English: After 4 weeks of treatment Duaklir Genuair implied improvement versus placebo in change from baseline in morning pre-dose (trough) FRC, the primary endpoint, but the difference was not statistically significant (-0.125 L; 95% CI=(-0.259, 0.010); p=0.069*).
Maltese: Wara 4 ġimgħat ta' kura, Duaklir Genuair implika titjib meta mqabbel mal-plaċebo f'bidla mil-linja bażi f'FRC (l-aktar baxx) ta' qabel id-doża ta' filgħodu, il-punt ta' tmiem primarju, iżda d-differenza ma kinitx statistikament sinifikanti (-0.125 L; 95% CI=(-0.259, 0.010); p=0.069*).
English: In addition, a higher percentage of patients receiving Duaklir Genuair responded with a clinically meaningful improvement in SGRQ total score compared to aclidinium and formoterol (56.6% compared to 53.9% and 52.2%, respectively; p=0.603 and p=0.270, respectively).
Maltese: Barra minn hekk, perċentwal ogħla ta' pazjenti li ngħataw Duaklir Genuair irrispondew b'titjib klinikament sinifikanti fil-punteġġ totali ta' SGRQ meta mqabbel ma' aclidinium u formoterol (56.6% meta mqabbel ma' 53.9% u 52.2%, rispettivament; p=0.603 and p=0.270, rispettivament).
English: In study AUGMENT, Duaklir Genuair showed improvements in FEV1 at 1 hour post-dose relative to placebo and aclidinium of 284 ml and 108 ml (both p<0.0001), respectively, and improvements in trough FEV1 relative to placebo and formoterol of 130 ml (p<0.0001) and 45 ml (p=0.01), respectively.
Maltese: Fl-istudju AUGMENT, Duaklir Genuair wera titjib f'FEV1 f'siegħa wara d-doża meta mqabbel ma' plaċebo u aclidinium ta' 284 ml u 108 ml (it-tnejn p<0.0001), rispettivament u titjib fl-FEV1 l-aktar baxx meta mqabbel ma' plaċebo u formoterol ta' 130 ml (p<0.0001) u 45 ml (p=0.01), rispettivament.
English: Duaklir Genuair showed improvements compared to placebo in lung volumes at 2-3h post dose (FRC=-0.366 L [95% CI=-0.515, -0.216; p<0.0001]; residual volume [RV]=-0.465 L [95% CI=0.648, -0.281; p<0.0001] and inspiratory capacity [IC]= 0.293 L [95% CI=0.208, 0.378; p<0.0001]).
Maltese: 465 L [95% CI=0.648, -0.281; p<0.0001] u kapaċità ispiratorja [IC]= 0.293 L [95% CI=0.208, 0.378; p<0.
English: Duaklir Genuair contains two bronchodilators: aclidinium is a long-acting muscarinic antagonist (also known as an anticholinergic) and formoterol is a long-acting β2-adrenergic agonist.
Maltese: Duaklir Genuair fih żewġ bronkodilaturi: aclidinium huwa antagonist muskariniku b'azzjoni fit-tul (magħruf ukoll bħala antikolinerġiku) u formoterol huwa agonist adrenerġiku β2 li jaġixxi fit-tul.
English: In addition, a higher percentage of patients receiving Duaklir Genuair responded with a clinically meaningful improvement in TDI focal score compared to either aclidinium or formoterol (61.9% compared to 55.7% and 57.0%, respectively; p=0.056 and p=0.100, respectively).
Maltese: Barra minn hekk, perċentwal ogħla ta' pazjenti li jingħataw Duaklir Genuair irrispondew b'titjib klinikament sinifikanti fil-punteġġ fokali TDI meta mqabbel ma' aclidinium jew formoterol (61.9% meta mqabbel ma' 55.7% u 57.0%, rispettivament; p=0.056 u p=0.100, rispettivament).
English: There is limited evidence on the management of overdose with Duaklir Genuair.
Maltese: Hemm evidenza limitata fuq il-ġestjoni ta' doża eċċessiva b'Duaklir Genuair.
English: Duaklir Genuair also showed improvements in exercise endurance time compared to placebo after 8 weeks of treatment (55 seconds [95% CI=5.6, 104.8; p=0.0292]; baseline value: 456 seconds).
Maltese: Duaklir Genuair wera wkoll titjib fil-ħin tar-reżistenza għall-eżerċizzju meta mqabbel mal-plaċebo wara 8 ġimgħat ta' kura (55 sekonda [95% CI=5.6, 104.8; p=0.0292]; valur bażali: 456 sekonda).