FrancophonIA/ELRC3.0 huggingface dataset:
English: Dronedarone can increase exposure of statins that are substrates of CYP 3A4 and/or P-gp substrates.
Maltese: Dronedarone jista' jżid l-espożizzjoni ta' statins li huma sustrati ta' CYP 3A4 u /jew sustrati ta' P-gp. Dronedarone (400 mg darbtejn kuljum) żied l-espożizzjoni ta' simvastatin u l-aċidu simvastatin b'4-darbiet u b'darbtejn rispettivament.
English: In subjects with moderate hepatic impairment, dronedarone unbound exposure is increased by 2-fold.
Maltese: Jekk tiġi kkonfermata t-tossiċità pulmonarja, il-kura għandha titwaqqaf.
English: International Normalised Ratio (INR) should be closely monitored after initiating dronedarone in patients taking vitamin K antagonists as per their label.
Maltese: LInternational Normalised Ratio (INR) għandu jiġi ċċekkjat mill-qrib wara li jinbeda dronedarone f'pazjenti li jieħdu antagonisti tal-vitamina K kif indikat fit-tiketta tagħhom.
English: In clinical studies, premature discontinuation due to adverse reactions occurred in 11.8% of the dronedarone-treated patients and in 7.7% in the placebo-treated group.
Maltese: F'studji kliniċi, it-twaqqif tal-kura qabel iż-żmien minħabba r-reazzjonijiet avversi seħħ f'11.8 % talpazjenti fuq kura b'dronedarone u f'7.7 % fil-grupp ikkurat bil-plaċebo.
English: Abdominal pain Dyspepsia
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: 50 film-coated tablets
Maltese: 50 pillola miksija b'rita
English: Patients ranged in age from 23 to 97 years and 42% were over 75 years old.
Maltese: L-etajiet tal-pazjenti kienu jvarjaw minn 23 sa 9 sena u 42 % kellhom iżjed minn 75 sena.
English: Recurrences of AF (including absence of conversion) were more frequent in the dronedarone group, whereas premature study drug discontinuations due to intolerance were more frequent in the amiodarone group.
Maltese: Ir-rikorrenzi ta' FA (inkluż in-nuqqas ta' konverżjoni) kienu aktar frekwenti fil-grupp ta' dronedarone, waqt li t-twaqqif qabel iż-żmien talmediċina taħt studju minħabba li ma ġietx ittollerata tajjeb kienu aktar frekwenti fil-grupp ta' amiodarone.
English: Monoamine Oxidases contribute partially to the metabolism of the active metabolite of dronedarone (see section 4.5).
Maltese: Il-kura għandha tinbeda u tiġi ssorveljata taħt superviżjoni ta' speċjalista biss (ara sezzjoni 4.4).
English: • Medicinal products inducing torsades de pointes such as phenothiazines, cisapride, bepridil,
Maltese: • Prodotti mediċinali li jikkawżaw torsades de pointes bħal phenothiazines, cisapride, bepridil, antidipressanti triċikliċi, terfenadine u ċerti makrolidi orali (bħal erythromycin), antiarritmiċi tal-Klassi I u III (ara sezzjoni 4.5)
English: No dose adjustment is required in other patients with renal impairment (see sections 4.4 and 5.2).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża f'pazjenti oħrajn b'indeboliment renali (ara sezzjonijiet 4.4 u 5.2).
English: However, proarrhythmic effects may occur in particular situations such as concomitant use with medicinal products favouring arrhythmia and/or electrolytic disorders (see sections 4.4 and 4.5).
Maltese: Madankollu, jistgħu jseħħu effetti proarritmiċi speċjalment f'sitwazzjonijiet bħal l-użu fl-istess ħin ta' prodotti mediċinali li jiffavorixxu l-arritmija u/jew disturbi elettrolitiċi (ara sezzjonijiet 4.4 u 4.5).
English: Dronedarone decreases arterial blood pressure and myocardial contractility (dP/dt max) with no change in left ventricular ejection fraction and reduces myocardial oxygen consumption.
Maltese: Dronedarone inaqqas il-pressjoni arterjali tad-demm u lkontrattilità mijokardika (dP/dt max) bla ebda tibdil fil-volum li jiġi mneħħi mill-ventriklu tax-xellug u jnaqqas il-konsum tal-ossiġenu min-naħa tal-mijokardju.
English: What MULTAQ looks like and content of the pack MULTAQ is a white, oval, film-coated tablet (tablet) with a double wave marking on one side and “4142” on the other side.
Maltese: MULTAQ hija pillola miksija b'rita (pillola) bajda, ovali, immarkata b'mewġa doppja fuq naħa u b'“4142” fuq in-naħa l-oħra.
English: 16 December 2011
Maltese: 16 ta' Diċembru 2011
English: Which products are affected by the review?
Maltese: Liema prodotti ġew affettwati mir-reviżjoni?
English: These include: Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; Monosol and a sodium chloride solution for haemodialysis.
Maltese: Dawn jinkludu: is-soluzzjonijiet Dianeal, Extraneal u Nutrineal għaddijaliżi peritoneali; is-soluzzjoni Monosol u soluzzjoni tal-klorur tas-sodju għall-emodijaliżi.
English: The European Medicines Agency has completed an investigation into the production processes at Baxter's manufacturing plant in Castlebar, Ireland.
Maltese: L-Aġenzija Ewropea għall-Mediċini temmet investigazzjoni tal-proċessi ta' produzzjoni fl-impjant ta' manifattura ta' Baxter f'Castlebar, fl-Irlanda.
English: However the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey).
Maltese: Madankollu l-Kumitat ipprova jnaqqas id-dipendenza mill-impjant u għamel rakkomandazzjonijiet f'Jannar 2011 dwar l-użu ta' prodotti importati minn erba' siti ta' produzzjoni barra l-UE (fil-Kanada, fl-Istati Uniti, f'Singapor u fit-Turkija).
English: What are the risks of exposure to endotoxins?
Maltese: X'inhuma r-riskji tal-esponiment għall-endotossini?
English: If a patient receives a medicine that contains endotoxins, there is a risk that the immune system, the body's defence mechanism, will react against the endotoxins and cause inflammation.
Maltese: Jekk pazjent jingħata mediċina li jkun fiha l-endotossini jkun hemm riskju li s-sistema immunitarja (il-mekkaniżmu ta' difiża tal-ġisem) tirreaġixxi kontra l-endotossini u tikkawża infjammazzjoni.
English: In order to facilitate this, the CHMP had earlier during the investigation made recommendations to formally include the production sites in Canada, USA, Turkey and Poland in the products' marketing authorisations in Europe.
Maltese: Sabiex jiffaċilita dan, aktar kmieni fl-investigazzjoni s-CHMP kien għamel rakkomandazzjonijiet biex jinkludi b'mod formali s-siti ta' produzzjoni fil-Kanada, fl-Istati Uniti, fit-Turkija u fil-Polonja fl-awtorizzazzjonijiet għat-tqegħid fis-suq tal-prodotti fl-Ewropa.
English: As part of the future risk management plan the Committee adopted proposals for a period of intense monitoring of any reports of aseptic peritonitis during the initial months of marketing new products from CastleBar.
Maltese: Bħala parti mill-pjan futur ta' ġestjoni tar-riskju l-Kumitat adotta proposti dwar perjodu ta' sorveljanza intensiva ta' kwalunkwe rapport ta' peritonite asettika waqt l-ewwel xhur ta' bejgħ ta' prodotti ġodda minn Castlebar.
English: The investigation follows the detection in December 2010 of endotoxins in dialysis solutions produced at the plant.
Maltese: L-investigazzjoni qiegħda ssegwi l-iskoperta ta' Diċembru 2010 ta' endotossini fis-soluzzjonijiet tad-dijaliżi prodotti fl-impjant.
English: What is the background to the current investigation?
Maltese: X'inhu l-isfond tal-investigazzjoni attwali?
English: The products affected by this review are some of the dialysis solutions produced at Baxter's Castlebar plant.
Maltese: Il-prodotti affettwati minn din ir-reviżjoni huma xi wħud mis-soluzzjonijiet tad-dijaliżi prodotti flimpjant ta' Baxter f'Castlebar.
English: Symptoms of aseptic peritonitis include cloudy effluent (the solution in the drainage bag), abdominal pain, nausea (feeling sick), vomiting and sometimes fever.
Maltese: Is-sintomi tal-peritonite asettika jinkludu ħmieġ imdardar (is-soluzzjoni fil-borża tal-ħmieġ), uġigħ addominali, nawżja (dardir), rimettar u xi drabi anke deni.
English: The CHMP concluded that the root cause of the presence of endotoxins in the affected production lines was a combination of factors: undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread.
Maltese: Is-CHMP ikkonkluda li l-kawża prinċipali tal-preżenza tal-endotossini fil-linji ta' produzzjoni affettwati kienet taħlita ta' fatturi: xquq mhux individwati fit-tagħmir seta' ppermetta l-iżvilupp tal-batterji, filwaqt li d-disinn tal-impjant u l-metodi ta' tindif użati setgħu ħallew il-kontaminazzjoni tinfirex.
English: Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time.
Maltese: Minħabba n-nuqqas ta' sorsi alternattivi suffiċjenti ta' soluzzjonijiet tad-dijaliżi, is-CHMP ma setax jirtira l-prodotti affettwati kollha mill-impjant ta' Castlebar f'dak iż-żmien.
English: The CHMP started the current review to investigate fully the issues related to the endotoxin contamination and to make recommendations to help protect public health and to prevent future supply shortages.
Maltese: Is-CHMP beda r-reviżjoni attwali biex jinvestiga b'mod sħiħ il-kwistjonijiet marbuta malkontaminazzjoni bl-endotossini u biex jagħmel ir-rakkomandazzjonijiet li jgħinu fil-protezzjoni tassaħħa pubblika u fil-prevenzjoni ta' nuqqasijiet ta' provvisti fil-futur.
English: • Patients who suspect they have aseptic peritonitis or notice any relevant symptoms (cloudy effluent in drain bag at the end of dialysis, abdominal pain, nausea, vomiting and fever) should contact their doctor.
Maltese: • Il-pazjenti li jaħsbu li jkollhom il-peritonite asettika jew li jinnotaw xi sintomi rilevanti (ħmieġ imdardar fil-borża tal-ħmieġ wara d-dijaliżi, uġigħ addominali, nawżja, rimettar u deni) għandhom jikkuntattjaw lit-tabib tagħhom.
English: The Agency was made aware of the presence of endotoxins in batches of Dianeal, Extraneal and Nutrineal made in the Castlebar plant in December 2010.
Maltese: F'Diċembru 2010 l-Aġenzija ġiet mgħarrfa dwar il-preżenza tal-endotossini f'lottijiet ta' Dianeal, Extraneal u Nutrineal magħmula fl-impjant ta' Castlebar.
English: The CHMP noted that improvements are being made to Castlebar plant to ensure future production of endotoxin-free dialysis solutions.
Maltese: Is-CHMP innota li qed isir titjib fl-impjant ta' Castlebar biex ikun żgurat li fil-ġejjieni l-produzzjoni ta' soluzzjonijiet tad-dijaliżi tkun ħielsa mill-endotossini.
English: Other information about Daxas:
Maltese: Informazzjoni oħra dwar Daxas:
English: Further information on Daxas can be found on the Agency's website: ema.europa/Find medicine/Human medicine/European public assessment reports.
Maltese: Aktar informazzjoni dwar Daxas tinstab fis-sit elettroniku tal-Aġenzija: ema.europa/Find medicine/Human medicine/European public assessment reports.
English: Daxas contains the active substance roflumilast.
Maltese: Daxas fih is-sustanza attiva roflumilast.
English: The active substance in Daxas, roflumilast, belongs to a group of medicines called ‘phosphodiesterase type 4 (PDE4) inhibitors'.
Maltese: Is-sustanza attiva f'Daxas, roflumilast, tagħmel parti minn grupp ta' mediċini li jissejjaħ ”inibituri tattip 4 ta' fosfodjesterażi (PDE4)”.
English: Around 18% (81 of 441 patients) of those started at 250 micrograms daily dropped out of the study, compared with 25% (109 of 443) of those starting with 500 micrograms daily.
Maltese: Madwar 18% (81 minn 441 pazjent) minn dawk li bdew b'250 mikrogramma kuljum irtiraw mill-istudju, imqabbel mal-25% (109 minn 443) minn dawk li bdew b'500 mikrogramma kuljum.
English: What are the risks associated with Daxas?
Maltese: X' inhuma r-riskji assoċjati ma' Daxas?
English: The most common side effects with Daxas (seen in between 1 and 10 patients in 100) are decreased weight, decreased appetite, insomnia (difficulty sleeping), headache, diarrhoea, nausea (feeling sick) and abdominal pain (stomach ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Daxas (li dehru f'bejn pazjent wieħed u 10 minn kull 100) huma tnaqqis fil-piż, tnaqqis fl-aptit, insomnija (diffikultà fl-irqad), uġigħ ta' ras, dijarea, nawżja (dardir) u wġigħ addominali (uġigħ fl-istonku).
English: Daxas is a medicine used to treat severe chronic obstructive pulmonary disease (COPD) in adults who have chronic bronchitis (long-term inflammation of the airways), and whose COPD flares up frequently.
Maltese: Daxas huwa mediċina li tintuża għall-kura ta' mard pulmonari ostruttiv kroniku sever (COPD - chronic obstructive pulmonary disease) f'adulti li għandhom bronkite kronika (infjammazzjoni fit-tul filpassaġġi tal-arja), u li l-COPD tagħhom tfeġġ ta' spiss.
English: Daxas received a marketing authorisation valid throughout the EU on 5 July 2010.
Maltese: Daxas irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fil-5 ta' Lulju 2010.
English: Daxas is available as tablets (250 and 500 micrograms) and can only be obtained with a prescription.
Maltese: Daxas jiġi bħala pilloli (250 u 500 mikrogramma) u jista' jinkiseb biss b'riċetta ta' tabib.
English: As for all medicines, data on the use of Daxas are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Daxas hija ssorveljata kontinwament.
English: Daxas 500 micrograms was shown to be more effective than placebo (a dummy treatment) at treating COPD in two main studies.
Maltese: Intwera li Daxas ta' 500 mikrogramma kien aktar effettiv mill-plaċebo (kura finta) biex jikkura s-COPD f'żewġ studji prinċipali.
English: The recommended dose of Daxas for treatment is one 500-microgram tablet once a day, but treatment is started with one 250-microgram tablet daily to reduce side effects that might make patients stop taking the medicine.
Maltese: Id-doża rakkomandata ta' Daxas għall-kura hija pillola waħda ta' 500 mikrogramma kuljum, iżda l-kura tibda b'pillola waħda ta' 250 mikrogramma kuljum biex jitnaqqsu l-effetti sekondarji li jistgħu iwaqqfu l-pazjenti milli jieħdu l-mediċina.
English: After taking 250 micrograms daily for 4 weeks, the dose is increased to 500 micrograms daily.
Maltese: Wara li jittieħdu 250 mikrogramma kuljum għal 4 ġimgħat, id-doża tiżdied għal 500 mikrogramma kuljum.
English: The company is also carrying out an observational study on the long-term safety of the medicine.
Maltese: Il-kumpanija qed twettaq ukoll studju ta' osservazzjoni dwar is-sigurtà fit-tul tal-mediċina.
English: Daxas is not used on its own but as an ‘add-on' to treatment with bronchodilators (medicines that widen the airways in the lungs).
Maltese: Daxas ma jintużax waħdu iżda jintuża bħala “żieda” għall-kura bi bronkodilataturi (mediċini li jwessgħu il-passaġġi tal-arja fil-pulmun).
English: At the beginning of the studies, both groups of patients had an FEV1 of around 1 litre (1,000 ml).
Maltese: Fil-bidu tal-istudji, iż-żewġ gruppi ta' pazjenti kellhom FEV1 ta' madwar litru wieħed (1,000 ml).
English: Another 12-week study involving 1,323 patients examined the effect of starting treatment with Daxas 250 micrograms daily for 4 weeks before increasing the dose to 500 micrograms daily, compared with starting at the higher dose.
Maltese: Studju ieħor ta' 12-il ġimgħa li involva 1,323 pazjent eżamina l-effett ta' kura li tibda b'Daxas ta' 250 mikrogramma kuljum għal 4 ġimgħat qabel ma tiżdied id-doża għal 500 mikrogramma kuljum, meta mqabbel ma' kura li tibda fl-ogħla doża.
English: The benefits in improving FEV1 were similar in both groups at the end of the study; however, patients who could not take 500 micrograms daily and were then just given 250 micrograms daily did not show an improvement in lung function.
Maltese: Il-benefiċċji fit-titjib tal-FEV1 kienu simili fiż-żewġ gruppi fit-tmiem tal-istudju; madankollu, il-pazjenti li ma setgħux jieħdu 500 mikrogramma kuljum u li mbagħad ingħataw biss 250 mikrogramma kuljum ma wrewx titjib fil-funzjoni tal-pulmuni.
English: These involved over 3,000 adults with severe COPD who had had at least one flare-up of their disease in the past year.
Maltese: Dawn involvew aktar minn 3,000 adult b'COPD severa li s-sena li għaddiet kellhom mill-inqas feġġa waħda tal-marda tagħhom.
English: The European Medicines Agency noted that there was a need for new COPD treatments and that the main studies showed a modest benefit of Daxas 500 micrograms in patients with severe COPD.
Maltese: L-Aġenzija Ewropea għall-Mediċini innotat li kien hemm ħtieġa għal kuri ġodda għal COPD u li l-istudji prinċipali wrew benefiċċju modest ta' Daxas ta' 500 mikrogramma f'pazjenti b'COPD severa.
English: For the full list of side effects of Daxas, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji b'Daxas, ara l-fuljett ta' tagħrif.
English: In addition, the patients who took Daxas had an average of 1.1 moderate or severe flare-ups of their disease, compared with 1.4 flare-ups in the patients who took placebo.
Maltese: Barra minn hekk, il-pazjenti li ngħataw Daxas kellhom medja ta' feġġiet moderati jew severi tal-marda ta' 1.1, meta mqabbla ma' feġġiet ta' 1.4 fil-pazjenti li ngħataw ilplaċebo.
English: How does Daxas work?
Maltese: X' inhu Daxas u għal xiex jintuża?
English: The company that makes Daxas will ensure that healthcare professionals who will prescribe the medicine in all Member States of the European Union (EU) are provided with educational materials containing information on the medicine's side effects and how it should be used.
Maltese: Il-kumpanija li tipproduċi Daxas sejra tiżgura li professjonisti tal-kura tas-saħħa, li jiktbu riċetta talmediċina fl-Istati Membri kollha tal-Unjoni Ewropea (UE) jiġu pprovduti b'materjali edukattivi li jkun fihom informazzjoni dwar l-effetti sekondarji tal-mediċina u kif għandha tintuża.
English: What measures are being taken to ensure the safe and effective use of Daxas?
Maltese: X' miżuri qed jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Daxas?
English: Although a dose of 250 micrograms daily does not improve lung function it was useful in preventing patients from dropping out because of side effects when starting treatment.
Maltese: Minkejja li doża ta' 250 mikrogramma kuljum ma ttejjibx il-funzjoni tal-pulmuni, hija kienet utli biex tipprevjeni lillpazjenti milli jirtiraw minħabba l-effetti sekondarji meta tibda l-kura.
English: It blocks the action of the PDE4 enzyme, which is involved in the inflammation process that leads to COPD.
Maltese: Din timblokka l-azzjoni tal-enzima PDE4, li hija involuta fil-proċess ta' infjammazzjoni li jwassal għal COPD. Billi timblokka l-azzjoni ta' PDE4, roflumilast tnaqqas linfjammazzjoni fil-pulmun, u tgħin fit-tnaqqis tas-sintomi tal-pazjent jew tipprevjeni milli dawn jiggravaw.
English: After considering all of the available data on the effects of the medicine, the Agency decided that Daxas's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: Wara li kkunsidrat id-data kollha disponibbli dwar l-effetti tal-mediċina, l-Aġenzija ddeċidiet li l-benefiċċji ta' Daxas huma akbar mirriskji tiegħu u li jista' jiġi awtorizzat biex jintuża fl-UE.
English: After a year, the patients who took Daxas had an average increase of 40 ml while those given placebo had an average decrease of 9 ml.
Maltese: Wara sena, il-pazjenti li ngħataw Daxas kellhom żieda medja ta' 40 ml filwaqt li dawk li ngħataw plaċebo kellhom tnaqqis ta' 9 ml.
English: Side effects reported with Daxas are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Daxas huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: EMA/601032/2014 EMEA/H/C/003952
Maltese: EMEA/H/C/003952
English: The full EPAR and risk management plan summary for Vylaer Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: L-EPAR sħiħ u s-sommarju tal-pjan tal-ġestjoni tar-riskju għal Vylaer Spiromax jinstabu fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Vylaer Spiromax is a ‘hybrid medicine'.
Maltese: Vylaer Spiromax huwa ‘mediċina ibrida'.
English: The reference medicine for Vylaer Spiromax is Symbicort Turbohaler.
Maltese: Il-mediċina ta' referenza għal Vylaer Spiromax hija Symbicort Turbohaler.
English: Vylaer Spiromax 160/4.5 microgram can be used for the regular treatment of asthma.
Maltese: Vylaer Spiromax 160/4.5 mikrogrammi jista' jintuża għall-kura regolari tal-ażma.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Vylaer Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be equivalent to the corresponding strengths of Symbicort Turbohaler.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li Vylaer Spiromax 160/4.5 mikrogrammi u 320/9 mikrogrammi wrew li għandhom profil ta' kwalità komparabbli u li huma ekwivalenti għall-qawwiet korrispondenti ta' Symbicort Turbohaler.
English: Other information about Vylaer Spiromax
Maltese: Informazzjoni oħra dwar Vylaer Spiromax
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vylaer Spiromax on 19 November 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Vylaer Spiromax fid-19 ta' Novembru 2014.
English: Formoterol is a long-acting beta-2 agonist.
Maltese: Formoterol huwa agonista tal-beta-2 li jaħdem għal żmien twil.
English: This is a summary of the European public assessment report (EPAR) for Vylaer Spiromax.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vylaer Spiromax.
English: This means that it is similar to a ‘reference medicine' containing the same active substances, but Vylaer Spiromax is given using a different inhaler.
Maltese: Dan ifisser li huwa simili għall-‘mediċina ta' referenza' li fiha listess sustanzi attivi, iżda Vylaer Spiromax jingħata bl-użu ta' inalatur differenti.
English: Vylaer Spiromax is also used to relieve the symptoms of severe chronic obstructive pulmonary disease (COPD) in adults who have had exacerbations (flare-ups) of the disease in the past despite regular treatment.
Maltese: Vylaer Spiromax jintuża wkoll biex inaqqas is-sintomi ta' marda pulmonari ostruttiva kronika (COPD) severa fl-adulti li kellhom taħrix (aggravar) tal-marda fil-passat minkejja l-kura regolari.
English: Vylaer Spiromax is a medicine that contains the active substances budesonide and formoterol.
Maltese: Vylaer Spiromax huwa mediċina li fiha s-sustanzi attivi budesonide u formoterol.
English: Why is Vylaer Spiromax approved?
Maltese: Għaliex ġie approvat Vylaer Spiromax?
English: It can be used in patients whose disease is not adequately controlled by treatment with other asthma medicines called corticosteroids and ‘short-acting beta-2 agonists' taken by inhalation, or in patients whose disease is adequately controlled by treatment with corticosteroids and ‘long-acting beta-2 agonists' taken by inhalation.
Maltese: Dan jista' jintuża f'pazjenti li l-marda tagħhom ma tkunx qiegħda tiġi kkontrollata sew bil-kura b'mediċina oħra tal-ażma msejħa kortikosterojdi u “agonisti tal-beta-2 li jaħdmu għal żmien qasir” li jittieħdu man-nifs, jew f'pazjenti li lmarda tagħhom qiegħda tiġi kkontrollata sew bil-kura bil-kortikosterojdi u b'“agonisti tal-beta-2 li jaħdmu għal żmien qasir” li jittieħdu man-nifs.
English: Studies were carried out to show that Vylaer Spiromax is bioequivalent to the reference medicine (i.e. produces the same level of the active substance in the body) and that the two medicines act in the same way.
Maltese: Studji li twettqu juru li Vylaer Spiromax huwa bijoekwivalenti għall-mediċina ta' referenza (jiġifieri jipproduċi l-istess livell tas-sustanza attiva fil-ġisem) u li ż-żewġ mediċini jaġixxu bl-istess mod.
English: How does Vylaer Spiromax work?
Maltese: Kif jintuża Vylaer Spiromax?
English: Therefore, the CHMP's view was that, as for Symbicort Turbohaler, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Symbicort Turbohaler, il-benefiċċju huwa akbar mir-riskju identifikat.
English: What are the benefits and risks of Vylaer Spiromax?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Vylaer Spiromax?