FrancophonIA/ELRC3.0 huggingface dataset:
English: Optional titration of the respective study drug doses to the next highest weight-based dose level was available by doubling the dose with each of the two allowed dose titrations, up to 600 mg (highest studied dose in adults) for aliskiren and 40 mg for enalapril in the ≥80 to ≤150 kg weight group, if medically necessary to control the mean sitting systolic blood pressure (i.e. msSBP should be less than the 90th percentile for age, gender and height).
Maltese: Titrazzjoni mhux obbligatorja tad-dożi tal-mediċina tal-istudju rispettivi sal-ogħla livell tad-doża bbażat fuq il-piż li jmiss kienet disponibbli permezz tal-irduppjar tad-doża ma' kull żewġ titrazzjonijiet tad-doża permessi, sa 600 mg (l-ogħla doża studjata fl-adulti) għal aliskiren u 40 mg għal enalapril fil-grupp tal-piż ta' ≥80 sa ≤150 kg jekk medikament neċessarju biex tkun ikkontrollata il-pressjoni sistolika tad-demm medja meta wieħed ikun bilqiegħda (jiġifieri, msSBP għandha tkun inqas mid-90 perċentil għall-età, sess tal-persuna u tul).
English: The incidence of adverse events tended to be higher in patients with diabetes, or with GFR <60 ml/min/1.73 m², or with age ≥ 65 years; however, there was no difference between patients treated with aliskiren and those treated with enalapril.
Maltese: Kien hemm tendenza li l-inċidenza ta' episodji avversi jkunu ogħla fost pazjenti bid-dijabete, jew b'GFR ta' <60 ml/min/1.73 m2, jew li għandhom ≥ 65 sena; madanakollu, ma kien hemm ebda differenza bejn pazjenti ttratati b'aliskiren u dawk ittrattati b'enalapril.
English: Anticholinergic agents and other medicinal products affecting gastric motility The bioavailability of thiazide-type diuretics may be increased by anticholinergic agents (e.g. atropine, biperiden), apparently due to a decrease in gastrointestinal motility and the stomach emptying rate.
Maltese: Sustanzi antikolinerġiċi u prodotti mediċinali oħrajn li jaffettwaw il-motilità gastrika Il-bijodisponibbiltà ta' dijuretiċi tat-tip thiazide tista' tiżdied b'sustanzi antikolinerġiċi (eż. atropina, biperiden), mid-dehra minħabba tnaqqis fil-moviment gastrointestinali spontanju u r-rata ta' tbattil talistonku.
English: Hypotensionc,a
Maltese: Pressjoni baxxac,a
English: • Skin rash (this may also be a sign of allergic reactions or angioedema - see “Rare” side effects below)
Maltese: • Raxx tal-ġilda (dan jista' jkun sinjali ta' reazzjonijiet allerġiċi jew anġjoedima - ara l-effetti sekondarji “Rari” hawn taħt)
English: If hypokalaemia develops during hydrochlorothiazide therapy Rasilez HCT should be discontinued until stable correction of the potassium balance.
Maltese: Jekk l-ipokalimja tiżviluppa waqt it-terapija b'hydrochlorothiazide Rasilez HCT għandu jitwaqqaf sakemm ikun hemm stabilità korretta fil- bilanċ tal-potassju.
English: Aliskiren has been evaluated for safety in a randomised, double-blind, 8-week study in 267 hypertensive patients aged 6 to 17 years, mostly overweight/obese, followed by an extension study including 208 patients treated for 52 weeks.
Maltese: Aliskiren kien evalwat għas-sigurtà fi studju randomised, double-blind, ta' 8 ġimgħat fuq 267 pazjent bi pressjoni għolja b'età minn 6 snin sa 17-il sena, il-biċċa l-kbira b'piż żejjed/ħoxnin ħafna, segwit minn studju ta' estensjoni li kien jinkludi 208 pazjenti ttrattati għal 52 ġimgħa.
English: Rasilez HCT 300 mg/25 mg may be administered in patients whose blood pressure is not adequately controlled with aliskiren 300 mg or hydrochlorothiazide 25 mg alone or by Rasilez HCT 300 mg/12.5 mg or Rasilez HCT 150 mg/25 mg.
Maltese: Rasilez HCT 300 mg/25 mg jista' jingħata lil pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata kif jixraq b'aliskiren 300 mg jew hydrochlorothiazide 25 mg waħedhom jew b'Rasilez HCT 300 mg/12.5 mg jew Rasilez HCT 150 mg/25 mg.
English: Aliskiren should be used with caution in patients with heart failure treated with furosemide or torasemide (see section 4.5).
Maltese: Madanakollu, l-użu ta' aliskiren mhuwiex irrakkomandat f'pazjenti b'indeboliment talkliewi qawwi (ara sezzjoni 4.4).
English: Pale yellow, biconvex, ovaloid film-coated tablet imprinted with “CLL” on one side and “NVR” on the other.
Maltese: Pillola ta' lewn isfar ċar, konvessa miż-żewġ naħat, b'għamla ovali miksija b'rita stampata b'“CVV” fuq naħa u “NVR” fuq in-naħa l-oħra.
English: PHARMACEUTICAL FORM AND CONTENTS 14 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 14-il pillola miksija b'rita.
English: Other antihypertensive medicinal products
Maltese: IL-PRODOTT MEDIĊINALI
English: Hypokalaemia may result in muscle spasms and/or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain antiarrhythmic medicinal products.
Maltese: Ipokalimja tista' twassal għall spażmi tal-muskoli u/jew arritmiji kardijaċi aktar evidenti assoċjati mal-użu fl-istess ħin ta' digitalis glycosides jew ċerti prodotti mediċinali kontra l-arritmiji.
English: How to store Rasilez HCT
Maltese: Għalxiex jintuża Rasilez HCT
English: Coadministration of thiazide diuretics, including hydrochlorothiazide, may increase the incidence of hypersensitivity reactions to allopurinol.
Maltese: L-għoti flimkien ta' dijuretiċi thiazide, inkluż hydrochlorthiazide, jista' jżid l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal allopurinol.
English: The starting doses for enalapril were 2.5/5/10 mg in the low, mid and high weight groups, respectively.
Maltese: Id-dożi tal-bidu għal enalapril kienu ta' 2.5/5/10 mg fil-gruppi ta' piż baxx, tannofs u għoli, rispettivament.
English: In an 8-week randomised, double-blind study with aliskiren monotherapy in 267 paediatric hypertensive patients aged 6 to 17 years, mostly overweight/obese, fasting trough aliskiren concentrations at day 28 were comparable to those observed in other studies in both adults and children using similar aliskiren doses.
Maltese: Fi studju ta' 8 ġimgħat randomised, double-blind b'aliskiren bħala monoterapija f'267 pazjent pedjatriku bi pressjoni għolja ta' età minn 6 snin sa 17-il sena, il-biċċa l-kbira b'piż żejjed/ħoxnin ħafna, il-konċentrazzjonijiet l-aktar baxxi fi stat sajjem ta' aliskiren f'jum 28 kienu komparabbli ma' dawk osservati fi studji oħra kemm f'adulti kif ukoll fi tfal bl-użu ta' dożi simili ta' aliskiren (ara sezzjoni 5.1).
English: - if you have diabetes or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: - an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or - an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Maltese: - jekk għandek id-dijabete jew funzjoni indebolita tal-kliewi u qed tiġi kkurat b'xi waħda minn dawn iż-żewġ klassijiet ta' mediċini li ġejjin li jintużaw għal kura ta' pressjoni tad-demm għolja: - inibitur tal-enzima li tikkonverti angiotensin bħal enalapril, lisinopril, ramipril jew - imblokkatur tar-riċetturi ta' angiotensin II bħal valsartan, telmisartan, irbesartan. - jekk il-pazjent ikollu età ta' inqas minn sentejn.
English: This decrease is likely due to an inhibition of organic anion transporting polypeptide-mediated uptake of aliskiren by components of fruit juice in the gastrointestinal tract.
Maltese: Dan it-tnaqqis x'aktarx jiġri minħabba l-inibizzjoni, medjata minn polipeptajd organiku li jittrasporta l-anjoni, tal-assorbiment ta' aliskiren permezz ta' komponenti tal-meraq tal-frott mill-passaġġ gastrointestinali.
English: Antidiabetic agents (e.g. insulin and oral antidiabetic agents) Thiazides may alter glucose tolerance.
Maltese: Aġenti antidijabetiċi (eż. insulina u sustanzi antidijabetiċi mill-ħalq) It-thiazides jistgħu jbiddlu t-tolleranza għaz-zokkor.
English: Over the 12 week period, aliskiren monotherapy lowered systolic/diastolic blood pressure by 14.0/5.1 mmHg, compared to 11.6/3.6 mmHg for ramipril, consistent with aliskiren being non-inferior to ramipril at the doses chosen and the differences in systolic and diastolic blood pressure were statistically significant.
Maltese: 6/3.6 mmHg għal ramipril, konsistenti b'aliskiren li mhuwiex inferjuri għal ramipril bid-dożi magħżula u d-differenzi fil-pressjoni sistolika u dijastolika tad-demm kienu sinjifikanti statistikament.
English: − The concomitant use of Rasilez HCT with an angiotensin converting enzyme inhibitors (ACEI)
Maltese: − L-użu fl-istess ħin ta' Rasilez HCT ma' inibituri tal-enzimi li jikkonvertu l-enzimi (angiotensin converting enzyme inhibitors, ACEI) jew imblukkaturi tar-riċetturi ta' angiotensin II
English: Respiratory, thoracic and mediastinal disorders Uncommon
Maltese: Disturbi respiratorji, toraċiċi u medjastinali Mhux komuni
English: • Rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions)
Maltese: • Raxx, ħakk, ħobbejż, diffikultà biex tieħu n-nifs jew biex tibla', sturdament (reazzjonijiet ta'
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy Special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Maltese: Stenożi tal-valv tal-aorta u mitrali, kardjomijopatija ipertrofika ostruttiva
English: 0.6 ml (10 mg/ml) 1 pre-filled syringe with needle guard + 1 alcohol swab pre-filled injector (glass) 0.6 ml (10 mg/ml) 1 pre-filled injector + 1 alcohol swab
Maltese: 0.6 ml (10 mg/ml) 1 injettatur mimli għal-lest + 1 swab bl-alkoħol
English: Immediate Packaging Content (concentration)
Maltese: Kontenut (konċentrazzjon i)
English: Pack size pre-filled syringe (glass) with needle guard
Maltese: Daqs tal-pakkett siringa mimlija għal-lest (ħġieġ) bil-kappa tal-labra
English: Route of Administration
Maltese: Mnejn għandu Jingħata
English: This summary was last updated in 03-2009.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 03-2009.
English: It is available as white, oval tablets (75, 150 and 300 mg).
Maltese: Huwa disponibbli f'pilloli ovali bojod (75, 150 u 300 mg).
English: The European Commission granted a marketing authorisation valid throughout the EU for Irbesartan BMS to Bristol-Myers Squibb Pharma EEIG on 19 January 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Irbesartan BMS lil Bristol-Myers Squibb Pharma EEIG fid-19 ta' Jannar 2007.
English: Its use in combination with hydrochlorothiazide was also examined in 1,736 patients.
Maltese: L-użu tiegħu ġie eżaminat fil-kombinazzjoni mal-hydrochlorothiazide f'1,736 pazjent.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) IRBESARTAN BMS EPAR summary for the public
Maltese: RAPPORT PUBBLIKU EWROPEW TA' VALUTAZZJONI (EPAR) IRBESARTAN BMS Sommarju tal-EPAR għall-pubbliku
English: Irbesartan BMS is a medicine that contains the active substance irbesartan.
Maltese: Irbesartan BMS huwa mediċina li fiha s-sustanza attiva irbesartan.
English: When used with hydrochlorothiazide, the effects of the two medicines were additive.
Maltese: Meta użat mal-hydrochlorothiazide, l-effetti taż-żewġ mediċini kienu addittivi.
English: Irbesartan BMS was compared with placebo (a dummy treatment) in 712 patients and with other medicines for hypertension (atenolol, enalapril or amlodipine) in 823 patients.
Maltese: Irbesartan BMS tqabbel mal-plaċebo (trattament finta) f'712-il pazjent u ma' mediċini antipertensivi oħra (atenolol, enalapril jew amlodipina) fi 823 pazjent.
English: The most common side effects with Irbesartan BMS (seen in more than 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, fatigue (tiredness) and increases in blood creatine kinase levels (an enzyme found in muscles).
Maltese: L-effetti sekondarji l-aktar komuni b'Irbesartan BMS (li dehru f'bejn pazjent 1 u 10 minn 100) huma sturdament, nawżea (dardir) jew remettar, għeja kbira u żieda fil-livelli ta' kreatina kinażi fid-demm (creatine kinase, enzima li tinsab fil-muskoli).
English: In addition, more than 1 patient in 100 with type 2 diabetes and kidney disease has the following side effects: hyperkalaemia (high blood potassium levels), orthostatic dizziness (dizziness when standing up), orthostatic hypotension (low blood pressure when standing up) and musculoskeletal (joint) pain.
Maltese: Barra minn hekk, f'aktar minn pazjent wieħed minn 100 bid-dijabete tat-tip 2 u mard tal-kliewi kellhom dawn l-effetti sekondarji: iperkalemija (livelli għoljin ta' potassju fid-demm), sturdament ortostatiku (sturdament meta l-pazjent iqum bilwieqfa), ipotensjoni ortostatika (pressjoni tad-demm baxxa meta l-pazjent iqum bilwieqfa) kif ukoll uġigħ muskoloskeletriku (fil-ġogi).
English: What is Irbesartan BMS?
Maltese: X'inhu Irbesartan BMS?
English: In patients with hypertension and type 2 diabetes, Irbesartan BMS is added to other treatments for hypertension.
Maltese: Fil-pazjenti b'ipertensjoni u b'dijabete tat-tip 2, Irbesartan BMS jiżdied ma' trattamenti oħra għallipertensjoni.
English: In the second kidney disease study, Irbesartan BMS reduced the relative risk of a doubling of blood creatinine levels, needing a kidney transplant or dialysis, or death during the study by 20% in comparison with placebo.
Maltese: Fit-tieni studju dwar il-mard talkliewi, Irbesartan BMS naqqas b'20% meta mqabbel mal-plaċebo r-riskju (tnaqqis relattiv) ta' rduppjar tal-livelli ta' kreatinina fid-demm, tal-bżonn ta' trapjant ta' kilwa jew ta' dijaliżi, jew taż-żmien qabel ilmewt tal-pazjent matul l-istudju.
English: Irbesartan BMS is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Maltese: Irbesartan BMS mhux rakkomandat sabiex jintuża fi tfal ta' inqas minn 18il sena, minħabba nuqqas ta' tagħrif fuq is-sigurtà u l-effikaċja f'dan il-grupp tal-età.
English: Other information about Irbesartan BMS:
Maltese: Aktar tagħrif dwar Irbesartan BMS:
English: Why has Irbesartan BMS been approved?
Maltese: Għaliex ġie approvat Irbesartan BMS?
English: For the full list of all side effects reported with Irbesartan BMS, see the Package Leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Irbesartan BMS, ara lFuljett ta' Tagħrif.
English: The active substance in Irbesartan BMS, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Maltese: Is-sustanza attiva f'Irbesartan BMS, irbesartan, hija tip ta' 'antagonist tar-riċetturi tal-anġjotensina
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Irbesartan BMS's benefits are greater than its risks for the treatment of essential hypertension and of renal disease in patients with hypertension and type 2 diabetes mellitus.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Irbesartan BMS huma ogħla mir-riskji tiegħu għat-trattament tal-ipertensjoni essenzjali u tal-mard renali f'pazjenti li jbatu minn ipertensjoni u mid-dijabete mellitu tat-tip 2.
English: For the treatment of kidney disease, Irbesartan BMS was studied in two large studies involving a total of 2,326 patients with type 2 diabetes.
Maltese: Għat-trattament tal-mard tal-kliewi, Irbesartan BMS ġie eżaminat f'żewġ studji fuq skala kbira li involvew total ta' 2,326 pazjent bid-dijabete tat-tip 2, li damu sentejn jieħdu l-mediċina jew aktar.
English: What is the risk associated with Irbesartan BMS?
Maltese: X'inhuma r-riskji assoċjati ma' Irbesartan BMS?
English: How has Irbesartan BMS been studied?
Maltese: Kif ġie studjat Irbesartan BMS?
English: Irbesartan BMS is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Maltese: Irbesartan BMS jintuża wkoll għat-trattament tal-mard tal-kliewi f'pazjenti b'ipertensjoni u b'dijabete tat-tip 2 (dijabete li mhix dipendenti fuq l-insulina).
English: In the first kidney disease study, Irbesartan BMS was more effective than placebo at reducing the risk of developing kidney damage as measured by protein excretion.
Maltese: Fl-ewwel studju dwar il-mard tal-kliewi, Irbesartan BMS irriżulta aktar effikaċi mill-plaċebo biex inaqqas ir-riskju ta' ħsara tal-kliewi skont it-tneħħija tal-proteina.
English: In the blood pressure studies, Irbesartan BMS was more effective than placebo at reducing diastolic blood pressure and had similar effects to the other medicines for hypertension.
Maltese: Fl-istudji dwar il-pressjoni tad-demm, irriżulta li Irbesartan BMS kien aktar effikaċi mill-plaċebo biex inaqqas il-pressjoni tad-demm dijastolika u kellu effetti simili għall-mediċini antipertensivi oħra.
English: The Committee recommended that Irbesartan BMS be given marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Irbesartan BMS jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How is Irbesartan BMS used?
Maltese: Kif jaħdem Irbesartan BMS?
English: Irbesartan BMS was originally studied in 11 trials for its effects on blood pressure.
Maltese: Irbesartan BMS ġie għall-ewwel studjat fi 11-il prova li saru biex jivvalutaw l-effetti tiegħu fuq ilpressjoni tad-demm.
English: Commission Decision dates: 29/06/2016 (nationally authorised products), 24/06/2016 (Relvar Ellipta, Revinty Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol Teva, Vylaer Spiromax).
Maltese: Dati tad-Deċiżjoni tal-Kummissjoni: 29/06/2016 (prodotti awtorizzati b'mod nazzjonali), 24/06/2016 (Relvar Ellipta, Revinty Ellipta), 04/07/2016 (BiResp Spiromax, DuoResp Spiromax), 06/07/2016 (Budesonide/Formoterol Teva, Vylaer Spiromax).
English: In the EU, the available products include the active substances beclomethasone, budesonide, flunisolide, fluticasone furoate or fluticasone propionate.
Maltese: Fl-UE, il-prodotti disponibbli jinkludu s-sustanzi attivi beclomethasone, budesonide, flunisolide, fluticasone furoate jew fluticasone propionate.
English: Beclomethasone, budesonide, flunisolide, fluticasone propionate and fluticasone furoate are corticosteroids authorised and marketed as inhalation formulations for use in COPD.
Maltese: Beclomethasone, budesonide, flunisolide, fluticasone propionate u fluticasone furoate huma kortikosterojdi awtorizzati u mqegħda fis-suq bħala formulazzjonijiet ta' inalazzjoni għallużu f'COPD.
English: They are similar to natural hormones normally produced by the adrenal glands (two small glands located above the kidneys).
Maltese: Dawn huma simili għall-ormoni naturali normalment prodotti mill-glandoli adrenali (żewġ glandoli żgħar li jinsabu 'l fuq mill-kliewi).
English: The review was initiated at the request of the European Commission on 7 May 2015, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami nbeda fis-7 ta' Mejju 2015, fuq talba tal-Kummissjoni Ewropea, skont l-Artikolu 31 tadDirettiva 2001/83/KE.
English: On 28 April 2016 EMA completed a review of the known risk of pneumonia (lung infection) in patients who take inhaled corticosteroid medicines to treat chronic obstructive pulmonary disease (COPD).
Maltese: Fit-28 ta' April 2016, l-EMA lestiet rieżami tar-riskju magħruf tal-pulmonite (infezzjoni fil-pulmun) f'pazjenti li jieħdu mediċini kortikosterojdi li jittieħdu man-nifs biex jikkuraw il-marda pulmonari ostruttiva kronika (COPD).
English: The evidence did not confirm any differences in risk between products.
Maltese: L-evidenza ma kkonfermat l-ebda differenzi fir-riskju bejn il-prodotti.
English: No clinical trials directly examined the risk of pneumonia with ICS head to head, and only indirect comparison in metaanalyses/systematic reviews or from observational studies is available.
Maltese: L-ebda prova klinika ma eżaminat direttament ir-riskju ta' pulmonite b'ICS ras għal ras, u tqabbil indirett biss f'metaanaliżi/rieżamijiet sistematiċi jew minn studji ta' osservazzjoni huwa disponibbli.
English: Review finds no differences between products in risk of pneumonia
Maltese: Ir-rieżami ma sab l-ebda differenza bejn il-prodotti fir-riskju tal-pulmonite
English: The review confirmed the risk of pneumonia with these products, which has been known for many years, and that it is common (can affect between 1 and 10 COPD patients in 100 using these medicines).
Maltese: Ir-rieżami kkonferma r-riskju tal-pulmonite b'dawn il-prodotti, li kien ilu magħruf għal ħafna snin, u li huwa komuni (jista' jaffettwa bejn pazjent 1 u 10 li jbatu minn COPD minn kull 100 li jużaw dawn ilmediċini).
English: The CHMP's opinion was then sent to the European Commission, which issued a final legally-binding decision valid throughout the EU.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti valida fl-UE kollha.
English: Due to the variability in the clinical data and multiple uncertainties with study methodologies, this does not provide conclusive evidence for intra-class differences in the magnitude of risk.
Maltese: Minħabba lvarjabbiltà fid-data klinika u inċertezzi multipli b'metodoloġiji ta' studju, ma hemm l-ebda evidenza klinika konklussiva għal differenzi ġewwa l-klassi fid-daqs tar-riskju.
English: Corticosteroids, also known as steroids, are anti-inflammatory medicines used for a wide range of conditions.
Maltese: Il-kortikosterojdi, magħrufin ukoll bħala sterojdi, huma mediċini antiinfjammatorji użati għal firxa wiesgħa ta' kundizzjonijiet.
English: • EMA has reviewed the risk of pneumonia in COPD patients using corticosteroid inhalers and has concluded that this risk applies to all medicines of this class.
Maltese: • L-EMA rrieżaminat ir-riskju tal-pulmonite f'pazjenti li jbatu minn COPD li jużaw l-inalaturi korikosterojdi u kkonkludiet li r-riskju japplika għall-mediċini kollha ta' din il-klassi.
English: • The product information for all medicines of the class will be updated to reflect current knowledge about pneumonia risk.
Maltese: • L-informazzjoni tal-prodott għall-mediċini kollha tal-klassi sejra tiġi aġġornata biex tirrifletti lgħarfien attwali dwar ir-riskju għall-pulmonite.
English: There is no conclusive clinical evidence for intra-class differences in the magnitude of the risk among ICS products.
Maltese: Ir-rieżami ma sab l-ebda evidenza konklużiva tad-differenzi f'dan ir-riskju għal prodotti differenti.
English: • The Agency's review included published data from randomised controlled clinical trials and a number of meta-analyses, as well as observational studies.
Maltese: • Ir-rieżami tal-Aġenzija kien jinkludi data ppubblikata minn provi kliniċi kkontrollati u randomizzati u numru ta' metaanaliżi, kif ukoll studji ta' osservazzjoni.
English: The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which adopted the Agency's opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC intbagħtu lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), li adotta l-opinjoni finali tal-Aġenzija.
English: Corticosteroid-containing medicines have been authorised in the EU through both central and national approval procedures.
Maltese: Il-mediċini li fihom il-kortikosterojdi ġew awtorizzati fl-UE permezz ta' proċeduri ta' approvazzjoni kemm ċentrali kif ukoll nazzjonali.
English: • Healthcare professionals should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of such infections overlap with the symptoms of COPD exacerbations.
Maltese: • Il-professjonisti fil-qasam tal-kura tas-saħħa għandhom jibqgħu viġilanti għall-iżvilupp possibbli tal-pulmonite f'pazjenti li jbatu minn COPD peress li l-fatturi kliniċi ta' dawn l-infezzjonijiet jikkoinċidu mas-sintomi tal-aggravar ta' COPD.
English: • There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been demonstrated conclusively across all studies.
Maltese: • Hemm xi evidenza ta' riskju miżjud ta' pulmonite aktar ma tiżdied id-doża ta' sterodji, iżda dan ma ntweriex b'mod konklussiv tul l-istudji kollha.