FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the claimed differences of hypersensitivity reactions with Omniscan versus other GdCAs based on meta-analyses of available epidemiological data, PRAC considered these differences are too subtle to influence the benefit-risk balance, and that extremely large clinical trials would be necessary to confirm a statistical difference in frequency of hypersensitivity reactions.
Maltese: Fid-dawl tad-differenzi ddikjarati ta' reazzjonijiet ta' sensittività eċċessiva b'Omniscan kontra GdCAs oħra abbażi ta' metaanaliżijiet ta' data epidemjoloġika disponibbli, il-PRAC ikkunsidra li dawn iddifferenzi huma wisq sottili biex jinfluwenzaw il-bilanċ bejn il-benefiċċju u r-riskju, u li huma meħtieġa provi kliniċi kbar ħafna biex jikkonfermaw differenza statistika fil-frekwenza ta' reazzjonijiet ta' sensittività eċċessiva.
English: The CHMP, as a consequence, considers that the benefit-risk balance of medicinal products containing intravenous gadobutrol, gadoteric acid, gadoteridol, gadoxetic acid, intravenous gadobenic acid in the indication of liver imaging, intra-articular gadoteric acid and intra-articular gadopentetic acid remains favourable subject to amendments to the product information.
Maltese: Bħala konsegwenza, is-CHMP, jikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' prodotti mediċinali li fihom gadobutrol ġol-vini, gadoteric acid, gadoteridol, gadoxetic acid, gadobenic acid ġol-vini flindikazzjoni tal-immaġni tal-fwied, gadoteric acid intraartikulari u gadopentetic acid intraartikulari jibqa' favorevoli soġġett għal emendi li ntlaħaq qbil dwarhom fl-informazzjoni dwar il-prodott.
English: The clinical finding (e.g. Radbruch et al.) that macrocyclic agents do not cause brain T1 hyperintensity was replicated by other groups and can therefore be considered to be substantiated.
Maltese: Is-sejba klinika (eż. Radbruch et al.) li l-aġenti makroċikliċi ma jikkawżawx sensittività eċċessiva ta' T1 fil-moħħ ġiet replikata minn gruppi oħra u tista' għalhekk tiġi kkunsidrata li hija sostanzjata.
English: Detailed conclusions from the meeting can be found in the enclosure 11 to the PRAC assessment report.
Maltese: Konklużjonijiet dettaljati mil-laqgħa jistgħu jinstabu fid-dokument mehmuż 11 għar-rapport ta' valutazzjoni tal-PRAC.
English: These observations leave the possibility that the method used for the Gd determination is unreliable under certain circumstances.
Maltese: Dawn l-osservazzjonijiet iħallu l-possibbiltà li l-metodu użat għad-determinazzjoni tal-Gd mhuwiex affidabbli taħt ċerti kondizzjonijiet.
English: Overall summary of the scientific evaluation by the PRAC Background
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika mill-PRAC Sfond
English: For the suspension of intravenous medicinal products containing gadodiamide, gadopentetic acid, and gadoversetamide to be lifted, the marketing authorisation holder(s) shall submit evidence:
Maltese: Biex titneħħa s-sospensjoni ta' prodotti mediċinali ġol-vini li fihom gadodiamide, gadopentetic acid, u gadoversetamide, id-detentur(i) tal-awtorizzazzjoni għat-tqegħid fis-suq għandu/għandhom jippreżenta(w) evidenza:
English: Premedication with antihistamines and corticosteroids could also be applied.
Maltese: Il-premedikazzjoni b'antistamini u b'kortikosterojdi tista' tiġi applikata wkoll.
English: This summary was last updated on 18/09/2015.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 18/09/2015.
English: It is available in pumps of different sizes (6 ml, 11 ml and 33 ml) delivering appropriate amounts of meloxicam for dogs of different weights.
Maltese: Huwa disponibbli f'pompi ta' daqsijiet differenti (6 ml, 11 ml u 33 ml) li jipproduċu l-ammonti xierqa ta' meloxicam għal klieb ta' piżijiet differenti.
English: RevitaCAM is a medicine that contains the active substance meloxicam.
Maltese: RevitaCAM huwa mediċina li fiha s-sustanza attiva meloxikam.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RevitaCAM on 23/02/2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida għall-Unjoni Ewropea kollha għal RevitaCAM fi 23/02/2012.
English: RevitaCAM is similar to Metacam oral solution containing the same active substance, but given in a different way, as an oromucosal spray.
Maltese: RevitaCAM huwa simili għas soluzzjoni orali ta' Metacam u fih l-istess sustanza attiva, li iżda tingħata b'mod differenti, permezz ta' sprej oromukosali.
English: If you want more information on the basis of the CVMP recommendations, read the scientific discussion (also part of the EPAR).
Maltese: Jekk tixtieq iktar informazzjoni relatata mar-rakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ benefiċċjuriskju jinstab fil-modulu 6 ta' dan l-EPAR.
English: Why has RevitaCAM been approved?
Maltese: Għaliex ġie approvat RevitaCAM?
English: Side effects sometimes seen with other NSAIDs, such as loss of appetite, vomiting, diarrhoea, blood appearing in the stools, renal (kidney) failure and apathy (lack of vitality) are occasionally seen with RevitaCAM.
Maltese: L-effetti sekondarji li kultant jidhru f'NSAIDs oħra, bħat-telf ta' aptit, rimetter, dijarrea, demm fil-feċi, insuffiċjenza renali (insuffiċjenza tal-kliewi) u apatija (nuqqas ta' vitalità) kultant jimmanifestaw ruħhom b'RevitaCAM ukoll.
English: It is available as a 5 mg/ml oromucosal spray (a spray administered to the back of the mouth, towards the gums and /or inner cheek) for dogs.
Maltese: Jiġi bħala sprej 5 mg/ml oromukosali (sprej amministrat fuq wara tal-ħalq, immirat lejn il-ħanek u/jew il-parti ta' ġewwa tal-ħaddejn) għallklieb.
English: Other information about RevitaCAM:
Maltese: Aktar tagħrif dwar RevitaCAM:
English: What is RevitaCAM?
Maltese: X'inhu RevitaCAM?
English: Treatment should be started at a single dose of 0.2 mg/kg body weight on the first day, and then continued at a maintenance dose of 0.1 mg/kg body weight once a day.
Maltese: Il-kura għandha tinbeda bħala doża singola ta' 0.2 mg/kg tal-piż korporju fl-ewwel jum, imbagħad titkompla doża ta' manteniment ta' 0.1 mg/kg tal-piż korporju darba kuljum.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku meloxikam
English: The CVMP considered that, in accordance with European Union requirements, RevitaCAM has been shown to be bioequivalent to Metacam.
Maltese: Is-CVMP ikkunsidra li, b'konformità mar-rekwiżiti tal-Unjoni Ewropea, RevitaCAM kien jidher bħala bijoekwivalenti għal Metacam.
English: RevitaCAM contains meloxicam, which belongs to a class of medicines called non-steroidal antiinflammatory drugs (NSAIDs).
Maltese: RevitaCAM fih il-meloxikam, li tagħmel parti minn klassi ta' mediċini msejħa mediċini antinfjammatorji mhux sterojdi (NSAIDs). Meloxicam taġixxi billi timblokka enzima msejħa ċiklo-ossiġenażi li hija involuta fil-produzzjoni tal-prostaglandina.
English: Studies provided for RevitaCAM were tests to determine that it is bioequivalent to the reference medicine, Metacam.
Maltese: L-istudji li saru fuq RevitaCAM kienu testijiet biex jiddeterminaw il-bijoekwivalenz tiegħu ma' Metacam, mediċina ta' referenza.
English: These generally occur within the first week of treatment and usually disappear once treatment has stopped.
Maltese: Normalment ikun hemm rispons wara bejn tlieta u erbat ijiem.
English: What is the risk associated with RevitaCAM?
Maltese: X'inhu r-riskju assoċjat ma' RevitaCAM?
English: How has RevitaCAM been studied?
Maltese: Kif ġie studjat RevitaCAM?
English: In very rare cases they may be serious or fatal.
Maltese: F'każijiet rari ħafna, jistgħu jkunu gravi jew fatali.
English: Consequently, RevitaCAM's benefit is taken as being the same as that of the reference medicine.
Maltese: Għaldaqstant, il-benefiċċju ta' RevitaCAM jitqies li huwa l-istess bħal dak tal-mediċina ta' referenza.
English: As prostaglandins trigger inflammation, pain, exudation and fever, meloxicam reduces these signs and symptoms.
Maltese: Peress li l-prostaglandini jikkawżaw l-infjamazzjoni, l-uġigħ, il-ħruġ ta' għaraq u d-deni, il-meloxikam tnaqqas dawn is-sinjali u s-sintomi.
English: Various studies looked at how RevitaCAM was absorbed and its effects in the body, in comparison with Metacam.
Maltese: Diversi studji ffukaw fuq kif RevitaCAM ġie assorbit u l-effetti tiegħu fil-ġisem, meta mqabbla ma' Metacam.
English: People who are hypersensitive to NSAIDs should avoid contact with RevitaCAM.
Maltese: Il-persuni li huma ipersensittivi għall-NSAIDs għandhom jevitaw il-kuntatt ma' RevitaCAM.
English: Meloxicam acts by blocking an enzyme called cyclo-oxygenase which is involved in the production of prostaglandins.
Maltese: Għal kura aktar fit-tul, Id-doża tista' titnaqqas għal-livell tal-aktar doża baxxa effettiva ġaladarba jkun deher rispons.
English: Therefore the CVMP's view was that, as for Metacam, RevitaCAM's benefits are greater than its risks when used for the approved indications and the
Maltese: Għaldaqstant il-fehma tas-CVMP kienet li, l-istess bħal Metacam, ilbenefiċċji ta' RevitaCAM huma akbar mir-riskji tiegħu meta jintuża għall-indikazzjonijiet approvati u lKumitat irrakkomanda li RevitaCAM jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: If accidental exposure occurs, hands should be washed immediately with soap and water.
Maltese: Jekk ikun hemm esponiment aċċidentali, il-persuna għandha taħsel idejha minnufih bis-sapun u bl-ilma.
English: What is RevitaCAM used for?
Maltese: Għal xiex jintuża RevitaCAM?
English: London, 23 October 2008 EMEA/438258/2008
Maltese: Londra, 23 ta' Ottubru 2008 EMEA/CHMP/619562/2008
English: Etoricoxib is a selective inhibitor of COX-2 (cyclooxygenase 2) indicated in the symptomatic relief of osteoarthritis (OA, 30-60mg once daily (od)), rheumatoid arthritis (RA, 90mg od) and the pain and signs of inflammation associated with acute gouty arthritis (120mg od).
Maltese: Etoricoxib huwa inibitur selettiv ta' COX-2 (ċiklossiġenażi 2) indikat fit-taffija tas-sintomi ta' osteoartrite (OA, 30-60 mg darba kuljum (od)), artrite rewmatojde (RA, 90 mg od) u l-uġigħ u s-sinjali ta' infjammazzjoni assoċjati ma' artrite gottuża akuta (120 mg od).
English: COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) OPINION FOLLOWING AN ARTICLE 6 (12) REFERRAL Arcoxia International non-proprietary name (INN): etoricoxib BACKGROUND INFORMATION *
Maltese: GĦALL-UŻU MILL-BNIEDEM (CHMP) OPINJONI WARA REFERENZA GĦALL-ARTIKOLU 6(12) Arcoxia Denominazzjoni Komuni Internazzjonali (DKI): etoricoxib INFORMAZZJONI ĠENERALI*
English: Written explanations were provided by the MAHs on 14 December 2008, 5 May 2008, 12 June 2008 and 20 June 2008.
Maltese: L-MAHs taw spjegazzjonijiet bil-miktub fl-14 ta' Diċembru 2007, fil-5 ta' Mejju 2008, fit12 ta' Ġunju 2008 u fl-20 ta' Ġunju 2008.
English: The CHMP concluded that the data confirmed the known renovascular safety profile of etoricoxib (hypertension, oedema and congestive heart failure).
Maltese: Is-CHMP ikkonkluda li d-dejta kienet tikkonferma l-profil ta' sigurtà renovaskulari magħruf ta' etoricoxib (ipertensjoni, edema u insuffiċjenza kardijaka konġestiva).
English: The referral procedure was initiated on 20 September 2007 with the adoption of a CHMP list of questions that were to be addressed by the marketing authorisation holders (MAHs).
Maltese: Il-proċedura ta' referenza nbdiet fl-20 ta' Settembru 2007 bl-adozzjoni ta' lista ta' mistoqsijiet tas-CHMP li kellhom jiġu ndirizzati mid-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq (MAHs).
English: The main unresolved areas of concern identified by France were concerns regarding long term safety of a daily dose of 90mg etoricoxib in the view of possible increased cardiovascular (CV) risk related to the use of the 90mg dose in the ankylosing spondylitis (AS) indication.
Maltese: L-oqsma ewlenin ta' tħassib li ma ġewx riżolti identifikati minn Franza kienu jinkludu tħassib rigward sigurtà għal tul ta' żmien twil ta' doża ta' 90 mg etoricoxib meħuda kuljum rigward il-possibbiltà ta' żieda fir-riskju kardjovaskulari (CV) relatat mal-użu ta' doża ta' 90 mg fl-indikazzjoni ta' spondilite ankilosanti (AS).
English: The data further confirmed a similar CV thrombotic risk like diclofenac and some degree of upper gastrointestinal (GI) safety advantage over naproxen and diclofenac (though no particular lower GI safety advantage).
Maltese: Id-dejta kompliet tikkonferma riskju trombotiku CV simili għal diclofenac u ċertu livell ta' sigurtà tal-passaġġ gastrointestinali (GI) ta' fuq meta mqabbel ma' naproxen u diclofenac (minkejja li ma kien jidher l-ebda livell iktar baxx ta' vantaġġ ta' sigurtà GI).
English: At the end of the mutual recognition procedure, there was a discrepancy between different European Union (EU) Member States regarding the safety of etoricoxib at the 90mg dose in the new proposed indication.
Maltese: Fi tmiem il-proċedura ta' rikonoxximent reċiproku, diversi Stati Membri tal-Unjoni Ewropea (UE) ma qablux rigward is-sigurtà ta' etoricoxib fid-doża ta' 90 mg fl-indikazzjoni l-ġdida proposta.
English: During the February 2008 plenary meeting Dr. Rafe Survana was appointed Co-Rapporteur, replacing Dr. Matthew Thatcher.
Maltese: Rafe Survana nħatar bħala Korelatur, biex jieħu post id-Dott.
English: As these concerns were not resolved during the course of the procedure, a notification of an official referral for arbitration under Article 6(12) of Commission Regulation EC No 1084/2003 to the CHMP was made by France on 19 September 2007.
Maltese: Peress li dan it-tħassib ma ġiex riżolt tul il-proċedura, Franza għamlet notifika ta' referenza ta' arbitraġġ uffiċjali skont l-Artikolu 6(12) tar-Regolament tal-Kummissjoni KE Nru 1084/2003 lis-CHMP fid19 ta' Settembru 2007.
English: France considered that a review of the benefit/risk profile of Arcoxia was needed.
Maltese: Franza kienet tal-fehma li kienet meħtieġa reviżjoni tal-profil bejn il-benefiċċji u rriskji ta' Arcoxia.
English: ∗ Notes: the information given in this document and its annexes reflects only the CHMP opinion dated 26 June 2008.
Maltese: ∗ Noti: it-tagħrif mogħti f'dan id-dokument u l-annessi tiegħu jirrifletti biss l-opinjoni tas-CHMP datata s-26 ta' Ġunju 2008.
English: Based on the review of the available data, the CHMP considered that the benefits of etoricoxib outweigh the risks in the treatment of ankylosing spondylitis.
Maltese: Abbażi tar-reviżjoni tad-dejta disponibbli, is-CHMP ikkunsidra li l-benefiċċji ta' etoricoxib huma akbar mir-riskji tiegħu fit-trattament tal-ispondilite ankilosanti.
English: The arbitration procedure was discussed by the CHMP at its plenary meeting in September 2007 and a Rapporteur (Dr. Karl Broich) and Co-Rapporteur (Dr. Matthew Thatcher) were appointed.
Maltese: Karl Broich) u Korelatur (Dott. Matthew Thatcher).
English: Data from clinical studies showed clinically meaningful treatment effect for the 90mg etoricoxib once daily dose for AS indication; however, some data are available to indicate that lower doses might also show effect.
Maltese: Id-dejta minn studji kliniċi wrew effett tat-trattament klinikament sinifikanti għad-doża ta' 90 mg etoricoxib meħuda darba kuljum għall-indikazzjoni AS.
English: This referral procedure relates to a request for arbitration concerning a type II variation for a new indication to include treatment of ankylosing spondylitis (AS), at a recommended daily dose of 90mg.
Maltese: Din il-proċedura ta' referenza tirrigwarda talba għal arbitraġġ dwar varjazzjoni tat-tip II sabiex indikazzjoni ġdida tkun tinkludi trattament ta' spondilite ankilosanti (AS), f'doża rakkomandata ta' 90 mg.
English: There was little direct comparative safety data for individual non-steroidal anti-inflammatory drugs (NSAIDs) other than diclofenac and naproxen.
Maltese: Kien hemm ftit dejta dwar is-sigurtà li setgħet titqabbel direttament għal mediċini antinfjammatorji mhux sterojdali individwali (NSAID) minbarra diclofenac u naproxen.
English: Healthcare professionals were to be reminded of these measures through a communication letter (Dear Healthcare Professional Letter).
Maltese: Il-professjonisti fil-qasam tas-saħħa għandhom jiġu mfakkra f'dawn il-miżuri permezz ta' ittra ta' komunikazzjoni (Dear Healthcare Professional Letter).
English: On 26 June 2008, the CHMP, having considered the data provided by the MAHs, recommended the granting of the variation to the marketing authorisations.
Maltese: Fis-26 ta' Ġunju 2008, is-CHMP, wara li kien ikkunsidra d-dejta pprovduta mill-MAHs, irrakkomanda l-għoti ta' varjazzjoni għall-awtorizzazzjonijiet għat-tqegħid fis-suq.
English: Drug utilisation data showed that some patients with high blood pressure are being initiated on etoricoxib.
Maltese: Id-dejta dwar l-użu tal-mediċini wriet li ċerti pazjenti li jbatu minn pressjoni tad-demm għolja qegħdin jibdew jieħdu etoricoxib.
English: Empagliflozin / linagliptin
Maltese: Empagliflozin / linagliptina
English: The full EPAR for Glyxambi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • Linagliptin is a dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: • Il-linagliptina hija inibitur ta' dipeptidyl-peptidase-4 (DPP-4).
English: This is a summary of the European public assessment report (EPAR) for Glyxambi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Glyxambi.
English: • Empagliflozin works by blocking a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: • L-empagliflozin taħdem billi timblokka proteina fil-kliewi msejħa kotrasportatur 2 ta' sodju-glukożju (SGLT2 - sodium-glucose co-transporter 2).
English: Adding linagliptin to treatment with empagliflozin and metformin for 24 weeks reduced HbA1c levels from 7.8% to 7.2%, compared with a reduction from 7.9% to 7.7% when placebo was added.
Maltese: Iż-żieda tal-linagliptina mal-kura b'empagliflozin u metformina għal 24 ġimgħa naqqset il-livelli ta' HbA1c minn 7.8 % għal 7.2 %, meta mqabbla mattnaqqis minn 7.9 % għal 7.7 % meta ġie miżjud il-plaċebo.
English: The most serious side effects are ketoacidosis (high blood levels of acids called ‘ketoacids'), pancreatitis (inflammation of the pancreas), hypersensitivity (allergic reactions) and hypoglycaemia (low blood sugar levels).
Maltese: L-effetti sekondarji l-aktar serji huma l-ketoaċidożi (livelli għoljin ta' aċidi fid-demm imsejin 'ketoaċidi'), il-pankreatite (infjammazzjoni tal-frixa), ipersensittività (reazzjonijiet allerġiċi) u l-ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: Empagliflozin in combination with linagliptin (the same combination as in Glyxambi) was evaluated in 3 main studies involving 1,221 adults with type 2 diabetes.
Maltese: L-empagliflozin f'kombinazzjoni mal-linagliptina (l-istess kombinazzjoni bħal fi Glyxambi) ġie evalwat fi 3 studji prinċipali li involvew 1,221 adult b'dijabete tat-tip 2.
English: Why is Glyxambi approved?
Maltese: Għaliex ġie approvat Glyxambi?
English: The most common side effects with Glyxambi (which may affect more than 7 in 100 people) are urinary infections.
Maltese: L-effetti sekondarji l-aktar komuni bi Glyxambi (li jistgħu jaffettwaw aktar minn 7 minn kull 100 persuna) huma infezzjonijiet urinarji.
English: Glyxambi is used in the following groups:
Maltese: Glyxambi jintuża fil-gruppi li ġejjin:
English: After 24 weeks treatment the fixed dose combination reduced HbA1c levels to under 6.9% whereas they were around 7.3% with empagliflozin and linagliptin used alone.
Maltese: Wara 24 ġimgħa ta' kura, il-kombinazzjoni ta' doża fissa naqqset il-livelli ta' HbA1c għal taħt 6.9 % filwaqt li dawn kienu madwar 7.3 % b'empagliflozin u linagliptina użati waħedhom.
English: It contains two active substances, empagliflozin and linagliptin.
Maltese: Fih żewġ sustanzi attivi, empagliflozin u linagliptina.
English: • patients whose blood glucose levels are not controlled well enough by a combination of one of Glyxambi's active substances (empagliflozin or linagliptin) with other diabetes medicines (metformin and/or a sulphonylurea);
Maltese: • pazjenti li l-livelli tal-glukożju fid-demm tagħhom mhumiex ikkontrollati tajjeb biżżejjed millkombinazzjoni ta' waħda mis-sustanzi attivi ta' Glyxambi (l-empagliflozin jew il-linagliptina) ma' mediċini oħrajn ta' kontra d-dijabete (metformina u/jew xi sulfonilurea);
English: • patients who are already taking empagliflozin and linagliptin as separate tablets.
Maltese: • pazjenti li diġà qegħdin jieħdu l-empagliflozin u l-linagliptin bħala pilloli separati.
English: The two active substances in Glyxambi work in different ways to lower glucose levels:
Maltese: Iż-żewġ sustanzi attivi f'Glyxambi jaħdmu b'modi differenti biex ibaxxu l-livelli tal-glukożju:
English: Regarding its safety profile, Glyxambi was well tolerated with side effects being characteristic of SGLT2 and DDP-4 inhibitors.
Maltese: Fir-rigward tal-profil tas-sigurtà tiegħu, Glyxambi ġie ttollerat sew b'effetti sekondarji li jkunu karatteristiċi ta' inibituri ta' SGLT2 u DDP-4.
English: The HbA1c levels were around 8% before treatment.
Maltese: Il-livelli ta' HbA1c kienu madwar 8 % qabel il-kura.
English: Results showed that when empagliflozin was added to linagliptin and metformin, HbA1c levels decreased by 0.7-0.8 percentage points after 24 weeks, compared with no reduction when placebo was added.
Maltese: Ir-riżultati wrew li meta l-empagliflozin żdied mal-linagliptina u l-metformina, il-livelli ta' HbA1c naqqsu b'0.7-0.8 punti perċentwali wara 24 ġimgħa, meta mqabbla mal-ebda tnaqqis meta żdied il-plaċebo.
English: What are the risks associated with Glyxambi?
Maltese: X'inhuma r-riskji assoċjati ma' Glyxambi?
English: Other information about Glyxambi
Maltese: Kif jintuża Glyxambi?
English: A further study compared a fixed dose combination of empagliflozin and linagliptin (given in addition to metformin) with treatment with metformin plus either empagliflozin or linagliptin in patients who were not sufficiently controlled with metformin alone.
Maltese: Studju ieħor qabbel kombinazzjoni ta' doża fissa ta' empagliflozin u linagliptina (mogħtija flimkien ma' metformina) mal-kura b'metformina flimkien ma' empagliflozin jew ma' linagliptina f'pazjenti li ma kinux ikkontrollati biżżejjed b'metformina waħdu.
English: The CHMP considered that Glyxambi is effective at controlling blood glucose levels, with both components contributing to the effect.
Maltese: Is-CHMP qies li Glyxambi huwa effettiv biex jikkontrolla l-livelli ta' glukożju fid-demm, biż-żewġ komponenti li jikkontribwixxu għall-effett.
English: HbA1c levels were just below 8% at the start of the study.
Maltese: Fil-bidu tal-istudju, il-livelli ta' HbA1c kienu ftit inqas minn 8 %.
English: If Glyxambi is used in combination with insulin or a sulphonylurea, their doses may need to be reduced to decrease the risk of hypoglycaemia (low blood sugar levels).
Maltese: Jekk Glyxambi jintuża f'kombinazzjoni mal-insulina jew xi sulfonilurea, jista' jkun hemm bżonn li d-dożi tagħhom jitnaqqsu sabiex inaqqsu r-riskju ta' ipogliċemija (livelli baxxi ta' zokkor fid-demm).
English: By prolonging the action of incretin hormones in the blood, linagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Maltese: Billi ttawwal l-azzjoni tal-ormoni inkretini fid-demm, il-linagliptina tistimula lfrixa biex tipproduċi aktar insulina meta l-livelli ta' glukożju fid-demm ikunu għoljin.
English: Glyxambi is available as tablets containing 10 or 25 mg of empagliflozin with 5 mg of linagliptin, and can only be obtained with a prescription.
Maltese: Glyxambi jiġi bħala pilloli li fihom 10 jew 25 mg ta' empagliflozin b'5 mg ta' linagliptina, u jista' jinkiseb biss b'riċetta ta' tabib.