FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Neuraceq, florbetaben (18F), is a type of medicine known as a radiopharmaceutical that emits low amounts of radiation and works by targeting and attaching to β-amyloid plaques in the brain.
Maltese: Is-sustanza attiva f'Neuraceq, florbetaben (18F), hija tip ta' mediċina msejħa radjofarmaċewtika li tarmi ammonti baxxi ta' radjazzjoni u taħdem billi timmira u teħel ma' plakek amilojde-β fil-moħħ.
English: Neuraceq is a solution for injection that contains the active substance florbetaben (18F); it is for diagnostic use only.
Maltese: Neuraceq huwa soluzzjoni għall-injezzjoni li fiha s-sustanza attiva florbetaben (18F); huwa għal użu djanjostiku biss.
English: If few or no β-amyloid plaques are seen in the PET scan (a negative scan), the patient is unlikely to have Alzheimer's disease.
Maltese: Jekk jidhru ftit plakek jew l-ebda plakek amilojde-β fil-PET skan (skan negattiv), il-pazjent mhuwiex probabbli li jkollu l-marda ta' Alzheimer.
English: Neuraceq delivers a very low amount of radiation with minimal risk of cancer or any hereditary abnormalities.
Maltese: Neuraceq iwassal ammont baxx ħafna ta' radjazzjoni b'riskju minimu ta' kanċer jew ta' xi abnormalitajiet ereditarji.
English: β-amyloid plaques are deposits sometimes present in the brain of people with memory problems caused by dementia (such as Alzheimer's disease, Lewy-body dementia and Parkinson's disease dementia) and also in the brain of some elderly people with no symptoms.
Maltese: Plakek amilojde-β huma depożiti li xi kultant ikunu preżenti fil-moħħ ta' persuni bi problemi fil-memorja kkawżati middimenzja (bħall-marda ta' Alzheimer, dimenzja b'Lewy-body u dimenzja fil-marda ta' Parkinson) u wkoll fil-moħħ ta' xi persuni anzjani li ma jkollhom l-ebda sintomi.
English: With regard to the safety profile of Neuraceq, this was considered reassuring, with the most common adverse events being related to injection site reactions.
Maltese: sigurtà ta' Neuraceq, dan kien meqjus rassiguranti, bl-aktar avvenimenti avversi komuni jkunu dawk relatati ma' reazzjonijiet fis-sit tal-injezzjoni.
English: What are the risks associated with Neuraceq?
Maltese: X'inhuma r-riskji assoċjati ma' Neuraceq?
English: The most common side effects with Neuraceq (which may affect up to 1 in 10 people) are pain, irritation and reddening of the skin at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni b'Neuraceq (li jistgħu jaffettwaw sa persuna 1 minn kull 10) huma wġigħ, irritazzjoni u ħmura tal-ġilda fis-sit tal-injezzjoni.
English: This means that the PET scans were able to correctly identify as positive 77.4% of the cases where patients had significant amounts of plaques, and that almost all patients without significant plaques were correctly rated as negative.
Maltese: Dan ifisser li l-PET skans kienu kapaċi jidentifikaw b'mod korrett bħala pożittiv 77.4% tal-każijiet fejn il-pazjenti kellhom ammonti sinifikanti ta' plakek, u li kważi l-pazjenti kollha li ma kellhomx plakek sinifikanti kienu korrettament klassifikati bħala negattivi.
English: For the full list of all side effects and restrictions with Neuraceq, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u restrizzjonijiet b'Neuraceq, ara l-fuljett ta' tagħrif.
English: There is however a risk of false positive results, and therefore Neuraceq should not be used as the sole diagnostic method for dementia, but in conjunction with clinical evaluation.
Maltese: Madanakollu hemm riskju ta' riżultati pożittivi li filfatt ikunu negattivi (false positive), u għalhekk Neuraceq m'għandux jintuża bħala l-uniku metodu biex tiġi djanjostikata d-dimenzja, iżda f'kombinazzjoni ma' valutazzjoni klinika.
English: A risk management plan has been developed to ensure that Neuraceq is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Neuraceq jintuża bl-aktar mod sigur possibbli.
English: PET scans with Neuraceq were shown to have high specificity and sensitivity when used for identifying patients with significant amounts of β-amyloid plaques in the brain.
Maltese: PET skans b'Neuraceq intwerew li kellhom speċifiċità u sensittività għolja meta ntużaw biex jidentifikaw pazjenti b'ammonti sinifikanti ta' plakek amilojde-β fil-moħħ.
English: After the image is obtained, it is read by physicians specially trained in interpreting PET scans with Neuraceq.
Maltese: Wara li tinkiseb l-immaġini, tinqara minn tobba mħarrġa apposta fl-interpretazzjoni ta' PET skans b'Neuraceq.
English: This is regarded as a significant improvement in the diagnosis of patients with memory problems who are being evaluated for Alzheimer's disease and other types of dementia.
Maltese: Dan huwa meqjus bħala titjib sinifikanti fid-dijanjosi ta' pazjenti bi problemi bil-memorja li qegħdin jiġu vvalutati għall-marda ta' Alzheimer u tipi oħra ta' dimenzja.
English: In addition, the usefulness of Neuraceq in predicting the development of Alzheimer's disease in patients with memory problems or in monitoring patients' response to treatment has not been established.
Maltese: Barra minn hekk, l-utilità ta' Neuraceq fittbassir tal-iżvilupp tal-marda ta' Alzheimer f'pazjenti bi problemi fil-memorja jew fil-monitoraġġ tarrispons tal-pazjenti għall-kura ma ġietx stabbilita.
English: Results from the main study demonstrated that PET scans with Neuraceq have high sensitivity and specificity for detecting β-amyloid plaques in the brain, with results of the scans closely reflecting what was seen at autopsy.
Maltese: Din id-dejta kienet ulterjorment appoġġjata mir-riżultati minn pazjenti addizzjonali vvalutati wara t-tmiem tal-istudju.
English: Neuraceq is used during brain scans in patients with memory problems so that doctors can see whether or not they have significant amounts of β‑amyloid plaques in the brain.
Maltese: Neuraceq jista' jinkiseb biss b'riċetta ta' tabib, u PET skans b'Neuraceq għandhom jintalbu biss minn tobba b'esperjenza fl-immaniġġjar ta' pazjenti b'mard bħall-marda ta' Alzheimer u dimenzji oħra.
English: How is Neuraceq used?
Maltese: Kif jintuża Neuraceq?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 ta' Jannar 2017
English: The full European Public Assessment Report for Xgeva 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: What is Xgeva?
Maltese: Kif jaħdem Xgeva?
English: The active substance in Xgeva, denosumab, is a monoclonal antibody, a protein that has been designed to recognise and attach to another protein called RANKL.
Maltese: Is-sustanza attiva f'Xgeva, id-denosumab, hija antikorp monoklonali, proteina li tfasslet biex tagħraf u teħel ma' proteina oħra msejħa RANKL.
English: What was Xgeva expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Xgeva?
English: On 13 January 2017, Amgen Europe BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for Xgeva to be used to treat hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer).
Maltese: Fit-13 ta' Jannar 2017, Amgen Europe BV għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni tagħha għal Xgeva biex jintuża fil-kura ta' iperkalċemija ta' tumur malinn (livelli għolja ta' kalċju fid-demm ikkawżat minn kanċer).
English: RANKL is involved in activating osteoclasts, the cells in the body that are involved in breaking down bone tissue.
Maltese: RANKL hi involuta fl-attivazzjoni tal-osteoklasti, iċ-ċelloli filġisem li huma involuti fit-tkissir tat-tessut tal-għadam.
English: The main measure of effectiveness was based on the number of patients who had a response to treatment, defined as having their blood calcium levels reduced to 2.9 mmol/l or lower within 10 days of the first dose.
Maltese: Il-kejl ewlieni tal-effikaċja kien ibbażat fuq in-numru ta' pazjenti li wieġbu għall-kura, ddefiniti bħala li għandhom il-livelli tal-kalċju fid-demm imnaqqsa għal 2.9 mmol/l jew inqas fi żmien 10 ijiem mill-ewwel doża.
English: The CHMP considered that there were several problems with the main study which did not allow the Committee to conclude on the effectiveness of Xgeva: the study did not compare Xgeva with any other treatments and only included a small number of patients; it was not certain whether the patients' condition had responded to bisphosphonates, as the patients' previous calcium levels were not available.
Maltese: Is-CHMP ikkunsidra li kien hemm diversi problemi bl-istudju ewlieni li ma ppermettewx lill-Kumitat jikkonkludi dwar l-effikaċja ta' Xgeva: l-istudju ma qabbilx lil Xgeva ma' xi kura oħra u inkluda biss numru żgħir ta' pazjenti; ma kienx ċert jekk il-kundizzjoni tal-pazjenti kinitx irrispondiet għallbisofosfonati, billi l-livelli tal-kalċju preċedenti tal-pazjenti ma kinux disponibbli.
English: It is used in patients who cannot be treated by surgery or in whom surgery would cause severe problems.
Maltese: Jintuża f'pazjenti li ma jistgħux jiġu kkurati permezz ta' kirurġija jew li fuqhom il-kirurġija tikkawża problemi severi.
English: Xgeva was also expected to be used to reduce hypercalcaemia of malignancy (high levels of calcium in the blood caused by cancer) that did not respond to previous treatment with medicines called bisphosphonates.
Maltese: Xgeva kien mistenni jintuża wkoll biex titnaqqas l-iperkalċemija ta' tumur malinn (livelli għoljin ta' kalċju fid-demm ikkawżati minn kanċer) li ma rrispondiex għal kura preċedenti b'mediċini msejħa bisfosfonati.
English: Xgeva is also used to treat a type of bone cancer called giant cell tumour of bone in adults and adolescents whose bones have fully developed.
Maltese: Xgeva jintuża wkoll biex jikkura tip ta' kanċer fl-għadam imsejjaħ tumur fl-għadam b'ċelluli ġganteski f'adulti u f'adolexxenti li l-għadam tagħhom ikunu żviluppaw kompletament.
English: The company presented the results of a study involving 33 patients with hypercalcaemia.
Maltese: Il-kumpanija ppreżentat ir-riżultati ta' studju li fih ħadu sehem 33 pazjent b'iperkalċemija.
English: Xgeva has been authorised since July 2011.
Maltese: Xgeva ilu awtorizzat minn Lulju 2011.
English: These complications include fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), or complications requiring radiotherapy (treatment with radiation) or surgery.
Maltese: Dawn il-kumplikazzjonijiet jinkludu fratturi (ksur fl-għadam), kompressjoni tal-ispina dorsali (meta l-ispina dorsali tiġi kkompressata mill-għadam), jew kumplikazzjonijiet li jeħtieġu r-radjuterapija (kura bir-radjazzjoni) jew kirurġija.
English: Based on the review of the data, at the time of the withdrawal the CHMP had some concerns and was of the provisional opinion that Xgeva could not have been approved for the treatment of hypercalcaemia caused by cancer and which did not respond to treatment with bisphosphonates.
Maltese: Fuq il-bażi tar-reviżjoni tad-data, fiż-żmien tal-irtirar, is-CHMP kellu xi tħassib u kien tal-idea provviżorja li Xgeva ma setax jiġi approvat għall-kura ta' iperkalċemija kkawżata mill-kanċer u li ma rrispondietx għall-kura b'bifosfonati.
English: Xgeva is a medicine used to prevent bone complications in adults with a solid tumour that has spread to the bone.
Maltese: Xgeva hu mediċina li jintuża għall-prevenzjoni ta' kumplikazzjonijiet fl-għadam fl-adulti b'tumur solidu li jkun nfirex lejn l-għadam.
English: By attaching to and blocking RANKL, denosumab reduces the formation and activity of the osteoclasts.
Maltese: Dan fih is-sustanza attiva denosumab u hu disponibbli bħala soluzzjoni li trid tġi injettata taħt il-ġilda.
English: The company informed the CHMP that there are currently no ongoing clinical trials or compassionate use programmes with Xgeva.
Maltese: Il-kumpanija għarrfet lis-CHMP li fil-preżent m'hemm ebda prova klinika jew programm ta' użu ta' kompassjoni b'Xgeva.
English: Ref. EMEA/342023/2007
Maltese: EMEA/482575/2007
English: London, 16 August 2007 Doc.
Maltese: Londra, 16 ta' Awwissu 2007 Dok. Ref.
English: International non-proprietary name (INN): fluocinolone acetonide
Maltese: Isem internazzjonali mhux patentat (INN): fluocinolone acetonide
English: The active substance in RETISERT, fluocinolone acetonide, is a synthetic corticosteroid.
Maltese: Is-sustanza attiva li hija RETISERT, fluocinolone acetonide, hija kortikosterojde sintetiku.
English: What is RETISERT?
Maltese: X'inhu RETISERT?
English: On 16 July 2007, Bausch & Lomb Ireland officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for RETISERT, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. RETISERT was designated an orphan medicinal product on 7 March 2005.
Maltese: RETISERT ġie klassifikat bħala prodott mediċinali orfni fis-7 ta' Marzu 2005.
English: RETISERT is an intravitreal implant (inserted into the vitreous humour, the jelly-like fluid in the central chamber of the eye).
Maltese: RETISERT huwa impjant intravitreali (imdaħħal fil-vitreous humour, il-fluwidu li jixbah il-jelly filkompartimenti ċentrali ta' l-għajn).
English: The CHMP normally takes up to 210 days to evaluate a new application.
Maltese: Normalment, il-CHMP jieħu madwar 210 jum biex jevalwa applikazzjoni ġdida.
English: It acts like corticosteroids (a family of naturally occurring hormones) by dampening down the activity of the immune system and reducing inflammation.
Maltese: Taġixxi bħal kortikosterojdi (familja ta' ormoni li jseħħu b'mod naturali) billi jrażżnu l-attività tas-sistema immuni u jnaqqsu l-infjammazzjoni.
English: The effects of RETISERT, implanted into the more severely affected eye, were compared to those of standard care (the use of corticosteroids or immunosuppressant medicines affecting the whole body).
Maltese: L-effetti ta' RETISERT, impjantat f'għajn affettwata b'mod aktar sever, ġew imqabbla ma' dawk ta' kura standard (l-użu ta' kortikosterojdi jew mediċini immunosuppressanti li jaffettwaw il-ġisem kollu).
English: Based on the review of the initial documentation, the CHMP prepares a list of questions at day 120, which is sent to the company.
Maltese: Abbażi tar-reviżjoni tad-dokumentazzjoni inizjali, il-CHMP jħejji lista ta' mistoqsijiet f'jum 120, li mbagħad tintbagħat lill-kumpanija.
English: RETISERT was studied in one main study involving 146 patients who had had non-infectious uveitis affecting the posterior part of one or both eyes for at least a year, and had been treated with corticosteroids or immunosuppressant medicines for at least a month.
Maltese: RETISERT ġie studjat fi studju prinċipali wieħed li jinvolvi 146 pazjent li kellhom uneite li ma tittiħidx li taffettwa l-parti ta' wara ta' l-għajn jew iż-żewġ għajnejn għal mill-inqas sena, u kienu ġew ittrattati b'korikosterojdi jew mediċini immunosuppressanti għal mill-inqas xahar.
English: What were the reasons given by the company to withdraw the application?
Maltese: Kemm kienet ilha għaddejja l-evalwazzjoni meta ġiet irtirata l-applikazzjoni?
English: The CHMP had formulated a list of questions to be answered by the company, but the company had not yet responded to the questions.
Maltese: Il-CHMP ifformula lista ta' mistoqsijiet li għandhom jiġu mwieġba mill-kumpanija, iżda l-kumpanija kienet għadha ma weġbitx għall-mistoqsijiet.
English: The use of RETISERT was also linked to side effects, including eye pain, increased pressure within the eyeball and cataracts, which led to vision problems in some patients.
Maltese: L-użu ta' RETISERT kien relatat ukoll ma' l-effetti sekondarji, inkluż uġigħ fl-għajn, pressjoni akbar fil-ballun ta' l-għajn u katarretti, li wasslu għal problemi fil-vista f'xi pazjenti.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before giving an opinion, ask any remaining questions at day 180.
Maltese: jagħti opinjoni, jistaqsi kwalunkwe mistoqsija addizzjonali f'jum 180.
English: How is RETISERT expected to work?
Maltese: Għal x'hiex huwa mistenni li jintuża RETISERT?
English: This anti-inflammatory activity was expected to reduce the symptoms of uveitis.
Maltese: Din l-attività anti-infjammatorja kienet mistennija li tnaqqas issintomi ta' uveite.
English: What are the consequences of the withdrawal for patients undergoing clinical trials with RETISERT?
Maltese: Kif inhu mistenni li jintuża RETISERT?
English: What documentation did the company present to support its application to the CHMP?
Maltese: X'dokumentazzjoni ppreżentat il-kumpanija biex tappoġġja l-applikazzjoni tagħha lill-CHMP?
English: This is inflammation within the eye, which is not caused by an infection, but which affects areas including the retina (the light-sensitive layer at the back of the eye), and the choroid (the layer below the retina that contains blood vessels).
Maltese: Din hija infjammazzjoni fi ħdan l-għajn, li m'hiex ikkawżata minn infezzjoni, iżda li taffettwa żoni inkluż ir-retina (is-saff sensittiv għad-dawl fuq wara ta' l-għajn), u lkorojde (is-saff taħt ir-retina li fih il-vini).
English: Further information on Qtrilmet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/qtrilmet.
Maltese: ema.europa.eu/medicines/human/EPAR/qtrilmet.
English: It is available in two strengths of tablets containing: metformin 850 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg; and metformin 1,000 mg, saxagliptin 2.5 mg and dapagliflozin 5 mg.
Maltese: Jiġi f'żewġ qawwiet ta' pilloli li fihom: metformina 850 mg, sażagliptina 2.5 mg u dapagliflożina 5 mg; u metformina 1,000 mg, sażagliptina 2.5 mg u dapagliflożina 5 mg.
English: Saxagliptin, a dipeptidyl-peptidase-4 (DPP-4) inhibitor, has been authorised in the EU as Onglyza since 2009.
Maltese: Is-sażagliptina, inibitur ta' dipepddil-peptidażi-4 (DPP-4), ilha awtorizzata fl-UE bħala Onglyza sa mill-2009.
English: • Dapagliflozin blocks the action of a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2).
Maltese: • Id-dapagliflożina timblokka l-azzjoni ta' proteina fil-kliewi msejħa kotrasportatur 2 tal-glukożju tassodju (SGLT2).
English: Qtrilmet is a diabetes medicine that contains the active substances metformin, saxagliptin and dapagliflozin.
Maltese: Qtrilmet huwa mediċina kontra d-dijabete li fiha s-sustanzi attivi metformina, sażagliptina u dapagliflożina.
English: Dapagliflozin has been authorised in the EU as Forxiga since 2012
Maltese: Id-dapagliflożina ilha awtorizzata fl-UE bħala Forxiga sa mill-2012;
English: Other information about Qtrilmet
Maltese: Informazzjoni oħra dwar Qtrilmet
English: The HbA1c levels of patients in the studies were at least 8% and treatment was aimed at reducing HbA1c levels to 7% or less.
Maltese: Il-livelli ta' HbA1c ta' pazjenti fl-istudji kienu tal-inqas 8 % u l-kura kellha fil-mira li tnaqqas il-livelli ta' HbA1c għal 7 % jew inqas.
English: In the third study in 320 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.82 percentage points compared with a reduction of 0.10 percentage points in patients receiving metformin, saxagliptin and placebo.
Maltese: Fit-tielet studju fuq 320 pazjent, il-kombinazzjoni ta' metformina, sażagliptina u dapagliflożina naqqset l-HbA1c medja b'0.82 punti perċentwali meta mqabbla ma' tnaqqis ta' 0.10 punti perċentwali f'pazjenti li rċevew il-metformina, is-sażagliptina u l-plaċebo.
English: • adults who are already taking metformin, saxagliptin and dapagliflozin.
Maltese: • adulti li diġà qed jieħdu l-metformina, is-sażagliptina u d-dapagliflożina.
English: In the second study in 315 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 0.51 percentage points compared with a reduction of 0.16 percentage points in patients receiving metformin, dapagliflozin and placebo (dummy treatment).
Maltese: Fit-tieni studju fuq 315-il pazjent, il-kombinazzjoni ta' metformina, sażagliptina u dapagliflożina naqqset l-HbA1c medja b'0.51 punt perċentwali meta mqabbla ma' tnaqqis ta' 0.16-il punt perċentwali f'pazjenti li rċevew il-metformina, id-dapagliflożina u l-plaċebo (kura finta).
English: Qtrilmet must not be used in people who are hypersensitive (allergic) to metformin, saxagliptin or dapagliflozin or to any of the other ingredients or in people who have had serious allergic reactions to a DPP-4 inhibitor (medicines similar to saxagliptin) or to a SGLT2 inhibitor (medicines similar to dapagliflozin).
Maltese: Qtrilmet ma għandux jintuża fuq persuni li huma ipersensittivi (allerġiċi) għall-metformina, għassażagliptina jew għad-dapagliflożina jew għal kwalunkwe ingredjent ieħor jew f'persuni li kellhom reazzjonijiet allerġiċi serji għal inibitur DPP-4 (mediċini simili għas-sażagliptina) jew għal inibitur SGLT2 (mediċini simili għad- dapagliflożina).
English: HbA1c (glycosylated haemoglobin) is an indicator of glucose levels in the blood over the previous 2 to 3 months.
Maltese: L-HbA1c (emoglobina glikosilata) hija indikatur tal-livelli tal-glukożju fid-demm matul ix-xahrejn jew it-tliet xhur preċedenti.
English: In the first main study in 534 patients, the combination of metformin, saxagliptin and dapagliflozin reduced average HbA1c by 1.47 percentage points compared with metformin combined with either saxagliptin (0.88 percentage point reduction) or dapagliflozin (1.20 percentage point reduction).
Maltese: Fl-ewwel studju ewlieni fuq 534 pazjent, il-kombinazzjoni ta' metformina, sażagliptina u dapagliflożina naqqset l-HbA1c medja b'1.47 punti perċentwali meta mqabbla mal-metformina flimkien ma' jew issażagliptina (tnaqqis ta' 0.88 punti perċentwali) jew id-dapagliflożina (tnaqqis ta' 1.20 punti perċentwali).
English: The most common side effects with Qtrilmet (which may affect more than 1 in 10 people) are infections of the nose and throat, hypoglycaemia (low blood sugar) when used with a sulphonylurea and effects on the gut such as nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Maltese: L-effetti sekondarji l-aktar komuni bi Qtrilmet (li jistgħu jaffettwaw aktar minn persuna waħda minn kull 10) huma infezzjonijiet tal-imnieħer u tal-griżmejn, ipogliċemija (zokkor baxx fid-demm) meta jintuża ma' sulfonilurea u effetti fuq l-imsaren bħal nawżja (tħossok imdardar), rimettar, dijarea, uġigħ addominali (fiż-żaqq) u nuqqas ta' aptit.
English: What are the risks associated with Qtrilmet?
Maltese: Kif jintuża Qtrilmet?
English: • adults whose blood sugar is not controlled well enough with metformin combined with either saxagliptin or dapagliflozin (including those also taking a sulphonylurea, another type of diabetes medicine);
Maltese: • adulti li z-zokkor fid-demm tagħhom ma jkunx ikkontrollat biżżejjed bil-metformina flimkien ma' jew sażagliptina jew dapagliflożina (inklużi dawk li jkunu qed jieħdu wkoll sulfonilurea, tip ta' mediċina oħra kontra d-dijabete);
English: Why is Qtrilmet authorised in the EU?
Maltese: Għaliex Qtrilmet ġie awtorizzat fl-UE?
English: • Saxagliptin blocks the breakdown of incretin hormones, which are released after a meal and cause the pancreas to produce insulin.
Maltese: • Is-sażagliptina timblokka t-tkissir tal-ormoni inkretini, li jiġu rrilaxxati wara ikla u jikkawżaw lillfrixa biex tipproduċi l-insulina.
English: The pattern of Qtrilmet's side effects is manageable and similar to that in patients treated with saxagliptin and dapagliflozin added to metformin.
Maltese: It-tendenza tal-effetti sekondarji ta' Qtrilmet hija maniġġabbli u simili għal dik f'pazjenti kkurati bissażagliptina u bid-dapagliflożina miżjuda mal-metformina.
English: An overview of Qtrilmet and why it is authorised in the EU
Maltese: Ħarsa ġenerali lejn Qtrilmet u għalfejn huwa awtorizzat fl-UE
English: What is Qtrilmet and what is it used for?
Maltese: X'inhuma l-benefiċċji ta' Qtrilmet li ħarġu mill-istudji?
English: Qtrilmet can only be obtained with a prescription.
Maltese: Aktar informazzjoni dwar Qtrilmet tinstab fis-sit web tal-Aġenzija: