FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and < 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Maltese: Tossiċitajiet CTC klinikament rilevanti li ġew irrapportati f' > 1 % u < 5 % (komuni) talpazjenti li ntgħażlu bl-addoċċ biex jirċievu pemetrexed jinkludu: infezzjoni mingħajr newtropenja newtropenja bid-deni, reazzjoni allerġika/sensittivita aċċessiva, żieda fil-krejatinina, newropatija motorja, newropatija sensittiva, eritema multiforme u wġigħ addominali.
English: Clinically relevant toxicity that was reported in ≥ 1% and ≤ 5% of the patients that were randomly assigned to receive cisplatin and pemetrexed include: AST increase, ALT increase, infection, febrile neutropenia, renal failure, pyrexia, dehydration, conjunctivitis, and creatinine clearance decrease.
Maltese: Tossiċitajiet klinikament rilevanti li ġew irrapportati f' ≥ 1 % u ≤ 5 % tal-pazjenti li ntgħażlu bl-addoċċ biex jirċievu cisplatin u pemetrexed jinkludu: żieda fl-AST, żieda fl-ALT, infezzjoni, newtropenja bid-deni, insuffiċjenza renali, deni, diżidratazzjoni, konġuntivite u tnaqqis fit-tneħħija ta' krejatinina.
English: Concomitant administration of nephrotoxic medicinal product (e.g. aminoglycoside, loop diuretics, platinum compounds, cyclosporin) could potentially result in delayed clearance of pemetrexed.
Maltese: Jekk jingħataw prodotti mediċinali nefrotossiċi (eż. aminoglikosidi, dijuretiċi li jaħdmu fuq il-liwja tubulari, komposti tal-platinu, cyclosporin) fl- istess żmien, dawn jistgħu jwasslu għal dewmien fittneħħija ta' pemetrexed.
English: ul.
Maltese: Jew
English: Grade
Maltese: Tqala
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Maltese: It-tabella hawn taħt tati l-frekwenza u s-severità ta' l-effetti mhux mixtieqa li ġew irrapportati f'> 5 % tal-265 pazjent li ntgħażlu b'mod arbitrarju biex jirċievu pemetrexed waħdu b'supplimentazzjoni ta' folic acid u vitamina
English: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Maltese: Studju ta' Fażi 3 kkontrollat bil-plaċebo, double-blind, magħmul f'ħafna ċentri u b'mod arbitrarju (JMEN), qabbel l-effikaċja u s-sigurtà ta' kura ta' tkomplija ta' manteniment b' pemetrexedflimkien ma' BSC (n=359) ma' dik ta' plaċebo flimkien ma' BSC (n=180) f'pazjenti li għandhom kanċer tal- pulmun mhux b'ċelluli żgħar u li jkun lokalment avanzat(Stadju IIIB) jew metastatiku (Stadju IV), ħlief meta l-istoloġija turi li fil-biċċa l-kbira ċ-ċelluli jkunu tat-tip squamous u li ma jwrew ebda progress wara 4 ċikli ta' kura primarja doppja ta' pemetrexed flimkien ma' cisplatin.
English: Cisplatin is also given by infusion into one of your veins, and is given approximately 30 minutes after the infusion of Pemetrexed Fresenius Kabi has finished.
Maltese: Cisplatin ukoll jingħata b'infużjoni f'waħda mill-vini tiegħek, u jingħata madwar 30 minuta wara li tkun spiċċat l-infużjoni ta' Pemetrexed Fresenius Kabi.
English: For instructions on reconstitution and dilution of Pemetrexed Fresenius Kabi before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq rikostituzzjoni u dilwizzjoni ta' Pemetrexed Fresenius Kabi qabel l- amministrazzjoni, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59 95% CI =
Maltese: Għal dawk il-pazjenti magħżula b'mod arbitrarju, kif mkejjel mill-bidu tal-kura primarja inizjali ta' pemetrexed flimkien ma' cisplatin, il-medjan tal-PFS evalwat mill-investigatur kien ta' 6.9 xhur għall-fergħa ta' pemetrexed u ta' 5.6 ta' xahar għall-fergħa tal-plaċebo (hazard ratio = 0.59, 95% CI = 0.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Maltese: Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq il-website tal-Aġenzija Ewropea għall-Mediċini (EMA) http://www.ema.europa.eu/.
English: Constipation Stomatitis/
Maltese: Dijarrea Rimettar Stomatite/ Farinġite
English: Acute renal failure
Maltese: Komuni ħafna
English: Each vial contains 500 mg of pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett fih 500 mg ta' pemetrexed (bħala pemetrexed diacid).
English: Time to treatment failure (TTTF - months) ▪ Median ▪ HR (95% CI)
Maltese: Log Rank p-value* Żmien medjan fil-progress tat-tumur (xhur) (95 % CI)
English: Inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed Fresenius Kabi / radiation therapy.
Maltese: B'Pemetrexed Fresenius Kabi / terapija ta' radjazzjoni kien hemm ukoll infjammazzjoni tar-rita talesofagu (passaġġ tal- ikel)
English: PARAMOUNT: Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Maltese: Dijagrammi Kaplan Meier ta' sopravivenza mingħajr progressjoni (PFS) u Sopravivenza Totali (OS) għat-tkomplija ta' manteniment bi pemetrexed kontra plaċebo f'pazjenti b'NSCLC minbarra dawk fejn l-istoloġija turi li ċ-ċelluli huma l-iżjed tat-tip squamous ( kkwantifikat permezz ta' għażla b'mod arbitrarju)
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed Fresenius Kabi is 500 mg/m
Maltese: F'pazjenti kkurati għall-kanċer tal-pulmun mhux b'ċelluli żgħar wara kimoterapija preċedenti, id-doża rakkomandata ta' Pemetrexed Fresenius Kabi hi ta' 500 mg/m
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (n = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Maltese: 10.3 xhur għall-fergħa tal-plaċebo (hazard ratio = 0.70, 95% CI = 0.56-0.88, p=0.002).
English: Pemetrexed is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Maltese: Pemetrexed (pemetrexed) huwa sustanza antifolatika, antikanċeroġenika u għandu iżjed minn obbjettiv wieħed.
English: For precautions to be taken before handling or administering Pemetrexed Fresenius Kabi, see section 6.6.
Maltese: Għal Prekawzjonijiet li għandhom jittieħdu qabel ma tmiss jew tamministra Pemetrexed Fresenius Kabi, ara sezzjoni 6.6.
English: Patients randomised to maintenance treatment were required to have an ECOG performance status 0 or 1.
Maltese: Il-pazjenti kollha inklużi f'dan l-istudju kellhom ECOG performance status ta' 0 jew 1.
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Maltese: Il-pazjenti fiż-żewġ fergħat tal-istudju ġew mogħtija l- folic acid u l-vitamina B12.
English: Including the induction phase the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Maltese: Meta tinkludi lfażi tal-induzzjoni l-medjan tal-OS għal pazjenti b'NSCLC minbarra dwak fejn l-istoloġija turi li ċ- ċelluli huma l-iżjed tat-tip squamous kien ta' 18.6 xhur għall-fergħa ta' pemetrexed u ta' 13.6 xhur għall-fergħa tal-plaċebo (hazard ratio =0.71, 95% CI = 0.56-0.88, p = 0.002).
English: Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p <0.001).
Maltese: ITT = intenzjoni li tikkura; N = daqs talpopolazzjoni kollha a Statistikament sinifikanti biex ma tkunx inferjuri, bl-intervall ta' kunfidenza għal HR kollu kemm hu ħafna taħt il-marġni ta' 1.17645 li turi li m'hemmx inferjorità (p <.001).
English: Progression-free survival (months) ▪ Median ▪ HR (95% CI)
Maltese: ▪ Medjan ▪ HR (95 % CI)
English: These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥CTC Grade 2 bleeding.
Maltese: Dawn il-kriterji jissodisfaw id-definizzjoni ta' ≥CTC Grad 2 ta' fsada tal-Kriterji ta' Tossiċità Komuni (CTC) ta' l-Istitut Nazzjonali tal-Kanċer (CTC v2.0; NCI 1998).
English: Each vial contains 100 mg of pemetrexed (as pemetrexed diacid).
Maltese: Kull kunjett fih 100 mg ta' pemetrexed (bħala pemetrexed diacid).
English: Common Platelets decreased
Maltese: Komuni Ħafna Komuni
English: Pemetrexed Fresenius Kabi is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Maltese: Ħlief meta l-istoloġija turi li ċ-ċelluli jkunu l-iżjed tat-tip squamous, Pemetrexed Fresenius Kabi huwa indikat bħala monoterapija fil-kura ta' manteniment tal-kanċer fil-pulmun mhux b'ċelluli żgħar li jkun lokalment avanzat jew metastatiku f'pazjenti fejn ma kienx hemm progress fil-marda immedjatament wara l- kemoterapija bbażata fuq il-platinum (ara sezzjoni 5.1).
English: Pemetrexed Fresenius Kabi is a medicine used in the treatment of cancer.
Maltese: Pemetrexed Fresenius Kabi huwa mediċina li jintuża fil-kura tal-kanċer.
English: This suggests that pemetrexed may impair male fertility.
Maltese: Ir- riskju jikber f'persuni li jkunu diġà immunosoppressi minħabba l-marda li jkollhom.
English: Concomitant use not recommended
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Maltese: ITT = intenzjoni li tikkura; n = daqs tal-popolazzjoni kollha
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Maltese: Fin-nuqqas ta' tagħrif dwar l-interazzjoni potenzjali ma' NSAIDs li jkollhom half-life itwal bħal piroxicam jew rofecoxib, l-għoti ta' pemetrexed fl-istess żmien f'pazjenti b'insuffiċjenza renali minn ħafifa għal moderata għandu jitwaqqaf mill-anqas minn 5 ijiem qabel, dakinhar u sa millinqas jumejn wara l-għoti ta' pemetrexed (ara sezzjoni 4.4).
English: The pharmacokinetics of pemetrexed are consistent over multiple treatment cycles.
Maltese: Ilfarmakokinetiċi ta' pemetrexed huma konsistenti f'diversi ċikli ta' kura.
English: Pemetrexed Fresenius Kabi in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Maltese: Il-pazjenti kollha kienu ddijanjostikati li kellhom NSCLC fi Stadju IIIB je IV u li diġà kienu rċevew kemoterapija bbażata fuq il-platinum.
English: When prepared as directed, chemical and physical in-use stability of reconstituted solution of pemetrexed was demonstrated for 24 hours at refrigerated temperature.
Maltese: Meta ppreparati kif, kimika u fiżika waqt l-użu tas-soluzzjoni rikostitwita ta 'pemetrexed ġiet murija għal 24 siegħa f'temperatura refriġerati.
English: Nadir ANC < 500 /mm and nadir platelets
Maltese: L-għadd l-iktar baxx ta' ANC < 500/mm u lgħadd l-iktar baxx ta' plejtlits ≥ 50,000/mm
English: ▪ Allergic reaction: if you develop skin rash (very common) / burning or prickling sensation (common), or fever (common).
Maltese: ▪ Reazzjoni allerġika: jekk tiżviluppa raxx fil-ġilda (komuni ħafna) / sensazzjoni ta' ħruq jew tingiż (komuni), jew deni (komuni).
English: 19 January 2017 EMA/747766/2016
Maltese: 19 ta' Jannar 2017 EMA/747766/2016
English: More information about Suliqua can be found on the Agency's website: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243/human_ med_002064.jsp
Maltese: Aktar informazzjoni dwar Suliqua tista' tinsab fuq is-sit elettroniku talAġenzija: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/004243 /human_med_002064.jsp
English: Suliqua is available in two different pens:
Maltese: Suliqua hu disponibbli f'żewġ pinen differenti:
English: The active substances in Suliqua are insulin glargine and lixisenatide.
Maltese: Is-sustanzi attivi f'Suliqua huma insulin glargine u lixisenatide.
English: Measures intended to reduce risk of confusion between two pens of different strengths
Maltese: Miżuri intiżi biex inaqqsu r-riskju ta' konfużjoni bejn iż-żewġ pinen ta' qawwiet differenti
English: • Suliqua is a fixed combination of insulin glargine/lixisenatide available in two strengths:
Maltese: • Suliqua hu taħlita fissa ta' insulin glargine/lixisenatide disponibbli f'żewġ qawwiet:
English: • Suliqua contains insulin glargine and a non-insulin medicine, lixisenatide.
Maltese: • Suliqua fih insulin glargine u mediċina li ma fihiex insulina, lixisenatide.
English: It is used for people needing 10-40 units of insulin daily.
Maltese: Din tintuża għal nies li jkollhom bżonn 10-40 unità ta' insulina kuljum.
English: Suliqua contains a combination of insulin glargine and a non-insulin medicine, lixisenatide.
Maltese: Suliqua fih taħlita ta' insulin glargine u mediċina li ma fihiex insulina, lixisenatide.
English: The prescription must state the type of pen to be used (either Suliqua 10-40 or Suliqua 30-60), the strength (i.e. insulin glargine 100 units/ml + lixisenatide 50 micrograms/ml or insulin glargine 100 units/ml + lixisenatide 33 micrograms/ml) and the number of dose steps to be administered.
Maltese: Ir-riċetta għandha tiddikjara t-tip ta' pinna li għandha tintuża (jew Suliqua 10-40 jew Suliqua 30-60), il-qawwa (jiġifieri, insulin glargine 100 unità/ml flimkien ma' lixisenatide 50 mikrogramma/ml jew insulin glargine 100 unità/ml flimkien ma' lixisenatide 33 mikrogramma/ml) u n-numru ta' żidiet fid-doża li għandhom jingħataw.
English: • As for similar medicines containing insulin with a non-insulin medicine, the dose is expressed in dose steps.
Maltese: • Għal dawk il-mediċini simili li fihom insulina ma' mediċina li ma fihiex insulina, id-doża hi espressa f'żidiet fid-doża.
English: − Suliqua 30-60 (containing insulin glargine 100 units/ml with lixisenatide 33 micrograms/ml)this pen can deliver between 30 and 60 dose steps per day.
Maltese: − Suliqua 30-60 (li fiha insulin glargine 100 unità/ml flimkien ma' lixisenatide 33 mikrogramma/ml) - din il-pinna tista' tagħti bejn 30 u 60 żieda fid-doża kuljum.
English: The amount of lixisenatide per dose step however varies (0.50 micrograms per dose step for the 10-40 pen and 0.33 micrograms per dose step for the 30-60 pen).
Maltese: Madankollu, l-ammont ta' lixisenatide għal kull żieda fid-doża jvarja (0.50 mikrogramma għal kull żieda fid-doża għall-pinna 10-40 u 0.33 mikrogramma għal kull żieda fid-doża għall-pinna 30-60).
English: − Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml)this pen can deliver between 10 and 40 dose steps per day.
Maltese: − Suliqua 10-40 (li fiha insulin glargine 100 unità/ml flimkien ma' lixisenatide 50 mikrogramma/ml) -din il-pinna tista' tagħti bejn 10 u 40 żieda fid-doża kuljum.
English: • Pharmacists are encouraged to check that patients and carers are able to read the strength of Suliqua, the dose range of the pre-filled pen and the dose counter of the pen device before dispensing Suliqua.
Maltese: • L-ispiżjara huma mħeġġa jivverifikaw li l-pazjenti u dawk li jieħdu ħsiebhom huma kapaċi jaqraw ilqawwa ta' Suliqua, il-firxa tad-doża tal-pinna mimlija għal-lest u l-kontatur tad-doża tal-apparat tal-pinna qabel jagħtu Suliqua.
English: • Explain the design and features of the pen to the patient and if the patient has been transferred from another pen device, highlight the differences in design between the two devices to avoid confusion (focus on colour differentiation, warning statements on carton/label).
Maltese: • Spjega d-disinn u l-funzjonijiet tal-pinna lill-pazjent u jekk il-pazjent ġie trasferit minn apparat talpinna ieħor, uri d-differenzi fid-disinn bejn iż-żewġ apparati sabiex tiġi evitata l-konfużjoni (iffuka fuq id-differenzjazzjoni tal-kulur, id-dikjarazzjonijiet tat-twissija fuq il-kartuna/it-tikketta).
English: This could lead to fluctuations in blood glucose control.
Maltese: Dan jista' jwassal għal flutwazzjonijiet fil-kontroll talglukożju fid-demm.
English: Suliqua 10-40 (containing insulin glargine 100 units/ml with lixisenatide 50 micrograms/ml) - this pen can deliver between 10 and 40 dose steps per day.
Maltese: Suliqua (insulin glargine 100 unità/ml flimkien ma' lixisenatide 50 mikrogramma/ml) pinna 10-40
English: Healthcare professionals and patients expected to use the diabetes medicine Suliqua will be given educational materials to ensure that the medicine is used correctly and prevent medication errors such as confusion between the two different strengths of the product.
Maltese: Il-professjonisti tal-kura tas-saħħa u l-pazjenti li mistennija li jużaw il-mediċina kontra d-dijabete Suliqua se jingħataw materjal edukattiv sabiex jiġi żgurat li l-mediċina tintuża b'mod korrett u sabiex jiġu evitati żbalji tal-mediċina bħal konfużjoni bejn iż-żewġ qawwiet differenti tal-prodott.
English: • The dose counter of the pen device shows the number of dose steps to be injected.
Maltese: • Il-kontatur tad-doża tal-apparat tal-pinna juri n-numru ta' żidiet fid-doża li għandhom jiġu injettati.
English: As for similar combination medicines used for the treatment of diabetes, the dose of Suliqua is expressed in ‘dose steps', with each dose step corresponding to one unit of insulin plus a fixed amount of lixisenatide.
Maltese: Għal mediċini ta' kombinazzjoni simili li jintużaw għall-kura tad-dijabete, id-doża ta' Suliqua hi espressa f'“żidiet fid-doża”, b'kull żieda fid-doża tikkorrispondi għal unità waħda ta' insulina flimkien ma' ammont fiss ta' lixisenatide.
English: Suliqua is a medicine that is used for the treatment of type-2 diabetes.
Maltese: Suliqua hu mediċina li tintuża għall-kura tad-dijabete tat-2 tip.
English: To reduce the risk of medication errors, educational materials will be sent out to relevant healthcare professionals in the EU where the product is marketed, to raise awareness about the differences between the two pens, the way the dose is expressed and how to use the medicine correctly.
Maltese: Sabiex jitnaqqas ir-riskju ta' żbalji fil-medikazzjoni, se jintbagħat materjal edukattiv lill-professjonisti tal-kura tas-saħħa rilevanti fl-UE fejn jitqiegħed fis-suq il-prodott, sabiex jiżdied l-għarfien dwar iddifferenzi bejn iż-żewġ pinen, il-mod ta' kif hi espressa d-doża u kif il-mediċina tintuża b'mod korrett.
English: Further information on Xigduo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/xigduo.
Maltese: Aktar informazzjoni dwar Xigduo tinstab fis-sit web tal-Aġenzija: ema.europa.eu/medicines/human/EPAR/xigduo.
English: Xigduo is used:
Maltese: Xigduo jintuża:
English: Xigduo received a marketing authorisation valid throughout the EU on 16 January 2014.
Maltese: Xigduo ngħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fis-16 ta' Jannar 2014.
English: It contains the active substances dapagliflozin and metformin.
Maltese: Fih iż-żewġ sustanzi attivi dapagliflożina u metformina.
English: Xigduo contains two different active substances, which work in different ways:
Maltese: Xigduo fih żewġ sustanzi attivi differenti, li jaħdmu b'modi differenti:
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: Dapagliflozin has been authorised in the European Union (EU) as Forxiga since 2012;
Maltese: Iddapagliflożina ilha awtorizzata fl-Unjoni Ewropea (UE) bħala Forxiga sa mill-2012;
English: • patients with reduced liver function;
Maltese: • f'pazjenti b'funzjoni tal-fwied mnaqqsa;
English: Xigduo is available as tablets containing 5 mg of dapagliflozin with 850 mg of metformin and as 5 mg of dapagliflozin with 1,000 mg of metformin.
Maltese: Xigduo jiġi bħala pilloli li fihom 5 mg ta' dapagliflożina flimkien ma' 850 mg ta' metformina u bħala 5 mg ta' dapagliflożina flimkien ma' 1,000 mg ta' metformina.
English: What are the risks associated with Xigduo?
Maltese: X'inhuma r-riskji assoċjati ma' Xigduo?
English: Further studies confirmed that different doses of dapagliflozin with metformin decreased HbA1c more than placebo plus comparable doses of metformin, and that dapagliflozin plus metformin was at least as effective in reducing HbA1c levels as the diabetes medicine glipizide (a type of medicine known as a sulphonylurea).
Maltese: Studji ulterjuri kkonfermaw li dożi differenti tad-dapagliflożina mal-metformina naqqsu l-HbA1c iktar minn plaċebo flimkien ma' dożi komparabbli tal-metformina, u li d-dapagliflożina flimkien malmetformina kienet tal-inqas effettiva daqs il-mediċina tad-dijabete glipiżid (tip ta' mediċina magħrufa bħala sulfonilurea) fit-tnaqqis tal-livelli tal-HbA1c.
English: • patients with any form of acute metabolic acidosis (build up of acid in the blood), such as diabetic ketoacidosis (high blood levels of acids called ‘ketones') or lactic acidosis (build-up of lactic acid in the body);
Maltese: • f'pazjenti li jbatu minn kwalunkwe forma ta' aċidożi metabolika akuta (akkumulazzjoni ta' aċidu fiddemm), bħal ketoaċidożi dijabetika (livelli għoljin ta' aċidi fid-demm imsejħa ‘ketoni') jew aċidożi lattika (akkumulazzjoni ta' aċidu lattiku fil-ġisem);
English: Two other studies showed that dapagliflozin taken with metformin and another diabetes medicine, sitagliptin or insulin, for 24 weeks, further decreased HbA1c: the dapagliflozin combination decreased HbA1c levels by 0.40 percentage points more than placebo and metformin when added to sitagliptin, and by 0.61 percentage points more than placebo and metformin when added to insulin.
Maltese: Żewġ studji oħrajn urew li d-dapagliflożina meta tittieħed mal-metformina u mediċina oħra taddijabete, is-sitagliptina jew l-insulina, għal 24 ġimgħa, naqqset iktar l-HbA1c: il-kombinazzjoni taddapagliflożina naqqset il-livelli ta' HbA1c b'0.40 punt perċentwali iktar minn plaċebo u l-metformina meta miżjuda mas-sitagliptina, u b'0.61 punt perċentwali iktar minn plaċebo u l-metformina meta miżjuda mal-insulina.
English: In one main study, when dapagliflozin was used at a dose of 5 mg twice a day in addition to metformin (the same combination as in Xigduo), it decreased HbA1c levels by 0.65 percentage points after 16 weeks, compared with a reduction of 0.30 percentage points with placebo (a dummy treatment) and metformin.
Maltese: Fi studju ewlieni, meta d-dapagliflożina ntużat f'doża ta' 5 mg darbtejn kuljum flimkien malmetformina (l-istess kombinazzjoni bħal f'Xigduo), naqqset il-livelli tal-HbA1c b'0.65 punt perċentwali wara 16-il ġimgħa, meta mqabbla ma' tnaqqis ta' 0.30 punt perċentwali bi plaċebo (kura finta) u lmetformina.
English: Other information about Xigduo
Maltese: Kif jintuża Xigduo?