FrancophonIA/ELRC3.0 huggingface dataset:
English: The addition of 25 mg alogliptin once daily to metformin hydrochloride therapy (mean dose = 1,847 mg) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Maltese: Iż-żieda ta' 25 mg alogliptin darba kuljum ma' terapija ta' metformin hydrochloride (doża medja = 1,847 mg) irriżultat f'titjib statistiku sinifikanti mil-linja bażi f'HbA1c u fil-glukosju filplażma wara s-sawm f'Ġimgħa 26 meta mqabbla maż-żieda ta' plaċebo (Tabella 2).
English: Combination requiring precautions for use
Maltese: Kombinazzjonijiet mhux studjati
English: Vipdomet 12.5 mg/1,000 mg film-coated tablets
Maltese: Vipdomet 12.5 mg/1,000 mg pilloli miksija b'rita
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9) and is, therefore, not recommended for use in such patients (see sections 4.2, 4.3 and 5.2).
Maltese: Alogliptin ma ġiex studjat f'pazjenti b'indeboliment sever tal-fwied (punteġġ Child-Pugh ta' >9) u għalhekk mhuwiex rakkomandat għall-użu f'dawn il-pazjenti (ara sezzjonijiet 4.2, 4.3 u 5.2).
English: Co-administration of 12.5 mg alogliptin and 1,000 mg metformin hydrochloride twice daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to either 12.5 mg alogliptin twice daily alone or 1,000 mg metformin hydrochloride twice daily alone.
Maltese: L-għoti konġunt ta' alogliptin 12.5 mg u 1,000 mg metformin hydrochloride darbtejn kuljum irriżulta f'titjib statistikament sinifikanti mil-linja bażi fl-HbA1c u l-glukosju fil-plażma wara s-sawm f'Ġimgħa 26 meta mqabbel kemm ma' alogliptin 12.5 mg darbtejn kuljum waħdu jew 1,000 mg metformin hydrochloride darbtejn kuljum waħdu.
English: For the different dose regimens Vipdomet is available in strengths of 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets.
Maltese: Għall-korsijiet ta' doża differenti, Vipdomet hu disponibbli f'qawwiet ta' pilloli miksija b'rita ta' 12.5 mg/850 mg u 12.5 mg/1,000 mg.
English: Pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side.
Maltese: Pilloli miksija b'rita ta' lewn isfar ċar, oblongi (madwar 22.3 mm fit-tul u 10.7 mm wiesgħa), imżaqqin fuq żewġ naħat bi “12.5/1000” imnaqqxa fuq naħa waħda u “322M” imnaqqxa fuq in-naħa l-oħra.
English: For patients switching from separate tablets of alogliptin and metformin (as dual therapy or as part of triple therapy with insulin), both alogliptin and metformin should be dosed at the total daily dose already being taken; the individual dose of alogliptin should be halved as it will be taken twice daily whilst the dosing of metformin should remain unchanged.
Maltese: Għal pazjenti li jaqilbu minn pilloli separati ta' alogliptin u metformin (bħala terapija doppja jew bħala parti minn terapija tripla mal-insulina), kemm alogliptin u metformin għandhom ikunu ddożati fid-doża totali ta' kuljum li diġà qed tittieħed; id-doża individwali ta' alogliptin għandha titnaqqas bin-nofs minħabba li ser tittieħed darbtejn kuljum waqt li l-doża ta' metformin għandha tibqa' mhux mibdula.
English: No adverse effects of alogliptin were observed upon fertility, reproductive performance, or early embryonic development in rats up to a systemic exposure far above the human exposure at the recommended dose.
Maltese: L-ebda effett avvers ta' alogliptin ma kien osservat fuq il-fertilità, prestazzjoni riproduttiva jew żvilupp embrijoniku bikri fil-firien sa espożizzjoni sistemika ferm ogħla mill-esponiment tal-bniedem fid-doża rrakkomandata.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/025 2x98 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/843/025 2x98 pilloli miksija b'rita
English: In addition, mean change from baseline in FPG at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Maltese: Barra minn hekk, bidla medja mil-linja bażi fil-FPG fil-Ġimgħa 52 għal alogliptin 25 mg flimkien ma' 30 mg pioglitazone u metformin kienet akbar b'mod sinifikanti minn dik għal 45 mg pioglitazone u metformin (p<0.001).
English: If no adequate strength of Vipdomet is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Vipdomet, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: The most effective method of removing lactate and metformin is haemodialysis.
Maltese: L-aktar metodu effettiv biex jitneħħa lactate u metformin hu b'emodijalisi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/026 2x98 film-coated tablets
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/13/843/026 2x98 pilloli miksija b'rita
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Maltese: Tnaqqis fil-funzjoni renali f'pazjenti anzjani huwa frekwenti u ma jinħassux sintomi.
English: Following a single intravenous dose of 12.5 mg alogliptin to healthy subjects, the volume of distribution during the terminal phase was 417 L indicating that the active substance is well distributed into tissues.
Maltese: Wara doża waħda ta' alogliptin 12.5 mg ġol-vina lil individwi b'saħħithom, il-volum ta' distribuzzjoni matul il-fażi terminali kienet ta' 417 L li jindika li s-sustanza attiva ġiet distribwita tajjeb fit-tessut.
English: Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Vipdomet (see section 4.4).
Maltese: Reazzjonijiet ta' sensittività eċċessiva, inkluż is-sindrome ta' Stevens-Johnson, reazzjonijiet anafilattiċi, u anġjoedema huma serji u attribwiti għall-komponent ta' alogliptin f'Vipdomet (ara sezzjoni 4.4). Aċidożi lattika hija reazzjoni avversa serja, li sseħħ rari ħafna (<1/10,000), u hija attribwita għall-komponent ta' metformin f'Vipdomet (ara sezzjoni 4.4).
English: The efficacy and safety of the recommended doses of alogliptin and metformin in a subgroup of patients with type 2 diabetes mellitus and ≥65 years old were reviewed and found to be consistent with the profile obtained in patients <65 years old.
Maltese: L-effikaċja u s-sigurtà tad-dożi rakkomandati ta' alogliptin u metformin f'sottogrupp ta' pazjenti b'dijabete mellitus ta' tip 2 u li kellhom ≥65 sena kienu evalwati u nstabu li huma konsistenti mal-profil miksub f'pazjenti ta' <65 sena.
English: For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin, the dose of Vipdomet should provide alogliptin dosed at 12.5 mg twice daily (25 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Għal pazjenti mhux ikkontrollati adegwatament fuq id-doża ta' kombinazzjoni b'insulina u d-doża massima ttollerata ta' metformin, id-doża ta' Vipdomet għandha tipprovdi alogliptin mogħti f'doża 12.5 mg darbtejn kuljum (doża toali ta' kuljum ta' 25 mg) u doża ta' metformin simili għad-doża li diġà qed tittieħed.
English: Total exposure to alogliptin was approximately 10% lower and peak exposure was approximately 8% lower in patients with moderate hepatic impairment compared to control subjects.
Maltese: L-espożizzjoni totali għal alogliptin kienet ta' madwar 10% aktar baxxa u l-espożizzjoni massima kienet madwar 8% aktar baxxa f'pazjenti b'indeboliment tal-fwied moderat meta mqabbel ma' individwi b'saħħithom bħala kontroll.
English: This summary was last updated in October 2008.
Maltese: Ottubru 2008.
English: Tetanus is an acute, often fatal disease caused by a neurotoxin produced by the bacterium Clostridium tetani.
Maltese: It-tetnu huwa marda akuta, ħafna drabi fatali kkawżata minn newrotossin prodott mill-batterju Clostridium tetani.
English: The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Maltese: Il-marda, li ġeneralment toriġina minn ġrieħi kontaminati, hija ikkaratterizzata minn riġidità (ebusija) ġenerali u spażmi konvulsivi tal-muskoli.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Te to Intervet International BV on 8 July 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida madwar l-Unjoni Ewropea kollha, għal Equilis Te lil Intervet International BV fit-8 ta' Lulju 2005.
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 aktar informazzjoni abbażi tarrakkomandazzjonijiet tas-CVMP, aqra d-Diskussjoni Xjentifika (ukoll parti mill-EPAR).
English: What is the risk associated with Equilis Te?
Maltese: X'riskji huma assoċjati ma' Equilis Te?
English: The vaccine also contains an ‘adjuvant' to stimulate a better immune response.
Maltese: Il-vaċċin fih ukoll ‘adjuvant' biex jistimula rispons immuni aħjar.
English: Why has Equilis Te been approved?
Maltese: Għaliex ġie approvat Equilis Te?
English: The benefit-risk balance may be found in module 6 of this EPAR.
Maltese: Il-bilanċ bejn il-benefiċċju u r-riskju jista' jinstab filmodulu 6 ta' dan l-EPAR.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Te exceeded the risks for the immunisation of horses from six months of age against tetanus to prevent mortality.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equilis Te huma ikbar mir-riskji tiegħu għat-tilqim ta' żwiemel mill-età ta' sitt xhur kontra ttetnu biex jimpedixxi l-mortalità.
English: For ethical reasons no challenge (infection) experiment was performed against tetanus.
Maltese: Għal raġunijiet etiċi, ma sar l-ebda esperiment bi sfida (infezzjoni) kontra t-tetnu.
English: It is available as a suspension for injection.
Maltese: Jiġi bħala sospensjoni għall-injezzjoni.
English: The main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid after vaccination.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-produzzjoni ta' livelli protettivi ta' antikorpi kontra t-tossojde tat-tetnu wara t-tilqima.
English: Other information about Equilis Te:
Maltese: Tagħrif ieħor dwar Equilis Te:
English: Most of the studies were performed with Equilis Prequenza Te, a vaccine that protects against equine influenza as well as against tetanus.
Maltese: Ħafna mill-istudji twettqu b'Equilis Prequenza Te, vaċċin li jipproteġi kontra linfluwenza ekwina kif ukoll kontra t-tetnu.
English: All studies were performed with Equilis Prequenza Te (comment: double; mentioned in next paragraph).
Maltese: L-istudji kollha twettqu b'Equilis Prequenza Te (kumment: id-doppju; imsemmi fil-paragrafu li jmiss).
English: It contains the toxoid (chemically inactivated toxin) from the tetanus bacterium.
Maltese: Fih it-tossojde (tossin inattivat kimikament) mill-batterju tat-tetnu.
English: This helps to protect against tetanus.
Maltese: Dan jgħin fil-protezzjoni kontra t-tetnu.
English: The effectiveness of Equilis Te has been studied in several trials under laboratory and field conditions.
Maltese: L-effikaċja ta' Equilis Te ġiet studjata f'diversi provi taħt kundizzjonjiet tal-laboratorju jew prattiċi.
English: What is Equilis Te?
Maltese: X'inhu Equilis Te?
English: Equilis Te is used to vaccinate horses from six months of age against tetanus to prevent mortality.
Maltese: Te jintuża fit-tilqim taż-żwiemel mill-età ta' sitt xhur kontra t-tetnu biex jimpedixxi lmortalità.
English: Zero days.
Maltese: Żero ġranet.
English: The first revaccination should be no later than 17 months after primary vaccination.
Maltese: It-tieni tilqima tkun trid tingħata mhux iktar minn 17-il xahar wara l-ewwel tilqima.
English: How has Equilis Te been studied?
Maltese: Kif ġie studjat Equilis Te?
English: Equilis Te is a vaccine containing purified tetanus toxoid.
Maltese: Biex iżommu l-protezzjoni kontra t-tetnu, iż-żwiemel ikunu jridu jitlaqqmu mill-ġdid.
English: Equilis Te is a vaccine for use in horses.
Maltese: Te huwa vaċċin għall-użu fiż-żwiemel.
English: The Committee recommended that Equilis Te should be given a marketing authorisation.
Maltese: Il-Kumitat irrakkomanda li Equilis Te jingħata lawtorizzazzjoni għat-tqegħid fis-suq.
English: 09 December 2015 EMA/680058/2015
Maltese: EMA/680058/2015
English: Fresh bilberry fruit EMA/680058/2015
Maltese: Frott frisk tal-mirtill EMA/680058/2015
English: In its assessment, the HMPC also considered clinical studies on disorders of the circulatory system which were performed 30 - 40 years ago.
Maltese: Fil-valutazzjoni tiegħu, lHMPC ikkunsidra wkoll għadd ta' studji kliniċi dwar id-disturbi tas-sistema taċ-ċirkolazzjoni li twettqu 30 - 40 sena ilu.
English: Fresh bilberry fruit
Maltese: Frott frisk tal-mirtill
English: Fresh bilberry fruit is the common name for the fresh fruit of the plant Vaccinium myrtillus L. Fresh bilberry fruit preparations are obtained using a technique to extract compounds from fresh plant material by dissolving them in a solvent (such as methanol), which is then evaporated to obtain a dry extract.
Maltese: Il-preparazzjonijiet tal-frott frisk tal-mirtill huma miksuba bl-użu ta' teknika għall-estrazzjoni ta' komponenti minn materjali friski tal-pjanta billi dawn jinħallu f'solvent (bħall-metanol), li mbagħad jiġi evaporat biex jinkiseb estratt xott.
English: Further information on the HMPC assessment of fresh bilberry fruit medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What are the risks associated with fresh bilberry fruit medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini li fihom il-frott frisk tal-mirtill?
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawżibbli u hemm evidenza li ilhom jintużaw b'mod sigur b'dan il-mod għal mill-inqas 30 sena (inkluż mill-inqas 15-il sena fl-UE).
English: Although possible beneficial effects were observed, there were limitations in the way the studies were conducted and, therefore, the HMPC conclusions on the use of fresh bilberry fruit medicines are based on their long-standing use.
Maltese: Għalkemm ġew osservati effetti possibbli ta' benefiċċju, kien hemm limitazzjonijiet filmod kif twettqu l-istudji u, għaldaqstant, il-konklużjonijiet tal-HMPC dwar l-użu ta' mediċini li fihom ilfrott frisk tal-mirtill huma bbażati fuq esperjenza tal-użu tagħhom fit-tul.
English: Further information on the risks associated with fresh bilberry fruit medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati ma' dawn il-mediċini li fihom il-frott frisk tal-mirtill, inklużi lprekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografija taħt it-tab ‘Id-dokumenti kollha' (All Documents') fil-websajt tal-Aġenzija:
English: Herbal medicines containing fresh bilberry fruit preparations are usually available in solid forms to be taken by mouth.
Maltese: Mediċini tal-ħxejjex li fihom il-preparazzjonijiet tal-frott frisk tal-mirtill normalment huma disponibbli f'forom solidi sabiex jittieħdu mill-ħalq.
English: The full EPAR for Jentadueto 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: It is available as tablets (2.5 mg/850 mg and 2.5 mg/1,000 mg).
Maltese: Jiġi bħala pilloli (2.5 mg/850 mg u 2.5 mg/1,000 mg).
English: This summary was last updated in 05-2016
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'05-2016.
English: Linagliptin is a dipeptidyl-peptidase-4 (DPP 4) inhibitor.
Maltese: Il-linagliptina hija inibitur ta' dipeptidil-peptidażi-4 (DPP 4).
English: Other information about Jentadueto
Maltese: Informazzjoni oħra dwar Jentadueto
English: The combination gave a reduction of 1.22 points when metformin was given at 500 mg and a reduction of 1.59 points when metformin was given at 1,000 mg.
Maltese: Il-kombinazzjoni wasslet għal tnaqqis ta' 1.22 punt meta ngħatat 500 mg ta' metformina u tnaqqis ta' 1.59 punt meta ngħatat 1,000 mg ta' metformina.
English: This is a summary of the European public assessment report (EPAR) for Jentadueto.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Jentadueto.
English: Jentadueto linagliptin / metformin hydrochloride
Maltese: Sommarju tal-EPAR għall-pubbliku linagliptina / metformina kloridrata
English: Jentadueto is a medicine that contains the active substances linagliptin and metformin hydrochloride.
Maltese: Jentadueto huwa mediċina li fiha s-sustanzi attivi linagliptina u metformina kloridrata.
English: This compared with a reduction of 0.45 with linagliptin alone, 0.64 with 500 mg metformin alone, 1.07 with 1,000 mg metformin alone, and 0.13 with placebo.
Maltese: Dan tqabbel ma' tnaqqis ta' 0.45 bil-linagliptina waħedha, 0.64 b'500 mg ta' metformina waħedha, 1.07 b' 1,000 mg ta' metformina waħedha, u 0.13 bi plaċebo.
English: The study looking at adding linagliptin 2.5 mg twice per day or 5 mg once per day to metformin showed a similar reduction in HbA1c levels compared with placebo (0.74 and 0.80 points more than placebo respectively).
Maltese: L-istudju li ħares lejn iż-żieda ta' 2.5 mg linagliptina darbtejn kuljum jew ta' 5 mg darba kuljum malmetformina wera tnaqqis simili fil-livelli ta' HbA1c meta mqabbla ma' plaċebo (0.74 u 0.80 punt aktar minn plaċebo rispettivament).
English: The active substances in Jentadueto, linagliptin and metformin hydrochloride, each working in a different way.
Maltese: Is-sustanzi attivi f'Jentadueto, il-linagliptina u l-metformina kloridrata, it-tnejn għandhom mod differenti ta' azzjoni.
English: The maximum dose is 5 mg of linagliptin and 2,000 mg of metformin per day.
Maltese: Id-doża massima hija ta' 5 mg ta' linagliptina u 2,000 mg ta' metformina kuljum.
English: The CHMP concluded that the combination of linagliptin and metformin has been shown to be effective at lowering HbA1c levels, and that linagliptin 2.5 mg twice per day was as effective as 5 mg once per day, which is approved in the EU for use on its own and in combination with metformin and with metformin plus a sulphonylurea or insulin.
Maltese: Is-CHMP ikkonkluda li l-kombinazzjoni ta' linagliptina u metformina ntweriet li hija effettiva fit-tnaqqis tal-livelli ta' HbA1c, u li l-linagliptina 2.5 mg darbtejn kuljum kienet effettiva daqs 5 mg darba kuljum, li hija approvata fl-UE għall-użu waħidha u f'kombinazzjoni mal-metformina u b'metformina flimkien mas-sulfonilurea jew l-insulina.
English: The studies looked at the effectiveness of linagliptin used on its own (503 patients), in combination with metformin (701 patients), with metformin plus a sulphonylurea (1,058 patients) or with another diabetes medicine pioglitazone (389 patients).
Maltese: L-istudji ħarsu lejn l-effikaċja tal-linagliptina użata waħidha (503 pazjenti), f'kombinazzjoni mal-metformina (701 pazjent), bil-metformina flimkien massulfonilurea (1,058 pazjent) jew ma' mediċina oħra kontra d-dijabete pioglitazone (389 pazjent).
English: • diabetic ketoacidosis or diabetic pre-coma (dangerous complications of diabetes);
Maltese: • ketoaċidożi dijabetika jew stat dijabetiku ta' qabel il-koma (kumplikazzjonijiet perikolużi taddijabete);
English: Why has Jentadueto been approved?
Maltese: Għaliex ġie approvat Jentadueto?
English: Linagliptin has been authorised in the European Union (EU) as Trajenta since 2011.
Maltese: Il-linagliptina ilha awtorizzata fl-Unjoni Ewropea (UE) bħala Trajenta sa mill-2011.
English: What is Jentadueto?
Maltese: X'inhu Jentadueto?
English: • moderately to severely reduced kidney function or with acute (sudden) conditions which can affect kidney function such as dehydration, severe infection or shock;
Maltese: • funzjoni tal-kliewi moderatament jew severament imnaqqsa b'kondizzjonijiet (f'daqqa waħda) gravi li jistgħu jaffettwaw il-kliewi bħal deidrazzjoni, infezzjoni severa jew xokk;
English: When given in combination, linagliptin with metformin gave a reduction of 0.56 points compared with a rise of 0.10 points; linagliptin with metformin plus a sulphonylurea gave a reduction of 0.72 points compared with 0.10 points.
Maltese: Meta mogħtija f'kombinazzjoni, il-linagliptina mal-metformina wasslet għal tnaqqis ta' 0.56 punt meta mqabbla ma' żieda ta' 0.10 punti; il-linagliptina mal-metformina flimkien mas-sulfonilurea wasslet għal tnaqqis ta' 0.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jentadueto on 20 July 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Jentadueto valida fl-Unjoni Ewropea kollha fl-20 ta' Lulju 2012.
English: • in patients who are already taking a combination of linagliptin and metformin as separate tablets;
Maltese: • f'pazjenti li diġà qegħdin jieħdu kombinazzjoni ta' linagliptina u metformina bħala pilloli separati;
English: Jentadueto is taken twice a day.
Maltese: Jentadueto jittieħed darbtejn kuljum.
English: What is the risk associated with Jentadueto?
Maltese: X'inhu r-riskju assoċjat ma' Jentadueto?
English: • in combination with a sulphonylurea or insulin (other types of diabetes medicines) in patients who are not satisfactorily controlled on this medicine and metformin.
Maltese: • f'kombinazzjoni ma' sulfonilurea jew insulina (tipi ta' mediċini oħra kontra d-dijabete) f'pazjenti li mhumiex ikkontrollati b'mod sodisfaċenti b'din il-mediċina u l-metformina.
English: How has Jentadueto been studied?
Maltese: Kif ġie studjat Jentadueto?
English: The most frequent side effect with the combination of linagliptin plus metformin was diarrhoea (seen in around 2% of patients, with a similar rate seen in patients taking metformin plus placebo).
Maltese: L-effett sekondarju l-aktar komuni bil-kombinazzjoni tal-linagliptina flimkien mal-metformina kien dijarea (li deher f'inqas minn 2% tal-pazjenti, b'rata simili tidher f'pazjenti li kienu qegħdin jieħdu lmetformina flimkien ma' plaċebo).
English: • a condition that could lead to reduced supply of oxygen to body tissues (such as in patients who are being treated for worsening heart failure, have recently had a heart attack, have difficulty breathing or a steep fall in blood pressure);
Maltese: • kondizzjoni li tista' twassal għal provvista mnaqqsa ta ossiġnu lejn it-tessuti tal-ġisem (bħal f'pazjenti li qed jiġu kkurati għal insuffiċjenza tal-qalb li sejra lura, riċentement soffrew attak talqalb, għandhom diffikultà biex jieħdu n-nifs jew nuqqas f'daqqa fil-pressjoni tad-demm);
English: A risk management plan has been developed to ensure that Jentadueto is used as safely and effectively as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Jentadueto jintuża bl-aktar mod sigur possibbli.
English: If Jentadueto is taken with a sulphonylurea or insulin, the dose of these medicines may need to be lowered, to avoid hypoglycaemia (low blood sugar levels).
Maltese: Jekk Jentadueto jittieħed ma' sulfonilurea jew mal-insulina, id-doża ta' dawn il-mediċini tista' teħtieġ titnaqqas, biex tiġi evitata ipogliċemija (livelli baxxi ta' zokkor fid-demm).