FrancophonIA/ELRC3.0 huggingface dataset:
English: Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Maltese: Wara l-għoti ta' doża supraterapewtika ta' 10 mg ta' linagliptin fl-istess ħin ma' 40 mg ta' simvastatin kuljum għal 6 ijiem, l-AUC ta' simvastatin fil-plażma żdiedet b'34%, u s-Cmax tal-plażma b'10%.
English: The efficacy and safety of linagliptin 2.5 mg twice daily versus 5 mg once daily in combination with metformin in patients with insufficient glycaemic control on metformin monotherapy was evaluated in a double-blind placebo-controlled study of 12 weeks duration.
Maltese: L-effikaċja u s-sigurtà ta' linagliptin 2.5 mg darbtejn kuljum versus 5 mg darba kuljum flimkien ma' metformin f'pazjenti b'kontroll insuffiċjenti taz-zokkor fid-demm fuq metformin mogħti waħdu ġew evalwati fi studju double-blind bi plaċebo bħala kontrollli dam 12-il ġimgħa.
English: Hypoglycaemia (frequency very common (may affect more than 1 in 10 people)) is an identified side effect for the combination of Jentadueto plus sulphonylurea and for the combination Jentadueto plus insulin.
Maltese: L-ipogliċemija (frekwenza: komuni ħafna) (tista' taffettwa aktar minn persuna 1 minn kull 10) hu effett sekondarju identifikat għall-kombinazzjoni ta' Jentadueto flimkien ma' sulphonylurea u għall-kombinazzjoni Jentadueto u l-insulina.
English: A statistically significant greater proportion of patients with a baseline HbA1c ≥7.0% and treated with linagliptin 5 mg achieved a target HbA1c of <7% compared to placebo.
Maltese: HbA1c ≥ 7.0% u kkurati b'linagliptin 5 mg kiseb HbA1c fil-mira ta' < 7% meta mqabbel ma' plaċebo.
English: In the treated population, severe hypoglycaemic events (requiring assistance) were reported in 3.0% of patients on linagliptin and in 3.1% on placebo.
Maltese: Fil-popolazzjoni ttrattata, avvenimenti ipogliċemiċi severi (li jeħtieġu għajnuna) kienu rrappurtati fi 3.0% tal-pazjenti fuq linagliptin u fi 3.1% ta' dawk fuq il-plaċebo.
English: After an oral dose of metformin, Tmax is reached in 2.5 hours.
Maltese: Wara doża orali ta' metformin, it-Tmax jintlaħaq fi żmien 2.5 sigħat.
English: The NOAEL for maternal-, embryo-fetal-, and offspring toxicity in rats was 49 times human exposure.
Maltese: L-NOAEL għal tossiċità materna, embriju-fetali, u tal-frieħ fil-firien kienet ta' 49 darba tal-esponiment uman.
English: After a median follow up of 6.25 years, linagliptin, when added to standard of care, did not increase the risk of major adverse cardiovascular events (table 5) as compared to glimepiride.
Maltese: Wara segwitu medjan ta' 6.25 sena, linagliptin, meta ġie miżjud ma' kura standard, ma żiedx ir-riskju ta' avvenimenti avversi kardjovaskulari maġġuri (tabella 5) meta mqabbel ma' glimepiride.
English: Both treatments were added to standard of care targeting regional standards for HbA1c and CV risk factors.
Maltese: Iż-żewġ trattamenti kienu miżjuda ma' kura standard immirata lejn standards reġjonali għal HbA1c u fatturi ta' riskju CV.
English: Incidence Rate per 1000 PY*
Maltese: 1,000 mg Darbtejn Kuljum
English: Hazard Ratio
Maltese: TAGĦRIF
English: What is type 2 diabetes?
Maltese: X'inhi dijabete ta' tip 2?
English: Linagliptin cardiovascular safety study (CAROLINA) CAROLINA was a randomized study in 6033 patients with early type 2 diabetes and increased CV risk or established complications who were treated with linagliptin 5 mg (3023) or glimepiride 1-4mg (3010) added to standard of care (including background therapy with metformin in 83% of patients) targeting regional standards for HbA1c and CV risk factors.
Maltese: Studju b'linagliptin dwar is-sigurtà kardjovaskulari (CAROLINA) CAROLINA kien studju randomised fuq 6,033 pazjent b'dijabete tat-tip 2 bikrija u riskju CV akbar jew komplikazzjonijiet stabbiliti li kienu ttrattati b'linagliptin 5 mg (3,023) jew glimepiride 1-4 mg (3,010) miżjuda ma' kura standard (inkluża terapija fl-isfond b'metformin fi 83% tal-pazjenti) li fih kienu mmirati standards reġjonali għal HbA1c u għal fatturi ta' riskju CV.
English: 500 mg Twice Daily
Maltese: 500 mg Darbtejn Kuljum
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Maltese: B12 li b'mod rari ħafna jista' jirriżulta f'defiċjenza klinikament sinifikanti ta' vitamina
English: Other risk factors for lactic acidosis are excessive alcohol intake, hepatic impairment, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Maltese: Fatturi oħra ta' riskju għal aċidożi lattika huma konsum eċċessiv ta' alkoħol, insuffiċjenza epatika, dijabete ikkontrollata b'mod mhux adegwat, ketożi, sawm fit-tul u kwalunkwe kundizzjoni assoċjata ma' nuqqas ta' ossiġnu fit-tessuti, kif ukoll l-użu fl-istess waqt ta' prodotti mediċinali li jistgħu jikkawżaw aċidożi lattika (ara sezzjonijiet 4.3 u 4.5).
English: Co-administration with 5 mg linagliptin did not alter the steady-state pharmacokinetics of levonorgestrel or ethinylestradiol.
Maltese: L-għoti flimkien ma' 5 mg ta' linagliptin ma bidilx il-farmakokinetika fl-istat fiss ta' levonorgestrel jew ethinylestradiol.
English: Linagliptin cardiovascular and renal safety study (CARMELINA) The CARMELINA study evaluated the cardiovascular and renal safety of linagliptin versus placebo in patients with type 2 diabetes and with increased CV risk evidenced by a history of established macrovascular or renal disease (see section 5.1).
Maltese: L-istudju CARMELINA evalwa s-sigurtà kardjovaskulari u renali ta' linagliptin kontra l-plaċebo f'pazjenti bid-dijabete tat-tip 2 u b'riskju CV miżjud muri permezz ta' storja ta' mard makrovaskulari jew renali stabbilit (ara sezzjoni 5.1).
English: Lactic acidosis very rare
Maltese: Aċidożi lattika rari ħafna
English: • Acute conditions with the potential to alter renal function such as: dehydration, severe infection,
Maltese: • Kundizzjonijiet akuti bil-potenzjal li jibdlu l-funzjoni tal-kliewi bħal: deidratazzjoni, infezzjoni severa, xokk.
English: Linagliptin cardiovascular and renal safety study (CARMELINA) CARMELINA was a randomized study in 6979 patients with type 2 diabetes with increased CV risk evidenced by a history of established macrovascular or renal disease who were treated with linagliptin 5 mg (3494) or placebo (3485) added to standard of care targeting regional standards for HbA1c, CV risk factors and renal disease.
Maltese: Studju dwar is-sigurtà kardjovaskulari u renali ta' linagliptin (CARMELINA) CARMELINA kien studju randomised fuq 6979 pazjent b'dijabete tat-tip 2 b'riskju CV miżjud muri permezz ta' storja ta' mard makrovaskulari jew renali stabbilit li kienu ttrattati b'linagliptin 5 mg (3494) jew plaċebo (3485) miżjuda ma' kura standard immirata lejn standards reġjonali għal HbA1c, fatturi ta' riskju CV u mard tal-kliewi.
English: In a 24-week placebo-controlled factorial study of initial therapy, linagliptin 2.5 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy as summarised in Table 3 (mean baseline HbA1c 8.65%).
Maltese: Fi studju fattorjali dwar it-terapija inizjali li dam 24 ġimgħa, bi plaċebo bħala kontroll, linagliptin 2.5 mg darbtejn kuljum flimkien ma' metformin (500 mg jew 1,000 mg darbtejn kuljum) ipprovda titjib sinifikanti fil-parametri glikemiċi meta mqabbel jew ma' xi waħda mill-mediċini mogħtija waħidha kif deskritt fil-qosor f'Tabella 3 (medja ta' HbA1c fil-linja bażi ta' 8.65%).
English: (1) reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, (2) in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilisation,
Maltese: (2) fil-muskoli, billi jżid is-sensittività għall-insulina, u jtejjeb l-assorbiment u l-użu tal-glucose periferali, (3) u d-dewmien tal-assorbiment tal-glucose intestinali.
English: Safety data from this study was in line with previous known safety profile of linagliptin.
Maltese: Data dwar is-sigurtà minn dan l-istudju kienet konformi mal-profil tassigurtà preċedenti magħruf ta' linagliptin.
English: Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes.
Maltese: Linagliptin hu impeditur kompetittiv dgħajjef u impeditur minn dgħajjef sa moderat ibbażat fuq mekkaniżmu ta' isożima CYP, CYP3A4, iżda ma jimpedixxix isożimi oħrajn ta' CYP. Mhuwiex induttur ta' isożimi ta' CYP.
English: Some patients have experienced the following side effects while taking Jentadueto with insulin - Uncommon: liver function disorders, constipation
Maltese: Xi pazjenti kellhom l-effetti sekondarji li ġejjin waqt li kienu qed jieħdu Jentadueto mal-insulina - Mhux komuni: disturbi fil-funzjoni tal-fwied, stitikezza
English: Jentadueto 2.5 mg/850 mg are oval, biconvex, light orange, film-coated tablets (tablets).
Maltese: Jentadueto 2.5 mg/850 mg huma pillola (pilloli) miksija b'rita, ovali, bikonvessi, ta' lewn oranġjo ċar.
English: Jentadueto 2.5 mg / 850 mg film-coated tablets Jentadueto 2.5 mg / 1,000 mg film-coated tablets linagliptin/metformin hydrochloride
Maltese: Jentadueto 2.5 mg / 850 mg pilloli miksija b'rita Jentadueto 2.5 mg / 1,000 mg pilloli miksija b'rita linagliptin/metformin hydrochloride
English: Linagliptin 24 month data, as add-on to metformin in comparison with glimepiride In a study comparing the efficacy and safety of the addition of linagliptin 5 mg or glimepiride (mean dose 3 mg) in patients with inadequate glycaemic control on metformin monotherapy, mean reductions in HbA1c were -0.16% with linagliptin (mean baseline HbA1c 7.69%) and -0.36% with glimepiride (mean baseline HbA1c 7.69%.)
Maltese: Fi studju li qabbel l-effikaċja u s-sigurtà taż-żieda ta' linagliptin 5 mg jew glimepiride (doża medja ta' 3 mg) f'pazjenti b'kontroll gliċemiku inadegwat li kienu fuq terapija b'metformin mogħti waħdu, it-tnaqqis medju f'HbA1c kien ta' -0.16% b'linagliptin (medja fil-linja bażi ta' HbA1c ta' 7.69%) u -0.36% bi glimepiride (medja tal-linja bażi ta' HbA1c ta' 7.69%) b'medja ta' differenza fit-trattament ta' 0.20% (97.5% CI: 0.09, 0.299).
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelluli ħomor tad-demm x'aktarx li l-aktar jirrappreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: Some symptoms need immediate medical attention You should stop taking Jentadueto and see your doctor straight away if you experience the following symptoms of low blood sugar (hypoglycaemia): trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change, or confusion.
Maltese: Xi sintomi jeħtieġu attenzjoni medika immedjata Għandek tieqaf tieħu Jentadueto u tara lit-tabib tiegħek immedjatament jekk ikollok is-sintomi li ġejjin ta' livell ta' zokkor baxx fid-demm (ipogliċemija): rogħda, għaraq, ansjetà, vista mċajpra, tnemnim fix-xufftejn, sfurija, tibdil fil-burdata jew konfużjoni.
English: Patients received metformin and/or sulphonylurea and/or insulin as background therapy.
Maltese: Il-pazjenti rċivew metformin u/jew sulphonylurea u/jew insulina bħala terapija fl-isfond.
English: Co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.
Maltese: L-għoti flimkien ta' dożi multipli orali ta' 5 mg ta' linagliptin u doża orali waħda ta' 1.75 mg ta' glibenclamide (glyburide) irriżulta fi tnaqqis klinikament mhux rilevanti ta' 14% kemm tal-AUC kif ukoll tas-Cmax ta' glibenclamide.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/032 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/033 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/034 (200 (2 x 100 x 1) film-coated tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/780/032 (120 (2 x 60 x 1) pillola miksija b'rita) EU/1/12/780/033 (180 (2 x 90 x 1) pillola miksija b'rita) EU/1/12/780/034 (200
English: Elderly Caution should be exercised when treating patients 80 years and older (see section 4.2).
Maltese: Għandu jkun hemm kawtela meta tingħata kura lil pazjenti li għandhom 80 sena u aktar (ara sezzjoni 4.2).
English: The incidence of hypoglycaemia in the linagliptin group (7.5%) was significantly lower than that in the glimepiride group (36.1%).
Maltese: L-inċidenza ta' ipogliċemija fil-grupp ta' linagliptin (7.5%) kienet iktar baxxa b'mod sinifikanti minn dik fil-grupp ta' glimepiride (36.1%).
English: These changes in linagliptin pharmacokinetics were not considered to be clinically relevant.
Maltese: Dan it-tibdil fil-farmakokinetika ta' linagliptin ma kienx ikkunsidrat li kien klinikament rilevanti.
English: - if you have liver problems.
Maltese: - jekk għandek problemi tal-fwied.
English: Linagliptin provided significant improvements in HbA1c (-0.64% change compared to placebo after 24 weeks), from a mean baseline HbA1c of 7.8%.
Maltese: Linagliptin ipprovda titjib sinifikanti fl-HbA1c (bidla ta' -0.64% meta mqabbel mal-plaċebo wara 24 ġimgħa), minn medja ta' HbA1c fil-linja bażi ta' 7.8%.
English: Bullous pemphigoid has been observed in patients taking linagliptin.
Maltese: L-ebda metaboliti ma ġew identifikati fil-bnedmin.
English: Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Maltese: Xi pazjenti kellhom raxx (frekwenza mhix komuni), urtikarja (frekwenza rari), u nefħa tal-wiċċ, xufftejn, ilsien, u tal-gerżuma li tista' tikkawża diffikultà biex tieħu n-nifs jew tibla' (anġjoedema; frekwenza rari).
English: Older subjects (65 to 80 years, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Maltese: II. Persuni aktar anzjani (65 sa 80 sena, l-ixjeħ pazjent kellu 78 sena) kellhom konċentrazzjonijiet ta' linagliptin fil-plażma li kienu komparabbli ma' dawk ta' persuni iżgħar.
English: The safety and efficacy of Jentadueto in children and adolescents aged 0 to 18 years have not been established.
Maltese: Jentadueto huwa kontraindikat fit-tfal u adolexxenti minn età ta' 0 sa 18-il sena ma ġewx determinati s'issa.
English: Age did not have a clinically relevant impact on the pharmacokinetics of linagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Maltese: L-età ma kellha l-ebda impatt klinikament rilevanti fuq il-farmakokinetika ta' linagliptin ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' dejta minn Fażi I u Fażi
English: No teratogenic effects were observed in rabbits at > 1,000 times human exposure.
Maltese: L-ebda effetti teratoġeniċi ma' ġew osservati fil-fniek f'> 1,000 darba tal-esponiment uman.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Maltese: Sintomi ta' aċidożi lattika jinkludu: rimettar uġigħ fl-istonku (uġigħ addominali) bugħawwieġ fil-muskoli sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa diffikultà biex tieħu n-nifs temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: This has been shown at therapeutic doses in controlled, medium-term or longterm clinical studies: metformin hydrochloride reduces total cholesterol, LDL cholesterol and triglyceride levels.
Maltese: Dan intwera f'dożi terapewtiċi fi studji kliniċi kkontrollati, li damu għal żmien medju jew twil: metformin hydrochloride inaqqas il-livelli tal-kolesterol totali, ta' LDL kolesterol u tat-triglycerides.
English: Linagliptin as add on to a combination of metformin and empagliflozin therapy In patients inadequately controlled with metformin and empagliflozin (10 mg (n=247) or 25 mg (n=217)), 24-weeks treatment with add-on therapy of linagliptin 5 mg provided adjusted mean HbA1c reductions from baseline by -0.53% (significant difference to add-on placebo -0.32% (95% CI -0.52, -0.13) and -0.58% (significant difference to add-on placebo -0.47% (95% CI -0.66; -0.28), respectively.
Maltese: Linagliptin bħala mediċina addizjonali ma' kombinazzjoni ta' terapija b'metformin u empagliflozin F'pazjenti li mhumiex ikkontrollati b'mod adegwat b'metformin u empagliflozin (10 mg (n=247) jew 25 mg (n=217)), trattament ta' 24 ġimgħa b'mediċina addizzjonali ta' linagliptin 5 mg irriżulta fi tnaqqis medju fl-HbA1c aġġustat mil-linja bażi b'-0.
English: Evaluation should include serum electrolytes and ketones, blood glucose and, if indicated, blood pH, lactate, pyruvate, and metformin levels.
Maltese: L-evalwazzjoni għandha tinkludi l-livell ta' elettroliti u ketoni fis-serum, il-livell tal-glucose fid-demm u, jekk indikat, il-pH tad-demm, u l-livelli ta' lactate, pyruvate, u metformin.
English: Metformin is a substrate of both transporters OCT1 and OCT2.
Maltese: Trasportaturi ta' ketajins organiċi (OCT - organic cation transporters) Metformin huwa sottostrat kemm tat-trasportaturi OCT1 kif ukoll ta' OCT2.
English: Metabolism plays a subordinate role in the elimination of linagliptin.
Maltese: Il-metaboliżmu għandu rwol subordinat fl-eliminazzjoni ta' linagliptin.
English: The study was designed to demonstrate non-inferiority for the primary cardiovascular endpoint which was a composite of the first occurrence of cardiovascular death or a non-fatal myocardial infarction (MI) or a non-fatal stroke (3P-MACE).
Maltese: L-istudju kien maħsub biex juri nuqqas ta' inferjorità għall-punt finali kardjovaskulari primarju li kien kompost mill-ewwel okkorrenza ta' mewt kardjovaskulari jew infart mijokardijaku (MI - myocardial infarction) mhux fatali jew puplesija mhux fatali (3P-MACE).
English: • Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction,
Maltese: • Marda li tista' tikkawża nuqqas ta' ossiġnu fit-tessuti (b'mod speċjali marda akuta, jew aggravament ta' marda kronika) bħal insuffiċjenza kardijaka mhux kumpensata, insuffiċjenza respiratorja, infart mijokardijaku riċenti, u xokk.
English: For the different doses of metformin, Jentadueto is available in strengths of 2.5 mg linagliptin plus 850 mg metformin hydrochloride and 2.5 mg linagliptin plus 1,000 mg metformin hydrochloride.
Maltese: Għad-dożi differenti ta' metformin, Jentadueto hu disponibbli f'qawwiet ta' 2.5 mg ta' linagliptin flimkien ma' 850 mg ta' metformin hydrochloride u 2.5 mg ta' linagliptin flimkien ma' 1,000 mg ta' metformin hydrochloride.
English: If you take more Jentadueto tablets than you should have, you may experience lactic acidosis.
Maltese: Jekk tieħu Jentadueto pilloli aktar milli suppost, jista' jkollok aċidożi lattika.
English: • Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.
Maltese: • Inibituri ta' OCT1 (bħal verapamil) jista' jnaqqas l-effikaċja ta' metformin.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD11
Maltese: Mediċini li jintużaw kontra d-dijabete, kombinazzjonijiet ta' mediċini orali li jbaxxu l-livelli tal-glucose fid-demm, Kodiċi ATC:
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/780/029 (120 (2 x 60 x 1) film-coated tablets) EU/1/12/780/030 (180 (2 x 90 x 1) film-coated tablets) EU/1/12/780/031 (200 (2 x 100 x 1) film-coated tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/12/780/029 (120 (2 x 60 x 1) pillola miksija b'rita) EU/1/12/780/030 (180 (2 x 90 x 1) pillola miksija b'rita) EU/1/12/780/031 (200 (2 x 100 x 1) pillola miksija b'rita)
English: In rats, effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1500 times human exposure.
Maltese: Fil-firien, l-effetti fuq l-organi riproduttivi, it-tirojde u l-organi limfojde ġew osservati f'livell ta' iktar minn 1,500 darba tal-esponiment uman.
English: The dose of Jentadueto should provide linagliptin dosed as 2.5 mg twice daily (5 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Maltese: Id-doża ta' Jentadueto għandha tipprovdi linagliptin iddożat bħala 2.5 mg darbtejn kuljum (5 mg doża totali ta' kuljum) u doża ta' metformin simili għad-doża li diġà tkun qed tittieħed.
English: The most frequently reported adverse reaction for linagliptin plus metformin was diarrhoea (1.6%) with a comparable rate on metformin plus placebo (2.4%).
Maltese: L-iktar reazzjoni avversa li ġiet irrappurtata b'mod frekwenti għal linagliptin flimkien ma' metformin kienet id-dijarea (1.6%) b'rata komparabbli fuq metformin flimkien ma' plaċebo (2.4%).
English: Linagliptin as add-on to a combination of metformin and sulphonylurea therapy A placebo-controlled study of 24 weeks in duration was conducted to evaluate the efficacy and safety of linagliptin 5 mg to placebo, in patients not sufficiently treated with a combination with metformin and a sulphonylurea.
Maltese: Linagliptin bħala mediċina addizzjonali ma' kombinazzjoni ta' terapija b'metformin u sulphonylurea Sar studju bi plaċebo bħala kontroll li dam 24 ġimgħa biex jevalwa l-effikaċja u s-sigurtà ta' linagliptin 5 mg mal-plaċebo, f'pazjenti mhux ittrattati biżżejjed b'kumbinazzjoni ma' metformin u sulphonylurea.
English: Oval, biconvex, light pink, film-coated tablet of 21.1 mm x 9.7 mm debossed with ”D2/1000" on one side and the company logo on the other.
Maltese: Jentadueto 2.5 mg/1,000 mg pilloli miksija b'rita Pillola miksija b'rita, ovali, bikonvessa, ta' lewn roża ċar, ta' 21.1 mm x 9.7 mm imnaqqxa b'"D2/1000" fuq naħa waħda u l-logo tal-kumpanija fuq in-naħa l-oħra.
English: * Based on lipase elevations >3xULN observed in clinical trials # Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reactions reported in patients who received metformin as monotherapy and that were not observed in patients receiving Jentadueto.
Maltese: * Ibbażat fuq żidiet fil-lipase >3xULN osservati fi provi kliniċi Ibbażat fuq l-Istudju dwar is-sigurtà kardjovaskulari u renali ta' linagliptin (CARMELINA), ara wkoll hawn taħt Reazzjonijiet avversi rrappurtati f'pazjenti li rċivew metformin bħala monoterapija u li ma kinux osservati f'pazjenti li kienu qed jirċievu Jentadueto.
English: Lactic acidosis is a medical emergency and must be treated in hospital.
Maltese: L-aċidożi lattika hi emerġenza medika u trid tiġi kkurata fi sptar.
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (li jingħataw permezz ta' rotot sistemiċi u lokali) agonisti beta-2, u dijuretiċi, għandhom attività iperglikemika intrinsika.
English: NAME OF THE MEDICINAL PRODUCT Jentadueto 2.5 mg/850 mg film-coated tablets Jentadueto 2.5 mg/1,000 mg film-coated tablets
Maltese: Jentadueto 2.5 mg/850 mg pilloli miksija b'rita Jentadueto 2.5 mg/1,000 mg pilloli miksija b'rita
English: In patients with mild moderate and severe hepatic impairment (according to the Child-Pugh classification), mean AUC and Cmax of linagliptin were similar to healthy matched controls following administration of multiple 5 mg doses of linagliptin.
Maltese: F'pazjenti b'indeboliment ħafif, moderat u sever tal-fwied (skont il-klassifikazzjoni ta' Child-Pugh), il-medja tal-AUC u tas-Cmax ta' linagliptin kienet simili għal kontrolli mqabbla b'saħħithom wara l-għoti ta' dożi multipli ta' 5 mg ta' linagliptin.