FrancophonIA/ELRC3.0 huggingface dataset:
English: Consistent with the half life, up to 22 % accumulation, with respect to plasma AUC, was observed at steady state.
Maltese: B'mod konsistenti mal-half-life, sa 22% akkumulazjoni, fir-rigward ta' AUC tal-plażma, ġiet osservata fl-istadju fiss.
English: Frequency categories are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenzi huma mfissra bħala komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), jew rari ħafna (< 1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: At baseline, 74 % of patients were being treated with metformin, 48 % with insulin, and 43 % with a sulfonylurea.
Maltese: Fil-linja bażi, 74 % tal-pazjenti kienu qegħdin jiġu ttrattati b'metformin, 48 % bl-insulina, u 43 % b'sulfonylurea.
English: Linagliptin cardiovascular and renal safety (CARMELINA) study
Maltese: Studju dwar is-sigurtà kardjovaskulari u renali ta' linagliptin (CARMELINA)
English: In moderate renal impairment, a moderate increase in exposure of about 1.7-fold was observed compared with control.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi, ġiet osservata żieda moderata fl-esponiment ta' madwar 1.7 darbiet meta mqabbla mal-kontroll.
English: Co-administration of empagliflozin with probenecid, an inhibitor of UGT enzymes and OAT3, resulted in a 26 % increase in peak empagliflozin plasma concentrations (Cmax) and a 53 % increase in area under the concentration-time curve (AUC).
Maltese: L-għoti flimkien ta' empagliflozin ma' probenecid, impeditur ta' enzimi UGT u OAT3, irriżulta f'żieda ta' 26% fl-ogħla konċentrazzjonijiet ta' empagliflozin fil-plażma (Cmax) u żieda ta' 53% fl-erja ta' taħt il-kurva ta' konċentrazzjoni mal-ħin (AUC).
English: For FPG, baseline FPG is also included.
Maltese: Għal FPG, huwa inkluż ukoll l-FPG tal-linja bażi.
English: Co-administration of a single 5 mg oral dose of linagliptin and multiple 200 mg oral doses of ritonavir, a potent inhibitor of P-glycoprotein and CYP3A4, increased the AUC and Cmax of linagliptin approximately twofold and threefold, respectively.
Maltese: L-għoti flimkien ta' doża waħda orali ta' 5 mg ta' linagliptin u dożi orali multipli ta' 200 mg ta' ritonavir, impeditur potenti ta' P-glikoproteina u CYP3A4, żiedu l-AUC u s-Cmax ta' linagliptin b'madwar id-doppju u t-tripplu, rispettivament.
English: A total of 6033 patients were treated (linagliptin 5 mg: 3023, glimepiride 1 mg to 4 mg: 3010) and followed for a median of 6.25 years.
Maltese: Total ta' 6,033 pazjent kienu ttrattati (linagliptin 5 mg: 3,023, glimepiride 1 mg sa 4 mg: 3,010) u segwiti għal medjan ta' 6.25 sena.
English: Overall, the safety profile of Glyxambi was in line with the safety profiles of the individual active substances (empagliflozin and linagliptin).
Maltese: B'mod ġenerali, il-profil tas-sigurtà ta' Glyxambi kien f'konformità mal-profili tas-sigurtà tas-sustanzi attivi individwali (empagliflozin u linagliptin).
English: Glyxambi showed a similar food effect as the individual active substances.
Maltese: Glyxambi wera effett simili mal-ikel bħas-sustanzi attivi individwali.
English: Do not take Glyxambi: - if you are allergic to empagliflozin, linagliptin, any other SGLT2 inhibitor (e.g. dapagliflozin, canagliflozin), any other DPP-4 inhibitor (e.g. sitagliptin, vildagliptin), or any of the other ingredients of this medicine (listed in section 6).
Maltese: Tiħux Glyxambi: - jekk inti allerġiku għal empagliflozin, linagliptin, kwalunkwe impeditur ta' SGLT2 ieħor (eż. dapagliflozin, canagliflozin), kwalunkwe impeditur ta' DPP-4 (eż. sitagliptin, vildagliptin), jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fis-sezzjoni 6).
English: In empagliflozin trials, vaginal moniliasis, vulvovaginitis, balanitis and other genital infections were reported more frequently for empagliflozin 10 mg (4.0 %) and empagliflozin 25 mg (3.9 %) compared to placebo (1.0 %).
Maltese: Fi provi b'empagliflozin, monolijasi vaġinali, vulvovaġinite, balanite u infezzjonijiet ġenitali oħra kienu rapportati bi frekwenza akbar għal empagliflozin 10 mg (4.0 %) u empagliflozin 25 mg (3.9 %) meta mqabbel ma' plaċebo (1.0 %).
English: C]-empagliflozin solution to healthy volunteers, approximately 96 % of the drug-related radioactivity was eliminated in faeces (41 %) or urine (54 %).
Maltese: C]-empagliflozin lil voluntiera b'saħħithom, madwar 96% tar-radjuattività marbuta mal-mediċina ġiet eliminata fl-ippurgar (41%) jew fl-awrina (54%).
English: In vitro studies suggest that the primary route of metabolism of empagliflozin in humans is glucuronidation by the uridine 5'diphospho-glucuronosyltransferases UGT2B7, UGT1A3, UGT1A8 and UGT1A9.
Maltese: Studji in vitro jissuġerixxu li r-rotta prinċipali ta' metaboliżmu ta' empagliflozin fil-bniedem hi l-glukuronidazzjoni permezz ta' uridine 5'-diphosphoglucuronosyltransferases UGT2B7, UGT1A3, UGT1A8, u UGT1A9.
English: The double-blind parallel group CAROLINA study evaluated the cardiovascular safety of linagliptin versus glimepiride as adjunct to standard care therapy in patients with type 2 diabetes and with increased CV risk.
Maltese: CAROLINA kien studju double-blind bi grupp parallel li evalwa s-sigurtà kardjovaskulari ta' linagliptin kontra glimepiride bħala żieda ma' terapija ta' kura standard f'pazjent bid-dijabete tat-tip 2 u b'riskju CV miżjud.
English: 45-60 ml/min/1.73 m2 and 7.7 % of 30-45 ml/min/1.73 m
Maltese: Madwar nofs il-pazjenti (52.2 %) kellhom eGFR ta' 60-90 ml/min/1.73 m 17.8 % ta' 45-60 ml/min/1.73 m2 u 7.7 % ta' 30-45 ml/min/1.73 m
English: In addition patients with T2DM and severe renal impairment (<30 mL/min) were compared to T2DM patients with normal renal function.
Maltese: Ukoll, pazjenti b'T2DM u indeboliment sever tal-kliewi (< 30 mL/min), tqabblu ma' pazjenti b'T2DM b'funzjoni normali tal-kliewi.
English: Insulin and sulphonylureas may increase the risk of hypoglycaemia.
Maltese: L-insulina u sulfonylureas jistgħu jgħollu r-riskju ta' ipogliċemija.
English: Liver, kidneys, stomach, reproductive organs, thymus, spleen, and lymph nodes were target organs of toxicity in Cynomolgus monkeys at more than 450-times the clinical exposure.
Maltese: Il-fwied, il-kliewi, l-istonku, l-organi riproduttivi, it-timu, il-milsa, u l-għoqod limfatiċi kienu organi fil-mira ta' tossiċità f'xadini Cynomolgus f'iktar minn 450 darba l-esponiment kliniku.
English: Focal areas of hepatocellular necrosis were found in the combination groups at ≥15: 30 mg/kg linagliptin: empagliflozin (3.8 times the clinical exposure for linagliptin and 7.8 times the clinical exposure for empagliflozin) as well as in the group treated with empagliflozin alone but not in the control group.
Maltese: Oqsma fokali ta' nekrożi epatoċellulari nstabu fil-gruppi tal-kombinazzjoni f'≥ 15: 30 mg/kg linagliptin: empagliflozin (3.8 darbiet l-esponiment kliniku għal linagliptin u 7.8 darbiet l-esponiment kliniku għal empagliflozin) kif ukoll fil-grupp ittrattat b'empagliflozin waħdu iżda mhux fil-grupp ta' kontroll.
English: One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “25/5” (tablet dimensions: 8 mm each side).
Maltese: Fuq naħa waħda hemm imnaqqxa s-simbolu tal-kumpanija Boehringer Ingelheim, fuq in-naħa l-oħra hemm imnaqqxa “25/5” (id-daqsijiet tal-pillola: 8 mm fuq kull naħa).
English: A total of 2,173 patients with type 2 diabetes mellitus and inadequate glycaemic control were treated in clinical studies to evaluate the safety and efficacy of Glyxambi; 1,005 patients were treated with Glyxambi 10 mg empagliflozin/5 mg linagliptin or 25 mg empagliflozin/5 mg linagliptin.
Maltese: Total ta' 2,173 pazjent b'dijabete mellitus ta' tip 2 u kontroll gliċemiku mhux adegwat kienu ttrattati fi studji kliniċi sabiex jiġu evalwati s-sigurtà u l-effikaċja ta' Glyxambi; 1,005 pazjenti kienu ttrattati b'Glyxambi 10 mg empagliflozin/5 mg linagliptin jew 25 mg empagliflozin/5 mg linagliptin.
English: One side is debossed with the Boehringer Ingelheim company symbol, the other side is debossed with “10/5” (tablet dimensions: 8 mm each side).
Maltese: Fuq naħa waħda hemm imnaqqxa s-simbolu tal-kumpanija Boehringer Ingelheim, fuq in-naħa l-oħra hemm imnaqqxa “10/5” (id-daqsijiet tal-pillola: 8 mm fuq kull naħa).
English: 7 x 1 film-coated tablets 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 60 x 1 film-coated tablets 70 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: 7 x 1 pillola miksija b'rita 10 x 1 pillola miksija b'rita 14 x 1 pillola miksija b'rita 28 x 1 pillola miksija b'rita 30 x 1 pillola miksija b'rita 60 x 1 pillola miksija b'rita 70 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: In patients with mild, moderate and severe hepatic insufficiency (Child-Pugh classification), mean AUC and Cmax of empagliflozin increased (AUC by 23 %, 47 %, 75 % and Cmax by 4 %, 23 %,48 %) compared to subjects with normal hepatic function (see section 4.2).
Maltese: F'individwi b'indeboliment tal-kliewi ħafif, moderat u sever (klassifikazzjoni ta' Child Pugh), il-medja tal-AUC u tas-Cmax ta' empagliflozin żdiedet (AUC bi 23%, 47%, 75% u Cmax b'4%, 23%,48%) meta mqabbla ma' individwi b'funzjoni tal-kliewi normali (ara sezzjoni 4.2).
English: In clinical trials with Glyxambi, the frequency of patients with increased blood creatinine (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0%) and decreased glomerular filtration rate (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.6%) has been comparable to those reported from the empagliflozin clinical trials.
Maltese: Fi provi kliniċi b'Glyxambi, il-frekwenza ta' pazjenti b'żieda fil-krejatinina fid-demm (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0%) u tnaqqis fir-rata ta' filtrazzjoni glomerulari (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.6%) kienet komparabbli ma' dawk rapportati mill-provi kliniċi b'empagliflozin.
English: Major hypoglycaemia with empagliflozin (events requiring assistance)
Maltese: Ipogliċemija maġġuri b'empagliflozin (avvenimenti li jeħtieġu għajnuna)
English: No clinically relevant difference in pharmacokinetics of empagliflozin and linagliptin were seen in population pharmacokinetic analysis and dedicated phase I studies.
Maltese: L-ebda differenza klinikament rilevanti fil-farmakokinetika ta' empagliflozin u linagliptin ma kienu osservati f'analiżi farmakokinetika tal-popolazzjoni u studji tal-Fażi I dedikati.
English: • In patients with an estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m2 or creatinine clearance (CrCl) ≥60 mL/min, no dose adjustment is required.
Maltese: • F'pazjenti li għandhom rata ta' filtrazzjoni glomerulari stmata (eGFR, estimated glomerular filtration rate) ta' ≥ 60 mL/min/1.73 m jew rata ta' tneħħija ta' kreatinina (CrCl) ta' ≥ 60 mL/min, mhu meħtieġ l-ebda aġġustament fid-doża.
English: One main metabolite with a relative exposure of 13.3 % of linagliptin at steady-state was detected which was found to be pharmacologically inactive and thus to not contribute to the plasma DPP-4 inhibitory activity of linagliptin.
Maltese: Metabolit ewlieni wieħed b'esponiment relattiv ta' 13.3% ta' linagliptin fl-istat fiss, ġie osservat u nstab li kien farmakoloġikament inattiv u għaldaqstant ma jikkontribwixxix għall-attività impeditorja ta' DPP-4 fil-plażma ta' linagliptin.
English: In clinical trials with empagliflozin, the overall frequency of patients with increased blood creatinine and decreased glomerular filtration rate were similar between empagliflozin and placebo (blood creatinine increased: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, placebo 0.5%; glomerular filtration rate decreased: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, placebo 0.3%).
Maltese: Fi provi kliniċi b'empagliflozin, il-frekwenza globali ta' pazjenti b'żieda fil-krejatinina fid-demm u tnaqqis fir-rata ta' filtrazzjoni glomerulari kienet simili bejn empagliflozin u plaċebo (żieda fil-krejatinina fid-demm: empagliflozin 10 mg 0.6%, empagliflozin 25 mg 0.1%, plaċebo 0.5%; tnaqqis fir-rata ta' filtrazzjoni glomerulari: empagliflozin 10 mg 0.1%, empagliflozin 25 mg 0%, plaċebo 0.3%).
English: Table 5 Treatment effect for the primary composite endpoint, its components and mortality
Maltese: Tabella 5 Effett tat-trattament għall-punt ta' tmiem kompost primarju, il-komponenti tiegħu u l-mortalità tiegħu
English: Patients ( %) achieving HbA1c <7 % with baseline HbA1c ≥7 % - 24 weeks
Maltese: Pazjenti (%) li jiksbu HbA1c < 7% b'HbA1c fil-linja bażi ≥ 7% - 24 ġimgħa
English: C] linagliptin dose to healthy subjects, approximately 85 % of the administered radioactivity was eliminated in faeces (80 %) or urine (5 %) within 4 days of dosing.
Maltese: C] lil persuni b'saħħithom, madwar 85% tar-radjuattività mogħtija ġiet eliminata fl-ippurgar (80%) jew fl-awrina (5%) fi żmien 4 ijiem mid-dożaġġ.
English: Linagliptin did not increase the risk of the combined endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke (MACE-3) [Hazard Ratio (HR)=0.98; (95 % CI 0.84, 1.14); p<0.0001 for non-inferiority], when added to standard of care in adult patients with type 2 diabetes with increased CV risk compared to glimepiride (see Table 6).
Maltese: Linagliptin ma żiedx ir-riskju tal-punt finali kkombinat ta' mewt CV, infart mijokardijaku mhux fatali jew puplesija mhux fatali (MACE-3) [Proporzjon ta' periklu (HR - Hazard Ratio)=0.98; (CI ta' 95 % 0.84, 1.14); p<0.0001 għal nuqqas ta' inferjorità], meta miżjud ma' kura standard f'pazjenti adulti b'dijabete tat-tip 2 b'riskju CV akbar meta mqabbel ma' glimepiride (ara Tabella 6).
English: At week 12, an adjusted mean (SE) improvement in HbA1c when compared to baseline of 0.11 % (0.02) in the placebo group, 0.65 % (0.02) and 0.71 % (0.02) in the empagliflozin 10 and 25 mg groups was observed.
Maltese: F'Ġimgħa 12, kien osservat titjib fil-medja aġġustata (SE) fl-HbA1c meta mqabbel mal-linja bażi ta' 0.11 % (0.02) fil-grupp tal-plaċebo, u 0.65 % (0.02) u 0.71 % (0.02) fil-gruppi ta' empagliflozin 10 u 25 mg.
English: The frequency of patients with hypoglycaemia was increased in patients treated with empagliflozin compared to placebo when given as add-on to metformin plus sulphonylurea (empagliflozin 10 mg: 16.1 %, empagliflozin 25 mg: 11.5 %, placebo: 8.4 %), add-on to basal insulin +/- metformin and +/-sulphonylurea (empagliflozin 10 mg: 19.5 %, empagliflozin 25 mg: 28.4 %, placebo: 20.6 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg and 25 mg: 36.1 %, placebo 35.3 % over the 78 week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 39.8 %, empagliflozin 25 mg: 41.3 %, placebo: 37.2 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 51.1 %, empagliflozin 25 mg: 57.7 %, placebo: 58 % over the 52-week trial).
Maltese: Il-frekwenza ta' pazjenti b'ipogliċemija żdiedet f'pazjenti ttrattati b'empagliflozin mqabbla ma' plaċebo meta mogħti bħala terapija aġġuntiva ma' metformin u sulfonylurea (empagliflozin 10 mg: 16.1%, empagliflozin 25 mg: 11.5%, plaċebo: 8.4%), terapija aġġuntiva għal insulina bażali +/- metformin u +/- sulfonylurea (empagliflozin 10 mg: 19.5%, empagliflozin 25 mg: 28.4%, plaċebo: 20.6 waqt l-ewwel 18-il ġimgħa ta' trattament meta l-insulina ma setgħetx tiġi aġġustata; empagliflozin 10 mg u 25 mg: 36.1%, plaċebo 35.3% fuq prova ta' 78 ġimgħa), u terapija aġġuntiva għal insulina
English: Linagliptin was a substrate for OATP8-, OCT2-, OAT4-, OCTN1- and OCTN2, suggesting a possible OATP8-mediated hepatic uptake, OCT2-mediated renal uptake and OAT4-, OCTN1- and OCTN2mediated renal secretion and reabsorption of linagliptin in vivo.
Maltese: Linagliptin kien sottostrat għal OATP8-, OCT2-, OAT4-, OCTN1- u OCTN2, li jissuġġerixxi teħid mill-fwied medjat b'OATP8 possibbli, teħid mill-kliewi medjat b'OCT2 u sekrezzjoni u riassorbiment mill-kliewi medjati b' OAT4-, OCTN1- u OCTN2 ta' linagliptin in vivo.
English: • blistering of skin (bullous pemphigoid)
Maltese: • infafet tal-ġilda (pemfigojd bulluża)
English: Elderly subjects (65 to 80 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Maltese: Persuni aktar anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta' linagliptin fil-plażma li kienu komparabbli ma' dawk ta' persuni iżgħar.
English: Linagliptin 5 mg in patients inadequately controlled on metformin and empagliflozin 10 mg or empagliflozin 25 mg
Maltese: Linagliptin 5 mg f'pazjenti mingħajr kontroll adegwat fuq metformin u empagliflozin 10 mg jew empagliflozin 25 mg
English: Bullous pemphigoid
Maltese: Żieda fil-lipase
English: It is responsible, as the predominant transporter, for the reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: Huwa responsabbli, bħala t-trasportatur predominanti, għar-riassorbiment ta' glukożju mill-filtrat glomerulari lura għal ġoċ-ċirkolazzjoni.
English: The study population included 1211 (17.4 %) patients ≥ 75 years of age, the mean HbA1c was 8.0 %, 63 % were male.
Maltese: Il-popolazzjoni tal-istudju kienet tinkludi 1211-il pazjent (17.4%) b'età ta' ≥ 75 sena, l-HbA1c medja kienet ta' 8.0%, 63% kienu rġiel.
English: • In patients with an eGFR <60 mL/min/1.73 m 2 or CrCl <60 mL/min, Glyxambi should not be initiated.
Maltese: • F'pazjenti li għandhom eGFR ta' < 60 mL/min/1.73 m 2 jew CrCl ta' < 60 mL/min, ma għandux jingħata Glyxambi.
English: After 24-weeks treatment with empagliflozin, both systolic and diastolic blood pressures were reduced, -2.6/-1.1 mmHg (n.s. versus placebo for SBP and DBP) for empagliflozin 25 mg and -1.3/-0.1 mmHg (n.s. versus placebo for SBP and DBP) for empagliflozin 10 mg.
Maltese: Wara trattament ta' 24 ġimgħa b'empagliflozin, kemm il-pressjoni tad-demm sistolika kif ukoll dik dijastolika naqsu, -2.6/-1.1 mmHg (n.s. kontra plaċebo għal SBP u DBP) għal empagliflozin 25 mg u -1.3/-0.1 mmHg (n.s. kontra plaċebo għal SBP u DBP) għal empagliflozin 10 mg.
English: At exposures greater than 1,500-times the clinical exposure, side effects on reproductive organs, thyroid and the lymphoid organs were seen in rats.
Maltese: Meta esposti għal dożi ta' iktar minn 1,500 darba d-doża klinika, ġew osservati effetti sekondarji fuq l-organi riproduttivi, it-tirojde u l-organi limfojdi fil-firien.
English: • increased pancreas enzyme lipase
Maltese: • żieda fil-lipase tal-enzimi tal-frixa
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2 and 4.5).
Maltese: Tnaqqis fid-doża ta' sulfonylurea jew insulina, tista' tiġi kkunsidrata (ara sezzjonijiet 4.2 u 4.5).
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection
Maltese: Monilijasi vaġinali, vulvovaġinite, balanite u infezzjoni ġenitali oħra
English: Experience with empagliflozin in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with empagliflozin in NYHA class III-IV.
Maltese: L-esperjenza b'empagliflozin fi klassi I-II tan-New York Heart Association hija ristretta, u m'hemmx esperjenza fi studji kliniċi b'empagliflozin fi klassi III-IV ta' NYHA.
English: Patients ( %) achieving HbA1c <7 % with baseline HbA1c ≥7 %24 weeks
Maltese: Pazjenti (%) li jiksbu HbA1c < 7% b'HbA1c fil-linja bażi ≥ 7%24 ġimgħa
English: The frequencies were comparable to the incidence of urinary tract infections in empagliflozin clinical trials (see section 4.8).
Maltese: Il-frekwenzi kienu komparabbli għall-inċidenza ta' infezzjonijiet tal-passaġġ urinarju fil-provi kliniċi b'empagliflozin (ara sezzjoni 4.8).
English: Haematocrit increased Serum lipids increased Blood creatinine increased/Glomerular filtration rate decreased derived from empagliflozin experiences derived from linagliptin experiences derived from linagliptin postmarketing experience derived from empagliflozin postmarketing experience Mean changes from baseline in haematocrit were 3.3% and 4.2% for Glyxambi 10 mg/5 mg and 25 mg/5 mg, respectively, compared to 0.2% for placebo.
Maltese: Żieda fil-lipidi fis-serum Żieda fil-krejatinina fid-demm/Tnaqqis fir-rata ta' filtrazzjoni glomerulari derivata mill-esperjenzi b'empagliflozin derivata mill-esperjenzi b'linagliptin derivata mill-esperjenza ta' wara t-tqegħid fis-suq b'linagliptin derivata mill-esperjenza ta' wara t-tqegħid fis-suq b'empagliflozin Bidliet medji mil-linja bażi fl-ematokrit kienu 3.3% u 4.2% għal Glyxambi 10 mg/5 mg u 25 mg/5 mg, rispettivament, mqabbla ma' 0.2% għal plaċebo.
English: OATP2, OATP8, OCTN1, OCT1 and OATP2 activities were slightly to weakly inhibited by linagliptin.
Maltese: L-attivitajiet ta' OATP2, OATP8, OCTN1, OCT1 u OATP2 kienu impeduti bejn ftit għal b'mod dgħajjef minn linagliptin.
English: Urinary tract infection, seen commonly The signs of urinary tract infection are:
Maltese: Infezzjonijiet tal-passaġġ urinarju, li ġew osservati b'mod komuni Is-sinjali ta' infezzjonijiet tal-passaġġ urinarju huma:
English: In a pool of placebo-controlled double-blind trials of 18 to 24 weeks duration, the overall frequency of urinary tract infection reported as adverse event was similar in patients treated with empagliflozin 25 mg and placebo and higher in patients treated with empagliflozin 10 mg (see section 4.8).
Maltese: F'ġabra ta' provi double-blind ikkontrollati bi plaċebo ta' 18 sa 24 ġimgħa, il-frekwenza globali ta' infezzjoni tal-passaġġ urinarju rapportata bħala każ avvers kienet simili f'pazjenti ttrattati b'empagliflozin 25 mg u plaċebo u ogħla f'pazjenti ttrattati b'empagliflozin 10 mg (ara sezzjoni 4.8).
English: Effects of other medicinal products on linagliptin
Maltese: L-effetti ta' prodotti mediċinali oħrajn fuq linagliptin
English: An interaction study with gemfibrozil, an in vitro inhibitor of OAT3 and OATP1B1/1B3 transporters, showed that empagliflozin Cmax increased by 15 % and AUC increased by 59 % following coadministration.
Maltese: OAT3 u OATP1B1/1B3, wera li Cmax ta' empagliflozin żded bi 15% u l-AUC żdied b'59% wara l-għoti flimkien.
English: INFORMATION IN BRAILLE Glyxambi 10 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Glyxambi 10 mg/5 mg
English: Based on the experience with empagliflozin and linagliptin, an increase of the risk of hypoglycaemia is expected with the concomitant treatment of insulin and /or sulphonylurea (see section 4.4 and information below)
Maltese: Ibbażat fuq l-esperjenza b'empagliflozin u linagliptin, hija mistennija żieda fir-riskju ta' ipogliċemija bit-trattament konkomitanti ta' insulina u / jew sulfonylurea (ara sezzjoni 4.4 u l-informazzjoni hawn taħt)
English: At high concentrations, where DPP-4 is fully saturated, 70-80 % of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20 % were unbound in plasma.
Maltese: F'konċentrazzjonijiet għolja, fejn DPP-4 ikun saturat għal kollox, 70-80% ta' linagliptin weħel ma' proteini oħra fil-plażma li mhumiex DPP-4, u għaldaqstant 30-20% ma kinux imwaħħlin fil-plażma.
English: • prior to initiation of any concomitant medicinal product that may have a negative impact on renal function.
Maltese: • Qabel il-bidu ta' kull prodott mediċinali li jingħata fl-istess waqt li jista' jkollu impatt negattiv fuq il-funzjoni tal-kliewi.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Maltese: Waqt il-provi kliniċi kkontrollati f'individwi b'saħħithom, dożi waħidhom ta' sa 600 mg ta' linagliptin (ekwivalenti għal 120 darba aktar mid-doża rrakkomandata) kienu ġeneralment ittollerati tajjeb.
English: The frequencies have been comparable to those reported from the empagliflozin clinical trials.
Maltese: Il-frekwenzi kienu komparabbli ma' dawk irrapportati mill-provi kliniċi b'empagliflozin.