FrancophonIA/ELRC3.0 huggingface dataset:
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, the combination of empagliflozin and linagliptin was not teratogenic and did not show maternal toxicity.
Maltese: F'esponimenti suffiċjentement eċċessivi mill-esponiment fil-bniedem wara dożi terapewtiċi, il-kombinazzjoni ta' empagliflozin u linagliptin ma kinitx teratoġenika u ma wrietx tossiċità tal-omm.
English: Non-CV mortality N (%) Hazard ratio vs. placebo (95% CI)
Maltese: Mortalita mhux CV N (%) Proporzjon ta' periklu vs. plaċebo (CI ta' 95%)
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita Glyxambi 25 mg/5 mg pilloli miksija b'rita
English: When used in combination with antidiabetics known to cause hypoglycaemia (e.g. sulphonylureas and/or insulin), the incidence of hypoglycaemia of both agents was increased (see section 4.8).
Maltese: Meta użati flimkien ma' mediċini kontra d-dijabete magħrufa li jikkawżaw ipogliċemija (eż. sulfonylureas u/jew insulina), l-inċidenza ta' ipogliċemija taż-żewġ aġenti żdiedet (ara sezzjoni 4.8).
English: If Fournier´s gangrene is suspected, Glyxambi should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Glyxambi għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: The unbound concentrations, which are usually less than 1 % at the therapeutic dose of linagliptin, were increased 4 to 5-fold after co-administration with ritonavir.
Maltese: Il-konċentrazzjonijiet mhux imwaħħla, li normalment ikunu inqas minn 1% tad-doża terapewtika ta' linagliptin, żdiedu b'4 sa 5 darbiet wara l-għoti flimkien ma' ritonavir.
English: Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:
Maltese: Glyxambi, kombinazzjoni ta' doża fissa ta' empagliflozin u linagliptin, huwa indikat f'adulti li għandhom 18-il sena u iktar b'dijabete mellitus ta' tip 2:
English: Glyxambi 25 mg/5 mg film-coated tablets EU/1/16/1146/010 (7 x 1 film-coated tablets) EU/1/16/1146/011 (10 x 1 film-coated tablets) EU/1/16/1146/012 (14 x 1 film-coated tablets) EU/1/16/1146/013 (28 x 1 film-coated tablets) EU/1/16/1146/014 (30 x 1 film-coated tablets) EU/1/16/1146/015 (60 x 1 film-coated tablets) EU/1/16/1146/016 (70 x 1 film-coated tablets) EU/1/16/1146/017 (90 x 1 film-coated tablets) EU/1/16/1146/018 (100 x 1 film-coated tablets)
Maltese: Glyxambi 25 mg/5 mg pilloli miksija b'rita EU/1/16/1146/010 (7 x 1 pillola miksija b'rita) EU/1/16/1146/011 (10 x 1 pillola miksija b'rita) EU/1/16/1146/012 (14 x 1 pillola miksija b'rita) EU/1/16/1146/013 (28 x 1 pillola miksija b'rita) EU/1/16/1146/014 (30 x 1 pillola miksija b'rita) EU/1/16/1146/015 (60 x 1 pillola miksija b'rita) EU/1/16/1146/016 (70 x 1 pillola miksija b'rita) EU/1/16/1146/017 (90 x 1 pillola miksija b'rita) EU/1/16/1146/018 (100 x 1 pillola miksija b'rita)
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
Maltese: Glyxambi 25 mg/5 mg pilloli miksija b'rita empagliflozin/linagliptin
English: In the pre- and postnatal toxicity study with linagliptin in rats, reduced weight gain in offspring was observed at maternal exposures approximately 1,500-times the maximal clinical exposure to linagliptin.
Maltese: Fi studji tossiċi b'linagliptin fuq firien qabel u wara t-twelid, tnaqqis fiż-żieda tal-piż tal-frieħ kien osservat f'esponimenti tal-omm ta' madwar 1,500 darba l-esponiment kliniku massimu għal linagliptin.
English: In clinical trials with empagliflozin, increased urination (including the predefined terms pollakiuria, polyuria, nocturia) was observed at higher frequencies in patients treated with empagliflozin (empagliflozin 10 mg: 3.5 %, empagliflozin 25 mg: 3.3 %) compared to placebo (1.4 %).
Maltese: Fi provi kliniċi b'empagliflozin, ġiet osservata żieda fil-mogħdija tal-awrina (li jinkludi t-termini mfissra minn qabel ta' pollakijurja, polijurja u nokturja) bi frekwenza ogħla f'pazjenti ttrattati b'empagliflozin (empagliflozin 10 mg: 3.5 %, empagliflozin 25 mg: 3.3 %) meta mqabbla ma' plaċebo (1.4 %).
English: NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita empagliflozin/linagliptin
English: In the CARMELINA study, bullous pemphigoid was reported in 0.2% of patients on treatment with linagliptin and in no patient on placebo.
Maltese: Fl-istudju CARMELINA, pemfigojd bulluża kienet irrappurtata f'0.2% tal-pazjenti li kienu fuq trattament b'linagliptin u fl-ebda pazjent fuq il-plaċebo.
English: Therefore, clinically relevant interactions would not be expected with other P-glycoprotein / CYP3A4 inhibitors.
Maltese: Għalhekk, interazzjonijiet klinikament rilevanti mhux se jkunu mistennija ma' impedituri oħrajn ta' P-glikoproteina / CYP3A4.
English: Pyelonephritis and urosepsis were not reported from the clinical trials in patients treated with Glyxambi.
Maltese: Pijelonefrite u urosepsi ma kinux irrapportati mill-provi kliniċi f'pazjenti ttrattati b'Glyxambi.
English: • In patients tolerating Glyxambi whose eGFR falls persistently below 60 mL/min/1.73 m2 or CrCl below 60 mL/min, the dose of Glyxambi should be adjusted to or maintained at 10 mg empagliflozin plus 5 mg linagliptin once daily.
Maltese: • F'pazjenti li jittolleraw Glyxambi li għandhom eGFR li jaqa' b'mod persistenti taħt 60 mL/min/1.73 m 2 jew CrCl taħt 60 mL/min, id-doża ta' Glyxambi għandha tiġi aġġustata jew tinżamm f'ammont ta' 10 mg empagliflozin u 5 mg linagliptin darba kuljum.
English: In clinical trials with Glyxambi, there was no notable difference in the frequency of volume depletion in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 0.4 %; Glyxambi 10 mg/5 mg: 0.8 %) compared to the patients treated with empagliflozin and linagliptin.
Maltese: Fi provi kliniċi b'Glyxambi, ma kien hemm l-ebda differenza notevoli fil-frekwenza ta' żvojtar tal-volum f'pazjenti ttrattati b'Glyxambi (Glyxambi 25 mg/5 mg: 0.4%; Glyxambi 10 mg/5 mg: 0.8%) mqabbla ma' pazjenti ttrattati b'empagliflozin u linagliptin.
English: EU/1/16/1146/001 7 x 1 film-coated tablets EU/1/16/1146/002 10 x 1 film-coated tablets EU/1/16/1146/003 14 x 1 film-coated tablets EU/1/16/1146/004 28 x 1 film-coated tablets EU/1/16/1146/005 30 x 1 film-coated tablets EU/1/16/1146/006 60 x 1 film-coated tablets EU/1/16/1146/007 70 x 1 film-coated tablets EU/1/16/1146/008 90 x 1 film-coated tablets EU/1/16/1146/009 100 x 1 film-coated tablets
Maltese: EU/1/16/1146/001 7 x 1 pillola miksija b'rita EU/1/16/1146/002 10 x 1 pillola miksija b'rita EU/1/16/1146/003 14 x 1 pillola miksija b'rita EU/1/16/1146/004 28 x 1 pillola miksija b'rita EU/1/16/1146/005 30 x 1 pillola miksija b'rita EU/1/16/1146/006 60 x 1 pillola miksija b'rita EU/1/16/1146/007 70 x 1 pillola miksija b'rita EU/1/16/1146/008 90 x 1 pillola miksija b'rita EU/1/16/1146/009 100 x 1 pillola miksija b'rita
English: Glyxambi 10 mg/5 mg film-coated tablets EU/1/16/1146/001 (7 x 1 film-coated tablets) EU/1/16/1146/002 (10 x 1 film-coated tablets) EU/1/16/1146/003 (14 x 1 film-coated tablets) EU/1/16/1146/004 (28 x 1 film-coated tablets) EU/1/16/1146/005 (30 x 1 film-coated tablets) EU/1/16/1146/006 (60 x 1 film-coated tablets) EU/1/16/1146/007 (70 x 1 film-coated tablets) EU/1/16/1146/008 (90 x 1 film-coated tablets) EU/1/16/1146/009 (100 x 1 film-coated tablets)
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita EU/1/16/1146/001 (7 x 1 pillola miksija b'rita) EU/1/16/1146/002 (10 x 1 pillola miksija b'rita) EU/1/16/1146/003 (14 x 1 pillola miksija b'rita) EU/1/16/1146/004 (28 x 1 pillola miksija b'rita) EU/1/16/1146/005 (30 x 1 pillola miksija b'rita) EU/1/16/1146/006 (60 x 1 pillola miksija b'rita) EU/1/16/1146/007 (70 x 1 pillola miksija b'rita) EU/1/16/1146/008 (90 x 1 pillola miksija b'rita) EU/1/16/1146/009 (100 x 1 pillola miksija b'rita)
English: After this double-blind period, treatment in both populations (metformin + empagliflozin 10 mg and metformin + empagliflozin 25 mg) linagliptin 5 mg provided statistically significant improvements in HbA1c compared to placebo; all patients continued treatment with metformin and empagliflozin during the study.
Maltese: Wara dan il-perjodu double-blind, it-trattament fiż-żewġ popolazzjonijiet (metformin + empagliflozin 10 mg u metformin + empagliflozin 25 mg) b'linagliptin 5 mg ta titjib statistikament sinifikanti f'HbA1c, mqabbel ma' plaċebo; il-pazjenti kollha komplew it-trattament b'metformin u empagliflozin matul l-istudju.
English: EU/1/16/1146/010 7 x 1 film-coated tablets EU/1/16/1146/011 10 x 1 film-coated tablets EU/1/16/1146/012 14 x 1 film-coated tablets EU/1/16/1146/013 28 x 1 film-coated tablets EU/1/16/1146/014 30 x 1 film-coated tablets EU/1/16/1146/015 60 x 1 film-coated tablets EU/1/16/1146/016 70 x 1 film-coated tablets EU/1/16/1146/017 90 x 1 film-coated tablets EU/1/16/1146/018 100 x 1 film-coated tablets
Maltese: EU/1/16/1146/010 7 x 1 pillola miksija b'rita EU/1/16/1146/011 10 x 1 pillola miksija b'rita EU/1/16/1146/012 14 x 1 pillola miksija b'rita EU/1/16/1146/013 28 x 1 pillola miksija b'rita EU/1/16/1146/014 30 x 1 pillola miksija b'rita EU/1/16/1146/015 60 x 1 pillola miksija b'rita EU/1/16/1146/016 70 x 1 pillola miksija b'rita EU/1/16/1146/017 90 x 1 pillola miksija b'rita EU/1/16/1146/018 100 x 1 pillola miksija b'rita
English: If you already take 25 mg empagliflozin and 5 mg linagliptin as separate tablets and you switch to Glyxambi, you can start directly with Glyxambi 25 mg/5 mg.
Maltese: Jekk diġa qed tieħu 25 mg empagliflozin u 5 mg linagliptin bħala pilloli separati u tibdel għal Glyxambi, tista' tibda mill-ewwel b'Glyxambi 25 mg/5 mg.
English: In Glyxambi clinical trials, the incidence of urinary tract infections was overall similar between the patients treated with Glyxambi and the patients treated with empagliflozin or linagliptin.
Maltese: Fi provi kliniċi bi Glyxambi, l-inċidenza ta' infezzjonijiet tal-passaġġ urinarju kien globalment simili bejn pazjenti ttrattati bi Glyxambi u l-pazjenti ttrattati b'empagliflozin jew linagliptin.
English: Empagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Empagliflozin jista' jżid l-effett dijuretiku ta' thiazide u dijuretiċi “loop” u jista' jżid ir-riskju ta' deidrazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: - The active substances are empagliflozin and linagliptin.
Maltese: - Is-sustanzi attivi huma empagliflozin u linagliptin.
English: Glyxambi 10 mg/5 mg film-coated tablets (tablets) are pale yellow, arc triangular, flat faced and bevel-edged.
Maltese: Glyxambi 10 mg/5 mg pilloli miksija b'rita (pilloli) huma sofor ċari, ark trijangolari, b'wiċċ ċatt u bit-truf imċanfrin.
English: In clinical trials with Glyxambi, increased urination in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 2.6 %; Glyxambi 10 mg/5 mg: 1.4 %) was reported more frequently than for linagliptin and with similar frequency than for empagliflozin.
Maltese: Fi provi kliniċi b'Glyxambi, żieda fil-mgħodija tal-awrina f'pazjenti ttrattati b'Glyxambi (Glyxambi 25 mg/5 mg: 2.6%; Glyxambi 10 mg/5 mg: 1.4%) kienu rapportati aktar frekwentement milli għal linagliptin iżda bi frekwenza simili milli għal empagliflozin.
English: The treatment with Glyxambi resulted in statistically significant improvements in HbA1c and fasting plasma glucose (FPG) compared to linagliptin 5 mg and also compared to empagliflozin 10 mg or 25 mg. Glyxambi also provided statistically significant improvements in body weight compared to linagliptin 5 mg.
Maltese: It-trattament b'Glyxambi rriżulta f'titjib statistikament rilevanti f'HbA1c u glukożju fil-plażma fi stat sajjem (FPG, fasting plasma glucose) mqabbel ma' linagliptin 5 mg kif ukoll imqabbel ma' empagliflozin 10 mg jew 25 mg.
English: Co-administration of rifampicin decreased linagliptin exposure by 40 %, suggesting that the efficacy of linagliptin may be reduced when administered in combination with a strong P-glycoprotein (P-gp) or cytochrome P450 (CYP) isozyme CYP3A4 inducer, particularly if these are administed long-term (see section 5.2).
Maltese: L-għoti flimkien ta' rifampicin naqqas l-esponiment ta' linagliptin b'40%, li jissuġġerixxi li l-effikaċja ta' linagliptin tista' tonqos meta jingħata flimkien ma' induttur potenti ta' P-glikoproteina (P-gp) jew ta' isożom (CYP) taċ-ċitokrom P450 CYP3A4, b'mod partikolari jekk dawn jingħataw għal żmien twil (ara sezzjoni 5.2).
English: Peak plasma levels of empagliflozin were roughly 20 % higher in subjects with mild and severe renal impairment as compared to subjects with normal renal function.
Maltese: L-ogħla livelli ta' empagliflozin fil-plażma kienu madwar 20% ogħla f'individwi b'indeboliment tal-kliewi ħafif għal sever meta mqabbla ma' pazjenti b'funzjoni tal-kliewi normali.
English: Loss of body fluid (dehydration), seen uncommonly The signs of dehydration are not specific, but may include:
Maltese: Telf ta' fluwidu tal-ġisem (deidrazzjoni), li ġie osservat b'mod mhux komuni Is-sinjali ta' deidrazzjoni mhumiex speċifiċi, iżda jistgħu jinkludu:
English: The recommended starting dose is 1 film-coated tablet of Glyxambi 10 mg/5 mg (10 mg empagliflozin plus 5 mg linagliptin) once daily.
Maltese: Id-doża rrakkomandata tal-bidu hija pillola waħda miksija b'rita ta' Glyxambi 10 mg/5 mg (10 mg empagliflozin flimkien ma' 5 mg linagliptin) darba kuljum.
English: In clinical trials with Glyxambi, genital infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 3.0 %; Glyxambi 10 mg/5 mg: 2.5 %) were reported more frequently than for linagliptin but less freqeuntly than for empagliflozin.
Maltese: Fi provi kliniċi b'Glyxambi, infezzjonijiet ġenitali f'pazjenti ttrattati b'Glyxambi (Glyxambi 25 mg/5 mg: 3.0%; Glyxambi 10 mg/5 mg: 2.5%) kienu rapportati aktar frekwentement milli għal linagliptin iżda inqas frekwentement milli għal empagliflozin.
English: In non-diabetic patients with mild, moderate and severe hepatic insufficiency (according to the ChildPugh classification), mean AUC and Cmax of linagliptin were similar to healthy subjects following administration of multiple 5 mg doses of linagliptin.
Maltese: F'pazjenti mhux dijabetiċi b'insuffiċjenza ħafifa, moderata u severa tal-fwied (skont il-klassifikazzjoni ta' Child-Pugh), il-medja tal-AUC u tas-Cmax ta' linagliptin kienu simili għal individwi b'saħħithom wara l-għoti ta' dożi multipli ta' 5 mg ta' linagliptin.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Maltese: L-età ma kellha l-ebda impatt klinikament rilevanti fuq il-farmakokinetika ta' empagliflozin jew linagliptin abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: In pooled clinical trials of Glyxambi in patients with type 2 diabetes and inadequate glycaemic control on background metformin, the frequency of the reported hypoglycaemic events was 2.4 %.
Maltese: Fi provi kliniċi miġbura ta' Glyxambi f'pazjenti b'dijabete ta' tip 2 u kontroll gliċemiku mhux adegwat fuq sfond ta' metformin, il-frekwenza tal-avvenimenti ipogliċemiċi rapportati kienet 2.4%.
English: The adverse reactions shown in the table below (see Table 1) are listed by system organ class and are based on the safety profiles of empagliflozin and linagliptin monotherapy.
Maltese: Ir-reazzjonijiet avversi murija fit-tabella hawn taħt (ara Tabella 1) huma elenkati skont is-sistema tal-klassifika tal-organi u huma bbażati fuq il-profili tas-sigurtà ta' monoterapija b'empagliflozin u linagliptin.
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Boehringer Ingelheim Pharma GmbH & Co.
English: Patients switching from empagliflozin (either 10 mg or 25 mg daily dose) and linagliptin (5 mg daily dose) to Glyxambi should receive the same daily dose of empagliflozin and linagliptin in the fixed dose combination as in separate tablets.
Maltese: Pazjenti li jaqilbu minn empagliflozin (jew 10 mg jew 25 mg doża ta' kuljum) u linagliptin (5 mg doża ta' kuljum) għal Glyxambi għandhom jingħataw l-istess doża ta' kuljum ta' empagliflozin u linagliptin fil-kombinazzjoni tad-doża fissa bħal dik tal-pilloli separati.
English: In controlled clinical studies single doses of up to 800 mg empagliflozin (equivalent to 32 times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg empagliflozin (equivalent to 4 times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity.
Maltese: Fi studji kliniċi b'kontroll dożi waħdenin ta' sa 800 mg empagliflozin (ekwivalenti għal 32 darba aktar mill-ogħla doża rrakkomandata għal kuljum) f'voluntieri b'saħħithom u dożi multipli ta' kuljum ta' sa 100 mg empagliflozin (ekwivalenti għal 4 darbiet aktar mill-ogħla doża rrakkomandata għal kuljum) f'pazjenti b'dijabete ta' tip 2 ma wrew l-ebda tossiċità.
English: The frequency of hypoglycaemia depended on the background therapy in the respective studies and was similar for empagliflozin and placebo as monotherapy, as add-on to metformin, and as add-on to pioglitazone +/- metformin.
Maltese: Il-frekwenza ta' ipogliċemija kienet tiddependi fuq it-terapija fl-isfond fl-istudji rispettivi u kienet simili għal empagliflozin u plaċebo bħala monoterapija, b'metformin bħala terapija aġġuntiva, u pioglitazone +/- metformin bħala terapija aġġuntiva.
English: Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2, ‘Warnings and precautions'): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi dijabetika (ara wkoll sezzjoni 2, ‘Twissijiet u prekawzjonijiet'): - żieda fil-livelli ta' “korpi ketaċoniċi” fl-awrina jew fid-demm tiegħek - telf malajr fil-piż - tħossok ma tiflaħx jew tkun ma tiflaħx - uġigħ fl-istonku - ikollok ħafna għatx - in-nifs ikun mgħaġġel u fil-fond - konfużjoni - ngħas jew għeja mhux normali - in-nifs jinxtamm ħelu, togħma ħelwa jew metallika f'ħalqek jew riħa differenti tal-awrina jew l-għaraq.
English: Systemic exposure of empagliflozin increased in a dose proportional manner.
Maltese: L-esponiment sistemiku ta' empagliflozin żdied f'manjiera proporzjonali mad-doża.
English: Empagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is 5,000 times more selective for SGLT2 versus SGLT1, the major transporter responsible for glucose absorption in the gut.
Maltese: Empagliflozin huwa impeditur riversibbli, qawwi ħafna (IC50 ta' 1.3 nmol) kompettitiv u selettiv ta' SGLT2. Empagliflozin ma jimpedixxix trasportaturi oħra tal-glukożju importanti għat-trasport ta' glukożju għal ġot-tessuti periferali u huwa 5,000 darba aktar silettiv għal SGLT2 kontra SGLT1, it-trasportatur ewlieni responsabbli għall-assorbiment ta' glukożju fl-imsaren.
English: It does this by blocking a protein called DPP-4.
Maltese: Jagħmel dan billi jimblokka proteina msejħa DPP-4.
English: Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Maltese: Il-ġeneru sesswali ma kellu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' empagliflozin jew linagliptin abbażi ta' analiżi farmakokinetika tal-popolazzjoni.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glukożju fid-demm, inqas minn 14 mmol/L (250 mg/dL).
English: Overall, the frequencies for Glyxambi have been comparable to those reported from the empagliflozin clinical trials.
Maltese: B'mod ġenerali, il-frekwenzi għal Glyxambi kienu komparabbli ma' dawk irrapportati mill-provi kliniċi b'empagliflozin.
English: Kidney function
Maltese: Funzjoni tal-kliewi
English: The inter subject and residual variabilities for empagliflozin oral clearance were 39.1 % and 35.8 %, respectively.
Maltese: Il-varjabilitajiet bejn individwu u ieħor u dawk residwali għat-tneħħija mill-ħalq ta' empagliflozin kienu 39.1% u 35.8% rispettivament.
English: No additional adverse reactions were identified with Glyxambi.
Maltese: L-ebda reazzjonijiet avversi oħra ma kienu identifikati b'Glyxambi.
English: In male rats, treatment related benign vascular proliferative lesions (haemangiomas) of the mesenteric lymph node were observed at the highest dose, but not at 300 mg/kg/day, which corresponds to approximately 26 times the maximal clinical exposure to empagliflozin.
Maltese: F'firien irġiel, ġrieħi proliferattivi vaskulari beninni marbuta mat-trattament (emanġjomas) tal-għenqud limfatiku mesenteriku kienu osservati fl-ogħla dożi, imma mhux f'doża ta' 300 mg/kg/jum, li tikkorispondi għal madwar 26 darba l-esponimet kliniku massimu ta' empagliflozin.
English: They have “25/5” on one side and the Boehringer Ingelheim logo on the other side.
Maltese: Għandhom “25/5” fuq naħa waħda u l-logo ta' Boehringer Ingelheim fuq in-naħa l-oħra.
English: Co-administration with known inducers of UGT enzymes should be avoided because of a risk of decreased efficacy of empagliflozin.
Maltese: L-għoti flimkien ma' indutturi tal-enzimi UGT għandu jiġi evitat minħabba r-riskju ta' tnaqqis fl-effikaċja ta' empagliflozin.
English: Based on the population pharmacokinetic analysis, the apparent terminal elimination half life of empagliflozin was estimated to be 12.4 hours and apparent oral clearance was 10.6 L/hour.
Maltese: Abbażi tal-analiżi farmakokinetika tal-popolazzjoni, il-half-life tal-eliminazzjoni terminali apparenti ta' empagliflozin kienet stmata li hi ta' 12.4 sigħat u t-tneħħija mill-ħalq apparenti kienet ta' 10.6 l/siegħa.
English: In a 2 year carcinogenicity study, empagliflozin did not increase the incidence of tumours in female rats up to the highest dose of 700 mg/kg/day, which corresponds to approximately 72 times the maximal clinical AUC exposure to empagliflozin.
Maltese: Fi studju li dam sejjer sentejn dwar il-karċinoġeniċità, empagliflozin ma żiedx l-inċidenza ta' tumuri f'firien nisa sal-ogħla doża ta' 700 mg/kg/jum, li jikkorispondi għal madwar 72 darba l-esponiment AUC massimu kliniku t'empagliflozin.
English: Based on in vitro studies, empagliflozin is considered unlikely to cause interactions with medicinal products that are P-gp substrates.
Maltese: Abbażi ta' studji in vitro, empagliflozin hu kkunsidrat li mhux probabbli jikkawża interazzjonijiet ma' prodotti mediċinali li huma sottostrati ta' P-gp.
English: Glyxambi 25 mg/5 mg film-coated tablets
Maltese: Glyxambi 25 mg/5 mg pilloli miksija b'rita
English: Therefore, a lower dose of insulin or sulphonylureas may be required to reduce the risk of hypoglycaemia when used in combination with Glyxambi (see sections 4.2, 4.4 and 4.8).
Maltese: Għalhekk, għandha mnejn tkun meħtieġa doża iktar baxxa ta' insulina jew ta' sulfonylureas biex jitnaqqas ir-riskju ta' ipogliċemija meta tintuża ma' Glyxambi (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: Administration of empagliflozin 25 mg after intake of a high-fat and high calorie meal resulted in slightly lower exposure; AUC decreased by approximately 16 % and Cmax by approximately 37 % compared to fasted condition.
Maltese: L-għoti ta' empagliflozin 25 mg wara teħid ta' ikla b'ħafna xaħam u ħafna kaloriji rriżulta f'esponiment ftit aktar baxx; l-AUC naqas b'madwar 16% u Cmax b'madwar 37% meta mqabbel mal-kondizzjoni tas-sawm.