natgillin/translations-raw huggingface dataset:
Rare cases of DKA, including life-threatening cases, have been reported in clinical trials and postmarketing in patients treated with SGLT2 inhibitors, including empagliflozin.
V kliničnih preskušanjih in v obdobju trženja so pri bolnikih, ki so bili zdravljeni z zaviralci SGLT2, vključno z empagliflozinom, poročali o redkih primerih DKA, vključno z življenje ogrožujočimi.
Patients ( %) achieving HbA1c <7 % with baseline HbA1c ≥7 %24 weeks
Bolniki (%), ki so dosegli vrednost HbA1c < 7% z izhodiščno vrednostjo HbA1c ≥ 7%24 tednov
Patients ( %) achieving HbA1c <7 % with baseline HbA1c ≥7 % - 24 weeks
Bolniki (%), ki so dosegli vrednost HbA1c < 7% z izhodiščno vrednostjo HbA1c ≥ 7% - 24 tednov
In vitro assessment of linagliptin
Ocena linagliptina in vitro
Your doctor may ask you to stop taking Glyxambi.
Zdravnik vam bo morda naročil, da prenehate jemati zdravilo Glyxambi;
In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 % the reduction from baseline in HbA1c with empagliflozin 25 mg/linagliptin 5 mg was -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg) and with empagliflozin 10 mg/ linagliptin 5 mg -1.3 % at 24 weeks (p<0.0001 versus placebo and linagliptin 5 mg).
V vnaprej specificirani podskupini bolnikov, pri katerih je bila izhodiščna vrednost HbA1c večja ali enaka 8,5 %, se je vrednost HbA1c glede na izhodišče z empagliflozinom 25 mg/linagliptinom 5 zmanjšala za -1,3 % v 24 tednih (p < 0,0001 v primerjavi s placebom in linagliptinom 5 mg) in z empagliflozinom 10 mg/linagliptinom 5 mg za -1,3 % v 24 tednih (p < 0,0001 v primerjavi s placebom in linagliptinom 5 mg).
Primary endpoint: HbA1c ( %) - 24 weeks
Primarni opazovani dogodek: Vrednost HbA1c (%) - 24 tednov
Following administration of an oral [
Po dajanju peroralnega odmerka [
Empagliflozin in patients inadequately controlled on metformin and linagliptin
Zdravljenje z empagliflozinom pri bolnikih, pri katerih z metforminom in linagliptinom ni bilo mogoče doseči ustrezne urejenosti bolezni
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.
V kliničnih preizkušanjih z zdravilom Glyxambi je bila pogostnost bolnikov z zvišano ravnjo kreatinina v krvi (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0 %) in zmanjšana hitrost glomerulne filtracije (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0,6 %) primerljiva s tisto, o kateri so poročali v kliničnih preskušanjih z empagliflozinom.
• increased blood enzyme amylase
• zvišana raven encima amilaze v krvi,
In vitro assessment of empagliflozin
Ocena empagliflozina in vitro
- 95.0 % CI - p-value vs. 25 mg vs. 10 mg
95,0-odstotni IZ vrednost p v primerjavi 25 mg v primerjavi 10 mg
Empagliflozin exposure is increased in patients with severe hepatic impairment and therapeutic experience in such patients is limited (see section 5.2).
Terapevtske izkušnje so pri teh bolnikih omejene (glejte poglavje 5.2).
Empagliflozin and linagliptin as single agents showed an incidence of hypoglycaemia comparable to placebo when used alone or in combination with other antidiabetics not known to cause hypoglycaemia (e.g. metformin, thiazolidinediones).
Pri uporabi samo empagliflozina ali linagliptina kot samostojnih zdravil ali v kombinaciji z drugimi antidiabetiki, za katere ni znano, da povzročajo hipoglikemijo (npr. metformin, tiazolidindioni), je bila pojavnost hipoglikemije primerljiva s placebom.
The rate and extent of absorption of empagliflozin and linagliptin in Glyxambi are equivalent to the bioavailability of empagliflozin and linagliptin when administered as individual tablets.The pharmacokinetics of empagliflozin and linagliptin as single agents have been extensively characterized in healthy subjects and patients with type 2 diabetes.
Hitrost in obseg absorpcije empagliflozina in linagliptina v zdravilu Glyxambi ustrezata biološki uporabnosti empagliflozina in linagliptina, danima kot ločeni tableti.
Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 and iron oxide red (E172).
Filmska obloga: hipromeloza, manitol (E421), smukec, titanov dioksid (E171), makrogol 6000 in rdeči železov oksid (E172).
How to store Glyxambi
Shranjevanje zdravila Glyxambi
Therapeutic experience is limited with Glyxambi in patients > 75 years of age, and, no experience is available in patients aged 85 years and older.
Terapevtske izkušnje z uporabo zdravila Glyxambi pri bolnikih, starih 75 let in več, so omejene.
2 (SE)
in 5.2).
Interaction studies suggest that the pharmacokinetics of empagliflozin were not influenced by coadministration with metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, warfarin, verapamil, ramipril, simvastatin, torasemide and hydrochlorothiazide.
Študije medsebojnega delovanja kažejo, da sočasna uporaba metformina, glimepirida, pioglitazona, sitagliptina, linagliptina, varfarina, verapamila, ramiprila, simvastatina, torasemida in hidroklorotiazida ni vplivala na farmakokinetiko empagliflozina.
Contact your doctor if you experience any of the following during treatment with Glyxambi:
Če med zdravljenjem z zdravilom Glyxambi opazite katerega koli od spodnjih simptomov, se posvetujte z zdravnikom:
The frequency of patients with major hypoglycaemic events was increased in patients treated with empagliflozin compared to placebo when given as add-on to basal insulin +/- metformin and +/sulphonylurea (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo: 0 % during initial 18 weeks treatment when insulin could not be adjusted; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1.3 %, placebo 0 % over the 78-week trial), and add-on to MDI insulin with or without metformin (empagliflozin 10 mg: 1.6 %, empagliflozin 25 mg: 0.5 %, placebo: 1.6 % during initial 18 weeks treatment when insulin could not be adjusted and over the 52-week trial).
Pogostnost hudih hipoglikemičnih dogodkov je bila v primerjavi s placebom večja pri bolnikih, ki so prejemali empagliflozin kot dodatno zdravljenje ob bazalnem insulinu z metforminom ali brez njega in s sulfonilsečnino ali brez nje (empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo: 0 % v prvih 18 tednih zdravljenja, ko insulina ni bilo mogoče prilagoditi; empagliflozin 10 mg: 0 %, empagliflozin 25 mg: 1,3 %, placebo 0 % v 78-tedenskem preskušanju), in kot dodatno zdravljenje ob insulinu MDI z metforminom ali brez njega (empagliflozin 10 mg: 1,6 %, empagliflozin 25 mg: 0,5 %, placebo: 1,6 % v prvih 18 tednih zdravljenja, ko insulina ni bilo mogoče prilagoditi, ter v 52-tedenskem preskušanju).
Patients randomized to the empagliflozin 10 mg or 25 mg groups were receiving Glyxambi 10 mg/5 mg or 25 mg/5 mg with background metformin
Bolniki, ki so bili randomizirani v skupino z empagliflozinom 10 mg ali 25 mg, so prejemali zdravilo Glyxambi 10 mg/5 mg ali 25 mg/5 mg skupaj z osnovnim zdravljenjem z metforminom.
Time to first event of CV death, non-fatal MI, or non-fatal stroke N (%) Hazard ratio vs. placebo (95.02% CI) p−value for superiority
Čas do prve srčno-žilne smrti, miokardnega infarkta brez smrtnega izida ali kapi brez smrtnega izida N (%) razmerje tveganja v primerjavi s placebom (95,02 % IZ) vrednost p za superiornost srčno-žilna smrt N (%) razmerje tveganja v primerjavi s placebom (95 % IZ) vrednost p miokardni infarkt brez smrtnega izida N
Pale pink, arc triangular, flat faced, bevel-edged, film-coated tablets.
Bledo rožnate, trikotne, ploščate filmsko obložene tablete s poševnim zaobljenim robom.
Patients randomized to the placebo group were receiving the placebo plus linagliptin 5 mg with background metformin Mixed-effects models for repeated measurements (MMRM) on FAS (OC) includes baseline HbA1c, baseline eGFR (MDRD), geographical region, visit treatment,and treatment by visit interaction.
Modeli mešanih učinkov za ponovljive meritve (MMRM, Mixed-effects models for repeated measurements) v analizi FAS (OC) vključuje izhodiščno vrednost HbA1c, izhodiščno vrednost eGFR (MDRD), geografsko regijo, obisk, zdravljenje in zdravljenje z obiskom.
- 95.0 % CI - p-value Last observation (prior to glycaemic rescue ) carried forward (LOCF) Mean adjusted for baseline value and stratification
Zadnje opazovanje, preneseno naprej (LOCF, last observation carried forward) (pred uporabo reševalnega zdravljenja za ureditev glikemije)
Empagliflozin improves both fasting and post prandial plasma glucose levels.
Empagliflozin izboljša raven glukoze v plazmi na tešče in po jedi.
Film coating: hypromellose, mannitol (E421), talc, titanium dioxide (E171), macrogol 6000 and iron oxide yellow (E172).
Filmska obloga: hipromeloza, manitol (E421), smukec, titanov dioksid (E171), makrogol 6000 in rumeni železov oksid (E172).
With once daily dosing, steady state plasma concentrations of empagliflozin were reached by the fifth dose.
Koncentracije v plazmi v stanju dinamičnega ravnovesja so bile pri odmerjanju enkrat na dan dosežene s petim odmerkom.
Elevated haematocrit
Zvišan hematokrit
Body mass index had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Indeks telesne mase ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina ali linagliptina na podlagi populacijske farmakokinetične analize.
No additional adverse reactions were identified with Glyxambi.
Za zdravilo Glyxambi niso poročali o nobenem dodatnem neželenem učinku.
OATP2, OATP8, OCTN1, OCT1 and OATP2 activities were slightly to weakly inhibited by linagliptin.
Linagliptin je rahlo do šibko zaviral delovanje OATP2, OATP8, OCTN1, OCT1 in OATP2.
A higher risk of volume depletion adverse reactions were reported in patients aged 75 years and older, treated with empagliflozin, especially at 25 mg/day (see section 4.8).
Pri bolnikih, starih 75 let in več, zdravljenih z empagliflozinom, zlasti pri odmerku 25 mg/dan, so poročali o večjem tveganju za zmanjšanje volumna (glejte poglavje 4.8).
The steady state plasma AUCτ,ss and Cmax,ss concentrations of linagliptin were 153 nmol*hr/L and 12.9 nmol/L for linagliptin 5 mg once daily for 7 days.
Za linagliptin 5 mg enkrat na dan 7 dni je koncentracija AUCτ,ss v stanju dinamičnega ravnovesja 153 nmol*ura/l, koncentracija Cmax,ss pa 12,9 nmol/l.
In patients inadequately controlled on maximally tolerated doses of metformin, open label empagliflozin 10 mg or empagliflozin 25 mg was added for 16 weeks.
Bolnikom, pri katerih z največjim dovoljenim odmerkom metformina, ki ga še prenašajo, ni bilo mogoče doseči ustrezne urejenosti glikemije, so 16 tednov dodatno dajali empagliflozin 10 mg ali empagliflozin 25 mg kot odprto zdravljenje.
For weight, baseline weight is also included.
Telesna masa vključuje tudi izhodiščno maso.
INFORMATION IN BRAILLE Glyxambi 10 mg/5 mg
PODATKI V BRAILLOVI PISAVI Glyxambi 10 mg/5 mg
Gender had no clinically relevant effect on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Spol ni imel klinično pomembnega učinka na farmakokinetiko empagliflozina ali linagliptina na podlagi populacijske farmakokinetične analize.
Your doctor may ask you to stop Glyxambi.
Vaš zdravnik vam bo morda naročil, da zdravilo Glyxambi prenehate jemati.
In a pre-specified subgroup of patients with baseline HbA1c greater or equal than 8.5 %, the reduction from baseline in HbA1c at 24 weeks with Glyxambi 25 mg/5 mg was -1.8 % (p<0.0001 versus linagliptin 5 mg, p<0.001 versus empagliflozin 25 mg) and with Glyxambi 10 mg/ 5 mg -1.6 % (p<0.01 versus linagliptin 5 mg, n.s. versus empagliflozin 10 mg).
V vnaprej specificirani podskupini bolnikov, pri katerih je bila izhodiščna vrednost HbA1c večja ali enaka 8,5 %, se je vrednost HbA1c v 24 tednih glede na izhodišče z zdravilom Glyxambi 25 mg/5 mg zmanjšala za -1,8 % (p < 0,0001 v primerjavi z linagliptinom 5 mg, p < 0,001 v primerjavi z empagliflozinom 25 mg) in z zdravilom Glyxambi 10 mg/5 mg za -1,6 % (p < 0,01 v primerjavi z linagliptinom 5 mg, »ni statistično značilno« v primerjavi z empagliflozinom 10 mg).
However, temporary interruption of Glyxambi should be considered in patients with complicated urinary tract infections.
Vendar pa je treba pri bolnikih z zapleteno okužbo sečil razmisliti o začasni prekinitvi jemanja zdravila Glyxambi.
Vaginal moniliasis, vulvovaginitis, balanitis and other genital infections Nasopharyngitis
pogosti pogosti neznana vaginalna kandidoza, vulvovaginitis, balanitis in druge okužbe spolovil nazofaringitis nekrotizirajoči fasciitis presredka (Fournierova gangrena)
Postmarketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have been reported in patients treated with empagliflozin.
V obdobju trženja so pri bolnikih, zdravljenih z empagliflozinom, poročali o primerih zapletenih okužb sečil, vključno s pielonefritisom in urosepso.
Age did not have a clinically meaningful impact on the pharmacokinetics of empagliflozin or linagliptin based on population pharmacokinetic analysis.
Starost ni imela klinično pomembnega učinka na farmakokinetiko empagliflozina ali linagliptina na podlagi populacijske farmakokinetične analize.
Contact your doctor immediately if you notice any of the following side effects:
Če opazite katerega koli od naslednjih neželenih učinkov, se takoj posvetujte z zdravnikom:
Baseline (mean) Change from baseline (adjusted mean) Comparison vs. placebo (adjusted mean) (95 % CI)
Izhodišče (povprečje) Sprememba od izhodišča (prilagojeno povprečje) Primerjava s placebom (prilagojeno povprečje) (95-odstotni IZ)
No data in humans are available on excretion of empagliflozin and linagliptin into milk.
Ni dovolj podatkov o izločanju empagliflozina in linagliptina v materino mleko.
Glyxambi 25 mg/5 mg film-coated tablets Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Glyxambi 25 mg/5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 25 mg empagliflozina in 5 mg linagliptina.
Linagliptin 5 mg in patients inadequately controlled on metformin and empagliflozin 10 mg or empagliflozin 25 mg
Zdravljenje z linagliptinom 5 mg pri bolnikih, pri katerih z metforminom in empagliflozinom 10 mg ali empagliflozinom 25 mg ni bilo mogoče doseči ustrezne urejenosti bolezni
Each film-coated tablet contains 25 mg empagliflozin and 5 mg linagliptin.
Ena filmsko obložena tableta vsebuje 25 mg empagliflozina in 5 mg linagliptina.
45-60 ml/min/1.73 m2 and 7.7 % of 30-45 ml/min/1.73 m
45 ml/min/1,73 m
Do not drive or use any tools or machines, if you experience any of these symptoms while taking Glyxambi.
Če imate med jemanjem zdravila Glyxambi katerega koli od naslednjih simptomov, ne vozite in ne upravljajte z orodji ali stroji.
INFORMATION IN BRAILLE Glyxambi 25 mg/5 mg
PODATKI V BRAILLOVI PISAVI Glyxambi 25 mg/5 mg
Your doctor may ask you to take a different medicine.
Zdravnik vam bo v tem primeru morda svetoval uporabo drugega zdravila;
Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Ena filmsko obložena tableta vsebuje 10 mg empagliflozina in 5 mg linagliptina.
- The active substances are empagliflozin and linagliptin.
- Zdravilni učinkovini sta empagliflozin in linagliptin.
Glyxambi 10 mg/5 mg film-coated tablets Each film-coated tablet contains 10 mg empagliflozin and 5 mg linagliptin.
Glyxambi 10 mg/5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg empagliflozina in 5 mg linagliptina.
Glyxambi 25 mg/5 mg film-coated tablets (tablets) are pale pink, arc triangular, flat faced and beveledged.
Glyxambi 25 mg/5 mg filmsko obložene tablete (tablete) so bledo rožnate, trikotne, ploščate tablete s poševnim zaobljenim robom.
However, caution is advised when Glyxambi is used in combination with antidiabetics.
Vendarje pri uporabi kombinacije zdravila Glyxambi in antidiabetikov potrebna previdnost.
In this case, do not continue taking any one of those tablets separately, if your are taking this medicine.
Če jemljete to zdravilo, prekinite z jemanjem obeh ločenih tablet.
Glyxambi 10 mg/5 mg film-coated tablets (tablets) are pale yellow, arc triangular, flat faced and bevel-edged.
Glyxambi 10 mg/5 mg filmsko obložene tablete (tablete) so svetlorumene, trikotne, ploščate tablete s poševnim zaobljenim robom.
Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets empagliflozin/linagliptin
Glyxambi 10 mg/5 mg filmsko obložene tablete Glyxambi 25 mg/5 mg filmsko obložene tablete empagliflozin/linagliptin
In clinical trials with Glyxambi, there was no notable difference of the frequency of urinary tract infections in patients treated with Glyxambi (Glyxambi 25 mg/5 mg: 8.5 %; Glyxambi 10 mg/5 mg: 7.5 %) compared to the patients treated with empagliflozin and linagliptin.
V kliničnih preskušanjih z zdravilom Glyxambi ni bilo opazne razlike v pogostnosti okužb sečil med bolniki, ki so prejemali zdravilo Glyxambi (Glyxambi 25 mg/5 mg: 8,5 %; Glyxambi 10 mg/5 mg: 7,5 %), in tistimi, ki so bili zdravljeni z empagliflozinom ali linagliptinom.
Pale yellow, arc triangular, flat faced, bevel-edged, film-coated tablets.
Svetlorumene, trikotne, ploščate filmsko obložene tablete s poševnim zaobljenim robom.
The apparent steady-state volume of distribution was estimated to be 73.8 L based on the population pharmacokinetic analysis.
Na podlagi populacijske farmakokinetične analize je bil navidezni volumen porazdelitve v stanju dinamičnega ravnovesja ocenjen na 73,8 l. Po peroralnem zaužitju raztopine [
Glyxambi 10 mg/5 mg film-coated tablets
Glyxambi 10 mg/5 mg filmsko obložene tablete
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.
V kliničnih preskušanjih z zdravilom Glyxambi ni bilo opazne razlike v pogostnosti zmanjšanja volumna med bolniki, ki so prejemali zdravilo Glyxambi (Glyxambi 25 mg/5 mg: 0,4 %; Glyxambi 10 mg/5 mg: 0,8 %), in tistimi, ki so bili zdravljeni z empagliflozinom ali linagliptinom.
Glyxambi 25 mg/5 mg film-coated tablets
Glyxambi 25 mg/5 mg filmsko obložene tablete
No clinically relevant difference in pharmacokinetics of empagliflozin and linagliptin were seen in population pharmacokinetic analysis and dedicated phase I studies.
Pri populacijski farmakokinetični analizi in namenskih študijah I faze ni bilo opažene klinično pomembne razlike v farmakokinetiki empagliflozina ali linagliptina.
Seen rarely • sore in the mouth
Bolezni prebavil občasni redki pankreatitis razjede v ustih
Linagliptin had no adverse effects on fertility or early embryonic development at exposures greater than 900-times the clinical exposure.
Pri izpostavljenostih, ki so bile večje od 900-kratne klinične izpostavljenosti, linagliptin ni imel neželenih učinkov na sposobnost razmnoževanja ali zgodnji razvoj zarodka.
No studies on the effect on human fertility have been conducted with Glyxambi or with the individual active substances.
Z zdravilom Glyxambi ali njegovima posameznima zdravilnima učinkovinama niso izvedli študij o učinku na plodnost pri človeku.
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.
V kliničnih preskušanjih z zdravilom Glyxambi so o pogostejšem uriniranju poročali pogosteje pri bolnikih, ki so prejemali zdravilo Glyxambi (Glyxambi 25 mg/5 mg: 2,6 %; Glyxambi 10 mg/5 mg: 1,4 %), kot pri bolnikih, ki so prejemali linagliptin, s podobno pogostnostjo pa pri bolnikih, ki so prejemali empagliflozin.
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg tablets empagliflozin/linagliptin
IME ZDRAVILA Glyxambi 10 mg/5 mg tablete empagliflozin/linagliptin
NAME OF THE MEDICINAL PRODUCT Glyxambi 25 mg/5 mg tablets empagliflozin/linagliptin
IME ZDRAVILA Glyxambi 25 mg/5 mg tablete empagliflozin/linagliptin
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER (perforated)
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU PRETISNI OMOT (perforiran)
Pyelonephritis and urosepsis were not reported from the clinical trials in patients treated with Glyxambi.
V kliničnih preizkušanjih v skupini bolnikov, ki so prejemali zdravilo Glyxambi, niso poročali o pielonefritisu in urosepsi.
NAME OF THE MEDICINAL PRODUCT Glyxambi 10 mg/5 mg film-coated tablets Glyxambi 25 mg/5 mg film-coated tablets
Glyxambi 10 mg/5 mg filmsko obložene tablete Glyxambi 25 mg/5 mg filmsko obložene tablete
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.
V kliničnih preskušanjih z zdravilom Glyxambi so pri bolnikih, ki so prejemali zdravilo Glyxambi pogosteje poročali o okužbah spolovil (Glyxambi 25 mg/5 mg: 3,0 %; Glyxambi 10 mg/5 mg: 2,5 %), kot pri bolnikih, ki so prejemali linagliptin, vendar manj pogosto kot pri bolnikih, ki so prejemali empagliflozin.
Hypoglycaemia (when used with sulphonylurea or insulin) Thirst
Presnovne in prehranske motnje pogosti pogosti redki hipoglikemija (pri uporabi s sulfonilsečnino ali insulinom) žeja diabetična ketoacidoza
In patients inadequately controlled after this 16 week period, patients received double-blind treatment with either empagliglozin 10 mg, empagliflozin 25 mg or placebo for 24-weeks.
Bolniki, pri katerih z največjim odmerkom metformina, ki ga še prenašajo, ni bilo mogoče doseči ustrezne urejenosti bolezni, so 16 tednov dodatno prejemali odprto zdravljenje z linagliptinom 5 mg. Bolniki, pri katerih v tem 16-tedenskem obdobju ni bilo mogoče doseči ustrezne urejenosti bolezni, so 24 tednov prejemali dvojno slepo zdravljenje z empagliflozinom 10 mg, empagliflozinom 25 mg ali placebom.
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.
V primerjavi z linagliptinom 5 mg in tudi empagliflozinom 10 mg ali 25 mg je zdravljenje z zdravilom Glyxambi pokazalo statistično pomembno izboljšanje vrednosti HbA1c in ravni glukoze v plazmi na tešče (FPG, fasting plasma glucose).
In clinical trials with empagliflozin, the overall frequency of volume depletion (including the predefined terms blood pressure (ambulatory) decreased, blood pressure systolic decreased, dehydration, hypotension, hypovolaemia, orthostatic hypotension, and syncope) was similar in patients treated with empagliflozin (empagliflozin 10 mg: 0.6 %, empagliflozin 25 mg: 0.4 %) and placebo (0.3 %).
V kliničnih preskušanjih z empagliflozinom je bila skupna pogostnost zmanjšanja volumna (vključno s predhodno opredeljenimi pojmi znižanje krvnega tlaka (ambulantno), znižanje sistoličnega krvnega tlaka, dehidracija, hipotenzija, hipovolemija, ortostatska hipotenzija in sinkopa) podobna pri bolnikih,
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)
Glyxambi 25 mg/5 mg filmsko obložene tablete EU/1/16/1146/010 (7 x 1 filmsko obložena tableta) EU/1/16/1146/011 (10 x 1 filmsko obložena tableta) EU/1/16/1146/012 (14 x 1 filmsko obložena tableta) EU/1/16/1146/013 (28 x 1 filmsko obložena tableta) EU/1/16/1146/014 (30 x 1 filmsko obložena tableta) EU/1/16/1146/015 (60 x 1 filmsko obložena tableta) EU/1/16/1146/016 (70 x 1 filmsko obložena tableta) EU/1/16/1146/017 (90 x 1 filmsko obložena tableta) EU/1/16/1146/018 (100 x 1 filmsko obložena tableta)