natgillin/translations-raw huggingface dataset:
There were no additional adverse reactions identified in the pooling of these two placebo-controlled trials that included metformin relative to the three placebo-controlled studies with ertugliflozin (see below).
V teh dveh združenih, s placebom nadzorovanih preskušanjih, ki sta vključevali metformin, ni bilo dodatnih neželenih učinkov v primerjavi s tremi s placebom nadzorovanimi študijami z ertugliflozinom (glejte spodaj).
Because renal function abnormalities can occur after initiating ertugliflozin, and metformin is known to be substantially excreted by the kidneys, Segluromet should be used with caution in the elderly.
Ker se po uvedbi ertugliflozina lahko pojavijo nepravilnosti v delovanju ledvic, metformin pa se v veliki meri izloča skozi ledvice, je pri starejših bolnikih pri uporabi Seglurometa potrebna previdnost.
The doctor may lower the dose of your insulin or other diabetes medicine.
Zdravnik vam lahko zmanjša odmerek insulina ali drugih zdravil za zdravljenje sladkorne bolezni.
Segluromet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Zdravilo Segluromet je indicirano pri odraslih, starih 18 let ali več, s sladkorno boleznijo tipa 2 kot dodatek k dieti in telesni aktivnosti za izboljšanje urejenosti glikemije:
• Inducers of OCT1 (such as rifampicin) may increase gastrointestinal absorption and efficacy of metformin.
• induktorji OCT1 (kot je rifampicin) lahko povečajo absorpcijo iz prebavil in učinkovitost metformina.
Only 1.5% of the administered dose was excreted as unchanged ertugliflozin in urine and 34% as unchanged ertugliflozin in faeces, which is likely due to biliary excretion of glucuronide metabolites and subsequent hydrolysis to parent.
Kot nespremenjeni ertugliflozin se je v urinu izločilo le 1,5 % uporabljenega odmerka, v blatu pa 34 % uporabljenega odmerka, kar je verjetno posledica izločanja glukuronidnih presnovkov v žolču in poznejše hidrolize teh v matično spojino.
• if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
• če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
Elderly patients are more likely to have decreased renal function.
Pri starejših bolnikih je večja verjetnost za zmanjšano delovanje ledvic.
The efficacy and safety of ertugliflozin in combination with metformin have been studied in 4 multi-centre, randomised, double-blind, placebo- and active comparator-controlled, Phase 3 clinical studies involving 3,643 patients with type 2 diabetes.
Učinkovitost in varnost ertugliflozina v kombinaciji z metforminom so preučevali v 4 multicentričnih, randomiziranih, dvojno slepih, s placebom ali primerjalno učinkovino nadzorovanih kliničnih študijah 3. faze, ki so vključevale 3.643 bolnikov s sladkorno boleznijo tipa 2.
Repeat-dose oral toxicity studies were conducted in mice, rats, and dogs for up to 13, 26, and 39 weeks, respectively.
Študije toksičnosti ponavljajočih se peroralnih odmerkov so izvedli pri miših (do 13 tednov), podganah (do 26 tednov) in psih (do 39 tednov).
Your doctor will decide when you must stop and when to restart your treatment with Segluromet.
Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Segluromet prenehati in kdaj lahko nadaljujete.
What Segluromet looks like and contents of the pack
Izgled zdravila Segluromet in vsebina pakiranja
In Phase 3 clinical trials, ertugliflozin was administered without regard to meals.
V kliničnih preskušanjih 3. faze so ertugliflozin uporabljali ne glede na obroke.
Segluromet has been shown to be bioequivalent to coadministration of corresponding doses of ertugliflozin and metformin tablets.
Pokazalo se je, da je zdravilo Segluromet bioekvivalentno sočasni uporabi ustreznih odmerkov tablet ertugliflozina in metformina.
The 24-hour urinary glucose excretion declined with increasing severity of renal impairment (see section 4.4).
24-urno izločanje glukoze v urinu se je z napredujočo stopnjo okvare ledvic zmanjševalo (glejte poglavje 4.4).
Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation.
Metformin zmanjša nastajanje glukoze v jetrih, zmanjša absorpcijo glukoze v črevesu in izboljša občutljivost za insulin z izboljšanjem perifernega privzema in izrabe glukoze.
Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maloštevilni podatki iz kliničnih preskušanj nakazujejo pogost pojav DKA, če se bolnike s sladkorno boleznijo tipa 1 zdravi z zaviralci SGLT2.
What Segluromet is and what it is used for
Kaj je zdravilo Segluromet in za kaj ga uporabljamo
The efficacy of ertugliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Učinkovitost ertugliflozina je odvisna od delovanja ledvic in je pri bolnikih z zmerno okvaro ledvic zmanjšana, pri bolnikih s hudo okvaro ledvic pa učinkovitosti verjetno ni (glejte poglavje 4.2).
The absolute bioavailability of a metformin hydrochloride 500-mg tablet given under fasting conditions is approximately 50-60%.
Absolutna biološka uporabnost tablet metforminijevega klorida v odmerku 500 mg, uporabljenih na tešče, je približno 50 do 60 %.
Before initiating Segluromet, factors in the patient history that may predispose to ketoacidosis should be considered.
Pred uvedbo zdravila Segluromet je treba glede na bolnikovo anamnezo upoštevati dejavnike, ki bi lahko povečali nagnjenost h ketoacidozi.
Segluromet should not be initiated in patients with a GFR below 60 ml/min.
Zdravila Segluromet se ne sme uvesti pri bolnikih z GFR pod 60 ml/min.
Sexual maturation was delayed in both sexes at 250 mg/kg/day (estimated 620 times the MRHD at 15 mg/day, based on AUC).
Spolno dozorevanje je bilo pri obeh spolih upočasnjeno pri odmerku 250 mg/kg/dan (ocenjeni 620-kratnik ob MRHD 15 mg/dan na podlagi AUC).
Dose-response modelling indicates that ertugliflozin 5 mg and 15 mg result in near maximal urinary glucose excretion (UGE) in patients with type 2 diabetes mellitus, providing 87% and 96% of maximal inhibition, respectively.
Modeliranje odmerka glede na odziv kaže, da odmerka 5 mg in 15 mg ertugliflozina pri bolnikih s sladkorno boleznijo tipa 2 povzročita skoraj maksimalno izločanje glukoze v urinu (UGE - urinary glucose excretion) in dosežeta 87 % (odmerek 5 mg) in 96 % (odmerek 15 mg) maksimalnega zavrtja.
A serious soft tissue infection of the genitals or the area between the genitals and the anus (see section “Warnings and precautions” for symptoms).
Resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom (za simptome glejte poglavje “Opozorila in previdnostni ukrepi”).
In an ongoing clinical study of ertugliflozin added to existing therapy in type 2 diabetes patients with a history of established cardiovascular disease, an approximately 1.2-1.6-fold increase in cases of lower limb amputation (primarily of the toe) has been observed in patients treated with ertugliflozin.
V potekajoči klinični študiji ertugliflozina, dodanega k obstoječemu zdravljenju, pri bolnikih s sladkorno boleznijo tipa 2 s potrjeno kardiovaskularno boleznijo v anamnezi, so pri bolnikih, zdravljenih z ertugliflozinom, opazili približno 1,2 - 1,6-kratno povečanje števila primerov amputacij na spodnjih okončinah (predvsem prstov).
Blood creatinine increased/Glomerular filtration rate decreased and renal-related events (ertugliflozin)
Zvišanje kreatinina v krvi/zmanjšanje hitrosti glomerulne filtracije in z ledvicami povezani dogodki (ertugliflozin)
Based on results from animal studies, ertugliflozin may affect renal development and maturation (see section 5.3).
Na podlagi rezultatov študij na živalih lahko ertugliflozin vpliva na razvoj in dozorevanje ledvic (glejte poglavje 5.3).
This decrease in ertugliflozin exposure is not considered clinically meaningful.
To zmanjšanje izpostavljenosti ertugliflozinu ne velja za klinično pomembno.
• Ertugliflozin works by blocking the SGLT2 protein in your kidneys.
• Ertugliflozin deluje tako, da zavira beljakovino SGLT2 v ledvicah.
Because of how Segluromet works, your urine will test positive for sugar (glucose) while you are on this medicine.
Zaradi načina delovanja zdravila Segluromet boste imeli med jemanjem tega zdravila pozitiven rezultat izvida za prisotnost sladkorja (glukoze) v urinu.
When ertugliflozin was added to metformin and compared to sulphonylurea, the incidence of hypoglycaemia was higher for the sulphonylurea (27%) compared to ertugliflozin (5.6% and 8.2% for ertugliflozin 5 mg and 15 mg, respectively).
Če so ertugliflozin dodali k metforminu in ga primerjali s sulfonilsečnino, je bila pojavnost hipoglikemij pri sulfonilsečnini večja (27 %) kot pri ertugliflozinu (5,6 % pri 5 mg ertugliflozina in 8,2 % pri 15 mg ertugliflozina).
When ertugliflozin was used as monotherapy, the incidence of hypoglycaemic events in the ertugliflozin groups was 2.6% in both groups and 0.7% in the placebo group.
Če so ertugliflozin uporabili kot samostojno zdravljenje, je bila pojavnost hipoglikemičnih dogodkov v obeh skupinah z ertugliflozinom 2,6 % in 0,7 % v skupini s placebom.
• You need to keep following your food and exercise plan while taking Segluromet.
• Med jemanjem zdravila Segluromet se morate še naprej držati načrta prehrane in telesne aktivnosti.
If you stop taking Segluromet
Če ste prenehali jemati zdravilo Segluromet
In the subgroup analyses in the broader pool of Phase 3 studies, subjects with eGFR < 60 mL/min/1.73 m2, subjects ≥ 65 years of age and subjects on diuretics had a higher incidence of volume depletion in the ertugliflozin groups relative to the comparator group (see sections 4.2 and 4.4).
V analizah podskupin širših združenih podatkov iz študij 3. faze so imele osebe z eGFR < 60 ml/min/1,73 m2, osebe stare ≥ 65 let in osebe na diuretikih v skupinah z ertugliflozinom večjo pojavnost hipovolemije kot v primerjalni skupini (glejte poglavji 4.2 in 4.4).
Urinary tract infections
Okužbe urinarnega trakta
• yeast infections of the penis
• glivične okužbe penisa,
Urinary glucose excretion and urinary volume
Izločanje glukoze v urinu in količina urina
The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 l. Metformin is negligibly bound to plasma proteins.
Navidezni volumen porazdelitve (V/F) metformina po enkratnih peroralnih odmerkih 850 mg metforminijevega klorida v tabletah je bil v povprečju 654 ± 358 l. Vezava metformina na beljakovine v plazmi je zanemarljiva.
• take medicines that increase your urine production (diuretics) or lower blood pressure
• če jemljete tablete, ki povečajo nastajanje urina (diuretike) ali znižajo krvni tlak,
Elderly patients may be at an increased risk of volume depletion.
Starejši bolniki imajo lahko povečano tveganje za hipovolemijo.
• hepatitis (a liver problem)
• hepatitis (bolezen jeter)
Plasma Cmax and AUC of ertugliflozin increase in a dose-proportional manner following single doses from 0.5 mg to 300 mg and following multiple doses from 1 mg to 100 mg.
Cmax in AUC ertugliflozina v plazmi se po enkratnih odmerkih od 0,5 mg do 300 mg in večkratnih odmerkih od 1 mg do 100 mg povečujeta sorazmerno odmerku.
Ertugliflozin increases the risk of genital mycotic infections.
Ertugliflozin poveča tveganje za glivične okužbe spolovil.
Coadministration of simvastatin with ertugliflozin resulted in a 24% and 19% increase in AUC and Cmax of simvastatin, respectively, and 30% and 16% increase in AUC and Cmax of simvastatin acid,
Sočasna uporaba simvastatina in ertugliflozina je povzročila povečanje AUC simvastatina za 24 % in njegove Cmax za 19 % ter povečanje AUC simvastatina v obliki kisline za 30 % in njegove Cmax za 16 %.
How to store Segluromet 6.
Shranjevanje zdravila Segluromet 6.
The pack sizes are 14, 28, 56, 60, 168, and 180 film-coated tablets in non-perforated blisters, multipack containing 196 (4 packs of 49) film coated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters.
Velikosti pakiranj so po 14, 28, 56, 60, 168 in 180 filmsko obloženih tablet v neperforiranih pretisnih omotih, multi pakiranje, ki vsebuje 196 (4 pakiranja po 49) filmsko obloženih tablet v neperforiranih pretisnih omotih, in 30 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek.
For patients switching from separate tablets of ertugliflozin and metformin Patients switching from separate tablets of ertugliflozin (5 mg or 15 mg total daily dose) and metformin to Segluromet should receive the same daily dose of ertugliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Za bolnike, ki preidejo z ločenih tablet ertugliflozina in metformina Bolniki, ki preidejo z ločenih tablet ertugliflozina (celokupni dnevni odmerek 5 mg ali 15 mg) in metformina na zdravilo Segluromet, morajo prejeti enak dnevni odmerek ertugliflozina in metformina, kot so ga že jemali, ali najbližji terapevtsko ustrezni odmerek metformina.
Initiation is not recommended in patients with a glomerular filtration rate less than 60 ml/min (see section 4.4).
Uvedba ni priporočljiva pri bolnikih s hitrostjo glomerulne filtracije manj kot 60 ml/min (glejte poglavje 4.4).
Initiation of this medicinal product is not recommended in patients with a GFR less than 60 ml/min (see section 4.4).
Uvedba tega zdravila ni priporočljiva pri bolnikih, ki imajo GFR manj kot 60 ml/min (glejte poglavje 4.4).
These doses are both approximately four times the maximum recommended human daily dose of 2,000 mg based on body surface area comparisons.
Oba odmerka sta na podlagi primerjav telesne površine približno 4-kratnik največjega priporočenega dnevnega odmerka 2.000 mg za človeka.
Effects of other medicinal products on the pharmacokinetics of ertugliflozin Metabolism by UGT1A9 and UGT2B7 is the primary clearance mechanism for ertugliflozin.
Vpliv drugih zdravil na farmakokinetiko ertugliflozina Glavni mehanizem očistka ertugliflozina je presnova z UGT1A9 in UGT2B7.
• blood tests may show changes related to kidney function (such as ‘creatinine')
• preiskave krvi lahko pokažejo spremembe, povezane z delovanjem ledvic (na primer pri
Regular assessment of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see section 4.4).
Da se pripomore k preprečevanju z metforminom povezane laktacidoze je treba redno preverjati delovanje ledvic, zlasti pri starejših bolnikih (glejte poglavje 4.4).
Pregnancy There are no data from the use of Segluromet in pregnant women.
Nosečnost O uporabi zdravila Segluromet pri nosečnicah ni podatkov.
In three placebo-controlled studies, ertugliflozin resulted in statistically significant reductions in FPG.
V treh s placebom nadzorovanih študijah je ertugliflozin povzročil statistično značilno znižanje glukoze v plazmi na tešče.
• The other ingredients are: o Tablet core: povidone (K29-32) (E1201), microcrystalline cellulose (E460), crospovidone (E1202), sodium lauryl sulfate (E487), magnesium stearate (E470b).
• Druge sestavine zdravila so: o Jedro tablete: povidon (K29-32) (E1201), mikrokristalna celuloza (E460), krospovidon (E1202), natrijev lavrilsulfat (E487), magnezijev stearat (E470b)
Talk with your doctor about the best way to feed your baby if you take this medicine.
Če jemljete to zdravilo, se z zdravnikom posvetujte o najboljšem načinu za hranjenje dojenčka.
Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8).
Upoštevati je treba delovanje ledvic in tveganje za hipovolemijo (glejte poglavji 4.4 in 4.8).
The no-observed-effect level (NOEL) for neoplasia was 5 mg/kg/day (approximately 16 times human unbound exposure at the MRHD of 15 mg/day).
Raven brez opaženega učinka (NOEL - no-observed-effect level) za novotvorbe je bila 5 mg/kg/dan (to je približno 16-kratnik izpostavljenosti nevezanemu zdravilu pri človeku ob MRHD 15 mg/dan).
• have ever had serious heart disease or if you have had a stroke.
• če ste v preteklosti imeli resno bolezen srca ali možgansko kap.
• hunger
• lakoto,
The major metabolic pathway for ertugliflozin is UGT1A9 and UGT2B7-mediated O-glucuronidation to two glucuronides that are pharmacologically inactive at clinically relevant concentrations.
Glavna presnovna pot ertugliflozina je O-glukuronidacija z UGT1A9 in UGT2B7, pri čemur nastaneta glukuronida, ki v klinično pomembnih koncentracijah nista farmakološko aktivna.
In patients with decreased renal function, the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in eGFR (see sections 4.3 and 4.4).
Pri bolnikih z zmanjšanim delovanjem ledvic se sorazmerno z zmanjšanjem eGFR razpolovni čas metformina v plazmi in krvi podaljša, ledvični očistek pa se zmanjša (glejte poglavji 4.3 in 4.4).
The absolute oral bioavailability of ertugliflozin following administration of a 15-mg dose is approximately 100%.
Absolutna peroralna biološka uporabnost ertugliflozina po uporabi odmerka 15 mg je približno 100 %.
• in patients not adequately controlled on their maximally tolerated dose of metformin alone
• pri bolnikih, s slabo urejeno glikemijo ob največjem toleriranem odmerku samega metformina,
Hepatic impairment Segluromet is contraindicated in patients with hepatic impairment (see sections 4.3 and 4.4).
Okvara jeter Zdravilo Segluromet je pri bolnikih z okvaro jeter kontraindicirano (glejte poglavji 4.3 in 4.4).
Administration of ertugliflozin with a high-fat and high-calorie meal decreases ertugliflozin Cmax by 29% and prolongs Tmax by 1 hour, but does not alter AUC as compared with the fasted state.
Uporaba ertugliflozina z obrokom z visoko vsebnostjo maščob in zelo kaloričnim obrokom v primerjavi z uporabo na tešče zmanjša Cmax ertugliflozina za 29 % in podaljša njegov tmax za 1 uro, ne spremeni pa AUC.
Segluromet is expected to have diminished efficacy in elderly patients with renal impairment (see sections 4.2 and 4.8).
Pričakovati je, da ima zdravilo Segluromet pri starejših bolnikih z okvaro ledvic zmanjšano učinkovitost (glejte poglavji 4.2 in 4.8).
• have had a lower limb amputation.
• če ste imeli amputacijo na spodnji okončini.
Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are substrates of these transporters.
V splošnem ni verjetno, da bi ertugliflozin vplival na farmakokinetiko sočasno uporabljenih zdravil, ki so substrati teh prenašalcev.
In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving ertugliflozin.
V primeru stanj, ki lahko povzročijo izgubo tekočine (npr. bolezni prebavil), se pri bolnikih, ki prejemajo ertugliflozin, priporoča skrbno spremljanje volumskega stanja (npr. s fizikalnim pregledom, meritvami krvnega tlaka, laboratorijskimi preiskavami, vključno s hematokritom) in elektrolitov.
* N includes all randomised, treated patients who had at least one measurement of the outcome variable.
95 % IZ) * n vključuje vse randomizirane, zdravljene bolnike, ki so imeli vsaj eno meritev spremenljivke izida.
There are limited data from the use of ertugliflozin in pregnant women.
Podatkov o uporabi ertugliflozina pri nosečnicah je malo.
Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje za laktacidozo.
Due to the mechanism of action of ertugliflozin, patients taking Segluromet will test positive for glucose in their urine.
Zaradi mehanizma delovanja ertugliflozina bodo rezultati testov glukoze v urinu pri bolnikih, ki jemljejo zdravilo Segluromet, pozitivni.
• redness of the skin
• pordelost kože,
Segluromet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Zdravilo Segluromet je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnima mehanizmoma delovanja, namenjena izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: ertugliflozina, zaviralca SGLT2, in metforminijevega klorida, ki spada v razred bigvanidov.
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products, including insulin The recommended starting dose of Segluromet should provide ertugliflozin 2.5 mg twice daily (5 mg daily dose) and the dose of metformin similar to the dose already being taken.
Za bolnike, ki niso ustrezno urejeni z metforminom kot samostojnim zdravljenjem ali z metforminom v kombinaciji z drugimi zdravili za zniževanje glukoze, vključno z insulinom Priporočeni začetni odmerek zdravila Segluromet mora zagotoviti 2,5 mg ertugliflozina dvakrat na dan (dnevni odmerek 5 mg) in odmerek metformina, podoben dosedaj jemanemu odmerku.
At a maternally toxic dose in rats (250 mg/kg/day), lower foetal viability and a higher incidence of a visceral malformation were observed at maternal exposure that was 510 times the maximum clinical dose of 15 mg/day.
Pri maternalnih toksičnih odmerkih pri podganah (250 mg/kg/dan) so pri maternalni izpostavljenosti, ki je bila 510-kratnik izpostavljenosti med uporabo največjega kliničnega odmerka 15 mg/dan, opažali manjšo viabilnost plodov in večjo pojavnost visceralnih malformacij.
When used as add-on to metformin, the incidence of hypoglycaemic events was 7.2% in the ertugliflozin 5 mg group, 7.8% in the ertugliflozin 15 mg group and 4.3% in the placebo group.
Če so ga uporabili kot dodatek k metforminu, je bila pojavnost hipoglikemičnih dogodkov v skupini s 5 mg ertugliflozina 7,2 %, v skupini s 15 mg ertugliflozina 7,8 % in v skupini s placebom 4,3 %.
49 film-coated tablets.
49 filmsko obloženih tablet.
Ertugliflozin and ertugliflozin glucuronides did not inhibit the activity of UGTs 1A6, 1A9 or 2B7 in vitro.
Ertugliflozin in njegovi glukuronidi in vitro niso zavirali aktivnosti UGT 1A6, 1A9 ali 2B7.
30x1 film-coated tablets
30 x 1 filmsko obložena tableta
In the rat fertility and embryonic development study, male and female rats were administered ertugliflozin at 5, 25, and 250 mg/kg/day.
V študiji plodnosti in razvoja zarodka pri podganah so podganji samci in samice prejemali ertugliflozin v odmerkih 5, 25 in 250 mg/kg/dan.
The safety of concomitantly administered ertugliflozin and metformin has been evaluated in 1,083 patients with type 2 diabetes mellitus treated for 26 weeks in a pool of two placebo-controlled trials: as ertugliflozin add on therapy to metformin and as ertugliflozin add-on therapy to sitagliptin and metformin (see section 5.1).
Varnost sočasne uporabe ertugliflozina in metformina so ocenili pri 1.083 bolnikih s sladkorno boleznijo tipa 2, ki so se 26 tednov zdravili v dveh združenih, s placebom nadzorovanih preskušanjih: z ertugliflozinom kot dodatnim zdravilom k metforminu in z ertugliflozinom kot dodatnim zdravilom k sitagliptinu in metforminu (glejte poglavje 5.1).