natgillin/translations-raw huggingface dataset:
Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.
Med bolniki s potencialno večjim tveganjem za DKA so bolniki z majhno funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 2 z nizko vrednostjo C-peptida ali latentno avtoimunsko sladkorno boleznijo odraslih (LADA - latent autoimmune diabetes in adults) ali bolniki z anamnezo pankreatitisa), bolniki z boleznimi, ki zmanjšajo uživanje hrane ali povzročijo hudo dehidracijo, bolniki po zmanjšanju odmerka insulina in bolniki s povečano potrebo po insulinu zaradi akutne bolezni, kirurškega posega ali zlorabe alkohola.
Dapagliflozin 3-O-glucuronide or other metabolites do not contribute to the glucose-lowering effects.
Dapagliflozin-3-O-glukuronid ali drugi presnovki ne prispevajo k učinkom zmanjšanja vrednosti glukoze.
In a separate study of pre- and postnatal development, maternal rats were dosed from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
V ločeni študiji pre- in postnatalnega razvoja so podganjim samicam-materam odmerjali to zdravilo od 6. dne gestacije do 21. postnatalnega dneva; mladiči so bili posredno izpostavljeni in utero in med obdobjem dojenja.
During clinical trials, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50%) and placebo/comparator (1.50%), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
Med kliničnimi preskušanji je bil celotni delež oseb z malignimi ali nespecificiranimi tumorji med tistimi, ki so prejemali dapagliflozin (1,50 %) in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %) podoben in podatki na živalih niso pokazali signalov kancerogenosti ali mutagenosti (glejte poglavje 5.3).
In male and female rats, dapagliflozin showed no effects on fertility at any dose tested.
Pri podganjih samcih in samicah dapagliflozin ni pokazal učinkov na plodnost pri nobenem od preskušanih odmerkov.
Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function.
Deleži neželenih dogodkov, vključujoč dehidracijo ali hipotenzijo, so bili podobni kot pri placebu in klinično pomembnih, z odmerkom povezanih sprememb laboratorijskih parametrov, vključno z elektroliti v serumu in biološkimi označevalci delovanja ledvic, niso ugotovili.
• if you have an increase in the amount of red blood cells in your blood, seen in tests.
• če imate povečano količino rdečih krvnih celic v vaši krvi, kar se določi s preiskavo.
There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Za sklepanje o izpostavljenosti bolnikov, starejših od 70 let, ni dovolj podatkov.
When considering the cases of tumours occurring in the different organ systems, the relative risk associated with dapagliflozin was above 1 for some tumours (bladder, prostate, breast) and below 1 for others (e.g. blood and lymphatic, ovary, renal tract), not resulting in an overall increased tumour risk associated with dapagliflozin.
Pri obravnavi primerov pojava tumorjev v različnih organskih sistemih, je bilo relativno tveganje povezano z dapagliflozinom večje od 1 za nekatere tumorje (mehurja, prostate, dojke) in manjše od 1 za ostale (npr. krvi in limfatičnega sistema, jajčnikov, urinarnega trakta), kar ni vodilo v celokupno povečanje tveganja za pojav tumorja v povezavi z dapagliflozinom.
• if you experience 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, contact a doctor or the nearest hospital straight away.
• če se vam pojavijo hitra izguba telesne mase, slabost ali bruhanje, bolečine v trebuhu, prekomerna žeja, hitro in globoko dihanje, zmedenost, neobičajna zaspanost ali utrujenost, sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja, se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
These are signs of dehydration: - very dry or sticky mouth, feeling very thirsty - feeling very sleepy or tired - passing little or no water (urine) - fast heart beat.
Znaki dehidracije so: - zelo suha ali lepljiva usta, občutek hude žeje - izrazita zaspanost ali utrujenost - odvajanje malo ali nič vode (urina) - hitro bitje srca.
Adverse drug reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Neželene učinke, povezane z zvišanjem kreatinina, so združili v skupino (npr. zmanjšan ledvični očistek kreatinina, okvara ledvic, zvišan kreatinin v krvi in zmanjšana hitrost glomerularne filtracije).
The frequency of minor episodes of hypoglycaemia was similar between treatment groups, including placebo, with the exceptions of studies with add-on sulphonylurea (SU) and add-on insulin therapies.
Pogostost blage hipoglikemije je bila med skupinami podobna, vključno s placebom, z izjemo študij zdravljenja z dodatkom sulfonilsečnin (SU) in dodatkom insulina.
Dapagliflozin does not impair normal endogenous glucose production in response to hypoglycaemia.
Dapagliflozin ne poslabša normalnega endogenega nastajanja glukoze kot odziva na hipoglikemijo.
The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Povprečni skupni sistemski očistek dapagliflozina, danega intravensko, je bil 207 ml/min.
In a pre-specified pooled analysis of 13 placebo-controlled studies, 2,360 subjects were treated with dapagliflozin 10 mg and 2,295 were treated with placebo.
V vnaprej specificirani kumulativni analizi 13, s placebom kontroliranih študij, je 2.360 preiskovancev bilo zdravljenih z 10 mg dapagliflozina in 2.295 je prejemalo placebo.
• if you have a liver problem - your doctor may start you on a lower dose.
• če imate težave z jetri - zdravnik bo pri vas morda začel zdravljenje z manjšim odmerkom.
You should stop taking this medicine if you become pregnant, since it is not recommended during the second and third trimesters of pregnancy.
Če zanosite, morate prekiniti zdravljenje z zdravilom Forxiga, saj uporaba zdravila v drugem in tretjem trimesečju nosečnosti ni priporočljiva.
Urinary glucose excretion may be associated with an increased risk of urinary tract infection; therefore, temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis.
Izločanje glukoze z urinom je lahko povezano s povečanjem tveganja za okužbe sečil, zato je med zdravljenjem pielonefritisa ali urosepse treba razmisliti o začasnem prenehanju uporabe dapagliflozina.
Haematocrit increase was observed with dapagliflozin treatment (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Povečanje hematokrita je bilo opaženo pri zdravljenju z dapagliflozinom (glejte poglavje 4.8); zato je potrebna previdnost pri bolnikih, ki že imajo povečan hematokrit.
Your doctor may ask you to stop taking Forxiga.
Zdravnik vam lahko svetuje, da prenehate z jemanjem zdravila Forxiga.
Dapagliflozin and related metabolites are primarily eliminated via urinary excretion with less than 2% as unchanged dapagliflozin.
Dapagliflozin in sorodni presnovki se izločijo predvsem z urinom, pri čemer je manj kot 2 % nespremenjenega dapagliflozina.
The results showed a similar mean reduction in HbA1c from baseline to Week 52, compared to glipizide, thus demonstrating non-inferiority (Table 3).
Rezultati so pokazali podobno povprečno zmanjšanje HbA1c od izhodišča do 52. tedna v primerjavi z glipizidom, s čemer je bila dokazana neinferiornost (Preglednica 3).
Forxiga 5 mg tablets and Forxiga 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Zdravili Forxiga 5 mg in 10 mg filmsko obložene tablete sta na voljo v pretisnih omotih v velikostih pakiranj s 14, 28 ali 98 filmsko obloženimi tabletami v neperforiranih koledarskih omotih ter s 30 x 1 ali 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
The most commonly reported adverse reaction related to renal function was increased serum creatinine.
Najpogosteje poročani neželeni učinek, povezan z delovanjem ledvic, je bil povečanje vrednosti kreatinina v serumu.
Dapagliflozin exposure is increased in patients with severe hepatic impairment (see sections 4.2 and 5.2).
Izpostavljenost dapagliflozinu je povečana pri bolnikih s hudo okvaro jeter (glejte poglavji 4.2 in 5.2).
The impact of hemodialysis on dapagliflozin exposure is not known.
Vpliv hemodialize na izpostavljenost dapagliflozinu ni znan.
• Your doctor may ask you to take Forxiga on its own if you are intolerant to metformin or together with other medicines to treat diabetes.
• Zdravnik vam lahko predpiše samo zdravilo Forxiga, če ne prenašate metformina, ali pa skupaj s kakšnim drugim zdravilom za zdravljenje sladkorne bolezni.
Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 5.2).
Treba je upoštevati delovanje ledvic in tveganje za pomanjkanje volumna (glejte poglavji 4.4 in 5.2).
Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Če se pojavijo ti simptomi, je treba takoj preveriti, ali gre za ketoacidozo, in sicer ne glede na koncentracijo glukoze v krvi.
• if you are allergic to dapagliflozin or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Forxiga: • če ste alergični na dapagliflozin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
“Type 2 diabetes mellitus” is the type of diabetes that usually starts when you are older.
"Sladkorna bolezen tipa 2" je oblika sladkorne bolezni, ki se običajno pojavi pri starejših.
There is limited experience in clinical trials in patients with hepatic impairment.
Izkušenj iz kliničnih preskušanj pri bolnikih z okvaro jeter je malo.
Hence, Forxiga can be administered with or without food.
Zdravilo Forxiga se torej lahko jemlje s hrano ali brez nje.
The renal pelvic and tubular dilatations observed in juvenile animals did not fully reverse within the approximate 1-month recovery period.
Pri mladih živalih ugotovljene razširitve ledvičnega meha in tubulov, med približno 1-mesečnim obdobjem okrevanja, niso povsem izginile.
• 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.
• diabetično ketoacidozo, ki je redka (lahko se pojavi pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi 2. poglavje, Opozorila in previdnostni ukrepi) so: - zvišana raven "ketonskih teles" v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v trebuhu - prekomerna žeja - hitro in globoko dihanje - zmedenost - neobičajna zaspanost ali utrujenost - sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja.
The most frequently reported adverse reaction was hypoglycaemia, which depended on the type of background therapy used in each study.
Najpogosteje so poročali o neželenem učinku hipoglikemiji, ki je bila odvisna od vrste zdravljenja, uporabljenega v vsaki študiji.
Urine laboratory assessments Due to its mechanism of action, patients taking Forxiga will test positive for glucose in their urine.
Bolniki, ki jemljejo zdravilo Forxiga, bodo zaradi njegovega mehanizma delovanja, pozitivni na preiskavi za prisotnost glukoze v urinu.
There are no data from the use of dapagliflozin in pregnant women.
O uporabi dapagliflozina pri nosečnicah ni podatkov.
Forxiga contains lactose (milk sugar).
Zdravilo Forxiga vsebuje laktozo (mlečni sladkor).
In an add-on to metformin and a sulphonylurea study, up to 24 weeks, no episodes of major hypoglycaemia were reported.
V študiji dodatka metforminu in sulfonilsečnini v obdobju do 24 tednov niso zabeležili hudih hipoglikemij.
• The active substance is dapagliflozin.
• Zdravilna učinkovina je dapagliflozin.
Due to the limited therapeutic experience in patients 75 years and older, initiation of dapagliflozin therapy is not recommended.
Zaradi malo izkušenj z zdravljenjem bolnikov, starih 75 let in več, uvedba zdravljenja z dapagliflozinom v tej skupini bolnikov ni priporočljiva.
• These are medicines taken by mouth for diabetes.
• To so zdravila za zdravljenje sladkorne bolezni, ki se jih zaužije.
Pyelonephritis was uncommon and occurred at a similar frequency to control.
Pielonefritis se je pojavljal občasno in s podobno pogostostjo kot pri primerjavi.
Thirteen double-blind, randomised, controlled clinical trials were conducted with 6,362 subjects with type 2 diabetes to evaluate the efficacy and safety of Forxiga; 4,273 subjects in these studies were treated with dapagliflozin.
Za oceno učinkovitosti in varnosti zdravila Forxiga so izvedli trinajst dvojno slepih, randomiziranih, kontroliranih kliničnih preskušanj, ki so zajela 6.362 oseb s sladkorno boleznijo tipa 2; 4.273 oseb je v teh študijah prejemalo dapagliflozin.
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 kažejo, da je DKA pri zdravljenju bolnikov s sladkorno boleznijo tipa 1 z zaviralci SGLT2 pogosta.
Once-daily treatment with dapagliflozin resulted in statistically significant (p < 0.0001) reductions in HbA1c compared to placebo (Table 2).
Zdravljenje z dapagliflozinom enkrat na dan je statistično značilno (p < 0,0001) zmanjšalo HbA1c v primerjavi s placebom (Preglednica 2).
There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Pri bolnikih, starih do 70 let, ni klinično pomembne večje izpostavljenosti zgolj zaradi starosti.
The effect of dapagliflozin on fertility in humans has not been studied.
Vpliv dapagliflozina na plodnost pri človeku ni bil raziskan.
Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV.
Izkušenj v razredih I in II po NYHA je malo, izkušenj iz kliničnih študij z dapagliflozinom v razredih III in IV po NYHA pa ni.
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).
V številnih primerih je bila klinična slika te motnje neznačilna in koncentracija glukoze v krvi je bila le zmerno zvišana, pod 14 mmol/l (250 mg/dl).
These infections were more frequent in females, and subjects with a prior history were more likely to have a recurrent infection.
O teh okužbah so pogosteje poročali pri ženskah ter pri preiskovancih s predhodno anamnezo in torej večjo verjetnostjo za pojav ponovne okužbe.
Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively.
Geometrični sredini vrednosti Cmax in AUCτ dapagliflozina v stanju dinamičnega ravnovesja sta bili po odmerkih 10 mg enkrat na dan 158 ng/ml in 628 ng h/ml.
Dapagliflozin was rapidly and well absorbed after oral administration.
Dapagliflozin se po peroralni uporabi hitro in dobro absorbira.
Despite the presence of hyperglycaemia in type 2 diabetes, reabsorption of filtered glucose continues.
Kljub hiperglikemiji je pri sladkorni bolezni tipa 2 reabsorpcija filtrirane glukoze ohranjena.
In clinical studies where once-daily doses of up to 100 mg (10 times the maximum recommended human dose) were administered for 2 weeks in healthy subjects and type 2 diabetes subjects, the incidence of hypoglycaemia was slightly higher than placebo and was not dose-related.
V kliničnih študijah, v katerih so zdravim osebam in osebam s sladkorno boleznijo tipa 2 dajali odmerke do 100 mg enkrat na dan (tj. 10-kratnik največjega priporočenega odmerka za človeka), 2 tedna, je bila pojavnost hipoglikemij rahlo večja kot s placebom in ni bila povezana z odmerkom.
Initiation of dapagliflozin therapy in this population is not recommended (see sections 4.2 and 5.2).
Uvedba zdravljenja z dapagliflozinom v tej skupini bolnikov ni priporočljiva (glejte poglavji 4.2 in 5.2).
The no observed adverse effect level (NOAEL) for developmental toxicity, the lowest dose tested, is associated with a maternal systemic exposure multiple that is approximately 19 times the human value at the maximum recommended human dose.
Raven brez opaženih neželenih učinkov (NOAELno observed adverse effect level) za razvojne toksične učinke - najmanjši preskušani odmerek - je povezana z večkratnikom maternalne sistemske izpostavljenosti, ki je približno 19-krat tolikšna kot izpostavljenost človeka pri največjemu priporočenemu odmerku za človeka.
hMean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5% versus 0.0%; HDL cholesterol 6.0% versus 2.7%; LDL cholesterol 2.9% versus -1.0%; triglycerides -2.7% versus -0.7%.
Povprečni odstotek spremembe od izhodišča za 10 mg dapagliflozina v primerjavi s placebom, je bil za: celokupni holesterol 2,5 % v primerjavi z 0,0 %; holesterol HDL 6,0 % v primerjavi z 2,7 %; holesterol LDL 2,9 % v primerjavi z -1,0 %; trigliceridi -2,7 % v primerjavi z -0,7 %.
Urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo (4.7% versus 3.5%, respectively; see section 4.4).
O okužbah sečil so pogosteje poročali v povezavi z 10 mg dapagliflozina v primerjavi s placebom (4,7 % v primerjavi s 3,5 %; glejte poglavje 4.4).
For studies of dapagliflozin in monotherapy, as add-on to metformin or as add-on to sitagliptin (with or without metformin), the frequency of minor episodes of hypoglycaemia was similar (< 5%) between treatment groups, including placebo up to 102 weeks of treatment.
V študijah dapagliflozina v monoterapiji, kot dodatek metforminu ali kot dodatek sitagliptinu (z ali brez metformina), je bila pogostost blagih hipoglikemij med terapevtskimi skupinami, vključno s placebom, do 102 tednov zdravljenja podobna (< 5 %).
Dapagliflozin acts independently of insulin secretion and insulin action.
Dapagliflozin deluje neodvisno od izločanja in delovanja insulina.
Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (time periods corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Neposredna uporaba dapagliflozina pri nedavno odstavljenih podganjih mladičih in posredna izpostavljenost med pozno brejostjo (časovni obdobji, ki ustrezata drugemu in tretjemu trimesečju nosečnosti glede na dozorevanje ledvic pri človeku) ter med obdobjem dojenja sta bili povezani z večjo pojavnostjo in/ali izrazitostjo razširitev ledvičnega meha in tubulov pri potomstvu.
• loss of too much fluid from your body (dehydration), seen uncommonly.
• čezmerna izguba tekočine iz vašega telesa (dehidracija), ki se lahko pojavi občasno.
Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Dapagliflozin ni bil raziskan v kombinaciji z analogi glukagonu podobnega peptida 1 (GLP-1glucagon-like peptide 1).
What Forxiga looks like and contents of the pack
Izgled zdravila Forxiga in vsebina pakiranja
Consequently, low-weight patients may have somewhat increased exposure and patients with high weight somewhat decreased exposure.
Zato je lahko izpostavljenost pri bolnikih z majhno telesno maso nekoliko večja in pri bolnikih z veliko telesno maso nekoliko manjša.
Dapagliflozin should not be used while breast-feeding.
Dapagliflozina se v obdobju dojenja ne sme uporabljati.
Dapagliflozin is not recommended for use in patients receiving loop diuretics (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as gastrointestinal illness).
Uporaba dapagliflozina ni priporočljiva pri bolnikih, ki prejemajo diuretike zanke (glejte poglavje 4.5) ali imajo pomanjkanje volumna, npr. zaradi akutne bolezni (kot je bolezen prebavil).
The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Nastajanje dapagliflozin-3-O-glukuronida poteka z encimom UGT1A9, ki je prisoten v jetrih in ledvicah; presnova s sistemom CYP je bila pri človeku manj pomembna pot očistka.
Moderate renal impairment (eGFR ≥ 30 to < 60 ml/min/1.73 m2) The efficacy of dapagliflozin was also assessed separately in a dedicated study of diabetic subjects with moderate renal impairment (252 subjects with mean eGFR 45 ml/min/1.73 m2).
Zmerna okvara ledvic (eGFR ≥ 30 do < 60 ml/min/1,73 m Učinkovitost dapagliflozina so ločeno ocenili tudi v namenski študiji sladkornih bolnikov z zmerno okvaro ledvic (252 preiskovancev s povprečnim eGFR 45 ml/min/1,73 m2).
Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Večjo pojavnost in izrazitost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le pri največjem preskušanem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1.415-krat in mladičev 137-krat večja od izpostavljenosti človeka pri največjemu priporočenemu odmerku za človeka).
Adverse reactions in placebo-controlled studiesa
Neželeni učinki v s placebom kontroliranih študijah a
The reductions in HbA1c observed at Week 24 were sustained in add-on combination studies (glimepiride and insulin) with 48-week data (glimepiride) and up to 104-week data (insulin).
Zmanjšanje HbA1c, ugotovljeno 24. teden, v študijah dodatka h kombiniranemu zdravljenju (z glimepiridom in insulinom), se je ohranilo do 48. tedna (glimepirid) in do 104. tedna (insulin).
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Forxiga, and during treatment:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Forxiga in med zdravljenjem z njim se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Forxiga was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%).
V 52-tedenski, z zdravilno učinkovino kontrolirani študiji neinferiornosti (z 52-tedenskim in 104tedenskim obdobjem podaljšanja), so zdravilo Forxiga ocenjevali kot dodatek k zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom k zdravljenju z metforminom pri osebah z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
approximately 15% of the dose was excreted as parent drug.
V blatu se je približno 15 % odmerka izločilo kot nespremenjenega.