FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Slovenian: Pri obravnavi primerov tumorjev različnih organskih sistemov je bilo relativno tveganje z dapagliflozinom večje od 1 za nekatere tumorje (sečnega mehurja, prostate, dojke) in manjše od 1 za druge (npr. krvi in limfatičnega sistema, jajčnikov, sečil), tako da z dapagliflozinom ni bilo povezano večje celokupno tveganje za tumorje.
English: The primary safety (non-inferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Slovenian: Primarni opazovani dogodek varnosti (neinferiornost) in učinkovitosti (superiornost) je bil sestavljen opazovani dogodek, ki je obsegal čas do prvega pojava katerega od naslednjih hudih neželenih srčno-žilnih dogodkov (MACE - major adverse CV events): srčno-žilne smrti, miokardnega infarkta brez smrtnega izida ali možganske kapi brez smrtnega izida.
English: Metformin: Metformin is excreted unchanged in the urine.
Slovenian: Metformin: Metformin se nespremenjen izloči v urinu.
English: It does not stimulate insulin secretion and therefore, does not produce hypoglycaemia.
Slovenian: Ker ne spodbuja izločanja insulina, ne povzroča hipoglikemije.
English: Caution should be exercised in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients.
Slovenian: Previdnost je potrebna pri bolnikih, za katere bi z dapagliflozinom povzročen padec krvnega tlaka lahko pomenil tveganje, npr. pri bolnikih z znano srčno-žilno boleznijo, bolnikih, ki se zdravijo z antihipertenzivi in imajo hipotenzijo v anamnezi, in pri starejših bolnikih.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19% increase in AUC of simvastatin and 31% increase in AUC of simvastatin acid.
Slovenian: Kombinacija enkratnega odmerka 20 mg dapagliflozina in simvastatina (substrat CYP3A4) je povzročila 19-odstotno povečanje vrednosti AUC simvastatina in 31-odstotno povečanje vrednosti AUC simvastatinske kisline.
English: The mean age was 54.6 years and 52.7% of patients were female.
Slovenian: Povprečna starost je bila 54,6 leta in 52,7 % je bilo žensk.
English: Use with insulin or insulin secretagogues known to cause hypoglycaemia
Slovenian: Uporaba z insulinom ali insulinskimi sekretagogi, ki povzročajo hipoglikemijo
English: Saxagliptin/dapagliflozin combination: Malignant and unspecified neoplasms were reported in 3 subjects included in the pooled safety analysis.
Slovenian: Kombinacija saksagliptina in dapagliflozina: O malignih in neopredeljenih novotvorbah so poročali pri 3 preiskovancih, vključenih v združeno analizo varnosti.
English: Your doctor may decide to temporarily or permanently stop your treatment with Qtrilmet.
Slovenian: Zdravnik se lahko odloči za začasno prenehanje ali trajno opustitev zdravljenja z zdravilom Qtrilmet.
English: Metformin hydrochloride: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analysed according to gender (males=19, females=16).
Slovenian: Metforminijev klorid: V analizi glede na spol se farmakokinetični parametri metformina niso značilno razlikovali med zdravimi preiskovanci in bolniki s sladkorno boleznijo tipa 2 (moški = 19, ženske = 16).
English: Medicinal products that can acutely impair renal function (such as anti-hypertensives, diuretics, and NSAIDs) should be initiated with caution in metformin-treated patients.
Slovenian: Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila [NSAIDs - non-steroidal anti-inflammatory drugs]), je treba pri bolnikih, ki prejemajo metformin, uvesti previdno.
English: Urine test Because of how Qtrilmet works, your urine will test positive for sugar while you are on this medicine.
Slovenian: Zaradi načina delovanja zdravila Qtrilmet bo med zdravljenjem s tem zdravilom vaš urin pozitiven v preiskavah za prisotnost sladkorja.
English: The reported adverse reactions of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Slovenian: Poročani neželeni učinki vulvovaginitis, balanitis in sorodne okužbe spolovil v združeni analizi varnosti odražajo varnostni profil dapagliflozina.
English: Diabetic ketoacidosis may occur rarely and lactic acidosis may occur very rarely (see section 4.4).
Slovenian: V redkih primerih se lahko pojavi diabetična ketoacidoza in v zelo redkih primerih laktacidoza (glejte poglavje 4.4).
English: If you are already taking metformin, saxagliptin and dapagliflozin as single tablets or saxagliptin and dapagliflozin as a combination together with metformin, your doctor may ask you to switch to this medicine so you only need to take one tablet.
Slovenian: Če že jemljete metformin, saksagliptin in dapagliflozin v ločenih tabletah, ali če jemljete saksagliptin in dapagliflozin v kombinirani tableti skupaj z metforminom, vam bo zdravnik morda svetoval, da preidete na to zdravilo, tako boste jemali samo po eno tableto.
English: Dapagliflozin: The mean dapagliflozin AUCss in females was estimated to be about 22% higher than in males.
Slovenian: Dapagliflozin: Ocenjena povprečna vrednost AUCss dapagliflozina je pri ženskah približno 22 % večja kot pri moških.
English: Change from baseline (adjusted mean (95% Confidence interval [CI])
Slovenian: Sprememba od izhodišča (prilagojeno povprečje (95 % interval zaupanja [IZ])
English: The adverse reactions associated with Qtrilmet are presented in Table 1.
Slovenian: Z zdravilom Qtrilmet povezani neželeni učinki so prikazani v preglednici 1.
English: Metformin may act via three mechanisms; by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle, and by delaying intestinal glucose absorption.
Slovenian: Metformin morda deluje preko treh mehanizmov: z zmanjšanjem nastajanja glukoze v jetrih zaradi zavrtja glukoneogeneze in glikogenolize, z zmernim povečanjem občutljivost na insulin s čimer izboljša periferni privzem in uporabo glukoze ter izrabo v mišicah in z upočasnitvijo absorpcije glukoze v črevesu.
English: If you stop taking Qtrilmet
Slovenian: Če ste prenehali jemati zdravilo Qtrilmet
English: If you take more Qtrilmet tablets than you should, talk to a doctor or go to a hospital straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Qtrilmet, kot bi smeli Če ste vzeli več tablet Qtrilmet, kot bi smeli, se morate takoj posvetovati z zdravnikom ali iti v bolnišnico.
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see section 4.3).
Slovenian: Okvara jeter Tega zdravila ne smejo uporabljati bolniki z okvaro jeter (glejte poglavje 4.3).
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the human values at the MRHD.
Slovenian: Pri podganah ni bil dapagliflozin ne embrioletalen ne teratogen pri izpostavljenostih, ki so bile do 1441-krat tolikšne kot ob največjem priporočenem odmerku za človeka.
English: The mean duration of T2DM when entering the study was 7.6 years, mean baseline HbA1c of 8.94% and patients had been on a stable dose of metformin (1,500 mg or greater per day) for at least 8 weeks prior to the screening visit.
Slovenian: Povprečno trajanje sladkorne bolezni tipa 2 ob vstopu v študijo je bilo 7,6 leta, povprečni izhodiščni HbA1c je bil 8,94 % in bolniki so bili na stabilnem odmerku metformina (1500 mg na dan ali več) vsaj 8 tednov pred presejalnim obiskom.
English: Stop taking Qtrilmet and see a doctor straight away if you notice any of the following serious side effects:
Slovenian: Prenehajte jemati zdravilo Qtrilmet in takoj pojdite k zdravniku, če opazite katerega od naslednjih resnih neželenih učinkov:
English: PA/alu/PVC/alu blister This medicinal product does not require any special storage conditions.
Slovenian: Pretisni omot iz PA/alu/PVC/alu Za shranjevanje zdravila niso potrebna posebna navodila.
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group.
Slovenian: Delež drugega sekundarnega opazovanega dogodka, umrljivosti zaradi vseh vzrokov, je bil v skupini s saksagliptinom 5,1 % in v skupini s placebom 4,6 %.
English: The most frequently reported adverse reactions associated with Qtrilmet are upper respiratory tract infections (very common), hypoglycaemia when used with SU (very common), gastrointestinal symptoms (very common) and urinary tract infections (common).
Slovenian: Najpogosteje poročani neželeni učinki, povezani z zdravilom Qtrilmet, so bile okužbe zgornjih dihal (zelo pogoste), hipoglikemija v primeru uporabe s SU (zelo pogosta), prebavni simptomi (zelo pogosti) in okužbe sečil (pogoste).
English: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections (see section 4.8).
Slovenian: Zdravljenje z zaviralci SGLT2 poveča tveganje za okužbe sečil (glejte poglavje 4.8).
English: In the SAVOR trial, a small increase in the rate for hospitalisation for heart failure was observed in the saxagliptin-treated patients compared to placebo, although a causal relationship has not been established (see section 5.1).
Slovenian: V preskušanju SAVOR so med prejemniki saksagliptina opažali majhen porast deleža sprejemov v bolnišnico zaradi srčnega popuščanja v primerjavi s prejemniki placeba, toda vzročne povezanosti niso ugotovili (glejte poglavje 5.1).
English: If a daily dose is missed and it is ≥ 12 hours until the next dose, the dose should be taken.
Slovenian: Če bolnik pozabi vzeti dnevni odmerek in je do naslednjega odmerka še ≥ 12 ur, mora odmerek vzeti.
English: Dapagliflozin: Dapagliflozin is extensively metabolised, primarily to yield dapagliflozin 3-O-glucuronide, which is an inactive metabolite.
Slovenian: Dapagliflozin: Dapagliflozin se obsežno presnovi, predvsem z nastankom dapagliflozin-3-O-glukuronida, ki je neaktiven presnovek.
English: Metformin passes into breast milk in small amounts.
Slovenian: Metformin v majhni količini prehaja v materino mleko.
English: The adjusted percent difference at week 52 between the treatment groups was 16.8%.
Slovenian: Prilagojena odstotna razlika med terapevtskima skupinama je bila po 52 tednih 16,8 %.
English: This medicinal product is not recommended for use in patients at risk of volume depletion (e.g. receiving loop diuretics) (see section 4.5) or who are volume depleted, e.g. due to acute illness (such as acute gastrointestinal illness with nausea, vomiting or diarrhoea).
Slovenian: Tega zdravila ni priporočljivo uporabljati pri bolnikih s tveganjem za zmanjšanje volumna (npr. pri bolnikih, ki prejemajo diuretike zanke) (glejte poglavje 4.5) in bolnikih, ki imajo zmanjšanje volumna, npr. zaradi akutne bolezni (kakršne so akutne bolezni prebavil z navzeo, bruhanjem ali drisko).
English: Dapagliflozin dosed to maternal rats from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Slovenian: Dapagliflozin je bil uporabljen pri podganjih samicah-materah od 6. do 21. postnatalnega dneva in mladiči so mu bili posredno izpostavljeni in utero ter med obdobjem dojenja.
English: For patients receiving Qtrilmet, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests, including haematocrit) and electrolytes is recommended.
Slovenian: Če se med zdravljenjem z zdravilom Qtrilmet pojavijo bolezni, ki lahko povzročijo zmanjšanje volumna, je bolnikom priporočljivo skrbno spremljati volumsko stanje (npr. s kliničnim pregledom, meritvami krvnega tlaka, laboratorijskimi preiskavami, vključno s hematokritom) in elektrolite.
English: Do not take a double dose of Qtrilmet to make up for a forgotten dose.
Slovenian: - Ne vzemite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
English: Patients had been on a stable dose of metformin (1,500 mg or greater per day) for at least 8 weeks prior to screening visit and were then treated with metformin and dapagliflozin 10 mg for 10 weeks ahead of the study start.
Slovenian: Bolniki so bili na stabilnem odmerku metformina (1500 mg ali več na dan) vsaj 8 tednov pred presejalnim obiskom in so nato prejemali zdravljenje z metforminom in 10 mg dapagliflozina 10 tednov pred začetkom študije.
English: Haematocrit values > 55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Slovenian: O vrednostih hematokrita > 55 % so poročali pri 1,3 % preiskovancev, zdravljenih z 10 mg dapagliflozina, in pri 0,4 % preiskovancev, ki so prejemali placebo.
English: 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.
Slovenian: Med bolniki, ki imajo lahko večje tveganje za DKA, so bolniki z majhno funkcijsko rezervo celic beta (npr. bolniki s sladkorno boleznijo tipa 2 z nizkim C-peptidom ali latentno avtoimunsko sladkorno boleznijo odraslih ali bolniki z anamnezo pankreatitisa), bolniki z boleznimi, ki zmanjšajo uživanje hrane ali povzročijo hudo dehidracijo, bolniki po zmanjšanju odmerka insulina in bolniki, ki imajo povečano potrebo po insulinu zaradi akutnih internističnih bolezni, operacije ali zlorabe alkohola.
English: Signs of dehydration: o very dry or sticky mouth, feeling very thirsty, o feeling very sleepy or tired, o passing little or no water (urine), o fast heartbeat.
Slovenian: Znaki dehidracije so: o zelo suha ali lepljiva usta, občutek hude žeje, o izrazita zaspanost ali utrujenost, o izločanje malo ali sploh nič urina (seča), o hitro bitje srca.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, dehydration, sudden reductions in insulin dose, or major surgery or serious illness (which increase the body's needs for insulin).
Slovenian: Tveganje za pojav diabetične ketoacidoze je lahko večje v primeru dolgotrajnega postenja, prekomernega uživanja alkoholnih pijač, dehidracije, nenadnega zmanjšanja odmerka insulina ali večje operacije ali resne bolezni (ki povečajo potrebe telesa po insulinu).
English: After a mean follow up of 2 years, the trial met its primary safety endpoint demonstrating saxagliptin does not increase the cardiovascular risk in patients with type 2 diabetes compared to placebo when added to current background therapy.
Slovenian: Po povprečno 2-letnem spremljanju je preskušanje doseglo primarni opazovani dogodek varnosti in je dokazalo, da saksagliptin, dodan trenutnemu osnovnemu zdravljenju, v primerjavi s placebom pri bolnikih s sladkorno boleznijo tipa 2 ne poveča srčno-žilnega tveganja.
English: This medicinal product should not be used in patients with moderate to severe renal impairment (patients with GFR < 60 mL/min (see sections 4.4, 4.8, 5.1 and 5.2).
Slovenian: Tega zdravila ne smejo uporabljati bolniki z zmerno do hudo okvaro ledvic (bolniki s GFR < 60 ml/min (glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: Signs of low blood sugar: o shaking, sweating, feeling very anxious, fast heartbeat, o feeling hungry, headache, change in vision, o a change in your mood or feeling confused.
Slovenian: Znaki nizkega krvnega sladkorja so: o tresenje, znojenje, občutek hude tesnobe, hitro bitje srca, o lakota, glavobol, spremembe vida, o sprememba razpoloženja ali zmedenost.
English: medicines to lower blood pressure including ACE inhibitors (such as enalapril or ramipril), angiotensin II receptor antagonists (such as losartan or candesartan); insulin, sulphonylureas (such as glimepiride) or pioglitazone to lower your blood sugar; medicines that increase urine production and lower blood pressure (diuretics).
Slovenian: - zdravila za znižanje krvnega tlaka, vključno z zaviralci ACE (npr. enalapril ali ramipril) in antagonisti receptorjev angiotenzina II (npr. losartan ali kandesartan); - insulin, sulfonilsečnine (npr. glimepirid) ali pioglitazon za znižanje krvnega sladkorja; - zdravila, ki povečujejo nastajanje urina in znižujejo krvni pritisk (diuretiki).
English: Decreased renal function
Slovenian: Zmanjšano delovanje ledvic
English: From these data, it appears that the change in metformin pharmacokinetics with aging is primarily accounted for by a change in renal function (see sections 4.2 and 4.4).
Slovenian: Na podlagi teh podatkov se zdi, da je spremenjena farmakokinetika metformina, povezana z naraščanjem starosti, predvsem posledica spremenjenega delovanja ledvic (glejte poglavji 4.2 in 4.4).
English: Metformin is excreted in human milk in small amounts.
Slovenian: Metformin se pri človeku v majhni količini izloča v materino mleko.
English: In patients where DKA is suspected or diagnosed, treatment with Qtrilmet should be discontinued immediately.
Slovenian: V primeru suma na DKA ali potrjene DKA je treba zdravljenje z zdravilom Qtrilmet takoj prekiniti.
English: Dapagliflozin: In the 21-study active- and placebo-controlled pool, 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).
Slovenian: Dapagliflozin: V združeni analizi 21 z učinkovino in placebom kontroliranih študij je bil celotni delež preiskovancev z malignimi ali neopredeljenimi tumorji med prejemniki dapagliflozina (1,50 %) in prejemniki placeba/primerjalnega zdravila (1,50 %) podoben; tudi pri živalih zbrani podatki niso pokazali signalov kancerogenosti ali mutagenosti (glejte poglavje 5.3).
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Slovenian: Nekatera zdravila lahko neugodno vplivajo na delovanje ledvic in lahko povečajo tveganje za laktacidozo; takšna zdravila so npr. NSAID, vključno s selektivnimi zaviralci ciklooksigenaze (COX) II, zaviralci ACE, antagonisti receptorjev angiotenzina II in diuretiki, zlasti diuretiki zanke.
English: The metabolism of dapagliflozin is primarily via glucuronide conjugation mediated by uridine diphosphate (UDP) glucuronosyltransferase 1A9 (UGT1A9).
Slovenian: Presnova dapagliflozina poteka predvsem z glukuronidno konjugacijo z uridinfosfat-glukuronoziltransferazo 1A9 (UGT1A9).
English: There is no experience in clinical trials with dapagliflozin in NYHA class III-IV.
Slovenian: Iz kliničnih preskušanj dapagliflozina ni izkušenj v razredih III in IV po NYHA.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije metformina na živalih ne kažejo škodljivih učinkov na nosečnost, razvoj zarodka ali ploda, porod ali poporodni razvoj (glejte poglavje 5.3).
English: The study population included those ≥ 65 years (n = 8,561) and ≥ 75 years (n = 2,330), with normal or mild renal impairment (n = 13,916) as well as moderate (n = 2,240) or severe (n = 336) renal impairment.
Slovenian: Skupina bolnikov v študiji je zajela bolnike, stare ≥ 65 let (n = 8561) in ≥ 75 let (n = 2330), z normalnim delovanjem ledvic ali blago okvaro ledvic (n = 13916) kot tudi z zmerno (n = 2240) ali hudo (n = 336) okvaro ledvic.
English: Dapagliflozin: Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (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.
Slovenian: Dapagliflozin: Neposredna uporaba dapagliflozina pri nedavno odstavljenih podganjih mladičih in posredna izpostavljenost med pozno brejostjo (to ustreza drugemu in tretjemu trimesečju nosečnosti glede na dozorevanje ledvic pri človeku) in v obdobju laktacije sta bili povezani z večjo pojavnostjo in/ali resnost razširitve ledvičnega meha in tubulov pri potomstvu.
English: Saxagliptin: Saxagliptin has effects on fertility in male and female rats at high doses producing overt signs of toxicity.
Slovenian: Saksagliptin: Saksagliptin vpliva na plodnost podganjih samcev in samic v velikih odmerkih, ki povzročijo očitne znake toksičnosti.
English: Each tablet contains a fixed dose of metformin, saxagliptin and dapagliflozin (see section 2).
Slovenian: Vsaka tableta vsebuje fiksen odmerek metformina, saksagliptina in dapagliflozina (glejte poglavje 2).
English: The safety profile is based on pooled analysis of three placebo controlled phase 3 clinical trials in 1,169 patients for up to 52 weeks, of which 492 patients received a combination of saxagliptin 5 mg, dapagliflozin 10 mg, plus metformin (see section 5.1).
Slovenian: Varnostni profil temelji na združeni analizi treh s placebom nadzorovanih kliničnih preskušanj faze III pri 1169 bolnikih, ki so trajala do 52 tednov; od teh bolnikov jih je 492 prejemalo kombinacijo 5 mg saksagliptina, 10 mg dapagliflozina in metformina (glejte poglavje 5.1).
English: This results in a glucose-dependent increase in insulin secretion, thus reducing fasting and post-prandial blood glucose concentrations.
Slovenian: Posledica je od glukoze odvisno povečanje izločanja insulina, s tem pa se zmanjša koncentracijo glukoze v krvi na tešče in postprandialno.
English: The majority of the genital infection adverse reactions were reported in females (84% of subjects with a genital infection), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy.
Slovenian: Večino neželenih učinkov okužb spolovil so zabeležili pri ženskah (84 % oseb s takšno okužbo); vse okužbe so bile blage ali zmerne, so se pojavile le enkrat in večina bolnikov je nadaljevala zdravljenje.
English: 14 modified-release tablets 28 modified-release tablets 56 modified-release tablets 60 modified-release tablets 196 modified-release tablets
Slovenian: 14 tablet s prirejenim sproščanjem 28 tablet s prirejenim sproščanjem 56 tablet s prirejenim sproščanjem 60 tablet s prirejenim sproščanjem 196 tablet s prirejenim sproščanjem
English: In additional studies of embryo-foetal development in rabbits, dapagliflozin caused neither maternal nor developmental toxicities at any dose tested; the highest dose tested corresponded to a systemic exposure 1,191 times the MRHD.
Slovenian: V dodatnih študijah embrio-fetalnega razvoja pri kuncih dapagliflozin ni v nobenem od testiranih odmerkov povzročil ne maternalnih ne razvojnih toksičnih učinkov; največji testirani odmerek je ustrezal sistemski izpostavljenosti, ki je bila 1191-kratnik tiste ob največjem priporočenem odmerku za človeka).