FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious allergic (hypersensitivity) reaction, seen rarely (may affect up to 1 in 1,000 people) Symptoms of serious allergic reaction: o rash, o raised red patches on your skin (hives), o swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Slovenian: - Resna alergijska (preobčutljivostna) reakcija, ki je redka (pojavi se lahko pri največ 1 od 1.000 bolnikov) Simptomi resne alergijske reakcije so: o izpuščaj, o dvignjene rdeče lehe na koži (koprivnica), o oteklost obraza, ustnic, jezika in žrela, ki lahko povzroči težave s požiranjem ali težave z dihanjem.
English: Cardiovascular death, MI, and stroke were observed with a hazard ratio of 0.77 (95% CI: 0.54, 1.10).
Slovenian: Srčno-žilno smrt, miokardni infarkt in možgansko kap so opažali z razmerjem ogroženosti 0,77 (95 % IZ: 0,54; 1,10).
English: Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Slovenian: Metformin se izloča skozi ledvice in zmerna do huda insuficienca ledvic poveča tveganje za laktacidozo (glejte poglavje 4.4).
English: Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.
Slovenian: Okužba zgornjih dihal obsega naslednje prednostne izraze: nazofaringitis, gripa, okužba zgornjih dihal, faringitis, rinitis, sinuzitis, bakterijski faringitis, tonzilitis, akutni tonzilitis, laringitis, virusni faringitis in virusna okužba zgornjih dihal
English: This medicinal product has not been studied in severe renal impairment (GFR < 30 mL/min) or end-stage renal disease (ESRD).
Slovenian: To zdravilo ni raziskano pri bolnikih s hudo okvaro ledvic (GFR < 30 ml/min) ali s končno odpovedjo ledvic.
English: There was a numerical imbalance in non-CV death, with more events on saxagliptin (1.8%) than placebo (1.4%) [HR = 1.27; (95% CI 1.00, 1.62); P = 0.051].
Slovenian: Obstajalo je številsko neravnovesje smrti, ki niso bile srčno-žilne; teh je bilo s saksagliptinom več (1,8 %) kot s placebom (1,4 %) [HR = 1,27, (95 % IZ 1,00; 1,62), p = 0,051]
English: It is unknown whether saxagliptin and dapagliflozin and/or their metabolites are excreted in human milk.
Slovenian: Ni znano, ali se saksagliptin in dapagliflozin in/ali njuni presnovki pri človeku izločajo v materino mleko.
English: In type 1 diabetes mellitus studies with dapagliflozin, DKA was reported with common frequency.
Slovenian: V študijah z dapagliflozinom pri bolnikih s sladkorno boleznijo tipa 1 so o DKA poročali s pogostnostjo “pogosti”.
English: Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation and increased risk of lactic acidosis.
Slovenian: Intravaskularna uporaba jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje za laktacidozo.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see section 5.3).
Slovenian: Farmakodinamični in toksikološki podatki za živali, ki so na voljo, kažejo izločanje dapagliflozina oz. njegovih presnovkov v mleko ter farmakološke učinke pri dojenih mladičih (glejte poglavje 5.3).
English: if blood tests show that the amount of red blood cells in your blood is too high.
Slovenian: - če ste stari 75 let ali več; - če preiskava krvi pokaže previsoko število rdečih krvnih celic v krvi.
English: Hypoglycaemia does not occur in patients receiving metformin alone under usual circumstances of use but could occur during concomitant use with other glucose-lowering agents.
Slovenian: V običajnih okoliščinah uporabe se hipoglikemija ne pojavi pri bolnikih, ki jemljejo samo metformin, lahko pa se pojavi med sočasno uporabo z drugimi zdravili, ki znižujejo glukozo.
English: Effect of metformin, saxagliptin or dapagliflozin on other medicinal products
Slovenian: Vpliv metformina, saksagliptina ali dapagliflozina na druga zdravila
English: If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtrilmet.
Slovenian: Če kaj od naštetega velja za vas (ali če ste negotovi), se posvetujte z zdravnikom, preden vzamete zdravilo Qtrilmet.
English: Saxagliptin: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Slovenian: Saksagliptin: Saksagliptin se je po peroralni uporabi na tešče hitro absorbiral; največjo koncentracijo v plazmi (Cmax) je dosegel v 2 urah, njegov glavni presnovek pa v 4 urah (tmax).
English: The coadministration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital, and phenytoin) has not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Slovenian: Sočasna uporaba saksagliptina in induktorjev CYP3A4/5 razen rifampicina (na primer karbamazepina, deksametazona, fenobarbitala ali fenitoina) ni raziskana; zmanjša se lahko koncentracija saksagliptina in poveča koncentracija njegovega glavnega presnovka v plazmi.
English: Saxagliptin: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Slovenian: Saksagliptin: vrednosti Cmax in AUC saksagliptina in njegovega glavnega presnovka sta naraščali sorazmerno odmerku saksagliptina.
English: Metformin hydrochloride: Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects.
Slovenian: Metforminijev klorid: Maloštevilni podatki kontroliranih farmakokinetičnih študij metformina pri zdravih starejših osebah kažejo v primerjavi z mladimi osebami manjši celotni plazemski očistek metformina, daljši razpolovni čas in večjo Cmax.
English: Caution is therefore advised, especially in patients with renal impairment, when these medicinal products are co-administered with metformin, as metformin plasma concentration may increase (see section 4.4).
Slovenian: Zato je v primeru sočasne uporabe teh zdravil z metforminom potrebna previdnost, še zlasti pri bolnikih z okvaro ledvic, kajti koncentracija metformina v plazmi se lahko poveča (glejte poglavje 4.4).
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure, such as baseline history of heart failure or impaired renal function.
Slovenian: Bolnike z večjim tveganjem za sprejem v bolnišnico zaradi srčnega popuščanja je bilo mogoče (ne glede na prejeto zdravljenje) prepoznati po znanih dejavnikih tveganja za srčno popuščanje, npr. po izhodiščni anamnezi srčnega popuščanja ali okvare ledvic.
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Slovenian: Če je akutni pankreatitis potrjen, se tega zdravila ne sme znova začeti uporabljati.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Slovenian: Vsebnost natrija Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus (see section 2 “Diabetic skin and foot problems”).
Slovenian: - Nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkih tkiv spolovil ali predela med spolovili in zadnjikom (presredka) (glejte poglavje 2, “Diabetične kožne spremembe in težave s stopali”).
English: Saxagliptin: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Slovenian: Saksagliptin: Pri opicah cynomolgus je saksagliptin povzročil reverzibilne spremembe (kraste, razjede in nekrozo) na ekstremitetah (rep, prsti, modnik in/ali nos).
English: PVC/PCTFE/alu blister: Do not store above 30°C.
Slovenian: Pretisni omot iz PVC/PCTFE/alu: Shranjujte pri temperaturi do 30 °C.
English: The other ingredients are: o tablet core: carmellose sodium (E466) (see section 2 ‘Sodium content'); cellulose, microcrystalline (E460i); crospovidone (E1202); hypromellose (E464); lactose (see section 2 ‘Qtrilmet contains lactose'); magnesium stearate (E470b); silica, dental type (E551).
Slovenian: - Druge sestavine zdravila so: o Jedro tablete: natrijev karmelozat (E466) (glejte poglavje 2 “Vsebnost natrija”); mikrokristalna celuloza (E460i); krospovidon (E1202); hipromeloza (E464); laktoza (glejte poglavje 2 “Zdravilo Qtrilmet vsebuje laktozo”); magnezijev stearat (E470b); silicijev dioksid, dentalni (E551).
English: if you take any of the following medicines: glucocorticoids, beta-2 agonists, diuretics, carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin as they may reduce the effect of Qtrilmet (see “Other medicines and Qtrilmet”);
Slovenian: - če jemljete katero od naslednjih zdravil: glukokortikoide, agoniste adrenergičnih receptorjev beta-2, diuretike, karbamazepin, deksametazon, fenobarbital, fenitoin ali rifampicin; ta zdravila namreč lahko zmanjšajo učinek zdravila Qtrilmet (glejte “Druga zdravila in zdravilo Qtrilmet”).
English: Vulvovaginitis, balanitis and related genital infection include the following preferred terms: vulvovaginal mycotic infection, balanoposthitis, genital infection fungal, vaginal infection, and vulvovaginitis.
Slovenian: Vulvovaginitis, balanitis in sorodne okužbe spolovil obsegajo naslednje prednostne izraze: vulvovaginalna mikotična okužba, balanopostitis, glivična okužba spolovil, vaginalna okužba in vulvovaginitis.
English: sleepiness, or your breath developing an unusual fruity smell; if you have ever had a diabetic coma; if you have severely reduced kidney function; if you have a severe infection; if you have lost a lot of water from your body (dehydration) - due to long-lasting or severe diarrhoea, or if you have vomited several times in a row (see “Warnings and precautions” below); if you have recently had a heart attack or if you have heart failure or serious problems with your blood circulation or difficulties in breathing; if you have problems with your liver; if you drink large amounts of alcohol, either every day or only from time to time (please see section “Qtrilmet with alcohol”).
Slovenian: Med simptomi so bolečine v trebuhu, hitro in globoko dihanje, zaspanost ali nenavaden vonj po sadju v izdihanem zraku; - če ste kdaj imeli diabetično komo; - če imate zelo zmanjšano delovanje ledvic; - če imate kakšno hudo okužbo; - če ste iz telesa izgubili veliko vode (to imenujemo dehidracija) - na primer zaradi dolgotrajne ali hude driske ali če ste bruhali večkrat zapored (glejte “Opozorila in previdnostni ukrepi”, spodaj); - če ste pred nedavnim imeli srčni infarkt, če imate srčno popuščanje, resne težave s krvnim obtokom ali težave z dihanjem; - če imate težave z jetri; - če pijete veliko alkohola, bodisi vsak dan bodisi le občasno (glejte poglavje “Zdravilo Qtrilmet skupaj z alkoholom”).
English: This is not considered clinically meaningful.
Slovenian: To ne velja za klinično pomembno.
English: The safety profile of the combined use of metformin, saxagliptin and dapagliflozin is comparable to the adverse reactions identified for the respective mono-components.
Slovenian: Varnostni profil kombinirane uporabe metformina, saksagliptina in dapagliflozina je bil podoben neželenim učinkom, ugotovljenim za vsako posamezno učinkovino.
English: This medicinal product is contraindicated in patients with GFR < 30 mL/min (see sections 4.3, 4.4, 4.8 and 5.2).
Slovenian: Pri bolnikih s GFR < 30 ml/min je to zdravilo kontraindicirano (glejte poglavja 4.3, 4.4, 4.8 in 5.2).
English: With this condition, the levels of substances called “ketone bodies” increase in your urine or blood and this can be picked up in tests.
Slovenian: Pri tej motnji se v urinu in krvi poveča koncentracija snovi, imenovanih “ketonska telesa”; motnjo je mogoče odkriti z laboratorijskimi testi.
English: C-saxagliptin, 24%, 36% and 75% of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
Slovenian: C-saksagliptina se je v urinu 24 % radioaktivnosti izločilo v obliki saksagliptina, 36 % v obliki njegovega aktivnega presnovka in 75 % celotne radioaktivnosti.
English: The use of this medicinal product, or its components (metformin hydrochloride, saxagliptin and dapagliflozin) has not been studied in pregnant women.
Slovenian: Uporaba tega zdravila ali njegovih sestavin (metforminijev klorid, saksagliptin in dapagliflozin) pri nosečnicah ni raziskana.
English: HbA1c subgroup analysis by baseline HbA1c at week 24 in randomised subjects
Slovenian: Analiza HbA1c v podskupinah randomiziranih preiskovancev po 24 tednih glede na izhodiščni HbA1c
English: The risk of lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems, and medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).
Slovenian: Tveganje za laktacidozo povečajo tudi neustrezno nadzorovana sladkorna bolezen, resne okužbe, dolgotrajno postenje ali uživanje alkohola, dehidracija (za dodatne informacije glejte spodaj), težave z jetri in bolezni, ki jih spremlja zmanjšana oskrba kakšnega dela telesa s kisikom (na primer akutna huda bolezen srca).
English: SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5% and < 12% (12,959 with established CV disease; 3,533 with multiple risk factors only) who were randomised to saxagliptin (n=8,280) or placebo (n=8,212) added to regional standards of care for HbA1c and CV risk factors.
Slovenian: Preskušanje SAVOR je bilo preskušanje srčno-žilnih izidov pri 16492 bolnikih s HbA1c ≥ 6,5 % in < 12 % (12959 z ugotovljeno srčno-žilno boleznijo in 3533 takšnih, ki so imeli le več dejavnikov tveganja), randomiziranih na saksagliptin (n = 8280) ali placebo (n = 8212), dodan regionalnemu standardnemu zdravljenju glede na HbA1c in srčno-žilne dejavnike tveganja.
English: Saxagliptin: The biotransformation of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Slovenian: Saksagliptin: Biotransformacija saksagliptina poteka predvsem prek citokroma P450 3A4/5 (CYP3A4/5).
English: Saxagliptin: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours, respectively, and the mean t1/2 value for plasma DPP-4 inhibition was 26.9 hours.
Slovenian: Saksagliptin: Povprečni plazemski terminalni razpolovni čas (t1/2) saksagliptina je 2,5 ure in njegovega glavnega presnovka 3,1 ure, povprečni t1/2 plazemskega zavrtja DPP-4 pa je 26,9 ure.
English: Caution is warranted if Qtrilmet is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Slovenian: Zdravilo Qtrilmet je treba uporabljati previdno pri bolnikih z znanimi dejavniki tveganja za sprejem v bolnišnico zaradi srčnega popuščanja, npr. pri bolnikih z anamnezo srčnega popuščanja ali z zmerno do hudo okvaro ledvic.
English: Creatinine renal clearance decreased haematocrit increased
Slovenian: Preiskave zmanjšan ledvični očistek kreatinina zvišan hematokrit
English: The difference in mean SBP between treatment groups was -3.6 mmHg (95% CI [-6.3, -1.0] p = 0.007).
Slovenian: Razlika v povprečnem SKT med terapevtskima skupinama je bila -3,6 mmHg (95 % IZ [-6,3; -1,0], p = 0,007).
English: In a 24-week study comparing the combination of saxagliptin and dapagliflozin plus metformin with or without SU, with insulin plus metformin with or without SU, the overall incidence rates for hypoglycaemia in patients without a background treatment of SU, were 12.7% for the combination compared to 33.1% for insulin.
Slovenian: V 24-tedenski študiji, ki je primerjala kombinacijo saksagliptina, dapagliflozina in metformina (s SU ali brez nje) z insulinom skupaj z metforminom (s SU ali brez nje), je bila celokupna pojavnost hipoglikemije pri bolnikih brez osnovnega zdravljenja s SU 12,7 % s kombinacijo in 33,1 % z insulinom.
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than
Slovenian: Intraindividualna koeficienta variacije vrednosti Cmax in AUC saksagliptina sta bila manj kot 12 %.
English: The no observed effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite, respectively, at the recommended human dose (RHD) of 5 mg/day.
Slovenian: Raven brez opaženega učinka (NOEL - no observed effect level) za te spremembe je 1-kratna človeška izpostavljenost saksagliptinu in 2-kratna človeška izpostavljenost njegovemu glavnemu presnovku, dosežena ob priporočenem odmerku za človeka 5 mg/dan.
English: 153 patients were randomised into the saxagliptin added to dapagliflozin plus metformin treatment group, and 162 patients were randomised into the placebo added to dapagliflozin plus metformin treatment group.
Slovenian: 153 bolnikov je bilo randomiziranih v terapevtsko skupino, ki je dobila saksagliptin, dodan dapagliflozinu in metforminu, 162 bolnikov pa v terapevtsko skupino, ki je dobila placebo, dodan dapagliflozinu in metforminu.
English: Gastrointestinal symptoms
Slovenian: Bolezni prebavil gastrointestin alni simptomi
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia, and hypothermia followed by coma.
Slovenian: Za laktacidozo so značilni acidotična dispneja, bolečine v trebuhu, mišični krči, astenija in hipotermija, ki jim sledi koma.
English: Vulvovaginitis, balanitis and related genital infections
Slovenian: Vulvovaginitis, balanitis in sorodne okužbe spolovil
English: Monitoring of renal function is necessary to aid in prevention of metformin associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4).
Slovenian: Da bi preprečili laktacidozo, povezano z metforminom, je treba spremljati delovanje ledvic; to še posebej velja za starejše bolnike (glejte poglavji 4.3 in 4.4).
English: Dapagliflozin: In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B) mean Cmax and AUC of dapagliflozin were up to 12% and 36% higher, respectively, compared to healthy matched control subjects.
Slovenian: Dapagliflozin: Pri preiskovancih z blago ali zmerno okvaro jeter (Child-Pugh A in B) je bila povprečna Cmax dapagliflozina do 12 % večja in njegova vrednost AUC do 36 % večja kot pri zdravih kontrolnih osebah.
English: One component of the secondary composite endpoint, hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5%) compared with the placebo group (2.8%), with nominal statistical significance favouring placebo [HR=1.27; (95% CI 1.07, 1.51); P = 0.007].
Slovenian: Delež enega elementa sekundarnega sestavljenega opazovanega dogodka - sprejemov v bolnišnico zaradi srčnega popuščanja - je bil v skupini s saksagliptinom večji (3,5 %) kot v skupini s placebom (2,8 %); nominalna statistična značilnost je bila v korist placeba [HR = 1,27, (95 % IZ 1,07; 1,51), p = 0,007].
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9 or 3A4.
Slovenian: V študijah in vitro saksagliptin in njegov glavni presnovek nista ne zavrla CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 ali 3A4 ne inducirala CYP1A2, 2B6, 2C9 ali 3A4.
English: The effect of this medicinal product, or its components (metformin hydrochloride, saxagliptin and dapagliflozin) on fertility in humans has not been studied.
Slovenian: Vpliva tega zdravila ali njegovih sestavin (metforminijevega klorida, saksagliptina in dapagliflozina) na plodnost pri človeku niso raziskali.
English: The majority of the urinary tract infections were reported in females (81% of subjects with UTI), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy.
Slovenian: O večini okužb sečil so poročali pri ženskah (81 % preiskovancev z okužbo sečil); okužbe so bile blage ali zmerne, so se pojavile le enkrat in večina bolnikov je nadaljevala zdravljenje.
English: Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
Slovenian: Zavedati se je treba, da se lahko pred nekrotizirajočim fasciitisom pojavi urogenitalna okužba ali perinealni absces.
English: You should not use Qtrilmet if you are breast-feeding or plan to breast-feed.
Slovenian: Zdravila Qtrilmet ne smete uporabljati, če dojite ali nameravate dojiti.
English: In one trial conducted for 24 weeks, saxagliptin and dapagliflozin added to metformin was compared to saxagliptin or dapagliflozin added to metformin.
Slovenian: V enem preskušanju, ki je potekalo 24 tednov, so saksagliptin in dapagliflozin, dodana metforminu, primerjali s saksagliptinom ali dapagliflozinom, dodanim metforminu.
English: The mean duration of T2DM when entering the study was 7.7 years, mean baseline HbA1c of 7.9%.
Slovenian: Povprečno trajanje sladkorne bolezni tipa 2 ob vstopu v študijo je bilo 7,7 leta in povprečni izhodiščni HbA1c je bil 7,9 %.
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (at maternal and pup dapagliflozin exposures of 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose [MRHD]).
Slovenian: Večjo pojavnost ali resnost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le ob največjem testiranem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1415-krat večja in mladičev 137-krat večja od izpostavljenosti človeka ob največjem priporočenem odmerku za človeka).
English: Additional developmental toxicity was limited to dose-related reductions in pup body weights, and observed only at doses ≥ 15 mg/kg/day (pup exposures ≥ 29 times the human values at the MRHD).
Slovenian: Dodatni toksični učinki na razvoj so bili omejeni na z odmerkom povezana zmanjšanja telesne mase mladičev, opazili pa so jih le pri odmerkih ≥ 15 mg/kg/dan (izpostavljenost mladičev ≥ 29-kratnik izpostavljenosti človeka ob največjem priporočenem odmerku za človeka).
English: In a juvenile study, when dapagliflozin was dosed directly to young rats from postnatal day 21 until postnatal day 90, renal pelvic and tubular dilatations (with dose-related increases in kidney weight and macroscopic kidney enlargement) were reported at all dose levels; pup exposures at the lowest dose tested were ≥ 15 times the maximum recommended human dose.
Slovenian: V študiji na mladičih so po neposredni uporabi dapagliflozina pri mladih podganah od 21. do 90. postnatalnega dneva pri vseh ravneh odmerkov ugotovili razširitve ledvičnega meha in tubulov (s povečanjem mase ledvic in makroskopskim povečanjem ledvic, odvisnima od odmerka); izpostavljenost mladičev pri najmanjšem testiranem odmerku je bila ≥ 15-krat tolikšna, kot je ob največjem priporočenem odmerku za človeka.
English: Patients should receive a total daily dose of Qtrilmet equivalent to saxagliptin 5 mg, dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken.
Slovenian: Bolniki morajo dobiti celoten dnevni odmerek zdravila Qtrilmet, enakovreden 5 mg saksagliptina, 10 mg dapagliflozina in celotnemu dnevnemu odmerku metformina, ali najbližji terapevtsko ustrezni odmerek, kot ga že jemljejo.