FrancophonIA/ELRC3.0 huggingface dataset:
English: Onglyza may have a negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Onglyza ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: They work by helping to control the level of sugar in your blood.
Slovenian: Ta zdravila delujejo tako, da pomagajo obvladovati raven sladkorja v krvi.
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Slovenian: • v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, vključno z insulinom, če ta zdravila ne zagotavljajo ustrezne urejenosti glikemije (glejte poglavja 4.4, 4.5 in 5.1 za podatke, ki so na voljo o različnih kombinacijah).
English: • If you forget to take a dose of Onglyza, take it as soon as you remember it.
Slovenian: • Če pozabite vzeti odmerek zdravila Onglyza, ga vzemite, čim se spomnite.
English: Event rate per 100 patient-yrs
Slovenian: Dogodki na 100 bolnik-let
English: The tablets contain lactose (milk sugar).
Slovenian: Tablete vsebujejo laktozo (mlečni sladkor).
English: Do not use this medicine if the package is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte tega zdravila, če je pakiranje poškodovano ali kaže znake, da ga je že kdo odpiral.
English: Tablets must not be split or cut.
Slovenian: Tablet se ne sme lomiti ali rezati.
English: This is a medicine used to lower blood pressure.
Slovenian: • diltiazem; uporablja se za zniževanje krvnega pritiska.
English: No dose adjustment is recommended based solely on age (see also sections 5.1 and 5.2).
Slovenian: Odmerka ni treba prilagoditi samo zaradi starosti (glejte tudi poglavji 5.1 in 5.2).
English: Dipeptidyl peptidase 4 (DPP4) inhibitors, ATC code: A10BH03
Slovenian: Zaviralci dipeptidilpeptidaze 4 (DPP4), Oznaka ATC: A10BH03
English: A double dose should not be taken on the same day.
Slovenian: Na isti dan ne sme vzeti dveh odmerkov.
English: Frequency of adverse reactions by treatment regimen
Slovenian: Pogostnost neželenih učinkov glede na režim zdravljenja
English: If you take more Onglyza than you should If you take more tablets than you should, talk to a doctor straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Onglyza, kot bi smeli Če vzamete več tablet, kot bi smeli, se takoj posvetujte z zdravnikom.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Slovenian: Spodaj opisani klinični podatki kažejo, da je tveganje za klinično pomembno medsebojno delovanje med sočasno uporabo drugih zdravil majhno.
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Slovenian: povečevanje odmerka metformina od 500 do 2000 mg dnevno kot je bil toleriran.
English: Patients experienced relief of symptoms after discontinuation of the medication and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Slovenian: Bolnikom so simptomi po prenehanju jemanja zdravila izginili, nekaterim bolnikom pa so se simptomi znova pojavili po ponovni uvedbi istega ali drugega zaviralca DPP4.
English: When driving or using machines, it should be taken into account that dizziness has been reported in studies with saxagliptin.
Slovenian: V primeru vožnje ali upravljanja strojev treba upoštevati, da je bila v študijah saksagliptina opisana omotica.
English: Table 4 Primary and Secondary Clinical Endpoints by Treatment Group in the SAVOR Study*
Slovenian: Preglednica 4: Primarni in sekundarni klinični opazovani dogodki po terapevtski skupini v preskušanju SAVOR*
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Onglyza in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Onglyza za eno ali več podskupin pediatrične populacije pri zdravljenju sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain.
Slovenian: Bolniki morajo biti seznanjeni o značilnih simptomih akutnega pankreatitisa: dolgotrajna, huda bolečina v trebuhu.
English: If pancreatitis is suspected, Onglyza should be discontinued; if acute pancreatitis is confirmed, Onglyza should not be restarted.
Slovenian: Če se pojavi sum na pankreatitis, je potrebno ukiniti zdravljenje z zdravilom Onglyza; če je akutni pankreatitis potrjen, se zdravila Onglyza ne sme ponovno začeti uporabljati.
English: • if you have reduced kidney function, your doctor will decide if you need to take a lower dose of Onglyza.
Slovenian: • če imate zmanjšano delovanje ledvic, se bo zdravnik odločil ali potrebujete nižji odmerek zdravila Onglyza.
English: The effects of smoking, diet, herbal products, and alcohol use on the pharmacokinetics of saxagliptin have not been specifically studied.
Slovenian: Vplivi kajenja, prehrane, zdravil rastlinskega izvora in alkohola na farmakokinetiko saksagliptina niso posebej raziskani.
English: In the SAVOR study subgroups over 65 and over 75 years of age, efficacy and safety were consistent with the overall study population.
Slovenian: V preskušanju SAVOR sta se učinkovitost in varnost v podskupinah starejših od 65 in starejših od 75 let skladali s tistima v celotni preiskovani populaciji.
English: Acute Pancreatitis
Slovenian: Akutni pankreatitis
English: Events accumulated consistently over time, and the event rates for Onglyza and placebo did not diverge notably over time.
Slovenian: Dogodki so se skozi čas kopičili stalno in deleži dogodkov se z zdravilom Onglyza in placebom skozi čas niso občutno razhajali.
English: The findings of these studies were confirmed with two subsequent 24-week regional (Asian) monotherapy studies comparing saxagliptin 5 mg with placebo.
Slovenian: Ugotovitve teh študij so bile potrjene z dvema nadaljnjima 24-tedenskima regionalnima (Azija) študijama monoterapije, ki sta primerjali saksagliptin 5 mg s placebom.
English: Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Slovenian: Zdravila Onglyza ne smete uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
English: During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema.
Slovenian: Iz izkušenj iz obdobja trženja, vključno s spontanimi poročili in kliničnimi preskušanji, so glede uporabe saksagliptina poročali o naslednjih neželenih učinkih: resnih preobčutljivostnih reakcijah, vključno z anafilaktično reakcijo, anafilaktičnim šokom, in angioedemom.
English: • if you suffer from heart failure or you have other risk factors for developing heart failure such as problems with your kidneys.
Slovenian: • če imate srčno popuščanje, ali imate kakšen drug dejavnik tveganja za pojav srčnega popuščanja, na primer težave z ledvicami.
English: In this study, 98.2% of the patients received other antihyperglycaemic treatments (75.3% on insulin and 31.2% on oral antihyperglycaemics; some received both).
Slovenian: V tej študiji je 98,2 % bolnikov prejemalo še druga antihiperglikemična zdravljenja (75,3 % insulin in 31,2 % peroralne antihiperglikemike; nekateri so prejemali oboje).
English: Onglyza should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Onglyza ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
English: Onglyza should not be used to treat these conditions;
Slovenian: Zdravila Onglyza se ne sme uporabljati za zdravljenje teh stanj,
English: Because increases of this magnitude are not clinically relevant, dose adjustment in patients with mild renal impairment is not recommended.
Slovenian: Ker povečanja takšnega velikostnega razreda niso klinično pomembna, bolnikom z blago okvaro ledvic odmerka ni treba prilagoditi.
English: Table 1 Frequency of adverse reactions by system organ class from clinical trials and postmarketing experience
Slovenian: Preglednica 1 Pogostnost neželenih učinkov po organskih sistemih iz kliničnih preskušanj in iz obdobja trženja
English: What Onglyza is and what it is used for
Slovenian: Kaj je zdravilo Onglyza in za kaj ga uporabljamo
English: • severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas (pancreatitis).
Slovenian: • huda in nenehna bolečina v trebuhu, ki se lahko širi v hrbet, pa tudi slabost in bruhanje, ker je to lahko znak vnetja trebušne slinavke (pankreatitisa).
English: Onglyza had no clinically meaningful effect on QTc interval or heart rate at oral doses up to 400 mg daily for 2 weeks (80 times the recommended dose).
Slovenian: Zdravilo Onglyza ni imelo klinično pomembnega vpliva na interval QTc ali srčno frekvenco v peroralnih odmerkih do 400 mg na dan 2 tedna (kar je 80-kratni priporočeni odmerek).
English: • if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
Slovenian: • če imate sladkorno bolezen tipa 1 (vaše telo ne izdeluje nič insulina) ali diabetično ketoacidozo (to je zaplet sladkorne bolezni, ki ga spremljajo visok krvni sladkor, hitro izgubljanje telesne mase, slabost v želodcu ali bruhanje).
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Slovenian: Intraindividualna koeficienta variacije Cmax in AUC saksagliptina sta bila manj kot 12 %.
English: You should not use Onglyza if you are pregnant.
Slovenian: Zdravila Onglyza ne smete uporabljati, če ste noseči.
English: Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Slovenian: Saksagliptin in njegov glavni presnovek se lahko odstranita s hemodializo (23 % odmerka v 4 urah).
English: This is not considered clinically meaningful, therefore, no dose adjustment for Onglyza is recommended on the basis of age alone.
Slovenian: To ni bilo ocenjeno kot klinično pomembno, zato odmerka zdravila Onglyza ni treba prilagoditi samo zaradi starosti.
English: The tablets contain lactose monohydrate.
Slovenian: Tablete vsebujejo laktozo monohidrat.
English: This is an antibiotic used to treat infections such as tuberculosis.
Slovenian: • rifampicin; to je antibiotik, ki se uporablja za zdravljenje okužb, kakršna je tuberkuloza.
English: The use of saxagliptin has not been studied in pregnant women.
Slovenian: Uporaba saksagliptina pri nosečnicah ni raziskana.
English: Adjusted mean change from baseline adjusted for baseline value (ANCOVA).
Slovenian: korigirana povprečna sprememba od izhodišča korigirana z izhodiščno vrednostjo (ANCOVA).
English: It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Slovenian: Pomembno je, da še naprej upoštevate navodila za dieto in telesno dejavnost, ki ste jih dobili od zdravnika ali medicinske sestre.
English: Placebo group had uptitration of glibenclamide from 7.5 to 15 mg total daily dose.
Slovenian: skupina s placebom je povečevala odmerek glibenklamida od 7,5 do 15 mg celotnega dnevnega odmerka.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Slovenian: Zato je, skladno z rutinsko oskrbo sladkornega bolnika, priporočljivo spremljanje kožnih sprememb kot so mehurji, razjede in izpuščaj.
English: The clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Slovenian: Klinični pomen zmanjšanja števila limfocitov v primerjavi s placebom ni znan.
English: What you need to know before you take Onglyza
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Onglyza
English: Keep taking Onglyza until your doctor tells you to stop.
Slovenian: Ne nehajte uporabljati zdravila Onglyza, dokler vam tega ne naroči zdravnik.
English: • Uncommon (may affect 1 to 10 users in 1,000): joint pain (arthralgia) and difficulties in getting or maintaining an erection (erectile dysfunction).
Slovenian: • Občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): bolečine v sklepih (artralgija) in težave pri nastanku in vzdrževanju erekcije (erektilna disfunkcija).
English: It is not known if Onglyza passes into human breast milk.
Slovenian: Ni znano, ali zdravilo Onglyza pri človeku prehaja v materino mleko.
English: Other medicines and Onglyza
Slovenian: Druga zdravila in zdravilo Onglyza
English: In addition, patients should be alerted to the risk of hypoglycaemia when Onglyza is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Slovenian: Poleg tega je treba bolnike opozoriti na tveganje za hipoglikemijo, če je zdravilo Onglyza uporabljeno v kombinaciji z drugimi antidiabetičnimi zdravili, za katere je znano, da povzročajo hipoglikemijo (npr. insulin, sulfonilsečnine).
English: The average renal clearance of saxagliptin (~230 ml/min) was greater than the average estimated glomerular filtration rate (~120 ml/min), suggesting some active renal excretion.
Slovenian: Povprečni ledvični očistek saksagliptina (230 ml/min) je bil večji kot povprečna ocenjena hitrost glomerularne filtracije (120 ml/min), kar kaže na določeno mero aktivnega ledvičnega izločanja.
English: • Tablets available in aluminium foil blisters.
Slovenian: • Tablete so na voljo v pretisnih omotih iz aluminijske folije.
English: What Onglyza is and what it is used for What you need to know before you take Onglyza How to take Onglyza
Slovenian: Kaj je zdravilo Onglyza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Onglyza Kako jemati zdravilo Onglyza Možni neželeni učinki
English: If you have these symptoms, stop taking Onglyza and call your doctor or nurse right away.
Slovenian: Če se pri vas pojavijo omenjeni simptomi, prenehajte jemati zdravilo Onglyza in takoj obvestite zdravnika ali medicinsko sestro.
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 (see Table 4).
Slovenian: Drug sekundarni opazovani dogodek, umrljivost zaradi vseh vzrokov, se je v skupini s saksagliptinom pojavil v 5,1 % in v skupini s placebom v 4,6 % (glejte preglednico 4).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase-4 (DPP4) inhibitor (see sections 4.4 and 4.8).
Slovenian: Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 ali resne alergijske reakcije, vključno z anafilaktično reakcijo, anafilaktičnim šokom in angioedemom, na katerega koli zaviralca dipeptidilpeptidaze 4 (DPP4) v anamnezi (glejte poglavji 4.4 in 4.8).
English: • Uncommon: tiredness, abnormal lipid (fatty acids) levels (dyslipidaemia, hypertriglyceridaemia).
Slovenian: • Občasni: utrujenost, nenormalen nivo lipidov (dislipidemija, hipertrigliceridemija).
English: • Study CV181039: initial combination with metformin Overall population (n=306) Baseline HbA1c ≥ 10% stratum (n=107)
Slovenian: • preskušanje CV181039: začetna kombinacija z metforminom celotna populacija (n=306) izhodišče HbA1c ≥10% skupina (n = 107)
English: The SAVOR trial included 8240 patients treated with Onglyza 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Slovenian: Preskušanje SAVOR je zajelo 8240 bolnikov, zdravljenih z 2,5 mg ali 5 mg zdravila Onglyza enkrat na dan, in 8173 bolnikov, ki so prejemali placebo.
English: Glycaemic control should be carefully assessed when saxagliptin is used concomitantly with a potent CYP3A4/5 inducer.
Slovenian: Glikemično kontrolo je treba pazljivo oceniti, kadar se saksagliptin uporablja skupaj z močnimi induktorji CYP3A4.
English: Your doctor may prescribe Onglyza alone or together with insulin or other anti-diabetic medicines.
Slovenian: Zdravnik vam bo zdravilo Onglyza lahko predpisal samostojno ali skupaj z insulinom ali drugim antidiabetičnim zdravilom.
English: Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics'.
Slovenian: Zdravilo Onglyza vsebuje učinkovino saksagliptin, ki spada v skupino zdravil, imenovanih peroralni antidiabetiki.
English: Onglyza should not be used in place of insulin;
Slovenian: Zdravila Onglyza se ne sme uporabljati namesto insulina,
English: If you feel dizzy while taking Onglyza, do not drive or use any tools or machines.
Slovenian: Če se med jemanjem zdravila Onglyza počutite omotični, ne upravljajte vozil ali strojev.
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Slovenian: Saksagliptin je spremljal tudi značilno manjši delež hipoglikemij (3 %; 19 dogodkov pri 13 bolnikih) kot glipizid (36,3 %; 750 dogodkov pri 156 bolnikih).
English: Method of administration The tablets can be taken with or without a meal at any time of the day.
Slovenian: Tablete je mogoče vzeti s hrano ali brez nje in ob kateremkoli času dneva.
English: In postmarketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis.
Slovenian: V obdobju trženja saksagliptina so spontano poročali o neželenem učinku akutnem pankreatitisu.
English: Caution is warranted if Onglyza 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: Previdnost je potrebna, če je zdravilo Onglyza uporabljeno pri bolnikih z znanimi dejavniki tveganja za hospitalizacijo zaradi srčnega popuščanja, npr. pri bolnikih z anamnezo srčnega popuščanja ali z zmerno do hudo okvaro ledvic.
English: Animal studies have shown excretion of saxagliptin and/or metabolite in milk.
Slovenian: Študije na živalih so pokazale, da se saksagliptin in/ali njegov presnovek izloča v mleku.
English: The most commonly reported adverse reactions in placebo-controlled trials reported in ≥5% of patients treated with Onglyza 5 mg and more commonly than in patients treated with placebo are upper respiratory tract infection (7.7%), urinary tract infection (6.8%) and headache (6.5%).
Slovenian: Najpogosteje poročani neželeni učinki v s placebom kontroliranih preskušanjih, ki so bili poročani pri  5 % bolnikih, ki so dobivali zdravilo Onglyza 5 mg in so bolj pogosti kot pri bolnikih, ki so dobivali placebo, so okužbe zgornjih dihal (7,7 % ), okužbe sečil (6,8 %) in glavobol (6,5 %).
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Slovenian: Večje izločanje insulina iz pankreatičnih celic beta in manjše izločanje glukagona iz pankreatičnih celic alfa sta bila povezana z nižjo koncentracijo glukoze na tešče in manjšim porastom glukoze po peroralni obremenitvi z glukozo ali po obroku.
English: The clinical relevance of the skin lesions is not known, however, clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Slovenian: Klinični pomen kožnih sprememb ni znan, vendar v kliničnih preskušanjih pri človeku niso opazili kliničnih korelatov kožnih sprememb pri opicah.
English: • if you are taking insulin or an anti-diabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with Onglyza in order to avoid low blood sugar;
Slovenian: • če jemljete insulin ali katero od zdravil proti sladkorni bolezni, ki se imenujejo "sulfonilsečnine", vam bo zdravnik med hkratno uporabo z zdravilom Onglyza morda zmanjšal odmerek insulina ali sulfonilsečnine, da bo preprečil nizek krvni sladkor,
English: Use with medicinal products known to cause hypoglycaemia Sulphonylureas and insulin are known to cause hypoglycaemia.
Slovenian: Uporaba z zdravili za katere je znano, da povzročajo hipoglikemijo Znano je, da sulfonilsečnine in insulin povzročajo hipoglikemijo.
English: Each tablet contains 99 mg lactose (as monohydrate).
Slovenian: Ena tableta vsebuje 99 mg laktoze (v obliki monohidrata).
English: Onglyza is not a substitute for insulin in insulin-requiring patients.
Slovenian: Zdravilo Onglyza ne more nadomestiti insulina pri bolnikih, ki potrebujejo zdravljenje z insulinom.
English: Table 2 Key efficacy results of Onglyza 5 mg per day in placebo-controlled monotherapy trials and in add-on combination therapy trials
Slovenian: Preglednica 2 Ključni rezultati o učinkovitosti 5 mg zdravila Onglyza na dan v preskušanjih monoterapije, kontroliranih s placebom, in preskušanjih z dodatkom v kombiniranem zdravljenju
English: There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.
Slovenian: Niso ugotovili neželenih učinkov na delovanje ledvic, ovrednoteno z oceno hitrosti glomerularne filtracije ali očistka kreatinina po 12 in 52 tednih.
English: Adverse reactions of hypoglycaemia were based on all reports of hypoglycaemia; a concurrent glucose measurement was not required.
Slovenian: Neželeni učinki hipoglikemije temeljijo na vseh poročilih o hipoglikemiji, sočasno merjenje glukoze v krvi ni bilo potrebno.
English: In addition, saxagliptin did not meaningfully alter the pharmacokinetics of metformin, glibenclamide, pioglitazone, digoxin, simvastatin, the active components of a combined oral contraceptive (ethinyl estradiol and norgestimate), diltiazem or ketoconazole.
Slovenian: Poleg tega saksagliptin ni pomembno spremenil farmakokinetike metformina, glibenklamida, pioglitazona, digoksina, simvastatina, učinkovin v kombiniranih peroralnih kontraceptivih (etinilestradiol in norgestimat), diltiazema ali ketokonazola.
English: Onglyza is used for adult patients aged 18 years and older with ‘type 2 diabetes', if the disease cannot be adequately controlled with one oral anti-diabetic medicine, diet and exercise.
Slovenian: Zdravilo Onglyza se uporablja za zdravljenje "sladkorne bolezni tipa 2" pri odraslih bolnikih, starih 18 let in več, če je ni mogoče ustrezno obvladati z enim samim peroralnim antidiabetikom, dieto in telesno dejavnostjo.
English: The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups.
Slovenian: Incidenca potrjenih hipoglikemij je bila v skupini s saksagliptinom nekoliko večja (9,4 %) kot v skupini s placebom (4,7 %), čeprav se število bolnikov, ki se jim je pojavila kakšna hipoglikemija, med terapevtskima skupinama ni razlikovalo.
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Slovenian: Študije na živalih so pokazala toksične učinke na sposobnost razmnoževanja pri velikih odmerkih (glejte poglavje 5.3).
English: • Study CV181168: sequential add-on to dapagliflozin + metformin (n=315)
Slovenian: • Študija CV181168: zaporedno dodajanje kombinaciji dapagliflozin + metformin (n = 315)
English: The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C <7% at baseline.
Slovenian: Večje tveganje za vse hipoglikemije in hujše hipoglikemije so ugotovili predvsem med preiskovanci, ki so imeli izhodiščno A1c < 7 %.