FrancophonIA/ELRC3.0 huggingface dataset:
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9) and is, therefore, not recommended for use in such patients (see sections 4.2, 4.3 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u >9) uporabe alogliptina niso raziskovali, zato njegova uporaba pri teh bolnikih ni priporočljiva (glejte poglavja 4.2, 4.3 in 5.2).
English: Hypersensitivity reactions, including Stevens-Johnson syndrome, anaphylactic reactions, and angioedema are serious and are attributed to the alogliptin component of Vipdomet (see section 4.4).
Slovenian: Preobčutljivostne reakcije, vključno s Stevens-Johnsonovim sindromom, anafilaktičnimi reakcijami in angioedemom, so resne in jih je mogoče pripisati vsebnosti alogliptina v zdravilu Vipdomet (glejte poglavje 4.4).
English: The highest doses of alogliptin administered in clinical studies were single doses of 800 mg to healthy subjects and doses of 400 mg once daily for 14 days to patients with type 2 diabetes mellitus (equivalent to 32 times and 16 times the recommended total daily dose of 25 mg alogliptin, respectively).
Slovenian: Največji odmerki alogliptina, uporabljeni v okviru kliničnih študij, so bili enkratni odmerki 800 mg pri zdravih osebah in odmerki 400 mg enkrat na dan v obdobju 14 dni pri bolnikih s sladkorno boleznijo tipa 2 (kar je 32-krat oziroma 16-krat več od priporočenega dnevnega odmerka 25 mg alogliptina).
English: Renal clearance of metformin is >400 mL/min indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Slovenian: Ledvični očistek metformina je večji od 400 ml/min, kar kaže, da se metformin izloča z glomerulno filtracijo in tubulno sekrecijo.
English: Interactions with metformin
Slovenian: Medsebojno delovanje z metforminom
English: Therefore, haemodialysis is of little clinical benefit in removing alogliptin in overdose.
Slovenian: Hemodializa ima v primeru prevelikega odmerjanja tako le majhno klinično korist za odstranitev alogliptina.
English: The following section outlines the pharmacokinetic properties of the individual components of Vipdomet (alogliptin/metformin) as reported in their respective Summary of Product Characteristics.
Slovenian: V nadaljevanju so navedene farmakokinetične lastnosti posameznih učinkovin zdravila Vipdomet (alogliptin/metformin), kot so navedene v njunih povzetkih glavnih značilnosti zdravila.
English: A total of 7,151 patients with type 2 diabetes mellitus, including 4,202 patients treated with alogliptin and metformin, participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies conducted to evaluate the effects of co-administered alogliptin and metformin on glycaemic control and their safety.
Slovenian: Skupno 7.151 bolnikov s sladkorno boleznijo tipa 2, vključno s 4.202 bolnikom, zdravljenim z alogliptinom in metforminom, je bilo vključenih v 7 dvojno slepih, s placebom ali z zdravilno učinkovino nadzorovanih kliničnih študij 3. faze, z namenom ovrednotenja učinkov sočasne uporabe alogliptina in metformina na urejenost glikemije in njuno varnost.
English: If you stop taking Vipdomet
Slovenian: Če ste prenehali jemati zdravilo Vipdomet
English: Vipdomet is taken when your blood sugar cannot be adequately controlled by diet, exercise and other anti-diabetic medicines such as metformin alone; insulin alone; or metformin and pioglitazone taken together.
Slovenian: Zdravilo Vipdomet uporabljamo, če krvnega sladkorja ni mogoče dovolj dobro nadzorovati z dieto, s telesno vadbo in z drugimi zdravili za zdravljenje sladkorne bolezni, kot so metformin sam, insulin sam ali metformin in pioglitazon, ki se ju jemlje skupaj.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Slovenian: Pri človeku ima metformin neodvisno od svojega delovanja na glikemijo ugodne učinke na presnovo lipidov.
English: crospovidone Type A, magnesium stearate, hypromellose, talc, titanium dioxide (E171) and yellow iron oxide (E172).
Slovenian: magnezijev stearat, hipromeloza, smukec, titanov dioksid (E171) in rumeni železov oksid
English: No data are available with regard to overdose of Vipdomet.
Slovenian: Podatki o prevelikem odmerjanju zdravila Vipdomet niso na voljo.
English: Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background treatment.
Slovenian: Klinično pomembna zmanjšanja vrednosti HbA1c v primerjavi s kontrolo so bila opažena tudi ne glede na osnovno zdravljenje v izhodišču.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Slovenian: Metformin je bigvanid z antihiperglikemičnim delovanjem, ki znižuje tako bazalno kot postprandialno koncentracijo glukoze v plazmi.
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Slovenian: Po uporabi peroralnega odmerka z radioaktivnim izotopom označenega [14C] alogliptina sta bila zaznana dva manj pomembna presnovka, in sicer N-demetiliran alogliptin, M-I (<1 % izvorne spojine), in N-acetiliran alogliptin, M-II (<6 % izvorne spojine).
English: In a clinical trial of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another trial as add-on to a sulphonylurea.
Slovenian: V kliničnem preskušanju alogliptina kot samostojnega zdravila je bila pojavnost hipoglikemije podobna kot pri placebu in manjša od pojavnosti pri placebu v drugem preskušanju, kjer je bil alogliptin uporabljen kot dodatek k zdravljenju s sulfonilsečnino.
English: Intravascular administration of iodinated contrast media may lead to contrast induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Slovenian: Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje laktacidoze.
English: These studies evaluated the effects of co-administered alogliptin and metformin on glycaemic control and their safety as initial combination therapy, as dual therapy in patients initially treated with metformin alone, and as add-on therapy to a thiazolidinedione or insulin.
Slovenian: Te študije so vrednotile učinke sočasne uporabe alogliptina in metformina na urejenost glikemije in njuno varnost v okviru začetnega kombiniranega zdravljenja, kombiniranega zdravljenja pri bolnikih, ki so se najprej zdravili samo z metforminom, in dodatka k zdravljenju s tiazolidindionom ali z insulinom.
English: - if you are taking another medicine for diabetes that contains a “sulphonylurea”, you should not start taking Vipdomet.
Slovenian: - če jemljete drugo zdravilo za zdravljenje sladkorne bolezni, ki vsebuje “sulfonilsečnino”,
English: What Vipdomet is Vipdomet contains two different medicines called alogliptin and metformin in one tablet:
Slovenian: Zdravilo Vipdomet v eni tableti združuje dve različni zdravilni učinkovini, imenovani alogliptin in metformin:
English: Alogliptin 25 mg once daily with insulin + metformin (n=126)
Slovenian: Alogliptin 25 mg enkrat na dan z insulinom + metformin (n=126)
English: There are no data from the use of Vipdomet in pregnant women.
Slovenian: Podatkov o uporabi zdravila Vipdomet pri nosečnicah ni.
English: Hepatic impairment Vipdomet must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter se zdravila Vipdomet ne sme uporabljati (glejte poglavja 4.3, 4.4 in 5.2).
English: Infections and infestations upper respiratory tract infections common common nasopharyngitis common common
Slovenian: Infekcijske in parazitske bolezni okužbe zgornjih dihal pogosti pogosti nazofaringitis pogosti pogosti
English: The other ingredients are mannitol, microcrystalline cellulose, povidone K30,
Slovenian: - Pomožne snovi so: manitol, mikrokristalna celuloza, povidon K30, krospovidon Tipa A,
English: The information provided is based on a total of 7,150 patients with type 2 diabetes mellitus, including 4,201 patients treated with alogliptin and metformin, who participated in 7 phase 3 double-blind, placebo- or active-controlled clinical studies.
Slovenian: Navedeni podatki temeljijo na skupno 7.150 bolnikih s sladkorno boleznijo tipa 2, vključno s 4.201 bolnikom, zdravljenim z alogliptinom in metforminom, ki so bili vključeni v 7 dvojno slepih, s placebom ali z zdravilno učinkovino nadzorovanih kliničnih študij 3. faze.
English: - if you have -severely reduced kidney function - if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactate acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Slovenian: - če imate nenadzorovano sladkorno bolezen, na primer s hudo hiperglikemijo (visoko ravnjo sladkorja v krvi), siljenjem na bruhanje, bruhanjem, drisko, hitro izgubo telesne mase, laktacidozo (glejte spodaj "Tveganje za laktacidozo") ali ketoacidozo.
English: Medicinal products with intrinsic hyperglycaemic activity Glucocorticoids (given by systemic and local routes), beta-2-agonists and diuretics (see also section 4.4) have intrinsic hyperglycaemic activity.
Slovenian: Glukokortikoidi (uporabljeni sistemsko ali lokalno), agonisti adrenergičnih receptorjev beta-2 in diuretiki (glejte tudi poglavje 4.4) imajo intrinzično hiperglikemično aktivnost.
English: Overall, treatment with the recommended total daily dose of 25 mg alogliptin in combination with metformin improved glycaemic control.
Slovenian: Zdravljenje z alogliptinom v priporočenem dnevnem odmerku 25 mg v kombinaciji z metforminom je na splošno izboljšalo urejenost glikemije.
English: Co-administration of 100 mg alogliptin once daily and 1,000 mg metformin hydrochloride twice daily for 6 days in healthy subjects had no clinically relevant effects on the pharmacokinetics of alogliptin or metformin.
Slovenian: Pri sočasni 6-dnevni uporabi alogliptina v odmerku 100 mg enkrat na dan in metforminijevega klorida v odmerku 1.000 mg dvakrat na dan pri zdravih osebah niso opazili klinično pomembnih učinkov na farmakokinetiko alogliptina ali metformina.
English: What Vipdomet contains - The active substances are alogliptin and metformin hydrochloride.
Slovenian: Kaj vsebuje zdravilo Vipdomet - Zdravilni učinkovini sta alogliptin in metforminijev klorid.
English: In studies performed with the individual active substances, both alogliptin and metformin were excreted in the milk of lactating rats.
Slovenian: Pri študijah, izvedenih s posameznima zdravilnima učinkovinama, sta se tako alogliptin kot metformin izločala v mleko doječih podgan.
English: No dose adjustment Maximum daily dose is 25 mg
Slovenian: Brez prilagajanja odmerka Največji dnevni odmerek je 25 mg.
English: However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population
Slovenian: Odmerka glede na starost ni treba prilagajati, vendar pa je pri bolnikih z višjo starostjo treba alogliptin odmerjati previdno, saj pri tej populaciji bolnikov obstaja tveganje za oslabljeno delovanje ledvic.
English: Concomitant treatment with alogliptin and metformin did not produce new toxicities and no effects on the toxicokinetics of either compound were observed.
Slovenian: Sočasno zdravljenje z alogliptinom in metforminom ni povzročilo novih toksičnih učinkov.
English: Studies in pregnant rats with alogliptin plus metformin as combination treatment have shown reproductive toxicity (see section 5.3) at approximately 5-20 times (for metformin and alogliptin respectively) the human exposure at the recommended dose.
Slovenian: Študije pri brejih podganah, ki so prejemale kombinacijo alogliptina in metformina, so pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3) pri izpostavljenosti, ki je bila približno 5-20-krat večja od izpostavljenosti človeka pri priporočenem odmerku.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness
Slovenian: Simptomi laktacidoze vključujejo: - bruhanje - bolečina v trebuhu (abdominalna bolečina) - mišične krče
English: If you need to have major surgery you must stop taking Vipdomet during and for some time before and after the procedure.
Slovenian: Če morate na večji kirurški poseg, morate v času posega in še nekaj časa po tem prenehati z jemanjem zdravila Vipdomet.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja pri klinično pomembnih odmerkih (glejte poglavje 5.3).
English: Administration of Vipdomet with food resulted in no change in total exposure (AUC) to alogliptin or metformin.
Slovenian: Pri uporabi zdravila Vipdomet skupaj s hrano se skupna izpostavljenost (AUC) alogliptinu ali metforminu ni spremenila.
English: Vipdomet must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.4.
Slovenian: Vipdomet je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.4.
English: Vipdomet should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable, see sections 4.2 and 4.5.
Slovenian: Vipdomet je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno, glejte poglavji 4.2 in 4.5.
English: The safety and efficacy of Vipdomet in children and adolescents <18 years old have not been established.
Slovenian: Varnost in učinkovitost zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
English: - in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.
Slovenian: - v kombinaciji z insulinom (tj. trotirno kombinirano zdravljenje) kot dodatek k dieti in telesni vadbi za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
English: Vipdomet is not a substitute for insulin in insulin-requiring patients.
Slovenian: Pri bolnikih, ki potrebujejo zdravljenje z insulinom, zdravilo Vipdomet ne more nadomestiti insulina.
English: - by delaying intestinal glucose absorption.
Slovenian: - upočasni absorpcijo glukoze v črevesju.
English: Isolated cases of hepatitis or liver function test abnormalities resolving on discontinuation of metformin have been reported.
Slovenian: Poročali so o posameznih primerih hepatitisa ali nenormalnostih pri preiskavah delovanja jeter, ki so spontano izzvenele po prenehanju zdravljenja z metforminom.
English: - as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin.
Slovenian: - kot dodatek k dieti in telesni vadbi za izboljšanje urejenosti glikemije pri odraslih bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju samo z metforminom v največjem odmerku, ki ga prenašajo, in pri bolnikih, ki se že zdravijo s kombinacijo alogliptina in metformina.
English: How to take Vipdomet
Slovenian: Kako jemati zdravilo Vipdomet
English: There was no change in the time to peak plasma concentration (Tmax) for alogliptin, but there was a delayed Tmax for metformin of 1.5 hours.
Slovenian: Pri alogliptinu niso opazili spremembe časa do nastopa največje koncentracije (Tmax) v plazmi, pri metforminu pa se je Tmax podaljšal za 1,5 ure.
English: In a pooled analysis of the data from 12 studies, the overall incidence of any episode of hypoglycaemia was similar in patients ≥65 years old treated with 25 mg alogliptin (3.8%) to that in patients <65 years old (3.6%).
Slovenian: V združeni analizi podatkov iz 12 študij je bila celotna pojavnost vseh epizod hipoglikemije pri bolnikih, starih 65 let ali starejših, ki so se zdravili s alogliptinom v odmerku 25 mg (3,8 %), podobna kot pri bolnikih, mlajših od 65 let (3,6 %).
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Acute pancreatitis is a serious adverse reaction and is attributed to the alogliptin component of Vipdomet (see section 4.4).
Slovenian: Akutni pankreatitis je resen neželeni učinek, ki ga je mogoče pripisati vsebnosti alogliptina v zdravilu Vipdomet (glejte poglavje 4.4).
English: Do not take Vipdomet: - if you are allergic to alogliptin, metformin or any of the other ingredients of this medicine (listed in section 6) - if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar.
Slovenian: Ne jemljite zdravila Vipdomet: - če ste alergični na alogliptin, metformin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Slovenian: Pri zdravih osebah je absolutna biološka uporabnost 500-mg ali 850-mg tablete metforminijevega klorida približno 50-60 %.
English: Nonfatal Myocardial Infarction
Slovenian: Neusodni miokardni infarkt
English: For patients inadequately controlled on the maximal tolerated dose of metformin hydrochloride alone, the recommended dose is one tablet of 12.5 mg/850 mg or 12.5 mg/1,000 mg twice daily, corresponding to 25 mg alogliptin plus 1,700 mg or 2,000 mg metformin hydrochloride daily, depending on the dose of metformin hydrochloride already being taken.
Slovenian: Pri bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju samo z metforminijevim kloridom v največjem odmerku, ki ga prenašajo, je priporočeni odmerek ena tableta 12,5 mg/850 mg ali 12,5 mg/1.000 mg dvakrat na dan, kar ustreza 25 mg alogliptina in 1.700 ali 2.000 mg metforminijevega klorida na dan, odvisno od odmerka metforminijevega klorida, ki ga bolnik že jemlje.
English: Therefore, a lower dose of insulin may be considered to reduce the risk of hypoglycaemia when this medicinal product is used in combination with Vipdomet (see section 4.2).
Slovenian: Zaradi zmanjšanja tveganja za pojav hipoglikemije bo tako morda treba razmisliti o zmanjšanju odmerka insulina, če se ta uporablja v kombinaciji z zdravilom Vipdomet (glejte poglavje 4.2).
English: Nervous system disorders headache common common metallic taste common
Slovenian: Bolezni živčevja glavobol pogosti pogosti kovinski okus pogosti
English: Vipdomet should be taken twice daily because of the pharmacokinetics of its metformin component.
Slovenian: Zdravilo Vipdomet je treba zaradi farmakokinetike metformina jemati dvakrat na dan. Treba ga je jemati ob obrokih, da se zmanjšajo neželeni učinki metformina na prebavila.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Slovenian: Metformin z delovanjem na glikogen-sintazo stimulira znotrajcelično sintezo glikogena.
English: - in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
Slovenian: - v kombinaciji s pioglitazonom (tj. trotirno kombinirano zdravljenje) kot dodatek k dieti in telesni vadbi pri odraslih bolnikih z neustrezno urejeno sladkorno boleznijo pri zdravljenju z metforminom v največjem odmerku, ki ga prenašajo, in s pioglitazonom.
English: The co-administration of alogliptin and metformin has been studied as dual therapy in patients initially treated with metformin alone, and as add-on therapy to a thiazolidinedione or insulin.
Slovenian: Sočasna uporaba alogliptina in metformina je bila raziskana v okviru kombiniranega zdravljenja pri bolnikih, ki so se najprej zdravili samo z metforminom, in v okviru dodatka k zdravljenju s tiazolidindionom ali z insulinom.
English: Very common (may affect more than 1 in 10 people): - Stomach ache - Diarrhoea - Loss of appetite - Feeling sick - Being sick.
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - Bolečina v želodcu.
English: The results of bioequivalence studies in healthy subjects demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Slovenian: Rezultati študij bioekvivalence pri zdravih osebah so pokazali, da so filmsko obložene tablete zdravila Vipdomet bioekvivalentne ustreznim odmerkom alogliptina in metformina, sočasno uporabljenim v obliki ločenih tablet.
English: For the different dose regimens Vipdomet is available in strengths of 12.5 mg/850 mg and 12.5 mg/1,000 mg film-coated tablets.
Slovenian: Za različne režime odmerjanja je zdravilo Vipdomet na voljo v različnih jakostih, in sicer v obliki 12,5 mg/850 mg in 12,5 mg/1.000 mg filmsko obloženih tablet.
English: LOCF = last observation carried forward *Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Slovenian: PPS = bolniki po protokolu (“per protocol set”) LOCF = prenos zadnjih opaženih vrednosti naprej (“last observation carried forward”) * Ne-inferiornost in superiornost statistično dokazana † Srednja vrednost najmanjših kvadratov, prilagojena gleda na predhodno antihiperglikemično zdravljenje in vrednosti v izhodišču
English: However, the results of bioequivalence studies have demonstrated that Vipdomet film-coated tablets are bioequivalent to the corresponding doses of alogliptin and metformin co-administered as separate tablets.
Slovenian: Vendar pa so rezultati študij bioekvivalence pokazali, da so filmsko obložene tablete zdravila Vipdomet bioekvivalentne ustreznim odmerkom alogliptina in metformina, sočasno uporabljenim v obliki ločenih tablet.
English: The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26- and 39-weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended total daily dose of 25 mg alogliptin.
Slovenian: Pri študijah toksičnosti pri ponavljajočih se odmerkih, ki so pri podganah trajale do 26 tednov, pri psih pa do 39 tednov, je bila mejna vrednost izpostavljenosti brez opaženih neželenih učinkov (NOAEL; “no-observed-adverse-effect level”) pri podganah 147-krat pri psih pa 227-krat večja od izpostavljenosti človeka pri priporočenem 25 mg odmerku alogliptina.
English: Adults (≥18 years old) with normal renal function (glomerular filtration rate (GFR)≥90 mL/min) The dose should be individualised on the basis of the patient's current treatment regimen.
Slovenian: Odrasli (stari 18 let in starejši) z normalnim delovanjem ledvic (ocenjena stopnja glomerulne filtracije (GFR - glomerular filtration rate) ≥90 ml/min)