natgillin/translations-raw huggingface dataset:
What Segluromet is and what it is used for 2.
Kaj je zdravilo Segluromet in za kaj ga uporabljamo 2.
Lactic acidosis has been reported in approximately 32% of metformin overdose cases (see section 4.4).
O laktacidozi so poročali v približno 32 % primerov prevelikega odmerjanja metformina (glejte poglavje 4.4).
Segluromet must be discontinued at the time of surgery under general, spinal, or epidural anaesthesia.
Uporabo zdravila Segluromet je treba v času kirurškega posega pod splošno, spinalno ali epiduralno anestezijo prekiniti.
This medicine has no or negligible influence on the ability to drive and use machines.
To zdravilo nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Gastrointestinalni simptomi, kot so navzea, bruhanje, diareja, abdominalna bolečina in izguba apetita, nastopijo najpogosteje med uvedbo zdravljenja in v večini primerov spontano izzvenijo.
Initial increases in mean creatinine and decreases in mean eGFR in patients treated with ertugliflozin were generally transient during continuous treatment.
Uvodno zvišanje povprečnega kreatinina in zmanjšanje povprečne eGFR pri bolnikih, zdravljenih z ertugliflozinom, je bilo med neprekinjenim zdravljenjem na splošno prehodno.
Similarly, there was no tumorigenic potential observed with metformin in male rats.
Podobno niso opazili tumorogenega potenciala metformina pri podganjih samcih.
The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Bolnika je treba s tem seznaniti in pogosteje opravljati teste za določanje koncentracije glukoze v krvi, zlasti na začetku zdravljenja s takimi zdravili.
Discontinue when GFR is persistently less than 45 ml/min.
Ukiniti, če je GFR trajno manj kot 45 ml/min.
An increase in cases of lower limb amputation (primarily of the toe) has also been observed in long-term clinical studies with another SGLT2 inhibitor.
Povečanje števila primerov amputacij na spodnjih okončinah (predvsem prstov) so opazili tudi v dolgotrajnih kliničnih študijah z drugim zaviralcem SGLT2.
Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2.
Ertugliflozin je močan selektiven in reverzibilen zaviralec SGLT2.
There is no information regarding the presence of ertugliflozin in human milk, the effects on the breast-fed infant, or the effects on milk production.
Glede prisotnosti ertugliflozina v materinem mleku, njegovih učinkih na dojenega otroka ali njegovih učinkih na nastajanje mleka ni podatkov.
If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Po potrebi je treba odmerek antidiabetika prilagoditi med zdravljenjem z drugim zdravilom in ob ukinitvi drugega zdravila.
Necrotising fasciitis of the perineum (Fournier's gangrene)*
nekrotizirajoči fasciitis presredka (Fournierjeva gangrena)*
No studies of metformin pharmacokinetic parameters according to race have been performed.
Študij farmakokinetičnih parametrov metformina glede na raso niso izvedli.
Alu/PVC/PA/Alu blisters.
Alu/PVC/PA/Alu pretisni omoti.
These symptoms could be a sign of “diabetic ketoacidosis”a problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Ti simptomi so lahko znak "diabetične ketoacidoze" - motnje, ki se lahko pojavi pri sladkorni bolezni zaradi zvišane ravni "ketonskih teles" v urinu ali krvi, kar se pokaže na laboratorijskih preiskavah.
Before initiating ertugliflozin/metformin, consider factors in the patient history that may increase the risk for amputation.
Pred uvedbo ertugliflozina/metformina je treba upoštevati dejavnike iz bolnikove anamneze, ki lahko povečajo tveganje za amputacijo.
†, 95% CI) * N includes all randomised, treated patients who had at least one measurement of the outcome variable.
†, 95 % IZ) * n vključuje vse randomizirane, zdravljene bolnike, ki so imeli vsaj eno meritev spremenljivke izida.
• a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat
• sladek zadah, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali potu.
This medicine does not require any special storage conditions.
Za to zdravilo ni posebnih pogojev shranjevanja.
Overdose of metformin hydrochloride has occurred, including ingestion of amounts greater than 50 g. Hypoglycaemia was reported in approximately 10% of cases, but no causal association with metformin hydrochloride has been established.
Prišlo je do prevelikega odmerjanja metforminijevega klorida, ki je vključevalo zaužitje količin nad 50 g. O hipoglikemiji so poročali v približno 10 % primerov, vendar vzročna povezanost z metforminijevim kloridom ni bila ugotovljena.
Your doctor may reduce the dose of your insulin or other medicine.
Zdravnik vam lahko zmanjša odmerek insulina ali drugega zdravila.
The most commonly reported adverse reactions across the clinical program were vulvovaginal mycotic infection, and other female genital mycotic infections.
Najpogosteje poročani neželeni učinki skozi celoten klinični program so bile vulvovaginalne glivične okužbe in druge glivične okužbe ženskih spolovil.
The incidence and type of adverse reactions in these two trials were similar to the adverse reactions seen with ertugliflozin.
Pojavnost in vrsta neželenih učinkov v teh dveh preskušanjih sta bili podobni kot pri neželenih učinkih pri uporabi ertugliflozina.
The mean age of the patients across these four studies ranged from 55.1 to 59.1 years (range 21 years to 86 years); 15.6% to 29.9% of patients were ≥65 years of age and 0.6% to 3.8% were ≥75 years of age.
Povprečna starost bolnikov v teh 4 študijah je bila od 55,1 do 59,1 leta (razpon od 21 do 86 let); 15,6 % do 29,9 % bolnikov je bilo starih ≥ 65 let in od 0,6 % do 3,8 % ≥ 75 let.
If Fournier's gangrene is suspected, Segluromet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Če obstaja sum na Fournierjevo gangreno, je treba zdravilo Segluromet ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
In rare instances, phimosis was reported and sometimes circumcision was performed (see section 4.4).
V redkih primerih so poročali o fimozi in včasih je bila izvedena cirkumcizija (glejte poglavje 4.4).
• in patients on their maximally tolerated doses of metformin in addition to other medicinal products for the treatment of diabetes
• pri bolnikih, ki uporabljajo največji tolerirani odmerek metformina skupaj z drugimi zdravili za zdravljenje sladkorne bolezni,
Across the four studies, the racial distribution ranged from 66.2% to 80.3% White, 10.6% to 20.3% Asian, 1.9% to 10.3% Black, and 4.5% to 7.4% other.
V teh 4 študijah je bila rasna porazdelitev naslednja: od 66,2 % do 80,3 % je bilo belcev, od 10,6 % do 20,3 % Azijcev, od 1,9 % do 10,3 % črncev in od 4,5 do 7,4 % drugih.
The risk of metformin-associated lactic acidosis increases with the patient's age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients.
Tveganje za z metforminom povezano laktacidozo se z bolnikovo starostjo povečuje, saj imajo starejši bolniki večjo verjetnost za okvaro jeter, ledvic ali srca kot mlajši bolniki.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Ne uporabljajte tega zdravila v primeru poškodovane ovojnine ali znakov, ki kažejo, da je bilo pakiranje odprto.
• Segluromet lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
• Zdravilo Segluromet znižuje vrednosti krvnega sladkorja pri odraslih bolnikih (starih 18 let ali več) s sladkorno boleznijo tipa 2.
You may be more likely to get dehydrated if you:
Verjetnost za dehidracijo je večja:
In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
V številnih primerih je bila klinična slika tega stanja neznačilna, z le zmerno zvišano koncentracijo glukoze v krvi, in sicer pod 14 mmol/l (250 mg/dl).
Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Pri bolnikih, pri katerih se je predhodno med zdravljenjem z zaviralcem SGLT2 pojavila DKA, ponovno zdravljenje z zaviralcem SGLT2 ni priporočljivo, razen če je ugotovljen in odpravljen drug jasen sprožilni dejavnik.
Other medicines and Segluromet
Druga zdravila in zdravilo Segluromet
In patients where DKA is suspected or diagnosed, treatment with Segluromet should be discontinued immediately.
Pri bolnikih s sumom na DKA ali z diagnosticirano DKA je treba zdravljenje z zdravilom Segluromet takoj ukiniti.
Ertugliflozin may add to the diuretic effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Ertugliflozin lahko doprinese k diuretičnemu učinku diuretikov in lahko poveča tveganje za dehidracijo in hipotenzijo (glejte poglavje 4.4).
These increases are not considered to be clinically meaningful.
Ta povečanja ne veljajo za klinično pomembna.
Ertugliflozin glucuronides had no effect on these isoforms.
Ertugliflozinovi glukuronidi nimajo vpliva na te izoforme.
The mean systemic plasma clearance following an intravenous 100 µg dose was 11 l/hr.
Povprečni sistemski plazemski očistek po intravenski uporabi odmerka 100 µg je bil 11 l/h.
Necrotising fasciitis of the perineum or Fournier's gangrene (not known, cannot be estimated from the available data)
Nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena (neznana pogostnost, pogostnosti iz razpoložljivih podatkov ni mogoče oceniti)
• Metformin works by inhibiting sugar (glucose) production in the liver.
• Metformin deluje tako, da zavre nastajanje sladkorja (glukoze) v jetrih.
Unlike sulphonylureas, metformin does not produce hypoglycaemia in either patients with type 2 diabetes or normal subjects, except in special circumstances (see section 4.5), and does not cause hyperinsulinaemia.
V nasprotju s sulfonilsečninami metformin tako pri bolnikih s sladkorno boleznijo tipa 2 kot tudi pri zdravih osebah ne povzroča hipoglikemije, razen v posebnih okoliščinah (glejte poglavje 4.5), in ne povzroča hiperinsulinemije.
Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Spodaj našteti neželeni učinki so razvrščeni po pogostnosti in organskem sistemu.
Urinary glucose excretion may be associated with an increased risk of urinary tract infections.
Izločanje glukoze z urinom je lahko povezano s povečanim tveganjem za okužbe urinarnega trakta.
The mean elimination half-life in type 2 diabetic patients with normal renal function was estimated to be 17 hours based on the population pharmacokinetic analysis.
Povprečni eliminacijski razpolovni čas pri bolnikih s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic, ocenjen na podlagi populacijske farmakokinetične analize, je bil 17 ur.
The mechanism for the small increases in simvastatin and simvastatin acid is unknown and is not perpetrated through OATP inhibition by ertugliflozin.
Mehanizem majhnega povečanja simvastatina in simvastatina v obliki kisline ni znan in ga ne povzroča zaviranje OATP s strani ertugliflozina.
Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or post-natal development (see section 5.3).
Študije metformina na živalih ne kažejo učinkov na nosečnost, embrionalni ali fetalni razvoj, porod ali postnatalni razvoj (glejte poglavje 5.3).
• Inhibitors of OCT2 (such as cimetidine, dolutegravir, ranolazine, trimethoprime, vandetanib, isavuconazole) may decrease the renal elimination of metformin and thus lead to an increase in metformin plasma concentration.
• zaviralci OCT2 (kot so cimetidin, dolutegravir, ranolazin, trimetoprim, vandetanib, isavukonazol) lahko zmanjšajo izločanje metformina skozi ledvice, kar lahko vodi do povečane koncentracije metformina v plazmi.
Segluromet should be taken orally twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Zdravilo Segluromet je treba jemati peroralno dvakrat na dan s hrano, da se zmanjša z metforminom povezane neželene učinke na prebavila.
Metformin is dialyzable with a clearance of up to 170 ml/min under good haemodynamic conditions.
Metformin se dializira in ima v dobrih hemodinamskih pogojih očistek do 170 ml/min.
Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Diagnostični laboratorijski izvidi so znižan pH krvi (< 7,35), zvišane ravni laktata v plazmi (> 5 mmol/l) in zvečana anionska vrzel ter razmerje laktat/piruvat.
• take other diabetes medicines; you are more likely to get low blood sugar with certain medicines.
• če jemljete druga zdravila za sladkorno bolezen; pri določenih zdravilih imate večjo verjetnost za pojav nizkega krvnega sladkorja.
Stop taking Segluromet for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Za kratek čas prenehajte jemati zdravilo Segluromet, če imate stanje, ki je lahko povezano z dehidracijo (znatna izguba telesnih tekočin), kot je hudo bruhanje, driska, zvišana telesna temperatura, izpostavljenost vročini ali če pijete manj tekočine kot običajno.
If you notice any of the side effects above, contact your doctor as soon as possible.
Če opazite katerega koli od zgoraj naštetih neželenih učinkov, se čim prej posvetujte z zdravnikom.
You should not use Segluromet if you are pregnant.
Ne uporabljajte zdravila Segluromet, če ste noseči.
Moderate hepatic impairment (based on the Child-Pugh classification) did not result in an increase in exposure of ertugliflozin.
Zmerna okvara jeter (na podlagi lestvice po Child-Pugh-u) ni povečala izpostavljenosti ertugliflozinu.
• have type 1 diabetes.
• če imate sladkorno bolezen tipa 1.
In controlled clinical studies of metformin in patients with type 2 diabetes, the antihyperglycaemic effect was comparable in Whites (n=249), Blacks (n=51), and Hispanics (n=24).
V nadzorovanih kliničnih študijah metformina pri bolnikih s sladkorno boleznijo tipa 2 je bil antihiperglikemični učinek pri belcih (n = 249), črncih (n = 51) in Latinoameričanih (n = 24) primerljiv.
If this happens, you must stop taking Segluromet and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
V tem primeru morate prenehati jemati zdravilo Segluromet in se takoj obrniti na zdravnika ali najbližjo bolnišnico, saj lahko laktacidoza vodi v komo.
CYP-mediated (oxidative) metabolism of ertugliflozin is minimal (12%).
Presnova ertugliflozina s CYP (oksidativna presnova) je minimalna (12 %).
• rapid weight loss
• hitro izgubljanje telesne mase,
Stop taking Segluromet and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Takoj prenehajte jemati zdravilo Segluromet in se obrnite na zdravnika ali najbližjo bolnišnico, če se pojavijo nekateri od simptomov laktacidoze, saj lahko to stanje vodi v komo.
There was no evidence of a mutagenic potential of metformin in the following in vitro tests: Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes).
V naslednjih testih in vitro ni bilo dokazov o mutagenem potencialu metformina: Amesov test (S. typhimurium), test genske mutacije (mišje limfomske celice) ali test kromosomskih aberacij (človeški limfociti).
Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Ob pojavu teh simptomov je treba pri bolnikih takoj preveriti, ali gre za ketoacidozo, ne glede na koncentracijo glukoze v krvi.
Metformin is present in human breast milk.
Metformin je prisoten v materinem mleku.
Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section “Warnings and precautions”):
Diabetična ketoacidoza (redka, pojavi se lahko pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi poglavje "Opozorila in previdnostni ukrepi") so:
During controlled clinical trials of metformin, maximum metformin plasma levels did not exceed 5 µg/mL, even at maximum doses.
V nadzorovanih kliničnih preskušanjih metformina največja koncentracija metformina v plazmi niti ob največjih odmerkih ni presegla 5 µg/ml.
Segluromet may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Zdravilo Segluromet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza, zlasti če ledvice ne delujejo pravilno.
Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with ertugliflozin in NYHA class III-IV.
Izkušenj pri razredih I in II po NYHA (New York Heart Association - NYHA) je malo, izkušenj iz kliničnih študij z ertugliflozinom pri razredih III in IV po NYHA pa ni.
Do not take Segluromet if any of the above apply to you.
Ne vzemite zdravila Segluromet, če kaj od naštetega velja za vas.
Segluromet should not be used to treat this condition.
Zdravila Segluromet se ne sme uporabljati za zdravljenje te bolezni.
Paediatric population No studies with ertugliflozin have been performed in paediatric patients.
Pediatrična populacija Študij z ertugliflozinom pri pediatričnih bolnikih niso izvedli.
Glucocorticoids (given by systemic and local routes), beta 2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Glukokortikoidi (dani sistemsko ali lokalno), beta-2-agonisti in diuretiki imajo intrinzično hiperglikemično aktivnost.
Ertugliflozin is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters.
Ertugliflozin je substrat prenašalcev p-glikoproteina in proteina odpornosti pri raku dojke (BCRPbreast cancer resistance protein).
Ertugliflozin was used as monotherapy in one trial and as add-on therapy in two trials (see section 5.1).
Ertugliflozin so v enem preskušanju uporabili kot samostojno zdravljenje, v dveh preskušanjih pa kot dodatno zdravljenje (glejte poglavje 5.1).
How to take Segluromet 4.
Kako jemati zdravilo Segluromet 4.
If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Segluromet before or at the time of the injection.
Če vam bodo v krvni obtok injicirali kontrastno sredstvo, ki vsebuje jod, na primer zaradi rentgenskega ali drugega slikanja, morate pred časom injiciranja ali v tem času prenehati z jemanjem zdravila Segluromet.
SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
SGLT2 je glavni prenašalec, odgovoren za reabsorpcijo glukoze iz glomerulnega filtrata nazaj v krvni obtok.
The effects of a high-fat meal on the pharmacokinetics of ertugliflozin and metformin when administered as Segluromet tablets are comparable to those reported for the individual tablets.
Vplivi obroka z visoko vsebnostjo maščob na farmakokinetiko ertugliflozina in metformina v obliki tablet zdravila Segluromet so bili podobni tistim, o katerih so poročali za posamezne tablete.
Similarly, in controlled clinical studies in patients with type 2 diabetes, the antihyperglycaemic effect of metformin was comparable in males and females.
Podobno je bil v nadzorovanih kliničnih študijah pri bolnikih s sladkorno boleznijo tipa 2 primerljiv antihiperglikemični učinek metformina pri moških in ženskah.
Other risk factors for lactic acidosis are excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting and any conditions associated with hypoxia, as well as concomitant use of medicinal products that may cause lactic acidosis (see sections 4.3 and 4.5).
Drugi dejavniki tveganja za laktacidozo so pretirano uživanje alkohola, jetrna insuficienca, neustrezno nadzorovana sladkorna bolezen, ketoza, dolgotrajen post in kakršna koli stanja, povezana s hipoksijo, ter sočasna uporaba zdravil, ki lahko povzročijo laktacidozo (glejte poglavji 4.3 in 4.5).
Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and non-steroidal anti-inflammatory drugs [NSAIDs]) should be initiated with caution in metformintreated patients.
Zdravila, ki lahko akutno okvarijo delovanje ledvic (kot so antihipertenzivi, diuretiki in nesteroidna protivnetna zdravila), je treba pri bolnikih, ki se zdravijo z metforminom, uvesti previdno.
There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Kliničnih izkušenj pri bolnikih z okvaro jeter v razredu C po Child-Pugh-u (huda okvara) ni.
Metformin is contraindicated in patients with GFR < 30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Metformin je kontraindiciran pri bolnikih z GFR < 30 ml/min in ga je treba začasno ukiniti, če se pojavijo stanja, ki spremenijo delovanje ledvic (glejte poglavje 4.3).
Before initiating Segluromet, volume status should be assessed and corrected if indicated.
Pred uvedbo zdravila Segluromet je treba oceniti volumsko stanje (volemijo) in ga korigirati, če je potrebno.
Lactic acidosis (very rare, may affect up to 1 in 10,000 people) Segluromet may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Laktacidoza (zelo redka, pojavi se lahko pri največ 1 od 10.000 bolnikov) Zdravilo Segluromet lahko povzroči zelo redek, a zelo resen neželeni učinek, imenovan laktacidoza (glejte poglavje "Opozorila in previdnostni ukrepi").
Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue.
Ertugliflozin lahko poveča tveganje za hipoglikemijo, če se uporablja v kombinaciji z insulinom in/ali insulinskim sekretagogom.
Patients [N (%)] with HbA1c < 7% Body Weight (kg)
Bolniki [n (%)] s HbA1c < 7 % Telesna masa (kg)
• experience rapid weight loss, feeling sick or being sick, stomach pain, excessive thirst, fast and deep breathing, confusion, unusual sleepiness or tiredness, a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat, contact a doctor or the nearest hospital straight away.
• če se pojavi hitro hujšanje, občutek slabosti ali bruhanje, bolečina v trebuhu, prekomerna žeja, hitro in globoko dihanje, zmedenost, neobičajna zaspanost ali utrujenost, sladek zadah, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali potu; v teh primerih se takoj posvetujte z zdravnikom ali pojdite v najbližjo bolnišnico.
• Segluromet can be used instead of taking both ertugliflozin and metformin as separate tablets.
• Zdravilo Segluromet se lahko uporablja namesto jemanja ertugliflozina in metformina v ločenih tabletah.
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD23.
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov; Oznaka ATC: A10BD23