FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Losec, omeprazole, is a proton pump inhibitor (PPI).
Slovenian: Zdravilna učinkovina zdravila Losec, omeprazol, je zaviralec protonske črpalke.
English: • reflux oesophagitis,
Slovenian: • refluksni ezofagitis,
English: • duodenal ulcers (treatment and prevention of relapse),
Slovenian: • razjede na dvanajstniku (zdravljenje in preprečevanje ponovitve),
English: Macrogol 8000
Slovenian: makrogol 8000
English: Your doctor may discuss the results with you.
Slovenian: Zdravnik se bo z vami pogovoril o rezultatih.
English: Distribution The estimated volume of distribution in humans is 19 L.
Slovenian: Porazdelitev Ocenjeni volumen porazdelitve pri človeku znaša 19 l.
English: Age, gender, race, body weight
Slovenian: Starost, spol, rasa, telesna masa
English: - if you have blood in your urine that your doctor has not checked.
Slovenian: • če opazite kri v urinu, ki je zdravnik še ni preveril.
English: A double dose should not be taken on the same day.
Slovenian: Bolnik v istem dnevu ne sme vzeti dvojnega odmerka.
English: It is important that you continue to follow the advice on diet and exercise that your nurse or doctor has given you.
Slovenian: Pomembno je, da se še naprej držite navodil glede diete in telesne vadbe, ki sta vam jih dala medicinska sestra ali zdravnik.
English: Your doctor will take this into account when treating your diabetes.
Slovenian: Zdravnik bo pri zdravljenju sladkorne bolezni to upošteval.
English: Take this leaflet or some tablets with you so that your doctor knows exactly what you have taken.
Slovenian: S seboj vzemite to navodilo za uporabo ali nekaj tablet, da bo zdravnik natančno vedel, kaj ste vzeli.
English: Environmental Risk Assessment (ERA)
Slovenian: Ocena tveganja za okolje (ERA - Environmental Risk Assessment)
English: Your doctor will tell you how much Incresync you need to take and if you need to change the amount of other medicines you take.
Slovenian: Zdravnik vam bo povedal kakšen odmerek zdravila Incresync morate jemati in če bo treba spremeniti količino drugih zdravil, ki jih jemljete.
English: If this applies to you, use appropriate contraception to avoid the possibility of an unplanned pregnancy.
Slovenian: Če se to nanaša na vas, za preprečitev nenamerne nosečnosti uporabljajte ustrezno kontracepcijo.
English: Some epidemiological studies have suggested a similarly increased risk of fracture in both men and women.
Slovenian: Nekatere epidemiološke študije kažejo na podobno povečano tveganje za zlome tako pri moških kot ženskah.
English: The presence of microcrystals exacerbated the hyperplastic response but was not considered to be the primary cause of hyperplastic changes.
Slovenian: Prisotnost mikrokristalov je poslabšalo hiperplastični odziv, vendar pa je ne ocenjujejo kot glavni vzrok hiperplastičnih sprememb.
English: The physician educational pack should contain:
Slovenian: Izobraževalno gradivo za zdravnike mora vsebovati:
English: Alogliptin is 20-30% bound to plasma proteins.
Slovenian: Alogliptin se v 20-30 % veže na plazemske proteine.
English: The tablets should be swallowed whole with water.
Slovenian: Tablete je treba pogoltniti cele skupaj z vodo.
English: Incresync should not be used in combination with insulin, as the safety and efficacy of this combination have not been established.
Slovenian: Zdravila Incresync se ne sme uporabljati v kombinaciji z insulinom, saj varnost in učinkovitost te kombinacije nista bili dokazani.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 September 2013
Slovenian: Datum prve odobritve: 19. september 2013 Datum zadnjega podaljšanja:
English: However, this did not lead to an increase in mortality in this study.
Slovenian: Vendar po to v tej študiji ni povzročilo večje umrljivosti.
English: Time-dependency
Slovenian: Časovna odvisnost
English: Prior to distribution of the prescriber guide in each Member State, the MAH must agree the content and format of the educational material, together with a communication plan, with the national competent authority.
Slovenian: Pred distribucijo priporočila za zdravnike v vsaki državi članici, se mora imetnik dovoljenja za promet z zdravilom glede vsebine in oblike izobraževalnega gradiva, vključno z načrtom obveščanja, dogovoriti s pristojnim nacionalnim organom.
English: Frequencies are defined as very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Slovenian: Pogostost neželenih učinkov je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: In the event of an overdose, appropriate supportive measures should be employed as dictated by the patient's clinical status.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti ustrezne podporne ukrepe, kot jih zahteva klinično stanje bolnika.
English: If you take anti-inflammatory medicines which can also cause fluid retention and swelling, you must also tell your doctor.
Slovenian: Če jemljete protivnetna zdravila, ki prav tako lahko povzročijo zastajanje tekočine in otekanje, morate o tem prav tako obvestiti zdravnika.
English: Do not stop taking Incresync without consulting your doctor first.
Slovenian: Ne prenehajte jemati zdravila Incresync, ne da bi se pred tem posvetovali z zdravnikom.
English: This has also been observed with other DPP-4 inhibitors.
Slovenian: To so opazili tudi pri drugih zaviralcih DPP-4.
English: Co. Wicklow Ireland
Slovenian: Co. Wicklow Irska
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Slovenian: Uporaba zaviralcev DPP-4 je povezana s tveganjem za razvoj akutnega pankreatitisa.
English: Approximately half of the study population had at least two of the cardiovascular history entry criteria.
Slovenian: Približno polovica študijske populacije je ustrezala vsaj dvema meriloma kardiovaskularne anamneze za vključitev.
English: Do not take Incresync and get your doctor to check your urine as soon as possible.
Slovenian: Ne jemljite zdravila Incresync in čim prej obiščite svojega zdravnika, da bo opravil ustrezne preiskave urina.
English: Absorption is not influenced by food intake.
Slovenian: Hrana ne vpliva na absorpcijo.
English: Your blood sugar could fall below the normal level, but can be increased again by taking sugar.
Slovenian: Vrednost krvnega sladkorja se lahko zniža pod normalno, vendar pa se jo z zaužitjem sladkorja lahko spet zviša.
English: Change at Week 26 (n=303)
Slovenian: Sprememba v 26. tednu (n=303)
English: Not known (frequency cannot be estimated from the available data): - An allergic reaction.
Slovenian: Neznana (pogostosti iz razpoložljivih podatkov ni mogoče oceniti):
English: The maximum reported dose of 120 mg/day for four days, then 180 mg/day for seven days was not associated with any symptoms.
Slovenian: Največji sporočeni odmerek 120 mg/dan v obdobju štirih dni in nato 180 mg/dan v obdobju sedmih dni ni bil povezan z nobenim simptomom.
English: Age (65-81 years old), gender, race (white, black and Asian) and body weight did not have any clinically relevant effect on the pharmacokinetics of alogliptin.
Slovenian: Starost (65-81 let), spol, rasa (belci, črnci in Azijci) in telesna masa niso imeli klinično pomembnega vpliva na farmakokinetiko alogliptina.
English: Glycaemic control should be monitored closely.
Slovenian: Urejenost glikemije je treba skrbno nadzirati.
English: On this basis, M-IV contribution to efficacy is approximately 3-fold that of pioglitazone whilst the relative efficacy of M-II is minimal.
Slovenian: Na isti osnovi je prispevek M-IV k učinkovitosti približno 3-krat večji od prispevka pioglitazona, relativna učinkovitost M-II pa je zelo majhna.
English: Although in very rare cases, fatal outcome has been reported, causal relationship has not been established.
Slovenian: V zelo redkih primerih so poročali o smrtnih izidih, vendar vzročne povezave niso ugotovili.
English: Absorption The absolute bioavailability of alogliptin is approximately 100%.
Slovenian: Absorpcija Absolutna biološka uporabnost alogliptina je približno 100 %.
English: (-infinity, -0.35)
Slovenian: (-neskončnost; -0,35)
English: The relevance of such a mechanism in humans is unclear.
Slovenian: Pomen takega mehanizma za človeka ni pojasnjen.
English: Alogliptin was not carcinogenic in 2-year carcinogenicity studies conducted in rats and mice.
Slovenian: Alogliptin ni bil karcinogen pri 2-letnih študijah karcinogenosti, izvedenih pri podganah in miših.
English: Change at Week 52 (n=303)
Slovenian: Sprememba v 52. tednu (n=303)
English: If this happens, do not drive or use any tools or machines.
Slovenian: V tem primeru ne smete voziti vozil ali upravljati z orodji ali s stroji.
English: Approximately one third of patients were receiving insulin in combination with metformin and/or a sulphonylurea.
Slovenian: Približno ena tretjina bolnikov se je zdravila z insulinom v kombinaciji z metforminom in/ali s sulfonilsečnino.
English: The study population had an average age of 62 years; the average duration of diabetes was 9.5 years.
Slovenian: Povprečna starost študijske populacije je bila 62 let, povprečno trajanje sladkorne bolezni pa 9,5 let.
English: ATC code: A10BD09.
Slovenian: Oznaka ATC: A10BD09
English: Three of the six identified pioglitazone metabolites are active (M-II, M-III, and M-IV).
Slovenian: Aktivni so trije od šestih ugotovljenih presnovkov pioglitazona (M-II, M-III in M-IV).
English: Reductions in HbA1c were similar across different subgroups including renal impairment, age, gender and body mass index, while differences between races (e.g. White and non-White) were small.
Slovenian: Zmanjšanja vrednosti HbA1c so bila pri različnih podskupinah podobna, tudi pri delitvi glede na okvaro ledvic, starost, spol in indeks telesne mase, razlike med rasami (npr. belci in nebelci) pa so bile majhne.
English: - if you have diabetic ketoacidosis (a serious complication of poorly controlled diabetes).
Slovenian: • če imate diabetično ketoacidozo (resen zaplet slabo urejene sladkorne bolezni).
English: Patients should be advised to adhere strictly to a calorie-controlled diet.
Slovenian: Bolnikom je treba svetovati, naj se strogo držijo diete z nadzorovanim vnosom kalorij.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom ali s farmacevtom, preden vzamete to zdravilo.
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Slovenian: Višja izhodiščna vrednost HbA1c je bila povezana z večjim zmanjšanjem vrednosti HbA1c.
English: These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Slovenian: Te izsledke so ugotovili pri vseh živalskih vrstah pri plazemskih koncentracijah, ki so bile ≤ 4-krat večje od klinične izpostavljenosti.
English: In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Slovenian: Pri živalih je mogoče v blatu ali urinu zaznati le majhno količino nespremenjenega pioglitazona.
English: Other medicines and Incresync
Slovenian: Druga zdravila in zdravilo Incresync
English: This study showed an increase in reports of heart failure, however this did not lead to an increase in mortality in this study.
Slovenian: Študija je pokazala porast poročil o srčnem popuščanju, vendar pa to v tej študiji ni povzročilo večje umrljivosti.
English: Cardiovascular Death*
Slovenian: Kardiovaskularna smrt*
English: Common (may affect up to 1 in 10 people): - Sudden and severe bone pain or immobility (particularly in women).
Slovenian: Pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): • Nenadna in huda bolečina v kosti ali nezmožnost premikanja (predvsem pri ženskah).
English: Manufacturer Takeda Ireland Limited Bray Business Park Kilruddery
Slovenian: Izdelovalec Takeda Ireland Limited Bray Business Park Kilruddery
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Slovenian: • previdnost pri uporabi pri starostnikih v luči tveganj, povezanih s starostjo (še posebej raka sečnega mehurja, zlomov in srčnega popuščanja).
English: Incresync has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Incresync nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Both of these groups of medicines are “oral anti-diabetics”.
Slovenian: Obe skupini zdravil spadata med “peroralne antidiabetike”.
English: What you need to know before you take Incresync
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Incresync
English: The European Medicines Agency has waived the obligation to submit the results of studies with Incresync in all 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 odstopila od zahteve za predložitev rezultatov študij z zdravilom Incresync za vse podskupine pediatrične populacije pri zdravljenju sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The study demonstrated that alogliptin did not increase the risk of having a MACE compared to placebo [Hazard Ratio: 0.96; 1-sided 99% Confidence Interval: 0-1.16].
Slovenian: Študija je pokazala, da alogliptin ni povečal tveganja za MACE v primerjavi s placebom [razmerje ogroženosti: 0,96; 1-stranski 99 % interval zaupanja: 0-1,16].
English: The effect of Incresync on fertility in humans has not been studied.
Slovenian: Učinek zdravila Incresync na plodnost pri ljudeh ni bil raziskan.
English: The mean serum elimination half-life of unchanged pioglitazone in man is 5 to 6 hours and for its total active metabolites 16 to 23 hours.
Slovenian: Povprečni razpolovni čas izločanja nespremenjenega pioglitazona iz seruma pri človeku znaša 5 do 6 ur, za vse njegove aktivne presnovke pa 16 do 23 ur.
English: When activity, concentrations and protein binding are taken into account, pioglitazone and metabolite M-III contribute equally to efficacy.
Slovenian: Ob upoštevanju aktivnosti, koncentracij in vezave na proteine pioglitazon in presnovek M-III enakovredno prispevata k učinkovitosti.
English: Inhibition of DPP-4 remained above 81% at 24 hours after 14 days of dosing.
Slovenian: Inhibicija DPP-4 je 24 ur po 14-dnevnem odmerjanju ostala nad 81 %.
English: STOP taking Incresync and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: PRENEHAJTE jemati zdravilo Incresync in nemudoma poiščite zdravniško pomoč, če opazite katerega koli od naslednjih resnih neželenih učinkov:
English: It helps your body make better use of the insulin it produces.
Slovenian: Telesu pomaga bolje izkoristiti insulin, ki nastaja v telesu.
English: If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking Incresync.
Slovenian: Če vam je zdravnik povedal, da imate intoleranco za nekatere sladkorje, se pred uporabo tega zdravila Incresync posvetujte s svojim zdravnikom.
English: The efficacy and safety of Incresync as triple therapy with a sulphonylurea has not been established and thus use is not recommended.
Slovenian: Učinkovitosti in varnosti zdravila Incresync pri trotirnem zdravljenju s sulfonilsečnino niso dokazali, zato takšna uporaba ni priporočljiva.
English: (-infinity, -0.28)
Slovenian: (-neskončnost; -0,28)
English: The inter-subject coefficient of variation for alogliptin AUC was small (17%).
Slovenian: Koeficient variacije vrednosti AUC alogliptina med posameznimi osebami je bil majhen (17 %).
English: These effects were independent of pioglitazone's effects on glycaemia and were statistically significantly different to glibenclamide.
Slovenian: Ti učinki so bili neodvisni od učinkov pioglitazona na glikemijo in so se statistično pomembno razlikovali od glibenklamida.
English: This check may be repeated at intervals.
Slovenian: Takšne preiskave bo morda treba opravljati v rednih časovnih presledkih.
English: It is recommended that you carry some sugar lumps, sweets,
Slovenian: Priporočamo, da imate pri sebi nekaj kock sladkorja, sladkarij, piškotov ali sladek sadni sok.
English: Oedema was reported in 6-9% of patients treated with pioglitazone over one year in controlled clinical studies.
Slovenian: O edemih so poročali pri 6-9 % bolnikov, ki so v nadzorovanih kliničnih študijah prejemali pioglitazon več kot eno leto.
English: Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing.
Slovenian: Skupna izpostavljenost (AUC(0-inf)) alogliptinu po prejemu enkratnega odmerka je bila podobna izpostavljenosti med obdobjem prejemanja enega odmerka (AUC(0-24)) po 6 dnevih odmerjanja enkrat na dan.
English: Generally, the effects of alogliptin on body weight and lipids were neutral.
Slovenian: Na splošno so bili učinki alogliptina na telesno maso in lipide nevtralni.
English: Before you start taking this medicine you will have a blood sample taken to check your liver and kidney function.
Slovenian: Pred uvedbo zdravljenja s tem zdravilom boste oddali vzorec krvi, na katerem bodo preverili delovanje jeter in ledvic.
English: However, patients who experience visual disturbance should be cautious when driving or using machines.
Slovenian: Vendar pa morajo biti bolniki z motnjami vida pri vožnji vozil ali upravljanju s stroji previdni.
English: What Incresync is and what it is used for
Slovenian: Kaj je zdravilo Incresync in za kaj ga uporabljamo
English: Liver enzymes should be checked prior to the initiation of therapy in all patients.
Slovenian: Jetrne encime je treba pred začetkom zdravljenja preveriti pri vseh bolnikih.
English: If you are following a diabetic diet, you should continue with this while you are taking Incresync.
Slovenian: Če ste na diabetični dieti, morate z njo med jemanjem zdravila Incresync nadaljevati.
English: Incresync should be taken once daily with or without food.
Slovenian: Zdravilo Incresync je treba jemati enkrat na dan s hrano ali brez nje.
English: It is not known if alogliptin is removed by peritoneal dialysis.
Slovenian: Ni znano, če se alogliptin lahko odstrani s peritonealno dializo.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Incresync therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z zdravilom Incresync, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: (Patients with end-stage renal disease underwent haemodialysis immediately after alogliptin dosing.
Slovenian: (Bolniki s končno ledvično odpovedjo so prejeli hemodializo neposredno po prejemu odmerka alogliptina.
English: • The risk of heart failure and relevant risk minimisation advice.
Slovenian: • tveganje za srčno popuščanje in ustrezen nasvet za zmanjšanje tveganja.
English: No data are available (see section 4.2).
Slovenian: Podatkov ni na voljo (glejte poglavje 4.2).
English: After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Slovenian: Tri do 6 mesecev po uvedbi zdravljenja z zdravilom Incresync je treba bolnike ponovno pregledati in oceniti ustreznost odziva na zdravljenje (npr. znižanje vrednosti HbA1c).
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 60 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet 100 filmsko obloženih tablet
English: - if you are elderly and are taking insulin, because you may have an increased risk of heart problems.
Slovenian: • če ste starostnik in se zdravite z insulinom, saj je v tem primeru tveganje za pojav težav s srcem lahko večje.
English: In some cases, weight increase may be a symptom of cardiac failure, therefore weight should be closely monitored.
Slovenian: V nekaterih primerih je povečanje telesne mase lahko simptom srčnega popuščanja, zato je treba telesno maso skrbno nadzirati.
English: Part of the treatment of diabetes is dietary control.
Slovenian: Del zdravljenja sladkorne bolezni je tudi kontrola telesne mase z dieto.
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Slovenian: Ta večinoma poteka preko citokroma P450 2C8, čeprav so lahko v manjši meri udeležene tudi druge izooblike.
English: Total serum concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Slovenian: Skupna koncentracija pioglitazona v serumu se ne spremeni, volumen porazdelitve pa je večji.
English: Patients should be alerted to the risk of hypoglycaemia when Incresync is used in combination with other anti-diabetic medicinal products known to cause hypoglycaemia.
Slovenian: Bolnike je treba opozoriti na možnost pojava hipoglikemije, če se zdravilo Incresync uporablja v kombinaciji z drugimi antidiabetiki, za katera je znano, da povzročajo hipoglikemijo.
English: You can take this medicine with or without food.
Slovenian: To zdravilo lahko jemljete s hrano ali brez nje.
English: Taking Incresync in combination with other anti-diabetic medicines can cause low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Slovenian: Pri jemanju zdravila Incresync v kombinaciji z drugimi antidiabetiki se lahko vrednost krvnega sladkorja prekomerno zniža (hipoglikemija), kar lahko vpliva na sposobnost za vožnjo vozil in upravljanje s stroji.
English: If you take more tablets than you should, or if someone else or a child takes your medicine, contact or go to your nearest emergency centre straight away.
Slovenian: Če ste vzeli večji odmerek zdravila Incresync, kot bi smeli Če ste vzeli več tablet, kot bi smeli, ali pa je vaše zdravilo vzela druga oseba ali otrok, se nemudoma obrnite na najbližji center za nujno medicinsko pomoč ali se odpravite tja.
English: Effects of other medicinal products on alogliptin
Slovenian: Učinki drugih zdravil na alogliptin
English: This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Slovenian: To izobraževalno gradivo je namenjeno ozaveščanju o pomembnih ugotovljenih tveganjih za rak sečnega mehurja in srčno popuščanje ter o splošnih priporočilih, da bi dosegli najboljše razmerje med koristjo in tveganjem na ravni bolnika.
English: Pioglitazone appears to act via activation of specific nuclear receptors (peroxisome proliferator activated receptor gamma) leading to increased insulin sensitivity of liver, fat and skeletal muscle cells in animals.
Slovenian: Kaže, da pioglitazon deluje preko aktivacije specifičnih jedrnih receptorjev (receptor gama, ki ga aktivira peroksisomski proliferator), kar pri živalih privede do povečane občutljivosti jetrnih, maščobnih in skeletno-mišičnih celic za insulin.
English: Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Slovenian: Velikosti pakiranj: 10, 14, 28, 30, 56, 60, 90, 98 ali 100 filmsko obloženih tablet.