FrancophonIA/ELRC3.0 huggingface dataset:
English: At high concentrations, where DPP-4 is fully saturated, 70-80% of linagliptin was bound to other plasma proteins than DPP-4, hence 30-20% were unbound in plasma.
Slovenian: Pri veliki koncentraciji, pri kateri je DPP-4 povsem zasičen, se je 70 do 80 % linagliptina vezalo še na druge beljakovine v plazmi poleg DPP-4, zato ga je bilo 30 do 20 % nevezanega v plazmi.
English: Race had no obvious effect on the plasma concentrations of linagliptin based on a composite analysis of available pharmacokinetic data, including patients of Caucasian, Hispanic, African, and Asian origin.
Slovenian: Rasa ni zaznavno vplivala na njegovo koncentracijo v plazmi, kar je pokazala sestavljena analiza razpoložljivih farmakokinetičnih podatkov, ki je zajela bolnike bele rase ter latinskoameriškega, afriškega in azijskega izvora.
English: If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is confirmed, Trajenta should not be restarted.
Slovenian: Pri sumu na pankreatitis je treba zdravljenje z zdravilom Trajenta prekiniti; če je akutni pankreatitis potrjen, zdravljenja z zdravilom Trajenta ni dovoljeno nadaljevati.
English: Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Slovenian: Podatki farmakokinetičnih študij kažejo, da prilagajanje odmerka bolnikom z jetrno okvaro ni potrebno, vendar z uporabo zdravila pri teh bolnikih ni kliničnih izkušenj.
English: The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Slovenian: Pojavnost hipoglikemije pri z linagliptinom zdravljenih bolnikih je bila podobna kot pri placebu (22,2 % linagliptin; 21,2 % placebo).
English: Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Slovenian: Nekateri bolniki so imeli med jemanjem zdravila Trajenta, samega ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, naslednje neželene učinke:
English: The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6% and 28.5%, respectively).
Slovenian: Koeficienti variacije AUC linagliptina med preizkušanci in pri posameznem preizkušancu so bili majhni (12,6 % oziroma 28,5 %).
English: Hypoglycaemia (frequency: very common, may affect more than 1 in 10 people) is an identified side effect when Trajenta is taken together with metformin and a sulphonylurea.
Slovenian: Hipoglikemija (pogostnost: zelo pogosti, pojavijo se lahko pri več kot 1 od 10 bolnikov) je prepoznani neželeni učinek, kadar se zdravilo Trajenta jemlje skupaj z metforminom in sulfonilsečnino.
English: This is an antibiotic used to treat infections such as tuberculosis.
Slovenian: • rifampicin, ki je antibiotik za zdravljenje okužb, na primer tuberkuloze.
English: Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
Slovenian: Zdravnik vam lahko predpiše jemanje zdravila Trajenta hkrati z drugim peroralnim antidiabetikom.
English: If you forget to take Trajenta
Slovenian: Če ste pozabili vzeti zdravilo Trajenta
English: A significantly higher incidence of malignant lymphomas only in female mice at the highest dose (> 200 times human exposure) is not considered relevant for humans (explanation: nontreatment related but due to highly variable background incidence).
Slovenian: Pomembno večja pojavnost malignih limfomov, ki so jo odkrili samo pri mišjih samicah, katere so prejemale največje odmerke (več kot 200-krat večje kot za človeka), pa ni pomembna za ljudi (pojasnilo: pojavnost ni bila povezana z zdravljenjem, temveč z močno spremenljivo osnovno pojavnostjo).
English: If you stop taking Trajenta
Slovenian: Če ste prenehali jemati zdravilo Trajenta
English: In clinical studies, as described below, linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives providing in vivo evidence of a low propensity for causing medicinal product interactions with substrates of CYP3A4, CYP2C9, CYP2C8, P-glycoprotein, and organic cationic transporter (OCT).
Slovenian: V opisanih kliničnih študijah linagliptin ni klinično pomembno vplival na farmakokinetiko metformina, gliburida, simvastatina, varfarina, digoksina ali peroralnih kontraceptivov, kar je kazalec in vivo, da je možnost povzročanja interakcij zdravila s substrati encimov CYP3A4, CYP2C9, CYP2C8, P-glikoproteina in organskih kationskih prenašalcev (OCT - organic cationic transporter) majhna.
English: Metabolism and nutrition disorders Hypoglycaemia very common
Slovenian: Presnovne in prehranske motnje hipoglikemija zelo pogosto
English: However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin.
Slovenian: Vendar pa je treba bolnike opozoriti na tveganje za pojav hipoglikemije, še posebej pri kombinaciji s sulfonilsečnino in/ali insulinom.
English: Due to the concentration dependent binding of linagliptin to DPP-4, the pharmacokinetics of linagliptin based on total exposure is not linear; indeed total plasma AUC of linagliptin increased in a less than dose-proportional manner while unbound AUC increases in a roughly dose-proportional manner.
Slovenian: Zaradi koncentracijsko odvisne vezave linagliptina na DPP-4 farmakokinetika linagliptina na osnovi celotne izpostavitve ni linearna; celokupni AUC linagliptina v plazmi se je povečeval manj kot bi sicer bilo sorazmerno z odmerkom medtem ko se AUC nevezane učinkovine povečuje rahlo sorazmerno z odmerkom.
English: Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
Slovenian: Zdravilo Trajenta lahko uporabljate hkrati z drugimi antidiabetiki, npr.metforminom, sulfonilsečnino (npr. glimepiridom, glipizidom), empagliflozinom ali insulinom.
English: Approximately 19% of the population had eGFR ≥45 to <60 mL/min/1.73 m2, 28% of the population had eGFR ≥30 to <45 mL/min/1.73 m2 and 15%
Slovenian: Približno 19 % populacije je imelo oGFR med ≥ 45 in < 60 ml/min/1,73 m2, 28 % populacije je imelo oGFR med ≥ 30 in < 45 ml/min/1,73 m oGFR pri 15 % populacije pa je znašal < 30 ml/min/1,73 m2.
English: As a result of tissue binding, the mean apparent volume of distribution at steady-state following a single 5 mg intravenous dose of linagliptin to healthy subjects is approximately 1,110 litres, indicating that linagliptin extensively distributes to the tissues.
Slovenian: Zaradi tkivne vezave je sredni navidezni volumen porazdelitve v stanju dinamičnega ravnovesja po intravenskem odmerku po 5 mg linagliptina pri zdravih preizkušancih približno 1.110 litrov, kar kaže, da se linagliptin obsežno porazdeli v tkiva.
English: The recommended dose of Trajenta is one 5 mg tablet once a day.
Slovenian: Priporočeni odmerek zdravila Trajenta je ena tableta po 5 mg enkrat na dan.
English: * Based on post-marketing experience ** Based on lipase elevations >3xULN observed in clinical trials Based on Linagliptin cardiovascular and renal safety study (CARMELINA), see also below Adverse reaction observed in combination with metformin plus sulphonylurea
Slovenian: * Na podlagi izkušenj po začetku trženja ** Na podlagi povečanja ravni lipaze > 3xULN, opaženo pri kliničnih preskušanjih Na podlagi Študije o srčno-žilni in ledvični varnosti linagliptina (CARMELINA), glejte spodaj Neželeni učinek opažen v kombinaciji z metforminom in sulfonilsečnino Neželeni učinek opažen v kombinaciji z insulinom
English: Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Slovenian: Zato niso verjetne klinično pomembne interakcije z drugimi zaviralci P-glikoproteina ali CYP3A4.
English: Simulations of steady-state plasma concentrations of linagliptin with and without ritonavir indicated that the increase in exposure will be not associated with an increased accumulation.
Slovenian: Simulacije plazemske koncentracije linagliptina v stanju dinamičnega ravnovesja ob prisotnosti ritonavirja in brez njega so pokazale, da povečane izpostavljenosti ne spremlja povečano kopičenje.
English: Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Slovenian: Preglednica 3 Pomembni neželeni srčno-žilni dogodki (MACE) in umrljivost po skupinah zdravljenja v študiji CAROLINA
English: Trajenta is used for ‘type 2 diabetes' in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone.
Slovenian: Zdravilo Trajenta je zdravilo za zdravljenje sladkorne bolezni tipa 2 pri odraslih bolnikih, kadar je ni možno ustrezno urediti z enim peroralnim antidiabetikom (metforminom ali sulfonilsečnino) ali dieto in telesno aktivnostjo.
English: The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of 5 mg linagliptin, is approximately 12 hours.
Slovenian: Efektivni razpolovni čas za kopičenje linagliptina, določen pri peroralnem dajanju večkratnih odmerkov po 5 mg, je približno 12 ur.
English: Glimepiride (1-4mg)
Slovenian: linagliptin 5 mg glimepiridin (1-4 mg)
English: Trajenta contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”.
Slovenian: Zdravilo Trajenta vsebuje zdravilno učinkovino linagliptin iz skupine zdravil, ki jih imenujemo »peroralni antidiabetiki«.
English: Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Slovenian: Linagliptin je v enem odmerku na dan klinično pomembno izboljšal urejenost glikemije, ne da bi povzročil klinično pomembno spremembo telesne mase.
English: During controlled clinical trials in healthy subjects, single doses of up to 600 mg linagliptin (equivalent to 120 times the recommended dose) were generally well tolerated.
Slovenian: V nadzorovanih kliničnih preskušanjih so zdravi preizkušanci na splošno dobro prenašali enkratne odmerke do 600 mg linagliptina (kar ustreza 120-kratnemu priporočenemu odmerku).
English: Strong pseudo-allergic reactions were observed in dogs at medium doses, secondarily causing cardiovascular changes, which were considered dog-specific.
Slovenian: Pri psih so po dajanju srednje velikih odmerkov opazili izrazite psevdoalergijske reakcije s sekundarnimi učinki na srce in žilje, ki so veljale za specifične reakcije pri psih.
English: 8 mm diameter round, light red film-coated tablet debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Slovenian: Okrogla, svetlo rdeča filmsko obložena tableta s premerom 8 mm, z oznako ''D5'' na eni in logotipom Boehringer Ingelheim na drugi strani.
English: There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
Slovenian: V 40-tedenskem obdobju sledenja je bilo dovoljeno prilagajanje odmerkov zdravil za osnovno zdravljenje sladkorne bolezni.
English: The study population included 2089 (35%) patients with cardiovascular disease and 1130 (19%) patients with renal impairment with an eGFR < 60ml/min/1.73m2 at baseline.
Slovenian: Študijska populacija je vključevala 2089 (35 %) bolnikov s srčno-žilno boleznijo in 1.130 (19 %) bolnikov z ledvično okvaro, ki so imeli izhodiščni eGFR < 60 ml/min/1,73 m2.
English: Plasma protein binding of linagliptin is concentration-dependent, decreasing from about 99% at 1 nmol/l to 75-89% at ≥30 nmol/l, reflecting saturation of binding to DPP-4 with increasing concentration of linagliptin.
Slovenian: Vezava linagliptina na beljakovine v plazmi je odvisna od koncentracije in se zmanjša od približno 99 % pri 1 nmol/l na 75 do 89 % pri 30 nmol/l ali več, kar priča o zasičenosti vezave na DPP-4 pri večanju koncentracije linagliptina.
English: At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Slovenian: Pri izpostavljenosti, ki je več kot 100-krat presegala tisto za človeka, je bil glavni izvid v teh opisih dražeč učinek v želodcu.
English: What Trajenta looks like and contents of the pack
Slovenian: Izgled zdravila Trajenta in vsebina pakiranja
English: When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
Slovenian: Kadar se linagliptin doda k metforminu, ostane odmerjanje metformina nespremenjeno, linagliptin pa se daje sočasno.
English: Driving and using machines Trajenta has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Trajenta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homeostasis.
Slovenian: Linagliptin odvisno od ravni glukoze poveča izločanje insulina in zmanjša izločanje glukagona ter tako izboljša skupno homeostazo glukoze.
English: - monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add on to metformin and empagliflozin - add-on to insulin with or without metformin
Slovenian: - v kratkotrajni monoterapiji, do 4 tedne, - v monoterapiji, ki je trajala 12 tednov ali več, - dodatno ob metforminu, - dodatno ob metforminu in sulfonilsečnini, - dodatno ob metforminu in empagliflozinu, - dodatno ob insulinu z metforminom ali brez njega.
English: Some patients experienced rash (frequency uncommon), hives (urticaria; frequency rare, may affect up to 1 in 1000 people), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing (angioedema; frequency rare).
Slovenian: Pri nekaterih bolnikih so se pojavili izpuščaj (pogostnost občasna), koprivnica (urtikarija; pogostnost redka, pojavi se lahko pri največ 1 od 1000 bolnikov) in otekanje obraza, ustnic, jezika in žrela, ki lahko povzročijo težave pri dihanju ali požiranju (angioedem; pogostnost redka).
English: Plasma concentrations of linagliptin decline in a triphasic manner with a long terminal half-life (terminal half-life for linagliptin more than 100 hours), that is mostly related to the saturable, tight binding of linagliptin to DPP-4 and does not contribute to the accumulation of the medicinal product.
Slovenian: Plazemska koncentracija linagliptina se manjša v treh fazah in z dolgim končnim razpolovnim časom (ki za to zdravilo znaša več kot 100 ur), ki je pretežno posledica nasičene, tesne vezave linagliptina na DPP-4 in ne povečuje kopičenja zdravila.
English: • 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: • imate sladkorno bolezen tipa 1 (v vašem telesu ne nastaja insulin) ali diabetično ketoacidozo (zaplet pri sladkorni bolezni z visoko ravnijo krvnega sladkorja, hitrim hujšanjem, slabostjo ali bruhanjem), za njihovo zdravljenje ne smete uporabljati zdravila Trajenta;
English: The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to <80 ml/min), moderate (30 to <50 ml/min), and severe (<30 ml/min), as well as patients with ESRD on hemodialysis.
Slovenian: Študija je zajela bolnike, pri katerih so ledvično odpoved na podlagi kreatininskega očistka opredelili kot blago (50 do < 80 ml/min), zmerno (30 do < 50 ml/min) in hudo (< 30 ml/min) ter bolnike s končno ledvično odpovedjo na hemodializi.
English: After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Slovenian: Po mediani spremljanja 2,2 leti, linagliptin ni povečal tveganja za hude neželene srčno-žilne dogodke ali ledvične izide, kadar je bil dodan standarni terapiji.
English: Following administration of a supratherapeutic dose of 10 mg linagliptin concomitantly with 40 mg of simvastatin daily for 6 days, the plasma AUC of simvastatin was increased by 34%, and the plasma Cmax by 10%.
Slovenian: Po 6-dnevnem sočasnem dajanju supraterapevtskega odmerka linagliptina po 10 mg in 40 mg simvastatina na dan se je AUC simvastatina v plazmi povečala za 34 %, njegova Cmax v plazmi pa za 10 %.
English: When linagliptin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin, may be considered to reduce the risk of hypoglycaemia (see section 4.4)
Slovenian: Če se bolnik zdravi z linagliptinom v kombinaciji s sulfonilsečnino ali insulinom, bo morda treba zmanjšati odmerek sulfonilsečnine ali insulina, da bi zmanjšali tveganje hipoglikemije (glejte poglavje 4.4).
English: In addition patients with T2DM and severe renal impairment (<30 ml/min) were compared to T2DM patients with normal renal function.
Slovenian: Poleg tega so bolnike s sladkorno boleznijo tipa 2 in hudo ledvično okvaro (< 30 ml/min) primerjali z bolniki s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic.
English: However, more frequent blood glucose testing might be recommended to minimise the risk for hypoglycaemia, especially when Trajenta is combined with sulphonylurea and/or insulin.
Slovenian: Morda vam bodo priporočili pogostejše merjenje ravni krvnega sladkorja, da bi zmanjšali tveganje za nastanek hipoglikemije, zlasti kadar se zdravilo Trajenta jemlje skupaj s sulfonilsečnino in/ali insulinom.
English: Liver, kidneys and gastrointestinal tract are the principal target organs of toxicity in mice and rats at repeat doses of linagliptin of more than 300 times the human exposure.
Slovenian: Jetra, ledvice in prebavila so glavni ciljni organi za toksičnost pri miših in podganah pri ponavljajočem odmerjanju linagliptina z več kot 300-krat večjo izpostavljenostjo kot pri človeku.
English: • Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
Slovenian: • Občasni: vnetje nosu ali grla (nazofaringitis), kašelj, zaprtje (v kombinaciji z insulinom),
English: After oral administration of a 5 mg dose to healthy volunteers or patients, linagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1.5 hours post-dose.
Slovenian: Po peroralnem dajanju odmerka po 5 mg se je linagliptin pri zdravih prostovoljcih ali bolnikih hitro absorbiral in dosegel največjo plazemsko koncentracijo (mediani Tmax) 1,5 ure po odmerku.
English: Patients treated with linagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glimepiride (-1.39 vs +1.29 kg).
Slovenian: Pri z linagliptinom zdravljenih bolnikih se je telesna masa v primerjavi z izhodiščnim stanjem pomembno zmanjšala, medtem ko se je pri bolnikih, ki so jemali glimepirid, pomembno povečala (-1,39 v primerjavi s +1,29 kg).
English: • when metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.
Slovenian: • kadar metformin ni primerno zdravilo, ker ga bolniki ne prenašajo ali je kontraindiciran zaradi ledvične okvare; kombinirano zdravljenje
English: After once daily dosing of 5 mg linagliptin, steady-state plasma concentrations are reached by the third dose.
Slovenian: Pri dajanju po 5 mg linagliptina enkrat na dan je plazemska koncentracija v stanju dinamičnega ravnovesja dosežena do tretjega odmerka.
English: How to take Trajenta
Slovenian: Kako jemati zdravilo Trajenta
English: Due to the impact of the background therapy on adverse reactions (e.g. on hypoglycaemias), adverse reactions were analysed based on the respective treatment regimens (monotherapy, add-on to metformin, add-on to meformin plus sulphonylurea, and add-on to insulin).
Slovenian: Zaradi vpliva osnovnega zdravljenja na neželene učinke (npr. hipoglikemije) so jih analizirali posebej za različne režime zdravljenja (kot so monoterapija, dodatno dajanje ob metforminu, dodatno ob metforminu in sulfonilsečnini in dodatno ob insulinu).
English: No studies on the effect on human fertility have been conducted for linagliptin.
Slovenian: Z linagliptinom niso izvedli študij o učinku na plodnost pri človeku.
English: Co-administration of a high-fat meal with linagliptin prolonged the time to reach Cmax by 2 hours and lowered Cmax by 15% but no influence on AUC 0-72h was observed.
Slovenian: Pri sočasnem obroku z veliko vsebnostjo maščob se je čas do dosežene Cmax podaljšal za dve uri, vrednost Cmax pa je bila za 15 % manjša, kar pa ni vplivalo na AUC0-72h.
English: The pack sizes are 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 and 120 x 1 tablets.
Slovenian: Velikosti pakiranja so 10 x 1, 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1, 100 x 1 in 120 x 1 tablet.
English: In rats effects on reproductive organs, thyroid and the lymphoid organs were seen at more than 1,500 times human exposure.
Slovenian: Pri podganah so odkrili učinkovanje na reproduktivne organe, ščitnico in limfne organe pri izpostavljenosti, ki je bila več kot 1.500-krat večja od izpostavljenosti pri človeku.
English: Trajenta is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control as: monotherapy
Slovenian: Zdravilo Trajenta je indicirano za zdravljenje odraslih bolnikov s sladkorno boleznijo tipa 2 kot dodatek k dieti in telesni aktivnosti za izboljšanje urejenosti glikemije, kot: samostojno zdravljenje
English: 10 x 1 film-coated tablets 14 x 1 film-coated tablets 28 x 1 film-coated tablets 30 x 1 film-coated tablets 56 x 1 film-coated tablets 60 x 1 film-coated tablets 84 x 1 film-coated tablets 90 x 1 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 120 x 1 film-coated tablets
Slovenian: 10 x 1 filmsko obloženih tablet 14 x 1 filmsko obloženih tablet 28 x 1 filmsko obloženih tablet 30 x 1 filmsko obloženih tablet 56 x 1 filmsko obloženih tablet 60 x 1 filmsko obloženih tablet 84 x 1 filmsko obloženih tablet 90 x 1 filmsko obloženih tablet 98 x 1 filmsko obloženih tablet 100 x 1 filmsko obloženih tablet 120 x 1 filmsko obloženih tablet
English: Patients received metformin and/or sulphonylurea and/or insulin as background therapy.
Slovenian: Bolniki so za osnovno zdravljenje uporabljali metformin in/ali sulfonilsečnino in/ali insulin.
English: Discontinuation of therapy due to adverse events was higher in patients who received placebo as compared to linagliptin 5 mg (4.3% versus 3.4%).
Slovenian: Ukinitev zdravljenja zaradi neželenih učinkov je bilo več pri bolnikih, ki so jemali placebo, kot pri tistih, ki so jemali linagliptin po 5 mg (4,3 % v primerjavi s 3,4 %).
English: The placebo-controlled studies included studies where linagliptin was given as
Slovenian: V s placebom nadzorovanih študijah so linagliptin uporabili:
English: Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received 5 mg linagliptin in double-blind studies as monotherapy or as add-on therapy are presented in the table below (see table 1).
Slovenian: Neželeni učinki, razvrščeni po organskih sistemih in navedeni po izrazih MedDRA, o katerih so poročali pri bolnikih, ki so jemali po 5 mg linagliptina v dvojno slepih študijah samostojno ali kot dodatno zdravilo, so navedeni v spodnji preglednici (glejte preglednico 1).
English: When linagliptin was added to a sulphonylurea (on a background of metformin), the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Slovenian: Po dodajanju linagliptina k sulfonilsečnini (ob osnovnem zdravljenju z metforminom) je bila pojavnost hipoglikemije večja kot pri placebu (glejte poglavje 4.8).
English: C] linagliptin oral 10 mg dose, approximately 5% of the radioactivity was excreted in urine.
Slovenian: C]linagliptina se je približno 5 % radioaktivnosti izločilo s sečem.