natgillin/translations-raw huggingface dataset:
Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Preglednica 2 Srčno-žilni in ledvični izidi po skupinah zdravljenja v študiji CARMELINA
Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia).
Pri nekaterih simptomih je potrebna takojšnja zdravniška pomoč Zdravilo Trajenta morate prenehati jemati in se nemudoma posvetovati s svojim zdravnikom, če se pojavijo naslednji simptomi znižanega krvnega sladkorja: tresenje, znojenje, tesnoba, meglen vid, mravljinci v predelu ustnic, bledica, sprememba razpoloženja ali zmedenost (hipoglikemija).
Most patients (80.5%) received insulin as background therapy, alone or in combination with other oral anti-diabetics such as sulphonylurea, glinide and pioglitazone.
Večina bolnikov (80,5 %) je za osnovno zdravljenje uporabljala insulin, samostojno ali v kombinaciji z drugimi peroralnimi antidiabetiki, kot so sulfonilsečnina, glinid in pioglitazon.
Taking Trajenta in combination with medicines called sulphonylureas and/or insulin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines or work without safe foothold.
Jemanje zdravila Trajenta v kombinaciji z zdravili, ki se imenujejo sulfonilsečnine in/ali insulin, lahko povzroči prenizko raven krvnega sladkorja (hipoglikemijo), ki lahko vpliva na vašo sposobnost vožnje in upravljanja s stroji ali delo v nevarnem okolju.
It is not known if Trajenta passes into human breast milk.
Ni znano, ali se zdravilo Trajenta izloča v materino mleko.
It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Pomembno je upoštevati nasvet o dieti in telesni aktivnosti, ki ste ga prejeli pri zdravniku ali medicinski sestri.
Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Navedena inkretinska hormona sodelujeta pri fiziološkem uravnavanju homeostaze glukoze.
• Trajenta is available in perforated aluminium/aluminium unit dose blisters.
• Zdravilo Trajenta je na voljo v perforiranih aluminij/aluminij pretisnih omotih za enkratni odmerek.
Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk.
Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje linagliptina oziroma njegovih presnovkov v mleko.
Linagliptin has no or negligible influence on the ability to drive and use machines.
Linagliptin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanjastrojev.
These changes in linagliptin pharmacokinetics were not considered to be clinically relevant.
Opisane spremembe farmakokinetike linagliptina ne veljajo za klinično pomembne.
Do not use Trajenta if the package is damaged or shows signs of tampering.
Ne uporabljajte zdravila Trajenta, če opazite, da je poškodovana ovojnina ali so vidni znaki kvarjenja.
What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
Kaj je zdravilo Trajenta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trajenta Kako jemati zdravilo Trajenta Možni neželeni učinki
If you take more Trajenta than you should
Če ste vzeli večji odmerek zdravila Trajenta, kot bi smeli
The dose of linagliptin is 5 mg once daily.
Odmerek linagliptina je 5 mg enkrat na dan.
Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Linagliptina ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1, prav tako z njim ne smemo zdraviti diabetične ketoacidoze.
If a dose is missed, it should be taken as soon as the patient remembers.
Če na odmerek pozabijo, ga morajo vzeti takoj, ko se spomnijo.
As a precautionary measure, it is preferable to avoid the use of linagliptin during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi linagliptina bolje izogibati.
The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m
Klinična preskušanja, ki so jih opravili pred izdajo dovoljenja za promet, so zajela bolnike z indeksom telesne mase do 40 kg/m
Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Starejši (65 do 80 let, najstarejši bolnik je imel 78 let) in mlajši preizkušanci so imeli primerljive plazemske koncentracije linagliptina.
A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Vaš zdravnik se bo moral odločiti ali boste prekinili z dojenjem ali boste prekinili/prenehali zdravljenje z zdravilom Trajenta.
There was no increased risk in hospitalization for heart failure which was an additional adjudicated endpoint observed compared to usual care without linagliptin in patients with type 2 diabetes (see table 2).
Ni bilo povečanega tveganja za hospitalizacijo zaradi srčnega popuščanja, kar je bil dodatni ugotovljeni izid v primerjavi s standardno terapijo brez jemanja linagliptina pri bolnikih s sladkorno boleznijo tipa 2 (glejte preglednico 2).
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Farmakoterapevtska skupina: zdravila za zdravljenje sladkorne bolezni, zaviralci dipeptidil peptidaze 4 (DPP-4), oznaka ATC: A10BH05
INFORMATION IN BRAILLE Trajenta 5 mg
PODATKI V BRAILLOVI PISAVI Trajenta 5 mg
Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
O pankreatitisu so poročali pogosteje pri bolnikih, razporejenih na linagliptin (7 dogodkov pri 6580 bolnikih, ki so prejemali linagliptin in 2 dogodka pri 4383 bolnikih, ki so prejemali placebo).
Linagliptin is an inhibitor of the enzyme DPP-4 (dipeptidyl peptidase 4, EC 3.4.14.5) an enzyme which is involved in the inactivation of the incretin hormones GLP-1 and GIP (glucagon-like peptide1, glucose-dependent insulinotropic polypeptide).
Linagliptin je zaviralec DPP-4 (dipeptidil peptidaze 4, EC 3.4.14.5), encima, ki sodeluje pri inaktivaciji dveh inkretinskih hormonov GLP-1 in GIP (glukagonu podoben peptid 1, od glukoze odvisni insulinotropni polipeptid).
The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
Nevezane koncentracije, ki so običajno pri terapevtskem odmerjanju linagliptina manjše od 1 %, so se povečale za 4-5-krat po sočasnem dajanju z ritonavirjem.
In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy volunteers.
Poleg tega so bile farmakokinetične značilnosti linagliptina podobne tudi pri zdravih prostovoljcih v študijah I. faze, ki so zajele Japonce, Kitajce in belce.
You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Priporočamo vam, da upoštevate priporočila o negi kože in stopal, ki ste jih prejeli od zdravnika ali medicinske sestre.
• are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
• jemljete antidiabetik sulfonilsečnino (npr. glimepirid, glipizid), vam bo zdravnik mogoče znižal odmerek sulfonilsečnine, če jo boste jemali hkrati z zdravilom Trajenta, da bi tako preprečil, da bi se raven krvnega sladkorja preveč znižala;
The reductions in glycosylated haemoglobin A1c (HbA1c) were similar across different subgroups including gender, age, renal impairment and body mass index (BMI).
Raven glikiranega hemoglobina A1c (HbA1c) se je podobno znižala v različnih podskupinah (razvrščenih po spolu, starosti, ledvični okvari in indeksu telesne mase).
Based on these results and in vivo interaction studies, linagliptin is considered unlikely to cause interactions with other P-gp substrates.
Na podlagi teh izsledkov in podatkov študij o medsebojnem delovanju in vivo ni verjetno, da bi linagliptin povzročal interakcije z drugimi substrati P-glikoproteina.
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.
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.
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.
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.
If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is confirmed, Trajenta should not be restarted.
Pri sumu na pankreatitis je treba zdravljenje z zdravilom Trajenta prekiniti; če je akutni pankreatitis potrjen, zdravljenja z zdravilom Trajenta ni dovoljeno nadaljevati.
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Podatki farmakokinetičnih študij kažejo, da prilagajanje odmerka bolnikom z jetrno okvaro ni potrebno, vendar z uporabo zdravila pri teh bolnikih ni kliničnih izkušenj.
The observed incidence of hypoglycaemia in patients treated with linagliptin was similar to placebo (22.2% linagliptin; 21.2% placebo).
Pojavnost hipoglikemije pri z linagliptinom zdravljenih bolnikih je bila podobna kot pri placebu (22,2 % linagliptin; 21,2 % placebo).
Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Nekateri bolniki so imeli med jemanjem zdravila Trajenta, samega ali v kombinaciji z drugimi zdravili za zdravljenje sladkorne bolezni, naslednje neželene učinke:
The intra-subject and inter-subject coefficients of variation for linagliptin AUC were small (12.6% and 28.5%, respectively).
Koeficienti variacije AUC linagliptina med preizkušanci in pri posameznem preizkušancu so bili majhni (12,6 % oziroma 28,5 %).
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.
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.
This is an antibiotic used to treat infections such as tuberculosis.
• rifampicin, ki je antibiotik za zdravljenje okužb, na primer tuberkuloze.
Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
Zdravnik vam lahko predpiše jemanje zdravila Trajenta hkrati z drugim peroralnim antidiabetikom.
If you forget to take Trajenta
Če ste pozabili vzeti zdravilo Trajenta
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).
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).
If you stop taking Trajenta
Če ste prenehali jemati zdravilo Trajenta
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).
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.
Metabolism and nutrition disorders Hypoglycaemia very common
Presnovne in prehranske motnje hipoglikemija zelo pogosto
However patients should be alerted to the risk of hypoglycaemia especially when combined with sulphonylurea and/or insulin.
Vendar pa je treba bolnike opozoriti na tveganje za pojav hipoglikemije, še posebej pri kombinaciji s sulfonilsečnino in/ali insulinom.
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.
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.
Trajenta may be used together with other anti-diabetic medicines e.g. metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin, or insulin.
Zdravilo Trajenta lahko uporabljate hkrati z drugimi antidiabetiki, npr.metforminom, sulfonilsečnino (npr. glimepiridom, glipizidom), empagliflozinom ali insulinom.
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%
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.
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.
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.
The recommended dose of Trajenta is one 5 mg tablet once a day.
Priporočeni odmerek zdravila Trajenta je ena tableta po 5 mg enkrat na dan.
* 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
* 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
Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Zato niso verjetne klinično pomembne interakcije z drugimi zaviralci P-glikoproteina ali CYP3A4.
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.
Simulacije plazemske koncentracije linagliptina v stanju dinamičnega ravnovesja ob prisotnosti ritonavirja in brez njega so pokazale, da povečane izpostavljenosti ne spremlja povečano kopičenje.
Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Preglednica 3 Pomembni neželeni srčno-žilni dogodki (MACE) in umrljivost po skupinah zdravljenja v študiji CAROLINA
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.
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.
The effective half-life for accumulation of linagliptin, as determined from oral administration of multiple doses of 5 mg linagliptin, is approximately 12 hours.
Efektivni razpolovni čas za kopičenje linagliptina, določen pri peroralnem dajanju večkratnih odmerkov po 5 mg, je približno 12 ur.
Glimepiride (1-4mg)
linagliptin 5 mg glimepiridin (1-4 mg)
Trajenta contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”.
Zdravilo Trajenta vsebuje zdravilno učinkovino linagliptin iz skupine zdravil, ki jih imenujemo »peroralni antidiabetiki«.
Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Linagliptin je v enem odmerku na dan klinično pomembno izboljšal urejenost glikemije, ne da bi povzročil klinično pomembno spremembo telesne mase.
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.
V nadzorovanih kliničnih preskušanjih so zdravi preizkušanci na splošno dobro prenašali enkratne odmerke do 600 mg linagliptina (kar ustreza 120-kratnemu priporočenemu odmerku).
Strong pseudo-allergic reactions were observed in dogs at medium doses, secondarily causing cardiovascular changes, which were considered dog-specific.
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.
8 mm diameter round, light red film-coated tablet debossed with "D5" on one side and the Boehringer Ingelheim logo on the other.
Okrogla, svetlo rdeča filmsko obložena tableta s premerom 8 mm, z oznako ''D5'' na eni in logotipom Boehringer Ingelheim na drugi strani.
There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
V 40-tedenskem obdobju sledenja je bilo dovoljeno prilagajanje odmerkov zdravil za osnovno zdravljenje sladkorne bolezni.
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.
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.
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.
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.
At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Pri izpostavljenosti, ki je več kot 100-krat presegala tisto za človeka, je bil glavni izvid v teh opisih dražeč učinek v želodcu.
What Trajenta looks like and contents of the pack
Izgled zdravila Trajenta in vsebina pakiranja
When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
Kadar se linagliptin doda k metforminu, ostane odmerjanje metformina nespremenjeno, linagliptin pa se daje sočasno.
Driving and using machines Trajenta has no or negligible influence on the ability to drive and use machines.
Zdravilo Trajenta nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Linagliptin glucose-dependently increases insulin secretion and lowers glucagon secretion thus resulting in an overall improvement in the glucose homeostasis.
Linagliptin odvisno od ravni glukoze poveča izločanje insulina in zmanjša izločanje glukagona ter tako izboljša skupno homeostazo glukoze.
- 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
- 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.
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).
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).
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.
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.
• 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).
• 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;
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.
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.
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.
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.
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%.
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 %.