FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased blood potassium levels, anxiety fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain; increased blood uric acid levels.
Slovenian: Menej časté vedľajšie účinky (môžu postihovať menej ako 1 zo 100 osôb): znížené hladiny draslíka v krvi, úzkosť, mdloba (náhle prechodné bezvedomie), pocit brnenia, mravčenia a pichania (parestézia), pocit závratu (vertigo), rýchly tep srdca (tachykardia), poruchy srdcového rytmu, nízky tlak krvi, náhly pokles tlaku krvi pri vstávaní, skrátený dych (dýchavičnosť), hnačka, sucho v ústach, plynatosť, bolesť chrbta, svalové kŕče, bolesť svalov, erektilná dysfunkcia (neschopnosť mať alebo udržať erekciu), bolesť v hrudníku a zvýšené hladiny kyseliny močovej v krvi.
English: Marketing Authorisation Holder Bayer AG
Slovenian: DRŽITEĽ ROZHODNUTIA O REGISTRÁCII Bayer AG
English: MARKETING AUTHORISATION HOLDER Bayer AG
Slovenian: Držiteľ rozhodnutia o registrácii Bayer AG
English: This can lead to permanent vision impairment, if not treated.
Slovenian: Ak sa neliečia, môžu viesť k trvalému poškodeniu zraku.
English: Kinzalkomb is available in blisters packs containing 14, 28, 56, or 98 tablets, or unit dose blister packs containing 28 x 1 tablets.
Slovenian: Kinzalkomb sa dodáva v blistroch obsahujúcich 14, 28, 56, 98 tabliet alebo v blistroch s jednotlivými dávkami, ktoré obsahujú 28 x 1 tabletu.
English: Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Slovenian: Kinzalkomb 80 mg/12,5 mg tablety sú červeno-biele, dvojvrstvové oválne tablety s vyrytým logom spoločnosti a kódom 'H8'.
English: Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.
Slovenian: precitlivenosť, anafylaktická reakcia, lieková vyrážka), nízka hladina cukru v krvi (u diabetických pacientov), žalúdočné ťažkosti, ekzém (ochorenie kože), artróza, zápal šliach, znížený hemoglobín (krvná bielkovina), ospalosť.
English: Talk to your doctor before taking Kinzalkomb:
Slovenian: Predtým, ako začnete užívať Kinzalkomb, obráťte sa na svojho lekára:
English: Jaundice hepatocellular, jaundice cholestatic Skin and subcutaneous tissue disorders Not known:
Slovenian: Poruchy kože a podkožného tkaniva Neznáme:
English: Yellow ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Slovenian: Sodná soľ karboxymetylškrobu (typ A) Sorbitol (E420)
English: Kinzalkomb 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number 'H4'.
Slovenian: Kinzalkomb 40 mg/12,5 mg tablety sú červeno-biele, dvojvrstvové oválne tablety s vyrytým logom spoločnosti a kódom 'H4'.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
Slovenian: NÁZOV LIEKU Kinzalkomb 80 mg/25 mg tablety telmisartan/hydrochlorotiazid
English: - Hypercalcaemia
Slovenian: - Hyperkalciémia
English: Erectile dysfunction General disorders and administration site conditions Uncommon: Rare:
Slovenian: Celkové poruchy a reakcie v mieste podania Menej časté: Zriedkavé:
English: Hypomagnesaemia
Slovenian: Hypomagneziémia
English: Vascular disorders Not known:
Slovenian: Poruchy ciev Neznáme:
English: Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Slovenian: Červený oxid železitý (E172) Hydroxid sodný
English: Hypercalcaemia
Slovenian: Hyperkaliémia
English: - Hypomagnesaemia
Slovenian: - Hypomagneziémia
English: Exacerbation or activation of systemic lupus erythematosus Metabolism and nutrition disorders Uncommon: Rare:
Slovenian: Exacerbácia alebo aktivácia systémového lupus erythematosus
English: Pressor amines (e.g. noradrenaline)
Slovenian: noradrenalín)
English: Presumably through blockade of the reninangiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Slovenian: Súbežné podávanie s telmisartanom vedie k zvráteniu straty draslíka spojenej s týmito diuretikami, a to pravdepodobne v dôsledku inhibície systému renínangiotenzín-aldosterón.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 40 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
English: Nephritis interstitial, renal dysfunction, glycosuria General disorders and administration site conditions Not known:
Slovenian: Intersticiálna nefritída, dysfunkcia obličiek, glykozúria
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: ČÍSLO VÝROBNEJ ŠARŽE
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Slovenian: LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 80 mg telmisartanu a 25 mg hydrochlorotiazidu.
English: Hepatic impairment
Slovenian: Nekrotizujúca vaskulitída
English: 6.3 Shelf life
Slovenian: 6.3 Čas použiteľnosti
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovenian: LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 80 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
English: Nausea
Slovenian: Závrat
English: - class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
Slovenian: bepridil, cisaprid, difemanil, erytromycín i.v., halofantrín, mizolastín, pentamidín, sparfloxacín, terfenadín, vinkamín i. v.).
English: Hypersensitivity, anaphylactic reactions Metabolism and nutrition disorders Uncommon: Rare:
Slovenian: Poruchy metabolizmu a výživy Menej časté:
English: Dizziness
Slovenian: Nepokoj
English: Psychiatric disorders Uncommon:
Slovenian: Psychické poruchy Menej časté:
English: Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb Reproductive system and breast disorders Uncommon:
Slovenian: Bolesť chrbta, svalové kŕče, myalgia Bolesť kĺbov, ochromenie svalov, bolesť v končatinách
English: Excretion Following administration of an oral [
Slovenian: Izločanje Po dajanju peroralnega odmerka [
English: Never take two doses on the same day.
Slovenian: Nikoli ne vzemite isti dan dveh odmerkov.
English: • have or have had a disease of the pancreas.
Slovenian: • imate ali ste imeli bolezen trebušne slinavke.
English: The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Slovenian: Varnost in učinkovitost linagliptina pri otrocih in mladostnikih še nista bili dokazani.
English: • have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
Slovenian: • ste imeli alergijske reakcije na nekatera druga zdravila, ki jih jemljete za urejanje količine sladkorja v krvi.
English: This was achieved with a stable insulin dose (40.1 IU).
Slovenian: Ta izid je bil dosežen ob stabilnem odmerku insulina (40,1 i.e.).
English: Children and adolescents Trajenta is not recommended for children and adolescents under 18 years.
Slovenian: Zdravilo Trajenta ni primerno za otroke in mladostnike, mlajše od 18 let.
English: Effects on plasma lipids were negligible.
Slovenian: Učinki na lipide v plazmi so bili zanemarljivi.
English: They work by helping the body reduce the level of sugar in your blood.
Slovenian: Delujejo tako, da telesu pomagajo znižati raven sladkorja v krvi.
English: The tablets can be taken with or without a meal at any time of the day.
Slovenian: Tablete lahko bolniki jemljejo s hrano ali brez nje ob kateri koli uri dneva.
English: A double dose should not be taken on the same day.
Slovenian: Isti dan ne smejo vzeti dvojnega odmerka.
English: There was no difference between groups in severe hypoglycaemic events.
Slovenian: Med skupinama ni bilo razlik v pojavnosti hudih hipoglikemičnih dogodkov.
English: If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
Slovenian: Če imate simptome akutnega pankreatitisa, kot je persistentna, huda bolečina v trebuhu, se posvetujte z zdravnikom.
English: Therefore, it is preferable to avoid using Trajenta if you are pregnant.
Slovenian: Zato je priporočljivo, da zdravila Trajenta ne uporabljate, če ste noseči.
English: Doses of background antidiabetic medicinal products were kept stable during the first 12 weeks, after which adjustments were permitted.
Slovenian: Prvih 12 tednov so bili odmerki osnovnih antidiabetikov stabilni, nato so bila dovoljena prilagajanja.
English: In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Slovenian: Še zlasti pomembno je, da zdravniku poveste, če uporabljate zdravila, ki vsebujejo katero od naštetih zdravilnih učinkovin:
English: What Trajenta is and what it is used for
Slovenian: Kaj je zdravilo Trajenta in za kaj ga uporabljamo
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) or not known (cannot be estimated from the available data).
Slovenian: Po pogostnosti so opredeljeni 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) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: However, if it is nearly time for the next dose, skip the missed dose.
Slovenian: Če je blizu čas za naslednji odmerek, pozabljenega izpustite.
English: STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:
Slovenian: Takoj PRENEHAJTE jemati zdravilo Trajenta in se posvetujte z zdravnikom, če opazite katerega od naslednjih resnih neželenih učinkov:
English: • Rare: blistering of skin (bullous pemphigoid).
Slovenian: • Redki: mehurjavost kože (bulozni pemfigoid).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. avgust 2011 Datum zadnjega podaljšanja: 22. marec 2016
English: Your doctor may ask you to stop Trajenta.
Slovenian: Vaš zdravnik vam bo morda naročil, da zdravilo Trajenta prenehate jemati.
English: There was a significant difference in reduction in HbA1c between Asian patients (0.8%) and White patients (0.5%) in the pooled studies.
Slovenian: Pomembna razlika v zmanjšanju HbA1c je bila med azijskimi bolniki (0,8 %) in bolniki belci (0,5 %) v združenih študijah.
English: • If you forget to take a dose of Trajenta, take it as soon as you remember it.
Slovenian: • Če ste pozabili vzeti odmerek zdravila Trajenta, ga vzemite takoj, ko se spomnite.
English: It is unknown if Trajenta is harmful to the unborn child.
Slovenian: Ni znano, ali lahko zdravilo Trajenta škoduje nerojenemu otroku.
English: Thus, full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Slovenian: Polna učinkovitost linagliptina pri kombiniranju z močnimi induktorji P-glikoproteina torej morda ne bo dosežena, zlasti pri dolgotrajni uporabi.
English: Other medicines and Trajenta
Slovenian: Druga zdravila in zdravilo Trajenta
English: The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
Slovenian: Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništva imetnika dovoljenja za promet z zdravilom:
English: If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away.
Slovenian: Če se pojavijo, katerikoli od zgoraj omenjenih znakov bolezni, zdravilo Trajenta prenehajte jemati in takoj pokličite zdravnika.
English: In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures if required.
Slovenian: V primeru prevelikega odmerjanja so smiselni običajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil, klinično spremljanje in po potrebi podporno zdravljenje.
English: Body weight did not differ significantly between the groups.
Slovenian: Med skupinama ni bilo pomembnih razlik v telesni masi.
English: Of these, 4.0% were mild and 0.9% were moderate and 0.1% were classified as severe in intensity.
Slovenian: Od tega je bilo po intenzivnosti opredeljenih 4,0 % kot blagi, 0,9 % kot zmerni in 0,1 % kot hudi.
English: Do not stop taking Trajenta without first consulting your doctor.
Slovenian: Zdravila Trajenta ne prenehajte jemati, ne da bi se posvetovali z zdravnikom.
English: • Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
Slovenian: • huda in persistentna trebušna bolečina (v predelu želodca), ki se lahko širi v hrbet; tudi slabost in bruhanje, ker so vsi lahko tudi znaki vnetja trebušne slinavke (pankreatitisa).
English: If you take more Trajenta than you should, talk to a doctor immediately.
Slovenian: Če ste vzeli več zdravila Trajenta, kot bi smeli, se takoj posvetujte z zdravnikom.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin 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 linagliptinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: You can take Trajenta with or without food.
Slovenian: Zdravilo Trajenta lahko jemljete s hrano ali brez nje.
English: Oral anti-diabetics are used to treat high blood sugar levels.
Slovenian: Peroralni antidiabetiki se uporabljajo za zdravljenje visoke ravni sladkorja v krvi.
English: Skin and subcutaneous tissue disorders Angioedema*
Slovenian: Bolezni kože in podkožja angioedem*
English: Diabetic skin lesions are a common complication of diabetes.
Slovenian: Diabetične okvare kože so pogost zaplet sladkorne bolezni.
English: The use of linagliptin has not been studied in pregnant women.
Slovenian: Uporabe linagliptina pri nosečnicah niso preučevali.
English: Elderly No dose adjustment is necessary based on age.
Slovenian: Starejši Prilagoditev odmerka glede na starost ni potrebna.
English: A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Slovenian: Morda bo treba odmerek sulfonilsečnine ali insulina zmanjšati (glejte poglavje 4.2).
English: • Common: level of lipase in the blood increased.
Slovenian: • Pogosti: zvišana raven lipaze v krvi.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with linagliptin in one or more subsets of the paediatric population in Type 2 diabetes (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z linagliptinom za eno ali več podskupin pediatrične populacije s sladkorno boleznijo tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Slovenian: Preglednica 2 Srčno-žilni in ledvični izidi po skupinah zdravljenja v študiji CARMELINA
English: 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).
Slovenian: 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).
English: Most patients (80.5%) received insulin as background therapy, alone or in combination with other oral anti-diabetics such as sulphonylurea, glinide and pioglitazone.
Slovenian: Večina bolnikov (80,5 %) je za osnovno zdravljenje uporabljala insulin, samostojno ali v kombinaciji z drugimi peroralnimi antidiabetiki, kot so sulfonilsečnina, glinid in pioglitazon.
English: 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.
Slovenian: 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.
English: It is not known if Trajenta passes into human breast milk.
Slovenian: Ni znano, ali se zdravilo Trajenta izloča v materino mleko.
English: It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse.
Slovenian: Pomembno je upoštevati nasvet o dieti in telesni aktivnosti, ki ste ga prejeli pri zdravniku ali medicinski sestri.
English: Both incretin hormones are involved in the physiological regulation of glucose homeostasis.
Slovenian: Navedena inkretinska hormona sodelujeta pri fiziološkem uravnavanju homeostaze glukoze.
English: • Trajenta is available in perforated aluminium/aluminium unit dose blisters.
Slovenian: • Zdravilo Trajenta je na voljo v perforiranih aluminij/aluminij pretisnih omotih za enkratni odmerek.
English: Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk.
Slovenian: Razpoložljivi farmakokinetični podatki pri živalih kažejo na izločanje linagliptina oziroma njegovih presnovkov v mleko.
English: Linagliptin has no or negligible influence on the ability to drive and use machines.
Slovenian: Linagliptin nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanjastrojev.
English: These changes in linagliptin pharmacokinetics were not considered to be clinically relevant.
Slovenian: Opisane spremembe farmakokinetike linagliptina ne veljajo za klinično pomembne.
English: Do not use Trajenta if the package is damaged or shows signs of tampering.
Slovenian: Ne uporabljajte zdravila Trajenta, če opazite, da je poškodovana ovojnina ali so vidni znaki kvarjenja.
English: What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
Slovenian: Kaj je zdravilo Trajenta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Trajenta Kako jemati zdravilo Trajenta Možni neželeni učinki
English: If you take more Trajenta than you should
Slovenian: Če ste vzeli večji odmerek zdravila Trajenta, kot bi smeli
English: The dose of linagliptin is 5 mg once daily.
Slovenian: Odmerek linagliptina je 5 mg enkrat na dan.
English: Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Slovenian: Linagliptina ne smejo uporabljati bolniki s sladkorno boleznijo tipa 1, prav tako z njim ne smemo zdraviti diabetične ketoacidoze.
English: If a dose is missed, it should be taken as soon as the patient remembers.
Slovenian: Če na odmerek pozabijo, ga morajo vzeti takoj, ko se spomnijo.
English: As a precautionary measure, it is preferable to avoid the use of linagliptin during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi linagliptina bolje izogibati.
English: The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m
Slovenian: Klinična preskušanja, ki so jih opravili pred izdajo dovoljenja za promet, so zajela bolnike z indeksom telesne mase do 40 kg/m
English: Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Slovenian: Starejši (65 do 80 let, najstarejši bolnik je imel 78 let) in mlajši preizkušanci so imeli primerljive plazemske koncentracije linagliptina.
English: A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Slovenian: Vaš zdravnik se bo moral odločiti ali boste prekinili z dojenjem ali boste prekinili/prenehali zdravljenje z zdravilom Trajenta.
English: 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).
Slovenian: 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).
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje sladkorne bolezni, zaviralci dipeptidil peptidaze 4 (DPP-4), oznaka ATC: A10BH05
English: INFORMATION IN BRAILLE Trajenta 5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Trajenta 5 mg
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: The unbound concentrations, which are usually less than 1% at the therapeutic dose of linagliptin, were increased 4-5-fold after coadministration with ritonavir.
Slovenian: Nevezane koncentracije, ki so običajno pri terapevtskem odmerjanju linagliptina manjše od 1 %, so se povečale za 4-5-krat po sočasnem dajanju z ritonavirjem.
English: In addition the pharmacokinetic characteristics of linagliptin were found to be similar in dedicated phase I studies in Japanese, Chinese and Caucasian healthy volunteers.
Slovenian: Poleg tega so bile farmakokinetične značilnosti linagliptina podobne tudi pri zdravih prostovoljcih v študijah I. faze, ki so zajele Japonce, Kitajce in belce.