FrancophonIA/ELRC3.0 huggingface dataset:
English: Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: Kinzalkomb 80 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 80 mg telmisartana i 25 mg hidroklorotiazida.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: NAZIV LIJEKA Kinzalkomb 40 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 40 mg telmisartana i 12,5 mg hidroklorotiazida.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna tableta sadrži 80 mg telmisartana i 12,5 mg hidroklorotiazida.
English: ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium)
Croatian: Lijekovi koji mogu povisiti vrijednosti kalija ili inducirati hiperkalemiju (npr. ACE inhibitori, diuretici koji štede kalij, nadomjesci kalija, zamjenske soli koje sadrže kalij, ciklosporin, ili drugi lijekovi kao što je heparin natrij)
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
Croatian: NAZIV LIJEKA Kinzalkomb 80 mg/12,5 mg tablete telmisartan/hidroklorotiazid
English: CV mortality and all cause mortality were numerically higher with the combination.
Croatian: Kombinacija telmisartana s ramiprilom nije imala dodatne pozitivne učinke u odnosu na monoterapiju ramiprila ili monoterapiju telmisartana, a KV smrtnost i smrtnost svih uzroka bile su brojčano veće uz kombinaciju.
English: Jaundice hepatocellular, jaundice cholestatic Skin and subcutaneous tissue disorders Not known:
Croatian: Poremećaji kože i potkožnog tkiva Nepoznato:
English: Hypomagnesaemia
Croatian: Hipokalemija
English: The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420)
Croatian: 6.1 Popis pomoćnih tvari laktoza hidrat magnezijev stearat škrob, kukuruzni meglumin celuloza, mikrokristalična povidon (K25) željezov oksid, crveni (E172) natrijev hidroksid natrijev škroboglikolat (vrsta A) sorbitol (E420)
English: Meglumine
Croatian: Kašalj
English: Hepatobiliary disorders Rare:
Croatian: Poremećaji imunološkog sustva Rijetko:
English: Back pain, muscle spasms, myalgia Arthralgia, muscle cramps, pain in limb Reproductive system and breast disorders Uncommon:
Croatian: Artralgija, grčevi mišića, bol u udovima Poremećaji reproduktivnog sustava i dojki Manje često:
English: Dyspnoea
Croatian: Somnolencija
English: Somnolence Respiratory, thoracic and mediastinal disorders Uncommon: Very rare:
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Manje često:
English: Combining telmisartan with ramipril did not add further benefit over ramipril or telmisartan alone.
Croatian: ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint
English: Restlessness
Croatian: Anksioznost
English: - Systemic lupus erythematosus (also called “lupus” or “SLE”) a disease where the body's immune system attacks the body.
Croatian: - sistemski lupus eritematozus (također zvan «lupus» ili «SLE»), bolest u kojoj imunološki sustav napada tijelo. - djelatna tvar, hidroklorotiazid może izazvati neobičnu reakciju koja rezultira smanjenjem vida i boli u očima, koji mogu biti simptomi povišenog tlaka u oku, a do njih może doći unutar nekoliko sati do tjedana primjene Kinzalkomba.
English: Never take two doses on the same day.
Croatian: Nikada ne uzimajte dvije doze u istom danu.
English: Date of latest renewal: 22 March 2016
Croatian: Datum posljednje obnove odobrenja: 22. ožujka 2016.
English: Children and adolescents Trajenta is not recommended for children and adolescents under 18 years.
Croatian: Trajenta se ne preporučuje djeci i adolescentima mlađim od 18 godina.
English: The tablets can be taken with or without a meal at any time of the day.
Croatian: Tablete se mogu uzimati sa ili bez obroka u bilo koje doba dana.
English: It is unknown if Trajenta is harmful to the unborn child.
Croatian: Nije poznato je li Trajenta štetna za nerođeno dijete.
English: You can take Trajenta with or without food.
Croatian: Trajentu možete uzimati sa ili bez hrane.
English: Body weight did not differ significantly between the groups.
Croatian: Tjelesna težina nije se značajno razlikovala među skupinama.
English: - The other ingredients are
Croatian: • Drugi sastojci su
English: • have or have had a disease of the pancreas.
Croatian: • imate ili ste imali bolest gušterače.
English: This is an antibiotic used to treat infections such as tuberculosis.
Croatian: Ovo je antibiotik koji se primjenjuje u liječenju infekcija kao što je tuberkuloza.
English: Lipase increased**
Croatian: Povišena lipaza**
English: Your blood sugar levels may increase when you stop taking Trajenta.
Croatian: Razina šećera u krvi se može povećati ako prestanete s uzimanjem Trajente.
English: Other medicines and Trajenta
Croatian: Drugi lijekovi i Trajenta
English: If you take more Trajenta than you should
Croatian: Ako uzmete više Trajente nego što ste trebali
English: What Trajenta is and what it is used for
Croatian: Što je Trajenta i za što se koristi
English: Your doctor may ask you to stop Trajenta.
Croatian: Vaš liječnik može zatražiti da prestanite uzimati Trajentu.
English: • have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
Croatian: • ste imali alergijske reakcije na neke druge lijekove koje uzimate radi kontrole količine šećera u krvi.
English: What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
Croatian: Što je Trajenta i za što se koristi Što morate znati prije nego počnete uzimati Trajentu
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik ili ljekarnik.
English: They work by helping the body reduce the level of sugar in your blood.
Croatian: Oni djeluju tako da pomažu tijelu u smanjenju razine šećera u krvi.
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.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni, ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Therefore, it is preferable to avoid using Trajenta if you are pregnant.
Croatian: Stoga se preporučuje izbjegavanje primjene Trajente ako ste trudni.
English: For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet:
English: What Trajenta looks like and contents of the pack
Croatian: Kako Trajenta izgleda i sadržaj pakiranja
English: There was no difference between groups in severe hypoglycaemic events.
Croatian: Nije bilo razlike između skupina u teškim hipoglikemijskim događajima.
English: This was achieved with a stable insulin dose (40.1 IU).
Croatian: Ovo je postignuto stabilnom dozom inzulina (40,1 IU).
English: Effects on plasma lipids were negligible.
Croatian: Učinci na lipide u plazmi bili su zanemarivi.
English: The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Croatian: Sigurnost i djelotvornost linagliptina u djece i adolescenata nisu ustanovljene.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Trajenta if you:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene Trajente ako:
English: Trajenta should not be used to treat these conditions.
Croatian: Trajenta se ne smije primjenjivati u liječenju ovih stanja;
English: Doses of background antidiabetic medicinal products were kept stable during the first 12 weeks, after which adjustments were permitted.
Croatian: Doze osnovnih antidijabetika bile su stabilne tijekom prvih 12 tjedana, nakon čega su bile dozvoljene prilagodbe.
English: • If you forget to take a dose of Trajenta, take it as soon as you remember it.
Croatian: • Ako ste zaboravili uzeti dozu Trajente, uzmite ju čim se sjetite.
English: STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PRESTANITE uzimati Trajentu i odmah se obratite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Croatian: Upotreba DPP-4 inhibitora povezana je s rizikom od razvoja akutnog pankreatitisa.
English: If you take more Trajenta than you should, talk to a doctor immediately.
Croatian: Ako uzmete više Trajente nego ste trebali, odmah se javite liječniku.
English: In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Croatian: Osobito je važno obavijestiti liječnika ako primjenjujete lijekove koji sadrže neku od sljedećih djelatnih tvari:
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
Croatian: • Tešku i stalnu bol u abdomenu (područje trbuha), koja se može protezati skroz do leđa, te mučninu i povraćanje, jer to može biti znak upale gušterače (pankreatitis).
English: • Trajenta is available in perforated aluminium/aluminium unit dose blisters.
Croatian: • Trajenta je dostupna u perforiranim aluminij/aluminij blisterima djeljivim na jedinične doze.
English: • Carbamazepine, phenobarbital or phenytoin.
Croatian: • karbamazepin, fenobarbital, ili fenitoin.
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).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: No clinically relevant effect of Cmax and Tmax changes is expected; therefore linagliptin may be administered with or without food.
Croatian: Ne očekuje se klinički značajan učinak promjena u Cmax i Tmax; stoga se linagliptin može primjenjivati s ili bez hrane.
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.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja linagliptinom, uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: As a precautionary measure, it is preferable to avoid the use of linagliptin during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu linagliptina tijekom trudnoće.
English: If pancreatitis is suspected, Trajenta should be discontinued; if acute pancreatitis is confirmed, Trajenta should not be restarted.
Croatian: Ako se sumnja na pankreatitis, primjena Trajente mora se prekinuti; a ukoliko se akutni pankreatitis potvrdi, Trajenta se ne smije ponovo primijeniti.
English: If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
Croatian: Ako imate simptome akutne upale gušterače, poput stalne jake boli u trbuhu (bol u abdomenu), morate se odmah obratiti Vašem liječniku.
English: The reductions in glycosylated haemoglobin A1c (HbA1c) were similar across different subgroups including gender, age, renal impairment and body mass index (BMI).
Croatian: Smanjenja glikoziliranog hemoglobina A1c (HbA1c) bila su slična u raznim podskupinama, uključujući spol, dob, oštećenje bubrega i indeks tjelesne mase (BMI).
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).
Croatian: • imate dijabetes tipa 1 (Vaše tijelo ne stvara inzulin) ili dijabetičku ketoacidozu (komplikacija dijabetesa s visokim vrijednostima šećera u krvi, brzim gubitkom težine, mučninom ili povraćanjem).
English: These studies had 929 patients of 65 years and over who were on linagliptin.
Croatian: Ova ispitivanja obuhvaćala su 929 bolesnika, od 65 i više godina starosti koji su bili na linagliptinu.
English: Trajenta contains the active substance linagliptin which belongs to a group of medicines called “oral anti-diabetics”.
Croatian: Trajenta sadrži djelatnu tvar linagliptin koja pripada skupini lijekova koji se nazivaju “oralni antidijabetici”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
Croatian: Datum prvog odobrenja: 24. kolovoza 2011.
English: Available pharmacokinetic data in animals have shown excretion of linagliptin/metabolites in milk.
Croatian: Dostupni farmakokinetički podaci u životinja pokazuju da se linagliptin/metaboliti izlučuju u mlijeko.
English: Skin and subcutaneous tissue disorders Angioedema*
Croatian: Poremećaji kože i potkožnog tkiva Angioedem*
English: The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m
Croatian: Provedena su klinička ispitivanja prije odobrenja za stavljanje lijeka u promet do ITM-a koji odgovara 40 kg/m
English: Older subjects (65 to 80, oldest patient was 78 years) had comparable plasma concentrations of linagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 do 80, najstariji bolesnik imao je 78 godina) imali su usporedive koncentracije linagliptina u plazmi, u usporedbi s mlađim osobama.
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).
Croatian: Značajno veća incidencija malignih limfoma samo na ženkama miševa, pri najvišim dozama (> 200 puta više od izloženosti kod ljudi), se ne smatra značajnom za ljude (objašnjenje: nije povezano s liječenjem, nego posljedica visokovarijabilne osnovne incidencije).
English: There was a significant difference in reduction in HbA1c between Asian patients (0.8%) and White patients (0.5%) in the pooled studies.
Croatian: Postojala je značajna razlika u smanjenju HbA1c između azijskih bolesnika (0,8%) i bijelaca (0,5%) u združenim ispitivanjima.
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.
Croatian: U slučaju predoziranja, razumno je primijeniti uobičajene suportivne mjere, npr. uklanjanje neapsorbiranog lijeka iz gastrointestinalnog trakta, uz kliničko praćenje te primjenu kliničkih mjera prema potrebi.
English: Oral 2 year carcinogenicity studies in rats and mice revealed no evidence of carcinogenicity in rats or male mice.
Croatian: 2-godišnja ispitivanja kancerogenosti oralne doze na štakorima i miševima nisu otkrila dokaze kancerogenosti u štakora ili mužjaka miševa.
English: Oral anti-diabetics are used to treat high blood sugar levels.
Croatian: Oralni antidijabetici se primjenjuju u liječenju visoke razine šećera u krvi.
English: If you stop taking Trajenta
Croatian: Ako prestanete uzimati Trajentu
English: At more than 100 times human exposure, irritation of the stomach was the major finding in these monkeys.
Croatian: Pri izloženosti većoj od 100 puta od one kod ljudi, glavni nalaz bila je nadraženost želuca kod ovih majmuna.
English: There was a further follow up 40 week treatment period during which dose adjustments in antidiabetes background therapies were allowed.
Croatian: Uslijedilo je daljnje 40-tjedno liječenje s praćenjem, tijekom kojeg je bilo dozvoljeno prilagođavanje doze osnovnih terapija antidijabeticima.
English: C] linagliptin dose to healthy subjects, approximately 85% of the administered radioactivity was eliminated in faeces (80%) or urine (5%) within 4 days of dosing.
Croatian: C] linagliptina kod zdravih osoba, oko 85% primijenjene radioaktivnosti bilo je eliminirano putem fecesa (80%) ili urina (5%) unutar 4 dana od doziranja.
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Croatian: Farmakoterapijska skupina: Lijekovi koji se primjenjuju u dijabetesu, inhibitori dipeptidil peptidaze 4 (DPP-4), ATK oznaka: A10BH05
English: • Common: level of lipase in the blood increased.
Croatian: • Često: povišena razina enzima lipaze u krvi.
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.
Croatian: Tijekom kontroliranih kliničkih ispitivanja na zdravim osobama, jednostruke doze do 600 mg linagliptina (što odgovara 120 puta višim dozama od preporučenih) bile su općenito dobro podnošene.
English: Linagliptin once daily produced clinically significant improvements in glycaemic control, with no clinically relevant change in body weight.
Croatian: Linagliptin jedanput dnevno doveo je do klinički značajnih poboljšanja kontrole glikemije, bez klinički relevantne promjene tjelesne težine.
English: Thus, full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Croatian: Stoga se ne mora nužno postići potpuna djelotvornost linagliptina u kombinaciji sa snažnim P-gp induktorima, osobito pri njihovoj dugotrajnoj primjeni.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: PRILOG II. A. PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET B. UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (PERFORATED)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI (PERFORIRANI)
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.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: It is not known if Trajenta passes into human breast milk.
Croatian: Nije poznato prelazi li Trajenta u majčino mlijeko.
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).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja linagliptina u jednoj ili više podskupina pedijatrijske populacije s dijabetesom tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Higher baseline HbA1c was associated with a greater reduction in HbA1c.
Croatian: Viša početna vrijednost HbA1c bila je povezana s većim smanjenjem u HbA1c.
English: When linagliptin is added to metformin, the dose of metformin should be maintained, and linagliptin administered concomitantly.
Croatian: Kada se linagliptin dodaje uz metformin, doza metformina se mora održavati, a linagliptin primjenjivati istodobno.
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).
Croatian: Potrebno je prekinuti uzimanje Trajente i odmah se javiti liječniku ako imate sljedeće simptome niske razine šećera u krvi: drhtanje, znojenje, tjeskoba, zamagljen vid, trnci usana, bljedilo, promjena raspoloženja ili smetenost (hipoglikemija).
English: A decision must be made by your doctor whether to discontinue breast-feeding or to discontinue/abstain from Trajenta therapy.
Croatian: Vaš liječnik mora odlučiti treba li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja Trajentom.
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.
Croatian: Nadalje, pronađena je sličnost farmakokinetičkih svojstava linagliptina u ciljanim ispitivanjima faze I na japanskim, kineskim i bjelačkim zdravim dobrovoljcima.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: Do not use Trajenta if the package is damaged or shows signs of tampering.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primjetite da je pakiranje oštećeno ili su vidljivi znakovi otvaranja.
English: The dose of linagliptin is 5 mg once daily.
Croatian: Doza linagliptina je 5 mg jedanput dnevno.
English: After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
Croatian: Nakon medijana praćenja od 6,25 godina, linagliptin nije povećao rizik od velikih štetnih kardiovaskularnih događaja (vidjeti tablicu 3) u usporedbi s glimepiridom.
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.
Croatian: Nevezane koncentracije, koje su obično niže od 1% pri terapijskoj dozi linagliptina, povećale su se 4-5 puta nakon istodobne primjene s ritonavirom.
English: Your doctor may prescribe Trajenta together with another oral anti-diabetic medicine.
Croatian: Liječnik Vam može propisati Trajentu u kombinaciji s drugim oralnim antidijabetikom.
English: If you forget to take Trajenta
Croatian: Ako ste zaboravili uzeti Trajentu
English: 8 phase III randomised controlled trials involving 5,239 patients with type 2 diabetes, of which 3,319 were treated with linagliptin were conducted to evaluate efficacy and safety.
Croatian: 8 randomiziranih kontroliranih ispitivanja faze 3, koja su uključivala 5 239 bolesnika s dijabetesom tipa 2, od kojih je 3 319 liječeno linagliptinom, provedeno je kako bi se ocijenila djelotvornost i sigurnost.
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.
Croatian: Nakon medijana praćenja od 2,2 godine, linagliptin, kada je bio dodan uobičajenom liječenju, nije povećao rizik od velikih štetnih kardiovaskularnih događaja ili događaja bubrežnog ishoda.
English: • Rare: blistering of skin (bullous pemphigoid).
Croatian: • Rijetko: stvaranje mjehura na koži (bulozni pemfigoid).