FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Incresync and get your doctor to check your urine as soon as possible.
Croatian: Ne uzimajte Incresync i čim prije se javite liječniku radi pretrage mokraće.
English: Do not stop taking Incresync without consulting your doctor first.
Croatian: Ne prekidajte liječenje lijekom Incresync bez prethodnog savjetovanja s liječnikom.
English: Pioglitazone can cause fluid retention, which may exacerbate or precipitate heart failure.
Croatian: Pioglitazon može uzrokovati zadržavanje tekućine, koje može pogoršati ili izazvati zatajenje srca.
English: The relevance to humans of the tumourigenic findings in the male rat cannot be excluded.
Croatian: Značaj ovih tumorogenih nalaza u mužjaka štakora za ljude se ne može isključiti.
English: Co. Wicklow Ireland
Croatian: Wicklow Irska
English: - if you have heart failure or have had heart failure in the past.
Croatian: • ako imate zatajenje srca ili ste prije imali zatajenje srca.
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravne ili neizravne štetne učinke s obzirom na reproduktivnu toksičnost (vidjeti dio 5.3).
English: Patients should be alerted to the risk of hypoglycaemia when Incresync is used in combination with other anti-diabetic medicinal products known to cause hypoglycaemia.
Croatian: Bolesnike treba upozoriti na rizik od hipoglikemije kad se Incresync primjenjuje u kombinaciji s drugim antidijabetičkim lijekovima za koje je poznato da mogu uzrokovati hipoglikemiju.
English: 10 film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 60 film-coated tablets 90 film-coated tablets 98 film-coated tablets 100 film-coated tablets
Croatian: 10 filmom obloženih tableta 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
English: No data are available (see section 4.2).
Croatian: Nema dostupnih podataka (vidjeti dio 4.2).
English: It is not known if alogliptin is removed by peritoneal dialysis.
Croatian: Nije poznato može li se alogliptin ukloniti peritonealnom dijalizom.
English: In animals, only a small amount of unchanged pioglitazone can be detected in either urine or faeces.
Croatian: U životinja se samo mala količina neizmijenjenog pioglitazona može otkriti u mokraći ili stolici.
English: Takeda Polska Sp. z o.o.
Croatian: Takeda Polska Sp. z o.o tel.
English: Generally, the effects of alogliptin on body weight and lipids were neutral.
Croatian: Općenito, učinak alogliptina na tjelesnu težinu i lipide bio je neutralan.
English: mood change or feeling confused.
Croatian: bljedilo, promjene raspoloženja i osjećaj smetenosti.
English: Furthermore, clinical data do not suggest interaction with p-glycoprotein inhibitors or substrates.
Croatian: Nadalje, klinički podaci ne ukazuju na interakcije s inhibitorima ili supstratima p-glikoproteina.
English: Absorption is not influenced by food intake.
Croatian: Na apsorpciju ne utječe unos hrane.
English: Following a single intravenous dose of 12.5 mg alogliptin to healthy subjects, the volume of distribution during the terminal phase was 417 L indicating that the active substance is well distributed into tissues.
Croatian: Nakon primjene jednokratne intravenske doze od 12,5 mg alogliptina u zdravih ispitanika, volumen distribucije tijekom terminalne faze bio je 417 l što pokazuje da se lijek dobro distribuira u tkiva.
English: - alogliptin belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors).
Croatian: - alogliptin pripada skupini lijekova pod nazivom DPP-4 inhibitori (inhibitori dipeptidil peptidaze-4).
English: After initiation of therapy with Incresync, patients should be reviewed after 3 to 6 months to assess adequacy of response to treatment (e.g. reduction in HbA1c).
Croatian: Bolesnike treba ponovo pregledati 3 do 6 mjeseci nakon početka terapije Incresyncom, kako bi se procijenilo imaju li odgovarajući odgovor na liječenje (tj. sniženje HbA1c).
English: Pack sizes of 10, 14, 28, 30, 56, 60, 90, 98 or 100 film-coated tablets.
Croatian: Veličine pakiranja od 10, 14, 28, 30, 56, 60, 98 ili 100 filmom obloženih tableta.
English: The (S)-enantiomer is not detectable at therapeutic doses.
Croatian: (S)-enantiomer se u terapijskim dozama ne nalazi.
English: The MAH shall perform the required 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 objašnjenje 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: Do not take Incresync: - if you are allergic to alogliptin, pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na alogliptin, pioglitazon ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: In healthy subjects, alogliptin had no effect on prothrombin time or International Normalised Ratio (INR) when administered concomitantly with warfarin.
Croatian: U zdravih ispitanika, alogliptin nije imao učinak na protrombinsko vrijeme ili Internacionalni Normalizirani Omjer (INR) kada se primjeni istodobno s varfarinom.
English: Placebo N=2,701 N=2,679
Croatian: 25 mg placebo N=2701 N=2679
English: If a dose is missed, it should be taken as soon as the patient remembers.
Croatian: Ako bolesnik propusti dozu, treba je uzeti čim se sjeti.
English: Total exposure (AUC(0-inf)) to alogliptin following administration of a single dose was similar to exposure during one dose interval (AUC(0-24)) after 6 days of once daily dosing.
Croatian: Ukupna izloženost (AUC(0-inf)) alogliptinu nakon primjene jednokratne doze bila je slična izloženosti tijekom intervala od 6 dana primjene jedanput na dan (AUC(0-24)).
English: This is predominantly via cytochrome P450 2C8 although other isoforms may be involved to a lesser degree.
Croatian: To se pretežno odvija putem citokroma P450 2C8, iako i drugi izoenzimi mogu biti uključeni u manjem stupnju.
English: Interaction with substrates of CYP 450 isoforms are thus not expected and have not been shown.
Croatian: Interakcija sa supstratima CYP 450 izoenzima se stoga ne očekuje niti je dokazana.
English: When treating patients who have at least one risk factor for development of congestive heart failure (e.g. prior myocardial infarction or symptomatic coronary artery disease or the elderly), physicians should start pioglitazone therapy with the lowest available dose and increase the dose gradually.
Croatian: Kod liječenja bolesnika koji imaju barem jedan faktor rizika od razvoja kongestivnog zatajenja srca (npr. prethodni infarkt miokarda ili simptomatska bolest koronarnih arterija ili starija dob), liječnici trebaju započeti terapiju s najnižom dostupnom dozom pioglitazona i postupno je povećavati.
English: Alogliptin does not undergo extensive metabolism, 60-70% of the dose is excreted as unchanged active substance in the urine.
Croatian: Alogliptin ne prolazi ekstenzivni metabolizam te se 60-70% doze izluči kao neizmijenjen lijek u mokraći.
English: It is unclear whether or not there is a direct association between pioglitazone and macular oedema but prescribers should be alert to the possibility of macular oedema if patients on Incresync report disturbances in visual acuity; an appropriate ophthalmological referral should be considered.
Croatian: Nije jasno postoji li izravna veza između pioglitazona i makularnog edema, ali liječnici trebaju imati na umu mogućnost makularnog edema ako bolesnici na Incresyncu prijave poremećaje oštrine vida; potrebno je razmotriti upućivanje bolesnika na odgovarajući oftalmološki pregled.
English: If you forget to take Incresync
Croatian: Ako ste zaboravili uzeti Incresync
English: Incresync is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
Croatian: Incresync je indiciran kao druga ili treća linija liječenja odraslih bolesnika u dobi od 18 godina i starijih sa šećernom bolešću tipa 2:
English: Therapy with Incresync should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Croatian: Terapija Incresyncom se ne smije započeti u bolesnika s povišenim početnim razinama jetrenih enzima (ALT > 2,5 puta iznad gornje granice normale) ili bilo kojim drugim dokazom bolesti jetre.
English: Not known (frequency cannot be estimated from the available data): - An allergic reaction.
Croatian: Nepoznato (učestalost se ne može procijeniti na temelju dostupnih podataka):
English: In a pre- and postnatal development study in rats, exposures far above the human exposure at the recommended dose did not harm the developing embryo or affect offspring growth and development.
Croatian: U ispitivanju prenatalnog i postnatalnog razvoja u štakora, izloženostima daleko iznad izloženosti kod ljudi pri preporučenoj dozi nisu naštetile razvoju embrija niti utjecale na rast i razvoj mladunčadi.
English: Close monitoring of glycaemic control should be considered (see section 4.4).
Croatian: Potrebno je razmotriti pomno praćenje kontrole glikemije (vidjeti dio 4.4).
English: Patients (≥ 65 years old) with type 2 diabetes mellitus are considered more susceptible to episodes of hypoglycaemia than patients < 65 years old.
Croatian: Bolesnici (≥ 65 godina starosti) sa šećernom bolešću tipa 2 smatraju se podložnijima epizodama hipoglikemije nego bolesnici < 65 godina starosti.
English: The inter-subject coefficient of variation for alogliptin AUC was small (17%).
Croatian: Koeficijent varijacije za AUC alogliptina u pojedinačnih ispitanika bio je mali (17%).
English: Minimal to mild simple transitional cell hyperplasia was seen in the urinary bladder of male rats at the lowest dose used (27 times the human exposure) without establishment of a clear NOEL (no observed effect level).
Croatian: Minimalna do blaga jednostavna hiperplazija tranzicijskih stanica viđena je u mokraćnom mjehuru muških štakora, kod najmanje primijenjene doze (27 puta veća od izloženosti kod ljudi) bez jasno određene razine bez opaženog učinka (RBON).
English: However, the incidences of oedema, weight gain and heart failure were increased.
Croatian: Međutim, incidencije edema, povećanja težine i zatajenja srca bile su povišene.
English: Total serum concentration of pioglitazone is unchanged, but with an increased volume of distribution.
Croatian: Ukupna koncentracija pioglitazona u plazmi nije izmijenjena, ali je volumen distribucije povećan.
English: Pharmacotherapeutic group: Drugs used in diabetes; combinations of oral blood glucose lowering drugs.
Croatian: Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti; kombinacije peroralnih lijekova za snižavanje glukoze u krvi.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/842/001-036
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/842/001-036
English: Alogliptin is 20-30% bound to plasma proteins.
Croatian: Vezanje alogliptina za proteine plazme je 20-30%.
English: The MAH shall provide an educational pack targeting all physicians who are expected to prescribe/use alogliptin/pioglitazone.
Croatian: Nositelj odobrenja osigurat će edukacijski paket namijenjen svim liječnicima koji očekuju da će propisivati/primjenjivati alogliptin/pioglitazon.
English: What Incresync is Incresync contains two different medicines called alogliptin and pioglitazone in one tablet:
Croatian: Što je Incresync Incresync sadrži dva različita lijeka koji se zovu alogliptin i piogliazon u jednoj tableti:
English: However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment of alogliptin for patients with mild renal impairment is necessary (see section 4.2).
Croatian: Međutim, kako je distribucija AUC vrijednosti za alogliptin u tih bolesnika bila unutar istog raspona kao i u kontrolnih ispitanika, prilagodba doze u bolesnika s blagim oštećenjem bubrega nije potrebna (vidjeti dio 4.2).
English: In clinical studies, patients have taken pioglitazone at higher than the recommended highest dose of 45 mg daily.
Croatian: U kliničkim ispitivanjima bolesnici su uzimali pioglitazon u dozama koje su bile više od najviše preporučene doze od 45 mg na dan.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain, which may radiate to the back.
Croatian: Bolesnike treba upozoriti na karakteristični simptom akutnog pankreatitisa: ustrajnu, jaku bol u abdomenu koja se širi prema leđima.
English: If any patient develops symptoms suggesting hepatic dysfunction, which may include unexplained nausea, vomiting, abdominal pain, fatigue, anorexia and/or dark urine, liver enzymes should be checked.
Croatian: Ako bilo koji bolesnik razvije simptome koji ukazuju na poremećaj funkcije jetre, koji mogu uključivati neobjašnjenu mučninu, povraćanje, bol u abdomenu, umor, anoreksiju i/ili tamnu mokraću, potrebno je provjeriti jetrene enzime.
English: HOMA analysis shows that pioglitazone improves beta-cell function as well as increasing insulin sensitivity.
Croatian: Analiza HOMA pokazuje da pioglitazon poboljšava funkciju beta stanica, kao i da povećava osjetljivost na inzulin.
English: - if you have or have had a disease of the pancreas.
Croatian: • ako imate ili ste imali bolest gušterače.
English: In addition, Incresync can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.
Croatian: Dodatno, Incresync može zamijeniti zasebne tablete alogliptina i pioglitazona u onih odraslih bolesnika u dobi od 18 godina i starijih sa šećernom bolešću tipa 2 koji se već liječe tom kombinacijom.
English: Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Croatian: Poremećaj vida prijavljen je uglavnom na početku liječenja i bio je povezan s promjenama glukoze u krvi zbog privremene promjene u napetosti i indeksu refrakcije leće kakav se vidi i kod drugih hipoglikemijskih liječenja.
English: The efficacy and safety of the recommended doses of alogliptin and pioglitazone in a subgroup of patients with type 2 diabetes mellitus and ≥ 65 years old were reviewed and found to be consistent with the profile obtained in patients < 65 years old.
Croatian: Djelotvornost i sigurnost preporučenih doza alogliptina i metformina u podskupini bolesnika sa šećernom bolešću tipa 2 i dobi ≥ 65 godina starosti su procijenjene i nađeno je da odgovaraju profilu dobivenom u bolesnika < 65 godina starosti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Incresync in all subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Incresync u jednoj ili više podskupina pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: After excluding patients in whom exposure to the medicinal product was less than one year at the time of diagnosis of bladder cancer, there were 7 cases (0.06%) on pioglitazone and 2 cases (0.02%) in control groups.
Croatian: Nakon isključenja bolesnika koji su u vrijeme dijagnoze karcinoma mokraćnog mjehura bili izloženi ispitivanom lijeku kraće od jedne godine, u skupinama na pioglitazonu bilo je 7 slučajeva (0,06%), a u kontrolnim skupinama 2 slučaja (0,02%).
English: DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucosedependent insulinotropic polypeptide), which are released by the intestine and levels are increased in response to a meal.
Croatian: DPP-4 je glavni enzim uključen u brzu degradaciju inkretinskih hormona, glukagonu sličnog peptida 1 (GLP-1) i GIP (inzulinotropnog polipeptida ovisnog o glukozi), koji se izlučuju u crijevu i razine su im povišene kao odgovor na obrok.
English: This educational pack is aimed at strengthening awareness of important identified risks of bladder cancer and heart failure and the overall recommendations intended to optimise the benefit-risk margin at the patient level.
Croatian: Svrha ovog edukacijskog paketa jest povisiti svijest o važnosti utvrđenih rizika od karcinoma mokraćnog mjehura i zatajenja srca te opće preporuke namijenjene optimizaciji raspona koristi-rizika na razini bolesnika.
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9).
Croatian: Alogliptin nije ispitan u bolesnika sa teškim oštećenjem jetre (Child-Pugh indeks >9).
English: - if you have liver disease.
Croatian: • ako imate bolest jetre.
English: - if you have a problem with your liver or kidneys.
Croatian: • ako imate probleme s jetrom ili bubrezima.
English: • Caution in use in the elderly in light of age related risks (in particular bladder cancer, fractures and heart failure).
Croatian: • Oprez kod primjene u starijih s obzirom na rizike povezane s dobi (osobito karcinom mokraćnog mjehura, prijelome i zatajenje srca).
English: In an animal model of familial adenomatous polyposis, treatment with two other thiazolidinediones increased tumour multiplicity in the colon.
Croatian: Na životinjskom modelu obiteljske adenomatozne polipoze, liječenje s dva druga tiazolidindiona povećala je brojnost tumora u debelom crijevu.
English: M-I is an active metabolite and is a highly selective inhibitor of DPP-4 similar to alogliptin; M-II does not display any inhibitory activity towards DPP-4 or other DPP-related enzymes.
Croatian: M-I je aktivni metabolit i visoko je selektivni inhibitor DPP-4 slično alogliptinu; M-II ne pokazuje nikakvu inhibicijsku aktivnost na DPP-4 ili bilo koji drugi DPP enzim.
English: • The risk of heart failure and relevant risk minimisation advice.
Croatian: • Rizik od zatajenja srca i odgovarajuće savjete o minimizaciji rizika.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na blisteru iza „Rok valjanosti“/ EXP.
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 (pancreatitis).
Croatian: • Jaka i ustrajna bol u trbuhu (u području želuca) koja može sezati do leđa, kao i mučnina i povraćanje, što može biti znak upale gušterače (pankreatitis).
English: Weight gain
Croatian: Povećanje težine
English: Incresync has no or negligible influence on the ability to drive and use machines.
Croatian: Alogliptin ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Alogliptin works to increase the levels of insulin in the body after a meal and decrease the amount of sugar in the body.
Croatian: Alogliptin djeluje tako da podiže razine inzulina u tijelu nakon obroka i smanjuje razinu šećera u krvi.
English: Following oral administration of radiolabelled pioglitazone to man, recovered label was mainly in faeces (55%) and a lesser amount in urine (45%).
Croatian: Nakon peroralne primjene radioaktivno označenog pioglitazona u čovjeka, označeni lijek većim se dijelom otkrio u stolici (55%) i u manjem dijelu u mokraći (45%).
English: Almost all subjects (95%) were receiving cardiovascular medicinal products (beta blockers, angiotensin-converting-enzyme (ACE) inhibitors, angiotensin II antagonists, calcium channel blockers, nitrates, diuretics, aspirin, statins, fibrates).
Croatian: Gotovo su svi ispitanici (95%) primali kardiovaskularne lijekove (beta blokatore, ACE inhibitore, antagoniste angiotenzina II, blokatore kalcijevih kanala, nitrate, diuretike, aspirin, statine, fibrate).
English: Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Croatian: Iako ispitivanje nije uspjelo u pogledu primarnog ishoda, koji je bio kompozitna smrtnost od svih uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar, akutni koronarni sindrom, velika amputacija noge, koronarna revaskularizacija i revaskularizacija noge, rezultati pokazuju da primjena pioglitazona nije nosila dugoročne kardiovaskularne rizike.
English: Pioglitazone dose adjustment within the recommended posology or changes in diabetic treatment should be considered (see section 4.5).
Croatian: Treba razmotriti prilagodbu doze pioglitazona unutar preporučenog doziranja ili promjena u liječenju šećerne bolesti (vidjeti dio 4.5).
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers and HMGCoA reductase inhibitors, are not to be expected.
Croatian: Ne očekuju se interakcije s lijekovima koje ti enzimi metaboliziraju, npr. oralnim kontraceptivima, ciklosporinom, blokatorima kalcijevih kanala i inhibitorima HMG-CoA reduktaze.
English: Total and peak exposure to alogliptin increased proportionately across single doses of 6.25 mg up to 100 mg alogliptin (covering the therapeutic dose range).
Croatian: Ukupna i vršna izloženost alogliptinu se proporcionalno povećavala povišenjem jednokratnih doza od 6,25 mg do 100 mg alogliptina (što obuhvaća raspon terapijskih doza).
English: Incresync is taken when your blood sugar cannot be adequately controlled by diet, exercise and other oral anti-diabetic medicines such as pioglitazone; or pioglitazone and metformin taken together.
Croatian: Incresync se uzima kad se šećer u krvi ne može odgovarajuće kontrolirati dijetom, tjelovježbom i drugim antidijabetičkim lijekovima poput pioglitazona, ili pioglitazona i metformina uzetih zajedno.
English: Absorption The absolute bioavailability of alogliptin is approximately 100%.
Croatian: Apsolutna bioraspoloživost alogliptina je približno 100%.
English: Effects of other medicinal products on alogliptin
Croatian: Učinci drugih lijekova na alogliptin
English: In studies in vitro, alogliptin was not an inhibitor of the following renal transporters; OAT1, OAT3 and OCT2.
Croatian: U ispitivanjima in vitro, alogliptin nije inhibirao sljedeće bubrežne transportere: OAT1, OAT3 i OCT2.
English: Higher doses of alogliptin were not teratogenic but resulted in maternal toxicity, and were associated with delayed and/or lack of ossification of bones and decreased foetal body weights.
Croatian: Više doze alogliptina nisu bile teratogene, ali su izazvale toksičnost u majke te su bile povezane s odgođenim i/ili nedovoljnim okoštavanjem kostiju i smanjenom fetalnom tjelesnom težinom.
English: Incresync should not be used during pregnancy.
Croatian: Incresync se ne smije primjenjivati tijekom trudnoće.
English: Following initiation of therapy with Incresync, it is recommended that liver enzymes be monitored periodically based on clinical judgement.
Croatian: Nakon početka terapije Incresyncom preporučuje se povremeno pratiti jetrene enzime na temelju kliničke procjene.
English: If ALT levels are increased to 3 x upper limit of normal during therapy, liver enzyme levels should be reassessed as soon as possible.
Croatian: Ako se tijekom terapije razine ALT-a povise do 3 puta iznad gornje granice normale, razine jetrenih enzima treba čim prije ponovno provjeriti.