FrancophonIA/ELRC3.0 huggingface dataset:
English: Alogliptin exists predominantly as the (R)-enantiomer (> 99%) and undergoes little or no chiral conversion in vivo to the (S)-enantiomer.
Croatian: In vivo alogliptin postoji predominantno kao (R)-enantiomer (>99%) i malo se ili nimalo ne konvertira u kiralni (S)-enantiomer.
English: Your doctor will prescribe Vipidia together with one or more other medicines to control your blood sugar levels.
Croatian: Liječnik će lijek Vipidia preporučiti zajedno s jednim ili više drugih lijekova za kontrolu šećera u krvi.
English: The effect of alogliptin on fertility in humans has not been studied.
Croatian: Učinak alogliptina na plodnost u ljudi nije ispitan.
English: Immune system disorders hypersensitivity not known
Croatian: Poremećaji imunološkog sustava preosjetljivost nepoznato
English: Interaction with substrates of CYP 450 isoforms are thus not expected and have not been shown.
Croatian: Interakcije sa supstratima CYP 450 izoenzima se stoga ne očekuju niti su dokazane.
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 veće od izloženosti kod ljudi ) bez jasno utvrđenog NOEL.
English: A decision on whether to discontinue breast-feeding or to discontinue alogliptin therapy should be made taking into account the benefit of breast-feeding for the child and the benefit of alogliptin therapy for the woman.
Croatian: Potrebno je odlučiti o prekidu dojenja ili prekidu terapije alogliptinom uzimajući u obzir korist dojenja za dijete i korist terapije alogliptinom za ženu.
English: Patients should be observed closely for possible liver abnormalities.
Croatian: Bolesnika treba pomno pratiti zbog mogućih abnormalnosti jetre.
English: In case of hypoglycaemia, a lower dose of the thiazolidinedione or metformin may be considered.
Croatian: U slučaju hipoglikemije može se razmotriti niža doza tiazolidindiona ili metformina.
English: There were 703 patients who experienced an event within the secondary MACE composite endpoint (first event of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke and urgent revascularization due to unstable angina).
Croatian: U 703 bolesnika javio se događaj unutar sekundarnog MACE kompozitnog ishoda (prvi događaj kardiovaskularne smrti, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda i hitnog postupka revaskularizacije zbog nestabilne angine).
English: Vipidia may, therefore, be administered with or without food.
Croatian: Vipidia se, stoga, može primjenjivati s hranom ili bez nje.
English: Pack sizes of 10, 14, 28, 30, 56, 60, 84, 90, 98 or 100 film-coated tablets.
Croatian: Veličine pakiranja od 10, 14, 28, 30, 56, 60, 90, 98 ili 100 filmom obloženih tableta.
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 zdravim ispitanicima, volumen distribucije tijekom terminalne faze bio je 417 l što pokazuje da se djelatna tvar dobro distribuira u tkiva.
English: The most common adverse reaction in patients treated with 25 mg alogliptin was headache.
Croatian: Najčešća nuspojava u bolesnika liječenih s 25 mg alogliptina bila je glavobolja.
English: However, as the distribution of AUC values for alogliptin in these patients was within the same range as control subjects, no dose adjustment 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: Vipidia has no or negligible influence on the ability to drive and use machines.
Croatian: Vipidia ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The pharmacokinetics of alogliptin has been shown to be similar in healthy subjects and in patients with type 2 diabetes mellitus.
Croatian: Farmakokinetika alogliptina bila je slična u zdravih ispitanika i bolesnika sa šećernom bolešću tipa 2.
English: As a precautionary measure, it is preferable to avoid the use of alogliptin during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu alogliptina tijekom trudnoće.
English: If you have mildly or moderately reduced liver function, the recommended dose of Vipidia is 25 mg once a day.
Croatian: Ako imate blago ili umjereno smanjenu funkciju jetre, preporučena doza lijeka Vipidia je 25 mg jedanput na dan.
English: DPP-4 is the principal enzyme involved in the rapid degradation of the incretin hormones, glucagon-like peptide-1 (GLP-1) and GIP (glucose-dependent 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 razgradnju 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: However, dosing of alogliptin should be conservative in patients with advanced age due to the potential for decreased renal function in this population.
Croatian: Međutim, u bolesnika starije dobi doziranje alogliptina treba biti konzervativno zbog moguće smanjene funkcije bubrega u toj populaciji.
English: Nervous system disorders headache common
Croatian: Poremećaji živčanog sustava glavobolja često
English: Vipidia contains the active substance alogliptin which belongs to a group of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) which are “oral anti-diabetics”.
Croatian: Vipidia sadrži djelatnu tvar alogliptin koja pripada skupini lijekova koji se zovu DPP-4 inhibitori (inhibitori dipeptidil peptidaze 4) koji su „oralni antidijabetici“.
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 prve jednokratne bila je slična izloženosti tijekom intervala od 6 dana primjene jedanput na dan (AUC(0-24)).
English: Following administration of an oral dose of [14C] alogliptin, 76% of total radioactivity was eliminated in the urine and 13% was recovered in the faeces.
Croatian: Nakon primjene peroralne doze [14C] alogliptina, 76% ukupne radioaktivnosti eliminirano je mokraćom, a 13% stolicom.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8).
Croatian: Preosjetljivost na djelatnu tvar ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1 ili s teškom reakcijom preosjetljivosti u anamnezi, uključujući anafilaktičku reakciju, anafilaktički šok i angioedem, na bilo koji inhibitor dipeptidil-peptidaze-4 (DPP-4) (vidjeti dijelove 4.4 i 4.8).
English: Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
Croatian: Alogliptin se prvenstveno izlučuje nepromijenjen u mokraći, a metabolizam putem enzimskog sustava citokroma (CYP) P450 mu je zanemariv (vidjeti dio 5.2.).
English: Pharmacotherapeutic group: Drugs used in diabetes; dipeptidyl peptidase 4 (DPP-4) inhibitors.
Croatian: Farmakoterapijska skupina: lijekovi za liječenje šećerne bolesti; inhibitori dipeptidil-peptidaze-4 (DPP-4).
English: The efficacy and safety of the recommended doses of alogliptin were investigated separately in a subgroup of patients with type 2 diabetes mellitus and severe renal impairment/end-stage renal disease in a placebo-controlled study (59 patients on alogliptin and 56 patients on placebo for 6 months) and found to be consistent with the profile obtained in patients with normal renal function.
Croatian: Djelotvornost i sigurnost preporučenih doza alogliptina zasebno su ispitane u podskupini bolesnika sa šećernom bolešću tipa 2 i teškim oštećenjem bubrega/završnim stadijem bolesti bubrega u placebom kontroliranom ispitivanju (59 bolesnika na alogliptinu i 56 bolesnika na placebu tijekom 6 mjeseci), te je nađeno da dosljedno odgovaraju profilu dobivenom u bolesnika s normalnom funkcijom bubrega.
English: Higher doses of alogliptin decreased offspring body weight and exerted some developmental effects considered secondary to the low body weight.
Croatian: Više doze alogliptina smanjile su tjelesnu težinu mladunčadi te dovele do razvojnih učinaka koji se smatraju posljedicom niske tjelesne težine.
English: Monotherapy placebo-controlled study
Croatian: Ispitivanje monoterapije kontrolirano placebom
English: In a clinical study of alogliptin as mono-therapy, the incidence of hypoglycaemia was similar to that of placebo, and lower than placebo in another study as add-on to a sulphonylurea.
Croatian: U kliničkom ispitivanju alogliptina kao monoterapije, incidencija hipoglikemije bila je slična kao za placebo, odnosno niža nego za placebo u drugom ispitivanju alogliptina kao dodatka sulfonilureji.
English: Results from studies with metformin, pioglitazone (thiazolidinedione), voglibose (alpha-glucosidase inhibitor) and glyburide (sulphonylurea) have shown no clinically relevant pharmacokinetic interactions.
Croatian: Rezultati iz ispitivanja s metforminom, pioglitazonom (tiazolidindion), voglibozom (inhibitor alfa-glukozidaze) i gliburidom (sulfonilureja) nisu pokazali klinički značajne farmakokinetičke interakcije.
English: The pharmacokinetics of alogliptin in children and adolescents < 18 years old has not been established.
Croatian: Farmakokinetika alogliptina u djece i adolescenata < 18 godina starosti nije utvrđena.
English: The no-observed-adverse-effect level (NOAEL) in the repeated dose toxicity studies in rats and dogs up to 26 and 39 weeks in duration, respectively, produced exposure margins that were approximately 147- and 227-fold, respectively, the exposure in humans at the recommended dose of 25 mg alogliptin.
Croatian: Razina bez opaženih štetnih učinaka (eng. no-observed-adverse-effect level - NOAEL) u ispitivanjima toksičnosti ponovljenih doza u štakora i pasa u trajanju do 26 i 39 tjedana pokazala je granice izloženosti koje su približno 147, odnosno 227 puta veće od izloženost koja se kod ljudi postiže pri preporučenoj dozi od 25 mg alogliptina.
English: Hypersensitivity reactions, including anaphylactic reactions, angioedema and exfoliative skin conditions including Stevens-Johnson syndrome and erythema multiforme have been observed for DPP-4 inhibitors and have been spontaneously reported for alogliptin in the post-marketing setting.
Croatian: Reakcije preosjetljivosti, uključujući i anafilaktičke reakcije, angioedem i eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom i multiformni eritem opaženi su za DPP-4 inhibitore i spontano su prijavljeni za alogliptin nakon stavljanja lijeka u promet.
English: After administration of single, oral doses of up to 800 mg in healthy subjects, alogliptin was rapidly absorbed with peak plasma concentrations occurring 1 to 2 hours (median Tmax) after dosing.
Croatian: Nakon primjene jednokratnih peroralnih doza do 800 mg u zdravih ispitanika, alogliptin se brzo apsorbirao i postizao vršne koncentracije u plazmi nakon 1 do 2 sata (medijan Tmax) nakon doziranja.
English: There is no experience of using Vipidia in pregnant women or during breast-feeding.
Croatian: Nema iskustava o primjeni lijeka Vipidia u trudnica ili tijekom dojenja.
English: Vipidia is not known to affect your ability to drive and use machines.
Croatian: Nije poznato da Vipidia utječe na sposobnost upravljanja vozilima i strojevima.
English: Polychlorotrifluoroethylene (PCTFE)/polyvinyl chloride (PVC) blisters with push through aluminium lidding foil.
Croatian: Blisteri od poliklorotrifluoroetilen (PCTFE)/polivinil klorida (PVC) sa protisnom aluminijskom folijom.
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 dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjenje u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2
English: Vipidia is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations).
Croatian: Vipidia je indicirana za odrasle u dobi od 18 i više godina sa šećernom bolešću tipa 2 za poboljšanje kontrole glikemije u kombinaciji s drugim lijekovima za snižavanje glukoze uključujući inzulin, kad oni zajedno s dijetom i tjelovježbom ne osiguravaju odgovarajuću kontrolu glikemije (vidjeti dijelove 4.4, 4.5 i 5.1 za dostupne podatke o različitim kombinacijama).
English: - A severe allergic reaction: skin lesions or spots on your skin that can progress to a sore surrounded by pale or red rings, blistering and/or peeling of the skin possibly with symptoms such as itching, fever, overall ill feeling, achy joints, vision problems, burning, painful or itchy eyes and mouth sores (Stevens-Johnson syndrome and Erythema multiforme).
Croatian: • Teška alergijska reakcija: oštećenja ili mrlje na koži, koje mogu napredovati do rana okruženih blijedim ili crvenim prstenovima, stvaranje mjehura i/ili ljuštenje kože, moguće sa simptomima poput svrbeža, vrućice, općeg lošeg osjećanja, bolnih zglobova, problema s vidom, pečenja, boli ili svrbeža očiju, te rana po sluznici usta (Stevens-Johnsonov sindrom i multiformni eritem).
English: If you stop taking Vipidia
Croatian: Ako prestanete uzimati lijek Vipidia
English: Alogliptin was not teratogenic in rats or rabbits with a systemic exposure at the NOAELs far above the human exposure at the recommended dose.
Croatian: Alogliptin nije bio teratogen u štakora ili kunića pri sistemskoj izloženosti na razinama NOAEL daleko iznad izloženosti kod ljudi pri preporučenoj dozi.
English: In the cardiovascular outcomes study the rates of pancreatitis reports in patients treated with alogliptin or placebo were 3 or 2 events per 1,000 patient years, respectively.
Croatian: U ispitivanjima kardiovaskularnih ishoda stopa prijavljenih pankreatitisa u bolesnika liječenih alogliptinom ili placebom bila je 3 odnosno 2 događaja na 1000 bolesnik godina.
English: Additional symptoms may include general itching and feeling of heat especially affecting the scalp, mouth, throat, palms of hands and soles of feet (Stevens-Johnson syndrome).
Croatian: Dodatni simptomi mogu uključivati opći svrbež i osjećaj vrućine koji posebice zahvaća vlasište, usta, grlo, dlanove ruku i tabane nogu (Stevens-Johnsonov sindrom).
English: Alogliptin may be administered without regard to the timing of dialysis.
Croatian: Alogliptin se može primjenjivati bez obzira na vrijeme dijalize.
English: No clinically relevant accumulation after multiple dosing was observed in either healthy subjects or in patients with type 2 diabetes mellitus.
Croatian: Nakon višestrukog doziranja nije opažena klinički značajna akumulacija ni u zdravih ispitanika niti u bolesnika sa šećernom bolešću tipa 2.
English: Alogliptin as monotherapy
Croatian: Alogliptin kao monoterapija
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 84 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 84 filmom obloženih tableta 90 filmom obloženih tableta 98 filmom obloženih tableta 100 filmom obloženih tableta
English: Higher rates of hypoglycaemia were observed with triple therapy with thiazolidinedione and metformin and in combination with insulin, as observed with other DPP-4 inhibitors.
Croatian: Više stope hipoglikemije opažene su s trojnom terapijom s tiazolidindionom i metforminom, te u kombinaciji s inzulinom, kako je opaženo i s drugim DPP-4 inhibitorima.
English: If you forget to take Vipidia
Croatian: Ako ste zaboravili uzeti lijek Vipidia
English: Shellac Iron oxide black (E172)
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172)
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Croatian: Nakon primjene peroralne doze [14C] alogliptina pronađena su dva manje zastupljena metabolita, N-demetilirani alogliptin, M-I (<1% izvornog spoja) i N-acetilirani alogliptin, M-II (<6% izvornog spoja).
English: Gastrointestinal disorders abdominal pain common gastroesophageal reflux disease common diarrhoea common acute pancreatitis not known
Croatian: Poremećaji probavnog sustava bol u abdomenu gastroezofagealna refluksna bolest diareja akutni pankreatitis često često često nepoznato
English: Taking Vipidia in combination with other anti-diabetic medicines called sulphonylureas, insulin or combination therapy with thiazolidinedione plus metformin can cause too low blood sugar levels (hypoglycaemia), which may affect your ability to drive and use machines.
Croatian: Uzimanje lijeka Vipidia u kombinaciji s drugim lijekovima za šećernu bolest zvanim sulfonilureje, inzulinom ili kombiniranom terapijom s tiazolidindionom uz metformin može uzrokovati preniske razine šećera u krvi (hipoglikemija), što može utjecati na sposobnost upravljanja vozilima i strojevima.
English: A single-dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis.
Croatian: Jednokratna doza od 50 mg alogliptina primijenjena je u 4 skupine bolesnika s različitim stupnjevima oštećenja bubrega (CrCl prema Cockcroft-Gault formuli): blago (CrCl = > 50 do ≤ 80 ml/min), umjereno (CrCl = ≥ 30 do ≤ 50 ml/min), teško (CrCl = < 30 ml/min) i završni stadij bolesti bubrega na hemodijalizi.
English: Administration of 25 mg alogliptin to patients with type 2 diabetes mellitus produced peak inhibition of DPP-4 within 1 to 2 hours and exceeded 93% both after a single 25 mg dose and after 14 days of once-daily dosing.
Croatian: Primjenom 25 mg alogliptina u bolesnika sa šećernom bolešću tipa 2 postignut je maksimum inhibicije DPP-4 unutar 1 do 2 sata koji prelazi 93% i nakon primjene jednokratne doze od 25 mg i nakon 14 dana doziranja jedanput na dan.
English: Adverse reaction Infections and infestations upper respiratory tract infections common nasopharyngitis common
Croatian: Infekcije i infestacije infekcije gornjeg respiratornog trakta nazofaringitis često često
English: Skin and subcutaneous tissue disorders pruritus common rash common exfoliative skin conditions including Stevens-Johnson syndrome erythema multiforme not known not known angioedema not known urticaria not known
Croatian: Poremećaji kože i potkožnog tkiva pruritis osip eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom multiformni eritem angioedem urtikarija često često nepoznato nepoznato nepoznato nepoznato
English: Primary Composite Endpoint [First Event of CV Death, Nonfatal MI and Nonfatal Stroke]
Croatian: Primarni kompozitni ishod [prvi događaj KV smrti, IM bez smrtnog ishoda i moždanog udara bez smrtnog ishoda]
English: However patients should be alerted to the risk of hypoglycaemia especially when combined with a sulphonylurea, insulin or combination therapy with thiazolidinedione plus metformin.
Croatian: Bolesnike međutim treba upozoriti na rizik od hipoglikemije, naročito kad se kombinira sa sulfonilurejom, inzulinom ili kombiniranom terapijom s tiazolidindionom i metforminom.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda
English: Animal studies have shown excretion of alogliptin in milk (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su da se alogliptin izlučuje u mlijeko (vidjeti dio 5.3).
English: For patients with severe renal impairment (CrCl < 30 mL/min) or end-stage renal disease requiring dialysis, one-quarter of the recommended dose of alogliptin should be administered (6.25 mg once daily).
Croatian: U bolesnika s teškim oštećenjem bubrega (CrCl < 30 ml/min) ili završnim stadijem bolesti bubrega koji zahtijevaju dijalizu potrebno je primijeniti jednu četvrtinu preporučene doze alogliptina (6,25 mg jedanput na dan).
English: In addition, a cardiovascular outcomes study with 5,380 patients with type 2 diabetes mellitus and a recent acute coronary syndrome event was conducted with 2,701 randomised to alogliptin and 2,679 randomised to placebo.
Croatian: Dodatno je provedeno ispitivanje kardiovaskularnih ishoda na 5380 bolesnika sa šećernom bolešću tipa 2 i nedavnim događajem akutnog koronarnog sindroma, od kojih je 2701 randomiziran na alogliptin i 2679 na placebo.
English: This was determined by clinically relevant and statistically significant reductions in glycosylated haemoglobin (HbA1c) and fasting plasma glucose compared to control from baseline to study endpoint.
Croatian: To je utvrđeno klinički i statistički značajnim sniženjima glikoziliranog hemoglobina (HbA1c) i glukoze natašte u usporedbi s kontrolnom skupinom od početne vrijednosti do ishoda ispitivanja.
English: Importantly, despite alogliptin and glipizide having similar HbA1c and fasting plasma glucose changes from baseline, episodes of hypoglycaemia were notably less frequent in patients receiving 25 mg alogliptin (5.4%) compared to those receiving glipizide (26.0%).
Croatian: Značajno je da su, iako alogliptin i glipizid postižu sličnu promjenu HbA1c i glukoze u plazmi natašte, epizode hipoglikemije bile značajno manje učestale u bolesnika koji su primali 25 mg alogliptina (5,4%) u usporedbi s onima koji su primali glipizid
English: For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of alogliptin is necessary (see section 5.2).
Croatian: U bolesnika s blagim oštećenjem bubrega (klirens kreatinina (CrCl) > 50 do ≤ 80 ml/min) nije potrebna prilagodba doze alogliptina (vidjeti dio 5.2).
English: If you forget to take a dose, take it as soon as you remember it. Do not take a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili uzeti dozu, uzmite je čim se sjetite.
English: (-infinity, 0.059)
Croatian: (-beskonačno; 0,059)