FrancophonIA/ELRC3.0 huggingface dataset:
English: If you miss a meal, skip that dose of Starlix and wait until your next meal.
Croatian: Ako preskočite obrok, preskočite tu dozu Starlixa i čekajte do sljedećeg obroka.
English: • Pregnancy and breast-feeding (see section 4.6)
Croatian: • trudnica ili dojilja (vidjeti dio 4.6)
English: Macrogol
Croatian: Makrogol
English: This depolarises the beta cell and leads to an opening of the calcium channels.
Croatian: To depolarizira beta stanice i vodi do otvaranja kalcijevih kanala.
English: Some people are more likely to get symptoms of low blood sugar than others.
Croatian: Kod nekih osoba veća je vjerojatnost da će imati simptome niskog šećera u krvi nego kod drugih.
English: What Starlix is and what it is used for
Croatian: Što je Starlix i za što se koristi
English: No clinically significant differences in nateglinide pharmacokinetics were observed between men and women.
Croatian: Nisu bile uočene nikakve klinički značajne razlike u farmakokinetici nateglinida između muškaraca i žena.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to fertility and post-natal development.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i toksičnosti za plodnost i postnatalni razvoj.
English: When given post-prandially, the extent of nateglinide absorption (AUC) remains unaffected.
Croatian: Kada se daje nakon obroka, opseg apsorpcije nateglinida (AUC) ostaje nepromijenjen.
English: Starlix works by stimulating the pancreas to produce insulin more quickly, which helps to keep blood sugar levels under control after meals.
Croatian: Starlix djeluje tako što stimulira gušteraču da brže proizvodi inzulin, što pomaže održavati razine šećera u krvi pod kontrolom nakon obroka.
English: Although safety was not compromised in this population dose adjustment may be required in view of low Cmax.
Croatian: Iako sigurnost nije bila kompromitirana u ovoj populaciji, može biti potrebno prilagođavanje doze s obzirom na niski Cmax.
English: However, there is a delay in the rate of absorption characterised by a decrease in Cmax and a delay in time to peak plasma concentration (tmax).
Croatian: Međutim, postoji odgoda u brzini apsorpcije koja je karakterizirana smanjenjem Cmax i odgodom u vremenu do vršne koncentracije u plazmi (tmax).
English: Interaction studies with a CYP3A4 inhibitor have not been carried out in vivo.
Croatian: Ispitivanja interakcije s CYP3A4 inhibitorom nisu bila provođena in vivo.
English: There are no data available on the use of nateglinide in patients under 18 years of age, and therefore its use in this age group is not recommended.
Croatian: Nema dostupnih podataka o primjeni nateglinida u bolesnika mlađih od 18 godina te se stoga ne preporučuje njegova primjena u ovoj dobnoj skupini.
English: - Diuretics (used to treat high blood pressure).
Croatian: - diuretike (koji se koriste za liječenje visokog krvnog tlaka).
English: At such times, it may be necessary to discontinue oral hypoglycaemic treatment and replace it with insulin on a temporary basis.
Croatian: U takvim okolnostima može biti potrebno prekinuti terapiju oralnim hipoglikemikom i privremeno je zamijeniti inzulinom.
English: Do not use any Starlix pack that is damaged or shows signs of tampering.
Croatian: Ne koristite niti jedno pakiranje Starlixa koje je oštećeno ili na kojem su vidljivi znakovi otvaranja.
English: As nateglinide is highly protein-bound, dialysis is not an efficient means of removing it from the blood.
Croatian: Budući da je nateglinid vezan za proteine u visokom postotku, dijaliza nije učinkovit način uklanjanja nateglinida iz krvi.
English: There is no experience in pregnant women, therefore the safety of Starlix in pregnant women cannot be assessed.
Croatian: Nema iskustva s trudnicama, pa se stoga sigurnost Starlixa u trudnica ne može ocijeniti.
English: The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
Croatian: Količina Starlixa koja Vam je potrebna može se promijeniti ako uzimate druge lijekove, budući da oni mogu uzrokovati povišenje ili sniženje razine šećera u krvi.
English: - Somatropin (a growth hormone).
Croatian: - somatropin (hormon rasta).
English: Post-marketing data revealed very rare cases of erythema multiforme.
Croatian: Podaci nakon stavljanja lijeka na tržište otkrili su vrlo rijetke slučajeve eritema multiforme.
English: If any of these apply to you, monitor your blood sugar levels more carefully.
Croatian: Ako išta od navedenoga vrijedi za Vas, pažljivije pratite razinu šećera u svojoj krvi.
English: It is best to take it right before a main meal but you can take it up to 30 minutes before.
Croatian: Najbolje je uzimati lijek neposredno prije obroka, ali možete ga uzeti i do 30 minuta prije.
English: Consistent with its short elimination half-life, there is no apparent accumulation of nateglinide upon multiple dosing with up to 240 mg three times daily.
Croatian: Sukladno njegovom kratkom poluvremenu eliminacije, nema vidljivog nakupljanja nateglinida nakon uzimanja višestrukih doza do 240 mg triput na dan.
English: Your treatment may need to be adjusted.
Croatian: Možda će trebati prilagoditi Vašu terapiju.
English: Nateglinide has shown a low potential for protein displacement in in vitro studies.
Croatian: Nateglinid je pokazao niski potencijal za istiskivanje proteina u in vitro ispitivanjima.
English: M1 concentration decreased markedly after haemodialysis.
Croatian: Koncentracija M1 se primjetno snizila nakon hemodijalize.
English: If you have low blood sugar you may experience sweating, tremors (feeling shaky), anxiety, difficulty concentrating, confusion, weakness or fainting or have other signs listed in section 4, “Possible side effects”.
Croatian: Ako imate niski šećer u krvi, možete iskusiti znojenje, nevoljno drhtanje, tjeskobu, poteškoće u koncentraciji, smetenost, slabost ili nesvjesticu ili imati druge znakove navedene u dijelu 4, „Moguće nuspojave“.
English: In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful titration is required to avoid hypoglycaemic reactions.
Croatian: U oslabljenih ili pothranjenih bolesnika početna doza i doza za održavanje trebaju biti konzervativne i potrebna je pažljiva titracija kako bi se izbjegle hipoglikemijske reakcije.
English: In a clinical study in patients, Starlix was administered in increasing doses up to 720 mg a day for 7 days and was well tolerated.
Croatian: U kliničkom ispitivanju provedenom na bolesnicima, Starlix se primjenjivao u rastućim dozama do 720 mg dnevno tijekom 7 dana i dobro se podnosio.
English: Patients should be advised to take precautions to avoid hypoglycaemia whilst driving.
Croatian: Bolesnicima treba savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju dok voze.
English: Although M1 metabolites show only slight hypoglycaemic activity (approximately 5 times lower than nateglinide), metabolite accumulation might increase the hypoglycaemic effect of the administered dose.
Croatian: Iako M1 metaboliti pokazuju samo blagu hipoglikemijsku aktivnost (približno 5 puta nižu od nateglinida), nakupljanje metabolita moglo bi povećati hipoglikemijski učinak primijenjene doze.
English: Pharmacotherapeutic group: D-phenylalanine derivative, ATC code: A10 BX 03
Croatian: Farmakoterapijska skupina: derivat D-fenilalanina, ATK oznaka: A10 BX 03
English: The dosage of nateglinide should be determined by the physician according to the patient's requirements.
Croatian: Dozu nateglinida treba odrediti liječnik u skladu s bolesnikovim potrebama.
English: If you take more Starlix than you should
Croatian: Ako uzmete više Starlixa nego što ste trebali
English: When a patient stabilised on any oral hypoglycaemic agent is exposed to stress such as fever, trauma, infection or surgery, a loss of glycaemic control may occur.
Croatian: Kada se bolesnik stabiliziran bilo kojim oralnim hipoglikemikom izloži stresu kao što je vrućica, trauma, infekcija ili kirurški zahvat, može doći do gubitka kontrole glikemije.
English: Take Starlix before meals.
Croatian: Starlix uzimajte prije obroka.
English: These are symptoms of low blood sugar (hypoglycaemia), which are usually mild.
Croatian: To su simptomi niske razine šećera u krvi (hipoglikemije) koji su obično blagi.
English: Oral antidiabetics, including Starlix, may also produce symptoms of hypoglycaemia.
Croatian: Oralni antidijabetici, uključujući Starlix, također mogu prouzročiti simptome hipoglikemije.
English: Do not take Starlix - if you are allergic to nateglinide or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Starlix - ako ste alergični na nateglinid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate šećernu bolest tipa 1 (tj.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Croatian: • s preosjetljivošću na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1
English: This may be increased to 120 mg three times daily.
Croatian: Ta se doza može povećati do 120 mg triput na dan.
English: Insulin is a substance produced in the body by the pancreas.
Croatian: Inzulin je tvar koju u tijelu proizvodi gušterača.
English: What Starlix is and what it is used for What you need to know before you take Starlix How to take Starlix
Croatian: Što je Starlix i za što se koristi Što morate znati prije nego počnete uzimati Starlix Kako uzimati Starlix
English: Starlix is contraindicated in patients with:
Croatian: Starlix je kontraindiciran u bolesnika:
English: Symptoms of hypoglycaemia (unconfirmed by blood glucose levels) were observed in patients whose baseline HbA1c was close to the therapeutic target (HbA1c <7.5%).
Croatian: Simptomi hipoglikemije (koja nije bila potvrđena razinama glukoze u krvi) bili su uočeni u bolesnika čiji je početni HbA1c bio blizu cilju terapije (HbA1c <7,5%).
English: There is no experience of an overdose of Starlix in clinical trials.
Croatian: Nema iskustava predoziranja Starlixom u kliničkim ispitivanjima.
English: This is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia.
Croatian: To je osobito važno kod onih koji imaju smanjenu ili nikakvu svijest o znakovima upozorenja za hipoglikemiju ili koji imaju učestale epizode hipoglikemije.
English: As patients with severe liver disease were not studied, nateglinide is contraindicated in this group.
Croatian: Budući da bolesnici s teškom bolešću jetre nisu ispitivani, nateglinid je u toj skupini kontraindiciran.
English: Although it is not known whether nateglinide is excreted in human milk, the potential for hypoglycaemia in breast-fed infants may exist and therefore nateglinide should not be used in lactating women.
Croatian: Iako nije poznato izlučuje li se nateglinid u majčinom mlijeku u ljudi, može postojati mogućnost hipoglikemije u dojenčadi, pa se stoga nateglinid ne smije koristiti u dojilja.
English: The effect of Starlix on the ability to drive or operate machinery has not been studied.
Croatian: Utjecaj Starlixa na sposobnost upravljanja vozilima ili rada sa strojevima nije do sada bio ispitivan.
English: Your doctor will prescribe Starlix together with metformin, if inadequately controlled despite a maximally tolerated dose of metformin.
Croatian: Liječnik će Vam propisati Starlix zajedno s metforminom, ako je nedovoljno kontrolirana usprkos najvećoj podnošljivoj dozi metformina.
English: The steady-state volume of distribution of nateglinide based on intravenous data is estimated to be approximately 10 litres.
Croatian: Procjenjuje se da je volumen distribucije nateglinida u stanju dinamičke ravnoteže na temelju intravenskih podataka otprilike 10 litara.
English: Combination with metformin is associated with an increased risk of hypoglycaemia compared to monotherapy.
Croatian: Kombinacija s metforminom povezana je s povećanim rizikom od hipoglikemije u usporedbi s monoterapijom.
English: Electrophysiological studies demonstrate that nateglinide has 45-300-fold selectivity for pancreatic beta cell versus cardiovascular K
Croatian: Elektrofiziološka ispitivanja pokazuju da nateglinid ima 45-300 puta veću selektivnost za beta stanice gušterače u odnosu na kardiovaskularne K
English: CYP2C9 and CYP3A4 substrates
Croatian: Supstrati CYP2C9 i CYP3A4
English: Dose adjustments should be based on periodic glycosylated haemoglobin (HbA1c) measurements.
Croatian: Prilagođavanja doze trebaju se temeljiti na periodičkim mjerenjima glikoziliranog hemoglobina (HbA1c).
English: Nateglinide should not be used in monotherapy.
Croatian: Općenito Nateglinid se ne smije koristiti u monoterapiji.
English: These were generally mild in nature and easily handled by intake of carbohydrates when necessary.
Croatian: Ti su simptomi općenito bili blagi i lako su se rješavali unosom ugljikohidrata prema potrebi.
English: Do not take Starlix if you are pregnant or planning to become pregnant.
Croatian: Ne uzimajte Starlix ako ste trudni ili planirate zatrudnjeti.
English: You should ask for doctor advice on driving if you have frequent episodes of hypoglycaemia or if you are not aware of the first signs of hypoglycaemia.
Croatian: Obratite se svom liječniku za savjet o upravljanju vozilom ako imate česte epizode hipoglikemije ili ako niste svjesni prvih znakova hipoglikemije.
English: • Very rare (may affect up to 1 in 10,000 people): skin rash with blisters affecting the lips, eyes and/or mouth, sometimes with headache, fever and/or diarrhoea
Croatian: • vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): kožni osip i mjehuriće na usnicama, očima i/ili ustima, ponekad uz glavobolju, vrućicu i/ili proljev.
English: Do not breast-feed during treatment with Starlix.
Croatian: Nemojte dojiti za vrijeme liječenja Starlixom.
English: The efficacy of nateglinide in combination with metformin has been compared to the combination of gliclazide plus metformin in a 6-month randomised, double-blind trial in 262 patients using a superiority design.
Croatian: Djelotvornost nateglinida u kombinaciji s metforminom bila je uspoređena s kombinacijom gliklazid plus metformin u šestomjesečnom randomiziranom, dvostruko slijepom ispitivanju na 262 bolesnika s ciljem dokazivanja superiornosti.
English: Nateglinide is rapidly and almost completely ( 90%) absorbed from an oral solution.
Croatian: Nateglinid se apsorbira brzo i gotovo u potpunosti (90%) iz oralne otopine.
English: In vitro studies show that nateglinide is extensively bound (97-99%) to serum proteins, mainly serum albumin and to a lesser extent alpha1-acid glycoprotein.
Croatian: In vitro ispitivanja pokazuju da se nateglinid veže u visokom postotku (97-99%) za serumske proteine, uglavnom serumski albumin i u manjoj mjeri alfa1-kiseli glikoprotein.
English: When these medicinal products - that enhance or reduce the hypoglycaemic effect of nateglinide - are administered to or withdrawn from patients receiving nateglinide, the patient should be observed closely for changes in glycaemic control.
Croatian: Kada se ti lijekovi - koji pojačavaju ili smanjuju hipoglikemijski učinak nateglinida - daju ili prestanu davati bolesnicima koji primaju nateglinid, bolesnika treba pažljivo promatrati zbog eventualnih promjena u kontroli glikemije.
English: What Starlix contains - The active substance is nateglinide.
Croatian: Što Starlix sadrži - Djelatna tvar je nateglinid.
English: Nateglinide is an amino acid (phenylalanine) derivative, which is chemically and pharmacologically distinct from other antidiabetic agents.
Croatian: Nateglinide je derivat aminokiseline (fenilalanina), koji se kemijski i farmakološki razlikuje od ostalih antidijabetika.
English: Early insulin secretion is a mechanism for the maintenance of normal glycaemic control.
Croatian: Rana sekrecija inzulina je mehanizam za održavanje normalne glikemijske kontrole.
English: If you do get symptoms of low blood sugar, eat or drink something containing sugar.
Croatian: Ako primijetite simptome niske razine šećera u krvi, pojedite ili popijte nešto što sadrži šećer.
English: The extent of serum protein binding is independent of drug concentration over the test range of 0.1-10 g Starlix/ml.
Croatian: Opseg vezanja za serumske proteine ne ovisi o koncentraciji lijeka u ispitanom rasponu od 0,1-10 g Starlixa/ml.
English: The risk of hypoglycaemia in type 2 diabetic patients may be increased by strenuous physical exercise, or ingestion of alcohol.
Croatian: Rizik od hipoglikemije u bolesnika sa šećernom bolešću tipa 2 može se povećati napornom fizičkom aktivnošću ili konzumiranjem alkohola.
English: Nateglinide is rapidly absorbed following oral administration of Starlix tablets prior to a meal, with mean peak drug concentration generally occurring in less than 1 hour.
Croatian: Nateglinid se brzo apsorbira nakon peroralne primjene tableta Starlixa prije obroka, pri čemu do srednje vršne koncentracije lijeka općenito dolazi za manje od 1 sata.
English: Based on the experience with nateglinide and with other hypoglycaemic agents, the following adverse reactions have been seen.
Croatian: Na temelju iskustva s nateglinidom i drugim hipoglikemijskim tvarima, uočene su sljedeće nuspojave.
English: Diabetic patients may develop symptoms associated with low blood sugar (also called hypoglycaemia).
Croatian: Bolesnici sa šećernom bolešću mogu razviti simptome povezane s niskim šećerom u krvi (što se naziva i hipoglikemijom).
English: If you experience symptoms of low blood sugar (listed in section 4, “Possible side effects”), eat or drink something containing sugar.
Croatian: Ako primijetite simptome niskog šećera u krvi (navedene u dijelu 4., „Moguće nuspojave“), pojedite ili popijte nešto što sadrži šećer.
English: This results in a blood-glucose-lowering effect throughout the meal period.
Croatian: To ima za posljedicu učinak snižavanja glukoze u krvi tijekom razdoblja obroka.
English: Hypoglycaemia has been observed in patients with type 2 diabetes on diet and exercise, and in those treated with oral antidiabetic agents (see section 4.8).
Croatian: Hipoglikemija je bila uočena u bolesnika sa šećernom bolešću tipa 2 koji su na dijeti i fizički su aktivni, te u onih liječenih oralnim antidijabeticima (vidjeti dio 4.8).
English: In rabbits, embryonic development was adversely affected and the incidence of gallbladder agenesis or small gallbladder was increased at doses of 300 and 500 mg/kg (approximately 24 and 28 times the human therapeutic exposure with a maximum recommended nateglinide dose of 180 mg, three times daily before meals), but not at 150 mg/kg (approximately 17 times the human therapeutic exposure with a maximum recommended nateglinide dose of 180 mg, three times daily before meals).
Croatian: U zečeva je došlo do štetnog utjecaja na razvoj embrija, a učestalost ageneze žučnog mjehura ili malog žučnog mjehura bila je povećana pri dozama od 300 i 500 mg/kg (približno 24 i 28 puta većim od terapijskih doza u ljudi s maksimalnom preporučenom dozom nateglinida od 180 mg, triput na dan prije obroka), ali ne pri dozi od 150 mg/kg (približno 17 puta većoj od terapijskih doza u ljudi, s maksimalnom preporučenom dozom nateglinida od 180 mg triput na dan prije obroka).
English: Since the primary therapeutic effect of Starlix is to reduce mealtime glucose (a contributor to HbA1c), the therapeutic response to Starlix may also be monitored with 1-2 hour post-meal glucose.
Croatian: Budući da je primarni terapijski učinak Starlixa snižavanje glukoze u vrijeme obroka (koja doprinosi HbA1c), terapijski odgovor na Starlix može se pratiti i mjerenjem glukoze 1-2 sata nakon obroka.
English: The main metabolites found in humans result from hydroxylation of the isopropyl side-chain, either on the methine carbon, or one of the methyl groups; activity of the main metabolites is about 5-6 and 3 times less potent than nateglinide, respectively.
Croatian: Glavni metaboliti koji se nalaze u ljudi rezultat su hidroksilacije postraničnog lanca izopropila, ili na metinski ugljik, ili na jednu od metilnih grupa; aktivnost glavnih metabolita je oko 5-6 odnosno 3 puta manje snažna od one nateglinida.
English: In completed clinical trials, symptoms of hypoglycaemia were reported in 10.4% with nateglinide monotherapy, 14.5% with nateglinide+metformin combination, 6.9% with metformin alone, 19.8% with glibenclamide alone, and 4.1% with placebo.
Croatian: U završenim kliničkim ispitivanjima simptomi hipoglikemije bili su prijavljeni u 10,4% kod monoterapije nateglinidom, 14,5% kod kombinacije nateglinid+metformin, 6,9% kod samog metformina, 19,8% kod samog glibenklamida, te 4,1% kod placeba.
English: In an interaction trial with sulfinpyrazone, a CYP2C9 inhibitor, a modest increase in nateglinide AUC (~28%) was observed in healthy volunteers, with no changes in the mean Cmax and elimination half-life.
Croatian: U ispitivanju interakcije sa sulfinpirazonom, CYP2C9 inhibitorom, uočeno je blago povećanje AUC-a nateglinida (~28%) u zdravih dobrovoljaca, bez promjena u srednjem Cmax i poluvremenu eliminacije.
English: Similarly, there was no clinically significant pharmacokinetic interaction of Starlix with other oral antidiabetic agents such as metformin or glibenclamide.
Croatian: Slično tome, nije bilo klinički značajne farmakokinetičke interakcije Starlixa s drugim antidijabeticima kao što su metformin ili glibenklamid.
English: The recommended starting dose is 60 mg three times daily before meals, particularly in patients who are near goal HbA1c.
Croatian: Preporučena početna doza je 60 mg triput na dan prije obroka, osobito u bolesnika koji su blizu postizanja ciljnog HbA1c.
English: Hypoglycaemic symptoms without loss of consciousness or neurological findings should be treated with oral glucose and adjustments in dosage and/or meal patterns.
Croatian: Simptome hipoglikemije bez gubitka svijesti ili neuroloških nalaza treba liječiti oralnom glukozom i prilagodbama u doziranju i/ili načinu uzimanja obroka.
English: Plasma concentrations decline rapidly and the elimination half-life of nateglinide typically averaged 1.5 hours in all studies of Starlix in volunteers and type 2 diabetic patients.
Croatian: Koncentracije u plazmi brzo se smanjuju, a poluvrijeme eliminacije nateglinida obično je bilo u prosjeku 1,5 sat u svim ispitivanjima Starlixa na dobrovoljcima i bolesnicima sa šećernom bolešću tipa 2.
English: Most of the [14C] nateglinide is excreted in the urine (83%), with an additional 10% eliminated in the faeces.
Croatian: C] nateglinida izlučuje se u urinu (83%), uz dodatnih 10% koji se eliminiraju putem stolice.
English: Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
English: What you need to know before you take Starlix
Croatian: Što morate znati prije nego počnete uzimati Starlix
English: Patients with severe renal impairment (see section 5.2) who have not undergone haemodialysis are more susceptible to the glucose-lowering effect of Starlix.
Croatian: Bolesnici s teškim oštećenjem bubrega (vidjeti dio 5.2) koji nisu bili na hemodijalizi više su podložni sniženju glukoze, učinku lijeka Starlix.
English: Elderly Age did not influence the pharmacokinetic properties of nateglinide.
Croatian: Starije osobe Starosna dob nije utjecala na farmakokinetička svojstva nateglinida.
English: However, an overdose may result in an exaggerated glucose-lowering effect, with the development of hypoglycaemic symptoms.
Croatian: Međutim, predoziranje može za posljedicu imati prenaglašeni učinak snižavanja glukoze, s razvojem simptoma hipoglikemije.