FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects and restrictions with Saxenda, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Saxenda potražite u uputi o lijeku.
English: It is especially important to mention the following:
Croatian: Osobito je važno spomenuti sljedeće:
English: Your body can also make too much sugar.
Croatian: Vaše tijelo također može proizvoditi previše šećera.
English: • twice daily by mouth
Croatian: • dvaput na dan kroz usta
English: • Take one tablet:
Croatian: • Uzmite jednu tabletu:
English: The expiry date refers to the last day of the month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: Consider the benefits and risks of concomitant use.
Croatian: Razmotrite koristi i rizike istodobne primjene.
English: Ristfor with alcohol
Croatian: Ristfor s alkoholom
English: If you miss a dose, take it as soon as you remember.
Croatian: Propustite li dozu, uzmite je čim se sjetite.
English: What Ristfor is and what it is used for
Croatian: Što je Ristfor i za što se koristi
English: Component of a multi-pack, can't be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati odvojeno.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 16 December 2014
Croatian: Datum posljednje obnove: 16. prosinca 2014.
English: An updated RMP should be submitted
Croatian: Ažurirani RMP treba dostaviti:
English: The safety and efficacy of Ristfor in children and adolescents from birth to < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Ristfor u djece i adolescenata od rođenja do < 18 godina nisu ustanovljene.
English: • digoxin (to treat irregular heart beat and other heart problems).
Croatian: • digoksin (za liječenje nepravilnog srčanog ritma i drugih problema sa srcem).
English: Ristfor should not be used during pregnancy.
Croatian: Ristfor se ne smije uzimati tijekom trudnoće.
English: What you need to know before you take Ristfor
Croatian: Što morate znati prije nego počnete uzimati Ristfor
English: Ristfor is contraindicated in patients with:
Croatian: Ristfor je kontraindiciran u bolesnika:
English: If you stop taking Ristfor, your blood sugar may rise again.
Croatian: Ako prestanete uzimati Ristfor, razina šećera u krvi može ponovno porasti.
English: You should not take this medicine during pregnancy or if you are breast-feeding.
Croatian: Ne smijete uzimati ovaj lijek tijekom trudnoće ili ako dojite.
English: p< 0.001 compared to placebo or placebo + combination treatment.
Croatian: p < 0,001 u usporedbi s placebom ili placebom + kombiniranim liječenjem.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Croatian: GFR je potrebno procijeniti prije početka liječenja i redovito nakon toga (vidjeti dio 4.2).
English: Data from the 73 % of patients who were taking metformin are presented in Table 2.
Croatian: Podaci za 73% bolesnika koji su uzimali i metformin prikazani su u Tablici 2.
English: What is type 2 diabetes?
Croatian: Što je šećerna bolest tip 2?
English: Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose.
Croatian: Ove su reakcije nastupile unutar prva 3 mjeseca nakon početka liječenja sitagliptinom, a u nekim slučajevima prijavljene su nakon prve doze.
English: • Your doctor may need to increase your dose to control your blood sugar.
Croatian: • Liječnik će možda trebati povisiti dozu lijeka kako bi kontrolirao Vaš šećer u krvi.
English: The clinical relevance of this decrease is unknown.
Croatian: Nije poznat klinički značaj tog smanjenja.
English: What Ristfor looks like and contents of the pack
Croatian: Kako Ristfor izgleda i sadržaj pakiranja
English: Uncommon: dry mouth, headache
Croatian: Manje često: suha usta, glavobolja
English: Sitagliptin was not carcinogenic in mice.
Croatian: Sitagliptin nije bio karcinogen u miševa.
English: Adults with normal renal function (GFR ≥ 90 mL/min)
Croatian: Odrasli s normalnom funkcijom bubrega (GFR≥90 ml/min)
English: This medicine helps to increase the levels of insulin produced after a meal and lowers the amount of sugar made by your body.
Croatian: Ovaj lijek pomaže povisiti razine inzulina koji se proizvodi nakon obroka i snižava količinu šećera kojeg proizvodi Vaše tijelo.
English: There is no experience with doses above 800 mg in clinical studies.
Croatian: Nema iskustava s dozama višim od 800 mg u kliničkim ispitivanjima.
English: If you stop taking Ristfor
Croatian: Ako prestanete uzimati Ristfor
English: Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Croatian: Budući da su sigurnosne granice visoke (19 puta više od razine bez učinka), ove se neoplastičke promjene ne smatraju značajnima za situaciju kod ljudi.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Croatian: Šećerna bolest tip 2 je stanje u kojem Vaše tijelo ne proizvodi dovoljno inzulina, a inzulin kojeg Vaše tijelo proizvede ne djeluje kako bi trebao.
English: A limited amount of data suggests the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Croatian: Ograničena količina podataka ukazuje na to da primjena metformina u trudnica nije povezana s povećanim rizikom od kongenitalnih malformacija.
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Croatian: Stariji ispitanici (65 do 80 godina) imali su približno 19% više koncentracije sitagliptina u plazmi u usporedbi s mlađim ispitanicima.
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) and 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: The fraction of sitagliptin reversibly bound to plasma proteins is low (38 %).
Croatian: Udio sitagliptina reverzibilno vezanog za proteine u plazmi je nizak (38%).
English: • If you have reduced kidney function, your doctor may prescribe a lower dose.
Croatian: • Ako imate smanjenu funkciju bubrega, liječnik Vam može propisati nižu dozu.
English: If acidosis of either form occurs, treatment must be stopped immediately and other appropriate corrective measures initiated.
Croatian: Ako se dogodi acidoza bilo kojeg oblika, mora se odmah prekinuti primjena lijeka i započeti s drugim odgovarajućim korektivnim mjerama.
English: Ristfor contains two different medicines called sitagliptin and metformin.
Croatian: Ristfor sadrži dva različita lijeka koji se zovu sitagliptin i metformin.
English: During treatment with Ristfor, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function.
Croatian: Tijekom liječenja lijekom Ristfor, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: What Ristfor is and what it is used for What you need to know before you take Ristfor How to take Ristfor
Croatian: Što je Ristfor i za što se koristi Što morate znati prije nego počnete uzimati Ristfor Kako uzimati Ristfor
English: The mean Vd ranged between 63 - 276 L.
Croatian: Srednja vrijednost volumena distribucije (Vd) kreće se između 63 - 276 l.
English: STOP taking Ristfor and contact a doctor immediately if you notice any of the following serious side effects:
Croatian: PRESTANITE uzimati Ristfor i odmah se javite liječniku ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: ACE-inhibitors may decrease the blood glucose levels.
Croatian: ACE-inhibitori mogu sniziti razine glukoze u krvi.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Croatian: Vršna koncentracija u krvi je niža nego u plazmi, a postiže se gotovo u isto vrijeme.
English: The red blood cells most likely represent a secondary compartment of distribution.
Croatian: Eritrociti su vrlo vjerojatno sekundarni odjeljak distribucije.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Croatian: O tome treba informirati bolesnika i češće pratiti glukozu u krvi, a osobito na početku liječenja ovim lijekovima.
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju "ketonska tijela" nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
English: • medicines which increase urine production (diuretics)
Croatian: • lijekovi koji povećavaju stvaranje mokraće (diuretici)
English: Your doctor will decide when you must stop and when to restart your treatment with Ristfor.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Ristfor.
English: Your doctor may ask you to stop Ristfor.
Croatian: Vaš liječnik može zatražiti da prestanete s uzimanjem lijeka Ristfor.
English: Hypoglycaemia has been reported in combination with sulphonylurea (13.8%) and insulin (10.9%).
Croatian: Hipoglikemija je prijavljena u kombinaciji sa sulfonilurejom (13,8%) i inzulinom (10,9%).
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Croatian: Nastavite uzimati ovaj lijek sve dok Vam ga liječnik propisuje kako biste šećer u krvi mogli i dalje regulirati.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30 %.
Croatian: Nakon peroralne doze, neapsorbirani dio koji se izlučio stolicom bio je 20-30%.
English: • specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
Croatian: • određeni lijekovi za liječenje bronhalne astme (ß-simpatomimetici)
English: When blood glucose levels are low, insulin release is not enhanced and glucagon secretion is not suppressed.
Croatian: Kada su razine glukoze u krvi niske, otpuštanje inzulina nije pojačano i sekrecija glukagona nije suprimirana.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Croatian: Bolesnike treba informirati o karakterističnom simptomu akutnog pankreatitisa: perzistirajućoj jakoj boli u abdomenu.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin povećava transportni kapacitet pojedinih tipova membranskih transportera glukoze (GLUT-1 i GLUT-4).
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example, in the context of an X-ray or scan, you must stop taking Ristfor before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Ristfor prije ili u vrijeme injekcije.
English: Ristfor must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Croatian: Primjena lijeka Ristfor mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Croatian: Pretklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, karcinogenog potencijala i reproduktivne toksičnosti.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Ristfor.
Croatian: Sljedeće izjave odražavaju farmakokinetička svojstva pojedinačnih djelatnih tvari lijeka Ristfor.
English: The most effective method to remove lactate and metformin is haemodialysis.
Croatian: Najdjelotvorniji način uklanjanja laktata i metformina je hemodijaliza.
English: Effects of other medicinal products on sitagliptin
Croatian: Učinci drugih lijekova na sitagliptin
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Croatian: Pretpostavlja se da farmakokinetika apsorpcije metformina nije linearna.
English: If you forget to take Ristfor
Croatian: Ako ste zaboravili uzeti Ristfor
English: • metformin belongs to a class of medicines called biguanides.
Croatian: • metformin pripada skupini lijekova koji se zovu bigvanidi.
English: Avoid excessive alcohol intake while taking Ristfor since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate Ristfor jer to može povećati rizik od laktacidoze (vidjeti dio “Upozorenja i mjere opreza”).
English: Ristfor should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Ristfor se mora uzimati dvaput na dan s hranom kako bi se smanjile gastrointestinalne nuspojave povezane s metforminom.
English: However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Croatian: Ipak, bolesnike s rizikom od toksičnosti digoksina treba pratiti kada se sitagliptin i digoksin primjenjuju istodobno.
English: C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing.
Croatian: C]sitagliptina zdravim ispitanicima, približno 100% primijenjene radioaktivnosti eliminiralo se stolicom (13%) ili mokraćom (87%) unutar jednog tjedna doziranja.
English: A GFR should be assessed before initiation of treatment with metformincontaining products and at least annually thereafter.
Croatian: GFR treba procijeniti prije početka liječenja lijekovima koji sadrže metformin te najmanje jedanput godišnje nakon toga.
English: This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones).
Croatian: Ovaj lijek se može uzimati sam ili s nekim drugim lijekovima za šećernu bolest (inzulin, sulfonilureje ili glitazoni).
English: Sitagliptin is not a substrate for OCT2 or OAT1 or PEPT1/2 transporters.
Croatian: Sitagliptin nije supstrat transportera OCT2, OAT1 ili PEPT1/2.
English: Combinations requiring precautions for use
Croatian: Kombinacije čija primjena zahtjeva mjere opreza
English: All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day.
Croatian: Svi bolesnici moraju se i dalje pridržavati preporučene dijete s odgovarajućom raspodjelom unosa ugljikohidrata tijekom dana.
English: If you need to have major surgery you must stop taking Ristfor during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Ristfor tijekom i još neko vrijeme nakon zahvata.
English: If no adequate strength of Ristfor is available, individual monocomponents should be used instead of the fixed-dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Ristfor, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: Sitagliptin, but not metformin, increased active GIP concentrations.
Croatian: Sitagliptin je, ali ne i metformin, povisio koncentraciju aktivnog GIP-a.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see also section 5.3).
Croatian: Istraživanja na životinjama s metforminom nisu pokazala štetne učinke na trudnoću, razvoj embrija i fetusa, porod i postnatalni razvoj (vidjeti također dio 5.3).
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Croatian: Te reakcije uključuju anafilaksiju, angioedem i eksfolijativna stanja kože, uključujući Stevens-Johnsonov sindrom.
English: For adult patients with type 2 diabetes mellitus:
Croatian: U odraslih bolesnika s dijabetesom mellitus tipa 2:
English: Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3 and 4.4).
Croatian: Potrebno je pratiti funkciju bubrega radi sprječavanja laktacidoze povezane s metforminom, pogotovo u starijih osoba (vidjeti dijelove 4.3 i 4.4).
English: The difference was mainly due to a higher percentage of patients in the placebo group experiencing 3 or more episodes of hypoglycaemia (9.1 vs. 19.8 %).
Croatian: Ta je razlika nastala uglavnom zbog većeg postotka bolesnika u skupini koja je primala placebo koji su imali 3 ili više epizoda hipoglikemije (9,1 naspram 19,8%).
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g., megaloblastic anaemia).
Croatian: Dugotrajno liječenje metforminom povezano je sa smanjenom apsorpcijom vitamina B12, što u vrlo rijetkim slučajevima može dovesti do klinički značajne deficijencije vitamina B12 (npr. megaloblastične anemije).
English: * All Patients Treated Population (an intention-to-treat analysis).
Croatian: * populacija svih liječenih bolesnika (analiza po planiranom planu ispitivanja, engl. intention-to-treat analysis).
English: The level of digoxin in your blood may need to be checked if taking with Ristfor.
Croatian: Možda će biti potrebno provjeravati razinu digoksina u Vašoj krvi ukoliko se uzima s lijekom Ristfor.
English: Along with diet and exercise, this medicine helps lower your blood sugar.
Croatian: Uz dijetu i tjelovježbu, ovaj lijek Vam pomaže sniziti šećer u krvi.
English: Food decreases the extent and slightly delays the absorption of metformin.
Croatian: Hrana smanjuje i neznatno odgađa apsorpciju metformina.
English: Packs of 14, 28, 56, 60, 112, 168, 180, 196 film-coated tablets, multi-packs containing 196 (2 packs of 98) and 168 (2 packs of 84) film-coated tablets.
Croatian: Pakiranja s 14, 28, 56, 60, 112, 168, 180, 196 filmom obloženih tableta, višestruka pakiranja koja sadrže 196 (2 pakiranja s 98) i 168 (2 pakiranja s 84) filmom obloženih tableta.
English: However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.
Croatian: Ipak, kod upravljanja vozilima ili rada sa strojevima treba uzeti u obzir da su pri primjeni sitagliptina prijavljene omaglica i somnolencija.
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
Croatian: • lijekovi koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib)
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Ristfor.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Ristfor.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR < 60 mL/min.
Croatian: Čimbenike koji mogu povećati rizik od laktacidoze (vidjeti dio 4.4) potrebno je provjeriti prije nego što se počne razmatrati uvođenje metformina u bolesnika s GFR<60 ml/min.
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 (including obtaining an electrocardiogram), and institute supportive therapy if required.
Croatian: U slučaju predoziranja, treba primijeniti uobičajene potporne mjere, npr. ukloniti neapsorbirani materijal iz gastrointestinalnog trakta, uvesti kliničko praćenje (uključujući i EKG) i po potrebi započeti potpornu terapiju.
English: Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain and loss of appetite occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: Gastrointestinalni simptomi poput mučnine, povraćanja, proljeva, bolova u abdomenu i gubitka apetita najčešće se javljaju tijekom početka terapije i u većini se slučajeva spontano sami povuku.
English: • dolutegravir, a medicine used to treat HIV infection
Croatian: • dolutegravir, lijek za liječenje HIV-infekcije
English: Detailed information on this medicine is available on the website of the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: These symptoms may happen when you start taking metformin and usually go away Common: a metallic taste
Croatian: Ovi se simptomi mogu pojaviti kad počnete uzimati metformin i obično se povuku.
English: Ristfor may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Ristfor može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Croatian: U ljudi, neovisno o djelovanju na glikemiju, metformin ima povoljan učinak na metabolizam lipida.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells.
Croatian: Kad su koncentracije glukoze u krvi normalne ili povišene, GLP-1 i GIP povećavaju sintezu inzulina i njegovo otpuštanje iz beta stanica gušterače.
English: • ranolazine, a medicine used to treat angina
Croatian: • ranolazin, lijek za liječenje angine pektoris
English: • with meals to lower your chance of an upset stomach.
Croatian: • s obrocima da smanjite mogućnost želučanih tegoba
English: • medicines (taken by mouth, inhalation, or injection) used to treat diseases that involve inflammation, like asthma and arthritis (corticosteroids)
Croatian: • lijekovi (koji se uzimaju kroz usta, udisanjem ili primjenjuju injekcijom) za liječenje upalnih bolesti kao što su astma i artritis (kortikosteroidi)
English: Because increases of this magnitude are not clinically relevant, dosage adjustment in these patients is not necessary.
Croatian: Budući da povećanja ovog reda nisu klinički relevantna, u ovih bolesnika nije potrebna prilagodba doze.
English: In case of dehydration (severe vomiting, diarrhoea, fever or reduced fluid intake), metformin should be temporarily discontinued and contact with a health care professional is recommended.
Croatian: U slučaju dehidracije (teško povraćanje ili proljev, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu metformina i preporučuje se obratiti se zdravstvenom radniku.
English: Ristfor may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Croatian: Ristfor može uzrokovati vrlo rijetku (može se javiti u manje od 1 korisnika na 10 000), ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).