FrancophonIA/ELRC3.0 huggingface dataset:
English: Onset of symptoms following initiation of drug therapy may be rapid or may occur after longer periods of treatment.
Croatian: Nastup simptoma nakon početka liječenja može biti brz ili se oni mogu pojaviti nakon dužih perioda liječenja.
English: Patients who completed the initial 24-week study period were eligible to enter a controlled 28-week long-term study extension (52 weeks).
Croatian: Bolesnici koji su završili inicijalni period ispitivanja od 24 tjedna, bili su prikladni za uključivanje u kontrolirani nastavak dugoročnog ispitivanja (52 tjedna).
English: Therefore, the efficacy and safety profile of saxagliptin in these patients has not been established.
Croatian: Stoga nije utvrđen profil djelotvornosti i sigurnosti saksagliptina u tih bolesnika.
English: You should call your doctor, pharmacist or nurse immediately if you experience any of these symptoms.
Croatian: Trebate odmah obavijestiti svog liječnika, ljekarnika ili medicinsku sestru ako osjetite bilo koji od tih simptoma.
English: Event rate per 100 patient-years
Croatian: Stopa događaja na 100 bolesnikgodina
English: The intent-to-treat analysis showed consistent results.
Croatian: Analiza populacije predviđene za liječenje (engl. intent-to-treat) pokazala je konzistentne rezultate.
English: Komboglyze with alcohol
Croatian: Komboglyze s alkoholom
English: If pancreatitis is suspected, this medicinal product should be discontinued; if acute pancreatitis is confirmed, this medicinal product should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prestati uzimati ovaj lijek; ako je akutni pankreatitis potvrđen, ovaj lijek se ne smije ponovno početi uzimati.
English: The safety and efficacy of this medicinal product in children and adolescents from birth to < 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost ovog lijeka u djece i adolescenata od rođenja do < 18 godina starosti nisu ustanovljene.
English: What Komboglyze is and what it is used for What you need to know before you take Komboglyze How to take Komboglyze
Croatian: Što je Komboglyze i za što se koristi Što morate znati prije nego počnete uzimati Komboglyze Kako uzimati Komboglyze
English: In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status.
Croatian: U slučaju predoziranja treba uvesti odgovarajuće potporno liječenje kako nalaže klinički status bolesnika.
English: Patients should be advised of the characteristic symptoms of heart failure, and to immediately report such symptoms.
Croatian: Bolesnike treba savjetovati o karakterističnim simptomima zatajenja srca, te da odmah prijave takve simptome.
English: What Komboglyze is and what it is used for
Croatian: Što je Komboglyze i za što se koristi
English: This medicinal product should not be used during pregnancy.
Croatian: Ovaj lijek se ne smije primjenjivati u trudnoći.
English: Komboglyze is not recommended for use in children and adolescents under 18 years.
Croatian: Komboglyze se ne preporučuje za primjenu u djece i adolescenata mlađih od 18 godina.
English: This is not considered clinically meaningful, therefore, no dose adjustment for this medicinal product is recommended on the basis of age alone.
Croatian: To se ne smatra klinički značajnim te se stoga ne preporučuje prilagođavati dozu ovog lijeka samo na temelju dobi bolesnika.
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 uporna bol u abdomenu (područje trbuha), koja se može proširiti i do leđa, kao i mučnina i povraćanje, jer to može biti znak upale gušterače (pankreatitis).
English: • Komboglyze is available in aluminium foil blister.
Croatian: • Komboglyze je dostupan u blisteru od aluminijske folije.
English: Both belong to a group of medicines called oral anti-diabetics.
Croatian: Oba lijeka pripadaju skupini lijekova koji se nazivaju oralnim antidijabeticima.
English: The frequencies are based on the experience from clinical trials.
Croatian: Učestalost se temelji na iskustvu iz kliničkih ispitivanja.
English: These reactions were also identified in the pre-approval clinical trials, but do not meet the criteria for Table 2.
Croatian: Ove su reakcije opažene i u kliničkim ispitivanjima prije dobivanja odobrenja za stavljanje u promet, ali ne zadovoljavaju kriterije za uključenje u Tablicu 1.
English: If you take more Komboglyze than you should If you take more Komboglyze tablets than you should, talk to a doctor or go to a hospital straight away.
Croatian: Ako uzmete više Komboglyze tableta nego što ste trebali Uzmete li više Komboglyze tableta nego što ste trebali, odmah se javite liječniku ili otiđite u bolnicu.
English: No metabolites have been identified in humans.
Croatian: Nema utvrđenih metabolita u ljudi.
English: • decreased vitamin B12 levels
Croatian: • smanjene razine vitamina B12
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Croatian: Liječnik će Vam možda propisati lijek za liječenje alergijske reakcije te neki drugi lijek za liječenje šećerne bolesti.
English: If no adequate strength of Komboglyze is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Komboglyze, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
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 povoljne učinke na metabolizam lipida.
English: If your doctor prescribes this medicine together with a sulphonylurea or insulin, remember to take this other medicine as directed by your doctor to achieve the best results for your health.
Croatian: Ako Vam liječnik propiše ovaj lijek zajedno sa sulfonilurejom ili s inzulinom, zapamtite da taj drugi lijek morate uzimati u skladu s uputama liječnika kako biste postigli najbolje rezultate za svoje zdravlje.
English: If you need to have an injection of contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Komboglyze 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 Komboglyze prije ili u vrijeme injekcije.
English: What Komboglyze looks like and contents of the pack
Croatian: Kako Komboglyze izgleda i sadržaj pakiranja
English: Side effects seen when taking metformin alone: Very common (may affect more than 1 in 10 people)
Croatian: Nuspojave zabilježene pri uzimanju samo metformina: Vrlo česte (mogu se javiti u više od 1 na 10 korisnika)
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), or very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalost pojavljivanja definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) ili nepoznato (ne može se procijeniti iz dostupnih podataka).
English: • infection of your sinuses, sometimes with a feeling of pain and fullness behind your cheeks and eyes (sinusitis)
Croatian: • infekcija sinusa, ponekad praćena osjećajem boli i začepljenosti iza obraza i očiju (sinusitis)
English: Plasma protein binding is negligible.
Croatian: Vezivanje za proteine u plazmi je zanemarivo.
English: • inflamed stomach (gastritis) or gut, sometimes caused by an infection (gastro-enteritis)
Croatian: • upala želuca (gastritis) ili crijeva, ponekad prouzročena infekcijom (gastroenteritis)
English: Hazard Ratio (95% CI)
Croatian: Omjer hazarda (95% CI)†
English: Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Croatian: Hrana ima relativno skromne učinke na farmakokinetiku saksagliptina u zdravih ispitanika.
English: Komboglyze should be given twice daily with meals to reduce the gastrointestinal adverse reactions associated with metformin.
Croatian: Komboglyze se mora uzimati dvaput na dan s obrokom kako bi se ublažile gastrointestinalne nuspojave povezane s metforminom.
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 istodobno.
English: Your doctor will decide when you must stop and when to restart your treatment with Komboglyze.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Komboglyze.
English: Elderly patients (65-80 years) had about 60% higher saxagliptin AUC than young patients (18-40 years).
Croatian: U starijih je bolesnika (65-80 godina) AUC saksagliptina bio oko 60% veći nego u mlađih bolesnika (18-40 godina).
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Croatian: Nije poznato je li ovaj lijek siguran i djelotvoran kada se primjenjuje u djece i adolescenata mlađih od 18 godina.
English: Komboglyze must be discontinued at the time of surgery with general, spinal or epidural anaesthesia.
Croatian: Lijek Komboglyze se mora prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Croatian: Nakon peroralne doze neapsorbirani dio koji se izluči fecesom iznosi 20-30%.
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: Neklinički podaci za metformin ne upućuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljene doze, genotoksičnosti, karcinogenog potencijala i reproduktivne toksičnosti.
English: * (uncommon), myalgia
Croatian: * (manje često), mialgija
English: Do not take Komboglyze - If you are allergic to saxagliptin, metformin or any of the other ingredients of this medicine (listed in section 6); - If you have had a serious allergic (hypersensitive) reaction to any other similar medications that you take to control your blood sugar.
Croatian: Nemojte uzimati Komboglyze - ako ste alergični na saksagliptin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6); - ako ste imali ozbiljnu alergijsku reakciju (reakciju preosjetljivosti) na bilo koji sličan lijek koji uzimate za regulaciju šećera u krvi.
English: The mean Vd ranged between 63-276 L.
Croatian: Srednja vrijednost volumena distribucije (Vd) u rasponu je od 63-276 l.
English: How to take this medicine
Croatian: Kako se lijek uzima
English: Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Croatian: Srednji apsolutni broj limfocita ostao je stabilan kod svakodnevne primjene lijeka u trajanju do 102 tjedna.
English: • The amount of this medicine that you will take varies depending on your condition and the doses you currently take of metformin and/or individual tablets of saxagliptin and metformin.
Croatian: • Količina ovog lijeka koju ćete uzeti ovisi o Vašem stanju te dozi metformina i/ili pojedinačnih tableta saksagliptina i metformina koju trenutno uzimate.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin povećava prijenosni kapacitet pojedinih tipova membranskih prijenosnika glukoze (GLUT-1 i GLUT-4).
English: What you need to know before you take Komboglyze
Croatian: Što morate znati prije nego počnete uzimati Komboglyze
English: In in vitro studies, saxagliptin and its major metabolite neither inhibited CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4, nor induced CYP1A2, 2B6, 2C9, or 3A4.
Croatian: U in vitro ispitivanjima saksagliptin i njegov glavni metabolit nisu inhibirali CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 i 3A4 niti su inducirali CYP1A2, 2B6, 2C9 i 3A4.
English: Thus, changes in blood protein levels in various disease states (e.g. renal or hepatic impairment) are not expected to alter the disposition of saxagliptin.
Croatian: Stoga se ne očekuje da će promjene razine proteina u različitim stanjima bolesnika (primjerice kod oštećenja bubrega ili jetre) promijeniti dispoziciju saksagliptina.
English: Events accumulated consistently over time, and the event rates for saxagliptin and placebo did not diverge notably over time.
Croatian: # Događaji su se postojano kumulirali tijekom vremena, a stope događaja za saksagliptin i placebo nisu značajno odstupale tijekom vremena.
English: Saxagliptin and its major metabolite can be removed by haemodialysis (23% of dose over 4 hours).
Croatian: Saksagliptin i njegov glavni metabolit mogu se ukloniti hemodijalizom (23% doze tijekom 4 sata).
English: Common • a metallic taste in your mouth.
Croatian: Česte • metalan okus u ustima.
English: Use of DPP4 inhibitors has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena DPP-4 inhibitora povezuje se s rizikom od razvoja akutnog pankreatitisa.
English: If you have an allergic reaction, stop taking this medicine and call your doctor right away.
Croatian: Ako imate alergijsku reakciju, prestanite uzimati ovaj lijek i odmah se obratite liječniku.
English: Patients should be informed of the characteristic symptoms of acute pancreatitis; persistent, severe abdominal pain.
Croatian: Bolesnike treba informirati o karakterističnim simptomima akutnog pankreatitisa: uporni jaki bolovi u abdomenu.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Croatian: Detaljne informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Avoid excessive alcohol intake while taking Komboglyze since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Komboglyze jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza”).
English: In case of suspected symptoms, the patient should stop taking Komboglyze and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati lijek Komboglyze i odmah potražiti pomoć liječnika.
English: Some patients have experienced constipation at a frequency not known (cannot be determined from the available data) when saxagliptin was used alone or in combination.
Croatian: Kod nekih bolesnika se pojavila konstipacija s nepoznatom učestalošću (ne može se odrediti iz dostupnih podataka) kada je saksagliptin bio korišten sam ili u kombinaciji.
English: • Take with a meal to lower your chance of getting an upset stomach.
Croatian: • Uzimajte ga uz obrok kako bi se umanjila mogućnost želučanih tegoba.
English: A limited amount of data suggest the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Croatian: Ograničeni podaci upućuju na to da primjena metformina u trudnica nije povezana s povećanim rizikom od prirođenih malformacija.
English: Primary endpoint was the proportion of patients reaching HbA1c < 7% without confirmed or severe hypoglycaemia.
Croatian: Primarna mjera ishoda bila je udio bolesnika koji su postigli HbA1c od < 7% bez potvrđene ili teške hipoglikemije.
English: The following statements reflect the information available on the individual active substances.
Croatian: Sljedeće tvrdnje odraz su dostupnih informacija o pojedinačnim djelatnim tvarima.
English: Clinical data described below suggest that the risk for clinically meaningful interactions with co-administered medicinal products is low.
Croatian: Klinički podaci opisani u nastavku upućuju na to da je rizik od klinički značajnih interakcija s istodobno primijenjenim lijekovima nizak..
English: • Lactic acidosis, Komboglyze may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Croatian: • Laktacidoza, lijek Komboglyze 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”).
English: If you need to have major surgery, you must stop taking Komboglyze during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Komboglyze tijekom i još neko vrijeme nakon zahvata.
English: Symptoms can include, but are not limited to, increasing shortness of breath, rapid increase in weight and swelling of the feet (pedal oedema);
Croatian: Simptomi mogu uključivati, ali nisu ograničeni na: pogoršanje nedostatka zraka, brzi porast tjelesne težine i oticanje stopala (edem stopala);
English: (uncommon), and erectile dysfunction (uncommon).
Croatian: (manje često) i erektilna disfunkcija (manje često).
English: The European Medicines Agency has waived the obligation to submit the results of studies with Komboglyze in all subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Komboglyze u svim podskupinama pedijatrijske populacije u šećernoj bolesti tipa 2 (vidjeti dio 4.2 za informacije o primjeni u pedijatriji).
English: Follow the recommendations for skin and foot care that your doctor or nurse gave you.
Croatian: Slijedite preporuke za njegu kože i stopala koje ste dobili od svog liječnika ili medicinske sestre.
English: • liver problems (hepatitis)
Croatian: • jetrene tegobe (hepatitis)
English: If the patient wishes to become pregnant, or if a pregnancy occurs, treatment with this medicinal product should be discontinued and switched to insulin treatment as soon as possible.
Croatian: Ako bolesnica planira trudnoću ili zatrudni, treba prekinuti liječenje ovim lijekom i što prije prijeći na liječenje inzulinom.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see section 5.3).
Croatian: Istraživanja metformina provedena na životinjama nisu pokazala štetne učinke na trudnoću, embrionalni i fetalni razvoj, porođaj i postnatalni razvoj (vidjeti dio 5.3).
English: Patients experienced relief of symptoms after discontinuation of the medicinal product and some experienced recurrence of symptoms with reintroduction of the same or another DPP4 inhibitor.
Croatian: U bolesnika je došlo do ublažavanja simptoma nakon prekida primjene lijeka, a u nekih je došlo do ponovne pojave simptoma nakon ponovnog uvođenja istog ili nekog drugog DPP4 inhibitora.
English: • in combination with other medicinal products for the treatment of diabetes, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
Croatian: • u kombinaciji sa ostalim lijekovima za liječenje šećerne bolesti, uključujući inzulin, u bolesnika koji nisu odovarajuće kontrolirani metforminom i tim lijekovima (vidjeti dijelove 4.4, 4.5 i 5.1 za dostupne podatke različitim kombinacijama.
English: Diabetic skin lesions are a common complication of diabetes.
Croatian: Dijabetičke kožne promjene su česta komplikacija šećerne bolesti.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of Komboglyze 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: 60x1 film-coated tablets in perforated unit dose blisters.
Croatian: 60x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: The clinical significance of this decrease in lymphocyte count relative to placebo is not known.
Croatian: Nije poznat klinički značaj ovog smanjenja broja limfocita u odnosu na placebo.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome, have not been studied in the saxagliptin clinical program.
Croatian: Imunokompromitirani bolesnici, primjerice bolesnici s presađenim organom ili s dijagnozom sindroma humane imunodeficijencije, nisu ispitivani u sklopu kliničkog programa saksagliptina.
English: - Metformin is contraindicated in patients with a GFR < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Croatian: - Metformin je kontraindiciran u bolesnika s GFR<30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, vidjeti dio 4.3).
English: You may need more frequent blood glucose and kidney function tests, or your doctor may adjust the dosage of Komboglyze.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Komboglyze.
English: SAVOR trial results
Croatian: Rezultati ispitivanja SAVOR
English: In addition, some patients have reported rash and skin reactions (hypersensitivity) while taking saxagliptin.
Croatian: Osim toga, neki su bolesnici prijavili osip i kožne reakcije (preosjetljivost) za vrijeme uzimanja saksagliptina.
English: Package leaflet: Information for the patient
Croatian: Uputa o lijeku: Informacije za korisnika
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Croatian: Doza metformina postupno se povećavala od 500 do 2000 mg na dan, prema podnošljivosti.
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: In case of dehydration (severe diarrhoea or vomiting, fever, heat, reduced fluid intake), Komboglyze should be temporarily discontinued and contact with a health care professional is recommended.
Croatian: U slučaju dehidracije (teški proljev ili povraćanje, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu lijeka Komboglyze i preporučuje se obratiti se zdravstvenom radniku.
English: Use with potent CYP3A4 inducers
Croatian: Primjena s potentnim induktorima CYP 3A4
English: Stop taking Komboglyze for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Croatian: Prestanite nakratko uzimati lijek Komboglyze ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
English: Along with diet and exercise, this helps lower your blood sugar.
Croatian: Uz dijetu i tjelovježbu ovaj Vam lijek pomaže sniziti razinu šećera u krvi.
English: To control your diabetes, you still need to diet and exercise, even when you are taking this medicine.
Croatian: Da biste šećernu bolest držali pod kontrolom i dalje morate provoditi propisanu dijetu i tjelovježbu, čak i dok uzimate ovaj lijek.
English: Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Croatian: Saksagliptin je izrazito potentan (Ki: 1,3 nM), selektivan, reverzibilan, kompetitivan inhibitor DPP-4.