FrancophonIA/ELRC3.0 huggingface dataset:
English: The following statements reflect the information available on the individual active substances.
Croatian: Sljedeće tvrdnje predstavljaju dostupne podatke o pojedinačnim djelatnim tvarima.
English: Your doctor may want to lower the dose of these other medicines, to prevent your blood sugar levels from getting too low (hypoglycaemia).
Croatian: Vaš liječnik će možda htjeti sniziti dozu tih drugih lijekova kako bi se spriječilo da razina šećera u Vašoj krvi ne postane preniska (hipoglikemija).
English: Your doctor will decide when you must stop and when to restart your treatment with Synjardy.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Synjardy.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 microgram/ml, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, maksimalne razine metformina u plazmi (Cmax) nisu prekoračivale 5 mikrograma/ml čak niti pri maksimalnim dozama.
English: A limited amount of data suggests that the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Croatian: Ograničeni podaci ukazuju da primjena metformina u trudnica nije povezana s povećanim rizikom od kongenitalnih malformacija.
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the population studied, see sections 4.4, 4.5 and 5.1.
Croatian: Za rezultate ispitivanja s obzirom na kombinacije, učinke na kontrolu glikemije i kardiovaskularne događaje te ispitivane populacije, vidjeti dijelove 4.4, 4.5 i 5.1.
English: Metformin must be discontinued at the time of surgery under general, spinal or epidural anaesthesia.
Croatian: Primjena metformina mora se prekinuti u vrijeme kirurškog zahvata pod općom, spinalnom ili epiduralnom anestezijom.
English: Adults with normal renal function (GFR ≥90 ml/min) The recommended dose is one tablet twice daily.
Croatian: Odrasli s normalnom funkcijom bubrega (GFR ≥90 ml/min) Preporučena doza je jedna tableta dvaput dnevno.
English: If you have type 2 diabetes, your pancreas does not make enough insulin to control the level of glucose in your blood, and your body is unable to use its own insulin effectively.
Croatian: Ako imate šećernu bolest tipa 2, Vaša gušterača ne stvara dovoljno inzulina za kontrolu razine glukoze u krvi, a Vaše tijelo ne može učinkovito koristiti vlastiti inzulin.
English: Measure your blood sugar if possible and rest.
Croatian: Ako je moguće, izmjerite razinu šećera u krvi i mirujte.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see section 4.5).
Croatian: • Oštećenje jetre, akutno trovanje alkoholom, alkoholizam (vidjeti dio 4.5).
English: Lactic acidosis Vitamin B12 deficiency
Croatian: Laktacidoza Deficijencija vitamina B12
English: Subgroup analysis for patients on additional background of metformin (FAS, LOCF)
Croatian: Analiza podskupine u bolesnika na dodatnoj osnovnoj terapiji metforminom (FAS, LOCF)
English: Metformin increases the transport capacity of all types of membrane glucose transporters (GLUTs) known to date.
Croatian: Metformin povećava kapacitet prijenosa svih dosad poznatih vrsta membranskih prijenosnika glukoze (GLUT).
English: If you stop taking Synjardy
Croatian: Ako prestanete uzimati Synjardy
English: As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Croatian: Budući da se doza pojedinačno titrirala na temelju glikemijske kontrole, ovi rezultati imaju ograničeni klinički značaj.
English: • necrotising fasciitis of the perineum or Fournier´s gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus
Croatian: • nekrotizirajući fasciitis perineuma ili Fournierova gangrena, ozbiljna infekcija mekog tkiva genitalija ili područja između genitalija i anusa
English: • if you have had a diabetic pre-coma;
Croatian: • ako ste imali dijabetičku pretkomu;
English: No effects have been shown in breastfed newborns/infants of treated women.
Croatian: Nisu opaženi učinci u dojene novorođenčadi/dojenčadi liječenih majki.
English: In the event of an overdose, treatment should be initiated as appropriate to the patient‘s clinical status.
Croatian: U slučaju predoziranja potrebno je započeti liječenje koje odgovara bolesnikovom kliničkom statusu.
English: No metabolites have been identified in humans.
Croatian: Metaboliti nisu utvrđeni u ljudi.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Croatian: Nakon oralne doze, prividni terminalni poluvijek eliminacije iznosi približno 6,5 sati.
English: If you need to have major surgery you must stop taking Synjardy during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Synjardy tijekom i još neko vrijeme nakon zahvata.
English: • Metformin works in a different way to lower blood sugar levels, mainly by blocking glucose production in the liver.
Croatian: • Metformin djeluje na drugačiji način na snižavanje razina šećera u krvi i to uglavnom blokiranjem stvaranja glukoze u jetri.
English: The frequency of reported nocturia was comparable between placebo and empagliflozin (<1%).
Croatian: Učestalost prijavljene nokturije je bila usporediva između placeba i empagliflozina (< 1 %).
English: Necrotising fasciitis of the perineum (Fournier´s gangrene)
Croatian: Nekrotizirajući fasciitis perineuma (Fournierova gangrena)
English: Dehydration, seen uncommonly (may affect up to 1 in 100 people) The signs of dehydration are not specific, but may include:
Croatian: Dehidracija, manje često (može se javiti u do 1 na 100 osoba) Znakovi dehidracije nisu specifični, ali mogu uključivati:
English: Figure 1 Time to occurrence of cardiovascular death in the EMPA-REG OUTCOME study
Croatian: Slika 1 Vrijeme do pojave kardiovaskularne smrti u ispitivanju EMPA-REG
English: • Severe renal failure (GFR <30 ml/min).
Croatian: • Teško zatajenje bubrega (GFR <30 ml/min).
English: The inter-subject and residual variabilities for empagliflozin oral clearance were 39.1% and 35.8%, respectively.
Croatian: Interindividualne i rezidualne varijabilnosti za oralni klirens empagliflozina iznosile su 39,1 % odnosno 35,8 %.
English: If no adequate strength of Synjardy is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Synjardy, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: Blood sugar levels, which are too high because of your type 2 diabetes, are thereby reduced.
Croatian: Razine šećera u krvi, koje su previsoke zbog šećerne bolesti tipa 2, time se snižavaju.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Synjardy.
Croatian: Sljedeće tvrdnje predstavljaju farmakokinetička svojstva za pojedinačne djelatne tvari lijeka Synjardy.
English: • corticosteroids (given by mouth, as an injection, or inhaled), which are used to treat inflammation in diseases like asthma and arthritis.
Croatian: • kortikosteroide (primjena kroz usta, u obliku injekcije ili inhalacijom), koji se primjenjuju za liječenje upale u bolestima poput astme i artritisa.
English: Synjardy with alcohol
Croatian: Synjardy i alkohol
English: Empagliflozin is a reversible, highly potent (IC50 of 1.3 nmol) and selective competitive inhibitor of SGLT2.
Croatian: Empagliflozin je reverzibilni, visoko potentni (IC50 iznosi 1,3 nmol) i selektivni kompetitivni inhibitor SGLT2.
English: If you take more Synjardy than you should
Croatian: Ako uzmete više lijeka Synjardy nego što ste trebali
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Synjardy.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Synjardy.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Croatian: Bolesnike se mora informirati o tome te im se češće pratiti glukoza u krvi, naročito na početku liječenja takvim lijekovima.
English: Food decreases the extent and slightly delays the absorption of metformin.
Croatian: Hrana smanjuje opseg i neznatno odgađa apsorpciju metformina.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Synjardy in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Synjardy u svim podskupinama pedijatrijske populacije sa šećernom bolešću tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia.
Croatian: On ne potiče sekreciju inzulina i stoga ne stvara hipoglikemiju.
English: Like for all diabetic patients it is important to counsel patients on routine preventative footcare.
Croatian: Kao i kod svih bolesnika s dijebetesom važno je savjetovati bolesnike o rutinskoj, preventivnoj njezi stopala.
English: Genital tract infections were mild and moderate in intensity, none was severe in intensity.
Croatian: Infekcije genitalnog trakta bile su blagog ili umjerenog intenziteta, niti jedna nije bila teškog intenziteta.
English: Metformin Concomitant use not recommended
Croatian: Metformin Istodobna primjena koja se ne preporučuje
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Croatian: • lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib)
English: See subsections below for additional information
Croatian: Za dodatne informacije vidjeti niže navedene odjeljke
English: Therefore, special attention should be given to their volume intake in case of coadministered medicinal products which may lead to volume depletion (e.g. diuretics, ACE inhibitors).
Croatian: Stoga je potrebno naročito paziti na njihov unos volumena u slučaju istodobne primjene lijekova koji mogu dovesti do deplecije volumena (npr. diuretici, ACE inhibitori).
English: In the population pharmacokinetic analysis, AUC was estimated to be 13.5% higher in Asians with a body mass index of 25 kg/m2 compared to non-Asians with a body mass index of 25 kg/m
Croatian: U farmakokinetičkoj analizi populacije procijenjeno je da je AUC bio 13,5 % viši u Azijata s indeksom tjelesne mase 25 kg/m2 u usporedbi s ne-Azijatima s indeksom tjelesne mase od 25 kg/m
English: Single dose study: after single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Croatian: Ispitivanje jednokratne doze: nakon jednokratnih doza metforminklorida od 500 mg, pedijatrijski bolesnici su pokazali farmakokinetički profil sličan profilu koji je opažen u zdravih odraslih osoba.
English: When the patient plans to become pregnant, and during pregnancy, it is recommended that diabetes is not treated with this medicinal product, but insulin be used to maintain blood glucose levels as close to normal as possible, to reduce the risk of malformations of the foetus associated with abnormal blood glucose levels.
Croatian: Kada bolesnica planira zatrudnjeti ili tijekom trudnoće, ne preporučuje se liječenje šećerne bolesti ovim lijekom, već je potrebno primjenjivati inzulin za održavanje razine glukoze u krvi što je moguće bliže normalnim vrijednostima kako bi se smanjio rizik od malformacija fetusa koje su povezane s abnormalnim razinama glukoze u krvi.
English: • medicines that contain alcohol (see section ‘Synjardy with alcohol').
Croatian: • lijekove koji sadrže alkohol (vidjeti dio ‘Synjardy i alkohol').
English: For patients with acute and unstable heart failure, Synjardy is contraindicated due to the metformin component (see section 4.3).
Croatian: Za bolesnike s akutnim i nestabilnim zatajenjem srca, Synjardy je kontraindiciran zbog sadržanog metformina (vidjeti dio 4.3).
English: • blood tests may show changes in blood fat (cholesterol) levels in your blood
Croatian: • krvne pretrage mogu pokazati promjene u razinama masnoća (kolesterol) u Vašoj krvi
English: Because metformin is excreted by the kidney and elderly patients are more likely to have decreased renal function, Synjardy should be used with caution in these patients.
Croatian: Budući da se metformin izlučuje putem bubrega, a stariji bolesnici su podložniji smanjenoj funkciji bubrega, Synjardy je potrebno primjenjivati s oprezom u tih bolesnika.
English: No major metabolites of empagliflozin were detected in human plasma, as defined by at least 10% of total drug-related material, and the most abundant metabolites were three glucuronide conjugates (2-, 3-, and 6-O-glucuronide).
Croatian: U humanoj plazmi nisu pronađeni glavni metaboliti empagliflozina prema definiciji od najmanje 10 % ukupnog materijala povezanog s lijekom, a najzastupljeniji metaboliti bila su tri konjugata glukuronida (2-, 3-, i 6-O-glukuronid).
English: In the double-blind placebo-controlled extension of these studies, reduction of HbA1c, body weight and blood pressure were sustained up to Week 76.
Croatian: U dvostruko slijepom i placebom kontroliranom produžetku ovih ispitivanja, sniženje vrijednosti HbA1c, tjelesne težine i krvnog tlaka bilo je održano do 76. tjedna.
English: • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Croatian: • određene lijekove za liječenje povišenog krvnog tlaka (ACE inhibitori i antagonisti receptora angiotenzina II)
English: Biotransformation Metformin is excreted unchanged in the urine.
Croatian: Biotransformacija Metformin se luči u nepromijenjenom obliku u urin.
English: By blocking this protein, the medicine causes blood sugar, sodium (salt) and water to be removed via the urine.
Croatian: Blokiranjem tog proteina ovaj lijek dovodi do uklanjanja šećera u krvi, natrija (soli) i vode putem mokraće.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza oznake „EXP“.
English: The tablet is 21.1 mm long and has a width of 9.7 mm.
Croatian: Tableta je dugačka 21,1 mm i široka 9,7 mm.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS (perforated)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI (perforirani)
English: • medicines which increase urine production (diuretic), as Synjardy may increase the risk of losing too much fluid.
Croatian: • lijekove koji povećavaju stvaranje mokraće (diuretici), budući da Synjardy može povećati rizik od prekomjernog gubitka tekućine.
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row.
Croatian: • ako ste izgubili puno vode iz tijela (dehidracija), npr. uslijed dugotrajnog ili teškog proljeva ili ako ste povraćali nekoliko puta uzastopce.
English: Therefore, caution should be exercised in patients for whom a empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.
Croatian: Stoga je potreban oprez u bolesnika u kojih bi empagliflozinom inducirani pad krvnog tlaka mogao predstavljati rizik, poput bolesnika s poznatom kardiovaskularnom bolešću, bolesnika na antihipertenzivnoj terapiji s hipotenzijom u anamnezi ili bolesnika u dobi od 75 i više godina.
English: In patients with stable chronic heart failure, Synjardy may be used with a regular monitoring of cardiac and renal function.
Croatian: U bolesnika sa stabilnim kroničnim zatajenjem srca, Synjardy se može primjenjivati uz redoviti nadzor funkcije srca i bubrega.
English: The majority of drug-related radioactivity recovered in faeces was unchanged parent drug and approximately half of drug-related radioactivity excreted in urine was unchanged parent drug.
Croatian: Većina radioaktivnosti povezane s lijekom, koja je pronađena u fecesu, bila je u obliku nepromijenjenog roditeljskog lijeka, a približno polovina radioaktivnosti povezane s lijekom, koja se izlučila mokraćom, bila je u obliku nepromijenjenog roditeljskog lijeka.
English: No Met
Croatian: Bez Met
English: Temporary interruption of treatment with Synjardy should be considered until the fluid loss is corrected.
Croatian: Potrebno je razmotriti privremeni prekid liječenja Synjardyom sve dok se gubitak tekućine ne korigira.
English: Glucocorticoids (given by systemic and local routes), beta 2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Glukokortikoidi (primijenjeni sistemskim ili lokalnim putevima), beta-2 agonisti i diuretici imaju intrinzičnu hiperglikemijsku aktivnost.
English: • reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis,
Croatian: • smanjenjem proizvodnje glukoze u jetri inhibicijom glukoneogeneze i glikogenolize,
English: Mean eGFR returned to baseline after treatment discontinuation suggesting acute haemodynamic changes may play a role in these renal function changes.
Croatian: Srednja vrijednost eGFR vratila se na početnu nakon prekida liječenja, što pokazuje da akutne hemodinamičke promjene mogu imati ulogu u ovim promjenama funkcije bubrega.
English: Both tumours are common in rats and are unlikely to be relevant to humans.
Croatian: Oba tumora su česti u štakora te se ne smatraju relevantnima za ljude.
English: • in muscle, by increasing insulin sensitivity, improving peripheral glucose uptake and utilization,
Croatian: • u mišiću, povećanjem osjetljivosti na inzulin, poboljšanjem perifernog unosa i iskorištavanja glukoze,
English: The tablet is 19.2 mm long and has a width of 9.4 mm.
Croatian: Tableta je dugačka 19,2 mm i široka 9,4 mm.
English: Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Synjardy may cause a very rare but very serious side effect called lactic acidosis (see section ‘Warnings and precautions').
Croatian: Laktacidoza, vrlo rijetko zabilježena (može se javiti u do 1 na 10 000 osoba) Synjardy može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).
English: Similar results were obtained when Synjardy (empagliflozin/metformin) combination tablets were administered with high-fat and high calorie meal.
Croatian: Slični rezultati postignuti su kada su se Synjardy (empagliflozin/metformin) kombinirane tablete primjenjivale uz obrok s visokim sadržajem masti i kalorija.
English: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection Urinary tract infection (including pyelonephritis and urosepsis)
Croatian: Vaginalna monilijaza, vulvovaginitis, balanitis i druge genitalne infekcije Infekcija mokraćnog sustava (uključujući pijelonefritis i urosepsu)
English: How to take Synjardy
Croatian: Kako uzimati Synjardy
English: Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines, in particular when Synjardy is used in combination with a sulphonylurea and/or insulin.
Croatian: Bolesnike je potrebno savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju tijekom upravljanja vozilima i rada sa strojevima, naročito ako se Synjardy primjenjuje u kombinaciji sa sulfonilurejom i/ili inzulinom.
English: Contact a doctor or the nearest hospital straight away if you have any of the following side effects:
Croatian: Odmah se javite liječniku ili u najbližu bolnici ako se u Vas pojavi bilo koja od sljedećih nuspojava:
English: Increased urination was mostly mild or moderate in intensity.
Croatian: Pojačano mokrenje je uglavnom bilo blagog ili umjerenog intenziteta.
English: Animal studies with empagliflozin and metformin do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Croatian: Ispitivanja na životinjama s empagliflozinom i metforminom ne ukazuju na izravne ili neizravne štetne učinke na plodnost (vidjeti dio 5.3).
English: If necessary, the dose of the anti hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Croatian: Ako je potrebno, doza antihiperglikemijskog lijeka mora se prilagoditi tijekom liječenja drugim lijekom ili nakon prekida njegovog uzimanja.
English: C]-empagliflozin solution to healthy volunteers, the red blood cell partitioning was approximately 37% and plasma protein binding was
Croatian: C]-empagliflozina u zdravih dobrovoljaca, raspodjela u crvene krvne stanice je iznosila približno 37 %, a vezanje na proteine plazme 86 %.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Croatian: Vršna vrijednost u krvi je niža od vršne vrijednosti u plazmi, a javlja se u približno isto vrijeme.
English: At exposures sufficiently in excess of exposure in humans after therapeutic doses, empagliflozin had no adverse effects on fertility or early embryonic development.
Croatian: Pri izloženosti dostatno višoj od izloženosti u ljudi nakon terapijskih doza, empagliflozin nije imao štetnih učinaka na plodnost ili rani embrionalni razvoj.
English: Type 2 diabetes is a disease that comes from both your genes and your lifestyle.
Croatian: Šećerna bolest tipa 2 je bolest za koju su odgovorni i geni i način života.
English: Cardiovascular outcome
Croatian: Kardiovaskularni ishod
English: Caution is therefore advised, especially in patients with renal impairment, when these drugs are coadministered with metformin, as metformin plasma concentration may increase.
Croatian: Stoga se savjetuje oprez, osobito u bolesnika s oštećenjem bubrežne funkcije, kad se ti lijekovi primjenjuju istodobno s metforminom, jer se koncentracija metformina u plazmi može povisiti.
English: After oral administration, metformin absorption is saturable and incomplete.
Croatian: Nakon peroralne primjene apsorpcija metformina je saturabilna i nepotpuna.
English: At the recommended metformin doses and dosing schedules, steady-state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 microgram/ml.
Croatian: Pri preporučenim dozama metformina i režimima doziranja, koncentracije u plazmi u stanju dinamičke ravnoteže postižu se unutar 24 do 48 sati te općenito iznose manje od 1 mikrogram/ml.
English: Synjardy can also be combined with other medicines for the treatment of diabetes.
Croatian: Synjardy se također može primjenjivati u kombinaciji s drugim lijekovima za liječenje šećerne bolesti.
English: 2 hour post-prandial glucose
Croatian: Vrijednost glukoze 2 sata nakon obroka
English: Both improvement of glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Croatian: Poboljšanje kontrole glikemije i smanjenje kardiovaskularnog morbiditeta i mortaliteta integralni su dio liječenja šećerne bolesti tipa 2.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD20
Croatian: Farmakoterapijska skupina: Lijekovi koji se primjenjuju u šećernoj bolesti, kombinacije oralnih lijekova za snižavanje glukoze u krvi, ATK oznaka: A10BD20
English: Patients with heart failure are more at risk of hypoxia and renal insufficiency.
Croatian: Bolesnici sa zatajenjem srca imaju veći rizik od hipoksije i insuficijencije bubrega.
English: This results in high levels of glucose in your blood which can lead to medical problems like heart disease, kidney disease, blindness, and poor circulation in your limbs.
Croatian: To rezultira visokim razinama glukoze u krvi, što može dovesti do medicinskih problema poput bolesti srca, bolesti bubrega, sljepoće i slabe cirkulacije u udovima.