FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you are taking another medicine for diabetes that contains “pioglitazone”, you should not start taking Forxiga.
Croatian: • ako uzimate neki drugi lijek za šećernu bolest koji sadrži “pioglitazon”, ne smijete početi uzimati lijek Forxiga.
English: In both cases, treatment with dapagliflozin may be restarted once the patient's condition has stabilised.
Croatian: U oba slučaja, liječenje dapagliflozinom može se ponovno započeti nakon što se bolesnikovo stanje stabiliziralo.
English: Cardiovascular safety
Croatian: Kardiovaskularna sigurnost
English: Monitoring of renal function is recommended as follows:
Croatian: Preporučuje se kontrolirati bubrežnu funkciju kako slijedi:
English: There are insufficient data to draw conclusions regarding exposure in patients > 70 years old.
Croatian: Nema dovoljno podataka da bi se donijeli zaključci o izloženosti bolesnika starijih od 70 godina.
English: • if you are 75 years old or older, you should not start taking Forxiga.
Croatian: • ako imate 75 ili više godina, ne smijete početi uzimati lijek Forxiga.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Croatian: Liječenje treba privremeno prekinuti u bolesnika koji su hospitalizirani zbog velikih kirurških zahvata ili akutnih ozbiljnih bolesti.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Forxiga, and during treatment:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete lijek Forxiga i tijekom liječenja:
English: Parathyroid hormone (PTH)
Croatian: Paratiroidni hormon (PTH)
English: Fifty-one percent (51%) of the subjects were men, 84% were White, 9% were Asian, 3% were Black and 4% were of other racial groups.
Croatian: Među ispitanicima je bilo 51% muškaraca, 84% bijelaca, 9% azijskog podrijetla, 3% crnaca i 4% pripadnika drugih rasnih skupina.
English: What Forxiga looks like and contents of the pack
Croatian: Kako Forxiga izgleda i sadržaj pakiranja
English: There is no clinically meaningful increase in exposure based on age alone in subjects up to 70 years old.
Croatian: Ne dolazi do klinički značajnog povećanja izloženosti temeljenog isključivo na dobi u ispitanika u dobi do 70 godina.
English: More information is given below in Other medicines and Forxiga.
Croatian: Više informacija možete pronaći niže u dijelu Drugi lijekovi i Forxiga.
English: Therapeutic experience in patients 75 years and older is limited.
Croatian: Iskustvo u liječenju bolesnika starijih od 75 godina je ograničeno.
English: If you take more Forxiga than you should
Croatian: Ako uzmete više lijeka Forxiga nego što ste trebali
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Croatian: Porast razine kreatinina bio je općenito prolazan tijekom kontinuiranog liječenja ili reverzibilan nakon prekida liječenja.
English: • if you have or develop nausea (feeling sick), vomiting or fever or if you are not able to eat or drink.
Croatian: • ako osjećate mučninu, povraćate ili imate vrućicu ili ako ne možete jesti ni piti.
English: • If it is less than 12 hours until your next dose, skip the missed dose.
Croatian: • Ako je do sljedeće doze preostalo manje od 12 sati, preskočite propuštenu dozu.
English: • Keep this medicine out of the sight and reach of children.
Croatian: • Ovaj lijek čuvajte izvan pogleda i dohvata djece.
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 u skladu s kliničkim statusom bolesnika.
English: Check with your doctor, phamacist or nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: • if you often get infections of the urinary tract.
Croatian: • ako često imate infekcije mokraćnih puteva.
English: A meta-analysis of cardiovascular events in the clinical program was performed.
Croatian: Provedena je meta-analiza kardiovaskularnih događaja u kliničkom programu.
English: Do not stop taking Forxiga without talking to your doctor first.
Croatian: Nemojte prestati uzimati lijek Forxiga ako najprije niste o tome razgovarali s liječnikom.
English: • if you have a history of serious heart disease or if you have had a stroke.
Croatian: • ako ste ranije imali teške srčane tegobe ili ste pretrpjeli moždani udar.
English: Paediatric population Interaction studies have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija provedena su samo u odraslih.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and fertility.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i toksičnosti za plodnost.
English: Frequency categories are defined according to the following convention: 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), 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), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Your doctor may ask you to stop taking Forxiga until you recover to prevent dehydration.
Croatian: Liječnik može zatražiti da prestanete uzimati lijek Forxiga dok se ne oporavite kako biste spriječili dehidraciju.
English: If well tolerated, the dose may be increased to 10 mg (see sections 4.4 and 5.2).
Croatian: Ako se dobro podnosi, doza se može povećati na 10 mg (vidjeti dijelove 4.4 i 5.2).
English: Not all pack sizes may be marketed in your country.
Croatian: Na tržištu u Vašoj zemlji se ne moraju nalaziti sve veličine pakiranja.
English: In patients with severe hepatic impairment, a starting dose of 5 mg is recommended.
Croatian: U bolesnika s teškim oštećenjem jetrene funkcije preporučuje se početna doza od 5 mg.
English: If you have type 2 diabetes, your pancreas does not make enough insulin or your body is not able to use the insulin it produces properly.
Croatian: Ako imate šećernu bolest tipa 2, gušterača Vam ne proizvodi dovoljno inzulina ili Vaše tijelo ne može pravilno iskoristiti proizvedeni inzulin.
English: Studies in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy (see section 5.3).
Croatian: Istraživanja na štakorima ukazala su na toksičnost za bubrege u razvoju u razdoblju koje odgovara drugom i trećem tromjesečju ljudske trudnoće (vidjeti dio 5.3).
English: Increased creatinine
Croatian: Povišene razine kreatinina
English: • Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter
Croatian: • prije početka istodobnog liječenja lijekovima koji mogu umanjiti bubrežnu funkciju i povremeno nakon toga
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 bolnicu ako se u Vas pojavi bilo koja od sljedećih nuspojava:
English: • if you are taking a medicine used to remove water from the body (diuretic).
Croatian: • ako uzimate lijek koji pomaže izlučiti vodu iz tijela (diuretik).
English: • They work by lowering the amount of sugar (glucose) in your blood.
Croatian: • Djeluju tako da snižavaju količinu šećera (glukoze) u krvi.
English: Therefore, the use of dapagliflozin is not recommended during the second and third trimesters of pregnancy.
Croatian: Stoga se ne preporučuje primjena dapagliflozina tijekom drugog i trećeg tromjesečja trudnoće.
English: Urinary uric acid excretion was also increased transiently (for 3-7 days) and accompanied by a sustained reduction in serum uric acid concentration.
Croatian: Izlučivanje mokraćne kiseline mokraćom također se privremeno povećalo (tijekom 3-7 dana), a bilo je popraćeno trajnim smanjenjem koncentracije mokraćne kiseline u serumu.
English: • changes in laboratory blood tests (for example creatinine or urea)
Croatian: • promjene u rezultatima laboratorijskih pretraga krvi (na primjer razine kreatinina ili ureje)
English: • Prior to initiation of dapagliflozin and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Croatian: • prije početka liječenja dapagliflozinom i barem jednom godišnje nakon toga (vidjeti dijelove 4.2, 4.8, 5.1 i 5.2)
English: What Forxiga contains
Croatian: Što Forxiga sadrži
English: There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Croatian: Rasa Nije bilo klinički značajnih razlika u sustavnoj izloženosti između ispitanika bijele, crne i azijske rase.
English: This may be another medicine taken by mouth and/or insulin given by injection.
Croatian: To može biti neki drugi lijek koji se uzima kroz usta i/ili inzulin koji se primjenjuje injekcijom.
English: A clinically relevant effect with other inducers (e.g. carbamazepine, phenytoin, phenobarbital) is not expected.
Croatian: Ne očekuje se klinički značajan učinak s drugim induktorima (npr. karbamazepinom, fenitoinom, fenobarbitalom).
English: Volume depletion
Croatian: Deplecija volumena
English: What Forxiga is and what it is used for What you need to know before you take Forxiga How to take Forxiga
Croatian: Što je Forxiga i za što se koristi Što morate znati prije nego počnete uzimati lijek Forxiga Kako uzimati lijek Forxiga
English: Possible signs of dehydration are listed at the top of section 4, ‘Possible side effects'.
Croatian: Mogući znakovi dehidracije navedeni su na početku dijela 4. "Moguće nuspojave".
English: Since the numerical imbalance of breast, bladder and prostate tumours must be considered with caution, it will be further investigated in post-authorisation studies.
Croatian: Budući da se brojčani nesrazmjer tumora na dojci, mokraćnom mjehuru i prostati mora pažljivo razmotriti, bit će dodatno istražen u ispitivanjima nakon dobivanja odobrenja za stavljanje u promet.
English: Paediatric population Pharmacokinetics in the paediatric population have not been studied.
Croatian: Pedijatrijska populacija Farmakokinetika u pedijatrijskoj populaciji nije ispitana.
English: • if you have “type 1 diabetes” - the type that usually starts when you are young, and your body does not produce any insulin.
Croatian: • ako imate "šećernu bolest tipa 1" - vrstu šećerne bolesti koja se obično javlja u mladosti i kod koje Vaše tijelo uopće ne proizvodi inzulin.
English: Remember to take these other medicine(s) as your doctor has told you.
Croatian: Nemojte zaboraviti uzeti te druge lijekove kako Vam je preporučio Vaš liječnik.
English: Forxiga works by removing excess sugar from your body via your urine.
Croatian: Forxiga djeluje tako da uklanja višak šećera iz tijela kroz mokraću.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Bolesnici s rijetkim nasljednim poremećajem nepodnošenja galaktoze, nedostatkom Lapp laktaze ili malapsorpcijom glukoze-galaktoze ne smiju uzimati ovaj lijek.
English: • Forxiga is used if your diabetes cannot be controlled with other medicines for diabetes, diet and exercise.
Croatian: • Forxiga se primjenjuje ako se šećerna bolest ne može kontrolirati drugim lijekovima za liječenje šećerne bolesti, dijetom i tjelovježbom.
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Croatian: Povećanje izloženosti simvastatinu i simvastatinskoj kiselini ne smatra se klinički značajnim.
English: • This medicine does not require any special storage conditions.
Croatian: • Lijek ne zahtijeva posebne uvjete čuvanja.
English: Combinations not studied Dapagliflozin has not been studied in combination with glucagon-like peptide 1 (GLP-1) analogues.
Croatian: Kombinacije koje nisu ispitane Dapagliflozin nije ispitan u kombinaciji s analozima peptida-1 nalik glukagonu (GLP1).
English: Do not drive or use any tools or machines, if you feel dizzy taking Forxiga.
Croatian: Nemojte upravljati vozilima ni rukovati alatima ili strojevima ako osjećate omaglicu nakon uzimanja lijeka Forxiga.
English: • if you are are on medicines to lower your blood pressure (anti-hypertensives) and have a history of low blood pressure (hypotension).
Croatian: • ako uzimate lijekove za snižavanje krvnog tlaka (antihipertenzive) i ranije ste patili od niskog krvnog tlaka (hipotenzije).
English: Possible signs of losing too much fluid from your body are listed at the top of section 4 ‘Possible side effects'.
Croatian: Mogući znakovi prekomjernog gubitka tekućine iz tijela navedeni su na početku dijela 4. "Moguće nuspojave".
English: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italy
Croatian: Bristol-Myers Squibb Company Contrada Fontana del Ceraso IT-03012 Anagni (FR) Italija
English: Twelve studies had a treatment period of 24 weeks duration, 8 with long-term extensions ranging from 24 to 80 weeks (up to a total study duration of 104 weeks), and one study was 52 weeks in duration with long-term extensions of 52 and 104 weeks (total study duration of 208 weeks).
Croatian: U dvanaest je ispitivanja liječenje trajalo 24 tjedna, 8 je bilo s dugoročnim produžecima u rasponu od 24 do 80 tjedana (do ukupnog trajanja ispitivanja od 104 tjedna), dok je jedno ispitivanje trajalo 52 tjedna s dugoročnim produžetkom od 52 i 104 tjedna (ukupno trajanje ispitivanja 208 tjedana).
English: Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved.
Croatian: Ponovno započinjanje liječenja SGLT2 inhibitorima u bolesnika s prethodnom pojavom DKA tijekom liječenja SGLT2 inhibitorima se ne preporučuje, osim ako nije identificiran i razriješen drugi jasni precipitirajući čimbenik.
English: • if you have very high levels of glucose in your blood which may make you dehydrated (lose too much body fluid).
Croatian: • ako imate vrlo visoke razine glukoze u krvi koje mogu dovesti do dehidracije (prekomjernog gubitka tekućine iz tijela).
English: Use in patients treated with pioglitazone
Croatian: Primjena u bolesnika liječenih pioglitazonom
English: Bone mineral density measurements in patients with normal or mildly impaired renal function did not indicate bone loss over a treatment period of two years.
Croatian: Mjerenja mineralne gustoće kostiju u bolesnika s normalnom ili blago oštećenom bubrežnom funkcijom nisu ukazala na koštani gubitak tijekom dvogodišnjeg razdoblja liječenja.
English: Elderly patients may be at a greater risk for volume depletion and are more likely to be treated with diuretics.
Croatian: U starijih bolesnika može postojati povećan rizik od deplecije volumena i veća je vjerojatnost da se liječe diureticima.
English: Tell your doctor before you start taking Forxiga if you have any of these signs.
Croatian: Obavijestite svoga liječnika prije uzimanja lijeka Forxiga ako imate neki od navedenih znakova.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with dapagliflozin in one or more subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja dapagliflozina u jednoj ili više podskupina pedijatrijske populacije u liječenju šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o primjeni u pedijatriji).
English: Taking this medicine
Croatian: Uzimanje lijeka
English: Volume depletion includes, e.g. the predefined preferred terms: dehydration, hypovolaemia, hypotension.
Croatian: Deplecija volumena uključuje, primjerice, unaprijed određene preferirane pojmove: dehidracija, hipovolemija, hipotenzija.
English: • if you are taking other medicines that lower the amount of sugar in your blood such as insulin or a “sulphonylurea” medicine.
Croatian: • ako uzimate druge lijekove koji snižavaju razinu šećera u krvi, poput inzulina ili “sulfonilureje”.
English: To control your diabetes, you still need to keep to diet and exercise, even when you are taking this medicine.
Croatian: Da biste šećernu bolest držali pod kontrolom, morate se i dalje pridržavati propisanoga režima prehrane i tjelovježbe, čak i dok uzimate ovaj lijek.
English: Your doctor may ask you to stop taking Forxiga.
Croatian: Liječnik može zatražiti da prestanete uzimati lijek Forxiga.
English: Protein binding was not altered in various disease states (e.g. renal or hepatic impairment).
Croatian: Vezanje za proteine nije se izmijenilo kod različitih bolesti (npr. oštećenja bubrežne ili jetrene funkcije).
English: Cardiovascular episodes were adjudicated by an independent adjudication committee.
Croatian: Kardiovaskularne epizode ocjenjivalo je neovisno povjerenstvo.
English: The SGLT2 is selectively expressed in the kidney with no expression detected in more than 70 other tissues including liver, skeletal muscle, adipose tissue, breast, bladder and brain.
Croatian: SGLT2 je selektivno eksprimiran u bubrezima, ali ekspresija nije uočena u više od 70 drugih tkiva, uključujući jetru, mišiće kostura, masno tkivo, dojke, mokraćni mjehur i mozak.
English: ANNEX II
Croatian: PRILOG II
English: When pregnancy is detected, treatment with dapagliflozin should be discontinued.
Croatian: Kad se utvrdi trudnoća, liječenje dapagliflozinom mora se obustaviti.
English: Forxiga is used for a type of diabetes called “type 2 diabetes mellitus” in adult patients (aged 18 years and older).
Croatian: Forxiga se primjenjuje za liječenje jedne vrste šećerne bolesti koja se naziva "šećerna bolest tipa 2" u odraslih bolesnika (u dobi od 18 ili više godina).
English: Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption.
Croatian: Dapagliflozin ne inhibira druge prijenosnike glukoze važne za prijenos glukoze u periferna tkiva i > 1400 puta je selektivniji za SGLT2 nego za SGLT1, najvažniji prijenosnik u crijevima odgovoran za apsorpciju glukoze.
English: The incidence of hypoglycaemia was similar to placebo.
Croatian: Incidencija hipoglikemije bila je slična kao kod primjene placeba.
English: Effect of dapagliflozin on other medicinal products
Croatian: Učinak dapagliflozina na druge lijekove
English: Stop taking Forxiga and see a doctor as soon as possible if you notice any of the following serious side effects:
Croatian: Prestanite uzimati lijek Forxiga i što prije se javite liječniku ako se pojavi bilo koja od navedenih ozbiljnih nuspojava:
English: Although uncommon, if you see blood in your urine, tell your doctor immediately.
Croatian: Iako se krv u mokraći javlja manje često, ako je primijetite, odmah obavijestite liječnika.
English: Due to the limited therapeutic experience in patients 75 years and older, initiation of dapagliflozin therapy is not recommended.
Croatian: Zbog ograničenog iskustva s liječenjem bolesnika starijih od 75 godina ne preporučuje se započinjati liječenje dapagliflozinom.
English: They have “10” on one side and “1428” on the other side.
Croatian: Na jednoj strani imaju oznaku “10”, a na drugoj “1428”.
English: The same recommendations for renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Croatian: U slučaju oštećenja bubrežne funkcije, za starije bolesnike vrijede iste preporuke kao i za sve ostale bolesnike (vidjeti dijelove 4.2, 4.4, 4.8 i 5.1).
English: Despite the presence of hyperglycaemia in type 2 diabetes, reabsorption of filtered glucose continues.
Croatian: Unatoč postojanju hiperglikemije u šećernoj bolesti tipa 2, reapsorpcija filtrirane glukoze se nastavlja.
English: Patients with baseline HbA1c ≥ 9%
Croatian: Bolesnici s početnom HbA1c ≥ 9%
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78%.
Croatian: Apsolutna oralna bioraspoloživost dapagliflozina nakon primjene doze od 10 mg iznosi 78%.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava omaglica
English: The following adverse reactions have been identified in the placebo-controlled clinical trials.
Croatian: Sljedeće su nuspojave zabilježene u placebom kontroliranim kliničkim ispitivanjima.
English: The primary end point was the time-to-first event of one of the following outcomes: cardiovascular death, stroke, myocardial infarction (MI) or hospitalisation for unstable angina.
Croatian: Primarna mjera ishoda bila je vrijeme do prve pojave jednog od sljedećih ishoda: smrti zbog kardiovaskularnog uzroka, moždanog udara, infarkta miokarda ili hospitalizacije zbog nestabilne angine.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in nursing offspring (see section 5.3).
Croatian: Dostupni farmakodinamički/toksikološki podaci u životinja pokazali su da se dapagliflozin/metaboliti izlučuju u mlijeko; također su ukazali na farmakološki posredovane učinke lijeka na mladunčad koja siše (vidjeti dio 5.3).
English: For patients receiving dapagliflozin, in case of intercurrent conditions that may lead to volume depletion, careful monitoring of volume status (e.g. physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended.
Croatian: U bolesnika koji primaju dapagliflozin, a u kojih istodobno postoje stanja koja mogu dovesti do deplecije volumena, preporučuje se pažljivo praćenje stanja volumena (npr. fizikalni pregled, mjerenje krvnog tlaka, laboratorijske pretrage uključujući određivanje vrijednosti hematokrita) i elektrolita.
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance.
Croatian: Kada se samo dijetom i tjelovježbom ne postiže dovoljno dobra regulacija glikemije u bolesnika u kojih se primjena metformina ne smatra prikladnom zbog nepodnošenja.
English: Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia.
Croatian: Inzulin i inzulinski sekretagozi, poput sulfonilureja, izazivaju hipoglikemiju.
English: Your doctor may prescribe Forxiga together with other medicine(s) to lower the amount of sugar in your blood.
Croatian: Liječnik može propisati lijek Forxiga s drugim lijekovima za snižavanje razine šećera u krvi.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Croatian: U brojnim slučajevima stanje se očitovalo atipično, uz samo umjereno povišene vrijednosti glukoze u krvi, ispod 14 mmol/l (250 mg/dl).
English: In additional studies of embryo-foetal development in rats and rabbits, dapagliflozin was administered for intervals coinciding with the major periods of organogenesis in each species.
Croatian: U dodatnim istraživanjima embriofetalnog razvoja u štakora i kunića dapagliflozin je primijenjen u intervalima koji odgovaraju glavnim razdobljima organogeneze svake vrste.
English: This glucose excretion (glucuretic effect) is observed after the first dose, is continuous over the 24-hour dosing interval and is sustained for the duration of treatment.
Croatian: To je izlučivanje glukoze (glikozurički učinak) vidljivo nakon prve doze, kontinuirano traje tijekom 24-satnog doznog intervala i održava se za cijelog trajanja liječenja.