FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, in such patients greater decreases in eGFR were reported (see sections 4.2 and 4.8).
Croatian: Dodatno, u takvih bolesnika prijavljena su veća smanjenja eGFR (vidjeti dijelove 4.2 i 4.8).
English: Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin.
Croatian: Kanagliflozin se opsežno veže na proteine u plazmi (99%), uglavnom na albumin.
English: Because of how this medicine works, your urine will test positive for sugar (glucose) while you are on this medicine.
Croatian: Radi načina na koji ovaj lijek djeluje, Vaša će mokraća dati pozitivan rezultat na šećere (glukozu) za vrijeme uzimanja ovog lijeka.
English: This medicine works by increasing the amount of sugar removed from your body in your urine.
Croatian: Ovaj lijek djeluje tako da povećava količinu šećera koji se mokraćom uklanja iz Vašeg tijela.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ili nastavite uzimati ovaj lijek.
English: Both UGT1A9 and UGT2B4 are subject to genetic polymorphism.
Croatian: I UGT1A9 i UGT2B4 podložni su genskom polimorfizmu.
English: • kidney failure (mainly as a consequence of loss of too much fluid from your body).
Croatian: • zatajenje bubrega (većinom kao posljedica prevelikog gubitka tekućine iz Vašeg tijela).
English: This happens more often in elderly people (aged 75 and over), people with kidney problems, and people taking water tablets (diuretics).
Croatian: To se događa češće u starijih osoba (u dobi od 75 godina i starijih), u osoba s bubrežnim problemima i u osoba koje uzimaju tablete za izlučivanje vode (diuretike).
English: * Related to volume depletion; see section 4.4.
Croatian: * Povezano s deplecijom volumena; vidjeti dio 4.4. ** Vidjeti dio 4.4.
English: Increases in serum creatinine of 10-11% and BUN of approximately 12% were observed with both doses of canagliflozin.
Croatian: Povišenja kreatinina u serumu od 10-11% i BUN-a oko 12% primijećena su s obje doze kanagliflozina.
English: Constipation, Thirstb, Nausea
Croatian: Konstipacija, žeđb, mučnina
English: This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
Croatian: To je bilo praćeno ravnomjernim smanjenjem koncentracije mokraćne kiseline u serumu za približno 20%.
English: Less than 1% of the dose was excreted as unchanged canagliflozin in urine.
Croatian: Manje od 1% doze bilo je izlučeno u mokraći kao nepromijenjeni kanagliflozin.
English: • digoxin or digitoxin (medicines used for certain heart problems).
Croatian: • digoksin ili digitoksin (lijekovi koji se uzimaju za određene probleme sa srcem).
English: This demonstrated that approximately two-thirds of the weight loss associated with canagliflozin was due to loss of fat mass relative to placebo.
Croatian: Ono je pokazalo da je približno dvije trećine gubitka težine povezanih s kanagliflozinom u odnosu na placebo bilo uzrokovano gubitkom težine masnoće.
English: Most infections were mild to moderate with no increase in the occurrence of serious adverse reactions.
Croatian: Većina infekcija bile su blage do umjerene bez povećanja pojave ozbiljnih nuspojava.
English: Kidney function Your kidneys will be tested by a blood test before you start taking and while you are on this medicine.
Croatian: Funkcija Vaših bubrega biti će provjeravana krvnim pretragama prije početka uzimanja i dok uzimate ovaj lijek.
English: Hypotension*, Orthostatic hypotension*
Croatian: Hipotenzija*, ortostatska hipotenzija*
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, and institute clinical measures if required.
Croatian: U slučaju predoziranja, opravdano je primjeniti uobičajene potporne mjere, npr. ukloniti neaprsorbirani lijek iz gastrointestinalnog sustava, vršiti klinički nadzor, te po potrebi uvesti kliničke mjere.
English: The incidence with canagliflozin treatment in the two active-controlled studies was similar to comparators.
Croatian: Incidencija uz liječenje kanagliflozinom u dva aktivno kontrolirana ispitivanja bila je slična komparatorima.
English: This can lead to serious medical conditions such as heart disease, kidney disease, blindness, and amputation.
Croatian: To može dovesti do ozbiljnih zdravstvenih stanja kao što su bolesti srca, bubrega, sljepoća i amputacija.
English: The 100 mg tablet also contains iron oxide yellow (E172).
Croatian: Tableta od 100 mg također sadrži željezov oksid, žuti (E172).
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 tipa 2 je stanje u kojem Vaše tijelo ne stvara dovoljno inzulina, a stvoreni inzulin ne djeluje kako bi trebao.
English: Talk to your doctor about whether to stop taking this medicine or to stop breast-feeding.
Croatian: Razgovarajte sa svojim liječnikom o tome hoćete li prestati uzimati ovaj lijek ili ćete prestati dojiti.
English: It is also important to keep following advice about diet and exercise given by your doctor or nurse.
Croatian: Također je važno da slijedite preporuke o dijeti ili vježbanju koje Vam je dao liječnik ili medicinska sestra.
English: • medicines used to lower your blood pressure (anti-hypertensives), including diuretics (medicines used to remove levels of excess water in the body, also known as water tablets) since this medicine can also lower your blood pressure by removing levels of excess water in the body.
Croatian: • lijekove koji se koriste za smanjenje krvnog tlaka (antihipertenzivi), uključujući diuretike (lijekove koji se uzimaju za uklanjanje prekomjerne vode iz tijela, također poznate kao tablete za izlučivanje vode) budući da oni smanjuju krvni tlak na način da uklanjaju prekomjernu vodu iz tijela.
English: Invokana is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Croatian: Invokana je indicirana u odraslih u dobi od 18 godina i starijih s šećernom bolešću tipa 2, za poboljšanje regulacije glikemije kao:
English: There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Croatian: Ne postoji kliničko iskustvo u bolesnika s Child-Pugh stadijem C (teško) oštećenja jetre.
English: • if you have diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea, or vomiting).
Croatian: • ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti s visokim šećerom u krvi, brzim gubitkom tjelesne težine, mučninom ili povraćanjem).
English: Active-controlled studies
Croatian: Aktivno-kontrolirana ispitivanja
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: Patients taking digoxin or other cardiac glycosides (e.g., digitoxin) should be monitored appropriately.
Croatian: Bolesnike koji uzimaju digoksin ili druge srčane glikozide (npr. digitoksin) mora se prikladno pratiti.
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Croatian: Niže navedene nuspojave, poredane su prema učestalosti i klasifikaciji organskih sustava (SOC).
English: Adverse reactions related to volume depletion
Croatian: Nuspojave povezane s deplecijom volumena
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Croatian: Uvidjelo se da su umjerena povišenja (uglavnom < 400 mL do 500 mL) u dnevnom volumenu mokraće umanjena kroz nekoliko dana doziranja.
English: • blood tests may show increases in your blood phosphate level
Croatian: • krvne pretrage mogu pokazati povišenje razine fosfata u Vašoj krvi
English: Do not use Invokana if the packaging is damaged or shows signs of tampering.
Croatian: Invokana se ne smije upotrijebiti ako primijetite oštećenje na pakiranju ili ako su vidljivi znakovi otvaranja.
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 faktor.
English: The recommended starting dose of canagliflozin is 100 mg once daily.
Croatian: Preporučena početna doza kanagliflozina je 100 mg jedanput dnevno.
English: There were no meaningful changes in bone density in trabecular and cortical regions.
Croatian: Nije bilo značajnih promjena gustoće kostiju trabekularnih i kortikalnih regija.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu.
English: There was no notable change in heart rate.
Croatian: Nije bilo značajnije promjene srčane frekvencije.
English: The mean absolute oral bioavailability of canagliflozin is approximately 65%.
Croatian: Srednja vrijednost apsolutne bioraspoloživosti kanagliflozina uzetog peroralno približno je 65%.
English: • If you forget to take a dose, take it as soon as you remember.
Croatian: Ako ste zaboravili uzeti lijek Invokana • Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite.
English: Inhibition of BCRP by canagliflozin cannot be excluded at an intestinal level and increased exposure may therefore occur for medicinal products transported by BCRP, e.g. certain statins like rosuvastatin and some anti-cancer medicinal products.
Croatian: Inhibicija BCRP-a kanagliflozinom ne može se isključiti u crijevima te se stoga povišena izloženost može pojaviti za lijekove koje prenosi BCRP, npr. određenim statinima poput rosuvastatina i nekim lijekovima protiv raka.
English: Each tablet contains 117.78 mg lactose.
Croatian: Jedna tableta sadrži 117,78 mg laktoze.
English: Each tablet contains 39.2 mg lactose.
Croatian: Jedna tableta sadrži 39,2 mg laktoze.
English: More information is given below in “Other medicines and Invokana”.
Croatian: Više informacija možete pronaći niže, u dijelu “Drugi lijekovi i
English: The majority of genital mycotic infections were treated with topical antifungal treatments, either prescribed by a healthcare professional or self-treated while continuing therapy with Invokana.
Croatian: Većinu genitalnih gljivičnih infekcija liječilo se topikalnim antimikoticima, bilo da je lijek propisao liječnik ili su se bolesnici liječili sami, uz nastavak liječenja lijekom Invokana.
English: The increases in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Croatian: Povećanje izloženosti simvastatinu i kiselini simvastatina ne smatra se klinički značajnim.
English: However, based on the potential to reduce postprandial plasma glucose excursions due to delayed intestinal glucose absorption, it is recommended that Invokana be taken before the first meal of the day (see sections 4.2 and 5.1).
Croatian: Međutim, na temelju potencijala za smanjenje postprandijalne glukoze zbog odgođene apsorpcije crijevne glukoze, Invokana se preporučuje uzeti prije prvog obroka u danu (vidjeti dijelove 4.2 i 5.1).
English: N/Ac
Croatian: N/Pc
English: The hazard ratios for the 100 mg and 300 mg doses were similar.
Croatian: Omjeri rizika za doze od 100 mg i 300 mg bio je sličan.
English: • rifampicin (an antibiotic used to treat tuberculosis)
Croatian: • rifampicin (antibiotik koji se uzima za liječenje tuberkuloze)
English: In a pooled analysis of eight placebo-controlled and active-controlled studies, the safety profile in elderly patients was generally consistent with younger patients.
Croatian: Analizom udruženih podataka osam placebom kontroliranih i aktivno kontroliranih ispitivanja, sigurnosni profil u starijih bolesnika općenito je u skladu s onim u mlađih bolesnika.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Croatian: Dodatne analize sigurnosti (uključujući dugotrajne podatke) iz podataka cijelog programa za kanagliflozin (placebo i aktivno kontrolirana ispitivanja) bila su provedena radi procjene prijavljenih nuspojava da bi se prepoznale nuspojave (vidjeti tablicu 1) (vidjeti dijelove 4.2 i 4.4).
English: • if you have severe kidney problems or are on dialysis
Croatian: • ako imate teške probleme s bubrezima ili ste na dijalizi
English: After 104 weeks of treatment, canagliflozin did not adversely affect bone mineral density.
Croatian: Nakon 104 tjedna liječenja, kanagliflozin nije štetno utjecao na mineralnu gustoću kostiju.
English: Approximately 33% of the administered radioactive dose was excreted in urine, mainly as O-glucuronide metabolites (30.5%).
Croatian: Približno 33% primijenjene radioaktivne doze bilo je izlučeno u mokraći, uglavnom kao O-glukuronidni metaboliti (30,5%).
English: Via C. Janssen Borgo San Michele 04100 Latina Italy
Croatian: Janssen Borgo San Michele 04100 Latina Italija
English: The level of digoxin or digitoxin in your blood may need to be checked if taken with Invokana.
Croatian: Možda će se morati provjeriti razina digoksina ili digitoksina u krvi ako se ti lijekovi uzimaju s lijekom Invokana.
English: Older patients
Croatian: Stariji bolesnici
English: Dosing of canagliflozin should occur at least 1 hour before or 4-6 hours after administration of a bile acid sequestrant to minimise possible interference with their absorption.
Croatian: Doziranje kanagliflozina mora biti barem 1 sat prije ili 4-6 sati nakon primjene sekvestranta žučne kiseline kako bi se na minimum smanjilo moguće međudjelovanje s njihovom apsorpcijom.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toskičnost (vidjeti dio 5.3).
English: You should not take this medicine if you are breast-feeding.
Croatian: Ne smijete uzimati ovaj lijek ako dojite.
English: It is unknown whether ossification delays can be attributed to effects of canagliflozin on calcium homeostasis observed in adult rats.
Croatian: Nije poznato mogu li se zakašnjele osifikacije pripisati učincima kanagliflozina na homeostazu kalcija koja je primijećena u odraslih štakora.
English: Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age.
Croatian: Bolesnici su imali ukupnu srednju vrijednost godina 59,6 godina (raspon 21 godina do 96 godina), s 3082 bolesnika starosti ≥ 65 godina i 510 bolesnika starosti ≥ 75 godina.
English: In particular, if you are following a diabetic weight control diet, continue to follow it while you are taking this medicine.
Croatian: Posebno, ako ste u programu dijete za kontrolu tjelesne težine prilagođene dijabetičkim bolesnicima, nastavite je slijediti za vrijeme uzimanja ovog lijeka.
English: A study in juvenile rats administered canagliflozin from day 1 through day 90 postnatal did not show increased sensitivity compared to effects observed in adults rats.
Croatian: Ispitivanje u mladunčadi štakora kojima je kanagliflozin primijenjen od dana 1 do dana 90 postnatalno, nije pokazalo povećanu osjetljivost u usporedbi s učincima koji su uočeni u odraslih štakora.
English: Gender, race/ethnicity, or body mass index had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis.
Croatian: Rasa/etnička pripadnost ili indeks tjelesne mase nisu imali značajan klinički učinak na farmakokinetiku kanagliflozina temeljenu na analizi populacijske farmakokinetike.
English: Diabetic ketoacidosis**
Croatian: Dijabetička ketoacidoza**
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before taking this medicine.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas (ili ako niste sigurni), razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom prije uzimanja ovog lijeka.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with canagliflozin in one or more subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja kanagliflozina u jednoj ili više podskupina pedijatrijske populacije u dijabetesu tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Significant improvements in body weight and reductions in systolic blood pressure compared to both glimepiride and sitagliptin were also observed.
Croatian: Također su uočena značajna poboljšanja tjelesne težine i smanjenja sistoličkog krvnog tlaka u usporedbi i s glimepiridom i sa sitagliptinom.
English: “Blood-glucose lowering drugs” are medicines used by adults to treat type 2 diabetes.
Croatian: “Lijekovi za snižavanje šećera u krvi” su lijekovi koje uzimaju odrasli za liječenje šećerne bolesti tipa 2.
English: Subjects responded to standard treatments while continuing canagliflozin treatment.
Croatian: Ispitanici su odgovorili na standardna liječenja nastavljajući liječenje kanagliflozinom.
English: The Leydig cell tumours are associated with an increase in luteinizing hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Croatian: Tumori Leydigovih stanica povezani su s povišenjem luteinizirajućeg hormona (LH), koji je poznat mehanizam nastajanja tumora Leydigovih stanica u štakora.
English: Age had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis (see sections 4.2, 4.4, and 4.8).
Croatian: Dob nije imala klinički značajan učinak na farmakokinetiku kanagliflozina na temelju analize populacijske farmakokinetike (vidjeti dijelove 4.2, 4.4 i 4.8).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek, te tijekom liječenja:
English: Invokana has not been studied in patients with type 1 diabetes and is therefore not recommended for use in these patients.
Croatian: Invokana nije ispitana u bolesnika s dijabetesom tipa 1, stoga se ne preporučuje njeno uzimanje u ovih bolesnika.
English: • blood tests may show changes in blood fat (cholesterol) levels and increases in amount of red blood cells in your blood (haematocrit).
Croatian: • krvne pretrage mogu pokazati promijenjenu u razini masnoća u krvi (kolesterol) i povišenje količine crvenih krvnih stanica u krvi (hematokrit).
English: When diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to intolerance or contraindications.
Croatian: Kada dijeta i tjelovježba sami nisu dostatni za primjerenu regulaciju glikemije u bolesnika u kojih primjena metformina nije prikladna radi nepodnošljivosti ili kontraindikacija.
English: In a 12-week clinical study, unstimulated LH did not increase in male patients treated with canagliflozin.
Croatian: U 12-tjednom kliničkom ispitivanju, nestimulirani LH nije se povisio u muških bolesnika liječenih kanagliflozinom.
English: Invokana is available in PVC/aluminium perforated unit dose blisters.
Croatian: Invokana je dostupna u PVC/aluminij perforiranim blisterima djeljivim na jedinične doze.
English: The highest dose of 100 mg/kg provided up to 14 times the clinical dose of 300 mg based on AUC exposure.
Croatian: Najviša doza od 100 mg/kg pružila je i do 14 puta kliničke doze od 300 mg na temelju izloženosti AUC,.
English: Drug/Laboratory test interference
Croatian: Interferencija s lijekovima/laboratorijskim pretragama
English: If you take more Invokana than you should
Croatian: Ako uzmete više lijeka Invokana nego što ste trebali
English: It is not known if DKA is more likely to occur with higher doses of canagliflozin.
Croatian: Nije poznato je li vjerojatnost pojave DKA veća pri višim dozama kanagliflozina.
English: Rashc, Urticaria not known
Croatian: Osipc, urtikarija nepoznato
English: In patients where DKA is suspected or diagnosed, treatment with canagliflozin should be discontinued immediately.
Croatian: U bolesnika u kojih se sumnja na DKA ili je ista dijagnosticirana, liječenje kanagliflozinom treba odmah prekinuti.
English: Temporary interruption of treatment with canagliflozin may be considered for patients who develop volume depletion while on canagliflozin therapy until the condition is corrected.
Croatian: Može se razmotriti privremeni prekid liječenja kanagliflozinom za bolesnike u kojih se razvije deplecija volumena tijekom liječenja kanagliflozinom do popravka stanja.
English: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function.
Croatian: Stariji bolesnici mogu imati veći rizik za depleciju volumena, obzirom na veću vjerojatnost da se liječe diureticima i da imaju oštećenu funkciju bubrega.
English: The SGLT2 transporter, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Croatian: SGLT2 transporter, eksprimiran u proksimalnim bubrežnim tubulima, odgovoran je za većinu reapsorpcije filtrirane glukoze iz tubularnog lumena.
English: Most reports of vulvovaginal candidiasis occurred during the first four months of treatment with canagliflozin.
Croatian: Većina prijavljenih vulvovaginalnih kandidijaza pojavila se tijekom prva četiri mjeseca liječenja kanagliflozinom.
English: b p<0.001 compared to placebo.
Croatian: b p < 0,001 u usporedbi s placebom.
English: Canagliflozin may add to the effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Croatian: Kanagliflozin može dodatno djelovati na učinak diuretika i može povećati rizik pojave dehidracije i hipotenzije (vidjeti dio 4.4).
English: No clinically relevant effect on CYP3A4 was observed in vivo (see section 4.5).
Croatian: In vivo nije zabilježen klinički značajan učinak na CYP3A4 (vidjeti dio 4.5).
English: Overall, 0.7% of all female patients discontinued canagliflozin due to vulvovaginal candidiasis (see section 4.4).
Croatian: Općenito, 0,7% svih ženskih bolesnika prekinulo je uzimanje kanagliflozina zbog vulvovaginalnih kandidijaza (vidjeti dio 4.4).
English: Co-administration of a high-fat meal with canagliflozin had no effect on the pharmacokinetics of canagliflozin; therefore, Invokana may be taken with or without food.
Croatian: Istovremena primjena obroka s visokim udjelom masti s kanagliflozinom nije imala učinak na farmakokinetiku kanagliflozina; stoga se Invokana može uzeti s ili bez hrane.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of canagliflozin/metabolites in milk, as well as pharmacologically mediated effects in breast-feeding offspring and juvenile rats exposed to canagliflozin (see section 5.3).
Croatian: Dostupni farmakodinamski/toksikološki podaci u životinja pokazuju da se kanagliflozin/metaboliti izlučuju u mlijeko, kao i farmakološki posredovani učinci u dojene mladunčadi i mladih štakora izloženih kanagliflozinu (vidjeti dio 5.3).
English: Postprandial glucose
Croatian: Postprandijalna glukoza