FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have any of these symptoms, or if you are in a situation that could increase your risk for DKA, you must check your ketones, either in the blood or in the urine.
Croatian: Ako imate bilo koji od navedenih simptoma ili ako se nalazite u situaciji koja bi mogla povećati rizik od dijabetičke ketoacidoze, morate provjeriti vrijednost ketona u krvi ili mokraći.
English: Due to its mechanism of action, patients taking sotagliflozin will test positive for glucose in their urine.
Croatian: Zbog njegova mehanizma djelovanja, bolesnici koji uzimaju sotagliflozin imat će pozitivan nalaz testa na glukozu u mokraći.
English: If ketones are high follow instructions given above in Table 1 (see section 4.2).
Croatian: Ako su vrijednosti ketona visoke, treba slijediti upute navedene u Tablici 1 (vidjeti dio 4.2).
English: The median Tmax ranged from 1.25 to 3 hours, over a single-dose range of 400 to 2000 mg.
Croatian: Medijan Tmax kretao se od 1,25 do 3 sata u rasponu jednokratnih doza od 400 do 2000 mg.
English: Temporary interruption of treatment with sotagliflozin should be considered until the fluid loss is corrected.
Croatian: Treba razmotriti privremeni prekid liječenja sotagliflozinom dok se ne korigira gubitak tekućine.
English: The recommended dose is 200 mg sotagliflozin once daily before the first meal of the day.
Croatian: Preporučena doza je 200 mg sotagliflozina jedanput na dan prije prvog dnevnog obroka.
English: Reduction in risk of documented hypoglycaemia, compared to insulin alone at threshold of ≤3.1 mmol/L (%)
Croatian: Smanjenje rizika od dokumentirane hipoglikemije u odnosu na primjenu samo inzulina pri graničnoj vrijednosti od ≤ 3,1 mmol/l (%)
English: • Guide for Health Care Professionals including a prescriber's checklist
Croatian: • Vodič za zdravstvene radnike, uključujući kontrolni popis za propisivača • Vodič za bolesnike/njegovatelje
English: Available toxicological data in animals have shown excretion of sotagliflozin into milk.
Croatian: Dostupni toksikološki podaci prikupljeni u životinja pokazali su da se sotagliflozin izlučuje u mlijeko.
English: Multiple doses of 800 mg once daily were administrated in healthy volunteers and these doses were well tolerated.
Croatian: U zdravih su dobrovoljaca primijenjene višestruke doze od 800 mg jedanput na dan, koje su se dobro podnosile.
English: Both sotagliflozin and its major human metabolite 3-O-glucuronide (M19), exhibited high binding to human plasma proteins in vitro (fraction unbound approx. 2%) which was not dependent on the concentration of sotagliflozin and M19.
Croatian: I sotagliflozin i njegov glavni metabolit u ljudi, 3-O-glukuronid (M19), pokazali su visok stupanj vezivanja za proteine plazme u ljudi in vitro (nevezani udio od približno 2%) koji nije ovisio o koncentraciji sotagliflozina ni metabolita M19.
English: Blood Ketone (betahydroxybutyrate)
Croatian: (beta-hidroksibutirat)
English: In patients where DKA is suspected or diagnosed, treatment with sotagliflozin should be discontinued immediately.
Croatian: U bolesnika u kojih se sumnja na DKA ili kojima se ona dijagnosticira, liječenje sotagliflozinom mora se odmah prekinuti.
English: • if you have no access to ketone testing materials or no immediate access to a doctor if blood or urine ketones are elevated
Croatian: • ako nemate pristup materijalima za određivanje vrijednosti ketona ili Vam nije odmah dostupan liječnik u slučaju povišenih vrijednosti ketona u krvi ili mokraći
English: Symptomatic hypotension may occur after initiating sotagliflozin particularly in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics.
Croatian: Nakon uvođenja sotagliflozina može se javiti simptomatska hipotenzija, osobito u bolesnika s oštećenjem funkcije bubrega, starijih osoba, bolesnika s niskim sistoličkim krvnim tlakom i bolesnika koji primjenjuju diuretike.
English: For the first meal on Day 1, patients were instructed to decrease their calculated (or usual) mealtime carbohydrate bolus insulin by 30%.
Croatian: Za prvi obrok prvog dana, bolesnici su dobili naputak da izračunatu (ili uobičajenu) dozu bolusnog inzulina prilagođenu količini ugljikohidrata smanje za 30%.
English: Subsequent bolus doses should be adjusted individually based on blood glucose results.
Croatian: Daljnje bolusne doze treba prilagoditi individualno na temelju vrijednosti glukoze u krvi.
English: In order to avoid hypoglycaemia with the first dose of sotagliflozin a 20% reduction in the first mealtime bolus insulin may be considered.
Croatian: Kako bi se izbjegla hipoglikemija kod prve doze sotagliflozina, može se razmotriti smanjenje prve doze bolusnog inzulina koji se primjenjuje uz obrok za 20%.
English: There are no data from the use of sotagliflozin in pregnant women.
Croatian: Nema podataka o primjeni sotagliflozina u trudnica.
English: • Sotagliflozin is not a substitute for insulin.
Croatian: • Sotagliflozin nije zamjena za inzulin.
English: • blood tests may show increase in the amount of red blood cells in your blood (called haematocrit)
Croatian: • krvni nalazi mogu pokazivati povećan broj crvenih krvnih stanica u krvi (koje se zovu hematokrit)
English: In a repeat-dose study evaluating potential mechanisms responsible for the increase incidence of thyroid carcinoma observed in the rat carcinogenicity study, it was concluded that the increase was associated with a sotagliflozin-related increase in thyroid stimulating hormone (TSH).
Croatian: U ispitivanju ponovljenih doza u kojem su se ocjenjivali potencijalni mehanizmi odgovorni za porast incidencije karcinoma štitnjače u ispitivanju kancerogenosti na štakorima zaključeno je da je taj porast bio povezan s povišenjem vrijednosti hormona koji stimulira štitnjaču (engl. thyroid stimulating hormone, TSH) uzrokovanim djelovanjem sotagliflozina.
English: If you develop symptoms contact your doctor or go to the nearest hospital right away.
Croatian: Ako primijetite te simptome, odmah se obratite svom liječniku ili otiđite u najbližu bolnicu.
English: Before initiating sotagliflozin, volume contraction should be assessed and volume status should be corrected if indicated.
Croatian: Prije uvođenja sotagliflozina potrebno je ocijeniti kontrakciju volumena i po potrebi korigirati volumni status.
English: The risk of developing diabetic ketoacidosis may be increased with prolonged fasting, excessive alcohol consumption, drug abuse, dehydration, sudden reductions in insulin dose, or a higher need for insulin due to major surgery, serious illness or infection.
Croatian: Rizik od razvoja dijabetičke ketoacidoze može biti povećan kod dugotrajnog gladovanja, prekomjerne konzumacije alkohola, zlouporabe droge, dehidracije, iznenadnih smanjenja doze inzulina ili veće potrebe za inzulinom zbog velikog kirurškog zahvata, ozbiljne bolesti ili infekcije.
English: Two cases (2 cases of cystitis) were serious; both occurred in male subjects in the sotagliflozin 400 mg group.
Croatian: Dva su slučaja bila ozbiljna (2 slučaja cistitisa) i oba su se javila u muškaraca liječenih sotagliflozinom u dozi od 400 mg.
English: The recommended dose of Zynquista is one 200-mg tablet once a day before the first meal of the day.
Croatian: Preporučena doza lijeka Zynquista je jedna tableta od 200 mg jedanput na dan prije prvog dnevnog obroka.
English: Fifteen of the 35 cases (43%) experienced DKA with glucose values in the glycaemic range 8 to 14 mmol/L.
Croatian: U 15 od 35 slučajeva (43%) bolesnici su imali DKA uz vrijednosti glukoze u glikemijskom rasponu od 8 do 14 mmol/l.
English: - Patients with increased insulin requirements due to acute medical illness or surgery.
Croatian: - bolesnici s povećanim potrebama za inzulinom zbog akutne bolesti ili kirurškog zahvata
English: Each tablet contains 200 mg sotagliflozin.
Croatian: Jedna tableta sadrži 200 mg sotagliflozina.
English: In in vitro studies, sotagliflozin did not inhibit CYP 1A2, 2C9, 2C19, 2D6, or 3A4, nor induced CYP 1A2, 2B6, or 3A4.
Croatian: U ispitivanjima in vitro sotagliflozin nije inhibirao CYP1A2, 2C9, 2C19, 2D6 ni 3A4 niti inducirao CYP1A2, 2B6 ni 3A4.
English: Sotagliflozin is a dual inhibitor of sodium glucose cotransporter type 1 (SGLT1) and SGLT2.
Croatian: Sotagliflozin je dvojni inhibitor suprijenosnika natrija i glukoze tipa 1 i tipa 2 (SGLT1 i SGLT2).
English: Manufacturer :
Croatian: Njemačka Proizvođač:
English: There is limited experience in clinical trials in patients with moderate and severe hepatic impairment.
Croatian: Postoji ograničeno iskustvo iz kliničkih ispitivanja s primjenom u bolesnika s umjerenim i teškim oštećenjem funkcije jetre.
English: Interaction studies in healthy volunteers showed that metformin, metoprolol, midazolam, rosuvastatin and oral contraceptives had no clinically relevant effect on the pharmacokinetics of sotagliflozin.
Croatian: Ispitivanja interakcija provedena u zdravih dobrovoljaca pokazala su da metformin, metoprolol, midazolam, rosuvastatin i oralni kontraceptivi nisu imali klinički značajnog učinka na farmakokinetiku sotagliflozina.
English: The 52-week completion rates were 84.2%, 86.6%, and 85.3% respectively.
Croatian: Udjeli bolesnika koji su završili 52 tjedna ispitivanja iznosili su 84,2%, 86,6% odnosno 85,3%.
English: The following adverse reactions have been identified in the pool of two 52-week placebo-controlled clinical trials described above.
Croatian: Sljedeće su nuspojave zabilježene u objedinjenim podacima iz dvaju prethodno opisanih 52-tjednih placebom kontroliranih kliničkih ispitivanja.
English: Please consult the Patient/Carer's Guide for more information discussed with your doctor about taking Zynquista and the risk of DKA.
Croatian: Pročitajte Vodič za bolesnika/njegovatelja za više informacija o uzimanju lijeka Zynquista i riziku od
English: What you need to know before you take Zynquista 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Zynquista
English: EU/1/19/1363/001 10 film coated tablets EU/1/19/1363/002 20 film coated tablets EU/1/19/1363/003 30 film coated tablets EU/1/19/1363/004 60 film coated tablets EU/1/19/1363/005 90 film coated tablets EU/1/19/1363/006 100 film coated tablets EU/1/19/1363/007 180 film coated tablets EU/1/19/1363/008 200 (2x100) film coated tablets (multipack)
Croatian: EU/1/19/1363/001 10 filmom obloženih tableta EU/1/19/1363/002 20 filmom obloženih tableta EU/1/19/1363/003 30 filmom obloženih tableta EU/1/19/1363/004 60 filmom obloženih tableta EU/1/19/1363/005 90 filmom obloženih tableta EU/1/19/1363/006 100 filmom obloženih tableta EU/1/19/1363/007 180 filmom obloženih tableta EU/1/19/1363/008 200 (2x100) filmom obloženih tableta (multipack)
English: When sotagliflozin tablets were administered with a high-caloric breakfast, plasma exposure to sotagliflozin as measured by Cmax and AUC0 inf was about 2.5- and 1.5-fold higher, respectively, compared to fasted condition.
Croatian: Kada su se tablete sotagliflozina primjenjivale uz visokokaloričan doručak, izloženost sotagliflozinu u plazmi izražena vrijednošću Cmax i AUC0 inf bila je približno 2,5 odnosno 1,5 puta veća nego kod primjene natašte.
English: Pharmacotherapeutic group: Drugs used in diabetes, sodium-glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK06
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, inhibitori suprijenosnika natrija i glukoze 2 (SGLT2); ATK oznaka: A10BK06
English: During the initial one to two weeks of treatment with sotagliflozin, ketones should be monitored on a regular basis.
Croatian: Tijekom prvih 1 - 2 tjedna liječenja sotagliflozinom potrebno je redovito pratiti vrijednosti ketona.
English: The patient should go to emergency department without delay and stop taking sotagliflozin.
Croatian: Bolesnik mora odmah otići u hitnu službu bez odgode i prestati uzimati sotagliflozin.
English: Frequency of occurrence Very common Common
Croatian: Učestalost pojavljivanja vrlo često često manje često
English: Unchanged [14C]-sotagliflozin was the predominant radioactive peak detected in faecal extracts representing a mean of 23% of the total administered radioactive dose.
Croatian: Nepromijenjeni [14C]-sotagliflozin predstavljao je predominantan radioaktivni materijal pronađen u fekalnim ekstraktima, koji je činio 23% primijenjene radioaktivne doze (srednja vrijednost).
English: Sotagliflozin should be taken once daily before the first meal of the day.
Croatian: Sotagliflozin se uzima jedanput na dan, prije prvog dnevnog obroka.
English: Non-interventional PASS: In order to estimate the incidence of DKA in T1DM sotagliflozin treated patients to assess the effectiveness of the risk minimisation measures implemented in Europe, the MAH should conduct and submit the results from an observational cohort study using existing data sources in European countries where sotagliflozin will be launched for T1DM.
Croatian: Neintervencijsko ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): Kako bi se procijenila incidencija DKA u bolesnika sa šećernom bolešću tipa 1 liječenih sotagliflozinom i ocijenila učinkovitost mjera minimizacije rizika implementiranih u Europi, nositelj odobrenja mora provesti i dostaviti rezultate opservacijskog kohortnog ispitivanja služeći se postojećim izvorima podataka iz europskih zemalja u kojima će sotagliflozin biti stavljen na tržište za liječenje šećerne bolesti tipa 1.
English: Local intestinal inhibition of SGLT1, the major transporter for glucose absorption, delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia.
Croatian: Lokalna crijevna inhibicija SGLT1, koji je glavni prijenosnik za apsorpciju glukoze, odgađa i smanjuje apsorpciju glukoze u proksimalnom crijevu, što ublažava i odgađa nastup postprandijalne hiperglikemije.
English: Increased urinationd, blood creatinine increased/ glomerular filtration decreased†
Croatian: povišene vrijednosti kreatinina u krvi / smanjena glomerularna filtracija†
English: • The patient alert card should be presented to any HCP consulted.
Croatian: • Karticu s upozorenjima za bolesnika treba pokazati svakom zdravstvenom radniku kojeg bolesnik posjeti.
English: In InTandem1 (study 1) and in InTandem2 (study 2) sotagliflozin was used as add on to optimised insulin and in InTandem3 (Study 3) sotagliflozin was used as add on to any existing insulin regimen in patients not on HbA1c goal.
Croatian: U ispitivanjima InTandem1 (ispitivanje 1) i InTandem2 (ispitivanje 2) sotagliflozin se primjenjivao kao dodatak optimiziranom inzulinskom režimu, dok se u ispitivanju InTandem3 (ispitivanje 3) primjenjivao kao dodatak bilo kojem postojećem inzulinskom režimu u bolesnika koji nisu postigli ciljnu vrijednost HbA1c.
English: • Ensure the patient is on optimal insulin therapy prior to initiation of sotagliflozin treatment.
Croatian: • Liječnik se mora uvjeriti da bolesnik primjenjuje optimalnu inzulinsku terapiju prije nego što mu uvede liječenje sotagliflozinom.
English: Diabetic ketoacidosis (DKA) is a potentially life-threatening problem you can get with diabetes because of increased levels of “ketone bodies” in your urine or blood, seen in tests.
Croatian: Dijabetička ketoacidoza (DKA) tegoba je koja može biti opasna po život, a javlja se kod šećerne bolesti zbog povišenih vrijednosti „ketonskih tijela“ u mokraći ili krvi, koje su vidljive u nalazima pretraga.
English: Rosuvastatin is a known OATP, BCRP and OAT3 substrate.
Croatian: Rosuvastatin je poznat supstrat OATP-a, BCRP-a i prijenosnika OAT3.
English: EU/1/19/1363/008 (200 mg - 2 packs of 100 film coated tablets)
Croatian: EU/1/19/1363/008 (200 mg- 2 pakiranja od 100 filmom obloženih tableta)
English: Based on in-vitro data, induction of CYP2C9, CYP2B6 and CYP1A2 cannot be ruled out.
Croatian: Prema podacima in vitro ne može se isključiti indukcija enzima CYP2C9, CYP2B6 i CYP1A2.
English: Patients with hypovolemia may be more susceptible to these changes.
Croatian: Tim promjenama mogu biti skloniji bolesnici s hipovolemijom.
English: Patients using an insulin infusion pump have a higher risk of DKA and should be experienced with pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur (issues with insertion site, clogged tubing, empty reservoir, etc.) and use of supplemental insulin injections with pen or syringe as needed in case of pump failure.
Croatian: Bolesnici koji koriste inzulinsku infuzijsku pumpu imaju veći rizik od DKA pa moraju imati iskustva s korištenjem pumpe, strategijama za rješavanje uobičajenih problema kod prekida u isporuci inzulina pumpom (problemi na mjestu ulaska u tijelo, začepljenje cijevi, prazan spremnik itd.) te primjenom dodatnih injekcija inzulina brizgalicom ili štrcaljkom po potrebi, u slučaju kvara pumpe.
English: All events were mild or moderate in intensity and no serious cases.
Croatian: Svi su događaji bili blage ili umjerene težine i nije prijavljen nijedan ozbiljan slučaj.
English: DKA episodes during sotagliflozin use can be atypical, with patients not having blood sugar levels as high as expected.
Croatian: Epizode DKA tijekom primjene sotagliflozina mogu biti atipične, pri čemu vrijednosti šećera u krvi bolesnika mogu biti niže od očekivanih.
English: • For pump users: restrict sotagliflozin prescription to patients experienced in pump use, common trouble-shooting strategies when interruptions of insulin delivery via pump occur in case of pump failure.
Croatian: • Za korisnike inzulinske pumpe: propisivanje sotagliflozina treba ograničiti na bolesnike koji imaju iskustva s korištenjem pumpe i strategijama za rješavanje uobičajenih problema kod prekida u isporuci inzulina pumpom u slučaju kvara pumpe.
English: The patient should immediately seek medical advice and stop taking sotagliflozin.
Croatian: Bolesnik treba odmah zatražiti savjet liječnika i prestati uzimati sotagliflozin.
English: Exposure of sotagliflozin was evaluated in a dedicated study of subjects with mild (creatinine clearance [CLcr]: 60 to less than 90 mL/min) and moderate (CLcr: 30 to less than 60 mL/min) renal impairment and with normal renal function.
Croatian: Izloženost sotagliflozinu ocjenjivala se u posebnom ispitivanju provedenom u ispitanika s blagim (klirens kreatinina [Clcr] od 60 do manje od 90 ml/min) i umjerenim (Clcr od 30 do manje od 60 ml/min) oštećenjem funkcije bubrega te onih s normalnom funkcijom bubrega.
English: Oval, blue, film-coated tablet printed with “2456” on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).
Croatian: Ovalna, plava, filmom obložena tableta s oznakom „2456“ otisnutom crnom tintom na jednoj strani (duljina tablete: 14,2 mm, širina tablete: 8,7 mm).
English: - Patient not on optimal insulin dose or who have recent issues with noncompliance or recurrent errors with insulin dosing and who are unlikely to maintain adequate insulin dosing.
Croatian: - bolesnici s malim potrebama za inzulinom - bolesnici koji ne primjenjuju optimalnu dozu inzulina ili koji su nedavno imali poteškoća s pridržavanjem liječenja ili opetovane pogreške s doziranjem inzulina i koji vjerojatno neće održavati odgovarajuće doziranje inzulina
English: In a study with subjects with reduced hepatic function, AUC of sotagliflozin was not increased in mild (Child Pugh A) hepatic impaired subjects, but was increased by ~3 fold in moderate (Child Pugh B) and ~ 6 fold in severe (Child Pugh C) hepatic impaired subjects.
Croatian: U ispitivanju provedenom u ispitanika sa smanjenom funkcijom jetre AUC sotagliflozina u bolesnika s blagim oštećenjem funkcije jetre (Child-Pugh stadija A) nije bio povećan, ali je bio ~3 puta veći u ispitanika s umjerenim oštećenjem funkcije jetre (Child-Pugh stadija B) i ~6 puta veći u onih s teškim oštećenjem funkcije jetre (Child-Pugh stadija C).
English: In placebo-controlled clinical trials of sotagliflozin, patients were advised to monitor urine or blood ketones in case of suspected symptoms of DKA and seek medical advice/attention if their selfmeasured blood ketone reading was > 0.6 mmol/l.
Croatian: U placebom kontroliranim kliničkim ispitivanjima sotagliflozina bolesnicima je rečeno da u slučaju sumnje na simptome DKA prate vrijednosti ketona u mokraći ili krvi te da potraže savjet/pomoć liječnika ako im samoizmjerena vrijednost ketona u krvi bude > 0,6 mmol/l.
English: With sotagliflozin DKA may be present with low, normal or high blood glucose levels.
Croatian: Kod primjene sotagliflozina DKA se može javiti uz niske, normalne ili visoke vrijednosti glukoze u krvi.
English: EU/1/19/1363/008 200 film-coated tablets (2 packs of 100)
Croatian: EU/1/19/1363/008 200 filmom obloženih tableta (2 pakiranja od 100 tableta)
English: • if you develop a combination of symptoms of pain, tenderness, redness, or swelling of the genitals or the area between the genitals and the anus with fever or feeling generally unwell.
Croatian: • ako se pojavi kombinacija simptoma boli, osjetljivosti na dodir, crvenila ili oticanja genitalija ili područja između genitalija i anusa, praćena vrućicom ili općim lošim osjećanjem.
English: After initiating sotagliflozin ketones should be monitored on a regular basis during the initial one to two weeks, then the frequency of ketone level testing should be individualised, according to the patient's lifestyle and/or risk factors.
Croatian: Nakon uvođenja sotagliflozina vrijednosti ketona treba redovito pratiti tijekom prvih 1 - 2 tjedna, a zatim učestalost određivanja vrijednosti ketona individualno prilagoditi u skladu s načinom života i/ili faktorima rizika kod pojedinog bolesnika.
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Croatian: Rizik od dijabetičke ketoacidoze mora se razmotriti u slučaju nespecifičnih simptoma poput mučnine, povraćanja, anoreksije, boli u abdomenu, prekomjerne žeđi, otežanog disanja, konfuzije, neuobičajenog umora ili pospanosti.
English: In the clinical trials (pool of two 52-week placebo-controlled trials) of sotagliflozin, the incidence of diabetic ketoacidosis (DKA) was higher in the sotagliflozin treatment group compared with the placebo group (see section 4.8).
Croatian: U kliničkim ispitivanjima sotagliflozina (objedinjeni podaci iz dvaju 52-tjednih placebom kontroliranih ispitivanja) incidencija dijabetičke ketoacidoze (DKA) bila je viša u skupini liječenoj sotagliflozinom nego u onoj koja je primala placebo (vidjeti dio 4.8).
English: EU/1/19/1363/001 (200 mg - 10 film coated tablets) EU/1/19/1363/002 (200 mg - 20 film coated tablets) EU/1/19/1363/003 (200 mg - 30 film coated tablets) EU/1/19/1363/004 (200 mg - 60 film coated tablets) EU/1/19/1363/005 (200 mg - 90 film coated tablets) EU/1/19/1363/006 (200 mg - 100 film coated tablets) EU/1/19/1363/007 (200 mg - 180 film coated tablets)
Croatian: EU/1/19/1363/001 (200 mg - 10 filmom obloženih tableta) EU/1/19/1363/002 (200 mg - 20 filmom obloženih tableta) EU/1/19/1363/003 (200 mg - 30 filmom obloženih tableta) EU/1/19/1363/004 (200 mg - 60 filmom obloženih tableta) EU/1/19/1363/005 (200 mg - 90 filmom obloženih tableta) EU/1/19/1363/006 (200 mg - 100 filmom obloženih tableta) EU/1/19/1363/007 (200 mg - 180 filmom obloženih tableta)
English: Assessment of renal function is recommended prior to initiation of sotagliflozin and periodically thereafter (see section 4.4).
Croatian: Preporučuje se ocijeniti funkciju bubrega prije uvođenja sotagliflozina i periodički nakon toga (vidjeti dio 4.4).
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility and pregnancy (see section 5.3).
Croatian: Ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na plodnost i trudnoću (vidjeti dio 5.3).
English: Based on a population PK analysis, sotagliflozin exposure was found to decrease with increased body weight.
Croatian: Populacijska farmakokinetička analiza pokazala je da se izloženost sotagliflozinu smanjuje s povećanjem tjelesne težine.
English: • Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenja mjera nakon davanja odobrenja: