FrancophonIA/ELRC3.0 huggingface dataset:
English: The Agency decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je zaključila da koristi lijeka Advate nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: The Agency concluded that Advate has been shown to be effective at treating and preventing bleeding in patients with haemophilia A and has an acceptable safety profile.
Croatian: Agencija je zaključila da se lijek Advate pokazao djelotvornim u liječenju i sprečavanju krvarenja u bolesnika s hemofilijom A i da ima prihvatljiv sigurnosni profil.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Advate have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Advate nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: For more information about treatment with Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Advate pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Advate is a medicine used for the treatment and prevention of bleeding in patients of all ages with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Croatian: Advate je lijek koji se koristi za liječenje i sprečavanje krvarenja u bolesnika svih dobi s hemofilijom A (nasljednim poremećajem krvarenja uzrokovanim manjkom faktora VIII).
English: Advate can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia and with resuscitation equipment available in case of severe allergic reaction (anaphylaxis).
Croatian: Lijek Advate izdaje se samo na recept, a liječenje mora započeti liječnik s iskustvom u liječenju hemofilije i opremom za reanimaciju dostupnom u slučaju teške alergijske reakcije (anafilaksa).
English: How is Advate used?
Croatian: Kako se Advate koristi?
English: Advate is available as a powder and solvent that are mixed together to make a solution for injection into a vein.
Croatian: Lijek Advate dostupan je u obliku praška i otapala koji se miješaju kako bi se pripremila otopina za intravensku injekciju.
English: The active substance in Advate, octocog alfa (human coagulation factor VIII), is a substance that helps the blood to clot.
Croatian: Djelatna tvar u lijeku Advate, oktokog alfa (ljudski koagulacijski faktor VIII), tvar je koja pomaže u zgrušavanju krvi.
English: For practical information about using Advate, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Advate bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svojem liječniku ili ljekarniku.
English: Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.
Croatian: Ispitana je primjena velike doze lijeka Advate kako bi se utvrdilo je li on djelotvoran u uklanjanju protutijela za faktor VIII iz krvi (postupak poznat kao liječenje metodom inducirane imunotolerancije) tako da liječenje faktorom VIII ostane djelotvorno.
English: Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.
Croatian: Lijekom Advate nadomješćuje se nedostatak faktora VIII tako što se njime zamjenjuje faktor VIII koji nedostaje, čime se omogućuje privremena kontrola poremećaja krvarenja.
English: Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control.
Croatian: Neki bolesnici mogu razviti inhibitore faktora VIII, odnosno protutijela (proteine) koje imunosni sustav proizvodi kako bi obranio organizam od faktora VIII, a koji mogu onemogućiti djelovanje lijeka i dovesti do gubitka kontrole nad krvarenjem.
English: For the full list of all side effects reported with Advate, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Advate potražite u uputi o lijeku.
English: What benefits of Advate have been shown in studies?
Croatian: Koje su koristi lijeka Advate utvrđene u ispitivanjima?
English: Patients or their carers may be able to administer Advate themselves at home once they have been trained appropriately.
Croatian: Nakon odgovarajuće obuke, bolesnici ili njihovi njegovatelji mogu samostalno primjenjivati lijek Advate kod kuće.
English: The effectiveness of Advate was rated as ‘excellent' or ‘good' in 86% of 510 new bleeding episodes.
Croatian: U 86 % od 510 novih epizoda krvarenja djelotvornost lijeka Advate ocijenjena je kao „izvrsna” ili „dobra”.
English: Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.
Croatian: Zbog toga je lijek Advate u okviru jednog glavnog ispitivanja, u kojem je sudjelovalo 111 bolesnika s hemofilijom A, uspoređen s lijekom Recombinate kako bi se dokazalo da su ta dva lijeka jednakovrijedna.
English: There is a risk with factor VIII medicines that some patients will develop inhibitors (antibodies) against factor VIII, causing the medicine to stop working and resulting in a loss of bleeding control.
Croatian: U nekih bolesnika koji uzimaju lijekove za nadomjestak faktora VIII mogu se razviti inhibitori (protutijela) faktora VIII koji onemogućuju djelovanje lijeka i dovode do gubitka kontrole nad krvarenjem.
English: How does Advate work?
Croatian: Kako djeluje Advate?
English: Date of first authorisation: 16 November 2015
Croatian: Datum prvog odobrenja: 16. studenog 2015.
English: • if you drink large amounts of alcohol, either every day or only from time to time (please see section “Ebymect with alcohol”).
Croatian: • ako pijete velike količine alkohola (bilo svakodnevno ili samo povremeno) (molimo pogledajte dio „Ebymect s alkoholom“).
English: Talk to your doctor, pharmacist or nurse before taking Ebymect, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Ebymect i tijekom liječenja:
English: Ebymect should not be used to treat this condition.
Croatian: Ebymect se ne smije koristiti za liječenje ove bolesti.
English: Subjects (%) achieving:
Croatian: Ispitanici (%) u kojih je postignut
English: To avoid overdose, do not continue taking dapagliflozin and metformin tablets, if you are taking Ebymect.
Croatian: Da biste izbjegli predoziranje, nemojte nastaviti uzimati tablete dapagliflozina i metformina ako uzimate Ebymect.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve informacije oovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet:
English: More information is given below under ‘Other medicines and Ebymect'.
Croatian: Više informacija možete pronaći u nastavku, u dijelu „Drugi lijekovi i Ebymect“
English: Avoid excessive alcohol intake while taking Ebymect since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Ebymect jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza“).
English: In case of suspected symptoms, the patient should stop taking Ebymect and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati Xigduo i odmah potražiti pomoć liječnika.
English: The safety and efficacy of Ebymect in patients with type 1 diabetes have not been established and Ebymect should not be used for treatment of patients with type 1 diabetes.
Croatian: Sigurnost i djelotvornost lijeka Ebymect u bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene te se Ebymect ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa 1.
English: If Fournier's gangrene is suspected, Ebymect should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Croatian: Ako se sumnja na Fournierovu gangrenu, potrebno je prekinuti uzimanje lijeka Ebymect te hitno započeti s liječenjem (uključujući antibiotike i kirurški debridman).
English: Ebymect has no or negligible influence on the ability to drive and use machines.
Croatian: Ebymect ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Ebymect is used for a type of diabetes called “type 2 diabetes” in adult patients (aged 18 years and older) and usually occurs when you are older.
Croatian: Ebymect 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), koja se obično javlja u starijoj dobi.
English: Volume depletion
Croatian: deplecija volumena
English: In active- and placebocontrolled clinical trials (dapagliflozin, N=5936, All control, N=3403), the frequency of rash was similar for dapagliflozin (1.4%) and all control (1.4%), respectively.
Croatian: U kliničkim ispitivanjima kontroliranim aktivnim lijekom i placebom (dapagliflozin, N=5936, sve kontrole, N=3403), učestalost osipa bila je slična za dapagliflozin (1,4%) i sve kontrole (1,4%).
English: • If renal function falls persistently below GFR 45 mL/min, treatment should be discontinued.
Croatian: • ako se bubrežna funkcija pogorša te je kontinuirano ispod vrijednosti GFR 45 ml/min, liječenje treba prekinuti.
English: Patients should be alerted to the risk of hypoglycaemia when this medicinal product is used in combination with other glucoselowering medicinal products known to cause hypoglycaemia.
Croatian: Bolesnike treba upozoriti na rizik od hipoglikemije kod primjene ovog lijeka u kombinaciji s drugim lijekovima koji snižavaju razinu glukoze za koje se zna da uzrokuju hipoglikemiju.
English: • Lactic acidosis, seen very rarely (may affect up to 1 in 10,000 people) Ebymect may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Croatian: • Laktacidoza, vrlo rijetka (može se javiti u manje od 1 na 10 000 osoba), ali vrlo ozbiljna nuspojava koja se naziva laktacidoza (vidjeti dio „Upozorenja i mjere opreza“).
English: Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)
Croatian: Doziranje Odrasli s normalnom funkcijom bubrega (brzina glomerularne filtracije [GFR] ≥90 ml/min)
English: Vulvovaginitis , balanitis and related genital infections
Croatian: Infekcije i infestacije vulvovaginitis, balanitis i srodne genitalne infekcije
English: Ebymect is indicated in adults for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise:
Croatian: Ebymect je indiciran za liječenje šećerne bolesti tipa 2 u odraslih kao dopuna dijeti i tjelovježbi:
English: These may be medicine(s) by mouth or given by injection, such as insulin or a GLP-1 receptor agonist.
Croatian: To mogu biti neki lijekovi koji se uzimaju kroz usta ili lijekovi, koji se primjenjuju injekcijom, kao što je inzulin ili agonist GLP-1 receptora.
English: Metformin may act via three mechanisms: by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis; by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation in muscle; by delaying intestinal glucose absorption.
Croatian: Metformin može djelovati putem triju mehanizama: - smanjujući proizvodnju glukoze u jetri time što inhibira glukoneogenezu i glikogenolizu, - umjereno povećavajući osjetljivost na inzulin, čime se poboljšava unos i iskorištavanje glukoze u perifernim tkivima u mišićima, - usporavajući apsorpciju glukoze u crijevima.
English: Ebymect combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Croatian: Ebymect sadrži kombinaciju dvaju antihiperglikemijskih lijekova s različitim, ali komplementarnim mehanizmima djelovanja koji poboljšavaju regulaciju glikemije u bolesnika sa šećernom bolešću tipa 2: dapagliflozin, inhibitor SGLT2, i metforminklorid, lijek iz skupine bigvanida.
English: Excipient(s) with known effect: Ebymect contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Croatian: Pomoćne tvari s poznatim učinkom: Ebymect sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: If you forget to take Ebymect
Croatian: Ako ste zaboravili uzeti Ebymect
English: Treatment with dapagliflozin 10 mg in combination with metformin (up to 2,000 mg per day) provided significant improvements in HbA1c compared to the individual components (Table 7), and led to greater reductions in FPG (compared to the individual components) and body weight (compared to metformin).
Croatian: Liječenje dapagliflozinom od 10 mg u kombinaciji s metforminom (do 2000 mg po danu) pružilo je značajno poboljšanje u HbA1c u usporedbi sa pojedinačnim komponentama (tablica 7), i dovelo do većeg smanjenja glukoze u plazmi natašte (u usporedbi sa pojedinačnim komponentama) i tjelesne težine (u usporedbi sa metforminom).
English: Dapagliflozin 5 mg twice daily provided statistically significant reductions in HbA1c at 16 weeks compared with subjects receiving placebo (p < 0.0001; Table 4).
Croatian: Dapagliflozin u dozi od 5 mg dvaput na dan doveo je do statistički značajnih smanjenja vrijednosti HbA1c u 16. tjednu u usporedbi s ispitanicima koji su primali placebo (p < 0,0001; Tablica 4)
English: Stop taking Ebymect and see a doctor as soon as possible if you notice any of the following serious or potentially serious effects:
Croatian: Prestanite uzimati Ebymect i što prije se javite liječniku ako se pojavi bilo koja od sljedećih ozbiljnih ili potencijalno ozbiljnih nuspojava:
English: hypersensitivity to the active substances or to any of the excipients listed in section 6.1; any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); diabetic pre-coma; severe renal failure (GFR < 30 mL/min) (see sections 4.2, 4.4 and 5.2); acute conditions with the potential to alter renal function such as: - dehydration, - severe infection, - shock; acute or chronic disease which may cause tissue hypoxia such as: - cardiac or respiratory failure, - recent myocardial infarction, - shock; hepatic impairment (see sections 4.2, 4.4 and 5.2); acute alcohol intoxication, alcoholism (see section 4.5).
Croatian: - preosjetljivih na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1; - s bilo kojom vrstom akutne metaboličke acidoze (kao što je laktacidoza, dijabetička ketoacidoza); - s dijabetičkom pretkomom; - s teškim zatajenjem bubrega (GFR<30 ml/min) (vidjeti dijelove 4.2, 4.4 i 5.2); - s akutnim stanjima koja mogu utjecati na funkciju bubrega kao što su: - dehidracija, - teška infekcija, - šok; - s akutnom ili kroničnom bolešću koja može izazvati hipoksiju tkiva kao što je: - zatajenje srca ili disanja, - nedavni infarkt miokarda, - šok; - s oštećenjem jetre (vidjeti dijelove 4.2, 4.4, i 5.2); - s akutnim trovanjem alkoholom, odnosno alkoholizmom (vidjeti dio 4.5).
English: Stop taking Ebymect and see a doctor straight away if you notice any of the following serious or potentially serious side effects:
Croatian: Prestanite uzimati Ebymect i odmah se javite liječniku ako se pojavi bilo koja od sljedećih ozbiljnih ili potencijalno ozbiljnih nuspojava:
English: Gastrointestinal symptoms i,§
Croatian: Poremećaji probavnog sustava gastrointestinaln i simptomi i,§
English: Ebymect should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see section 4.2).
Croatian: Liječenje lijekom Ebymect se ne smije započeti u bolesnika s GFR < 60 ml/min, a ako su vrijednosti GFR neprekidno ispod 45 ml/min, liječenje treba prekinuti (vidjeti dio 4.2).
English: film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (only Ebymect 5 mg/850 mg).
Croatian: film ovojnica: poli(vinilni) alkohol (E1203), makrogol 3350 (E1521), talk (E553b), titanijev dioksid (E171), željezovi oksidi žuti (E172), željezov oksid crveni (E172) (samo Ebymect 5 mg/850 mg).
English: After administration of a 50 mg C]-dapagliflozin dose, 96% was recovered, 75% in urine and 21% in faeces.
Croatian: C] dapagliflozina u dozi od 50 mg pronađeno je 96% lijeka, od čega 75% u mokraći i 21% u fecesu.
English: Ebymect 5 mg/850 mg film-coated tablets EU/1/15/1051/001 5 mg/850 mg 14 tablets EU/1/15/1051/002 5 mg/850 mg 28 tablets EU/1/15/1051/003 5 mg/850 mg 56 tablets EU/1/15/1051/004 5 mg/850 mg 60 tablets EU/1/15/1051/005 5 mg/850 mg 60 x 1 tablet (unit dose) EU/1/15/1051/006 5 mg/850 mg 196 (2 x 98) tablets (multipack)
Croatian: Ebymect 5 mg/850 mg filmom obložene tablete EU/1/15/1051/001 Ebymect 5 mg/850 mg 14 tableta EU/1/15/1051/002 Ebymect 5 mg/850 mg 28 tableta EU/1/15/1051/003 Ebymect 5 mg/850 mg 56 tableta EU/1/15/1051/004 Ebymect 5 mg/850 mg 60 tableta EU/1/15/1051/005 Ebymect 5 mg/850 mg 60 x 1 tableta (jedinična doza) EU/1/15/1051/006 Ebymect 5 mg/850 mg 196 (2 x 98) tableta (višestruko pakiranje)
English: • diarrhoea or stomach ache • loss of appetite
Croatian: • proljev ili bolovi u trbuhu
English: Mean eGFR was 85.2 mL/min/1.73 m of patients had eGFR < 60 mL/min/1.73 m2, and 30.3% of patients had micro- or macroalbuminuria (urine albumin to creatinine ratio [UACR] ≥ 30 to ≤ 300 mg/g or > 300 mg/g, respectively).
Croatian: Srednja vrijednost eGFR-a iznosila je 85,2 ml/min/1,73 m2, 7,4% bolesnika imalo je eGFR < 60 ml/min/1,73 m2, a njih 30,3% imalo je mikroalbuminuriju ili makroalbuminuriju (omjer albumina i kreatinina u mokraći ≥ 30 i ≤ 300 mg/g odnosno > 300 mg/g).
English: Renal composite endpoint defined as: sustained confirmed ≥ 40% decrease in eGFR to eGFR <60 mL/min/1.73 m 2 and/or end stage renal disease (dialysis ≥ 90 days or kidney transplantation, sustained confirmed eGFR < 15 mL/min/1.73 m 2) and/or renal or cardiovascular death.
Croatian: Objedinjena mjera bubrežnih ishoda definira se kao: održano potvrđeno smanjenje eGFR-a za ≥ 40% do vrijednosti eGFR-a < 60 ml/min/1,73 m2 i/ili završni stadij bubrežne bolesti (dijaliza ≥ 90 dana ili presađivanje bubrega, održan potvrđen eGFR < 15 ml/min/1,73 m2) i/ili smrt zbog bubrežnog ili kardiovaskularnog uzroka.
English: The efficacy of dapagliflozin was assessed in a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2 who had inadequate glycaemic control on usual care.
Croatian: Djelotvornost dapagliflozina ispitana je u posebnom ispitivanju u bolesnika sa šećernom bolešću koji su imali eGFR ≥ 45 do < 60 mL/min/1,73 m2sa nedovoljnom regulacijom glikemije uz standardnu terapiju.
English: Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A
Croatian: Jezgra tablete hidroksipropilceluloza (E463) celuloza, mikrokristalična (E460(i)) magnezijev stearat (E470b) natrijev škroboglikolat, tip A
English: Urticaria Erythema Pruritus
Croatian: Poremećaji kože i potkožnog tkiva osip urtikarija eritem pruritus
English: The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical studies, dapagliflozin clinical studies and metformin clinical studies and postmarketing experience.
Croatian: Sljedeće su nuspojave zabilježene u placebom kontroliranim kliničkim ispitivanjima dapagliflozina u kombinaciji s metforminom, kliničkim ispitivanjima dapagliflozina i kliničkim ispitivanjima metformina te nakon stavljanja lijeka u promet.
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73 m2 (18.5% dapagliflozin 10 mg versus 9.3% placebo).
Croatian: Te su reakcije bile češće u bolesnika čiji je početni eGFR iznosio ≥ 30 i < 60 ml/min/1,73 m2 (18,5% bolesnika koji su primali dapagliflozin u dozi od 10 mg naspram 9,3% onih koji su primali placebo).
English: In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and
Croatian: U skupini koja je primala placebo zabilježeno je povećanje od 10,5 IU na dan u odnosu na početnu dozu (srednja prosječna doza od 84 IU na dan ) u tjednu 48 odnosno 18,3 IU na dan u odnosu na početnu dozu (srednja prosječna doza od 92 IU na dan) u tjednu 104.
English: on one side and “1069” on the other side.
Croatian: Na jednoj strani imaju oznaku „5/1000“, a na drugoj „1069“.
English: The combination of dapagliflozin 10 mg and prolonged-release exenatide demonstrated significantly greater weight reductions compared to either agent alone (Table 8).
Croatian: Kombinacija dapagliflozina od 10 mg i eksenatida sa produljenim oslobađanjem pokazala je značajno veće smanjenje tjelesne težine u usporedbi s jednom i drugom djelatnom tvari zasebno (Tablica 8.).
English: EU/1/15/1051/009 5 mg/1000 mg 56 tablets EU/1/15/1051/010 5 mg/1000 mg 60 tablets EU/1/15/1051/011 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/15/1051/012 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Croatian: Ebymect 5 mg/1000 mg filmom obložene tablete EU/1/15/1051/007 Ebymect 5 mg/1000 mg 14 tableta EU/1/15/1051/008 Ebymect 5 mg/1000 mg 28 tableta EU/1/15/1051/009 Ebymect 5 mg/1000 mg 56 tableta EU/1/15/1051/010 Ebymect 5 mg/1000 mg 60 tableta EU/1/15/1051/011 Ebymect 5 mg/1000 mg 60 x 1 tableta (jedinična doza) EU/1/15/1051/012 Ebymect 5 mg/1000 mg 196 (2 x 98) tableta (višestruko pakiranje)
English: Patients insufficiently controlled on metformin alone or in combination with other medicinal products for the treatment of diabetes should receive a total daily dose of Ebymect equivalent to dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken.
Croatian: Za bolesnike u kojih glikemija nije dovoljno dobro regulirana monoterapijom metforminom ili metforminom u kombinaciji s drugim lijekovima za liječenje šećerne bolesti Bolesnici u kojih glikemija nije dovoljno dobro regulirana metforminom samim ili u kombinaciji s drugim lijekovima za liječenje šećerne bolesti trebaju primati ukupnu dnevnu dozu lijeka Ebymect ekvivalentnu dozi dapagliflozina od 10 mg, plus ukupnu dnevnu dozu metformina ili najsličniju terapijski prikladnu dozu, koju bolesnik već uzima.
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
Croatian: U posebnom ispitivanju u bolesnika sa šećernom bolešću koji su imali eGFR ≥ 45 do < 60 ml/min/1,73 m2, liječenje dapagliflozinom pokazalo je smanjenje razine glukoze u plazmi natašte u tjednu 24: -1,19 mmol/l (-21,46 mg/dl) u usporedbi sa -0,27 mmol/l (-4,87 mg/dl) kod bolesnika koji su primili placebo (p=0,001).
English: • Ebymect 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets.
Croatian: • Ebymect 5 mg/850 mg su ovalne, smeđe, filmom obložene tablete veličine 9,5 x 20 mm.