FrancophonIA/ELRC3.0 huggingface dataset:
English: Automated mini-doser operating temperature range is 15ºC to 40ºC.
Croatian: Raspon temperature za rad automatiziranog mini-dozatora je od 15°C do 40°C. www.devicepatents.com
English: • Do not use if the pre-filled pen has been dropped.
Croatian: • Nemojte koristiti napunjenu brizgalicu ako je napunjena brizgalica pala.
English: DO NOT tap the syringe needle.
Croatian: NEMOJTE lupkati po igli štrcaljke.
English: Cartridge bottom Medicine
Croatian: Dno uloška Lijek
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001).
Croatian: Repatha je značajno smanjila početne vrijednosti LDL-C-a do srednje vrijednosti u 10. i 12. tjednu u usporedbi i s placebom i s ezetimibom (p < 0,001).
English: G Clean the cartridge bottom.
Croatian: Očistite dno uloška.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK CARTON PRE-FILLED PEN (with blue box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA VIŠESTRUKOG PAKIRANJA NAPUNJENIH BRIZGALICA (uključujući plavi okvir)
English: Repatha significantly reduced LDL-C from baseline to mean of weeks 10 and 12 compared with placebo (p < 0.001).
Croatian: Repatha je značajno smanjila početne vrijednosti LDL-C-a do srednje vrijednosti u 10. i 12. tjednu, u usporedbi s placebom (p < 0,001).
English: Light Off beep-beep-beep
Croatian: Ugašena lampica bip-bip-bip
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED SYRINGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU BRIZGALICU
English: • You hear several beeps.
Croatian: • Čujete zvučni signal nekoliko puta.
English: Repatha 420 mg solution for injection in cartridge evolocumab
Croatian: Repatha 420 mg otopina za injekciju u ulošku evolokumab
English: Repatha 140 mg solution for injection in pre-filled pen 3 years.
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj brizgalici 3 godine
English: Grey needle cap off
Croatian: Sivi zatvarač igle skinut
English: • Do not pull the skin adhesive backing off of the automated mini-doser.
Croatian: • Nemojte odvajati podlogu prianjajuće površine s automatiziranog mini-dozatora.
English: • Do not reuse the automated mini-doser and cartridge.
Croatian: • Nemojte ponovno primjenjivati automatizirani mini-dozator i uložak.
English: Treatment effects of Repatha compared with placebo in patients with homozygous familial hypercholesterolaemia - mean percent change from baseline to week 12 (%, 95% CI)
Croatian: Učinci liječenja lijekom Repatha u usporedbi s placebom u bolesnika s homozigotnom obiteljskom hiperkolesterolemijom - srednji postotak promjene od početne vrijednosti do 12. tjedna (%, 95% CI)
English: Adverse reactions with Repatha
Croatian: Nuspojave povezane s lijekom Repatha
English: Treatment effects of Repatha compared with ezetimibe in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to average of weeks 10 and 12 (%, 95% CI)
Croatian: Učinci liječenja lijekom Repatha u usporedbi s ezetimibom u bolesnika s primarnom hiperkolesterolemijom i miješanom dislipidemijom - srednji postotak promjene od početne vrijednosti do prosječne vrijednosti u 10. i 12. tjednu (%, 95% CI)
English: Remove the grey needle cap from the pre-filled syringe until you are ready to inject.
Croatian: To može oštetiti štrcaljku. skidati sivi zatvarač igle s napunjene štrcaljke sve dok niste spremni za injiciranje.
English: Repatha 140 mg solution for injection in pre-filled syringe evolocumab
Croatian: Repatha 140 mg otopina za injekciju u napunjenoj brizgalici evolokumab
English: Orange cap off
Croatian: Narančasti zatvarač skinut
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a), and increased HDL-C and ApoA1 at week 52 compared with placebo (p < 0.001) (table 4).
Croatian: Repatha je značajno smanjila vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a, VLDL-C-a, TG-a i Lp(a)-a te povećala vrijednosti HDL-C-a i ApoA1-a u 52. tjednu u usporedbi s placebom (p < 0,001) (Tablica 4).
English: Right pull tab
Croatian: Desni jezičac za povlačenje
English: LAPLACE-2 was an international, multicentre, double-blind, randomised, 12-week study in 1,896 patients with primary hypercholesterolaemia or mixed dyslipidaemia who were randomised to receive Repatha in combination with statins (rosuvastatin, simvastatin or atorvastatin).
Croatian: LAPLACE-2 je bilo međunarodno, multicentrično, dvostruko-slijepo, randomizirano ispitivanje u trajanju od 12 tjedana, na 1896 bolesnika s primarnom hiperkolesterolemijom ili miješanom dislipidemijom.
English: • Do not use the Repatha pre-filled pen after the expiration date.
Croatian: • Nemojte koristiti Repatha napunjenu brizgalicu ako je prošao rok valjanosti.
English: Treatment effects of Repatha compared with placebo in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to average of weeks 10 and 12 (%, 95% CI)
Croatian: Učinci liječenja lijekom Repatha u usporedbi s placebom u bolesnika s primarnom hiperkolesterolemijom i miješanom dislipidemijom - srednji postotak promjene od početne vrijednosti do prosječne vrijednosti u 10. i 12. tjednu (%, 95% CI)
English: Population (N)
Croatian: (N)
English: Medicine window Pull tabs
Croatian: Prozorčić lijeka Jezičci za povlačenje
English: • Do not use if the expiration date printed on the carton label has passed.
Croatian: • Nemojte koristiti ako je istekao rok valjanosti otisnut na kutiji.
English: You must remove both green pull tabs to turn the loaded automated mini-doser on. You will hear beeping and see a flashing blue status light.
Croatian: Morate povući oba zelena jezičca kako biste upalili napunjeni automatizirani mini-dozator.
English: • Do not shake the automated mini-doser and cartridge.
Croatian: • Nemojte tresti automatizirani mini-dozator i uložak.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each SureClick pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna SureClick napunjena brizgalica sadrži 140 mg evolokumaba u 1 ml otopine.
English: • Do not use the pre-filled pen if medicine is cloudy or discoloured or contains large lumps,
Croatian: • Nemojte koristiti napunjenu brizgalicu ako je lijek mutan ili promijenjene boje, sadrži velike grudice, pahuljaste čestice ili čestice.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, VLDL-C, TG and Lp(a) and increased HDL-C and ApoA1 from baseline to mean of weeks 10 and 12 compared to placebo (p < 0.05) (see table 2).
Croatian: Repatha je značajno smanjila početne vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a, VLDL-C-a, TG-a i Lp(a)-a te povećala početne vrijednosti HDL-C-a i ApoA1-a do srednje vrijednosti u 10. i 12. tjednu, u odnosu na placebo (p < 0,05) (vidjeti Tablicu 2).
English: • Thigh.
Croatian: • Bedro.
English: put the grey needle cap back onto the pre-filled syringe.
Croatian: To može oštetiti iglu. vratiti sivi zatvarač igle natrag na napunjenu štrcaljku.
English: 4.7 Effects on ability to drive and use machines Repatha has no known influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001) (see table 3).
Croatian: Repatha je značajno smanjila početne razine TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a i Lp(a)-a, do srednje vrijednosti u 10. i 12. tjednu u usporedbi i s placebom i s ezetimibom (p < 0,001) (vidjeti Tablicu 3).
English: Used syringe barrel
Croatian: Iskorišteno tijelo štrcaljke
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled syringe contains 140 mg of evolocumab in 1 mL of solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena štrcaljka sadrži 140 mg evolokumaba u 1 ml otopine.
English: Apheresis
Croatian: • Bedro
English: NAME OF THE MEDICINAL PRODUCT Repatha 140 mg solution for injection evolocumab
Croatian: Repatha 140 mg otopina za injekciju evolokumab
English: Do not twist, bend or wiggle the orange cap. Do not put the orange cap back onto the pre-filled pen.
Croatian: Nemojte okretati ili savijati narančasti zatvarač.
English: Plunger rod
Croatian: Bijeli klip
English: Before starting Repatha, you should be on a diet to lower your cholesterol.
Croatian: Trebali biste biti na dijeti za snižavanje razine kolesterola prije početka primjene lijeka Repatha.
English: Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1 and Lp(a), from baseline to mean of weeks 10 and 12 compared to ezetimibe (p < 0.001) (see table 3).
Croatian: Repatha je značajno smanjila početne vrijednosti TC-a, ApoB-a, non-HDL-C-a, TC/HDL-C-a, ApoB/ApoA1-a i Lp(a)-a do srednje vrijednosti u 10. i 12. tjednu u usporedbi s ezetimibom (p < 0,001) (vidjeti Tablicu 3).
English: Using your automated mini-doser and cartridge
Croatian: Korištenje automatiziranog mini-dozatora i uloška
English: Treatment effects of Repatha compared with placebo in patients with primary hypercholesterolaemia and mixed dyslipidaemia - mean percent change from baseline to week 52 (%, 95% CI)
Croatian: Tablica 4. Učinci liječenja lijekom Repatha u usporedbi s placebom u bolesnika s primarnom hiperkolesterolemijom i miješanom dislipidemijom - srednji postotak promjene od početne vrijednosti do 52. tjedna (%, 95% CI)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/007
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1016/007
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each pre-filled pen contains 140 mg of evolocumab in 1 mL of solution.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna napunjena brizgalica sadrži 140 mg evolokumaba u 1 ml otopine.
English: Stretch method for belly
Croatian: Metoda s rastegnutom kožom za trbuh
English: NAME OF THE MARKETING AUTHORISATION HOLDER Amgen Europe B.V.
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Amgen Europe B.V.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1016/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/006
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1016/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/001
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1016/001
English: Used Needle
Croatian: Iskorištena igla
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1016/005
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/15/1016/005
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL CARTRIDGE
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA ULOŠKU
English: Cartridge
Croatian: Urtikarija
English: The status light turns solid green, and the device beeps, when done.
Croatian: Po završetku, lampica svijetli stalnom zelenom svjetlošću i čuje se zvučni signal.
English: Further information on Zynquista can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynquista.
Croatian: Više informacija o lijeku Zynquista možete naći na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zynquista.
English: The recommended dose is 1 tablet once a day before the first meal of the day.
Croatian: Uobičajena doza lijeka jedna je tableta jedanput dnevno prije prvog dnevnog obroka.
English: After 3 months, the doctor may increase the dose to 2 tablets once a day if additional blood sugar control is needed.
Croatian: Nakon tri mjeseca liječnik može povećati dozu na dvije tablete jedanput dnevno ako je potrebno dodatno kontrolirati razinu šećera u krvi.
English: In addition, precautions have been recommended to reduce the risk of diabetic ketoacidosis.
Croatian: Osim toga, preporučene su mjere opreza kako bi se smanjio rizik od dijabetičke ketoacidoze.
English: In addition, patients treated with the medicine have beneficial reductions in weight and blood pressure.
Croatian: Osim toga, u bolesnika liječenih ovim lijekom zabilježeno je korisno smanjenje težine i krvnog tlaka.
English: What measures are being taken to ensure the safe and effective use of Zynquista?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zynquista?
English: Zynquista is available as 200 mg tablets.
Croatian: Lijek Zynquista dostupan je u obliku tableta od 200 mg.
English: Other information about Zynquista
Croatian: Ostale informacije o lijeku Zynquista
English: Side effects reported with Zynquista are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zynquista pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common side effect with Zynquista (which may affect more than 1 in 10 people) is genital infection in women.
Croatian: Najčešća nuspojava lijeka Zynquista (koja se može javiti u više od 1 na 10 osoba) jest genitalna infekcija u žena.
English: The company that markets Zynquista will provide information on measures to reduce the risk of diabetic ketoacidosis, including a patient alert card and guide for patients and their carers, as well as a guide for healthcare professionals, including a prescriber's checklist.
Croatian: Tvrtka koja lijek Zynquista stavlja u promet dostavit će informacije o mjerama za smanjenje rizika od dijabetičke ketoacidoze, uključujući karticu s upozorenjima za bolesnika, kao i vodič za bolesnike i njihove njegovatelje te vodič za zdravstvene radnike, uključujući kontrolni popis za liječnika koji propisuje lijek.
English: However, since Zynquista increases the risk of diabetic ketoacidosis considerably in patients with type 1 diabetes, it is recommended only in overweight and obese patients who are expected to benefit most from treatment.
Croatian: Međutim, s obzirom na to da lijek Zynquista značajno povećava rizik od dijabetičke ketoacidoze u bolesnika s dijabetesom tipa 1, primjena lijeka preporučuje se samo u bolesnika s prekomjernom težinom i pretilih bolesnika, za koje se očekuje da će imati najviše koristi od liječenja.
English: As for all medicines, data on the use of Zynquista are continuously monitored.
Croatian: Kao za sve lijekove, podaci o primjeni lijeka Zynquista kontinuirano se prate.
English: Adding Zynquista 200 or 400 mg to insulin led to a reduction in HbA1c levels of about 0.4 percentage points after 24 weeks of treatment, compared with almost no reduction in HbA1c levels after adding placebo to insulin.
Croatian: Dodavanje lijeka Zynquista od 200 ili 400 mg inzulinu rezultiralo je smanjenjem razine tvari HbA1c za otprilike 0,4 postotna boda nakon 24 tjedna liječenja, u usporedbi s gotovo nikakvim smanjenjem razine tvari HbA1c kod dodavanja placeba inzulinu.
English: Other common side effects (which may affect up to 1 in 10 people) include diabetic ketoacidosis, diarrhoea and genital infection in men.
Croatian: Ostale česte nuspojave (koje se mogu javiti u manje od 1 na 10 osoba) uključuju dijabetičku ketoacidozu, proljev i genitalne infekcije u muškaraca.
English: The medicine should be used with precautions to reduce the risk of diabetic ketoacidosis (a serious complication of diabetes with high levels of ketones in the blood).
Croatian: Potreban je oprez pri primjeni lijeka kako bi se smanjio rizik od dijabetičke ketoacidoze (ozbiljna komplikacija dijabetesa koja uzrokuje visoke razine ketona u krvi).
English: What is Zynquista and what is it used for?
Croatian: Što je Zynquista i za što se primjenjuje?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynquista have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Zynquista nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Croatian: Primjenjuje se u bolesnika s prekomjernom tjelesnom težinom (indeks tjelesne mase od najmanje 27 kg/m2) kada se inzulinom kao monoterapijom razina šećera u krvi ne kontrolira dovoljno dobro.
English: In the third study involving 1,405 patients, only the higher dose of Zynquista (400 mg) was studied.
Croatian: U trećem ispitivanju, koje je obuhvatilo 1405 bolesnika, ispitivana je samo primjena više doze lijeka Zynquista (400 mg).
English: In two of these studies, involving a total of 1,575 patients, two doses of Zynquista (200 and 400 mg) were compared with placebo when given in addition to insulin.
Croatian: U dvama od tih ispitivanja kojima je bilo obuhvaćeno ukupno 1575 bolesnika dvije doze lijeka Zynquista (200 i 400 mg) uspoređene su s placebom pri primjeni u kombinaciji s inzulinom.
English: The active substance in Zynquista, sotagliflozin, blocks the action of two proteins known as glucose transporters (SGLT1 and SGLT2) which are found in the intestine and the kidneys.
Croatian: Djelatna tvar lijeka Zynquista, sotagliflozin, inhibira djelovanje dvaju proteina koji su poznati kao prijenosnici glukoze (SGLT1 i SGLT2) koji se nalaze u crijevima i bubrezima.
English: An overview of Zynquista and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zynquista i zašto je odobren u EU-u
English: The main measure of effectiveness was the level of glycosylated haemoglobin (HbA1c), which indicates how well blood glucose is controlled.
Croatian: Glavno mjerilo djelotvornosti bila je koncentracija glikoliziranog hemoglobina (HbA1c) u krvi, koja upućuje na to koliko se dobro kontrolira glukoza u krvi.
English: For more information about using Zynquista, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Zynquista pogledajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Why is Zynquista authorised in the EU?
Croatian: Zašto je lijek Zynquista odobren u EU-u?
English: What are the risks associated with Zynquista?
Croatian: Koji su rizici povezani s lijekom Zynquista?
English: On this basis, Zynquista 400 mg added to insulin was effective in around 29% of patients, compared with 15% of patients receiving placebo plus insulin.
Croatian: Na temelju toga, primjena lijeka Zynquista od 400 mg u kombinaciji s inzulinom bila je učinkovita u otprilike 29 % bolesnika, u usporedbi s 15 % bolesnika koji su primali placebo i inzulin.
English: The European Medicines Agency decided that Zynquista's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi lijeka Zynquista nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: Zynquista's common side effects, which are related to the way the medicine works, such as increased genital infections, are considered manageable and similar to those of other medicines of a similar class.
Croatian: Česte nuspojave lijeka Zynquista, povezane s načinom djelovanja lijeka, kao što je povećan rizik od genitalnih infekcija, moguće je kontrolirati te su slične onima kod ostalih lijekova istog razreda.
English: The main measure of effectiveness was the proportion of patients who had HbA1c levels less than 7.0% and no episodes of severe hypoglycaemia (low blood glucose levels) or diabetic ketoacidosis.
Croatian: HbA1c bila niža od 7,0 % i koji nisu imali epizode teške hipoglikemije (niska razina glukoze u krvi) ili dijabetičke ketoacidoze.
English: Zynquista contains the active substance sotagliflozin.
Croatian: Zynquista sadrži djelatnu tvar sotagliflozin.
English: Zynquista can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in managing type 1 diabetes.
Croatian: Zynquista se izdaje samo na liječnički recept, a liječenje treba započeti i nadzirati liječnik s iskustvom u liječenju dijabetesa tipa
English: The company will also conduct a study to estimate the frequency of diabetic ketoacidosis in patients with type 1 diabetes treated with the medicine.
Croatian: Tvrtka će provesti i ispitivanje kako bi se procijenila učestalost dijabetičke ketoacidoze u bolesnika s dijabetesom tipa 1 koji se liječe ovim lijekom.
English: How does Zynquista work?
Croatian: Kako djeluje Zynquista?
English: Zynquista, taken together with insulin, is effective in lowering blood glucose levels in patients with type 1 diabetes whose blood sugar is not controlled well enough with insulin alone.
Croatian: Lijek Zynquista u kombinaciji s inzulinom djelotvoran je u snižavanju razine glukoze u krvi u bolesnika s dijabetesom tipa 1 u kojih se inzulinom kao monoterapijom razina šećera u krvi ne kontrolira dovoljno dobro.
English: In type 1 diabetes, the body does not make enough insulin to control the amount of glucose (sugar) in the blood, resulting in high levels of glucose in the blood.
Croatian: Dijabetes tipa 1 bolest je pri kojoj tijelo ne proizvodi dovoljno inzulina za kontrolu razine glukoze (šećera) u krvi, što rezultira visokom razinom glukoze u krvi.
English: By blocking SGLT1 in the intestine, sotagliflozin delays the absorption of glucose into the blood after a meal.
Croatian: Inhibirajući SGLT1 u crijevima sotagliflozin odgađa apsorpciju glukoze u krv nakon obroka.
English: As result, sotagliflozin causes the kidney to pass out more glucose in the urine, thereby reducing the levels of glucose in the blood.
Croatian: Kao rezultat toga, sotagliflozin potiče bubrege na izlučivanje veće količine glukoze mokraćom, čime se smanjuje razina glukoze u krvi.
English: Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes.
Croatian: Zynquista je lijek za liječenje šećerne bolesti koji se primjenjuje u kombinaciji s inzulinom za liječenje odraslih osoba s dijabetesom tipa
English: What benefits of Zynquista have been shown in studies?
Croatian: Koje su koristi lijeka Zynquista utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Zynquista, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Zynquista potražite u uputi o lijeku.
English: How is Zynquista used?
Croatian: Kako se Zynquista primjenjuje?
English: In the kidneys, sotagliflozin blocks SGLT2 involved in stopping glucose in the bloodstream from being passed out into the urine.
Croatian: Sotagliflozin u bubrezima inhibira SGLT2 koji je uključen u zaustavljanje izlučivanja glukoze iz krvotoka u mokraću.
English: Zynquista was found effective at controlling blood glucose levels in 3 main studies in patients with type 1 diabetes.
Croatian: U trima glavnim ispitivanjima u bolesnika s dijabetesom tipa 1 utvrđeno je da lijek Zynquista učinkovito kontrolira razine glukoze u krvi.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1021/001 Pregabalin Zentiva 25 mg Capsule, hard
Croatian: Put primjene Unutarnje pakovanje Veličina pakiranja blister (OPA/alu/PVC/alu) 84 kapsule
English: He or she will take the appropriate measures.
Croatian: On ili ona će poduzeti odgovarajuće mjere.
English: * n=18 subjects.
Croatian: * n=18 ispitanika.
English: Maximum concentration (Cmax)
Croatian: Maksimalna koncentracija (Cmax)
English: Free elastase was immeasurably low in all samples.
Croatian: Slobodna elastaza bila je neizmjerno niska u svim uzorcima.
English: *Produced from the plasma of human donors.
Croatian: *Proizveden iz plazme ljudskih donora.
English: Date of first authorisation: 20 August 2015
Croatian: Datum prvog odobrenja: 20. kolovoza 2015.
English: Submission of final clinical study report by 31 March 2025
Croatian: Podnošenje konačnog izvješća o kliničkom ispitivanju do 31. ožujka 2025.