FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web side: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske Agencije za lijekove (EMA) http://www.ema.europa.eu
English: Week 2 (day 8-14): Take one 10 mg tablet once a day (pale yellow to yellow, oval shaped) for 7 days.
Croatian: 2. tjedan (8.-14. dan): Uzimajte jednu tabletu od 10 mg jednom dnevno (blijedožutu do žutu, ovalnog oblika) tijekom 7 dana.
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Croatian: Ako ste nedavno promijenili, ili namjeravate značajno promijeniti svoj način prehrane (npr. s normalne prehrane na strogu vegetarijansku prehranu), ili ako bolujete od stanja renalne tubularne acidoze (RTA - izrazito povećana količina tvari koje tvore kiseline u krvi zbog poremećaja rada bubrega (slaba funkcija bubrega)) ili teških infekcija mokraćnog trakta (struktura kroz koje prolazi mokraća), trebali bi obavijestiti svog liječnika jer će Vam liječnik možda morati prilagoditi dozu lijeka.
English: Administration of Axura in patients with severe hepatic impairment is not recommended.
Croatian: Ne preporučuje se primjena Axure kod bolesnika s teškim oštećenjem jetrene funkcije.
English: Package leaflet: Information for the user Axura 20 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za korisnika Axura 20 mg filmom obložene tablete memantinklorid
English: EU/1/02/218/017 14 film-coated tablets EU/1/02/218/018 28 film-coated tablets EU/1/02/218/019 42 film-coated tablets EU/1/02/218/020 56 film-coated tablets EU/1/02/218/021 98 film-coated tablets EU/1/02/218/024 14 film-coated tablets EU/1/02/218/025 28 film-coated tablets EU/1/02/218/026 42 film-coated tablets EU/1/02/218/027 56 film-coated tablets EU/1/02/218/028 98 film-coated tablets
Croatian: EU/1/02/218/017 14 filmom obloženih tableta EU/1/02/218/018 28 filmom obloženih tableta EU/1/02/218/019 42 filmom obložene tablete EU/1/02/218/020 56 filmom obloženih tableta EU/1/02/218/021 98 filmom obloženih tableta EU/1/02/218/024 14 filmom obloženih tableta EU/1/02/218/025 28 filmom obloženih tableta EU/1/02/218/026 42 filmom obložene tablete EU/1/02/218/027 56 filmom obloženih tableta EU/1/02/218/028 98 filmom obloženih tableta
English: From Week 4 on: The patient should take two 10 mg film-coated tablets (20 mg) per day.
Croatian: Bolesnik treba uzimati dvije filmom obložene tablete od 10 mg (20 mg) dnevno.
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipacks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Croatian: Axura filmom obložene tablete dostupne su u pakiranjima s blisterima od 14 tableta, 28 tableta, 30 tableta, 42 tablete, 50 tableta, 56 tableta, 98 tableta, 100 tableta, 112 tableta; i višestrukim pakiranjima od 840 (20 pakiranja od 42) tableta, 980 (10 pakiranja od 98) tableta ili 1000 (20 pakiranja od 50) tableta.
English: two pump actuations week 3
Croatian: 2. tjedan dva potiska pumpice
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or in multipacks of 840 (20 x 42) tablets.
Croatian: Axura filmom obložene tablete su dostupne u pakiranjima s blisterima od 14 tableta, 28 tableta, 42 tablete, 56 tableta, 98 tableta i višestrukim pakiranjima od 840 (20 pakiranja od 42) tableta.
English: EU/1/02/218/010 1000 film-coated tablets (20 packs of 50) EU/1/02/218/015 980 film-coated tablets (10 packs of 98) EU/1/02/218/030 840 film-coated tablets (20 packs of 42)
Croatian: EU/1/02/218/010 1000 filmom obloženih tableta (20 pakiranja po 50) EU/1/02/218/015 980 filmom obloženih tableta (10 pakiranja po 98) EU/1/02/218/030 840 filmom obloženih tableta (20 pakiranja po 42)
English: Package leaflet: Information for the user Axura 10 mg film-coated tablets
Croatian: Uputa o lijeku: Informacija za korisnika Axura 10 mg filmom obložene tablete memantinklorid
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated tablets of 5 mg, 7 film-coated tablets of 10 mg, 7 film-coated tablets of 15 mg and 7 film-coated tablets of 20 mg.
Croatian: Svako pakiranje sadržava 28 filmom obloženih tableta u 4 PVDC/PE/PVC/Al-blistera ili PP/Al-blistera sa 7 filmom obloženih tableta od 5 mg, 7 filmom obloženih tableta od 10 mg, 7 filmom obloženih tableta od 15 mg i 7 filmom obloženih tableta od 20 mg.
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (grey-orange, oval-oblong) for 7 days.
Croatian: 3. tjedan (15.-21. dan): Uzimajte jednu tabletu od 15 mg jednom dnevno (sivo-narančastu, duguljasto ovalnu) tijekom 7 dana.
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Croatian: Kod bolesnika s teškim oštećenjem bubrebubrežne funkcije (klirens kreatinina 5-29 ml/min) dnevna doza bi trebala biti 10 mg (1 ml otopine, što odgovara dva potiska pumpice) na dan.
English: EU/1/02/218/012 14 film-coated tablets EU/1/02/218/007 28 film-coated tablets EU/1/02/218/001 30 film-coated tablets EU/1/02/218/013 42 film-coated tablets EU/1/02/218/002 50 film-coated tablets EU/1/02/218/008 56 film-coated tablets EU/1/02/218/014 98 film-coated tablets EU/1/02/218/003 100 film-coated tablets EU/1/02/218/009 112 film-coated tablets
Croatian: EU/1/02/218/012 14 filmom obloženih tableta EU/1/02/218/007 28 filmom obloženih tableta EU/1/02/218/001 30 filmom obloženih tableta EU/1/02/218/013 42 filmom obložene tablete EU/1/02/218/002 50 filmom obloženih tableta EU/1/02/218/008 56 filmom obloženih tableta EU/1/02/218/014 98 filmom obloženih tableta EU/1/02/218/003 100 filmom obloženih tableta EU/1/02/218/009 112 filmom obloženih tableta
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Croatian: 1595 ih je dobivalo placebo sveukupna stopa incidencije nuspojava u skupini liječenoj Axurom nije se razlikovala od stope incidencije nuspojava u skupini koja je primala placebo.
English: Week 4 (day 22-28): Take one 20 mg tablet per day (grey-red, oval-oblong) for 7 days.
Croatian: 4. tjedan (22.-28. dan): Uzimajte jednu tabletu od 20 mg dnevno (sivo-crvenu, duguljasto ovalnu) tijekom 7 dana.
English: From Week 4 on: The patient should take one 20 mg film-coated tablet per day.
Croatian: Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg dnevno.
English: EU/1/02/218/005 EU/1/02/218/006 EU/1/02/218/011
Croatian: EU/1/02/218/005 EU/1/02/218/006
English: How to store Axura
Croatian: Kako čuvati Axuru
English: one pump actuation week 2
Croatian: 1. tjedan jedan potisak pumpice
English: Very rare (may affect up to 1 in 10,000 users): • Seizures
Croatian: Vrlo rijetke (mogu se javiti u do 1 na 10 000 osoba):
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating.
Croatian: Drugi sastojci su: mikrokristalična celuloza,umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i žuti željezov oksid (E 172), sve u ovojnici tablete.
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171), iron oxide yellow and red (E 172), all in the tablet coating.
Croatian: Drugi sastojci su: mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i žuti željezov oksid, žuti i crveni (E 172), sve u ovojnici tablete.
English: The other ingredients for Axura 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 10 mg film-coated tablets is iron oxide yellow (E 172) and for Axura 15 mg and Axura 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Croatian: umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E 171) i dodatno za Axura 10 mg filmom obložene tablete žuti željezov oksid (E 172), a za Axura 15 mg i Axura 20 mg filmom obložene tablete žuti i crveni željezov oksid (E 172), sve u ovojnici tablete.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Croatian: U 6. mjesecu ispitivanja pokazani su povoljni učinci liječenja memantinom u usporedbi s placebom (analiza opaženih slučajeva za promjene bazirane na dojmu kliničara nakon intervjua (CIBIC-plus; engl. the clinician´s interview based impression of change): p=0,025; kooperativno ispitivanje
English: Axura should be administered orally once a day.
Croatian: Axuru treba primjenjivati na usta jedanput na dan.
English: Package leaflet: Information for the user Axura 5 mg/pump actuation, oral solution
Croatian: Uputa o lijeku: Informacija za korisnika Axura 5 mg/potisak, oralna otopina memantinklorid
English: Do not use Axura after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i blisteru nakon “Rok valjanosti”.
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Croatian: • Pri istodobnoj primjeni memantina i hidroklorotiazida (HCT-a) ili bilo koje od kombinacija s
English: Axura 5 mg/pump actuation, oral solution Memantine hydrochloride
Croatian: Axura 5 mg/potisak, oralna otopina memantinklorid
English: Axura 15 mg 7 film-coated tablets.
Croatian: Axura 15 mg 7 filmom obloženih tableta.
English: Axura 5 mg film-coated tablets Axura 10 mg film-coated tablets Axura 15 mg film-coated tablets Axura 20 mg film-coated tablets Memantine hydrochloride
Croatian: Axura 5 mg filmom obložene tablete Axura 10 mg filmom obložene tablete Axura 15 mg filmom obložene tablete Axura 20 mg filmom obložene tablete memantinklorid
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets
Croatian: Axura 5 mg+10 mg+15 mg+20 mg filmom obložene tablete
English: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Axura 5 mg, 7 tablets of Axura 10 mg, 7 tablets of Axura 15 mg and 7 tablets of Axura 20 mg.
Croatian: 7 Axura tableta od 10 mg, 7 Axura tableta od 15 mg i 7 Axura tableta od 20 mg.
English: Do not use Axura after the expiry date which is stated on the carton and the bottle label after the EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kartonskoj kutiji i naljepnici boce nakon “Rok valjanosti”.
English: Axura 20 mg film-coated tablets Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Croatian: Axura 20 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 20 mg memantinklorida, što odgovara 16,62 mg memantina.
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Croatian: 30-49 ml/min), dnevna doza bi trebala biti 10 mg (1 ml otopine, što odgovara dva potiska pumpice).
English: Axura 10 mg 7 film-coated tablets.
Croatian: Axura 10 mg 7 filmom obloženih tableta.
English: From Week 4 on: The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day.
Croatian: Bolesnik treba uzimati 2 ml otopine (20 mg) što odgovara četiri potiska pumpice dnevno.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Axura 20 mg film-coated tablets
Croatian: Axura 5 mg+10 mg+15 mg+20 mg filmom obložene tablete Axura 20 mg filmom obložene tablete
English: Axura 5 mg 7 film-coated tablets.
Croatian: Axura 5 mg 7 filmom obloženih tableta.
English: Axura 20 mg film-coated tablets
Croatian: Axura 20 mg filmom obložene tablete
English: Axura 10 mg film-coated tablets Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Croatian: Axura 10 mg filmom obložene tablete Svaka filmom obložena tableta sadrži 10 mg memantinklorida, što odgovara 8,31 mg memantina.
English: Axura 5 mg, 10 mg, 15 mg, 20 mg film-coated tablets Memantine hydrochloride
Croatian: Axura 5 mg, 10 mg, 15 mg, 20 mg filmom obložene tablete memantinklorid
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer´s disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 last observation carried forward (LOCF).
Croatian: Alzheimer´s disease assessment scale) (p=0,003) i CIBIC-plus (p=0,004) u 24. tjednu liječenja (zadnje opažanje preneseno dalje (LOCF; engl. last observation carried forward)).
English: Axura 10 mg film-coated tablets
Croatian: Axura 10 mg filmom obložene tablete
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura oral solution (listed in section 6).
Croatian: - ako ste alergični (preosjetljivi) na memantinklorid ili neki drugi sastojak Axura oralne otopine
English: Axura 10 mg film-coated tablets Memantine hydrochloride
Croatian: Axura 10 mg filmom obložene tablete memantinklorid
English: Axura 20 mg film-coated tablets Memantine hydrochloride
Croatian: Axura 20 mg filmom obložene tablete memantinklorid
English: Axura 5 mg/pump actuation, oral solution
Croatian: Axura 5 mg/potisak, oralna otopina
English: • Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Croatian: Manje česte (mogu se javiti u do 1 na 100 osoba): • umor, gljivične infekcije, smetenost, halucinacije, povraćanje, poremećaj hoda, zatajenje srca i zgrušavanje venske krvi (tromboza/tromboembolija)
English: Axura 5 mg film-coated tablets are presented as white to off-white, oval-oblong with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Croatian: Axura 5 mg filmom obložene tablete su bijele do gotovo bijele, ovalno duguljaste s utisnutom oznakom ‘5' na jednoj strani i ‘MEM' na drugoj strani.
English: Uncommon (may affect up to 1 in 100 users):
Croatian: Česte(mogu se javiti u do 1 na 10 osoba):
English: The 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Croatian: Filmom obložene tablete od 10 mg su blijedožute do žute, filmom obložene tablete ovalnog oblika, s razdjelnom crtom i utisnutom oznakom “1-0” na jednoj strani i “M M” na drugoj strani.
English: Axura 15 mg film-coated tablets are presented as orange to grey-orange, oval-oblong with imprint ‘15' on one side and imprint ‘MEM' on the other side.
Croatian: Axura 15 mg filmom obložene tablete su narančaste do sivo-narančaste, ovalno duguljaste s utisnutom oznakom ‘15' na jednoj strani i ‘MEM' na drugoj strani.
English: Week 1 (day 1-7): The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Croatian: Bolesnik treba uzimati jednu i pol filmom obloženu tabletu od 10 mg (15 mg) dnevno tijekom 7 dana.
English: Axura 20 mg film-coated tablets are presented as are pale red to grey-red, oval-oblong with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Croatian: Axura 20 mg filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
English: Axura film-coated tablets are presented as pale red to grey-red, oval-oblong film-coated tablets with imprint ‘20' on one side and imprint ‘MEM' on the other side.
Croatian: Axura filmom obložene tablete su blijedocrvene do sivo-crvene, ovalno duguljaste filmom obložene tablete s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
English: Gastrointestinal disorders
Croatian: - oralnih antikoagulansa
English: Tél: +352 45 07 07-1
Croatian: HANFF Global Health Solutions s.à r.l. Tél: +352 45 07 07-1
English: Axura film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings "1-0" on one side and "M M" on the other side.
Croatian: Axura filmom obložene tablete su blijedožute do žute boje, filmom obložene tablete ovalnog oblika s razdjelom crtom i utisnutim oznakama “1-0” na jednoj strani te “M M” na drugoj strani.
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Croatian: 30-49 ml/min), dnevna doza bi trebala biti 10 mg na dan.
English: Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red (E 172)
Croatian: željezov oksid, žuti i crveni (E 172) Axura 20 mg filmom obložene tablete
English: Each pack of 28 film- coated tablets for a 4 week treatment schedule contains: 7 x Axura 5 mg
Croatian: Svako pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
English: Week 3 (day 15-21): The patient should take one 15 mg film-coated tablet per day (grey-orange, oval-oblong) for 7 days.
Croatian: Bolesnik treba uzimati jednu filmom obloženu tabletu od 15 mg (sivo-narančastu, duguljasto ovalnu) dnevno tijekom 7 dana.
English: If the pump does not function properly, consult your doctor or a pharmacist.Lock the dosing pump after using Axura.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Axura
English: Tablet coating for 5/10/15/20 mg film-coated tablets Hypromellose
Croatian: Drugi sastojci Axura 5/ 10/ 15 i 20 mg filmom obloženih tableta su mikrokristalična celuloza,
English: Tablet coating
Croatian: Često omaglica
English: List of the names, pharmaceutical forms, strengths of the medicinal products, route of administration and marketing authorisation holders in the Member States
Croatian: Popis naziva, farmaceutskih oblika, jačina lijekova, putova primjene i nositelja odobrenja u državama članicama
English: Radnička cesta 80 10000 Zagreb Croatia
Croatian: AstraZeneca d.o.o. Radnička cesta 80 10000 Zagreb Croatia
English: Luxembourg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Croatian: Luksemburg NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
English: C/ Serrano Galvache 56, 28033 Madrid,
Croatian: C/ Serrano Galvache 56,
English: Palazzo Galileo, Via F. Sforza, 20080 Basiglio (MI), Italy
Croatian: Sforza, 20080 Basiglio (MI), Italy
English: Belgium NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels,
Croatian: NV AstraZeneca SA Egide Van Ophemstraat 110 B-1180 Brussels, Belgium
English: AstraZeneca BV Louis Pasteurlaan 5 2719 EE Zoetermeer The Netherlands
Croatian: Nizozemska AstraZeneca BV Louis Pasteurlaan 5
English: AstraZeneca Farmacéutica Spain, S.A. Parque Norte.Edificio Roble.
Croatian: Parque Norte.Edificio Roble.
English: AstraZeneca UK Ltd. 2 Kingdom Street, London W2 6BD, United Kingdom
Croatian: 2 Kingdom Street, London W2 6BD, United Kingdom
English: Crestor 20 mg 20 mg
Croatian: CRESTOR 20 mg
English: CRESTOR 40 mg 40mg
Croatian: CRESTOR 40 mg
English: • Some medicine may be present in your tears.
Croatian: • Nešto bi lijeka moglo biti prisutno u Vašim suzama.
English: 4 days (including the day of administration)
Croatian: 4 dana (uključujući dan primjene)
English: Followed by 5 days
Croatian: Nakon čega slijedi 5 dana
English: This will be repeated on your other eye at least 6 days afterwards.
Croatian: Ovo će se ponoviti na Vašem drugom oku nakon barem 6 dana.
English: 31 subjects were enrolled, 13 males and 18 females.
Croatian: Bio je uključen 31 ispitanik, 13 muških i 18 ženskih.
English: Your doctor will talk to you about the anaesthesia and how it will be given to you.
Croatian: Liječnik će razgovarati s Vama o anesteziji i o tome kako ćete je dobiti.
English: If it does occur, your doctor will treat the symptoms as necessary.
Croatian: Ako dođe do toga, liječnik će liječiti Vaše simptome prema potrebi.
English: Control, N = 10
Croatian: Kontrolna skupina, N = 10
English: • Change of the electrical activity of the heart
Croatian: • Promjena električne aktivnosti srca
English: Do not stop taking the medicine without first talking to your doctor.
Croatian: Nemojte prestati uzimati lijek a da prije toga ne razgovarate s liječnikom.
English: Vertical dotted lines represent additional 25% above and below the box.
Croatian: Okomite isprekidane linije predstavljaju dodatnih 25% iznad i ispod pravokutnika.
English: Followed by 5 days of one dose every other day
Croatian: Nakon čega slijedi 5 dana primjene jedne doze svaki drugi dan
English: Study 301 was an open-label, randomised, controlled study.
Croatian: Ispitivanje 301 bilo je otvoreno, randomizirano, kontrolirano ispitivanje.
English: The virus used to deliver the gene does not cause disease in humans.
Croatian: Virus koji se koristi za isporuku gena ne uzrokuje bolest u ljudi.
English: 22 November 2018
Croatian: 22. studenog 2018.
English: What Luxturna is and what it is used for
Croatian: Što je Luxturna i za što se koristi
English: There are no known clinically significant interactions.
Croatian: Nema poznatih klinički značajnih interakcija.
English: Your doctor may be able to help reduce any discomfort caused by these temporary disturbances.
Croatian: Liječnik bi Vam mogao pomoći smanjiti moguću nelagodu uzrokovanu tim privremenim smetnjama.
English: Patients may resume swimming and strenuous activity, after a minimum of one to two weeks, on the advice of their healthcare professional.
Croatian: Bolesnici mogu nastaviti s plivanjem i napornim aktivnostima nakon najmanje jednog do dva tjedna, prema savjetu svog zdravstvenog radnika.
English: The interval between injection to the eyes for each subject was from 6 to 18 days.
Croatian: Interval između injekcija u pojedino oko za svakog ispitanika bio je od 6 do 18 dana.
English: The effects of this medicine on pregnancy and the unborn child are not known.
Croatian: Učinci ovog lijeka na trudnoću i nerođeno dijete nisu poznati.
English: 10 subjects were randomised to the control (non-intervention) group.
Croatian: Deset ispitanika bilo je randomizirano u kontrolnu (neintervencijsku) skupinu.
English: Luxturna is given under anaesthesia.
Croatian: Luxturna se daje pod anestezijom.
English: Please talk to your doctor before travelling.
Croatian: Razgovarajte sa svojim liječnikom prije putovanja.
English: After receiving Luxturna:
Croatian: Nakon što primite Luxturnu:
English: The average age was 15 years (range 4 to 44 years), including 64% paediatric subjects (n=20, age from 4 to 17 years) and 36% adults (n=11).
Croatian: Prosječna dob bila je 15 godina (raspon od 4 do 44 godine), uključujući 64% pedijatrijskih ispitanika (n=20, dob od 4 do 17 godina) i 36% odraslih (n=11).