FrancophonIA/ELRC3.0 huggingface dataset:
English: At the beginning of treatment you will start by using Ebixa 5 mg film-coated tablets once a day.
Croatian: Liječenje ćete započeti korištenjem Ebixa filmom obloženih tableta od 5 mg jedanput na dan.
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), 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), trebali bi obavijestiti svog liječnika jer će Vam liječnik možda morati prilagoditi dozu lijeka.
English: Do not take Ebixa if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na memantin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: To do this, the dosing pump head has to be turned in the direction of the arrow about one eighth of a turn, until a resistance is felt (fig. 4)
Croatian: Da bi se to učinilo, vrh pumpice za doziranje treba okrenuti u smjeru strelice za oko jednu osminu okretaja, dok se ne osjeti otpor (sl. 4)
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Ebixa dose during the first 3 weeks of treatment.
Croatian: Preporučena doza za liječenje od 20 mg dnevno postiže se postupnim povećanjem doze Ebixe tijekom prva 3 tjedna liječenja.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,ask your doctor or pharmacist for advice before taking this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: Excipients with known effect: Each millilitre of solution contains 100 mg sorbitol (E420) and 0.5 mg potassium, see section 4.4.
Croatian: Pomoćne tvari s poznatim učinkom: svaki mililitar otopine sadrži 100 mg sorbitola (E420) i 0,5 mg kalija, vidjeti dio 4.4.
English: The bottle should be placed on a flat, horizontal surface, for example a table top, and only use it in a vertical position.
Croatian: Bočicu treba staviti na ravnu, horizontalnu površinu, na primjer na površinu stola, i treba se koristiti samo u vertikalnom položaju.
English: Hold a glass with a little water or a spoon below the nozzle.
Croatian: Ispod štrcaljke stavite čašu s malo vode ili žlicu.
English: Prior to first use the dosing pump has to be screwed on the bottle.
Croatian: Prije prve uporabe treba pumpicu za doziranje pričvrstiti zavrtanjem na bočicu.
English: • The other ingredients are potassium sorbate, sorbitol E420 and purified water.
Croatian: • Drugi sastojci su kalijev sorbat, sorbitol E420 i pročišćena voda.
English: Slide the plastic dip tube carefully into the bottle.
Croatian: Pažljivo umetnite plastičnu cjevčicu u bočicu.
English: The dosing pump has to be removed from the plastic bag (fig. 2) and placed on top of the bottle, sliding the plastic dip tube carefully into the bottle.
Croatian: Pumpicu za doziranje treba odstraniti iz plastične vrećice (sl. 2) i postaviti na vrh bočice, kližući plastičnu cjevčicu pažljivo u bočicu.
English: Oral solution Multipack: 500 ml (10 bottles of 50 ml) oral solution.
Croatian: oralna otopina Višestruko pakiranje: 500 ml (10 bočica od 50 ml) oralne otopine.
English: EU/1/02/219/ 013500 ml (10 bottles of 50 ml)
Croatian: EU/1/02/219/ 013 500 ml (10 bočica od 50 ml)
English: CARTON AND LABEL FOR BOTTLE
Croatian: KUTIJA I NAJEPNICA ZA BOČICU
English: Component of a multipack, can't be sold separately.
Croatian: Sastavnica višestrukog pakiranja ne može se prodavati zasebno.
English: Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Croatian: Ebixa djeluje na navedene NMDA receptore poboljšavajući prijenos živčanih signala i pamćenje.
English: The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.
Croatian: Otopinu se ne smije uliti ili uštrcati u usta izravno iz bočice ili pumpice, već mora biti dozirana u žlicu ili u čašu vode korištenjem pumpice.
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (fig. 6).
Croatian: Sljedeći put kada se vrh pumpice za doziranje potpuno pritisne prema dolje (odgovara jednom pokretanju pumpice), raspršit će se ispravna doza (sl. 6).
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Ebixa did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Croatian: U kliničkim ispitivanjima blage do teške demencije, u kojima je 1784 bolesnika liječeno Ebixom, a 1595 ih je dobivalo placebo, sveukupna stopa učestalosti nuspojava u skupini liječenoj Ebixom nije se razlikovala od stope učestalosti nuspojava u skupini koja je primala placebo; nuspojave su uglavnom bile blage do umjerene težine.
English: The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Ebixa and since its introduction in the market.
Croatian: Nuspojave prikazane u tablici ispod prikupljene su tijekom kliničkih ispitivanja s Ebixom i nakon stavljanja lijeka u promet.
English: The bottle with the mounted pump may only be kept and transported in a vertical position.
Croatian: Bočica s namještenom pumpicom može se čuvati i prenositi samo u vertikalnom položaju.
English: If the pump does not function properly, consult your doctor or a pharmacist.
Croatian: Ako pumpica ne radi ispravno, obratite se svom liječniku ili ljekarniku.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 µmol in human frontal cortex.
Croatian: Pri dozi od 20 mg memantina dnevno, razine u CSL-u odgovaraju ki-vrijednosti (ki = konstanta inhibicije) memantina, koja u frontalnom korteksu kod ljudi iznosi 0,5 µmol.
English: CARTON FOR BLISTER PACK
Croatian: KUTIJA ZA BLISTER
English: Ebixa is used for the treatment of patients with moderate to severe Alzheimer's disease.
Croatian: Ebixa se koristi za liječenje bolesnika s umjerenom do teškom Alzheimerovom bolešću.
English: Place the bottle on a flat, horizontal surface, for example a table top, and only use it in an upright position.
Croatian: Stavite bočicu na ravnu, horizontalnu površinu, na primjer na površinu stola, i koristite samo u uspravnom položaju.
English: Other Anti-dementia drugs, ATC code: N06DX01.
Croatian: Farmakoterapijska skupina: psihoanaleptici; ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
English: This dose is increased in the second week to two pump actuations once daily (1 x 10 mg), and in the third week to three pump actuations once daily (1 x 15 mg).
Croatian: Ova doza se u drugom tjednu povećava na dva pokretanja pumpice jednom dnevno (1 x 10 mg), a u trećem tjednu na tri pokretanja pumpica jednom dnevno (1 x 15 mg).
English: EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg film-coated tablets
Croatian: EU/1/02/219/022 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg filmom obloženih tableta EU/1/02/219/036 7 x 5 mg + 7 x 10 mg + 7 x 15 mg 7 x 20 mg filmom obloženih tableta
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5 - 1 µmol) with large interindividual variations.
Croatian: Dnevne doze od 20 mg dovode do plazmatskih koncentracija memantina u stanju dinamičke ravnoteže u rasponu od 70 do 150 ng/ml (0,5 - 1 µmol) s velikim interindividualnim razlikama.
English: For the intended use the dosing pump is only screwed on once when starting the use, and should never be unscrewed.
Croatian: Za namijenjenu uporabu pumpicu za doziranje treba pričvrstiti zavrtanjem samo jednom na početku uporabe, i ne bi je više trebalo odvrtati.
English: The solution also contains potassium sorbate and sorbitol E420.
Croatian: Otopina također sadrži kalijev sorbat i sorbitol E420.
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).
Croatian: Sljedeći put kad se vrh pumpice za doziranje potpuno pritisne prema dolje (istovjetno jednom pokretanju pumpice), raspršit će se ispravna doza (1 pokretanje pumpice odgovara 0,5 ml oralne otopine, i sadržava 5 mg djelatne tvari memantinklorida; sl. 6).
English: The dosing pump may only be used with the memantine hydrochloride solution in the bottle provided, not for other substances or containers.
Croatian: Pumpica za doziranje može se koristiti samo za otopinu memantinklorida u predviđenoj bočici, ne za druge tvari ili spremnike.
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 ml/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Croatian: Kod dobrovoljaca s normalnom funkcijom bubrega, ukupni klirens (Cltot) iznosi do 170 ml/min/1,73 m², te se dio ukupnog bubrežnog klirensa postiže tubularnom sekrecijom.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.
Croatian: U tim slučajevima liječenje mora biti pažljivo nadzirano, a Vaš liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja Ebixe.
English: Mounting the dosing pump on the bottle:
Croatian: Namještanje pumpice za doziranje na bočicu:
English: A glass with a little water or a spoon should be held below the nozzle and the dosing pump head has to be pushed down in a firm but calm and steady manner (not too slowly) right down to the stop (fig. 7, fig. 8).
Croatian: Ispod štrcaljke treba staviti čašu s malo vode ili žlicu i vrh pumpice za doziranje treba pritisnuti prema dolje, snažno, ali smireno i mirno (ne presporo) sve do kraja (sl. 7, sl.
English: The pack sizes 49 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are presented in unit dose blister.
Croatian: Veličine pakiranja 49 x 1, 56 x 1, 98 x 1 i 100 x 1 filmom obloženih tableta nalaze se u perforiranim blisterima djeljivima na jedinične doze.
English: Uncommon (affects 1 to 10 users in 1,000):
Croatian: Manje česte (javljaju se kod 1 do 10 od 1000 korisnika):
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Croatian: U slučajevima predoziranja s dozom manjom od 140 mg ili nepoznatom dozom, bolesnici su opisivali simptome središnjeg živčanog sustava (konfuziju, uspavanost, somnolenciju, vrtoglavicu, agitaciju, agresiju, halucinacije i poremećaj hoda) i/ili gastrointestinalne simptome (povraćanje i proljev).
English: To unlock, turn the pump head in the direction of the arrow until it cannot be turned any further (about one eighth of a turn, fig. 4).
Croatian: Da bi se otključao, okrenite vrh pumpice za doziranje u smjeru strelice, sve do točke u kojoj se ne može okrenuti dalje (za oko jednu osminu okretaja, sl. 4).
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p0.0001).
Croatian: Kada je ustanovljeno istodobno pogoršanje stanja bolesnika u sva tri područja, rezultati su pokazali statistički značajan učinak memantina u sprječavanju pogoršanja, u skupini bolesnika liječenih placebom bilo je dvostruko više pogoršanja u sva tri područja nego u skupini bolesnika liječenih memantinom (21% naspram 11%, p<0,0001).
English: Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 film-coated tablets of Ebixa 5 mg
Croatian: Svako pakiranje s 28 filmom obloženih tableta za plan liječenja za 4 tjedna sadržava: 7 Ebixa 5 mg filmom obloženih tableta
English: 2500 Valby Denmark
Croatian: 2500 Valby DANSKA
English: The dosing pump must only be used with the Ebixa solution in the bottle provided, not for other substances or containers.
Croatian: Pumpica za doziranje smije se koristiti samo za Ebixa otopinu u predviđenoj bočici, a ne za druge tvari ili spremnike.
English: Ebixa oral solution is presented as a clear, colourless to light yellowish solution.
Croatian: Ebixa oralna otopina je bistra, bezbojna do svijetlo žućkasta otopina.
English: Ebixa should be administered orally once a day and should be taken at the same time every day.
Croatian: Ebixu je potrebno primjenjivati peroralno jednom dnevno i potrebno ju je uzimati svaki dan u isto vrijeme.
English: Ebixa belongs to a group of medicines called NMDAreceptor antagonists.
Croatian: Ebixa spada u skupinu lijekova poznatih kao antagonisti NMDA receptora.
English: EU/1/02/219/035 840 (20 packs of 42) film-coated tablets EU/1/02/219/049 840 (20 packs of 42) film-coated tablets
Croatian: EU/1/02/219/035 840 (20 pakiranja od 42) filmom obloženih tableta EU/1/02/219/049 840 (20 pakiranja od 42) filmom obloženih tableta
English: Lundbeck Pharma d.o.o.
Croatian: Slovenija Lundbeck Pharma d.o.o.
English: Film-coated tablets 50 film-coated tablets 98 film-coated tablets
Croatian: filmom obložene tablete 50 filmom obloženih tableta 98 filmom obloženih tableta
English: The dosing pump head has two positions and is easy to turn: - anticlockwise to unlock and - clockwise to lock.
Croatian: Vrh pumpice za doziranje ima dva položaja i može se lako okrenuti: - u smjeru suprotnom od kazaljke na satu za otključavanje i - u smjeru kazaljke na satu za zaključavanje.
English: Paediatric population No data are available.
Croatian: Pedijatrijska populacija Nema podataka o primjeni u djece.
English: The bottle with the mounted pump must be kept and transported in an upright position only.
Croatian: Bočica s namještenom pumpicom mora se čuvati i prenositi samo u uspravnom položaju.
English: The cap must be turned anticlockwise, unscrewed completely and removed (fig. 1).
Croatian: Čep se mora okrenuti u smjeru suprotnom od kazaljke na satu, potpuno ga odvrnuti i ukloniti (sl. 1).
English: The recommended dose of Ebixa for adults and older people is four pump actuations, equivalent to 20 mg once a day.
Croatian: Preporučena doza Ebixe za odrasle i starije osobe je četiri pokretanja pumpice, što odgovara 20 mg jednom dnevno.
English: 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 filmcoated tablets of 20 mg.
Croatian: Svako pakiranje sadrži 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: Not all pack sizes may be marketed.
Croatian: Na tržištu se ne morejo nalaziti sve veličine pakiranja.
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substanceactive substance interaction of memantine with glyburide/metformin or donepezil was observed.
Croatian: U farmakokinetičkim ispitivanjima (PK) u kojima su primijenjene pojedinačne doze kod mladih zdravih ispitanika nije uočena značajna interakcija djelatna tvar-djelatna tvar memantina s gliburidom/metforminom ili donepezilom.
English: The dosing pump is only screwed on once when starting the use, and should never be unscrewed.
Croatian: Pumpicu za doziranje treba pričvrstiti zavrtanjem jednom na početku uporabe, i ne bi je više trebalo odvrtati.
English: From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).
Croatian: Od četvrtog tjedna nadalje, uobičajena doza je 2 tablete jedanput na dan (1 x 20 mg).
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 ml/min) no dose adjustment is required.
Croatian: Kod bolesnika s blagim oštećenjem funkcije bubrega (klirens kreatinina 50-80 ml/min) nije potrebna prilagodba doze.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar pojedine skupine učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Therefore, the pump must be prepared (primed) by pushing the dosing pump head down completely five times in succession (fig. 5).
Croatian: Stoga se pumpica mora pripremiti potpunim pritiskom na vrh pumpice za doziranje prema dolje pet puta zaredom (sl. 5).
English: CARTON AND LABEL FOR BOTTLE AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: KUTIJA I NAJEPNICA ZA BOČICU KAO SREDNJE PAKIRANJE / SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: One treatment initiation pack contains 28 tablets in 4 blisters with 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg and 7 tablets of Ebixa 20 mg.
Croatian: Jedno pakiranje za uvođenje liječenja sadržava 28 tableta u 4 blistera sa 7 Ebixa tableta od 5 mg, 7 Ebixa tableta od 10 mg, 7 Ebixa tableta od 15 mg i 7 Ebixa tableta od 20 mg.
English: Women taking Ebixa should not breast-feed.
Croatian: Žene koje uzimaju Ebixu ne smiju dojiti.
English: From the fourth week the recommended dose is four pump actuations once daily (1x 20 mg).
Croatian: Od četvrtog tjedna, preporučena doza je četiri pokretanja pumpice jednom dnevno (1 x 20 mg).
English: The dosing pump head can then be released and is ready for the next pump actuation.
Croatian: Nakon toga pumpicu za doziranje možete otpustiti, te je spremna za sljedeće pokretanje.
English: H. Lundbeck AB Tel: +46 4069 98200
Croatian: Lundbeck AB Tel: +46 4069 98200
English: Excipients: The oral solution contains sorbitol.
Croatian: Pomoćne tvari: Oralna otopina sadrži sorbitol.
English: The recommended dose of Ebixa for adults and older people is 20 mg once a day.
Croatian: Preporučena doza Ebixe za odrasle i starije osobe je 20 mg jednom dnevno.
English: The dosing pump head has two positions and is easy to turn - anticlockwise (unlocked position) and clockwise (locked position).
Croatian: Vrh pumpice za doziranje ima dva položaja i lako ga je okrenuti - u smjeru suprotnom od kazaljke na satu (otključani položaj) i u smjeru kazaljke na satu (zaključani položaj).
English: Ebixa should be taken orally once daily at the same time each day.
Croatian: Ebixu je potrebno uzimati peroralno jednom dnevno, svaki dan u isto vrijeme.
English: CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Croatian: KUTIJA ZA 28 TABLETA - PAKIRANJE ZA POČETAK
English: EU/1/02/219/021 980 (10 packs of 98) film-coated tablets EU/1/02/219/012 1000 (20 packs of 50) film-coated tablets
Croatian: EU/1/02/219/021 980 (10 pakiranja od 98) filmom obloženih tableta EU/1/02/219/012 1000 (20 pakiranja od 50) filmom obloženih tableta
English: Each tablet contains 5/10/15/20 mg ofmemantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
Croatian: Svaka filmom obložena tableta sadrži 5/ 10/ 15/ 20 mg memantinklorida, što odgovara 4,15/ 8,31/ 12,46/ 16,62 mg memantina.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER
English: This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablets once a day in the third week.
Croatian: Ova doza se povećava na jednu tabletu jedanput na dan (1 x 10 mg) u drugom tjednu, te na jednu i pol tabletu jednom dnevno u trećem tjednu.
English: Hold the dosing pump onto the neck of the bottle and screw it clockwise until it fits firmly (fig. 3).
Croatian: Držite pumpicu za doziranje na vratu bočice i zavrćite ju u smjeru kazaljke na satu dok nije pričvršćena (sl. 3).
English: Then the dosing pump needs to be held onto the neck of the bottle and screwed clockwise until it is firmly attached (fig 3).
Croatian: Zatim pumpicu za doziranje treba držati na vratu bočice i zavrtati u smjeru kazaljke na satu dok nije pričvršćena (sl. 3).
English: Oral solution 50 ml
Croatian: oralna otopina 50 ml
English: How to take Ebixa
Croatian: Kako uzimati Ebixu
English: The usual starting dose is one pump actuation once daily (1x 5 mg) for the first week.
Croatian: Uobičajena početna doza je jedno pokretanje pumpice jednom dnevno (1 x 5 mg) tijekom prvog tjedna.
English: In postmarketing experience these reactions have been reported in patients treated with Ebixa.
Croatian: Ove nuspojave su prijavljene u postmarketinškom razdoblju kod bolesnika liječenih Ebixom.
English: Administration of Ebixa is not recommended in patients with severe hepatic impairment.
Croatian: Ne preporučuje se primjena Ebixe kod bolesnika s teškim oštećenjem jetre.
English: - The other ingredients for Ebixa 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 Ebixa 10 mg film-coated tablets is iron oxide yellow (E172) and for Ebixa 15 mg and Ebixa 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Croatian: - Drugi sastojci Ebixa 5/ 10/ 15 i 20 mg filmom obloženih tableta su mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E171) i dodatno za Ebixa 10 mg filmom obložene tablete žuti željezov oksid (E172), a za Ebixa 15 mg i Ebixa 20 mg filmom obložene tablete žuti i crveni željezov oksid (E172), sve u ovojnici tablete.
English: Multipack containing 980 (10 packs of 98) and 1000 (20 packs of 50) film-coated tablets.
Croatian: Višestruko pakiranje sadrži 980 (10 pakiranja po 98) i 1000 (20 pakiranja po 50) filmom obloženih tableta.
English: How the dosing pump works:
Croatian: Kako radi pumpica za doziranje:
English: For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig.1).
Croatian: Za otklanjanje čepa s bočice, čep se mora okrenuti u smjeru suprotnom od kazaljke na satu i potpuno odvrnuti (sl.1).
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Croatian: Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan (20 mg jednom dnevno), kao što je gore opisano.