natgillin/translations-raw huggingface dataset:
CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
KUTIJA ZA 28 TABLETA - PAKIRANJE ZA POČETAK
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
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
Each tablet contains 5/10/15/20 mg ofmemantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
Svaka filmom obložena tableta sadrži 5/ 10/ 15/ 20 mg memantinklorida, što odgovara 4,15/ 8,31/ 12,46/ 16,62 mg memantina.
MINIMUM PARTICULARS TO APPEAR ON BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER
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.
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.
Hold the dosing pump onto the neck of the bottle and screw it clockwise until it fits firmly (fig. 3).
Držite pumpicu za doziranje na vratu bočice i zavrćite ju u smjeru kazaljke na satu dok nije pričvršćena (sl. 3).
Then the dosing pump needs to be held onto the neck of the bottle and screwed clockwise until it is firmly attached (fig 3).
Zatim pumpicu za doziranje treba držati na vratu bočice i zavrtati u smjeru kazaljke na satu dok nije pričvršćena (sl. 3).
Oral solution 50 ml
oralna otopina 50 ml
How to take Ebixa
Kako uzimati Ebixu
The usual starting dose is one pump actuation once daily (1x 5 mg) for the first week.
Uobičajena početna doza je jedno pokretanje pumpice jednom dnevno (1 x 5 mg) tijekom prvog tjedna.
In postmarketing experience these reactions have been reported in patients treated with Ebixa.
Ove nuspojave su prijavljene u postmarketinškom razdoblju kod bolesnika liječenih Ebixom.
Administration of Ebixa is not recommended in patients with severe hepatic impairment.
Ne preporučuje se primjena Ebixe kod bolesnika s teškim oštećenjem jetre.
- 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.
- 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.
Multipack containing 980 (10 packs of 98) and 1000 (20 packs of 50) film-coated tablets.
Višestruko pakiranje sadrži 980 (10 pakiranja po 98) i 1000 (20 pakiranja po 50) filmom obloženih tableta.
How the dosing pump works:
Kako radi pumpica za doziranje:
For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig.1).
Za otklanjanje čepa s bočice, čep se mora okrenuti u smjeru suprotnom od kazaljke na satu i potpuno odvrnuti (sl.1).
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.
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.
EU/1/02/219/023 14 film-coated tablets EU/1/02/219/024 28 film-coated tablets EU/1/02/219/025 42 film-coated tablets EU/1/02/219/026 49 x 1 film-coated tablets EU/1/02/219/027 56 film-coated tablets EU/1/02/219/028 56 x 1 film-coated tablets EU/1/02/219/029 70 film-coated tablets EU/1/02/219/030 84 film-coated tablets EU/1/02/219/031 98 film-coated tablets EU/1/02/219/032 98 x 1 film-coated tablets EU/1/02/219/033 100 x 1 film-coated tablets EU/1/02/219/034 112 film-coated tablets EU/1/02/219/037 14 film-coated tablets EU/1/02/219/038 28 film-coated tablets EU/1/02/219/039 42 film-coated tablets EU/1/02/219/040 49 x 1 film-coated tablets EU/1/02/219/041 56 film-coated tablets EU/1/02/219/042 56 x 1 film-coated tablets EU/1/02/219/043 70 film-coated tablets EU/1/02/219/044 84 film-coated tablets EU/1/02/219/045 98 film-coated tablets EU/1/02/219/046 98 x 1 film-coated tablets EU/1/02/219/047 100 x 1 film-coated tablets EU/1/02/219/048 112 film-coated tablets
EU/1/02/219/023 14 filmom obloženih tableta EU/1/02/219/024 28 filmom obloženih tableta EU/1/02/219/025 42 filmom obložene tablete EU/1/02/219/026 49 x 1 filmom obloženih tableta EU/1/02/219/027 56 filmom obloženih tableta EU/1/02/219/028 56 x 1 filmom obloženih tableta EU/1/02/219/029 70 filmom obloženih tableta EU/1/02/219/030 84 filmom obloženih tableta EU/1/02/219/031 98 filmom obloženih tableta EU/1/02/219/032 98 x 1 filmom obloženih tableta EU/1/02/219/033 100 x 1 filmom obloženih tableta EU/1/02/219/034 112 filmom obloženih tableta EU/1/02/219/037 14 filmom obloženih tableta EU/1/02/219/038 28 filmom obloženih tableta EU/1/02/219/039 42 filmom obložene tablete EU/1/02/219/040 49 x 1 filmom obloženih tableta EU/1/02/219/041 56 filmom obloženih tableta EU/1/02/219/042 56 x 1 filmom obloženih tableta EU/1/02/219/043 70 filmom obloženih tableta EU/1/02/219/044 84 filmom obloženih tableta EU/1/02/219/045 98 filmom obloženih tableta EU/1/02/219/046 98 x 1 filmom obloženih tableta EU/1/02/219/047 100 x 1 filmom obloženih tableta EU/1/02/219/048 112 filmom obloženih tableta
Multipack: 980 ( 10 packs of 98) film-coated tablets.
Višestruko pakiranje: 980 (10 pakiranja od 98) filmom obloženih tableta.
Film-coated tablets Multipack: 840 (20 packs of 42) film-coated tablets.
filmom obložene tablete Višestruko pakiranje: 840 (20 pakiranja od 42) filmom obloženih tableta.
Suomi/Finland Oy H. Lundbeck Ab Puh/Tel: +358 2 276 5000
Lundbeck Ab Puh/Tel: +358 2 276 5000
Additional for 15 mg and 20 mg film-coated tablets: Iron oxide yellow and red
Dodatno kod 15 mg i 20 mg filmom obloženih tableta: željezov oksid, žuti i crveni
Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza Rok valjanosti.
Keep out of the reach and sight of children.
Čuvati izvan pogleda i pogleda djece.
Ebixa should be administered orally once a day.
Ebixu treba primjenjivati na usta jedanput na dan.
Use of the dosing pump for dispensing:
Uporaba pumpice za doziranje za raspršivanje:
Perforated unit dose blister: PVDC/PE/PVC/Al-blister or PP/Al-blister Pack sizes 49 x 1, 56 x1, 98 x 1 and 100 x 1 film-coated tablets .
Perforirani blister djeljiv na jedinične doze: PVDC/PE/PVC/Al blister ili PP/Al blister Veličine pakiranja od 49 x 1, 56 x 1, 98 x 1 i 100 x 1 filmom obloženih tableta.
Ebixa 5 mg film-coated tablets Ebixa 10 mg film-coated tablets Ebixa 15 mg film-coated tablets Ebixa 20 mg film-coated tablets
Ebixa 5 mg filmom obložene tablete Ebixa 10 mg filmom obložene tablete Ebixa 15 mg filmom obložene tablete Ebixa 20 mg filmom obložene tablete memantinklorid
One pump actuation contains 5 mg memantine hydrochloride.
Jedno pokreatnje pumpice sadržava 5 mg memantinklorida.
EU/1/02/219/016 14 film-coated tablets EU/1/02/219/007 28 film-coated tablets EU/1/02/219/001 30 film-coated tablets EU/1/02/219/017 42 film-coated tablets EU/1/02/219/010 49 x 1 film-coated tablets EU/1/02/219/002 50 film-coated tablets EU/1/02/219/008 56 film-coated tablets EU/1/02/219/014 56 x 1 film-coated tablets EU/1/02/219/018 70 film-coated tablets EU/1/02/219/019 84 film-coated tablets EU/1/02/219/020 98 film-coated tablets EU/1/02/219/015 98 x 1 film-coated tablets EU/1/02/219/003 100 film-coated tablets EU/1/02/219/011 100 x 1 film-coated tablets EU/1/02/219/009 112 film-coated tablets
EU/1/02/219/016 14 filmom obloženih tableta EU/1/02/219/007 28 filmom obloženih tableta EU/1/02/219/001 30 filmom obloženih tableta EU/1/02/219/017 42 filmom obložene tablete EU/1/02/219/010 49 x 1 filmom obloženih tableta EU/1/02/219/002 50 filmom obloženih tableta EU/1/02/219/008 56 filmom obloženih tableta EU/1/02/219/014 56 x 1 filmom obloženih tableta EU/1/02/219/018 70 filmom obloženih tableta EU/1/02/219/019 84 filmom obloženih tableta EU/1/02/219/020 98 filmom obloženih tableta EU/1/02/219/015 98 x 1 filmom obloženih tableta EU/1/02/219/003 100 filmom obloženih tableta EU/1/02/219/011 100 x 1 filmom obloženih tableta EU/1/02/219/009 112 filmom obloženih tableta
two pump actuations week 3
2. tjedan dva pokretanja pumpice
Ebixa 20 mg tablets
Ebixa 20 mg tablete
one pump actuation week 2
1. tjedan jedno pokretanje pumpice
Multipack: 1000 ( 20 packs of 50) film-coated tablets
Višestruko pakiranje: 1000 (20 pakiranja od 50) filmom obloženih tableta.
From Week 4 on The patient should take 2 ml solution (20 mg) equivalent to four pump actuations once a day.
Od 4. tjedna nadalje Bolesnik treba uzimati 2 ml otopine (20 mg) istovjetno četirima pokretanjima pumpice dnevno.
EXP {MM.YYYY} See embossed stamp.
Rok valjanosti {MM/GGGG} Vidjeti otisnuti žig.
Ebixa 20 mg film-coated tablets: Pack sizes of 14, 28, 42, 56, 70, 84, 98, 112 film-coated tablets.
Ebixa 20 mg filmom obložene tablete: Veličine pakiranja od 14, 28, 42, 56, 70, 84, 98, 112 filmom obloženih tableta.
Ebixa 10 mg tablets
Ebixa 10 mg tablete
Do not use this medicine after the expiry date which is stated on the carton and the bottle label after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza Rok valjanosti.
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).
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): p=0,025; kooperativno ispitivanje Alzheimerove bolesti - aktivnosti svakodnevnog života (ADCS-ADLsev): p=0,003; skup znakova teške onesposobljenosti (SIB): p=0,002).
three pump actuations week 4 and beyond
4. tjedan i nadalje četiri pokretanja pumpice
Multipack containing 840 (20 x 42) film-coated tablets
Višestruko pakiranje sadrži 840 (20 x 42) filmom obloženih tableta.
Ebixa contains the active substance memantine hydrochloride.
Ebixa sadrži djelatnu tvar memantinklorid.
week 1
1. tjedan (1. - 7. dan)
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as described above.
Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg dnevno (dvije filmom obložene tablete od 10 mg ili jednu filmom obloženu tabletu od 20 mg jednom dnevno), kao što je gore opisano.
Additional for 10 mg film-coated tablets: Iron oxide yellow
Dodatno kod 10 mg filmom obloženih tableta: željezov oksid, žuti
Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 49 x 1 tablets, 50 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 tablets, 100 x 1 tablets, 112 tablets, 980 (10 x 98) tablets or 1000 (20 x 50) tablets.
Ebixa filmom obložene tablete dostupne su u pakiranjima s blisterima od 14 tableta, 28 tableta, 30 tableta, 42 tablete, 49 x 1 tableta, 50 tableta, 56 tableta, 56 x 1 tableta, 70 tableta, 84 tablete, 98 tableta, 98 x 1 tableta, 100 tableta, 100 x 1 tableta, 112 tableta, 980 (10 x 98) tableta ili 1000 (20 x 50) tableta.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (2 ml solution, equivalent to four pump actuations) as described above.
Temeljem kliničkih ispitivanja, preporučena doza za bolesnike starije od 65 godina iznosi 20 mg na dan (2 ml otopine istovjetno četirima pokretanja pumpice), kao što je gore opisano.
- 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 (E171) and iron oxide yellow (E172), all in the tablet coating.
Drugi sastojci su mikrokristalična celuloza, umrežena karmelozanatrij, koloidni bezvodni silicijev dioksid i magnezijev stearat, sve u jezgri tablete; te hipromeloza, makrogol 400, titanijev dioksid (E171) i žuti željezov oksid (E172), sve u ovojnici tablete.
• There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
• Pri istodobnoj primjeni memantina i hidroklorotiazida (HCT-a) ili bilo koje od kombinacija s HCT-om, postoji mogućnost smanjenja koncentracije HCT-a u serumu.
one and a half 10 mg tablets week 4 and beyond two 10 mg tablets once a day
4. tjedan i nadalje dvije tablete od 10 mg jednom dnevno
EXP {MM.YYYY}
Rok valjanosti {MM.GGGG}
- The active substance is memantine hydrochloride.
- Djelatna tvar je memantinklorid.
• The active substance is memantine hydrochloride.
• Djelatna tvar je memantinklorid.
Week 2 (day 8-14) The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
2. tjedan (8. - 14. dan) Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg (10 mg) dnevno tijekom 7 dana.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA KAO SREDNJE PAKIRANJE / SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
Additional for 20 mg film-coated tablets: Irion oxide yellow and red
Dodatno kod 20 mg filmom obloženih tableta: željezov oksid, žuti i crveni
Tablet cores for 10/20 mg film-coated tablets: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Jezgra tablete za 10 mg/20 mg filmom obložene tablete: celuloza, mikrokristalična karmelozanatrij, umrežena silicijev dioksid, koloidni, bezvodni magnezijev stearat
Memantine hydrochloride Week 4, Day 22 23 24 25 26 27 28 7 Film-coated tablets Ebixa 20 mg
4. tjedan, 22., 23., 24., 25., 26., 27., 28. dan 7 Ebixa 20 mg filmom obloženih tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA ZA SREDNJE PAKIRANJE/ SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
Memantine hydrochloride Week 1, Day 1 2 3 4 5 6 7 7 Film-coated tablets Ebixa 5 mg
1. tjedan, 1., 2., 3., 4., 5., 6., 7. dan 7 Ebixa 5 mg filmom obloženih tableta
In patients with severe renal impairment (creatinine clearance 5 - 29 ml/min) daily dose should be 10 mg per day.
Kod bolesnika s teškim oštećenjem bubrega (klirens kreatinina 5-29 ml/min) dnevna doza bi trebala biti 10 mg dnevno.
Week 1 (day 1-7) The patient should take half a 10 mg film-coated tablet (5 mg) per day for 7 days.
1. tjedan (1. - 7. dan) Bolesnik treba uzimati polovicu filmom obložene tablete od 10 mg (5 mg) dnevno tijekom 7 dana.
Film-coated tablets 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 49 x 1 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 84 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
filmom obložene tablete 14 filmom obloženih tableta 28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 49 x 1 filmom obloženih tableta 50 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 70 filmom obloženih tableta 84 filmom obloženih tableta 98 filmom obloženih tableta 98 x 1 filmom obloženih tableta 100 filmom obloženih tableta 100 x 1 filmom obloženih tableta 112 filmom obloženih tableta
Read the package leaflet before use.
Prije uporabe pročitjte Uputu o lijeku.
In patients with severe renal impairment (creatinine clearance 529 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations) per day.
Kod bolesnika s teškim oštećenjem bubrega (klirens kreatinina 5-29 ml/min) dnevna doza bi trebala biti 10 mg (1 ml otopine, istovjetno dvama pokretanjima pumpice) na dan.
Memantine hydrochloride Week 2, Day 8 9 10 11 12 13 14 7 Film-coated tablets Ebixa 10 mg
2. tjedan, 8., 9., 10., 11., 12., 13., 14. dan 7 Ebixa 10 mg filmom obloženih tableta
Film-coated tablets 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 49 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 84 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets 100 x 1 film-coated tablets 112 film-coated tablets
filmom obložene tablete 14 filmom obloženih tableta 28 filmom obloženih tableta 42 filmom obložene tablete 49 x 1 filmom obloženih tableta 56 filmom obloženih tableta 56 x 1 filmom obloženih tableta 70 filmom obloženih tableta 84 filmom obloženih tableta 98 filmom obloženih tableta 98 x 1 filmom obloženih tableta 100 x 1 filmom obloženih tableta 112 filmom obloženih tableta
Lot {number} See embossed stamp.
Vidjeti otisnuti žig.
Respiratory, thoracic and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja često dispneja
Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
3. tjedan (15. - 21. dan) Bolesnik treba uzimati jednu i pol filmom obloženu tabletu od 10 mg (15 mg) dnevno tijekom 7 dana.
Memantine hydrochloride Week 3, Day 15 16 17 18 19 20 21 7 Film-coated tablets Ebixa 15 mg
3. tjedan, 15., 16., 17., 18., 19., 10., 21. dan 7 Ebixa 15 mg filmom obloženih tableta
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day.
Kod bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30-49 ml/min), dnevna doza bi trebala biti 10 mg na dan.
Before you take Ebixa
Nemojte uzimati Ebixu
Ebixa 10 mg film-coated tablets Ebixa 20 mg film-coated tablets
Ebixa 10 mg filmom obložene tablete Ebixa 20 mg filmom obložene tablete
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two pump actuations).
Kod bolesnika s umjerenim oštećenjem bubrega (klirens kreatinina 30-49 ml/min), dnevna doza bi trebala biti 10 mg (1 ml otopine, istovjetno dvama pokretanjima pumpice).
Treatment initiation pack
Pakiranje za početak liječenja.
Ebixa film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 49 x 1 tablets, 56 tablets, 56 x 1 tablets, 70 tablets, 84 tablets, 98 tablets, 98 x 1 tablets, 100 x 1 tablets, 112 tablets or 840 (20 x 42) tablets.
Ebixa filmom obložene tablete su dostupne u pakiranjima s blisterima od 14 tableta, 28 tableta, 42 tablete, 49 x 1 tableta, 56 tableta, 56 x 1 tableta, 70 tableta, 84 tablete, 98 tableta, 98 x 1 tableta, 100 x
How to store Ebixa
Kako čuvati Ebixu
Ebixa 10 mg film-coated tablets: Pack sizes of 14, 28, 30, 42, 50, 56, 70, 84, 98, 100,112 film-coated tablets.
Veličine pakiranja od 14, 28, 30, 42, 50, 56, 70, 84, 98, 100, 112 filmom obloženih tableta.
The maximum daily dose is 20 mg once daily.
Maksimalna dnevna doza je 20 mg dnevno.
Ebixa 10 mg film-coated tablets
Ebixa 10 mg filmom obložena tablete
OUTER WRAPPER LABEL ON MULTIPACKS WRAPPED IN FOIL (INCLUDING BLUE BOX)
U FOLIJU (UKLJUČUJE PLAVI OKVIR)
Ebixa 5 mg/pump actuation oral solution Memantine hydrochloride
Ebixa 5 mg/oralna otopina s pokretanjem pomoću pumpice memantinklorid
Ebixa 20 mg film-coated tablets.
Ebixa 20 mg filmom obložene tablete.
Ebixa 5 mg film-coated tablets.
Ebixa 5 mg filmom obložene tablete.
Film-coated tablets
filmom obložene tablete
Potassium sorbate Sorbitol E420
6.1 Popis pomoćnih tvari kalijev sorbat sorbitol E420 voda, pročišćena
Detailed information on this medicine is available on the the European Medicines Agency web site:http://www.ema.europa.eu
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu.
Ebixa 20 mg film-coated tablets
Ebixa 20 mg filmom obložena tablete
Ebixa 10 mg film-coated tablets Memantine hydrochloride
Ebixa 10 mg filmom obložene tablete memantinklorid
Ebixa 5 mg/pump actuation oral solution.
Ebixa 5 mg/ oralna otopina s pokretanjem pomoću pumpice.
Ebixa 15 mg film-coated tablets.
Ebixa 15 mg filmom obložene tablete.
Week 3 (day 15-21) The patient should take 1.5 ml solution (15 mg) equivalent to three pump actuations per day for 7 days.
Bolesnik treba uzimati 1,5 ml otopine (15 mg) istovjetno trima pokretanjima pumpice dnevno, tijekom 7 dana.
Ebixa 20 mg film-coated tablets Memantine hydrochloride
Ebixa 20 mg filmom obložene tablete memantinklorid
Each pump actuation delivers 0.5 ml of solution which contains 5 mg of memantine hydrochloride which is equivalent to 4.16 mg memantine.
Svako pokretanje pumpice otpušta 0,5 ml otopine koja sadrži 5 mg memantinklorida, što odgovara 4,16 mg memantina.
Ebixa 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.
Ebixa filmom obložene tablete od 5 mg su bijele do gotovo bijele, ovalno duguljaste s utisnutom oznakom ‘5' na jednoj strani i ‘MEM' na drugoj strani.
Lot {number}
Broj serije{broj}
Pale red to grey-red, oval-oblong film-coated tablets with imprint “20” on one side and “MEM” on the other side
Blijedocrvene do sivo crvene duguljaste ovalne filmom obložene tablete s ugraviranim oznakama “20” na jednoj strani i “MEM” na drugoj strani.
Ebixa 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.
Ebixa filmom obložene tablete od 15 mg su narančaste do sivo-narančaste, ovalno duguljaste s utisnutom oznakom ‘15' na jednoj strani i ‘MEM' na drugoj strani.
Ebixa 5 mg/pump actuation oral solution
Ebixa 5 mg/oralna otopina s pokretanjem pomoću pumpice
Ebixa 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.
Ebixa filmom obložene tablete od 20 mg su blijedocrvene do sivo-crvene, ovalno duguljaste s utisnutom oznakom ‘20' na jednoj strani i ‘MEM' na drugoj strani.
Week 1 (day 1-7) The patient should take one 5 mg film-coated tablet per day (white to off-white, oval-oblong) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg (bijelu do prljavo bijelu, duguljasto ovalnu) dnevno tijekom 7 dana.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu
Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove http://www.ema.europa.eu
Week 1 (day 1-7) The patient should take 0.5 ml solution (5 mg) equivalent to one pump actuation per day for 7 days.
Bolesnik treba uzimati 0,5 ml otopine (5 mg) istovjetno jednom pokretanju pumpice dnevno, tijekom 7 dana.
Infections and infestations
Infekcije i infestacije manje često gljivične infekcije
H. Lundbeck A/S, Taani Tel: + 45 36301311
Lundbeck A/S, Taani Tel: + 45 36301311
Pale yellow to yellow, oval shaped film-coated tablets with breaking line and imprint “1 0” on one side and “M M” on the other side.
Blijedožuta do žuta filmom obložena tableta ovalnog oblika, s razdjelnom crtom i ugraviranim oznakama “1 0” na jednoj strani i “M M” na drugoj strani.