natgillin/translations-raw huggingface dataset:
In order to reduce the risk of undesirable effects, the maintenance dose is achieved by upward titration of 5 mg per week over the first 3 weeks as follows.
Radi smanjenja rizika od nuspojava, doza održavanja se postiže titracijom povećavanjem doze od 5 mg tjedno tijekom prva 3 tjedna na sljedeći način.
Nemdatine belongs to a group of medicines known as anti-dementia medicines.
Nemdatine se ubraja u skupinu lijekova poznatih kao lijekovi protiv demencije.
How to take Nemdatine
Kako uzimati Nemdatine
The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Preporučena doza održavanja je 20 mg jedanput na dan, te se postiže na početku 4. tjedna.
Do not take Nemdatine - if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine
Nemojte uzimati Nemdatine - ako ste alergični na memantinklorid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
Pharmacotherapeutic group: Psychoanaleptics, other Anti-dementia drugs, ATC code: N06DX01.
Farmakoterapijska skupina: psihoanaleptici,ostali lijekovi protiv demencije, ATK oznaka: N06DX01.
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Upravljanje vozilima i strojevima Liječnik će Vam reći dopušta li Vam bolest sigurno upravljanje vozilima i rad na strojevima.
Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. Pharmacokinetic/pharmacodynamic relationship
Ispitivanja na dobrovoljcima pokazala su linearnu farmakokinetiku u rasponu doza od 10 do 40 mg.
Balance disorders Uncommon Gait abnormal Very rare
Manje često abnormalni hod Vrlo rijetko napadaji
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.
Kod dobrovoljaca s normalnom funkcijom bubrega ukupni klirens (Cltot) iznosi do 170 ml/min/1,73 m², a dio se ukupnog bubrežnog klirensa postiže tubularnom sekrecijom.
The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Nemdatine dose during the first 3 weeks of treatment.
Preporučena doza za liječenje od 20 mg dnevno postiže se postupnim povećanjem doze lijeka Nemdatine tijekom prva 3 tjedna liječenja.
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.
U tim slučajevima liječenje mora biti pažljivo nadzirano, a liječnik treba redovito ponovno procjenjivati kliničku korist od uzimanja lijeka Nemdatine.
Not known (frequency cannot be estimated from the available data) - Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Nepoznate učestalosti (učestalost se ne može procijeniti iz raspoloživih podataka) upala gušterače, upala jetre (hepatitis) i psihotične reakcije
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).
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).
- The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate.
Drugi sastojci su: Jezgra tablete: mikrokristalična celuloza, krospovidon vrste A, talk i magnezijev stearat.
Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Nemdatine djeluje na navedene NMDA receptore poboljšavajući prijenos živčanih signala i pamćenje.
The recommended dose of Nemdatine for adults and older people is 20 mg once a day.
Preporučena doza lijeka Nemdatine za odrasle i starije osobe je 20 mg jedanput na dan.
At the beginning of treatment you will start by using Nemdatine 5 mg film-coated tablets once a day.
Liječenje ćete započeti korištenjem Nemdatine filmom obloženih tableta od 5 mg jedanput na dan.
Treatment initiation pack.
Pakiranje za početak liječenja.
The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3 % vs. 5.6 %, respectively), headache (5.2 % vs. 3.9 %), constipation (4.6 % vs. 2.6 %), somnolence (3.4 % vs. 2.2 %) and hypertension (4.1 % vs. 2.8 %).
naspram 5,6%), glavobolja (5,2% naspram 3,9%), konstipacija (4,6% naspram 2,6%), somnolencija (3,4% naspram 2,2%) i hipertenzija (4,1% naspram 2,8%).
Day 15, 16, 17, 18, 19, 20, 21
15., 16., 17., 18., 19., 20., 21. dan
HDPE bottle: 100 film-coated tablets.
HDPE boca: 100 filmom obloženih tableta.
In patients with mildly impaired renal function (creatinine clearance 50 − 80 ml/min) no dose adjustment is required.
Kod bolesnika s blagim oštećenjem funkcije bubrega (klirens kreatinina 50-80 ml/min) nije potrebna prilagodba doze.
Keep this medicine out of the sight and reach of children.
Kako čuvati Nemdatine Ovaj lijek čuvajte izvan pogleda i dohvata djece.
Day 1, 2, 3, 4, 5, 6, 7
1., 2., 3., 4., 5., 6., 7. dan
In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - amantadine, ketamine, dextromethorphan - dantrolene, baclofen - cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine - hydrochlorothiazide (or any combination with hydrochlorothiazide) - anticholinergics (substances generally used to treat movement disorders or intestinal cramps) - anticonvulsants (substances used to prevent and relieve seizures) - barbiturates (substances generally used to induce sleep) - dopaminergic agonists (substances such as L-dopa, bromocriptine) - neuroleptics (substances used in the treatment of mental disorders) - oral anticoagulants
Posebice, Nemdatine može promijeniti učinak sljedećih lijekova te će liječnik možda morati prilagoditi njihovu dozu: - amantadin, ketamin, dekstrometorfan - dantrolen, baklofen - cimetidin, ranitidin, prokainamid, kinidin, kinin, nikotin - hidroklorotiazid (ili bilo koja kombinacija s hidroklorotiazidom)
Day 22, 23, 24, 25, 26, 27, 28
4. tjedan 22., 23., 24., 25., 26., 27., 28. dan
Day 8, 9, 10, 11, 12, 13, 14
8., 9., 10., 11., 12., 13., 14. dan
Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.
Pakiranja s blisterima: 28, 30, 42, 50, 56, 60, 98 i 112 filmom obloženih tableta.
The usual starting dose is 5 mg memantine once a day for the first week.
Uobičajena početna doza iznosi 5 mg memantina jedanput na dan tijekom prvog tjedna.
From the fourth week on, the usual dose is 20 mg memantine once a day.
Od četvrtog tjedna nadalje, uobičajena doza je 20 mg memantina jedanput na dan.
Uncommon (affects 1 to 10 users in 1,000) - Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Manje česte (javljaju se kod 1 do 10 na 1000 korisnika) umor, gljivične infekcije, smetenost, halucinacije, povraćanje, poremećaj hoda, zatajenje srca i zgrušavanje venske krvi (tromboza/tromboembolija)
- The other ingredients for Nemdatine 5, 10, 15 and 20 mg film-coated tablets are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate.
- Drugi sastojci za Nemdatine 5, 10, 15 i 20 mg filmom obložene tablete su: Jezgra tablete: mikrokristalična celuloza, krospovidon vrste A, talk i magnezijev stearat.
The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows: Week 1 (day 1-7):
Preporučena početna doza je 5 mg dnevno, koja se postupno povećava tijekom prva 4 tjedna liječenja, te doseže preporučenu dozu održavanja na sljedeći način:
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
potpunim nedostatkom laktaze ili malapsorpcijom glukoze i galaktoze ne bi smjeli uzimati ovaj lijek.
engraved on one side.
„M20” na jednoj strani.
The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Tablični popis nuspojava Sljedeće nuspojave koje su prikupljene tijekom kliničkih ispitivanja s memantinom i nakon stavljanja lijeka u promet su prikazane u tablici ispod.
This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week.
Ova doza se povećava na 10 mg memantina u drugom tjednu, te na 15 mg memantina jedanput na dan u trećem tjednu.
Bottle: 100 film-coated tablets.
Boca: 100 filmom obloženih tableta.
Nemdatine contains lactose monohydrate
Nemdatine sadrži laktozu hidrat
What Nemdatine contains - The active substance is memantine hydrochloride.
Što Nemdatine sadrži - Djelatna tvar je memantinklorid.
One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg.
Jedno pakiranje za početak liječenja sadrži 28 tableta u 4 blistera u preklopnom pakiranju ili višestruko pakiranje od 4 blistera u 4 unutarnje kutije i jednoj vanjskoj kutiji sa 7 tableta od Nemdatine 5 mg, 7 tableta od Nemdatine 10 mg, 7 tableta od Nemdatine 15 mg i 7 tableta od Nemdatine 20 mg.
28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 60 film-coated tablets 98 film-coated tablets 112 film-coated tablets
28 filmom obloženih tableta 30 filmom obloženih tableta 42 filmom obložene tablete 50 filmom obloženih tableta 56 filmom obloženih tableta 60 filmom obloženih tableta 98 filmom obloženih tableta 112 filmom obloženih tableta
Additional for 15 mg film-coated tablets Iron oxide yellow, red and black (E172) Additional for 20 mg film-coated tablets Iron oxide red and yellow (E172)
Dodatno kod 15 mg filmom obloženih tableta željezov oksid, žuti, crveni i crni (E172) Dodatno kod 20 mg filmom obloženih tableta željezov oksid, crveni i žuti (E172) 6.2 Inkompatibilnosti
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „EXP“.
What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Nemdatine se koristi za liječenje odraslih bolesnika s umjerenom do teškom Alzheimerovom bolešću.
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Prilog I.: Sažetak opisa svojstava lijeka, dio 4.2.).
Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP'.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju, blisteru i naljepnici na boci iza „EXP“.
Each pack contains 28 film-coated tablets (7 film-coated 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) in a wallet pack or as a pack of 4 blisters in 4 separate immediate cartons and one outer carton.
Jedno pakiranje sadrži 28 filmom obloženih tableta (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) u preklopnom pakiranju ili višestrukom pakiranju od 4 blistera u 4 unutarnje kutije i jednoj vanjskoj kutiji.
How does Nemdatine work
Kako djeluje Nemdatine
Each tablet contains 5, 10, 15 or 20 mg of memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine.
Jedna tableta sadrži 5, 10, 15 ili 20 mg memantinklorida, što odgovara 4,15; 8,31; 12,46 ili 16,62 mg memantina.
The 20 mg tablets furthermore contain iron oxide red and yellow (E172).
Osim toga, tablete od 20 mg sadrže željezov oksid, crveni i žuti (E172).
Nemdatine should be administered orally once a day.
Nemdatine treba primjenjivati kroz usta jedanput na dan.
This medicinal product contains lactose.
Ovaj lijek sadrži laktozu hidrat.
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)).
Bolesnici liječeni memantinom pokazali su statistički značajno bolji učinak nego bolesnici koji su primali placebo u pogledu primarnih ishoda: skala procjene Alzheimerove bolesti (ADAS-cog) (p=0,003) i CIBIC-plus
- The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Zbog farmakoloških učinaka i mehanizma djelovanja memantina moguće su sljedeće interakcije: Način djelovanja sugerira da bi učinci L-dope, dopaminergičkih agonista i antikolinergika mogli biti pojačani pri istodobnom liječenju NMDA-antagonistima poput memantina.
In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
U tom slučaju liječnik treba u određenim razmacima nadzirati funkciju bubrega.
The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172).
Osim toga, tablete od 15 mg sadrže željezov oksid, žuti, crveni i crni (E172).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING.
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU
Nemdatine contains the active substance memantine hydrochloride.
Nemdatine sadrži djelatnu tvar memantinklorid.
Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.
2. tjedan (8. - 14. dan): Uzimajte jednu tabletu od 10 mg jedanput na dan (bijelu, u obliku kapsule) tijekom 7 dana.
This is increased to two tablets once a day (1x 10 mg) in the second week and to three tablets once a day (1x 15 mg) in the third week.
Ova doza se povećava na dvije tablete jedanput na dan (1x 10 mg) u drugom tjednu, te na tri tablete jedanput na dan (1x 15 mg) u trećem tjednu.
Nemdatine belongs to a group of medicines called NMDAreceptor antagonists.
Nemdatine spada u skupinu lijekova poznatih kao antagonisti NMDA
If you take more Nemdatine than you should - In general, taking too much Nemdatine should not result in any harm to you.
- Općenito, uzimanje previše lijeka Nemdatine ne bi Vam trebalo naškoditi.
From the fourth week on, the usual dose is 4 tablets once a day (1x 20 mg).
Od četvrtog tjedna nadalje, uobičajena doza je 4 tablete jedanput na dan (1x 20 mg).
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 dnevno
Common (affects 1 to 10 users in 100) - Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
Česte (javljaju se kod 1 do 10 na 100 korisnika) glavobolja, pospanost, zatvor, povišeni rezultati testova jetrene funkcije, omaglica, poremećaji ravnoteže, nedostatak zraka, visoki krvni tlak i preosjetljivost na lijek
The patient should take four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) per day.
Bolesnik treba uzimati četiri filmom obložene tablete od 5 mg (20 mg), dvije filmom obložene tablete od 10 mg (20 mg) ili jednu filmom obloženu tabletu od 20 mg (20 mg) dnevno.
Tablet cores for 5, 10, 15 and 20 mg film-coated tablets Microcrystalline cellulose
Jezgra tablete za 5, 10, 15 i 20 mg filmom obložene tablete celuloza, mikrokristalična krospovidon vrste
From the fourth week on, the usual dose is 2 tablets once a day (1x 20 mg).
Od četvrtog tjedna nadalje, uobičajena doza je 2 tablete jedanput na dan (1x 20 mg).
Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
3. tjedan (15. - 21. dan): Uzimajte jednu tabletu od 15 mg jedanput na dan (narančastu, ovalnog oblika) tijekom 7 dana.
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 (1x 15 mg) in the third week.
Ova doza se povećava na jednu tabletu jedanput na dan (1x 10 mg) u drugom tjednu, te na 1 i pol tabletu jedanput na dan (1x 15 mg) u trećem tjednu.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant)
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.
Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
1. tjedan (1. - 7. dan): Uzimajte jednu tabletu od 5 mg jedanput na dan (bijelu, ovalnog oblika) tijekom 7 dana.
Sun.
Ned.
28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
28 filmom obloženih tableta 42 filmom obložene tablete 56 filmom obloženih tableta 98 filmom obloženih tableta
The usual starting dose is one tablet once a day (1x 5 mg) for the first week.
Uobičajena početna doza iznosi jedna tableta jedanput na dan (1x 5 mg) tijekom prvog tjedna.
Administration of Nemdatine is not recommended in patients with severe hepatic impairment.
Ne preporučuje se primjena lijeka Nemdatine kod bolesnika s teškim oštećenjem jetre.
The usual starting dose is half a tablet once a day (1x 5 mg) for the first week.
Uobičajena početna doza iznosi pola tablete jedanput na dan (1x 5 mg) tijekom prvog tjedna.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FORTREATMENT INITIATION PACK
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTER ZA TABLETE ZA PAKIRANJE ZA POČETAK
One and a half 10 mg tablets Week 4 and beyond Two 10 mg tablets once a day
3. tjedan jedna i pol tableta od 10 mg 4. tjedan i nadalje dvije tablete od 10 mg jedanput na dan
INFORMATION IN BRAILLE Nemdatine 20 mg
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 20 mg
A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3 − 14) included a total of 252 outpatients.
Alzheimerove bolesti (početne vrijednosti kratkog testa određivanja mentalnog statusa (MMSE) bile su 3-14) uključivalo je ukupno 252 ambulantna bolesnika.
Two 5 mg tablets
2. tjedan dvije tablete od 5 mg
EU/1/13/824/014 28 film-coated tablets EU/1/13/824/015 42 film-coated tablets EU/1/13/824/016 56 film-coated tablets EU/1/13/824/017 98 film-coated tablets
EU/1/13/824/014 28 filmom obloženih tableta EU/1/13/824/015 42 filmom obložene tablete EU/1/13/824/016 56 filmom obloženih tableta EU/1/13/824/017 98 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE
PODACI KOJE MORA SADRŽAVATI UNUTARNJE PAKIRANJE NALJEPNICA ZA BOCU
EU/1/13/824/003 28 film-coated tablets EU/1/13/824/004 30 film-coated tablets EU/1/13/824/005 42 film-coated tablets EU/1/13/824/006 50 film-coated tablets EU/1/13/824/007 56 film-coated tablets EU/1/13/824/008 60 film-coated tablets EU/1/13/824/009 98 film-coated tablets EU/1/13/824/010 112 film-coated tablets
EU/1/13/824/003 28 filmom obloženih tableta EU/1/13/824/004 30 filmom obloženih tableta EU/1/13/824/005 42 filmom obložene tablete EU/1/13/824/006 50 filmom obloženih tableta EU/1/13/824/007 56 filmom obloženih tableta EU/1/13/824/008 60 filmom obloženih tableta EU/1/13/824/009 98 filmom obloženih tableta EU/1/13/824/010 112 filmom obloženih tableta
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA I PREKLOPNO PAKIRANJE ZA 28 TABLETA - PAKIRANJE ZA POČETAK
CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX)
ZA 4 TJEDNA - UNUTARNJA KUTIJA (BEZ BLUE BOX)
Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day
3. tjedan tri tablete od 5 mg 4. tjedan i nadalje četiri tablete od 5 mg jedanput na dan
How to store Nemdatine
Moguće nuspojave Kako čuvati Nemdatine
Elevated liver function test Not known Hepatitis
Često povišeni rezultat testa jetrene funkcije
Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Ovojnica tablete: hipromeloza 6cP, titanijev dioksid (E171), laktoza hidrat, makrogol 3350 i triacetin.
The patient should take three 5 mg film-coated tablets (15 mg) or one 15 mg film-coated tablet (15 mg) per day for 7 days.
Bolesnik treba uzimati tri filmom obložene tablete od 5 mg (15 mg) ili jednu filmom obloženu tabletu od 15 mg (15 mg) dnevno tijekom 7 dana.
Blister packs: 28, 42, 56 and 98 film-coated tablets.
Pakiranja s blisterima: 28, 42, 56 i 98 filmom obloženih tableta.
On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (four 5 mg film-coated tablets (20 mg), two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet (20 mg) once a day) as described above.
(četiri filmom obložene tablete od 5 mg (20 mg), dvije filmom obložene tablete od 10 mg (20 mg) ili jedna filmom obložena tableta od 20 mg (20 mg) dnevno) kao što je gore opisano.
Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg
Pakiranje za početak liječenja s 28 (4x7) filmom obloženih tableta za plan liječenja za 4 tjedna sadrži:
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/011 7 film-coated tablets EU/1/13/824/012 42 film-coated tablets EU/1/13/824/013 98 film-coated tablets
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/824/011 7 filmom obloženih tableta EU/1/13/824/012 42 filmom obložene tablete EU/1/13/824/013 98 filmom obloženih tableta
- 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
INFORMATION IN BRAILLE Nemdatine 15 mg
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 15 mg
Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Nemdatine 20 mg filmom obložene tablete (tablete) su tamno ružičaste, ovalnog oblika, bikonveksne, veličine 12,6 mm x 7 mm i s ugraviranom oznakom „M20” na jednoj strani.
Vascular disorders
- oralni antikoagulansi
The patient should take one 5 mg film-coated tablet (5 mg) or half a 10 mg film-coated tablet (5 mg) per day for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 5 mg (5 mg) ili polovicu filmom obložene tablete od 10 mg (5 mg) dnevno tijekom 7 dana.
The patient should take two 5 mg film-coated tablets (10 mg) or one 10 mg film-coated tablet (10 mg) per day for 7 days.
Bolesnik treba uzimati dvije filmom obložene tablete od 5 mg (10 mg) ili jednu filmom obloženu tabletu od 10 mg (10 mg) dnevno tijekom 7 dana.
Half a 10 mg tablet
1. tjedan pola tablete od 10 mg
INFORMATION IN BRAILLE Nemdatine 10 mg
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 10 mg
The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 20 mg dnevno (tamno ružičastu, ovalnog oblika) tijekom 7 dana.
INFORMATION IN BRAILLE Nemdatine 5 mg
16. PODACI NA BRAILLEOVOM PISMU Nemdatine 5 mg
The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days.
Bolesnik treba uzimati jednu filmom obloženu tabletu od 10 mg dnevno (bijelu, u obliku kapsule) tijekom 7 dana.