natgillin/translations-raw huggingface dataset:
In patients with moderate renal impairment (creatinine clearance 3049 ml/min) daily dose should be 10 mg per day.
Pri bolnikih z zmerno okvaro ledvičnega delovanja (kreatininski očistek 30 − 49 ml/min) naj bo dnevni odmerek 10 mg.
How to take Nemdatine
Kako jemati zdravilo Nemdatine
Standard clinical procedures to remove active substance material, e.g. gastric lavage, carbo medicinalis (interruption of potential entero-hepatic recirculation), acidification of urine, forced diuresis should be used as appropriate.
Pri odstranjevanju učinkovine uporabljamo ustrezne standardne klinične postopke, kot so izpiranje želodca, medicinsko oglje (preprečevanje morebitne enterohepatične recirkulacije), nakisanje urina, prisilna diureza.
In man, about 80 % of the circulating memantine-related material is present as the parent compound.
Pri človeku je okoli 80 % memantina v obtoku v izvorni (nespremenjeni) obliki.
What you need to know before you take Nemdatine
Kaj morate vedeti, preden boste vzeli zdravilo Nemdatine Ne jemljite zdravila Nemdatine
Contents of the pack and other information
Shranjevanje zdravila Nemdatine Vsebina pakiranja in dodatne informacije
Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg
Vsako pakiranje z 28 filmsko obloženimi tabletami za štiri tedenski program zdravljenja vsebuje: 7 filmsko obloženih tablet Nemdatine 5 mg
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.
Bolnik mora jemati štiri 5-miligramske filmsko obložene tablete (20 mg), dve 10-miligramski filmsko obloženi tableti (20 mg) ali eno 20-miligramsko filmsko obloženo tableto (20 mg) na dan.
For up-titration other tablet strengths are available.
Za lažje povečevanje odmerka so na voljo tudi druge jakosti tablete.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na pretisnem omotu poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant)
Pri odmerku 20 mg memantina na dan so vrednosti v CSL skladne z vrednostjo ki (ki = konstanta inhibicije) memantina, ki je v frontalnem korteksu pri človeku 0,5°µmol.
INFORMATION IN BRAILLE Nemdatine 20 mg
PODATKI V BRAILLOVI PISAVI Nemdatine 20 mg
Bottle: 100 film-coated tablets.
Plastenka: 100 filmsko obloženih tablet.
The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market.
V preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in od začetka trženja.
What Nemdatine looks like and contents of the pack
Izgled zdravila Nemdatine in vsebina pakiranja
The usual starting dose is one tablet once a day (1x 5 mg) for the first week.
Običajni začetni odmerek je ena tableta enkrat dnevno (1 x 5 mg) v prvem tednu.
Titanium dioxide (E171)
(E172).
Reykjavikurvegur 78, 200 Hafnarfjörður Iceland
Reykjavikurvegur 78, 200 Hafnarfjörður Islandija
Week 4
Teden 4
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.
V drugem tednu povišamo odmerek na dve tableti enkrat dnevno (1x10 mg) in v tretjem tednu na tri tablete (1x15 mg) enkrat dnevno.
28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
28 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet
Hepatic impairment
Neznani hepatitis
INFORMATION IN BRAILLE Nemdatine 15 mg
PODATKI V BRAILLOVI PISAVI Nemdatine 15 mg
Tablet cores for 5, 10, 15 and 20 mg film-coated tablets Microcrystalline cellulose
Jedro tablete za 5, 10, 15 in 20 mg filmsko obložene tablete mikrokristalna celuloza krospovidon (Tip A) smukec magnezijev stearat
- There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
- Ob sočasni uporabi memantina in hidroklorotiazida (HCT) oziroma zdravil, ki vsebujejo HCT, lahko pride do zmanjšane serumske koncentracije HCT.
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.
Največji dnevni odmerek je 20 mg. Da bi zmanjšali pojavnost neželenih učinkov, je v prvih treh tednih zdravljenja potrebno postopno povečevanje odmerka po 5 mg na teden, dokler ni dosežen vzdrževalni odmerek.
There was no evidence of any carcinogenicity in life long studies in mice and rats.
V študijah na miših in podganah, ki so potekale vso življenjsko dobo, niso opazili karcinogenosti.
Nemdatine contains the active substance memantine hydrochloride.
Zdravilo Nemdatine vsebuje učinkovino memantinijev klorid.
The recommended dose of Nemdatine for adults and older people is 20 mg once a day.
Odmerjanje Za odrasle in starejše ljudi je priporočeni odmerek zdravila Nemdatine 20 mg enkrat dnevno.
Week 2
Teden 2
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE
PODATKI, KI MORAJO BITI NAVEDENI NA PRIMARNEM PAKIRANJU NALEPKA ZA PLASTENKE
Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Nemdatine spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA. Nemdatine deluje na receptorje NMDA in izboljša prenos živčnih signalov in spomin.
Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
1. teden (1.-7. dan): Vzemite po eno 5 mg tableto enkrat dnevno (bela, ovalne oblike), jemljite 7 dni.
Week 3
Teden 3
Nemdatine should be administered orally once a day.
Zdravilo Nemdatine jemljite peroralno enkrat dnevno.
Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.
2. teden (8.-14. dan): Vzemite po eno 10 mg tableto enkrat dnevno (bela, v obliki kapsule), jemljite 7 dni.
Week 4 (day 22-28): Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.
4. teden (22.-28. dan): Vzemite po eno 20 mg tableto enkrat dnevno (temno rožnata, ovalne oblike), jemljite 7 dni.
Date of latest renewal:
DATUM ZADNJE REVIZIJE BESEDILA1.
What Nemdatine is and what it is used for
Kaj je zdravilo Nemdatine in za kaj ga uporabljamo Kako deluje zdravilo Nemdatine
Half a 10 mg tablet
Ena in pol 10 mg tableta
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.
drugem tednu povišamo odmerek na eno tableto enkrat dnevno (1x10 mg) in v tretjem tednu na 1 tableto in pol (1x15 mg) enkrat dnevno.
The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days.
Bolnik mora sedem dni jemati eno 10-miligramsko filmsko obloženo tableto (belo, v obliki kapsule) na dan.
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 za 15 mg filmsko obložene tablete rumeni, rdeči in črni železov oksid (E172)
Nemdatine belongs to a group of medicines known as anti-dementia medicines.
znanih kot zdravila za zdravljenje demence.
Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
3. teden (15.-21. dan): Vzemite po eno 15 mg tableto enkrat dnevno (oranžna, ovalne oblike), jemljite 7 dni.
Common (affects 1 to 10 users in 100) - Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
Pogosti (pojavijo se pri 1 do 10 bolnikov od 100 bolnikov): - glavobol, zaspanost, zaprtje, zvišane vrednosti testov jetrne funkcije, omotica, motnje ravnotežja, zasoplost, visok krvni tlak in preobčutljivost za zdravilo
The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days.
Bolnik mora sedem dni jemati eno 20-miligramsko filmsko obloženo tableto (temno rožnato, ovalno) na dan.
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.
Eno pakiranje za začetno zdravljenje vsebuje 28 tablet v 4 pretisnih omotih v zgibanki ali v skupnem pakiranju 4 blistrov v 4 ločenih notranjih škatlah in eni zunanji škatli s 7 tabletami Nemdatine 5 mg, 7
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)
Občasni (pojavijo se pri 1 do 10 bolnikov od 1.000 bolnikov): - utrujenost, glivična okužba, zmedenost, halucinacije, bruhanje, neobičajna hoja, odpoved srca in krvni strdki v venah (tromboza/tromboembolija) Zelo redki (pojavijo se pri manj kot 1 bolniku od 10.000 bolnikov):
Reykjavíkurvegi 78 220 Hafnarfjörður Iceland
Reykjavíkurvegi 78 220 Hafnarfjörður Islandija
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
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET 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
7 film-coated tablets of Nemdatine 20 mg
7 filmsko obloženih tablet Nemdatine 20 mg
PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
Uncommon Fungal infections
Občasni glivična okužba
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.
Eno pakiranje vsebuje 28 filmsko obloženih tablet (7 filmsko obloženih tablet po 5 mg, 7 filmsko obloženih tablet po 10 mg, 7 filmsko obloženih tablet po 15 mg, 7 filmsko obloženih tablet po 20 mg)
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 filmsko obloženih tablet EU/1/13/824/004 30 filmsko obloženih tablet EU/1/13/824/005 42 filmsko obloženih tablet EU/1/13/824/006 50 filmsko obloženih tablet EU/1/13/824/007 56 filmsko obloženih tablet EU/1/13/824/008 60 filmsko obloženih tablet EU/1/13/824/009 98 filmsko obloženih tablet EU/1/13/824/010 112 filmsko obloženih tablet
< 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
- epileptični napadi Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
In another monotherapy study in mild to moderate Alzheimer's disease a total of 470 patients (MMSE total scores at baseline of 11 − 23) were randomised.
V drugi študiji zdravljenja z monoterapijo pri blagi do zmerni Alzheimerjevi bolezni (skupna ocena pri KPSS ob vključitvi od 11 do 23 točk), je bilo zajetih in randomiziranih 470 bolnikov.
Two 5 mg tablets
Dve 5 mg tableti
Each film-coated tablet contains 1.42 mg lactose monohydrate.
Ena filmsko obložena tableta vsebuje 1,42 mg laktoze monohidrata.
Blister packs: 28, 42, 56 and 98 film-coated tablets.
Pretisni omoti: 28, 42, 56 in 98 filmsko obloženih tablet.
In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.
Zdravnik naj redno ocenjuje klinično korist zdravila Nemdatine.
7 film-coated tablets of Nemdatine 15 mg
7 filmsko obloženih tablet Nemdatine 15 mg
Each film-coated tablet contains 1.89 mg lactose monohydrate.
Ena filmsko obložena tableta vsebuje 1,89 mg laktoze monohidrata.
Each film-coated tablet contains 0.95 mg lactose monohydrate.
Ena filmsko obložena tableta vsebuje 0,95 mg laktoze monohidrata.
Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day
Štiri 5 mg tablete enkrat dnevno
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.
Bolnik mora sedem dni jemati tri 5-miligramske filmsko obložene tablete (15 mg) ali eno 15-miligramsko filmsko obloženo tableto (15 mg) na dan.
28 film-coated tablets
7 filmsko obloženih tablet
Administration of Nemdatine is not recommended in patients with severe hepatic impairment.
Dajanje zdravila Nemdatine bolnikom s hudo jetrno okvaro ni priporočljivo.
Nemdatine 20 mg film-coated tablets:
Nemdatine 20 mg filmsko obložene tablete:
In the most extreme case of overdose, the patient survived the oral intake of a total of 2,000 mg memantine with effects on the central nervous system (coma for 10 days, and later diplopia and agitation).
Pojavili so se učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
7 film-coated tablets of Nemdatine 10 mg
7 filmsko obloženih tablet Nemdatine 10 mg
Each film-coated tablet contains 0.47 mg lactose monohydrate.
Ena filmsko obložena tableta vsebuje 0,47 mg laktoze monohidrata.
Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.
Nemdatine 5 mg filmsko obložene tablete so bele, ovalne, bikonveksne, velikosti 8 mm x 4,5 mm z vtisnjeno oznako “M5” na eni strani.
Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg
Pakiranje z 28 (4x7) filmsko obloženimi tabletami za štiri tedenski začetni program zdravljenja:
Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.
Velikosti pakiranj Pretisni omoti: 7, 42 in 98 filmsko obloženih tablet.
One 10 mg tablet
Ena 10 mg tableta
Pack sizes Blister packs: 42 and 98 film-coated tablets.
Velikosti pakiranj Pretisni omoti: 42 in 98 filmsko obloženih tablet.
Nemdatine 20 mg film-coated tablets
Nemdatine 20 mg filmsko obložene tablete
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.
Bolnik mora sedem dni jemati dve 5-miligramski filmsko obloženi tableti (10 mg) ali eno 10-miligramsko filmsko obloženo tableto (10 mg) na dan.
Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Obloga tablete: (Opadry II belo 33G28435): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350 in triacetin.
PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 42 filmsko obložene tablete 98 filmsko obloženih tablet.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
PRETISNI OMOT ZA TABLETE- PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - ŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA
Nemdatine 10 mg film-coated tablets:
Nemdatine 10 mg filmsko obložene tablete:
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.
Bolnik mora sedem dni jemati eno 5-miligramsko filmsko obloženo tableto (5 mg) ali polovico 10-miligramske filmsko obložene tablete (5 mg) na dan.
What Nemdatine looks like and contents of the pack 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.
Izgled zdravila Nemdatine in vsebina pakiranja Nemdatine 20 mg filmsko obložene tablete so temno rožnate, ovalne, bikonveksne, velikosti 12,6 mm x 7 mm, z vtisnjeno oznako “M20” na eni strani.
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.
V temeljno klinično študijo je bilo vključenih 252 bolnikov z zmerno do hudo Alzheimerjevo boleznijo, ki so ob vključitvi pri kratkem preizkusu spoznavnih sposobnosti (KPSS, angl. Mini mental state examination, MMSE) dosegli 3-14 točk.
Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Nemdatine 15 mg filmsko obložene tablet so oranžne, ovalne, bikonveksne, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
The film-coated tablets can be taken with or without food.
Zdravilo Nemdatine je treba jemati peroralno enkrat dnevno in ob istem času vsak dan. Filmsko obloženo tableto lahko bolnik zaužije s hrano ali brez.
EU/1/13/824/002 98 film-coated tablets
EU/1/13/824/001 42 filmsko obloženih tablet EU/1/13/824/002 98 filmsko obloženih tablet
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 filmsko obložene tablete so temno rožnate, ovalne, bikonveksne, velikosti 12,6 mm x 7 mm z vtisnjeno oznako “M20” na eni strani.
Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets
Nemdatine 5 mg filmsko obložene tablete Nemdatine 10 mg filmsko obložene tablete Nemdatine 15 mg filmsko obložene tablete Nemdatine 20 mg filmsko obložene tablete
One 5 mg tablet
Ena 5 mg tableta
What Nemdatine looks like and contents of the pack Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Izgled zdravila Nemdatine in vsebina pakiranja Nemdatine 15 mg filmsko obložene tablet so oranžne, ovalne, bikonveksne, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Nemdatine 10 mg filmsko obložene tablet so bele, v obliki kapsule, bikonveksne, velikosti 9,8 mm x 4,9 mm z razdelilno zarezo in vtisnjeno oznako “M10” na zarezani strani.
Nemdatine 15 mg film-coated tablets
Nemdatine 15 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
ŠKATLA IN ZGIBANKA ZA 28 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJEŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA-Sprednja stran
Nemdatine 10 mg film-coated tablets
Nemdatine 10 mg filmsko obložene tablete
What Nemdatine looks like and contents of the pack Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side
Izgled zdravila Nemdatine in vsebina pakiranja Nemdatine 10 mg filmsko obložene tablet so bele, v obliki kapsule, bikonveksne, velikosti 9,8 mm x 4,9 mm z razdelilno zarezo in vtisnjeno oznako “M10” na zarezani strani.
In post-marketing experience these reactions have been reported in patients treated with memantine.
Pri bolnikih, zdravljenih z memantinom, so o teh učinkih poročali po začetku trženja zdravila.
Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172).
Obloga tablete: (Opadry II oranžno 33G230001): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350 in triacetin in rumeni, rdeči in črni železov oksid (E172).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX)
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 7 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - ŠTIRI TEDENSKI
Nemdatine contains lactose monohydrate
Zdravilo Nemdatine vsebuje laktozo
Week 1: Take one tablet daily of Nemdatine 5 mg. Week 2: Take one tablet daily of Nemdatine 10 mg. Week 3: Take one tablet daily of Nemdatine 15 mg. Week 4: Take one tablet daily of Nemdatine 20 mg.
Tteden 1: 7 filmsko obloženih tablet Nemdatine 5 mg Teden 2: 7 filmsko obloženih tablet Nemdatine 10 mg Teden 3: 7 filmsko obloženih tablet Nemdatine 15 mg Teden 4: 7 filmsko obloženih tablet Nemdatine 20 mg
Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets memantine hydrochloride
Nemdatine 5 mg filmsko obložene tablete Nemdatine 10 mg filmsko obložene tablete Nemdatine 15 mg filmsko obložene tablete Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
Nemdatine 10 mg and 20 mg film-coated tablets:
Nemdatine 10 mg in 20 mg filmsko obložene tablete: Plastenka HDPE.
Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Temno rožnata, ovalna, bikonveksna filmsko obložena tableta, velikosti 12,6 mm x 7 mm z vtisnjeno oznako “M20” na eni strani.
Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Temno rožnate, ovalne, bikonveksne filmsko obložene tablete, velikosti 12,6 mm x 7 mm z vtisnjeno oznako “M20” na eni strani.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Inside
ŠKATLA IN ZGIBANKA ZA 28 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJEŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA-Notranja stran
Uncommon Fatigue
Občasni utrujenost
Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Oranžne, ovalne, bikonveksne filmsko obložene tablete, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
PRETISNI OMOT ZA TABLETE ZA ZAČETNO ZDRAVLJENJE
Nemdatine 20 mg film-coated tablets memantine hydrochloride
Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
GENERAL CLASSIFICATION FOR SUPPLY
OZNAČEVANJE NAVODILO ZA UPORABO
Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Oranžna, ovalna, bikonveksna filmsko obložena tableta, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/824/018
Nemdatine 5 mg film-coated tablets
Nemdatine 5 mg filmsko obložene tablete
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FORTREATMENT INITIATION PACK
PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA ZA PLASTENKE
NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg tablets memantine hydrochloride
IME ZDRAVILA Nemdatine 20 mg tablete memantinijev klorid
White, capsule-shaped, biconvex film-coated tablets, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Bele, v obliki kapsule, bikonveksne filmsko obložene tablete, velikosti 9,8 mm x 4,9 mm z razdelilno zarezo in vtisnjeno oznako “M10” na zarezani strani.
Gastrointestinal disorders
memantinijev klorid
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/824/019
White, capsule-shaped, biconvex film-coated tablet, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.
Bela, v obliki kapsule, bikonveksna filmsko obložena tableta, velikosti 9,8 mm x 4,9 mm z razdelilno zarezo in vtisnjeno oznako “M10” na zarezani strani.
MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/824/020
NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Imetnik dovoljenja za promet Actavis Group PTC ehf.