FrancophonIA/ELRC3.0 huggingface dataset:
English: The following Adverse Reactions listed in the table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Slovenian: V preglednici so navedeni podatki o neželenih učinkih memantina, zbrani v kliničnih študijah in od začetka trženja.
English: What Nemdatine looks like and contents of the pack
Slovenian: Izgled zdravila Nemdatine in vsebina pakiranja
English: The usual starting dose is one tablet once a day (1x 5 mg) for the first week.
Slovenian: Običajni začetni odmerek je ena tableta enkrat dnevno (1 x 5 mg) v prvem tednu.
English: Titanium dioxide (E171)
Slovenian: (E172).
English: Reykjavikurvegur 78, 200 Hafnarfjörður Iceland
Slovenian: Reykjavikurvegur 78, 200 Hafnarfjörður Islandija
English: Week 4
Slovenian: Teden 4
English: 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.
Slovenian: V drugem tednu povišamo odmerek na dve tableti enkrat dnevno (1x10 mg) in v tretjem tednu na tri tablete (1x15 mg) enkrat dnevno.
English: 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Slovenian: 28 filmsko obloženih tablet 42 filmsko obloženih tablet 56 filmsko obloženih tablet 98 filmsko obloženih tablet
English: Hepatic impairment
Slovenian: Neznani hepatitis
English: INFORMATION IN BRAILLE Nemdatine 15 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Nemdatine 15 mg
English: Tablet cores for 5, 10, 15 and 20 mg film-coated tablets Microcrystalline cellulose
Slovenian: Jedro tablete za 5, 10, 15 in 20 mg filmsko obložene tablete mikrokristalna celuloza krospovidon (Tip A) smukec magnezijev stearat
English: - There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is co-administered with HCT or any combination with HCT.
Slovenian: - Ob sočasni uporabi memantina in hidroklorotiazida (HCT) oziroma zdravil, ki vsebujejo HCT, lahko pride do zmanjšane serumske koncentracije HCT.
English: 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.
Slovenian: 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.
English: There was no evidence of any carcinogenicity in life long studies in mice and rats.
Slovenian: V študijah na miših in podganah, ki so potekale vso življenjsko dobo, niso opazili karcinogenosti.
English: Nemdatine contains the active substance memantine hydrochloride.
Slovenian: Zdravilo Nemdatine vsebuje učinkovino memantinijev klorid.
English: The recommended dose of Nemdatine for adults and older people is 20 mg once a day.
Slovenian: Odmerjanje Za odrasle in starejše ljudi je priporočeni odmerek zdravila Nemdatine 20 mg enkrat dnevno.
English: Week 2
Slovenian: Teden 2
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA PRIMARNEM PAKIRANJU NALEPKA ZA PLASTENKE
English: Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Slovenian: Nemdatine spada v skupino zdravil, ki se imenujejo antagonisti receptorjev NMDA. Nemdatine deluje na receptorje NMDA in izboljša prenos živčnih signalov in spomin.
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
Slovenian: 1. teden (1.-7. dan): Vzemite po eno 5 mg tableto enkrat dnevno (bela, ovalne oblike), jemljite 7 dni.
English: Week 3
Slovenian: Teden 3
English: Nemdatine should be administered orally once a day.
Slovenian: Zdravilo Nemdatine jemljite peroralno enkrat dnevno.
English: Week 2 (day 8-14): Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.
Slovenian: 2. teden (8.-14. dan): Vzemite po eno 10 mg tableto enkrat dnevno (bela, v obliki kapsule), jemljite 7 dni.
English: Week 4 (day 22-28): Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.
Slovenian: 4. teden (22.-28. dan): Vzemite po eno 20 mg tableto enkrat dnevno (temno rožnata, ovalne oblike), jemljite 7 dni.
English: Date of latest renewal:
Slovenian: DATUM ZADNJE REVIZIJE BESEDILA1.
English: What Nemdatine is and what it is used for
Slovenian: Kaj je zdravilo Nemdatine in za kaj ga uporabljamo Kako deluje zdravilo Nemdatine
English: Half a 10 mg tablet
Slovenian: Ena in pol 10 mg tableta
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 (1x 15 mg) in the third week.
Slovenian: drugem tednu povišamo odmerek na eno tableto enkrat dnevno (1x10 mg) in v tretjem tednu na 1 tableto in pol (1x15 mg) enkrat dnevno.
English: The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days.
Slovenian: Bolnik mora sedem dni jemati eno 10-miligramsko filmsko obloženo tableto (belo, v obliki kapsule) na dan.
English: 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)
Slovenian: Dodatno za 15 mg filmsko obložene tablete rumeni, rdeči in črni železov oksid (E172)
English: Nemdatine belongs to a group of medicines known as anti-dementia medicines.
Slovenian: znanih kot zdravila za zdravljenje demence.
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
Slovenian: 3. teden (15.-21. dan): Vzemite po eno 15 mg tableto enkrat dnevno (oranžna, ovalne oblike), jemljite 7 dni.
English: Common (affects 1 to 10 users in 100) - Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
Slovenian: 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
English: The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days.
Slovenian: Bolnik mora sedem dni jemati eno 20-miligramsko filmsko obloženo tableto (temno rožnato, ovalno) na dan.
English: 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.
Slovenian: 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
English: 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)
Slovenian: 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):
English: Reykjavíkurvegi 78 220 Hafnarfjörður Iceland
Slovenian: Reykjavíkurvegi 78 220 Hafnarfjörður Islandija
English: 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
Slovenian: 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
English: 7 film-coated tablets of Nemdatine 20 mg
Slovenian: 7 filmsko obloženih tablet Nemdatine 20 mg
English: PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 28 filmsko obloženih tablet
English: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Slovenian: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
English: Uncommon Fungal infections
Slovenian: Občasni glivična okužba
English: 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.
Slovenian: 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)
English: 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
Slovenian: 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
English: < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Slovenian: - epileptični napadi Neznana pogostnost (pogostosti ni mogoče oceniti iz razpoložljivih podatkov):
English: 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.
Slovenian: 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.
English: Two 5 mg tablets
Slovenian: Dve 5 mg tableti
English: Each film-coated tablet contains 1.42 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 1,42 mg laktoze monohidrata.
English: Blister packs: 28, 42, 56 and 98 film-coated tablets.
Slovenian: Pretisni omoti: 28, 42, 56 in 98 filmsko obloženih tablet.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.
Slovenian: Zdravnik naj redno ocenjuje klinično korist zdravila Nemdatine.
English: 7 film-coated tablets of Nemdatine 15 mg
Slovenian: 7 filmsko obloženih tablet Nemdatine 15 mg
English: Each film-coated tablet contains 1.89 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 1,89 mg laktoze monohidrata.
English: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 0,95 mg laktoze monohidrata.
English: Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day
Slovenian: Štiri 5 mg tablete enkrat dnevno
English: 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.
Slovenian: Bolnik mora sedem dni jemati tri 5-miligramske filmsko obložene tablete (15 mg) ali eno 15-miligramsko filmsko obloženo tableto (15 mg) na dan.
English: 28 film-coated tablets
Slovenian: 7 filmsko obloženih tablet
English: Administration of Nemdatine is not recommended in patients with severe hepatic impairment.
Slovenian: Dajanje zdravila Nemdatine bolnikom s hudo jetrno okvaro ni priporočljivo.
English: Nemdatine 20 mg film-coated tablets:
Slovenian: Nemdatine 20 mg filmsko obložene tablete:
English: 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).
Slovenian: Pojavili so se učinki na centralni živčni sistem (desetdnevna koma, kasneje diplopija in vznemirjenost).
English: 7 film-coated tablets of Nemdatine 10 mg
Slovenian: 7 filmsko obloženih tablet Nemdatine 10 mg
English: Each film-coated tablet contains 0.47 mg lactose monohydrate.
Slovenian: Ena filmsko obložena tableta vsebuje 0,47 mg laktoze monohidrata.
English: 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.
Slovenian: Nemdatine 5 mg filmsko obložene tablete so bele, ovalne, bikonveksne, velikosti 8 mm x 4,5 mm z vtisnjeno oznako “M5” na eni strani.
English: Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg
Slovenian: Pakiranje z 28 (4x7) filmsko obloženimi tabletami za štiri tedenski začetni program zdravljenja:
English: Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.
Slovenian: Velikosti pakiranj Pretisni omoti: 7, 42 in 98 filmsko obloženih tablet.
English: One 10 mg tablet
Slovenian: Ena 10 mg tableta
English: Pack sizes Blister packs: 42 and 98 film-coated tablets.
Slovenian: Velikosti pakiranj Pretisni omoti: 42 in 98 filmsko obloženih tablet.
English: Nemdatine 20 mg film-coated tablets
Slovenian: Nemdatine 20 mg filmsko obložene tablete
English: 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.
Slovenian: Bolnik mora sedem dni jemati dve 5-miligramski filmsko obloženi tableti (10 mg) ali eno 10-miligramsko filmsko obloženo tableto (10 mg) na dan.
English: Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Slovenian: Obloga tablete: (Opadry II belo 33G28435): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350 in triacetin.
English: PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 42 filmsko obložene tablete 98 filmsko obloženih tablet.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Slovenian: PRETISNI OMOT ZA TABLETE- PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - ŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA
English: Nemdatine 10 mg film-coated tablets:
Slovenian: Nemdatine 10 mg filmsko obložene tablete:
English: 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.
Slovenian: Bolnik mora sedem dni jemati eno 5-miligramsko filmsko obloženo tableto (5 mg) ali polovico 10-miligramske filmsko obložene tablete (5 mg) na dan.
English: 5 mg tablet
Slovenian: 5 mg tableta
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: The film-coated tablets can be taken with or without food.
Slovenian: Zdravilo Nemdatine je treba jemati peroralno enkrat dnevno in ob istem času vsak dan. Filmsko obloženo tableto lahko bolnik zaužije s hrano ali brez.
English: EU/1/13/824/002 98 film-coated tablets
Slovenian: EU/1/13/824/001 42 filmsko obloženih tablet EU/1/13/824/002 98 filmsko obloženih tablet
English: 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.
Slovenian: 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.
English: Nemdatine 5 mg film-coated tablets Nemdatine 10 mg film-coated tablets Nemdatine 15 mg film-coated tablets Nemdatine 20 mg film-coated tablets
Slovenian: Nemdatine 5 mg filmsko obložene tablete Nemdatine 10 mg filmsko obložene tablete Nemdatine 15 mg filmsko obložene tablete Nemdatine 20 mg filmsko obložene tablete
English: One 5 mg tablet
Slovenian: Ena 5 mg tableta
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: Nemdatine 15 mg film-coated tablets
Slovenian: Nemdatine 15 mg filmsko obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
Slovenian: ŠKATLA IN ZGIBANKA ZA 28 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJEŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA-Sprednja stran
English: Nemdatine 10 mg film-coated tablets
Slovenian: Nemdatine 10 mg filmsko obložene tablete
English: 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
Slovenian: 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.
English: In post-marketing experience these reactions have been reported in patients treated with memantine.
Slovenian: Pri bolnikih, zdravljenih z memantinom, so o teh učinkih poročali po začetku trženja zdravila.
English: Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172).
Slovenian: 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).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA 7 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJE - ŠTIRI TEDENSKI
English: Nemdatine contains lactose monohydrate
Slovenian: Zdravilo Nemdatine vsebuje laktozo
English: 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.
Slovenian: 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
English: 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
Slovenian: 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
English: Nemdatine 10 mg and 20 mg film-coated tablets:
Slovenian: Nemdatine 10 mg in 20 mg filmsko obložene tablete: Plastenka HDPE.
English: Dark pink, oval shaped, biconvex film-coated tablet, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Slovenian: Temno rožnata, ovalna, bikonveksna filmsko obložena tableta, velikosti 12,6 mm x 7 mm z vtisnjeno oznako “M20” na eni strani.
English: Dark pink, oval shaped, biconvex film-coated tablets, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.
Slovenian: Temno rožnate, ovalne, bikonveksne filmsko obložene tablete, velikosti 12,6 mm x 7 mm z vtisnjeno oznako “M20” na eni strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Inside
Slovenian: ŠKATLA IN ZGIBANKA ZA 28 TABLET - PAKIRANJE ZA ZAČETNO ZDRAVLJENJEŠTIRI TEDENSKI PROGRAM ZDRAVLJENJA-Notranja stran
English: Uncommon Fatigue
Slovenian: Občasni utrujenost
English: Orange, oval shaped, biconvex film-coated tablets, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Slovenian: Oranžne, ovalne, bikonveksne filmsko obložene tablete, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
Slovenian: PRETISNI OMOT ZA TABLETE ZA ZAČETNO ZDRAVLJENJE
English: Nemdatine 20 mg film-coated tablets memantine hydrochloride
Slovenian: Nemdatine 20 mg filmsko obložene tablete memantinijev klorid
English: GENERAL CLASSIFICATION FOR SUPPLY
Slovenian: OZNAČEVANJE NAVODILO ZA UPORABO
English: Orange, oval shaped, biconvex film-coated tablet, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.
Slovenian: Oranžna, ovalna, bikonveksna filmsko obložena tableta, velikosti 11,4 mm x 6,4 mm z vtisnjeno oznako “M15” na eni strani.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/13/824/018
English: Nemdatine 5 mg film-coated tablets
Slovenian: Nemdatine 5 mg filmsko obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FORTREATMENT INITIATION PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI ŠKATLA ZA PLASTENKE
English: NAME OF THE MEDICINAL PRODUCT Nemdatine 20 mg tablets memantine hydrochloride
Slovenian: IME ZDRAVILA Nemdatine 20 mg tablete memantinijev klorid
English: 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.
Slovenian: 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.
English: Gastrointestinal disorders
Slovenian: memantinijev klorid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/019
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/824/019
English: 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.
Slovenian: 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.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/020
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/824/020
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Slovenian: Imetnik dovoljenja za promet Actavis Group PTC ehf.
English: Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Slovenian: Obloga tablete: (Opadry II rožnato 33G240000): hipromeloza 6cP, titanov dioksid (E171), laktoza monohidrat, makrogol 3350, triacetin in rdeči ter rumeni železov oksid