FrancophonIA/ELRC3.0 huggingface dataset:
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21 % vs. 11 %, p < 0.0001).
Icelandic: á öllum þremur sviðum kom fram hjá sjúklingum, sýndu niðurstöður tölfræðilega marktæk áhrif memantíns í að draga úr versnun, þar sem tvisvar sinnum fleiri sjúklingar sem meðhöndlaðir voru með lyfleysu en þeir sem fengu memantín, sýndu versnun á öllum sviðunum þremur (21 % á móti 11 %, p < 0,0001).
English: 1 Hallucinations have mainly been observed in patients with severe Alzheimer´s disease.
Icelandic: Höfuðverkur Þreyta 1 Ofskynjanir hafa aðallega komið fram hjá sjúklingum með alvarlegan Alzheimers-sjúkdóm.
English: 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.
Icelandic: Ráðlögðum skammti af Nemdatine sem nemur 20 mg á sólarhring er náð með því að auka smátt og smátt skammtinn af Nemdatine á fyrstu 3 vikum meðferðar.
English: 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
Icelandic: 56 filmuhúðaðar töflur 60 filmuhúðaðar töflur 98 filmuhúðaðar töflur 112 filmuhúðaðar töflur
English: Nemdatine 20 mg Week 4
Icelandic: Nemdatine 20 mg Vika 4
English: Week 1
Icelandic: Ofskynjanir1
English: In single-dose pharmacokinetic (PK) studies in young healthy subjects, no relevant active substanceactive substance interaction of memantine with glyburide/metformin or donepezil was observed.
Icelandic: Í einskammta lyfjahvarfarannsóknum hjá ungum, heilbrigðum einstaklingum komu ekki fram neinar milliverkanir sem máli skipta milli virku efnanna memantíns og glýbúríðs/metformíns eða dónezepíls.
English: Nemdatine 10 mg and 20 mg film-coated tablets:
Icelandic: Nemdatine 10 mg og 20 mg filmuhúðaðar töflur:
English: What is Nemdatine used for Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Icelandic: Nemdatine er notað við meðferð fullorðinna sjúklinga sem haldnir eru miðlungs til alvarlegum Alzheimers-sjúkdómi.
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.
Icelandic: Skammturinn er aukinn í tvær töflu einu sinni á sólarhring (1x 10 mg) aðra vikuna og í þrjár töflur einu sinni á sólarhring (1x 15 mg) þriðju vikuna.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Icelandic: LYFJAFORM OG INNIHALD 100 töflur
English: In a study using orally administered 14C-memantine, a mean of 84 % of the dose was recovered within 20 days, more than 99 % being excreted renally.
Icelandic: Í rannsókn þar sem notað var geislavirkt 14C-memantín til inntöku, skildist að meðaltali 84 %
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.
Icelandic: Til að draga úr líkum á aukaverkunum er skammtur hækkaður um 5 mg á viku fyrstu þrjár vikurnar upp að viðhaldsskammti sem hér segir.
English: Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Icelandic: Skammtur hjá sjúklingum með skerta nýrnastarfsemi Sé sjúklingur með skerta nýrnastarfsemi ákveður læknirinn hvaða skammtur hæfir best.
English: If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme.
Icelandic: 7 daga meðferð má auka skammtinn í allt að 20 mg/sólarhring samkvæmt venjulegu skammtaaðlögunarskema.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.
Icelandic: Sé svo þarf að fylgjast grannt með meðferðinni og læknirinn þarf að meta reglulega klínískan ávinning af töku Nemdatine.
English: From the fourth week on, the usual dose is 20 mg memantine once a day.
Icelandic: Frá fjórðu viku er skammturinn yfirleitt 20 mg af memantíni einu sinni á sólarhring.
English: The 20 mg tablets furthermore contain iron oxide red and yellow (E172).
Icelandic: 20 mg töflurnar innihalda einnig rautt og gult járnoxíð (E172).
English: Nemdatine contains lactose monohydrate
Icelandic: Nemdatine inniheldur laktósaeinhýdrat
English: How to take Nemdatine
Icelandic: Ef gleymist að taka Nemdatine
English: Each pack with 28 film-coated tablets for a 4 week treatment schedule contains: Week 1: 7 film-coated tablets of Nemdatine 5 mg
Icelandic: Hver pakkning með 28 filmuhúðuðum töflum fyrir 4 vikna meðferðaráætlun inniheldur: 7 filmuhúðaðar töflur af Nemdatine 5 mg.
English: The usual starting dose is 5 mg memantine once a day for the first week.
Icelandic: Venjan er að byrja á 5 mg af memantíni einu sinni á sólarhring fyrstu vikuna.
English: 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):
Icelandic: Ráðlagður upphafsskammtur er 5 mg á sólarhring, aukinn skref fyrir skref á fyrstu 4 vikum meðferðar þar til hann nær ráðlögðum viðhaldsskammti sem hér segir.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Icelandic: Klínískar rannsóknir benda til þess að ráðlagður skammtur fyrir sjúklinga yfir 65 ára aldri sé 20 mg á sólarhring eins og lýst var hér að framan.
English: Memantine has an absolute bioavailability of approximately 100 %.
Icelandic: Aðgengi memantíns er u.þ.b. 100 %.
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Icelandic: Rétt er að láta lækni vita ef ætlunin er að breyta verulega um mataræði eða ef því hefur verið breytt nýlega (t.d. ef venjulegu mataræði er hætt og tekið upp strangt jurtafæði) eða ef þú þjáist af nýrnapíplublóðsýringu
English: The recommended daily dose is 20 mg once a day.
Icelandic: Ráðlagður dagsskammtur er 20 mg einu sinni á sólarhring.
English: PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets
Icelandic: LYFJAFORM OG INNIHALD 42 filmuhúðaðar töflur
English: One 15 mg tablet Week 4 and beyond One 20 mg tablet once a day
Icelandic: Ein 15 mg tafla Vika 4 og eftir það Ein 20 mg tafla einu sinni á sólarhring
English: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg film-coated tablets memantine hydrochloride
Icelandic: Nemdatine 5 mg Nemdatine 10 mg Nemdatine 15 mg Nemdatine 20 mg filmuhúðaðar töflur memantínhýdróklóríð
English: Balance disorders Uncommon Gait abnormal Very rare
Icelandic: Sýkingar af völdum sýkla og sníkjudýra Sjaldgæfar
English: Each film-coated tablet contains 1.42 mg lactose monohydrate.
Icelandic: Hver filmuhúðuð tafla inniheldur 1,42 mg af laktósaeinhýdrati.
English: Very Rare (affects less than 1 user in 10,000) - Seizures
Icelandic: Koma örsjaldan fyrir (koma fyrir hjá færri en 1 af hverjum 10.000 notendum):
English: - The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate.
Icelandic: Örkristallaður sellulósi, krospóvídón Týpa A, talkúm og magnesíumsterat.
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.
Icelandic: Ein pakkning fyrir upphafsmeðferð inniheldur 28 töflur í 4 þynnum í veski eða fjölpakkningu með 4 þynnum í 4 aðskildum öskjum og einni ytri öskju með 7 Nemdatine 5 mg töflum, 7
English: Blister packs: 28, 42, 56 and 98 film-coated tablets.
Icelandic: 28, 42, 56 og 98 filmuhúðaðar töflur.
English: Two 5 mg tablets
Icelandic: Tvær 5 mg töflur
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
Icelandic: EU/1/13/824/003 28 filmuhúðaðar töflur EU/1/13/824/004 30 filmuhúðaðar töflur EU/1/13/824/005 42 filmuhúðaðar töflur EU/1/13/824/006 50 filmuhúðaðar töflur EU/1/13/824/007 56 filmuhúðaðar töflur EU/1/13/824/008 60 filmuhúðaðar töflur EU/1/13/824/009 98 filmuhúðaðar töflur EU/1/13/824/010 112 filmuhúðaðar töflur
English: See section 4.
Icelandic: Vika 4:
English: The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172).
Icelandic: 15 mg töflurnar innihalda einnig gult, rautt og svart járnoxíð (E172).
English: Pack sizes
Icelandic: Þunnupakkningar:
English: Week 4: 7 film-coated tablets of Nemdatine 20 mg
Icelandic: Vika 4: 7 filmuhúðaðar töflur af Nemdatine 20 mg.
English: 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
Icelandic: EU/1/13/824/014 28 filmuhúðaðar töflur EU/1/13/824/015 42 filmuhúðaðar töflur EU/1/13/824/016 56 filmuhúðaðar töflur EU/1/13/824/017 98 filmuhúðaðar töflur
English: Titanium dioxide (E171)
Icelandic: Hýprómellósi 6cP Laktósaeinhýdrat Títantvíoxíð (E171)
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.
Icelandic: Sjúklingurinn skal taka þrjár 5 mg filmuhúðaðar töflur (15 mg) eða eina 15 mg filmuhúðaða töflu (15 mg) á sólarhring í 7 daga.
English: The recommended maintenance dose is 20 mg per day.
Icelandic: Ráðlagður viðhaldsskammtur er 20 mg á sólarhring.
English: Tablet coat for 5 mg and 10 mg film-coated tablets
Icelandic: Töfluhúð fyrir 5 mg og 10 mg filmuhúðaðar töflur:
English: Bottle: 100 film-coated tablets.
Icelandic: 100 filmuhúðaðar töflur.
English: Administration of Nemdatine is not recommended in patients with severe hepatic impairment.
Icelandic: Ekki er mælt með lyfjagjöf Nemdatine hjá sjúklingum með alvarlega skerta lifrarstarfsemi.
English: Paediatric population No data are available.
Icelandic: Börn Engar upplýsingar liggja fyrir.
English: Blister packs: 7, 42 and 98 film-coated tablets.
Icelandic: 7, 42 og 98 filmuhúðaðar töflur.
English: Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Icelandic: Hýprómellósi 6cP Títantvíoxíð (E171) Laktósaeinhýdrat Makrógól 3350
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM ÞYNNA FYRIR TÖFLUR - PAKKNING FYRIR UPPHAFSMEÐFERÐ4 VIKNA MEÐFERÐARÁÆTLUN
English: The usual starting dose is one tablet once a day (1x 5 mg) for the first week.
Icelandic: Venjan er að byrja á einni töflu einu sinni á sólarhring (1x 5 mg) fyrstu vikuna.
English: Reykjavíkurvegi 78 220 Hafnarfjörður Iceland
Icelandic: Reykjavíkurvegi 78 220 Hafnarfjörður Ísland
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.
Icelandic: Sjúklingurinn skal taka eina 5 mg filmuhúðaða töflu (5 mg) eða hálfa 10 mg filmuhúðaða töflu (5 mg) á sólarhring í 7 daga.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM ÞYNNA FYRIR TÖFLUR
English: 7 film-coated tablets of Nemdatine 20 mg
Icelandic: 7 filmuhúðaðar töflur af Nemdatine 20 mg.
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)
Icelandic: - Þreyta, sveppasýkingar, ringlun, ofskynjanir, uppköst, óeðlilegt göngulag, hjartabilun og segamyndun í bláæðum (blóðtappamyndun/blóðsegarek)
English: Each film-coated tablet contains 0.47 mg lactose monohydrate.
Icelandic: Hver filmuhúðuð tafla inniheldur 0,47 mg af laktósaeinhýdrati.
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.
Icelandic: Sjúklingurinn skal taka tvær 5 mg filmuhúðaðar töflur (10 mg) eða eina 10 mg filmuhúðaða töflu (10 mg) á sólarhring í 7 daga.
English: The maximum daily dose is 20 mg per day.
Icelandic: Hámarks dagsskammtur er 20 mg á sólarhring.
English: Tablet cores for 5, 10, 15 and 20 mg film-coated tablets
Icelandic: Töfluhúð fyrir 5, 10, 15 og 20 mg filmuhúðaðar töflur
English: Week 2: 7 film-coated tablets of Nemdatine 10 mg
Icelandic: Vika 2: 7 filmuhúðaðar töflur af Nemdatine 10 mg.
English: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Icelandic: Hver filmuhúðuð tafla inniheldur 0,95 mg af laktósaeinhýdrati.
English: Each film-coated tablet contains 1.89 mg lactose monohydrate.
Icelandic: Hver filmuhúðuð tafla inniheldur 1,89 mg af laktósaeinhýdrati.
English: Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Icelandic: Nemdatine hefur áhrif á NMDA-viðtakana og bætir sendingu taugaboða ásamt minni.
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.
Icelandic: Lykilrannsókn á einlyfja meðferð var gerð hjá samtals 252 sjúklingum utan stofnana með miðlungs til alvarlegan Alzheimers-sjúkdóm (heildarstigatala vitræns mats (MMSE) á grunnlínu 3 - 14).
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)
Icelandic: Einnig í 15 mg filmuhúðuðum töflum Gult, rautt og svart járnoxíð (E172)
English: Nemdatine 20 mg film-coated tablets
Icelandic: Nemdatine 20 mg filmuhúðaðar töflur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 10 mg af memantínhýdróklóríði, samsvarandi 8,31 mg af memantíni.
English: Nemdatine 20 mg film-coated tablets:
Icelandic: Nemdatine 20 mg filmuhúðaðar töflur:
English: Week 3: 7 film-coated tablets of Nemdatine 15 mg
Icelandic: Vika 3: 7 filmuhúðaðar töflur af Nemdatine 15 mg.
English: This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week.
Icelandic: Skammturinn er aukinn í 10 mg af memantíni einu sinni á sólarhring aðra vikuna og í 15 mg af memantíni einu sinni á sólarhring þriðju vikuna.
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.
Icelandic: Nemdatine 20 mg filmuhúðuðu töflurnar (töflurnar) eru dökk bleikar, sporöskjulaga, tvíkúptar, 12,6 mm x 7 mm að stærð, með „M20“ grafið í aðra hliðina
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Icelandic: NAFN OG HEIMILISFANG MARKAÐSLEYFISHAFA [Merki Actavis Group PTC efh.]
English: 7 film-coated tablets of Nemdatine 15 mg
Icelandic: 7 filmuhúðaðar töflur af Nemdatine 15 mg.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 20 mg af memantínhýdróklóríði, samsvarandi 16,62 mg af memantíni.
English: 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Icelandic: 42 filmuhúðaðar töflur 98 filmuhúðaðar töflur
English: 7 film-coated tablets of Nemdatine 10 mg
Icelandic: 7 filmuhúðaðar töflur af Nemdatine 10 mg.
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
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/824/011 7 filmuhúðaðar töflur EU/1/13/824/012 42 filmuhúðaðar töflur EU/1/13/824/013
English: Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Icelandic: Töfluhúð: Hýprómellósi 6cP, títantvíoxíð (E171), laktósaeinhýdrat, makrógól 3350 og tríacetín.
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.
Icelandic: Nemdatine 10 mg filmuhúðuðu töflurnar (töflurnar) eru hvítar, hylkjalaga, tvíkúptar, 9,8 mm x 4,9 mm að stærð, með deiliskoru og merkingunni „M 10“ á sömu hlið.
English: Blister packs: 42 and 98 film-coated tablets.
Icelandic: 42 og 98 filmuhúðaðar töflur.
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.
Icelandic: Nemdatine 5 mg filmuhúðuðu töflurnar (töflurnar) eru hvítar, sporöskjulaga, tvíkúptar, 8 mm x 4,5 mm að stærð, með merkinguna„M5“ á annari hliðinni.
English: Renal impairment
Icelandic: Nemdatine inniheldur
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.
Icelandic: Nemdatine 15 mg filmuhúðuðu töflurnar (töflurnar) eru appelsínugular, sporöskjulaga, tvíkúptar, 11,4 mm x 6,4 mm að stærð, með „M15“ grafið í aðra hliðina.
English: One 5 mg tablet
Icelandic: Ein 5 mg tafla
English: Nemdatine 15 mg film-coated tablets
Icelandic: Nemdatine 15 mg filmuhúðaðar töflur
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 5 mg af memantínhýdróklóríði, samsvarandi 4,15 mg af memantíni.
English: Nemdatine 10 mg film-coated tablets
Icelandic: Nemdatine 10 mg filmuhúðaðar töflur
English: Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
Icelandic: Reykjavíkurvegur 76-78 220 Hafnarfjörður Ísland
English: Reykjavikurvegur 78, 200 Hafnarfjörður Iceland
Icelandic: Reykjavikurvegur 78, 220 Hafnarfjörður Ísland
English: Nemdatine 10 mg film-coated tablets:
Icelandic: Nemdatine 10 mg filmuhúðaðar töflur:
English: Nemdatine 15 mg film-coated tablets:
Icelandic: Nemdatine 15 mg filmuhúðaðar töflur:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 15 mg of memantine hydrochloride equivalent to 12.46 mg memantine.
Icelandic: VIRK(T) EFNI Hver tafla inniheldur 15 mg af memantínhýdróklóríði, samsvarandi 12,46 mg af memantíni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM ÞYNNA FYRIR TÖFLUR - PAKKNING FYRIR UPPHAFSMEÐFERÐ
English: STATEMENT OF ACTIVE SUBSTANCE(S) memantine hydrochloride
Icelandic: VIRK(T) EFNI memantínhýdróklóríð
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.
Icelandic: Hvít, hylkjalaga, tvíkúpt filmuhúðuð tafla, 9,8 mm x 4,9 mm að stærð, með deiliskoru og merkingunni „M 10“ á sömu hlið.
English: Nemdatine 5 mg film-coated tablets
Icelandic: Nemdatine 5 mg filmuhúðaðar töflur
English: NAME OF THE MARKETING AUTHORISATION HOLDER [Actavis Group PTC ehf.
Icelandic: NAFN MARKAÐSLEYFISHAFA [Merki Actavis Group PTC ehf.]
English: Nemdatine 5 mg film-coated tablets:
Icelandic: Nemdatine 5 mg filmuhúðaðar töflur:
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.
Icelandic: Appelsínugul, sporöskjulaga, tvíkúpt filmuhúðuð tafla, 11,4 mm x 6,4 mm að stærð, með „M15“ grafið í aðra hliðina.
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).
Icelandic: Hýprómellósi 6cP, títantvíoxíð (E171), laktósaeinhýdrat, makrógól 3350, tríacetín og gult, rautt og svart járnoxíð (E172).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
Icelandic: LÁGMARKS UPPLÝSINGAR SEM SKULU KOMA FRAM Á ÞYNNUM ÞYNNA FYRIR TÖFLUR MEÐ 28 TÖFLUM - PAKKNING FYRIR UPPHAFSMEÐFERÐ4 VIKNA MEÐFERÐARÁÆTLUN
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.
Icelandic: Dökk bleik, sporöskjulaga, tvíkúpt filmuhúðuð tafla, 12,6 mm x 7 mm að stærð, með „M20“ grafið í aðra hliðina
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.
Icelandic: Appelsínugular, sporöskjulaga, tvíkúptar filmuhúðaðar töflur, 11,4 mm x 6,4 mm að stærð, með „M15“ grafið í aðra hliðina.
English: Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).
Icelandic: Hýprómellósi 6cP, títantvíoxíð (E171), laktósaeinhýdrat, makrógól 3350, tríacetín og rautt og gult járnoxíð (E172).
English: Week 1 (day 1-7): Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.
Icelandic: Taka skal eina 5 mg töflu einu sinni á sólarhring (hvít, sporöskjulaga) í 7 sólarhringa.
English: FREQUENCY ADVERSE REACTION
Icelandic: Línulegt/ólínulegt samband
English: Other medicines and Nemdatine
Icelandic: Nemdatine og pakkningastærðir
English: Week 3 (day 15-21): Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.
Icelandic: Taka skal eina 15 mg töflu einu sinni á sólarhring (appelsínugul, sporöskjulaga) í 7 sólarhringa.
English: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking “M5”
Icelandic: Hvít, sporöskjulaga, tvíkúpt filmuhúðuð tafla, 8 mm x 4,5 mm að stærð, með merkinguna „M5“ á annari hliðinni.
English: White, oval shaped, biconvex film-coated tablets, 8 mm x 4.5 mm in size, with the marking “M5”
Icelandic: Hvítar, sporöskjulaga, tvíkúptar filmuhúðaðar töflur, 8 mm x 4,5 mm að stærð, með merkinguna„M5“ á annari hliðinni.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR BOTTLE
Icelandic: UPPLÝSINGAR SEM EIGA AÐ KOMA FRAM Á INNRI UMBÚÐUM MIÐI FYRIR GLAS
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant)
Icelandic: Við 20 mg dagskammt memantíns er magn í mænuvökva (CSF) í samræmi við ki-gildi (ki = hömlunarfasti) memantíns, sem er 0,5 μmól í framanverðum heilaberki manna.
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.
Icelandic: Dökk bleikar, sporöskjulaga, tvíkúptar filmuhúðaðar töflur, 12,6 mm x 7 mm að stærð, með „M20“ grafið í aðra hliðina
English: Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day
Icelandic: Vika 4 og eftir það Fjórar 5 mg töflur á sólarhring
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/021
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/824/021
English: Nemdatine 20 mg film-coated tablets memantine hydrochloride
Icelandic: Nemdatine 20 mg filmuhúðaðar töflur memantínhýdróklóríð
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/018
Icelandic: MARKAÐSLEYFISNÚMER EU/1/13/824/018
English: The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days.
Icelandic: Sjúklingurinn skal taka eina 10 mg filmuhúðaða töflu á sólarhring í 7 daga.
English: Tablet coat for 20 mg film-coated tablets
Icelandic: Töfluhúð fyrir 20 mg filmuhúðaðar töflur: