FrancophonIA/ELRC3.0 huggingface dataset:
English: Day 22, 23, 24, 25, 26, 27, 28
Danish: 4. uge Dag 22, 23, 24, 25, 26, 27, 28
English: How to take Nemdatine
Danish: Sådan skal De tage Nemdatine
English: 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)).
Danish: Hos patienter behandlet med memantin sås statistisk signifikant bedre effekt på de primære effektmål end hos patienter behandlet med placebo: Alzheimer´s disease assessment scale (ADAS-cog) (p=0,003) og CIBIC-plus (p=0,004) i uge 24 (last observation carried forward (LOCF)).
English: From the fourth week on, the usual dose is 20 mg memantine once a day.
Danish: Fra og med den fjerde uge er den normale dosis 20 mg memantin en gang dagligt.
English: What Nemdatine contains - The active substance is memantine hydrochloride.
Danish: Nemdatine indeholder - Det aktive stof er memantinhydrochlorid.
English: Always take this medicine exactly as your doctor has told you.
Danish: Tag altid Nemdatine nøjagtigt efter lægens anvisning.
English: Manufacturer Actavis hf.
Danish: Fremstiller Actavis hf.
English: The recommended maintenance dose is 20 mg per day.
Danish: Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
English: This leaflet was last revised in {MM/YYYY}
Danish: Denne indlægsseddel blev senest ændret {MM/YYYY} Andre informationskilder
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/824/001 42 film-coated tablets
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/001 42 filmovertrukne tabletter
English: Some factors that may raise urine pH (see section 5.2 ‘Elimination') may necessitate careful monitoring of the patient.
Danish: Visse faktorer, der kan forhøje urin-pH (se ‘Elimination' i pkt.
English: 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.
Danish: På baggrund af de kliniske studier er den anbefalede dosis til patienter over 65 år 20 mg dagligt (fire 5 mg filmovertrukne tabletter (20 mg), to 10 mg filmovertrukne tabletter (20 mg) eller en 20 mg filmovertrukket tablet (20 mg) en gang dagligt), som beskrevet ovenfor.
English: At the beginning of treatment you will start by using Nemdatine 5 mg film-coated tablets once a day.
Danish: Behandlingen startes med en Nemdatine 5 mg filmovertrukket tablet én gang dagligt.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL TABLETTER - BEHANDLINGSSTARTPAKKE - 4-UGERS BEHANDLINGSPLAN
English: A pivotal monotherapy study of memantine in the treatment of mild to moderate Alzheimer's disease (MMSE total scores at baseline of 10 to 22) included 403 patients.
Danish: I en væsentlig monoterapiundersøgelse med memantin til behandling af mild til moderat Alzheimers sygdom (med en samlet MMSE score ved baseline på 10 til 22) indgik 403 patienter.
English: HDPE bottle: 100 film-coated tablets.
Danish: HDPE-tabletbeholder: 100 filmovertrukne tabletter.
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.
Danish: I en væsentlig monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med en samlet mini mental state examination (MMSE) score ved baseline på 314), indgik i alt 252 ambulante patienter.
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Danish: In vitroer der ikke fundet nogen cytokrom P450-metabolisme.
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.
Danish: Denne øges til to tabletter en gang dagligt (1 x 10 mg) i den anden uge og til tre tabletter en gang dagligt (1x 15 mg) i den tredje uge.
English: 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 98 film-coated tablets
Danish: 28 filmovertrukne tabletter 42 filmovertrukne tabletter 56 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Nemdatine 10 mg and 20 mg film-coated tablets:
Danish: Nemdatine 10 mg og 20 mg filmovertrukne tabletter:
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.
Danish: Denne øges til en tablet en gang dagligt (1 x 10 mg) i den anden uge og til 1½ tablet en gang dagligt (1x 15 mg) i den tredje uge.
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):
Danish: Den anbefalede startdosis er 5 mg pr. dag med trinvis dosisøgning i de første 4 uger af behandlingen, indtil den anbefalede vedligeholdelsesdosis nås, som følger:
English: Nemdatine belongs to a group of medicines known as anti-dementia medicines.
Danish: Det tilhører gruppen af medicin kaldet antidemensmedicin (medicin til behandling af demens).
English: Nemdatine contains lactose monohydrate
Danish: Nemdatine indeholder laktosemonohydrat
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.
Danish: I et studie med peroral indgivelse af 14C-memantin blev gennemsnitligt 84 % af dosis udskilt inden for
English: 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.
Danish: Patienten bør tage fire filmovertrukne 5 mg-tabletter (20 mg), to 10 mg filmovertrukne tabletter (20 mg) eller en 20 mg filmovertrukket tablet (20 mg) dagligt.
English: PHARMACEUTICAL FORM AND CONTENTS 100 tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 100 tabletter
English: Iron oxide red and yellow (E172)
Danish: Rød og gul jernoxid (E172)
English: Reykjavikurvegur 78, 200 Hafnarfjörður Iceland
Danish: Reykjavikurvegur 78, 200 Hafnarfjörður Island
English: Treatment initiation pack with 28 (4x7) film-coated tablets for a 4 week treatment schedule: 7 film-coated tablets of Nemdatine 5 mg
Danish: Behandlingsstartpakke med 28 (4x7) filmovertrukne tabletter til en 4-ugers behandlingsplan: 7 filmovertrukne Nemdatine 5 mg tabletter
English: Iron oxide yellow, red and black (E172)
Danish: Gul, rød og sort jernoxid (E172)
English: From the fourth week on, the usual dose is 4 tablets once a day (1x 20 mg).
Danish: Fra og med den fjerde uge er den normale dosis 4 tabletter en gang dagligt (1 x 20 mg).
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
Danish: Hver pakke med 28 filmovertrukne tabletter til en 4-ugers behandlingsplan indeholder: 1. uge: 7 filmovertrukne Nemdatine 5 mg tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE.
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.
Danish: Én startpakke indeholder 28 tabletter i 4 blisterkort i en lommepakning eller en multipakning med 4 blisterkort i 4 separate indre æsker og en ydre æske med 7 stk. Nemdatine 5 mg tabletter, 7 stk.
English: PHARMACEUTICAL FORM AND CONTENTS 42 film-coated tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 42 filmovertrukne tabletter
English: Elevated liver function test Not known Hepatitis
Danish: Almindelig Forhøjet leverfunktionstest Ikke kendt
English: One 15 mg tablet Week 4 and beyond One 20 mg tablet once a day
Danish: En tablet à 15 mg 4. uge og derefter En tablet à 20 mg én gang dagligt
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: The usual starting dose is half a tablet once a day (1x 5 mg) for the first week.
Danish: Den sædvanlige startdosis er en halv tablet en gang dagligt (1 x 5 mg) i den første uge.
English: The usual starting dose is one tablet once a day (1x 5 mg) for the first week.
Danish: Den normale startdosis er en tablet én gang dagligt (1 x 5 mg) i den første uge.
English: Bottle: 100 film-coated tablets.
Danish: Tabletbeholder: 100 filmovertrukne tabletter.
English: Tablet coat for 5, 10, 15 and 20 mg film-coated tablets Hypromellose 6cP
Danish: Tabletovertræk for 5, 10, 15 og 20 mg filmovertrukne tabletter Hypromellose 6cP
English: Hypertension Uncommon Venous thrombosis/thromboembolism
Danish: Almindelig Hypertension Ikke almindelig Venetrombose/tromboembolisme Luftveje, thorax og mediastinum Almindelig Dyspnø Mave-tarmkanalen
English: Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.
Danish: Nemdatine kan måske også påvirke Deres reaktionsevne, så det ikke er hensigtsmæssigt at køre bil, motorcykel eller cykel eller arbejde med værktøj og maskiner.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS FOR TREATMENT INITIATION PACK
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP BLISTER TIL TABLETTER FOR BEHANDLINGSSTARTPAKKE
English: The 20 mg tablets furthermore contain iron oxide red and yellow (E172).
Danish: 20 mg tabletterne indeholder desuden rød og gul jernoxid (E172).
English: Tablet coat for 5 mg and 10 mg film-coated tablets
Danish: Tabletovertræk for 5 mg og 10 mg filmovertrukne tabletter
English: 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.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 5, 10, 15 eller 20 mg memantinhydrochlorid svarende til 4,15, 8,31, 12,46 eller 16,62 mg memantin.
English: PHARMACEUTICAL FORM AND CONTENTS 7 film-coated tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 7 filmovertrukne tabletter
English: Week 4
Danish: 4. uge
English: INFORMATION IN BRAILLE Nemdatine 20 mg
Danish: INFORMATION I BRAILLE-SKRIFT Nemdatine 20 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
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/13/824/011 7 filmovertrukne tabletter EU/1/13/824/012 42 filmovertrukne tabletter EU/1/13/824/013 98 filmovertrukne tabletter
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.
Danish: Hver pakke indeholder 28 filmovertrukne tabletter (7 filmovertrukne tabletter på 5 mg, 7 filmovertrukne tabletter på 10 mg, 7 filmovertrukne tabletter på 15 mg og 7 filmovertrukne tabletter på 20 mg).
English: Tablet cores for 5, 10, 15 and 20 mg film-coated tablets Microcrystalline cellulose
Danish: Tabletkerner for 5, 10, 15 og 20 mg filmovertrukne tabletter Mikrokrystallinsk cellulose
English: The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172).
Danish: 15 mg tabletterne indeholder desuden gul, rød og sort jernoxid (E172).
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
Danish: EU/1/13/824/014 28 filmovertrukne tabletter EU/1/13/824/015 42 filmovertrukne tabletter EU/1/13/824/016 56 filmovertrukne tabletter EU/1/13/824/017 98 filmovertrukne tabletter
English: Hepatic impairment
Danish: Almindelig Hovedpine
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Nemdatine Fortæl det altid til lægen eller på apoteket, hvis De bruger anden medicin eller har brugt det for nylig.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Danish: Brug ikke Nemdatine efter den udløbsdato, der står på æsken og blisteret efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
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.
Danish: Patienten bør tage én filmovertrukket 5 mg-tablet (5 mg) eller en halv 10 mg filmovertrukket tablet (5 mg) dagligt i 7 dage.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE - OUTER CARTON (WITH BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 28 TABLETTER - BEHANDLINGSSTARTPAKKE - 4-UGERS BEHANDLINGSPLAN -YDRE ÆSKE (MED BLUE BOX)
English: Tablet cores for 5, 10, 15 and 20 mg film-coated tablets
Danish: Tabletkerner for 5, 10, 15 og 20 mg filmovertrukne tabletter
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.
Danish: Patienten bør tage to filmovertrukne 5 mg-tabletter (10 mg) eller en 10 mg filmovertrukket tablet (10 mg) dagligt i 7 dage.
English: Hypromellose 6cP Titanium dioxide (E171) Lactose monohydrate Macrogol 3350
Danish: Hypromellose 6cP Titandioxid (E171) Laktosemonohydrat Macrogol 3350
English: Reykjavíkurvegi 78 220 Hafnarfjörður Iceland
Danish: Reykjavíkurvegi 78 220 Hafnarfjörður Island
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)
Danish: Yderligere for 15 mg filmovertrukne tabletter Gul, rød og sort jernoxid (E172)
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
Danish: EU/1/13/824/003 28 filmovertrukne tabletter EU/1/13/824/004 30 filmovertrukne tabletter EU/1/13/824/005 42 filmovertrukne tabletter EU/1/13/824/006 50 filmovertrukne tabletter EU/1/13/824/007 56 filmovertrukne tabletter EU/1/13/824/008 60 filmovertrukne tabletter EU/1/13/824/009 98 filmovertrukne tabletter EU/1/13/824/010 112 filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 7 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE -IMMEDIATE CARTON (WITHOUT BLUE BOX)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 7 TABLETTER - BEHANDLINGSSTARTPAKKE - 4-UGERS BEHANDLINGSPLAN - INDRE ÆSKE (UDEN BLUE BOX)
English: Each film-coated tablet contains 1.42 mg lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 1,42 mg laktosemonohydrat.
English: Continue to take Nemdatine as long as it is of benefit to you.
Danish: Bliv ved med at tage Nemdatine, så længe De har gavn af det. Deres læge bør regelmæssigt vurdere Deres behandling.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De ikke smidemedicinrester i afløbet, toilettet eller skraldespanden.
English: PHARMACEUTICAL FORM AND CONTENTS 100 film-coated tablets
Danish: LÆGEMIDDELFORM OG ANTAL (PAKNINGSSTØRRELSE) 100 filmovertrukne tabletter
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE.
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
Danish: Nemdatine 5 mg filmovertrukne tabletter Nemdatine 10 mg filmovertrukne tabletter Nemdatine 15 mg filmovertrukne tabletter Nemdatine 20 mg filmovertrukne tabletter
English: INFORMATION IN BRAILLE Nemdatine 5 mg
Danish: INFORMATION I BRAILLE-SKRIFT Nemdatine 5 mg
English: The patient should take one 10 mg film-coated tablet per day (white, capsule shaped) for 7 days.
Danish: Patienten bør tage én 10 mg filmovertrukket tablet pr. dag (hvid, kapselformet) i 7 dage.
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.
Danish: Nemdatine 20 mg filmovertrukne tabletter (tabletter) er mørkt rosa, ovale, bikonvekse, har en størrelse på 12,6 mm x 7 mm og er præget “M20” på den ene side.
English: Blister packs: 28, 42, 56 and 98 film-coated tablets.
Danish: Blisterpakker: 28, 42, 56 og 98 filmovertrukne tabletter.
English: INFORMATION IN BRAILLE Nemdatine 15 mg
Danish: INFORMATION I BRAILLE-SKRIFT Nemdatine 15 mg
English: Each film-coated tablet contains 1.89 mg lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 1,89 mg laktosemonohydrat.
English: of memantine, which is 0.5 μmol in human frontal cortex.
Danish: Ved en dosis af memantin på 20 mg pr. dag svarer CSF-niveauerne til ki-værdien (ki = hæmningsfaktor) for memantin, som er 0,5 μmol i den humane frontale cortex.
English: INFORMATION IN BRAILLE Nemdatine 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Nemdatine 10 mg
English: Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Danish: Tabletovertræk: Hypromellose 6cP, titandioxid (E171), laktosemonohydrat, macrogol 3350 og triacetin.
English: Week 4: 7 film-coated tablets of Nemdatine 20 mg
Danish: 4. uge: 7 filmovertrukne Nemdatine 20 mg tabletter
English: Week 2: 7 film-coated tablets of Nemdatine 10 mg
Danish: 2. uge: 7 filmovertrukne Nemdatine 10 mg tabletter
English: A meta-analysis of patients with moderate to severe Alzheimer's disease (MMSE total scores < 20) from the six phase III, placebo-controlled, 6-month studies (including monotherapy studies and studies with patients on a stable dose of acetylcholinesterase inhibitors) showed that there was a statistically significant effect in favour of memantine treatment for the cognitive, global, and functional domains.
Danish: En metaanalyse af patienter med moderat til svær Alzheimers sygdom (med en samlet MMSE score < 20) fra de seks fase III, placebokontrollerede undersøgelser af 6 måneders varighed (inkl.
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
Danish: Nemdatine 5 mg filmovertrukne tabletter Nemdatine 10 mg filmovertrukne tabletter Nemdatine 15 mg filmovertrukne tabletter Nemdatine 20 mg filmovertrukne tabletter memantinhydrochlorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) memantine hydrochloride
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER memantinhydrochlorid
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON AND WALLET FOR 28 TABLETS - TREATMENT INITIATION PACK4 WEEK TREATMENT SCHEDULE - Frontside
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE OG PAPOMSAG TIL 28 TABLETTER - BEHANDLINGSSTARTPAKKE - 4-UGERS BEHANDLINGSPLAN - Forside
English: Each film-coated tablet contains 0.95 mg lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 0,95 mg laktosemonohydrat.
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.
Danish: Nemdatine 5 mg filmovertrukne tabletter (tabletter) er hvide, ovale, bikonvekse, har en størrelse på 8 mm x 4,5 mm og er præget med “M5” på den ene side.
English: What Nemdatine is and what it is used for What you need to know before you take Nemdatine How to take Nemdatine
Danish: Det skal De vide, før De begynder at tage Nemdatine Sådan skal De tage Nemdatine Bivirkninger
English: Each film-coated tablet contains 0.47 mg lactose monohydrate.
Danish: Hver filmovertrukket tablet indeholder 0,47 mg laktosemonohydrat.
English: Tablet coat for 20 mg film-coated tablets
Danish: Tabletovertræk for 20 mg filmovertrukne tabletter
English: Nemdatine 20 mg film-coated tablets:
Danish: Nemdatine 20 mg filmovertrukne tabletter:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 10 mg memantinhydrochlorid svarende til 8,31 mg memantin.
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.
Danish: Nemdatine 15 mg filmovertrukne tabletter (tabletter) er orange, ovale, bikonvekse, har en størrelse på 11,4 mm x 6,4 mm og er præget “M15” på den ene side.
English: Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.
Danish: Tabletovertræk (Opadry II White 33G28435): Hypromellose 6cP, titandioxid (E171), laktosemonohydrat, macrogol 3350 og triacetin.
English: Lactose monohydrate Titanium dioxide (E171) Macrogol 3350
Danish: Hypromellose 6cP Laktosemonohydrat Titandioxid (E171) Macrogol 3350
English: The patient should take one 20 mg film-coated tablet per day (dark pink, oval shaped) for 7 days.
Danish: Patienten bør tage én 20 mg filmovertrukket tablet pr. dag (mørkt rosa, oval) i 7 dage.
English: The patient should take one 15 mg film-coated tablet per day (orange, oval shaped) for 7 days.
Danish: Patienten bør tage én 15 mg filmovertrukket tablet pr. dag (orange, oval) i 7 dage.
English: Week 3: 7 film-coated tablets of Nemdatine 15 mg
Danish: 3. uge: 7 filmovertrukne Nemdatine 15 mg tabletter
English: Three 5 mg tablets Week 4 and beyond Four 5 mg tablets once a day
Danish: 4. uge og derefter Fire tabletter à 5 mg én gang dagligt
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De vil have yderligere oplysninger om Nemdatine, skal De henvende Dem til den lokale repræsentant:
English: 7 film-coated tablets of Nemdatine 20 mg
Danish: 7 filmovertrukne Nemdatine 20 mg tabletter
English: Nemdatine 20 mg film-coated tablets
Danish: Nemdatine 20 mg filmovertrukne tabletter
English: Uncommon Cardiac failure
Danish: Ikke almindelig Hjertesvigt
English: Seizures
Danish: Dosistitrering
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL TABLETBEHOLDER
English: Blister packs: 42 and 98 film-coated tablets.
Danish: Blisterpakker: 42 og 98 filmovertrukne tabletter.
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).
Danish: Tabletovertræk (Opadry II Orange 33G230001): Hypromellose 6cP, titandioxid (E171), laktosemonohydrat, macrogol 3350, triacetin og gul, rød og sort jernoxid (E172).
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.
Danish: Nemdatine 10 mg filmovertrukne tabletter (tabletter) er hvide, kapselformede, bikonvekse, har en størrelse på 9,8 mm x 4,9 mm og delekærv og er præget “M 10” på siden med delekærven.
English: Uncommon Fatigue
Danish: Ikke almindelig Udmattelse
English: Tablet coat for 15 mg film-coated tablets
Danish: Tabletovertræk for 15 mg filmovertrukne tabletter
English: One and a half 10 mg tablets Week 4 and beyond Two 10 mg tablets once a day
Danish: 4. uge og derefter To tabletter à 10 mg én gang dagligt
English: Pack sizes Blister packs: 7, 42 and 98 film-coated tablets.
Danish: Pakningsstørrelser Blisterpakker: 7, 42 og 98 filmovertrukne tabletter.