FrancophonIA/ELRC3.0 huggingface dataset:
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som er fastsat i artikel 107c, stk. 7, i direktiv 2001/83/ EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: EL-69300 Rodopi Greece
Danish: EL-69300 Rodopi Grækenland
English: Polyvinyl alcohol Macrogol 3350
Danish: Polyvinylalkohol Macrogol 3350
English: The same may be true for ketamine and dextromethorphan (see also section 4.4).
Danish: Det samme kan gøre sig gældende for ketamin og dextromethorfan (se også under punkt 4.4).
English: • The other ingredients are:
Danish: Øvrige indholdsstoffer:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres din læge eller apoteket til råds, før De tager dette lægemiddel.
English: Both active substances are chemically related NMDA-antagonists.
Danish: Begge aktive substancer er kemisk beslægtede NMDA-antagonister.
English: Children and adolescents Memantine LEK is not recommended for children and adolescents under the age of 18 years.
Danish: Børn og teenagere Memantine LEK anbefales ikke til børn og unge under 18 år.
English: 2Isolated cases reported in post-marketing experience.
Danish: 2Enkeltstående tilfælde rapporteret efter markedsføringen.
English: There are no or limited amount of data from the use of memantine in pregnant women.
Danish: Der er ingen eller begrænset mængde data fra brugen af memantin hos gravide kvinder.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem, anført i bilag V.
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Danish: Studier hos frivillige forsøgspersoner har vist en lineær farmakokinetik i doser mellem 10 og 40 mg.
English: Common Not known
Danish: Ikke kendt
English: • In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
Danish: • Efter markedsføringen er der rapporteret enkeltstående tilfælde af stigninger i international normalized ratio (INR) hos patienter i samtidig behandling med warfarin.
English: If you forget to take Memantine LEK - If you find you have forgotten to take your dose of Memantine LEK, wait and take your next dose at the usual time.
Danish: Hvis De har glemt at tage Memantine LEK - Hvis De har glemt at tage Deres dosis af Memantine LEK, skal De vente og tage Deres næste dosis på det sædvanlige tidspunkt.
English: Memantine LEK is for oral use.
Danish: Memantine LEK er til oral brug.
English: (≥1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥1/10,000 to <1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er opdelt efter organklassesystem med følgende betegnelser: Meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100), sjælden (≥1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: These active substances act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Danish: Disse aktive substancer påvirker det samme receptorsystem som memantin, og derfor kan bivirkninger (hovedsageligt relaterede til centralnervesystemet (CNS)) indtræffe hyppigere og være mere udtalte (se også under punkt 4.5).
English: 1Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Danish: 1Hallucinationer er hovedsageligt observeret hos patienter med svær Alzheimers sygdom.
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).
Danish: I det alvorligste tilfælde af overdosering overlevede patienten en oral indtagelse af i alt 2.000 mg memantin med virkninger på centralnervesystemet (koma i 10 dage og senere diplopi og agitation).
English: If you take more Memantine LEK than you should - In general, taking too much Memantine LEK should not result in any harm to you.
Danish: Hvis De har taget for meget Memantine LEK - Generelt bør indtagelse af for meget Memantine LEK ikke være skadeligt for Dem.
English: In particular, Memantine LEK may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Danish: I særdeleshed kan Memantine LEK ændre virkningen af følgende medicin, og lægen kan derfor være nødt til at ændre doseringen:
English: Verovškova 57, 1526 Ljubljana Slovenia
Danish: Verovškova 57, 1526 Ljubljana Slovenien
English: Pharmacotherapeutic group: Psychoanaleptics; Other Anti-dementia drugs, ATC code: N06DX01.
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika; andet antidemenspræparat, ATC-kode: N06DX01.
English: • Other active substances such as cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine that use the same renal cationic transport system as amantadine may also possibly interact with memantine leading to a potential risk of increased plasma levels.
Danish: • Andre aktive stoffer såsom cimetidin, ranitidin, procainamid, quinidin, quinin og nikotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer.
English: • Periodic safety update reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine LEK reassessed by your doctor on a regular basis.
Danish: I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Memantine LEK skal regelmæssigt vurderes af Deres læge.
English: In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations.
Danish: I kortidsstudier på rotter har memantin ligesom andre NMDA-antagonister kun induceret neuronal vakuolisering og nekrose (Olney-læsioner) efter doser, der medfører meget høje maksimale serumkoncentrationer.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IFAPPROPRIATE
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE AF UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
English: In volunteers with normal kidney function, total clearance (Cltot) amounts to 170 mL/min/1.73 m² and part of total renal clearance is achieved by tubular secretion.
Danish: Hos frivillige forsøgspersoner med normal nyrefunktion er den totale clearance (Cltot) 170 ml/min/1,73 m2, og en del af den totale renale clearance opnås ved tubulær sekretion.
English: • There may be a possibility of reduced serum level of hydrochlorothiazide (HCT) when memantine is coadministered with HCT or any combination with HCT.
Danish: • Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT.
English: The most frequently occurring adverse reactions with a higher incidence in the memantine group than in the placebo group were dizziness (6.3% vs 5.6%, respectively), headache (5.2% vs 3.9%), constipation (4.6% vs 2.6%), somnolence (3.4% vs 2.2%) and hypertension (4.1% vs 2.8%).
Danish: De bivirkninger, der forekom oftest og med en højere incidens i memantin-gruppen end i placebogruppen, var svimmelhed (hhv. 6,3% vs. 5,6%), hovedpine (5,2% vs. 3,9%), forstoppelse (4,6% vs. 2,6%), sløvhed (søvntrang) (3,4% vs. 2,2%) og hypertension (4,1% vs. 2,8%).
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse events of memantine were noted on fertility.
Danish: Memantin var ikke teratogent hos rotter og kaniner, selv ved maternale toksiske doser, og der blev ikke noteret nogen bivirkninger af memantin i forbindelse med fertilitet.
English: amantadine, ketamine, dextromethorphan dantrolene, baclofen cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine hydrochlorothiazide (or any combination with hydrochlorothiazide) anticholinergics (substances generally used to treat movement disorders or intestinal cramps) anticonvulsants (substances used to prevent and relieve seizures) barbiturates (substances generally used to induce sleep) dopaminergic agonists (substances such as L-dopa, bromocriptine) neuroleptics (substances used in the treatment of mental disorders) oral anticoagulants
Danish: amantadin, ketamin, dextromethorfan dantrolen, baklofen cimetidin, ranitidin, procainamid, quinidin, quinin, nikotin hydrochlorothiazid (eller en hvilken som helst kombination med hydrochlorothiazid antikolinergika (stoffer, der generelt bruges til behandling af lidelser i bevægeapparatet eller tarmkramper) antikonvulsiva (stoffer, der bruges til at forebygge og afhjælpe krampeanfald) barbiturater (stoffer, der generelt bruges som sovemidler) dopaminerge agonister (stoffer såsom L-dopa, bromokriptin) neuroleptika (stoffer, der bruges til behandling af sindslidelser) orale antikoagulantia
English: - If you take a large overdose of Memantine LEK, contact your doctor or get medical advice, as you may need medical attention.
Danish: - Hvis De tager en stor overdosis af Memantine LEK, skal De søge læge, da De kan have behov for medicinsk behandling.
English: Memantine did not inhibit CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxygenase, epoxide hydrolase or sulphation in vitro.
Danish: Memantin hæmmede ikke CYP 1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin indeholdende monoxygenase, epoxid hydrolase eller sulfatering in vitro.
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxy-memantine, and 1-nitroso-3,5-dimethyl-adamantane.
Danish: Humane hovedmetabolitter er N-3,5-dimethyl-gludantan, den isomeriske blanding af 4- og 6-hydroxy-memantin og 1-nitroso-3,5-dimethyl-adamantan.
English: Concomitant administration of memantine with the antispasmodic medicinal products, dantrolene or baclofen, can modify their effects and a dose adjustment may be necessary.
Danish: Samtidig administration af memantin og antispastika, dantrolen eller baklofen, kan modificere disses virkninger, og en dosisjustering kan være nødvendig.
English: The score line is not intended for breaking the tablet.
Danish: Delekærven er ikke at kunne brække tabletten.
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:
Danish: Den anbefalede startdosis er 5 mg dagligt, som gradvist forøges, som nedenfor angivet, over de første 4 ugers behandling, for at opnå den anbefalede vedligeholdelsesdosis:
English: Pharmathen International S.A. Industrial Park Sapes Rodopi Prefecture Block No 5
Danish: Industrial Park Sapes Rodopi Prefecture Block No 5
English: Memantine LEK is not recommended for use in children and adolescents below 18 years due to a lack of data on safety and efficacy.
Danish: Memantine LEK bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: Titanium dioxide (E 171) Talc
Danish: Titandioxid (E 171) Talcum
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).
Danish: Når patienterne havde fået konstateret en samtidig forværring i alle tre domæner, viste resultaterne en statistisk signifikant effekt af memantin hvad angår forebyggelse af forværring, eftersom dobbelt så mange placebobehandlede patienter som memantinbehandlede patienter frembød forværring i alle tre domæner (21% vs. 11%, p<0,0001).
English: If you go into hospital, let your doctor know that you are taking Memantine LEK.
Danish: Hvis De kommer på hospitalet, skal De sige til lægen, at De får Memantine LEK.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 April 2013
Danish: Dato for første markedsføringstilladelse: 22 April 2013 Dato for seneste fornyelse:
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken og blisteret efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The use of medicinal products called amantadine (for the treatment of Parkinson's disease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.
Danish: Samtidig brug af medicin ved navn amantadin (til behandling af Parkinsons sygdom), ketamin (et middel, der anvendes til bedøvelse), dextromethorfan (anvendes generelt til behandling af hoste) og andre NMDA-antagonister bør undgås.
English: This is increased to one tablet of 10 mg once a day (1x 10 mg) in the second week and to 1 and a half tablet of 10 mg once a day in the third week.
Danish: Denne øges til en tablet på 10 mg en gang om dagen (1 x 10 mg) i den anden uge og til 1 og en halv tablet på 10 mg en gang om dagen i den tredje uge.
English: Memantine LEK should be administered once a day and should be taken at the same time every day.
Danish: Memantine LEK skal tages én gang dagligt på samme tidspunkt hver dag.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis De har yderligere spørgsmål angående anvendelsen af dette produkt, skal De spørge lægen eller på apoteket.
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/mL (0.5 - 1 μmol) with large interindividual variations.
Danish: Daglige doser på 20 mg giver steady-state-plasmakoncentrationer for memantin på mellem 70 og 150 ng/ml (0,5 - 1 µmol) med store interindividuelle variationer.
English: Dose in patients with impaired kidney function
Danish: Dosis til patienter med nedsat nyrefunktion
English: From the fourth week on, the usual dose is 2 tablets once a day (1 x 20 mg).
Danish: Fra den fjerde uge er den normale dosis 2 tabletter en gang om dagen (1 x 20 mg).
English: When daily doses of 5 to 30 mg were administered, a mean cerebrospinal fluid (CSF)/serum ratio of 0.52 was calculated.
Danish: Ved indgivelse af daglige doser på 5 til 30 mg udregnedes en gennemsnitlig (cerebrospinalvæske) CSF/serumværdi på 0,52.
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.
Danish: Brug af Memantine LEK sammen med mad og drikke De bør informere Deres læge, hvis De for nylig har ændret eller har i sinde at ændre Deres kost væsentligt (f.eks. fra en normal kost til en streng vegetarisk kost), eller hvis De lider at tilstande med renal tubulær acidose (RTA, overskud af syredannende stoffer i blodet på grund af nedsat nyrefunktion) eller alvorlige infektioner i urinvejene (som urinen udskilles igennem), da Deres læge i så fald kan være nødt til at justere dosis af Deres medicin.
English: Memantine LEK acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Danish: Memantine LEK indvirker på disse NMDAreceptorer og forbedrer overførslen af nervesignaler samt hukommelsen.
English: In post-marketing experience these reactions have been reported in patients treated with memantine.
Danish: Efter markedsføringen er disse reaktioner rapporteret hos patienter i behandling med memantin.
English: Furthermore, Memantine LEK has minor or moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Danish: Derudover har Memantine LEK mindre eller moderat indflydelse på evnen til at føre motorkøretøj eller betjene en maskine, hvorfor ambulante patienter skal gøres opmærksom på at være særligt forsigtige.
English: These events have been reported in patients treated with memantine.
Danish: Disse følger er blevet set hos patienter i behandling med memantin.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pharmathen S.A.
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Pharmathen S.A.
English: The recommended dose of Memantine LEK for adults and elderly patients is 20 mg once a day.
Danish: DosisDen anbefalede dosis af Memantine LEK til voksne og til ældre patienter er 20 mg en gang om dagen.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE EMBALLAGE
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis De oplever bivirkninger bør De tale med Deres læge eller apoteket.
English: Memantine LEK contains the active substance memantine hydrochloride.
Danish: Memantine LEK indeholder det aktive stof memantinhydrochlorid.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki= inhibition constant) 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: The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory.
Danish: Hjernen indeholder såkaldte NMDA-receptorer, der er involveret i overførslen af nervesignaler, som er vigtige for indlæring og hukommelse.
English: Also, Memantine LEK may change your reactivity, making driving or operating machinery inappropriate.
Danish: Derudover kan Memantine LEK påvirke Deres reaktionsevne, så det ikke er hensigtsmæssigt at køre bil eller betjene maskiner.
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Danish: Vedligeholdelsesdosis: Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
English: • if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Memantine LEK - hvis De er allergisk over for memantinhydrochlorid eller et af de øvrige indholdsstoffer i lægemiddel (angivet i punkt 6).
English: The usual starting dose is half a tablet of 10 mg once a day (1x 5 mg) for the first week.
Danish: Den normale startdosis er en halv tablet på 10 mg en gang om dagen (1x 5 mg) i den første uge.
English: What is Memantine LEK used for Memantine LEK is used for the treatment of adult patients with moderate to severe Alzheimer's disease.
Danish: Memantine LEK anvendes til behandling af voksne patienter med moderat til svær Alzheimers sygdom.
English: Magyarország Sandoz Hungária Kft. Tel.: + 36 1 430 2896
Danish: Sandoz Hungária Kft. Tel.: + 36 1 430 2896
English: What you need to know before you take Memantine LEK
Danish: Det skal De vide, før De begynder at tage Memantine lek
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with memantine and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with memantine did not differ from those with placebo; the adverse reactions were usually mild to moderate in severity.
Danish: I kliniske forsøg med 1.784 patienter i behandling med memantin for mild til svær demens og med 1.595 patienter i placebobehandling adskilte den generelle incidensrate for biverkninger med memantin sig ikke fra placebobehandlingen, og bivirkningerne var som regel milde til moderate.
English: No adverse reactions of memantine were noted on male and female fertility.
Danish: Ingen bivirkninger af memantin blev noteret i forbindelse med mænds og kvinders fertilitet.
English: Memantine LEK belongs to a group of medicines known as anti-dementia medicines.
Danish: Memantine LEK tilhører gruppen af medicin kaldet antidemensmedicin (medicin til behandling af demens).
English: 15351 Pallini, Attiki Greece
Danish: 15351 Pallini, Attiki Grækenland
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.
Danish: I en anden monoterapiundersøgelse med mild til moderat Alzheimers sygdom blev i alt 470 patienter randomiseret (samlet MMSE-score ved baseline 11 - 23).
English: INFORMATION IN BRAILLE Memantine LEK 10 mg
Danish: INFORMATION I BRAILLE-SKRIFT Memantine LEK 10 mg
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan De skal bortskaffemedicinrester.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske lægemiddelagenturs (EMAs) hjemmeside http://www.ema.europa.eu.
English: Women taking Memantine LEK should not breast-feed.
Danish: Kvinder, der tager Memantine LEK, bør ikke amme.
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.
Danish: Følgende bivirkninger i nedenstående tabel er indrapporteret i forbindelse med kliniske forsøg med memantin og efter markedsføring.
English: INFORMATION IN BRAILLE Memantine LEK 20 mg
Danish: INFORMATION I BRAILLE-SKRIFT Memantine LEK 20 mg
English: Memantine LEK should be administered orally once a day.
Danish: Memantine LEK bør indtages gennem munden én gang dagligt.
English: In patients with mildly impaired renal function (creatinine clearance 50 - 80 mL/min) no dose adjustment is required.
Danish: Hos patienter med let nedsat nyrefunktion (kreatinin-clearance 50-80 ml/min) er dosisjustering ikke påkrævet.
English: What Memantine LEK contains
Danish: Memantine LEK indeholder:
English: Memantine LEK belongs to a group of medicines called NMDA-receptor antagonists.
Danish: Memantine LEK hører til en gruppe af medicin kaldet N-methyl-D-aspartat (NMDA)-receptor-antagonister.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within 20
Danish: I et studie med peroral indgivelse af 14C-memantin blev gennemsnitligt 84% af dosis udskilt inden for 20 dage, mere end 99% blev udskilt via nyrerne.
English: In patients with moderate renal impairment (creatinine clearance 30 - 49 mL/min) daily dose should be 10 mg per day.
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatinin-clearance 30-49 ml/min) er daglig dosis 10 mg pr. dag.