FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Marixino: - if you are allergic to memantine or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Marixino: - hvis du er allergisk over for memantin eller et af de øvrige indholdsstoffer i Marixino (angivet i punkt 6).
English: In man, about 80 % of the circulating memantine-related material is present as the parent compound.
Danish: Hos mennesket er ca. 80% af det cirkulerende memantin-relaterede materiale til stede som modersubstans.
English: If you take more Marixino than you should - In general, taking too much Marixino should not result in any harm to you.
Danish: Hvis du har taget for meget Marixino - Generelt burde indtagelse af for meget Marixino ikke være skadeligt for dig.
English: None of these metabolites exhibit NMDAantagonistic activity.
Danish: Ingen af disse metabolitter udviser NMDA-antagonistisk aktivitet.
English: C-memantine, a mean of 84 % of the dose was recovered within 20 days, more than 99 % being excreted renally.
Danish: C-memantin blev gennemsnitligt 84% af dosis udskilt inden for 20 dage, mere end 99% blev udskilt via nyrerne.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Marixino reassessed by your doctor on a regular basis.
Danish: I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Marixino skal regelmæssigt vurderes af din læge.
English: There was no evidence of any carcinogenicity in life long studies in mice and rats.
Danish: Der var ingen tegn på karcinogenicitet i livstidsstudier af rotter og mus.
English: Marixino should be administered orally once a day and should be taken at the same time every day.
Danish: Marixino gives oralt én gang om dagen og bør indtages på samme tidspunkt hver dag.
English: There are no or limited amount of data from the use of memantine in pregnant women.
Danish: Der er ingen eller begrænset mængde af data fra anvendelse af memantin til gravide kvinder.
English: Marixino belongs to a group of medicines called NMDA-receptor antagonists.
Danish: Marixino hører til en gruppe af lægemidler kaldet NMDA-receptor-antagonister.
English: Hallucinations have mainly been observed in patients with severe Alzheimer's disease.
Danish: Hallucinationer er hovedsageligt observeret hos patienter med svær Alzheimers sygdom.
English: The renal elimination rate of memantine under alkaline urine conditions may be reduced by a factor of 7 to 9 (see section 4.4).
Danish: Den renale eliminationsrate for memantin kan, under alkaliske urinforhold, reduceres med en faktor på 7 til 9 (se punkt 4.4).
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg.
Danish: Studier med frivillige forsøgspersoner har vist en lineær farmakokinetik i doser på mellem 10 og 40 mg.
English: - If you take a large overdose of Marixino, contact your doctor or get medical advice, as you may need medical attention.
Danish: - Hvis du tager en stor overdosis af Marixino, skal du søge læge, da du kan have behov for medicinsk behandling.
English: - Concomitant use of memantine and amantadine should be avoided, owing to the risk of pharmacotoxic psychosis.
Danish: - Samtidig brug af memantin og amantadin skal undgås på grund af risikoen for farmakotoksisk psykose.
English: Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Danish: Dyrestudier antyder en potentiel mulighed for intrauterin væksthæmning ved eksponeringsniveauer, der er identiske med eller lidt højere end human eksponering (se punkt 5.3).
English: Magnesium stearate (E470b)
Danish: Magnesiumstearat (E470b)
English: If you go into hospital, let your doctor know that you are taking Marixino.
Danish: Hvis du kommer på hospitalet, skal du sige til lægen, at du får Marixino.
English: If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
Danish: Hvis du har nedsat nyrefunktion (nyreproblemer), bør din læge nøje overvåge din nyrefunktion og om nødvendigt tilpasse memantin-dosen derefter.
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 potentiel risiko for forhøjede plasmaniveauer.
English: There is one published case report on a possible risk also for the combination of memantine and phenytoin.
Danish: Der findes en publiceret kasuistik, der også viser en mulig risiko ved kombination af memantin og phenytoin.
English: Once daily
Danish: Én gang dagligt.
English: Memantine was not teratogenic in rats and rabbits, even at maternally toxic doses, and no adverse effects of memantine were noted on fertility.
Danish: Memantin var ikke teratogent i rotter og kaniner, selv ved maternale toksiske doser, og der blev ikke noteret nogen bivirkninger af memantin i forbindelse med fertilitet.
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: Furthermore, Marixino has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Danish: Derudover har Marixino mindre til moderat indflydelse på evnen til at føre motorkøretøj eller betjene maskiner, hvorfor ambulante patienter skal gøres opmærksom på at være særlig forsigtige.
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.
Danish: - Der er mulighed for en reduktion i serumkoncentrationen af hydrochlorthiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT.
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 INR (international normalized ratio) hos patienter i samtidig behandling med warfarin.
English: Isolated cases reported in post-marketing experience.
Danish: Enkeltstående tilfælde rapporteret efter markedsføringen.
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 af rotter har memantin ligesom andre NMDA-antagonister kun induceret neuronal vakuolisering og nekrose (Olney-læsioner) efter doser, der medfører meget høje maksimale serumkoncentrationer.
English: In rats, foetal growth reduction was noted at exposure levels, which are identical or slightly higher than at human exposure.
Danish: Der blev noteret en føtal vækstreduktion i rotter ved eksponeringsniveauer, der var identiske med eller lidt højere end ved human eksponering.
English: These compounds 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 forbindelser påvirker det samme receptorsystem som memantin, og der kan derfor forekomme hyppigere og mere udtalte bivirkninger (hovedsageligt i centralnervesystemet (CNS)) (se også punkt 4.5).
English: Treatment of adult patients with moderate to severe Alzheimer's disease.
Danish: Behandling af voksne patienter med moderat til svær Alzheimers sygdom.
English: Specific ophthalmoscopic examinations in clinical studies with memantine did not disclose any ocular changes.
Danish: Specifikke oftalmoskopiske undersøgelser i kliniske studier med memantin afslørede ingen okulære forandringer.
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 N-methyl-D-aspartat (NMDA)-receptorer, der er involveret i overførslen af nervesignaler, som er vigtige for indlæring og hukommelse.
English: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven GERMANY
Danish: TAD Pharma GmbH Heinz-Lohmann-Straße 5 27472 Cuxhaven TYSKLAND
English: Concomitant administration of memantine with the antispasmodic agents, 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: In particular, Marixino may change the effects of the following medicines and their dose may need to be adjusted by your doctor: - 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: I særdeleshed kan Marixino ændre virkningen af følgende lægemidler, og lægen kan derfor være nødt til at ændre doseringen: - amantadin, ketamin, dextromethorfan - dantrolen, baklofen - cimetidin, ranitidin, procainamid, quinidin, quinin, nikotin - hydrochlorthiazid (eller en hvilken som helst kombination med hydrochlorthiazid) - 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: Very Rare (may affect up to 1 in 10,000 people): - Seizures.
Danish: Meget sjældne (kan forekomme hos op til 1 ud af 10.000 personer): Krampeanfald
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 monooxygenase, epoxid hydrolase eller sulfatering in vitro.
English: Not known (frequency cannot be estimated from the available data): - Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra forhåndenværende data): Betændelse i bugspytkirtlen, leverbetændelse (hepatitis) og psykotiske reaktioner.
English: Marixino acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Danish: Marixino indvirker på disse NMDA-receptorer og forbedrer overførslen af nervesignaler samt hukommelsen.
English: Talk to your doctor or pharmacist before taking Marixino: - if you have a history of epileptic seizures - if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Danish: Kontakt lægen eller apotekspersonalet, før du tager Marixino: - hvis du tidligere har haft epileptiske anfald - hvis du for nylig har haft blodprop i hjertet (myokardieinfarkt), eller hvis du lider af dårligt hjerte eller ukontrolleret forhøjet blodtryk (hypertension).
English: In patients with mild or moderate hepatic impaired function (Child-Pugh A and Child-Pugh B), no dose adjustment is needed.
Danish: Hos patienter med let eller moderat nedsat leverfunktion (Child-Pugh Klasse A og Child-Pugh Klasse B) er dosisjustering ikke nødvendig.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4
Danish: Den anbefalede vedligeholdelsesdosis er 20 mg én gang dagligt, som nås i begyndelsen af den 4. uge.
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 gruppen behandlet med memantin end i gruppen behandlet med placebo, 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: 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 udviste forværring i alle tre domæner (21% vs. 11%, p<0,0001).
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: Du bør informere din læge, hvis du for nylig har ændret eller har i sinde at ændre din kost væsentligt (f.eks. fra en normal kost til en streng vegetarisk kost), eller hvis du lider af 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 din læge i så fald kan være nødt til at justere dosis af din medicin.
English: Pharmacotherapeutic group: Psychoanaleptics, other anti-dementia drugs, ATC code: N06DX01.
Danish: Farmakoterapeutisk klassifikation: Psykoanaleptika, andre antidemenspræparater, ATC-kode: N06DX01.
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4- and 6-hydroxymemantine, 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: Blister (PVC/PVDC-Alu foil): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets, in a carton box.
Danish: Blister (PVC/PVDC-Alu-folie): 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 og 112 filmovertrukne tabletter i en æske.
English: See section 2 "Marixino contains lactose".
Danish: Se punkt 2 ”Marixino indeholder lactose”.
English: From Week 4 on:
Danish: Fra 4. uge:
English: The 10 mg film-coated tablet can be divided into equal doses.
Danish: De 10 mg filmovertrukne tabletter kan deles i 2 lige store doser.
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet 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 (to 10 mg filmovertrukne tabletter eller en 20 mg filmovertrukken tablet én gang dagligt), som beskrevet ovenfor.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold:
English: It 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: Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ketamine or dextromethorphan should be avoided.
Danish: Samtidig brug af N-metyl-D-aspartat (NMDA)-antagonister såsom amantadin, ketamin eller dextromethorfan bør undgås.
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: Marixino is used for the treatment of patients with moderate to severe Alzheimer's disease.
Danish: Marixino anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: To benefit from your medicine you should take it regularly every day at the same time of the day.
Danish: For at opnå størst mulig virkning af tabletterne bør de tages regelmæssigt hver dag på samme tidspunkt af dagen.
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:
Danish: For at reducere risikoen for bivirkninger opnås vedligeholdelsesdosis ved en gradvis dosisøgning på 5 mg om ugen i de første 3 uger som følger:
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 lægemidler 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: These factors include drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or a massive ingestion of alkalising gastric buffers.
Danish: Disse faktorer omfatter drastiske ændringer i kosten, f.eks. fra en kødholdig til en vegetarisk kost eller fra en massiv indtagelse af alkaliserende gastriske buffere.
English: What you need to know before you take Marixino
Danish: Det skal du vide, før du begynder at tage Marixino
English: Maintenance dose The recommended maintenance dose is 20 mg per day.
Danish: Vedligeholdelsesdosis Den anbefalede vedligeholdelsesdosis er 20 mg dagligt.
English: Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Danish: Din læge vil informere dig, om din sygdom tillader, at du uden risiko kan køre bil eller motorcykel og om du kan cykle eller arbejde med værktøj og maskiner.
English: This is increased to one tablet once a day (1 x 10 mg) in the second week and to 1 and a half tablets once a day (1 x 15 mg) in the third week.
Danish: Denne øges til én tablet én gang dagligt (1 x 10 mg) i den anden uge og til halvanden tablet én gang dagligt (1 x 15 mg) i den tredje uge.
English: Breast-feeding Women taking Marixino should not breast-feed.
Danish: Amning Kvinder, der tager Marixino, bør ikke amme.
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p = 0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p = 0.003; severe impairment battery (SIB): p = 0.002).
Danish: Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (”observed cases analysis” for the Clinician's interview based impression of change (CIBIC-plus): p=0,025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0,003; severe impairment battery (SIB): p = 0,002).
English: From the fourth week on, the usual dose is two tablets once a day (1 x 20 mg).
Danish: Fra og med den fjerde uge er den normale dosis 2 tabletter en gang dagligt(1x 20 mg).
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 bivirkninger med memantin sig ikke fra placebobehandlingen, og bivirkningerne var som regel milde til moderate.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller på apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: How to take Marixino
Danish: Sådan skal du tage Marixino
English: - The other ingredients (excipients) are:
Danish: - Øvrige indholdsstoffer:
English: Moderate to severe Alzheimer's disease usually causes impairment of driving performance and compromises the ability to use machinery.
Danish: Moderat til svær Alzheimers sygdom nedsætter normalt evnen til at føre et motorkøretøj eller betjene maskiner.
English: Marixino should be administered orally once a day.
Danish: Marixino bør indtages gennem munden én gang dagligt.
English: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Danish: Patienten bør tage to filmovertrukne 10 mg-tabletter (20 mg) eller en 20 mg filmovertrukken tablet dagligt.
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: Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Danish: I gnavere blev der observeret phospholipidose i pulmonale makrofager på grund af akkumulation af memantin i lysosomer.
English: These events have been reported in patients treated with memantine.
Danish: Disse hændelser er rapporteret hos patienter i behandling med memantin.
English: Alkalisation of urine may result from drastic changes in diet, e.g. from a carnivore to a vegetarian diet, or from the massive ingestion of alkalising gastric buffers.
Danish: Alkalisering af urin kan skyldes drastiske ændringer i kosten, f.eks. fra en kødholdig til en vegetarisk kost eller fra en kraftig indtagelse af alkaliserende gastriske buffere.
English: Do not use this medicine after the expiry date which is stated on the blister and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blister og æske efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The film-coated tablets can be taken with or without food.
Danish: De filmovertrukne tabletter kan indtages uafhængigt af måltider.
English: The recommended dose of Marixino for adults and older people is 20 mg once a day.
Danish: Den anbefalede dosis af Marixino til voksne og til ældre mennesker er 20 mg én gang dagligt.
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Sodyum laurilsulfate
Danish: Methacrylsyre-ethylacrylat copolymer (1:1) Natriumlaurilsulfat