FrancophonIA/ELRC3.0 huggingface dataset:
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 De har nedsat nyrefunktion (nyreproblemer), bør Deres læge nøje overvåge Deres nyrefunktion og om nødvendigt tilpasse memantin-dosis derefter.
English: Multipack 500 ml, comprising 10 packs, each containing 1 bottle with 50 ml oral solution.
Danish: Multipakning 500 ml, bestående af 10 pakninger, som hver indeholder 1 flaske med 50 ml oral opløsning.
English: Memantine Merz is not recommended for children and adolescents under the age of 18 years.
Danish: Memantine Merz anbefales ikke til børn og unge under 18 år.
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: • 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 nicotin, der bruger samme renale kationiske transportsystem som amantadin, kan muligvis også have interaktion med memantin, hvilket kan medføre en risiko for forhøjede plasmaniveauer.
English: • The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine.
Danish: • Virkemåden antyder, at effekten af L-dopa, dopaminerge agonister og antikolinergika kan forstærkes ved samtidig behandling med NMDA-antagonister såsom memantin.
English: One tablet daily
Danish: En tablet dagligt
English: Dosage in patients with impaired kidney function
Danish: Dosis til patienter med nedsat nyrefunktion
English: Furthermore, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially potassium-free.
Danish: Denne medicin indeholder også kalium, mindre end 1 mmol (39 mg) kalium pr. dosis, dvs. den er i det væsentlige kaliumfri.
English: In case of signs and symptoms of general Central Nervous System (CNS) overstimulation, careful symptomatic clinical treatment should be considered.
Danish: Hvis der er tegn og symptomer på generel overstimulering af centralnervesystemet (CNS), skal det overvejes at give omhyggelig symptomatisk, klinisk behandling.
English: Although no causal relationship has been established, close monitoring of prothrombin time or INR is advisable for patients concomitantly treated with oral anticoagulants.
Danish: Selvom der ikke er påvist nogen årsagssammenhæng, tilrådes nøje overvågning af protrombintid eller INR hos patienter i samtidig behandling med orale antikoagulantia.
English: The tablet can be divided into equal doses.
Danish: Tabletten kan deles i to lige store doser.
English: Balance disorder
Danish: Balanceforstyrrelser
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 hydrochlorothiazid (HCT), når memantin administreres sammen med HCT eller sammen med kombinationspræparater med HCT.
English: Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated with either only symptoms of tiredness, weakness and/or diarrhoea or no symptoms.
Danish: Relativt store overdoseringer (hhv. 200 mg og 105 mg/dag i 3 dage) har været forbundet med symptomer på enten træthed, svaghed og/eller diarré eller ingen symptomer.
English: Only limited experience with overdose is available from clinical studies and post-marketing experience.
Danish: Der er kun begrænset erfaring med overdosering fra kliniske studier og efter markedsføring.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Hvis Deres læge har fortalt Dem, at De ikke tåler visse sukkerarter, skal De kontakte Deres læge, inden De begynder at tage denne medicin.
English: In most clinical trials, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV), or uncontrolled hypertension were excluded.
Danish: I de fleste kliniske forsøg blev patienter med nyligt myokardieinfarkt, ubehandlet hjerteinsufficiens (NYHA klasse III-IV) eller ukontrolleret hypertension ekskluderet.
English: Phospholipidosis in pulmonary macrophages due to accumulation of memantine in lysosomes was observed in rodents.
Danish: Fosfolipidose i pulmonale makrofager på grund af akkumulation af memantin i lysosomer blev observeret hos gnavere.
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 hos rotter og kaniner, selv ved maternale toksiske doser, og der blev ikke noteret nogen bivirkninger af memantin i forbindelse med fertilitet.
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: Titanium dioxide (E 171)
Danish: Titandioxid (E 171)
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: Memantine Merz with food and drink
Danish: Brug af Memantine Merz sammen med mad og drikke
English: The most frequently occurring adverse reactions with a higher incidence in the Memantine Merz 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 Memantine Merz-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: When used for the first time, the dosing pump does not dispense the correct amount of oral solution.
Danish: Når doseringspumpen anvendes første gang, kan den ikke dosere den korrekte mængde oral opløsning.
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: Oral solution.
Danish: Oral opløsning.
English: Take one tablet once a day.
Danish: Tag en tablet om dagen.
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 okulare forandringer.
English: - If you find you have forgotten to take your dose of Memantine Merz, wait and take your next dose at the usual time.
Danish: - Hvis De har glemt at tage Deres dosis af Memantine Merz, skal De vente og tage Deres næste dosis på det sædvanlige tidspunkt.
English: Blister packs containing either 7, 10, 14 or 20 tablets per blister strip (Alu/PP).
Danish: Blisterpakninger med enten 7, 10, 14 eller 20 tabletter pr. blisterstrip (Alu/PP).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER FOR TABLETS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTER TIL TABLETTER
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: Push down the dosing pump head in a firm but calm and steady manner - not too slowly (fig. 7, fig. 8).
Danish: Tryk ned på doseringspumpen med en fast, men stille og og rolig bevægelse - ikke for langsomt (fig. 7 og 8).
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 stigning i international normalized ratio (INR) hos patienter i samtidig behandling med warfarin.
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 medicinen bør de tages regelmæssigt hver dag på samme tidspunkt af dagen.
English: Do not store above 30°C.
Danish: Må ikke opbevares over 30 ºC.
English: Memantine Merz is not recommended for use in children below 18 years due to a lack of data on safety and efficacy.
Danish: Memantine Merz bør ikke anvendes til børn under 18 år pga. manglende dokumentation for sikkerhed og virkning.
English: EXP {MM/YYYY} See embossed stamp.
Danish: EXP {MM/ÅÅÅÅ} Se præget stempel.
English: There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular at NMDA-receptors, contributes to both expression of symptoms and disease progression in neurodegenerative dementia.
Danish: Ved neurodegenerativ demens er der meget der tyder på, at malfunktion af den glutamaterge neurotransmission, i særdeleshed ved NMDA-receptorer, både medvirker til, at symptomerne kommer til udtryk, og at sygdommen forværres.
English: No genotoxicity has been observed following testing of memantine in standard assays.
Danish: Der er ikke observeret nogen genotoksicitet efter afprøvning af memantin ved standardundersøgelser.
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 20 dage, mere end 99% blev udskilt via nyrerne.
English: The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.
Danish: Den anbefalede vedligeholdelsesdosis er 20 mg en gang dagligt, som nås i begyndelsen af den 4. uge.
English: The patient experienced central nervous system symptoms such as restlessness, psychosis, visual hallucinations, proconvulsiveness, somnolence, stupor, and unconsciousness.
Danish: Patienten havde symptomer fra centralnervesystemet såsom rastløshed, psykose, visuelle hallucinationer, pro-konvulsiv aktivitet, søvntrang, sløvhed og bevidstløshed.
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine Merz dose during the first 3 weeks of treatment.
Danish: Den anbefalede dosis på 20 mg Memantine Merz dagligt opnås ved en gradvis øgning af Memantine Merz dosis i løbet af de første tre ugers behandling.
English: Pharmacotherapeutic group: Other Anti-dementia drugs, ATC code: N06DX01.
Danish: Farmakoterapeutisk klassifikation: Andet antidemenspræparat, ATC-kode: N06DX01.
English: Lot {number} See embossed stamp.
Danish: Lot {nummer} Se præget stempel.
English: The dosing pump is then ready for use.
Danish: Doseringspumpen er herefter klar til brug.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR 28 TABLETS - TREATMENT INITIATION PACK - 4 WEEK TREATMENT SCHEDULE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL 28 TABLETTER - BEHANDLINGSINDLEDENDE PAKNING - 4 UGERS BEHANDLINGSSKEMA
English: For memantine, no clinical data on exposed pregnancies are available.
Danish: For memantin foreligger der ingen kliniske data om anvendelse under graviditet.
English: Confusion
Danish: Forvirring
English: Memantine Merz is used for the treatment of patients with moderate to severe Alzheimer's disease.
Danish: Memantine Merz anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: The patient recovered without permanent sequelae.
Danish: Patienten kom sig uden varige følgetilstande.
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 antispasmotika, dantrolen eller baclofen, kan modificere disses virkninger, og dosisjustering kan være nødvendig.
English: In the most extreme case of overdose, the patient survived the oral intake of a total of 2000 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: Excipients: The oral solution contains sorbitol.
Danish: Hjælpestoffer: Den orale opløsning indeholder sorbitol.
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.
Danish: Hvis 10 mg pr. dag er veltolereret efter mindst 7 dages behandling, kan dosis øges op til 20 mg pr. dag efter det almindelige dosistitreringsskema.
English: The solution must not be poured or pumped directly into the mouth from the bottle or pump.
Danish: De må ikke drikke eller pumpe opløsningen ind i munden direkte fra flasken eller pumpen.
English: Memantine Merz contains sorbitol
Danish: Memantine Merz indeholder sorbitol
English: Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy.
Danish: Forsigtighed anbefales hos patienter, som lider af epilepsi, som tidligere har haft kramper, eller som er disponeret for epilepsi.
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 kraftig indtagelse af alkaliserende buffere.
English: The solution must not be poured or pumped into the mouth directly from the bottle or the pump, but should be dosed onto a spoon or into a glass of water using the pump.
Danish: Opløsningen må ikke hældes eller pumpes ind i munden direkte fra flasken eller pumpen, men skal doseres på en ske eller i et glas vand vha. pumpen.
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 motorkøretøj og betjene maskiner.
English: Always take Memantine Merz exactly as your doctor has told you.
Danish: Tag altid Memantine Merz nøjagtigt efter lægens anvisning.
English: The solution is clear and colourless to light yellowish.
Danish: Opløsningen er klar og farveløs til let gullig.
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: Component of a multipack, can't be sold separately.
Danish: Komponenterne i en multipakning kan ikke sælges separat.
English: The dosing pump should be locked after use.
Danish: Doseringspumpen skal lukkes efter brug.
English: Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Danish: Alzheimers sygdom er blevet sat i forbindelse med depression, selvmordsforestilling og selvmord.
English: Once daily For continuation of your treatment please consult your doctor.
Danish: En gang dagligt Konsulter Deres læge angående fortsættelse af behandlingen.
English: 42 film-coated tablets Component of a multipack, can't be sold separately.
Danish: 42 filmovertrukne tabletter Komponenterne i en multipakning kan ikke sælges separat.
English: The patient had received 400 mg memantine orally.
Danish: Patienten havde fået 400 mg memantin peroralt.
English: Studies in volunteers have demonstrated linear pharmacokinetics in the dose range of 10 to 40 mg. Pharmacokinetic/pharmacodynamic relationship
Danish: Studier hos frivillige forsøgspersoner har vist en lineær farmakokinetik i doser mellem 10 og 40 mg.
English: Memantine Merz oral solution is presented as a clear, colourless to light yellowish solution.
Danish: Memantine Merz oral opløsning er en klar, farveløs til let gullig opløsning.
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: Memantine Merz oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Danish: Memantine Merz oral opløsning fås i flasker med 50 ml eller 100 ml og multipakninger med 500 ml (10 x 50 ml).
English: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate
Danish: Mikrokrystallinsk cellulose Croscarmellosenatrium Kolloid vandfri silica Magnesiumstearat
English: This is increased to one tablet once a day (1x 10 mg) in the second week and to 1 and a half tablet once a day in the third week.
Danish: Denne øges til en tablet en gang om dagen (1 x 10 mg) i den anden uge og til 1 og en halv tablet en gang om dagen i den tredje uge.
English: - If you take a large overdose of Memantine Merz, contact your doctor or get medical advice, as you may need medical attention.
Danish: - Hvis De tager en stor overdosis af Memantine Merz, skal De søge læge, da De kan have behov for medicinsk behandling.
English: Memantine hydrochloride
Danish: Memantinhydrochlorid
English: Excipients: Each one millilitre of solution contains 100 mg sorbitol (E 420) and 0.5 mg potassium, see section 4.4.
Danish: Hjælpestoffer: Hver milliliter opløsning indeholder 100 mg sorbitol (E 420) og 0,5 mg kalium, se pkt.
English: The Memantine Merz treatment initiation pack is only to be used for the beginning of the treatment with Memantine Merz.
Danish: Denne pakke er til den indledende behandling med Memantine Merz og må kun anvendes i begyndelsen af behandlingen med Memantine Merz.
English: When opened, use within 3 months.
Danish: Anvendes inden for 3 måneder efter anbrud.
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 buffere.
English: Prior to first use the dosing pump has to be screwed on the bottle.
Danish: Før doseringspumpen tages i brug første gang, skal den skrues fast på flasken.
English: Each pack contains 28 film-coated tablets in 4 PVDC/PE/PVC/Al-blister or PP/Al-blisters with 7 filmcoated 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.
Danish: Hver pakke indeholder 28 filmovertrukne tabletter i 4 PVDC/PE/PVC/Alu-blisterstrips eller PP/Alu-blisterstrips med 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: - In general, taking too much Memantine Merz should not result in any harm to you.
Danish: - Generelt bør indtagelse af for meget Memantine Merz ikke være skadeligt for Dem.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥1/10), common (≥1/100 to < 1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
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: 50 ml oral solution Component of a multipack, can't be sold separately.
Danish: 50 ml oral opløsning Komponenterne i en multipakning kan ikke sælges separat.
English: Memantine Merz should be taken once daily at the same time each day.
Danish: Memantine Merz skal tages én gang dagligt på samme tidspunkt hver dag.
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 derfor kan bivirkninger (hovedsageligt relaterede til centralnervesystemet (CNS)) indtræffe hyppigere og være mere udtalte (se også under punkt 4.5).
English: The next time the dosing pump head is pushed downwards completely (equivalent to one pump actuation), it dispenses the correct dose (1 pump actuation is equivalent to 0.5 ml oral solution, and contains 5 mg of the active substance memantine hydrochloride; fig. 6).
Danish: Næste gang doseringspumpen trykkes helt ned (svarende til ét tryk på pumpen), pumpes den korrekte dosis ud (ét tryk på pumpen svarer til 0,5 ml oral opløsning og indeholder ca. 5 mg af det aktive stof memantinhydrochlorid - fig. 6).
English: The tablets can be taken with or without food.
Danish: Tabletterne kan indtages uafhængigt af måltider.
English: week 1
Danish: 1. uge
English: Very rare (may affect up to 1 in 10,000 users): • Seizures
Danish: Meget sjældne (kan påvirke op til 1 ud af 10.000 brugere): • Krampeanfald
English: Multipack 840 (20 packs of 42) film-coated tablets
Danish: Multipakning 840 (20 pakninger a 42) filmovertrukne tabletter
English: • Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions Alzheimer's disease has been associated with depression, suicidal ideation and suicide.
Danish: • Betændelse i bugspytkirtlen, leverbetændelse (hepatitis) og psykotiske reaktioner Alzheimers sygdom er blevet sat i forbindelse med depression, selvmordsforestilling og selvmord.
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Danish: In vitro er der ikke fundet nogen cytokrom P450-metabolisme.
English: Memantine Merz acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Danish: Memantine Merz indvirker på disse NMDA-receptorer og forbedrer overførslen af nervesignaler samt hukommelsen.
English: The solution thus dispensed is discarded.
Danish: Den opløsning, der således er pumpet ud, skal kasseres.
English: Women taking memantine should not breast-feed.
Danish: Kvinder, der tager memantin, bør ikke amme.
English: EU/1/12/799/028 500 ml (10 bottles of 50 ml)
Danish: EU/1/12/799/028 500 ml (10 x 50 ml)