FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Dexamed outweigh its risks for second-line treatment of ADHD and recommended that the marketing authorisation be granted in all concerned Member States.
Danish: Efter vurdering af de foreliggende data og den videnskabelige drøftelse i udvalget konkluderede CHMP derfor, at fordelene ved Dexamed opvejer risiciene til andetvalgsbehandling af ADHD, og at der bør udstedes markedsføringstilladelse for Dexamed i alle berørte medlemsstater.
English: The experts' group advised that while there is some evidence that medicines of the same type as Dexamed are more likely to induce dependence than other treatments for ADHD, based on clinical practice the risk of developing dependence in patients treated with dexamfetamine is considered to be low and could be adequately managed with appropriate risk minimisation measures.
Danish: Ekspertgruppen udtalte, at der er nogen dokumentation for, at lægemidler af samme type som Dexamed er mere tilbøjelige til at medføre afhængighed af andre midler mod ADHD, men at klinisk praksis viser, at risikoen for afhængighed hos patienter i behandling med dexamfetamin må anses for at være lav og kan håndteres tilfredsstillende med passende risikominimeringsforanstaltninger.
English: The grounds for the referral were concerns raised by the Netherlands that Dexamed presents a higher risk for abuse and dependence compared with other ADHD treatments, and that the data submitted to support the application did not provide sufficient evidence to demonstrate its effectiveness as a second-line treatment for ADHD.
Danish: Begrundelsen for indbringelsen var betænkeligheder rejst af Nederlandene om, at Dexamed medfører større risiko for misbrug og afhængighed end andre midler mod ADHD, og at den indsendte dokumentation i ansøgningen ikke gav tilstrækkeligt bevis for virkningen til andetvalgsbehandling af ADHD.
English: Dexamfetamine belongs to a group of medicines called ‘psychostimulants' and is thought to work by activating certain areas of the brain that control attention and concentration, thus helping to reduce impulsive behaviour.
Danish: Det menes at virke ved at øge aktiviteten i de områder af hjernen, der styrer opmærksomhed og koncentration, og begrænser derved den impulsive adfærd.
English: Although the CHMP acknowledged that there is a risk of abuse and dependence with Dexamed, it concluded that the risk minimisation measures proposed to mitigate this risk are adequate.
Danish: Udvalget konkluderede dog, at de påtænkte risikominimeringsforanstaltninger i denne forbindelse er tilstrækkelige.
English: MA (EU) Number (Invented) name Strength
Danish: MF (EU)-nummer (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: Axura with food and drink
Danish: Brug af Axura sammen med mad og drikke
English: Date of first authorisation: 17 May 2002 Date of latest renewal: 17 May 2007
Danish: Dato for første markedsføringstilladelse: 17 maj 2002 Dato for seneste genregistrering: 17 maj 2007
English: Axura is not recommended for children and adolescents under the age of 18 years.
Danish: Axura anbefales ikke til børn og unge under 18 år.
English: In particular, Axura may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
Danish: I særdeleshed kan Axura ændre virkningen af følgende medicin, og lægen kan derfor være nødt til at ændre doseringen:
English: - In general, taking too much Axura should not result in any harm to you.
Danish: - generelt bør indtagelse af for meget Axura ikke være skadeligt for Dem.
English: In these situations the treatment should be carefully supervised, and the clinical benefit of Axura reassessed by your doctor on a regular basis.
Danish: I disse situationer bør behandlingen overvåges nøje, og den kliniske gavn af Axura skal regelmæssigt vurderes af Deres læge.
English: Always take Axura exactly as your doctor has told you.
Danish: Tag altid Axura nøjagtigt efter lægens anvisning.
English: Axura contains sorbitol
Danish: Axura indeholder sorbitol
English: If you go into hospital, let your doctor know that you are taking Axura.
Danish: Hvis De kommer på hospitalet, skal De sige til lægen, at De får Axura.
English: The Axura treatment initiation pack is only to be used for the beginning of the treatment with Axura.
Danish: Denne pakke er til den indledende behandling med Axura og må kun anvendes i begyndelsen af behandlingen med Axura.
English: - If you find you have forgotten to take your dose of Axura, wait and take your next dose at the usual time.
Danish: - hvis De har glemt at tage Deres dosis af Axura, skal De vente og tage Deres næste dosis på det sædvanlige tidspunkt.
English: The most frequently occurring adverse reactions with a higher incidence in the Axura 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 Axura-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: The safety and efficacy of Axura in children aged below 18 years has not been established.
Danish: Sikkerhed og virkning af Axura hos børn under 18 år er ikke klarlagt.
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 under pkt.
English: If you forget to take Axura
Danish: Hvis De har glemt at tage Axura
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: 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 under pkt.
English: Blister packs containing 14 film-coated tablets per PVDC/PE/PVC/Al-blister or PP/Al-blister strip.
Danish: Blisterpakninger indeholder 14 filmovertrukne tabletter pr. PVDC/PE/PVC/Alu-blisterstrip eller PP/Alu-blisterstrip.
English: What is Axura used for
Danish: Hvad anvendes Axura til?
English: - If you take a large overdose of Axura, contact your doctor or get medical advice, as you may need medical attention.
Danish: - Hvis De tager en stor overdosis af Axura, skal De søge læge, da De kan have behov for medicinsk behandling.
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 pkt.
English: Furthermore, Axura 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 Axura mindre til moderat indflydelse på evnen til at føre motorkøretøj og betjene maskiner, hvorfor ambulante patienter skal informeres om at være særligt forsigtige.
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Axura dose during the first 3 weeks of treatment.
Danish: Den anbefalede dosis på 20 mg Axura dagligt opnås ved en gradvis øgning af Axura dosis i løbet af de første tre ugers behandling.
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: Axura is used for the treatment of patients with moderate to severe Alzheimer's disease.
Danish: Axura anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: Axura should be taken once daily at the same time each day.
Danish: Axura skal tages én gang dagligt på samme tidspunkt hver dag.
English: What you need to know before you take Axura Do not take Axura
Danish: Det skal de vide, før de begynder at tage Axura Tag ikke Axura
English: Axura acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Danish: Axura indvirker på disse NMDA-receptorer og forbedrer overførslen af nervesignaler samt hukommelsen.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis De ønsker yderligere oplysninger om Axura, skal De henvende Dem til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Women taking Axura should not breast-feed.
Danish: Kvinder, der tager Axura, bør ikke amme.
English: Axura oral solution is available in bottles of 50 ml, 100 ml or a multipack of 500 ml (10 x 50 ml).
Danish: Axura oral opløsning fås i flasker med 50 ml eller 100 ml og multipakninger med 500 ml (10 x 50 ml).
English: Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 x Axura 5 mg
Danish: Hver pakke med 28 filmovertrukne tabletter til et 4-ugers behandlingsforløb indeholder: 7 x Axura 5 mg
English: EU/1/02/218/011 500 ml (10 bottles of 50 ml)
Danish: EU/1/02/218/011 500 ml (10 x 50 ml)
English: Content of the pack and other information What Axura contains
Danish: Pakningsstørrelser og yderligere oplysninger Axura indeholder
English: Axura oral solution is presented as a clear, colourless to light yellowish solution.
Danish: Axura oral opløsning er en klar, farveløs til let gullig opløsning.
English: Other medicines and Axura
Danish: Brug af anden medicin sammen med Axura
English: In clinical trials in mild to severe dementia, involving 1,784 patients treated with Axura and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions with Axura 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 Axura for mild til svær demens og med 1.595 patienter i placebobehandling adskilte den generelle incidensrate for biverkninger med Axura sig ikke fra placebobehandlingen, og bivirkningerne var som regel milde til moderate.
English: Axura contains the active substance memantine hydrochloride.
Danish: Axura indeholder det aktive stof memantinhydrochlorid.
English: The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with Axura and since its introduction in the market.
Danish: Følgende bivirkninger i nedenstående tabel er indrapporteret i forbindelse med kliniske forsøg med Axura og efter markedsføring.
English: In postmarketing experience these events have been reported in patients treated with Axura.
Danish: Efter markedsføringen er disse hændelser rapporteret hos patienter i behandling med Axura.
English: Also, Axura may change your reactivity, making driving or operating machinery inappropriate.
Danish: Desuden kan Axura påvirke Deres reaktionsevne, så det ikke er hensigtsmæssigt at køre bil eller betjene maskiner.
English: Axura belongs to a group of medicines called NMDAreceptor antagonists.
Danish: Axura hører til en gruppe af medicin kaldet NMDA-receptor-antagonister.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Administration of Axura in patients with severe hepatic impairment is not recommended.
Danish: Administration af Axura til patienter med svært nedsat leverfunktion kan ikke anbefales.
English: Do not use Axura after the expiry date which is stated on the carton and the bottle label after the EXP.
Danish: Brug ikke Axura efter den udløbsdato, der står på æsken og flaskeetiketten efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: These events have been reported in patients treated with Axura.
Danish: Disse følger er blevet set hos patienter i behandling med Axura.
English: Axura belongs to a group of medicines known as anti-dementia medicines.
Danish: Axura tilhører gruppen af medicin kaldet antidemensmedicin (medicin til behandling af demens).
English: Each tablet contains 5/10/15/20 mg of memantine hydrochloride equivalent to 4.15/8.31/12.46/16.62 mg memantine.
Danish: Hver tablet indeholder 5/10/15/20 mg memantinhydrochlorid (svarende til 4,15/8,31/12,46/16,62 mg memantin).
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: 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: Talk to your doctor or pharmacist before taking Axura - 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 apoteketspersonalet, før De tager Axura - hvis De tidligere har haft epileptiske anfald - hvis De for nylig har haft en blodprop i hjertet (myokardieinfarkt), eller hvis De lider af dårligt hjerte eller ukontrolleret forhøjet blodtryk (hypertension).
English: Do not use Axura after the expiry date which is stated on the carton and the blister after EXP.
Danish: Brug ikke Axura efter den udløbsdato, der står på æsken og blisteret efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets 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: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter 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: Tablet coating for 5/10/15/20 mg film-coated tablets Hypromellose
Danish: Tabletovertræk for 5/10/15/20 mg filmovertrukne tabletter Hypromellose
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura tablets (listed in section 6).
Danish: - hvis De er allergisk (overfølsom) over for memantinhydrochlorid eller et af de øvrige indholdsstoffer i Axura tabletter (angivet ise afsnit 6).
English: - if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Axura oral solution (listed in section 6).
Danish: - hvis De er allergisk (overfølsom) over for memantinhydrochlorid eller et af de øvrige indholdsstoffer i Axura oral opløsning (angivet ise afsnit 6).
English: Tablet cores for 5/10/15/20 mg film-coated tablets Microcrystalline cellulose Croscarmellose sodium
Danish: Tabletkerne for 5/10/15/20 mg filmovertrukne tabletter Mikrokrystallinsk cellulose Croscarmellosenatrium
English: Package leaflet: Information for the user Axura 20 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Axura 20 mg filmovertrukne tabletter
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 42 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter 112 filmovertrukne tabletter
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets EU/1/02/218/016
Danish: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter EU/1/02/218/016
English: Package leaflet: Information for the user Axura 5 mg/pump actuation, oral solution
Danish: Indlægsseddel: Information til brugeren Axura 5 mg/pumpetryk, oral opløsning
English: For removing the screw cap from the bottle the cap must be turned anticlockwise and unscrewed completely (fig. 1).
Danish: For at fjerne skruelåget fra flasken skal det drejes mod uret og skrues helt af (fig. 1).
English: Package leaflet: Information for the user Axura 10 mg film-coated tablets
Danish: Indlægsseddel: Information til brugeren Axura 10 mg filmovertrukne tabletter
English: EU/1/02/218/016 28 film-coated tablets EU/1/02/218/023 28 film-coated tablets
Danish: EU/1/02/218/016 28 filmovertrukne tabletter EU/1/02/218/023 28 filmovertrukne tabletter
English: Axura 10 mg film-coated tablets EU/1/02/218/001
Danish: Axura 10 mg filmovertrukne tabletter EU/1/02/218/001
English: Axura 20 mg film-coated tablets EU/1/02/218/017
Danish: Axura 20 mg filmovertrukne tabletter EU/1/02/218/017
English: The recommended dose of Axura for adults and older people is four pump actuations, equivalent to 20 mg once a day.
Danish: Den anbefalede dosis af Axura til voksne og til ældre patienter er fire tryk på pumpen, hvilket svarertil 20 mg en gang om dagen.
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets Each filmcoated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine.
Danish: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter Hver tablet indeholder 5 mg memantinhydrochlorid svarende til 4,15 mg memantin.
English: How to take Axura
Danish: Sådan skal de tage Axura
English: The other ingredients for Axura 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and additional for Axura 10 mg film-coated tablets is iron oxide yellow (E 172) and for Axura 15 mg and Axura 20 mg film-coated tablets are iron oxide yellow and red (E 172), all in the tablet coating.
Danish: Øvrige indholdsstoffer for Axura 5/10/15 og 20 mg filmovertrukne tabletter er mikrokrystallinsk cellulose, croscarmellosenatrium, kolloid vandfri silica, magnesiumstearat, som alle findes i tablettens kerne, og hypromellose, macrogol 400, titandioxid (E 171) og desuden for Axura 10 mg filmovertrukne tabletter er gul jernoxid (E 172) og for Axura 15 mg og Axura 20 mg filmovertrukne tabletter også gul og rød jernoxid (E 172), som alle findes i tablettens overtræk.
English: Axura 5 mg, 10 mg, 15 mg, 20 mg tablets
Danish: Axura 5 mg, 10 mg, 15 mg, 20 mg tabletter
English: Axura 20 mg tablets
Danish: Axura 20 mg tabletter
English: At the beginning of treatment you will start by using Axura 5 mg film-coated tablets once a day.
Danish: Den normale startdosis er en Axura 5 mg filmovertrukket tablet en gang om dagen.
English: Axura 10 mg tablets
Danish: Axura 10 mg tabletter
English: The recommended dose of Axura for adults and older people is 20 mg once a day.
Danish: Den anbefalede dosis af Axura til voksne og til ældre patienter er 20 mg en gang om dagen.
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 42 tablets, 56 tablets, 98 tablets or in multipacks of 840 (20 x 42) tablets.
Danish: Axura filmovertrukne tabletter fås i blisterpakninger med 14 tabletter, 28 tabletter, 42 tabletter, 56 tabletter eller 98 tabletter og multipakninger med 840 (20 x 42) tabletter.
English: Axura should be administered orally once a day.
Danish: Axura bør indtages gennem munden én gang dagligt.
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 under pkt.
English: Axura film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipacks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Danish: Axura filmovertrukne tabletter fås i blisterpakninger med 14 tabletter, 28 tabletter, 30 tabletter, 42 tabletter, 50 tabletter, 56 tabletter, 98 tabletter, 100 tabletter, 112 tabletter og multipakninger med 840 (20 x 42) tabletter, 980 (10 x 98) tabletter og 1.000 (20 x 50) tabletter.
English: EU/1/02/218/022 840 film-coated tablets (20 packs of 42) EU/1/02/218/029 840 film-coated tablets (20 packs of 42)
Danish: EU/1/02/218/022 840 filmovertrukne tabletter (20 x 42) EU/1/02/218/029 840 filmovertrukne tabletter (20 x 42)
English: EU/1/02/218/017 14 film-coated tablets EU/1/02/218/018 28 film-coated tablets EU/1/02/218/019 42 film-coated tablets EU/1/02/218/020 56 film-coated tablets EU/1/02/218/021 98 film-coated tablets EU/1/02/218/024 14 film-coated tablets EU/1/02/218/025 28 film-coated tablets EU/1/02/218/026 42 film-coated tablets EU/1/02/218/027 56 film-coated tablets EU/1/02/218/028 98 film-coated tablets
Danish: EU/1/02/218/017 14 filmovertrukne tabletter EU/1/02/218/018 28 filmovertrukne tabletter EU/1/02/218/019 42 filmovertrukne tabletter EU/1/02/218/020 56 filmovertrukne tabletter EU/1/02/218/021 98 filmovertrukne tabletter EU/1/02/218/024 14 filmovertrukne tabletter EU/1/02/218/025 28 filmovertrukne tabletter EU/1/02/218/026 42 filmovertrukne tabletter EU/1/02/218/027 56 filmovertrukne tabletter EU/1/02/218/028 98 filmovertrukne tabletter
English: Axura 5 mg+10 mg+15 mg+20 mg film-coated tablets The 5 mg film-coated tablets are white to off-white, oval-oblong film-coated tablets with imprint ‘5' on one side and imprint ‘MEM' on the other side.
Danish: Axura 5 mg+10 mg+15 mg+20 mg filmovertrukne tabletter De hvide til grålighvide filmovertrukne tabletter på 5 mg er ovale-aflange tabletter præget med ”5” på den ene side og ”MEM” på den anden side.
English: What Axura is and what it is used for How does Axura work
Danish: Virkning og Anvendelse Hvordan virker Axura?