FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared with a fall of 4.3 per week in the patients taking placebo.
Danish: I den første undersøgelse reducerede en daglig dosis på 9 g antallet af katapleksianfald med 16,1 (fra 23,5 til 8,7) pr. uge sammenlignet med et fald på 4,3 anfald pr. uge hos patienter, der tog placebo.
English: Why has Xyrem been approved?
Danish: Hvorfor blev Xyrem godkendt?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xyrem, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Xyrem, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: Xyrem is used to treat adults who have narcolepsy with cataplexy.
Danish: Xyrem anvendes til behandling af voksne, som lider af narkolepsi med katapleksi.
English: The company that makes Xyrem will minimise the risk of abuse of Xyrem by providing educational materials to healthcare workers and patients, strictly controlling the distribution of the medicine, and monitoring its use.
Danish: Virksomheden, som fremstiller Xyrem, skal minimere risikoen for misbrug af Xyrem ved at udarbejde informationsmateriale til fagfolk inden for sundhedssektoren og til patienter, ved nøje at kontrollere udleveringen af lægemidlet og ved at overvåge anvendelsen af dette.
English: Xyrem treatment should be started and given under the guidance of a doctor who has experience in the treatment of sleep disorders.
Danish: Behandling med Xyrem bør indledes og overvåges af en læge med erfaring i behandling af søvnforstyrrelser.
English: The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over four weeks of treatment.
Danish: Den første undersøgelse (136 patienter) så på, hvilken virkning Xyrem havde på antallet af katapleksianfald over en behandlingsperiode på fire uger.
English: The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient's existing dose of modafinil (a stimulant medicine used to treat narcolepsy).
Danish: I de andre to undersøgelser (516 patienter) så man på, hvilken virkning Xyrem havde på den overdrevne søvntrang i dagtimerne og andre symptomer på narkolepsi, når det enten blev taget alene eller som tillægsbehandling til patientens eksisterende dosis af modafinil (et stimulerende lægemiddel til behandling af narkolepsi).
English: Xyrem also reduced excessive daytime sleepiness in patients who continued to take modafinil, as well as in those who took Xyrem alone.
Danish: Xyrem reducerede også den udtalte søvntrang i dagtimerne hos patienter, som fortsatte med at tage modafinil, ligeså vel som hos de patienter, der kun tog Xyrem.
English: The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over two weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 attacks in those switching to placebo.
Danish: Den anden undersøgelse viste, at Xyrem fortsatte med at forhindre katapleksianfald efter langvarig behandling: i løbet af 2 uger var der ingen ændring i antallet af anfald hos patienterne, som fortsatte med at tage Xyrem, sammenlignet med en stigning på 21,0 anfald hos de patienter, der skiftede til placebo.
English: The starting dose should be halved in patients who have problems with their liver.
Danish: Startdosis skal halveres hos patienter med leverproblemer.
English: Patients are also advised against taking alcohol while on treatment with Xyrem.
Danish: Det frarådes patienterne at indtage alkohol under behandlingen med Xyrem.
English: The active substance in Xyrem, sodium oxybate, is a central nervous system depressant.
Danish: Det aktive stof i Xyrem, natriumoxybat, er et middel, som nedsætter aktiviteten i centralnervesystemet.
English: What is Xyrem?
Danish: Hvad er Xyrem?
English: Because sodium oxybate can be abused, doctors must carefully monitor patients using Xyrem.
Danish: Da natriumoxybat kan skabe afhængighed, skal lægen nøje overvåge patienter, der tager Xyrem.
English: The dose of Xyrem should also be reduced by a fifth if patients are taking the medicine valproate for another condition at the same time as they are taking Xyrem.
Danish: Dosen af Xyrem bør desuden reduceres med en femtedel, hvis patienterne samtidig med behandlingen med Xyrem får valproat for en anden lidelse.
English: The second study, including 56 patients who had been taking Xyrem for at least six months, compared the effects of continuing to take Xyrem at the same dose as before, with the effects of switching to placebo.
Danish: I den anden undersøgelse, der omfattede 56 patienter, som havde taget Xyrem i mindst seks måneder, sammenlignedes virkningen ved at fortsætte med den samme dosis Xyrem med virkningen ved at skifte til placebo.
English: Because sodium oxybate can be abused, doctors should check for a history of or susceptibility to drug abuse before treatment, and monitor for misuse and abuse during treatment.
Danish: Da natriumoxybat kan misbruges, bør lægen kontrollere, om patienten tidligere har været stofmisbruger eller er i fare for at udvikle et stofmisbrug, før behandlingen indledes, samt foretage overvågning for forkert brug eller misbrug under behandlingen.
English: The main measure of effectiveness was the change in daytime sleepiness.
Danish: Virkningen blev hovedsagelig bedømt på ændringen i søvntrangen i dagtimerne.
English: For the full list of all side effects reported with Xyrem, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Xyrem fremgår af indlægssedlen.
English: What benefit has Xyrem shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Xyrem?
English: How has Xyrem been studied?
Danish: Hvordan blev Xyrem undersøgt?
English: What is Xyrem used for?
Danish: Hvad anvendes Xyrem til?
English: How is Xyrem used?
Danish: Hvordan anvendes Xyrem?
English: How does Xyrem work?
Danish: Hvordan virker Xyrem?
English: Xyrem sodium oxybate
Danish: Xyrem natriumoxybat
English: These measures will help protect the environment.
Danish: Disse forholdsregler vil hjælpe med at beskytte miljøet.
English: Do not pass it on to others.
Danish: Lad derfor være med at give den til andre.
English: EXP After opening: 1 month
Danish: EXP Efter åbning: 1 måned
English: Centro Empresarial Osa Mayor Avda.
Danish: Centro Empresaial Osa Mayor Avda.
English: These reactions are not in themselves an indication of sensitisation.
Danish: Disse reaktioner er ikke i sig selv en indikation på overfølsomhed.
English: • Check the dose is still correct.
Danish: • Kontrollér, at dosis stadig er korrekt.
English: • You can also mix your medicine with water in a small glass.
Danish: • Du kan også blande din medicin i et lille glas vand.
English: The in vivo micronucleus test was negative.
Danish: In vivo Micronucleus-testen var negativ.
English: • At the request of the European Medicines Agency;
Danish: • I tilfælde af en forespørgsel fra Det Europæiske Lægemiddelagentur.
English: The major metabolite NAP226-90 also did not show a genotoxic potential.
Danish: Hovedmetabolitten NAP226-90 viste heller ikke et genotoksisk potentiale.
English: Each bottle contains 250 capsules.
Danish: Hver flaske indeholder 250 kapsler.
English: Stir and drink all of the mixture.
Danish: Omrør og drik hele blandingen.
English: It is not known if this occurs in humans.
Danish: Det er endnu ukendt, om dette også forekommer hos mennesker.
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Danish: Det tillader fortsat monitorering af fordele/risici-balancen af lægemidlet.
English: Do not refrigerate or freeze.
Danish: Må ikke opbevares i køleskab eller nedfryses.
English: Warnings and precautions
Danish: Advarsler og forholdsregler
English: Each box contains 2, 4 or 8
Danish: Hver æske indeholder 2, 4 eller 8 blister.
English: Use of scopolamine as an antidote is not recommended.
Danish: Anvendelse af skopolamin som antidot kan ikke anbefales.
English: These patients have some side effects more often.
Danish: Disse patienter får visse bivirkninger oftere.
English: Store in an upright position.
Danish: Opbevares i opretstående stilling.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du kan også rapportere bivirkninger direkte via det Nationale rapporteringssystem anført i Bilag V. Ved at rapportere bivirkninger, kan du hjælpe med til at give mere information om sikkerheden af denne medicin.
English: Contains sodium benzoate (E 211).
Danish: Indeholder natriumbenzoat (E 211).
English: 28023 (Aravaca) Madrid España
Danish: 28023 (Aravaca) Madrid Espana
English: Osa Mayor, nº 4
Danish: Osa Mayor no 4
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 du er gravid eller ammer, tror du kan være gravid eller planlægger at få en baby, skal du spørge din læge eller på apoteket, før di tager denne medicin.
English: Date of first authorisation: 11/12/2009 Date of first renewal: 11/07/2014
Danish: Dato for første tilladelse: 11/12/2009Dato for første fornyelse: 11/07/2014
English: Only for carton box: PC:
Danish: Kun for kartonæske: PC:
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicin du ikke længere tager.
English: D-90429 Nuremberg Germany
Danish: D-90429 Nuremberg Tyskland
English: No clinical data on exposed pregnancies are available.
Danish: Der foreligger ikke kliniske data om eksponering under graviditet.
English: While bioavailability of rivastigmine is greater in elderly than in young healthy volunteers, studies in Alzheimer patients aged between 50 and 92 years showed no change in bioavailability with age.
Danish: Selv om biotilgængeligheden for rivastigmin er højere hos ældre end hos yngre raske frivillige forsøgspersoner, viste undersøgelser af Alzheimerpatienter i alderen mellem 50 og 92 år ingen ændring i biotilgængelighed med alderen.
English: 28 hard capsules 56 hard capsules 112 hard capsules
Danish: 28 hårde kapsler 56 hårde kapsler 112 hårde kapsler
English: Your doctor will tell you what dose of Rivastigmine HEXAL to take.
Danish: Din læge vil fortælle dig, hvilken dosis Rivastigmine HEXAL du skal tage.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Danish: Det er vigtigt at rapportere mistænkte bivirkninger efter autorisation af lægemidlet.
English: 250 hard capsules
Danish: 250 hårde kapsler
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette omfatter bivirkninger, som ikke er anført her.
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000);
Danish: Hyppighed er angivet efter følgende regler: 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);
English: E-08210 Barberà del Vallès, Barcelona Spain
Danish: E-08210 Barberà del Vallès, Barcelona Spanien
English: If the dates for submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Danish: Hvis der opstår sammenfald mellem datoerne for indsendelse af PSUR og opdatering af risikohåndteringsplanen, kan disse indsendes samtidig.
English: Oral solution Clear, yellow solution.
Danish: Oral opløsning Klar, gul opløsning.
English: • A few tiny bubbles are not important and will not affect your dose in any way.
Danish: • Tilstedeværelse af små luftbobler er uden betydning og vil ikke påvirke doseringen.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du begynder at tage medicinen, fordi den indeholder vigtige oplysninger.
English: Effects of rivastigmine on human fertility are not known.
Danish: Virkningerne af rivastigmin på human fertilitet er ukendte.
English: Rivastigmine should not be used during pregnancy unless clearly necessary.
Danish: Rivastigmin bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
English: Sick sinus syndrome
Danish: Syg sinus-syndrom
English: Talk to your doctor before taking Rivastigmine HEXAL - if you have, or have ever had, irregular or slow heartbeat.
Danish: Tal med din læge før du tager Rivastigmine HEXAL - hvis du har eller har haft uregelmæssig eller langsom hjerterytme (puls).
English: If you find you have forgotten to take your dose of Rivastigmine HEXAL, wait and take the next dose at the usual time.
Danish: Hvis du finder ud af, at du har glemt at tage en dosis Rivastigmine HEXAL, skal du blot vente og tage næste dosis på det sædvanlige tidspunkt.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Smid ikke nogen form for medicin ud i afløbet eller sammen med husholdningsaffald.
English: Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists.
Danish: Der kan foregå vedligeholdelsesbehandling så længe, der er terapeutisk effekt for patienten.
English: Dehydration can be associated with serious outcomes.
Danish: Dehydrering kan få alvorlige følger
English: • Push down and pull up the plunger a few times to get rid of any large bubbles.
Danish: • Træk sprøjtestemplet et par gange frem og tilbage for at fjerne eventuelle store luftbobler.
English: 50 ml or 120 ml bottle.
Danish: Flaske med 50 ml eller 120 ml.
English: Protein binding of rivastigmine is approximately 40%.
Danish: Proteinbinding af rivastigmin er ca. 40 %.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersonalet anmodes om at rapportere alle mistænkte bivirkninger via det nationale rapporteringssystem, der er anført i bilag V.
English: If this applies to you, tell your doctor and do not take Rivastigmine HEXAL.
Danish: Hvis dette gælder for dig, skal du fortælle det til lægen og ikke tage Rivastigmine HEXAL.
English: If you have not taken Rivastigmine HEXAL for more than three days, do not take the next dose until you have talked to your doctor.
Danish: Hvis du ikke har taget Rivastigmine HEXAL i mere end tre dage, må du ikke tage den næste dosis, før du har talt med din læge.
English: Based on evidence from animal studies the major cytochrome P450 isoenzymes are minimally involved in rivastigmine metabolism.
Danish: Resultater fra dyreundersøgelser viser, at cytokrom-P450 iso-enzymer kun i ringe grad er involveret i rivastigmin-metabolisering.
English: Removing bubbles
Danish: Fjernelse af luftbobler
English: Therefore, the clinical benefit of rivastigmine should be reassessed on a regular basis, especially for patients treated at doses less than 3 mg twice a day.
Danish: Derfor bør den kliniske effekt af rivastigmin revurderes løbende, specielt hos patienter, der behandles med doser mindre end 3 mg to gange daglig.
English: The effective dose is 3 to 6 mg twice a day; to achieve maximum therapeutic benefit patients should be maintained on their highest well tolerated dose.
Danish: Den effektive dosis er 3 til 6 mg to gange daglig; for at opnå maksimal terapeutisk fordel skal patienterne holdes på den højeste dosis, som de tåler godt.
English: This leaflet was last revised in
Danish: Denne indlægsseddel blev senest revideret i
English: The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Danish: Indehaveren af markedsføringstilladelsen skal sikre, at det lægemiddelovervågningssystem, præsenteret i Modul 1.8.1. af ansøgningen om markedsføringstilladelsen, er på plads og fungerer, før og under markedsføringen af lægemidlet.
English: Do not use Rivastigmine HEXAL after the expiry date which is stated on the carton.
Danish: Brug ikke Rivastigmine HEXAL efter den udløbsdato, der står på pakningen.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Danish: Hos patienter med Alzheimers sygdom eller demens, som skyldes Parkinsons sygdom, dør visse nerveceller i hjernen, hvilket fører til lave niveauer af acetylkolin-neurotransmitter (et stof, der gør det muligt for nerveceller at kommunikere med hinanden).
English: In peri/postnatal studies in rats, an increased gestation time was observed.
Danish: I peri-/postnatale undersøgelser på rotter blev der observeret en forlænget drægtighedsperiode.
English: Slow heartbeat and fainting may also occur.
Danish: Langsom hjerterytme og besvimelsesanfald kan ligeledes forekomme.
English: Additive effects leading to bradycardia (which may result in syncope) have been reported with the combined use of various beta-blockers (including atenolol) and rivastigmine.
Danish: Additive virkninger, der fører til bradykardi (hvilket kan resultere i synkope), er blevet rapporteret i forbindelse med kombineret anvendelse af forskellige betablokkere (herunder atenolol) og rivastigmin.
English: Absolute bioavailability after a 3 mg dose is about 36%±13%.
Danish: Absolut biotilgængelighed efter en 3 mg dosis er ca. 36%±13 %.
English: Cardiovascular betablockers are expected to be associated with the greatest risk, but reports have also been received in patients using other beta-blockers.
Danish: Kardiovaskulære betablokkere forventes at være forbundet med den største risiko, men der er også modtaget rapporter om patienter, som bruger andre betablokkere.
English: As a consequence, rivastigmine has minor or moderate influence on the ability to drive and use machines.
Danish: Som følge heraf har rivastigmin en mild eller moderat indvirkning på evnen til at føre motorkøretøj og betjene maskiner.
English: There have been rare post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal).
Danish: Der har været sjældne post-marketing-indberetninger om patienter, der har fået allergisk kontakteksem (dissemineret) efter administration af rivastigmin uanset administrationsvej (oral, transdermal).
English: 2 Mean data shown for convenience, categorical analysis performed using van Elteren test
Danish: 2 Middeldata vist for belejlighed, kategorisk analyse, der blev udført ved brug af van Elteren-test
English: It is possible that some patients sensitised to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form.
Danish: Det er muligt, at nogle af de patienter, der er sensibiliseret over for rivastigmin ved eksponering for rivastigminplasteret, ikke vil kunne tage nogen form for rivastigmin.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Danish: • Hvis risikohåndteringssystemet ændres eller der modtages nye oplysninger, der kan føre til signifikante ændringer i fordele/risici-balancen af lægemidlet, eller som følge af, at en vigtig milepæl (minimering af bivirkninger eller risici) passeres.
English: Subsequent increases to 4.5 mg and then 6 mg twice a day should also be based on good tolerability of the current dose and may be considered after a minimum of two weeks of treatment at that dose level.
Danish: Efterfølgende øgninger til 4,5 mg og dernæst 6 mg to gange daglig skal også være baseret på god tolerance af den aktuelle dosis og kan overvejes efter mindst to ugers behandling på det pågældende dosisniveau.
English: Hallucinations Aggression, restlessness
Danish: Hallucinationer Aggression, rastløshed
English: - HDPE bottles with plastic closure with induction inner seal.
Danish: - HDPE-flaske med plastiklukke med indre tætningsanordning.
English: In case of severe vomiting associated with rivastigmine treatment, appropriate dose adjustments as recommended in section 4.2 must be made.
Danish: I tilfælde af alvorlig opkastning, der er associeret med rivastigmin-behandling, skal der foretages passende dosisjustering som anbefalet i pkt.
English: Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia or dementia associated with Parkinson's disease.
Danish: Behandlingen bør indledes og overvåges af en læge, der har erfaring med diagnosticering og behandling af Alzheimers demens eller demens, der er associeret med Parkinsons sygdom.
English: • Then, remove the syringe from the bottle.
Danish: • Fjern derefter doseringssprøjten fra flasken.
English: Efficacy has been established by the use of two independent scales which were assessed at regular intervals during a 6-month treatment period as shown in Table 5 below: the ADAS-Cog, a measure of cognition, and the global measure ADCS-CGIC (Alzheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
Danish: Effekten blevet fastslået ved hjælp af to uafhængige skalaer, som blev vurderet ved regelmæssige intervaller i løbet af en 6-måneders behandlingsperiode, som vist i tabel 5 nedenfor: ADAS-Cog, en måling af kognition og den globale måling ADCS-CGIC (Alheimer's Disease Cooperative Study-Clinician's Global Impression of Change).
English: An initial dose of 0.03 mg/kg intravenous atropine sulphate is recommended, with subsequent doses based on clinical response.
Danish: En initial dosis på 0,03 mg/kg intravenøs atropinsulfat anbefales med efterfølgende doser afhængig af klinisk respons.
English: What Rivastigmine HEXAL is and what it is used for
Danish: Hvad er Rivastigmine HEXAL og hvad det bruges til
English: However, use of rivastigmine patch may lead to allergic contact dermatitis.
Danish: Anvendelse af rivastigmin kan imidlertid føre til allergisk kontakteksem.
English: The PSUR cycle of Rivastigmine Hexal is aligned with the cross-referred product, Exelon, until otherwise specified.
Danish: PSUR-cyklussen for Rivastigmine HEXAL skal følge den, der gælder for kryds-reference-produktet Exelon, indtil andet specificeres.
English: Taking the two medicines together could cause problems such as slowing of the heartbeat (bradycardia) leading to fainting or loss of consciousness.
Danish: Hvis de to lægemidler tages samtidig, kan det give problemer som f.eks. langsommere hjerteslag (bradykardi), der fører til besvimelse eller tab af bevidsthed.
English: However, rivastigmine may be used in this patient population and close monitoring is necessary.
Danish: Rivastigmine kan imidlertid anvendes hos denne patientpopulation, men det er nødvendigt at følge patienterne tæt.
English: No pharmacokinetic interaction was observed between rivastigmine and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers.
Danish: Der sås ingen farmakokinetisk interaktion mellem rivastigmin og digoxin, warfarin, diazepam eller fluoxetin i undersøgelser med raske frivillige forsøgspersoner.
English: No evidence of carcinogenicity was found in studies in mice and rats at the maximum tolerated dose, although the exposure to rivastigmine and its metabolites was lower than the human exposure.
Danish: Der var ingen tegn på karcinogenicitet i undersøgelser på mus og rotter ved den maksimalt tolererede dosis, selvom optagelsen af rivastigmin og dets metabolitter var lavere end den humane optagelse.