FrancophonIA/ELRC3.0 huggingface dataset:
English: Outcome of a procedure under Article 6(13) of Regulation (EC) 1084/2003 as amended
Danish: Resultat af en indbringelsesprocedure i henhold til artikel 6, stk. 13, i forordning (EF) nr. 1084/2003 med senere ændringer
English: Seroquel XR is authorised in Austria, Belgium, Cyprus, Germany, Denmark, Greece, Spain, Finland, Ireland, Iceland, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, and Sweden under a mutual recognition procedure on the basis of the initial authorisation granted by the ‘reference Member State', the Netherlands, in August 2007.
Danish: Seroquel XR er godkendt i Østrig, Belgien, Cypern, Tyskland, Danmark, Grækenland, Spanien, Finland, Irland, Island, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal og Sverige efter en gensidig anerkendelsesprocedure på grundlag af den første tilladelse, der blev udstedt af "referencemedlemsstaten", Nederlandene, i august 2007.
English: The company that markets these medicines is Astra Zeneca.
Danish: Virksomheden, som markedsfører disse lægemidler, er Astra Zeneca.
English: However, Astra Zeneca was not in agreement with the grounds for refusal and, on 22 May 2009, it referred the matter to the CHMP for arbitration.
Danish: Astra Zeneca var imidlertid ikke enig i begrundelsen for afslaget, og den 22. maj 2009 indbragte virksomheden sagen for CHMP med henblik på voldgift.
English: 30 October 2009, 25 January 2010, 22 February 2010, 26 March 2010
Danish: 30. oktober 2009, 25. januar 2010, 22. februar 2010, 26. marts 2010
English: Prolonged-release means that the active substance is released slowly from the tablet over a few hours.
Danish: Depottablet betyder, at det aktive stof frigives langsomt fra tabletten over nogle timer.
English: The variation to the marketing authorisation was rejected because the Member States concluded that the benefit-risk balance of the medicine was unfavourable.
Danish: Ændringen i markedsføringstilladelsen blev afvist, fordi medlemsstaterne konkluderede, at benefit/riskforholdet for lægemidlet var ugunstigt.
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that a new indication for Seroquel XR can be granted.
Danish: På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at en ny indikation for Seroquel XR kan godkendes.
English: Seroquel XR is also marketed under other trade names: Seroquel Depot, Seroquel Prolong, and Seroquel SR.
Danish: Seroquel XR markedsføres også under andre særnavne: Seroquel Depot, Seroquel Prolong og Seroquel SR.
English: As neurotransmitters are chemicals that allow nerve cells to communicate with each other, this disrupts signals transmitted between brain cells.
Danish: Eftersom neurotransmitterne er kemikalier, der bevirker, at nervecellerne kan kommunikere med hinanden, afbryder dette de signaler, som hjernecellerne sender til hinanden.
English: It is used in patients with schizophrenia, a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Danish: Det anvendes til patienter med skizofreni, som er en psykisk sygdom med symptomer, der blandt andet består i desorganiseret tankegang og tale, hallucinationer (opfattelsen af at høre eller se ting, som ikke er der), mistænksomhed og vrangforestillinger (forestillinger, der er ude af trit med virkeligheden).
English: The exact mechanism of action of quetiapine is unknown, but it attaches to several receptors on the surface of nerve cells in the brain, including the receptors for the neurotransmitters dopamine and serotonin.
Danish: Quetiapins nøjagtige virkningsmekanisme kendes ikke, men man ved, at det bindes til flere forskellige receptorer på overfladen af nervecellerne i hjernen, heriblandt receptorer for neurotransmitterne dopamin og serotonin.
English: The European Medicines Agency has completed an arbitration procedure for Seroquel XR and associated names.
Danish: Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure for Seroquel XR og relaterede navne.
English: What is Seroquel XR?
Danish: Hvad er Seroquel XR?
English: Not enough data had been submitted to support the restriction to patients not responsive to standard antidepressants.
Danish: Der var ikke indleveret tilstrækkelige data til at understøtte begrænsningen til patienter, som ikke responderer på standardbehandling med antidepressiva.
English: Why was Seroquel XR reviewed?
Danish: Hvorfor blev Seroquel XR vurderet igen?
English: Seroquel XR is an antipsychotic medicine that contains the active substance quetiapine.
Danish: Seroquel XR er et antipsykotisk lægemiddel, som indeholder det aktive stof quetiapin.
English: On 15 May 2009, the Netherlands and all the other concerned Member States rejected a change (variation) to the marketing authorisation to add as a new indication the treatment of recurrent depressive episodes in patients with major depressive disorder (MDD).
Danish: Den 15. maj 2009 afviste Nederlandene og alle de øvrige berørte medlemsstater en ændring i markedsføringstilladelsen, hvor der skulle tilføjes en ny behandlingsindikation med tilbagevendende depressive episoder hos patienter med svær depression (MDD).
English: Since these neurotransmitters are involved in schizophrenia and bipolar disorder, quetiapine helps to normalise the activity of the brain, reducing the symptoms of these diseases.
Danish: Disse neurotransmittere er aktive ved skizofreni og bipolar lidelse, og quetiapin medvirker derfor til at normalisere hjerneaktiviteten, så symptomerne på disse sygdomme mindskes.
English: It is also used for the prevention and treatment of bipolar disorder, a mental illness in which patients have manic episodes (periods of abnormally high mood), alternating with periods of normal mood, as well as episodes of depression.
Danish: Det anvendes også til forebyggelse og behandling af bipolar lidelse, som er en psykisk sygdom, hvor patienterne har maniske episoder (perioder med unormal opstemthed) vekslende med perioder med normal tilstand og episoder med depression.
English: The indication excluded the use of Seroquel XR as initial treatment, and restricted its use only to patients who cannot be appropriately managed on alternative antidepressant treatment.
Danish: Denne indikation udelukkede anvendelse af Seroquel XR som indledende behandling og begrænsede anvendelsen alene til patienter, som ikke kan behandles på en tilstrækkelig måde med alternative antidepressiva.
English: Seroquel XR is available as prolonged-release tablets.
Danish: Seroquel XR er tilgængeligt som depottabletter.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that Seroquel XR can be used as add-on to ongoing treatment for major depressive episodes in patients with major depressive disorder who have had sub-optimal response to treatment with other antidepressants.
Danish: Lægemiddelagenturets Udvalg for Lægemidler til Mennesker (CHMP) har konkluderet, at Seroquel XR kan anvendes som tillægsbehandling af svære depressive episoder hos patienter med svær depression, der har responderet suboptimalt på behandling med andre antidepressiva.
English: The Committee recommended that the medicine be used as add-on to ongoing treatment for major depressive episodes in MDD patients who have had sub-optimal response to monotherapy with another antidepressant.
Danish: CHMP anbefalede, at lægemidlet anvendes som tillægsbehandling til igangværende behandling for svær depression hos MDD-patienter, som responderer suboptimalt på monoterapi med andre antidepressiva.
English: No special treatment is required.
Danish: Der behøves ingen specialbehandling.
English: These medicines should be taken in the morning.
Danish: Disse lægemidler bør tages om morgenen.
English: • is pregnant or might be pregnant.
Danish: • er gravid eller kan tænkes at være gravid.
English: The combination should be avoided.
Danish: Denne kombination bør undgås.
English: Bioavailability is in the order of 15%.
Danish: Biotilgængeligheden er i størrelsesordenen 15 %.
English: Terminal half life (t½) is 3.5-4 hours.
Danish: Den terminale halveringstid (t½) er 3,5-4 timer.
English: Frequency not known (reported from use in adults)
Danish: Hyppighed kendes ikke (rapporteret fra anvendelse hos voksne)
English: - suffers from an autoimmune disease (where the body's own immune (defence) system attacks parts of the body).
Danish: - har en autoimmun sygdom (hvor kroppens eget forsvarssystem (immunforsvaret) angriber dele af kroppen).
English: Treatment difference (SE)
Danish: Behandlingsbetinget forskel (SE)
English: Treatment was administered for up to two years.
Danish: Behandlingen blev administreret i op til to år.
English: 5- or 8-methoxypsoralen
Danish: 5- eller 8-methoxypsoralen
English: The treatment effects on sleep variables were associated with improved parents' well-being.
Danish: Behandlingens virkninger på søvnvariabler var forbundet med bedre trivsel hos forældrene.
English: Interaction studies have only been performed in adults.
Danish: Der er kun foretaget interaktionsstudier hos voksne.
English: It is important to continue taking this medicine to treat the condition.
Danish: Det er vigtigt at fortsætte med at tage dette lægemiddel for at behandle sygdommen.
English: If possible, administration of NSAIDs should be avoided in the evening.
Danish: Om muligt bør det undgås at administrere NSAID om aftenen.
English: What it is used for
Danish: Hvad anvendes det til?
English: Tablets should be swallowed whole.
Danish: Tabletterne bør synkes hele.
English: Common: may affect between 1 in 100 to 1 in 10 people
Danish: Almindelig: kan optræde hos mellem 1 ud af 100 til 1 ud af 10 personer
English: The tablets should be taken after the evening meal, i.e. on a full stomach.
Danish: Tabletterne bør tages efter aftensmaden, dvs. på fuld mave.
English: Autoimmune diseases
Danish: Autoimmune sygdomme
English: There is a significant first pass effect with an estimated first pass metabolism of 85%.
Danish: Der er en væsentlig first pass-effekt med en skønnet first pass-metabolisering på 85 %.
English: Data are available for up to 2 years' treatment.
Danish: Der foreligger data for behandling i op til 2 år.
English: If this change in behaviour occurs, you must tell your doctor.
Danish: Indtræder der en sådan ændring i adfærd, skal du sige det til lægen.
English: Do not give this medicine to children below the age of 2 years as it has not been tested and its effects are unknown.
Danish: Børn under 2 år Giv ikke dette lægemiddel til børn under 2 år, da det ikke er testet, og dets virkninger er ukendte.
English: Mood swings, Aggression, Irritability
Danish: Humørsvingninger, aggression, irritabilitet
English: The medicine can help you or your child fall asleep and may help you or your child sleep for longer during the night.
Danish: Lægemidlet kan hjælpe dig eller dit barn til at falde i søvn og kan hjælpe dig eller dit barn til at sove længere om natten.
English: Melatonin is a hormone produced naturally by the body.
Danish: Melatonin er et hormon, der naturligt dannes af kroppen.
English: • Low levels of white blood cells (neutropenia)
Danish: • Lavt antal hvide blodlegemer (neutropeni)
English: Interactions with other medicines
Danish: Interaktioner med andre lægemidler
English: Total score
Danish: Samlet score
English: For social functioning (CGAS), the differences between Slenyto and placebo were small and not statistically significant (Table 1).
Danish: For social funktion (CGAS) var forskellene mellem Slenyto og placebo små og ikke statistisk signifikante (tabel 1).
English: The absorption of orally ingested melatonin is complete in adults and may be decreased by up to 50% in the elderly.
Danish: Absorptionen af oralt indtaget melatonin er fuldstændig hos voksne, men kan være op til 50 % nedsat hos de ældre.
English: Open label treatment period results (91weeks)
Danish: Resultater af åben behandlingsfase (91 uger)
English: Slenyto should be taken in the evening, 30 to 60 minutes before bedtime.
Danish: Slenyto bør tages om aftenen, 30-60 minutter før sengetid.
English: Unexpected changes in behaviour, such as aggression, may occur commonly (affecting between 1 in 100 to 1 in 10 people).
Danish: Uventet ændret adfærd, såsom aggression, kan forekomme almindeligt (hos mellem 1 ud af 100 og 1 ud af 10 personer).
English: Smoking can increase the breakdown of melatonin by the liver, which may make this medicine less effective.
Danish: Rygning kan øge nedbrydningen af melatonin i leveren, hvilket kan gøre dette lægemiddel mindre effektivt.
English: As a precautionary measure, it is preferable to avoid the use of melatonin during pregnancy.
Danish: Som forsigtighedsregel må det foretrækkes at undgå anvendelse af melatonin under graviditet.
English: Taking more than the recommended daily dose may make you/your child feel drowsy.
Danish: Ved at tage mere end den anbefalede daglige dosis kan du/dit barn blive døsig.
English: For children and adolescents aged 2-18
Danish: For børn og unge i alderen 2-18 år
English: DO NOT take Slenyto if you or your child: - is allergic to melatonin or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag IKKE Slenyto hvis du eller dit barn: - er allergisk over for melatonin eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6).
English: This finding is compatible with the short half-life of melatonin in humans.
Danish: Dette resultat er foreneligt med den korte halveringstid af melatonin hos mennesker.
English: Concomitant administration resulted in increased impairment of attention, memory and co-ordination compared to zolpidem alone.
Danish: Samtidig administration resulterede i øget svækkelse af opmærksomhed, hukommelse og koordination i forhold til zolpidem alene.
English: DATE OF REVISION OF THE TEXT {DD month YYYY}
Danish: DATO FOR ÆNDRING AF TEKSTEN {DD måned ÅÅÅÅ}
English: - This medicine has been prescribed for you or your child only.
Danish: - Dette lægemiddel er ordineret til dig eller til dit barn personligt.
English: The maximum daily dose that you/your child will receive is 10 mg (two 5-mg tablets).
Danish: Den maksimale daglige dosis, som du/dit barn vil få, er 10 mg (to 5 mg-tabletter).
English: 4.7 Effects on ability to drive and use machines Melatonin has a moderate influence on the ability to drive and use machines.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Melatonin påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: After at least 3 months of treatment, the physician should evaluate the treatment effect and consider stopping treatment if no clinically relevant treatment effect is seen.
Danish: Efter mindst 3 måneders behandling bør lægen evaluere behandlingseffekten, og overveje seponering hvis der ikke ses klinisk relevant behandlingseffekt.
English: Read all of this leaflet carefully before you or your child starts taking this medicine because it contains important information.
Danish: Læs hele denne indlægsseddel grundigt, inden du eller dit barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger.
English: Do not drink alcohol before, during or after taking Slenyto, because alcohol weakens the effect of the medicine.
Danish: Indtag ikke alkohol før, under eller efter indtagelse af Slenyto, da alkohol nedsætter lægemidlets virkning.
English: A five-fold variability in Cmax between different members of the same sex has also been observed.
Danish: Der er desuden set en forskel på en faktor 5 i Cmax mellem forskellige personer af samme køn.
English: Patients had a significantly decreased total excretion of 6-sulfatoxymelatonin compared with controls.
Danish: Patienterne havde væsentligt nedsat total udskillelse af 6-sulfatoxymelatonin i forhold til kontrolpersonerne.
English: After taking this medicine, you or your child should not drive a vehicle, ride a bicycle, or use machinery until completely recovered.
Danish: Efter at have taget dette lægemiddel bør du eller dit barn ikke føre motorkøretøj, cykle eller betjene maskiner, før virkningen helt har fortaget sig.
English: In the absence of specific studies in children, the drug interactions with melatonin are those known in adults.
Danish: I mangel af specifikke studier hos børn er lægemiddelinteraktionerne med melatonin dem, der kendes fra voksne.
English: Slenyto shortens the time it takes to fall asleep and lengthens the duration of sleep.
Danish: Slenyto forkorter den tid, det tager at falde i søvn, og forlænger søvnen.
English: A slight effect on post-natal growth and viability was found in rats only at very high doses, equivalent to approximately 2000 mg/day in humans.
Danish: Der er kun fundet ringe effekt på den postnatale vækst og levedygtighed hos rotter ved meget høje doser svarende til ca. 2 000 mg/dag hos mennesker.
English: However, no pharmacodynamic differences between males and females were found despite differences in blood levels.
Danish: Der er imidlertid ikke fundet farmakodynamiske forskelle mellem personer af hun- og hankøn trods forskelle i blodkoncentration.
English: 5 mg strength
Danish: Styrke 5 mg
English: How much
Danish: Hvor meget
English: Data in animals indicate maternal transfer of melatonin to the foetus via the placenta or in the milk.
Danish: Data fra dyr tyder på, at der overføres melatonin fra moderen til fostret via placenta eller gennem mælken.
English: If there is no improvement in your/your child's symptoms, your doctor may increase the dose of Slenyto to find the most suitable dose for you/your child.
Danish: Hvis der ikke er bedring i dine eller dit barns symptomer, vil lægen muligvis sætte dosis af Slenyto op for at finde den bedst egnede dosis til dig/dit barn.
English: How long
Danish: Hvor længe
English: If an inadequate response has been observed, the dose should be increased to 5 mg, with a maximal dose of 10 mg.
Danish: Ved inadækvat respons bør dosis øges til 5 mg; den maksimale dosis er 10 mg.
English: Concomitant use of the following medicinal products should be considered with caution:
Danish: Samtidig brug af følgende lægemidler kræver nøje overvejelse:
English: There is no relevant use of melatonin in children aged 0 to 2 years for the treatment of insomnia.
Danish: Det er ikke relevant at anvende melatonin hos børn i alderen 0 til 2 år til behandling af søvnløshed.
English: Slenyto should be taken once daily, 0.5-1 hour before bedtime and with or after food.
Danish: Slenyto tages én gang dagligt, 0,5-1 time før sengetid, sammen med eller efter et måltid.
English: Adverse reactions are listed according to MedDRA system organ class and frequency category.
Danish: Bivirkninger er opført efter MedDRA-systemorganklasse og hyppighed.
English: - has liver or kidney problems.
Danish: - har lever- eller nyreproblemer.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release Iberfar Indústria Farmacêutica S.A.,
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE Navn og adresse på fremstilleren (fremstillerne) ansvarlig(e) for batchfrigivelse Iberfar Indústria Farmacêutica S.A.,
English: 74 patients completed 104 weeks of treatment, 39 completed 2 years and 35 completed 21 months of Slenyto treatment.
Danish: 74 patienter gennemførte 104 ugers behandling, 39 gennemførte 2 år, og 35 gennemførte 21 måneder med behandling med Slenyto.
English: After 2 weeks withdrawal on placebo, a descriptive reduction in most scores was seen but levels were still significantly better than baseline levels with no signs of rebound effects.
Danish: Efter 2 ugers seponering på placebo sås en deskriptiv reduktion i de fleste scoreværdier, som dog stadig var væsentligt bedre end baseline-niveauerne, uden at der var tegn på rebound-effekt.
English: If a lower treatment effect is seen after titration to a higher dose, the prescriber should first consider a down-titration to a lower dose before deciding on a complete discontinuation of treatment.
Danish: Hvis der ses lavere behandlingseffekt efter titrering til en højere dosis, bør den ordinerende først overveje nedtitrering til en lavere dosis, inden der tages stilling til fuldstændig seponering af behandlingen.
English: In a clinical trial, there was clear evidence for a transitory pharmacodynamic interaction between melatonin and zolpidem one hour following co-dosing.
Danish: I et klinisk studie var der tydelige tegn på forbigående farmakodynamisk interaktion mellem melatonin og zolpidem en time efter samtidig administration.
English: Alcohol should not be taken with melatonin, because it reduces the effectiveness of melatonin on sleep.
Danish: Alkohol Alkohol bør ikke indtages sammen med melatonin, da det reducerer virkningen af melatonin på søvn.
English: If the tablets are mixed with any other type of food, the tablets may not work properly.
Danish: Hvis tabletterne blandes med andre typer fødevarer, vil tabletterne muligvis ikke virke korrekt.
English: Thioridazine and imipramine
Danish: Thioridazin og imipramin
English: If any of the following side effects get serious or are troublesome, contact your doctor or seek medical advice:
Danish: Bliver nogen af følgende bivirkninger alvorlige eller generende, skal du kontakte lægen eller søge medicinsk rådgivning:
English: The recommended starting dose is 2 mg (two 1-mg tablets) once daily.
Danish: Den anbefalede startdosis er 2 mg (to 1-mg tabletter) 1 gang dagligt.
English: It is for the treatment of insomnia (sleeplessness) when a healthy sleeping routine (such as a regular bedtime and soothing sleeping environment) has not worked well enough.
Danish: Det er beregnet til at behandle søvnløshed, når sunde soverutiner (såsom regelmæssige sengetider og et beroligende sovemiljø) ikke har virket tilstrækkeligt.
English: France e-mail: regulatory@neurim.com
Danish: Frankrig e-mail: regulatory@neurim.com
English: The kinetics of melatonin are linear over the range of 2-8 mg.
Danish: Kinetikken af melatonin er lineær i området 2-8 mg
English: The activity of melatonin at the melatonin receptors (MT1, MT2 and MT3) is believed to contribute to its sleep-promoting properties, as these receptors (mainly MT1 and MT2) are involved in the regulation of circadian rhythms and sleep regulation.
Danish: Aktiviteten af melatonin ved melatonin-receptorerne (MT1, MT2 og MT3) antages at bidrage til dets søvnfremmende egenskaber, da disse receptorer (hovedsagelig MT1 og MT2) er involveret i reguleringen af døgnrytmen og søvn.
English: • quinolones (for example ciprofloxacin and norfloxacin) and rifampicin (used in the treatment of bacterial infections)
Danish: • quinoloner (f.eks. ciprofloxacin og norfloxacin) og rifampicin (anvendes til behandling af bakterielle infektioner)
English: A 3-4-fold increase in Cmax is apparent for women compared to men.
Danish: Der ses 3-4 gange højere Cmax hos kvinder end hos mænd.
English: The in vitro plasma protein binding of melatonin is approximately 60%.
Danish: In vitro-plasmaproteinbindingen af melatonin er ca. 60 %.
English: Combination with thioridazine and imipramine should be avoided.
Danish: Kombination med thioridazin og imipramin bør undgås.
English: Prepubertal children and young adults metabolize melatonin faster than adults.
Danish: Præpubertale børn og unge voksne metaboliserer melatonin hurtigere end voksne.
English: The effect of melatonin on newborns/infants is unknown.
Danish: Effekten af melatonin på nyfødte/spædbørn kendes ikke.
English: Table 1: CHILD BEHAVIOUR (13 weeks Double-blind)
Danish: Tabel 1: Gruppen vedrørende BØRNS ADFÆRD (13 ugers dobbeltblind)
English: The patient should be monitored at regular intervals (at least every 6 months) to check that Slenyto is still the most appropriate treatment.
Danish: Patienten bør overvåges med jævne mellemrum (mindst hver 6. måned) for at kontrollere, at Slenyto stadig er den bedst egnede behandling.
English: Please tell your doctor if you or your child starts or stops smoking during treatment.
Danish: Fortæl det til lægen, hvis du eller dit barn begynder at ryge eller holder op med at ryge under behandlingen.