FrancophonIA/ELRC3.0 huggingface dataset:
English: As explained in the referral application dossier, animal studies have shown that mirtazapine induces only a small and temporary increase in noradrenalin and serotonin levels in the hippocampus (data available on request).
Danish: Som forklaret i ansøgningsdokumentationen ved indbringelsen har dyreundersøgelser vist, at mirtazapin kun fremkalder en lille og midlertidig stigning i noradrenalin- og serotoninniveauerne i hippocampus (data tilgængelige efter anmodning).
English: Further the recommendations by the Pharmacovigilance Working Party with respect to the core SPC for antidepressants were implemented.
Danish: Desuden blev anbefalingerne fra arbejdsgruppen vedrørende lægemiddelovervågning med henblik på det grundlæggende produktresumé for antidepressiva implementeret.
English: If you are supposed to take your dose once a day
Danish: Hvis du skal tage din dosis én gang daglig
English: Mirtazapine is a centrally active presynaptic α2-antagonist, which increases central noradrenergic and serotonergic neurotransmission.
Danish: Mirtazapin er en centralt virkende præsynaptisk α2-antagonist, som øger den centrale noradrenerge og serotonerge neurotransmission.
English: In addition, the most recent EU Guideline was only established in 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/EWP/225/02).
Danish: Desuden blev den seneste EU-vejledning for vurdering af farmakokinetikken for lægemidler hos patienter med nedsat nyrefunktion først fastlagt i 1994 (Note for Guidance on the evaluation on the pharmacokinetics of medicinal products in patients with impaired renal function, CHMP/EWP/225/02).
English: Finally, the referral SPCs were revised in accordance with the European Commission (EC) Guideline on SPC, October 2005.
Danish: Endelig blev de indbragte produktresuméer revideret i henhold til Europa-Kommissionens retningslinje vedrørende produktresuméer fra oktober 2005.
English: Organon Hellas S.A. 122, Vouliagmenis Av. Helliniko
Danish: Grækenland Organon Hellas S.A. 122, Vouliagmenis Av.
English: - Although Remeron is not addictive, post-marketing experience shows that abrupt termination of treatment after long term administration may sometimes result in withdrawal symptoms.
Danish: - Selvom Remeron ikke er afhængighedsskabende, viser postmarketing erfaringerne, at brat ophør af behandlingen efter langtidsadministration kan medføre seponeringssymptomer.
English: You could be more sensitive to the side-effects of antidepressants.
Danish: Du kan være mere følsom overfor bivirkninger af antidepressiv medicin.
English: The CHMP considered that a contraindication is acceptable, given the marginal influence on noradrenaline and serotonin levels and the post-marketing experience available to date.
Danish: CHMP vurderede, at en kontraindikation er acceptabel, i betragtning af den marginale indvirkning på noradrenalin- og serotoninniveauerne og den aktuelle erfaring efter markedsføring.
English: Major pathways of biotransformation are demethylation and oxidation, followed by conjugation.
Danish: Hovedbiotransformationsvejene er demethylering og oxidering efterfulgt af konjugering.
English: 1 bottle containing 66 ml
Danish: 1 flaske á 66 ml
English: With regards to the pathological alterations of blood count, the CHMP considered that proposed wording is acceptable, based on the meta-analysis report provided in the applicant/MAH's responses.
Danish: Med hensyn til de patologiske ændringer i blodtællingen vurderede CHMP, at den foreslåede formulering er acceptabel, på grundlag af den meta-analyserapport, som er tilvejebragt i svarene fra ansøgeren/indehaveren af markedsføringstilladelsen.
English: Abnormal dreams Confusion
Danish: Livagtige drømme Konfusion
English: Remeron may also be given in two divided doses (once in the morning and once at night-time, the higher dose should be taken at night).
Danish: Remeron kan også indtages som to delte doser (en dosis om morgenen og en dosis om aftenen ved sengetid; den største dosis bør tages om aftenen).
English: Cases of overdose should receive appropriate symptomatic and supportive therapy for vital functions.
Danish: I tilfælde af overdosering gives passende symptomatisk behandling og sikring af vitale funktioner.
English: • if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).
Danish: - hvis du tager eller for nyligt (inden for de sidste to uger) har taget medicin, der kaldes monoaminooxidase (MAO) hæmmere.
English: During the last PSUR period (01 Sep 2004 to 01 Sep 2007), 36 cases of hyponatraemia and 8 cases of SIADH were reported for mirtazapine (Remeron).
Danish: I løbet af den seneste PSUR-periode (1. sept. 2004 til 1. sept. 2007) blev der rapporteret 36 tilfælde af hyponatriæmi, og 8 tilfælde af SIADH blev rapporteret for mirtazapin (Remeron).
English: Since it is indicated in the Annex that aspartame, containing a source of phenylalanine may be harmful for people with phenylketonuria (and no comment is included in the Annex that a contraindication should be included in the SPC, such as done for peanut oil), this is not considered to be an absolute contraindication.
Danish: Da det fremgår af bilaget, at aspartam, der indeholder en kilde til fenylalanin, kan være skadelig for personer med fenylketonuri (og der ingen kommentarer er i bilaget om, at der skal være en kontraindikation i produktresuméet, som for jordnøddeolie), anses dette ikke for at være en absolut kontraindikation.
English: The tablet can be divided into equal halves.
Danish: Tabletten kan deles i to lige dele.
English: 4 N.B. dose reduction generally does not lead to less somnolence/sedation but can jeopardize antidepressant efficacy.
Danish: 4 N.B. dosisreduktion fører generelt ikke til mindre udtalt somnolens/sedation, men kan nedsætte den antidepressive virkning.
English: In the postmarketing period with Remeron very rare cases of agranulocytosis have been reported, mostly reversible, but in some cases fatal.
Danish: I postmarketingperioden for Remeron er der i meget sjældne tilfælde blevet rapporteret om agranulocytose, de fleste reversible, men i nogle tilfælde fatale.
English: Remeron oral solution comes with a metering pump to help you measure your dose.
Danish: Remeron oral opløsning leveres med en doseringspumpe til hjælp for at måle din dosis.
English: If you still don't feel better, your doctor may prescribe a higher dose.
Danish: Hvis du stadig ikke føler en forbedring, kan lægen forhøje dosis.
English: For consistency, the CHMP considered that these undesirable effects should also be stated under 4.8 (Undesirable Effects).
Danish: Af hensyn til konsekvensen vurderede CHMP, at disse bivirkninger også skal angives under 4.8 (Bivirkninger).
English: Since the mechanism of interaction is different for MAO-Is with mirtazapine compared to MAO-Is and SSRIs, it is unlikely that the risk of serotonin syndrome is as high as with other serotonergic antidepressants, such as SSRIs.
Danish: Da interaktionsmekanismen er forskellig for MAO-I med mirtazapin sammenlignet med MAO-I og SSRI'er, er det usandsynligt, at risikoen for serotoninsyndrom er lige så høj som med andre serotonerge antidepressiva, f.eks. SSRI'er.
English: Taking Remeron with food and drink You may get drowsy if you drink alcohol while you are taking Remeron.
Danish: Brug af Remeron sammen med mad og drikke Du kan blive søvnig, hvis du drikker alkohol samtidig med at du bruger Remeron.
English: However, caution should be exercised when used during pregnancy.
Danish: Men der bør udvises forsigtighed, når det bruges under graviditet.
English: The histamine H1-antagonistic activity of mirtazapine is associated with its sedative properties.
Danish: Mirtazapins histamin H1-antagonistiske aktivitet er forbundet med de sederende egenskaber.
English: In section 4.1 Therapeutic Indications of the SPC, the CHMP considered that the indication should be amended to: Episodes of major depression (or treatment of episodes of major depression) in accordance with the wording agreed for this indication for other products of which the SPC is harmonised in Europe.
Danish: I afsnit 4.1, Terapeutiske indikationer, i produktresuméet vurderede CHMP, at indikationen skulle ændres til: Svære depressive episoder (eller behandling af svære depressive episoder) i henhold til den vedtagne formulering for denne indikation for andre produkter, som produktresuméet er harmoniseret for i Europa.
English: The demethyl metabolite is pharmacologically active and appears to have the same pharmacokinetic profile as the parent compound.
Danish: Demethyl metabolitten er farmakologisk aktiv og synes at have den samme farmakokinetiske profil som mirtazapin.
English: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, carcinogenicity or genotoxicity.
Danish: Prækliniske data afslører ingen speciel fare for mennesker på baggrund af konventionelle studier af safety farmakologi, repeated dose toksicitet, carcinogenicitet eller genotoksicitet.
English: Additionally in Section 4.5 of the SPC, the CHMP considered it sufficient to state that Lithium and mirtazapine showed no pharmacokinetic interactions (last paragraph section 4.5) without further specifications.
Danish: I afsnit 4.5 i produktresuméet vurderede CHMP desuden, at det er tilstrækkeligt at angive, at litium og mirtazapin ikke havde nogen farmakokinetiske interaktioner (sidste punkt i afsnit 4.5) uden yderligere specifikationer.
English: Patients who are sensitive to phenylalanine are usually aiming for low phenylalanine levels (e.g. through diet), not complete abstinence of this source.
Danish: Patienter, der er overfølsomme over for fenylalanin, tilstræber normalt lave fenylalaninniveauer (f.eks. via kosten), ikke komplet abstinens fra denne kilde.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Remeron should be made taking into account the benefit of breastfeeding to the child and the benefit of Remeron therapy to the woman.
Danish: En beslutning om, hvorvidt amningen skal fortsætte eller stoppe eller om behandlingen med Remeron skal fortsætte eller stoppe, bør være baseret på afvejning af fordelene for barnet ved amning og fordelene af Remeron behandlingen for kvinden.
English: To investigate the impact of renal impairment on the pharmacokinetics of mirtazapine, the applicant/MAH made reference to a clinical trial that was designed specifically for that purpose (trial 22503).
Danish: For at undersøge virkningen af nyrebeskadigelse på farmakokinetikken for mirtazapin henviser ansøgeren/indehaveren af markedsføringstilladelsen til en klinisk undersøgelse, som blev udformet specifikt til dette formål (undersøgelse 22503).
English: The following amendments to the PIL were recommended, in line with the changes made to the SPC.
Danish: Følgende ændringer til indlægssedlen anbefaledes, i overensstemmelse med ændringerne i produktresuméet.
English: The enhancement of serotonergic neurotransmission is specifically mediated via 5-HT1 receptors, because 5-HT2 and 5-HT3 receptors are blocked by mirtazapine.
Danish: Øgningen af den serotonerge neurotransmission er specifikt medieret via 5-HT1 receptorer, fordi 5-HT2 og 5-HT3 receptorerne bliver blokeret af mirtazapin.
English: The Annex explicitly mentions those excipients that require to be mentioned as a contraindication (e.g. hypersensitivity to peanut or soya oil).
Danish: Bilaget angiver udtrykkeligt de hjælpestoffer, der skal nævnes som en kontraindikation (f.eks. overfølsomhed over for jordnødde- eller soyaolie).
English: The use of aspartame as presented in these amounts in Remeron orodispersible tablets is not an absolute contraindication.
Danish: Brugen af aspartam i de mængder, det findes i Remeron smeltetabletter, er ikke en absolut kontraindikation.
English: Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
Danish: Desuden gøres opmærksom på, at patienter under 18 år har øget risiko for bivirkninger som f.eks. selvmordsforsøg, selvmordstanker og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede), når de behandles med denne type medicin.
English: Mirtazapine displays linear pharmacokinetics within the recommended dose range.
Danish: Mirtazapin udviser lineær farmakokinetik indenfor den anbefalede dosering.
English: The meta-analysis considered 20 trials, with a planned duration of treatment up to 12 weeks, with 1501 patients (134 person years) receiving doses of mirtazapine up to 60 mg and 850 patients (79 person years) receiving placebo.
Danish: Metaanalysen omfattede 20 forsøg, med en planlagt behandlingsvarighed på op til 12 uger, med 1501 patienter (134 person-år), som anvendte mirtazapin med doser op til 60 mg, og 850 patienter (79 person-år), der anvendte placebo.
English: WHAT REMERON IS AND WHAT IT IS USED FOR Remeron is one of a group of medicines called antidepressants.
Danish: REMERON'S VIRKNING OG HVAD DU SKAL BRUGE DET TIL Remeron tilhører gruppen af medicin, der kaldes antidepressiva.
English: Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and
Danish: Træk forsigtig folien af ved at starte i det hjørne, som er markeret med en pil (figur 2 og 3)
English: The low number of post-marketing reports suggests that this interaction does not occur frequently and do not warrant any change to the location in the SPC where the warning for concomitant use of Remeron with MAO-Is is provided.
Danish: Det lave antal rapporteringer efter markedsføring antyder, at denne interaktion ikke forekommer hyppigt og ikke berettiger til en ændring af placeringen af advarslen for samtidig anvendelse af Remeron med MAO-I i produktresuméet.
English: Each blister contains six tablet pockets, which are separated by perforations.
Danish: Hver blister indeholder seks tabletlommer, som er adskilt med perforationer.
English: Mirtazapine is indicated for episodes of major depression.
Danish: Mirtazapin er indiceret ved svære depressive episoder.
English: As a conclusion to the discussion, the following text was subsequently agreed between the CHMP and the applicant/MAH to include the following: deletion of reference to section 4.3 for serotonin syndrome, deletion of “other” and the addition of “venlafaxine” in the text below.
Danish: Som en konklusion på drøftelsen blev følgende tekst efterfølgende vedtaget mellem CHMP og ansøgeren/indehaveren af markedsføringstilladelsen, idet den indeholder følgende: sletning af henvisningen til afsnit 4.3 for serotoninsyndrom, sletning af "andre" og tilføjelsen af "venlafaxin" i teksten nedenfor.
English: After a click, there should be one final tightening to ensure that the pump is securely screwed in place.
Danish: Efter et klik bør man stramme til endnu en gang for at sikre, at pumpen er skruet helt fast.
English: Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.
Danish: Selvmordsrelateret adfærd (selvmordsforsøg og selvmordstanker) og fjendtlighed (fortrinsvis aggression, oppositionel adfærd og vrede) blev i kliniske undersøgelser observeret hyppigere blandt børn og unge behandlet med antidepressive midler i forhold til gruppen behandlet med placebo.
English: In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow.
Danish: I sjældne tilfælde kan disse symptomer være tegn på forstyrrelser i produktionen af blodceller i knoglemarven.
English: Do not suddenly stop taking Remeron, even when your depression has lifted.
Danish: Du må ikke pludselig stoppe behandlingen med Remeron, også selv om din depression er blevet bedre.
English: At that time, in 1989, the cut-off values for the level of renal impairment were in line with FDA draft Guidance for Industry on “Pharmacokinetics and Pharmacodynamics in patients with Impaired renal function: study design, data analysis, and impact on dosing and labelling”.
Danish: På dette tidspunkt, i 1989, var grænseværdierne for niveauet af nyrebeskadigelse på linje med udkastet til FDA's branchevejledning for farmakokinetik og farmakodynamik hos patienter med nedsat nyrefunktion: undersøgelsesopbygning, dataanalyse og indvirkning på dosering och etikettering.
English: Elderly patients are often more sensitive, especially with regard to the undesirable effects of antidepressants.
Danish: Ældre patienter er ofte mere følsomme, især hvad angår bivirkninger ved brug af antidepressiva.
English: The CHMP was of the opinion that Phenylketonuria, MAO inhibitors, and pathological alterations of blood count are considered absolute contra-indications.
Danish: CHMP var af den holdning, at fenylketonuri, MAO-inhibitorer og patologiske ændringer i blodtællingen anses for at være absolutte kontraindikationer.
English: When the pump is pressed for the first time it will not discharge the correct quantity of oral solution.
Danish: Når pumpen første gang trykkes ned, kan den ikke pumpe den korrekte mængde oral opløsning op.
English: • the antidepressant nefazodone.
Danish: • Den antidepressive medicin nefazodon.
English: The tablets should be taken orally.
Danish: Tabletterne bør indtages oralt.
English: In Section 4.2 Posology and method of administration of the SPC, the CHMP considered that the sentence “Treatment should preferably be continued until the patient has been completely symptomfree for 4-6 months” should be replaced by “Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free from symptoms.” (in accordance with the wording of other antidepressants).
Danish: I afsnit 4.2, Dosering og indgivelsesmåde, i produktresuméet vurderede CHMP, at sætningen "Behandlingen bør fortsætte, indtil patienten har været helt symptomfri i 4-6 måneder" skal erstattes med "Patienter med depression skal behandles i en tilstrækkelig periode på mindst 6 måneder for at sikre, at de er fri for symptomer."
English: When it is locked, no liquid will come out.
Danish: Når den er lukket, kan opløsningen ikke komme ud.
English: As at a higher dose of mirtazapine a more pronounced effect can not be excluded, it is advisable to monitor the INR in case of concomitant treatment of warfarin with mirtazapine.
Danish: Da det ikke kan udelukkes, at højere doser af mirtazapin kan forårsage en mere udtalt effekt, er det tilrådeligt at monitorere INR i tilfælde af samtidig behandling med warfarin og mirtazapin.
English: If you get a combination of these symptoms, talk to your doctor immediately.
Danish: Hvis du får en kombination af disse symptomer, skal du straks konsultere din læge.
English: Reversible agranulocytosis has been reported as a rare occurrence in clinical studies with Remeron.
Danish: Reversibel agranulocytose er rapporteret som en sjælden tilstand i kliniske studier med Remeron.
English: • sleeping problems
Danish: • søvnproblemer
English: Limited experience with Remeron administration to pregnant women does not indicate an increased risk.
Danish: Den begrænsede erfaring med administration af Remeron til gravide kvinder angiver ikke nogen øget risiko.
English: The applicant/MAH restricted the contra-indication to hypersensitivity only, in accordance with the EC Guideline on SPC, as only absolute contraindications should be mentioned and relative contraindications should move to the warning section 4.3 or section.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen begrænsede kontraindikationen til overfølsomhed i henhold til EU-vejledningen vedrørende produktresuméer, da kun absolutte kontraindikationer skal nævnes, og relative kontraindikationer skal flyttes til advarselsafsnit 4.4.
English: - Akathisia/psychomotor restlessness: The use of antidepressants have been associated with the development of akathisia, characterised by a subjectively unpleasant or distressing restlessness and need to move often accompanied by an inability to sit or stand still.
Danish: - Akatisi/psykomotorisk uro: Anvendelse af antidepressiva er blevet forbundet med udvikling af akatisi, karakteriseret ved subjektiv ubehagelig eller generende uro og behov for ofte at bevæge sig ledsaget af manglende evne til at sidde eller stå stille.
English: United Kingdom Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
Danish: Storbritannien Organon Laboratories Ltd, Cambridge Science Park, Milton Road,
English: Patients with a history of mania/hypomania should be closely monitored.
Danish: Patienter med mani/hypomani i anamnesen bør monitoreres tæt.
English: The frequency of adverse reactions from spontaneous reporting for which no cases in the randomized placebo-controlled patient trials were observed with mirtazapine has been classified as ‘not known'.
Danish: Hyppigheden af bivirkninger fra spontan rapportering, for hvilke der ikke blev observeret tilfælde i de randomiserede placebo-kontrollerede patientforsøg med mirtazapin, er klassificeret som ‘ikke kendt'.
English: Patients should therefore be advised to avoid alcoholic beverages while taking mirtazapine.
Danish: Patienter bør derfor tilrådes at undgå alkoholiske drikke, mens de tager mirtazapin.
English: The mean half-life of elimination is 20-40 hours; longer half-lives, up to 65 hours, have occasionally been recorded and shorter half-lives have been seen in young men.
Danish: Mirtazapin elimineres med en gennemsnitlig halveringstid på 20-40 timer; der er lejlighedsvis konstateret længere halveringstider på op til 65 timer, og kortere halveringstider er set hos unge mænd.
English: - Mirtazapine may increase the CNS depressant effect of alcohol.
Danish: - Mirtazapin kan øge den CNS-deprimerende effekt af alkohol.
English: Treatment should be discontinued in any patient who develops seizures, or where there is an increase in seizure frequency.
Danish: Behandlingen bør afbrydes hos patienter, der udvikler epileptiske anfald, eller hvor der ses en øgning i anfaldsfrekvensen.
English: The referral was triggered by the applicant and aims to harmonise major areas of discrepancy between the EU member states, with regard to the Summary of Product Characteristics (SPCs), Package Leaflets (PLs), labelling and Module 3 of the following products containing the active substance mirtazapine:
Danish: Indbringelsen blev foranlediget af ansøgeren og har til formål at harmonisere større uoverensstemmende områder mellem EU's medlemsstater med hensyn til produktresuméer, indlægssedler, etikettering og afsnit 3 for følgende produkter, der indeholder det aktive stof mirtazapin:
English: It has practically no anticholinergic activity and, at therapeutic doses, has practically no effect on the cardiovascular system.
Danish: Det har praktisk taget ingen anticholinerg aktivitet og har næsten ingen indvirkning på det kardiovaskulære system, når det gives i terapeutiske doser.
English: Invented Name Strength Pharmaceutical Form Route of administration
Danish: INN Navneforslag Styrke Farmaceutisk Form
English: • The active substance is mirtazapine.
Danish: • Aktivt stof: mirtazapin.
English: Present experience concerning overdose with Remeron alone indicates that symptoms are usually mild.
Danish: Erfaringen vedrørende overdosering med mirtazapin alene viser, at symptomerne sædvanligvis er lette.
English: Therefore, the following wording on pharmacodynamic interactions for Section 4.5 of the SPC was recommended:
Danish: Derfor anbefales følgende formulering for de farmakodynamiske interaktioner i afsnit 4.5 i produktresuméet:
English: It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Remeron:
Danish: Det er vigtigt, at du taler med din læge om virkningen af Remeron i de første par uger af behandlingen:
English: • if you have forgotten to take both doses, do not attempt to make up for the missed doses.
Danish: • Hvis har glemt begge doser, skal du ikke forsøge at erstatte de glemte doser.