FrancophonIA/ELRC3.0 huggingface dataset:
English: - Mirtazapine may increase the sedating properties of benzodiazepines and other sedatives (notably most antipsychotics, antihistamine H1 antagonists, opioids).
Danish: - Mirtazapin kan øge den sederende egenskab ved benzodiazepiner og andre sedativer (især de fleste former for antipsykotika, antihistamin H1 antagonister, opioider).
English: • if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers.
Danish: • Hvis du udvikler tegn på infektioner såsom uforklarlig høj feber, ondt i halsen og sår i munden.
English: Skip both doses and continue the next day with your normal morning and evening doses.
Danish: Spring begge doser over og fortsæt behandlingen med din normale morgen- og aftendosis.
English: The SPC proposals by the company were mainly based upon this MRP.
Danish: Forslagene til produktresuméet fra virksomheden var primært baseret på denne gensidige anerkendelsesprocedure.
English: The most commonly reported adverse reactions, occurring in more than 5 % of patients treated with Remeron in randomized placebo-controlled trials (see below) are somnolence, sedation, dry mouth, weight increased, increase in appetite, dizziness and fatigue.
Danish: De mest almindelige, rapporterede bivirkninger der forekom hos mere end 5 % af de patienter, der blev behandlet med Remeron i randomiserede, placebo-kontrollerede forsøg (se herunder), er somnolens, sedation, mundtørhed, vægtøgning, øget appetit, svimmelhed og træthed.
English: SPC Section 4.5 Special Warnings and precautions for use
Danish: Produktresumé, afsnit 4.5 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: The applicant/ MAH also agreed to include the interaction with MAOIs in section 4.3 of the SPC:
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen accepterede også at inkludere interaktionen med MAO-inhibitorer i afsnit 4.3 i produktresuméet:
English: It can increase the amount of Remeron in your blood.
Danish: Det kan øge mængden af Remeron i dit blod.
English: • Press the nozzle down as far as it will go, three times.
Danish: • Tryk tuden helt ned 3 gange.
English: Elevations in serum transaminase activities
Danish: Forøget serumtransaminase aktivitet
English: Tear off one tablet pocket along the dotted lines (Figure 1).
Danish: Riv en tabletlomme af langs perforationen (figur 1).
English: • If you have forgotten to take your dose of Remeron, do not take the missed dose.
Danish: • Hvis du har glemt at tage din Remeron dosis, må du ikke tage den glemte dosis.
English: 6 Cases of suicidal ideation and suicidal behaviours have been reported during mirtazapine therapy or early after treatment discontinuation (see section 4.4).
Danish: 6 Der er rapporteret tilfælde af selvmordstanker og selvmordsadfærd under mirtazapin behandling eller kort tid efter behandlingsophør (se pkt.
English: These do not include hereditary deficiencies of amino acid (phenylalanine) metabolism, such as phenylketonuria.
Danish: Disse omfatter ikke arvelige stofskiftesygdomme på grund af aminosyremangel (fenylalanin), f.eks. fenylketonuri.
English: Interaction with serotonergic active substances: serotonin syndrome may occur when selective serotonin reuptake inhibitors (SSRIs) are used concomitantly with other serotonergic active substances (see section 4.5).
Danish: Interaktion med serotonerge aktive stoffer: serotonergt syndrom kan forekomme, når selektive serotonin reuptake inhibitorer (SSRI'er) gives samtidig med andre serotonerge aktive stoffer (se pkt.
English: On 14 February 2007 a combined renewal via MRP was concluded for Remeron film-coated tablets 45 mg, Remeron 15, 30, 45 mg, Remeron oral solution 15 mg/ml, Mirtazapine orodispersible tablets 15, 30, 45 mg., involving in total 8 Member States, including the Reference Member State (RMS).
Danish: Den 14. februar 2007 vedtoges en kombineret fornyelse, via den gensidige anerkendelsesprocedure, for Remeron filmovertrukne tabletter, 45 mg, Remeron, 15, 30, 45 mg, Remeron oral opløsning 15 mg/ml, Mirtazapin smeltetabletter, 15, 30, 45 mg, som omfattede i alt otte medlemsstater, herunder referencemedlemsstaten (RMS).
English: • epileptic attack (convulsions) → Stop taking Remeron and tell your doctor straight away.
Danish: • Epileptiske anfald (kramper) → Stop behandlingen med Remeron og kontakt straks lægen.
English: The amount of phenylalanine is low in Remeron orodispersible tablets.
Danish: Mængden af fenylalanin er lav i Remeron smeltetabletter.
English: • inappropriate anti-diuretic hormone secretion
Danish: • Uhensigtsmæssig produktion af antidiuretisk hormon
English: Like with other antidepressants, the following should be taken into account: - Worsening of psychotic symptoms can occur when antidepressants are administered to patients with schizophrenia or other psychotic disturbances; paranoid thoughts can be intensified.
Danish: Som ved andre antidepressiva bør der tages højde for følgende: - Forværring af psykotiske symptomer kan forekomme, når antidepressiva administreres til patienter med skizofreni eller andre psykotiske tilstande.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG UMIDDELBARE PAKNING
English: A warning concerning the use during pregnancy and the possible risk of withdrawal effects on the newborn were recommended to be included in the PIL.
Danish: Det anbefaledes at medtage en advarsel i indlægssedlen om brugen under graviditet og den mulige risiko for seponeringssymptomer hos den nyfødte.
English: It is recommended to discontinue treatment with mirtazapine gradually to avoid withdrawal symptoms (see section 4.4).
Danish: Det anbefales at stoppe behandlingen med mirtazapin gradvist for at undgå abstinenssymptomer (se pkt.
English: In rare cases Remeron can cause disturbances in the production of blood cells (bone marrow depression).
Danish: I sjældne tilfælde kan Remeron give forstyrrelser i produktionen af blodlegemer (knoglemarvsdepression).
English: Bottles contain 250 film-coated tablets.
Danish: Glassene indeholder 250 filmovertrukne tabletter.
English: The carton contains one brown (type III) glass bottle containing 66 ml of Remeron oral solution and one metering pump.
Danish: Æsken indeholder en brun (type III) glasflaske indeholdende 66 ml Remeron oral opløsning og en doseringspumpe.
English: BEFORE YOU TAKE REMERON
Danish: FØR DU TAGER REMERON
English: Convulsions (insults) Serotonin syndrome Oral paraesthesia
Danish: Kramper (anfald) Serotonergt syndrom Oral paræstesi
English: Outer carton and label, 15 mg/ml
Danish: Ydre emballage og mærke, 15 mg/ml
English: Therefore, the addition of a cross reference to section 4.3 of the SPC in section 4.5 (after the wording related to the interaction with MAOIs) was recommended, in line with the harmonised SPC for SSRIs and in line with the SPC for venlafaxine - a SNRI.
Danish: Derfor anbefales tilføjelsen af en krydshenvisning til afsnit 4.3 i produktresuméet i afsnit 4.5 (efter formuleringen angående interaktionen med MAO-inhibitorer), hvilket er i tråd med det harmoniserede produktresumé for SSRI'er og med produktresuméet for venlafaxin - et SNRI.
English: • if you have forgotten to take your morning dose, simply take it together with your evening dose.
Danish: • Hvis du har glemt din morgendosis, skal du tage den sammen med din aftendosis.
English: This should be taken into account when prescribing Remeron to this category of patients, particularly with severe hepatic impairment, as patients with severe hepatic impairment have not been investigated (see section 4.4).
Danish: Dette bør tages i betragtning ved ordinering af Remeron til denne gruppe patienter og især ved svær leverinsufficiens, idet patienter med svær leverinsufficiens ikke har været undersøgt (se pkt.
English: Remeron oral solution contains small amounts of ethanol (alcohol), less than 100 mg per daily dose.
Danish: Remeron oral opløsning indeholder en mindre mængde alkohol, mindre end 100 mg pr. daglig dosis.
English: The half-life of elimination is sufficient to justify once-a-day dosing.
Danish: Halveringstiden er tilstrækkelig til at begrunde doseringen med én daglig dosis.
English: The most likely signs of an overdose of Remeron (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
Danish: De mest almindelige symptomer på en overdosering med Remeron (uden anden medicin og alkohol) er søvnighed, desorientering og hjertebanken.
English: • thoughts of harming or killing yourself → Contact your doctor or go to a hospital straight away.
Danish: • Tanker om at gøre skade på dig selv eller selvmordstanker → Kontakt straks lægen, eller tag på hospitalet.
English: Blisters containing 7 and 10 film-coated tablets are available.
Danish: Der fås blisterkort med 7 og 10 filmovertrukne tabletter.
English: It may be harmful for patients with phenylketonuria.
Danish: Det kan være skadeligt for patienter med phenylketonuri.
English: The tablet will rapidly disintegrate and can be swallowed without water.
Danish: Tabletten vil hurtig opløses og kan synkes uden vand.
English: • sensations of numbness in the mouth (oral hypoaesthesia)
Danish: • fornemmelse af følelsesløshed i munden (oral hypoaesthesia)
English: Some people become less resistant to infection because Remeron can cause a temporary shortage of white blood cells (granulocytopenia).
Danish: Hos nogle personer vil kroppens modstandskraft overfor infektioner nedsættes, da Remeron kan medføre nedsættelse i antallet af hvide blodlegemer (granulocytopeni).
English: The metering pump is packed in a sealed plastic bag.
Danish: Doseringspumpen er pakket i en forseglet plasticpose.
English: Patients should avoid the performance of potentially dangerous tasks, which require alertness and good concentration, such as driving a motor vehicle or operating machinery, at any time when affected.
Danish: Patienter i behandling med antidepressiva bør undgå at udføre potentielt farlige opgaver, som kræver årvågenhed og stor koncentration, såsom at føre motorkøretøj eller betjene maskiner.
English: • drowsiness or sleepiness
Danish: • søvnighed og træthed
English: If you use Remeron until, or shortly before birth, your baby should be supervised for possible adverse effects.
Danish: Hvis du bruger Remeron indtil eller til kort før fødslen, skal dit nyfødte barn undersøges for eventuelle bivirkninger.
English: The supplied metering pump is packed in a sealed polyethylene bag.
Danish: Doseringspumpen er pakket i en forseglet polyethylen pose.
English: During clinical research with Remeron, undesirable effects have not been reported more often in elderly patients than in other age groups.
Danish: Klinisk forskning med Remeron har ikke vist en hyppigere frekvens af bivirkninger hos ældre patienter end hos andre aldersgrupper.
English: Also, do not take Remeron during the two weeks after you have stopped taking MAO inhibitors.
Danish: Du må heller ikke tage Remeron i to uger efter, at du er stoppet med at tage MAO-hæmmere.
English: Bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia thrombocytopenia) Eosinophilia
Danish: Knoglemarvsdepression (granulocytopeni, agranulocytose, aplastisk anæmi trombocytopeni) Eosinofili
English: Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters made of opaque polyvinyl chloride film and aluminium foil containing a heat-seal coating on the side in contact with the filmcoated tablets.
Danish: Remeron 15, 30 og 45 mg filmovertrukne tabletter er pakket i blisterkort fremstillet af ugennemsigtig polyvinyl chlorid film og aluminiumsfolie belagt med en varmforseglet belægning på den side, der er i kontakt med de filmovertrukne tabletter.
English: The carton contains one brown glass bottle with 66 ml of Remeron oral solution and one metering pump.
Danish: Æsken indeholder en brun glasflaske med 66 ml remeron oral opløsning og en doseringspumpe.
English: All randomized placebo-controlled trials in patients (including indications other than major depressive disorder), have been evaluated for adverse reactions of Remeron.
Danish: Alle randomiserede placebo-kontrollerede forsøg (inklusive andre indikationer end major depression), er blevet vurderet mht. bivirkninger ved Remeron.
English: The orodispersible tablets are packed in a child-resistant perforated unit dose blister.
Danish: Smeltetabletterne er pakket i en børnesikret perforeret enkeltdosis blister.
English: In laboratory evaluations in clinical trials transient increases in transaminases and gammaglutamyltransferase have been observed (however associated adverse events have not been reported statistically significantly more frequently with Remeron than with placebo).
Danish: Laboratorievurderinger i kliniske forsøg har vist kortvarige stigninger i transaminaser og gammaglutamyltransferaser (bivirkningerne er dog ikke set statistisk signifikant hyppigere med Remeron sammenlignet med placebo).
English: Children and adolescents under the age of 18 years Remeron should not be used in children and adolescents under the age of 18 years (see section 4.4).
Danish: Børn og unge under 18 år Remeron bør ikke anvendes til behandling af børn og unge under 18 år (se pkt.
English: → If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
Danish: → Hvis du på et eller andet tidspunkt tænker på at skade dig selv eller begå selvmord, skal du straks kontakte lægen eller tage på hospitalet.
English: Remeron contains aspartame, a source of phenylalanine.
Danish: Remeron indeholder aspartam som stammer fra phenylalanin.
English: • medicines for anxiety or insomnia such as benzodiazepines; medicines for schizophrenia such as olanzapine; medicines for allergies such as cetirizine; medicines for severe pain such as morphine.
Danish: • Medicin mod angst eller søvnløshed såsom benzodiazepiner; medicin mod skizofreni såsom olanzapin; medicin mod allergier såsom cetirizin; medicin mod voldsomme smerter såsom morfin.
English: Each tablet with 15 mg, 30 mg and 45 mg mirtazapine corresponds to 2.6 mg, 5.2 mg and 7.8 mg phenylalanine, respectively.
Danish: Hver tablet med 15 mg, 30 mg og 45 mg mirtazapin indeholder hhv. 2,6 mg, 5,2 mg og 7,8 mg phenylalanin.
English: Anxiety2, 5
Danish: Angst2, 5
English: It is best to take Remeron as a single dose before you go to bed.
Danish: Det er bedst at indtage Remeron som en enkelt dosis før sengetid.
English: Swallow your prescribed dose of Remeron without chewing, with some water or juice.
Danish: Tag tabletten uden at tygge på den, sammen med vand eller juice.
English: Insomnia3, 5
Danish: Søvnløshed3, 5
English: When carbamazepine or any other inducer of hepatic metabolism (such as rifampicin) is added to mirtazapine therapy, the mirtazapine dose may have to be increased.
Danish: Når carbamazapin eller en hvilken som helst anden induktor af levermetabolisme (såsom rifampicin) anvendes samtidig med mirtazapin behandling, skal mirtazapindosis muligvis forhøjes.
English: You need to prime it before your first dose.
Danish: Derfor skal du fylde pumpen inden du tager din første dosis.
English: 1 ml of Remeron oral solution contains 700 mg maltitol liquid.
Danish: 1 ml Remeron oral opløsning indeholder 700 mg flydende maltitol.
English: Remeron are film-coated tablets.
Danish: Remeron er filmovertrukne tabletter.
English: Do not store above 30 °C Store in the original package in order to protect from light and moisture
Danish: Må ikke opbevares over 30 °C Opbevares i den originale pakning for at beskytte mod lys og fugt
English: Among the various reported withdrawal symptoms, dizziness, agitation, anxiety, headache and nausea are the most frequently reported.
Danish: Blandt de forskellige seponeringssymptomer er de hyppigst rapporterede svimmelhed, agitation, angst, hovedpine og kvalme.
English: If you take more Remeron than you should → If you or someone else have taken too much Remeron, call a doctor straight away.
Danish: Hvis du har taget for meget Remeron → Hvis du eller andre har taget for meget Remeron, skal du straks kontakte lægen.
English: Mirtazapine
Danish: Mirtazapin
English: In that case, talk to your doctor again after another 2 to 4 weeks.
Danish: Efter yderligere 2 til 4 uger kontaktes lægen igen.
English: If you stop taking Remeron → Only stop taking Remeron in consultation with your doctor.
Danish: Hvis du holder op med at tage Remeron → Behandlingen med Remeron må kun stoppes efter aftale med din læge.
English: BEFORE YOU TAKE REMERON Take care when taking Remeron in combination with:
Danish: FØR DU TAGER REMERON Vær forsigtig, når du tager Remeron samtidig med:
English: Remeron tablets 15, 30 and 45 mg Remeron orodispersible tablets 15, 30 and 45 mg Remeron oral solution 15 mg/ml
Danish: Remeron, tabletter, 15, 30 og 45 mg Remeron, smeltetabletter, 15, 30 og 45 mg Remeron, oral opløsning, 15 mg/ml
English: SPECIAL STORAGE CONDITIONS Do not store above 30 °C
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares over 30 °C
English: Important information about some of the ingredients of Remeron Remeron tablets contain lactose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Remeron Remeron tabletter indeholder lactose.
English: Clear, colourless-to-straw aqueous solution with a characteristic citrus-orange odour.
Danish: Klar, farveløs til gullig vandig opløsning med en karakteristisk citrus/appelsinduft.
English: Inappropriate antidiuretic hormone secretion
Danish: Uhensigstsmæssig produktion af antidiuretisk hormon
English: Do not take Remeron in combination with:
Danish: Tag ikke Remeron samtidig med:
English: • feeling anxious
Danish: • følelse af ophidsethed
English: Remeron 15, 30 and 45 mg film-coated tablets are packed in blisters or bottles.
Danish: Remeron 15, 30 og 45 mg filmovertrukne tabletter er pakket i blisterkort eller i glas.
English: Pharmacodynamic interactions - Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Danish: Farmakodynamiske interaktioner - Mirtazapin bør ikke administreres samtidig med MAO-inhibitorer eller inden for to uger efter ophør med behandling med MAO-inhibitorer.
English: Remeron oral solution is a clear, colourless - to pale yellow solution with a citrus-orange odour.
Danish: Remeron oral opløsning er en klar, farveløs til gullig vandig opløsning med en karakteristisk citrus/appelsinduft.
English: Mirtazapine should be discontinued in any patient entering a manic phase.
Danish: Behandling med mirtazapin bør ophøre, såfremt en patient går i manisk fase.
English: Hallucinations Psychomotor restlessness (incl.
Danish: Psykomotorisk uro (inkl.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Danish: Disse tanker kan blive værre, lige når du begynder at tage antidepressiva, fordi det tager tid, før denne form for medicin begynder at virke.
English: 6 orodispersible tablets 18 orodispersible tablets 30 orodispersible tablets 48 orodispersible tablets 96 orodispersible tablets
Danish: 6 smeltetabletter 18 smeltetabletter 30 smeltetabletter 48 smeltetabletter 96 smeltetabletter
English: Organon (Ireland) Limited, PO Box 2857,
Danish: Organon (Ireland) Limited, PO Box 2857, Drynam Road, Swords, Co. Dublin, Ireland
English: SPECIAL STORAGE CONDITIONS Store in the original package in order to protect from light and moisture
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale pakning for at beskytte mod lys og fugt
English: • if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Remeron.
Danish: Tag ikke Remeron - hvis du er allergisk (overfølsom) over for mirtazapin eller et af de øvrige indholdsstoffer.
English: SPC Section 4.1 Therapeutic Indications
Danish: Produktresumé, afsnit 4.1 Terapeutiske indikationer
English: Store in the original package in order to protect from light and moisture Medicines should not be disposed of via wastewater or household waste.
Danish: Opbevares i den originale pakning for at beskytte mod lys og fugt Af hensyn til miljøet må du ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: The bottle containing the oral solution is closed with a child-resistant screw cap and a seal which is broken when the cap is unscrewed.
Danish: Flasken med oral opløsning er lukket med et skruelåg med børnesikring og forsegling, som brydes når låget skrues af.
English: Oral hypoaesthesia
Danish: Oral hypoastesi
English: To open the nozzle, turn it anticlockwise as far as it will go (about one-quarter turn).
Danish: For at åbne drejes tuden mod uret indtil den ikke kan drejes længere (ca. en kvart omgang).
English: Member State Marketing Authorisation Holder
Danish: Medlemslande Indehaver af markedsføringstilladelsen
English: Mirtazapine should not be administered concomitantly with MAO inhibitors or within two weeks after discontinuation of MAO inhibitor therapy.
Danish: Mirtazapin bør ikke administreres samtidig med MAO-inhibitorer eller inden for to uger efter ophør med behandling med MAO-inhibitorer.
English: Nightmares2
Danish: Mareridt2
English: You can take Remeron with or without food.
Danish: Du kan indtage Remeron sammen med mad og drikke.
English: The unlocked position is the normal position for discharging the oral solution.
Danish: Den åbne position er normalindstillingen når man ønsker at pumpe opløsning op.
English: Use in children and adolescents under 18 years of age Remeron should normally not be used for children and adolescents under 18 years.
Danish: Remeron bør normalt ikke anvendes til børn og unge under 18 år.
English: Tear off one tablet pocket
Danish: Riv en tabletlomme af
English: There are slight pharmacokinetic differences between oral solution and tablets; although these differences are likely to be of no clinical relevance, care should be taken when switching from tablets to oral solution.
Danish: Selv om disse forskelle sandsynligvis ikke er kliniske relevante bør der udvises forsigtighed, når der skiftes fra tabletter til oral opløsning.
English: - the Summaries of Products Characteristic, labelling, package leaflet and Module 3 proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - Produktresuméer, etikettering, indlægsseddel og afsnit 3, som foreslået af indehaverne af markedsføringstilladelsen, er blevet vurderet på grundlag af den indsendte dokumentation og den faglige drøftelse i udvalget anbefaler CHMP en ændring af markedsføringstilladelserne for Remeron og tilknyttede navne (sebilag I).
English: It will rapidly disintegrate and can be swallowed without water.
Danish: Tabletterne vil hurtigt opløses og kan synkes uden vand.
English: Mirtazapine Zispin® Soltab® orodispersible tablets
Danish: Mirtazapine Zispin® Soltab® smeltetabletter
English: SPC Section 4.3 Contraindications
Danish: Produktresumé, afsnit 4.3 Kontraindikationer
English: The solution should be taken orally, in a glass containing some water.
Danish: Opløsningen indtages oralt, opløst i et glas vand.
English: Binding of mirtazapine to plasma proteins is approx. 85 %.
Danish: Ca. 85 % af mirtazapin bindes til plasmaproteiner.
English: The supplied bottle with Remeron oral solution is closed with a sealed, polypropylene screw cap which has child-resistant features.
Danish: Flasken med Remeron oral opløsning er lukket med et forseglet, polypropylen skruelåg med børnesikring.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling, package leaflet and Module 3.
Danish: Ud fra følgende betragtninger: - Formålet med indbringelsen af sagen var harmonisering af produktresuméer, etikettering, indlægsseddel og afsnit 3.
English: Oral use mirtazapine Remeron
Danish: Oral anvendelse mirtazapine Remeron
English: In combination with Remeron these medicines can reduce the amount of Remeron in your blood.
Danish: Disse typer medicin kan i kombination med Remeron nedsætte mængden af Remeron i dit blod.