FrancophonIA/ELRC3.0 huggingface dataset:
English: Press the nozzle down as far as it will go. Use a firm, smooth action - not too slow.
Danish: Tryk tuden helt i bund med en fast og jævn bevægelse - ikke for langsom.
English: If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms.
Danish: Hvis det, under hensyntagen til kliniske behov, alligevel besluttes at behandle patienter i denne gruppe, bør disse overvåges omhyggeligt for selvmordssymptomer.
English: • increase in appetite and weight gain
Danish: • øget appetit og vægtøgning
English: In rare cases Remeron can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
Danish: I sjældne tilfælde kan Remeron også bevirke en mangel på røde og hvide blodlegemer, såvel som blodplader (aplastik anæmi), blodplademangel (thrombocytopenia) eller et øget antal hvide blodlegemer (eosinophilia).
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Danish: Patienter (og omsorgspersoner) bør være meget opmærksomme på nødvendigheden af at monitorere for udvikling af kliniske forværringer, selvmordsadfærd eller selvmordstanker og unormale ændringer i opførelsen og på at søge lægelig hjælp med det samme, hvis sådanne symptomer er til stede.
English: As advised in section 4.2, it is recommended to discontinue treatment with mirtazapine gradually.
Danish: 4.2, anbefales det at nedtrappe behandling med mirtazapin gradvist.
English: Ethanol This medicinal product contains small amounts of ethanol, less than 100 mg per daily dose.
Danish: Ethanol Denne medicin indeholder en mindre mængde alkohol, mindre end 100 mg pr. daglig dosis.
English: In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure A).
Danish: Knus ikke smeltetabletten For at undgå knusning af smeltetabletten må du ikke trykke på tabletlommen (figur A).
English: Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported very rarely with the use of mirtazapine.
Danish: Hyponatriæmi, sandsynligvis forårsaget af uhensigstsmæssig produktion af antidiuretisk hormon (SIADH), har været rapporteret i meget sjældne tilfælde med mirtazapin.
English: Mirtazapine was not genotoxic in a series of tests for gene mutation and chromosomal and DNA damage.
Danish: Mirtazapin udviste ikke genotoksicitet i en række tests for genmutation og kromosom- og DNAskader.
English: Mirtazapine is extensively metabolized and eliminated via the urine and faeces within a few days.
Danish: Mirtazapin metaboliseres i udstrakt grad og udskilles via urinen og afføringen indenfor få dage.
English: The applicant/MAH was therefore asked to provide support for the cut-off at 40 ml/min as the range is normally defined as 30- 50 ml/min (moderate renal impairment).
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen blev derfor bedt om at støtte grænseværdien på 40 ml/min., da intervallet normalt defineres som 30- 50 ml/min.
English: Animal studies and limited human data have shown excretion of mirtazapine in breast milk only in very small amounts.
Danish: Dyreforsøg og begrænset erfaring fra kvinder har vist, at mirtazapin kun udskilles i meget små mængder i brystmælk.
English: If you suddenly stop taking Remeron you may feel sick, dizzy, agitated or anxious, and have headaches.
Danish: Hvis du pludselig stopper behandling med Remeron kan du komme til at føle dig utilpas, svimmel, ophidset eller ængstelig, og få hovedpine.
English: 15 mg 1 press 30 mg 2 presses 45 mg 3 presses
Danish: 15 mg 1 tryk 30 mg 2 tryk 45 mg 3 tryk
English: Mirtazapine does not significantly inhibit or induce CYP iso-enzymes.
Danish: Mirtazapin hverken hæmmer eller inducerer CYP-isoenzymer signifikant.
English: Therefore, the pump must be prepared (primed) by fully pressing down the nozzle 3 times; the oral solution which comes out of the nozzle should be disposed of.
Danish: Derfor skal den fyldes ved at den trykkes helt ned 3 gange; den orale opløsning som kommer ud af tuden bør kasseres.
English: The applicant/MAH stated that there are no data indicating that mirtazapine aggravates conditions where blood count is altered.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen fremførte, at der ikke findes data, som angiver, at mirtazapin forværrer tilstande med ændringer i blodtællingen.
English: Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson's disease).
Danish: Eksempler på MAO-hæmmere er moclobemid, tranylcypromine (begge er antidepressiva) og selegilin (anvendes ved Parkinsons sygdom).
English: • Not known:
Danish: • Ikke kendt:
English: Switching from tablets to oral solution
Danish: Skift fra tabletter til oral opløsning
English: That is the reason for the cut-off value of 40 ml/min/1.73 m2.
Danish: Dette er årsagen til grænseværdien på 40 ml/min./1,73 m2.
English: Importantly, patients with renal impairment and their doctors should be aware of the fact that in subjects with impaired renal function exposure to mirtazapine may be increased and that there is a positive correlation between severity and exposure.
Danish: Det er vigtigt, at patienter med nyrebeskadigelse samt deres læger er opmærksomme på, at forsøgspersoner med forringet nyrefunktion kan have en øget eksponering for mirtazapin, og at der er en positiv korrelation mellem sværhedsgrad og eksponering.
English: Make a note of the date of opening of the bottle.
Danish: Noter, hvornår flasken er åbnet første gang.
English: The effective daily dose is usually between 15 and 45 mg; the starting dose is 15 or 30 mg. Mirtazapine begins to exert its effect in general after 1-2 weeks of treatment.
Danish: Den effektive daglige dosis er sædvanligvis 15-45 mg. Startdosis er 15 eller 30 mg. Mirtazapins virkning begynder normalt efter 1-2 ugers behandling.
English: Both enantiomers of mirtazapine are presumed to contribute to the antidepressant activity, the S(+) enantiomer by blocking α2 and 5-HT2 receptors and the R(-) enantiomer by blocking 5-HT3 receptors.
Danish: Begge mirtazapins enantiomerer menes at medvirke til den antidepressive virkning, S(+) enantiomeren ved at blokere α2 og 5-HT2 receptorerne, og R(-) enantiomeren ved at blokere 5-HT3 receptorerne.
English: Remeron can increase the effects of warfarin on the blood.
Danish: Remeron kan øge effekten af warfarin i blodet.
English: Pharmacokinetic interactions.
Danish: Farmakokinetiske interaktioner.
English: Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.
Danish: Fortæl lægen eller apoteket, hvis du bruger (eller planlægger at bruge) en af nedenfor nævnte typer medicin.
English: In Sections 4.3 (Contra-indications) and 4.5 (Interaction with other medicinal products and forms of interaction) of the SPC, the interaction with MAOIs concerns an absolute contra-indication in accordance with the SPCs for SSRIs and SNRIs.
Danish: I afsnit 4.3 (Kontraindikationer) og 4.5 (Interaktion med andre lægemidler og andre former for interaktion) i produktresuméet vedrører interaktionen med MAO-inhibitorer en absolut kontraindikation i henhold til produktresuméerne for SSRI'er og SNRI'er.
English: Inform your doctor if you are using this medicine.
Danish: Fortæl lægen, hvis du bruger denne medicin.
English: A single dose of mirtazapine does not result in any acute effect on the pharmacokinetics of lithium at steady state.
Danish: En enkelt dosis mirtazapin resulterer ikke i nogen akut effekt på farmakokinetikken for litium ved steadystate.
English: Caution should be exercised when prescribing to pregnant women.
Danish: Forsigtighed bør udvises ved ordination til gravide kvinder.
English: - No significant pharmacokinetic interactions are expected between mirtazapine and other psychotropic active substances because most psychotropic active substances are metabolized by multiple cytochrome P450 (CYP) iso-enzymes and one metabolic pathway will compensate for the other in case of inhibition of one or more CYP iso-enzymes.
Danish: - Der forventes ingen signifikante farmakokinetiske interaktioner mellem mirtazapin og andre aktive psykotroper, da de fleste aktive psykotroper metaboliseres af flere cytokrome P450 (CYP) isoenzymer, og én stofskiftebane kan kompensere for en anden i tilfælde af inhibition af ét eller flere CYP-isoenzymer.
English: Close supervision of patients and in particular those at high risk should accompany therapy with antidepressants especially in early treatment and following dose changes.
Danish: Patienterne, specielt højrisikopatienterne, bør følges nøje under behandlingen med antidepressiva og især i starten af behandlingen samt ved dosisændringer.
English: The applicant/MAH argues that it does not have data from clinical trials evaluating interactions between MAO inhibitors (MAO-Is) and mirtazapine.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen anfører, at man ikke har data fra kliniske undersøgelser, der vurderer interaktioner mellem MAO-inhibitorer (MAO-I) og mirtazapin.
English: - diabetes mellitus: In patients with diabetes, antidepressants may alter glycaemic control.
Danish: - Diabetes mellitus: Hos patienter med diabetes, kan antidepressiva påvirke den glykæmiske kontrol.
English: Ask your doctor whether you can breast-feed, while taking Remeron.
Danish: Spørg din læge, om du må amme, mens du tager Remeron.
English: - Mirtazapine dosed at 30 mg once daily caused a small but statistically significant increase in the international normalized ratio (INR) in subjects treated with warfarin.
Danish: - Mirtazapin doseret med 30 mg én gang daglig kan medføre en lille, men statistisk signifikant øgning i INR (international normalized ratio) hos personer, der behandles med warfarin.
English: Bone marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Remeron.
Danish: Knoglemarvsdepression, der sædvanligvis viser sig som granulocytopeni eller agranulocytose, er blevet rapporteret under behandling med Remeron.
English: The applicant/MAH argued that, according to the Guideline on SPC (October 2005) contraindications “arising from the presence of certain excipients (under reference to the Guideline on excipients in the label and package leaflet of medicinal products for human use)” should be included.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen argumenterede for inkluderingen af kontraindikationer, "som opstår ved tilstedeværelsen af visse hjælpestoffer (under henvisning til retningslinjen vedrørende hjælpestoffer på etiketten og indlægssedlen for humanmedicinske lægemidler)", i henhold til retningslinjen for produktresuméer (oktober 2005).
English: Careful dosing as well as regular and close monitoring is necessary in patients with: - epilepsy and organic brain syndrome: Although clinical experience indicates that epileptic seizures are rare during mirtazapine treatment, as with other antidepressants, Remeron should be introduced cautiously in patients who have a history of seizures.
Danish: Forsigtig dosering samt regelmæssig og nøje monitorering er nødvendig hos patienter med: - Epilepsi og organisk hjernesyndrom: Selvom klinisk erfaring har vist, at epileptiske anfald sjældent optræder hos patienter i behandling med mirtazapin, ligesom for andre antidepressiva, bør behandling med Remeron startes med forsigtighed til patienter, der har epileptiske anfald i anamnesen.
English: Limited data of the use of mirtazapine in pregnant women do not indicate an increased risk for congenital malformations.
Danish: Begrænsede data vedrørende gravide kvinders brug af mirtazapin indikerer ikke øget risiko for kongenit misdannelser.
English: → 2 to 4 weeks after you have started taking Remeron, talk to your doctor about how this medicine has affected you.
Danish: → Kontakt lægen 2 til 4 uger efter, du har startet med at tage Remeron, og fortæl hvilken virkning medicinen har haft.
English: akathisia, hyperkinesia)
Danish: akatasi, hyperkinesi)
English: Sugar spheres (containing sucrose) and aspartame (E951) See leaflet for further information.
Danish: LISTE OVER HJÆLPESTOFFER Saccharosekugler og aspartam (E951) Se yderligere oplysninger i indlægssedlen.
English: • vivid dreams
Danish: • livagtige drømme
English: When to take Remeron → Take Remeron at the same time each day.
Danish: Hvornår skal Remeron indtages → Indtag Remeron på samme tidspunkt hver dag.
English: Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Danish: Patienter med selvmordsforsøg i anamnesen, og de der udviser en høj grad af selvmordstanker før start af behandling, vides at have større risiko for at få selvmordstanker og forsøg på selvmord, og bør derfor monitoreres meget nøje under behandlingen.
English: At two-fold systemic exposure compared to maximum human therapeutic exposure, there was an increase in postimplantation loss, decrease in the pup birth weights, and reduction in pup survival during the first three days of lactation in rats.
Danish: Ved dobbelt systemisk ekponering sammelignet med maksimum human terapeutisk ekponering var der en stigning i postimplantationstab, et fald i ungernes fødselsvægt og en reduktion i ungernes overlevelse de første tre dage af amningen hos rotter.
English: Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
Danish: Oplysninger fra kliniske forsøg har udvist en større risiko for selvmordsadfærd hos voksne under 25 år med psykiske lidelser, og som blev behandlet med antidepressiv medicin.
English: Depression of the central nervous system with disorientation and prolonged sedation have been reported, together with tachycardia and mild hyper- or hypotension.
Danish: Der er rapporteret om påvirkning af centralnervesystemet med desorientering og længerevarende sedation samtidig med takykardi og let hyper- eller hypotension.
English: Take out the orodispersible tablet with dry hands and place it on the tongue.
Danish: Tag smeltetabletten ud med tørre hænder og læg den på tungen (figur 4).
English: Jaundice Treatment should be discontinued if jaundice occurs.
Danish: Gulsot Behandlingen bør afbrydes såfremt der optræder gulsot.
English: In vitro data from human liver microsomes indicate that cytochrome P450 enzymes CYP2D6 and CYP1A2 are involved in the formation of the 8-hydroxy metabolite of mirtazapine, whereas CYP3A4 is considered to be responsible for the formation of the N-demethyl and N-oxide metabolites.
Danish: In vitro data fra humane levermikrosomer indikerer at cytokrom P450 enzymerne CYP2D6 og CYP1A2 er involveret i dannelsen af 8-hydroxy metabolitten af mirtazapin, og at CYP3A4 er ansvarlig for dannelsen af N-demethyl og N-oxid metabolitterne.
English: → Stop taking Remeron and consult your doctor immediately for a blood test.
Danish: → Stop behandlingen med Remeron og kontakt straks lægen for at få taget en blodprøve.
English: Thyroid gland tumours found in a rat carcinogenicity study and hepatocellular neoplasms found in a mouse carcinogenicity study are considered to be species-specific, non-genotoxic responses associated with long-term treatment with high doses of hepatic enzyme inducers.
Danish: Fundet af tumorer i skjoldbruskkirtlen i et carcinogenicitetsstudie på rotter og fundet af hepatocellulære neoplasmer i et carcinogenicitetsstudie på mus anses for at være artsbestemt, nongenotoksisk respons i forbindelse med langtidsbehandling med høje doser af leverenzyminduktorer.
English: Food intake has no influence on the pharmacokinetics of mirtazapine.
Danish: Indtagelse af føde har ingen indflydelse på mirtazapins farmakokinetik.
English: The tablets should be taken orally, with fluid, and swallowed without chewing.
Danish: Tabletterne bør indtages oralt sammen med væske og uden at tygge på dem.
English: If you are taking Remeron and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Remeron.
Danish: Hvis du tager Remeron, og du bliver gravid eller planlægger at blive gravid, skal du spørge din læge, om du skal fortsætte med at tage Remeron.
English: Child-resistant, peel-to-open, rigid perforated unit dose blister, formed from a laminate of aluminum foil and plastic films sealed to a paper-based laminate of aluminum foil coated with a heat seal lacquer.
Danish: Børnesikret, peel-to-open ubøjeligt og perforeret blisterkort fremstillet af et laminat af aluminiumsfolie og plastikfilm forseglet til et papirbaseret laminat af aluminiumsfolie overtrukket med en varmeforseglet lak.
English: If Remeron is used until, or shortly before birth, postnatal monitoring of the newborn is recommended to account for possible discontinuation effects.
Danish: Hvis Remeron bruges indtil, eller til kort før fødslen, anbefales postnatal monitorering af den nyfødte, med henblik på mulige abstinenssymptomer.
English: Caution should be exercised in patients at risk, such as elderly patients or patients concomitantly treated with medications known to cause hyponatraemia.
Danish: Der bør udvises forsigtighed ved behandling af patienter, der har denne risiko, f.eks. ældre patienter eller patienter, der samtidig behandles med medicin kendt for at kunne forårsage hyponatiæmi.
English: This should be taken into account when prescribing Remeron to this category of patients (see section 4.4).
Danish: Der skal tages højde for dette, når Remeron ordineres til denne gruppe patienter (se afsnit 4.4).
English: Mania Agitation2
Danish: Mani Agitation2
English: If you stop taking Remeron, do not take MAO inhibitors during the next two weeks either.
Danish: Hvis du holder op med at tage Remeron, må du heller ikke tage MAO-hæmmere i de første to uger herefter.
English: The CHMP considered that the arguments provided by the applicant/MAH were insufficient to justify that mirtazapine would act different from SSRIs and SNRIs (e.g. venlafaxine).
Danish: CHMP vurderede, at de af ansøgeren/indehaveren af markedsføringstilladelsen tilvejebragte argumenter var utilstrækkelige til at begrunde, at mirtazapin har en anden virkning end SSRI'er og SNRI'er (f.eks. venlafaxin).
English: In very rare cases Remeron alone or the combination of Remeron with these medicines, can lead to a so-called serotonin syndrome.
Danish: I meget sjældne tilfælde kan Remeron alene eller kombinationen af Remeron og disse lægemidler resultere i et såkaldt serotoninsyndrom.
English: Preparing the Remeron metering pump for use Before you take Remeron, you need to fit the pump onto the bottle.
Danish: Gør Remeron doseringspumpen klar til brug Før du begynder at tage Remeron, skal du sætte pumpen på flasken.
English: No significant differences were found in patients with mild renal impairment (creatinine clearance <80 ml/min) as compared to the control group.
Danish: Der blev ikke fundet signifikante forskelle hos patienter med mild nyreinsufficiens (kreatininclearance < 80 ml/min), sammenlignet med kontrolgruppen.
English: If you forget to take Remeron
Danish: Hvis du har glemt at tage Remeron
English: - Care should be taken in patients with micturition disturbances like prostate hypertrophy and in patients with acute narrow-angle glaucoma and increased intra-ocular pressure (although there is little chance of problems with Remeron because of its very weak anticholinergic activity).
Danish: - Der bør udvises forsigtighed hos patienter med miktionsforstyrrelser såsom prostatahypertrofi og hos patienter med akut snævervinklet glaukom og forhøjet intraokulært tryk (også her er der en lille risiko for problemer under behandling med Remeron på grund af den meget svage anticholinerge aktivitet).
English: From post marketing experience it appears that serotonin syndrome occurs very rarely in patients treated with Remeron alone (see section 4.8).
Danish: Postmarketingerfaringen viser, at serotonergt syndrom sjældent optræder hos patienter, der alene behandles med Remeron (se pkt.
English: Moreover, the CHMP was of the opinion that the mechanism of interaction with MAOIs with mirtazapine is different from SSRIs.
Danish: Desuden mente CHMP, at interaktionsmekanismen mellem MAO-inhibitorer og mirtazapin er anderledes end med SSRI'er.
English: If treatment with such medicinal product is discontinued, it may be necessary to reduce the mirtazapine dose.
Danish: Hvis behandlingen med disse lægemidler stoppes, skal mirtazapindosis muligvis nedsættes.
English: Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Remeron in this age group have not yet been demonstrated.
Danish: Derudover foreligger der ikke langtidsdata om sikkerhed for Remeron med hensyn til vækst, modning og kognitiv og adfærdsmæssig udvikling i denne aldersgruppe.
English: • medicines to prevent blood clotting such as warfarin.
Danish: • Blodfortyndende medicin såom warfarin.
English: Studies in animals have not shown any teratogenic effects of clinical relevance, however developmental toxicity has been observed (see section 5.3).
Danish: Dyreforsøg har ikke vist teratogen effekt af klinisk relevans; dog er der observeret tilfælde af forgiftning (se pkt.
English: Thereafter, each pump will give the correct dose (1 ml containing 15 mg of the active substance mirtazapine).
Danish: Derefter vil hvert tryk på pumpen give den korrekte dosis (1 ml indeholder 15 mg af det aktive indholdsstof mirtazapin).
English: - cardiac diseases like conduction disturbances, angina pectoris and recent myocardial infarction, where normal precautions should be taken and concomitant medicines carefully administered.
Danish: - Hjertesygdomme såsom ledningsforstyrrelser, angina pectoris og nyligt myokardieinfarkt, hvor de sædvanlige forsigtighedsregler bør tages og samtidig medicinindtagelse administreres forsigtigt.
English: Preparation of the bottle
Danish: Klargøring af flasken
English: Symptoms of serotonin syndrome may be hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, mental status changes that include confusion, irritability and extreme agitation progressing to delirium and coma.
Danish: Symptomer på serotonergt syndrome kan være forhøjet legemstemperatur, stivhed, myokloni, autonom instabilitet eventuelt med hurtige fluktuationer af vitale funktioner, mentale ændringer som inkluderer konfusion, irritabilitet og ekstrem agitation, der kan udvikle sig til delirium og coma.
English: A meta-analysis of placebocontrolled clinical trials of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old.
Danish: En metaanalyse af placebo-kontrolleret kliniske undersøgelser med antidepressiva af psykiatriske lidelser hos voksne patienter viste en øget risiko for selvmordspræget adfærd ved indtagelse af antidepressiva sammenlignet med placebo hos patienter under 25 år.
English: → Tell your doctor about these conditions before taking Remeron, if not done previously -seizures (epilepsy).
Danish: → Fortæl lægen om disse tilstande, inden du tager Remeron, hvis ikke du allerede har gjort det. -Epilepsianfald.
English: This procedure is given in symbolic instructions on the top of the screw cap.
Danish: Denne fremgangsmåde er beskrevet med symboler på toppen af låget.
English: • medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.
Danish: • Medicin mod epilepsi såsom carbamazepin og phenytoin, og medicin mod tuberkulose, såsom rifampicin.