FrancophonIA/ELRC3.0 huggingface dataset:
English: Thoughts of suicide and worsening of your depression If you are depressed, you can sometimes have thoughts of harming or killing themselves.
Danish: Selvmordstanker eller forværring af din depression Hvis du er deprimeret, kan du sommetider have selvmordstanker eller tanker om at gøre skade på dig selv.
English: Consider gastric lavage only if within one hour of a potentially fatal overdose.
Danish: Overvej kun maveskylning inden for en time efter en potentielt dødelig overdosis.
English: Nocturnal enuresis
Danish: Enuresis nocturna
English: During chronic use and after administration in the final weeks of pregnancy, neonatal withdrawal symptoms can occur.
Danish: Ved kronisk brug og efter administration i graviditetens sidste uger kan der forekomme neonatale seponeringssymptomer.
English: After reduction of the depressive symptoms the treatment with amitriptyline should be continued for up to 6 month.
Danish: Når de depressive symptomer er blevet mindre, bør behandlingen med amitriptylin fortsætte i op til 6 måneder.
English: If you have difficulty in swallowing the capsules, you can open them and put the pellets in e.g. yoghurt or a cold drink.
Danish: Hvis du har svært ved at sluge kapslerne, kan du åbne dem og putte pellets (de små kugler) i f.eks. yoghurt eller en kold drik.
English: Patients who are prescribed psychotropic medication may be expected to have some impairment in general attention and concentration and should be cautioned about their ability to drive or operate machinery.
Danish: Patienter, der får ordineret psykotrope lægemidler, kan forventes at have en vis svækkelse i opmærksomhed og koncentration og skal advares herom for så vidt angår deres evne til at føre motorkøretøj og betjene maskiner.
English: Unrest and convulsions may be treated with diazepam.
Danish: Uro og kramper kan behandles med diazepam.
English: • delirium (especially in elderly patients), hallucinations (especially in patients with schizophrenia),
Danish: • delirium (særligt hos ældre patienter), hallucinationer (især hos skizofrene patienter),
English: If you are treated with X, you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI.
Danish: Hvis du er i behandling med {X}, skal du holde op med at tage det og vente i 14 dage, inden du begynder behandling med en MAO-hæmmer.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION [To be completed nationally]
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Skal udfyldes nationalt]
English: A risk to the suckling child cannot be excluded.
Danish: Der kan ikke udelukkes en risiko for børn, der ammes.
English: In treating depression the duration of treatment is individual, and is usually at least 6 months.
Danish: Ved behandling af depression varierer behandlingsvarigheden fra person til person, men den vil normalt være mindst 6 måneder.
English: This medicine can be taken with or without food.
Danish: Du kan tage medicinen med eller uden mad.
English: Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Danish: Amitriptylin anbefales ikke under graviditet, medmindre det er klart nødvendigt og kun efter nøje overvejelse af risici og fordele.
English: It has marked anticholinergic and sedative properties.
Danish: Det har markante antikolinerge og sedative egenskaber.
English: • if you have a severe liver disease.
Danish: • hvis du har en alvorlig leversygdom.
English: Recent myocardial infarction.
Danish: Nyligt myokardieinfarkt.
English: This leaflet was last revised in <{MM/YYYY}> <{month YYYY}>.
Danish: Denne indlægsseddel blev senest ændret <{MM/YYYY}> <{måned ÅÅÅÅ}>.
English: • blue discolouration of the skin
Danish: • blå misfarvning af huden
English: Children are especially susceptible to cardiotoxicity and seizures.
Danish: Børn er særligt følsomme for kardiotoksicitet og krampeanfald.
English: Duration of treatment Do not change the dose of the medicine or stop taking the medicine without consulting your doctor first.
Danish: Varighed af behandlingen Du må ikke ændre dosis eller stoppe med at tage lægemidlet uden først at rådføre dig med din læge.
English: Saroten and associated names is indicated for: • the treatment of major depressive disorder in adults
Danish: Saroten og relaterede navne er indiceret til: • behandling af major depression hos voksne
English: If a dose of X is missed Make a new appointment for an injection with your physician.
Danish: Hvis en dosis {X} blev glemt Aftal en ny tid med din læge til en injektion.
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) skal informeres om nødvendigheden af at overvåge for eventuel klinisk forværring, selvmordsadfærd eller selvmordstanker samt usædvanlige ændringer i adfærd og om straks at søge læge, hvis sådanne symptomer opstår.
English: The efficacy and safety of amitriptyline has been demonstrated for treatments of nocturnal enuresis in children aged 6 years and above (see section 4.1).
Danish: Amitriptylins virkning og sikkerhed er blevet påvist ved behandling af enuresis nocturna hos børn i alderen 6 år og derover (se punkt 4.1).
English: If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.
Danish: Hvis gentagne behandlingsforløb med amitriptylin er nødvendige, skal der foretages en klinisk vurdering hver 3. måned.
English: X contains lactose
Danish: X indeholder laktose
English: The efficacy and safety of amitriptyline has been demonstrated in treatments of the following indications in adults:
Danish: Amitriptylins virkning og sikkerhed er blevet påvist ved behandling af følgende indikationer hos voksne:
English: Patency of the airway is maintained by intubation, where required.
Danish: Luftvejene holdes åbne ved intubation, hvis det er nødvendigt.
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Danish: Den maksimale daglige dosis på 150 mg amitriptylin, givet som injektion/infusion, må ikke overskrides.
English: (tmax = 3.89±1.87 hours; range 1.93-7.98 hours).
Danish: (tmax = 3,89±1,87 timer (1,93-7,98 timer)).
English: It is not advised to drink alcohol during treatment with this medicine as it might increase the sedative effect.
Danish: Det tilrådes ikke at drikke alkohol under behandling med denne medicin, da det kan forstærke den sløvende virkning af alkohol.
English: Annex III SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: Bilag III PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: • aged below 6 years: see section 2 Do not take X
Danish: • under 6 år: se punkt 2, Tag ikke {X|
English: Ingestion of 750 mg or more by an adult may result in severe toxicity.
Danish: Indtagelse af 750 mg eller mere af en voksen kan resultere i alvorlig toksicitet.
English: Monitor for rhabdomyolysis if the patient has been unconscious for a considerable time.
Danish: Monitorer for rabdomyolyse, hvis patienten har været bevidstløs i lang tid.
English: Check arterial blood gases-look for acidosis.
Danish: Tjek arterielle blodgasser - vær opmærksom på acidose.
English: A single dose above 75 mg is not recommended.
Danish: Enkeltdoser over 75 mg anbefales ikke.
English: However, literature data suggested a risk for malformations and delays in ossification of mice, hamsters, rats and rabbits at 9 33 times the maximum recommended dose.
Danish: Men litteraturdata antyder en risiko for misdannelser og forsinkelser i ossifikation hos mus, hamstere, rotter og kaniner ved 9-33 gange den maksimalt anbefalede dosis.
English: • dizziness when you stand up due to low blood pressure (orthostatic hypotension)
Danish: • svimmelhed når du rejser dig op på grund af lavt blodtryk (ortostatisk hypotension)
English: The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies.
Danish: Amitriptylins genotoksiske potentiale er blevet undersøgt i forskellige in vitro og in vivo studier.
English: During awakening possibly again confusion, agitation and hallucinations and ataxia.
Danish: Under opvågning kan der igen forekomme forvirring, agitation samt hallucinationer og ataksi.
English: These symptoms may be due to parts of the intestine becoming paralysed.
Danish: Disse symptomer kan skyldes lammelse af en del af tarmen.
English: Suicide/suicidal thoughts
Danish: Selvmord/selvmordstanker
English: *Case reports of suicidal thoughts or behaviour were reported during the treatment with or just after conclusion of the treatment with amitriptyline (see section 4.4).
Danish: *Case-rapporter med selvmordstanker eller selvmordsrelateret adfærd blev rapporteret under behandling eller lige efter afslutning af behandling med amitriptylin (se punkt 4.4).
English: Due to avoiding the first-pass-metabolism in the liver after intravenous administration the drug reaches maximal plasma concentrations very rapidly and completely with a rapid biphasic consequent decline, which reflects generation of the distribution equilibrium between tissue, peripheral and central compartments.
Danish: Ved intravenøs administration undgås first pass metabolisering i leveren, og den maksimale plasmakoncentration nås meget hurtigt og fuldstændigt med et efterfølgende hurtigt bifasisk fald, som afspejler fordelingsligevægt mellem væv og perifere og centrale rum.
English: - Any yellowing of the skin and the white in the eyes (jaundice).
Danish: - Enhver gulfarvning af huden og det hvide i øjnene (gulsot).
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Danish: Depression er forbundet med en øget risiko for selvmordstanker, selvdestruktive handlinger og selvmord (selvmordsrelaterede hændelser).
English: The ratio milk concentration/plasma concentration in women is around 1:1.
Danish: Mælk/plasma-ratio hos kvinder er cirka 1:1.
English: Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting).
Danish: Effekten på blodet kan være et nedsat antal røde blodlegemer (som transporterer ilt rundt i kroppen), hvide blodlegemer (som hjælper med at bekæmpe infektioner) og blodplader (som hjælper ved størkning af blodet).
English: • low blood pressure, weak pulse, pallor
Danish: • lavt blodtryk, svag puls, bleghed
English: • feeling thirsty.
Danish: • tørst.
English: Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain.
Danish: Forebyggelse af genoptagelse af disse monoamin-neurotransmittere potenserer deres virkning i hjernen.
English: In plasma the amount of total 10-hydroxynortriptyline dominates but most of the metabolites are conjugated.
Danish: I plasma dominerer mængden af total 10-hydroxynortriptylin, men de fleste af metabolitterne er konjugerede.
English: Prolonged QT interval
Danish: Forlænget QT-interval
English: No data on the effects of amitriptyline on human fertility are available.
Danish: Der foreligger ingen data om indvirkningen af amitriptylin på fertiliteten hos mennesker.
English: Dosage and duration of treatment will be determined by you physician based on the severity of your disease and your clinical response.
Danish: Lægen vil bestemme dosis og behandlingsvarighed på basis af sværhedsgraden af din sygdom og det kliniske respons.
English: Reduced renal function Renal failure has no influence on the kinetics.
Danish: Nedsat nyrefunktion Nedsat nyrefunktion påvirker ikke kinetikken.
English: Due to the often delayed gastrointestinal tract passage maximum plasma concentrations are reached after 1 to 5 (-8) hours.
Danish: På grund af den ofte forsinkede passage gennem mave-tarm-kanalen opnås maksimal plasmakoncentration efter 1 til 5 (- 8) timer.
English: Polymorphism
Danish: Polymorfisme
English: Treatment with antidepressants is symptomatic and must therefore be continued for an appropriate length of time usually up to 6 months after recovery in order to prevent relapse.
Danish: Behandling med antidepressiva er symptomatisk og skal derfor fortsættes i et passende tidsrum normalt op til 6 månder efter bedring for at forhindre tilbagefald.
English: The excretion proceeds mainly with urine.
Danish: Udskillelsen er hovedsagelig med urinen.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Danish: Det kan måske være en hjælp at tale med en ven eller pårørende om, at du er deprimeret, og bede dem om at læse denne indlægsseddel.
English: As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
Danish: Da bedring ikke nødvendigvis opnås i løbet af de første få behandlingsuger eller mere, skal patienterne overvåges nøje, indtil der sker en sådan bedring.
English: Some of the below mentioned side effects e.g. headache, tremor, disturbance in attention, constipation and decreased libido may also be symptoms of depression and usually attenuate when the depressive state improves.
Danish: Nogle af de nedenfor nævnte bivirkninger, f.eks. hovedpine, tremor, forstyrrelse i opmærksomhed, obstipation og nedsat libido, kan også være symptomer på depression og aftager normalt, når den depressive tilstand bedres.
English: However, the capsules can be opened and the pellets swallowed with a cold drink or e.g. yoghurt.
Danish: Kapslerne kan dog åbnes, og pellets kan synkes sammen med kold væske eller f.eks. yoghurt.
English: Give 50 g of charcoal if within one hour of ingestion.
Danish: Giv 50 g kul, hvis der er gået mindre end en time efter indtagelse.
English: These adverse effects can be potentiated by the concomitant intake of alcohol.
Danish: Disse virkninger kan forstærkes ved samtidig indtagelse af alkohol.
English: Contents of the pack and other information What X contains
Danish: Pakningsstørrelser og yderligere oplysninger {X} indeholder
English: Amitriptyline is a tricyclic antidepressant and an analgesic.
Danish: Amitriptylin er et tricyklisk antidepressivum og et analgetikum.
English: • diabetes as you might need and adjustment of your antidiabetic medicine.
Danish: • diabetes, da det er muligt, at din diabetesmedicin skal justeres.
English: tmax = 7.1±1.9 hours; range 2.010.0 hours.
Danish: tmax = 7,1 ± 1,9 timer (2,0-10,0 timer).
English: As with other tricyclic antidepressants, amitriptyline should not be given to patients receiving monoamine oxidase inhibitors (MAOIs).
Danish: Som med andre tricykliske antidepressive midler bør amitriptylin ikke gives til patienter, der får monoaminoxidasehæmmere (MAO-hæmmere).
English: • sexual disturbances (decreased sex-drive, problems with erection)
Danish: • seksuelle forstyrrelser (nedsat sexlyst, rejsningsproblemer)
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 noget tidspunkt får tanker om selvmord eller om at gøre skade på dig selv, skal du straks kontakte din læge eller tage på skadestuen.
English: • excitement, anxiety, difficulties sleeping, nightmares
Danish: • opstemthed, angst, søvnbesvær, mareridt
English: Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.
Danish: Du skal også fortælle din tandlæge, at du tager denne medicin, hvis du skal lokalbedøves.
English: Long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are not available (see section 4.2).
Danish: Der foreligger ingen langtidssikkerhedsdata hos børn og unge vedrørende vækst, modning og kognitiv og adfærdsmæssig udvikling (se punkt 4.2).
English: Use in children and adolescents X should not be given to children or adolescents.
Danish: Børn og unge {X} må ikke gives til børn og unge.
English: Wrongly administered injections (subcutaneous, paravenous or intra-arterial injection) must be avoided due to the risk of considerable tissue injury.
Danish: Forkert administration af injektionen (subkutan, paravenøs eller intra-arteriel) skal undgås på grund af risiko for betydelig vævsskade.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blisters
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP Blistere
English: In contrast to the tablet serum curves which show a distinct initial peak, the capsule curves rise slowly to a plateau level with lower concentrations than the peak of the tablet curves.
Danish: I modsætning til serumkurverne for tabletterne, som viser en tydelig initial spidskoncentration, stiger kurverne for kapslerne langsomt til et plateau med lavere koncentration end spidsværdien for kurverne for tabletterne.
English: The solution for injection should mainly be used for acute treatment.
Danish: Injektionsvæsken bør hovedsagligt anvendes til akut behandling.
English: The dosing scheme and treatment duration given for the oral formulation should be followed from henceforward.
Danish: Doseringsskemaet og behandlingsvarigheden for den orale lægemiddelform skal herefter følges.
English: The dose may be increased depending on individual patient response and tolerability.
Danish: Dosen kan øges afhængigt af den enkelte patients reaktion og tolerabilitet.
English: Amitriptyline for enuresis should not be combined with an anticholinergic drug.
Danish: Amitriptylin mod enuresis bør ikke kombineres med et antikolinergt lægemiddel.
English: Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.
Danish: Nogle lægemidler kan påvirke andre lægemidlers virkning, hvilket undertiden kan forårsage alvorlige bivirkninger.
English: In the listing below the following convention is used: MedDRA system organ class / preferred term; Very common (> 1/10);
Danish: Følgende konvention er brugt i tabellen nedenfor: MedDRA-systemorganklasse/foretrukken term; Meget almindelig (> 1/10);
English: Longer half-lives and decreased oral (Clo) clearance values due to a reduced rate of metabolism have been demonstrated in elderly patients.
Danish: Længere halveringstid og nedsat oral clearance (Clo) på grund af langsommere metabolisering er blevet påvist hos ældre patienter.
English: The efficacy and safety of amitriptyline (as solution for injection) has been demonstrated for the indication Major Depressive Disorder.
Danish: Virkningen og sikkerheden af amitriptylin (som injektionsvæske) er blevet påvist til indikationen af svær depression.
English: Episodes of mania
Danish: Maniske episoder
English: Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions.
Danish: Patienter bør titreres individuelt til den dosis, der giver tilstrækkelig analgesi med acceptable bivirkninger.
English: Take the container of this medicine with you if you go to a doctor or hospital.
Danish: Medbring lægemiddelpakningen, hvis du tager til lægen eller på hospitalet.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i bilag V.
English: Amitriptyline reduced the pregnancy rate in rats (see section 5.3).
Danish: Amitriptylin reducerede drægtighedsraten hos rotter (se punkt 5.3).
English: • particular forms of abnormal heart rhythm (so called torsades de pointes)
Danish: • en særlig form for unormal hjerterytme (såkaldt torsades de pointes)
English: CYP1A2 and CYP2C9.
Danish: CYP1A2 og CYP2C9.
English: Doses above 100 mg should be used with caution and your doctor might choose to follow you more closely.
Danish: Doser over 100 mg bør gives med forsigtighed, og din læge kan vælge at overvåge dig nøje.
English: Therefore, amitriptyline may increase the risk for cardiac arrhythmia (see section 4.4).
Danish: Derfor kan amitriptylin øge risikoen for hjertearytmi (se punkt 4.4).
English: • rifampicin (to treat infections)
Danish: • rifampicin (til behandling af infektioner)
English: Assess and treat ABC's (airway, breathing and circulation) as appropriate.
Danish: Bedøm og behandl luftveje, respiration og cirkulation efter behov.
English: Additionally, this combination can inhibit the metabolism of tramadol to the active metabolite and thereby increasing tramadol concentrations potentially causing opioid toxicity.
Danish: Derudover kan denne kombination hæmme metaboliseringen af tramadol til den aktive metabolit og dermed øge koncentrationen af tramadol, hvilket potentielt kan forårsage opioid toksicitet.
English: This includes any possible side effects not listed in this leaflet.
Danish: Dette gælder også mulige bivirknigner, som ikke er medtaget i denne indlægsseddel.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig, såsom:
English: • disorder of the peripheral nerves
Danish: • sygdom i perifere nerver
English: • diarrhoea, vomiting
Danish: • diarré, opkastning
English: Saroten injectable solution is used in hospitalized patients especially for the initial treatment of depressive disorders.
Danish: Saroten injektionsvæske bruges hos hospitalsindlagte patienter, især til den indledende behandling af depression.
English: For treatment of depression, doses of up to 200 mg daily and, occasionally, up to 300 mg daily have been used in severely depressed patients in hospital only.
Danish: Ved behandling af depression er doser op til 200 mg dagligt og undertiden op til 300 mg dagligt udelukkende blevet anvendt hos svært deprimerede hospitalsindlagte patienter.
English: Levels above 300-400 ng/ml are associated with increased risk of disturbance in cardiac conduction in terms of prolonged QRS-complex or AV block.
Danish: Niveauer over 300-400 nanogram/ml er forbundet med øget risiko for ledningsforstyrrelser i hjertets elektriske aktivitet i form af forlænget QRS-kompleks eller AV-blok.
English: Treatment with amitriptyline may be instituted 14 days after discontinuation of irreversible non-selective MAOIs and minimum one day after discontinuation of the reversible moclobemide.
Danish: Behandling med amitriptylin kan indledes 14 dage efter seponering af irreversible non-selektive MAO-hæmmere og mindst én dag efter seponering af den reversible moclobemid.
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 forstærkes, når du begynder at tage medicin for depression (antidepressiv medicin), fordi medicinen er et stykke tid om at virke, ofte omkring 14 dage, men nogle gange længere.
English: Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather.
Danish: Der er rapporteret hyperpyreksi med tricykliske antidepressiva, når disse administreres sammen med antikolinergika eller antipsykotika, specielt i varmt vejr.
English: The tablets are swallowed with water independent of meals.>
Danish: Slug tabletterne med vand uafhængigt af måltider.>
English: • Depression in adults (major depressive episodes)
Danish: • Til at behandle depression hos voksne (svære depressive episoder)
English: • children aged 6 to 10 years: 10 mg - 20 mg. A more suitable dosage form should be used for this age group.
Danish: • børn mellem 6 og 10 år: 10-20 mg. En anden, mere hensigtsmæssig lægemiddelform skal benyttes til denne aldersgruppe.
English: If you forget to take X Take the next dose at the usual time.
Danish: Tag den næste dosis på det sædvanlige tidspunkt.
English: It is advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.
Danish: Det tilrådes at gennemgå al antihypertensiv behandling under behandling med tricykliske antidepressiva.