FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will instruct you whether to take the doses once daily or divide into two doses.
Danish: Din læge vil fortælle dig, om du skal tage dosis én gang dagligt, eller om du skal fordele den på to lige store doser.
English: It prevents the re-uptake, and hence the inactivation of noradrenaline and serotonin at nerve terminals.
Danish: Det forhindrer genoptagelse og dermed inaktivering af noradrenalin og serotonin ved nerveterminalerne.
English: The effects in overdose will be potentiated by simultaneous ingestion of alcohol and other psychotropic.
Danish: Virkningerne af overdosering vil blive potenseret af samtidig indtagelse af alkohol og andre psykotrope stoffer.
English: After about 1 to 2 weeks a stepwise reduction together with a change to the oral formulations for further treatment can be initiated.
Danish: Efter ca. 1 til 2 uger kan en trinvis reduktion påbegyndes sammen med et skift til en oral lægemiddelform for den videre behandling.
English: Bed-wetting at night Your doctor will evaluate if the treatment should be continued after 3 months.
Danish: Sengevædning (enuresis) Efter 3 måneder vil din læge vurdere, om behandlingen skal fortsætte.
English: The solution for infusion prepared with sodium chloride solution 0.9% must be used immediately.
Danish: Infusionsvæske fortyndet med 0,9 % natriumchloridinfusionsvæske skal anvendes med det samme.
English: This might also occur in usual doses if you have pre-existing heart disease.
Danish: Det kan også forekomme ved de sædvanlige doser, hvis du har en hjertesygdom.
English: Amitriptyline and the main metabolite nortriptyline pass across the placental barrier.
Danish: Amitriptylin og hovedmetabolitten nortriptylin passerer placentabarrieren.
English: Initially 50 mg daily in the evening.
Danish: Initialt 50 mg dagligt om aftenen.
English: Take this medicine 1-1½ hours before bedtime.
Danish: Lægemidlet skal tages 1-1½ time inden sengetid.
English: Elderly patients Longer half-lives values due to a reduced rate of metabolism have been demonstrated in elderly patients.
Danish: Ældre patienter Længere halveringstid på grund af langsommere metabolisering er blevet påvist hos ældre patienter.
English: Pyrexia.
Danish: Pyreksi
English: Elderly often require a considerably lower dose and often show at half the daily dose a satisfying success of treatment.
Danish: Ældre patienter har ofte brug for en betydeligt lavere dosis og udviser ofte tilfredsstillende behandlingseffekt med halvdelen af den daglige normaldosis.
English: Heart failure, hypotension, cardiogenic shock.
Danish: Hjertesvigt, hypotension, kardiogent shock.
English: The CYP3A4 and CYP1A2 isozymes metabolise amitriptyline to a lesser extent.
Danish: CYP3A4- og CYP1A2-isozymer metaboliserer amitriptylin i mindre omfang.
English: Admission to hospital (intensive care unit) if required.
Danish: Hospitalsindlæggelse (på intensivafdeling), hvis det er nødvendigt.
English: The tablets should be swallowed with water.
Danish: Kapslerne skal sluges med vand.
English: Dose to be administered 1-1½ hours before bedtime.
Danish: Dosis skal administreres 1-1½ time før sengetid.
English: Saroten and associated names is indicated for in-hospital treatment of major depressive disorders in adults.
Danish: Saroten og tilknyttede navne er indiceret til hospitalsbehandling af svære depressioner hos voksne.
English: Fever.
Danish: Feber.
English: Do not give flumazenil to reverse benzodiazepine toxicity in mixed overdoses.
Danish: Giv ikke flumazenil for at reversere benzodiazepin-toxicitet ved blandede overdoser.
English: Plasma concentrations of amitriptyline and nortriptyline vary very widely between individuals and no simple correlation with therapeutic response has been established.
Danish: Plasmakoncentrationerne af amitriptylin og nortriptylin varierer meget fra person til person, og der er ikke etableret nogen simpel sammenhæng med den terapeutiske respons.
English: X belongs to a group of medicines known as tricyclic antidepressants.
Danish: X tilhører gruppen af medicin, der kaldes tricykliske antidepressiva.
English: • pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)
Danish: • pylorusstenose (forsnævring af den nederste del af mavesækken) og paralytisk ileus (blokering af tarmen)
English: Amitriptyline is a sedative drug.
Danish: Amitriptylin er et sedativt lægemiddel.
English: Tricyclic antidepressants possess affinity for muscarinic and histamine H1 receptors to varying degrees.
Danish: Tricykliske antidepressiva har affinitet for muskarine og histamine H1-receptorer i forskellig grad.
English: Perform electrocardiograph-look for QRS>0.16 seconds 4.
Danish: Tag et elektrokardiogram - vær opmærksom på QRS >0,16 sekunder.
English: The solution for injection prepared with sodium chloride solution 0.9% must be used immediately.
Danish: Injektionsvæske, som er blandet med 0,9 % natriumchloridinfusionsvæske, skal anvendes med det samme.
English: Combinations that are not recommended
Danish: Kombinationer, som frarådes
English: X is used for the in-hospital treatment of depression in adults (major depressive episodes).
Danish: {X} bruges på hospitaler til at behandle depression hos voksne (svære depressive episoder).
English: Your doctor may take blood samples to determine the level this medicine in the blood (see also section 2).
Danish: Din læge kan tage blodprøver for at bestemme indholdet af dette lægemiddel i blodet (se også punkt 2).
English: • acute increase of pressure in the eye
Danish: • akut stigning af trykket i øjet
English: Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs.
Danish: Forsigtighed tilrådes hos patienter med signifikant bradykardi, hos patienter med ukompenseret hjerteinsufficiens og hos patienter, der samtidig tager lægemidler, der kan forlænge QT-intervallet.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities Not applicable.
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer [Skal udfyldes nationalt] 6.2 Uforligeligheder Ikke relevant.
English: • congested nose.
Danish: • tilstoppet næse.
English: Fatigue, feeling thirst.
Danish: Almindelig Træthed, tørst
English: • phenytoin and carbamazepine (used to treat epilepsy)
Danish: • phenytoin og carbamazepin (til behandling af epilepsi)
English: Neuropathic pain, chronic tension type headache and migraine prophylaxis Your doctor will adjust the medication according to your symptoms and your response to the treatment.
Danish: Neuropatiske smerter, forebyggende mod kronisk spændingshovedpine og migræne Din læge vil justere medicinen ud fra dine symptomer, og hvordan du reagerer på behandlingen.
English: If necessary the dose can be increased by 25 mg or 50 mg after 1 week up to 150 mg daily.
Danish: Om nødvendigt kan dosis øges med 25 mg eller 50 mg efter en uge, op til 150 mg dagligt.
English: Delirium (in elderly patients), hallucination (in schizophrenic patients), suicidal thoughts or behaviour*.
Danish: Delirium (hos ældre patienter), hallucination (hos skizofrene patienter), selvmordstanker eller selvmordsrelateret adfærd*
English: Convulsions, fever.
Danish: Kramper, feber.
English: Elderly patients (above 65 years of age) and patients with cardiovascular disease Elderly often require a considerably lower dose and often show at half the daily dose a satisfying success of treatment.
Danish: Ældre patienter (over 65 år) og patienter med kardiovaskulær sygdom Ældre patienter har tit brug for betydeligt lavere doser, og udviser tit tilfredsstillende behandlingseffekt med halvdelen af den daglige dosis.
English: Before starting treatment, your doctor will conduct an ECG of your heart to check for sign of unusual heartbeat.
Danish: Inden behandlingen startes, vil lægen tage et EKG (elektrokardiogram) af hjertet for at undersøge, om der tegn på en usædvanlig hjerterytme.
English: Very rare
Danish: Meget almindelig
English: After 1-2 weeks the oral formulations should be used for further treatment.
Danish: Efter 1-2 uger bør orale lægemiddelformer derfor gives til videre behandling.
English: Initially 25 mg 2 times daily (50 mg daily).
Danish: Initialt 25 mg 2 gange dagligt (50 mg dagligt).
English: • if you have heart problems such as disturbances in heart rhythm which are seen on an electrocardiogram (ECG), heart block, or coronary artery disease
Danish: • hvis du har hjerteproblemer, såsom ledningsforstyrrelser, der kan ses på et elektrokardiogram (EKG), hjerteblok eller en hjerte-kar-sygdom
English: • abnormal results of liver function tests.
Danish: • unormale resultater af prøver for leverfunktionen.
English: Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2).
Danish: Din læge kan tage blodprøver for at bestemme indholdet af amitriptylin i blodet (se også punkt 2).
English: • numbness or tingling in the arms or legs
Danish: • følelsesløshed eller prikkende fornemmelse i arme eller ben
English: Amitriptyline inhibited ion channels, which are responsible for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations.
Danish: Amitriptylin hæmmer ionkanaler, som er ansvarlige for kardiel repolarisering (hERG-kanaler), i det øvre mikromolære område ved terapeutiske plasmakoncentrationer.
English: Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache, feeling unwell, sleeplessness and irritability).
Danish: Din læge vil beslutte, hvornår og hvordan du skal stoppe behandlingen for at undgå eventuelle ubehagelige symptomer, som kan forekomme, hvis du stopper behandlingen pludseligt (f.eks. hovedpine, utilpashed, søvnløshed og irritabilitet).
English: There was a possible association with an effect on fertility in rats, namely a lower pregnancy rate.
Danish: Der var en mulig sammenhæng med en virkning på fertiliteten hos rotter, nemlig en lavere drægtighedsrate.
English: These should not be taken at the same time as X (see section 2 Do not take X)
Danish: Disse må ikke tages samtidig som {X} (se punkt 2 Tag ikke {X})
English: Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline.
Danish: Forstyrrelser i hjerterytme og hypotension kan forekomme, hvis du får en høj dosis amitriptylin.
English: Depression, neuropathic pain, chronic tension type headache and migraine prophylaxis Do not give this medicine to children and adolescents aged below 18 years for these treatments as safety and efficacy have not been established in this age group.
Danish: Depression, neuropatiske smerter, forebyggende mod kronisk spændingshovedpine og migræne Giv ikke dette lægemiddel til børn og unge under 18 år med henblik på sådan behandling, da sikkerheden og virkningen ikke er klarlagt for denne aldersgruppe.
English: <[Saroten and associated names 50 mg film-coated tablets] After oral administration amitriptyline is absorbed slowly but completely.
Danish: <[Saroten og relaterede navne 50 mg filmovertrukne tabletter] Efter oral administration absorberes amitriptylin langsomt, men fuldstændigt.
English: • fast or irregular heartbeats
Danish: • hurtig eller uregelmæssig puls
English: • This medicines should not be taking at the same time as an anticholinergic drug (see also section 2 Other medicines and X)
Danish: • Dette lægemiddel må ikke tages samtidig med et antikolinergt lægemiddel (se også punkt 2 Brug af anden medicin sammen med {X})
English: • astemizole and terfenadine (used to treat allergies and hayfever)
Danish: • astemizol og terfenadin (til behandling af allergier og høfeber)
English: Severe liver disease.
Danish: Alvorlig leversygdom.
English: Amitriptyline may induce side effects similar to other tricyclic antidepressants.
Danish: Amitriptylin kan fremkalde bivirkninger, der ligner bivirkninger ved andre tricykliske antidepressiva.
English: The general duration of treatment will be decided by the treating physician on an individual basis.
Danish: Lægen vil bestemme den generelle behandlingsvarighed for den enkelte patient.
English: These patients may have higher plasma concentrations of amitriptyline and its active metabolite nortriptyline.
Danish: Disse patienter kan have højere plasmakoncentrationer af amitriptylin og dets aktive metabolit nortriptylin.
English: The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increments.
Danish: En passende lægemiddelform/styrke skal vælges til startdosis og eventuelle efterfølgende doser (inkl.
English: Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia).
Danish: Samtidig administration af amitriptylin og MAO-hæmmere kan forårsage serotoninsyndrom (en kombination af symptomer, der kan inkludere agitation, konfusion, tremor, myoklonus og hypertermi).
English: • various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock,
Danish: • forskellige hjertesymptomer, som f.eks. hjerteblok, hjertesvigt, hypotension, hjerteshock,
English: Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden du får dette lægemiddel, da den indeholder vigtige oplysninger.
English: In the case of acute surgery, the anaesthetist should be informed about the treatment of amitriptyline.
Danish: I tilfælde af akut operation skal anæstesilægen informeres om, at du er i behandling med amitriptylin.
English: • sleepiness/drowsiness
Danish: • søvnighed/døsighed
English: These drugs may produce substantial decreases in TCA metabolism and marked increases in plasma concentrations.
Danish: Disse lægemidler kan bevirke betydeligt nedsat TCA metabolisering og markant stigning i plasmakoncentrationen.
English: • changes in taste
Danish: • smagsforandringer
English: • ritonavir (used to treat HIV)
Danish: • ritonavir (til behandling af HIV)
English: • methadone (used to treat pain and for detoxification)
Danish: • methadon (til behandling af smerter og ved misbrug)
English: Stopping treatment with Saroten solution for injection Your doctor will decide when and how to stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache, feeling unwell, sleeplessness and irritability).
Danish: Hvis du stopper behandlingen med Saroten injektionsvæske, opløsning Din læge vil beslutte, hvornår og hvordan du skal stoppe din behandling for at undgå eventuelle ubehagelige symptomer, som kan forekomme, hvis den stoppes pludseligt (f.eks. hovedpine, utilpashed, søvnløshed og irritabilitet).
English: Do not give this medicine to children and adolescents aged below 18 years for these treatments, as safety and efficacy have not been established in this age group.
Danish: Giv ikke dette lægemiddel til børn og unge under 18 år med henblik på sådan behandling, da langtidssikkerheden og langtidsvirkningen ikke er klarlagt for denne aldersgruppe.
English: • narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye)
Danish: • snævervinklet glaukom (grøn stær) (synstab på grund af abnormt højt tryk i øjet)
English: The elimination half-life (t½ β) amitriptyline after peroral administration is about 25 hours (24.65±6.31 hours; range 16.49-40.36 hours).
Danish: Eliminationshalveringstiden (t½ β) amitriptylin efter peroral administration er cirka 25 timer (24,65±6,31 timer; interval 16,49-40,36 timer).
English: The main active metabolite is the secondary amine, nortriptyline.
Danish: Den vigtigste aktive metabolit er den sekundære amin, nortriptylin.
English: For amitriptyline only limited clinical data are available regarding exposed pregnancies.
Danish: Der foreligger kun begrænsede kliniske data for amitriptylin vedrørende eksponering under graviditet.
English: The noradrenaline, sodium and the NMDA effects are mechanisms known to be involved in the maintenance of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis.
Danish: Virkningerne af noradrenalin, natrium og NMDA er mekanismer, der vides at være involveret i opretholdelse af neuropatiske smerter og i profylakse mod kronisk spændingshovedpine og migræne.
English: This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment.
Danish: Lægemidlet kan især i begyndelsen af behandlingen virke sløvende og forårsage svimmelhed.
English: When stopping treatment, amitriptyline should be withdrawn gradually.
Danish: Hvis behandlingen afbrydes, skal amitriptylin seponeres gradvist.
English: You should also tell your doctor, if you take or have recently taken medicine that may affect the heart´s rhythm.
Danish: Du skal også fortælle din læge, hvis du tager eller for nylig har taget medicin, som påvirker hjerterytmen, f.eks.:
English: Combinations requiring precautions for use
Danish: Kombinationer, hvor der skal udvises forsigtighed
English: Syncope and torsade de pointes have occurred.
Danish: Synkope og torsades de pointes kan forekomme.
English: The estimated daily infant exposure (amitriptyline + nortriptyline) averages 2% of the corresponding maternal weight related doses of amitriptyline (in mg/kg) (see section 4.6).
Danish: Den estimerede daglige eksponering (amitriptylin + nortriptylin) for et ammet spædbarn er i gennemsnit 2 % af den tilsvarende maternelle vægtrelaterede dosis af amitriptylin (i mg/kg) (se punkt 4.6).
English: • have an over active thyroid gland or receive thyroid medication.
Danish: • har en overaktiv skjoldbruskkirtel eller får thyreoideamedicin.
English: The dosage therefore can be increased in 25 mg amitriptyline hydrochloride steps.
Danish: Dosis kan derfor øges i trin på 25 mg amitriptylinhydrochlorid.
English: The antidepressant effect usually sets in after 2-4 weeks; the sedative action is not delayed.
Danish: Den antidepressive virkning begynder normalt efter 2-4 uger; den sedative virkning er ikke forsinket.
English: Great care is necessary if amitriptyline is administered to hyperthyroid patients or to those receiving thyroid medication, since cardiac arrhythmias may develop.
Danish: Der kræves stor forsigtighed, hvis amitriptylin administreres til hyperthyreoide patienter eller til patienter, der får thyreoidepræparater, da der kan opstå hjertearytmier.
English: Elderly are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure (see also section 4 Possible side effects).
Danish: Ældre patienter har større sandsynlighed for at få visse bivirkninger, såsom svimmelhed, når de rejser sig op på grund af lavt blodtryk (se også punkt 4 Bivirkninger).
English: • loss of consciousness
Danish: • bevidsthedstab
English: This may include irritability, hypertonia , tremor, irregular breathing, poor drinking and loud crying and possibly anticholinergic symptoms (urinary retention, constipation).
Danish: Disse kan omfatte irritabilitet, hypertoni, tremor, uregelmæssig vejrtrækning, dårlig sutteevne og høj gråd og muligvis antikolinerge symptomer (urinretention, obstipation).
English: • increased sensitivity to sunlight
Danish: • huden er mere følsom for lys
English: Depending on individual patient response, a lower dose of amitriptyline should be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to amitriptyline treatment (see section 4.5).
Danish: Afhængigt af den enkelte patients respons skal en lavere dosis amitriptylin overvejes, hvis en potent CYP2D6-hæmmer (f.eks. bupropion, kinidin, fluoxetin, paroxetin) føjes til behandlingen med amitriptylin (se punkt 4.5).
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: Det vides, at patienter med en anamnese med selvmordsrelaterede hændelser, og patienter, der udviser en signifikant grad af selvmordstanker inden behandlingsstart, har en større risiko for selvmordstanker eller selvmordsforsøg, og sådanne patienter skal overvåges nøje under behandlingen.
English: Warnings and precautions Talk to your doctor or pharmacist before taking X.
Danish: Advarsler og forsigtighedsregler Tal med lægen eller apotekspersonalet, før du tager {X}.
English: Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) are known to be conditions increasing the proarrythmic risk.
Danish: Elektrolytforstyrrelser (hypokaliæmi, hyperkaliæmi, hypomagnesæmi) er kendt for at være tilstande, som kan øge den proarytmiske risiko.
English: Any degree of heart block or disorders of cardiac rhythm and coronary artery insufficiency.
Danish: Enhver grad af hjerteblok eller hjerterytmeforstyrrelse og koronar insufficiens.
English: MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3).
Danish: MAO-hæmmere (ikke-selektive samt selektiv A (moclobemid) og B (selegilin)) - risiko for “serotoninsyndrom” (se punkt 4.3).
English: The score line facilitates breaking of the retard tablet into 3 parts.
Danish: Kærvlinjerne gør det lettere at dele depottabletten i 3 dele.
English: Neuropathic pain, chronic tension type headache and migraine prophylaxis It might take a few weeks before your feel any improvement of your pain.
Danish: Neuropatiske smerter, forebyggende mod kronisk spændingshovedpine og migræne Der kan gå et par uger, før du mærker en bedring i dine smerter.
English: Uncommon Tinnitus.
Danish: Ikke almindelig Tinnitus.
English: • cisapride (used to treat certain types of indigestion)
Danish: • cisaprid (til behandling af visse typer mavebesvær)
English: • methylphenidate (used to treat ADHD)
Danish: • methylphenidat (til behandling af ADHD)
English: Suicidal thoughts or behaviour.
Danish: − Selvmordstanker eller selvmordsrelateret adfærd.
English: Cardiac symptoms: Arrhythmias (ventricular tachyarrhythmias, torsade de pointes, ventricular fibrillation).
Danish: Kardiale symptomer: Arytmier (ventrikulær takyarytmi, torsades de pointes, ventrikelflimren).
English: Consider to monitor TCA plasma levels, whenever a TCA is to be co-administered with another drug known to be an inhibitor of CYP2D6.
Danish: Overvej at monitorere TCA-plasmakoncentrationer, når en TCA skal administreres sammen med et lægemiddel, som vides at hæmme CYP2D6.
English: • Suicidal thoughts and behaviours may also develop during early treatment with antidepressants for disorders other than depression; the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis
Danish: • Selvmordstanker og selvmordsrelateret adfærd kan også forekomme under tidlig behandling med antidepressive lægemidler for andre lidelser end depression; de samme forholdsregler, der træffes ved behandling af patienter med depression, skal derfor følges ved behandling af patienter med enuresis
English: • adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
Danish: • adrenalin, ephedrin, isoprenalin, noradrenalin, phenylephrin og phenylpropanolamin (disse lægemidler findes muligvis i hostesaft eller forkølelsesmedicin og i visse bedøvelsesmidler)
English: • halofantrine (used to treat malaria)
Danish: • halofantrin (til behandling af malaria)
English: A meta-analysis of placebocontrolled clinical trials of antidepressant drugs 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 meta-analyse af placebo-kontrollerede kliniske studier af antidepressiva givet til voksne patienter med psykiske lidelser viste en øget risiko for selvmordsadfærd med antidepressiva sammenlignet med placebo hos patienter under 25 år.