FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension.
Danish: Anæstetika administreret under behandling med tri-/tetracykliske antidepressiva kan øge risikoen for arytmier og hypotension.
English: Examples of strong CYP2D6 inhibitors include bupropion, fluoxetine, paroxetine and quinidine.
Danish: Eksempler på potente CYP2D6-hæmmere omfatter bupropion, fluoxetin, paroxetin og kinidin.
English: Do not use this medicine after the expiry date which is stated on the label afterr EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Pharmacotherapeutic group: Antidepressants - Non-selective monoamine reuptake inhibitor (tricyclic antidepressant)
Danish: Farmakoterapeutisk gruppe: Antidepressiva - non-selektiv monoamin-genoptagelseshæmmer (tricyklisk antidepressivum)
English: Use caution when using amitriptyline and methadone concomitantly due to a potential for additive effects on the QT interval and increased risk of serious cardiovascular effects.
Danish: Der skal udvises forsigtighed ved samtidig brug af amitriptylin og methadon på grund af potentielt additive virkninger på QT-intervallet og en øget risiko for alvorlige kardiovaskulære virkninger.
English: administration of 40-60 mg amitriptyline hydrochloride was 10.1-27.8 h and of 15 mg 15.5-19.5 h. In elderly subjects the half-life is prolonged.
Danish: Elimination Eliminationshalveringstiden fra plasma efter intravenøs administration af 40-60 mg amitriptylinhydrochlorid var 10,1-27,8 timer og 15,5-19,5 timer for 15 mg. Halveringstiden er længere hos ældre patienter.
English: • medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
Danish: • lægemidler til behandling af visse psykiske sygdomme (f.eks. pimozid og sertindol)
English: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs.
Danish: Epidemiologiske studier, hovedsageligt udført hos patienter på 50 år og derover, viser en øget risiko for knoglebrud hos patienter som får SSRI'er og TCA'er.
English: Usually the X is added to a solution for infusion.
Danish: X tilsættes normalt til en infusionsvæske.
English: • absent sensation of appetite
Danish: • manglende appetit
English: • disturbance in attention
Danish: • opmærksomhedsforstyrrelse
English: Doses can be increased with 10 mg - 25 mg every 3 - 7 days as tolerated.
Danish: Dosis kan øges med 10-25 mg hver 3.-7. dag, afhængigt af tolerans.
English: The mechanism of action also includes ion-channel blocking effects on sodium, potassium and NMDA channel at both central and spinal cord level.
Danish: Virkningsmekanismen inkluderer også ionkanal-blokerende virkninger på natrium-, kalium- og NMDAkanaler både centralt og i rygmarven.
English: If necessary, the dose can be increased by 25 mg every other day up to 150 mg daily divided into two doses.
Danish: Om nødvendigt kan dosis øges med 25 mg hver anden dag op til 150 mg dagligt fordelt på to doser.
English: Clinically relevant interactions may be expected with concomitant use of amitriptyline and strong CYP3A4 inhibitors such as ketoconazole, itraconazole and ritonavir.
Danish: Klinisk relevante interaktioner kan forventes ved samtidig brug af amitriptylin og potente CYP3A4hæmmere som ketoconazol, itraconazol og ritonavir.
English: Allergic inflammation of the pulmonary alveoli and of the lung tissue, respectively (alveolitis, Löffler's syndrome).
Danish: Meget sjælden Allergisk inflammation i lungealveoler og lungevæv (alveolitis, Löfflers syndrom)
English: Some patients with manic-depressive illness may enter into a manic phase.
Danish: Nogle patienter med bipolar lidelse (manio-depression) kan gå over i den maniske fase.
English: The daily dose may be increased up to 100 mg - 150 mg, depending on individual patient response and tolerability.
Danish: Den daglige dosis kan øges op til 100-150 mg afhængigt af den enkelte patients respons og tolerabilitet.
English: Other metabolites such as cis- and trans- 10-hydroxyamitriptyline and cis- and trans10-hydroxynortriptyline have the same profile as nortriptyline but are considerably less potent.
Danish: Andre metabolitter såsom cis- og trans-10-hydroxyamitriptylin og cis- og trans-10-hydroxynortriptylin har samme profil som nortriptylin, men er betydeligt mindre potente.
English: • irregular, hard, or rapid heartbeat
Danish: • uregelmæssig, kraftig eller hurtig puls
English: X can be added to an infusion or injected into a big muscle.
Danish: Du kan få {X} som en infusion eller som en injektion i en stor muskel.
English: Those parts currently not needed can be stored in the reservoir of the tablet box.
Danish: De tabletdele, du ikke tager med det samme, kan opbevares i rummet i tabletæsken.
English: Bed-wetting at night Use in children and adolescents The recommended doses for children:
Danish: Sengevædning(enuresis) Børn og unge Den anbefalede dosis til børn:
English: <[Saroten and associated names 75 mg, modified release tablets] In contrast to the tablet serum curves which show a distinct initial peak, the modified release tablets curves rise slowly to a plateau level with lower concentrations than the peak of the tablet curves.
Danish: <[Saroten og relaterede navne 75 mg tabletter med modificeret udløsning] I modsætning til serumkurverne for tabletterne, som viser en tydelig initial spidskoncentration, stiger kurverne for tabletterne med modificeret udløsning langsomt til et plateau med lavere koncentration end spidsværdien for kurverne for tabletterne.
English: The mean absolute oral bioavailability is 53% (Fabs = 0.527±0.123; range 0.219-0.756).>
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 53 % (Fabs = 0,527±0,123 (0,219-0,756)).>
English: Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose).
Danish: Amitriptylin og dets metabolitter udskilles i human mælk (svarende til 0,6 - 1 % af moderens dosis).
English: • diuretics (“water tablets” e.g. furosemide)
Danish: • diuretika (vanddrivende tabletter, f.eks. furosemid)
English: In patients with the rare condition of shallow anterior chamber and narrow chamber angle, attacks of acute glaucoma due to dilation of the pupil may be provoked.
Danish: Hos patienter med den sjældne tilstand forsnævring af forreste øjenkammer og snæver kammervinkel kan akut glaukomanfald fremprovokeres pga. pupildilatation.
English: Amitriptyline hydrochloride
Danish: Amitriptylinhydrochlorid
English: <[Saroten and associated names prolonged-release capsules, hard] Swallow the capsules with a drink of water.
Danish: <[Saroten og relaterede navne depotkapsler, hårde] Slug kapslerne med et glas vand.
English: Reduced liver function Careful dosing and, if possible, a serum level determination is advisable.
Danish: Nedsat leverfunktion Forsigtighed tilrådes ved dosering, og måling af serumkoncentration anbefales, hvis det er muligt.
English: Dose adjustment of amitriptyline may be necessary (see section 4.2).
Danish: Dosisjustering af amitriptylin kan være nødvendigt (se punkt 4.2).
English: Check urea and electrolytes-look for low potassium and monitor urine output.
Danish: Tjek urinstof og elektrolytter - vær opmærksom på lavt kalium og monitorer diuresen.
English: The recommended doses are provided in section 4.2.
Danish: De anbefalede doser er angivet i pkt.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Meget
English: Steady state plasma levels of amitriptyline + nortriptyline are reached within a week for most patients, and in steady state the plasma level comprises approximately equal parts of amitriptyline and nortriptyline around the clock following treatment with conventional tablets 3 times a day.
Danish: Steady state plasmakoncentrationen af amitriptylin+nortriptylin nås inden for en uge hos de fleste patienter, og ved steady state er der omtrent lige meget amitriptylin og nortriptylin i plasma døgnet rundt efter behandling med konventionelle tabletter 3 gange om dagen.
English: The therapeutic plasma concentration in major depression is around 80-200 ng/ml (≈ 280-700 nmol/l) (for amitriptyline + nortriptyline).
Danish: Den terapeutiske plasmakoncentration ved svær depression er omkring 80-200 nanogram/ml (≈ 280700 nanomol/l) (for amitriptylin + nortriptylin).
English: • the treatment of nocturnal enuresis in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products.
Danish: • behandling af enuresis nocturna hos børn på 6 år og derover, når organisk patologi, inklusive rygmarvsbrok og relaterede lidelser, er udelukket, og der ikke er opnået respons ved al anden ikkemedicinsk og medicinsk behandling, inklusive antispasmodika og vasopressinlignende præparater.
English: X contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Danish: Dette lægemiddel indeholder under 1 mmol natrium (23 mg) per dosis, dvs. det er praktisk talt natriumfrit.
English: If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine.
Danish: Hvis du skal opereres og skal have fuld eller lokal bedøvelse, skal du fortælle lægen, at du får denne medicin.
English: • if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
Danish: • hvis du tager lægemidler, der kaldes monoaminoxidasehæmmere (MAO-hæmmere)
English: • tramadol (painkiller)
Danish: • tramadol (smertestillende middel)
English: • if you recently have had a heart attack (myocardial infarction)
Danish: • hvis du har haft et hjertetilfælde (hjerteinfarkt) for nyligt
English: Adrenergic neurone blockers: Tricyclic antidepressants may counteract the antihypertensive effects of centrally acting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and methyldopa.
Danish: Adrenerge neuroblokkere: Tricykliske antidepressiva kan modvirke de antihypertensive virkninger af centralt virkende antihypertensiva såsom guanethidin, betanidin, reserpin, clonidin og methyldopa.
English: • children aged 11 years and above: 25 mg - 50 mg daily
Danish: • børn på 11 år og derover: 25-50 mg dagligt
English: • medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
Danish: • medicin til behandling af svampeinfektioner (f.eks. fluconazol, terbinafin, ketoconazol og itraconazol)
English: Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline.
Danish: Behandling med MAOhæmmere kan indledes 14 dage efter seponering af amitriptylin.
English: <[Saroten and associated names prolonged-release capsules, hard] X contains sucrose
Danish: <[Saroten og relaterede navne depotkapsler, hårde] X indeholder saccharose
English: What you need to know before you take X 3.
Danish: Det skal du vide, før du begynder at tage {X} 3.
English: Pharmacokinetic / Pharmacodynamic relationship
Danish: Farmakokinetiske/farmakodynamiske forhold
English: • Major Depressive Disorder
Danish: • Major depression
English: Nortriptyline is a more potent inhibitor of noradrenaline than of serotonin reuptake, while amitriptyline inhibits the reuptake of noradrenaline and serotonin equally well.
Danish: Nortriptylin er en mere potent hæmmer af noradrenalin- end af serotonin-optagelse, mens amitriptylin hæmmer optagelsen af noradrenalin og serotonin lige godt.
English: Anticholinergic symptoms: Mydriasis, tachycardia, urinary retention, dry mucous membranes, reduced bowel motility.
Danish: Antikolinerge symptomer: Mydriasis, takykardi, urinretention, tørre slimhinder, nedsat tarmmotilitet.
English: Nortriptyline is a more potent inhibitor of noradrenaline than of serotonin uptake, while amitriptyline inhibits the uptake of noradrenaline and serotonin equally well.
Danish: Nortriptylin er en mere potent hæmmer af noradrenalin end af serotonin-optagelse, mens amitriptylin hæmmer optagelsen af noradrenalin og serotonin lige godt.
English: Not known Anorexia, elevation or lowering of blood sugar levels.
Danish: Anoreksi, højt eller lavt blodsukker
English: • antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), and bupropion)
Danish: • antidepressive lægemidler (f.eks. SSRI'er (fluoxetin, paroxetin, fluvoxamin) og bupropion)
English: Uncommon Collapse conditions, worsening of cardiac failure.
Danish: Ikke almindelig Tilstande med kollaps, forværring af hjertesvigt
English: Sympathomimetic agents: Amitriptyline may potentiate the cardiovascular effects of adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine, and phenylpropanolamine (e.g. as contained in local and general anaesthetics and nasal decongestants).
Danish: Sympatomimetika: Amitriptylin kan potensere de kardiovaskulære virkninger af adrenalin, ephedrin, isoprenalin, noradrenalin, phenylephrin og phenylpropanolamin (som f.eks. findes i bedøvelsesmidler til lokal og generel bedøvelse samt næsedråber).
English: The daily dose may be increased up to 100 mg - 150 mg divided into two doses, depending on individual patient response and tolerability.
Danish: Den daglige dosis kan øges op til 100-150 mg fordelt på to doser afhængigt af den enkelte patients respons og tolerabilitet.
English: • medicine to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
Danish: • medicin til behandling af højt blodtryk, for eksempel calciumantagonister (f.eks. diltiazem og verapamil), guanethidin, betanidin, clonidin reserpin og methyldopa
English: Major depressive disorder
Danish: Major depression
English: • elevation or lowering of blood sugar levels
Danish: • højt eller lavt blodsukker
English: The pain-reducing effect of amitriptyline is not linked to its antidepressive properties.
Danish: Den smertereducerende virkning af amitriptylin effekt er ikke knyttet til midlets antidepressive egenskaber.
English: This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis.
Danish: Lægemidlet må ikke gives til børn eller unge til behandling af neuropatiske smerter eller forebyggende mod kronisk spændingshovedpine og migræne.
English: • aged 11 years and above: 25 mg - 50 mg.
Danish: • 11 år og derover: 25 - 50 mg.
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem Sjælden
English: X can also be injected into a big muscle (i.m.
Danish: X kan også injiceres i en stor muskel (intramuskulær injektion).
English: The recommended initial dose is 50 mg in the evening.
Danish: Den anbefalede startdosis er 50 mg om aftenen.
English: 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally] 6.5 Nature and contents of container <and special equipment for use, administration or implantation> [To be completed nationally] 6.6 Special precautions for disposal <and other handling>
Danish: 6.3 Opbevaringstid [Skal udfyldes nationalt] 6.4 Særlige opbevaringsforhold [Skal udfyldes nationalt] 6.5 Emballagetype og pakningsstørrelser <og specielt udstyr til anvendelse, administration eller implantation> [Skal udfyldes nationalt] 6.6 Regler for bortskaffelse <og anden håndtering> Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Unless prescribed otherwise adults will receive their daily dosages in 250 to 500 ml sodium chloride solution 0.9% for 2-3 hours as a drip infusion under control of blood pressure and ECG.
Danish: Medmindre andet er ordineret, vil voksne patienter få deres daglige doser i 250-500 ml 0,9 % natriumchloridinfusionsvæske i løbet af 2-3 timer som et intravenøst drop under kontrol af blodtryk og EKG.
English: • Bed-wetting at night in children aged 6 years and above, only when organic causes, such as spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including muscle relaxants and desmopressin.
Danish: • Til at behandle sengevædning hos børn på 6 år og derover, når legemlige årsager såsom rygmarvsbrok og relaterede lidelser, er udelukket, og der ikke er opnået respons ved al anden ikke-medicinsk og medicinsk behandling, inklusive muskelafslappende lægemidler og desmopressin.
English: However, fluvoxamine (strong CYP1A2 inhibitor) was shown to increase amitriptyline plasma concentrations and this combination should be avoided.
Danish: Det er imidlertid vist, at fluvoxamin (potent CYP1A2-hæmmer) øger plasmakoncentrationen, og kombinationen bør undgås.
English: Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk.
Danish: Amitriptylin anbefales ikke under graviditet, medmindre din læge mener, at det er klart nødvendigt.
English: • increased pressure in the eye ball
Danish: • forhøjet tryk i øjet
English: Treatment of the following will be decided on a case by case basis: - Wide QRS-intervals, cardiac failure and ventricular arrhythmias - Circulatory failure - Hypotension - Hyperthermia - Convulsions - Metabolic acidosis.
Danish: Behandling af følgende skal besluttes i hvert enkelt tilfælde: - Brede QRS-intervaller, hjertesvigt og ventrikulære arytmier - Kredsløbssvigt - Hypotension - Hypertermi - Kramper - Metabolisk acidose.
English: • thioridazine (used to treat schizophrenia)
Danish: • thioridazin (til at behandle skizofreni)
English: Antifungals such as fluconazole and terbinafine increase serum concentrations of tricyclics and accompanying toxicity.
Danish: Antimykotika såsom fluconazol og terbinafin øger serumkoncentrationen af TCA med ledsagende toksicitet.
English: You will not be given X: if you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for amitriptylin eller et af de øvrige indholdsstoffer i lægemidlet (angivet i punkt 6)
English: Other medicines and Saroten solution for injection Some medicines may affect the action of other medicines and this can sometimes cause serious side effects.
Danish: Brug af anden medicin sammen med Saroten injektionsvæske, opløsning Nogle lægemidler kan påvirke andre lægemidlers virkning, hvilket undertiden kan forårsage alvorlige bivirkninger.
English: Potential for amitriptyline to affect other medicinal products
Danish: Amitriptylins potentiale for at påvirke andre lægemidler
English: The recommended initial dose is 25 mg two times daily.
Danish: Den anbefalede startdosis er 25 mg to gange dagligt.
English: Bone marrow depression, agranulocytosis, leucopenia, eosinophilia, thrombocytopenia.
Danish: Knoglemarvsdepression, agranulocytose, leukopeni, eosinofili, trombocytopeni
English: If you get any of the following symptoms you should see your doctor immediately:
Danish: Søg straks læge, hvis du får nogen af følgende symptomer:
English: The mean absolute oral bioavailability is 53% (Fabs = 0.527±0.123; range 0.219-0.756).
Danish: Den gennemsnitlige absolutte orale biotilgængelighed er 53 % (Fabs = 0,527±0,123 (0,219
English: In reproductive studies teratogenic effects were not observed in mice, rats, or rabbits when amitriptyline was given orally at doses of 2-40 mg/kg/day (up to 13 times the maximum recommended human amitriptyline dose of 150 mg/day or 3 mg/kg/day for a 50-kg patient).
Danish: Der er ikke observeret teratogene virkninger i reproduktionsstudier hos mus, rotter eller kaniner, som fik amitriptylin oralt i doser på 2-40 mg/kg/dag (op til 13 gange den maksimale anbefalede humane dosis amitriptylin på 150 mg/dag eller 3 mg/kg/dag for en patient på 50 kg).
English: • enlarged prostate
Danish: • forstørret prostata
English: • have slow heart rate,
Danish: • har langsom puls
English: The daily dosage is in general between 1 and 3 ampoules of 2 ml (equivalent to 50-150 mg amitriptyline hydrochloride/day, equivalent to 44.2 - 132.6 mg amitriptyline/day).
Danish: Den daglige dosis er generelt mellem 1 og 3 ampuller af 2 ml (svarende til 50-150 mg amitriptylinhydrochlorid dagligt svarende til 44,2-132,6 mg amitriptylin dagligt).
English: After prolonged administration, abrupt cessation of therapy may produce withdrawal symptoms such as headache, malaise, insomnia and irritability.
Danish: Efter længere tids administration kan pludselig seponering medføre seponeringsymptomer såsom hovedpine, utilpashed, søvnløshed og irritabilitet.
English: Metabolic acidosis, hypokalemia.
Danish: metabolisk acidose, hypokaliæmi.
English: metabolic acidosis, hypokalemia.
Danish: Metabolisk acidose, hypokaliæmi.
English: Your doctor will advise you whether to start/continue/stop breast-feeding, or stop using this medicine taking into account the benefit of breast-feeding for your child and the benefit of therapy for you.
Danish: Din læge vil rådgive dig, om du skal begynde/fortsætte/stoppe med at amme, eller behandlingen med medicinen skal stoppes, idet der tages højde for fordelene ved amning for dit barn i forhold til de behandlingsmæssige fordele for dig.
English: • coma
Danish: • koma
English: Potential of other medicinal products to affect amitriptyline
Danish: Andre lægemidler, der potentielt kan påvirke amitriptylin
English: • aged 6 to 10 years: 10 mg - 20 mg daily.
Danish: • børn mellem 6 og 10 år: 10 - 20 mg dagligt.
English: This medicinal product should only be prescribed by a healthcare professional with expertise in the management of persistent enuresis.
Danish: Dette lægemiddel må kun ordineres af læger med erfaring i behandling af persisterende enuresis.
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: • severe liver disease
Danish: • alvorlig leversygdom
English: This medical product should be used with caution in patients with convulsive disorders, urinary retention, prostatic hypertrophy, hyperthyroidism, paranoid symptomatology and advanced hepatic or cardiovascular disease, pylorus stenosis and paralytic ileus.
Danish: Dette lægemiddel skal anvendes med forsigtighed hos patienter med krampeanfald, urinretention, prostatahypertrofi, hypertyreoidisme, paranoid symptomatologi, fremskreden lever- eller hjerte-karsygdom, pylorusstenose og paralytisk ileus.
English: - Bruising, bleeding, pallor or persistent sore throat and fever.
Danish: - Blå mærker, blødning, bleghed eller vedvarende halsbetændelse og feber.
English: Caution is also advised for co-administration of amitriptyline and diuretics inducing hypokalaemia (e.g. furosemide)
Danish: Der anbefales ligeledes forsigtighed ved samtidig administration af amitriptylin og diuretika, som kan fremkalde hypokaliæmi (f.eks. furosemid).
English: Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability.
Danish: Dosering bør initieres på lavt niveau og dosis øges gradvist under omhyggelig overvågning af klinisk respons og eventuelle tegn på intolerans.
English: Very rare (<1/10,000);
Danish: Meget sjælden (<1/10.000);
English: The active substance is amitriptyline.
Danish: Aktivt stof: amitriptylin.
English: Doses above 75 mg should be used with caution.
Danish: Doser over 75 mg skal anvendes med forsigtighed.
English: Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses.
Danish: Patienter med leversygdomme eller personer, som vides at omsætte visse lægemidler dårligt, får som regel en lavere dosis.