FrancophonIA/ELRC3.0 huggingface dataset:
English: It prevents the re-uptake, and hence the inactivation of noradrenaline and serotonin at nerve terminals.
Slovenian: Preprečuje ponovni privzem in s tem inaktivacijo noradrenalina in serotonina na živčnih končičih.
English: Unrest and convulsions may be treated with diazepam.
Slovenian: Nemir in konvulzije se lahko zdravi z diazepamom.
English: Assess and treat ABC's (airway, breathing and circulation) as appropriate.
Slovenian: ABC (airway, breathing, circulation) ocena in zdravljenje, kot je primerno.
English: • low sodium concentration in the blood
Slovenian: • nizka koncentracija natrija v krvi
English: • feeling of inner restlessness and a compelling need to be in constant motion
Slovenian: • občutek notranjega nemira in potreba po stalnem gibanju
English: • have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
Slovenian: • imate težavo, zaradi katere imate nizke vrednosti kalija ali magnezija ali visoke vrednosti kalija v krvi,
English: • Suicidal thoughts or behaviour.
Slovenian: • samomorilne misli ali vedenje
English: Contraindicated combinations
Slovenian: Kontraindicirane kombinacije
English: During awakening possibly again confusion, agitation and hallucinations and ataxia.
Slovenian: Med zbujanjem se lahko ponovno pojavijo zmedenost, vznemirjenost, halucinacije in ataksija.
English: There was a possible association with an effect on fertility in rats, namely a lower pregnancy rate.
Slovenian: Obstaja možna povezava z učinkom na plodnost pri podganah, in sicer manjša stopnja brejosti.
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.
Slovenian: Bolniki, ki jim je bilo predpisano psihotropno zdravilo, lahko pričakujejo poslabšanje splošne pozornosti in koncentracije, zato jih je treba opozoriti glede njihove sposobnosti vožnje in upravljanja strojev.
English: • loss of consciousness
Slovenian: • izgubo zavesti
English: The dose can be taken once daily, or be divided into two doses.
Slovenian: Odmerek se lahko jemlje enkrat na dan ali se razdeli na dva odmerka.
English: The pellets must not be chewed.>
Slovenian: Zrnc se ne sme žvečiti.>
English: Side effects listed below have been reported in the following frequencies:
Slovenian: O spodaj naštetih neželenih učinkih so poročali z naslednjimi pogostnostmi.
English: Continuous ECG-monitoring of cardiac function for 3-5 days.
Slovenian: Nadaljnje spremljanje delovanja srca z EKG naslednje 3 do 5 dni.
English: Paediatric population The recommended doses for:
Slovenian: Pediatrična populacija Priporočeni odmerki so:
English: Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.
Slovenian: Tudi zobozdravnika obvestite, da jemljete to zdravilo, če morate prejeti lokalni anestetik.
English: If you stop taking X
Slovenian: Če ste prenehali jemati zdravilo X
English: In treating depression the duration of treatment is individual, and is usually at least 6 months.
Slovenian: Trajanje zdravljenja depresije je odvisno od posameznika in običajno traja vsaj 6 mesecev.
English: • disorder of the peripheral nerves
Slovenian: • motnje perifernega živčevja
English: • changes in taste
Slovenian: • spremenjen okus
English: (24.65±6.31 hours; range 16.49-40.36 hours).
Slovenian: (24,65 ± 6,31 ure; razpon 16,49 - 40,36 ure).
English: If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.
Slovenian: Če je potrebnih več ciklov zdravljenja z amitriptilinom, je treba vsake 3 mesece opraviti zdravniški pregled.
English: • If you have previously had thoughts about killing or harming yourself.
Slovenian: • če ste že kdaj razmišljali o tem, da bi storili samomor ali se sami poškodovali,
English: Do not use this medicine after the expiry date which is stated on the card box and ampoule.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in ampuli.
English: How and when to take X
Slovenian: Kdaj in kako jemati zdravilo X
English: Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose).
Slovenian: Amitriptilin in njegovi presnovki se izločajo v materino mleko (to ustreza 0,6 % - 1 % odmerka za mater).
English: The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies.
Slovenian: Genotoksični potencial amitriptilina so preučevali v različnih in vitro in in vivo študijah.
English: Contact your doctor or nearest hospital casualty department immediately.
Slovenian: Takoj se posvetujte z zdravnikom ali pojdite v najbližji urgentni oddelek bolnišnice.
English: Your doctor will most likely choose to initiate your treatment with Saroten film-coated tablets before starting treatment with X.
Slovenian: Zdravnik se bo verjetno najprej odločil za začetno zdravljenje z zdravilom Saroten filmsko obložene tablete, preden vas bo začel zdraviti z zdravilom X.
English: The solution for injection should mainly be used for acute treatment.
Slovenian: Raztopina za injiciranje se uporablja predvsem za akutno zdravljenje.
English: The ratio milk concentration/plasma concentration in women is around 1:1.
Slovenian: Razmerje med koncentracijo v materinem mleku/koncentracijo v plazmi pri ženskah je približno 1:1.
English: The score line facilitates breaking of the tablet into 4 parts (12.5 mg/part).
Slovenian: Razdelilna zareza olajša lomljenje tablete na 4 dele (12,5 mg/del).
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.
Slovenian: Vendar podatki iz literature kažejo na tveganje za malformacije in zakasnelo zakostenevanje pri miših, hrčkih, podganah in kuncih pri 9-33-kratniku največjega priporočenega odmerka.
English: The pellets in the capsule contain sucrose.
Slovenian: Zrnca v kapsuli vsebujejo saharozo.
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.
Slovenian: Ravni nad 300 - 400 ng/ml so povezane z večjim tveganjem za motnje prevodnosti srca kot so podaljšanje kompleksa QRS ali AV blok.
English: Reuptake prevention of these monoamine neurotransmitters potentiate their action in the brain.
Slovenian: Preprečitev ponovnega privzema teh živčnih prenašalcev monoamina okrepi njihov učinek v možganih.
English: • aged below 6 years: see section 2 Do not take X
Slovenian: • mlajše od 6 let: glejte poglavje 2, »Ne jemljite zdravila X«
English: Nocturnal enuresis
Slovenian: Nočna enureza
English: Elderly patients are particularly susceptible to orthostatic hypotension.
Slovenian: Starejši bolniki so še posebno dovzetni za ortostatsko hipotenzijo.
English: Some patients with manic-depressive illness may enter into a manic phase.
Slovenian: Pri nekaterih bolnikih z manično depresivno motnjo se lahko pojavi manična faza.
English: After reduction of the depressive symptoms the treatment with amitriptyline should be continued for up to 6 month.
Slovenian: Ko se simptomi depresije zmanjšajo, je treba zdravljenje z amitriptilinom nadaljevati še do 6 mesecev.
English: X can be taken with or without food.
Slovenian: Zdravilo X se lahko jemlje s hrano ali brez nje.
English: • if you recently have had a heart attack (myocardial infarction)
Slovenian: • če ste imeli pred kratkim srčni napad (miokardni infarkt)
English: • dizziness when you stand up due to low blood pressure (orthostatic hypotension)
Slovenian: • omotica pri vstajanju zaradi nizkega krvnega tlaka (ortostatska hipotenzija)
English: During chronic use and after administration in the final weeks of pregnancy, neonatal withdrawal symptoms can occur.
Slovenian: Ob dolgotrajni uporabi in po dajanju v zadnjih tednih nosečnosti se lahko pri novorojencu pojavijo odtegnitveni simptomi.
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.
Slovenian: Zdravljenje z antidepresivi je simptomatsko in se mora zato nadaljevati ustrezno dolgo, običajno do 6 mesecev po okrevanju, da se prepreči ponovitev.
English: However, the capsules can be opened and the pellets swallowed with a cold drink or e.g. yoghurt.
Slovenian: Kapsule se lahko tudi odpre in zrnca zaužije s hladno pijačo ali npr. z jogurtom.
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.
Slovenian: Nekateri spodaj omenjeni neželeni učinki, npr. glavobol, tremor, motnje pozornosti, zaprtje in zmanjšan libido so lahko tudi simptomi depresije, ki običajno oslabijo, ko se depresivno stanje izboljša.
English: Amitriptyline inhibited ion channels, which are responsible for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations.
Slovenian: Amitriptilin zavira ionske kanale, ki so odgovorni za repolarizacijo srca (kanali hERG), v zgornjem mikromolarnem razponu terapevtskih koncentracij v plazmi.
English: The metabolism is subject to genetic polymorphism.
Slovenian: Presnova je odvisna od genetskega polimorfizma.
English: tmax = 7.1±1.9 hours; range 2.010.0 hours.
Slovenian: tmax = 7,1 ± 1,9 ure; razpon 2,0 - 10,0 ure.
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).
Slovenian: Učinkovitost in varnost amitriptilina je bila dokazana pri zdravljenju nočne enureze pri otrocih, starih 6 let in več (glejte poglavje 4.1).
English: The elimination half-life (t½ β) amitriptyline after peroral administration is about 25 hours
Slovenian: Razpolovni čas izločanja (t½ β) amitriptilina po peroralni aplikaciji je približno 25 ur
English: • bipolar disorder
Slovenian: • bipolarno motnjo
English: Polymorphism
Slovenian: Polimorfizem
English: The recommended doses are provided in section 4.2.
Slovenian: Glede priporočenih odmerkov glejte poglavje 4.2.
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Slovenian: Depresija je povezana s povečanim tveganjem za pojav samomorilnih misli, samopoškodovanja in samomorilnosti (s samomorom povezani dogodki).
English: They may also occur in patients with pre-existing heart disease taking normal dosage.
Slovenian: Pojavijo se lahko tudi pri bolnikih s prisotno boleznijo srca, ki jemljejo običajne odmerke.
English: • oral contraceptives
Slovenian: • peroralni kontraceptivi
English: X with alcohol
Slovenian: Zdravilo X skupaj z alkoholom
English: The solution for injection prepared with sodium chloride solution 0.9% must be used immediately.
Slovenian: Raztopino za infundiranje, pripravljeno z 0,9 % raztopino natrijevega klorida, je treba uporabiti takoj.
English: You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet.
Slovenian: Morda vam bo v pomoč, če boste sorodniku ali dobremu prijatelju povedali, da ste depresivni , in ga prosili, da prebere to navodilo.
English: • delirium (especially in elderly patients), hallucinations (especially in patients with schizophrenia),
Slovenian: • delirij (zlasti pri starejših bolnikih), halucinacije (zlasti pri bolnikih s shizofrenijo)
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Slovenian: Največjega dnevnega odmerka 150 mg amitriptilina, danega kot injekcijo/infuzijo, se ne sme preseči..
English: Amitriptyline is a tricyclic antidepressant and an analgesic.
Slovenian: Amitriptilin je triciklični antidepresiv in analgetik.
English: (tmax = 3.89±1.87 hours; range 1.93-7.98 hours).
Slovenian: (tmax = 3,89 ± 1,87 ur; razpon 1,93 - 7,98 ur).
English: Saroten injectable solution is used in hospitalized patients especially for the initial treatment of depressive disorders.
Slovenian: Zdravilo Saroten raztopina za injiciranje se uporablja pri hospitaliziranih bolnikih, predvsem za začetno zdravljenje depresije.
English: This might also occur in usual doses if you have pre-existing heart disease.
Slovenian: To se lahko pojavi tudi pri običajnih odmerkih, če imate bolezen srca.
English: In case of sufficient effect, the dose should be as low as possible.
Slovenian: Če je učinek zadosten, je treba odmerek čim prej zmanjšati.
English: Plasma concentrations of amitriptyline and nortriptyline vary very widely between individuals and no simple correlation with therapeutic response has been established.
Slovenian: Koncentracije amitriptilina in nortriptilina v plazmi se med posamezniki zelo razlikujejo; preprosta korelacija s terapevtskim odzivom ni bila dokazana.
English: These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
Slovenian: Po prvem zdravljenju z antidepresivi lahko te misli postanejo še hujše, saj ta zdravila začnejo delovati šele čez nekaj časa, običajno čez dva tedna, nekatera pa tudi kasneje.
English: X can be used as drip infusion or as intramuscular injection.
Slovenian: Zdravilo X se lahko uporablja kot kapalna infuzija ali v obliki intramuskularne injekcije.
English: Your doctor will instruct you whether to take the doses once daily or divide into two doses.
Slovenian: Zdravnik vam bo svetoval, ali odmerke jemljete enkrat na dan ali razdeljene na dva odmerka.
English: In manic-depressives, a shift towards the manic phase may occur; should the patient enter a manic phase amitriptyline should be discontinued.
Slovenian: Pri manično-depresivnih bolnikih se lahko pojavi premik proti manični fazi; če pri bolniku pride do manične faze, je treba dajanje amitriptilina prekiniti.
English: In nursing mothers amitriptyline and nortriptyline are excreted in small amounts with the breast milk.
Slovenian: Pri doječih materah se amitriptilin in nortriptilin izločata v majhnih količinah z materinem mlekom.
English: A more suitable dosage form should be used for this age group.
Slovenian: Pri tej starostni skupini je treba uporabiti primernejšo farmacevtsko obliko zdravila.
English: X is used for the in-hospital treatment of depression in adults (major depressive episodes).
Slovenian: Zdravilo X se uporablja za bolnišnično zdravljenje depresije pri odraslih (hude depresivne epizode).
English: Dosage and duration of treatment will be determined by you physician based on the severity of your disease and your clinical response.
Slovenian: Odmerjanje in trajanje zdravljenja bo določil zdravnik glede na resnost bolezni in vašega odziva na zdravljenje.
English: The maximum period of treatment course should not exceed 3 months.
Slovenian: Cikel zdravljenja ne sme biti daljši kot 3 mesece.
English: In plasma the amount of total 10-hydroxynortriptyline dominates but most of the metabolites are conjugated.
Slovenian: Količina celokupnega 10-hidroksinortriptilina v plazmi prevladuje, vendar je večina presnovkov konjugiranih.
English: However, fluvoxamine (strong CYP1A2 inhibitor) was shown to increase amitriptyline plasma concentrations and this combination should be avoided.
Slovenian: Vendar pa se je pokazalo, da fluvoksamin (močan zaviralec CYP1A2) poveča koncentracije amitriptilina v plazmi, zato se je treba tej kombinaciji izogibati.
English: Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk.
Slovenian: Uporaba amitriptilina se med nosečnostjo ne priporoča, razen če vaš zdravnik meni, da je nujno potreben, in le po skrbni presoji razmerja med koristmi in tveganji.
English: Concomitant treatment with MAOIs (monoamine oxidase inhibitors) is contra-indicated (see section 4.5).
Slovenian: Sočasno zdravljenje z zaviralci monoaminooksidaze (MAOI - monoamine oxidase inhibitors) je kontraindicirano (glejte poglavje 4.5).
English: Initial treatment:
Slovenian: Začetno zdravljenje
English: Before starting treatment, your doctor will conduct an ECG of your heart to check for sign of unusual heartbeat.
Slovenian: Pred začetkom zdravljenja bo zdravnik naredil EKG srca, da bo preveril ali obstaja neobičajen srčni ritem.
English: Hepatic impairment may reduce hepatic extraction resulting in higher plasma levels and caution should be exercised when dosing these patients (see section 4.2).
Slovenian: Zaradi okvare jeter se lahko zmanjša izločanje preko jeter, kar povzroči večje ravni v plazmi, zato je pri odmerjanju zdravila tem bolnikom potrebna previdnost (glejte poglavje 4.2).
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).
Slovenian: Pri starejših je bolj verjetno, da se bodo pojavili določeni neželeni učinki, kot je omotica ob vstajanju zaradi nizkega krvnega tlaka (glejte tudi poglavje 4, »Možni neželeni učinki«).
English: MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3).
Slovenian: Zaviralci MAO (neselektivni in selektivni zaviralci MAO A (moklobemid) in B (selegilin)) - tveganje za pojav »serotoninskega sindroma« (glejte poglavje 4.3).
English: Due to the often delayed gastrointestinal tract passage maximum plasma concentrations are reached after 1 to 5 (-8) hours.
Slovenian: Zaradi pogosto zakasnelega prehoda skozi prebavila je največja koncentracija v plazmi dosežena po 1 do 5 (-8) urah.
English: At the start of treatment, the dose should be gradually increased, when treatment is discontinued, it must be reduced gradually.
Slovenian: Na začetku zdravljenja je treba odmerek postopno povečevati, pri prenehanju zdravljenja pa ga je treba postopno zmanjševati.
English: Check arterial blood gases-look for acidosis.
Slovenian: Preverjanje plinov v arterijski krvi - posebna pozornost glede acidoze.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, kot so:
English: ATC code: N 06 AA 09
Slovenian: Oznaka ATC: N06AA09 Mehanizem delovanja
English: • various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock,
Slovenian: • različne simptome bolezni srca, kot so srčni blok, srčno popuščanje, hipotenzija, kardiogeni šok,
English: The main active metabolite is the secondary amine, nortriptyline.
Slovenian: Glavni aktivni presnovek je sekundarni amin, nortriptilin.
English: • slurred or slow speech
Slovenian: • nerazločen ali počasen govor
English: Therefore, amitriptyline may increase the risk for cardiac arrhythmia (see section 4.4).
Slovenian: Zato lahko amitriptilin poveča tveganje za srčno aritmijo (glejte poglavje 4.4).
English: Combinations requiring precautions for use
Slovenian: Kombinacije, pri katerih je potrebna previdnost
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.
Slovenian: Če se zdravite z zdravilom X, morate zdravilo prenehati jemati in počakati 14 dni, preden se lahko začnete zdraviti z zaviralci monoaminooksidaze.
English: The pain-reducing effect of amitriptyline is not linked to its antidepressive properties.
Slovenian: Učinek amitriptilina na zmanjšanje bolečine ni povezan z njegovimi antidepresivnimi lastnostmi.
English: Prolonged-release Capsules, hard
Slovenian: Kapsule s podaljšanim sproščanjem, trde
English: Contents of the pack and other information What X contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X
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.
Slovenian: Za zdravljenje depresije so uporabili odmerke do 200 mg na dan in, občasno, do 300 mg na dan pri hudo depresivnih bolnikih, ki so se zdravili v bolnišnici.
English: Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths.
Slovenian: Vseh farmacevtskih oblik/jakosti ni mogoče uporabiti pri vseh shemah odmerjanja.
English: Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia).
Slovenian: Sočasno dajanje amitriptilina in zaviralcev MAO lahko povzroči serotoninski sindrom (kombinacija simptomov, ki lahko vključujejo agitacijo, zmedenost, tremor, mioklonus in hipertermijo).
English: • low blood pressure, weak pulse, pallor
Slovenian: • nizek krvni tlak, šibek utrip, bledico
English: Treatment is symptomatic and should therefore be continued for an appropriate length of time.
Slovenian: Zdravljenje je simptomatsko, zato je treba z njim nadaljevati ustrezno dolgo.
English: Reduced renal function Renal failure has no influence on the kinetics.
Slovenian: Zmanjšano delovanje ledvic Ledvična odpoved nima vpliva na kinetiko.
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.
Slovenian: Zdravljenje z amitriptilinom se lahko uvede 14 dni po prekinitvi zdravljenja z ireverzibilnimi neselektivnimi zaviralci MAO in vsaj en dan po prekinitvi zdravljenja z reverzibilnim moklobemidom.
English: As described for other psychotropics, amitriptyline may modify insulin and glucose responses calling for adjustment of the antidiabetic therapy in diabetic patients; in addition the depressive illness itself may affect patients' glucose balance.
Slovenian: Kot je opisano za druge psihotropne snovi, lahko amitriptilin spremeni odziv na insulin in glukozo, zato je treba pri bolnikih s sladkorno boleznijo prilagoditi antidiabetično zdravljenje; poleg tega lahko sama depresivna bolezen vpliva na ravnovesje glukoze pri bolniku.
English: Elderly often require a considerably lower dose and often show at half the daily dose a satisfying success of treatment.
Slovenian: Pri starejših bolnikih so pogosto potrebni znatno manjši odmerki in za uspešno zdravljenje pogosto zadostuje polovični dnevni odmerek.
English: Wrongly administered injections (subcutaneous, paravenous or intra-arterial injection) must be avoided due to the risk of considerable tissue injury.
Slovenian: Nepravilnemu injiciranju (subkutana, paravenska ali intraarterijska injekcija) se je treba izogibati zaradi tveganja znatne poškodbe tkiva.
English: If possible, discontinue this medicinal product several days before surgery; if emergency surgery is unavoidable, the anaesthetist should be informed that the patient is being so treated.
Slovenian: Če je možno, je treba več dni pred kirurškim posegom zdravljenje prekiniti; če je potreben nujen kirurški poseg, je treba anesteziologa obvestiti o zdravljenju bolnika z amitriptilinom.
English: These adverse effects can be potentiated by the concomitant intake of alcohol.
Slovenian: Ti neželeni učinki so lahko hujši pri sočasnem uživanju alkohola.
English: Not Known Paranoia.
Slovenian: neznana pogostnost paranoja
English: Your doctor may take blood samples to determine the level this medicine in the blood (see also section 2).
Slovenian: Zdravnik vam bo morda vzel vzorce krvi za določitev ravni tega zdravila v krvi (glejte tudi poglavje 2).
English: Elderly patients over 65 years of age:
Slovenian: Starejši bolniki, stari več kot 65 let
English: You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm.
Slovenian: Zdravnika morate obvestiti tudi, če jemljete ali ste pred kratkim jemali zdravila, ki lahko vplivajo na srčni ritem, npr.:
English: A single dose above 75 mg is not recommended.
Slovenian: Enkratni odmerek nad 75 mg ni priporočljiv.
English: • feeling thirsty.
Slovenian: • občutek žeje