natgillin/translations-raw huggingface dataset:
MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3). 
Zaviralci MAO (neselektivni in selektivni zaviralci MAO A (moklobemid) in B (selegilin)) - tveganje za pojav »serotoninskega sindroma« (glejte poglavje 4.3).
Due to the often delayed gastrointestinal tract passage maximum plasma concentrations are reached after 1 to 5 (-8) hours. 
Zaradi pogosto zakasnelega prehoda skozi prebavila je največja koncentracija v plazmi dosežena po 1 do 5 (-8) urah.
At the start of treatment, the dose should be gradually increased, when treatment is discontinued, it must be reduced gradually. 
Na začetku zdravljenja je treba odmerek postopno povečevati, pri prenehanju zdravljenja pa ga je treba postopno zmanjševati.
Check arterial blood gases-look for acidosis. 
Preverjanje plinov v arterijski krvi - posebna pozornost glede acidoze.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as: 
Obvestite zdravnika ali farmacevta, če jemljete ali ste pred kratkim jemali katero koli drugo zdravilo, kot so:
ATC code: N 06 AA 09 
Oznaka ATC: N06AA09 Mehanizem delovanja
• various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, 
• različne simptome bolezni srca, kot so srčni blok, srčno popuščanje, hipotenzija, kardiogeni šok,
The main active metabolite is the secondary amine, nortriptyline. 
Glavni aktivni presnovek je sekundarni amin, nortriptilin.
• slurred or slow speech 
• nerazločen ali počasen govor
Therefore, amitriptyline may increase the risk for cardiac arrhythmia (see section 4.4). 
Zato lahko amitriptilin poveča tveganje za srčno aritmijo (glejte poglavje 4.4).
Combinations requiring precautions for use 
Kombinacije, pri katerih je potrebna previdnost
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. 
Če se zdravite z zdravilom X, morate zdravilo prenehati jemati in počakati 14 dni, preden se lahko začnete zdraviti z zaviralci monoaminooksidaze.
The pain-reducing effect of amitriptyline is not linked to its antidepressive properties. 
Učinek amitriptilina na zmanjšanje bolečine ni povezan z njegovimi antidepresivnimi lastnostmi.
Prolonged-release Capsules, hard 
Kapsule s podaljšanim sproščanjem, trde
Contents of the pack and other information What X contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo X
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. 
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.
Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. 
Vseh farmacevtskih oblik/jakosti ni mogoče uporabiti pri vseh shemah odmerjanja.
Simultaneous administration of amitriptyline and MAOIs may cause serotonin syndrome (a combination of symptoms, possibly including agitation, confusion, tremor, myoclonus and hyperthermia). 
Sočasno dajanje amitriptilina in zaviralcev MAO lahko povzroči serotoninski sindrom (kombinacija simptomov, ki lahko vključujejo agitacijo, zmedenost, tremor, mioklonus in hipertermijo).
• low blood pressure, weak pulse, pallor 
• nizek krvni tlak, šibek utrip, bledico
Treatment is symptomatic and should therefore be continued for an appropriate length of time. 
Zdravljenje je simptomatsko, zato je treba z njim nadaljevati ustrezno dolgo.
Reduced renal function Renal failure has no influence on the kinetics. 
Zmanjšano delovanje ledvic Ledvična odpoved nima vpliva na kinetiko.
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. 
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.
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. 
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.
Elderly often require a considerably lower dose and often show at half the daily dose a satisfying success of treatment. 
Pri starejših bolnikih so pogosto potrebni znatno manjši odmerki in za uspešno zdravljenje pogosto zadostuje polovični dnevni odmerek.
Wrongly administered injections (subcutaneous, paravenous or intra-arterial injection) must be avoided due to the risk of considerable tissue injury. 
Nepravilnemu injiciranju (subkutana, paravenska ali intraarterijska injekcija) se je treba izogibati zaradi tveganja znatne poškodbe tkiva.
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. 
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.
These adverse effects can be potentiated by the concomitant intake of alcohol. 
Ti neželeni učinki so lahko hujši pri sočasnem uživanju alkohola.
Not Known Paranoia. 
neznana pogostnost paranoja
Your doctor may take blood samples to determine the level this medicine in the blood (see also section 2). 
Zdravnik vam bo morda vzel vzorce krvi za določitev ravni tega zdravila v krvi (glejte tudi poglavje 2).
Elderly patients over 65 years of age: 
Starejši bolniki, stari več kot 65 let
You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm. 
Zdravnika morate obvestiti tudi, če jemljete ali ste pred kratkim jemali zdravila, ki lahko vplivajo na srčni ritem, npr.:
A single dose above 75 mg is not recommended. 
Enkratni odmerek nad 75 mg ni priporočljiv.
• feeling thirsty. 
• občutek žeje
Elderly (above 65 years of age) and patients with cardiovascular disease 
Starejši (stari več kot 65 let) in bolniki s srčno-žilno boleznijo
Treatment with MAOIs may be introduced 14 days after discontinuation of amitriptyline. 
Zdravljenje z zaviralci MAO se lahko uvede 14 dni po prekinitvi zdravljenja z amitriptilinom.
• if you have taken moclobemide the day before 
• če ste prejšnji dan vzeli moklobemid
Saroten and associated names is for oral use. 
Zdravilo Saroten in povezana imena je namenjeno za peroralno uporabo.
The efficacy and safety of amitriptyline (as solution for injection) has been demonstrated for the indication Major Depressive Disorder. 
Učinkovitost in varnost amitriptilina (v obliki raztopine za injiciranje) je bila dokazana za indikacijo hude depresije.
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. 
Če boste imeli kirurški poseg in morate prejeti splošni ali lokalni anestetik, zdravnika obvestite, da jemljete to zdravilo.
Amitriptyline should not be used in children and adolescents aged less than 18 years, as safety and efficacy have not been established (see section 4.4). 
Amitriptilina se ne sme uporabljati pri otrocih in mladostnikih, mlajših od 18 let, saj varnost in učinkovitost nista bili dokazani (glejte poglavje 4.4).
• This medicines should not be taking at the same time as an anticholinergic drug (see also section 2 Other medicines and X) 
• Teh zdravil ne smete jemati hkrati z antiholinergičnimi zdravili (glejte tudi poglavje 2 »Druga zdravila in zdravilo X«).
There is considerably individual variability in response to overdose. 
Med posameznimi bolniki so velike razlike glede odziva na preveliko odmerjanje.
It has marked anticholinergic and sedative properties. 
Ima izrazite antiholinergične in sedativne lastnosti.
Continue to take this medicine for as long as your doctor recommends. 
Z jemanjem tega zdravila nadaljujte, dokler vam to priporoča zdravnik.
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. 
Metaanaliza s placebom kontroliranih kliničnih preskušanj antidepresivov pri odraslih bolnikih s psihiatričnimi motnjami je pokazala povečano tveganje za samomorilno vedenje pri bolnikih, mlajših od 25 let, ki so prejemali antidepresive v primerjavi s tistimi, ki so prejemali placebo.
Ingestion of 750 mg or more by an adult may result in severe toxicity. 
Zaužitje 750 mg ali več amitriptilina lahko pri odraslem povzroči resno toksičnost.
Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit. 
Med nosečnostjo se uporaba amitriptilina ne priporoča, razen če je nujno potreben, in le po skrbni presoji razmerja med tveganji in koristmi.
Doses above 100 mg should be used with caution and your doctor might choose to follow you more closely. 
Odmerke, večje od 100 mg, je treba uporabljati previdno in morda se bo v teh primerih zdravnik odločil, da vas bolj skrbno spremlja.
Bed-wetting at night 
Nočno močenje postelje
Do not drive or work with tools or machinery if you are affected. 
Če se vam to zgodi, ne vozite in ne upravljajte orodij ali strojev.
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. 
Starejši bolniki (stari več kot 65 let) in bolniki s srčno-žilno boleznijo Pri starejših bolnikih so pogosto potrebni znatno manjši odmerki in za uspešno zdravljenja pogosto zadostuje polovični dnevni odmerek.
Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends. 
O trajanju zdravljenja se posvetujte z zdravnikom in to zdravilo jemljite tako dolgo, kot priporoča zdravnik.
No data on the effects of amitriptyline on human fertility are available. 
Podatkov o vplivu amitriptilina na plodnost ni na voljo.
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. 
Ker se po intravenski aplikaciji prepreči presnova prvega prehoda v jetrih, zdravilo zelo hitro in v celoti doseže največjo koncentracijo v plazmi, nato pa hitro dvofazno upade, kar kaže na ravnovesje porazdelitve v perifernih in osrednjih tkivih.
• have a surgery planned as it might be necessary to stop the treatment with amitriptyline before you are given anaesthetics. 
• imate načrtovan kirurški poseg, saj bo morda treba prekiniti zdravljenje z amitriptilinom, preden boste dobili anestetik.
If you take more X than you should 
Če ste vzeli večji odmerek zdravila X, kot bi smeli
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from the therapy of this medicinal product taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja s tem zdravilom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
The therapeutic plasma concentration in major depression is around 80 - 200 ng/ml (≈ 280 - 700 nmol/l) (for amitriptyline + nortriptyline). 
Terapevtska koncentracija v plazmi pri hudi depresiji je približno 80 - 200 ng/ml (≈ 280 - 700 nmol/l) (za amitriptilin + nortriptilin).
Additionally, this combination can inhibit the metabolism of tramadol to the active metabolite and thereby increasing tramadol concentrations potentially causing opioid toxicity. 
Ta kombinacija lahko dodatno zavira presnovo tramadola v aktivni presnovek in s tem poveča koncentracije tramadola, kar lahko povzroči opioidno toksičnost.
How you will be given Saroten solution for injection 
Kako boste prejeli zdravilo Saroten raztopina za injiciranje
It is not advised to drink alcohol during treatment with this medicine as it might increase the sedative effect. 
Med zdravljenjem s tem zdravilom ni priporočljivo uživati alkohola, saj lahko poveča njegov sedativni
6.4 Special precautions for storage [To be completed nationally] 
POSEBNA NAVODILA ZA SHRANJEVANJE [izpolni država članica]
Prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine in adults Treatment must be continued for an appropriate length of time. 
Preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene pri odraslih Zdravljenje je treba nadaljevati ustrezno dolgo.
How to take X 
Kako jemati zdravilo X
After 1-2 weeks the oral formulations should be used for further treatment. 
Po 1 - 2 tednih je treba za nadaljevanje zdravljenja uporabiti peroralno obliko.
Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2). 
Zdravnik vam bo morda vzel vzorce krvi za določitev vrednosti amitriptilina v krvi (glejte tudi poglavje 2).
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). 
Ocenjena dnevna izpostavljenost dojenčka (amitriptilin + nortriptilin) je povprečno 2 % odmerka amitriptilina (v mg/kg) glede na telesno maso matere (glejte poglavje 4.6).
Antifungals such as fluconazole and terbinafine increase serum concentrations of tricyclics and accompanying toxicity. 
Antimikotiki, kot sta flukonazol in terbinafin, povečajo koncentracije tricikličnih antidepresivov v serumu in posledično njihovo toksičnost.
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). 
• če ste alergični na amitriptilin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Demethylnortriptyline and amitriptyline-N-oxide are only present in plasma in minute amounts; the latter is almost inactive. 
Demetilnortriptilin in amitriptilin N-oksid sta v plazmi prisotna v minimalnih količinah; slednji je skoraj neaktiven.
Tricyclic antidepressants possess affinity for muscarinic and histamine H1 receptors to varying degrees. 
Triciklični antidepresivi imajo različno afiniteto do muskarinskih in histaminskih receptorjev H1.
Deaths by deliberate or accidental overdosage have occurred with this class of medicament. 
Prišlo je do primerov smrti pri namernem ali nenamernem prevelikem odmerjanju zdravil iz te skupine.
It is not advised to drink alcohol during treatment with X as it might increase the sedative effect. 
Med zdravljenjem z zdravilom X ni priporočljivo uživati alkohola, saj lahko poveča njegov seadtivni
Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather. 
O hiperpireksiji pri uporabi tricikličnih antidepresivov so poročali kadar so jih uporabili z antiholinergiki ali nevroleptiki, predvsem v vročem vremenu.
Syncope and torsade de pointes have occurred. 
Pojavila sta se sinkopa in torsade de pointes.
• difficulty breathing 
• težave z dihanjem
metabolic acidosis, hypokalemia. 
metabolna acidoza, hipokaliemija
Duration of treatment Do not change the dose of the medicine or stop taking the medicine without consulting your doctor first. 
Odmerka zdravila ne spreminjajte in ne prenehajte jemati zdravila, ne da bi se pred tem posvetovali z zdravnikom.
The efficacy and safety of amitriptyline has been demonstrated in treatments of the following indications in adults: 
Klinična učinkovitost in varnost Učinkovitost in varnost amitriptilina je bila dokazana pri zdravljenju naslednjih indikacij pri odraslih:
Reduced liver function Careful dosing and, if possible, a serum level determination is advisable. 
Priporočljivo je previdno odmerjanje in če je možno, določitev serumske vrednosti zdravila.
• disturbed coordination 
• motnje koordinacije
These patients may have higher plasma concentrations of amitriptyline and its active metabolite nortriptyline. 
Ti bolniki imajo v plazmi morda večje koncentracije amitriptilina in njegovega aktivnega presnovka nortriptilina.
X contains lactose 
Zdravilo X vsebuje laktozo
Nortriptyline is a more potent inhibitor of noradrenaline than of serotonin uptake, while amitriptyline inhibits the uptake of noradrenaline and serotonin equally well. 
Nortriptilin je močnejši zaviralec privzema noradrenalina kot serotonina, medtem ko amitriptilin enako dobro zavira privzem noradrenalina in serotonina.
When stopping treatment, amitriptyline should be withdrawn gradually. 
Pri prenehanju zdravljenja je treba odmerek amitriptilina zmanjševati postopno.
6.6 Special precautions for disposal <and other handling> Any unused medicinal product or waste material should be disposed of in accordance with local requirements. 
6.6 Posebni varnostni ukrepi za odstranjevanje Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi.
Very rare (<1/10,000); 
Zelo redki (< 1/10.000);
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). 
V študijah vpliva na sposobnost razmnoževanja niso opazili teratogenih učinkov pri miših, podganah ali kuncih, ki so jim amitriptilin dajali peroralno v odmerkih 2 - 40 mg/kg/dan (do 13-kratnika največjega priporočenega odmerka amitriptilina pri ljudeh tj. 150 mg/dan ali 3 mg/kg/dan za 50-kg bolnika).
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. 
Če začnete kadar koli razmišljati o samopoškodovanju ali samomoru, se takoj posvetujte z zdravnikom ali poiščite pomoč v najbližji bolnišnici.
• astemizole and terfenadine (used to treat allergies and hayfever) 
• astemizol in terfenadin (uporabljata se za zdravljenje alergij in senenega nahoda)
• if you have a severe liver disease. 
• če imate hudo bolezen jeter
• numbness or tingling in the arms or legs 
• odrevenelost ali mravljinčenje v rokah ali nogah
X belongs to a group of medicines known as tricyclic antidepressants. 
Zdravilo X spada v skupino zdravil, imenovanih triciklični antidepresivi.
Caution is advised in patients with significant bradycardia, in patients with uncompensated heart failure, or in patients concurrently taking QT-prolonging drugs. 
Previdnost je potrebna pri bolnikih s klinično pomembno bradikardijo, pri bolnikih z nekompenziranim srčnim popuščanjem ali pri bolnikih, ki sočasno jemljejo zdravila, ki podaljšajo interval QT.
Anaesthetics given during tri/tetracyclic antidepressant therapy may increase the risk of arrhythmias and hypotension. 
Anestetiki, ki se uporabijo med zdravljenjem s tri-/tetracikličnimi antidepresivi, lahko povečajo tveganje za aritmije in hipotenzijo.
• irregular, hard, or rapid heartbeat 
• neredno, močno ali hitro bitje srca
• skin rash, nettle rash (urticarial), swelling of the face and tongue 
• kožni izpuščaj, koprivnica (urtikarija), oteklost obraza in jezika
Do not chew the pellets.> 
Zrnc ne žvečite.>
These drugs may produce substantial decreases in TCA metabolism and marked increases in plasma concentrations. 
Ta zdravila lahko pomembno zmanjšajo presnovo TCA in močno povečajo koncentracije v plazmi.
The general duration of treatment will be decided by the treating physician on an individual basis. 
Trajanje zdravljenja bo določil lečeči bolnik za vsakega posameznega bolnika.
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. 
Epidemiološke študije, opravljene predvsem pri bolnikih, starih 50 let, ali več, kažejo na povečano tveganje za zlome kosti pri bolnikih, ki prejemajo zaviralce ponovnega privzema serotonina in triciklične antidepresive.
• pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine) 
• stenozo pilorusa (zožitev izhoda iz želodca) in paralitični ileus (zapora črevesja)
• abnormal results of liver function tests. 
• nenormalni izvidi jetrnih testov
In the presence of ethanol amitriptyline free plasma concentrations and nortriptyline concentrations were increased. 
V prisotnosti etanola so se povečale proste koncentracije amitriptilina in nortriptilina v plazmi.
• have or had a problem where your heart cannot pump the blood round your body as well as it should (a condition called heart failure), 
• imate ali ste imeli srčno popuščanje (stanje, ko srce ne more črpati krvi po telesu, tako kot običajno),
Patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions. 
Pri vsakem posameznem bolniku je treba odmerek titrirati do odmerka, ki zagotavlja ustrezno analgezijo z neželenimi učinki na zdravilo, ki jih še lahko prenaša.
• coma 
• komo
Examples of strong CYP2D6 inhibitors include bupropion, fluoxetine, paroxetine and quinidine. 
Močni zaviralci CYP2D6 so na primer bupropion, fluoksetin, paroksetin in kinidin.
Patients known as “poor metabolisers” usually receive lower doses. 
Bolniki s »slabo presnovo« običajno prejmejo manjše odmerke.
After about 1 to 2 weeks a stepwise reduction together with a change to the oral formulations for further treatment can be initiated. 
Po približno 1 do 2 tednih se lahko postopno zmanjšuje odmerek, hkrati pa se lahko preide na peroralno obliko za nadaljevanje zdravljenja.
This may include irritability, hypertonia , tremor, irregular breathing, poor drinking and loud crying and possibly anticholinergic symptoms (urinary retention, constipation). 
Ti lahko vključujejo razdražljivost, hipertonijo, tremor, neredno dihanje, slabo pitje in glasno jokanje ter možne antiholinergične simptome (zastajanje urina, zaprtje).
• heart block 
• srčni blok
Intramuscular application 
Intramuskularna aplikacija
• have slow heart rate, 
• imate počasen srčni utrip,
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. 
V nasprotju s krivuljami serumske koncentracije za tablet e, ki kažejo izrazit začetni vrh, se krivulje za kapsule počasi dvigajo do platoja, kjer so koncentracije nižje, kot je vrh krivulj za tablete.
Dose adjustment of amitriptyline may be necessary (see section 4.2). 
Morda bo treba prilagoditi odmerek amitriptilina (glejte poglavje 4.2).
*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). 
*Med zdravljenjem ali tik po zdravljenju z amitriptilinom so poročali o primerih samomorilnih misli ali vedenja (glejte poglavje 4.4)
• fast or irregular heartbeats 
• hiter ali nepravilen utrip srca
This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. 
Tega zdravila se ne sme dajati otrokom ali mladostnikom za zdravljenje nevropatske bolečine, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene.
These should not be taken at the same time as X (see section 2 Do not take X) 
Ne jemljite jih sočasno z zdravilom X (glejte poglavje 2 »Ne jemljite zdravila X«)