natgillin/translations-raw huggingface dataset:
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«)
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).
Glede na odziv bolnika je treba razmisliti o nižjem odmerku amitriptilina, če se zdravljenju z amitriptilinom doda močan zaviralec CYP2D6 (npr. bupropion, kinidin, fluoksetin, paroksetin) (glejte poglavje 4.5).
• diuretics (“water tablets” e.g. furosemide)
• diuretiki (tablete za odvajanje vode, npr. furosemid)
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.
Pri sočasni uporabi amitriptilina in metadona je potrebna previdnost zaradi možnih aditivnih učinkov na interval QT in povečanega tveganja za resne kardiovaskularne učinke.
As with other tricyclic antidepressants, amitriptyline should not be given to patients receiving monoamine oxidase inhibitors (MAOIs).
Tako kot drugih tricikličnih antidepresivih se tudi amitriptilina ne sme dajati bolnikom, ki prejemajo zaviralce MAO.
Bed-wetting at night Your doctor will evaluate if the treatment should be continued after 3 months.
Zdravnik bo ocenil, ali naj po 3 mesecih nadaljujete zdravljenje.
X contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
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.
aplikaciji 40 - 60 mg amitriptilinijevega klorida je bil 10,1 - 27,8 ure in za 15 mg 15,5 - 19,5 ure za odmerek po 15 mg.
Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses.
Bolniki z boleznijo jeter ali bolniki s »slabo presnovo« običajno prejmejo manjše odmerke zdravila.
The score line facilitates breaking of the tablet into 4 equal doses.
Razdelilna zareza olajša lomljenje tablete na 4 enake dele.
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• zdravila za zdravljenje nekaterih duševnih bolezni (npr. pimozid in sertindol)
• Anticholinergic drugs such as certain medicines to treat Parkinsons disease and gastrointerstinal disorders (e.g. atropine, hyoscyamine)
• antiholinergiki, kot so nekatera zdravila za zdravljenje Parkinsonove bolezni in prebavnih motenj (npr. atropin, hiosciamin)
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.
Nevropatska bolečina, preprečevanje kroničnega glavobola tenzijskega tipa in preprečevanje migrene Zdravnik bo odmerek zdravila prilagodil glede na simptome pri vas in vaš odziv na zdravljenje.
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• če jemljete zdravila, imenovana zaviralci monoaminooksidaze (MAO)
• phenytoin and carbamazepine (used to treat epilepsy)
• fenitoin in karbamazepin (uporabljata se za zdravljenje epilepsije)
The apparent volume of distribution (Vd)β estimated after intravenous administration is 1221±280 l; range 769-1702 l (16±3 l/kg).
Navidezni volumen porazdelitve (Vd)β, ocenjen po intravenski uporabi, je 1221 l ± 280 l; razpon 7691702 l (16 ± 3 l/kg).
Other metabolites such as cis- and trans-10-hydroxyamitriptyline and cis- and trans-10-hydroxynortriptyline have the same profile as nortriptyline but is considerably weaker.
Drugi presnovki, kot so cis- in trans-10-hidroksiamitriptilin ter cis- in trans-10-hidroksinortriptilin, imajo enak profil kot nortriptilin, a so dosti bolj šibki.
• enlarged prostate
• povečano prostato
Adrenergic neurone blockers: Tricyclic antidepressants may counteract the antihypertensive effects of centrally acting antihypertensives such as guanethidine, betanidine, reserpine, clonidine and methyldopa.
Zaviralci adrenergičnih nevronov: Triciklični antidepresivi lahko izničijo antihipertenzivne učinke centralno delujočih antihipertenzivov, kot so gvanetidin, betanidin, reserpin, klonidin in metildopa.
• methadone (used to treat pain and for detoxification)
• metadon (uporablja se za lajšanje bolečin in za razstrupljevanje)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• adrenalin, efedrin, izoprenalin, noradrenalin, fenilefrin in fenilpropanolamin (prisotni so lahko v zdravilih proti kašlju ali prehladu in v nekaterih anestetikih)
Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Za potrditev primernosti zdravljenja za bolnika, se priporočajo redne ponovne ocene zdravljenja.
Discontinuation of treatment
Prenehanje zdravljenja
The analgesic effect is normally seen after 2 - 4 weeks of dosing.
Analgetični učinek je običajno opazen po 2 do 4 tednih zdravljenja.
Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) are known to be conditions increasing the proarrythmic risk.
Znano je, da motnje v ravnovesju elektrolitov (hipokaliemija, hiperkaliemija, hipomagneziemija) povečajo tveganje za aritmije.
If you use antidepressants such as Selective Serotonin Re-uptake Inhibitors (SSRIs), your doctor might consider to changing the dose of your medicine (see also section 2 Other medicines and X and section 3)
Če uporabljate antidepresive, kot so selektivni zaviralci ponovnega privzema serotonina (SSRI), se lahko zdravnik odloči, da vam spremeni odmerek zdravila (glejte tudi poglavje 2, »Druga zdravila in zdravilo X« in poglavje 3)
This medicine should only be prescribed by doctors with expertise in treating patients with persistent bed-wetting.
To zdravilo lahko predpiše samo zdravnik z izkušnjami pri zdravljenju bolnikov s trdovratnim močenjem postelje.
Read all of this leaflet carefully before this medicine is administered to you because it contains important information for you.
Preden vam bodo dali to zdravilo, natančno preberite navodilo, ker vsebuje za vas pomembne podatke!
Tramadol: Concomitant use of tramadol (a CYP2D6 substrate) and tricyclic antidepressants (TCAs), such as amitriptyline increases the risk for seizures and serotonin syndrome.
Tramadol: Sočasna uporaba tramadola (substrat CYP2D6) in tricikličnih antidepresivov (TCA), kot je amitriptilin, poveča tveganje za epileptične napade in serotoninski sindrom.
In the case of acute surgery, the anaesthetist should be informed about the treatment of amitriptyline.
V primeru nujnega kirurškega posega morate anesteziologa obvestiti, da se zdravite z amitriptilinom.
Doses above 75 mg should be used with caution.
Odmerke, večje od 75 mg, je treba uporabljati previdno.
Amitriptyline may induce side effects similar to other tricyclic antidepressants.
Amitriptilin lahko povzroči neželene učinke, podobne tistim pri drugih tricikličnih antidepresivih.
The daily dose may be increased up to 100 mg - 150 mg, depending on individual patient response and tolerability.
Dnevni odmerek se lahko povečuje do 100 mg - 150 mg, odvisno od odziva posameznega bolnika in prenašanja zdravila.
Amitriptyline reduced the pregnancy rate in rats (see section 5.3).
Pri podganah je amitriptilin zmanjšal stopnjo brejosti (glejte poglavje 5.3).
X can also be injected into a big muscle (i.m.
Zdravilo X se lahko injicira tudi v veliko mišico (i.m.
If required, the available dose range can be exploited.
Če je potrebno, je treba določiti razpon odmerkov.
Thoughts of suicide and worsening of your depression If you are depressed, you can sometimes have thoughts of harming or killing themselves.
Če ste depresivni, vas lahko včasih obdajajo misli, da bi se poškodovali ali naredili samomor.
Potential for amitriptyline to affect other medicinal products
Možnost vpliva amitriptilina na delovanje drugih zdravil
Do not give flumazenil to reverse benzodiazepine toxicity in mixed overdoses.
Za zmanjšanje toksičnosti benzodiazepinov se ne sme uporabljati flumazenila v prevelikih odmerkih.
Nervous system disorders Very common Somnolence, tremor, dizziness, headache, drowsiness, speech disorder (dysarthria).
Bolezni živčevja zelo pogosti somnolenca, tremor, omotica, glavobol, dremavost, motnja govora (disartrija)
Caution is also advised for co-administration of amitriptyline and diuretics inducing hypokalaemia (e.g. furosemide)
Previdnost je potrebna tudi pri sočasnem dajanju amitriptilina in diuretikov, ki inducirajo hipokaliemijo (npr. furosemid).
Take this medicine 1-1½ hours before bedtime.
Zdravilo je treba vzeti 1-1,5 ure pred spanjem.
Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each other; this may lead to a lowered convulsion threshold, and seizures.
Triciklični antidepresivi in nevroleptiki lahko svojo presnovo vzajemno zavirajo; to lahko povzroči nižji prag za konvulzije in epileptične napade.
Those parts currently not needed can be stored in the reservoir of the tablet box.
Dele, ki jih trenutno ne potrebujete, lahko shranite v predalček škatle za tablete.