FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Liječenje antidepresivima je simptomatsko i stoga se mora nastaviti tijekom odgovarajuće dugog razdoblja, obično do 6 mjeseci nakon oporavka kako bi se spriječio relaps.
English: Wrongly administered injections (subcutaneous, paravenous or intra-arterial injection) must be avoided due to the risk of considerable tissue injury.
Croatian: Krivo primijenjene injekcije (supkutane, paravenske ili intraarterijske injekcije) moraju se izbjegavati zbog rizika od znatnog oštećenja tkiva.
English: Combinations requiring precautions for use
Croatian: Kombinacije koje zahtijevaju mjere opreza pri primjeni
English: X belongs to a group of medicines known as tricyclic antidepressants.
Croatian: X pripada skupini lijekova poznatih pod nazivom triciklički antidepresivi.
English: Examine for clinical features.
Croatian: Pregled kliničkih znakova.
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.
Croatian: Po mogućnosti, prestanite primjenjivati ovaj lijek nekoliko dana prije kirurškog zahvata; ako se hitni kirurški zahvat ne može izbjeći, anesteziologa je potrebno obavijestiti da bolesnik uzima ovaj lijek.
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.
Croatian: Neke od niže navedenih nuspojava, npr., glavobolja, tremor, poremećaj pozornosti, zatvor i smanjeni libido, mogu biti i simptomi depresije i obično oslabe kad se depresivno stanje poboljša.
English: If a dose increase is required this should be done stepwise within 3 to 7 days.
Croatian: Ako je potrebno povećati dozu, to treba učiniti postupno unutar 3 do 7 dana.
English: • dizziness when you stand up due to low blood pressure (orthostatic hypotension)
Croatian: • omaglica pri ustajanju zbog niskog krvnog tlaka (ortostatska hipotenzija)
English: Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose).
Croatian: Amitriptilin i njegovi metaboliti izlučuju se u majčino mlijeko (što odgovara 0,6 % - 1 % majčine doze).
English: The score line facilitates breaking of the tablet into 4 parts (12.5 mg/part).
Croatian: Urez olakšava lomljenje tablete na 4 dijela (12,5 mg/dijelu).
English: • If you have previously had thoughts about killing or harming yourself.
Croatian: • ako ste i prije razmišljali o samoubojstvu ili samoozljeđivanju.
English: • if you have taken moclobemide the day before
Croatian: • ako ste prethodnog dana uzimali moklobemid
English: Check arterial blood gases-look for acidosis.
Croatian: Provjeriti plinove u arterijskoj krvi - paziti na acidozu.
English: Your doctor will instruct you whether to take the doses once daily or divide into two doses.
Croatian: Liječnik će Vam dati uputu da li da uzimate doze jedanput na dan ili da ih podijelite u dvije doze.
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).
Croatian: Djelotvornost i sigurnost amitriptilina dokazana je u liječenju noćne enureze u djece u dobi od 6 i više godina (vidjeti dio 4.1).
English: These symptoms can be the first signs that your blood or bone marrow may be affected.
Croatian: Ovi simptomi mogu biti prvi znakovi zahvaćenosti krvi ili koštane srži.
English: This medicine should not be given to children or adolescents for treatment of depression.
Croatian: Ovaj se lijek ne smije davati djeci ili adolescentima za liječenje depresije.
English: • increased blood pressure
Croatian: • povišen krvni tlak
English: X can be used as drip infusion or as intramuscular injection.
Croatian: X se može primijeniti kao drip infuzija ili intramuskularna injekcija.
English: Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk.
Croatian: Amitriptilin se ne preporučuje tijekom trudnoće osim ako Vaš liječnik smatra da postoji jasna potreba i samo nakon pažljive procjene koristi i rizika.
English: Elderly often require a considerably lower dose and often show at half the daily dose a satisfying success of treatment.
Croatian: Starijim je bolesnicima često potrebna znatno niža doza i oni često pokazuju zadovoljavajući uspjeh liječenja uz polovicu dnevne doze.
English: Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events).
Croatian: Depresija je povezana s povećanim rizikom od suicidalnih misli, samoozljeđivanja i samoubojstva (događaja povezanih sa samoubojstvom).
English: Not Known Paranoia.
Croatian: nepoznato paranoja
English: Plasma concentrations of amitriptyline and nortriptyline vary very widely between individuals and no simple correlation with therapeutic response has been established.
Croatian: Koncentracije amitriptilina i nortriptilina u plazmi uvelike se razlikuju od osobe do osobe pa nije ustanovljena nikakva jednostavna korelacija s terapijskim odgovorom.
English: Patients known as “poor metabolisers” usually receive lower doses.
Croatian: Bolesnici poznati kao „spori metabolizatori“ obično primaju niže doze.
English: It is not advised to drink alcohol during treatment with this medicine as it might increase the sedative effect.
Croatian: Ne savjetuje se piti alkohol tijekom liječenja ovim lijekom jer to može pojačati njegov sedativni učinak.
English: • heart block
Croatian: • srčani blok
English: Continue to take this medicine for as long as your doctor recommends.
Croatian: Nastavite uzimati ovaj lijek onoliko dugo koliko to liječnik preporučuje.
English: They may also occur in patients with pre-existing heart disease taking normal dosage.
Croatian: One mogu nastati i u bolesnika s već prisutnom srčanom bolešću koji uzimaju normalne doze.
English: Dose increase
Croatian: Povišenje doze
English: Ingestion of 750 mg or more by an adult may result in severe toxicity.
Croatian: Unos 750 mg ili više može kod odrasle osobe dovesti do teške toksičnosti.
English: Side effects listed below have been reported in the following frequencies:
Croatian: Niže navedene nuspojave zabilježene su u sljedećim učestalostima:
English: Do not stop the treatment without consulting your doctor first.
Croatian: Nemojte prestati s liječenjem a da se prethodno niste savjetovali s liječnikom.
English: The effects in overdose will be potentiated by simultaneous ingestion of alcohol and other psychotropic.
Croatian: Učinci predoziranja bit će pojačani istovremenim unosom alkohola i drugih psihotropnih tvari.
English: Amitriptyline inhibited ion channels, which are responsible for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations.
Croatian: Amitriptilin je inhibirao ionske kanale koji su odgovorni za srčanu repolarizaciju (hERG kanali) u gornjem mikromolarnom rasponu terapijskih koncentracija u plazmi.
English: After reduction of the depressive symptoms the treatment with amitriptyline should be continued for up to 6 month.
Croatian: Nakon smanjenja depresivnih simptoma, liječenje amitriptilinom potrebno je nastaviti do 6 mjeseci
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.
Croatian: U bolesnika kojima je propisan psihotropni lijek može se očekivati da imaju određeno smanjenje opće pozornosti i koncentracije te ih treba upozoriti na sposobnost upravljanja vozilima i rada sa strojevima.
English: In the case of acute surgery, the anaesthetist should be informed about the treatment of amitriptyline.
Croatian: U slučaju hitnog kirurškog zahvata, anesteziolog mora biti obaviješten o liječenju amitriptilinom.
English: It has marked anticholinergic and sedative properties.
Croatian: Ima izrazita antikolinergička i sedativna svojstva.
English: In many patients, therapy may be needed for several years.
Croatian: Mnogim je bolesnicima potrebno nekoliko godina liječenja.
English: Due to the often delayed gastrointestinal tract passage maximum plasma concentrations are reached after 1 to 5 (-8) hours.
Croatian: Zbog često usporenog prolaska kroz gastrointestinalni trakt, maksimalne koncentracije u plazmi postižu se nakon 1 do 5 (-8) sati.
English: The dose may be increased depending on individual patient response and tolerability.
Croatian: Dozu se može povisiti ovisno o odgovoru pojedinog bolesnika i podnošljivosti.
English: Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerability.
Croatian: Doziranje je potrebno započeti s nižom dozom i postupno je povećavati, uz pažljivo praćenje kliničkog odgovora i bilo kakvog dokaza nepodnošljivosti.
English: Elderly patients are particularly susceptible to orthostatic hypotension.
Croatian: Stariji bolesnici su osobito skloni ortostatskoj hipotenziji.
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Croatian: Ne smije se prekoračiti maksimalna dnevna doza od 150 mg amitriptilina koja se daje injekcijom/infuzijom.
English: Amitriptyline for enuresis should not be combined with an anticholinergic drug.
Croatian: Amitriptilin za enurezu se ne smije kombinirati s antikolinergičkim lijekom.
English: The efficacy and safety of amitriptyline (as solution for injection) has been demonstrated for the indication Major Depressive Disorder.
Croatian: Djelotvornost i sigurnost amitriptilina (u obliku otopine za injekciju) dokazana je u indikaciji velikog depresivnog poremećaja.
English: Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment, are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
Croatian: Poznato je da su bolesnici koji u anamnezi imaju događaje povezane sa samoubojstvom ili koji pokazuju značajan stupanj suicidalne ideacije prije početka liječenja pod većim rizikom od suicidalnih misli ili pokušaja samoubojstva i da ih je potrebno pažljivo nadzirati tijekom liječenja.
English: Give 50 g of charcoal if within one hour of ingestion.
Croatian: 6. Dati 50 g medicinskog ugljena ako je unutar jednog sata od unosa.
English: The efficacy and safety of amitriptyline has been demonstrated in treatments of the following indications in adults:
Croatian: Djelotvornost i sigurnost amitriptilina dokazana je u liječenju odraslih u sljedećim indikacijama:
English: No data on the effects of amitriptyline on human fertility are available.
Croatian: Nema dostupnih podataka o učincima amitriptilina na plodnost u ljudi.
English: The maximum period of treatment course should not exceed 3 months.
Croatian: Maksimalno trajanje ciklusa liječenja ne smije biti dulje od 3 mjeseca.
English: X is used for the in-hospital treatment of depression in adults (major depressive episodes).
Croatian: X se primjenjuje za bolničko liječenje depresije u odraslih (velike depresivne epizode).
English: INFORMATION IN BRAILLE [To be completed nationally] UNIQUE IDENTIFIER - 2D BARCODE Not applicable.
Croatian: JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Nije primjenjivo.
English: The solution for injection should mainly be used for acute treatment.
Croatian: Otopinu za injekciju uglavnom treba primjenjivati za akutno liječenje.
English: • weight loss • abnormal results of liver function tests.
Croatian: • gubitak tjelesne težine • abnormalni rezultati testova funkcije jetre
English: • if you recently have had a heart attack (myocardial infarction)
Croatian: • ako ste nedavno imali srčani udar (infarkt miokarda)
English: Not known Hepatitis.
Croatian: nepoznato hepatitis
English: How to take X
Croatian: Kako uzimati X
English: Amitriptyline and the main metabolite nortriptyline pass across the placental barrier.
Croatian: Amitriptilin i glavni metabolit nortriptilin prelaze placentalnu barijeru.
English: During chronic use and after administration in the final weeks of pregnancy, neonatal withdrawal symptoms can occur.
Croatian: Tijekom kronične primjene i nakon primjene tijekom zadnjih tjedana trudnoće mogu nastati simptomi ustezanja kod novorođenčeta.
English: It is advisable to review all antihypertensive therapy during treatment with tricyclic antidepressants.
Croatian: Savjetuje se provjeriti svu antihipertenzivnu terapiju tijekom liječenja tricikličkim antidepresivima.
English: Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses.
Croatian: Bolesnici s bolešću jetre ili osobe poznate kao „spori metabolizatori“ obično primaju niže doze.
English: It is not advised to drink alcohol during treatment with X as it might increase the sedative effect.
Croatian: Ne savjetuje se piti alkohol tijekom liječenja lijekom X jer to može pojačati njegov sedativni učinak.
English: Additionally, this combination can inhibit the metabolism of tramadol to the active metabolite and thereby increasing tramadol concentrations potentially causing opioid toxicity.
Croatian: Uz to, ova kombinacija može inhibirati metabolizam tramadola do aktivnog metabolita i tako povećati koncentracije tramadola, što može uzrokovati opioidnu toksičnost.
English: If you forget to take X Take the next dose at the usual time.
Croatian: Uzmite sljedeću dozu u uobičajeno vrijeme.
English: Amitriptyline reduced the pregnancy rate in rats (see section 5.3).
Croatian: Plodnost Amitriptilin je smanjio stopu graviditeta u štakora (vidjeti dio 5.3).
English: X can be added to an infusion or injected into a big muscle.
Croatian: X se može dodati u infuziju ili ubrizgati u veliki mišić.
English: MAOIs (non-selective as well as selective A (moclobemide) and B (selegiline)) - risk of “serotonin syndrome” (see section 4.3).
Croatian: MAO inhibitori (neselektivni, kao i selektivni A (moklobemid) i B (selegilin)) - rizik od “serotoninskog sindroma” (vidjeti dio 4.3).
English: Hyperpyrexia has been reported with tricyclic antidepressants when administered with anticholinergic or with neuroleptic medications, especially in hot weather.
Croatian: Zabilježena je hiperpireksija kad se triciklički antidepresivi primjenjuju s antikolinergičkim ili neuroleptičkim lijekovima, osobito po toplom vremenu.
English: • elevation or lowering of blood sugar levels
Croatian: • povišenje ili sniženje razine šećera u krvi
English: At the start of treatment, the dose should be gradually increased, when treatment is discontinued, it must be reduced gradually.
Croatian: Na početku liječenja, dozu je potrebno postupno povećavati, a kad se prestaje s liječenjem, dozu se mora postupno smanjivati.
English: • shakiness of hands or other body parts
Croatian: • drhtanje ruku ili drugih dijelova tijela
English: 6.5 Nature and contents of container <and special equipment for use, administration or implantation> [To be completed nationally]
Croatian: 6.5 Vrsta i sadržaj spremnika <i posebna oprema za uporabu, primjenu ili ugradnju>
English: You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm.
Croatian: Također trebate obavijestiti liječnika ako uzimate ili ste nedavno uzimali lijek koji može utjecati na srčani ritam, npr.:
English: Nocturnal enuresis
Croatian: Noćna enureza
English: Do not take X: • if you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section
Croatian: Nemojte uzimati X: • ako ste alergični na amitriptilin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Saroten and associated names is for oral use.
Croatian: Saroten i pridružena imena se primjenjuje peroralno.
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).
Croatian: Oštećenje funkcije jetre može smanjiti uklanjanje lijeka jetrom što dovodi do viših razina u plazmi pa je potreban oprez kod doziranja u ovih bolesnika (vidjeti dio 4.2).
English: The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increases.
Croatian: Potrebno je odabrati odgovarajuću formulaciju/jačinu za početnu dozu i sljedeća povećanja doze.
English: Syncope and torsade de pointes have occurred.
Croatian: Pojavile su se sinkopa i torsade de pointes.
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.
Croatian: Međutim, podaci iz literature ukazuju na rizik od malformacija i odgođene osifikacije u miševa, hrčaka, štakora i kunića pri dozi 9-33 puta višoj od maksimalne preporučene doze.
English: The main active metabolite is the secondary amine, nortriptyline.
Croatian: Glavni aktivni metabolit je sekundarni amin, nortriptilin.
English: The score line facilitates breaking of the retard tablet into 3 parts.
Croatian: Urez olakšava lomljenje retard tablete na 3 dijela.
English: MedDRA system organ class / preferred term; Very common (> 1/10);
Croatian: MedDRA klasifikacija organskih sustava / preporučeni pojam; Vrlo često (> 1/10);
English: Treatment is symptomatic and should therefore be continued for an appropriate length of time.
Croatian: Liječenje je simptomatsko i stoga se treba provoditi tijekom odgovarajuće dugog razdoblja.
English: • disturbed coordination
Croatian: • poremećena koordinacija
English: In manic-depressives, a shift towards the manic phase may occur; should the patient enter a manic phase amitriptyline should be discontinued.
Croatian: U manično-depresivnih osoba može nastupiti pomak prema maničnoj fazi; ako bolesnik uđe u maničnu fazu, potrebno je prekinuti primjenu amitriptilina.
English: Tricyclic antidepressants and neuroleptics mutually inhibit the metabolism of each other; this may lead to a lowered convulsion threshold, and seizures.
Croatian: Triciklički antidepresivi i neuroleptici inhibiraju metabolizam jedni drugih; to može dovesti do sniženja praga za izbijanje konvulzija i do napadaja.
English: • bipolar disorder
Croatian: • bipolarni poremećaj
English: Patients (and caregivers of patients) should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Croatian: potrebno je upozoriti na potrebu da obrate pozornost na svako moguće kliničko pogoršanje, suicidalno ponašanje ili misli i neobične promjene ponašanja te da odmah potraže liječnički savjet ako se pojave ti simptomi.
English: 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.
Croatian: Budući da lijek nakon intravenske primjene zaobilazi metabolizam prvog prolaska kroz jetru, vrlo brzo i potpuno postiže maksimalne koncentracije u plazmi koje nakon toga brzo bifazično opadaju, što je odraz stvaranja distribucijske ravnoteže između tkiva, perifernih i centralnih odjeljaka.
English: • have a problem that gives you a low level of potassium or magnesium, or a high level of potassium in your blood
Croatian: • imate problem zbog kojeg su Vam razine kalija ili magnezija niske ili razina kalija u krvi visoka
English: The pain-reducing effect of amitriptyline is not linked to its antidepressive properties.
Croatian: Učinak amitriptilina na smanjenje boli nije povezan s njegovim antidepresivnim svojstvima.
English: During awakening possibly again confusion, agitation and hallucinations and ataxia.
Croatian: Tijekom buđenja ponovno su moguće konfuzija, agitacija i halucinacije te ataksija.
English: Amitriptyline is a tricyclic antidepressant and an analgesic.
Croatian: Amitriptilin je triciklički antidepresiv i analgetik.
English: • if you have a severe liver disease.
Croatian: • ako imate tešku bolest jetre.
English: The dosing scheme and treatment duration given for the oral formulation should be followed from henceforward.
Croatian: Od tog trenutka nadalje potrebno je pridržavati se rasporeda doziranja i trajanja liječenja propisanog za oralne formulacije.
English: As with other tricyclic antidepressants, amitriptyline should not be given to patients receiving monoamine oxidase inhibitors (MAOIs).
Croatian: Kao ni drugi triciklički antidepresivi, amitriptilin se ne smije davati bolesnicima koji primaju inhibitore monoaminooksidaze (MAO).
English: Duration of treatment The maximum period of treatment course should not exceed 3 months.
Croatian: Trajanje liječenja Maksimalno trajanje ciklusa liječenja ne smije biti dulje od 3 mjeseca.
English: When stopping treatment, amitriptyline should be withdrawn gradually.
Croatian: Kod prestanka liječenja, amitriptilin je potrebno postupno ukidati.
English: Consider gastric lavage only if within one hour of a potentially fatal overdose.
Croatian: 5. Razmotriti ispiranje želuca samo ako je unutar jednog sata od potencijalno smrtonosnog predoziranja.
English: Dose adjustment of amitriptyline may be necessary (see section 4.2).
Croatian: Može biti potrebna prilagodba doze amitriptilina (vidjeti dio 4.2).
English: Recent myocardial infarction.
Croatian: Nedavni infarkt miokarda.
English: Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Croatian: Amitriptilin se ne preporučuje tijekom trudnoće osim kad za tim postoji jasna potreba i samo nakon pažljivog razmatranja omjera rizika i koristi.
English: However, fluvoxamine (strong CYP1A2 inhibitor) was shown to increase amitriptyline plasma concentrations and this combination should be avoided.
Croatian: Međutim, pokazalo se da fluvoksamin (jak inhibitor CYP1A2) povećava koncentracije amitriptilina u plazmi pa tu kombinaciju treba izbjegavati.
English: If repeated courses of amitriptyline are needed, a medical review should be conducted every 3 months.
Croatian: Ako je potrebno ponoviti ciklus liječenja amitriptilinom, liječnički pregled treba provoditi svaka 3 mjeseca.
English: X can also be injected into a big muscle (i.m.
Croatian: X se također može ubrizgati u veliki mišić (i.m. injekcija).
English: Unrest and convulsions may be treated with diazepam.
Croatian: Nemir i konvulzije mogu se liječiti diazepamom.
English: infusion and i.m.
Croatian: Otopina za i.v. infuziju i i.m. injekciju
English: Do not give flumazenil to reverse benzodiazepine toxicity in mixed overdoses.
Croatian: Nemojte davati flumazenil za poništenje toksičnog učinka benzodiazepina kod mješovitih predoziranja.
English: • low sodium concentration in the blood
Croatian: • niska koncentracija natrija u krvi
English: • fast or irregular heartbeats
Croatian: • ubrzani ili nepravilni otkucaji srca
English: The mechanism of action also includes ion-channel blocking effects on sodium, potassium and NMDA channel at both central and spinal cord level.
Croatian: Mehanizam djelovanja također uključuje učinke blokiranja ionskih kanala na natrijevim, kalijevim i NMDA kanalima na centralnoj razini i razini kralježničke moždine.
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).
Croatian: U reproduktivnim ispitivanjima, teratogeni učinci nisu bili opaženi u miševa, štakora ili kunića kada se amitriptilin davao peroralno u dozama od 2 do 40 mg/kg na dan (do 13 puta veća doza od maksimalne preporučene doze amitriptilina u ljudi od 150 mg/dan ili 3 mg/kg na dan za bolesnika težine 50 kg).