FrancophonIA/ELRC3.0 huggingface dataset:
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia (loss of coordination), increased appetite, lethargy (very common); emesis (vomiting), aggression (see section “Special warnings”) (common); hyperactivity, somnolence (drowsiness), hypersalivation (uncommon).
Croatian: Tijekom pretkliničkih i kliničkih ispitivanja provedenih kako bi se potkrijepio argument za liječenje fobije od buke opažene su sljedeće nuspojave: ataksija (gubitak koordinacije), pojačan apetit, letargija (vrlo često); emeza (povraćanje), agresija (vidjeti dio „Posebna upozorenja“) (često); hiperaktivnost, somnolencija (pospanost), hipersalivacija (manje često).
English: Additionally, fewer adverse events were noted for polyuria (10% vs 19% of dogs), polydipsia (14% vs 23%) and marked sedation (14% vs 25%) when comparing imepitoin to phenobarbital.
Croatian: polidipsiju (14% naspram 23%) i izrazitu sedaciju (14% naspram 25%).
English: The following adverse reactions have been observed during preclinical and clinical studies conducted to support the noise phobia claim: ataxia, increased appetite, lethargy (very common); emesis, aggression (see section 4.5) (common); hyperactivity, somnolence, hypersalivation (uncommon).
Croatian: Tijekom pretkliničkih i kliničkih ispitivanja provedenih kako bi se potkrijepio argument za liječenje fobije od buke opažene su sljedeće nuspojave: ataksija, pojačan apetit, letargija (vrlo često); povraćanje, agresija (vidi dio 4.5) (često); hiperaktivnost, somnolencija, hipersalivacija (manje često).
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia (loss of coordination), emesis (vomiting), polyphagia (increased appetite) at the beginning of treatment, somnolence (drowsiness) (very common); hyperactivity (much more active than usual), apathy, polydipsia (increased thirst), diarrhoea, disorientation, anorexia (loss of appetite), hypersalivation (increased saliva production), polyuria (increased urine production) (common); prolapsed nictitating membrane (visible third eyelid) and decreased sight (isolated reports).
Croatian: U pretkliničkim i kliničkim ispitivanjima provedenima kako bi se potkrijepio argument za liječenje epilepsije opažene su sljedeće blage i najčešće prolazne štetne reakcije redoslijedom prema sve manjoj učestalosti: ataksija (gubitak koordinacije), emeza (povraćanje), polifagija (pojačan apetit) na početku liječenja, somnolencija (pospanost) (vrlo često); hiperaktivnost (aktivnost veća nego obično), apatija,
English: Pexion 400 mg tablets for dogs imepitoin
Croatian: Pexion 400 mg tablete za pse imepitoin
English: 116 animals in the imepitoin group and 110 animals in the phenobarbital group).
Croatian: U oba liječenja neškodljivost je procijenjena na cijelom skupu podataka za analizu (ili sigurnosni skup podataka, tj. 116 životinja u skupini koja je primala imepitoin i 110 životinja u skupini koja je primala fenobarbital).
English: Please refer to section "Adverse reactions" for further details.
Croatian: Za više pojedinosti vidjeti dio "Nuspojave".
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Croatian: DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
English: ROUTE(S) OF ADMINISTRATION Oral use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: The following mild and generally transient adverse reactions have been observed in pre-clinical and clinical studies for the epilepsy claim in order of decreasing frequency: ataxia, emesis, polyphagia at the beginning of treatment, somnolence (very common); hyperactivity, apathy, polydipsia, diarrhoea, disorientation, anorexia, hypersalivation, polyuria (common); prolapsed nictitating membrane and decreased sight (isolated reports).
Croatian: U pretkliničkim i kliničkim ispitivanjima provedenima kako bi se potkrijepio argument za liječenje epilepsije, opažene su sljedeće blage i najčešće prolazne nuspojave redoslijedom prema sve manjoj učestalosti: ataksija, povraćanje, polifagija, somnolencija (vrlo često); hiperaktivnost, apatija,
English: In non-responders, an increase in seizure frequency may be observed.
Croatian: U pasa u kojih nema odgovora na liječenje, mogu se opaziti učestaliji napadaji.
English: It is most important to increase the dose gradually.
Croatian: Najvažnije je postupno povećavati dozu.
English: Amitriptyline is authorised worldwide in more than 56 countries.
Croatian: Amitriptilin je odobren diljem svijeta u više od 56 zemalja.
English: The therapeutic effect is normally seen after 2-4 weeks of dosing.
Croatian: Terapijski učinak obično se primjećuje nakon 2 do 4 tjedna primjene doze.
English: It is also available as solution for injection (2ml, 50 mg).
Croatian: Dostupan je i kao otopina za injekciju (2 ml, 50 mg).
English: In many patients, therapy for neuropathic pain may be needed for several years.
Croatian: U mnogih bolesnika liječenje neuropatske boli može biti potrebno nekoliko godina.
English: Therapeutic Indications
Croatian: Terapijske indikacije
English: In addition, as treatment is symptomatic it should be continued for an appropriate length of time.
Croatian: Osim toga, budući da je liječenje simptomatsko, potrebno ga je nastaviti u odgovarajućem vremenskom razdoblju.
English: If necessary, the dose can be increased by 25 mg every other week.
Croatian: Prema potrebi doza se može povećati za 25 mg svaki drugi tjedan.
English: Regular reassessment is recommended to confirm that continuation of the treatment remains appropriate for the patient.
Croatian: Preporučuje se redovita ponovna procjena kako bi se potvrdilo je li nastavak liječenja prikladan za bolesnika.
English: As part of the assessment of a previous PSUR procedure for amitriptyline (PSUSA/0000168/201501), the Lead Member, Greece, identified the need to harmonise the product information for the originator Saroten across the EU.
Croatian: U okviru ocjene prethodnog PSUR postupka za amitriptilin (PSUSA/0000168/201501), vodeća država članica Grčka utvrdila je da postoji potreba za usklađivanjem informacija za originalni lijek Saroten diljem EU-a.
English: In addition, treatment duration should not to exceed a period of 3-months and ECG should be performed prior to initiating therapy to exclude long QT syndrome.
Croatian: Nadalje, trajanje liječenje ne smije premašivati razdoblje od 3 mjeseca, a EKG treba napraviti prije početka liječenje kako bi se isključio sindrom dugog QT intervala.
English: In this patient population doses above 75 mg should be used with caution.
Croatian: U toj skupini bolesnika doze veće od 75 mg trebaju se koristiti uz oprez.
English: The posology schemes cannot be achieved with every available formulation/strength and a suitable formulation/strength should be sought for a specific dose.
Croatian: Sheme doziranja ne mogu se postići sa svakom dostupnom formulacijom/jačinom te treba pronaći odgovarajuću formulaciju/jačinu za određenu dozu.
English: The maintenance dose is the lowest effective dose and doses above 150 mg daily are not recommended.
Croatian: Održavana doza je najniža djelotvorna doza, a doze iznad 150 mg na dan ne preporučuju se.
English: Amitriptyline is a well-known tricyclic antidepressant with an established mechanism of action and use (Brunton 2011)1.
Croatian: Amitriptilin dobro je poznat triciklički antidepresiv s uspostavljenim mehanizmom djelovanja i uporabe (Brunton 2011).
English: Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Croatian: Primjena amitriptilin ne preporučuje se u trudnoći, osim ako je to prijeko potrebno i samo nakon pažljivog proučavanja omjera koristi i rizika.
English: Finally, section 5.3 on preclinical safety data has been modified according to the most recent and relevant information from literature to reflect current knowledge with regards to cardiac toxicity, genotoxic potential, embryotoxicity and effect on fertility.
Croatian: Konačno, dio 5.3. o prekliničkim podatcima o sigurnosti primjene izmijenjen je u skladu s najnovijim i najvažnijim informacijama iz literature kako bi odrazio trenutačno znanje o kardiološkoj toksičnosti, genotoksičnom potencijalu, embriotoksičnosti i utjecaju na plodnost.
English: Saroten is available for oral use in film-coated tablets and modified-release capsules and tablets, with strengths including 10, 25, 50 and 75 mg.
Croatian: Saroten je dostupan za oralnu primjenu filmom obloženih tableta te kapsula i tableta s prilagođenim oslobađanjem jačine od 10, 25, 50 i 75 mg.
English: For the elderly patients over 65 years of age and patients with cardiovascular disease it is generally recommended to initiate treatment in the lower dose range as recommended for adult, as these populations are particularly susceptible to the known adverse reactions and in particular cardiac toxicity.
Croatian: Za bolesnike starije od 65 godina i bolesnike s kardiovaskularnim bolestima obično se preporučuje početak liječenja nižom dozom za odrasle bolesnike jer su te skupine posebno osjetljive na poznate nuspojave, a posebno na kardiološku toksičnost.
English: In the EU the originator product for amitriptyline is marketed as Saroten (and associated names including Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex and Redomex Diffucaps).
Croatian: Amitriptilin je prvi put odobren u SAD-u 1961. U EU-u originalni proizvod koji sadrži amitriptilin u promet je stavljen kao lijek Saroten (i povezanih naziva, uključujući Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex i Redomex Diffucaps).
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Croatian: Ne smije se prekoračiti najveća dnevna doza od 150 mg amitriptilina koja se primjenjuje injekcijom/infuzijom.
English: • the scope of the referral was the harmonisation of the product information,
Croatian: • Područje primjene upućivanja bilo je usklađivanje informacija o lijeku.
English: The current SmPCs approved in the EU Member States differ significantly in the approved indications, posology and recommendations for use.
Croatian: Postojeći sažetci opisa svojstava koji su odobreni u državama članica EU-a značajno se razlikuju u pogledu odobrenih indikacija, doziranja i preporuka za uporabu.
English: Finally, based on current recommendations by national and international treatment guidelines and available literature, the use of amitriptyline for enuresis nocturna in children was restricted to third line therapy in children aged 6 years and above when organic pathology, including spina bifida and related disorders, have been excluded and no response has been achieved to all other non-drug and drug treatments, including antispasmodics and vasopressin-related products.
Croatian: Konačno, na temelju postojećih preporuka nacionalnih i međunarodnih smjernica o liječenju i dostupne stručne literature, primjena amitriptilina u liječenju noćnog mokrenja u djece ograničena je na treću liniju liječenja u djece u dobi od 6 godina i starije ako je isključena organska patologija, uključujući spinu bifidu i povezane poremećaje te ako nije bilo reakcije na sve druge terapije lijekovima i drugim proizvodima, uključujući proizvode protiv mišićnih spazama i proizvode povezane s vazopresinom.
English: • The committee considered the divergences identified in the notification for Saroten and associated names, as well as the remaining sections of the product information.
Croatian: • Odbor je u obzir uzeo utvrđene razlike u obavijesti za Saroten i povezane nazive, kao i preostale dijelove informacija o lijeku.
English: Its main metabolite, nortriptyline, is a more potent and selective norepinephrine reuptake inhibitor, although it still blocks serotonin uptake.
Croatian: Njegov glavni metabolit nortriptilin jači je i selektivniji inhibitor ponovnog unosa norefinefrina, iako i dalje blokira ponovni unos serotonina.
English: • the product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Croatian: • Informacije o lijeku koje su predložili nositelji odobrenja za stavljanje u promet procijenjene su na temelju dostavljene dokumentacije i znanstvene rasprava s Odborom.
English: Moreover, the CHMP did not endorse a separate indication in nociceptive pain due to the insufficient evidence provided in relation to back pain and visceral pain.
Croatian: Štoviše, CHMP nije podržao zasebnu indikaciju za nociceptivnu bol zbog nedovoljnih dokaza u pogledu boli u leđima i visceralne boli.
English: Based on the drug reference Martindale (Martindale 2014) the recommended dose for nocturnal enuresis is 10 mg to 20 mg for children aged 6 to 10 years and 25 mg to 50 mg for children aged 11 years to 17 years.
Croatian: Na temelju referentnog priručnika Martindale (Martindale 2014) preporučena doza za noćno mokrenje je 10 do 20 mg u djece u dobi od 6 do 10 godina te 25 do 50 mg u djece od 11 do 17 godina.
English: A starting dose of 10-25 mg in the evening are recommended for this patient population and although the dose may be increased depending on individual patient response and tolerability, doses above 100 mg should be used with caution.
Croatian: Za tu skupinu bolesnika preporučuje se početna doza od 10 do 25 mg navečer i iako se doza može povećati na temelju odgovora i tolerancije pojedinačnog bolesnika, doze veće od 100 mg trebaju se primjenjivati uz oprez.
English: The MAHs have performed an analysis of their databases and considered all available information in the literature including classical textbooks such as Martindale (Martindale 2014), in order to justify the inclusion of adverse drug reactions, for which a causal relationship is at least a reasonable possibility.
Croatian: Nositelji odobrenja za stavljanje u promet proveli su analizu svojih baza podataka i razmotrili sve podatke dostupne u literaturi, uključujući klasične priručnike kao što je priručnik Martindale (Martindale 2014), kako bi opravdali uključivanje nuspojava lijeka za čiju uzročnu vezu postoji barem razumna mogućnost.
English: • The committee reviewed the totality of the data submitted by the MAHs as well as relevant available literature in support of the proposed harmonisation of the product information, the CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Saroten and associated names (see Annex I).
Croatian: • Odbor je pregledao cjelovite podatke koje su dostavili nositelji odobrenja za stavljanje u promet, kao i dostupnu relevantnu literaturu koja podržava predloženo usklađivanje informacija o lijeku, CHMP je preporučio izmjenu pojmova u odobrenjima za stavljanje u promet čije su informacije o lijeku navedene u prilogu III. za Saroten i povezane nazive (vidjeti prilog I.).
English: Amitriptyline has potent anticholinergic, antihistaminergic, and sedative properties and it potentiates the effects of catecholamines.
Croatian: Amitriptilin ima jaka antikolinergična, antihistaminska i sedativna svojstva te pojačava učinke kateholamina.
English: Generally, patients should be individually titrated to the dose that provides adequate analgesia with tolerable adverse drug reactions and in all cases the lowest effective dose should be used for the shortest duration required to treat the symptoms.
Croatian: Bolesnicima bi se doza pojedinačno trebala povećavati do doze koja omogućuje odgovarajuću anelgeziju uz podnošljive nuspojave te bi se u svakom slučaju trebala primjenjivati najmanja djelotvorna doza u najkraćem vremenskom razdoblju potrebnom za liječenje simptoma.
English: The MAHs proposed harmonised dosing recommendations based on the doses studied in clinical trials and in line with the reference book Martindale (Martindale 2014).
Croatian: Nositelji odobrenja za stavljanje u promet (MAH) predložili su usklađene preporuke o doziranju na temelju doza ispitivanih u kliničkim ispitivanjima i u skladu s referentnim priručnikom Martindale (Martindale 2014).
English: Section 4.5 of the SmPC on drug interactions was revised based on a review of the latest literature available.
Croatian: Dio 4.5. u sažetku opisa svojstava o interakcijama lijeka revidiran je na temelju pregleda najnovije dostupne literature.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Croatian: Izmjene sažetka opisa svojstava dosljedno su uključene u označivanje ako je bilo potrebno, međutim sadržaj većine odjeljaka određivao se na nacionalnoj razini.
English: The recommended starting dose for the treatment of pain in the elderly and patients with cardiovascular disease is 10 mg to 25 mg in the evening.
Croatian: Preporučena početna doza za liječenje boli u starijih bolesnika i bolesnika s kardiovaskularnim bolestima je 10 do 25 mg navečer.
English: In addition, the CHMP concluded that the totality of the data provided by the MAHs was supportive of a first line treatment for amitriptyline in the prophylactic treatment of chronic tension type headache (CTTH) and migrane in adults, although a specific indication in fibromyalgia was not agreed.
Croatian: Nadalje, CHMP je zaključio da ukupni podatci koje su dostavili nositelji odobrenja za stavljanje u promet podržavaju prvu liniju liječenja amitriptilinom u profilaktičkom liječenju kronične tenzijske glavobolje (CTTH) i migrena u odraslih bolesnika, iako nije donesena odluka o specifičnoj indikaciji za fibromijalgiju.
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC was updated based on the review and analysis of all the available data provided by MAHs including literature, and post marketing data from the MAH Global Safety database.
Croatian: U pogledu plodnosti, trudnoće i dojenja, dio 4.6. sažetka opisa svojstava ažuriran je na temelju pregleda i analize svih dostupnih podataka koje su dostavili nositelji odobrenja za stavljanje u promet, uključujući literaturu i postmarketinške podatke iz globalne baze podataka o sigurnosti nositelja odobrenja za stavljanje u promet.
English: It is authorised in the following Member States: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO and SE. Other amitriptyline containing products are also authorised under different brand names in the EU.
Croatian: Odobren je u sljedećim državama članicama EU-a: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO i SE.
English: Taking into account current treatment guidelines and recent systematic reviews published in the literature, the CHMP endorsed an indication for amitriptyline in the treatment of major depressive disorder in adults.
Croatian: Uzimajući u obzir postojeće smjernice o liječenju i nedavne sustavne procjene objavljene u stručnoj literaturi, CHMP je podržao indikaciju amitriptilina u liječenju teškog depresivnog poremećaja u odraslih bolesnika.
English: Based on the available clinical data of parenteral amitriptyline administration to depressed patients as well as on pharmacokinetic parameters the recommended dosage is 50 - 150 mg/day, given in 1 to 3 ampoules daily.
Croatian: Na temelju dostupnih kliničkih podataka o parenteralnoj primjeni amitriptilina u depresivnih bolesnika te na temelju farmakokinetičkih parametara, preporučena doza je 50 do 150 mg na dan putem 1 do 3 ampule dnevno.
English: On the other hand, the evidence provided by the MAH on the use of amitriptyline in non-specific neuropathic conditions such as phantom pain, cancer neuropathy and HIV neuropathy was not considered adequate to support a specific indication in these pain categories.
Croatian: Međutim, dokazi koje je dostavio nositelj odobrenja za stavljanje u promet (MAH) o primjeni amitriptilina u liječenju nespecifičnih neuropatskih stanja kao što je fantomska bol, neuropatija kod oboljelih od raka i HIV-a, ne smatraju se dovoljnima za podržavanje specifične indikacije za te kategorije boli.
English: A warning was added in section 4.4 of the SmPC on the risk of QT prolongation.
Croatian: U dio 4.4. u sažetku opisa svojstava dodano je upozorenje o riziku od produljenja QT intervala.
English: Amitriptyline is a tertiary amine that acts primarily as a serotonin-norepinephrine reuptake inhibitor.
Croatian: Amitriptilin je tercijarni amin koji prvenstveno djeluje kao inhibitor ponovnog unosa serotonina-norefinefrina.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Saroten and associated names remains favourable, subject to the agreed changes to the product information.
Croatian: Na temelju toga CHMP je zaključio da omjer koristi i rizika za Saroten i povezane nazive ostaje povoljan pod uvjetom da se u informacije u lijeku unesu dogovorene izmjene.
English: In addition, section 4.9 of the SmPC focusing on the management of overdose has been streamlined.
Croatian: Osim toga, dio 4.9. u sažetku opisa svojstava koji se odnosi na upravljanje predoziranjem pojednostavljen je.
English: On review of all available data the recommended doses for the treatment of depression in adults is of 50 mg daily.
Croatian: Nakon pregleda svih dostupnih podataka, za liječenje depresije u odraslih bolesnika preporučena doza je 50 mg na dan.
English: Amitriptyline is a well-established product with a long standing use as antidepressant.
Croatian: Amitriptilin je dobro poznat lijek koji se već dugo koristi kao antidepresiv.
English: For the treatment of pain (neuropathic pain, prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine) in adults doses are in general lower than in depression, with doses rarely exceeding 100 mg. Dosing should start with 10mg at bedtime and then titrated in 1025mg increments every 3-7 days.
Croatian: Za liječenje boli (neuropatska bol, profilaktičko liječenje kronične tenzijske glavobolje i profilaktičko liječenje migrene) u odraslih bolesnika, doze su obično manje od doza za liječenje depresije, pri čemu doza rijetko premašuje 100 mg.
English: Section 5.1 was revised to include a short factual description of the mechanism of action and Section 5.2 was updated to include data supporting the pharmacokinetic properties, especially of the parenteral formulation have been presented and discussed.
Croatian: Dio 5.2. je ažuriran podatcima koji podržavaju farmakokinetička svojstva, a posebno su predstavljeni i obrazloženi podatci koji se odnose na parenteralnu formulaciju.
English: Although the use of amitriptyline in a broad indication in chronic pain was not agreed by the CHMP, the use of amitriptyline in the treatment of neuropathic pain in adults was considered supported by recent systematic reviews and meta-analysis of pharmacological treatments of this condition.
Croatian: Iako CHMP nije donio odluku o primjeni amitriptilina u široj indikaciji za kroničnu bol, nedavne sustavne procjene i meta analize farmakološkog liječenja podržavaju upotrebu amitriptilina u liječenju neuropatske boli u odraslih bolesnika.
English: Therefore, due to the divergent national decisions taken by Member States concerning the authorisation of amitriptyline-containing products, Greece notified the Agency on 17 December 2015 of a referral under Article 30 of Directive 2001/83/EC for Saroten and associated names, in order to resolve divergences amongst the nationally authorized SmPCs for the above-mentioned product and thus to harmonise its divergent SmPCs across the EU.
Croatian: Direktive 2001/83/EZ za Saroten i povezane nazive kako bi se riješile razlike u nacionalno odobrenim sažetcima opisa svojstava za prethodno navedeni lijek te za usklađenje tih sažetaka diljem EU-a.
English: The data supporting contraindications included in section 4.3 of the SmPC was discussed by the MAHs and the rationale provided for keeping them in the SmPC was agreed by the CHMP for the following ones:
Croatian: Nositelji odobrenja za stavljanje u promet razmotrili su podatke koji podržavaju kontraindikacije navedene u dijelu 4.3. u sažetku opisa svojstava, te se CHMP složio s obrazloženjem za zadržavanje sljedećih kontraindikacija u sažetku opisa svojstava: - preosjetljivost na djelatnu tvar ili neku od pomoćnih tvari