FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: V EU se originalno zdravilo z amitriptilinom trži pod imenom Saroten (in povezanimi imeni, vključno s Saroten Retard, Saroten Tabs, Sarotex, Sarotex Retard, Redomex in Redomex Diffucaps).
English: Amitriptyline is not recommended during pregnancy unless clearly necessary and only after careful consideration of the risk/benefit.
Slovenian: Amitriptilin med nosečnostjo ni priporočljiv, razen če je to nujno potrebno in le po skrbni oceni razmerja med koristmi in tveganji.
English: In addition, as treatment is symptomatic it should be continued for an appropriate length of time.
Slovenian: Ker je zdravljenje simptomatsko, mora trajati primerno dolgo.
English: The posology schemes cannot be achieved with every available formulation/strength and a suitable formulation/strength should be sought for a specific dose.
Slovenian: Shem odmerjanja ni mogoče doseči z vsako razpoložljivo formulacijo/jakostjo, zato je treba za ustrezen odmerek poiskati primerno formulacijo/jakost.
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.
Slovenian: Kot del ocene predhodnega postopka PSUR za amitriptilin (PSUSA/0000168/201501) je vodilna država članica, Grčija, prepoznala potrebo po uskladitvi informacij o zdravilu za originalno zdravilo Saroten po vsej EU.
English: Amitriptyline was first approved by the US in 1961.
Slovenian: Amitriptilin je dovoljenje za promet najprej pridobil v ZDA leta 1961.
English: In this patient population doses above 75 mg should be used with caution.
Slovenian: Pri tej populaciji bolnikov je treba odmerke nad 75 mg uporabljati previdno.
English: A maximum daily dosage of 150 mg amitriptyline given by injection/infusion should not be exceeded.
Slovenian: Največji dnevni odmerek 150 mg amitriptilina, ki se daje z injekcijo/infuzijo, se ne sme preseči.
English: In many patients, therapy for neuropathic pain may be needed for several years.
Slovenian: Pri številnih bolnikih je potrebno večletno zdravljenje nevropatske bolečine.
English: Amitriptyline is a well-known tricyclic antidepressant with an established mechanism of action and use (Brunton 2011)1.
Slovenian: Amitriptilin je dobro znan triciklični antidepresiv z uveljavljenim mehanizmom delovanja in uporabo (Brunton 2011).
English: The maintenance dose is the lowest effective dose and doses above 150 mg daily are not recommended.
Slovenian: Vzdrževalni odmerek je najmanjši učinkoviti odmerek, odmerki nad 150 mg dnevno pa niso priporočljivi.
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.
Slovenian: Odbor CHMP tudi ni podprl ločene indikacije za nociceptivno bolečino zaradi nezadostnih dokazov, predloženih v povezavi z bolečino v hrbtu in visceralno bolečino.
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.
Slovenian: Poleg tega zdravljenje ne sme trajati več kot tri mesece, pred začetkom zdravljenja pa je treba zaradi izključitve sindroma dolgega intervala QT opraviti EKG.
English: The current SmPCs approved in the EU Member States differ significantly in the approved indications, posology and recommendations for use.
Slovenian: Trenutni povzetki glavnih značilnosti zdravila, odobreni v državah članicah EU, se bistveno razlikujejo glede na odobrene indikacije, odmerjanje in priporočila za uporabo.
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.
Slovenian: • odbor je obravnaval razlike, prepoznane v obvestilu za zdravilo Saroten in povezana imena, ter preostala poglavja informacij o zdravilu;
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.
Slovenian: Zato je zaradi različnih nacionalnih odločitev, ki so jih sprejele države članice v zvezi z izdajo dovoljenja za promet z zdravili, ki vsebujejo amitriptilin, Grčija 17. decembra 2015 obvestila agencijo o napotitvi v skladu s členom 30 Direktive 2001/83/ES za zdravilo Saroten in povezana imena z namenom odprave neskladij med nacionalno odobrenimi povzetki glavnih značilnosti zdravila za zgoraj navedeno zdravilo in uskladitve različnih povzetkov glavnih značilnosti zdravila po vsej EU.
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.
Slovenian: Za bolnike, starejše od 65 let, in bolnike s srčno-žilnimi boleznimi je običajno priporočljivo zdravljenje uvesti v nižjem razponu odmerka, kot je sicer priporočljivo za odrasle, saj sta ti populaciji še posebno dovzetni za znane neželene učinke, zlasti za srčno toksičnost.
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.
Slovenian: Na podlagi trenutnih priporočil nacionalnih in mednarodnih smernic zdravljenja in razpoložljive literature so uporabo amitriptilina za nočno enurezo pri otrocih omejili na tretjo izbiro zdravljenja pri otrocih, starih šest let in več, kadar se izključi organska patologija, vključno s spino bifido in povezanimi motnjami, in ni odziva na druga nefarmakološka in farmakološka zdravljenja, vključno z antispazmodiki in zdravili, povezanimi z vazopresinom.
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.
Slovenian: Priporočeni začetni odmerek za zdravljenje bolečine pri starejših in bolnikih s srčno-žilnimi boleznimi je 10 mg-25 mg zvečer.
English: Its main metabolite, nortriptyline, is a more potent and selective norepinephrine reuptake inhibitor, although it still blocks serotonin uptake.
Slovenian: Njegov glavni presnovek, nortriptilin, je močnejši in selektivnejši zaviralec ponovnega privzema noradrenalina, kljub temu pa še vedno zavira privzem serotonina.
English: Changes introduced in the SmPC were consistently reflected in the labelling where relevant, however most sections were left to be completed nationally.
Slovenian: Spremembe, ki so jih uvedli v povzetek glavnih značilnosti zdravila, so bile dosledno vključene v označevanje, kadar je bilo to ustrezno, vendar je bilo treba večino poglavij dopolniti na nacionalni ravni.
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.
Slovenian: Na podlagi leksikona zdravil Martindale (Martindale 2014) je priporočeni odmerek za nočno enurezo 10 mg-20 mg za otroke, stare od šest do deset let, in 25 mg-50 mg za otroke, stare od 11 do 17 let.
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).
Slovenian: Imetniki dovoljenja za promet z zdravilom so predlagali usklajena priporočila za odmerjanje na podlagi odmerkov, ki so jih preučevali v kliničnih preskušanjih, in v skladu z referenčnim učbenikom Martindale (Martindale 2014).
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.
Slovenian: Imetniki dovoljenj za promet z zdravilom so opravili analizo svojih zbirk podatkov in preučili vse razpoložljive informacije v literaturi, vključno s klasičnimi učbeniki, kot je Martindale (Martindale 2014), da bi utemeljili vključenost neželenih učinkov, za katere obstaja vsaj razumna možnost vzročne povezave.
English: On review of all available data the recommended doses for the treatment of depression in adults is of 50 mg daily.
Slovenian: Po pregledu vseh razpoložljivih podatkov je priporočeni odmerek za zdravljenje depresije pri odraslih 50 mg dnevno.
English: Amitriptyline has potent anticholinergic, antihistaminergic, and sedative properties and it potentiates the effects of catecholamines.
Slovenian: Amitriptilin ima močne antiholinergične, antihistaminergične in sedativne lastnosti ter okrepi učinke kateholaminov.
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.
Slovenian: Poglavje 5.1 je bilo popravljeno in vključuje kratek, stvaren opis mehanizmov delovanja, poglavje 5.2 pa je bilo posodobljeno in vključuje predstavitev in razpravo o podatkih, ki podpirajo farmakokinetične lastnosti, zlasti parenteralne formulacije.
English: Amitriptyline is a well-established product with a long standing use as antidepressant.
Slovenian: Amitriptilin je dobro uveljavljeno zdravilo z dolgotrajno uporabo kot antidepresiv.
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.
Slovenian: Odbor CHMP je z upoštevanjem trenutnih smernic zdravljenja in nedavnih sistematičnih pregledov, objavljenih v literaturi, podprl indikacijo za amitriptilin pri zdravljenju velike depresivne motnje pri odraslih.
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.
Slovenian: Po drugi strani pa dokazi, ki jih je predložil imetnik dovoljenja za promet z zdravilom o uporabi amitriptilina pri nespecifičnih nevropatskih stanjih, kot so fantomska bolečina, rakava nevropatija in nevropatija, povezana z virusom HIV, niso bili ocenjeni kot zadostni za podporo določene indikacije pri teh kategorijah bolečine.
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.
Slovenian: Za zdravljenje bolečine (nevropatske bolečine, profilaktično zdravljenje kroničnega glavobola tenzijskega tipa in profilaktično zdravljenje migrene) pri odraslih so odmerki na splošno manjši kot pri depresiji, in sicer redko presegajo 100 mg. Zdravljenje je treba začeti z odmerkom 10 mg pred spanjem in ga nato titrirati po korakih 10-25 mg vsakih 3-7 dni.
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.
Slovenian: Poleg tega je odbor CHMP zaključil, da vsi podatki, ki so jih predložili imetniki dovoljenj za promet z zdravilom, podpirajo amitriptilin kot prvo izbiro zdravljenja za profilaktično zdravljenje kroničnega glavobola tenzijskega tipa in migrene pri odraslih, čeprav se niso dogovorili za določeno indikacijo za fibromialgijo.
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.
Slovenian: Na podlagi razpoložljivih kliničnih podatkov o parenteralnem dajanju amitriptilina bolnikom z depresijo in na podlagi farmakokinetičnih parametrov je priporočeni odmerek 50-150 mg/dan, ki se daje v obliki ene do treh ampul dnevno.
English: A warning was added in section 4.4 of the SmPC on the risk of QT prolongation.
Slovenian: V poglavje 4.4. povzetka glavnih značilnosti zdravila je bilo dodano opozorilo o tveganju za podaljšanje intervala QT.
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.
Slovenian: V skladu z najnovejšimi in ustreznimi informacijami iz literature je bilo spremenjeno tudi poglavje 5.3 o predkliničnih podatkih o varnosti, ki zdaj vključuje trenutno znanje glede srčne toksičnosti, genotoksičnega potenciala, embriotoksičnosti in učinka na plodnost.
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.
Slovenian: Čeprav se odbor CHMP ni strinjal z uporabo amitriptilina pri splošni indikaciji kronične bolečine, velja, da je uporaba amitriptilina pri zdravljenju nevropatske bolečine pri odraslih podprta z nedavnimi sistematičnimi pregledi in metaanalizo farmakološkega zdravljenja tega stanja.
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.
Slovenian: Dovoljenje za promet ima v naslednjih državah članicah: AT, BE, CY, DK, DE, EE, EL, LU, NL, NO in SE.
English: Section 4.5 of the SmPC on drug interactions was revised based on a review of the latest literature available.
Slovenian: Poglavje 4.5. povzetka glavnih značilnosti zdravila o medsebojnem delovanju zdravil je bilo popravljeno skladno s pregledom najnovejše razpoložljive literature.
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.
Slovenian: Zdravilo Saroten je na voljo za peroralno uporabo v obliki filmsko obloženih tablet ter kapsul in tablet s prirejenim sproščanjem z jakostmi 10, 25, 50 in 75 mg. Na voljo je tudi kot raztopina za injiciranje (2 ml, 50 mg).
English: The package leaflet was amended in accordance with the changes made to the SmPC.
Slovenian: Navodilo za uporabo je bilo spremenjeno skladno s spremembami v povzetku glavnih značilnosti zdravila.
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.
Slovenian: Poglavje 4.6 v zvezi s plodnostjo, nosečnostjo in dojenjem je bilo posodobljeno na podlagi pregleda in analize vseh razpoložljivih podatkov, ki so jih predložili imetniki dovoljenj za promet z zdravilom, vključno z literaturo, ter podatkov iz obdobja trženja in svetovne zbirke podatkov o varnosti imetnikov dovoljenj za promet z zdravilom.
English: Amitriptyline is a tertiary amine that acts primarily as a serotonin-norepinephrine reuptake inhibitor.
Slovenian: Gre za terciarni amin, ki deluje predvsem kot zaviralec ponovnega privzema serotonina in noradrenalina.
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,
Slovenian: • odbor je na podlagi predložene dokumentacije in znanstvene razprave v odboru ocenil informacije o zdravilu, ki so jih predlagali imetniki dovoljenj za promet z zdravilom;
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.
Slovenian: Čeprav se odmerek lahko poveča glede na odziv in prenašanje zdravila pri posameznem bolniku, je treba odmerke nad 100 mg uporabljati previdno.
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.
Slovenian: Na splošno je treba odmerek titrirati pri vsakem bolniku posebej do odmerka, ki zagotavlja ustrezno analgezijo z znosnimi neželenimi učinki.
English: In addition, section 4.9 of the SmPC focusing on the management of overdose has been streamlined.
Slovenian: Poleg tega je bilo posodobljeno poglavje 4.9 povzetka glavnih značilnosti zdravila o zdravljenju prevelikega odmerjanja.
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.
Slovenian: Priporočil je spremembo pogojev dovoljenj za promet z zdravilom Saroten in povezanimi imeni, za katera so v Prilogi III navedene informacije o zdravilu (glejte Prilogo I); je odbor CHMP posledično zaključil, da je razmerje med tveganji in koristmi zdravila Saroten in povezanih imen še naprej ugodno, če se upoštevajo dogovorjene spremembe informacij o zdravilu.
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).
Slovenian: • odbor je pregledal vse podatke, ki so jih predložili imetniki dovoljenja za promet z zdravilom, ter ustrezno literaturo v podporo predlagane uskladitve informacij o zdravilu.
English: Annex II Scientific conclusions
Slovenian: Dodatek II
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:
Slovenian: Imetniki dovoljenja za promet z zdravilom so razpravljali o podatkih, ki podpirajo kontraindikacije, vključene v poglavje 4.3 povzetka glavnih značilnosti zdravila.
English: EMEA/H/C/002779/001 Vimizim 1 mg/ml
Slovenian: EMEA/H/C/002779/001 Vimizim 1 mg/ml Koncentrat za raztopino za infundiranje
English: Concentrate for solution for infusion
Slovenian: Intravenska uporaba
English: 36 hours.
Slovenian: 36 ur
English: Your surgeon will inform you about this.
Slovenian: Vaš kirurg vas bo o tem obvestil.
English: Email: info@chiesi.com
Slovenian: E-pošta: info@chiesi.com
English: Only a very small number of children have been treated so far, so it is not known whether the medicine is safe for use in children or how effective it may be.
Slovenian: Do sedaj je bilo zdravljeno le majhno število otrok, zato ni znano, ali je uporaba zdravila pri otrocih varna in kako učinkovita je.
English: This level of efficacy is similar to that observed in the treated patients overall.
Slovenian: Ta raven učinkovitosti je podobna tisti, ki so jo opazili pri splošni populaciji zdravljenih bolnikov.
English: • Autologous means that they are your own cells.
Slovenian: • Avtologno pomeni, da gre za vaše lastne celice.
English: Additional clinically-relevant parameters were evaluated as secondary efficacy assessments.
Slovenian: Dodatni klinično pomembni parametri so bili ocenjeni kot sekundarna ocena učinkovitosti.
English: This is to protect it from contamination by bacteria.
Slovenian: To je za zagotovitev zaščite pred kontaminacijo z bakterijami.
English: Date of latest renewal: 11/12/2017
Slovenian: Datum zadnjega podaljšanja: 11/12/2017
English: Currently available data are described in section 4.8 and 5.1, but no recommendation on posology can be made.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8 in 5.1, vendar pa priporočil o odmerjanju ni mogoče dati.
English: Although limited with regard to the number of subjects, data from both studies showed a success rate around 70% of treated cases in the elderly population.
Slovenian: Čeprav je bilo število oseb omejeno, podatki iz obeh študij kažejo na približno 70-odstotno stopnjo uspeha, pri zdravljenih primerih iz starejše populacije.
English: The picture shows where the limbus is in your eye.
Slovenian: Na sliki je prikazano, kje v očesu je limbus.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/987/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/14/987/001
English: Patient's Date of Birth:
Slovenian: Rojstni datum bolnika:
English: The safety of Holoclar is demonstrated in the results obtained from the two retrospective clinical studies.
Slovenian: Varnost zdravila Holoclar je dokazana z rezultati, pridobljenimi v dveh retrospektivnih kliničnih študijah.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17/02/2015
Slovenian: Datum prve odobritve: 17/02/2015
English: The implantation must be followed by an appropriate monitoring schedule.
Slovenian: Implantaciji mora slediti ustrezen načrt spremljanja.
English: These new cells can replace the damaged cells in your eye.
Slovenian: Te nove celice lahko nadomestijo poškodovane celice v očesu.
English: Do not sterilise
Slovenian: Ne sterilizirajte.
English: Although the risk is considered to be low and controlled in the manufacturing.
Slovenian: Vendar pa je tveganje ocenjeno kot majhno in se med izdelavo nadzoruje.
English: No recommendation on posology can be made (see sections 4.8 and 5.1).
Slovenian: Priporočil o odmerjanju ni mogoče dati (glejte poglavji 4.8 in 5.1).
English: Holoclar must be applied no later than 15 minutes after opening the primary container.
Slovenian: Zdravilo Holoclar je treba aplicirati najkasneje 15 minut po odprtju primarne ovojnine.
English: It will take several weeks to produce Holoclar.
Slovenian: Do izdelave zdravila Holoclar bo minilo nekaj tednov.
English: The safety and efficacy of Holoclar in children and adolescents aged 0 to 18 years has not yet been established.
Slovenian: Varnost in učinkovitost zdravila Holoclar pri otrocih in mladostnikih, starih 0 do 18 let, še nista bili dokazani.
English: The education material should also include both an Educational Manual and a training programme which will incorporate verification of physicians' comprehension of the training provided.
Slovenian: Izobraževalno gradivo mora zajemati tudi Priročnik za izobraževanje in program usposabljanja, ki bo vključeval potrditev zdravnikovega razumevanja omogočenega usposabljanja.
English: The product is implanted locally.
Slovenian: Zdravilo se implantira lokalno.
English: • Bleeding around the site of the operation where Holoclar was inserted
Slovenian: • krvavitev okoli mesta operacije, kjer je bilo vstavljeno zdravilo Holoclar
English: HOUR: (Time zone)
Slovenian: URA: (časovni pas)