FrancophonIA/ELRC3.0 huggingface dataset:
English: What is Eucreas used for?
Slovenian: Za kaj se zdravilo Eucreas uporablja?
English: How has Eucreas been studied?
Slovenian: Kako je bilo zdravilo Eucreas raziskano?
English: What is Eucreas?
Slovenian: Kaj je zdravilo Eucreas?
English: How is Eucreas used?
Slovenian: Kako se zdravilo Eucreas uporablja?
English: It is used in the following ways:
Slovenian: Zdravilo Eucreas se uporablja:
English: Very common: may affect more than 1 in 10 people are listed below:
Slovenian: Zelo pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov, so navedeni spodaj:
English: In case of overdose, standard supportive measures should be instituted as required.
Slovenian: V primeru prevelikega odmerjanja je treba uvesti standardne podporne ukrepe.
English: Dose and time linearity
Slovenian: Odmerek in časovna linearnost
English: If you forget to take a dose,take your capsules as soon as you remember.
Slovenian: Če ste pozabili vzeti odmerek, vzemite kapsulo takoj, ko se spomnite.
English: • The active substance is tafamidis.
Slovenian: • Učinkovina je tafamidis.
English: Amyloid can build up around your nerves and in other places in your body, preventing them from working normally.
Slovenian: Amiloid se lahko nabira okoli živcev in na drugih mestih v vašem telesu, s čimer jim onemogoča, da bi normalno delovali.
English: Data in the elderly patients are very limited.
Slovenian: Podatki o uporabi zdravila pri starejših bolnikih so zelo omejeni.
English: Concomitant administration of food decreased the rate of absorption, but not the extent of absorption.
Slovenian: Sočasno uživanje hrane je zmanjšalo hitrost absorpcije, ne pa tudi obseg absorpcije.
English: Tafamidis is highly protein bound (99.9%) in plasma.
Slovenian: Tafamidis se v veliki meri veže na beljakovine v plazmi (99,9 %).
English: Date of latest renewal: 22 July 2016
Slovenian: Datum prve odobritve: 16. november 2011 Datum zadnjega podaljšanja: 22. julij 2016
English: TTR is a protein that carries other substances, such as hormones, through the body.
Slovenian: TTR je beljakovina, ki po telesu prenaša druge snovi, na primer hormone.
English: Tafamidis meglumine is a specific stabilizer of transthyretin.
Slovenian: Tafamidis meglumin je specifični stabilizator transtiretina.
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measure: Description
Slovenian: Ker gre za odobritev v izjemnih okoliščinah in ob upoštevanju člena 14(8) Uredbe (ES) št. 726/2004, mora imetnik dovoljenja za promet v spodaj navedenem časovnem okvirju izvesti naslednje ukrepe:
English: Therequirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: These results support the administration of tafamidis with or without food.
Slovenian: Ti rezultati podpirajo jemanje tafamidisa skupaj s hrano ali brez nje.
English: Vyndaqel N=64 P-value
Slovenian: Vyndaqel n = 64 vrednost p
English: The apparent steady state volume of distribution is 25.7 liters.
Slovenian: Navidezni volumen porazdelitve v stanju dinamičnega ravnovesja je 25,7 litrov.
English: Cmax(ss) and Cmin(ss) was 2.7 and 1.6 µg/ml, respectively.
Slovenian: Cmax(ss) je bila 2,7 µg/ml in Cmin(ss) 1,6 µg/ml.
English: Vyndaqel is therefore not used for children and adolescents.
Slovenian: Zato se zdravilo Vyndaqel pri otrocih in mladostnikih ne uporablja.
English: Do not use this medicine after the expiry date which is stated on the blister card and on the carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli.
English: • Urinary tract infection (symptoms may include: pain or a burning sensation when you urinate or a frequent need to urinate)
Slovenian: • okužba sečil (simptomi lahko vključujejo: bolečino ali pekoč občutek pri odvajanju urina, ali potrebo po pogostejšem uriniranju)
English: Component of a multipack, can't be sold separately.
Slovenian: Del skupnega pakiranja, ni za posamično prodajo.
English: • Vaginal infection in women
Slovenian: • okužba nožnice pri ženskah
English: This route of biotransformation is plausible in humans, as approximately 59% of the total administered dose is recovered in faeces, and approximately 22% recovered in urine.
Slovenian: Ta pot biotransformacije je pri ljudeh verjetna, saj se približno 59 % celotnega zaužitega odmerka izloči z blatom, približno 22 % pa z urinom.
English: You should not take more capsules than your doctor tells you to.
Slovenian: Ne smete vzeti več kapsul kot vam jih je predpisal zdravnik.
English: Vyndaqel % change relative to Placebo
Slovenian: Vyndaqel % sprememb glede na placebo
English: Eventually, the amyloid causes the symptoms of this disease.
Slovenian: Sčasomalahko pride do tega, da amiloid povzroči simptome te bolezni.
English: This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.
Slovenian: Navodilo je bilo nazadnje revidirano dne {MM/LLLL}.
English: In repeated dose toxicity studies the liver appeared as a target organ for toxicity in the different species tested.
Slovenian: V študijah toksičnosti pri ponavljajočih se odmerkih se je pokazalo, da naj bi bila jetra ciljni organ za toksičnost pri različnih preskušanih vrstah.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of tafamidis in milk.
Slovenian: Razpoložljivi farmakodinamični/toksikološki podatki pri živalih kažejo na izločanje tafamidisa v mleko.
English: The effects of tafamidis on cardiac disease progression have not yet been adequately characterised.
Slovenian: Vplivov tafamidisa na napredovanje obolenja srca še niso zadovoljivo opredelili.
English: The soft capsules should be swallowed whole, not crushed or cut, and taken with or without food.
Slovenian: Mehke kapsule je treba pogoltniti cele, ne sme se jih zdrobiti ali prerezati, lahko pa se jih vzame skupaj s hrano ali brez nje.
English: The pre-specified Efficacy Evaluable analysis used observed data for those patients who completed the 18 month treatment per protocol.
Slovenian: Pri predhodno določeni analizi učinkovitosti, ki jo je mogoče ovrednotiti, so bili upoštevani podatki za tiste bolnike, ki so po protokolu zaključili 18 mesecev trajajoče zdravljenje.
English: Within the frequency group, adverse reactions are presented in order of decreasing seriousness.
Slovenian: Znotraj skupine pogostnosti so neželeni učinki razvrščeni po padajoči resnosti.
English: The Physician Information Leaflet should contain the following key messages:
Slovenian: Navodilo za uporabo zdravila, namenjeno zdravniku, mora vsebovati naslednja ključna sporočila:
English: However, the difference in clearance would not be clinically significant and would not result in clinically relevant different steady-state levels compared to younger subjects.
Slovenian: Vendar pa razlika v očistku naj ne bi bila klinično pomembna in naj ne bi imela za posledico klinično pomembnih različnih ravni v stanju dinamičnega ravnovesja v primerjavi z mlajšimi preskušanci.
English: In patients with this disease, TTR breaks up and may form fibres called amyloid.
Slovenian: Pri bolnikih s to boleznijo se TTR razgrajuje in lahko tvori vlakna, imenovana amiloid.
English: This medicine is used to treat adult patients with this disease whose nerves have been affected (people with symptomatic polyneuropathy) to delay further progression.
Slovenian: To zdravilo se uporablja za zdravljenje odraslih bolnikov s to boleznijo, pri katerih so prizadeti živci (ljudje s simptomatsko polinevropatijo), za upočasnitev napredovanja bolezni.
English: • That physicians are encouraged to enter patients in the Transthyretin Amyloidosis Outcome Survey (THAOS) and provided with details how to enroll patients into this international disease registry
Slovenian: • o spodbujanju zdravnikov za vključitev bolnikov v register izidov transtiretinske amiloidoze [Transthyretin Amyloidosis Outcome Survey (THAOS)] in seznanitev s podrobnostmi, kako bolnike vključiti v ta mednarodni register bolezni.
English: Annual Reassessment
Slovenian: Vsakoletna ponovna ocena
English: mBMI was derived as the product of serum albumin and Body Mass Index.
Slovenian: mBMI je izpeljan kot zmnožek koncentracije albumina v serumu in indeksa telesne mase.
English: • Push capsule through the exposed aluminium foil.
Slovenian: • Potisnite kapsulo skozi odkrito aluminijasto folijo.
English: Based on repeated measures analysis of variance with change from baseline as the dependent variable, an unstructured covariance matrix, treatment, month and treatment-by-month as fixed effects, and subject as a random effect in the model.
Slovenian: Na podlagi analize variance za ponovljene meritve, s spremembo od izhodišča kot odvisno spremenljivko, nestrukturirano matriko kovarianc, zdravljenjem, mesecem in zdravljenjem po mesecih kot fiksnimi učinki ter preskušancem kot slučajnim učinkom v modelu.
English: You should inform your doctor or pharmacist if you are taking any of the following:
Slovenian: Opozorite zdravnika ali farmacevta, če jemljete katero od naslednjih zdravil:
English: Pharmacotherapeutic group: Other nervous system drugs, ATC code N07XX08 Mechanism of action
Slovenian: Farmakoterapevtska skupina: Druga zdravila, ki učinkujejo na živčni sistem, oznaka ATC: N07XX08
English: To remove capsule: tear off one individual blister, peel the paper at the curved arrow and push through the aluminium foil.
Slovenian: Da odstranite kapsulo, odtrgajte en posamezni pretisni omot, odlepite papir na mestu, kjer je narisana ukrivljena puščica, in potisnite skozi aluminijasto folijo.
English: Within the planned post-authorisation sub-study of the THAOS registry the MAH shall evaluate in non-V30M patients the effects of Vyndaqel on disease progression and its long term safety as detailed in a CHMP agreed protocol, and shall provide yearly updates on the collected data within the annual re-assessment.
Slovenian: V okviru načrtovane podštudije registra THAOS po pridobitvi dovoljenja za promet z zdravilom, bo imetnik dovoljenja za promet z zdravilom pri bolnikih z ne-V30M ovrednotil učinke zdravila Vyndaqel na napredovanje bolezni in varnost njegove dolgotrajne uporabe, kot je to podrobno predstavljeno v protokolu, dogovorjenem s CHMP, in bo letno poskrbel za posodobitev zbranih podatkov v okviru vsakoletne ponovne ocene.
English: Pfizer Europe MA EEIG (as MA Holder logo)
Slovenian: Pfizer Europe MA EEIG (kot logo imetnika dovoljenja za promet)
English: • That patients should be advised to contact their doctor about adverse events and that physicians/pharmacists should report suspected adverse reactions to Vyndaqel since there is limited knowledge about the clinical safety due to the rare nature of transthyretin amyloidosis.
Slovenian: • da je bolnikom treba svetovati, naj se z zdravnikom posvetujejo o neželenih učinkih, in da morajo zdravniki/farmacevti poročati o domnevnih neželenih učinkih zdravila Vyndaqel, ker je poznavanje klinične varnosti zaradi redkosti transtiretinske amiloidoze omejeno.
English: The secondary endpoints demonstrated that tafamidis meglumine treatment resulted in less deterioration of neurologic function and improved nutritional status (mBMI) compared with placebo, as shown in the following table.
Slovenian: Sekundarni opazovani dogodki so pokazali, da je imelo zdravljenje s tafamidis megluminom za posledico manjše poslabšanje nevrološke funkcije in izboljšanje s prehrano povezane ocene (mBMI) v primerjavi s placebom, kot je prikazano v naslednji preglednici.
English: If this leaflet is difficult to see or read or you would like it in a different format, please contact the Marketing Authorisation Holder's local office number that is provided in this leaflet.
Slovenian: V primeru, da je besedilo tega navodila za vas težko berljivo, ali če bi ga morebiti želeli imeti v drugačni obliki, se obrnite na številko lokalnega predstavništva imetnika dovoljenja za promet z zdravilom, ki je navedena v tem navodilu.
English: If it is within 6 hours before your next dose, skip the missed dose and take the next dose at the usual time.
Slovenian: Če je do naslednjega odmerka zdravila le še 6 ur, izpustite pozabljeni odmerek in naslednji odmerek vzemite ob običajnem času.
English: Eighty-six of the 91 patients completing the 18 month treatment period subsequently enrolled in an open label extension study, where they all received once daily 20 mg tafamidis meglumine for an additional 12 months.
Slovenian: Šestinosemdeset od 91 bolnikov, ki so zaključili 18 mesecev trajajoče obdobje zdravljenja, je bilo pozneje vključenih v odprto podaljšano študijo, v kateri so vsi bolniki dodatnih 12 mesecev prejemali tafamidis meglumin v odmerku 20 mg enkrat na dan.
English: The European Medicines Agency has waived the obligation to submit the results of studies with tafamidis meglumine in all subsets of paediatric population in familial amyloid polyneuropathy (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s tafamidis megluminom za vse podskupine pediatrične populacije pri družinski amiloidni polinevropatiji (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: TTR amyloid polyneuropathy is caused by a protein called TTR that does not work properly.
Slovenian: TTR amiloidno polinevropatijo povzroča beljakovina imenovana TTR, ki ne deluje ustrezno.
English: If you are allergic to tafamidis meglumine or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Če ste alergični na tafamidis meglumin ali katerokoli sestavinotegazdravila (navedenov poglavju 6).
English: • The existence and scope of the Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO) program and the details how to report pregnancies in women who are being treated with Vyndaqel.
Slovenian: • o obstoju in namenu izpopolnjenega programa za nadzor izidov nosečnosti pri uporabi tafamidisa [Tafamidis Enhanced Surveillance for Pregnancy Outcomes (TESPO)] in o podrobnostih, kako je treba poročati o nosečnostih pri ženskah, ki se zdravijo z zdravilom Vyndaqel.
English: Adverse reactions are listed below by MedDRA System Organ Class (SOC) and frequency categories using the standard convention: Very common (1/10), Common (1/100 to <1/10), and Uncommon (1/1,000 to <1/100).
Slovenian: Neželeni učinki spodaj so navedeni v skladu s klasifikacijo organskih sistemov MedDRA in z navedbo pogostnosti po standardni konvenciji: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
English: The inhibition of transthyretin tetramer dissociation forms the rationale for the use of tafamidis to slow disease progression.
Slovenian: Zavrtje disociacije transtiretinskega tetramera je osnova za uporabo tafamidisa za upočasnjevanje napredovanja bolezni.
English: Tafamidis binds non-cooperatively to the two thyroxine binding sites on the native tetrameric form of transthyretin preventing dissociation into monomers.
Slovenian: Tafamidis se nekooperativno veže na dve vezavni mesti za tiroksin na osnovni tetramerni obliki transtiretina in preprečuje disociacijo v monomere.
English: The NOAEL for viability and growth in the F1 generation offspring following maternal treatment during pregnancy and lactation with tafamidis was 5 mg/kg (HED=0.8 mg/kg), a dose approximately 4.6-times the recommended dose.
Slovenian: NOAEL za preživetje in rast v generaciji potomcev F1 po zdravljenju mater med brejostjo in dojenjem s tafamidisom je bil 5 mg/kg (HED = 0,8 mg/kg), kar je približno 4,6-kratnik priporočenega odmerka.
English: No interaction studies have been performed evaluating the effect of other medicinal products on tafamidis meglumine.
Slovenian: Študij medsebojnega delovanja, v katerih bi ocenjevali vpliv drugih zdravil na tafamidis meglumin, niso izvedli.
English: Excipients with known effect
Slovenian: Pomožna snov z znanim učinkom:
English: No cases of acute overdose have been reported.
Slovenian: Poročil o akutnem prevelikem odmerjanju ni.
English: The soft capsule should be swallowed whole, not crushed or cut.
Slovenian: Mehko kapsulo morate pogoltniti celo, ne smete je zdrobiti ali prerezati.
English: • The need to counsel patients on important risks associated with Vyndaqel therapy and appropriate precautions when using the medicine, particularly the avoidance of pregnancy and the need for effective contraception.
Slovenian: • da je bolnike treba seznaniti s pomembnimi tveganji, ki spremljajo zdravljenje z zdravilom Vyndaqel in z ustreznimi previdnostnimi ukrepi, ki jih je med uporabo zdravila treba upoštevati, zlasti z ukrepi za preprečevanje nosečnosti in potrebo po učinkoviti kontracepciji.
English: As Vyndaqel works by stabilizing the TTR protein, if you stop taking Vyndaqel, the protein will no longer be stabilized, and your disease may progress.
Slovenian: Ker zdravilo Vyndaqel deluje tako, da stabilizira beljakovino TTR, v primeru prenehanja jemanja zdravila Vyndaqel ta beljakovina ne bi bila več stabilizirana in bi bolezen pri vas lahko napredovala.
English: In clinical trials of healthy volunteers, the highest dose of tafamidis given was 480 mg in a single dose and 60 mg once daily for two weeks.
Slovenian: V kliničnih preskušanjih pri zdravih prostovoljcih so uporabili največje odmerke tafamidisa v velikosti 480 mg kot enkratni odmerek oziroma 60 mg enkrat na dan v obdobju dveh tednov.
English: As patients with moderate hepatic impairment have lower TTR levels than healthy subjects, dosage adjustment is not necessary as the stoichiometry of tafamidis with its target protein TTR would be sufficient for stabilization of the TTR tetramer.
Slovenian: Ker so pri bolnikih z zmerno okvaro jeter ravni TTR nižje kot pri zdravih preskušancih, prilagajanje odmerka ni potrebno, ker stehiometrično razmerje med tafamidisom in njegovim tarčnim proteinom TTR zadostuje za stabilizacijo tetramera TTR.
English: If you take more capsules than you have been told to take, contact your doctor.
Slovenian: Če ste vzeli več kapsul kot vam je bilo predpisano, se posvetujte z zdravnikom.
English: Health care professionals are asked to report any suspected adverse reactions.
Slovenian: Zdravstvene delavce naprošamo, da poročajo o kateremkoli domnevnem neželenem učinku zdravila.
English: Decreased foetal weights in males were associated with delayed sexual maturation (preputial separation) and impaired performance in a water-maze test for learning and memory.
Slovenian: Zmanjšane mase plodov pri živalih moškega spola so bile povezane s poznejšo spolno zrelostjo (ločitev prepucija) in slabšim rezultatom pri izvajanju preskusa z vodnim labirintom za učenje in pomnjenje.
English: Tafamidis meglumine should not be used during breast-feeding.
Slovenian: Tafamidis meglumina se med dojenjem ne sme uporabljati.
English: Studies in animals have shown developmental toxicity (see section 5.3).
Slovenian: Študije na živalih so pokazale škodljiv vpliv na razvoj (glejte poglavje 5.3).
English: Results from once-daily dosing with tafamidis meglumine 15, 30, or 60 mg for 14 days demonstrated dose-dependent increases in Cmax and AUC between doses of 15 mg and 30 mg and less than dose proportional between 30 and 60 mg, indicating saturation of absorption process beyond 30 mg.
Slovenian: Rezultati odmerjanja tafamidis meglumina v odmerkih 15, 30 ali 60 mg enkrat na dan v obdobju 14 dni, so pokazali od odmerka odvisno zvečanje Cmax in AUC med odmerkoma 15 mg in 30 mg, med odmerkoma 30 in 60 mg pa je bilo zvečanje manjše od sorazmernega zvečanja pri tem odmerku, kar kaže na nasičenje pri procesu absorpcije odmerkov, večjih od 30 mg.
English: Although data are limited, (one open label study in 21 patients), taking into account the mechanism of action of tafamidis and the results on TTR stabilisation, tafamidis meglumine is expected to be beneficial in patients with stage 1 TTR amyloid polyneuropathy due to mutations other than V30M.
Slovenian: Čeprav so podatki omejeni (ena odprta študija pri 21 bolnikih), ob upoštevanju mehanizma delovanja tafamidisa in rezultatov stabilizacije TTR za tafamidis meglumin pričakujejo, da bo koristen tudi pri bolnikih s TTR amiloidno polinevropatijo v stadiju 1, ki imajo mutacijo, različno od V30M.
English: In vitro data also indicated that tafamidis meglumine does not significantly inhibit cytochrome P450 enzymes CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and CYP2D6.
Slovenian: In vitro podatki so pokazali tudi, da tafamidis meglumin encimov citokroma P450 CYP1A2, CYP3A4, CYP3A5, CYP2B6, CYP2C8, CYP2C9, CYP2C19 in CYP2D6 ne zavira v pomembnem obsegu.
English: No dosage adjustment is required for elderly patients (≥ 65 years).
Slovenian: Pri starejših bolnikih ( 65 let) prilagajanje odmerka ni potrebno.
English: These intermediates then misassemble into soluble oligomers, profilaments, filaments, and amyloid fibrils.
Slovenian: Ti intermediati se nato na nepravilen način združujejo v topne oligomere, profilamente, filamente in amiloidne fibrile.
English: The reported treatment-related adverse events were mild to moderate and included: headache, somnolence, myalgia, insomnia, hordeolum, photosensitivity reaction, and presyncope.
Slovenian: Poročali so o neželenih učinkih, povezanih z zdravljenjem, ki so bili blagi do zmerni ter so vključevali: glavobol, somnolenco, mialgijo, nespečnost, hordeol, fotosenzitivnostne reakcije in presinkopo.
English: Physicians should monitor patients and continue to assess the need for other therapy, including the need for liver transplantation, as part of this standard of care.
Slovenian: Zdravniki morajo stanje bolnikov nadzirati, kot del te običajne skrbi zanje pa morajo še naprej preverjati potrebo po dodatnem zdravljenju, vključno s potrebo po presaditvi jeter.
English: As there are no data available regarding the use of tafamidis meglumine post-liver transplantation, tafamidis meglumine should be discontinued in patients who undergo liver transplantation.
Slovenian: Ker ni na voljo nobenih podatkov glede uporabe tafamidis meglumina pri bolnikih po presaditvi jeter, je treba zdravljenje s tafamidis megluminom pri teh bolnikih prekiniti.
English: Vyndaqel versus Placebo: NIS-LL and TQOL at Month 18 (Study Fx-005) Placebo
Slovenian: Zdravilo Vyndaqel v primerjavi s placebom: NIS-LL in TQOL po 18 mesecih (Študija Fx-005) placebo
English: Based on preclinical data, it is suggested that tafamidis is metabolised by glucuronidation and excreted via the bile.
Slovenian: Na osnovi predkliničnih podatkov se domneva, da se tafamidis presnavlja z glukuronidacijo in izloča z žolčem.
English: Other outcome measures included composite scores of large nerve fiber (nerve conduction, vibration threshold and heart rate response to deep breathing - HRDB) and small nerve fiber function (heat pain and cooling threshold and HRDB) and nutritional assessments utilizing the modified body mass index (mBMI - BMI multiplied by serum albumin in g/L).
Slovenian: Druga merila izida so vključevala sestavljene ocene delovanja debelih živčnih vlaken (prevajanje dražljaja po živcu, vibracijski prag in odziv frekvence srčnega utripa na globoko dihanje - HRDB) in delovanja tankih živčnih vlaken (z vročino povzročena bolečina in prag pri ohlajanju, ter HRBD) ter ocene povezane s prehrano, pri čemer je bil uporabljen prilagojen indeks telesne mase (mBMI - BMI pomnožen s koncentracijo albumina v serumu v g/L).