FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacokinetic data indicated decreased systemic exposure (approximately 40%) and increased total clearance (0.52 l/h vs. 0.31l/h) of tafamidis in patients with moderate hepatic impairment (Child-Pugh Score of 7-9 inclusive) compared to healthy subjects due to a higher unbound fraction of tafamidis.
Slovenian: Farmakokinetični podatki kažejo na zmanjšano sistemsko izpostavljenost (približno 40 %) in zvečan celokupni očistek (0,52 l/h v primerjavi z 0,31 l/h) tafamidisa pri bolnikih z zmerno okvaro jeter (ocena po lestvici Child-Pugh 7 do vključno 9) v primerjavi z zdravimi preskušanci, zaradi obsežnejše nevezane frakcije tafamidisa.
English: Pharmacokinetic parameters were similar after single and repeated administration of 20 mg dose, indicating a lack of induction or inhibition of tafamidis metabolism.
Slovenian: Farmakokinetični parametri so bili po enkratnem ali večkratnem dajanju 20 mg odmerkov podobni, kar kaže na odsotnost induciranja oziroma zaviranja presnavljanja tafamidisa.
English: • The other ingredients are: gelatin (E441), glycerin (E422), sorbitol (E420), mannitol (E421), sorbitan, yellow iron oxide (E172), titanium dioxide (E171), purified water, macrogol 400 (E1521), sorbitan monooleate (E494), polysorbate 80 (E433), ethyl alcohol, isopropyl alcohol, polyvinyl acetate phthalate, propylene glycol (E1520), carmine (E120), brilliant blue FCF (E133) and ammonium hydroxide (E527).
Slovenian: • Druge sestavine zdravila so: želatina (E441), glicerol (E422), sorbitol (E420), manitol (E421), sorbitan, rumeni železov oksid (E172), titanov dioksid (E171), prečiščena voda, makrogol 400 (E1521), sorbitan monooleat (E494), polisorbat 80 (E433), etanol, izopropilalkohol, polivinilacetat ftalat, propilenglikol (E1520), karmin (E120), briljantno modro FCF (E133) in amonijev hidroksid (E527).
English: The folded monomers undergo partial denaturation to produce alternatively folded monomeric amyloidogenic intermediates.
Slovenian: Pri zloženih monomerih pride do delne denaturacije, pri čemer prihaja do tvorbe na drugačen način zloženih monomernih amiloidogenih intermediatov.
English: Based on population PK results, subjects older than 60 years old had an average 19% lower estimate of clearance at steady-state compared to subjects less than 60 years old.
Slovenian: Na osnovi rezultatov populacijske FK je bila pri preskušancih, starejših od 60 let, ocena očistka v stanju dinamičnega ravnovesja v povprečju 19 % manjša kot pri preskušancih, ki so bili mlajši od 60 let.
English: Vyndaqel is believed to have no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Vyndaqel naj ne bi imelo vpliva ali naj bi imelo zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: After oral administration of the soft capsule, the maximum plasma concentration (Cmax) is achieved at a median time (tmax) of 2 hours after dosing in the fasted state.
Slovenian: Po peroralnem zaužitju mehke kapsule je največja plazemska koncentracija (Cmax) po odmerjanju na tešče dosežena po mediani časa (tmax) 2 ur.
English: Vyndaqel is indicated for the treatment of transthyretin amyloidosis in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.
Slovenian: Zdravilo Vyndaqel je indicirano za zdravljenje transtiretinske amiloidoze pri odraslih bolnikih s simptomatsko polinevropatijo stadija 1 za preprečevanje pojava perifernih nevroloških okvar.
English: 6 SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF SIGHTAND REACH OF CHILDREN
Slovenian: POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
English: Vyndaqel is available in two pack sizes of PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters: a pack of 30 x 1 soft capsules and a multipack of 90 soft capsules comprising of 3 cartons, each containing 30 x 1 soft capsules.
Slovenian: Zdravilo Vyndaqel je na voljo v dveh velikostih pakiranja perforiranih pretisnih omotov za enkratni odmerek iz PVC/PA/alu/PVC-alu/PET/papirja: pakiranje po 30 x 1 mehka kapsula in skupno pakiranje 90 mehkih kapsul, sestavljeno iz 3 škatel, od katerih vsaka vsebuje po 30 x 1 mehko kapsulo.
English: Do not stop taking Vyndaqel without first speaking to your doctor.
Slovenian: Z jemanjem zdravila Vyndaqel ne smete prenehati, ne da bi se pred tem posvetovali z zdravnikom.
English: 4 PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: • If you are able to become pregnant, you must use birth control during treatment and for one month after stopping treatment.
Slovenian: • Če bi lahko zanosili, morate med zdravljenjem in še en mesec po prenehanju zdravljenja uporabljati ustrezno kontracepcijo.
English: The recommended dose of tafamidis meglumine is 20 mg orally once daily.
Slovenian: Priporočeni odmerek tafamidis meglumina je 20 mg peroralno enkrat na dan.
English: Macrogol 400 (E1521) Sorbitan monooleate (E494) Polysorbate 80 (E433)
Slovenian: Vsebina kapsule makrogol 400 (E1521) sorbitan monooleat (E494) polisorbat 80 (E433)
English: In vitro studies with tafamidis meglumine suggest that it is unlikely tafamidis meglumine will cause drug interactions at clinically relevant concentrations with substrates of UDP glucuronosyltransferase (UGT), P-gp transporters, or organic anion-transporting polypeptide transporters (OATP1B1 and 1B3).
Slovenian: Študije in vitro s tafamidis megluminom kažejo, da je malo verjetno, da bi tafamidis meglumin v klinično pomembnih koncentracijah povzročil medsebojna delovanja s substrati UDP-glukuroniltransferaze (UGT), prenašalcev P-gp ali polipeptidnih prenašalcev organskih anionov (OATP1B1 in 1B3).
English: There are no data on the use of Vyndaqel in pregnant women.
Slovenian: Podatkov o uporabi zdravila Vyndaqel pri nosečnicah ni.
English: Capsule contents
Slovenian: mehka kapsula
English: Children and adolescents do not have the symptoms of TTR amyloid polyneuropathy.
Slovenian: Pri otrocih in mladostnikih se simptomi TTR amiloidne polinevropatije ne pojavljajo.
English: 4 CLINICAL PARTICULARS 4.1 Therapeutic indication
Slovenian: 4.1 Terapevtske indikacije
English: Other medicines and Vyndaqel
Slovenian: Druga zdravila in zdravilo Vyndaqel
English: Results of once-daily dosing with tafamidis meglumine 20 mg for 14 days demonstrated that steadystate was achieved by Day 14.
Slovenian: Rezultati odmerjanja tafamidis meglumina v odmerku 20 mg enkrat na dan v obdobju 14 dni so pokazali, da je bilo stanje dinamičnega ravnovesja doseženo do 14. dne.
English: The primary outcome measures were the Neuropathy Impairment Score of the Lower Limb (NIS-LL - a physician assessment of the neurologic exam of the lower limbs) and the Norfolk Quality of Life - Diabetic Neuropathy (Norfolk QOL-DN - a patient reported outcome, total quality of life score [TQOL]).
Slovenian: Primarni merili izida sta bili ocena okvare spodnjih okončin zaradi nevropatije [Neuropathy Impairment Score of the Lower Limb] (NIS-LL - zdravnikova ocena nevrološkega pregleda spodnjih okončin) in ocena kakovosti življenja v skladu z Norfolško študijo - diabetična nevropatija [Norfolk Quality of Life - Diabetic Neuropathy] (Norfolk QOL-DN - izid, o katerem je poročal bolnik, skupna ocena kakovosti življenja [TQOL]).
English: Secondary Endpoints Changes from Baseline to Month 18 LSMean (Standard Error) (Intentto-Treat Population) (Study Fx-005) Placebo N=61
Slovenian: Spremembe pri sekundarnih opazovanih dogodkih od izhodišča do 18. meseca - povprečje najmanjših kvadratov (standardna napaka) (populacija ITT) (študija Fx-005) placebo n = 61
English: There are no data on the use of tafamidis meglumine in pregnant women.
Slovenian: Podatkov o uporabi tafamidis meglumina pri nosečnicah ni.
English: TTR amyloid polyneuropathy is a multi-faceted, progressive, axonal degenerative neuropathy characterized by sensory, motor and autonomic impairment.
Slovenian: TTR amiloidna polinevropatija je v več oblikah pojavljajoča se, napredujoča, degenerativna nevropatija, ki prizadene aksone; zanjo so značilne senzorične, motorične in avtonomne okvare.
English: Liver effects were seen at doses above (>3) human exposure and have generally been shown to be reversible.
Slovenian: Vplive na jetra so opažali pri odmerkih, ki so za več kot trikrat presegali izpostavljenosti pri ljudeh, zanje pa so ugotavljali, da so običajno reverzibilni.
English: Tafamidis meglumine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Tafamidis meglumina ne uporabljajte pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: The capsule contains sorbitol (E420).
Slovenian: Kapsula vsebuje sorbitol (E420).
English: Nonclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, fertility and early embryonic development, genotoxicity and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, plodnosti in zgodnjega embrionalnega razvoja, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Tafamidis meglumine has not been studied in patients with severe hepatic impairment and caution is recommended (see section 5.2).
Slovenian: Tafamidis meglumina pri bolnikih s hudo okvaro jeter niso preskušali, zato je pri teh bolnikih priporočljiva previdnost (glejte poglavje 5.2).
English: Tafamidis has not specifically been evaluated in patients with renal impairment, but a dosage adjustment in patients with renal impairment is considered not necessary.
Slovenian: Pri bolnikih z okvaro ledvic tafamidisa niso posebej ovrednotili, vendar pa prilagajanje odmerka pri bolnikih z okvaro ledvic ni potrebno.
English: Vyndaqel contains the active substance tafamidis.
Slovenian: Zdravilo Vyndaqel vsebuje učinkovino tafamidis.
English: Vyndaqel, can prevent TTR from breaking up and forming amyloid deposits.
Slovenian: Zdravilo Vyndaqel lahko prepreči, da bi prišlo do razgrajevanja TTR in do nastajanja amiloidnih oblog.
English: The pivotal study of tafamidis meglumine was an 18-month, multicenter, randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of once-daily 20 mg tafamidis meglumine in 128 patients with TTR amyloid polyneuropathy with the V30M mutation and primarily stage 1 disease (do not routinely require assistance with ambulation).
Slovenian: Ključna študija tafamidis meglumina je bila 18 mesecev trajajoča, multicentrična, randomizirana, dvojno slepa, s placebom nadzorovana študija za oceno varnosti in učinkovitost enkratnega dnevnega 20 mg odmerka tafamidis meglumina pri 128 bolnikih s TTR amiloidno polinevropatijo z mutacijo
English: The overall clinical data reflect exposure of 127 TTR amyloid polyneuropathy patients to 20 mg of tafamidis meglumine administered daily for an average of 538 days (ranging from 15 to 994 days).
Slovenian: Celokupni klinični podatki kažejo izpostavljenosti 127 bolnikov s TTR amiloidno polinevropatijo, ki so povprečno 538 dni (razpon od 15 do 994 dni) prejemali 20 mg tafamidis meglumina na dan. Neželeni učinki so bili običajno blagi do zmerni.
English: Adverse reactions reported from the clinical programme in the tabular listing below reflect the rates at which they occurred in the Phase 3, double-blind, placebo-controlled study (Fx-005).
Slovenian: Neželeni učinki, o katerih so poročali v kliničnem programu, so predstavljeni v spodnji preglednici in prikazujejo pogostnosti, s katerimi so se pojavili v dvojno slepi, s placebom nadzorovani študiji (Fx005) tretje faze.
English: A supra-therapeutic, single, 400 mg oral dose of tafamidis solution in healthy volunteers demonstrated no prolongation of the QTc interval.
Slovenian: Pri zdravih prostovoljcih enkratni 400 mg peroralni supraterapevtski odmerek raztopine tafamidisa ni podaljšal intervala QTc.
English: 9 SPECIAL STORAGE CONDITIONS
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE
English: What you need to know before you take Vyndaqel 3.
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vyndaqel
English: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Slovenian: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgija
English: Likewise, tafamidis meglumine inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) with IC50=2.9 µM and IC50=2.36 µM, respectively, and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters (e.g. non-steroidal anti-inflammatory drugs, bumetanide, furosemide, lamivudine, methotrexate, oseltamivir, tenofovir, ganciclovir, adefovir, cidofovir, zidovudine, zalcitabine).
Slovenian: Podobno tafamidis meglumin zavira privzemne prenašalce OAT1 in OAT3 (prenašalci organskih anionov) z vrednostjo IC50 = 2,9 µM oziroma IC50 = 2,36 µM in lahko pri klinično pomembnih koncentracijah povzroči medsebojna delovanja s substrati teh prenašalcev (npr. nesteroidnimi protivnetnimi zdravili, bumetanidom, furosemidom, lamivudinom, metotreksatom, oseltamivirjem, tenofovirjem, ganciklovirjem, adefovirjem, cidofovirjem, zidovudinom, zalcitabinom).
English: In the open-label extension study, the rate of change in the NIS-LL during the 12 months of treatment was similar to that observed in those patients randomised and treated with tafamidis in the previous double blind 18 month period.
Slovenian: V odprti podaljšani študiji je bila hitrost spreminjanja NIS-LL v 12 mesecev trajajočem obdobju zdravljenja podobna tisti, ki so jo opažali pri bolnikih, ki so bili v predhodnem 18-mesečnem obdobju dvojno slepe študije randomizirani v skupino in zdravljeni s tafamidisom.
English: In the rat peri- and post-natal development study with tafamidis, decreased pup survival and reduced pup weights were noted following maternal treatment during pregnancy and lactation at doses of 15 and 30 mg/kg.
Slovenian: V študiji peri- in postnatalnega razvoja s tafamidisom pri podganah so opazili zmanjšano preživetje mladičev in zmanjšano maso mladičev po zdravljenju mater med brejostjo in dojenjem z odmerki 15 in 30 mg/kg.
English: Contraceptive measures should be used by women of childbearing potential during treatment with tafamidis meglumine, and for one month after stopping treatment, due to the prolonged half life.
Slovenian: Ženske v rodni dobi morajo uporabljati ustrezno kontracepcijo med zdravljenjem s tafamidis megluminom in še en mesec po prenehanju zdravljenja, zaradi podaljšanega razpolovnega časa zdravila.
English: Vyndaqel contains sorbitol
Slovenian: Zdravilo Vyndaqel vsebuje sorbitol
English: There is no relevant use of tafamidis in the paediatric population.
Slovenian: Tafamidis ni namenjen za uporabo pri pediatrični populaciji.
English: Diarrhoea Upper abdominal pain
Slovenian: Bolezni prebavil driska bolečina v zgornjem delu trebuha
English: • Tear off one individual blister from the blister card along the perforated line.
Slovenian: • Odtrgajte posamezni pretisni omot iz pretisnega omota vzdolž perforacije.
English: Each soft capsule contains no more than 44 mg of sorbitol (E420).
Slovenian: Ena mehka kapsula vsebuje največ 44 mg sorbitola (E420).
English: Following daily administration of a 20 mg dose of tafamidis meglumine for 14 days in healthy subjects, mean steady-state half-life was 59 h and mean total clearance was 0.42 l/h.
Slovenian: Po dnevnem odmerjanju 20 mg tafamidis meglumina v časovnem obdobju 14 dni je povprečni razpolovni čas v stanju dinamičnega ravnovesja pri zdravih preskušancih znašal 59 ur, povprečni celokupni očistek pa 0,42 l/h.
English: 30 x 1 soft capsules.
Slovenian: 30 x 1 mehka kapsula.
English: Treatment should be initiated by and remain under the supervision of a physician knowledgeable in the management of patients with transthyretin amyloid polyneuropathy.
Slovenian: Zdravljenje mora uvesti in ves čas nadzirati zdravnik z izkušnjami pri zdravljenju bolnikov s transtiretinsko amiloidno polinevropatijo.
English: • Women that can become pregnant should use birth control while taking Vyndaqel and should continue using birth control for one month after stopping treatment with Vyndaqel.
Slovenian: • Ženske, ki bi lahko zanosile, morajo v obdobju jemanja zdravila Vyndaqel uporabljati ustrezno kontracepcijo in morajo z uporabo le-te nadaljevati še en mesec po prenehanju zdravljenja z zdravilom Vyndaqel.
English: The recommended dose is one capsule (20 mg Tafamidis meglumine) of Vyndaqel once a day.
Slovenian: Priporočeni odmerek je ena kapsula (20 mg tafamidis meglumina) zdravila Vyndaqel enkrat na dan.
English: Soft capsule Yellow, opaque, oblong (approximately 21 mm) capsule imprinted with “VYN 20” in red.
Slovenian: Rumena, neprozorna, podolgovata (približno 21 mm dolga) kapsula z rdečim napisom “VYN 20”.
English: • Peel back the paper at the curved arrow to expose the aluminium foil.
Slovenian: • Odlepite papir na mestu, kjer je narisana ukrivljena puščica, da odkrijete aluminijasto folijo.
English: However, in vitro tafamidis meglumine inhibits the efflux transporter BCRP (breast cancer resistant protein) with IC50=1.16 µM and may cause drug-drug interactions at clinically relevant concentrations with substrates of this transporter (e.g. methotrexate, rosuvastatin, imatinib).
Slovenian: Vendar pa tafamidis meglumin in vitro zavira izločevalni prenašalec BCRP (BCRP - Breast Cancer Resistance Protein) z vrednostjo IC50 = 1,16 µM in lahko pri klinično pomembnih koncentracijah povzroči medsebojna delovanja s substrati tega prenašalca (npr. metotreksatom, rosuvastatinom, imatinibom).
English: 4.7 Effects on ability to drive and use machines On the basis of the pharmacodynamic and pharmacokinetic profile, tafamidis meglumine is believed to have no or negligible influence on the ability to drive or use machines.
Slovenian: Na podlagi farmakodinamičnega in farmakokinetičnega profila naj tafamidis meglumin ne bi imel vpliva ali naj bi imel zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: What Vyndaqel looks like and contents of the pack
Slovenian: Izgled zdravila Vyndaqel in vsebina pakiranja
English: Brilliant Blue FCF (E133) Ammonium hydroxide (E527) 28%
Slovenian: polivinilacetat ftalat propilenglikol (E1520) karmin (E120) briljantno modro FCF (E133) amonijev hidroksid (E527) 28 %
English: Vyndaqel is a medicine which treats a disease called Transthyretin (TTR) amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Slovenian: Vyndaqel je zdravilo, ki se uporablja za zdravljenje bolezni, imenovane transtiretinska (TTR) amiloidna polinevropatija, ki je znana tudi kot TTR družinska amiloidna polinevropatija (TTR-FAP).
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Slovenian: V predkliničnih študijah niso opazili škodljivih vplivov na plodnost (glejte poglavje 5.3).
English: The dissociation of the transthyretin tetramer to monomers is the rate limiting step in the pathogenesis of TTR amyloid polyneuropathy, also known as TTR familial amyloid polyneuropathy (TTR-FAP).
Slovenian: Disociacija transtiretinskega tetramera v monomere je stopnja, ki omejuje hitrost patogeneze TTR amiloidne polinevropatije, znane tudi kot TTR družinska amiloidna polinevropatija (TTR-FAP).
English: • Stomach ache or abdominal pain
Slovenian: • bolečina v želodcu ali trebuhu
English: Vyndaqel contains sorbitol (E420).
Slovenian: Zdravilo Vyndaqel vsebuje sorbitol (E420).
English: If you stop taking Vyndaqel
Slovenian: Če ste prenehali jemati zdravilo Vyndaqel
English: If no capsule is identified, then no additional dose is necessary, with resumption of dosing the next day as usual.
Slovenian: Če kapsule ne izbruha, dodaten odmerek ni potreben, zdravljenje pa se nadaljuje z naslednjim odmerkom zdravila Vyndaqel naslednji dan, kot običajno.
English: 4.5 Interaction with other medicinal products and other forms of interaction In a clinical study in healthy volunteers, tafamidis meglumine did not induce or inhibit the cytochrome P450 enzyme CYP3A4.
Slovenian: V klinični študiji pri zdravih prostovoljcih tafamidis meglumin ni niti induciral niti zaviral encima citokroma P450 CYP3A4.
English: Vyndaqel soft capsules are yellow, opaque, oblong (approximately 21 mm) imprinted with “VYN 20” in red.
Slovenian: Mehke kapsule zdravila Vyndaqel so rumene, neprozorne, podolgovate (približno 21 mm dolge) z rdečim napisom “VYN 20”.
English: Tafamidis meglumine should be added to the standard of care for the treatment of the transthyretin familial amyloid polyneuropathy (TTR-FAP) patient.
Slovenian: Tafamidis meglumin je treba uporabiti kot dodatek običajni skrbi za bolnika pri zdravljenju transtiretinske družinske amiloidne polinevropatije (TTR-FAP).
English: If vomiting occurs after dosing, and the intact Vyndaqel capsule is identified, then an additional dose of Vyndaqel should be administered if possible.
Slovenian: Če po zaužitju zdravila pride do bruhanja in bolnik izbruha nepoškodovano kapsulo zdravila Vyndaqel, naj vzame še en odmerek zdravila Vyndaqel, če je mogoče.
English: Vyndaqel 20 mg soft capsules
Slovenian: Vyndaqel 20 mg mehke kapsule
English: 30 x 1 soft capsules
Slovenian: 30 x 1 mehka kapsula
English: 4.4 Special warnings and precautions for use Women of childbearing potential should use appropriate contraception when taking tafamidis meglumine and continue to use appropriate contraception for 1-month after stopping treatment with tafamidis meglumine (see section 4.6).
Slovenian: Ženske v rodni dobi morajo med jemanjem tafamidis meglumina uporabljati ustrezno kontracepcijo in z njeno uporabo nadaljevati še 1 mesec po prenehanju zdravljenja s tafamidis megluminom (glejte poglavje 4.6).
English: Vyndaqel 20 mg soft capsules tafamidis meglumine
Slovenian: Vyndaqel 20 mg mehke kapsule tafamidis meglumin
English: PVC/PA/Alu/PVC-Alu/PET/Paper perforated unit dose blisters.
Slovenian: Perforirani pretisni omoti za enkratni odmerek iz PVC/PA/alu/PVC-alu/PET/papirja.
English: Pack sizes: a pack of 30 x 1 soft capsules and a multipack containing 90 (3 packs of 30 x 1) soft capsules.
Slovenian: Velikosti pakiranj: pakiranje po 30 x 1 mehka kapsula in skupno pakiranje, ki vsebuje 90 (3 pakiranja po 30 x 1) mehkih kapsul.
English: 12 MARKETING AUTHORISATION NUMBER(S)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
English: If you forget to take Vyndaqel
Slovenian: Če ste pozabili vzeti zdravilo Vyndaqel
English: Pack of 30 x 1 soft capsules - WITH BLUE BOX
Slovenian: Pakiranje po 30 x 1 mehka kapsula - Z MODRIM OKENCEM
English: NIS-LL Responders (% Patients) Difference (Vyndaqel minus Placebo) 95% CI of Difference (p-value) TQOL Change from Baseline LSMean (SE) Difference in LSMeans (SE) 95% CI of Difference (p-value) In the pre-specified ITT NIS-LL Responder analysis, patients who discontinued prior to the 18-month time point due to liver transplantation were categorized as non-responders.
Slovenian: NIS-LL odzivni bolniki (% bolnikov) Razlika (Vyndaqel minus placebo) 95 % IZ pri razliki (vrednost p) Sprememba skupne ocene kakovosti življenja [TQOL] glede na izhodišče - povprečje najmanjših kvadratov (standardna napaka [SE]) Razlika v povprečju najmanjših kvadratov (standardna napaka [SE]) 95 % IZ pri razliki (vrednost p) Pri predhodno določeni analizi ITT NIS-LL odzivnih bolnikov so bili kot neodzivni bolniki opredeljeni tisti bolniki, ki so zaradi presaditve jeter z zdravljenjem prenehali pred zaključkom 18-mesečnega časovnega obdobja.
English: 11 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: NA=Not applicable
Slovenian: N/A = Navedba smiselno ni potrebna.
English: In a developmental toxicity study in rabbits, a slight increase in skeletal malformations and variations, abortions in few females, and reduction in foetal weights were observed at an AUC0-24 ratio of 3.2-fold, based on the human AUC at steady state.
Slovenian: V študijah škodljivih vplivov na razvoj pri zajcih so pri 3,2-kratniku razmerja AUC0-24, izhajajoč iz vrednosti AUC v stanju dinamičnega ravnovesja pri ljudeh, opažali rahel porast skeletnih malformacij in variacij, splave pri nekaj samicah in zmanjšanje mase ploda.
English: How to take Vyndaqel
Slovenian: Kako jemati zdravilo Vyndaqel