FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH submitted six abstracts of selected publications to support the claimed indication increased tone and spasticity of the skeletal muscles due to organic neurological disorders.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil šest povzetkov izbranih objav, da bi podprl navedeno indikacijo povečan ton in spastičnost skeletnih mišic zaradi organskih nevroloških obolenj.
English: The MAH presented 15 abstracts on the indication “muscular hypertension and muscular spasm accompanying locomotors diseases”.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil 15 povzetkov o indikaciji „mišična hipertenzija in mišični spazmi, ki spremljajo bolezni lokomotornega sistema“.
English: The MAH stated, after assessment of own PK data, that no significant difference was observed in the relevant bibliographic data reviewed concerning similar products containing tolperisone.
Slovenian: Imetnik dovoljenja za promet z zdravilom je po presoji svojih farmakokinetičnih podatkov navedel, da v ustreznih pregledanih bibliografskih podatkih, ki zadevajo podobna zdravila, ki vsebujejo tolperizon, ni bilo znatnejših razlik.
English: The MAH only presented a list of drugs used in combination or in parallel with tolperisone and stated that no report on unwanted interaction with tolperisone had been reported in the clinical trials.
Slovenian: Imetnik dovoljenja za promet z zdravilom je predložil samo seznam zdravil, ki jih uporabljajo v kombinaciji ali vzporedno s tolperizonom, in navedel, da se v kliničnih preskušanjih ni poročalo o neželenem medsebojnem delovanju s tolperizonom.
English: Question 4 - The MAH was asked to provide data taken from scientific literature on possible drug-drug interactions especially with drugs metabolised by CYP2D6 enzyme system.
Slovenian: Vprašanje 4 - Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži podatke iz znanstvene literature o morebitnem medsebojnem delovanju z drugimi zdravili, predvsem z zdravili, ki jih presnavlja encimski sistem CYP2D6.
English: The MAH emphasized the inter-individual differences in the AUC and Cmax of the drug which were variable after oral tolperisone treatment.
Slovenian: Imetnik dovoljenja je poudaril medsebojne razlike v vrednostih AUC in Cmax zdravila, ki so bile variabilne po peroralnem zdravljenju s tolperizonom.
English: The CHMP, based on the data submitted by the MAH, concluded that the benefit/risk ratio of clinical use of tolperisone is negative.
Slovenian: Odbor za zdravila za uporabo v humani medicini je na podlagi podatkov, ki jih je predložil imetnik dovoljenja za promet z zdravilom, zaključil, da je razmerje med tveganji in koristmi klinične uporabe tolperizona negativno.
English: Still, one of the studies performed by Stamonova et al (2005) was a dose range, dose titration study.
Slovenian: Vendar pa je bila ena izmed študij, ki so jo izvedli Stamenova in dr. (2005), študija o razponu odmerka titraciji odmerka.
English: The MAH claimed that the PK variability occurred due to genetic polymorphism of drug metabolizing enzymes, without providing reliable data on that reasoning.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel tudi, da je do farmakokinetične variabilnosti prišlo zaradi genetskega polimorfizma encimov, ki presnavljajo zdravilo, ne da bi predložil zanesljive podatke o tem argumentiranju.
English: According to the published data, tolperisone can be co-administered with: sedatives, hypnotics, and NSAID-s with no relevant or unwanted drug interactions.
Slovenian: Glede na objavljene podatke je tolperizon mogoče sočasno dajati s: sedativi, hipnotiki, nesteroidnimi protivnetnimi zdravili brez pomembnega ali neželenega medsebojnega delovanja.
English: This study, according to the MAH, confirmed the PK parameters of the relevant publications.
Slovenian: Ta študija je po navedbah imetnika dovoljenja za promet z zdravilom potrdila farmakokinetične parametre zadevnih objav.
English: The MAH admitted that no formal or specific drug interaction studies with tolperisone have been performed and only limited clinical reports are available from several publications.
Slovenian: Imetnik dovoljenja za promet z zdravilom je navedel, da niso bile izvedene nobene formalne ali specifične študije medsebojnega delovanja s tolperizonom in da so na voljo samo omejena klinična poročila iz več objav.
English: The MAH decided to submit a set of abstracts with any scientific discussion related.
Slovenian: Imetnik dovoljenja za promet z zdravilom se je odločil predložiti vrsto povzetkov z morebitno povezano znanstveno razpravo.
English: The CHMP noted that no formal or specific drug interaction studies have been performed.
Slovenian: Odbor za zdravila za uporabo v humani medicini ugotavlja, da niso bile izvedene formalne ali specifične študije medsebojnega delovanja zdravil.
English: The CHMP addressed a list of questions and a further list of outstanding issues to the Marketing Authorisation Holder to clarify its concerns regarding: efficacy (including therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je na imetnika dovoljenja za promet z zdravilom naslovil seznam vprašanj in dodatni seznam nerešenih vprašanj, da bi slednji pojasnil zaskrbljenost glede: učinkovitosti (vključno s terapevtsko indikacijo in optimalnim dnevnim odmerkom), varnosti (medsebojno delovanje), kinetičnih lastnosti in obsega uporabe tolperizona.
English: None of the CHMP questions were sufficiently answered.
Slovenian: Na nobeno vprašanje, ki ga je zastavil Odbor za zdravila za uporabo v humani medicini, ni ustrezno odgovoril.
English: The CHMP is of the opinion that the documentation submitted by the MAH is not sufficient to demonstrate the efficacy and safety of tolperisone.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) meni, da dokumentacija, ki jo je predložil imetnik dovoljenja za promet z zdravilom, ne zadostuje, da bi dokazala učinkovitost in varnost tolperizona.
English: No dose-response relationship has been established; the MAH used as main reference, in justifying the posology of Myderison, the SPC of Mydeton, DRUGDEX and other un-specified products.
Slovenian: Razmerje med odmerkom in odzivom ni bilo ugotovljeno; imetnik dovoljenja za promet z zdravilom je kot glavno referenco za utemeljitev odmerjanja zdravila Myderison uporabil povzetek glavnih značilnosti zdravila Mydeton, DRUGDEX in druga neopredeljena zdravila.
English: In addition, to further support the claimed indication the MAH submitted a number of publications on the originator.
Slovenian: Poleg tega je imetnik dovoljenja za promet z zdravilom, da bi dodatno podprl navedeno indikacijo, predložil številne objave o originatorskem zdravilu.
English: To further justify the data submitted, the MAH referred to the SPC of the authorised originator product (Mydeton).
Slovenian: Da bi dodatno upravičil predložene podatke, se je imetnik dovoljenja za promet z zdravilom skliceval na povzetek glavnih značilnosti zdravila odobrenega originatorskega zdravila (Mydeton).
English: b./ muscular hypertension and muscular spasm accompanying locomotors diseases c./ rehabilitation after orthopaedic and traumatological surgery.
Slovenian: a./ povečan ton in spastičnost skeletnih mišic zaradi organskih nevroloških obolenj, b./ mišična hipertenzija in mišični spazmi, ki spremljajo bolezni lokomotornega sistema, c./ rehabilitacija po ortopedski in travmatološki operaciji.
English: The CHMP retained his concerns regarding: efficacy (therapeutic indication and the optimal daily dose), safety (drug interactions), kinetic properties, and extent of use of tolperisone.
Slovenian: Odbor za zdravila za uporabo v humani medicini je še vedno zaskrbljen zaradi: učinkovitosti (vključno s terapevtsko indikacijo in optimalnim dnevnim odmerkom), varnosti (medsebojno delovanje), kinetičnih lastnosti in obsega uporabe tolperizona.
English: The CHMP noted that in his response the MAH refers to in vitro studies focusing on the enzymes which are involved in the metabolism of tolperisone.
Slovenian: Odbor za zdravila za uporabo v humani medicini ugotavlja, da se imetnik dovoljenja za promet z zdravilom v svojem odgovoru sklicuje na študije in vitro, osredotočene na encime, ki so udeleženi pri presnavljanju tolperizona.
English: In conclusion, the CHMP is of the opinion that the MAH's response is not sufficient to have reliable information about the PK characteristics of Myderison.
Slovenian: Če zaključimo, Odbor za zdravila za uporabo v humani medicini meni, da odgovor imetnika dovoljenja za promet z zdravilom ne zadostuje, da bi zagotovil zanesljive informacije o farmakokinetičnih značilnostih zdravila Myderison.
English: The safety profile of tolperisone was not analysed in detail by the MAH.
Slovenian: Varnostnega profila tolperizona imetnik dovoljenja za promet z zdravilom ni podrobno analiziral.
English: The CHMP noted that the data provided on the extent of use of tolperisone in Europe was inconclusive.
Slovenian: Odbor za zdravila za uporabo v humani medicini ugotavlja, da predloženi podatki o obsegu uporabe tolperizona v Evropi niso imeli dokazne moči.
English: Question 3 - The MAH was asked to provide data from scientific literature justifying the dosing recommended in the proposed SPC.
Slovenian: Vprašanje 3 - Imetnik dovoljenja za promet z zdravilom je bil pozvan, naj predloži podatke iz znanstvene literature, ki upravičujejo odmerjanje, kot je predlagano v povzetku glavnih značilnosti zdravila.
English: The MAH argued that no specifically designed dose-response/dose-titration study was performed for tolperisone.
Slovenian: Imetnik dovoljenja za promet z zdravilom je zatrjeval, da za tolperizon ni bila izvedena nobena specifično oblikovana študija odziva na odmerek/titracije odmerka.
English: The MAH did not intend to claim different dosage range and posology.
Slovenian: Imetnik dovoljenja za promet z zdravilom ni nameraval zahtevati drugačnega razpona odmerka in odmerjanja.
English: The CHMP is of the opinion that the MAH's responses to the questions raised are insufficient to support the WEU application of Myderison.
Slovenian: Odbor za zdravila za uporabo v humani medicini meni, da odgovori imetnika dovoljenja za promet z zdravilom ne zadostujejo, da bi podprli uporabo zdravila Myderison na podlagi dobro uveljavljene uporabe.
English: The Marketing Application of Myderison had been submitted under the WEU (well established use) legal basis.
Slovenian: Vloga za pridobitev dovoljenja je bila vložena na pravni podlagi dobro uveljavljene uporabe.
English: - the documentation submitted is not sufficient to cover all aspect of the efficacy and safety assessment of tolperisone, in particular to justify the claimed therapeutic indication and posology.
Slovenian: - predložena dokumentacija ne zadostuje, da bi zajela vse vidike presoje učinkovitosti in varnosti tolperizona, še zlasti ne, da bi upravičila navedeno terapevtsko indikacijo in odmerjanje, - imetnik dovoljenja za promet z zdravilom ni pojasnil pomembnosti predloženih farmakokinetičnih podatkov, ki zadevajo zdravilo, drugačen od zdravila Myderison, - so manjkale informacije o medsebojnem delovanju z drugimi zdravili, - imetniku dovoljenja za promet z zdravilom ni uspelo jasno dokazati, da je uporaba tolperizona razširjena,
English: Oral use blister (PVC/PCTFE/PVC/Al)
Slovenian: 123 mg kapsula, trda peroralna uporaba pretisni omot (PVC/PCTFE/PVC/Al)
English: EMA/CHMP/55623/2016
Slovenian: EU/1/15/1082/001 Galafold
English: Annex A
Slovenian: Stična ovojnina
English: a. These data are preliminary.
Slovenian: a. Ti podatki so predhodni.
English: Date of first authorisation: 16 January 2014 Date of latest renewal: 17 September 2018
Slovenian: Datum prve odobritve: 16. januar 2014 Datum zadnjega podaljšanja: 17. september 2018
English: This is so your doctor can:
Slovenian: Razlogov za to je, da se lahko vaš zdravnik:
English: It is therefore very important that you (or your partner) do not become pregnant during this therapy.
Slovenian: Zato je zelo pomembno, da vi (ali vaš partner) med to terapijo ne zanosite.
English: b. These are exploratory or Phase 2 studies.
Slovenian: b. To so raziskovalne študije ali študije 2. faze.
English: If you have any of these side effects, do not drive or use any tools or machines.
Slovenian: Če imate katerega od teh neželenih učinkov, ne vozite in ne uporabljajte orodij ali strojev.
English: The optimal regimen and treatment duration have not been established.
Slovenian: Optimalni režim in optimalno trajanje zdravljenja nista bila določena.
English: In clinical studies - Adults
Slovenian: V kliničnih študijah - odrasli
English: The clinical significance of these findings is unknown.
Slovenian: Klinični pomen teh izsledkov ni znan.
English: The majority of patients (69%) had been infected through vertical transmission.
Slovenian: Večina bolnikov (69 %) se je okužila z vertikalnim prenosom.
English: It is commonly taken with either:
Slovenian: Pogosto se jemlje bodisi:
English: The response rates observed for patients over 65 years of age were similar to that of younger patients across treatment groups.
Slovenian: Stopnje odziva, ki so jih opazili pri bolnikih, starejših od 65 let, so bile podobne kot pri mlajših bolnikih v vseh skupinah zdravljenja.
English: The effects of higher doses are unknown.
Slovenian: Učinki višjih odmerkov so neznani.
English: If this applies to you, tell your doctor immediately.
Slovenian: Če to velja za vas, o tem takoj obvestite zdravnika.
English: Ribavirin can damage your unborn baby.
Slovenian: Ribavirin lahko škoduje vašemu nerojenemu otroku.
English: <12 g/dL despite 4 weeks at reduced dose
Slovenian: < 12 g/dl kljub 4-tedenski uporabi zmanjšanega odmerka
English: Preliminary SVR12 data are available for 210 patients.
Slovenian: Predhodni podatki SVR12 so na voljo za 210 bolnikov.
English: This medicine works by lowering the amount of hepatitis C virus in your body and removing the virus from your blood over a period of time.
Slovenian: To zdravilo deluje tako, da zmanjša količino virusa hepatitisa C v vašem telesu in sčasoma virus odstrani iz krvi.
English: c. See Special patient populations - Patients awaiting liver transplantation below.
Slovenian: c. Glejte posebne populacije bolnikov - bolniki, ki čakajo na presaditev jeter spodaj.
English: In 5 patients (12.5%), study drugs were discontinued, modified or interrupted due to adverse events.
Slovenian: Pri 5 bolnikih (12,5 %) so uporabo študijskega zdravila zaradi neželenih učinkov ukinili, prilagodili ali prekinili.
English: Patient population (Study number/name)
Slovenian: Populacija bolnikov (številka/ime študije)
English: c. Summary data from both studies.
Slovenian: c. Zbirni podatki iz obeh študij.
English: Effects on drug levels.
Slovenian: Učinek na raven zdravila.
English: Eight patients (20%) received epoetin and/or a blood product.
Slovenian: Osem bolnikov (20 %) je prejelo epoetin in/ali krvi pripravek.
English: You can also report any side effects directly to the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: 95% of patients received antiretroviral therapy at the time of enrolment.
Slovenian: 95 % bolnikov je v času vključitve prejemalo protiretrovirusno terapijo.
English: Regimen/Duration
Slovenian: Režim/trajanje
English: Most patients had no prior HCV treatment (81.3%).
Slovenian: Največ bolnikov se predhodno še ni zdravilo zaradi HCV (81,3 %).
English: 12 weeksa,b
Slovenian: 12 tednova, b
English: The outcomes should be interpreted with caution, as subject numbers are small and SVR rates may be impacted by the selection of patients.
Slovenian: Izide je treba razlagati previdno, saj so števila oseb majhna, na stopnje SVR pa lahko vpliva izbira bolnikov.
English: Response rates for selected subgroups are presented in Table 8.
Slovenian: Stopnje odzivov za izbrane podskupine so prisotne v preglednici 8.
English: • feeling tired and irritable
Slovenian: • občutek utrujenosti in razdražljivosti
English: c. All patients were non-cirrhotic in these two studies.
Slovenian: c. Vsi bolniki v teh dveh študijah so bili brez ciroze.
English: • Have diabetes.
Slovenian: • imate sladkorno bolezen.
English: Skin disorders Frequency not known: Stevens-Johnson syndrome
Slovenian: Pogostnost neznana: Stevens-Johnsonov sindrom
English: SVR12 rate % (n/N)
Slovenian: Stopnja SVR12 % (n/N)
English: The proportions of patients who were interferon intolerant, ineligible, or unwilling were 9%, 44%, and 47%, respectively.
Slovenian: Razmerje med bolniki, ki so interferona niso prenašali, niso bili primerni oz. voljni, je bilo 9 %, 44 % in 47 %.
English: • If you are allergic to sofosbuvir or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
Slovenian: • če ste alergični na sofosbuvir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Animal studies do not indicate harmful effects on fertility.
Slovenian: Študije na živalih ne kažejo škodljivih učinkov na plodnost.
English: Previously treated adults - FUSION (study 108)
Slovenian: Predhodno zdravljeni odrasli - študija FUSION (študija 108)
English: It is very important that you complete the full course of treatment to give the medicines the best chance to treat your hepatitis C virus infection.
Slovenian: Zelo pomembno je, da zaključite polni cikel zdravljenja, saj ima tako zdravilo največ možnosti, da ozdravi vašo okužbo z virusom hepatitisa C.
English: • You or your partner must use an effective birth control method during treatment and afterwards.
Slovenian: • Vi ali vaš partner morate med zdravljenjem in še po njem uporabljati učinkovito metodo za preprečevanje nosečnosti.
English: Assessment of adverse reactions is based on pooled data from five Phase 3 clinical studies (both controlled and uncontrolled).
Slovenian: Ocena neželenih učinkov temelji na združenih podatkih iz petih kliničnih študij 3. faze (kontroliranih in nekontroliranih).
English: The presence of 40% human serum had no effect on the anti-HCV activity of sofosbuvir.
Slovenian: Prisotnost 40 % humanega seruma ni vplivala na aktivnost sofosbuvirja proti HCV.
English: • Have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely;
Slovenian: • imate ali ste imeli okužbo z virusom hepatitisa B, ker vas bo zdravnik morda bolj skrbno spremljal
English: The active metabolite is formed in hepatocytes and not observed in plasma.
Slovenian: Aktivni presnovek nastaja v hepatocitih in ga niso opazili v plazmi.
English: Your doctor will tell you for how long you should take Sovaldi.
Slovenian: Vaš zdravnik vam bo povedal, kako dolgo morate jemati zdravilo Sovaldi.
English: Treatment of overdose with Sovaldi consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Slovenian: Zdravljenje prevelikega odmerka z zdravilom Sovaldi je sestavljeno iz splošnih podpornih ukrepov, ki vključujejo spremljanje vitalnih znakov in opazovanje kliničnega stanja bolnika.
English: Virologic response in evaluable patientsa a. Evaluable patients are defined as those who have reached the specified time point at the time of the interim analysis.
Slovenian: Virološki odziv pri bolnikih, primernih za oceniteva a. Bolniki, primerni za ocenitev, so opredeljeni kot bolniki, ki so v času vmesne analize dosegli specificirano časovno točko.
English: Outcome for patients without SVR12
Slovenian: Izid za bolnike brez SVR12
English: However, neither of these entities has been evidenced to be a general surrogate marker for efficacy (SVR12) at the therapeutic 400 mg dose.
Slovenian: Vendar pa ni bilo za nobeno od teh spojin dokumentirano, da sta splošna nadomestna kazalca učinkovitosti (SVR12) pri terapevtskem odmerku 400 mg.
English: Patients in these studies had compensated liver disease including cirrhosis.
Slovenian: Bolniki v teh študijah so imeli kompenzirano bolezen jeter, vključno s cirozo.
English: Thus, the optimal treatment duration in this population has not been established (see also sections 4.2 and 5.1).
Slovenian: Zato optimalno trajanje zdravljenja pri tej populaciji ni bilo določeno (glejte tudi poglavji 4.2 in 5.1).
English: In patients that discontinued therapy at 24 weeks, according to protocol, the relapse rate was 11/15.
Slovenian: Pri bolnikih, ki so zdravljenje prekinili v 24. tednu, v skladu s protokolom, je bila stopnja relapsa
English: • slow or irregular heartbeat or heart rhythm problems
Slovenian: • počasno ali neredno bitje srca ali težave s srčnim ritmom
English: Adult patients awaiting liver transplantation - Study 2025
Slovenian: Odrasli bolniki, ki čakajo na presaditev jeter - študija 2025
English: Such regimens should only be used for patients that are intolerant to or ineligible for interferon therapy, and are in urgent need of treatment.
Slovenian: Taki režimi se lahko uporabljajo samo za bolnike, ki zdravljenja z interferonom ne prenašajo ali zanj niso primerni in ki nujno potrebujejo zdravljenje.
English: Body weight kg (lbs)
Slovenian: Telesna masa v kg (lbs)
English: SVR12 was achieved in 100 % (18/18) of patients treated with ledipasvir/sofosbuvir.
Slovenian: SVR12 je doseglo 100 % (18/18) bolnikov, zdravljenih z ledipasvirjem/sofosbuvirjem.
English: Pregnancy and concomitant use with ribavirin
Slovenian: Nosečnost in sočasna uporaba z ribavirinom
English: Overall SVR12
Slovenian: Celokupni SVR12
English: The recommended dose is one tablet (400 mg) once a day with food.
Slovenian: Priporočeni odmerek je ena tableta enkrat (400 mg) na dan s hrano.
English: • Have liver problems other than hepatitis C, e.g. if you are awaiting a liver transplantation;
Slovenian: • imate poleg hepatitisa C tudi druge težave z jetri, npr. če čakate na presaditev jeter
English: The extent of absorption of sofosbuvir was increased approximately 1.8-fold, with little effect on peak concentration.
Slovenian: Obseg absorpcije sofosbuvirja se je povečal za približno 1,8-krat, učinek na najvišje koncentracije pa je bil majhen.
English: Among these, one patient was found to have a NS5B RAV substitution (F289L).
Slovenian: Med njimi je bila pri enem bolniku ugotovljena substitucija NS5B RAV (F289L).
English: Adult liver transplant recipients - Study 0126
Slovenian: Odrasli prejemniki presajenih jeter - študija 0126
English: The SVR rate was 95% (56/59); of the three patients that did not achieve SVR12, one had completed sofosbuvir with velpatasvir treatment and relapsed.
Slovenian: je bila 95 % (56/59); od treh bolnikov, ki niso dosegli SVR12, je eden zaključil zdravljenje s sofosbuvirjem in velpatasvirjem ter doživel relaps.
English: If vomiting occurs more than 2 hours after dosing, no further dose is needed.
Slovenian: Če se bruhanje pojavi več kot 2 uri po odmerjanju, dodaten odmerek ni potreben.
English: All patients who achieved SVR12 achieved SVR24 and SVR48.
Slovenian: Vsi bolniki, ki so dosegli SVR12, so dosegli SVR24 in SVR48.
English: Patients should be instructed to swallow the tablet whole.
Slovenian: Bolnikom je treba naročiti, naj pogoltnejo celo tableto.
English: Sovaldi has moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo Sovaldi ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Frequencies are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to
Slovenian: Neželeni učinki so po pogostnosti opredeljeni, kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000) ali zelo redki (< 1/10.000).