FrancophonIA/ELRC3.0 huggingface dataset:
English: What benefit has Thelin shown during the studies?
Slovenian: Kakšne koristi je zdravilo Thelin izkazalo med študijami?
English: The CHMP concluded that Thelin had shown an effectiveness that was as expected for this class of medicines.
Slovenian: CHMP je zaključil, da je zdravilo Thelin izkazalo učinkovitost, ki je v skladu s pričakovano učinkovitostjo tega razreda zdravil.
English: Because the number of patients with pulmonary arterial hypertension is low, the disease is considered ‘rare', and Thelin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 October 2004.
Slovenian: Ker je število bolnikov s pljučno arterijsko hipertenzijo majhno, velja ta bolezen za redko, zato je bilo zdravilo Thelin dne 21. oktobra 2004 določeno kot „zdravilo sirota“ (zdravilo, ki se uporablja pri redkih boleznih).
English: The company will also set up a system to monitor Thelin's side effects, suspected interactions with other medicines and the outcome of any pregnancies that may happen in women using the medicine.
Slovenian: Poleg tega bo družba vzpostavila sistem za spremljanje neželenih učinkov zdravila Thelin, domnevnih interakcij z drugimi zdravili in izide nosečnosti, do katerih je prišlo pri ženskah, ki jemljejo to zdravilo.
English: Thelin was more effective than placebo at improving exercise capacity.
Slovenian: Zdravilo Thelin je bilo pri izboljšanju vadbene zmogljivosti učinkovitejše od placeba.
English: Therefore, the Committee decided that Thelin's benefits are greater than its risks for patients with class III disease and recommended that it be given marketing authorisation.
Slovenian: Odbor je zato zaključil, da so koristi zdravila Thelin za bolnike z boleznijo razreda III večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Slovenian: Povzetek mnenja Odbora za zdravila sirote o zdravilu Thelin je na voljo tukaj.
English: Thelin sitaxentan sodium
Slovenian: Thelin natrijev sitaksentanat
English: This document is a summary of the European public assessment report (EPAR) for Thelin.
Slovenian: Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Thelin.
English: Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Slovenian: Zdravilo Thelin se uporablja za zdravljenje odraslih bolnikov (starih 18 let ali več) s pljučno arterijsko hipertenzijo (PAH) za izboljšanje vadbene zmogljivosti (sposobnosti opravljanja fizične dejavnosti).
English: See the package leaflet for full details.
Slovenian: Za več podrobnosti glejte navodilo za uporabo.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thelin.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicine (CHMP) ocenil zdravilo Thelin, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: What is the risk associated with Thelin?
Slovenian: Kakšna tveganja so povezana z zdravilom Thelin?
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Slovenian: PAH pomeni nenormalno visok krvni tlak v pljučnih arterijah.
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Slovenian: Zdravilo Thelin se uporablja pri bolnikih z boleznijo razreda III. „Razred“ odraža resnost bolezni: „razred III“ vključuje izrazito omejitev fizične dejavnosti.
English: The active substance in Thelin, sitaxentan sodium, blocks the receptors for a hormone called endothelin-1 (ET-1), which causes blood vessels to constrict.
Slovenian: Zdravilna učinkovina v zdravilu Thelin, natrijev sitaksentanat, zavira receptorje hormona, imenovanega endotelin-1 (ET-1), ki povzroča konstrikcijo krvnih žil.
English: PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Slovenian: PAH je izčrpavajoča bolezen, pri kateri pride do hude konstrikcije (zoženja) krvnih žil v pljučih.
English: Thelin should not be used in people who may be hypersensitive (allergic) to sitaxentan sodium or any of the other ingredients.
Slovenian: Zdravila Thelin ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) natrijev sitaksentanat ali katero koli drugo sestavino zdravila.
English: Thelin is a medicine that contains the active substance sitaxentan sodium.
Slovenian: Thelin je zdravilo, ki vsebuje zdravilno učinkovino natrijev sitaksentanat.
English: Thelin must not be taken with ciclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver and kidney transplants).
Slovenian: Zdravilo Thelin se ne sme jemati skupaj s ciklosporinom A (zdravilom za zdravljenje psoriaze in revmatoidnega artritisa ter za preprečevanje zavrnitve presadka jeter in ledvic).
English: For the full list of all side effects reported with Thelin, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Thelin, glejte navodilo za uporabo.
English: It causes high blood pressure in the vessels taking blood from the heart to the lungs.
Slovenian: To povzroči visok krvni tlak v žilah, po katerih se pretaka kri iz srca v pljuča.
English: The patient's liver should be monitored before and during the treatment.
Slovenian: Pred zdravljenjem in po njem je treba spremljati delovanje bolnikovih jeter.
English: Why has Thelin been approved?
Slovenian: Zakaj je bilo zdravilo Thelin odobreno?
English: Thelin should only be started and monitored by a doctor who has experience in the treatment of PAH.
Slovenian: Zdravilo Thelin lahko uvede in spremlja le zdravnik, ki ima izkušnje z zdravljenjem pljučne arterijske hipertenzije.
English: By blocking the effect of ET-1, Thelin allows the vessels to dilate (expand), helping to lower the blood pressure and improving symptoms.
Slovenian: Zdravilo Thelin z zaviranjem učinka hormona ET-1 dilatira (razširi) žile, kar pomaga pri zniževanju krvnega tlaka in izboljšanju simptomov.
English: Thelin has been shown to be effective in PAH with no identified cause and PAH caused by connective tissue disease.
Slovenian: Zdravilo Thelin se je izkazalo kot učinkovito pri zdravljenju pljučne arterijske hipertenzije brez odkritega vzroka in tisti pljučni arterijski hipertenziji, katere vzrok je bolezen vezivnega tkiva.
English: How has Thelin been studied?
Slovenian: Kako je bilo zdravilo Thelin raziskano?
English: What is Thelin used for?
Slovenian: Za kaj se zdravilo Thelin uporablja?
English: How does Thelin work?
Slovenian: Kako zdravilo Thelin deluje?
English: What is Thelin?
Slovenian: Kaj je zdravilo Thelin?
English: Thelin must not be used in women who are breastfeeding.
Slovenian: Prav tako ga ne smejo uporabljati doječe matere.
English: How is Thelin used?
Slovenian: Kako se zdravilo Thelin uporablja?
English: The full EPAR for Thelin can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Thelin je na voljo tukaj.
English: This can cause damage to the affected areas.
Slovenian: To lahko povzroči škodo na prizadetih območjih.
English: Data exists only in the adult population.
Slovenian: Podatki obstajajo le za odraslo populacijo.
English: Date of first authorisation: 10/04/2017
Slovenian: Datum prve odobritve: 10/04/2017
English: Reabsorption is not complete.
Slovenian: Reabsorpcija ni popolna.
English: Efficacy and safety was studied in two retrospective trials in two centres in Europe.
Slovenian: Učinkovitost in varnost sta bili raziskani v dveh retrospektivnih študijah v dveh centrih v Evropi.
English: This medicine is for long-term use.
Slovenian: To zdravilo je za dolgoročno uporabo.
English: If you stop taking this medicine your symptoms may worsen.
Slovenian: Če zdravilo prenehate jemati, se vaši simptomi lahko poslabšajo.
English: Do not refrigerate or freeze.
Slovenian: Ne hranite v hladilniku ali zamrzovalniku.
English: - The other ingredients are:
Slovenian: - Druge pomožne snovi so:
English: The suspension should be stored in a glass bottle.
Slovenian: Suspenzijo je treba hraniti v steklenici.
English: Limited safety data are available (see section 4.8).
Slovenian: Na voljo so omejeni podatki o varnosti (glejte poglavje 4.8).
English: However, these patients should be carefully monitored and the dose titrated individually.
Slovenian: Vendar pa je treba te bolnike skrbno spremljati in odmerek individualno prilagoditi.
English: The capsules can be taken with or without food.
Slovenian: Kapsule lahko vzamete s hrano ali brez.
English: The three adverse reactions were all nonserious.
Slovenian: Vsi trije neželeni učinki niso bili resni.
English: Liver function should also be monitored.
Slovenian: Prav tako je treba spremljati delovanje jeter.
English: Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture.
Slovenian: Vaš zdravnik ali farmacevt vam bo dal navodila o tem, koliko in kako pogosto mora vaš otrok jemati mešanico.
English: Side effects of unknown frequency (cannot be estimated from the available data)
Slovenian: Neželeni učinki neznane pogostosti (ni mogoče oceniti iz razpoložljivih podatkov)
English: The suspension is stable for up to 7 days.
Slovenian: Suspenzija je stabilna do 7 dni.
English: Additional or more frequent investigations may need to be undertaken to monitor therapy during periods of fast growth, concomitant disease and pregnancy (see section 4.6).
Slovenian: Dodatne ali pogostejše preiskave bo morda treba izvesti za spremljanje zdravljenja v obdobjih hitre rasti, sočasne bolezni in v nosečnosti (glejte poglavje 4.6).
English: The events were transitory and did not interfere with the therapy.
Slovenian: Dogodki so prehodni in niso vplivali na zdravljenje.
English: Please speak to your doctor if you are taking any of these medicines.
Slovenian: Prosimo, da se pogovorite s svojim zdravnikom, če jemljete katero od teh zdravil.
English: Germany e-mail: info@leadiantbiosciences.com
Slovenian: Nemčija e-pošta: info@leadiantbiosciences.com
English: Stir the mixture until all the powder is in suspension.
Slovenian: Zmes mešajte, dokler se ves prašek ne raztopi v suspenzijo.
English: The suspension is then stable for up to 7 days.
Slovenian: Suspenzija je nato stabilna do 7 dni.
English: (aluminium oxide)
Slovenian: (aluminijev oksid)
English: *number of divided doses dependant on advice from doctor.
Slovenian: *število razdeljenih odmerkov glede na nasvet zdravnika.
English: This mixture will be provided to you by your pharmacy.
Slovenian: To mešanico vam bodo pripravili v lekarni.
English: Paediatric population (1 month -18 years)
Slovenian: Pediatrična populacija (1 mesec -18 let)
English: Signs and symptoms of the disease remained stable in most of the patients.
Slovenian: Znaki in simptomi bolezni pri večini bolnikov so ostali stabilni.
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Slovenian: Reabsorpcija henodeoksiholne kisline je spremenljiva (29-84 %).
English: Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps.
Slovenian: Pazite, da postrgate celoten prah s strani posode v zmes in mešajte (približno 5 minut), da zagotovo odstranite grudice.
English: The doctor will decide how many times and when your child should receive the dose(s) to make up the total dose for the day.
Slovenian: Zdravnik se bo odločil, kolikokrat in kdaj mora otrok prejeti odmerek(-e), za doseganje skupnega odmerka za tisti dan.
English: The safety and efficacy in neonates less than one month of age has not been established.
Slovenian: Varnost in učinkovitost pri novorojenčkih, starih manj kot en mesec, ni bila ugotovljena.
English: Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Slovenian: Zdravnik vam bo povedal, koliko kapsul morate vzeti in kdaj jih morate vzeti.
English: The mixture is ready when there are no visible lumps or powder.
Slovenian: Zmes je pripravljena, ko ni vidnih grudice ali prahu.
English: Please discuss suitable contraceptive methods with your doctor.
Slovenian: Prosimo, da se o ustrezni kontracepciji pogovorite s svojim zdravnikom.
English: Daily dose:
Slovenian: Dnevni odmerek:
English: Patients who are unable to swallow capsules
Slovenian: Bolniki, ki ne morejo pogoltniti kapsul
English: - if you are allergic to chenodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6)
Slovenian: - če ste alergični na henodeoksiholno kislino ali katero koli sestavino tega zdravila (navedeno v poglavju 6)
English: The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
Slovenian: Izdelana suspenzija vsebuje 22,9 mg natrija na ml, kar je treba upoštevati pri bolnikih na dieti z malo natrija.
English: This substance is normally produced by the liver from cholesterol.
Slovenian: Ta snov se običajno proizvaja v jetrih iz holesterola.
English: Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake “EXP”.
English: No formal preclinical safety studies have been conducted however data in the literature reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Slovenian: Formalne predklinične študije o varnosti niso bile izvedene, vendar podatki v literaturi ne kažejo posebnega tveganja na osnovi običajnih študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala.
English: Use in children (aged one month to 18 years)
Slovenian: Uporaba pri otrocih (starih od enega meseca do 18 let)
English: Developmental toxicity studies in rats, hamsters and primates showed an absence of teratogenic effects.
Slovenian: Študije razvojne toksičnosti pri podganah, hrčkih in primatih so pokazale odsotnost teratogenih učinkov.
English: 80538 Munich
Slovenian: 22 80538 München
English: Phenobarbital
Slovenian: Fenobarbital
English: Further information is provided in the package leaflet under Information for Healthcare Professionals Only.
Slovenian: Dodatne informacije so na voljo v navodilih za uporabo v Informacijah samo za zdravstvene delavce.
English: Neonates less than one month of age
Slovenian: Novorojenčki, stari manj kot en mesec
English: • Constipation • Abnormal liver test values
Slovenian: • Zaprtje • Nenormalne testne vrednosti jeter
English: The hard capsules should be taken whole with sufficient water at approximately the same time each day.
Slovenian: Trde kapsule je treba pogoltniti cele z zadostno količino vode, vsak dan približno ob istem času.
English: Chenodeoxycholic acid supplementation was re-started and maintained at a lower dose of 5 mg/kg/day with no further complications.
Slovenian: Dodajanje henodeoksiholne kisline je bilo ponovno uvedeno in ohranjeno na najnižjem odmerku 5 mg/kg/dan brez nadaljnjih zapletov.
English: See section 4.5 for further details.
Slovenian: Glejte poglavje 4.5 za več podrobnosti.
English: However, cholic acid is still formed via an alternate microsomal pathway.
Slovenian: Holna kislina se kljub temu tvori po alternativni mikrosomski poti.
English: In babies and children the dose will be calculated from the child's weight.
Slovenian: Pri dojenčkih in otrocih se bo odmerek izračunal glede na otrokovo telesno maso.
English: A similar effect on CYP27A1, albeit at higher doses, is also seen with sirolimus.
Slovenian: Podoben učinek pri CYP27A1, vendar pri višjih odmerkih je viden tudi pri sirolimusu.
English: Information for healthcare professionals only Patients who are unable to swallow capsules
Slovenian: Informacije samo za zdravstveno osebje Bolniki, ki ne morejo pogoltniti kapsul
English: Packs size: 100 capsules
Slovenian: Velikost pakiranja: 100 kapsul
English: Concurrent elevation of liver enzymes above normal levels may indicate overdose.
Slovenian: Sočasno zvišanje jetrnih encimov nad normalno ravnijo lahko nakazuje na prevelik odmerek.
English: Diarrhoea disappeared in 100% (23/23 patients) of the patients who had this symptom at baseline.
Slovenian: Driska je izginila pri 100 % (23/23 bolnikov) bolnikov, ki so imeli ta simptom na izhodišču.
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Slovenian: Epilepsija je izginila pri 100 % (3/3 bolnikov) in polinevropatija se je stabilizirala ali izboljšala pri 100 %
English: • phenobarbital (a medicine used for epilepsy)
Slovenian: • fenobarbital (zdravilo za zdravljenje epilepsije)
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Slovenian: Faks: +49 (0) 89 55 066 75 25 e-pošta: info@leadiantbiosciences.com
English: Neurological disability scale scores (Rankin and EDSS) stabilised or improved by the clinical current visit in 84.6% and 76.9% of patients respectively.
Slovenian: Rezultati lestvice nevrološke invalidnosti (Rankin in EDSS) so se stabilizirali ali izboljšali s trenutnim kliničnim obiskom pri v 84,6 % in 76,9 % bolnikih.
English: The only infant enrolled presented with raised liver function tests within six weeks of treatment start.
Slovenian: Samo pri enem od vključenih otrok so se pojavili povišani testi jetrne funkcije v šestih tednih po začetku zdravljenja.
English: There was a statistically significant (p = 0.04) improvement (decrease) of -0.31 ± 0.48 in the mean Rankin score for the < 21 years of age subgroup.
Slovenian: Pojavilo se je statistično bistveno (p = 0,04) izboljšanje (zmanjšanje) pri -0,31 ± 0,48 povprečnega rezultata Rankin v podskupini starosti <21 let.
English: The correct volumes should preferably be marked on the oral syringe.
Slovenian: Pravilne količine je treba po možnosti označiti na peroralni brizgi.
English: It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food.
Slovenian: Je del žolča, tekočina, ki pomaga pri prebavi maščob in vitaminov iz hrane.
English: During your treatment, your doctor will carry out blood and urine tests to monitor your response to this medicine, and adjust your dose if necessary.
Slovenian: Med zdravljenjem bo zdravnik opravljal preiskave krvi in urina za spremljanje vašega odziva na zdravilo in bo po potrebi prilagodil odmerek.
English: Due to the rarity of CTX, the available literature is not sufficient to detect a difference in the safety of chenodeoxycholic acid within paediatric age groups or between paediatric patients and adults.
Slovenian: Zaradi redkosti CTX, razpoložljiva literatura ne zadošča za zaznavanje razlike varnosti henodeoksiholne kisline v pediatričnih starostnih skupinah ali med otroci in odraslimi.
English: Your doctor may decide to increase your dose depending on how your body responds to treatment.
Slovenian: Zdravnik se lahko odloči za zvišanje odmerka odvisno od tega, kako se vaše telo odziva na zdravljenje.
English: The mean age of the patient population in the pivotal study was younger at 25.8 years than the supporting study population at 35 years which also reflected the level of disability present in the two cohorts prior to treatment start, with the supporting study having a higher disability score at baseline.
Slovenian: Povprečna starost populacije bolnikov v ključni študiji je bila nižja od 25,8 let kot podporna študijska populacija pri 35 letih, kar se je odrazilo tudi na stopnjo invalidnosti, ki je bila prisotna v dveh skupinah pred začetkom zdravljenja, s podporno študijo, ki ima višjo oceno invalidnosti na začetku.
English: Disease signs and symptoms resolved, improved or stabilised in a majority of patients over the course of the study.
Slovenian: Bolezenski znaki in simptomi so se tekom študije izboljšali ali stabilizirali pri večini bolnikov.
English: Your doctor may change the dose depending on how your child responds to treatment.
Slovenian: Zdravnik bo morda spremenil odmerek, odvisno od tega, kako se vaš otrok odziva na zdravljenje.
English: In two non-interventional studies with chenodeoxycholic acid a total of three adverse reactions were reported in three out of 63 patients (safety population).
Slovenian: V dveh neintervencijskih študijah s henodeoksiholno kislino so poročali o skupno treh neželenih učinkih pri treh od 63 bolnikov (varna populacija).
English: Mean Rankin and EDSS scores showed a very small increase (worsening) from baseline to clinical current visit at 0.08 ± 0.74 and 0.27 ± 1.24 in the overall population and this increase was not statistically significant.
Slovenian: Povprečni rezultati Rankin in EDSS so pokazali zelo majhno povečanje (poslabšanje) od izhodišča do trenutnega kliničnega obiska pri 0,08 ± 0,74 in 0,27 ± 1,24 v celotni populaciji in to povečanje ni bilo statistično bistveno.
English: There was a resolution, improvement or stabilisation in 88.9% (16/18) of patients with cognitive impairment.
Slovenian: izboljšanje ali stabilizacija se je pojavila pri 88,9 % (16/18) bolnikov s kognitivno motnjo.
English: Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)
Slovenian: Ovojnica kapsule: želatina, titanov dioksid (E 171), kinolinsko rumeno (E 104), eritrozin (E
English: Pyramidal dysfunction improved or stabilised in 60% (10/15) and cerebellar dysfunction in 88.7% (12/14).
Slovenian: Piramidalna disfunkcija se je izboljšala ali stabilizirala pri 60 % (10/15) in disfunkcije malih možganov pri 88,7 % (12/14).
English: Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CTX will require treatment for the rest of their life.
Slovenian: Kapsule zdravila Henodeoksiholna kislina Leadiant se lahko uporabljajo od starosti od enega meseca in pri bolnikih z CTX bo potrebno zdravljenje do konca življenja.
English: However, parkinsonian symptoms, a rare disease manifestation/association that occurred in only 2 patients during the course of the study, did not respond.
Slovenian: Vendar pa ni bilo odziva na simptome Parkinsonove bolezni, redke bolezni, ki se je pojavila pri samo 2 bolnikih v času študije.
English: Capsules are packed in polyvinyl chloride (PVC) blisters sealed with aluminium foil and packed in cardboard boxes.
Slovenian: Kapsule so pakirane v pretisne omote iz polivinil klorida (PVC), zaprte z aluminijasto folijo in zapakirane v kartonske škatle.
English: • ciclosporin and sirolimus (medicines used to suppress the immune system)
Slovenian: • ciklosporin in sirolimus (zdravila za zaviranje imunskega sistema)
English: Biological half-life of chenodeoxycholic acid is about 4 days.
Slovenian: Biološka razpolovna doba henodeoksiholne kisline je približno 4 dni.
English: This deficiency blocks the synthesis of primary bile acids via the classical (neutral pathway) and the alternative (acidic) pathway.
Slovenian: To pomanjkanje preprečuje sintezo primarnih žolčnih kislin po klasični (nevtralna pot) in alternativni (kislinska) poti.
English: All paediatric patients received 15 mg/kg/day as their starting dose.
Slovenian: Vsi pediatrični bolniki so kot začetni odmerek prejemali 15 mg/kg/dan.
English: The usual starting dose in adults is one 250 mg capsule three times a day.
Slovenian: Običajni začetni odmerek za odrasle je ena 250 mg kapsula trikrat na dan.