FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are in a compassionate use programme and need more information about your treatment, contact the doctor who is giving it to you.
Croatian: Ako sudjelujete u programu milosrdnog davanja lijekova te vam je potrebno više informacija o liječenju, obratite se liječniku koji vas liječi.
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Croatian: Koje posljedice ima ovo povlačenje zahtjeva za bolesnike u kliničkim ispitivanjima ili u programima milosrdnog davanja lijekova?
English: Prohippur was not studied directly in patients with these conditions.
Croatian: Prohippur nije ispitivan izravno u bolesnika s tim stanjima.
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it needed more time to prepare adequate answers to questions raised by the CHMP.
Croatian: U svojem dopisu kojim obavještava Agenciju o povlačenju zahtjeva, tvrtka je navela da joj je potrebno više vremena kako bi pripremila prikladne odgovore na pitanja koje je postavio CHMP.
English: The application was withdrawn after the CHMP had evaluated the documentation provided by the company and formulated lists of questions.
Croatian: Zahtjev je povučen nakon što je CHMP procijenio dokumentaciju koju je tvrtka dostavila i sastavio popise pitanja.
English: Both glycine and ammonia are harmful in high amounts and can cause severe brain damage.
Croatian: I glicin i amonijak štetni su u velikim količinama i mogu prouzročiti teško oštećenje mozga.
English: On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.
Croatian: Dana 3. travnja 2018. tvrtka Lucane Pharma službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) da želi povući svoj zahtjev za izdavanje odobrenje za stavljanje u promet lijeka Prohippur za liječenje neketotične hiperglicinemije i poremećaja ciklusa ureje.
English: Prohippur is a medicine containing the active substance sodium benzoate.
Croatian: Prohippur je lijek koji sadržava djelatnu tvar natrijev benzoat.
English: What is Prohippur?
Croatian: Što je Prohippur?
English: The CHMP noted that the published studies submitted by the company did not provide enough evidence of the effectiveness and safety of sodium benzoate in the various disorders.
Croatian: CHMP je smatrao da objavljena ispitivanja koja je dostavila tvrtka ne pružaju dovoljno dokaza o učinkovitosti i sigurnosti natrijeva benzoata u različitim poremećajima.
English: Furthermore, as Prohippur was not used in clinical trials, the company should have provided data to show that Prohippur granules worked in the same way as the sodium benzoate used in the published studies.
Croatian: Nadalje, kako Prohippur nije bio primijenjen u kliničkim ispitivanjima, tvrtka je trebala pružiti podatke koji bi pokazali da su granule lijeka Prohippur djelovale na jednaki način kao i natrijev benzoat primjenjivan u objavljenim ispitivanjima.
English: Prohippur was designated an ‘orphan medicine' (a medicine to be used in rare diseases) for non-ketotic hyperglycinaemia on 11 September 2002 and for urea cycle disorders on 14 July 2016, 29 August 2016 and 18 November 2016.
Croatian: Prohippur je uvršten na popis lijekova za rijetke bolesti za neketotičnu hiperglicinemiju 11. rujna 2002., a za cikličke poremećaje ureje 14. srpnja 2016., 29. kolovoza 2016. i 18. studenoga 2016.
English: Withdrawal of the marketing authorisation application for Prohippur (sodium benzoate)
Croatian: Povlačenje zahtjeva za izdavanje odobrenja za stavljanje u promet lijeka Prohippur (natrijev benzoat)
English: The company informed the CHMP that there are no ongoing clinical trials with Prohippur and that a compassionate use programme approved in France will continue as planned.
Croatian: Tvrtka je obavijestila CHMP da nema kliničkih ispitivanja s lijekom Prohippur koja još traju te da će se program milosrdnog davanja lijekova odobren u Francuskoj nastaviti kako je planirano.
English: Prohippur also helps remove excess nitrogen from the body, thereby lowering levels of ammonia.
Croatian: Prohippur pomaže i ukloniti višak dušika iz tijela pri čemu snižava koncentracije amonijaka.
English: How far into the evaluation was the application when it was withdrawn?
Croatian: U kojoj je fazi bila procjena zahtjeva kada je povučen?
English: The company had not responded to the last round of questions at the time of the withdrawal.
Croatian: U trenutku povlačenja tvrtka još nije dostavila svoje odgovore na posljednji niz pitanja.
English: Finally, the CHMP had questions about the high levels of a substance in Prohippur (butylated methacrylate copolymer), the method of administration and quality control of the medicine in general.
Croatian: Konačno, CHMP je imao pitanja o visokim razinama tvari u lijeku Prohippur (butilirani metakrilatni kopolimer), načinu primjene i kontroli kakvoće lijeka općenito.
English: At the time of the withdrawal, the CHMP had some concerns.
Croatian: U trenutku povlačenja CHMP je smatrao da postoje razlozi za zabrinutost.
English: Withdrawal of the marketing authorisation application for Prohippur (sodium benzoate) EMA/258015/2018
Croatian: (natrijev benzoat) EMA/258015/2018
English: What did the company present to support its application?
Croatian: Što je tvrtka dostavila u prilog svojem zahtjevu?
English: The active substance in Prohippur, sodium benzoate, helps reduce harmful levels of glycine by attaching to glycine and forming a substance that is more easily removed by the kidneys.
Croatian: Djelatna tvar u lijeku Prohippur, natrijev benzoat, pomaže smanjiti štetne koncentracije glicina tako što se pričvrsti na glicin i stvori tvar koju se lakše ukloni iz bubrega.
English: • urea cycle disorders, a group of conditions where abnormally high levels of nitrogen occur in the body in the form of ammonia.
Croatian: • poremećaja ciklusa ureje, skupine stanja pri kojima se u tijelu pojave nenormalno visoke koncentracije dušika u obliku amonijaka.
English: • non-ketotic hyperglycinaemia, where abnormally high levels of the amino acid glycine occur in the blood.
Croatian: • neketotične hiperglicinemije, pri kojoj se u krvi pojave nenormalno visoke koncentracije aminokiseline glicin
English: What was Prohippur expected to be used for?
Croatian: Za što se Prohippur trebao koristiti?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 April 2018 EMA/258015/2018 EMEA/H/C/004150
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. travnja 2018.
English: The company presented data from published studies on the use of sodium benzoate in patients with non-ketotic hyperglycinaemia and urea cycle disorders.
Croatian: Tvrtka je dostavila podatke objavljenih ispitivanja o primjeni natrijeva benzoata u bolesnika s neketotičnom hiperglicinemijom i poremećajima ciklusa ureje.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Prohippur did not outweigh its risks.
Croatian: U skladu s navedenim, CHMP je u vrijeme povlačenja smatrao kako koristi od lijeka Prohippur ne nadmašuju s njim povezane rizike.
English: How does Prohippur work?
Croatian: Kako djeluje Prohippur?
English: Further information on the orphan designation can be found here.
Croatian: Dodatne informacije o uvrštenju lijekova za rijetke bolesti možete pronaći ovdje
English: 5 years.
Croatian: 5 godina.
English: Take the next capsule at the usual time.
Croatian: Uzmite sljedeću kapsulu u uobičajeno vrijeme.
English: The average half-life is 6-7 hours.
Croatian: Prosječni poluvijek je 6-7 sati.
English: This leaflet was last revised in:
Croatian: Ova uputa je zadnji puta revidirana u:
English: Ask your pharmacist how to throw away medicines you no longer take.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne uzimate.
English: The other ingredients are:
Croatian: Drugi sastojci su:
English: Don't stop taking Zavesca without talking to your doctor.
Croatian: Nemojte prestati uzimati Zavescu bez razgovora s liječnikom.
English: Zavesca can be taken with or without food.
Croatian: Zavesca se može uzeti s hranom ili bez nje.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: What Zavesca is and what it is used for
Croatian: Što je Zavesca i za što se koristi
English: Adult
Croatian: Odrasli
English: Always take this medicine exactly as your doctor has told you.
Croatian: Uvijek primjenjujte ovaj lijek točno onako kako Vam je savjetovao liječnik.
English: They may lower the amount of Zavesca in your body.
Croatian: To može sniziti količinu Zavesce u Vašem tijelu.
English: The greatest prevalence was observed between 6 and 12 months.
Croatian: Najveća prevalencija primijećena je između 6 i 12
English: If you take more Zavesca than you should
Croatian: Ako uzmete više Zavesce nego što ste trebali
English: Date of first authorisation: 20 November 2002 Date of latest renewal: 20 November 2012
Croatian: Datum posljednje obnove odobrenja: 20. studenoga 2012.
English: Capsule, hard 84 capsules
Croatian: Kapsula, tvrda 84 kapsule
English: - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6)
Croatian: - ako ste alergični na miglustat ili bilo koji drugi sastojak ovog lijeka (popis u dijelu 6)
English: Management In case of overdose general medical care is recommended.
Croatian: U slučaju predoziranja preporučuje se opća medicinska skrb.
English: Recommended dose 200 mg three times a day 200 mg twice a day 100 mg three times a day 100 mg twice a day 100 mg once a day
Croatian: 200 mg triput dnevno 200 mg dvaput dnevno 100 mg triput dnevno 100 mg dvaput dnevno 100 mg jednom dnevno
English: At present, there is insufficient clinical experience in these patients to provide dosing recommendations.
Croatian: Trenutno nema dovoljno kliničkog iskustva s takvim bolesnicima za davanje preporuka za doziranje.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: You should not take Zavesca if you are pregnant or thinking of becoming pregnant.
Croatian: Zavescu ne smijete uzeti ako ste trudni ili ako namjeravate zatrudniti.
English: Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice.
Croatian: Bolesnike s kroničnim proljevom ili drugim perzistirajućim gastrointestinalnim pojavama koji ne reagiraju na te intervencije treba pregledati u skladu s kliničkom praksom.
English: If you do lose some weight when you start treatment with Zavesca don't worry.
Croatian: Ako izgubite na težini kad počnete liječenje Zavescom, ne brinite.
English: Weight loss has been reported in 55% of patients.
Croatian: U 55 % bolesnika zabilježen je gubitak tjelesne težine.
English: The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Zavesca (see section 4 for further details).
Croatian: Ove pretrage će pomoći liječniku ustanoviti jesu li ti učinci posljedica bolesti ili drugih postojećih bolesti ili su posljedica nuspojava Zavesce (za daljnje pojedinosti vidjeti dio 4).
English: Do not give this medicine to children and adolescents (below 18 years old) with type 1 Gaucher disease because it is not known if it works in this disease.
Croatian: Ovaj lijek nemojte davati djeci ni adolescentima (mlađim od 18 godina) s Gaucherovom bolesti tipa 1 jer nije poznato djeluje li kod te bolesti.
English: Tremor usually began within the first month, and in many cases resolved during treatment after between 1 and 3 months.
Croatian: Tremor obično počinje u prvom mjesecu, a u mnogo slučajeva prestaje tijekom liječenja između 1. i 3. mjeseca.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Croatian: Za sve informacije o ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet
English: These findings were considered to be secondary to debilitation.
Croatian: Ovi se nalazi smatraju sekundarnima za onesposobljenje.
English: Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Croatian: Leukopenija i neutropenija su također primijećene u sličnoj skupini bolesnika koji su primali dozu od 800 mg/dan ili višu.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Zavesca.
Croatian: Obavijestite svog liječnika ako uzimate lijekove koji sadrže imiglucerazu, koji se ponekad uzimaju istovremeno sa Zavescom.
English: Contents of the pack and other information What Zavesca contains
Croatian: Sadržaj pakiranja i druge informacije Što Zavesca sadrži
English: Titanium dioxide (E171).
Croatian: Titanijev dioksid (E171).
English: There are no adequate data from the use of miglustat in pregnant women.
Croatian: Nema dovoljno podataka o primjeni miglustata u trudnica.
English: What you need to know before you take Zavesca Do not take Zavesca
Croatian: Što morate znati prije nego počnete uzimati Zavescu
English: Other medicines and Zavesca
Croatian: Drugi lijekovi i Zavesca
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Croatian: Farmakoterapijska skupina: Drugi lijekovi za bolesti probavnog trakta i metabolizma, ATK oznaka: A16AX06
English: Do not take this medicine after the expiry date which is stated on the carton after ‘EXP'.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji iza „EXP“.
English: 29 patients continued in the extension period.
Croatian: 29 bolesnika nastavilo je u produljenom razdoblju.
English: If you stop taking Zavesca
Croatian: Ako prestanete uzimati Zavescu
English: He or she may reduce the dose of Zavesca or recommend other medicines to help control side effects.
Croatian: On ili ona može smanjiti dozu Zavesce ili preporučiti drugi lijek koji bi pomogao kontrolirati te nuspojave.
English: Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Croatian: Miglustat nije pokazao nikakav potencijal za mutagene ili klastogene učinke u standardnom nizu testova na genotoksičnost.
English: Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment.
Croatian: Kod većine bolesnika dođe do jedne ili više od tih nuspojava, obično na početku liječenja ili u razmacima tijekom liječenja.
English: Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Croatian: Preporučuje se redovito praćenje razine vitamina B12 zbog visoke prevalencije pomanjkanja vitamina B12 u bolesnika s Gaucherovom bolesti tipa 1.
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Croatian: Istovremeno uzimanje hrane smanjuje brzinu apsorpcije (Cmax je smanjen za 36% a tmax je 2 sata dulje), ali nema statistički značajnog utjecaja na apsorpciju miglustata (AUC snižena za 14%).
English: The requirements 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.
Croatian: • Periodička izvješća o neškodljivosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: In the first 6 months in patients who were switched to Zavesca, liver and spleen organ volumes and haemoglobin levels were unchanged.
Croatian: U prvih 6 mjeseci kod bolesnika koji su prešli na Zavescu, volumeni organa jetre i slezene i razine hemoglobina bili su nepromijenjeni.
English: This study also indicated that Zavesca has no or limited effect on the pharmacokinetics of imiglucerase.
Croatian: To ispitivanje ukazuje također na to da Zavesca nema nikakav ili ima ograničen učinak na farmakokinetiku imigluceraze.
English: What Zavesca looks like and contents of the pack
Croatian: Kako Zavesca izgleda i sadržaj pakiranja
English: If you forget to take Zavesca
Croatian: Ako zaboravite uzeti Zavescu
English: Your doctor will perform some tests before and during treatment with Zavesca to assess this (see section 2).
Croatian: Liječnik će provesti neke pretrage prije i za vrijeme liječenja Zavescom kako bi to procijenio (vidjeti dio 2).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a..
English: OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO ROK VALJANOSTI
English: Among the 41 patients enrolled in the trial 14 patients were treated with Zavesca for more than 3 years.
Croatian: Od 41 bolesnika uključenih u ispitivanje 14 bolesnika je liječeno Zavescom duže od 3 godine.
English: Weight loss, decreased appetite
Croatian: Gubitak težine, oslabljen tek
English: Sometimes your doctor will need to reduce the dose or stop Zavesca treatment to stop the tremor.
Croatian: Ponekad će Vam liječnik reći da smanjite dozu ili potpuno prekinete liječenje Zavescom kako bi otklonio tremor.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of Zavesca monotherapy (20 and 6 patients, respectively).
Croatian: U usporedbi s mjerenjima provedenim nakon 6 mjeseci, nadzor bolesti bio je nepromijenjen nakon 18 i 24 mjeseca monoterapije Zavescom (20 odnosno 6 bolesnika).
English: After 3 years of continuous Zavesca treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Croatian: Nakon 3 godine neprekidnog liječenja Zavescom, prosječno smanjenje volumena organa jetre i slezene bilo je 17,5% odnosno 29,6%.
English: Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces.
Croatian: Nakon davanja jedne doze od 100 mg 14C-miglustata zdravim dobrovoljcima, 83% radioaktivno označenog lijeka izlučeno je s urinom a 12% fecesu.
English: Talk to your doctor or pharmacist before taking Zavesca - if you suffer from kidney disease
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Zavescu ako patite od bolesti bubrega ako patite od bolesti jetre
English: Zavesca has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Croatian: Zavesca je korištena u kliničkim ispitivanjima u deset puta većim dozama od preporučenih: to je uzrokovalo smanjenje broja bijelih krvnih zrnaca i druge nuspojave slične onima opisanim u dijelu 4.
English: The efficacy of Zavesca in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Croatian: Djelotvornost Zavesce kod djece i adolescenata u dobi 0 do 17 godina s Gaucherovom bolesti tipa 1 nije ustanovljena.
English: Capsule shell Gelatin,
Croatian: Ovojnica kapsule Želatina,
English: Box of 4 blister strips, each blister strip containing 21 capsules providing a total of 84 capsules.
Croatian: Kutija s 4 blister stripa, svaki blister strip sadrži 21 kapsulu što je ukupno 84 kapsule.
English: The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Croatian: Metabolit u najvećoj količini u urinu bio je miglustat glukuronid koji je činio 5% doze.
English: The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Croatian: Glavni učinci kod svih vrsta bili su gubitak tjelesne težine i proljev, a pri višim dozama, oštećenje gastrointestinalne sluznice (erozije i ulceracije).
English: Male patients should maintain reliable contraceptive methods while taking Zavesca (see sections 4.4 and 5.3).
Croatian: Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju Zavescu (vidjeti dijelove 4.4 i 5.3).
English: There is no experience with the use of Zavesca in patients over the age of 70.
Croatian: Nema iskustava s primjenom Zavesce u bolesnika starijih od 70 godina.
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu.
English: The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state.
Croatian: Metabolit uzročnik toga nije određen, ali se može akumulirati i dosegnuti koncentracije koje nadilaze one u miglustatu pri stanju dinamičke ravnoteže.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODACI NA KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA
English: Data to support safety and efficacy of Zavesca in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Croatian: Podatci koji podupiru sigurnost i djelotvornost Zavesce u Niemann-Pickovoj bolesti tipa C potječu iz prospektivnog otvorenog kliničkog ispitivanja i retrospektivne analize.
English: Eighteen patients then continued to receive Zavesca under an optional extended treatment protocol.
Croatian: Osamnaest bolesnika je tada nastavilo primati Zavescu u neobaveznom protokolu proširenog liječenja.
English: Blood and lymphatic system disorders Common
Croatian: Poremećaji krvi i limfnog sustava
English: Limited data suggest that co-administration of Zavesca and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Croatian: Ograničeni podatci ukazuju na to da istovremena primjena Zavesce i enzimskog nadomjestka s imiglucerazom u bolesnika s Gaucherovom bolesti tipa 1 može za posljedicu imati smanjenu izloženost miglustatu (približno smanjenje od 22% u Cmax i 14% u AUC zabilježeno u malom ispitivanju s paralelnim skupinama).
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Croatian: U prikupljenoj analizi nekontroliranih podataka su Z-vrijednosti mineralne gustoće kosti lumbalne kralježnice i vrata bedrene kosti povećane za više od 0,1 jedinice od početka u 27 (57%) i 28 (65%) bolesnika s longitudinalnim mjerenjima gustoće kostiju.