natgillin/translations-raw huggingface dataset:
The most common serious adverse reaction reported with miglustat treatment in clinical studies was peripheral neuropathy (see section 4.4).
Najčešća ozbiljna nuspojava zabilježena liječenjem miglustatom u kliničkim ispitivanjima bila je periferna neuropatija (vidjeti dio 4.4).
Limited data in patients with Fabry disease and impaired renal function showed that CL/F decreases with decreasing renal function.
Ograničeni podaci za bolesnike s Fabryjevom bolesti i poremećajem funkcije bubrega pokazuju da CL/F opada sa slabljenjem funkcije bubrega.
Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Kod više od 80% bolesnika primijećeni su gastrointestinalni događaji, uglavnom proljev, bilo u početku liječenja ili na mahove tijekom liječenja (vidjeti dio 4.8).
In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that miglustat monotherapy may not maintain the same control of disease activity in all patients.
U nekih je bolesnika došlo do smanjenja broja trombocita i do povećanja aktivnosti hitotriozidaze što ukazuje na to da monoterapija miglustatom ne može u svih bolesnika jednako držati bolest pod nadzorom.
The neurological manifestations are considered secondary to the abnormal accumulation of glycosphingolipids in neuronal and glial cells.
Neurološke manifestacije se smatraju sekundarnima na abnormalno nakupljanje glikosfingolipida u živčanim i glijalnim stanicama.
Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at Month 24.
Među njima je bilo 18 bolesnika s početnim volumenom jetre i slezene, razinama hemoglobina i brojem trombocita unutar utvrđenih terapijskih ciljeva, a 16 bolesnika je ostalo unutar svih tih terapijskih ciljeva u 24. mjesecu.
Further effects seen in animals at doses that result in exposure levels similar to or moderately higher than the clinical exposure level were: changes in lymphoid organs in all species tested, transaminase changes, vacuolation of thyroid and pancreas, cataracts, nephropathy and myocardial changes in rats.
Nadalje učinci zabilježeni u životinja pri dozama koje su uzrokovale razine izloženosti slične ili umjereno više od kliničkih razina izloženosti, bili su: promjene na limfoidnim organima u svih ispitanih vrsta, promjene vrijednosti transaminaza, vakuolizacija štitnjače i gušterače, katarakta, nefropatije i promjene miokarda u štakora.
In type 1 Gaucher disease, a substance called glucosylceramide is not removed from your body.
Kod Gaucherove bolesti tipa 1tvar nazvana glukozilceramid se ne uklanja iz Vašeg tijela.
Clinical benefit has been assessed at 24 and 36 months in 13 patients.
Klinička korist ocijenjena je kod 13 bolesnika nakon 24 i 36 mjeseci.
Peripheral neuropathy seems to be more common in patients with type 1 Gaucher disease compared to the general population.
Čini se da je periferna neuropatija češća u bolesnika s Gaucherovom bolesti tipa 1 u usporedbi s općom populacijom.
At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
U 12 mjeseci prosječno smanjenje volumena jetre bilo je za 12,1% i prosječno smanjenje volumena slezene bilo je za 19,0%.
Other studies revealed changes in sperm parameters (motility and morphology) consistent with an observed reduction in fertility.
Ostala su ispitivanja otkrila promjene u parametrima sperme (motilitet i morfologija) sukladne opažanjima smanjene plodnosti.
There are no pharmacokinetic data available in patients with liver impairment, in children or adolescents with type 1 Gaucher disease or in the elderly (> 70 years).
Nema dostupnih farmakokinetičkih podataka za bolesnike s oštećenjem funkcije jetre, djecu ili adolescente s Gaucherovom bolesti tipa 1 ili za starije bolesnike (> 70 godina).
This can result in disturbances in neurological functions such as slow eye movements, balance, swallowing, and memory, and in seizures.
To za posljedicu može imati poremećaje neuroloških funkcija kao što su sporo pokretanje oka, ravnoteža, gutanje i pamćenje, te epileptički napadaji.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
U sklopu svake kategorije učestalosti, nuspojave su prikazane prema opadajućoj ozbiljnosti.
Yargesa may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Yargesa se smije koristiti samo u liječenju bolesnika kod kojih enzimska nadomjesna terapija nije prikladna (vidjeti dijelove 4.4 i 5.1).
PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil containing 21 capsules.
Blister od PVC-a i poliklorotrifluoroetilena (PCTFE) zatvoren aluminijskom folijom koji sadrži 21 kapsulu.
- the other ingredients are sodium starch glycolate (type A), povidone (K-29/32), magnesium stearate, gelatin, purified water, titanium dioxide (E171), printing ink (shellac glaze, iron oxide black (E172), propylene glycol and concentrated ammonia solution)
- drugi sastojci su: natrijev škroboglikolat (vrsta A), povidon (K-29/32), magnezijev stearat, želatina, pročišćena voda, titanijev dioksid (E171), tinta za označavanje (šelak glazura, crni željezov oksid (E172), propilenglikol i koncentrirana otopina amonijaka).
Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
Osamnaest bolesnika je tada nastavilo primati miglustat u neobaveznom protokolu nastavka liječenja.
If your diarrhoea does not respond to these measures, or if you have any other abdominal complaint, consult your doctor.
Ako proljev ne reagira na te mjere, ili ako osjećate bilo kakvu drugu bol u trbuhu, obratite se svom liječniku.
Dizziness has been reported as a common adverse reaction, and patients suffering from dizziness should not drive or use machines.
Omaglica je zabilježena kao česta nuspojava pa bolesnici koji pate od omaglice ne bi trebali upravljati vozilom ili raditi sa strojevima.
Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Miglustat se uglavnom eliminira izlučivanjem bubrezima, pri čemu se u urinu pronašlo 70 - 80% doze neizmijenjenog lijeka.
Based on mg/kg/day and corrected for differences in faecal excretion, the doses corresponded to 8, 16 and 33/19 times the highest recommended human dose (200 mg t.i.d.).
Doze koje se temelje na mg/kg/dan i korigirane za razlike pri izlučivanju fecesa, odgovaraju 8, 16 i 33/19 puta višim preporučenim dozama za ljude (200 mg triput dnevno).
The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease.
Djelotvornost i sigurnost miglustata nije posebno procjenjivana kod bolesnika s teškom Gaucherovom bolesti.
Tremor Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Približno 37% bolesnika u kliničkim ispitivanjima kod Gaucherove bolesti tipa 1 i 58% bolesnika u kliničkim ispitivanjima kod Niemann-Pickove bolesti tipa C izvijestilo je o tremoru tijekom liječenja.
Male patients should maintain reliable contraceptive methods while taking Yargesa (see sections 4.4 and 5.3).
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju lijek Yargesa (vidjeti dijelove 4.4 i 5.3).
The most common adverse reactions reported in clinical studies with miglustat were diarrhoea, flatulence, abdominal pain, weight loss and tremor (see section 4.4).
Najčešće nuspojave zabilježene u kliničkim ispitivanjima s miglustatom bile su proljev, flatulencija, bol u trbuhu, gubitak težine i tremor (vidjeti dio 4.4).
Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Yargesa je indicirana za liječenje progresivne neurološke manifestacije u odraslih bolesnika i pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C (vidjeti dijelove 4.4 i 5.1).
In some patients, temporary dose reduction may be necessary.
Kod nekih će bolesnika možda biti potrebno privremeno smanjenje doze.
In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
U kliničkoj praksi, primijećeno je da gastrointestinalni događaji potaknuti miglustatom, reagiraju na individualiziranu prilagodbu prehrane (na primjer smanjeno uzimanje saharoze, laktoze i drugih ugljikohidrata), uzimanje miglustata između obroka, i/ili na lijekove protiv proljeva poput loperamida.
Studies in animals have shown reproductive toxicity, including dystocia (see section 5.3).
Ispitivanja na životinjama pokazala su reproduktivnu toksičnost, uključujući i distociju (vidjeti dio 5.3).
A second open, controlled study of miglustat randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
U drugom otvorenom, kontroliranom, randomiziranom ispitivanju na 36 bolesnika koji su najmanje 2 godine bili liječeni ERT-om, u tri skupine liječenja: nastavak liječenja imiglucerazom, imiglucerazom u kombinaciji s miglustatom, ili prelazak na miglustat.
Yargesa is only used when a patient is considered unsuitable for treatment with enzyme replacement therapy.
Yargesa se primjenjuje samo kada se bolesnik smatra nepodobnim za enzimsko nadomjesno liječenje.
Twenty-one patients completed 24 months of miglustat treatment.
Dvadeset jedan bolesnik završio je liječenje miglustatom u trajanju od 24 mjeseca.
Tremor usually began within the first month, and in many cases resolved during treatment after between 1 and 3 months.
Tremor obično počinje liječenja između 1. i 3. mjeseca.
While the numbers of subjects with mild and moderate renal impairment were very small, the data suggest an approximate decrease in CL/F of 40% and 60% respectively, in mild and moderate renal impairment (see section 4.2).
Iako je broj ispitanika s blagim ili umjerenim poremećajem funkcije bubrega bio vrlo malen, podatci ukazuju na približno povećanje CL/F od 40% odnosno 60%, kod blagog ili umjerenog poremećaja funkcije bubrega (vidjeti dio 4.2).
All patients should undergo baseline and repeat neurological evaluation.
Sve bolesnike treba neurološki procijeniti na početku i kasnije ponoviti neurološku procjenu.
There is a close relationship between renal function and clearance of miglustat, and exposure to miglustat is markedly increased in patients with severe renal impairment (see section 5.2).
Postoji uska povezanost između funkcije bubrega i klirensa miglustata, a izloženost miglustatu je znatno povećana u bolesnika s teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
Miglustat has not been evaluated in patients with a history of significant gastrointestinal disease, including inflammatory bowel disease.
Miglustat nije procjenjivan kod bolesnika s anamnezom značajne gastrointestinalne bolesti, uključujući i upalnu bolest crijeva.
Most serious side effects
Najozbiljnije nuspojave
If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Yargesa together with food, or to temporarily reduce your dose.
Ako imate proljev liječnik može zatražiti prilagodbu prehrane kako biste smanjili uzimanje laktoze i drugih ugljikohidrata kao što je saharoza (šećer iz trske), ili neuzimanje lijeka Yargese s hranom ili privremeno smanjenje doze.
Pack size: 84 x 1 capsules.
Veličina pakiranja: 84 x 1 kapsula.
They could be signs of peripheral neuropathy, due to side effects of Yargesa or they could be due to existing conditions.
To mogu biti znakovi periferne neuropatije, koji se javljaju zbog nuspojava lijeka Yargesa ili su se javili zbog postojeće bolesti.
Pharmacokinetic data indicate increased systemic exposure to miglustat in patients with renal impairment.
Farmakokinetički podatci ukazuju na povećanu sistemsku izloženost miglustatu u bolesnika s oštećenjem funkcije bubrega.
Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Miglustat je ispitivan u indikacijama kod kojih su neki događaji zabilježeni kao nuspojave, poput neuroloških i neurofizioloških simptoma/znakova, kognitivne disfunkcije i trombocitopenije mogli biti i posljedica bolesti od koje se bolesnik liječi.
Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Farmakokinetički podatci dobiveni su od pedijatrijskih bolesnika s Gaucherovom bolesti tipa 3 u dobi od 3 do 15 godina i bolesnika s Niemann-Pickovom bolesti tipa C u dobi od 5 do 16 godina.
Elderly There is no experience with the use of Yargesa in patients over the age of 70.
Nema iskustava s primjenom lijeka Yargesa u bolesnika starijih od 70 godina.
The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil.
Kapsule se nalaze u blisteru od PVC-a i poliklorotrifluoroetilena (PCTFE) koji je zatvoren aluminijskom folijom.
What you need to know before you take Yargesa
Što morate znati prije nego počnete uzimati lijek Yargesa
Cases of peripheral neuropathy have been reported in patients treated with miglustat with or without concurrent conditions such as vitamin B12 deficiency and monoclonal gammopathy.
Kod bolesnika liječenih miglustatom zabilježeni su slučajevi periferne neuropatije prisutne bez ili sa popratnim stanjima kao što su nedostatak vitamina B12 i monoklonalna gamapatija.
Use of Yargesa in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended.
Primjena lijeka Yargesa kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min/1,73 m2) se ne preporučuje.
Growth should be monitored in paediatric and adolescent patients during treatment with Yargesa; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
U tijeku liječenja Yargesa treba pratiti rast pedijatrijskih bolesnika i adolescenata; omjer koristi/rizika treba ponovo individualno procjenjivati za nastavak liječenja.
Very common effects - may affect more than 1 in 10 people The most common side effects are diarrhoea, flatulence (wind), abdominal (stomach) pain, weight loss and decreased appetite.
Vrlo česte nuspojave - mogu se javiti u više od 1 na 10 osoba Najčešće nuspojave su proljev, flatulencija (vjetrovi), bol u trbuhu, gubitak težine i smanjen tek.
Yargesa should not be taken during breast-feeding.
Lijek Yargesa ne smije se uzimati tijekom dojenja.
Overall the data show that treatment with Yargesa can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Ukupni podatci pokazuju da liječenje Yargesa može smanjiti progresiju klinički relevantnih neuroloških simptoma u bolesnika s Niemann-Pickove bolesti tipa C.
• For Niemann-Pick type C disease: For adults and adolescents (over 12 years old), the usual dose is two capsules (200 mg) three times a day (morning, afternoon and evening).
• Za Niemann-Pickovu bolest tipa C: za odrasle i adolescente (starije od 12 godina) uobičajena doza su dvije kapsule (200 mg) tri puta dnevno (ujutro, popodne i navečer).
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy.
To je ispitivanje provedeno u 6-mjesečnom randomiziranom komparativnom razdoblju nakon čega je slijedilo 18 mjesečni nastavak u kojem su svi bolesnici primali monoterapiju miglustatom.
OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET
In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Kod bolesnika uključenih u kliničko ispitivanje, 40% - 50% bolesnika broj trombocita na početku bio je ispod donje granice normale.
Other possible side effects are muscular spasms or weakness, fatigue, chills and malaise, depression, difficulty sleeping, forgetfulness and reduced libido.
Ostale moguće nuspojave su grčevi u mišićima ili slabost, umor, zimica i malaksalost, depresija, poteškoće sa spavanjem, zaboravljivost i smanjen libido.
Use in patients with severe renal impairment (creatinine clearance < 30 ml/min/1.73 m2) is not recommended (see sections 4.4 and 5.2).
Primjena kod bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina < 30 ml/min/1,73 m2) se ne preporučuje (vidjeti dijelove 4.4 i 5.2).
Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Periferna neuropatija, ataksija, amnezija, parestezija, hipoestezija, glavobolja, omaglica
In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 µM.
In vitro, miglustat inhibira glukozilceramid sintazu s IC50 koji iznosi 20 37 µM.
Pharmacokinetic parameters of miglustat were assessed in healthy subjects, in a small number of patients with type 1 Gaucher disease, Fabry disease, HIV-infected patients, and in adults, adolescents and children with Niemann-Pick type C disease or type 3 Gaucher disease.
Farmakokinetički parametri miglustata ocjenjivani su u zdravih osoba, kod malog broja bolesnika s Gaucherovom bolesti tipa 1, Fabrijevom bolesti, kod bolesnika zaraženih HIV-om, te kod odraslih, adolescenata i djece s Niemann-Pickovom bolesti tipa C ili Gaucherovom bolesti tipa
Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Primjena miglustata kod muških i ženskih CD1 miševa oralnom sondom tijekom 2 godine u dozama od 210, 420 i 840/500 mg/kg/dan (smanjenje doze nakon pola godine) za rezultat je imala povećanu incidenciju upalnih i hiperplastičnih lezija u debelom crijevu kod oba spola.
Miglustat affected embryo/foetal survival in rats and rabbits, dystocia was reported, postimplantation losses were increased, and an increased incidence of vascular anomalies occurred in rabbits.
Miglustat djeluje na preživljavanje embrija/fetusa u štakora i kunića, primijećena je distocija, porasli su gubitci nakon implantacije i došlo je do povećane incidencije vaskularnih anomalija kod kunića.
The mechanism is most likely inhibition of intestinal disaccharidases such as sucrase-isomaltase in the gastrointestinal tract leading to reduced absorption of dietary disaccharides.
Mehanizam je najvjerojatnije inhibicija intestinalnih disaharidaza kao što je sukraza-izomaltaza u probavnom traktu, što dovodi do smanjene apsorpcije disaharida iz hrane.
• Yargesa is also used to treat progressive neurological symptoms in Niemann-Pick type C disease in adults and in children.
• Yargesa se također primjenjuje za liječenje progresivnih neuroloških simptoma kod Niemann-Pickove bolesti tipa C u odraslih i djece.
There is limited experience with the use of Yargesa in Niemann-Pick type C disease patients under the age of 4 years.
Postoji ograničeno iskustvo u primjeni Yargesa kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađih od 4 godine.
Capsule content sodium starch glycolate (Type A) povidone (K-29/32) magnesium stearate
Sadržaj kapsule natrijev škroboglikolat (vrsta A), povidon (K-29/32), magnezijev stearat.
These findings were considered to be secondary to debilitation.
Ovi se nalazi smatraju posljedicom slabljenja organizma.
Gaucher disease is an inherited metabolic disorder caused by a failure to degrade glucosylceramide resulting in lysosomal storage of this material and widespread pathology.
Gaucherova bolest je nasljedni poremećaj metabolizma uzrokovan nemogućnošću razgradnje glukozilceramida, što za posljedicu ima pohranjivanje tog materijala u lizosomima i raširenu patologiju.
If you take more capsules than you were told to, consult your doctor immediately.
Ako uzmete više lijeka Yargesa nego što ste trebali Smjesta se obratite svom liječniku ako ste uzeli više kapsula nego
Reduced growth has been reported in some paediatric patients with Niemann-Pick type C disease in the early phase of treatment with miglustat where the initial reduced weight gain may be accompanied or followed by reduced height gain.
Kod nekih pedijatrijskih bolesnika s Niemann-Pickovom bolesti tipa C zabilježeno je smanjenje rasta u ranoj fazi liječenja miglustatom kada početno smanjeno dobivanje na težini može biti popraćeno smanjenjem rasta ili ono može uslijediti kasnije.
Peel back paper at arrows
Odvojite pozadinski papir kod strelica
If any of these side effects cause problems, consult your doctor.
Ako Vam bilo koja od tih nuspojava stvara poteškoće, obratite se Vašem liječniku.
Male patients should maintain reliable contraceptive methods while taking Yargesa.
Muški bolesnici trebaju primjenjivati pouzdane metode kontracepcije dok uzimaju lijek Yargesa.
Pack size of 84 capsules.
Veličina pakiranja: 84 kapsule.
The benefit of treatment with Yargesa for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be reappraised after at least 1 year of treatment with Yargesa.
Korist od liječenja Yargesa kod neuroloških manifestacija u bolesnika s Niemann-Pickovom bolesti tipa C treba redovito ocjenjivati, npr. svakih 6 mjeseci; nastavak liječenja treba ponovo procijeniti nakon najmanje 1 godine liječenja Yargesa.
Several metabolites were identified in urine and faeces.
U urinu i fecesu uočeno je nekoliko metabolita.
He or she may reduce the dose of Yargesa or recommend other medicines to help control side effects.
Liječnik može smanjiti dozu lijeka Yargesa ili preporučiti drugi lijek koji bi pomogao držati pod nadzorom te nuspojave.
This leaflet was last revised in
Ova uputa je zadnji put revidirana u <{MM/GGGG}> <{mjesec GGGG}>.
The benefit to the patient of treatment with Yargesa should be evaluated on a regular basis (see section 4.4).
Potrebno je redovito procjenjivati korist za bolesnika od liječenja Yargesa (vidjeti dio 4.4).
If you stop taking Yargesa
Ako prestanete uzimati lijek Yargesa
There was no drug-related increase in tumour incidence in any other organ.
Nije bilo povećanja incidencije tumora povezanih s lijekom bilo kojeg drugog organa.
The reason for these tests is that some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Yargesa.
Razlog za te pretrage je taj što što su neki bolesnici, dok su uzimali lijek Yargesa, osjećali trnce ili obamrlost u šakama i stopalima ili im se smanjila tjelesna težina.
The kinetics of miglustat appear to be dose linear and time independent.
Pokazalo se da je kinetika miglustata ovisna o dozi a neovisna o vremenu.
Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Miglustat je inhibitor glukozilceramid sintaze, enzima odgovornog za prvi korak u sintezi većine glikolipida.