natgillin/translations-raw huggingface dataset:
It starts to build up in certain cells of the body's immune system.
Počinje se nakupljati u nekim stanicama imunološkog sustava tijela.
If you have a problem with your kidneys you may receive a lower starting dose.
Ako imate poteškoće s bubrezima možete primati nižu početnu dozu.
Effects on spermatogenesis
Djelovanje na spermatogenezu
Do not throw away any medicines via wastewater or household waste.
Nikada nemojte nikakve lijekove bacati u otpadne vode ili u kućni otpad.
Maximum plasma concentrations are reached about 2 hours after dose.
Maksimalne koncentracije u plazmi dostignute su u roku od oko 2 sata nakon doze.
SN: {number}
SN: {broj}
UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
JEDINSTVENI IDENTIFIKATOR - PODACI ČITLJIVI LJUDSKIM OKOM PC: {broj}
The tremor often disappears without needing to stop the treatment.
Tremor često nestaje bez potrebe za prekidom liječenja.
Do not stop taking Yargesa without talking to your doctor.
Nemojte prestati uzimati lijek Yargesa bez razgovora s liječnikom.
The Netherlands
Nizozemska
At present, there is insufficient clinical experience in these patients to provide dosing recommendations.
Trenutačno nema dovoljno kliničkog iskustva s takvim bolesnicima za davanje preporuka za doziranje.
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
Preporučena doza 200 mg triput dnevno 200 mg dvaput dnevno 100 mg triput dnevno 100 mg dvaput dnevno 100 mg jednom dnevno
Miglustat crosses the placenta and should not be used during pregnancy.
Miglustat prolazi kroz placentu i ne smije se uzimati tijekom trudnoće.
Patients with chronic diarrhoea or other persistent gastrointestinal events that do not respond to these interventions should be investigated according to clinical practice.
Bolesnike s kroničnim proljevom ili drugim perzistirajućim gastrointestinalnim događajima koji ne reagiraju na te intervencije treba pregledati u skladu s kliničkom praksom.
These effects occurred at exposure levels similar to those in patients, but showed reversibility.
Ovi su se učinci javili pri razinama izloženosti sličnim onima kod bolesnika, ali su bili reverzibilni.
Do not take Yargesa - if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6)
Nemojte uzimati lijek Yargesa - ako ste alergični na miglustat ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
The terminal half-life of radioactivity in plasma was 150 h suggesting the presence of one or more metabolites with very long half-life.
Terminalni poluvijek radioaktivnosti u plazmi bio je 150 sati, što ukazuje na prisutnost jednog ili više metabolita s vrlo dugim poluvijekom.
Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required.
Smanjenje doze može umanjiti tremor, obično u nekoliko dana, ali ponekad može biti potrebno prekinuti liječenje.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
17. JEDINSTVENI IDENTIFIKATOR - 2D BAR KOD <Sadrži 2D bar kod s jedinstvenim identifikatorom.>
If you are pregnant, breast feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent.
Razina bez opaženog učinka (NOEL - No Observed Effect Level) nije ustanovljena i učinak nije bio ovisan o dozi.
Liver volume (primary efficacy variable) was unchanged from baseline to the end of treatment.
Volumen jetre (primarna varijabla djelotvornosti) bio je nepromijenjen od početka do kraja liječenja.
No acute symptoms of overdose have been identified.
Nisu uočeni akutni simptomi predoziranja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Datum prvog odobrenja: 22 Ožujak 2017
- the active substance is miglustat.
- djelatna tvar je miglustat.
What Yargesa looks like and contents of the pack
Kako Yargesa izgleda i sadržaj pakiranja
If you do lose some weight when you start treatment with Yargesa don't worry.
Ako izgubite na težini kad počnete liječenje lijekom Yargesa, ne brinite.
You should not take Yargesa if you are pregnant or thinking of becoming pregnant.
Lijek Yargesa ne smijete uzeti ako ste trudni ili ako namjeravate zatrudnjeti.
Apparent oral clearance (CL/F) is 230 ± 39 ml/min.
Prividan peroralni klirens (CL/F) je 230 ± 39 ml/min.
What Yargesa is and what it is used for
Što je Yargesa i za što se koristi
Mechanistic studies revealed a rat specific mechanism which is considered to be of low relevance for humans.
Ispitivanja mehanizma otkrila su specifičan mehanizam u štakora koji se smatra od male važnosti za ljude.
In healthy subjects miglustat is rapidly absorbed.
Kod zdravih se osoba miglustat brzo apsorbirao.
Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Yargesa (see section 4).
Liječnik može smanjiti Vašu dozu, npr. na jednu kapsulu (100 mg) jednom ili dvaput dnevno, ako imate proljev dok uzimate lijek Yargesa (vidjeti dio 4).
The systemic exposure at the lowest dose was below or comparable to that observed in humans (based on AUC0-∞) at the recommended human dose.
Sistemska izloženost pri najnižoj dozi bila je niža ili se mogla usporediti s onom zapaženom kod ljudi (na osnovu AUC0-∞) pri preporučenoj dozi za ljude.
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Yargesa.
Obavijestite svog liječnika ako uzimate lijekove koji sadrže imiglucerazu, koji se ponekad uzimaju istodobno s lijekom Yargesa.
Absolute bioavailability has not been determined.
Nije utvrđena apsolutna bioraspoloživost.
For the full list of excipients, see section 6.1.
Za cjeloviti popis pomoćnih tvari, vidjeti dio 6.1.
Most patients get one or more of these side effects, usually at the start of treatment or at intervals during treatment.
Kod većine bolesnika dođe do jedne ili više tih nuspojava, obično na početku liječenja ili u razmacima tijekom liječenja.
Leukopenia and neutropenia have also been observed in a similar group of patients receiving 800 mg/day or higher dose.
Leukopenija i neutropenija također su primijećene u sličnoj skupini bolesnika koji su primali dozu od 800 mg/dan ili višu.
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 Yargesa (see section 4 for further details).
Ove pretrage će pomoći liječniku ustanoviti jesu li ti učinci posljedica ove bolesti ili drugih postojećih bolesti ili su posljedica nuspojava lijeka Yargesa (za daljnje pojedinosti vidjeti dio 4).
What Yargesa contains
Što Yargesa sadrži
Common effects - may affect up to 1 in 10 people
Česte nuspojave - mogu se javiti kod manje od 1 na 10 osoba
MARKETING AUTHORISATION NUMBER(S) EU/1/17/1176/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/17/1176/001
Thirteen patients discontinued treatment due to an adverse event.
Trinaest bolesnika je liječenje prekinulo zbog štetnih događaja.
If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Ako imate blagi tremor, obično drhtanje ruku, zatražite savjet svog liječnika što je prije moguće.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC Code: A16AX06
Farmakoterapijska skupina: Drugi lijekovi za probavni sustav i metabolizam, ATK oznaka: A16AX06
There are no adequate data from the use of miglustat in pregnant women.
Nema odgovarajućih podataka o primjeni miglustata u trudnica.
Carcinomas in the large intestine occurred occasionally at all doses with a statistically significant increase in the high dose group.
Karcinomi debelog crijeva javljali su se povremeno pri svim dozama, uz statistički značajno povećanu učestalost u skupini s visokom dozom.
Yargesa has negligible influence on the ability to drive and use machines.
Yargesa zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Regular monitoring of vitamin B12 level is recommended because of the high prevalence of vitamin B12 deficiency in patients with type 1 Gaucher disease.
Preporučuje se redovito praćenje razine vitamina B12 zbog visoke prevalencije nedostatka vitamina B12 u bolesnika s Gaucherovom bolesti tipa 1.
Six patients had miglustat treatment prematurely discontinued for potential disease worsening, as defined in the study.
Šest bolesnika je liječenje miglustatom prekinulo ranije zbog mogućeg pogoršanja bolesti, kako je definirano u ispitivanju.
Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Nuspojave u kliničkim ispitivanjima i iz spontanih prijava bolesnika koje su se javljale kod >1%, bolesnika, navedene su u donjoj tablici prema klasifikaciji organskih sustava i učestalosti (vrlo često: ≥ 1/10, često: ≥ 1/100 < 1/10, manje često: ≥ 1/1.000 i < 1/100, rijetko: ≥ 1/10.000 i < 1/1.000, vrlo rijetko: < 1/10.000).
Miglustat 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.
Miglustat je korišten u kliničkim ispitivanjima u deset puta većim dozama od preporučenih: to je uzrokovalo smanjenje broja bijelih krvnih stanica i druge nuspojave slične onima opisanim u dijelu 4.
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.
Ovaj lijek nemojte davati djeci ni adolescentima (mlađim od 18 godina) s Gaucherovom bolesti tipa 1 jer nije poznato djeluje li kod njih.
Over the range of data available, no significant relationships or trends were noted between miglustat pharmacokinetic parameters and demographic variables (age, BMI, gender or race).
U rasponu dostupnih podataka, nisu primijećeni značajni odnosi ili trendovi između farmakokinetičkih parametara miglustata i demografskih varijabli (dob, indeks tjelesne mase, spol ili rasa).
Miglustat did not show any potential for mutagenic or clastogenic effects in the standard battery of genotoxicity tests.
Miglustat nije pokazao nikakav potencijal za mutagene ili klastogene učinke u standardnom nizu testova genotoksičnosti.
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%).
Istovremeno uzimanje hrane smanjuje brzinu apsorpcije (Cmax je smanjen za 36% a tmax je 2 sata dulji), ali nema statistički značajnog utjecaja na apsorpciju miglustata (AUC snižena za 14%).
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.
Nakon davanja jedne doze od 100 mg 14C-miglustata zdravim dobrovoljcima, 83% radioaktivno označenog lijeka izlučeno je u urinu a 12% u fecesu.
In some cases the doctor may prescribe anti-diarrhoeal medicines such as loperamide.
U nekim slučajevima liječnik može propisati lijek protiv proljeva kao što je loperamid.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Preosjetljivost na djelatnu tvar ili bilo koju od pomoćnih tvari navedenih u dijelu 6.1.
Gastrointestinal disturbances
Gastrointestinalni poremećaji
Rouboslaan 32 (ground floor) 2252 TR, Voorschoten
Rouboslaan 32 (ground floor) 2252 TR, Voorschoten Nizozemska
In the first 6 months in patients who were switched to miglustat, liver and spleen organ volumes and haemoglobin levels were unchanged.
U prvih 6 mjeseci kod bolesnika koji su prešli na miglustat, volumeni jetre i slezene i razine hemoglobina bili su nepromijenjeni.
Among the 41 patients enrolled in the trial 14 patients were treated with Yargesa for more than 3 years.
Od 41 bolesnika uključenih u ispitivanje 14 bolesnika je liječeno Yargesa duže od 3 godine.
Dosing in patients under the age of 12 years should be adjusted on the basis of body surface area as illustrated below:
Doziranje u bolesnika mlađih od 12 treba prilagoditi ovisno o veličini površine tijela kako je niže prikazano:
This means a daily maximum of six capsules (600 mg).
To znači da je dnevni maksimum šest kapsula (600 mg).
Repeated-dose toxicity studies in rats showed effects on the seminiferous epithelium of the testes.
Ispitivanja toksičnosti ponovljenih doza na štakorima pokazala su učinke na seminiferni epitel testisa.
An additional monotherapy study was performed in 18 patients at a total daily dose of 150 mg, and results indicate reduced efficacy compared to a total daily dose of 300 mg.
Dodatno ispitivanje monoterapije provedeno je na 18 bolesnika s ukupnom dnevnom dozom od 150 mg, a rezultati ukazuju na smanjenu djelotvornost u usporedbi s ukupnom dnevnom dozom od 300 mg.
When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
U usporedbi s mjerenjima provedenim nakon 6 mjeseci, kontrola bolesti bila je nepromijenjena nakon 18 i 24 mjeseca monoterapije miglustatom (20 odnosno 6 bolesnika).
PHARMACEUTICAL FORM AND CONTENTS 84 x 1 hard capsules
OBLIK I SADRŽAJ 84 x 1 tvrda kapsula
Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Podatci kod teškog poremećaja funkcije bubrega ograničeni su na dva bolesnika s klirensom kreatinina u rasponu od 18 - 29 ml/min i ne mogu se ekstrapolirati ispod tog raspona.
The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Najprisutniji metabolit u urinu bio je miglustat glukuronid koji je činio 5% doze.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS BLISTER
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER BLISTER
This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase.
To ispitivanje ukazuje također na to da miglustat nema nikakvo ili ima ograničeno djelovanje na farmakokinetiku imigluceraze.
These data suggest a decrease in CL/F by at least 70% in patients with severe renal impairment.
Ti podatci ukazuju na smanjenje CL/F za najmanje 70% u bolesnika s teškim poremećajem funkcije bubrega.
Depression, insomnia, libido decreased Nervous system disorders Very common
Depresija, nesanica, smanjen libido Poremećaji živčanog sustava Vrlo često
BATCH NUMBER<, DONATION AND PRODUCT CODES> Lot
13. BROJ SERIJE<, OZNAKE DONACIJE I PROIZVODA> Serija
Your doctor will perform some tests before and during treatment with Yargesa to assess this (see section 2).
Liječnik će provesti neke pretrage prije i za vrijeme liječenja lijekom Yargesa kako bi to procijenio (vidjeti dio 2).
In type 1 Gaucher disease, these tremors were described as an exaggerated physiological tremor of the hands.
Kod Gaucherove bolesti tipa 1, ti su tremori opisani kao pretjerani fiziološki tremor ruku.
Changes in lactation were observed in female rats in a 1-year study.
Tijekom 1-godišnjeg ispitivanja uočene su promjene u laktaciji kod ženskih štakora.
If you do get any of these effects, please seek medical advice from your doctor as soon as possible.
Ako imate bilo koju od tih nuspojava, zatražite savjet svog liječnika što je prije moguće.
In addition 12 paediatric patients were enrolled in an uncontrolled substudy for an overall average duration of 3.1 years and up to 4.4 years.
Osim toga 12 pedijatrijskih bolesnika bilo je uključeno u nekontrolirano podispitivanje u ukupnom prosječnom trajanju od 3,1 godine pa do 4,4 godine.
Other medicines and Yargesa Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Both data sets included paediatric, adolescent and adult patients with an age range of 1 year to 43 years.
Oba seta podataka uključuju pedijatrijske, adolescentne i odrasle bolesnike dobnog raspona od 1 do 43 godine.
Driving and using machines Yargesa may make you feel dizzy.
Upravljanje vozilima i strojevima Yargesa može uzrokovati omaglicu.
Data to support safety and efficacy of Yargesa in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Podatci koji podupiru sigurnost i djelotvornost Yargesa u Niemann-Pickovoj bolesti tipa C potječu iz prospektivnog otvorenog kliničkog ispitivanja i retrospektivne analize.
Niemann-Pick type C disease is a very rare, invariably progressive and eventually fatal neurodegenerative disorder characterised by impaired intracellular lipid trafficking.
Niemann-Pickova bolest tipa C je vrlo rijedak, uvijek progresivan i u konačnici smrtonosan neurodegenerativni poremećaj koji karakterizira poremećen intracelularni transport lipida.
The main effects common to all species were weight loss and diarrhoea, and, at higher doses, damage to the gastrointestinal mucosa (erosions and ulceration).
Glavni učinci zajednički svim vrsta bili su gubitak tjelesne težine i proljev, a pri višim dozama, oštećenje gastrointestinalne sluznice (erozije i ulceracije).
Of these patients, 132 had type 1 Gaucher disease, and 40 had Niemann-Pick type C disease.
Od tih bolesnika, 132 su imala Gaucherovu bolest tipa 1, a 40 je imalo Niemann-Pickovu bolest tipa
If you have Niemann-Pick type C disease, fats such as glycosphingolipids build up in the cells of your brain.
Ako imate Niemann-Pickovu bolest tipa C, masti kao što su glikosfingolipidi nakupljaju se u stanicama Vašeg mozga.
Limited data suggest that co-administration of miglustat 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).
Ograničeni podaci ukazuju na to da istodobna primjena miglustata 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).
For children less than 12 years old, your doctor will adjust the dose for Niemann-Pick type C disease.
Kod djece mlađe od 12 godina, liječnik će prilagoditi dozu za Niemann-Pickovu bolest tipa C.
Contraceptive measures should be used by women of childbearing potential.
Metode kontracepcije trebaju koristiti i žene reproduktivne dobi.
An open-label, non-comparative, 2-year study enrolled 42 patients with type 1 Gaucher disease, who had received a minimum of 3 years of ERT and who fulfilled criteria of stable disease for at least 2 years.
Nekomparativno, 2-godišnje otvoreno ispitivanje uključivalo je 42 bolesnika s Gaucherovom bolesti tipa 1, koji su najmanje 3 godine primali ERT, a koji su zadovoljavali kriterij stabilne bolesti od najmanje 2 godine.
After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Nakon 3 godine neprekidnog liječenja miglustatom, prosječno smanjenje volumena jetre i slezene bilo je 17,5% odnosno 29,6%.
There was no drug-related increase in tumour incidence in male or female rats in any other organ.
Nije bilo povećanja incidencije tumora povezanih s lijekom u muških ili ženskih štakora ni u kojem drugom organu.
The metabolite accounting for this has not been identified, but may accumulate and reach concentrations exceeding those of miglustat at steady state.
Metabolit koji je za to odgovoran nije utvrđen, ali se može akumulirati i dosegnuti koncentracije koje nadilaze one miglustata pri stanju dinamičke ravnoteže.
This means a daily maximum of three capsules (300 mg).
To znači da je dnevni maksimum tri kapsule (300 mg).
Yargesa is a white hard capsule that consists of an opaque white cap and body with “708” printed in black on the body.
Yargesa je bijela tvrda kapsula s neprozirnom bijelom kapicom i tijelom na kojem je crnom bojom otisnuto „708“.
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.
U objedinjenoj 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.
The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years.
U kliničko ispitivanje bilo je uključeno 29 odraslih i mlađih bolesnika u 12-mjesečnom kontroliranom razdoblju, nakon čega je slijedilo produljeno liječenje u prosječnom ukupnom trajanju od 3,9 godina pa do 5,6 godina.
Sometimes your doctor will need to reduce the dose or stop Yargesa treatment to stop the tremor.
Ponekad će Vam liječnik reći da smanjite dozu ili potpuno prekinete liječenje lijekom Yargesa kako bi otklonio tremor.
Yargesa contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Yargesa sadrži djelatnu tvar miglustat koja pripada skupini lijekova koji djeluju na metabolizam.
This can result in liver and spleen enlargement, changes in the blood and bone disease.
To za posljedicu može imati povećanje jetre i slezene, promjene u krvi i bolest kostiju.
Niemann-Pick type C disease
Niemann-Pickova bolest tipa C
At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
U stanju dinamičke ravnoteže, koncentracija miglustata u cerebrospinalnom likvoru kod bolesnika s 6 Gaucherovom bolesti tipa 3 bila je 31,4-67,2% koncentracije u plazmi.
The efficacy of Yargesa in children and adolescents aged 0-17 years with type 1 Gaucher disease has not been established.
Djelotvornost lijeka Yargesa kod djece i adolescenata u dobi od 0 do 17 godina s Gaucherovom bolesti tipa 1 nije ustanovljena.
The survey included a case series of 66 patients treated with Yargesa outside of the clinical trial for a mean duration of 1.5 years.
Analiza je uključivala seriju slučajeva od 66 bolesnika liječenih Yargesa izvan kliničkog ispitivanja u prosječnom trajanju od 1,5 godine.
In addition, inhibitory action on a non-lysosomal glycosylceramidase has been demonstrated experimentally in vitro.
Osim toga, inhibitorno djelovanje na nelizosomalne glikozilceramidaze eksperimentalno se pokazalo in vitro.
No patient showed rapid deterioration of type 1 Gaucher disease following the switch to miglustat monotherapy.
Niti jedan bolesnik nije pokazao brzo pogoršanje Gaucherove bolesti tipa 1 nakon prelaska na monoterapiju miglustatom.
Capsule shell gelatin purified water titanium dioxide (E171)
Ovojnica kapsule želatina, pročišćena voda, titanijev dioksid (E171).
Twenty-eight patients with mild to moderate type 1 Gaucher disease were enrolled in this 12-month non-comparative study, and 22 patients completed the study.
Dvadeset i osam bolesnika s blagom do umjerenom Gaucherovom bolesti tipa 1 uključeno je u ovo 12-mjesečno nekomparativno ispitivanje, a 22 bolesnika završila su ispitivanje.
This medicine does not require any special storage conditions.
Lijek ne zahtijeva posebne uvjete čuvanja.
The usual treatment for type 1 Gaucher disease is enzyme replacement therapy.
Uobičajeno liječenje Gaucherove bolesti tipa 1 je enzimsko nadomjesno liječenje.