FrancophonIA/ELRC3.0 huggingface dataset:
English: The range of velaglucerase alfa clearance in paediatric patients (N=7, age range 4 to 17 years) was contained within the range of clearance values in adult patients (N=15, age range 19 to 62 years).
Croatian: Raspon klirensa velagluceraze alfa kod pedijatrijskih bolesnika (N=7, raspon dobi od 4 do 17 godina) bio je unutar raspona vrijednosti klirensa kod odraslih bolesnika (N=15, raspon dobi od 19 do 62 godine).
English: By month 57, 8 out of the 8 patients had achieved a reduction of at least 2 points in the lumbar spine Bone Marrow Burden (BMB) score as assessed by MRI scan.
Croatian: Do 57. mjeseca, 8 od 8 bolesnika postiglo je redukciju od najmanje 2 točke u rezultatu opterećenja koštane srži (BMB, engl.
English: Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38)
Croatian: Bolesnici koji su prešli s dugotrajnog liječenja imiglucerazom na velaglucerazu alfa (N=38)
English: This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Croatian: Ovaj lijek se smije primjenjivati samo pod odgovarajućim medicinskim nadzorom liječnika koji je educiran za liječenje Gaucherove bolesti.
English: It requires reconstitution and dilution and is intended for intravenous infusion only.
Croatian: Zahtijeva pripremu i razrjeđivanje i namijenjen je isključivo intravenskoj infuziji.
English: The most common adverse reactions were infusion-related reactions.
Croatian: Najčešće nuspojave bile su reakcije u vezi s infuzijom.
English: See section 4.4.
Croatian: Pogledajte dio 4.4.
English: A total of 95 patients (73 adult and 22 paediatric) who participated in studies 032, 034, and 039 enrolled in the open label extension study and were treated with velaglucerase alfa.
Croatian: Ukupno 95 bolesnika (73 odraslih i 22 pedijatrijska) koji su sudjelovali u ispitivanjima 032, 034 i 039 bili su uključeni u otvoreni produžetak ispitivanja i liječeni velaglucerazom alfa.
English: The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements:
Croatian: Priručnik za bolesnike s Gaucherovom bolešću koji primaju infuzije kod kuće mora sadržavati sljedeće ključne elemente:
English: For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting.
Croatian: Za bolesnike koji razviju anafilaksiju prilikom primjene kod kuće, treba razmotriti nastavak liječenja u kliničkom okruženju.
English: 63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase.
Croatian: Monomer ima oko 63 kDa, 497 aminokiselina, te isti slijed aminokiselina kao i glukocerebrozidaza, ljudski enzim koji se pojavljuje u prirodi.
English: Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20
Croatian: 6.1 Popis pomoćnih tvari saharoza natrijev citrat dihidrat (E331) citratna kiselina hidrat (E330) polisorbat 20
English: These reactions include; - headache - dizziness - fever/body temperature increased - decreased blood pressure or increased blood pressure - nausea and tiredness - chest discomfort - difficulty in breathing - itching
Croatian: Te reakcije uključuju: - glavobolju - omaglicu - vrućicu/povišenu tjelesnu temperaturu - sniženi krvni tlak ili povišeni krvni tlak - mučninu i umor - nelagodu u prsnom košu - otežano disanje - svrbež
English: Phase I/II study HGT-GCB-068 was conducted to explore the efficacy and safety of velaglucerase alfa ERT in treatment naïve children and adolescents with type 3 Gaucher disease.
Croatian: Ispitivanje faze I/II, HGT-GCB-068, provedeno je da bi se istražile djelotvornost i sigurnost primjene velagluceraze alfa kao enzimskog nadomjesnog liječenja djece i adolescenata s Gaucherovom bolešću tipa 3, koji prethodno nisu bili liječeni.
English: Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa.
Croatian: Protutijela mogu igrati ulogu u reakcijama u vezi s liječenjem koje su zabilježene u primjeni velagluceraze alfa.
English: Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to velaglucerase alfa).
Croatian: Ispitivanje 058 bilo je otvoreno kliničko ispitivanje sigurnosti na 211 bolesnika uključujući 205 bolesnika koji su ranije primali terapiju imiglucerazom, 6 bolesnika koji prethodno nisu bili liječeni i 57 bolesnika u dobi od 65 godina ili starijih (56/57 je prešlo s imigluceraze na velaglucerazu alfa).
English: If the dates of submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Croatian: Ako se rokovi podnošenja periodičkog izvješća o neškodljivosti (PSUR) podudaraju s nadopunama Plana (RMP), dokumenti mogu biti podneseni istodobno.
English: Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Croatian: Svaka će bočica sadržavati volumen od 4,0 ml (100 jedinica/ml) koji se može izvući.
English: Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme that catalyzes the hydrolysis of glucocerebroside to glucose and ceramide in the lysosome, reducing the amount of accumulated glucocerebroside and correcting the pathophysiology of Gaucher disease.
Croatian: Velagluceraza alfa nadomješta ili zamjenjuje beta-glukocerebrozidazu, enzim koji katalizira hidrolizu glukocerebrozida do glukoze i ceramida u lizosomu, smanjujući količinu nakupljenog glukocerebrozida i ispravljajući patofiziologiju Gaucherove bolesti.
English: There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni velagluceraze alfa u trudnica ograničeni.
English: Do not use if the solution is discoloured or if foreign particles are present.
Croatian: Nemojte koristiti ako otopina promijeni boju ili ako su prisutne vidljive čestice.
English: Treatment with velaglucerase alfa was administered as the same number of units and regimen as their imiglucerase dose.
Croatian: Liječenje velaglucerazom alfa bilo je primijenjeno u istom broju jedinica te režimu liječenja kao što je bila njihova doza imigluceraze.
English: Mean change from baseline (95% CI)
Croatian: Srednja promjena u odnosu na početnu vrijednost (95% CI)
English: Patients received doses ranging from 30 to 60 Units/kg (median dose 35 Units/kg) every other week for up to 84 months (7 years).
Croatian: Bolesnici su primili doze u rasponu od 30 do 60 jedinica/kg (medijan doze od 35 jedinica/kg) svaki drugi tjedan kroz najviše 84 mjeseca (7 godina).
English: Normal spleen is defined as 0.2% of body weight; normal liver as 2.5% of body weight Note: Imputation was applied to intermittent missing data.
Croatian: Normalna slezena definira se kao 0,2% tjelesne težine; normalna jetra kao 2,5% tjelesne težine
English: VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.
Croatian: VPRIV se može davati starijima (u dobi preko 65 godina) u istoj dozi i učestalosti kao kod odraslih.
English: - The active substance is velaglucerase alfa.
Croatian: - Djelatna tvar je velagluceraza alfa.
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: To se treba uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
Croatian: U ispitivanju 034, 25 od 40 bolesnika primilo je terapiju kod kuće barem jednom tijekom 12-mjesečnog ispitivanja.
English: Patients treated with imiglucerase for 9 months and then velaglucerase alfa for 15 months (N=16)
Croatian: Bolesnici liječeni imiglucerazom 9 mjeseci i zatim velaglucerazom alfa 15 mjeseci (N=16)
English: It is not known whether velaglucerase alfa is excreted in human milk.
Croatian: Nije poznato izlučuje li se velagluceraza alfa u majčino mlijeko.
English: If you are breast feeding or considering breast-feeding, you should talk to your doctor before this medicine is used.
Croatian: Ako dojite ili razmatrate mogućnost dojenja, morate razgovarati sa svojim liječenikom prije primjene ovog lijeka.
English: 20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.
Croatian: Bočica od 20 ml (staklo tipa I) s čepom (butilnom gumom prevučenom fluoro-rezinom), jednodijelnim zatvaračem i „flip-off“ poklopcem.
English: This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Croatian: Taj manjak enzima dovodi do nakupljanja glukocerebrozida prvenstveno u makrofagima, zbog čega nastaju pjenaste stanice ili „Gaucherove stanice“.
English: Very common side effects are: - bone pain - joint pain - back pain - weakness/loss of strength/tiredness
Croatian: Vrlo česte nuspojave su: - bol u kostima - bol u zglobovima - bol u leđima - slabost/gubitak snage/umor
English: Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises.
Croatian: Zahvaćanje kostiju dovodi do abnormalnosti skeleta te deformiteta kao i do kriza s bolovima u kostima.
English: Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Croatian: Reakcije povezane s infuzijom bile su najčešće opažene nuspojave kod bolesnika liječenih u kliničkim ispitivanjima.
English: Gaucher disease is an autosomal recessive disorder caused by mutations in the GBA gene which results in a deficiency of the lysosomal enzyme beta-glucocerebrosidase.
Croatian: Gaucherova bolest je autosomno recesivni poremećaj izazvan mutacijama u genu GBA koji dovodi do manjka lizosomalnog enzima beta-glukocerebrozidaze.
English: Nervous system disorders headache, dizziness
Croatian: Poremećaji živčanog sustava glavobolja, omaglica
English: - If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment - Most of the time you can still be given VPRIV even if you experience one of these reactions.
Croatian: - U slučajevima teških reakcija i/ili gubitka učinka ovog lijeka, liječnik će obaviti pretragu krvi kako bi provjerio protutijela koja mogu utjecati na ishod Vašeg liječenja.
English: The safety profile of VPRIV in clinical studies involving children and adolescents aged 4 to 17 years was similar to that observed in adult patients.
Croatian: Profil sigurnosti VPRIV-a u kliničkim ispitivanjima koja su obuhvaćala djecu i adolescente u dobi od 4 do 17 godina bio je sličan onom zabilježenom kod odraslih bolesnika.
English: See section 5.2.
Croatian: Pogledajte dio 5.2.
English: VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only.
Croatian: VPRIV zahtijeva rekonstituciju i razrjeđivanje i namijenjen je isključivo primjeni putem intravenske infuzije.
English: This increase in haemoglobin concentration was demonstrated to be clinically and statistically non-inferior to imiglucerase (mean treatment difference of change from baseline to 9 months [velaglucerase alfa - imiglucerase]: 0.135 g/dl).
Croatian: Taj se porast koncentracije hemoglobina pokazao klinički i statistički neinferioran u odnosu na imiglucerazu (srednja vrijednost razlike liječenja u promjeni od početne vrijednosti do 9 mjeseci [velagluceraza alfa - imigluceraza]: 0,135 g/dl).
English: Patients previously treated with imiglucerase received a median of 8 velaglucerase alfa infusions with median duration of treatment of 15.1 weeks.
Croatian: Bolesnici koji su prije bili liječeni imiglucerazom primili su medijan od 8 infuzija velagluceraze alfa s medijanom trajanja liječenja od 15,1 tjedana.
English: • Organisation: Home environment/Caregiver/Treating physician;
Croatian: • organizacijiske uvjete liječenja: kućno okruženje/njegovatelj/nadležni liječnik;
English: This medicinal product contains 12.15 mg sodium per vial.
Croatian: Ovaj lijek sadržava 12,15 mg natrija po bočici.
English: There were no statistically significant differences between velaglucerase alfa and imiglucerase in changes in platelet counts and liver and spleen volumes after 9 months of velaglucerase alfa treatment, and in the time to first haemoglobin response (defined as 1 g/dl increase from baseline).
Croatian: Nije bilo statistički značajnih razlika između velagluceraze alfa i imigluceraze u promjeni broja trombocita i volumena jetre i slezene nakon 9 mjeseci liječenja velaglucerazom alfa te u vremenu do prvog odgovora hemoglobina (definiranog kao porast od 1 g/dl u odnosu na početnu vrijednost).
English: In the paediatric population (ages 4 to 17 years studied), increases in the mean height Z-score were seen through 60 months of treatment in the overall treatment-naïve population, suggesting a beneficial treatment effect with velaglucerase alfa on linear growth.
Croatian: U pedijatrijskoj populaciji (ispitana je dob od 4 do 17 godina), porast u srednjem Z-rezultatu visine primijećen je tijekom 60 mjeseci liječenja u ukupnoj populaciji koja nije prethodno liječena, što ukazuje na koristan učinak liječenja velaglucerazom alfa na linearni rast.
English: If you are currently being treated for Gaucher disease with another ERT and your doctor wants to change you to VPRIV, you can initially receive VPRIV at the same dose and frequency you had been receiving the other ERT.
Croatian: Ako trenutno liječite Gaucherovu bolest pomoću druge enzimske nadomjesne terapije, a Vaš je liječnik želi zamijeniti VPRIV-om, možete u početku primati VPRIV u istoj dozi i učestalosti u kojima ste primali drugu enzimsku nadomjesnu terapiju.
English: Patients were required to have Gaucher disease-related anaemia and either thrombocytopenia or organomegaly.
Croatian: Zahtijevalo se da bolesnici imaju anemiju povezanu s Gaucherovom bolešću te trombocitopeniju ili organomegaliju.
English: The most commonly observed symptoms of infusion-related reactions were: headache, dizziness, hypotension, hypertension, nausea, fatigue/asthenia, and pyrexia/body temperature increased (see section 4.4 for further information).
Croatian: Najčešće zabilježeni simptomi reakcija u vezi s infuzijom bili su: glavobolja, omaglica, hipotenzija, hipertenzija, mučnina, umor/astenija te vrućica/povišena tjelesna temperatura (dodatne informacije potražite u dijelu 4.4).
English: After a minimum of 12 months of continuous treatment with velaglucerase alfa, all patients qualified to have the dose of velaglucerase alfa reduced in a step-wise fashion from 60 to 30 Units/kg after achieving at least 2 of the 4 “Year 1” therapeutic goals of ERT for type 1 Gaucher disease.
Croatian: Nakon najmanje 12 mjeseci kontinuiranog liječenja velaglucerazom alfa, svi su se bolesnici kvalificirali za postupno smanjenje doze velagluceraze alfa sa 60 na 30 jedinica/kg nakon postizanja najmanje 2 od 4 terapijska cilja enzimskog nadomjesnog liječenja za Gaucherovu bolest tipa 1 za „prvu godinu“.
English: The number of vials to be reconstituted is determined based on the individual patient's weight and the prescribed dose.
Croatian: Broj bočica za pripremu određuje se na temelju tjelesne težine pojedinog bolesnika te propisane doze.
English: Contains sodium, see leaflet for further information.
Croatian: Sadržava natrij; vidjeti uputu o lijeku za dodatne informacije.
English: - If you experience any of the symptoms, you must tell your doctor immediately.
Croatian: - Ako osjetite neki od tih simptoma, morate odmah obavijestiti svog liječnika.
English: If anaphylactic or other acute reactions occur, in the clinic or home setting, immediately discontinue the infusion and initiate appropriate medical treatment.
Croatian: Ako anafilaktička ili druga akutna reakcija nastupi u kliničkom okruženju ili tijekom primjene kod kuće, infuzija se mora odmah prekinuti i uvesti odgovarajuće medicinsko liječenje.
English: Normalized Liver Volume* (%BW) Normalized Spleen Volume* (%BW) Excludes patients with splenectomy.
Croatian: Normalizirani volumen jetre* (%TT) Normalizirani volumen slezene* (%TT)
English: This was a multicentre, open-label study in which 60 U/kg of velaglucerase alfa was administered by intravenous infusion every other week (EOW) over 12 months in 6 patients (2 to 17 years of age at enrolment) with a confirmed diagnosis of type 3 Gaucher disease.
Croatian: To je bilo multicentrično, otvoreno ispitivanje u kojem se 60 jedinica/kg velagluceraze alfa primjenjivalo intravenskom infuzijom svaki drugi tjedan tijekom 12 mjeseci u 6 bolesnika (u dobi od 2 do 17 godina u vrijeme uključenja) s potvrđenom dijagnozom Gaucherove bolesti tipa
English: Similar treatment effects were seen through 48 months in the paediatric population who received 9 months of imiglucerase followed by velaglucerase alfa.
Croatian: Slični učinci liječenja primijećeni su tijekom 48 mjeseci u pedijatrijskoj populaciji koja je dobivala imiglucerazu tijekom 9 mjeseci, a nakon toga velaglucerazu alfa.
English: Haemoglobin concentration and platelet counts were evaluated as changes from baseline, which was defined as the end of the patient's treatment with imiglucerase.
Croatian: Koncentracija hemoglobina i broj trombocita procijenjeni su kao promjene u odnosu na početnu vrijednost, koja je bila definirana kao kraj bolesnikova liječenja imiglucerazom.
English: What VPRIV contains
Croatian: Što VPRIV sadrži
English: Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency.
Croatian: Bolesnici koji trenutno primaju enzimsku nadomjesnu terapiju za Gaucherovu bolest tipa 1 u obliku imigluceraze, mogu se prebaciti na terapiju sa VPRIV-om, u istoj dozi i s istom učestalošću.
English: Infusion-related-reactions
Croatian: Reakcije povezane s infuzijom
English: No patients developed IgE antibodies to velaglucerase alfa.
Croatian: Ni jedan bolesnik nije razvio IgE protutijela na velaglucerazu alfa.
English: Velaglucerase alfa was initially administered in a dose-escalating fashion in the first 3 patients (15, 30, 60 Units/kg) and the 9 remaining patients began treatment with 60 Units/kg.
Croatian: Velagluceraza alfa je u početku primjenjivan postupnim povećanjem doze kod prva 3 bolesnika (15, 30, 60 jedinica/kg) te sa 60 jedinica/kg kod preostalih 9 bolesnika.
English: The recommended dose is 60 Units/kg given every other week.
Croatian: Preporučena doza je 60 jedinica/kg koja se daje svaki drugi tjedan.
English: VPRIV has no or negligible influence on your ability to drive or use machines.
Croatian: VPRIV ne utječe ili zanemarivo utječe na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: 9/l), liver volume was reduced from 1.46 to 1.22 times normal (mean reduction of 17%) and spleen volume was reduced from 14.0 to 5.75 times normal (mean reduction of 50%).
Croatian: 9/l), volumen jetre bio je smanjen s 1,46 na 1,22 puta normalnu vrijednost (srednja vrijednost smanjenja od 17%), a volumen slezene bio je smanjen s 14,0 na 5,75 puta normalnu vrijednost (srednja vrijednost smanjenja od 50%).
English: Common side effects are: - stomach ache/feeling sick (nausea) - easy bleeding / easy bruising - skin flushing - rapid heart beat - rash/hives - developing antibodies to VPRIV (see section 2)
Croatian: Česte nuspojave su: - bol u trbuhu/mučnina - lako krvarenje/lako zadobivanje modrica - crvenilo kože uz osjećaj užarenosti - brzi otkucaji srca - osip/koprivnjača - razvijanje protutijela na VPRIV (vidjeti dio 2)
English: In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs.
Croatian: U ovom lizosomalnom poremećaju nakupljanja, kliničke značajke odraz su distribucije Gaucherovih stanica u jetri, slezeni, koštanoj srži, kostima i plućima.
English: Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience.
Croatian: Reakcije preosjetljivosti, uključujući simptome koji odgovaraju anafilaksiji, zabilježene su kod bolesnika u kliničkim ispitivanjima i nakon stavljanja lijeka u promet.
English: Among 31 treatment-naïve adult patients treated with velaglucerase alfa, the mean lumbar spine BMD Z-score at baseline was -1.820 (95% CI: -2.21, -1.43) and increased by 0.62 (95% CI: 0.39, 0.84) from baseline following 24 months of treatment with velaglucerase alfa.
Croatian: Od 31 odraslih bolesnika liječenih velaglucerazom alfa koji nisu bili prethodno liječeni, srednji Z-rezultat BMD-a lumbalne kralježnice na početku ispitivanja bio je -1,820 (95% CI: -2,21,1,43) i povećao se za 0,62 (95% CI: 0,39, 0,84) u odnosu na početnu vrijednost nakon 24 mjeseca liječenja velaglucerazom alfa.
English: See section 5.1.
Croatian: Pogledajte dio 5.1.
English: Vials should not be shaken.
Croatian: . Bočice se ne smiju tresti.
English: The product should be mixed gently.
Croatian: Lijek je potrebno promiješati pažljivo.
English: VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease.
Croatian: Liječenje VPRIV-om treba nadgledati liječnik s iskustvom u liječenju bolesnika s Gaucherovom bolešću.
English: Sustained clinical activity continued to be demonstrated during treatment as observed by improvements in haemoglobin concentrations and platelet counts and reduced liver and spleen volumes.
Croatian: Održana klinička aktivnost nastavila se pokazivati tijekom liječenja, a primijećena je na temelju poboljšanja koncentracije hemoglobina i broja trombocita te smanjenja volumena jetre i slezene.
English: Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 1.
Croatian: Nuspojave zabilježene kod bolesnika s Gaucherovom bolešću tipa 1 navedene su u tablici 1.
English: In patients who switched from long-term imiglucerase to velaglucerase alfa, lumbar spine BMD was maintained at 24 months.
Croatian: Kod bolesnika koji su prešli s dugotrajnog liječenja imiglucerazom na velaglucerazu alfa, održan je BMD lumbalne kralježnice nakon 24 mjeseca.
English: Upon reconstitution, vials should be mixed gently.
Croatian: Nakon rekonstitucije, bočice je potrebno promiješati pažljivo
English: Use in elderly
Croatian: Primjena u starijih
English: The mean haemoglobin concentration and platelet count of patients previously treated with imiglucerase were maintained throughout the study and remained within the reference intervals.
Croatian: Srednja koncentracija hemoglobina i broj trombocita u bolesnika koji su prethodno bili liječeni imiglucerazom održavali su se tijekom cijelog ispitivanja i ostali su u referentnim intervalima.
English: No infusion-related reactions were reported for this patient.
Croatian: Kod ovog bolesnika nisu utvrđene reakcije u vezi s infuzijom.
English: 9/l), liver volume was reduced from 1.40 to 1.24 times normal (mean reduction of 6%) and spleen volume was reduced from 14.5 to 9.50 times normal (mean reduction of 40%).
Croatian: 9/l), volumen jetre bio je smanjen s 1,40 na 1,24 puta normalnu vrijednost (srednja vrijednost smanjenja od 6%), a volumen slezene bio je smanjen s 14,5 na 9,50 puta normalnu vrijednost (srednja vrijednost smanjenja od 40%).
English: If you experience any side effect like these, please tell your doctor immediately.
Croatian: Ako osjetite bilo koju nuspojavu poput ovih, molimo da odmah obavijestite svog liječnika.
English: After seven years of treatment, the mean increase from baseline in Z-scores were 0.7 (95% CI 0.4, 1.0) for the lumbar spine and 0.5 (95% CI 0.2, 0.7) for the femoral neck.
Croatian: Nakon sedam godina liječenja srednje povećanje Z-rezultata u odnosu na početnu vrijednost iznosilo je 0,7 (95% CI 0,4; 1,0) za lumbalnu kralježnicu i 0,5 (95% CI 0,2; 0,7) za vrat femura.
English: Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase.
Croatian: Gaucherova bolest genetski je poremećaj izazvan nedostatkom ili oštećenjem enzima nazvanog glukocerebrozidaza.