FrancophonIA/ELRC3.0 huggingface dataset:
English: The total volume of infusion should be delivered over a period of 60 minutes.
Slovenian: Celoten volumen zdravila je treba infundirati 60 minut.
English: When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body.
Slovenian: Če ta encim manjka, ali če ne deluje pravilno, se snov, imenovana glukocerebrozid, kopiči v telesnih celicah.
English: All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Slovenian: Vsi bolniki so najmanj 2 leti prejemali nadomestno encimsko zdravljenje, spremljali pa so jih povprečno 4,5 leta (najmanj 2,3 leta in največ 5,8 leta).
English: VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
Slovenian: Zdravila VPRIV ne infundirajte z drugimi zdravili v isti liniji za infundiranje, saj združljivosti v raztopini z drugimi zdravili niso ocenili.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.ema.europa.eu.
English: In this study, BMD was assessed using dual x-ray absorptiometry of the lumbar spine and femoral neck.
Slovenian: V tej študiji so BMD ocenili z uporabo dvoenergijske rentgenske absorpciometrije ledvene hrbtenice in stegneničnega vratu.
English: • Organisation: Home environment/Caregiver/Treating physician;
Slovenian: • organizacija: domače okolje/skrbnik/lečeči zdravnik;
English: The Guide for Healthcare Professionals Treating Patients with Gaucher Disease should contain the following key elements:
Slovenian: Vodnik za zdravstvene delavce, ki zdravijo bolnike z Gaucherjevo boleznijo, mora vsebovati naslednje ključne elemente:
English: The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Slovenian: Kopičenje glukocerebrozidaze v jetrih in vranici povzroča organomegalijo.
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.
Slovenian: Skupno 95 bolnikov (73 odraslih in 22 otrok), ki so sodelovali v študijah 032, 034 in 039, se je vključilo v odprto podaljšanje in dobivalo velaglucerazo alfa.
English: Velaglucerase alfa is a glycoprotein.
Slovenian: Velagluceraza alfa je glikoprotein.
English: In this small, exploratory study, the non-neurological efficacy findings and the safety profile of intravenous velaglucerase alfa in type 3 Gaucher patients were consistent with those observed in patients with type 1 Gaucher disease.
Slovenian: V tej majhni eksploratorni študiji so se ugotovitve glede ne-nevrološke učinkovitosti in varnostni profil intravenske velagluceraze alfa pri bolnikih z Gaucherjevo boleznijo tipa 3 ujemale s tistimi, ki so jih ugotovili pri bolnikih z Gaucherjevo boleznijo tipa 1.
English: VPRIV has no or negligible influence on the ability to drive or use machines.
Slovenian: Zdravilo VPRIV nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
Slovenian: K zdravljenju moramo pristopiti previdno pri bolnikih, ki so kazali simptome preobčutljivosti na velaglucerazo alfa ali na drugo encimsko nadomestno zdravljenje.
English: The active substance of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human cell line.
Slovenian: Učinkovina v zdravilu VPRIV je velagluceraza alfa, ki se izdeluje s tehnologijo aktivacije genov v humani celični liniji.
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).
Slovenian: Razpon očistka velagluceraze alfa pri pediatričnih bolnikih (N = 7, razpon starosti od 4 do 17 let) je bil znotraj razpona vrednosti očistkov pri odraslih bolnikih (N = 15, razpon starosti od 19 do 62 let).
English: 20 ml glass vial containing a white to off-white powder.
Slovenian: 20-mililitrska steklena viala, ki vsebuje bel do skoraj bel prašek.
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.
Slovenian: - Če so reakcije resne in/ali pride do izgube učinka tega zdravila, bo zdravnik opravil krvno preiskavo, s katero bo preveril protitelesa, ki lahko vplivajo na izid vašega zdravljenja.
English: Doses higher than 60 Units/kg have not been studied.
Slovenian: Študij z odmerki, večjimi od 60 enot/kg, niso izvedli.
English: - The active substance is velaglucerase alfa.
Slovenian: - Učinkovina je velagluceraza alfa.
English: These treatment effects on haemoglobin, platelet count, organ volumes, bone mineral density and height were maintained through the end of the study.
Slovenian: Ti učinki zdravljenja na hemoglobin, število trombocitov, prostornino organov, mineralno gostoto kosti in višino so se ohranili do konca študije.
English: There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Slovenian: Podatkov o uporabi velagluceraze alfa pri nosečnicah ni oziroma so omejeni.
English: Do not use if the solution is discoloured or if foreign particles are present.
Slovenian: Ne uporabljajte, če je raztopina obarvana ali če so prisotni vidni tujki.
English: • Guide for Healthcare Professionals Treating Patients with Gaucher Disease;
Slovenian: • vodnik za zdravstvene delavce, ki zdravijo bolnike z Gaucherjevo boleznijo;
English: Patients were required to have Gaucher disease-related anaemia and either thrombocytopenia or organomegaly.
Slovenian: Bolniki so morali imeti anemijo, povezano z Gaucherjevo boleznijo, in bodisi trombocitopenijo ali organomegalijo.
English: In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
Slovenian: V študiji 025EXT je 7 od 10 bolnikov prejelo zdravljenje na domu vsaj enkrat v 60 mesecih zdravljenja.
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.
Slovenian: Do 57. meseca je 8 od 8 bolnikov doseglo zmanjšanje rezultata obremenitve kostnega mozga (BMB) v ledvenem delu hrbtenice, ocenjenega z magnetnim resonančnim slikanjem, za vsaj 2 točki.
English: No infusion-related reactions were reported for this patient.
Slovenian: Pri tem bolniku niso poročali o nobenih reakcijah, povezanih z infundiranjem.
English: This medicinal product contains 12.15 mg sodium per vial.
Slovenian: To zdravilo vsebuje 12,15 mg natrija na vialo.
English: The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnih gradiv za uporabo zdravila VPRIV pri infundiranju na domu, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z malo natrija.
English: The educational materials for the use of VPRIV in home infusion are aimed at providing guidance on how to manage risk of infusion-related reactions including allergic-type hypersensitivity reactions in a home setting.
Slovenian: Izobraževalna gradiva za uporabo zdravila VPRIV pri infundiranju na domu so zagotavljanju smernic za obvladovanje tveganja z infuzijo povezanih reakcij, vključno s preobčutljivostnimi reakcijami alergijskega tipa, v domačem okolju.
English: Ask your pharmacist how to throwaway medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: In studies with VPRIV additional side effects have also been reported:
Slovenian: V študijah z zdravilom VPRIV so poročali tudi o dodatnih neželenih učinkih:
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.
Slovenian: Bolniki, ki trenutno prejemajo nadomestno encimsko zdravljenje z imiglucerazo za Gaucherjevo bolezen tipa 1, lahko preidejo na zdravilo VPRIV, pri čemer se uporabita enak odmerek in pogostnost uporabe.
English: Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Slovenian: Pri bolnicah z Gaucherjevo boleznijo, ki zanosijo, se lahko pojavi obdobje povečane aktivnosti bolezni med nosečnostjo in pri otročnici.
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.
Slovenian: Pri tej lizosomski motnji shranjevanja (LSD) klinične značilnosti izražajo porazdelitev Gaucherjevih celic v jetrih, vranici, kostnem mozgu, okostju in pljučih.
English: - The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
Slovenian: - Pomožne snovi so saharoza, natrijev citrat dihidrat, monohidrat citronske kisline in polisorbat 20 (glejte poglavje 2 »Zdravilo VPRIV vsebuje natrij«).
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.
Slovenian: Študijo faze I/II HGT-GCB-068 so opravili, da bi raziskali učinkovitost in varnost nadomestnega encimskega zdravljenja z velaglucerazo alfa za zdravljenje še nezdravljenih otrok in mladostnikov z Gaucherjevo boleznijo tipa 3.
English: The number of vials to be reconstituted is determined based on the individual patient's weight and the prescribed dose.
Slovenian: Število vial, ki jih je treba rekonstituirati, določite glede na bolnikovo telesno maso in predpisani odmerek.
English: The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements:
Slovenian: Vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu, mora vsebovati naslednje ključne elemente:
English: There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Slovenian: Med bolnicami in bolniki z Gaucherjevo boleznijo tipa 1 ni bilo nobenih očitnih farmakokinetičnih razlik.
English: The majority of these side effects were mild in intensity.
Slovenian: Večina teh neželenih učinkov je bilo blagih.
English: Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
Slovenian: Vaš zdravnik bo nadzoroval odziv na zdravljenje in lahko sčasoma zviša ali zniža odmerek.
English: In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
Slovenian: Pri bolnikih, ki še niso prejemali nadomestnega encimskega zdravljenja, se je večina reakcij, povezanih z infundiranjem, pojavila v prvih 6 mesecih zdravljenja.
English: This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Slovenian: Pomanjkanje encima povzroča akumulacijo glukocerebrozida predvsem v makrofagih, kar povzroči nastanek penastih celic ali »Gaucherjevih celic«.
English: Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Slovenian: Volumen, ki ga lahko odvzamete iz ene viale je 4,0 ml (100 enot/ml).
English: The most common adverse reactions were infusion-related reactions.
Slovenian: Najpogostejši neželeni učinki so bile reakcije, povezane z infundiranjem.
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).
Slovenian: Študija 058 je bila odprta klinična študija varnosti pri 211 bolnikih, vključno z 205 bolniki, ki so se predhodno zdravili z imiglucerazo, 6 bolniki, ki še niso prejemali nobenega zdravljenja, in 57 bolniki, starimi 65 let ali več (56/57 jih je z imiguceraze prešlo na velaglucerazo alfa).
English: • Manual for patients with Gaucher Disease who receive home infusion;
Slovenian: • vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu;
English: Each 400 Units vial of this medicine contains 12.15 mg sodium.
Slovenian: Ena viala s 400 enotami tega zdravila vsebuje 12,15 mg natrija.
English: In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
Slovenian: V študiji 034 je 25 od 40 bolnikov prejelo zdravljenje na domu vsaj enkrat v 12 mesecih zdravljenja.
English: • Annex: Package Leaflet, Infusion diary, Patient Reconstitution Guide, Emergency plan.
Slovenian: • priloge: navodilo za uporabo, dnevnik infuzij, vodnik za bolnike glede rekonstitucije, načrt za nujne primere.
English: 63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase.
Slovenian: Monomer ima molekulsko maso približno 63 kDa, 497 aminokislin in isto zaporedje aminokislin kot glukocerebrozidaza, naravni encim pri človeku.
English: Adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics.
Slovenian: Neželeni učinki zdravila, ki izvirajo iz poročil po prihodu zdravila na trg, ki niso intervencijska klinična preskušanja, so natisnjena v poševnem zapisu.
English: Patients previously treated with imiglucerase received a median of 8 velaglucerase alfa infusions with median duration of treatment of 15.1 weeks.
Slovenian: Bolniki, ki so se predhodno zdravili z imiglucerazo, so prejeli mediano število 8 infundiranj velagluceraze alfa z mediano trajanja zdravljenja 15,1 tedna.
English: For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting.
Slovenian: Za bolnike, pri katerih se razvije anafilaksija v domačem okolju, pride v poštev nadaljevanje zdravljenja v kliničnem okolju.
English: VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults.
Slovenian: Zdravilo VPRIV se lahko starejšim bolnikom (starim več kot 65 let) daje v enakem odmerku in z enako pogostnostjo kot pri odraslih.
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.
Slovenian: Velagluceraza alfa dopolnjuje ali zamenja beta-glukocerebrozidazo, encim, ki katalizira hidrolizo glukocerebrozida v glukozo in ceramid v lizosomu, kar zmanjša količine nakopičenega glukocerebrozida ter popravi patofiziologijo Gaucherjeve bolezni.
English: Must be administered through a 0.22 µm filter.
Slovenian: Infundirati je treba skozi 0,22-mikrometrski filter.
English: Talk to your doctor before VPRIV is used - If you are treated with VPRIV, you may experience side effects during or following the infusion (see section 4, possible side effects).
Slovenian: Pred uporabo zdravila VPRIV se posvetujte s svojim zdravnikom - Če se zdravite z zdravilom VPRIV, boste morda med infundiranjem ali po njem imeli neželene učinke (glejte poglavje 4, možni neželeni učinki).
English: VPRIV may be given to children and adolescents (2 to 17 years of age) at the same dose and frequency as in adults.
Slovenian: Zdravilo VPRIV se lahko uporablja pri otrocih in mladostnikih, starih od 2 do 17 let, v enakih odmerkih in z enako pogostnostjo kot pri odraslih.
English: There is no experience with overdose of velaglucerase alfa.
Slovenian: Izkušenj s prevelikim odmerjanjem velagluceraze alfa ni.
English: The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients.
Slovenian: Varnostni profil zdravila VPRIV v kliničnih študijah, ki so vključevale bolnike, stare 65 let in več, je bil podoben kot pri drugih odraslih bolnikih.
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.
Slovenian: Gaucherjeva bolezen je avtosomska recesivna bolezen, ki jo povzroča mutacija gena GBA, ki ima za posledico pomanjkanje lizosomskega encima beta-glukocerebrozidaze.
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).
Slovenian: Najpogosteje opaženi simptomi reakcij, povezanih z infundiranjem, so bili glavobol, omotica, hipotenzija, hipertenzija, navzeja, utrujenost/astenija in pireksija/zvišana telesna temperatura (za dodatne informacije glejte poglavje 4.4).
English: Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study.
Slovenian: Pri samo 1 od 163 bolnikov, pri katerih so opravili oceno med študijo, so se razvila protitelesa proti velaglucerazi alfa.
English: Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Huda alergijska reakcija na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
English: After preparation, your doctor or nurse will give the medicine to you through a drip into a vein (by intravenous infusion) over a period of 60 minutes.
Slovenian: Po pripravi se zdravilo daje s kapalno infuzijo v veno (z intravensko infuzijo), ki traja 60 minut.
English: Skin and subcutaneous tissue disorders rash, urticaria, pruritus
Slovenian: Bolezni kože in podkožja izpuščaj, urtikarija, pruritus
English: To be administered as a 60-minute intravenous infusion.
Slovenian: Zdravilo je treba odmerjati v obliki 60-minutne intravenske infuzije.
English: 20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap.
Slovenian: 20-mililitrska steklena viala (steklo vrste I) z zamaškom (butilna guma, obložena s fluorovo smolo), enodelnim tesnilom in zaporko »flip-off«.
English: Haemoglobin concentration (g/dL) Platelet count (x 10
Slovenian: Koncentracija hemoglobina (g/dl) Število trombocitov (x 10
English: Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38)
Slovenian: Bolniki, ki so prešli z dolgotrajnega zdravljenja z imiglucerazo na velaglucerazo alfa (n = 38)
English: It should not be shaken.
Slovenian: Ne smete ga pretresati.
English: Ten patients who completed Study 025 enrolled in an open-label extension study (025EXT), 8 of whom completed the study.
Slovenian: Deset bolnikov, ki je zaključilo študijo 025, je sodelovalo v podaljšani odprti študiji (025EXT).
English: Study in patients switching from imiglucerase treatment to VPRIV Study 034 was a 12-month, open-label safety study in 40 patients aged 2 years and older who had been receiving treatment with imiglucerase at doses ranging from 15 to 60 Units/kg for a minimum of 30 consecutive months.
Slovenian: Študije pri bolnikih, ki so prešli z zdravljenja z imiglucerazo na zdravilo VPRIV Študija 034 je bila 12-mesečna odprta študija varnosti pri 40 bolnikih, starih 2 leti in več, ki so prejemali imiglucerazo v odmerkih od 15 do 60 enot/kg najmanj 30 mesecev zapored.
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.
Slovenian: To je bila multicentrična odprta študija, v kateri so 12 mesecev dajali 60 enot/kg velagluceraze alfa z intravensko infuzijo vsak drugi teden 6 bolnikom (ki so bili ob vključitvi v študijo stari 2 do 17 let) s potrjeno diagnozo Gaucherjeve bolezni tipa 3.
English: What you need to know before VPRIV is used
Slovenian: Kaj morate vedeti preden boste uporabili zdravilo VPRIV
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.
Slovenian: Koncentracijo hemoglobina in število trombocitov so ocenili kot spremembo glede na izhodiščno vrednost, ki je bila opredeljena kot vrednost ob koncu bolnikovega zdravljenja z imiglucerazo.
English: Frequency is defined as very common (1/10), common (1/100 to <1/10), and uncommon (≥1/1,000 to <1/100).
Slovenian: Podatki so razvrščeni po organskih sistemih in pogostnosti, skladno s konvencijo MedDRA. Neželeni učinki so po pogostnosti opredeljeni kot zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10) in občasni ( 1/1.000 do < 1/100).
English: Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia.
Slovenian: Nalaganje v kostnem mozgu in sekvestracija vranice povzročata klinično pomembno anemijo in trombocitopenijo.
English: Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 1.
Slovenian: Neželeni učinki, o katerih so poročali pri bolnikih z Gaucherjevo boleznijo tipa 1, so navedene v preglednici 1.
English: Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises.
Slovenian: Zaradi vpletenosti kosti se pojavijo abnormalnosti in deformacije skeleta ter kriz zaradi bolečin v kosteh.
English: Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20
Slovenian: 6.1 Seznam pomožnih snovi saharoza natrijev citrat dihidrat (E 331) monohidrat citronske kisline (E 330) polisorbat 20
English: After the end of the infusion, velaglucerase alfa serum concentrations fell rapidly in a monophasic or biphasic fashion with a mean t1/2 ranging from 5 to 12 minutes at doses of 15, 30, 45, and 60 Units/kg.
Slovenian: Po koncu infundiranja so se koncentracije velagluceraze alfa v serumu hitro znižale na monofazični ali bifazični način, pri odmerkih 15, 30, 45 in 60 enot/kg pa je bila srednja vrednost t1/2 od 5 do 12 minut.
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
Slovenian: Te reakcije vključujejo: - glavobol, - omotico, - povišano telesno temperaturo, - znižan ali povišan krvni tlak, - slabost in utrujenost, - neugodje v prsih, - oteženo dihanje, - srbenje.
English: If anaphylactic or other acute reactions occur, in the clinic or home setting, immediately discontinue the infusion and initiate appropriate medical treatment.
Slovenian: Če se bodisi v kliničnem okolju bodisi doma pojavijo anafilaktična ali druge akutne reakcije, nemudoma prekinite infuzijo in začnite z ustreznim medicinskim zdravljenjem.
English: This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease.
Slovenian: To zdravilo se lahko uporablja samo pod nadzorom zdravnika z izkušnjami pri zdravljenju Gaucherjeve bolezni.
English: Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week.
Slovenian: V kliničnih študijah so ocenili odmerke od 15 do 60 enot/kg vsak drugi teden.