natgillin/translations-raw huggingface dataset:
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. 
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.
This should be taken into consideration by patients on a controlled sodium diet. 
To je treba upoštevati pri bolnikih na dieti z malo natrija.
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. 
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.
Ask your pharmacist how to throwaway medicines you no longer use. 
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
In studies with VPRIV additional side effects have also been reported: 
V študijah z zdravilom VPRIV so poročali tudi o dodatnih neželenih učinkih:
Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency. 
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.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium. 
Pri bolnicah z Gaucherjevo boleznijo, ki zanosijo, se lahko pojavi obdobje povečane aktivnosti bolezni med nosečnostjo in pri otročnici.
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. 
Pri tej lizosomski motnji shranjevanja (LSD) klinične značilnosti izražajo porazdelitev Gaucherjevih celic v jetrih, vranici, kostnem mozgu, okostju in pljučih.
- The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”). 
- Pomožne snovi so saharoza, natrijev citrat dihidrat, monohidrat citronske kisline in polisorbat 20 (glejte poglavje 2 »Zdravilo VPRIV vsebuje natrij«).
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. 
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.
The number of vials to be reconstituted is determined based on the individual patient's weight and the prescribed dose. 
Število vial, ki jih je treba rekonstituirati, določite glede na bolnikovo telesno maso in predpisani odmerek.
The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements: 
Vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu, mora vsebovati naslednje ključne elemente:
There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease. 
Med bolnicami in bolniki z Gaucherjevo boleznijo tipa 1 ni bilo nobenih očitnih farmakokinetičnih razlik.
The majority of these side effects were mild in intensity. 
Večina teh neželenih učinkov je bilo blagih.
Your doctor will monitor your response to treatment and may change your dose (up or down) over time. 
Vaš zdravnik bo nadzoroval odziv na zdravljenje in lahko sčasoma zviša ali zniža odmerek.
In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment. 
Pri bolnikih, ki še niso prejemali nadomestnega encimskega zdravljenja, se je večina reakcij, povezanih z infundiranjem, pojavila v prvih 6 mesecih zdravljenja.
This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells". 
Pomanjkanje encima povzroča akumulacijo glukocerebrozida predvsem v makrofagih, kar povzroči nastanek penastih celic ali »Gaucherjevih celic«.
Each vial will contain an extractable volume of 4.0 ml (100 Units/ml). 
Volumen, ki ga lahko odvzamete iz ene viale je 4,0 ml (100 enot/ml).
The most common adverse reactions were infusion-related reactions. 
Najpogostejši neželeni učinki so bile reakcije, povezane z infundiranjem.
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). 
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).
• Manual for patients with Gaucher Disease who receive home infusion; 
• vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu;
Each 400 Units vial of this medicine contains 12.15 mg sodium. 
Ena viala s 400 enotami tega zdravila vsebuje 12,15 mg natrija.
In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study. 
V študiji 034 je 25 od 40 bolnikov prejelo zdravljenje na domu vsaj enkrat v 12 mesecih zdravljenja.
• Annex: Package Leaflet, Infusion diary, Patient Reconstitution Guide, Emergency plan. 
• priloge: navodilo za uporabo, dnevnik infuzij, vodnik za bolnike glede rekonstitucije, načrt za nujne primere.
63 kDa, has 497 amino acids, and the same amino acid sequence as the naturally occurring human enzyme, glucocerebrosidase. 
Monomer ima molekulsko maso približno 63 kDa, 497 aminokislin in isto zaporedje aminokislin kot glukocerebrozidaza, naravni encim pri človeku.
Adverse drug reactions derived from post-marketing reports other than interventional clinical trials are printed in italics. 
Neželeni učinki zdravila, ki izvirajo iz poročil po prihodu zdravila na trg, ki niso intervencijska klinična preskušanja, so natisnjena v poševnem zapisu.
Patients previously treated with imiglucerase received a median of 8 velaglucerase alfa infusions with median duration of treatment of 15.1 weeks. 
Bolniki, ki so se predhodno zdravili z imiglucerazo, so prejeli mediano število 8 infundiranj velagluceraze alfa z mediano trajanja zdravljenja 15,1 tedna.
For patients developing anaphylaxis in a home setting it should be considered to continue treatment in a clinical setting. 
Za bolnike, pri katerih se razvije anafilaksija v domačem okolju, pride v poštev nadaljevanje zdravljenja v kliničnem okolju.
VPRIV may be given to the elderly (aged over 65 years) at the same dose and frequency as in adults. 
Zdravilo VPRIV se lahko starejšim bolnikom (starim več kot 65 let) daje v enakem odmerku in z enako pogostnostjo kot pri odraslih.
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. 
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.
Must be administered through a 0.22 µm filter. 
Infundirati je treba skozi 0,22-mikrometrski filter.
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). 
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).
VPRIV may be given to children and adolescents (2 to 17 years of age) at the same dose and frequency as in adults. 
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.
There is no experience with overdose of velaglucerase alfa. 
Izkušenj s prevelikim odmerjanjem velagluceraze alfa ni.
The safety profile of VPRIV in clinical studies involving patients aged 65 years and above was similar to that observed in other adult patients. 
Varnostni profil zdravila VPRIV v kliničnih študijah, ki so vključevale bolnike, stare 65 let in več, je bil podoben kot pri drugih odraslih bolnikih.
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. 
Gaucherjeva bolezen je avtosomska recesivna bolezen, ki jo povzroča mutacija gena GBA, ki ima za posledico pomanjkanje lizosomskega encima beta-glukocerebrozidaze.
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). 
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).
Only 1 out of 163 patients assessed developed anti-velaglucerase alfa antibodies during the study. 
Pri samo 1 od 163 bolnikov, pri katerih so opravili oceno med študijo, so se razvila protitelesa proti velaglucerazi alfa.
Severe allergic reaction to the active substance or to any of the excipients listed in section 6.1. 
Huda alergijska reakcija na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1. 4.4 Posebna opozorila in previdnostni ukrepi
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. 
Po pripravi se zdravilo daje s kapalno infuzijo v veno (z intravensko infuzijo), ki traja 60 minut.
Skin and subcutaneous tissue disorders rash, urticaria, pruritus 
Bolezni kože in podkožja izpuščaj, urtikarija, pruritus
To be administered as a 60-minute intravenous infusion. 
Zdravilo je treba odmerjati v obliki 60-minutne intravenske infuzije.
20 ml vial (type I glass) with a stopper (fluoro-resin coated butyl rubber), one piece seal, and flip-off cap. 
20-mililitrska steklena viala (steklo vrste I) z zamaškom (butilna guma, obložena s fluorovo smolo), enodelnim tesnilom in zaporko »flip-off«.
Haemoglobin concentration (g/dL) Platelet count (x 10 
Koncentracija hemoglobina (g/dl) Število trombocitov (x 10
Patients who switched from long-term imiglucerase treatment to velaglucerase alfa (N=38) 
Bolniki, ki so prešli z dolgotrajnega zdravljenja z imiglucerazo na velaglucerazo alfa (n = 38)
It should not be shaken. 
Ne smete ga pretresati.
Ten patients who completed Study 025 enrolled in an open-label extension study (025EXT), 8 of whom completed the study. 
Deset bolnikov, ki je zaključilo študijo 025, je sodelovalo v podaljšani odprti študiji (025EXT).
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. 
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.
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. 
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.
What you need to know before VPRIV is used 
Kaj morate vedeti preden boste uporabili zdravilo VPRIV
Haemoglobin concentration and platelet counts were evaluated as changes from baseline, which was defined as the end of the patient's treatment with imiglucerase. 
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.
Frequency is defined as very common (1/10), common (1/100 to <1/10), and uncommon (≥1/1,000 to <1/100). 
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).
Deposits in the bone marrow and splenic sequestration lead to clinically significant anaemia and thrombocytopenia. 
Nalaganje v kostnem mozgu in sekvestracija vranice povzročata klinično pomembno anemijo in trombocitopenijo.
Adverse reactions reported in patients with type 1 Gaucher disease are listed in Table 1. 
Neželeni učinki, o katerih so poročali pri bolnikih z Gaucherjevo boleznijo tipa 1, so navedene v preglednici 1.
Bone involvement results in skeletal abnormalities and deformities as well as bone pain crises. 
Zaradi vpletenosti kosti se pojavijo abnormalnosti in deformacije skeleta ter kriz zaradi bolečin v kosteh.
Sodium citrate dihydrate (E331) Citric acid monohydrate (E330) Polysorbate 20 
6.1 Seznam pomožnih snovi saharoza natrijev citrat dihidrat (E 331) monohidrat citronske kisline (E 330) polisorbat 20
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. 
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.
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 
Te reakcije vključujejo: - glavobol, - omotico, - povišano telesno temperaturo, - znižan ali povišan krvni tlak, - slabost in utrujenost, - neugodje v prsih, - oteženo dihanje, - srbenje.
If anaphylactic or other acute reactions occur, in the clinic or home setting, immediately discontinue the infusion and initiate appropriate medical treatment. 
Če se bodisi v kliničnem okolju bodisi doma pojavijo anafilaktična ali druge akutne reakcije, nemudoma prekinite infuzijo in začnite z ustreznim medicinskim zdravljenjem.
This medicine is only to be used under appropriate medical supervision of a doctor who is knowledgeable in the treatment of Gaucher disease. 
To zdravilo se lahko uporablja samo pod nadzorom zdravnika z izkušnjami pri zdravljenju Gaucherjeve bolezni.
Clinical studies have evaluated doses ranging from 15 to 60 Units/kg every other week. 
V kliničnih študijah so ocenili odmerke od 15 do 60 enot/kg vsak drugi teden.
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. 
Pri pediatrični populaciji (preučevali so bolnike, stare od 4 do 17 let) so v 60-mesečnem obdobju zdravljenja pri celotni še nezdravljeni populaciji opažali povečanja srednje Z-vrednosti višine, kar kaže na pozitiven učinek velagluceraze alfa na linearno rast.
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. 
Po najmanj 12 mesecih neprekinjenega zdravljenja z velaglucerazo alfa so vsem bolnikom zmanjšali odmerek velagluceraze alfa po korakih s 60 na 30 enot/kg, potem ko so dosegli vsaj 2 od 4 terapevtskih ciljev za 1. leto NEZ za Gaucherjevo bolezen tipa 1.
Similar treatment effects were seen through 48 months in the paediatric population who received 9 months of imiglucerase followed by velaglucerase alfa. 
Podobne rezultate zdravljenja so opažali v obdobju 48 mesecev pri pediatrični populaciji, ki je 9 mesecev dobivala imiglucerazo in nato velaglucerazo alfa.
Velaglucerase alfa exhibited an approximately linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased approximately proportional to the dose over the dose range 15 to 60 Units/kg. 
Pri velaglucerazi alfa je bil farmakokinetični profil približno linearen (tj. profil prvega reda), v razponu odmerkov od 15 do 60 enot/kg pa so se vrednosti Cmax in AUC povečevale približno sorazmerno z odmerkom.
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. 
Med 31 še nezdravljenimi odraslimi bolniki, ki so dobivali velaglucerazo alfa, je bila srednja Z-vrednost mineralne gostote kosti (BMD) ledvenega dela hrbtenice ob izhodišču1,820 (95-odstotni IZ: -2,21; -1,43) in se je po 24 mesecih zdravljenja z velaglucerazo alfa povečala za 0,62 (95-odstotni IZ: 0,39; 0,84) glede na izhodišče.
• Annex: SmPC; Healthcare Professional Reconstitution Guide, Infusion diary 
• priloge: povzetek glavnih značilnostih zdravila (SmPC); vodnik za zdravstvene delavce glede rekonstitucije, dnevnik infuzij.
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. 
Če trenutno prejemate drugo nadomestno encimsko zdravljenje zaradi Gaucherjeve bolezni ali če vaš zdravnik želi, da preidete na zdravilo VPRIV, vam lahko odmerjajo zdravilo VPRIV pri istem odmerku in enako pogosto kot prejšnje NEZ.
Patients received either 60 Units/kg of velaglucerase alfa (N=17) or 60 Units/kg of imiglucerase (N=17) every other week. 
Bolniki so prejemali 60 enot/kg velagluceraze alfa (N = 17) ali 60 enot/kg imigluceraze (N = 17) vsak drugi teden.
Each vial is reconstituted using sterile water for injections: 
Vsako vialo rekonstituirajte s sterilno vodo za injekcije: Velikost viale
Very common side effects are: - bone pain - joint pain - back pain - weakness/loss of strength/tiredness 
Zelo pogosti neželeni učinki so: - bolečine v kosteh, - bolečine v sklepih, - bolečine v hrbtu, - šibkost/izguba moči/utrujenost.
VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease. 
Zdravljenje z zdravilom VPRIV mora nadzirati zdravnik z izkušnjami pri obravnavanju bolnikov z Gaucherjevo boleznijo.
The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received velaglucerase alfa at doses ranging from 15 to 60 Units/kg every other week in 5 clinical studies. 
Podatki, opisani spodaj, izražajo izpostavljenost 94 bolnikov z Gaucherjevo boleznijo tipa 1, ki so v 5 kliničnih študijah prejemali velaglucerazo alfa v odmerkih od 15 do 60 enot/kg vsak drugi teden.
Treatment with velaglucerase alfa was administered as the same number of units and regimen as their imiglucerase dose. 
Pri zdravljenju z velaglucerazo alfa sta bila število enot in režim odmerjanja enaka kot pri odmerku imigluceraze.
Twenty of the 94 patients (21%) who received velaglucerase alfa during clinical studies were in the paediatric and adolescent age range (4 to 17 years). 
Od 94 bolnikov, ki so prejemali velaglucerazo alfa v kliničnih študijah, je bilo 20 bolnikov (21 %) v pediatričnem ali mladostniškem obdobju (od 4 do 17 let).
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. 
Po sedmih letih zdravljenja sta bili povprečni povišanji vrednosti Z glede na izhodiščno vrednost 0,7 (95-odstotni IZ 0,4, 1,0) za ledveni del hrbtenice in 0,5 (95-odstotni IZ 0,2, 0,7) za stegnenični vrat.
It requires reconstitution and dilution and is intended for intravenous infusion only. 
Prašek je treba rekonstituirati in razredčiti, zdravilo pa je namenjeno samo za intravensko infundiranje.
VPRIV 400 Units powder for solution for infusion 
VPRIV 400 enot prašek za raztopino za infundiranje
Due to the risk for hypersensitivity reactions including anaphylaxis appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered. 
Zaradi tveganja za preobčutljivostne reakcije vključno z anafilaksijo mora biti pri dajanju velagluceraze alfa takoj na voljo ustrezna medicinska podpora, vključno z osebjem, ki je ustrezno usposobljeno za izvajanje nujnih ukrepov.
Upon reconstitution, mix vials gently. 
Po rekonstituciji viale nežno premešajte.
Fifty-four patients were naïve to ERT and 40 patients switched from imiglucerase to VPRIV. 
Štiriinpetdeset bolnikov še ni prejemalo NEZ, 40 bolnikov pa je pred zdravilom VPRIV prejemalo imiglucerazo.
To further evaluate the relationship, in cases of severe infusion-related reactions and in cases of lack or loss of effect patients should be tested for the presence of antibodies and the results reported to the company. 
Da bi lahko nadalje ocenili to povezavo, je treba pri bolnikih, pri katerih se pojavijo hude reakcije, povezane z infuzijo, ali pri katerih se učinek zdravila zmanjša ali zdravilo sploh ni učinkovito, testirati prisotnost protiteles in rezultate sporočiti izdelovalcu zdravila.
VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease. 
Zdravilo VPRIV vsebuje učinkovino, ki se imenuje velagluceraza alfa in je namenjena nadomeščanju manjkajočega ali okvarjenega encima glukocerebrozidaze pri bolnikih z Gaucherjevo boleznijo.
Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease. 
Velagluceraza alfa zviša koncentracijo hemoglobina in število trombocitov ter zmanjša prostornino jeter in vranice pri bolnikih z Gaucherjevo boleznijo tipa 1.
Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase. 
Gaucherjeva bolezen je dedna motnja, ki jo povzroča pomanjkanje ali okvara encima, imenovanega glukocerebrozidaza.
The product should be mixed gently. 
Zdravilo morate nežno premešati.
Vascular disorders hypertension, hypotension, flushing 
Žilne bolezni hipertenzija, hipotenzija, vročinski oblivi
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. 
Normalna vranica je opredeljena kot 0,2 % telesne mase in normalna jetra kot 2,5 % telesne mase.