natgillin/translations-raw huggingface dataset:
VPRIV is supplied in a vial as a packed powder which is mixed with sterile water and further diluted in sodium chloride 9 mg/ml (0.9%) solution prior to intravenous infusion. 
Zdravilo VPRIV je na voljo v viali, v obliki stisnjenega praška, ki se zmeša s sterilno vodo in nato dodatno razredči v 0,9-odstotni raztopini natrijevega klorida (9 mg/ml) pred intravenskim infundiranjem.
Prevention and Management of infusion related reactions including hypersensitivity reactions The management of infusion-related reactions should be based on the severity of the reaction, and include slowing the infusion rate, treatment with medicinal products such as antihistamines, antipyretics and/or corticosteroids, and/or stopping and resuming treatment with increased infusion time. 
Reakcije, povezane z infundiranjem, je treba obravnavati na podlagi njihove resnosti, obravnava pa naj vključuje počasnejše infundiranje, zdravljenje z zdravili, kot so antihistaminiki, anitpiretiki in/ali kortikosteroidi, in/ali prekinitev in nadaljevanje zdravljenja z daljšim časom infundiranja.
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). 
Bolniki so prejemali velaglucerazo alfa v odmerkih od 30 do 60 enot/kg (mediana odmerka 35 enot/kg) vsak drugi teden do 84 mesecev (7 let).
Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease. 
Obvestite zdravnika, če ste pri drugih encimskih nadomestnih zdravljenjih (NEZ) za Gaucherjevo bolezen imeli reakcijo, povezano z infundiranjem.
Musculoskeletal and connective tissue disorders bone pain, arthralgia, back pain 
Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh, artralgija, bolečina v hrbtu
Patients treated with imiglucerase for 9 months and then velaglucerase alfa for 15 months (N=16) 
Bolniki, zdravljeni 9 mesecev z imiglucerazo in nato 15 mesecev z velaglucerazo alfa (n = 16)
Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa. 
V reakcijah, povezanih z zdravljenjem, ki so jih odkrili pri uporabi velagluceraze alfa, lahko sodelujejo protitelesa.
Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred. 
Poleg simptomov, povezanih s preobčutljivostnimi reakcijami, se lahko IRR pokažejo kot utrujenost, omotica, zvišana telesna temperatura, zvišanje krvnega tlaka, pruritus ali zamegljen vid.
The recommended dose is 60 Units/kg given every other week. 
Priporočeni odmerek je 60 enot/kg, vsak drugi teden.
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. 
Pri prvih treh bolnikih so odmerek velagluceraze alfa povečevali (15, 30, 60 enot/kg), pri drugih 9 bolnikih pa se je zdravljenje začelo z odmerkom 60 enot/kg.
VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only. 
Zdravilo VPRIV je treba rekonstituirati in razredčiti, namenjeno je samo za intravensko infundiranje.
The calculated volume of medicinal product is withdrawn from the appropriate number of vials and the total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Odvzemite izračunani volumen zdravila iz ustreznega števila vial in razredčite skupno odvzeto količino v 100 ml 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za infundiranje.
Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy. 
Za določanje zdravljenja pri posameznicah je treba pozorno spremljati nosečnost in klinične znake Gaucherjeve bolezni.
Study 039 was a 9-month, randomized, double-blind, non-inferiority, active-comparator (imiglucerase) controlled, parallel-group efficacy study in 34 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry). 
Študija 039 je bila 9-mesečna randomizirana, dvojno slepa, ne-inferiorna študija učinkovitosti, nadzorovana z aktivno primerjalno učinkovino (imiglucerazo), z vzporednimi skupinami pri 34 bolnikih, starih 2 leti ali več, ki predhodno niso prejemali NEZ (opredeljeno kot to, da niso prejemali NEZ vsaj 12 mesecev pred vstopom v študijo).
One vial contains 400 Units* of velaglucerase alfa**. 
Ena viala vsebuje 400 enot* velagluceraze alfa**.
Clinically meaningful improvements from baseline were observed in haemoglobin concentration and platelet counts as early as 3 months and in liver and spleen volumes at both 6 months and 9 months following the initiation of treatment with velaglucerase alfa. 
Pri koncentraciji hemoglobina in številu trombocitov so klinično pomembne izboljšave glede na izhodišče opazili že po 3 mesecih, pri prostornini jeter in vranice pa po 6 in 9 mesecih po začetku zdravljenja z velaglucerazo alfa.
These are called infusion related reactions and might appear as a hypersensitivity reaction with symptoms like nausea, rash, difficulty in breathing, back pain, chest discomfort (chest tightness), hives, joint pain or headache. 
Ti neželeni učinki se imenujejo reakcije, povezane z infundiranjem, in se lahko pojavijo kot preobčutljivostna reakcija s simptomi, kot so navzea, izpuščaj, oteženo dihanje, bolečina v hrbtu, neugodje v prsih (stiskanje v prsih), koprivnica, bolečine v sklepih ali glavobol.
None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase alfa antibodies on the days of pharmacokinetic evaluation. 
Ob dnevih, ko so v farmakokinetičnih študijah ocenjevali farmakokinetiko, nobeden izmed preskušancev ni bil pozitiven za protitelesa proti velaglucerazi alfa.
No patients developed IgE antibodies to velaglucerase alfa. 
Pri nobenem bolniku se niso pojavila protitelesa IgE proti velaglucerazi alfa.
VPRIV 400 Units powder for solution for infusion velaglucerase alfa 
VPRIV 400 enot prašek za raztopino za infundiranje velagluceraza alfa
No patients were classified at a more severe WHO classification of bone density compared to baseline. 
Nobenega bolnika niso uvrstili v skupino z resnejšimi težavami z gostoto kosti (po razvrstitvi SZO) v primerjavi z izhodiščem.
Velaglucerase alfa is manufactured to contain predominantly high-mannose-type glycans to facilitate internalisation of the enzyme by the phagocytic target cells via the mannose receptor. 
Velagluceraza alfa se izdeluje tako, da vsebuje predvsem glikane z veliko manoze, kar spodbuja internalizacijo encima v fagocitne tarčne celice prek receptorja za manozo.
What VPRIV looks like and contents of the pack 
Izgled zdravila VPRIV in vsebina pakiranja
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%). 
Prostornina jeter se je zmanjšala z 1,40- na 1,24-kratno normalno vrednost (povprečno 6-odstotno zmanjšanje), prostornina vranice pa s 14,5- na 9,50-kratno normalno vrednost (povprečno 40-odstotno zmanjšanje).
Velaglucerase alfa 60 Units/kg given intravenously every other week demonstrated clinically meaningful increases from baseline in mean haemoglobin concentration (+2.4 g/dl) and platelet count (+50.9 x 10 
Pri intravenskem odmerjanju 60 enot/kg velagluceraze alfa vsak drugi teden so opazili klinično pomembno povečanje koncentracije hemoglobina (+ 2,4 g/dl) in števila trombocitov (+ 50,9 x 10
Nervous system disorders headache, dizziness 
Bolezni živčevja glavobol, omotica,
Powder for solution for infusion. 
prašek za raztopino za infundiranje.
In patients who switched from imiglucerase to velaglucerase alfa, haemoglobin concentrations and platelet counts were sustained at therapeutic levels through 12 months of treatment. 
Pri bolnikih, ki so prešli z imigluceraze na velaglucerazo alfa, so se koncentracije hemoglobina in število trombocitov ohranile na terapevtski ravni vseh 12 mesecev zdravljenja.
Mean change from baseline (95% CI) 
Srednja sprememba od izhodišča [95odstotni IZ]
For intravenous infusion use only. 
Samo za intravensko infundiranje.
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. 
Velagluceraza alfa je med zdravljenjem kazala trajno klinično aktivnost, kar so opazili po izboljšavah v koncentraciji hemoglobina in številu trombocitov ter zmanjšanju prostornine jeter in vranice.
Powder for solution for infusion 25 vials 
Prašek za raztopino za infundiranje 25 vial
Normalized Liver Volume* (%BW) Normalized Spleen Volume* (%BW) Excludes patients with splenectomy. 
9/l) Normalizirana prostornina jeter* (% TM) Normalizirana prostornina vranice* (% TM) Bolniki s splenektomijo izključeni; n = 30, 6 in 34 za zgornje 3 skupine.
Upon reconstitution, vials should be mixed gently. 
Po rekonstituciji morate viale nežno premešati.
Similar results were seen in treatment-naïve patients who received 9 months of imiglucerase followed by velaglucerase alfa for 15 months. 
Podobne rezultate so opazili pri še nezdravljenih bolnikih , ki so 9 mesecev dobivali imiglucerazo in nato 15 mesecev velaglucerazo alfa.
Patients transferring from imiglucerase were administered velaglucerase alfa infusions every other week at the same number of units as imiglucerase within the range of 15 to 60 Units/kg. 
Bolnikom, ki so prešli z imigluceraze, so velaglucerazo alfa infundirali vsak drugi teden z enakim številom enot kot pri imiglucerazi, z razponom od 15 do 60 enot/kg.
See section 5.1 for further information. 
Dodatne informacije so v poglavju 5.1.
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. 
V kliničnih študijah, v katerih so sodelovali otroci in mladostniki, stari od 4 do 17 let, je bil varnostni profil zdravila VPRIV podoben kot pri odraslih bolnikih.
Infusion-related-reactions 
Reakcije, povezane z infundiranjem
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%). 
Prostornina jeter se je zmanjšala z 1,46- na 1,22-kratno normalno vrednost (povprečno 17-odstotno zmanjšanje), prostornina vranice pa s 14,0- na 5,75-kratno normalno vrednost (povprečno 50-odstotno zmanjšanje).
One vial contains 400 Units of velaglucerase alfa. 
Ena viala vsebuje 400 enot velagluceraze alfa.
Paediatric subjects who switched from long-term imiglucerase to velaglucerase alfa in study 034 had greater mean height Z-scores at baseline and their mean height Z-scores remained stable over time. 
Pediatrični preskušanci, ki so v študiji 034 prešli z dolgoročnega zdravljenja z imiglucerazo na velaglucerazo alfa, so imeli v izhodišču večje srednje Z-vrednosti višine in pri njih se srednja Z-vrednost višine s časom ni spremenila.
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) 
Pogosti neželeni učinki so: - bolečine v trebuhu/slabost (navzea), - hiter pojav krvavitve/hiter pojav podplutb, - rdečica kože, - hitro bitje srca, - izpuščaj/koprivnica, - pojav protiteles proti zdravilu VPRIV (glejte poglavje 2).
CLINICAL PARTICULARS 
Klinični parametri
It is for single-use only and is administered through a 0.22 µm filter. 
Zdravilo je samo za enkratno uporabo in treba ga je infundirati skozi 0,22-mikrometrski filter.
If any of these happen tell your doctor immediately. 
Če se pri vas pojavi karkoli od navedenega, se takoj posvetujte s svojim zdravnikom.
The mean haemoglobin concentration and platelet count of patients previously treated with imiglucerase were maintained throughout the study and remained within the reference intervals. 
Pri bolnikih, ki so se predhodno zdravili z imiglucerazo, sta se povprečna koncentracija hemoglobina in število trombocitov vzdrževala med celotno študijo ter sta ostala znotraj referenčnega razpona.
Other medicines and VPRIV 
Druga zdravila in zdravilo VPRIV
VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease. 
Zdravilo VPRIV je indicirano za dolgoročno nadomestno encimsko zdravljenje (NEZ) bolnikov z Gaucherjevo boleznijo tipa 1.
In patients who switched from long-term imiglucerase to velaglucerase alfa, lumbar spine BMD was maintained at 24 months. 
Pri bolnikih, ki so prešli z dolgoročnega zdravljenja z imiglucerazo na velaglucerazo alfa, se BMD ledvene hrbtenice po 24 mesecih ni spremenila.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and toxicity to reproduction and development. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
Patients transferring from a dose of <15 Units/kg imiglucerase were administered 15 Units/kg of velaglucerase alfa. 
Bolniki, pri katerih je bil odmerek imigluceraze ob prehodu < 15 enot/kg, so prejemali odmerek velagluceraze alfa 15 enot/kg.
If you are breast feeding or considering breast-feeding, you should talk to your doctor before this medicine is used. 
Če dojite ali nameravate dojiti, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
Studies in treatment naïve patients 
Uporaba pri starejših bolnikih
After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa. 
Po rekonstituciji en ml raztopine vsebuje 100 enot velagluceraze alfa.
If you experience any side effect like these, please tell your doctor immediately. 
Če opazite kakršnekoli tovrstne neželene učinke, takoj obvestite svojega zdravnika.
Patients were randomized to receive velaglucerase alfa at a dose of either 45 Units/kg (N=13) or 60 Units/kg (N=12) every other week. 
Bolnike so naključno razporedili, tako da so prejemali velaglucerazo alfa v odmerku 45 enot/kg (N = 13) ali 60 enot/kg (N = 12) vsak drugi teden.
Caution should be exercised when prescribing to a breast-feeding woman. 
Pri predpisovanju zdravila ženskam, ki dojijo, je potrebna previdnost.
Respiratory, thoracic and mediastinal disorders dyspnea 
Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
Study 032 was a 12-month, randomized, double-blind, parallel-group efficacy study in 25 patients aged 2 years and older who were naïve to ERT (defined as having not been treated with ERT for at least 30 months prior to study entry). 
Študija 032 je bila 12-mesečna randomizirana, dvojno slepa študija učinkovitosti z vzporednimi skupinami pri 25 bolnikih, starih več kot 2 leti, ki predhodno niso prejemali NEZ (opredeljeno kot to, da niso prejemali NEZ vsaj 30 mesecev pred vstopom v študijo).
Study 025 was a 9 month, open-label study in 12 adult (≥18 years) patients who were naïve to ERT (defined as having not been treated with ERT for at least 12 months prior to study entry). 
Študije zdravljenja predhodno nezdravljenih bolnikov Študija 025 je bila 9-mesečna odprta študija pri 12 odraslih bolnikih (starih ≥ 18 let), ki predhodno niso prejemali NEZ (opredeljeno kot to, da niso prejemali NEZ vsaj 12 mesecev pred vstopom v študijo).
In this one event, the antibodies were determined to be neutralising in an in vitro assay. 
V tem primeru so ugotovili, da protitelesa nevtralizirajo zdravilo v preizkusih in vitro.
Description of selected adverse reactions Vomiting 
Opis izbranih neželenih učinkov
VPRIV is a long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease. 
Zdravilo VPRIV je namenjeno dolgoročnemu nadomestnemu encimskemu zdravljenju (NEZ) bolnikov z Gaucherjevo boleznijo tipa 1.
Ask your doctor or pharmacist for advice before this medicine is used. 
Pred uporabo tega zdravila se posvetujte z zdravnikom ali farmacevtom.
What VPRIV is and what it is used for What you need to know before VPRIV is used How VPRIV is used 
Kaj je zdravilo VPRIV in za kaj ga uporabljamo Kaj morate vedeti preden boste uporabili zdravilo VPRIV Kako uporabljati zdravilo VPRIV Možni neželeni učinki
OUTER CARTON - 400 UNITS (25 vial pack) 
ZUNANJA ŠKATLA - 400 ENOT (pakiranje s 25 vialami)
Powder for solution for infusion 5 vials 
Prašek za raztopino za infundiranje 5 vial
VPRIV is a powder for solution for infusion. 
Zdravilo VPRIV je prašek za raztopino za infundiranje.
Meaningful increases from baseline were observed in the 45 Units/kg dose group in haemoglobin concentration (+2.4 g/dl) and platelet count (+40.9 x 10 
V skupini, ki je prejemala odmerek 45 enot/kg, so opazili klinično pomembno povečanje koncentracije hemoglobina (+ 2,4 g/dl) in števila trombocitov (+ 40,9 x 10
Powder for solution for infusion 1 vial 
Prašek za raztopino za infundiranje 1 viala
OUTER CARTON - 400 UNITS (5 vial pack) 
ZUNANJA ŠKATLA - 400 ENOT (pakiranje s 5 vialami)
In the clinical trials, one of 94 (1%) patients developed IgG-class antibodies to velaglucerase alfa. 
V kliničnih preskušanjih so se protitelesa razreda IgG proti velaglucerazi alfa pojavila pri enem od 94 bolnikov (1 %).
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). 
Pri številu trombocitov in prostornini jeter in vranice po 9 mesecih zdravljenja z velaglucerazo alfa ter v času do prvega odziva hemoglobina (opredeljeno kot povišanje koncentracije za 1 g/dl glede na izhodiščno vrednost) ni bilo statistično pomembnih razlik med velaglucerazo alfa in imiglucerazo.
Appropriate medical support, including adequately trained personnel in emergency measures, should be readily available when velaglucerase alfa is administered. 
Pri dajanju velagluceraze alfa mora biti takoj na voljo ustrezna medicinska podpora, vključno z osebjem, ki je ustrezno usposobljeno za izvajanje nujnih ukrepov.
OUTER CARTON - 400 UNITS (single vial pack) 
ZUNANJA ŠKATLA - 400 ENOT (pakiranje z eno vialo)
VPRIV contains sodium 
Zdravilo VPRIV vsebuje natrij
Sodium citrate dihydrate 
saharoza natrijev citrat, dihidrat monohidrat citronske kisline polisorbat 20
Velaglucerase alfa serum concentrations rose rapidly for the first 20 minutes of the 60-minute infusion before leveling off, and Cmax was typically attained between 40 and 60 minutes after the start of the infusion. 
Koncentracije velagluceraze alfa v serumu so se v prvih 20 minutah 60-minutnega infundiranja hitro zvišale, nato pa so se ustalile.
If anaphylactic or other acute reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment. 
Če se pojavijo anafilaktična ali druge akutne reakcije, nemudoma prekinite infuzijo in začnite z ustreznim medicinskim zdravljenjem (glejte poglavje 4.4).
The most frequently reported symptoms of hypersensitivity include nausea, rash, dyspnoea, back pain, chest discomfort (including chest tightness), urticaria, arthralgia, and headache. 
Simptomi preobčutljivosti, o katerih najpogosteje poročajo, vključujejo navzeo, izpuščaj, dispnejo, bolečino v hrbtu, neugodje v prsih (vključno s stiskanjem v prsih), urtikarijo, artralgijo in glavobol.
Extractable volume 
Volumen, ki ga lahko odvzamete
Overall velaglucerase alfa group (N=39) 
Celotna skupina z velaglucerazo alfa
The total volume required is diluted in 100 ml of sodium chloride 9 mg/ml (0.9%) solution for infusion. 
Razredčite zahtevan volumen v 100 ml 0,9-odstotne raztopine natrijevega klorida za infundiranje.
Posology The recommended dose is 60 Units/kg administered every other week. 
Odmerjanje Priporočeni odmerek je 60 enot/kg, vsak drugi teden.
White to off-white powder. 
Bel ali belkast prašek.
A risk-benefit assessment is required for women with Gaucher disease who are considering pregnancy. 
Pri ženskah z Gaucherjevo boleznijo, ki si želijo zanositi, je treba oceniti tveganja in koristi zdravljenja.
It is not known whether velaglucerase alfa is excreted in human milk. 
Podatkov iz študij pri doječih ženskah ni. Ni znano, ali se velagluceraza alfa izloča v materino mleko.
Table 1: Adverse reactions reported with VPRIV observed in patients with type 1 Gaucher disease Italic text denotes post-marketing event. 
Preglednica 1: Neželeni učinki, o katerih so poročali pri uporabi zdravila VPRIV, ki so jih opazili pri bolnikih z Gaucherjevo boleznijo tipa 1.
Infusion-related reaction, asthenia/fatigue, pyrexia/body temperature increased 
Splošne težave in spremembe na mestu aplikacije reakcije, povezane z infundiranjem, astenija/utrujenost, pireksija/zvišana telesna temperatura neugodje v prsih
No dosing adjustment is recommended in patients with renal or hepatic impairment based on current knowledge of the pharmacokinetics and pharmacodynamics of velaglucerase alfa. 
Na podlagi trenutnega znanja o farmakokinetiki in farmakodinamiki velagluceraze alfa prilagoditev odmerka pri bolnikih z okvaro ledvic in jeter ni priporočljiva.
Improvement from baseline in mean lumbar spine and femoral neck bone mineral density (BMD) Z-scores were observed at month 24 (0.4; 95% CI 0.1, 0.7) and month 33 (0.4; 95% CI 0.2, 0.6), respectively. 
(0,4; 95-odstotni IZ 0,1, 0,7) oziroma 33. mesecu (0,4; 95-odstotni IZ 0,2, 0,6).
In this study, haemoglobin concentration, platelet count, liver volume and spleen volume were assessed in treatment-naïve patients after 24 months of treatment. 
V tej študiji so pri bolnikih, ki se prej še niso zdravili, po 24 mesecih zdravljenja ocenili koncentracije hemoglobina, število trombocitov, prostornino jeter in prostornino vranice.
- Apart from symptoms of hypersensitivity reactions infusion-related reactions might show as dizziness, high blood pressure, tiredness, fever, itching, or blurry vision. 
- Poleg simptomov preobčutljivostnih reakcij se lahko reakcije, povezane z infundiranjem, pokažejo kot omotica, visok krvni tlak, utrujenost, zvišana telesna temperatura, srbenje ali zamegljen vid. - Če se pojavijo kateri koli od teh simptomov, morate takoj obvestiti zdravnika.
The mean absolute increase from baseline in haemoglobin concentrations was 1.624 g/dl (±0.223 SE) following 9 months of treatment with velaglucerase alfa. 
Po 9 mesecih zdravljenja z velaglucerazo alfa je bilo povprečno absolutno zvišanje koncentracije hemoglobina glede na izhodiščno vrednost 1,624 g/dl (± 0,223 SD).
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). 
(povprečna razlika spremembe pri zdravljenju od izhodiščne vrednosti do 9 mesecev [velagluceraza alfa - imigluceraza]: 0,135 g/dl).
Hypersensitivity reactions, including symptoms consistent with anaphylaxis, have been reported in patients in clinical studies and in post-marketing experience. 
V kliničnih študijah in izkušnjah po prihodu zdravila na trg so pri bolnikih poročali o preobčutljivostnih reakcijah, vključno s simptomi, ki se skladajo z anafilaksijo.
What VPRIV contains 
Kaj vsebuje zdravilo VPRIV
Symptoms consistent with anaphylaxis have been reported in patients in clinical studies and in post-marketing experience. 
V kliničnih študijah in izkušnjah po prihodu zdravila na trg so poročali o simptomih, ki ustrezajo anafilaksiji.
Sucrose 
Odmerek
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 26. avgust 2010
VPRIV must not be used: 
Ne uporabljajte zdravila VPRIV:
Contains sodium, see leaflet for further information. 
Shranjevanje zdravila VPRIV Vsebina pakiranja in dodatne informacije
The marketing authorisation holder is Boehringer Ingelheim International GmbH. 
Imetnik dovoljenja za promet z zdravilom je družba Boehringer Ingelheim International GmbH.