FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: 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.
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.
Slovenian: 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.
English: Similar treatment effects were seen through 48 months in the paediatric population who received 9 months of imiglucerase followed by velaglucerase alfa.
Slovenian: Podobne rezultate zdravljenja so opažali v obdobju 48 mesecev pri pediatrični populaciji, ki je 9 mesecev dobivala imiglucerazo in nato velaglucerazo alfa.
English: 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.
Slovenian: 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.
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.
Slovenian: 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.
English: • Annex: SmPC; Healthcare Professional Reconstitution Guide, Infusion diary
Slovenian: • priloge: povzetek glavnih značilnostih zdravila (SmPC); vodnik za zdravstvene delavce glede rekonstitucije, dnevnik infuzij.
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.
Slovenian: 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.
English: Patients received either 60 Units/kg of velaglucerase alfa (N=17) or 60 Units/kg of imiglucerase (N=17) every other week.
Slovenian: Bolniki so prejemali 60 enot/kg velagluceraze alfa (N = 17) ali 60 enot/kg imigluceraze (N = 17) vsak drugi teden.
English: Each vial is reconstituted using sterile water for injections:
Slovenian: Vsako vialo rekonstituirajte s sterilno vodo za injekcije: Velikost viale
English: Very common side effects are: - bone pain - joint pain - back pain - weakness/loss of strength/tiredness
Slovenian: Zelo pogosti neželeni učinki so: - bolečine v kosteh, - bolečine v sklepih, - bolečine v hrbtu, - šibkost/izguba moči/utrujenost.
English: VPRIV treatment should be supervised by a physician experienced in the management of patients with Gaucher disease.
Slovenian: Zdravljenje z zdravilom VPRIV mora nadzirati zdravnik z izkušnjami pri obravnavanju bolnikov z Gaucherjevo boleznijo.
English: 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.
Slovenian: 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.
English: Treatment with velaglucerase alfa was administered as the same number of units and regimen as their imiglucerase dose.
Slovenian: Pri zdravljenju z velaglucerazo alfa sta bila število enot in režim odmerjanja enaka kot pri odmerku imigluceraze.
English: 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).
Slovenian: 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).
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.
Slovenian: 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.
English: It requires reconstitution and dilution and is intended for intravenous infusion only.
Slovenian: Prašek je treba rekonstituirati in razredčiti, zdravilo pa je namenjeno samo za intravensko infundiranje.
English: VPRIV 400 Units powder for solution for infusion
Slovenian: VPRIV 400 enot prašek za raztopino za infundiranje
English: 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.
Slovenian: 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.
English: Upon reconstitution, mix vials gently.
Slovenian: Po rekonstituciji viale nežno premešajte.
English: Fifty-four patients were naïve to ERT and 40 patients switched from imiglucerase to VPRIV.
Slovenian: Štiriinpetdeset bolnikov še ni prejemalo NEZ, 40 bolnikov pa je pred zdravilom VPRIV prejemalo imiglucerazo.
English: 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.
Slovenian: 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.
English: VPRIV contains a substance called velaglucerase alfa which is designed to replace the missing or defective enzyme, glucocerebrosidase, in patients with Gaucher disease.
Slovenian: Zdravilo VPRIV vsebuje učinkovino, ki se imenuje velagluceraza alfa in je namenjena nadomeščanju manjkajočega ali okvarjenega encima glukocerebrozidaze pri bolnikih z Gaucherjevo boleznijo.
English: Velaglucerase alfa increases haemoglobin concentration and platelet counts and reduces liver and spleen volumes in patients with type 1 Gaucher disease.
Slovenian: Velagluceraza alfa zviša koncentracijo hemoglobina in število trombocitov ter zmanjša prostornino jeter in vranice pri bolnikih z Gaucherjevo boleznijo tipa 1.
English: Gaucher disease is a genetic disorder caused by a missing or defective enzyme named glucocerebrosidase.
Slovenian: Gaucherjeva bolezen je dedna motnja, ki jo povzroča pomanjkanje ali okvara encima, imenovanega glukocerebrozidaza.
English: The product should be mixed gently.
Slovenian: Zdravilo morate nežno premešati.
English: Vascular disorders hypertension, hypotension, flushing
Slovenian: Žilne bolezni hipertenzija, hipotenzija, vročinski oblivi
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.
Slovenian: Normalna vranica je opredeljena kot 0,2 % telesne mase in normalna jetra kot 2,5 % telesne mase.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
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).
Slovenian: 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).
English: Tell your doctor if you have previously experienced an infusion-related reaction with other ERT for Gaucher disease.
Slovenian: Obvestite zdravnika, če ste pri drugih encimskih nadomestnih zdravljenjih (NEZ) za Gaucherjevo bolezen imeli reakcijo, povezano z infundiranjem.
English: Musculoskeletal and connective tissue disorders bone pain, arthralgia, back pain
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva bolečina v kosteh, artralgija, bolečina v hrbtu
English: Patients treated with imiglucerase for 9 months and then velaglucerase alfa for 15 months (N=16)
Slovenian: Bolniki, zdravljeni 9 mesecev z imiglucerazo in nato 15 mesecev z velaglucerazo alfa (n = 16)
English: Antibodies may play a role in treatment-related reactions found with the use of velaglucerase alfa.
Slovenian: V reakcijah, povezanih z zdravljenjem, ki so jih odkrili pri uporabi velagluceraze alfa, lahko sodelujejo protitelesa.
English: Apart from symptoms associated with hypersensitivity reactions IRRs might show as fatigue, dizziness, pyrexia, blood pressure increase, pruritus, or vision blurred.
Slovenian: Poleg simptomov, povezanih s preobčutljivostnimi reakcijami, se lahko IRR pokažejo kot utrujenost, omotica, zvišana telesna temperatura, zvišanje krvnega tlaka, pruritus ali zamegljen vid.
English: The recommended dose is 60 Units/kg given every other week.
Slovenian: Priporočeni odmerek je 60 enot/kg, vsak drugi teden.
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.
Slovenian: 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.
English: VPRIV requires reconstitution and dilution, and is intended for intravenous infusion only.
Slovenian: Zdravilo VPRIV je treba rekonstituirati in razredčiti, namenjeno je samo za intravensko infundiranje.
English: 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.
Slovenian: 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.
English: Close monitoring of the pregnancy and clinical manifestations of Gaucher disease is necessary for the individualisation of therapy.
Slovenian: Za določanje zdravljenja pri posameznicah je treba pozorno spremljati nosečnost in klinične znake Gaucherjeve bolezni.
English: 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).
Slovenian: 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).
English: One vial contains 400 Units* of velaglucerase alfa**.
Slovenian: Ena viala vsebuje 400 enot* velagluceraze alfa**.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: None of the subjects in the pharmacokinetic studies were positive for anti-velaglucerase alfa antibodies on the days of pharmacokinetic evaluation.
Slovenian: Ob dnevih, ko so v farmakokinetičnih študijah ocenjevali farmakokinetiko, nobeden izmed preskušancev ni bil pozitiven za protitelesa proti velaglucerazi alfa.
English: No patients developed IgE antibodies to velaglucerase alfa.
Slovenian: Pri nobenem bolniku se niso pojavila protitelesa IgE proti velaglucerazi alfa.
English: VPRIV 400 Units powder for solution for infusion velaglucerase alfa
Slovenian: VPRIV 400 enot prašek za raztopino za infundiranje velagluceraza alfa
English: No patients were classified at a more severe WHO classification of bone density compared to baseline.
Slovenian: Nobenega bolnika niso uvrstili v skupino z resnejšimi težavami z gostoto kosti (po razvrstitvi SZO) v primerjavi z izhodiščem.
English: 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.
Slovenian: Velagluceraza alfa se izdeluje tako, da vsebuje predvsem glikane z veliko manoze, kar spodbuja internalizacijo encima v fagocitne tarčne celice prek receptorja za manozo.
English: What VPRIV looks like and contents of the pack
Slovenian: Izgled zdravila VPRIV in vsebina pakiranja
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%).
Slovenian: 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).
English: 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
Slovenian: 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
English: Nervous system disorders headache, dizziness
Slovenian: Bolezni živčevja glavobol, omotica,
English: Powder for solution for infusion.
Slovenian: prašek za raztopino za infundiranje.
English: In patients who switched from imiglucerase to velaglucerase alfa, haemoglobin concentrations and platelet counts were sustained at therapeutic levels through 12 months of treatment.
Slovenian: 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.
English: Mean change from baseline (95% CI)
Slovenian: Srednja sprememba od izhodišča [95odstotni IZ]
English: For intravenous infusion use only.
Slovenian: Samo za intravensko infundiranje.
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.
Slovenian: 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.
English: Powder for solution for infusion 25 vials
Slovenian: Prašek za raztopino za infundiranje 25 vial
English: Normalized Liver Volume* (%BW) Normalized Spleen Volume* (%BW) Excludes patients with splenectomy.
Slovenian: 9/l) Normalizirana prostornina jeter* (% TM) Normalizirana prostornina vranice* (% TM) Bolniki s splenektomijo izključeni; n = 30, 6 in 34 za zgornje 3 skupine.
English: Upon reconstitution, vials should be mixed gently.
Slovenian: Po rekonstituciji morate viale nežno premešati.
English: Similar results were seen in treatment-naïve patients who received 9 months of imiglucerase followed by velaglucerase alfa for 15 months.
Slovenian: Podobne rezultate so opazili pri še nezdravljenih bolnikih , ki so 9 mesecev dobivali imiglucerazo in nato 15 mesecev velaglucerazo alfa.
English: 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.
Slovenian: 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.
English: See section 5.1 for further information.
Slovenian: Dodatne informacije so v poglavju 5.1.
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.
Slovenian: 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.
English: Infusion-related-reactions
Slovenian: Reakcije, povezane z infundiranjem
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%).
Slovenian: 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).
English: One vial contains 400 Units of velaglucerase alfa.
Slovenian: Ena viala vsebuje 400 enot velagluceraze alfa.
English: 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.
Slovenian: 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.
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)
Slovenian: 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).
English: CLINICAL PARTICULARS
Slovenian: Klinični parametri
English: It is for single-use only and is administered through a 0.22 µm filter.
Slovenian: Zdravilo je samo za enkratno uporabo in treba ga je infundirati skozi 0,22-mikrometrski filter.
English: If any of these happen tell your doctor immediately.
Slovenian: Če se pri vas pojavi karkoli od navedenega, se takoj posvetujte s svojim zdravnikom.
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.
Slovenian: 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.
English: Other medicines and VPRIV
Slovenian: Druga zdravila in zdravilo VPRIV
English: VPRIV is indicated for long-term enzyme replacement therapy (ERT) in patients with type 1 Gaucher disease.
Slovenian: Zdravilo VPRIV je indicirano za dolgoročno nadomestno encimsko zdravljenje (NEZ) bolnikov z Gaucherjevo boleznijo tipa 1.
English: In patients who switched from long-term imiglucerase to velaglucerase alfa, lumbar spine BMD was maintained at 24 months.
Slovenian: Pri bolnikih, ki so prešli z dolgoročnega zdravljenja z imiglucerazo na velaglucerazo alfa, se BMD ledvene hrbtenice po 24 mesecih ni spremenila.
English: 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.
Slovenian: 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.
English: Patients transferring from a dose of <15 Units/kg imiglucerase were administered 15 Units/kg of velaglucerase alfa.
Slovenian: Bolniki, pri katerih je bil odmerek imigluceraze ob prehodu < 15 enot/kg, so prejemali odmerek velagluceraze alfa 15 enot/kg.
English: If you are breast feeding or considering breast-feeding, you should talk to your doctor before this medicine is used.
Slovenian: Če dojite ali nameravate dojiti, se pred uporabo tega zdravila posvetujte s svojim zdravnikom.
English: Studies in treatment naïve patients
Slovenian: Uporaba pri starejših bolnikih
English: After reconstitution, one ml of the solution contains 100 Units of velaglucerase alfa.
Slovenian: Po rekonstituciji en ml raztopine vsebuje 100 enot velagluceraze alfa.
English: If you experience any side effect like these, please tell your doctor immediately.
Slovenian: Če opazite kakršnekoli tovrstne neželene učinke, takoj obvestite svojega zdravnika.
English: 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.
Slovenian: 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.
English: Caution should be exercised when prescribing to a breast-feeding woman.
Slovenian: Pri predpisovanju zdravila ženskam, ki dojijo, je potrebna previdnost.
English: Respiratory, thoracic and mediastinal disorders dyspnea
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja