natgillin/translations-raw huggingface dataset:
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.
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.