natgillin/translations-raw huggingface dataset:
1 The decrease in percent predicted FVC is not clinically significant over this timeframe, and absolute lung volumes continued to increase commensurate with changes in height in growing paediatric patients. 
1 Znižanje predvidenega odstotka FVC ni klinično pomembno v tem časovnem okviru, celotni volumen pljuč pa se je še naprej zviševal sorazmerno s spremembami v višini pediatričnih bolnikov, ki še rastejo.
The open label extension study showed improvement and/or maintenance of these effects up to 208 weeks in the Aldurazyme/Aldurazyme group and 182 weeks in the Placebo/Aldurazyme group as indicated in the table below. 
Razširjena odprta študija je pokazala izboljšanje in/ali vzdrževanje navedenih učinkov do 208 tedna pri skupini, ki je prejemala Aldurazyme/Aldurazyme, in 182 tednov pri skupini, ki je prejemala placebo/Aldurazyme, kot je navedeno spodaj.
The occurrence of IgE antibodies was not fully explored. 
Pojavnost protiteles IgE ni popolnoma raziskana.
At 182 weeks 
vsaka 2 tedna.
The younger patients with the severe phenotype (< 2.5 years) and all 4 patients with the intermediate phenotype exhibited a normal rate of mental development, whereas the older patients with a severe phenotype made limited or no gains in cognition. 
Mlajši bolniki z resnim fenotipom (< 2,5 let) in vsi 4 bolniki z vmesnim fenotipom so pokazali normalno stopnjo mentalnega razvoja, medtem ko so starejši bolniki z resnim fenotipom kazali omejen napredek ali nobenega napredka v kogniciji.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer of the biological active substance BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, USA Name and address of the manufacturer responsible for batch release Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Ireland The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch. 
Ime in naslov izdelovalca biološke zdravilne učinkovine BioMarin Pharmaceutical Inc, Galli Drive Facility, 46 Galli Drive, Novato, CA 94949, ZDA Ime in naslov izdelovalca, odgovornega za sproščanje serij Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija Genzyme Ireland Ltd, IDA Industrial Park, Old Kilmeaden Road, Waterford, Irska V natisnjenem navodilu za uporabo zdravila morata biti navedena ime in naslov izdelovalca, odgovornega za sprostitev zadevne serije.
The volume of distribution decreased with continued treatment, possibly related to antibody formation and/or decreased liver volume. 
Volumen porazdelitve se je z nadaljevanjem zdravljenja zmanjšal, kar je verjetno povezano s tvorbo protiteles in/ali pomanjšanjem jeter.
One study mainly assessed the safety and pharmacokinetics of Aldurazyme in patients less than 5 years old, but some efficacy measurements were included as well. 
V eni študiji so ocenjevali predvsem varnost in farmakokinetiko zdravila Aldurazyme pri bolnikih, mlajših od 5 let, vključenih pa je bilo tudi nekaj meritev učinkovitosti.
Other medicines and Aldurazyme 
Druga zdravila in zdravilo Aldurazyme
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH CHILDREN 
POSEBNO OPOZORILO O SHRANJEVANJU ZDRAVILA ZUNAJ DOSEGA IN POGLEDA OTROK
ADRs to Aldurazyme reported during the Phase 3 study and its extension in a total of 45 patients age 5 years and older and treated up to 4 years are listed below using the following categories of frequency: very common (≥1/10); common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 
Neželeni učinki zdravila Aldurazyme, o katerih so poročali v tretji fazi študije in njenem podaljšanju pri 45 bolnikih, starih 5 let in več ter zdravljenih do 4 leta, so razporejeni v spodnji preglednici po naslednjih kategorijah pogostosti: zelo pogosto (≥1/10); pogosto (≥1/100 do < 1/10), občasno (≥1/1.000 do <1/100), redko (≥1/10.000 do <1/1.000), zelo redko (<1/10.000) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Inform your doctor if you are using medicines containing chloroquine or procaine, due to a possible risk of decreasing the action of Aldurazyme. 
Obvestite svojega zdravnika, če jemljete zdravila s klorokvinom ali prokainom, ker obstaja možno tveganje zmanjšanja delovanja zdravila Aldurazyme.
All patients subsequently enrolled in an open label extension study where they all received 100 U/kg of Aldurazyme every week for an additional 3.5 years (182 weeks). 
Pozneje so vsi bolniki sodelovali v razširjeni odprti študiji, kjer so vsi vsak teden dobivali 100 e/kg zdravila Aldurazyme dodatnih 3,5 let (182 tednov).
No definite benefit was shown with the higher doses over the recommended dose. 
Niso opazili izrazitih prednosti višjih odmerkih v primerjavi s priporočenim odmerkom.
The safety and efficacy of Aldurazyme was assessed in a randomised, double-blind, placebo controlled, Phase 3 Study of 45 patients, ranging in age from 6 to 43 years. 
Varnost in učinkovitost zdravila Aldurazyme je bila ocenjena v randomizirani dvojno slepi in s placebom nadzorovani tretji fazi študije na 45 bolnikih, starih od 6 do 43 let.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
A. IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IZDELOVALEC,
Side effects were mainly seen while patients were being given the medicine or shortly after (infusionassociated reactions). 
Neželene učinke so v glavnem opazili pri bolnikih, ko so prejeli zdravilo ali pa kmalu zatem (reakcije, povezane z infuzijo).
When you experience such a reaction, you should immediately contact your doctor. 
Če doživite takšno reakcijo, morate nemudoma kontaktirati svojega zdravnika.
Upon study completion, all patients showed reductions in liver size and 50% (9/18) had normal liver size. 
Po zaključku študije je bilo pri vseh bolnikih opazno zmanjšanje velikosti jeter in 50 % (9/18) je imelo normalno velika jetra.
• feeling hot, feeling cold 
• občutek vročine, občutek mraza
It is given to treat the non-neurological manifestations of the disease. 
Zdravilo je namenjeno zdravljenju manifestacij bolezni, ki niso nevrološke narave.
To address the heterogeneity in disease manifestation across patients, using a composite endpoint that summed up clinically significant changes across five efficacy variables (percent predicted normal FVC, 6MWT distance, shoulder flexion range of motion, AHI, and visual acuity) the global response was an improvement in 26 patients (58%), no change in 10 patients (22%), and a deterioration in 9 patients (20%). 
Heterogenost manifestacije bolezni pri bolnikih smo obravnavali z uporabo sestavljene končne vrednosti, ki je povzela klinično pomembne spremembe petih spremenljivk učinkovitosti (predvideni normalni odstotek FVC, razdalja 6 min preizkusa hoje (MWT), obseg gibanja ramena, IAH in ostrina vida); globalni odgovor je bil izboljšanje pri 26 bolnikih (58 %), brez spremembe pri 10 bolnikih (22 %) in poslabšanje pri 9 bolnikih (20 %).
QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 100 U (approximately 0.58 mg) of laronidase. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA 1 ml vsebuje 100 e (približno 0,58 mg) laronidaze.
Four patients (three in the Phase 3 study and one in the Phase 2 study) showed marginal to low level in vitro inhibition of laronidase enzymatic activity, which did not appear to impact clinical efficacy and/or urinary GAG reduction. 
Pri štirih bolnikih (treh iz tretje faze študije in enem iz druge faze študije) je bila opažena mejna do nizka in vitro inhibicija encimske aktivnosti laronidaze, ki ni imela očitnega vpliva na klinično učinkovitost in/ali zmanjšanje vrednosti GAG v urinu.
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, United Kingdom. 
Genzyme Ltd., 37 Hollands Road, Haverhill, Suffolk CB9 8PU, Velika Britanija.
Some of the symptoms of such a severe allergic reaction were life-threatening and included extreme difficulty breathing, swelling of the throat, low blood pressure, and low oxygen level in the body. 
Nekateri simptomi takšne alergične reakcije so bili življenje ogrožajoči in so vključevali izjemno oteženo dihanje, otekanje žrela, nizek krvni tlak in nizko raven kisika v telesu.
Aldurazyme is used to treat patients with MPS I disease (Mucopolysaccharidosis I). 
Aldurazyme se uporablja za zdravljenje bolnikov z boleznijo MPS I (mukopolisaharidoza I).
After intravenous infusion, laronidase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors. 
Po intravenski infuziji laronidaza hitro zapusti krvni obtok in celice jo zajamejo v lizosome, najverjetneje z receptorji za manozo-6-fosfat.
Patients treated with Aldurazyme should be closely monitored and all cases of infusion-associated reactions, delayed reactions and possible immunological reactions reported. 
Bolnike, ki se zdravijo z zdravilom Aldurazyme, morate skrbno nadzorovati in poročati o vseh reakcijah ob infuziji, zapoznelih reakcijah ali morebitnih imunoloških reakcijah.
Of the 26 patients with abnormal liver volumes at pre-treatment baseline, 22 (85%) achieved a normal liver size by the end of the study. 
Izmed 26 bolnikov z abnormalnimi volumni jeter glede na izhodiščno točko, jih je 22 (85 %) doseglo normalno velikost jeter do zaključka študije.
The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyse the accumulated substrate and to prevent further accumulation. 
Osnovni cilj terapije z nadomestnimi encimi je obnovitev encimske aktivnosti na raven, ki zadošča za hidrolizo nakopičenih substratov in preprečevanje njihovega nadaljnjega kopičenja.
To date there are no clinical data that demonstrate any benefit on the neurological manifestations of the disorder. 
Ni kliničnih podatkov, ki bi prikazali kakršnekoli izboljšave nevroloških manifestacij te motnje.
Each vial of Aldurazyme is intended for single use only. 
Vsaka viala z zdravilom Aldurazyme je namenjena samo enkratni uporabi.
As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible. 
Kot pri vseh pripravkih s proteini za intravensko uporabo obstaja možnost pojava težkih alergičnih reakcij.
Laronidase is a recombinant form of human α-L-iduronidase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. 
Laronidaza je rekombinantna oblika človeške -L-iduronidaze in se proizvaja s tehnologijo rekombinacije DNA z uporabo ovarijske celične kulture kitajskih hrčkov.
If you are given more Aldurazyme than needed No case of overdose of Aldurazyme has been reported. 
Če ste prejeli večji odmerek zdravila Aldurazyme, kot ga potrebujete Ni poročil o primerih prevelikega odmerjanja.
The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment). 
Večino z zdravilom povezanih neželenih dogodkov v kliničnih preskušanjih so opredelili kot reakcije, povezane z infuzijami (infusion associated reactions, IARs)), do katerih je prišlo pri 53 % bolnikov v tretji fazi študije (zdravljenje do 4 let) in 35 % bolnikov mlajših od 5 let (zdravljenje do 1 leta).
After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26. 
Po intravenski uporabi laronidaze s časom infundiranja 240 minut in z odmerkom 100 e/kg telesne mase so merili farmakokinetične lastnosti v 1., 12. in 26. tednu zdravljenja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS) 
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 10 VIAL, 25 VIAL)
The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17). 
Odstotek bolnikov z blago hipertropijo na levem prekatu se je znižal s 53 % (10/19) na 17 % (3/18), srednja masa levega prekata se je normalizirala, saj se je telesna površina znižala za 0,9 Z-Score (n=17).
Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22. 
Pri štirih bolnikih se je zadnjih 26 tednov študije odmerek povišal na 200 e/kg zaradi zvišanih vrednosti GAG v urinu v 22. tednu.
The 200 U/kg IV every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions; however, there is no evidence that the long term clinical efficacy of these two dose regimens is equivalent. 
vsaka 2 tedna je sprejemljivi alternativni režim za bolnike, ki imajo težave pri tedenskih infuzijah, vendar pa ni dokazov o ekvivalentnosti dolgotrajnejše klinične učinkovitosti teh dveh režimov odmerjanja.
Because there are no data available in neonates exposed to laronidase via breast milk, it is recommended to stop breast-feeding during Aldurazyme treatment. 
Ker ni podatkov o novorojenčkih, ki so z materinim mlekom prejemali laronidazo, materam priporočamo, da med zdravljenjem z zdravilom Aldurazyme prekinejo dojenje.
Laronidase may be excreted in milk. 
Obstaja verjetnost, da se laronidaza izloča v materino mleko.
Based on the Phase 3 clinical trial, almost all patients are expected to develop IgG antibodies to laronidase, mostly within 3 months of initiation of treatment. 
Po izsledkih tretje faze kliničnega preskušanja lahko pričakujemo, da se bodo pri skoraj vseh bolnikih razvila protitelesa IgG za laronidazo, večinoma v prvih treh mesecih zdravljenja.
By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted. 
Do zaključka tretje faze študije (ali ob času zgodnjega umika iz študije) pri 13 bolnikih (od 45 bolnikov) radioimunološki obarjalni preskus (RIP) ni zaznal protiteles, vključno pri 3 bolnikih, pri katerih ni nikoli prišlo do serokonverzije.
Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus. 
Očiščena laronidaza je glikoprotein z molekularno maso približno 83 kDa. Laronidaza je po odcepitvi N-terminala sestavljena iz 628 aminokislin.
For information on pre-treatment, see section 4.4. 
Informacije glede predhodnega zdravljenja so v poglavju 4.4.
Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8). 
Huda preobčutljivost (npr. anafilaktična reakcija) na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavji 4.4 in 4.8).
The primary efficacy endpoints were changes in percent of predicted normal FVC and absolute distance travelled in the six-minute walk test (6MWT). 
Osnovna merila učinkovitosti so bile spremembe v odstotku predvidene normalne forsirane vitalne kapacitete in absolutne razdalje, ki so jo bili zmožni prehoditi v 6-minutnem preizkusu (6MWT).
As there is little experience on resumption of treatment following prolonged interruption, use caution due to the theoretical increased risk of hypersensitivity reaction after treatment interruption. 
Izkušenj z nadaljevanjem zdravljenja po daljši prekinitvi je malo, zato bodite previdni, saj obstaja teoretična nevarnost pojava preobčutljivostnih reakcij po prekinitvi zdravljenja.
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease (see section 5.1). 
Zdravilo Aldurazyme je namenjeno dolgoročni terapiji z nadomestnimi encimi pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I (MPS I; pomanjkanje α-L-iduronidaze), in sicer za zdravljenje nenevroloških znakov bolezni (glejte poglavje 5.1).
The third study was conducted to evaluate the pharmacodynamics and safety of different dose regimens of Aldurazyme. 
Tretja klinična študija pa je ocenjevala farmakodinamiko in varnost različnih režimov odmerjanja zdravila Aldurazyme.
Renal elimination of laronidase is considered to be a minor pathway for clearance (see section 4.2). 
Za laronidazo velja, da se skozi ledvice izloča le v manjši meri (glejte poglavje 4.2).
The safety and efficacy of Aldurazyme in patients older than 65 years have not been established and no dosage regimen can be recommended in these patients. 
Varnost in učinkovitost zdravila Aldurazyme pri bolnikih, starejših od 65 let, nista bili dokazani, zato pri teh bolnikih ne moremo priporočati režima odmerjanja.
Almost all patients developed IgG antibodies to laronidase. 
Pri skoraj vseh bolnikih je prišlo do tvorbe protiteles IgG na laronidazo.
What Aldurazyme is and what it is used for What you need to know before you are given Aldurazyme How Aldurazyme is given 
Kaj je zdravilo Aldurazyme in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Aldurazyme Kako boste prejeli zdravilo Aldurazyme Možni neželeni učinki
Most patients seroconverted within 3 months of initiation of treatment; although seroconversion in patients under 5 years old with a more severe phenotype occurred mostly within 1 month (mean 26 days versus 45 days in patients 5 years and older). 
Pri večini bolnikov se je pojavila serokonverzija v 3 mesecih od začetka zdravljenja; čeprav se je serokonverzija pri bolnikih, mlajših od 5 let, s hujšo obliko fenotipa pojavila predvsem v prvem mesecu (povprečno 26 dni proti 45 dni pri bolnikih, starih 5 let in več).
PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion. 
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala s koncentratom za raztopino za infundiranje.
Sodium chloride, 
Natrijev klorid,
The molecule contains 6 N-linked oligosaccharide modifications sites. 
Molekula vsebuje 6 mest za reakcije z oligosaharidi, vezanih z dušikom.
Antibody status should be regularly monitored and reported. 
Redno preverjajte stanje protiteles in o tem poročajte.
Each vial of 5 ml contains 1.29 mmol sodium. 
Ena 5 ml viala vsebuje 1,29 mmol natrija.
The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people. 
Alergične (anafilaktične) reakcije in otekanje obraza spadajo med pogoste neželene učinke in se lahko pojavijo pri 1 od 10 bolnikov.
If you miss an infusion of Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor. 
Če niste dobili infuzije zdravila Aldurazyme Če niste dobili infuzije zdravila Aldurazyme, se posvetujte s svojim zdravnikom.
If clinically indicated, administration of pre-treatment medications with subsequent infusions of Aldurazyme should be considered. 
Če je to klinično indicirano, premislite o predhodni terapiji z zdravili in poznejšimi infuzijami zdravila Aldurazyme.
You should not be given this medicine after the expiry date which is stated on the label after the letters EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini za oznako EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens. 
V 4. fazi študije so ocenjevali farmakodinamične učinke vrednosti GAG v urinu, volumen jeter in vrednosti 6MWT pri različnih režimih odmerjanja zdravila Aldurazyme.
Therefore Aldurazyme should not be used during pregnancy unless clearly necessary. 
Zato zdravila Aldurazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Severe IARs have been reported in patients with pre-existent severe underlying upper airway involvement and therefore specifically these patients should continue to be closely monitored and only be infused with Aldurazyme in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available. 
Hude reakcije so se ob infuziji pojavile pri bolnikih, ki so imeli že prej močno prizadeta zgornja dihala, zato je treba te bolnike nenehno skrbno opazovati, zdravilo Aldurazyme pa se jim lahko infundira le v ustrezni klinični ustanovi, kjer imajo pri roki opremo za oživljanje za reševanje nujnih zdravstvenih primerov.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). 
To zdravilo vsebuje natrij; zdravilo infundirajte v obliki 0,9 % intravenske raztopine natrijevega klorida (glejte poglavje 6.6).
The presence of antibodies did not appear to be related to the incidence of IARs, although the onset of IARs typically coincided with the formation of IgG antibodies. 
Ni dokazov, da bi bila prisotnost protiteles povezana s pojavom reakcij povezanih z infuzijo, čeprav so se reakcije ob infuziji navadno pojavile skupaj s tvorbo IgG protiteles.
Laronidase is a protein and is expected to be metabolically degraded through peptide hydrolysis. 
Laronidaza je beljakovina in naj bi se presnavljala s hidrolizo peptidov.
Only clear and colourless solutions without visible particles should be used. 
Uporabite lahko le bistro in brezbarvno raztopino brez vidnih delcev.
The current medical standards for emergency treatment are to be observed. 
Pri tem se zgledujte po trenutnih zdravstvenih standardih za oskrbo nujnih primerov.
The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients. 
Varnost in učinkovitost zdravila Aldurazyme pri bolnikih z jetrno ali ledvično okvaro ni ocenjena, zato pri teh bolnikih ne moremo priporočati režima odmerjanja.
If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor. 
Če se pojavijo te reakcije, morate nemudoma prenehati z infundiranjem zdravila Aldurazyme, vaš zdravnik pa bo pričel z ustreznim zdravljenjem.
Reduced or absent α-L-iduronidase activity results in the accumulation of the GAGs, dermatan sulfate and heparan sulfate in many cell types and tissues. 
Zmanjšano delovanje ali odsotnost -L-iduronidaze povzroča kopičenje glikozaminoglikanov, dermatan sulfata in heparan sulfata v mnogih vrstah celic in tkiv.
This medicinal product contains 1.29 mmol sodium per vial. 
To zdravilo vsebuje 1,29 mmol natrija na vialo.
No information is available on the effects of Aldurazyme on fertility. 
Ni podatkov o učinku zdravila Aldurazyme na plodnost..
A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype). 
Opravljena je bila druga faza odprte enoletne študije, v kateri je bila ocenjena predvsem varnost in farmakokinetika zdravila Aldurazyme pri 20 bolnikih, ki so bili v času vključitve v študijo mlajši od 5 let (16 bolnikov je imelo hudo, 4 pa srednjo obliko fenotipa bolezni).
Consequently, impaired liver function is not expected to affect the pharmacokinetics of laronidase in a clinically significant way. 
Zato ni verjetno, da bi poslabšano delovanje jeter v klinično pomembni meri vplivalo na farmakokinetiko laronidaze.
Each vial of 5 ml contains 500 U of laronidase. 
Vsaka 5 ml viala vsebuje 500 e laronidaze.