natgillin/translations-raw huggingface dataset:
The majority of these reactions can be attributed to the formation of IgG antibodies and/or complement activation. 
Većina navedenih reakcija može se pripisati stvaranju IgG protutijela i/ili aktiviranju komplemenata.
If severe allergic or anaphylactic-type reactions occur, immediate discontinuation of the administration of Fabrazyme should be considered and appropriate treatment initiated. 
Ako se pojave alergijske ili anafilaktičke reakcije, treba razmotriti trenutni prekid primjene lijeka Fabrazyme i započeti odgovarajuće liječenje.
The majority of patients developed IgG antibodies to r-hαGAL, typically within 3 months of the first infusion with Fabrazyme. 
U većine su se bolesnika razvila IgG protutijela na r-hαGAL, obično unutar 3 mjeseca nakon prve infuzije lijeka Fabrazyme.
Plasma GL-3 was cleared in a dose dependent manner, but was less consistent at the dose of 0.3 mg/kg. 
Klirens GL-3 iz plazme ovisio je o dozi, ali je bio manje konzistentan kod doze od 0,3 mg/kg.
Infusion associated reactions consisted most often of fever and chills. 
Reakcije povezane s infuzijom najčešće su bile vrućica i zimica.
In clinical trials, sixty seven percent (67 %) of the patients experienced at least one infusionassociated reaction (see section 4.8). 
U kliničkim je ispitivanjima šezdeset i sedam posto (67%) bolesnika doživjelo barem jednu reakciju povezanu s infuzijom (vidjeti dio 4.8).
Infusion associated reactions 
Reakcije povezane s infuzijom
The reconstituted solution must be further diluted. 
Pripremljena otopina mora se dodatno razrijediti.
Sixty seven percent (67%) of the patients experienced at least one infusion-associated reaction. 
U šezdeset i sedam posto (67%) bolesnika javila se barem jedna reakcija povezana s infuzijom.
In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related reactions”). 
U kliničkim su ispitivanjima nuspojave uglavnom zabilježene tijekom primjene lijeka ili nedugo nakon toga ("reakcije povezane s infuzijom").
If not used immediately, in-use storage and conditions prior to use are the responsibility of the user. 
Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene odgovornost su korisnika.
Agalsidase beta is a protein and is expected to be metabolically degraded through peptide hydrolysis. 
Agalzidaza beta je protein i očekuje se da će se metabolički razgraditi peptidnom hidrolizom.
Package sizes: 1, 5 and 10 vials per carton. 
Veličine pakiranja: 1, 5 i 10 bočica u kutiji.
• influenza-like illness 
• bolest nalik gripi
Adverse reactions were mostly mild to moderate in severity: 
Nuspojave su uglavnom bile blagog do umjerenog intenziteta:
List of other side effects: 
Popis ostalih nuspojava:
If you experience a reaction like this, you should tell your doctor immediately. 
Ako doživite takvu reakciju, odmah o tome obavijestite svoga liječnika.
Renal function, as measured by glomerular filtration rate and serum creatinine, as well as proteinuria, remained stable in the majority of the patients. 
Bubrežna funkcija, mjerena brzinom glomeluralne filtracije i vrijednošću kreatinina u serumu te proteinurijom, ostala je stabilna u većine bolesnika.
No interaction studies and no in vitro metabolism studies have been performed. 
Nisu provedena ispitivanja interakcija ni ispitivanja metabolizma in vitro.
The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician. 
Odluka da se bolesnika prebaci na primjenu infuzije kod kuće smije se donijeti tek nakon procjene i preporuke nadležnog liječnika.
In clinical trials doses up to 3 mg/kg body weight were used. 
U kliničkim ispitivanjima primjenjivane su doze do 3 mg/kg tjelesne težine.
These patients should be treated with caution when re-administering agalsidase beta (see section 4.8). 
U tih bolesnika kod ponovne primjene agalzidaze beta liječenje treba provoditi uz oprez (vidjeti dio 4.8).
Another double-blind, placebo-controlled study of 82 patients was performed to determine whether Fabrazyme would reduce the rate of occurrence of renal, cardiac, or cerebrovascular disease or death. 
Provedeno je još jedno dvostruko slijepo, placebom kontrolirano ispitivanje s 82 bolesnika kako bi se utvrdilo može li Fabrazyme smanjiti stopu bubrežnih, srčanih ili cerebrovaskularnih bolesti odnosno smrti.
Plasma GL-3 levels rapidly normalised with treatment and remained normal through 5 years. 
Razine GL-3 u plazmi brzo su se normalizirale s liječenjem i ostale na normalnoj razini tijekom 5 godina.
Dose and infusion rate should remain constant while at home, and not be changed without supervision of a healthcare professional. 
Kad se infuzija primjenjuje kod kuće, doza i brzina moraju biti konstantne i ne smiju se mijenjati bez nadzora zdravstvenog djelatnika.
This finding was further supported by a statistically significant decrease in GL-3 inclusions in kidney, heart and skin combined and in the individual organs in patients treated with agalsidase beta compared to placebo patients (p<0.001). 
Ovaj nalaz dodatno podupire statistički značajno smanjenje inkluzija GL-3 u bubrezima, srcu i koži zajedno te u pojedinačnim organima u bolesnika liječenih agalzidazom beta u usporedbi s bolesnicima koji su primali placebo (p < 0,001).
Life threatening hypersensitivity (anaphylactic reaction) to the active substance or any of the excipients listed in section 6.1. 
Po život opasna preosjetljivost (anafilaktička reakcija) na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1.
In the first placebo-controlled clinical trial, Fabrazyme was effective in clearing GL-3 from the vascular endothelium of the kidney after 20 weeks of treatment. 
U prvom placebom kontroliranom kliničkom ispitivanju Fabrazyme je učinkovito pročistio GL-3 iz krvožilnog endotela bubrega nakon 20 tjedana liječenja.
Remove the airspace within the infusion bag to minimize the air/liquid interface. 
Uklonite zrak iz infuzijske vrećice da bi kontakt između zraka i tekućine bio što manji.
Uncommon (may affect up to 1 in 100 people): • tremor 
Manje česte (mogu se javiti u manje od 1 na 100 osoba): • nevoljno drhtanje
Each vial of Fabrazyme is intended for single use only. 
Jedna bočica lijeka Fabrazyme namijenjena je isključivo za jednokratnu uporabu.
This clearance was achieved in 69% (20/29) of the Fabrazyme treated patients, but in none of the placebo patients (p<0.001). 
Takav je klirens postiglo 69% (20/29) bolesnika liječenih lijekom Fabrazyme, no niti jedan bolesnik koji je primao placebo (p < 0,001).
Because there are no data available on effects in neonates exposed to agalsidase beta via breast milk, it is recommended to stop breast-feeding when Fabrazyme is used. 
Budući da nema podataka o učincima izlaganja novorođenčadi agalzidazi beta putem majčinog mlijeka, preporučuje se prekinuti dojenje tijekom primjene lijeka Fabrazyme.
The risks and benefits of Fabrazyme in children aged 5 to 7 years have not yet been established and therefore no dose can be recommended for this age group. 
Rizici i koristi lijeka Fabrazyme u djece u dobi od 5 do 7 godina još nisu ustanovljeni pa se za tu dobnu skupinu ne može preporučiti doza.
Fabrazyme is given through a drip into a vein (by intravenous infusion). 
Fabrazyme se daje kapanjem (dripom) u venu (intravenskom infuzijom).
Investigations oxygen saturation decreased 
Pretrage smanjena saturacija kisikom
After IgG seroconversion, there was no apparent change in CL (+24% and +6%, resp.), while Vss was 1.8 and 2.2 fold higher, with the net effect being a small decrease in Cmax (up to -34% and -11%, resp.) and no change in AUC (-19% and6%, resp.). 
Nakon IgG serokonverzije nije bilo vidljive promjene CL-a (redom +24% odnosno +6%), dok je Vss bio 1,8 odnosno 2,2 puta viši s neto učinkom malog smanjenja Cmax vrijednosti (do -34% odnosno -11%) i bez promjene AUC vrijednosti (-19% odnosno
Adverse reaction terminology is based upon the Medical Dictionary for Regulatory Activities (MedDRA) 
Terminologija nuspojava temelji se na medicinskom rječniku za regulatorne poslove
• Home infusion manual for healthcare professionals 
• priručnik za primjenu infuzije kod kuće za zdravstvene djelatnike
In some of these patients, an increase of some of the following symptoms was spontaneously reported: pain, paraesthesia and diarrhoea, as well as cardiac, central nervous system and renal manifestations. 
U nekih od tih bolesnika spontano je prijavljeno povećanje nekih od sljedećih simptoma: boli, parestezije i proljeva te manifestacija na srcu, središnjem živčanom sustavu i bubrezima.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 5 VIALS, 10 VIALS) 
VANJSKO PAKIRANJE (1 BOČICA, 5 BOČICA, 10 BOČICA)
If you forget to use Fabrazyme 
Ako ste zaboravili primijeniti Fabrazyme
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes. 
Farmakoterapijska skupina: Ostali lijekovi za probavni sustav i metabolizam, enzimi.
Agalsidase beta may be excreted in milk. 
Agalzidaza beta može se izlučivati u mlijeko.
The closure consists of a siliconised butyl stopper and an aluminium seal with a plastic flip-off cap. 
Zatvarač se sastoji od silikoniziranog butilnog čepa i aluminijskog zaštitnog zatvarača s plastičnom "flip-off" kapicom.
The infusion-associated reactions were managed by a reduction in the infusion rate together with the administration of non-steroidal anti-inflammatory medicinal products, antihistamines and/or corticosteroids. 
Reakcije povezane s infuzijom ublažene su smanjenjem brzine infuzije u kombinaciji s primjenom nesteroidnih protuupalnih lijekova, antihistaminika i/ili kortikosteroida.
The results of these studies indicate that Fabrazyme treatment at 1 mg/kg every other week provides clinical benefit on key clinical outcomes in patients with early and advanced Fabry disease. 
Rezultati tih ispitivanja ukazuju na to da liječenje lijekom Fabrazyme u dozi od 1 mg/kg svaki drugi tjedan poboljšava ključne pokazatelje kliničkog ishoda u bolesnika s ranom i uznapredovalom Fabryjevom bolešću.
Patients experiencing adverse events during the home infusion need to immediately stop the infusion process and seek the attention of a healthcare professional. 
Bolesnici u kojih se tijekom primanja infuzije pojave nuspojave moraju odmah prekinuti infuziju i potražiti pomoć zdravstvenog djelatnika.
The reconstituted solution cannot be stored and should be promptly diluted; only the diluted solution can be held for up to 24 hours at 2°C-8°C. 
Rekonstituirana otopina ne može se čuvati i mora se odmah razrijediti; samo se razrijeđena otopina može čuvati do 24 sata na temperaturi od 2°C do 8°C.
Agalsidase beta is a recombinant form of human α-galactosidase A and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture. 
Agalzidaza beta je rekombinantni oblik ljudske α-galaktozidaze A, a proizvodi se tehnologijom rekombinantne DNK na staničnoj kulturi sisavaca, odnosno jajnika kineskog hrčka (engl.
Cardiac Disorders tachycardia, palpitations, bradycardia sinus bradycardia -- 
Srčani poremećaji tahikardija, palpitacije, bradikardija sinusna bradikardija --
Determine the total volume of sodium chloride 0.9% solution for infusion (between 50 and 500 ml) based on the individual dose. 
Odredite ukupni volumen 0,9% otopine natrijevog klorida za infuziju (između 50 i 500 ml) na temelju pojedinačne doze.
Fabry disease is an inherited heterogeneous and multisystemic progressive disease, that affects both males and females. 
Fabryjeva bolest Fabryjeva bolest je nasljedna heterogena i višesustavna progresivna bolest koja pogađa i muškarce i žene.
Patients with antibodies to r-hαGAL have a greater potential to experience infusion-associated reactions (IARs), which are defined as any related adverse event occurring on the infusion day. 
U bolesnika s protutijelima na r-hαGAL postoji veća vjerojatnost od pojave reakcija povezanih s infuzijom koje se definiraju kao bilo koja povezana nuspojava koja se pojavi na dan infuzije.
The diluted solution can be held for up to 24 hours at 2°C - 8°C. 
Razrijeđena se otopina može čuvati do 24 sata na temperaturi 2°C - 8°C.
Vss ranged from 8.3-40.8 l, plasma clearance from 119-345 ml/min and the mean elimination half-life from 80-120 minutes. 
Vrijednost Vss iznosila je od 8,3 do 40,8 l, klirens iz plazme od 119 do 345 ml/min, a srednje poluvrijeme eliminacije od 80 do 120 minuta.
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands 
Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska
Very common symptoms (may affect more than 1 in 10 people) include chills, fever, feeling cold, nausea, vomiting, headache and abnormal feelings in the skin such as burning or tingling. 
Vrlo česti simptomi (mogu se javiti u više od 1 na 10 osoba) uključuju zimicu, vrućicu, osjećaj hladnoće, mučninu, povraćanje, glavobolju i neuobičajene osjete na koži, poput žarenja ili trnaca.
Reduced or absent αgalactosidase activity results in the accumulation of GL-3 in the lysosomes of many cell types including the endothelial and parenchymal cells, ultimately leading to life-threatening clinical deteriorations as a result of renal, cardiac and cerebrovascular complications. 
Smanjena aktivnost α-galaktozidaze ili njezin potpuni izostanak dovodi do kumulacije GL-3 u lizosomima mnogih vrsta stanica, uključujući stanice endotela i parenhimske stanice, što u konačnici dovodi do po život opasnih kliničkih pogoršanja kao posljedice bubrežnih, srčanih i cerebrovaskularnih komplikacija.
The educational material for patients should include information on the following key elements: - The prescribing physician may decide that Fabrazyme may be administered at home. 
Edukacijski materijal za bolesnike mora sadržavati informacije o sljedećim ključnim elementima: - Liječnik propisivač može donijeti odluku o primjeni lijeka Fabrazyme kod kuće.
Gently invert or lightly massage the infusion bag to mix the diluted solution. 
Lagano preokrenite ili protrljajte infuzijsku vrećicu kako biste promiješali razrijeđenu otopinu.
The marketing authorisation holder (MAH) shall agree the details of the educational programme for Fabrazyme home infusion with the National Competent Authorities prior to implementing the programme nationally. 
Nositelj odobrenja obvezuje se u suradnji s nacionalnim nadležnim tijelima dogovoriti podrobnosti programa edukacije za kućnu primjenu infuzije lijeka Fabrazyme prije provedbe programa na nacionalnoj razini.
What you need to know before you use Fabrazyme Do not use Fabrazyme 
Što morate znati prije nego počnete primjenjivati Fabrazyme
Do not use this medicine after the expiry date which is stated on the label after ‘EXP'. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake "Rok valjanosti".
Do not drive or use machines if you experience dizziness, sleepiness, vertigo or fainting during or shortly after administration of Fabrazyme (see section 4). 
Nemojte upravljati vozilima ni raditi na strojevima ako osjetite omaglicu, pospanost, vrtoglavicu ili nesvjesticu tijekom ili nedugo nakon primjene lijeka Fabrazyme (vidjeti dio 4).
• increased sensitivity to pain 
• povećana osjetljivost na bol
Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal development (see section 5.3). 
Istraživanja na životinjama ne ukazuju na izravne niti neizravne štetne učinke na razvoj zametka/ploda
Clearance of GL-3 was also achieved in several other cell types from the kidney. 
Klirens GL-3 postignut je i u nekoliko drugih vrsta bubrežnih stanica.
After intravenous infusion, agalsidase beta is rapidly removed from the circulation and taken up by vascular endothelial and parenchymal cells into lysosomes, likely through the mannose-6 phosphate, mannose and asialoglycoprotein receptors. 
Nakon intravenske infuzije agalzidaza beta se brzo uklanja iz krvotoka jer je stanice krvožilnog endotela i parenhimske stanice prenose u svoje lizozome, vjerojatno putem manoza-6-fosfatnih, manoznih i azialoglikoproteinskih receptora.
• low heart rate due to conduction disturbances 
• spori otkucaji srca zbog smetnji provođenja impulsa
The initial infusion rate should be no more than 0.25 mg/min (15 mg/hour) to minimise the potential occurrence of infusion-associated reactions. 
Početna brzina infuzije ne smije biti veća od 0,25 mg/min (15 mg/sat) kako bi se mogućnost pojave reakcija povezanih s infuzijom svela na najmanju moguću mjeru.
However, the effect of Fabrazyme treatment on the kidney function was limited in some patients with advanced renal disease. 
Međutim, učinak liječenja lijekom Fabrazyme na bubrežnu funkciju bio je ograničen u nekih bolesnika s uznapredovalom bolešću bubrega.
Both baseline and 5-year kidney biopsies were obtained in a subset of 6 patients: in all, kidney capillary endothelium GL-3 scores were reduced to zero but highly variable effects were observed in podocyte GL-3, with a reduction in 3 patients. 
Biopsije bubrega na početku i nakon 5 godina su pribavljene u podskupini od 6 bolesnika: u svih su vrijednosti GL-3 u endotelu kapilara bubrega bile smanjene na nulu, ali primjećeni su visoko varijabilni rezultati u GL-3 vrijednostima u podocitima, sa smanjenjem u 3 bolesnika.
Immune system disorders anaphylactoid reaction 
Poremećaji imunološkog sustava anafilaktoidna reakcija
Infections and infestations nasopharyngitis rhinitis 
Infekcije i infestacije nazofaringitis rinitis
No clinical studies have been performed in children 0-4 years old. 
U djece u dobi od 0 do 4 godine nisu provedena klinička ispitivanja.
• red eyes 
• crvenilo očiju
For doses lower than 35 mg use a minimum of 50 ml, for doses 35 to 70 mg use a minimum of 100 ml, for doses 70 to 100 mg use a minimum of 250 ml and for doses greater than 100 mg use only 500 ml. 
Za doze manje od 35 mg uzmite najmanje 50 ml, za doze od 35 do 70 mg najmanje 100 ml, za doze od 70 do 100 mg najmanje 250 ml, a za doze iznad 100 mg uzmite isključivo
In an additional study, 21 male patients were enrolled to follow GL3 clearance in kidney and skin tissues at an alternative dosing regimen. 
U dodatno ispitivanje uključen je 21 bolesnik muškog spola, a pratio se klirens GL3 iz tkiva bubrega i kože kod primjene alternativnog režima doziranja.
A reduction in GL-3 was observed in kidney, heart, skin and plasma at all doses. 
Pri svim je dozama primijećeno smanjenje vrijednosti GL-3 u bubrezima, srcu, koži i plazmi.
This is done by slow dropwise addition of the water for injection down the inside of the vial and not directly onto the lyophilized cake. 
To se postiže polaganim ulijevanjem vode za injekcije kap po kap niz unutarnju stijenku bočice, a ne izravno na liofilizirani kolačić.
There is a theoretical risk of decreased agalsidase beta activity. 
Postoji teoretska mogućnost da oni umanje aktivnost agalzidaze beta.
• Home infusion manuals for patients 
• priručnike za primjenu infuzije kod kuće za bolesnike
EU/1/01/188/001 Fabrazyme 35 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/002 Fabrazyme 35 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/003 Fabrazyme 35 mg 10 vials of powder for concentrate for solution for infusion EU/1/01/188/004 Fabrazyme 5 mg 1 vial of powder for concentrate for solution for infusion EU/1/01/188/005 Fabrazyme 5 mg 5 vials of powder for concentrate for solution for infusion EU/1/01/188/006 Fabrazyme 5 mg 10 vials of powder for concentrate for solution for infusion 
EU/1/01/188/001 Fabrazyme 35 mg 1 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/002 Fabrazyme 35 mg 5 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/003 Fabrazyme 35 mg 10 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/004 Fabrazyme 5 mg 1 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/005 Fabrazyme 5 mg 5 bočica praška za koncentrat za otopinu za infuziju EU/1/01/188/006 Fabrazyme 5 mg 10 bočica praška za koncentrat za otopinu za infuziju
The safety and efficacy of Fabrazyme in patients older than 65 years have not been established and no dosage regimen can presently be recommended in these patients. 
U bolesnika starijih od 65 godina sigurnost i djelotvornost lijeka Fabrazyme nisu utvrđene pa trenutno za te bolesnike nije moguće preporučiti režim doziranja.
Determine the number of vials to be reconstituted based on the individual patient's weight and remove the required vials from the refrigerator in order to allow them to reach room temperature (in approximately 30 minutes). 
Na temelju tjelesne težine pojedinog bolesnika odredite broj bočica koje treba rekonstituirati i izvadite ih iz hladnjaka da se ugriju na sobnu temperaturu (otprilike 30 minuta).
Pregnancy There are no adequate data from the use of agalsidase beta in pregnant women. 
Nema odgovarajućih podataka o primjeni agalzidaze beta u trudnica.
After reconstitution it is recommended to promptly dilute the vials, to minimise protein particle formation over time. 
Nakon rekonstitucije preporučuje se odmah razrijediti sadržaj bočica kako bi se stvaranje čestica proteina s vremenom svelo na najmanju moguću mjeru.
• decreased mouth sensitivity 
• smanjena osjetljivost u ustima
Fabrazyme pharmacokinetics was also evaluated in two paediatric studies. 
Farmakokinetika lijeka Fabrazyme ocijenjena je i u dva ispitivanja s pedijatrijskom populacijom.
Fabrazyme is supplied as a white to off-white powder. 
Fabrazyme dolazi u obliku bijelog do bjelkastog praška.
Use Aseptic Technique 
Primijenite aseptički postupak
Renal elimination of agalsidase beta is considered to be a minor pathway for clearance. 
Eliminacija agalzidaze beta bubrezima smatra se sporednim putem klirensa.
• infusion site reaction 
• reakcija na mjestu primjene infuzije
Lower dosing regimens have been used in clinical studies. 
U kliničkim su ispitivanjima primijenjeni i niži režimi doziranja.
The effect of Fabrazyme treatment on the kidneys may be limited in patients with advanced renal disease. 
Učinak liječenja lijekom Fabrazyme na bubrege može biti ograničen u bolesnika s uznapredovalom bubrežnom bolešću.
After patient tolerance is established, the infusion rate may be increased gradually with subsequent infusions. 
Nakon što se u bolesnika utvrdi podnošljivost, brzina infuzije može se u sljedećim infuzijama postupno povećavati.
Fabrazyme contains the active substance agalsidase beta and is used as enzyme replacement therapy in Fabry disease, where the level of α-galactosidase enzyme activity is absent or lower than normal. 
Fabrazyme sadrži djelatnu tvar agalzidazu beta, a primjenjuje se kao enzimska nadomjesna terapija u liječenju Fabryjeve bolesti kod koje enzim α-galaktozidaza nije aktivan ili je njegova aktivnost niža od normalne.
Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases. 
Liječenje lijekom Fabrazyme mora nadzirati liječnik s iskustvom u liječenju bolesnika s Fabryjevom bolešću ili drugim nasljednim metaboličkim bolestima.
Then slowly inject the reconstituted solution directly into the 0.9% sodium chloride intravenous solution (not in any remaining airspace) to a final concentration between 0.05 mg/ml and 0.7 mg/ml. 
Zatim polako ubrizgavajte rekonstituiranu otopinu izravno u 0,9% otopinu natrijevog klorida za intravensku primjenu (ne u prostor ispunjen zrakom) do konačne koncentracije između 0,05 mg/ml i 0,7 mg/ml.
In the dose finding study, the effects of 0.3, 1.0 and 3.0 mg/kg once every 2 weeks and 1.0 and 3.0 mg/kg once every 2 days were evaluated. 
U ispitivanju za utvrđivanje doze procijenjeni su učinci doza od 0,3, 1,0 i 3,0 mg/kg primijenjenih jedanput svaka 2 tjedna te doza od 1,0 i 3,0 mg/kg primijenjenih jedanput svaka 2 dana.
The rate of clinical events was substantially lower among Fabrazyme-treated patients compared to placebo-treated patients (risk reduction = 53% intent-to-treat population (p=0.0577); risk reduction = 61 % per-protocol population (p=0.0341)). 
Stopa kliničkih događaja bila je znatno niža u bolesnika liječenih lijekom Fabrazyme nego u bolesnika koji su primali placebo (smanjenje rizika = 53% u populaciji svih uključenih bolesnika (p=0,0577);