natgillin/translations-raw huggingface dataset:
Common (likely to occur in fewer than 1 in 10 patients and more than 1 in 100 patients): diarrhoea, indigestion, abdominal pain, constipation, flatulence Very rare (likely to occur in fewer than 1 in 10,000 patients): intestinal obstruction.
Zelo pogosti (verjetnost, da se pojavijo pri več kot 1 od 10 bolnikov): slabost, bruhanje Pogosti (verjetnost, da se pojavijo pri manj kot 1 od 10 bolnikov in pri več kot 1 od 100 bolnikov):, driska, slaba prebava, bolečine v trebuhu, zaprtje, vetrovi Zelo redki (verjetnost, da se pojavijo pri manj kot 1 od 10, 000 bolnikov): črevesna zapora.
Most of these events are also commonly observed in patients with chronic kidney disease and are not necessarily due to Renagel.
Večina teh učinkov se pogosto pojavlja tudi pri bolnikih s kronično ledvično boleznijo in niso nujno posledica uporabe zdravila Renagel.
Since constipation may be a preceding symptom in very rare cases of intestinal obstruction, please inform your doctor or pharmacist.
Ker je zaprtje v redkih primerih lahko predhoden pojav črevesne zapore, vas prosimo, da o tem obvestite svojega zdravnika ali farmacevta.
HOW TO STORE RENAGEL
SHRANJEVANJE ZDRAVILA RENAGEL
Do not use Renagel after the expiry date stated on the labelling after the letters “ EXP”.
Zdravila Renagel ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden za oznako: “ EXP ”.
47 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
What Renagel contains
Kaj vsebuje zdravilo Renagel
- The active substance is selevamer.
- Zdravilna učinkovina je sevelamer.
- The other ingredients are silica colloidal anhydrous and stearic acid.
- Pomožne snovi so brezvodni koloidni silicijev dioksid in stearinska kislina.
The tablet coating contains
Obloga tablet vsebuje
hypromellose and diacetylated monoglycerides.
hipromelozo in diacetilirane monogliceride.
The printing ink contains iron oxide black (E172), hypromellose and propylene glycol.
Tiskarsko črnilo vsebuje črni železov oksid (E172), hipromelozo in propilenglikol.
Renagel tablets are film coated, off white, oval tablets with Renagel 400 imprinted on one side.
Izgled zdravila Renagel in vsebina pakiranja Renagel tablete so sivo- bele, ovalne, filmsko obložene tablete z natisnjeno oznako Renagel 400 na eni strani.
The tablets are packed in high density polyethylene bottles with a child resistant polypropylene cap and an induction seal.
Tablete so pakirane v plastenkah iz polietilena visoke gostote, s pokrovčkom iz polipropilena, ki je varen za otroke in indukcijskim tesnilom.
1 x 360 tablets 2 x 360 tablets 3 x 360 tablets
1 x 360 tablet 2 x 360 tablet 3 x 360 tablet.
Genzyme Ltd 12 Rookwood Way Haverhill, Suffolk CB9 8PB United Kingdom
12 Rookwood Way Haverhill, Suffolk CB9 8PB Velika Britanija
48 For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
48 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Ísland Vistor hf.
Ísland Vistor hf.,
If any of the following applies to you, please consult your doctor before taking Renagel: • you are not on dialysis • swallowing problems • problems with motility (movement) in your stomach and bowel • retention of stomach contents • active inflammation of the bowel • have undergone major surgery on your stomach or bowel.
50 • se ne zdravite z dializo • imate težave s požiranjem • imate težave z nenormalnim ali nepravilnim gibanjem želodca in črevesja • imate težave z zastajanjem hrane v želodcu • imate vnetje črevesja • ste prestali zahtevnejše operacije želodca ali črevesja.
The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used in transplant patients) may be reduced by Renagel.
Učinki zdravil, kot so ciklosporin, mikofenolat mofetil in takrolimus (udravila, ki se uporabljajo pri transplantiranih bolnikih) se lahko zmanjšajo zaradi zdravila Renagel.
51 Driving and using machines Renagel is unlikely to affect your ability to drive or to operate machines.
Vpliv na sposobnost upravljanja vozil in strojev Skorajda ni verjetnosti, da bi Renagel vplival na vašo sposobnost vožnje in upravljanja s stroji.
The recommended starting dose of Renagel for adults and the elderly (> 65 years) is one or two tablets with each meal 3 times a day.
Priporočljiv začetni odmerek zdravila Renagel za odrasle in starejše (> 65 let) je ena ali dve tableti pri vsakem glavnem obroku 3 krat dnevno.
Your doctor will check the levels of phosphate in your blood periodically and he/ she may adjust the dose of Renagel when necessary (between 1 and 5 tablets of 800 mg per meal) to reach an adequate phosphate level.
Vaš zdravnik bo občasno preveril koncentracijo fosfatov v vaši krvi in lahko se zgodi, da bo odmerek zdravila Renagel po potrebi spremenil (med 1 in 5 tablet po 800 mg na obrok), da bi na ta način dosegel ustrezno koncentracijo.
Very rare (likely to occur in fewer than 1 in 10,000 patients): intestinal obstruction.
Zelo pogosti (verjetnost, da se pojavijo pri več kot 1 od 10 bolnikov): slabost, bruhanje Pogosti (verjetnost, da se pojavijo pri manj kot 1 od 10 bolnikov in pri več kot 1 od 100 bolnikov):, driska, slaba prebava, bolečine v trebuhu, zaprtje, vetrovi Zelo redki (verjetnost, da se pojavijo pri manj kot 1 od 10, 000 bolnikov): črevesna zapora.
52 Medicines should not be disposed of via wastewater or household waste.
Zdravila ne smete odvreči v odpadne vode ali med gospodinjske odpadke.
Renagel tablets are film coated, off white, oval tablets with Renagel 800 imprinted on one side.
Izgled zdravila Renagel in vsebina pakiranja Renagel tablete so sivo- bele, ovalne, filmsko obložene tablete z natisnjeno oznako Renagel 800 na eni strani.
6 x 30 tablets 1 x 100 tablets 1x 180 tablets 2 x 180 tablets 3 x 180 tablets
6 x 30 tablet 1 x 100 tablet 1 x 180 tablet 2 x 180 tablet 3 x 180 tablet.
Manufacturing authorisation holders responsible for batch release:
Izdelovalca, odgovorna za sproščanje serij:
12 Rookwood Way Haverhill, Suffolk CB9 8PB United Kingdom
12 Rookwood Way Haverhill, Suffolk CB9 8PB Velika Britanija
53 For any information about this medicine, please contact the local representative of the Marketing Authorisation holder.
53 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu
If you want more information on the basis of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
Če potrebujete več informacij o vašem zdravstvenem stanju ali zdravljenju, preberite Navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom. Če želite več informacij, ki temeljijo na priporočilih CHMP, preberite znanstveno razpravo (ki je prav tako del EPAR).
Replagal is a solution for infusion into the body containing the active substance agalsidase alfa.
Replagal je raztopina za infundiranje v telo, ki vsebuje zdravilno učinkovino agalzidaza alfa.
Replagal is used to treat patients who have Fabry disease, a rare inherited disorder.
Replagal se uporablja za zdravljenje bolnikov, ki imajo Fabryjevo bolezen, ki je redka dedna bolezen.
Patients with Fabry disease do not have enough of an enzyme, alpha-galactosidase A.
Bolniki s Fabryjevo boleznijo nimajo dovolj encima alfa- galaktozidaze A.
This enzyme normally breaks down a fatty substance called globotriaosylceramide (Gb3).
Ta encim običajno razgradi maščobno snov, imenovano globotriaozilceramid (Gb3).
If the enzyme is not present, Gb3 cannot be broken down and it builds up in the cells, such as kidney cells.
Če encima ni, se Gb3 ne razgradi in se začne kopičiti v celicah, na primer v celicah ledvic.
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems, and stroke.
Ljudje z Fabryjevo boleznijo imajo številne znake in simptome, vključno hude zdravstvene težave, kot so odpoved ledvic, težave s srcem in kap.
Because the number of patients with Fabry disease is low, the disease is considered ‘ rare’, and Replagal was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 8 August 2000.
Bolnikov s Fabryjevo boleznijo je malo, bolezen se šteje za „ redko “, zato je bilo zdravilo Replagal dne 8. avgusta 2000 določeno kot „ zdravilo sirota “ (zdravilo, ki se uporablja pri redkih boleznih).
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Replagal.
Zdravilo Replagal lahko daje samo zdravnik, ki ima izkušnje z zdravljenjem bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
It is used as an intravenous infusion of 0.2 mg/ kg body weight over 40 minutes given once every 2 weeks.
Zdravilo se daje vsaka dva tedna v obliki 40 - minutne intravenske infuzije v odmerku 0, 2 mg/ kg telesne mase.
Some studies have looked at what happens to Replagal when given to children, and they suggested that Replagal could be used in children between 7 and 18 years of age at the same dose.
V nekaterih študijah so raziskovali, kaj se zgodi, če se zdravilo Replagal daje otrokom in predlagali, da bi se zdravilo Replagal lahko uporabljalo pri otrocih od 7 do 18 leta v enakih odmerkih.
Patients who have severe kidney damage may have a weaker response to treatment.
Bolniki z resnimi ledvičnimi poškodbami se utegnejo slabše odzvati na zdravljenje.
Replagal is intended for long-term use.
Zdravilo Replagal je namenjeno za dolgotrajno uporabo.
Replagal is an enzyme replacement therapy.
Replagal je encimska nadomestna terapija.
Replagal is designed to replace the human enzyme, alpha-galactosidase A, which people with Fabry disease are lacking.
Replagal je namenjen nadomeščanju človeškega encima, alfa- galaktozidaze A, ki ga ljudem s Fabryjevo boleznijo primanjkuje.
The active substance in Replagal, agalsidase alfa, is a copy of the human enzyme, produced by a method known as ‘ recombinant DNA technology’.
Zdravilna učinkovina zdravila Replagal, agalzidaza alfa, je kopija človeškega encima, ki je izdelana po metodi „ rekombinantne DNA tehnologije “.
It is made by a cell that has received a gene (DNA), which makes it able to produce the enzyme.
Encim izdela celica, ki je prejela gen (DNA), ki ji omogoča izdelovanje encima.
The replacement enzyme helps to break down the Gb3 and stops it building up (accumulating) in the cells.
Nadomestni encim pomaga razgraditi Gb3 in preprečiti njegovo kopičenje (akumulacijo) v celicah.
Replagal has been examined in two clinical studies, involving a total of 40 male patients.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 68 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Gb3 iz levega prekata (srčna mišica).
A further study was also carried out in 15 female (carrier) patients.
Dodatna študija je bila izvedena na 15 bolnicah (nosilkah).
Replagal has also been studied in 24 children aged between 6 and a half and 18 years of age.
Zdravilo Replagal so preučevali tudi pri 24 otrocih, starih od 6 let in pol do 18 let.
What benefit has Replagal shown during the studies?
Kakšne koristi je zdravilo Replagal izkazalo med raziskavami?
After 6 months of therapy Replagal significantly reduced pain in patients when compared to placebo (dummy) treated patients.
Po šestih mesecih zdravljenja je bila bolečina pri bolnikih, zdravljenih z Replagalom bistveno manjša kot pri bolnikih, ki so prejemali placebo (zdravilo brez zdravilne učinkovine).
Replagal reduced left ventricle mass by an average of 11.5 g while patients receiving placebo had an increase in left ventricular mass of 21.8 g.
Replagal je zmanjšal maso levega prekata povprečno za 11, 5 g, medtem ko se je masa levega prekata pri bolnikih, ki so prejemali placebo, povečala za 21, 8 g.
These results suggest the symptoms of the disease improving or the disease becoming stable.
Ti rezultati kažejo na izboljšanje bolezenskih simptomov ali na ustalitev bolezni.
The effects in female patients were shown to be comparable to the results seen in male patients.
Učinki pri ženskah so se izkazali za primerljive z rezultati pri moških bolnikih.
Children who received 6-month treatment with Replagal had no increase in heart, and the levels of Gb3 in their blood was reduced.
Pri otrocih, ki so prejeli 6- mesečno zdravljenje z zdravilom Replagal, ni bilo povečanja srca, ravni Gb3 v njihovi krvi pa so bile znižane.
During the studies the most common side effects (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Med študijami je večino neželenih učinkov (opaženih pri več kot enem od desetih bolnikov) povzročila infuzija in manj zdravilo.
These reactions are mainly chills, headache, nausea, pyrexia (fever), flushing and fatigue (tiredness), and are rarely severe.
Ti učinki so najpogosteje mrazenje, glavobol, slabost, pireksija (povišana telesna temperatura), zardevanje in utrujenost, ter so redko resni.
Other very common side effects were pain and discomfort.
Med drugimi zelo pogostimi neželenimi učinki sta bolečina in nelagodje.
Side effects reported in children are similar to those seen in adult patients.
Neželeni učinki, o katerih so poročali pri otrocih, o podobni tistim opaženim pri odraslih.
For the full list of all side effects reported with Replagal, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Replagal, glejte Navodilo za uporabo.
Patients who receive Replagal can develop antibodies (proteins that are produced in response to Replagal and can affect treatment).
Bolniki, ki prejemajo zdravilo Replagal lahko razvijejo protitelesa (beljakovine, ki nastanejo zaradi zdravila Replagal in lahko vplivajo na zdravljenje).
Replagal should not be used in people who may be hypersensitive (allergic) to agalsidase alfa or any of the other ingredients.
Zdravila Replagal ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) agalzidazo alfa ali katerokoli drugo sestavino.
The Committee for Medicinal products for Human Use (CHMP) decided that for patients with Fabry disease, treatment with Replagal might provide long-term clinical benefits.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da lahko bolnikom s Fabryjevo boleznijo zdravljenje z zdravilom Replagal zagotovi dolgoročne klinične koristi.
The CHMP decided that Replagal’ s benefits are greater than its risks and recommended that Replagal be given marketing authorisation.
CHMP je odločil, da so koristi zdravila Replagal večje od z njim povezanih tveganj, zato je za zdravilo Replagal priporočil podelitev dovoljenja za promet.
Replagal has been authorised under "Exceptional Circumstances", because, as the disease is rare, it has not been possible to obtain complete information on the medicine.
Ker je bolezen redka, ni bilo mogoče pridobiti vseh informacij o zdravilu, zato je bilo dovoljenje za promet z zdravilom podeljeno v „ izjemnih okoliščinah “.
Every year, the European Medicines Agency (EMEA) reviews any new information that may have become available and this summary will be updated as necessary.
Vsako leto Evropska agencija za zdravila (EMEA) pregleda vse nove razpoložljive informacije in bo po potrebi posodobila ta povzetek.
What information is still awaited for Replagal?
Katere informacije o zdravilu Replagal še pričakujemo?
The company that makes Replagal will carry further studies with the medicine, looking in particular at the results of 5-year treatment, other dosages, maintenance dosages, and studies in children.
Družba, ki proizvaja zdravilo Replagal, bo opravila še dodatne raziskave zdravila, še zlasti v zvezi z rezultati petletnega zdravljenja, rezultati z drugimi odmerki, vzdrževalnimi odmerki in raziskave pri otrocih.
Other information about Replagal:
Druge informacije o zdravilu Replagal:
The European Commission granted a marketing authorisation valid throughout the European Union for Replagal to TKT Europe AB on 3 August 2001.
Evropska komisija je dovoljenje za promet z zdravilom Replagal, veljavno po vsej Evropski uniji, odobrila družbi TKT Europe AB dne 3. avgusta 2001.
The record of Replagal’ s designation as an Orphan medicine is available here.
Zapis o določitvi zdravila Replagal kot zdravila sirote je na voljo tukaj.
The full EPAR for Replagal is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Replagal je na voljo tukaj.
Replagal 1 mg/ ml concentrate for solution for infusion.
Replagal 1 mg/ ml koncentrat za pripravo raztopine za infundiranje.
1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa.
1 ml koncentrata za pripravo raztopine za infundiranje vsebuje 1 mg agalzidaze alfa.
Each vial of 1 ml of concentrate contains 1 mg of agalsidase alfa.
Vsaka viala z 1 ml koncentrata vsebuje 1 mg agalzidaze alfa.
Each vial of 3.5 ml of concentrate contains 3.5 mg of agalsidase alfa.
Vsaka viala s 3, 5 ml koncentrata vsebuje 3, 5 mg agalzidaze alfa.
Agalsidase alfa is the human protein α -galactosidase A produced in a human cell line by genetic engineering technology.
Agalzidaza alfa je človeški protein α- galaktozidaza A, izdelan s tehnologijo genskega inženiringa v človeški celični liniji.
A clear and colourless solution.
Koncentrat za pripravo raztopine za infundiranje Bistra in brezbarvna raztopina.
Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α -galactosidase A deficiency).
Replagal je indiciran za dolgoročno encimsko nadomestno zdravljenje pri bolnikih s potrjeno diagnozo Fabryjeve bolezni (pomanjkanje α- galaktozidaze A).
Replagal is administered at a dose of 0.2 mg/ kg body weight every other week by intravenous infusion over 40 minutes.
Replagal dajte v odmerku 0, 2 mg/ kg telesne mase vsak drugi teden s 40- minutno intravensko infuzijo.
For preparation and administration instructions, see section 6.6.
Za navodila za pripravo in način uporabe glejte 6. 6.
Patients aged over 65 years Studies in patients over the age of 65 have not been performed and no dosage regimen can presently be recommended in these patients as safety and efficacy have not yet been established.
Bolniki, starejši od 65 let Študije pri bolnikih, starejših od 65 let, niso bile opravljene, zato trenutno ni mogoče priporočiti režima odmerjanja pri teh bolnikih, saj varnost in učinkovitost zdravila še nista ugotovljeni.
The presence of extensive renal damage (eGFR < 60mL/ min) may limit the renal response to enzyme replacement therapy.
Hude poškodbe ledvic (eGFR [receptor za epidermalni rastni faktor] < 60 ml/ min) lahko omejijo odziv ledvic na encimsko nadomestno zdravljenje.
Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.
Prilagoditev odmerka ni priporočljiva.
Paediatric Patients The experience in children is limited.
Pediatrični bolniki Izkušnje pri otrocih so omejene.
Studies in children (0-6 years) have not been performed and no dosage regimen can presently be recommended in the patients as safety and efficacy have not yet been established.
Varnost in učinkovitost nista bili ugotovljeni, zato za to skupino bolnikov ni mogoče priporočiti odmerkov.
Limited clinical data in children (7-18 years) do not permit to recommend an optimal dosage regimen presently (see section 5.2).
Zaradi omejenih kliničnih podatkov pri otrocih (starih od 7 do 18 let), trenutno ni možno priporočiti optimalnega režima odmerjanja (glejte poglavje 5. 2).
Because no unexpected safety issues were encountered in
Pri odmerku Replagala 0, 2 mg/ kg pri otrocih,
2 the 6 month study with Replagal administered at 0.2 mg/ kg in this population, this dose regimen is suggested for children between 7– 18 years of age.
2 starih od 7 do 18 let, v šestmesečni študiji ni bilo nepričakovanih varnostnih težav, zato se ta odmerek priporoča za to populacijo bolnikov.
Hypersensitivity to the active substance or any of the excipients.
Preobčutljivost za zdravilno učinkovino ali katero koli pomožno snov.
Idiosyncratic infusion related reactions 13.7% of patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Idiosinkratične reakcije, povezane z infundiranjem 13, 7% bolnikov, zdravljenih z Replagalom v kliničnih preskušanjih, je izkusilo idiosinkratične reakcije, povezane z infundiranjem.
Overall, the percentage of infusion related reactions was significantly lower in females than males.
Odstotek reakcij, povezanih z infundiranjem je bil pri ženskah manjši kot pri moških.
Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/ vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue.
O resnih infuzijskih reakcijah so poročali občasno; med njihovimi simptomi so bili zvišanje telesne temperature, okorelost, tahikardija, urtikarija, navzeja/ bruhanje, angionevrotski edem s stiskanjem grla, stridor in otekanje jezika.
In addition, oral or intravenous pre-treatment with antihistamines and/ or corticosteroids, from 1 to 24 hours prior to infusion may prevent subsequent reactions in those cases where symptomatic treatment was required.
Poleg tega dodatno peroralno ali intravensko predhodno zdravljenje z antihistaminiki in/ ali kortikosteroidi 1 do 24 ur pred infuzijo lahko prepreči kasnejše reakcije v primerih, ko je potrebno simptomatsko zdravljenje.
Allergic-type hypersensitivity reactions As with any intravenous protein product, allergic-type hypersensitivity reactions are possible.
Preobčutljivostne reakcije alergijskega tipa Kot pri vsakem intravenskem proteinskem izdelku so tudi tu možne preobčutljivostne reakcije alergijskega tipa.
If severe allergic or anaphylactic-type reactions occur, the administration of Replagal should be discontinued immediately and appropriate treatment initiated.
Če pride do hudih alergijskih ali anafilaktičnih reakcij, takoj prekinite dajanje zdravila Replagal in uvedite ustrezno zdravljenje.
IgG antibodies to the protein As with all protein pharmaceutical products, patients may develop IgG antibodies to the protein.
Protitelesa IgG proti proteinu Kot pri vseh proteinskih farmacevtskih izdelkih lahko bolniki tudi v tem primeru začno izdelovati protitelesa IgG proti proteinu.
A low titre IgG antibody response has been observed in approximately 24% of the male patients treated with Replagal.
Odziv z majhnim titrom protiteles IgG so opazili pri približno 24% moških bolnikov, ki so jih zdravili z zdravilom Replagal.
Based on limited data this percentage has been found to be lower (7%) in the male paediatric population.
Na podlagi navedenih podatkov je ta odstotek manjši (7%) pri moških pediatričnih bolnikih.
These IgG antibodies appeared to develop following approximately 3-12 months of treatment.
Kaže, da so se ta protitelesa IgG razvila po približno 3- 12 mesecih zdravljenja.
After 12 to 54 months of therapy, 17% of Replagal treated patients were still antibody positive whereas 7% showed evidence for the development of immunologic tolerance, based on the disappearance of IgG antibodies over time.
Po 12 do 54 mesecih zdravljenja je bilo 17% bolnikov, ki so jih zdravili z Replagalom, še vedno pozitivnih na protitelesa, pri 7% pa so se kazali znaki imunske tolerance, kar se je kazalo kot izginjanje protiteles IgG s časom.
The remaining 76% remained antibody negative throughout.
Preostalih 76% bolnikov je ostalo ves čas negativnih na protitelesa.
No IgE antibodies have been detected in any patient receiving Replagal.
Pri nobenem bolniku, ki so ga zdravili z Replagalom, niso odkrili protiteles IgE.