natgillin/translations-raw huggingface dataset:
Common: headache, dizziness, vertigo, paresthaesia Very rare: confusion 
Pogosti: glavobol, omotica, vrtoglavost, parestezija.
6.3 Shelf life <[To be completed nationally]> 6.4 Special precautions for storage <[To be completed nationally]> 6.5 Nature and contents of container <[To be completed nationally]> 6.6 Instructions for use and handling < and disposal> <[To be completed nationally]> 
6.5 Posebna navodila za shranjevanje <[Izpolniti nacionalno]>
ClCR ≥ 60 
Priporočeni odmerek očistek kreatinina ≥ 60
Dosage adjustment in renal impairment: 
Prilagajanje odmerka pri bolnikih z ledvičnim popuščanjem:
Pacemaker therapy is indicated for therapy-resistant bradycardia. 
Srčni spodbujevalnik je indiciran pri bolnikih z bradikardijo, ki se ne odziva na zdravljenje.
Neutropenia/Agranulocytosis/Thrombocytopenia/Anaemia: 
Nevtropenija, agranulocitoza, trombocitopenija, anemija:
<COVERSYL and associated names> 4 mg: 4 mg perindopril tert-butylamine salt, equivalent to 3.338 mg perindopril 
KAKOVOSTNA IN KOLIČINSKA SESTAVA <COVERSYL in sorodna imena> 4 mg:
Symptomatic hypotension may occur following initiation of therapy with < COVERSYL and associated names>; this is more likely in patients who are being treated concurrently with diuretics. 
Ob uvedbi zdravljenja z zdravilom <COVERSYL in sorodna imena> se lahko pojavi simptomatična hipotenzija.
Symptomatic heart failure: 
Srčnožilne bolezni:
The maximum exposure was 5.6 years. 
Največja izpostavljenost je znašala 5,6 let.
The study was structured in two periods. 
Študija je bila oblikovana v dveh obdobjih.
Not all mutations have been tested. 
Vse mutacije niso bile preizkušene.
(see section 5.2). 
(glejte poglavje 5.2).
PULL out card on the right 3. 
POVLECITE kartico v desno 3.
This will help you remember which day you did not take the medicine. 
Tako si boste lažje zapomnili, kateri dan zdravila niste vzeli.
• Protein in the urine 
• Beljakovine v urinu
PUSH capsule through the foil 4. 
POTISNITE kapsulo skozi folijo 4.
This medicine has not been studied in children and adolescents under the age of 16 years; therefore, the safety and efficacy in this age group has not been established. 
Tega zdravila pri otrocih in mladostnikih, mlajših od 16 let, niso raziskovali, zato varnost in učinkovitost zdravila pri tej starostni skupini nista bili dokazani.
You may get a headache and feel dizzy. 
Lahko dobite glavobol in postanete omotični.
Galafold should be taken every other day at the same time of day to ensure optimal benefits to the patient. 
Zdravilo Galafold je treba jemati vsak drugi dan ob istem času, da se zagotovi optimalna korist za bolnika.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines because certain other medicines may increase or decrease the amount of Galafold in your body. 
Obvestite zdravnika, farmacevta ali medicinsko sestro, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo, saj nekatera druga zdravila lahko zvečajo ali zmanjšajo količino zdravila Galafold v vašem telesu.
Frequencies are defined as: 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). 
Pogostnost je opredeljena kot: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
UNKNOWN 
NEZNANO
The safety and efficacy of Galafold in children aged 0 to 15 years has not yet been established. 
Varnost in učinkovitost zdravila Galafold pri otrocih, starih od 0 do 15 let, še nista bili dokazani.
Starting date: 
Datum začetka:
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder (if you cannot reach your Amicus representative by phone please contact via the e-mail address listed below): 
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom (če ne uspete stopiti v stik s predstavnikom družbe Amicus za vašo regijo prek telefona, uporabite naslov e-pošte, naveden spodaj):
In case of overdose, general medical care is recommended. 
V primeru prevelikega odmerka se priporoča splošna medicinska oskrba.
• raised levels of creatine phosphokinase in blood tests 
• Zvišane ravni kreatin fosfokinaze v krvnih testih
Take one capsule every other day at the same time of the day. 
Vzemite eno kapsulo vsak drugi dan ob istem času.
In these cases, the question marks in the accompanying parentheses indicate that the changes provided therein have not been experimentally confirmed and may not be correct. 
V teh primerih vprašaji v oklepajih pomenijo, da spremembe še niso bile eksperimentalno potrjene in zato morda niso pravilne.
PVC / PCTFE / PVC/Al blister. 
Pretisni omot iz PVC/PCTFE/PVC/Al.
PUSH card back into holder 
POTISNITE kartico nazaj v držalo
Very common: may affect more than 1 in 10 people • Headache 
Zelo pogosti: prizadenejo lahko več kot 1 osebo od 10 • glavobol
UNKNOWN in the column of ‘protein sequence change' indicate that the changes to the protein sequence caused by the mutations cannot be readily deduced from the nucleotide changes and need to be experimentally determined. 
NEZNANO v stolpcu „Sprememba proteinskega zaporedja“ pomeni, da sprememb proteinskega zaporedja, ki jih povzročajo mutacije, ni mogoče zlahka ugotoviti iz sprememb nukleotidov in jih je treba določiti eksperimentalno.
Depending upon the kind of mutation (change) in the gene that produces α-Gal A, the enzyme does not work properly or is completely absent. 
Glede na vrsto mutacije (spremembe) v genu, ki proizvaja encim α-Gal A, encim ne deluje pravilno ali pa je v celoti odsoten.
Following administration of the same doses, the mean elimination half-life (t1/2) ranged from approximately 3 to 5 hours. 
Po aplikaciji enakih odmerkov je bil srednji razpolovni čas odstranjevanja iz telesa (t1/2) približno od 3 do 5 ur.
The pharmacokinetic characteristics of migalastat were not significantly different between females and males in either healthy volunteers or in patients with Fabry disease. 
Farmakokinetične lastnosti migalastata se med spoloma niso pomembno razlikovale niti pri zdravih prostovoljcih niti pri bolnikih s Fabryjevo boleznijo.
The amino acid mutation (protein sequence change) is most relevant when determining amenability. 
Mutacija aminokislin (sprememba proteinskega zaporedja) je najpomembnejša pri določanju odzivnosti.
Clear liquids, including carbonated drinks, can be consumed during this period. 
V tem obdobju lahko uživate bistre tekočine, vključno z gaziranimi pijačami.
Your doctor will decide whether you need to stop breast-feeding or temporarily stop your medicine. 
Vaš zdravnik se bo odločil, ali morate prekiniti dojenje ali pa začasno prenehati jemati zdravilo.
This medicine works by stabilising the enzyme that your body produces naturally, so that it can work better to reduce the amount of GL-3 that has accumulated in your cells and tissues. 
To zdravilo deluje tako, da stabilizira encim, ki ga vaše telo proizvaja naravno, in tako učinkoviteje zmanjšuje količino GL-3, ki se kopiči v vaših celicah in tkivih.
Fertility in men 
Plodnost pri moških
Common: may affect up to 1 in 10 people 
Pogosti: prizadenejo lahko največ 1 osebo od 10
It is unlikely that this medicine will affect your ability to drive and use machines. 
Malo verjetno je, da bo to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
The capsules must not be cut, crushed, or chewed. 
Kapsul se ne sme razrezati, zdrobiti ali žvečiti.
The most common adverse reaction was headache, which was experienced by approximately 10% of patients who received Galafold. 
Najpogostejši neželeni učinek je bil glavobol, ki se je pojavil pri približno 10 % bolnikov, ki so prejeli zdravilo Galafold.
This medicine is used for the long-term treatment of Fabry disease in adults and adolescents aged 16 years and older who have certain genetic mutations (changes). 
To zdravilo se uporablja za dolgoročno zdravljenje Fabryjeve bolezni pri odraslih in mladostnikih, starih 16 let ali več, ki imajo določene genske mutacije (spremembe).
PRESS and hold tab at the left 2. 
PRITISNITE in držite jeziček na levi 2.
This study also indicated that agalsidase has no effect on the pharmacokinetics of migalastat. 
Ta študija je pokazala tudi, da agalzidaza nima vpliva na farmakokinetiko migalastata.
The recommended dosage regimen in adults and adolescents 16 years and older is 123 mg migalastat (1 capsule) once every other day at the same time of day. 
Priporočeni režim odmerjanja pri odraslih in mladostnikih, starih 16 let ali več, je 123 mg migalastata (1 kapsula) vsak drugi dan ob istem času.
Do not use this medicine after the expiry date, which is stated on the carton and blister after EXP. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake „EXP“.
• Palpitations (the feeling of a pounding heart) 
• Palpitacije (občutek razbijanja srca)
There is very limited experience with the use of this medicine in pregnant women. 
Izkušnje z uporabo tega zdravila pri nosečnicah so zelo omejene.
At the 150 mg dose, CL/F was approximately 11 to 14 L/hr. 
Pri odmerku 150 mg je bil CL/F približno 11 do 14 l/h.
In case of meaningful clinical deterioration, further clinical evaluation or discontinuation of treatment with Galafold should be considered. 
V primeru izrazitega kliničnega poslabšanja je treba razmisliti o nadaljnji klinični oceni ali prenehanju zdravljenja z zdravilom Galafold.
Then, punch out the left-most capsule labelled Day 1. 
Nato vzemite kapsulo iz najbolj levega mehurčka, kjer je oznaka za 1. dan.
Approximately 9% of the total radioactivity was unassigned. 
Približno 9 % celotne radioaktivnosti je ostalo nepripisane.
To access the package leaflet, scan the code below. 
Za dostop do navodila za uporabo odčitajte spodnjo kodo.
Other medicines and Galafold 
Druga zdravila in zdravilo Galafold
Capsules must be swallowed whole. 
Kapsule je treba pogoltniti cele.
Instructions to open 
Navodila za odpiranje
g.>5.5kbdel to 3UTR 
g.>5.5kbdel v 3UTR
The European Medicines Agency has deferred the obligation to submit the results of studies with Galafold in one or more subsets of the paediatric population in the treatment of Fabry disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Galafold za eno ali več podskupin pediatrične populacije pri zdravljenju Fabryjeve bolezni (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Composite Clinical Outcomes 
Sestavljeni klinični izidi
On your first day of taking this medicine from a new blister sleeve, record the date on the blister sleeve. 
Prvi dan, ko vzamete zdravilo iz novega pretisnega omota, zabeležite datum na pretisni omot.
This minimum 4 hours fast around taking your medicine is needed to allow your medicine to be fully absorbed. 
To, da skupno vsaj 4 ure ne pojeste ničesar, je potrebno, da se lahko vaše zdravilo v celoti absorbira.
Accordingly, a risk of migalastat exposure to the breast-feeding infant cannot be excluded. 
Nevarnosti izpostavitve dojenega otroka migalastatu zato ni mogoče izključiti.
The GLA mutations are also accessible by health care providers at www.galafoldamenabilitytable.com. 
Mutacije gena GLA so izvajalcem zdravstvenih dejavnosti dostopne tudi na spletnem naslovu www.galafoldamenabilitytable.com.
However, migalastat has been shown to be expressed in the milk of lactating rats. 
Dokazano pa je izločanje migalastata v mleko doječih podgan.
If you stop taking Galafold Do not stop taking this medicine without talking to your doctor. 
Če ste prenehali jemati zdravilo Galafold Ne prenehajte jemati zdravilo, ne da bi se o tem posvetovali z zdravnikom.
The nucleotide changes listed represent potential DNA sequence changes that result in the amino acid mutation. 
Navedene spremembe nukleotidov predstavljajo možne spremembe zaporedja DNK, kar posledično privede do mutacij aminokislin.
QR code to be included + www.galafoldsmpc.co.uk 
Vključiti kodo QR+ www.galafoldsmpc.co.uk
• Reduced sense of touch or sensation 
• Zmanjšana občutljivosti za dotik ali bolečino
Take at the same time each day. 
Zdravilo vzemite vsak dan ob istem času.
The frequency of events in patients treated with Galafold over 30 months (32%) was similar to the 18 month period. 
Pogostnost dogodkov je bila pri bolnikih, ki so bili več kot 30 mesecev zdravljeni z zdravilom Galafold (32 %), podobna kot pri bolnikih, ki so bil zdravljeni več kot 18 mesecev.
Galafold has no or negligible influence on the ability to drive and use machines. 
Zdravilo Galafold nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Approximately 20% of the total radiolabeled dose was excreted in faeces, with unchanged migalastat being the only measured component. 
Približno 20 % celotnega radioaktivno označenega odmerka se je izločilo z blatom, pri čemer je bil nespremenjeni migalastat edina izmerjena sestavina.
The effects of Galafold on fertility in humans have not been studied. 
Učinki zdravila Galafold na plodnost pri ljudeh niso bili raziskani.
All patients received the recommended dosage of 123 mg Galafold every other day. 
Vsi bolniki so prejeli priporočeni odmerek 123 mg zdravila Galafold vsak drugi dan.
If a double mutation is present on different chromosomes (only in females) that patient is amenable if either one of the individual mutations is present in Table 2. 
Če je dvojna mutacija prisotna na različnih kromosomih (samo pri ženskah), je bolnica odzivna na zdravljenje, če je v preglednici 2 prisotna katera koli od posameznih mutacij.
If a double mutation is present on the same chromosome (males and females), that patient is amenable if the double mutation is present in one entry in Table 2 (e.g., D55V/Q57L). 
Če je na istem kromosomu (moški in ženske) prisotna dvojna mutacija, je bolnik odziven na zdravljenje, če je dvojna mutacija prisotna v enem vnosu v preglednici 2 (npr. D55V/Q57L).
One Galafold blister sleeve = 14 hard capsules = 28 days of therapy 
En pretisni omot zdravila Galafold = 14 trdih kapsul = 28 dni zdravljenja
Certain GLA mutations can result in the production of abnormally folded and unstable mutant forms of α-Gal A. Migalastat is a pharmacological chaperone that is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of -Gal A, the genotypes of which are referred to as amenable mutations. 
Nekatere mutacije gena GLA lahko povzročijo nastanek nenormalno zvitih in nestabilnih mutantnih oblik α-Gal A. Migalastat je farmakološki šaperon, oblikovan za visokoafinitetno selektivno in reverzibilno vezavo na aktivna mesta nekaterih mutantnih oblik -Gal A, katerih genotipe imenujemo odzivne mutacije.
Within each frequency grouping, adverse reactions are presented in order of decreasing frequency within each System Organ Class. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči pogostnosti v okviru posameznega organskega sistema.
From the metabolism and excretion pathways, it is not expected that a decreased hepatic function may affect the pharmacokinetics of migalastat. 
Glede na poti presnove in izločanja ni pričakovati, da bi oslabljeno delovanje jeter lahko vplivalo na farmakokinetiko migalastata.
Reduced -Gal A activity is, therefore, associated with the progressive accumulation of substrate in vulnerable organs and tissues, which leads to the morbidity and mortality associated with Fabry disease. 
Zmanjšana aktivnost -Gal A je torej povezana z napredujočim kopičenjem substrata v ranljivih organih in tkivih, kar vodi v obolevnost in umrljivost, povezani s Fabryjevo boleznijo.
Nucleotide change 
Sprememba nukleotida
Treatment with Galafold should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Fabry disease. 
Zdravljenje z zdravilom Galafold lahko uvede in nadzoruje le zdravnik specialist z izkušnjami z diagnosticiranjem in zdravljenjem Fabryjeve bolezni.
Women of childbearing potential/Contraception in males and females Galafold is not recommended in women of childbearing potential not using contraception. 
Ženske v rodni dobi/kontracepcija pri moških in ženskah Zdravilo Galafold ni priporočljivo pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
Pharmacotherapeutic group: Various alimentary tract and metabolism products ATC code: A16AX14 
Farmakoterapevtska skupina:, razna zdravila za bolezni prebavil in presnove, oznaka ATC: A16AX14
What you need to know before you take Galafold 3. 
Kaj morate vedeti, preden boste vzeli zdravilo Galafold 3.
In the absence of similar findings in females, no findings in the genotoxicity battery or in the carcinogenicity study with Tg.rasH2 mice, and no pre-neoplastic pancreatic findings in the rodents or monkeys, this observation in male rats is not considered related to treatment and its relevance to humans is unknown. 
V odsotnosti podobnih ugotovitev pri samicah, ugotovitev v bateriji za genotoksičnost in študiji kancerogenosti pri miših Tg.rasH2 ter v odsotnosti preneoplastičnih pankreatičnih pojavov pri glodavcih in opicah se šteje, da ugotovitev pri podganjih samcih ni povezana z zdravljenjem, njena relevantnost za ljudi pa ni znana.
What Galafold is and what it is used for 2. 
Kaj je zdravilo Galafold in za kaj ga uporabljamo 2.
If your condition worsens, your doctor may evaluate you further or may discontinue your treatment with Galafold. 
Če se bo stanje poslabšalo, vas bo zdravnik morda nadalje ocenil ali pa prekinil zdravljenje z zdravilom Galafold.
If you forget to take Galafold 
Če ste pozabili vzeti zdravilo Galafold
The first OLE trial (AT1001-041) included patients from Phase 2 and Phase 3 studies and has completed. 
Prvo odprto podaljšano preskušanje (AT1001-041) je vključevalo bolnike iz študij 2. faze in 3. faze in je že zaključeno.
During the first period (18-months) ERT-experienced patients were randomised to switch from ERT to Galafold or continue with ERT. 
V prvem obdobju (18 mesecev) so bolniki, ki so bili zdravljeni z ERT, prešli z ERT na zdravilo Galafold ali pa so nadaljevali z zdravljenjem z ERT.
Elderly (> 65 years) Clinical studies of Galafold included small number of patients aged 65 and over. 
Klinične študije zdravila Galafold so vključile majhno število bolnikov, starih 65 let ali več.
The second period was an optional 12-month open-label extension in which all subjects received Galafold. 
V drugem obdobju je potekalo neobvezno odprto 12-mesečno podaljšanje, v katerem so vsi bolniki prejemali zdravilo Galafold.
A decision must be made whether to discontinue breast-feeding or to discontinue Galafold, taking into account the benefit of breast-feeding for the child relative to the benefit of therapy for the mother. 
Odločiti se je treba med prenehanjem dojenja in prenehanjem zdravljenja z zdravilom Galafold, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
c.207_369+651del814ins231 UNKNOWN (del Exon2?) 
c.207_369+651del814ins231 NEZNANO (del Exon2?)
Migalastat binding stabilizes these mutant forms of -Gal A in the endoplasmic reticulum and facilitates their proper trafficking to lysosomes. 
Vezava migalastata stabilizira te mutantne oblike -Gal A v endoplazemskem retikulumu in olajša njihovo ustrezno razmeščanje v lizosome.
UNKNOWN (delExon3_3'UTR?) 
NEZNANO (delExon3_3'UTR?)
The clinical efficacy and safety of Galafold have been evaluated in two Phase 3 pivotal trials and two open-label extension (OLE) trials. 
Klinična učinkovitost in varnost zdravila Galafold sta bili ocenjeni v dveh ključnih preskušanjih faze 3 in v dveh odprtih podaljšanih preskušanjih.
UNKNOWN IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T UNKNOWN 
NEZNANO IVS6-10G>A; IVS6-22C>T c.1000-10G>A/1000-22C>T NEZNANO
• Painful stiff neck 
• Boleč, trd vrat
Galafold exposure is decreased by approximately 40% when taken with food and therefore food should not be consumed at least 2 hours before and 2 hours after taking Galafold to give a minimum 4 hours fast. 
Pri jemanju s hrano se izpostavljenost zdravilu Galafold zmanjša za približno 40 %, zato bolnik ne sme uživati hrane vsaj 2 uri pred jemanjem in 2 uri po jemanju zdravila Galafold, tako da skupno vsaj 4 ure ne uživa nobene hrane.
Capsule contents Pregelatinised starch (maize) Magnesium stearate 
Vsebina kapsule predgelirani škrob (koruzni) magnezijev stearat
Approximately 5% of the total sample radioactivity was unassigned components. 
Približno 5 % celotne radioaktivnosti se je izločilo kot nepripisane sestavine.
In the ERT-experienced trial, an analysis of a composite clinical outcome composed of renal, cardiac, and cerebrovascular events, or death, showed that the frequency of events observed in the Galafold treatment group was 29% compared to 44% in the ERT group over 18 months. 
Pri preskušanju s predhodnim ERT je analiza sestavljenega kliničnega izida sestavljena iz renalnih, kardialnih in cerebrovaskularnih dogodkov ali smrti pokazala, da je bila pogostnost dogodkov v skupini, ki je bila zdravljena z zdravilom Galafold, 29 %, v primerjavi s skupino bolnikov, zdravljenih z ERT več kot 18 mesecev, kjer je bila pogostnost dogodkov 44 %.
In a rat 104-week carcinogenicity study, there was an increased incidence of pancreatic islet cell adenomas in males at a dose level 19-fold higher than the exposure (AUC) at the clinically efficacious dose. 
V 104-tedenski študiji kancerogenosti pri podganah se je pri 19-krat višjem odmerku od izpostavljenosti (AUC) pri klinično učinkovitem odmerku povečala incidenca adenomov pankreasnih otočkov.
Disease Substrate 
Substrat bolezni
Complete reversibility was seen after 4 weeks off-dose. 
Učinek na plodnost je popolnoma prešel po 4 tednih od prenehanja dajanja zdravila.
What Galafold is and what it is used for 
Kaj je zdravilo Galafold in za kaj ga uporabljamo
Furthermore, migalastat is not an inhibitor or a substrate of CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5. 
Migalastat tudi ni inhibitor ali substrat encimov CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 in 3A4/5.
If you forget to take your capsule at the usual time but remember later, you can take the capsule only if it is within 12 hours of your normal dosing time. 
Če ste pozabili vzeti kapsulo ob običajnem času in se nanjo spomnite pozneje, lahko vzamete kapsulo le, če ni preteklo več kot 12 ur od običajnega časa, ko bi morali vzeti odmerek.
Based upon in vitro data, migalastat is not an inducer of CYP1A2, 2B6, or 3A4. 
Na podlagi podatkov in vitro migalastat ni induktor encimov CYP1A2, 2B6 in 3A4.
In addition, migalastat is not a substrate for MATE1, MATE2-K, OAT1, OAT3, or OCT2, nor is it an inhibitor of OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1, or MATE2-K human uptake transporters. 
Poleg tega migalastat ni substrat humanih privzemnih prenašalcev MATE1, MATE2-K, OAT1, OAT3 in OCT2 ali inhibitor humanih privzemnih prenašalcev OATP1B1, OATP1B3, OAT1, OAT3, OCT1, OCT2, MATE1 in MATE2-K.
Titanium dioxide (E171) Indigotine (E132) 
Ovoj kapsule želatina titanov dioksid (E171)
Plasma lyso- Gb3 levels also remained low in patients on ERT for up to 18 months. 
Prav tako je plazemska koncentracija lizo-Gb3 ostala nizka pri bolnikih, zdravljenih z ERT do 18 mesecev.
Black iron oxide Potassium hydroxide 
Črnilo šelak črni železov oksid kalijev hidroksid
UNKNOWN (Exon2_4dup?) 
NEZNANO (Exon2_4dup?)
Pack size of 14 capsules. 
Velikost pakiranja: 14 kapsul.
Fabry disease is caused by the lack of or a faulty enzyme called alpha-galactosidase A (α-Gal A). 
Fabryjevo bolezen povzroča pomanjkanje ali nepravilno delovanje encima, imenovanega αgalaktozidaza A (α-Gal A).