natgillin/translations-raw huggingface dataset:
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).
In healthy volunteers, the volume of distribution (Vz/F) of migalastat following ascending single oral doses (25-675 mg migalastat HCl) ranged from 77 to 133 L, indicating it is well distributed into tissues and greater than total body water (42 litres).
Pri zdravih prostovoljcih je volumen porazdelitve migalastata (Vz/F) po naraščajočih enkratnih peroralnih odmerkih (25-675 mg migalastatijevega klorida) segal od 77 do 133 litrov, kar presega celotno količino vode v telesu (42 litrov) in pomeni, da se je zdravilo dobro razporedilo v tkivih.
C]-migalastat hydrochloride revealed that approximately 77% of the radiolabeled dose was recovered in urine of which 55% of was excreted as unchanged migalastat and 4% as combined metabolites M1, M2 and M3.
C]-migalastatijevega klorida pri zdravih moških prostovoljcih je pokazalo, da se je približno 77 % radioaktivno označenega odmerka izločilo v urinu, od tega se je 55 % izločilo kot nespremenjeni migalastat, 4 % pa kot kombinacija presnovkov M1, M2 in M3.
In rabbits, developmental toxicity was observed only at maternally toxic doses (see section 5.3).
Pri kuncih je bila razvojna toksičnost ugotovljena le pri maternalno toksičnih odmerkih (glejte poglavje 5.3).
Limited data suggest that co-administration of a single dose of Galafold and a standard enzyme replacement therapy infusion results in an increased exposure to agalsidase of up to 5-fold.
Omejeni podatki kažejo, da sočasno dajanje odmerka zdravila Galafold in infuzije standardnega encimskega nadomestnega zdravljenja poveča izpostavljenost agalzidazi za približno do 5-krat.
The infertility associated with migalastat treatment was reported at clinically relevant exposures.
Neplodnost pri zdravljenju z migalastatom je bila ugotovljena ob klinično relevantni izpostavitvi.
On the next day, punch out the perforated white circle labelled Day 2.
Naslednji dan preluknjajte bel krogec, kjer je oznaka za 2. dan.
In the rabbit embryo-foetal toxicity study, findings including embryo-foetal death, a reduction in mean foetal weight, retarded ossification, and slightly increased incidences of minor skeletal abnormalities were observed only at doses associated with maternal toxicity.
V študiji embriofetalne toksičnosti pri kuncih so bile ugotovljene embriofetalna smrt, znižanje povprečne mase plodov, zapoznela osifikacija in nekoliko pogostejše manjše skeletne nepravilnosti, vendar le pri odmerkih, povezanih z maternalno toksičnostjo.
Transient and fully reversible infertility in male rats was associated with migalastat treatment at all doses assessed.
Prehodna in v celoti reverzibilna neplodnost pri podganjih samcih se je izrazila pri vseh ocenjevanih odmerkih.
Galafold is available in a blister pack containing 14 capsules.
Zdravilo Galafold je na voljo v pretisnem omotu s 14 kapsulami.
There are limited data from the use of Galafold in pregnant women.
Podatki o uporabi zdravila Galafold pri nosečnicah so omejeni.
Plasma migalastat exposure (AUC0-∞) and Cmax demonstrated dose-proportional increases at migalastat hydrochloride oral doses from 50 mg to 1,250 mg.
Plazemska izpostavljenost migalastatu (AUC0-∞) in Cmax sta pri peroralnih odmerkih migalastatijevega klorida od 50 mg do 1 250 mg pokazala odmerku sorazmeren porast.
Talk to your doctor before taking Galafold if you are currently taking enzyme replacement therapy.
Pred začetkom jemanja zdravila Galafold obvestite zdravnika, če trenutno prejemate encimsko nadomestno zdravljenje.
Galafold is indicated for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation (see the tables in section 5.1).
Zdravilo Galafold je indicirano za dolgoročno zdravljenje odraslih in mladostnikov, starih 16 let ali več, s potrjeno diagnozo Fabryjeve bolezni (pomanjkanje α-galaktozidaze A) in odzivno mutacijo (glejte preglednice v poglavju 5.1).
It is not yet known if this medicine affects fertility in men.
Ni še znano, ali to zdravilo vpliva na plodnost pri moških.
Similar findings have been noted pre-clinically following treatment with other iminosugars (see section 5.3).
Ugotovitve so bile podobne tudi v predkliničnih študijah po zdravljenju z drugimi iminosladkorji (glejte poglavje 5.3).
Fax: +353 (0) 1 588 6851 e-mail: info@amicusrx.co.uk
Faks: +353 (0) 1 588 6851 e-pošta: info@amicusrx.co.uk
Migalastat administered with a high-fat meal, or 1 hour before a high-fat or light meal, or 1 hour after a light meal, resulted in significant reductions of 37% to 42% in mean total migalastat exposure (AUC0-∞) and reductions of 15% to 40% in mean peak migalastat exposure (Cmax) compared with the fasting state.
Pri migalastatu, vzetem z maščobno bogatim obrokom ali 1 uro pred maščobno bogatim ali lahkim obrokom ali 1 uro po lahkem obroku, sta se v primerjavi z jemanjem na prazen želodec pomembno zmanjšali srednja celotna izpostavljenost migalastatu (AUC0-∞), in sicer za 37 do 42 %, ter srednja najvišja izpostavljenost migalastatu (Cmax), in sicer za 15 do 40 %.
Treatment with Galafold in Phase 2 pharmacodynamic trials generally resulted in increases in endogenous α-Gal A activity in WBCs, as well as in skin and kidney for the majority of patients.
Zdravljenje z zdravilom Galafold je v farmakodinamičnih preskušanjih faze 2 pri večini bolnikov na splošno povečalo aktivnost endogenega α-Gal A v levkocitih, pa tudi v koži in ledvicah.
If more than 12 hours has passed the patient should resume taking Galafold at the next planned dosing day and time according to the every other day dosing schedule.
Če je preteklo več kot 12 ur, naj bolnik nadaljuje z jemanjem zdravila Galafold ob naslednjem načrtovanem dnevu in uri za odmerek, skladno z urnikom odmerjanja vsak drugi dan.
Fabry disease-causing mutations in the GLA gene result in a deficiency of the lysosomal enzyme -galactosidase A (-Gal A) that is required for glycosphingolipid substrate (e.g., GL-3, lyso-Gb3) metabolism.
Mutacije gena GLA, ki povzročijo Fabryjevo bolezen, se odražajo v pomanjkanju lizosomskega encima -galaktozidaze A (-Gal A), potrebnega za presnovo glikosfingolipidnih substratov (npr. GL-3, lyso-Gb3).
The absolute bioavailability (AUC) for a single oral 150 mg migalastat hydrochloride dose or a single 2-hour 150 mg intravenous infusion was approximately 75%.
Absolutna biološka uporabnost (AUC) enkratnega peroralnega odmerka 150 mg migalastatijevega klorida ali enkratne dveurne 150-mg intravenske infuzije je bila približno 75 %.
What you need to know before you take Galafold
Kaj morate vedeti, preden boste vzeli zdravilo Galafold
Migalastat is not a substrate for MDR1 or BCRP, nor is it an inhibitor of BCRP, MDR1, or BSEP human efflux transporters.
Migalastat ni substrat humanih izločevalnih prenašalcev MDR1 in BCRP ali inhibitor humanih izločevalnih prenašalcev BCRP, MDR1 in BSEP.
The first Phase 3 trial (ATTRACT) was a randomised open-label active comparator trial that evaluated the efficacy and safety of Galafold compared to enzyme replacement therapy (ERT) (agalsidase beta, agalsidase alfa) in 52 male and female patients with Fabry disease who were receiving ERT prior to trial entry and who have amenable mutations (ERT-experienced trial).
Prvo preskušanje faze 3 (ATTRACT) je bilo randomizirano odprto aktivno primerjalno preskušanje, ki je ocenilo učinkovitost in varnost zdravila Galafold v primerjavi z encimskim nadomestnim zdravljenjem (ERT, enzyme replacement therapy) (agalzidaza beta, agalzidaza alfa) pri 52 bolnikih in bolnicah s Fabryjevo boleznijo, ki so pred sodelovanjem v preskušanju prejemali ERT in imajo odzivne mutacije (preskušanje s predhodnim ERT).
See package leaflet for further instructions.
Za dodatna navodila glejte navodilo za uporabo.
Galafold is not recommended during pregnancy.
Zdravilo Galafold v nosečnosti ni priporočljivo.
During the open-label extension, statistically significant (p<0.05) improvements from baseline were observed in the diarrhoea and indigestion domains, with a trend of improvement in the constipation domain.
V odprtem podaljšanju je bilo statistično značilno (p < 0,05) izboljšanje od izhodišča ugotovljeno na področju diareje in dispepsije, s trendom izboljšanja na področju konstipacije.
DD month YYYY
DD. mesec LLLL
UNKNOWN (E66_Y123del; del Exon2)
NEZNANO (E66_Y123del; del Exon2)
If you take more capsules than you should, then you should stop taking the medicine and contact your doctor.
Če ste vzeli večji odmerek zdravila Galafold, kot bi smeli Če ste vzeli več kapsul, kot bi smeli, morate prenehati jemati zdravilo in se posvetovati z zdravnikom.
If more than 12 hours has passed you should resume taking Galafold at the next planned dosing day and time according to your every other day dosing schedule.. Do not take two capsules to make up for your missed dose.
Če je preteklo več kot 12 ur, morate nadaljevati z jemanjem zdravila Galafold ob naslednjem načrtovanem dnevu in uri za odmerek, skladno z urnikom odmerjanja vsak drugi dan. Ne vzemite dveh kapsul, če ste pozabili vzeti prejšnji odmerek.
Galafold is not intended for concomitant use with enzyme replacement therapy.
Zdravilo Galafold ni namenjeno uporabi ob sočasnem encimskem nadomestnem zdravljenju.
Size 2 hard capsule (6.4x18.0 mm) with an opaque blue cap and opaque white body with “A1001” printed in black, containing white to pale brown powder.
Trda kapsula velikosti 2 (6,4 x 18,0 mm) z neprozornim modrim pokrovčkom in neprozornim belim telesom s črno oznako „A1001“, ki vsebuje bel do bledo rjav prašek.
C]-migalastat HCl revealed that 99% of the radiolabeled dose recovered in plasma was comprised of unchanged migalastat (77%) and 3 dehydrogenated O-glucuronide conjugated metabolites, M1to M3 (13%).
C]-migalastat HCl pri zdravih moških prostovoljcih je pokazalo, da so 99 % radioaktivno označenega odmerka v plazmi predstavljali nespremenjen migalastat (77 %) in trije dehidrogenirani z O-glukuronidom konjugirani presnovki, M1 do M3 (13 %).
Galafold is not indicated for use in patients with non-amenable mutations (see section 5.1).
Zdravilo Galafold ni indicirano za uporabo pri bolnikih z neodzivnimi mutacijami (glejte razdelek 5.1).
Galafold is not intended for concomitant use with enzyme replacement therapy (see section 4.4).
Zdravilo Galafold ni namenjeno uporabi ob sočasnem encimskem nadomestnem zdravljenju (glejte poglavje 4.4).
Elderly population No dosage adjustment is required based on age (see section 5.2).
Starejša populacija Prilagajanje odmerka glede na starost ni potrebno (glejte poglavje 5.2).
Fabry disease is a progressive X-linked lysosomal storage disorder which affects males and females.
Fabryjeva bolezen je napredujoča na kromosom X vezana motnja lizosomskega skladiščenja, ki prizadene moške in ženske.
Patient-Reported Outcome - Gastrointestinal Symptoms Rating Scale In the ERT-naïve trial, analyses of the Gastrointestinal Symptoms Rating Scale demonstrated that treatment with Galafold was associated with statistically significant (p<0.05) improvements versus placebo from baseline to month 6 in the diarrhoea domain, and in the reflux domain for patients with symptoms at baseline.
Izid po poročanju bolnikov - lestvica za oceno gastrointestinalnih simptomov Pri preskušanju brez predhodnega ERT so analize lestvice za oceno gastrointestinalnih simptomov pokazale, da je bilo zdravljenje z zdravilom Galafold povezano s statistično značilnim (p < 0,05) izboljšanjem v primerjavi s placebom na področju diareje od izhodišča do 6. meseca ter na področju refluksa pri bolnikih s simptomi v izhodišču.
Once in lysosomes dissociation of migalastat restores -Gal A activity, leading to the catabolism of GL-3 and related substrates.
V lizosomih nato disociacija migalastata obnovi aktivnost -Gal A, kar omogoči katabolizem GL-3 in sorodnih substratov.
Galafold should not be taken on 2 consecutive days.
Zdravilo Galafold se ne sme vzeti 2 dneva zapored.
A pharmacokinetic trial in healthy male volunteers with 150 mg [
Farmakokinetično preskušanje s 150 mg [
Non-clinical studies suggest no specific hazard for humans on the basis of single-and repeat-dose studies, with the exception of transient and fully reversible infertility in male rats associated with migalastat treatment.
Predklinične študije s enkratnimi in ponavljajočimi odmerki niso pokazale nobene posebne nevarnosti za ljudi, povezane z zdravljenjem z migalastatom, razen prehodne in v celoti reverzibilne neplodnosti pri podganjih samcih.
UNKNOWN (E66_Y123del; del Exon2?)
NEZNANO (E66_Y123del; del Exon2?)
This enzyme defect leads to abnormal deposits of a fatty substance known as globotriaosylceramide (GL-3) in kidneys, heart, and other organs, leading to the symptoms of Fabry disease.
Zaradi te okvare encima se maščobna snov, znana kot globotriaozilceramid (GL-3), začne nenormalno kopičiti v ledvicah, srcu in drugih organih, kar povzroči simptome Fabryjeve bolezni.
It is not yet known whether this medicine passes into breast milk.
Ni še znano, ali se to zdravilo izloča v materino mleko.
Table 3: Mutations not amenable to Galafold (migalastat)
Preglednica 3: Mutacije, ki na zdravilo Galafold (migalastat) niso odzivne
c.760-762delGTT or c.761-763del c.760_762delGTT or c.761_763del p.V254del
c.760-762delGTT ali c.761763del c.760_762delGTT ali c.761_763del p.V254del
Marketing Authorisation Holder Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
Imetnik dovoljenja za promet z zdravilom Amicus Therapeutics Europe Limited Block 1, Blanchardstown Corporate Park Ballycoolen Road
The second Phase 3 trial (FACETS) was a 6-month randomised double-blind placebo-controlled trial (through month 6) with an 18-month open-label period to evaluate the efficacy and safety of Galafold in 50 male and female patients with Fabry disease who were naïve to ERT, or had previously been on ERT and had stopped for at least 6 months and who have amenable mutations (ERT-naïve trial).
Drugo preskušanje faze 3 (FACETS) je bilo 6-mesečno randomizirano dvojno slepo s placebom kontrolirano preskušanje (do konca 6. meseca) z 18-mesečnim odprtim obdobjem za oceno učinkovitosti in varnosti zdravila Galafold pri 50 bolnikih in bolnicah s Fabryjevo boleznijo, ki še niso prejemali ERT ali pa so se že zdravili z ERT in so z zdravljenjem prenehali pred vsaj 6 meseci in imajo odzivne mutacije (preskušanje brez predhodnega ERT).
No clinically significant differences were observed during the initial 6-month placebo-controlled period.
V začetnem 6-mesečnem s placebom nadzorovanem obdobju niso bile ugotovljene nobene klinično pomembne razlike.
MINIMUM PARTICULARS TO APPEAR ON INTERMEDIATE PACKAGING
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA VMESNIH OVOJNINAH
What Galafold looks like and contents of the pack Opaque, blue, and white hard capsules, marked with “A1001” in black ink, containing white to pale brown powder.
Neprozorne, modre in bele trde kapsule, ki imajo črno oznako „A1001“ in vsebujejo bel do bledo rjav prašek.
Each capsule contains migalastat hydrochloride equivalent to 123 mg migalastat - The other ingredients are: Capsule contents: Pregelatinised maize starch and magnesium stearate Capsule shell: Gelatin, titanium dioxide, and indigotine Printing ink: Shellac, black iron oxide, and potassium hydroxide
- Druge sestavine zdravila so: Vsebina kapsule: predgelirani koruzni škrob in magnezijev stearat Ovoj kapsule: želatina, titanov dioksid in indigotin Črnilo: šelak, črni železov oksid in kalijev hidroksid
The mean extent of exposure to the marketed dose of Galafold 123 mg QOD in patients completing study AT1001-041 was 3.57 (±1.23) years (n=85).
Povprečen obseg izpostavljenosti odmerku zdravila Galafold, ki je bil dan v promet, torej 123 mg vsak drugi dan, je bil pri bolnikih, ki so zaključili študijo AT1001-041, 3,57 (± 1,23) let (n = 85).
How to store Galafold 6.
Shranjevanje zdravila Galafold 6.
Table 1: Adverse reactions with Galafold in clinical trials System Organ Class
Preglednica 1: Neželeni učinki zdravila Galafold, o katerih so poročali v kliničnih preskušanjih Organski sistem
The second OLE trial (AT1001-042) included patients that both transferred from OLE study AT1001-041 and directly from Phase 3 study ATTRACT, and is ongoing.Renal Function
Drugo odprto podaljšano preskušanje (AT1001-042) je vključevalo bolnike, ki so bili preusmerjeni tako iz odprte podaljšane študije AT1001-041, kot tudi neposredno iz študije 3. faze ATTRACT, in še vedno poteka.
Swallow the capsule whole.
Kapsulo pogoltnite celo.
In patients with amenable mutations, GL-3 levels tended to decrease in urine and in kidney interstitial capillaries.
Pri bolnikih z odzivnimi mutacijami so se ravni GL-3 v urinu in ledvičnih intersticijskih kapilarah večinoma znižale.
If a dose is missed entirely for the day, the patient should take the missed dose of Galafold only if it is within 12 hours of the normal time the dose is taken.
Če bolnik v celoti izpusti odmerek za posamezen dan, naj vzame zamujeni odmerek zdravila Galafold le, če ni preteklo več kot 12 ur od običajnega časa, ko bi moral vzeti odmerek.
Take Galafold capsule every other day and punch out the perforated circle on the blister sleeve on the days you are not taking Galafold.
Vzemite zdravilo Galafold vsak drugi dan in preluknjate krogec na pretisnem omotu na dan, ko zdravila Galafold ne vzamete.
Similar findings have been noted pre-clinically following treatment with other iminosugars.
Ugotovitve so bile podobne tudi v predkliničnih študijah po dajanju drugih iminosladkorjev.
In the ERT- naïve trial and open-label extension, renal function remained stable for up to 5 years of treatment with Galafold.
Pri preskušanju brez predhodnega ERT in odprtem podaljšanem preskušanju je delovanje ledvic ostalo stabilno do 5 let od začetka zdravljenja z zdravilom Galafold.
Your doctor will monitor your condition and whether your medicine is working every 6 months while you are taking Galafold.
Med jemanjem zdravila Galafold bo zdravnik vsakih 6 mesecev preveril vaše stanje in ali zdravilo pri vas učinkuje.
Do not eat food at least 2 hours before and 2 hours after taking your medicine.
Vsaj 2 uri pred jemanjem in 2 uri po jemanju zdravila ne jejte.
Qualitative reductions in GL-3 levels were observed in multiple renal cell types: podocytes, mesangial cells, and glomerular endothelial cells, respectively, over 12 months of treatment with Galafold.
Kvalitativno je bilo zmanjšanje ravni GL-3 v 12 mesecih zdravljenja z zdravilom Galafold ugotovljeno pri različnih tipih ledvičnih celic: podocitih, mezangijskih celicah in glomerulnih endotelijskih celicah.