natgillin/translations-raw huggingface dataset:
Following an intravenous administration of agalsidase beta to adults at doses of 0.3 mg, 1 mg and 3 mg/kg body weight, the AUC values increased more than dose proportional, due to a decrease in clearance, indicating a saturated clearance.
Po intravenski aplikaciji agalzidaze beta pri odraslih v odmerkih 0,3 mg, 1 mg in 3 mg/kg telesne mase so se vrednosti AUC povečale več kot sorazmerno odmerku zaradi zmanjšanja očistka, kar kaže na zasičenje očistka.
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.
Pri nekaterih od teh bolnikov so spontano poročali o povečanju nekaterih od naslednjih simptomov: bolečine, parestezija in driska ter kardiološke, centralnoživčne in ledvične manisfestacije.
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.
Imetnik dovoljenja za promet z zdravilom se bo z nacionalnimi pristojnimi organi dogovoril o podrobnem izobraževalnem programu o infundiranju zdravila Fabrazyme doma pred nacionalno uvedbo programa.
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 z infuzijo, so zdravili z zmanjšanjem hitrosti infundiranja in sočasno uporabo nesteroidnih protivnetnih zdravil, antihistaminikov in/ali kortikosteroidov.
Reconstituted and diluted solutions
Rekonstituirana in razredčena raztopina
The decision to have a patient move to home infusion should be made after evaluation and recommendation by the treating physician.
Odločitev o prehodu na infuzije doma mora temeljiti na presoji in priporočilu lečečega zdravnika.
Cardiac Disorders tachycardia, palpitations, bradycardia sinus bradycardia --
Srčne bolezni tahikardija, palpitacije, bradikardija sinusna bradikardija
Avoid forceful impact of the water for injections on the powder and avoid foaming.
Preprečite močan curek vode za injekcije na prašek in nastajanje pene.
Genzyme Europe B.V.-NL Store in a refrigerator (2°C - 8°C).
Genzyme Europe B.V.-NL Shranjujte v hladilniku (2 °C - 8 °C).
After reconstitution it is recommended to promptly dilute the vials, to minimise protein particle formation over time.
Priporočljivo je, da viale razredčite takoj po rekonstituciji, da čimbolj zmanjšate tvorbo beljakovinskih delcev čez čas.
If not used immediately, in-use storage and conditions prior to use are the responsibility of the user.
Če ni uporabljeno takoj, je za shranjevanje med uporabo in pogoje pred uporabo odgovoren uporabnik.
A small number of patients have experienced reactions suggestive of immediate (Type I) hypersensitivity.
Manjše število bolnikov je imelo reakcije, ki nakazujejo na takojšnjo preobčutljivost (vrste 1).
Fabrazyme should not be used during pregnancy unless clearly necessary.
Zdravila Fabrazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
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).
Potrebne viale vzemite iz hladilnika, da se lahko segrejejo na sobno temperaturo (po približno 30 minutah).
Ten (10) patients met per protocol dose increase criteria, two (2) had a dose increase to the recommended dose of 1.0 mg/kg every 2 weeks.
Deset (10) bolnikov je izpolnilo po protokolu določena merila za povečanje odmerka in dvema (2) so odmerek povečali na priporočeni odmerek 1,0 mg/kg vsaka 2 tedna.
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.).
Po serokonverziji IgG se CL ni opazno spremenil (pri prvih +24 %, pri drugih +6 %), medtem ko je bil Vss pri prvih 1,8-krat in pri drugih 2,2-krat večji; končni učinek je bilo majhno zmanjšanje Cmax (do -34 % pri prvih in -11 % pri drugih), AUC pa se ni spremenila (-19 % pri prvih in -6 % pri drugih).
Due to the limitations of the study design (small number of patients), no definitive conclusion regarding the dose maintenance regimen can be drawn, but these findings suggest that, after an initial debulking dose of 1.0 mg/kg every 2 weeks, 0.3 mg/kg every 2 weeks may be sufficient in some patients to maintain clearance of GL-3.
Zaradi omejitev zasnove študije (majhno število bolnikov), dokončnih sklepov v zvezi z režimom vzdrževalnega odmerjanja ni možno oblikovati, vendar pa izsledki kažejo, da morda po začetnem odstranitvenem odmerku 1,0 mg/kg vsaka 2 tedna, odmerek 0,3 mg/kg vsaka 2 tedna pri nekaterih bolnikih zadošča za vzdrževanje očistka GL-3.
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.
Po intravenskem infundiranju se agalzidaza beta hitro odstrani iz krvnega obtoka, ker jo absorbirajo celice žilnega endotelija in parenhimske celice v svoje lizosome, verjetno prek manoza-6-fosfatnih, manoznih in asialoglikoproteinskih receptorjev.
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.
Vss je bil od 8,3-40,8 l, plazemski očistek od 119-345 ml/min in srednji razpolovni čas izločanja od 80
What you need to know before you use Fabrazyme Do not use Fabrazyme
Kaj morate vedeti, preden boste uporabili zdravilo Fabrazyme Ne uporabljajte zdravila Fabrazyme
Package sizes: 1, 5 and 10 vials per carton.
Velikost pakiranja: 1, 5 in 10 vial na škatlo.
Fabrazyme is given through a drip into a vein (by intravenous infusion).
Zdravilo Fabrazyme se daje s kapalno infuzijo v veno (v obliki intravenske infuzije).
Fabrazyme should not be administered with chloroquine, amiodarone, benoquin or gentamycin due to a theoretical risk of inhibition of intra-cellular α-galactosidase A activity.
Zdravila Fabrazyme ne smete uporabljati sočasno s klorokvinom, amiodaronom, benokvinom ali gentamicinom zaradi teoretičnega tveganja za inhibicijo znotrajcelične aktivnosti α-galaktozidaze A.
Contents of the pack and other information What Fabrazyme contains
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Fabrazyme
• decreased mouth sensitivity
• zmanjšana občutljivost v ustih
Lower dosing regimens have been used in clinical studies.
V kliničnih študijah so uporabljali režime odmerjanja z nižjim odmerkom.
Fabrazyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Fabry disease.
Zdravilo Fabrazyme se uporablja le pod nadzorom zdravnika, ki se spozna na zdravljenje Fabryjeve bolezni.
Sustained clearance of GL-3 from kidney vascular endothelium upon agalsidase beta treatment was demonstrated further in the open label extension of this trial.
Trajen očistek GL-3 iz žilnega endotelija ledvic po zdravljenju z agalzidazo beta so nadalje dokazali v razširitvi te študije odprtega tipa.
• exacerbated difficulty in breathing
• poslabšanje težav z dihanjem
Name and address of the manufacturer of the biological active substance
Ime in naslov proizvajalca biološke zdravilne učinkovine
Common (may affect up to 1 in 10 people): • chest pain
Pogosti (se lahko pojavijo pri največ 1 bolniku od 10 bolnikov): • bolečine v prsih
Agalsidase beta may be excreted in milk.
Agalzidaza beta se lahko izloča v materino mleko.
Other medicines and Fabrazyme
Druga zdravila in zdravilo Fabrazyme
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove, encimi.
Fabrazyme may have a minor influence on the ability to drive or use machines on the day of Fabrazyme administration because dizziness, somnolence, vertigo and syncope may occur (see section
Zdravilo Fabrazyme lahko ima blag vpliv na sposobnost vožnje in upravljanja s stroji na dan dajanja zdravila Fabrazyme, ker se lahko pojavijo omotica, zaspanost, vrtoglavica in sinkopa (glejte poglavje 4.8).
The recommended dose of Fabrazyme for children and adolescents 8 - 16 years is 1 mg/kg body weight, once every 2 weeks.
Priporočeni odmerek zdravila Fabrazyme za otroke in mladostnike od 8 do 16 let je 1 mg/kg telesne mase, enkrat na vsaka 2 tedna.
In clinical studies side effects were mainly seen while patients were being given the medicine or shortly after (“infusion related reactions”).
Neželeni učinki so bili v kliničnih študijah vidni med infundiranjem ali kmalu po končanem infundiranju zdravila („reakcije, povezane z infuzijo“).
In one of these studies, performed in adult male patients, after an initial dose of 1.0 mg/kg every 2 weeks for 6 months, 0.3 mg/kg every 2 weeks may maintain clearance of GL-3 in certain cell types in some patients; however, the long term clinical relevance of these findings has not been established (see section 5.1).
V eni od študij, ki je bila narejena pri odraslih bolnikih moškega spola, lahko po začetnem odmerku 1,0 mg/kg vsaka 2 tedna v trajanju 6 mesecev, 0,3 mg/kg vsaka 2 tedna vzdržuje očistek GL-3 pri nekaterih vrstah celic in pri nekaterih bolnikih; vendar pa dolgoročne klinične pomembnosti teh izsledkov niso ugotovili (glejte poglavje 5.1).
No unexpected safety issues were encountered in patients with an increase in exposure after seroconversion.
Pri bolnikih s povečano izpostavljenostjo po serokonverziji ni prišlo do nepričakovanih spornih varnostnih vprašanj.
Superficial skin capillary endothelium GL-3 scores were reduced to zero or maintained at zero at all time points post-baseline upon treatment in 19/27 patients completing the study without a dose increase.
Ocene GL-3 v endoteliju površinskih kožnih kapilar so se med zdravljenjem zmanjšale na nič ali so ostale nič na vseh časovnih točkah od izhodišča dalje pri 19 od 27 bolnikov, ki so študijo dokončali brez povečanja odmerka.
• infusion site reaction
• reakcija na mestu infundiranja
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.
Potem počasi vbrizgajte rekonstituirano raztopino neposredno v 0,9 % raztopino natrijevega klorida za intravensko uporabo (ne v preostali zrak) do končne koncentracije med 0,05 mg/ml in 0,7 mg/ml.
• difficulty in breathing
• težave pri dihanju
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.
Zdravilo Fabrazyme vsebuje zdravilno učinkovino agalzidaza beta in se uporablja kot encimska nadomestna terapija pri Fabryjevi bolezni, pri kateri bodisi ni encima α-galaktozidaze, ali pa je količina tega encima manjša od normalne.
In this trial, the initial rechallenge administration was at a low dose and a lower infusion rate (1/2 the therapeutic dose at 1/25 the initial standard recommended rate).
V tem preskušanju so začetno ponovno izzivalno dajanje izvajali ob manjšem odmerku in manjši hitrosti infundiranja (1/2 terapevtskega odmerka pri 1/25
Prior to adding the reconstituted volume of Fabrazyme required for the patient dose, it is recommended to remove an equal volume of 0.9% sodium chloride intravenous solution, from the infusion bag.
Pred dodajanjem rekonstituirane količine zdravila Fabrazyme, potrebne za bolnikov odmerek, je priporočljivo odstraniti enako količino 0,9 % raztopine natrijevega klorida za intravensko uporabo iz infuzijske vrečke.
The MAH shall ensure that all Healthcare Professional who are expected to prescribe/use Fabrazyme are provided with an educational pack aiming to facilitate the training of the patients/caregivers and also to guide prescribers regarding patient evaluation and selection and organisational requirements for home infusion.
Imetnik dovoljenja za promet z zdravilom bo zagotovil, da bo vse zdravstveno osebje, za katero se predvideva, da bodo predpisovali/uporabljali zdravilo Fabrazyme, prejelo izobraževalno gradivo s ciljem pospeševanja usposabljanja bolnikov/negovalcev ter vodenja zdravnikov pri ocenjevanju in izbiranju bolnikov ter organizacijskih zahtevah za infundiranje na domu.
Once a patient tolerates the infusion, the dose may be increased to reach the therapeutic dose of 1 mg/kg and the infusion rate may be increased by slowly titrating upwards, as tolerated.
Ko bolnik tako infuzijo dobro prenaša, lahko odmerek povečate do terapevtskega odmerka 1 mg/kg, hitrost infundiranja pa lahko počasi večate s titracijo navzgor, v skladu s prenašanjem bolnika.
Fabrazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency).
Zdravilo Fabrazyme je indicirano za dolgoročno encimsko nadomestno terapijo pri bolnikih s potrjeno diagnozo Fabryjeve bolezni (pomanjkanje α-galaktozidaze A).
After intravenous administration of agalsidase beta to adults with an infusion time of approximately 300 minutes and at a dose of 1 mg/kg body weight, biweekly, mean Cmax plasma concentrations ranged from 2000-3500 ng/ml, while the AUCinf ranged from 370-780 µg min/ml.
Po intravenski aplikaciji agalzidaze beta pri odraslih s trajanjem infundiranja približno 300 minut in pri odmerku 1 mg/kg telesne mase na vsaka 2 tedna so bile srednje vrednosti Cmax plazemske koncentracije od 2.000 do 3.500 ng/ml, medtem ko je bila vrednost AUCinf od 370 do 780 µg min/ml.
The reconstituted solution contains 5 mg agalsidase beta per ml, and appears as a clear colourless solution.
Rekonstituirana raztopina vsebuje 5 mg agalzidaze beta na ml in je videti kot bistra brezbarvna raztopina.
Patients experiencing adverse events during the home infusion need to immediately stop the infusion process and seek the attention of a healthcare professional.
Bolniki, pri katerih se med infundiranjem doma pojavijo neželeni dogodki, morajo prekiniti infundiranje in se posvetovati z zdravstvenim osebjem.
• fast breathing
• hitro dihanje
However, at the lower dose, IgG antibodies may play a role with respect to GL-3 clearance in some patients.
Vendar pa imajo lahko pri nekaterih bolnikih, pri nizkih odmerkih, protitelesa IgG pomembno vlogo na očistek GL-3.
A reduction in GL-3 was observed in kidney, heart, skin and plasma at all doses.
Pri vseh odmerkih so ugotavljali zmanjšanje količine GL-3 v ledvicah, srcu, koži in 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 naredite tako, da kapljice vode za injekcije dodajate s počasnim spuščanjem po notranjosti viale in ne neposredno na liofilizirano sredico.
Fabrazyme may get into breast milk.
Zdravilo Fabrazyme lahko prehaja v materino mleko.
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.
Zelo pogosti (se lahko pojavijo pri več kot 1 osebi od 10) so mrzlica, zvišana telesna temperatura, občutek mraza, občutek siljenja na bruhanje, bruhanje, glavobol in nenormalen občutek v koži (pekoč občutek ali mravljinci).
This was achieved in 47 of the 49 patients (96%) with available information at month 6, and in 8 of the 8 patients (100%) with available information at the end of the study (up to a total of 5 years of treatment).
6. meseca, in pri 8 od 8 bolnikov (100 %) s podatki, ki so bili na voljo ob koncu študije (do največ 5 let zdravljenja).
No interaction studies and no in vitro metabolism studies have been performed.
Raziskave medsebojnega delovanja in presnove in vitro niso bile opravljene.
Limited information from clinical trials suggests that the safety profile of Fabrazyme treatment in paediatric patients ages 5-7, treated with either 0.5 mg/kg every 2 weeks or 1.0 mg/kg every 4 weeks is similar to that of patients (above the age of 7) treated at 1.0 mg/kg every 2 weeks.
Omejeni podatki iz kliničnih študij nakazujejo, da je varnostni profil zdravljenja z zdravilom Fabrazyme pri pediatričnih bolnikih, starih od 5 do 7 let, zdravljenih z 0,5 mg/kg vsaka 2 tedna ali 1,0 mg/kg vsake 4 tedne, podoben tistemu pri bolnikih (nad starostjo 7 let), zdravljenih z 1,0 mg/kg vsaka 2 tedna.
Clearance of GL-3 in the superficial skin vascular endothelium was achieved in all patients who had accumulated GL-3 at baseline.
Očistek GL-3 v žilnem endoteliju vrhnje plasti kože so dosegli pri vseh bolnikih, ki so GL-3 kopičili v osnovi.
Since agalsidase beta (r-hαGAL) is a recombinant protein, the development of IgG antibodies is expected in patients with little or no residual enzyme activity.
Ker je agalzidaza beta (r-hαGAL) rekombinantni protein, pričakujemo tvorjenje protiteles IgG pri bolnikih z majhno ali neobstoječo preostalo encimsko aktivnostjo.
Reactions suggestive of immediate (Type I) hypersensitivity have been reported in a small number of patients (see section
O reakcijah, ki so nakazovale akutno preobčutljivost (tipa I), so poročali pri majhnem številu bolnikov (glejte poglavje 4.4).
• low heart rate due to conduction disturbances
• počasno bitje srca zaradi motenj v prevajanju
If you are treated with Fabrazyme, you may develop infusion associated reactions.
Pri zdravljenju z zdravilom Fabrazyme lahko pride do reakcij, povezanih z infuzijo.
• bronchospasm
• bronhospazem
• decreased sensitivity to pain
• zmanjšana občutljivost za bolečino
Additional symptoms included mild or moderate dyspnoea, hypoxia (oxygen saturation decreased), throat tightness, chest discomfort, flushing, pruritus, urticaria, face oedema, angioneurotic oedema, rhinitis, bronchospasm, tachypnoea, wheezing, hypertension, hypotension, tachycardia, palpitations, abdominal pain, nausea, vomiting, infusion-related pain including pain at the extremities, myalgia, and headache.
Dodatni simptomi so bili blaga ali zmerna dispneja, hipoksija (zmanjšana nasičenost s kisikom), stiskanje v grlu, neugodje v prsih, navali vročine, pruritus, urtikarija, obrazni edem, angionevrotični edem, rinitis, bronhospazem, tahipneja, sopihajoče in piskajoče dihanje, hipertenzija, hipotenzija, tahikardija, palpitacije, trebušne bolečine, navzea, bruhanje, bolečine zaradi infuzije, vključno z bolečinami v udih, mialgijo in glavobolom.
Fabrazyme treatment should be supervised by a physician experienced in the management of patients with Fabry disease or other inherited metabolic diseases.
Zdravljenje z zdravilom Fabrazyme mora potekati pod nadzorom zdravnika, izkušenega v zdravljenju bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
White to off-white lyophilised cake or powder.
Bela do sivkastobela, liofilizirana sredica ali prašek.
Fabrazyme is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease.
Zdravilo Fabrazyme je indicirano za uporabo v obliki dolgoročne encimske nadomestne terapije pri bolnikih s potrjeno diagnozo Fabryjeve bolezni.
There is no experience with the use of Fabrazyme in pregnant women.
Izkušenj z uporabo zdravila Fabrazyme pri nosečih ženskah ni.
• (mottled purplish) skin discoloration
• (lisasto vijolično) obarvanje kože
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 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/002 Fabrazyme 35 mg 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/003 Fabrazyme 35 mg 10 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/004 Fabrazyme 5 mg 1 viala praška za koncentrat za raztopino za infundiranje EU/1/01/188/005 Fabrazyme 5 mg 5 vial praška za koncentrat za raztopino za infundiranje EU/1/01/188/006 Fabrazyme 5 mg 10 vial praška za koncentrat za raztopino za infundiranje
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.
Začetna hitrost infundiranja ne sme preseči 0,25 mg/min (15 mg/uro), da zmanjšamo pojavljanje morebitnih infuzijskih reakcij na najmanjšo možno mero.
No changes in dose are necessary for patients with kidney disease.
Pri bolnikih z ledvičnimi boleznimi ni potrebna sprememba odmerka.
Infusion associated reactions consisted most often of fever and chills.
Reakcije, povezane z infuzijo Reakciji, povezani z infuzijo, sta najpogosteje zvišana telesna temperatura in mrzlica.
No clinical studies have been performed in children 0-4 years old.
Pri otrocih, starih od 0 do 4 leta, ni bilo opravljenih kliničnih študij.
How to use Fabrazyme
Kako uporabljati zdravilo Fabrazyme
In one of these studies, 15 paediatric patients with available pharmacokinetics data, aged 8.5 to 16 years weighing 27.1 to 64.9 kg were treated with 1.0 mg/kg every 2 weeks.
V eni od teh študij, je bilo 15 pediatričnih bolnikov, starih od 8,5 do 16 let s telesno maso od 27,1 do 64,9 kg, za katere so bili na voljo farmakokinetični podatki, zdravljenih z odmerkom 1,0 mg/kg vsaka 2 tedna.
Studies have not been performed to examine the effects of Fabrazyme on fertility.
Študije o učinkih zdravila Fabrazyme na plodnost niso bile opravljene.
Fabrazyme is supplied as a white to off-white powder.
Zdravilo Fabrazyme je dobavljeno kot bel do sivkastobel prašek.
The educational pack should contain the following:
Izobraževalno gradivo za bolnike mora vsebovati informacije o naslednjih ključnih elementih:
The recommended dose of Fabrazyme for adults is 1 mg/kg body weight, once every 2 weeks.
Priporočeni odmerek zdravila Fabrazyme za odrasle je 1 mg/kg telesne mase, enkrat na vsaka 2 tedna.
Adverse reactions only reported during the Post Marketing period are also included in the table below at a frequency category of “not known” (cannot be estimated from the available data).
V preglednici spodaj so v kategoriji »neznana« (ni mogoče oceniti iz razpoložljivih podatkov) zajeti tudi neželeni učinki, o katerih se je poročalo samo med obdobjem po začetku trženja.
The recommended dose of Fabrazyme is 1 mg/kg body weight administered once every 2 weeks as an intravenous infusion.
Priporočeni odmerek zdravila Fabrazyme je 1 mg/kg telesne mase in ga dajemo enkrat na vsaka 2 tedna v obliki intravenske infuzije.
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.
letno biopsijo ledvic so opravili v podskupini 6 bolnikov: ocene GL-3 v endoteliju ledvičnih kapilar so se pri vseh zmanjšale na nič, učinki na GL-3 v podocitih pa so bili zelo različni; zmanjšanje so zabeležili pri 3 bolnikih.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH VIALA
• skin discoloration
• obarvanje kože
- That it is the responsibility of the prescribing physician to provide appropriate training to the non-healthcare professional, such as the patient for self-administration or a caregiver who will administer the treatment at home, if the treating physician decides that this is appropriate.
- Da je zdravnik, ki predpiše zdravilo Fabrazyme, odgovoren za ustrezno usposabljanje nezdravstvenega osebja, kot je bolnik v primeru samodajanja ali negovalec v primeru uporabe zdravila na domu, če lečeči zdravnik presodi, da je to primerno.