natgillin/translations-raw huggingface dataset:
If the dates of submission of a PSUR and the update of a RMP coincide, they can be submitted at the same time.
Če predložitev PSUR in posodobitev RMP sovpadata, se lahko predložita sočasno.
There was no indication of significant improvements of the neurological manifestations of type 3 Gaucher disease except for one patient in this study.
Nič ni kazalo na pomembno izboljšanje nevroloških manifestacij Gaucherjeve bolezni tipa 3, razen pri enem bolniku v tej študiji.
• Description on how to prepare and administer the infusion including safety information;
• opis načina priprave in dajanja infuzij, vključno s podatki o varnosti;
What VPRIV is and what it is used for
Kaj je zdravilo VPRIV in za kaj ga uporabljamo
Investigations activated partial thromboplastin time prolonged, neutralizing antibody positive
Preiskave podaljšan aktivirani parcialni tromboplastinski čas, pozitivna nevtralizirajoča protitelesa
• Emergency plan provided by the prescriber including who to call and what to do in the case of a serious hypersensitivity reaction.
• načrt za nujne primere, ki ga bo posredoval zdravnik, ki predpisuje zdravilo, in bo vključeval podatke o tem, koga je treba poklicati in kaj storiti v primeru resne preobčutljivostne reakcije.
These medicines may include antihistamines, antipyretics, and corticosteroids.
Med temi zdravili so lahko antihistaminiki, antipiretiki in kortikosteroidi.
• About the disease, treatment and home infusion;
• o bolezni, zdravljenju in infuzijah na domu;
Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 USA
Drug Substance Manufacture Shire Human Genetic Therapies, Inc 400 Shire Way, Lexington, Massachusetts 02421 Združene države Amerike
The safety profile in these patients was similar to that observed in other clinical trials.
Varnostni profil pri teh bolnikih je bil podoben kot v drugih kliničnih preskušanjih.
Gaucher disease may become more active in a woman during pregnancy and for a few weeks after birth.
Gaucherjeva bolezen se lahko pri ženskah poslabša med nosečnostjo in v prvih nekaj tednih po porodu.
The infusion should be initiated within 24 hours from the time of reconstitution.
Infundiranje je treba začeti v 24 urah po rekonstituciji.
- if you are severely allergic to velaglucerase alfa or any of the other ingredients of this medicine (listed in section 6).
- če ste hudo alergični na velaglucerazo alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
These are called infusion-related reactions and may affect more than 1 in 10 people (very common).
Ti učinki se imenujejo reakcije, povezane z infundiranjem, in se lahko pojavijo pri več kot 1 od 10 bolnikov (zelo pogosto).
It is given by a doctor or nurse by intravenous infusion.
Daje ga zdravnik ali medicinska sestra z intravenskim infundiranjem.
The steady state volume of distribution was approximately 10% of the body weight.
Volumen porazdelitve v stanju dinamičnega ravnovesja je bil približno 10 % telesne mase.
*An enzyme unit is defined as the amount of enzyme that is required to convert one micromole of p-nitrophenyl β-D-glucopyranoside to p-nitrophenol per minute at 37ºC.
* Encimska enota je opredeljena kot količina encima, potrebna za pretvorbo enega mikromola p-nitrofenil ß-D-glukopiranozida v p-nitrofenol na minuto pri 37 ºC.
The MAH shall ensure that in each Member State where VPRIV is marketed, all healthcare professionals and patients/carers who are expected to prescribe, dispense or use VPRIV have access to/are provided with the following educational package:
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vsaki državi članici, kjer se trži zdravilo VPRIV, vsi zdravstveni delavci in bolniki/skrbniki za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo VPRIV, imeli dostop ali prejeli naslednji paket izobraževalnih gradiv:
Water for Injections
Sterilna voda za injekcije
Use in the age group 4 to 17 is supported by evidence from controlled studies in adults and paediatric [20 of 94 (21%)] patients.
Uporabo v starostni skupini od 4 do 17 let podpirajo dokazi iz nadzorovanih študij pri odraslih in pediatričnih [20 od 94 (21 %)] bolnikih.
Patients were required to have a stable dose of imiglucerase for at least 6 months prior to study enrolment.
Bolniki so morali prejemati stabilen odmerek imigluceraze vsaj 6 mesecev pred začetkom študije.
The maximum dose of velaglucerase alfa in clinical studies was 60 Units/kg.
Največji odmerek velagluceraze alfa v kliničnih študijah je bil 60 enot/kg.
The safety and efficacy profiles were similar between paediatric and adult patients.
Profili varnosti in učinkovitosti pri pediatričnih in odraslih bolnikih so bili podobni.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Zaradi pomanjkanja študij inkompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
VIAL - 400 UNITS
VIALA - 400 ENOT
Most side effects occurred during the infusion or shortly after.
Večina neželenih učinkov se je pojavila med infundiranjem ali takoj po njem.
Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 USA
Cell Bank storage and Drug Substance Manufacture Shire Human Genetic Therapies, Inc 205 Alewife Brook Parkway, Cambridge, Massachusetts 02138 Združene države Amerike
Cartons with 1, 5 or 25 vials.
Škatle z 1, 5 ali 25 vialami.
Patients were between 4 and 71 years old at the time of first treatment with VPRIV, and included 46 male and 48 female patients.
Pri prvem zdravljenju z zdravilom VPRIV so bili bolniki stari od 4 do 71 let, med njimi pa je bilo 46 moških in 48 žensk.
In Studies 025EXT and 034, patients were offered home therapy.
V študijah 025EXT in 034 so bolnikom ponudili zdravljenje na domu.
Excipient with known effect: One vial contains 12.15 mg sodium.
Pomožna snov z znanim učinkom: Ena viala vsebuje 12,15 mg natrija.
Do not use this medicine after the expiry date which is stated on the carton and label after ‘EXP'.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepkipoleg oznake »Uporabno do«.
If you are tolerating your infusions well in the clinic, your doctor or nurse may administer your infusions at home.
Če dobro prenašate infundiranje na kliniki, lahko zdravnik ali medicinska sestra izvaja infundiranje tudi pri vas doma.
Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB10.
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove - encimi, oznaka ATC: A16AB10.
• Organisation of home infusion/preparation of infusion;
• organiziranje infuzij na domu/priprava infuzij;
Therefore, it was not possible to evaluate the effect of antibody response on the pharmacokinetic profile of velaglucerase alfa.
Zaradi tega ni bilo mogoče oceniti učinka odziva protiteles na farmakokinetični profil velagluceraze alfa.
Elderly population (≥65 years)
Starejši bolniki (≥ 65 let)
Fertility Animal studies show no evidence of impaired fertility.
Plodnost Študije na živalih ne kažejo dokazov za zmanjšano plodnost.
57 patients were treatment-naïve.
57 bolnikov je bilo še nezdravljenih.
Each 400 Units vial is reconstituted with 4.3 ml of sterile water for injections.
Vsako vialo s 400 enotami rekonstituirajte s 4,3 ml sterilne vode za injekcije.
The only adverse reaction leading to discontinuation of treatment was an infusion-related reaction.
Edini neželeni učinek, zaradi katerega je bilo treba prekiniti zdravljenje, je bil reakcija, povezana z infundiranjem.
Uncommon side effects are: - blurry vision (may be associated with an infusion-related reaction) - vomiting
Občasni neželeni učinki so: - zamegljen vid (lahko je povezan z infundiranjem povezano reakcijo), - bruhanje.
A severe allergic reaction, with difficulty breathing, swelling of the face, lips, tongue or throat occured.
Pojavile so se hude alergijske reakcije s težavami pri dihanju, otekanjem obraza, ustnic, jezika ali grla.
Chemical and physical in-use stability has been demonstrated for 24 hours at 2C to 8C under protection from light.
Raztopina ostane kemično in fizično stabilna 24 ur pri temperaturi od 2 °C do 8 °C, zaščitena pred svetlobo.
An infusion-related reaction is defined as any adverse drug reaction occurring within 24 hours after the initiation of velaglucerase alfa infusion.
Reakcija, povezana z infundiranjem, je opredeljena kot vsaka neželena reakcija na zdravilo, ki nastopi v 24 urah po začetku infundiranja velagluceraze alfa.
Immune system disorders hypersensitivity reactions (includes dermatitis allergic and anaphylactic/anaphylactoid reactions)
Bolezni imunskega sistema preobčutljivostna reakcija (vključuje alergijski dermatitis in anafilaktične/anafilaktoidne reakcije)
The required vials are removed from the refrigerator.
Vzemite viale iz hladilnika.
- If the reaction is severe, your doctor will stop the intravenous infusion immediately and start giving you appropriate medical treatment.
- Če je reakcija resna, bo vaš zdravnik takoj prekinil intravensko infundiranje in vam začel nuditi ustrezno zdravljenje.
The European Medicines Agency has waived the obligation to submit the results of studies with VPRIV in all subsets of the paediatric population with type 2 Gaucher disease.
Evropska agencija za zdravila odstopa od obveznosti predložitve rezultatov študij z zdravilom VPRIV pri vseh podskupinah pediatričnih bolnikov z Gaucherjevo boleznijo tipa 2.
** produced in an HT-1080 human fibroblast cell line by recombinant DNA technology.
** Izdelano s tehnologijo rekombinantne DNA v humani fibroblastni celični liniji HT-1080.
However a few patients experienced an allergic skin reaction which may affect up to 1 in 10 people (common) such as severe rash or itching.
Nekaj bolnikov je imelo alergijsko kožno reakcijo, ki se lahko pojavi pri največ 1 od 10 bolnikov (pogosto), kot je hud izpuščaj ali srbenje.
Infusion-related reactions (IRR) were the most commonly observed adverse reactions in patients treated in clinical studies.
Reakcije, povezane z infundiranjem (IRR), so bile najpogosteje opažene neželene reakcije pri bolnikih, ki so bili zdravljeni v kliničnih študijah.
The build-up of this material causes the signs and symptoms found in Gaucher disease.
Kopičenje te snovi povzroča znake in simptome, ki se pojavljajo pri Gaucherjevi bolezni.
Women with Gaucher disease who are pregnant or considering pregnancy should talk with their doctor before this medicine is used.
Ženske z Gaucherjevo boleznijo, ki so noseče ali nameravajo zanositi, se morajo pred uporabo tega zdravila posvetovati z zdravnikom.
Reconstituted and diluted solution for infusion:
Rekonstituirana in razredčena raztopina za infundiranje:
Table 2: Results at 24 months - Change from Baseline - Study 044 ITT Population Clinical Parameters
Preglednica 2: Rezultati po 24 mesecih - sprememba od izhodišča - populacija ITT v študiji 044
Elderly patients may be treated within the same dose range (15 to 60 units/kg) as other adult patients.
Starejši bolniki se lahko zdravijo z enakim razponom odmerkov (od 15 do 60 enot/kg) kot drugi odrasli bolniki.
The most serious adverse reactions in patients in clinical trials were hypersensitivity reactions.
Najresnejši neželeni učinki pri bolnikih v kliničnih preskušanjih so bile preobčutljivostne reakcije.
The high clearance of velaglucerase alfa from serum (mean 6.7 to 7.6 ml/min/kg) is consistent with the rapid uptake of velaglucerase alfa into macrophages via mannose receptors.
Visok očistek velagluceraze alfa iz seruma (povprečna vrednost 6,7 do 7,6 ml/min/kg) je skladen s hitrim privzemom velagluceraze alfa v makrofage prek receptorjev za manozo.
The total volume of infusion should be delivered over a period of 60 minutes.
Celoten volumen zdravila je treba infundirati 60 minut.
When this enzyme is missing or does not work properly, a substance called glucocerebroside builds up inside cells in the body.
Če ta encim manjka, ali če ne deluje pravilno, se snov, imenovana glukocerebrozid, kopiči v telesnih celicah.
All patients received at least 2 years of ERT and were followed for a mean of 4.5 years (min. 2.3 years, max 5.8 years).
Vsi bolniki so najmanj 2 leti prejemali nadomestno encimsko zdravljenje, spremljali pa so jih povprečno 4,5 leta (najmanj 2,3 leta in največ 5,8 leta).
VPRIV should not be infused with other medicines in the same infusion as the compatibility in solution with other medicines has not been evaluated.
Zdravila VPRIV ne infundirajte z drugimi zdravili v isti liniji za infundiranje, saj združljivosti v raztopini z drugimi zdravili niso ocenili.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA): http://www.ema.europa.eu.
In this study, BMD was assessed using dual x-ray absorptiometry of the lumbar spine and femoral neck.
V tej študiji so BMD ocenili z uporabo dvoenergijske rentgenske absorpciometrije ledvene hrbtenice in stegneničnega vratu.
• Organisation: Home environment/Caregiver/Treating physician;
• organizacija: domače okolje/skrbnik/lečeči zdravnik;
The Guide for Healthcare Professionals Treating Patients with Gaucher Disease should contain the following key elements:
Vodnik za zdravstvene delavce, ki zdravijo bolnike z Gaucherjevo boleznijo, mora vsebovati naslednje ključne elemente:
The accumulation of glucocerebroside in the liver and spleen leads to organomegaly.
Kopičenje glukocerebrozidaze v jetrih in vranici povzroča organomegalijo.
A total of 95 patients (73 adult and 22 paediatric) who participated in studies 032, 034, and 039 enrolled in the open label extension study and were treated with velaglucerase alfa.
Skupno 95 bolnikov (73 odraslih in 22 otrok), ki so sodelovali v študijah 032, 034 in 039, se je vključilo v odprto podaljšanje in dobivalo velaglucerazo alfa.
In this small, exploratory study, the non-neurological efficacy findings and the safety profile of intravenous velaglucerase alfa in type 3 Gaucher patients were consistent with those observed in patients with type 1 Gaucher disease.
V tej majhni eksploratorni študiji so se ugotovitve glede ne-nevrološke učinkovitosti in varnostni profil intravenske velagluceraze alfa pri bolnikih z Gaucherjevo boleznijo tipa 3 ujemale s tistimi, ki so jih ugotovili pri bolnikih z Gaucherjevo boleznijo tipa 1.
VPRIV has no or negligible influence on the ability to drive or use machines.
Zdravilo VPRIV nima ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
Treatment should be approached with caution in patients who have exhibited symptoms of hypersensitivity to velaglucerase alfa or other enzyme replacement therapy.
K zdravljenju moramo pristopiti previdno pri bolnikih, ki so kazali simptome preobčutljivosti na velaglucerazo alfa ali na drugo encimsko nadomestno zdravljenje.
The active substance of VPRIV is velaglucerase alfa, which is produced by gene activation technology in a human cell line.
Učinkovina v zdravilu VPRIV je velagluceraza alfa, ki se izdeluje s tehnologijo aktivacije genov v humani celični liniji.
The range of velaglucerase alfa clearance in paediatric patients (N=7, age range 4 to 17 years) was contained within the range of clearance values in adult patients (N=15, age range 19 to 62 years).
Razpon očistka velagluceraze alfa pri pediatričnih bolnikih (N = 7, razpon starosti od 4 do 17 let) je bil znotraj razpona vrednosti očistkov pri odraslih bolnikih (N = 15, razpon starosti od 19 do 62 let).
20 ml glass vial containing a white to off-white powder.
20-mililitrska steklena viala, ki vsebuje bel do skoraj bel prašek.
- If the reactions are severe and/or there is a loss of effect from this medicine, your doctor will perform a blood test to check for antibodies which may affect the outcome of your treatment - Most of the time you can still be given VPRIV even if you experience one of these reactions.
- Če so reakcije resne in/ali pride do izgube učinka tega zdravila, bo zdravnik opravil krvno preiskavo, s katero bo preveril protitelesa, ki lahko vplivajo na izid vašega zdravljenja.
Doses higher than 60 Units/kg have not been studied.
Študij z odmerki, večjimi od 60 enot/kg, niso izvedli.
- The active substance is velaglucerase alfa.
- Učinkovina je velagluceraza alfa.
These treatment effects on haemoglobin, platelet count, organ volumes, bone mineral density and height were maintained through the end of the study.
Ti učinki zdravljenja na hemoglobin, število trombocitov, prostornino organov, mineralno gostoto kosti in višino so se ohranili do konca študije.
There are no or limited amount of data from the use of velaglucerase alfa in pregnant women.
Podatkov o uporabi velagluceraze alfa pri nosečnicah ni oziroma so omejeni.
Do not use if the solution is discoloured or if foreign particles are present.
Ne uporabljajte, če je raztopina obarvana ali če so prisotni vidni tujki.
• Guide for Healthcare Professionals Treating Patients with Gaucher Disease;
• vodnik za zdravstvene delavce, ki zdravijo bolnike z Gaucherjevo boleznijo;
Patients were required to have Gaucher disease-related anaemia and either thrombocytopenia or organomegaly.
Bolniki so morali imeti anemijo, povezano z Gaucherjevo boleznijo, in bodisi trombocitopenijo ali organomegalijo.
In Study 025EXT, 7 of 10 patients received home therapy at least once during 60 months of treatment.
V študiji 025EXT je 7 od 10 bolnikov prejelo zdravljenje na domu vsaj enkrat v 60 mesecih zdravljenja.
By month 57, 8 out of the 8 patients had achieved a reduction of at least 2 points in the lumbar spine Bone Marrow Burden (BMB) score as assessed by MRI scan.
Do 57. meseca je 8 od 8 bolnikov doseglo zmanjšanje rezultata obremenitve kostnega mozga (BMB) v ledvenem delu hrbtenice, ocenjenega z magnetnim resonančnim slikanjem, za vsaj 2 točki.
No infusion-related reactions were reported for this patient.
Pri tem bolniku niso poročali o nobenih reakcijah, povezanih z infundiranjem.
This medicinal product contains 12.15 mg sodium per vial.
To zdravilo vsebuje 12,15 mg natrija na vialo.
The Marketing Authorisation Holder (MAH) must agree on the content and format of the educational materials for use of VPRIV in home infusion, including communication media, distribution modalities and any other aspects of the programme, with the National Competent Authority.
Imetnik dovoljenja za promet z zdravilom se mora s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnih gradiv za uporabo zdravila VPRIV pri infundiranju na domu, vključno s sredstvi obveščanja, načini razdeljevanja in vsemi drugimi vidiki programa.
This should be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti z malo natrija.
The educational materials for the use of VPRIV in home infusion are aimed at providing guidance on how to manage risk of infusion-related reactions including allergic-type hypersensitivity reactions in a home setting.
Izobraževalna gradiva za uporabo zdravila VPRIV pri infundiranju na domu so zagotavljanju smernic za obvladovanje tveganja z infuzijo povezanih reakcij, vključno s preobčutljivostnimi reakcijami alergijskega tipa, v domačem okolju.
Ask your pharmacist how to throwaway medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
In studies with VPRIV additional side effects have also been reported:
V študijah z zdravilom VPRIV so poročali tudi o dodatnih neželenih učinkih:
Patients currently treated with imiglucerase enzyme replacement therapy for type 1 Gaucher disease may be switched to VPRIV, using the same dose and frequency.
Bolniki, ki trenutno prejemajo nadomestno encimsko zdravljenje z imiglucerazo za Gaucherjevo bolezen tipa 1, lahko preidejo na zdravilo VPRIV, pri čemer se uporabita enak odmerek in pogostnost uporabe.
Patients who have Gaucher disease and become pregnant may experience a period of increased disease activity during pregnancy and the puerperium.
Pri bolnicah z Gaucherjevo boleznijo, ki zanosijo, se lahko pojavi obdobje povečane aktivnosti bolezni med nosečnostjo in pri otročnici.
In this lysosomal storage disorder (LSD), clinical features are reflective of the distribution of Gaucher cells in the liver, spleen, bone marrow, skeleton, and lungs.
Pri tej lizosomski motnji shranjevanja (LSD) klinične značilnosti izražajo porazdelitev Gaucherjevih celic v jetrih, vranici, kostnem mozgu, okostju in pljučih.
- The other ingredients are sucrose, sodium citrate dihydrate, citric acid monohydrate and polysorbate 20 (see section 2 “VPRIV contains sodium”).
- Pomožne snovi so saharoza, natrijev citrat dihidrat, monohidrat citronske kisline in polisorbat 20 (glejte poglavje 2 »Zdravilo VPRIV vsebuje natrij«).
Phase I/II study HGT-GCB-068 was conducted to explore the efficacy and safety of velaglucerase alfa ERT in treatment naïve children and adolescents with type 3 Gaucher disease.
Študijo faze I/II HGT-GCB-068 so opravili, da bi raziskali učinkovitost in varnost nadomestnega encimskega zdravljenja z velaglucerazo alfa za zdravljenje še nezdravljenih otrok in mladostnikov z Gaucherjevo boleznijo tipa 3.
The number of vials to be reconstituted is determined based on the individual patient's weight and the prescribed dose.
Število vial, ki jih je treba rekonstituirati, določite glede na bolnikovo telesno maso in predpisani odmerek.
The manual for patients with Gaucher Disease who receive home infusion should contain the following key elements:
Vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu, mora vsebovati naslednje ključne elemente:
There were no apparent pharmacokinetic differences between male and female patients with type 1 Gaucher disease.
Med bolnicami in bolniki z Gaucherjevo boleznijo tipa 1 ni bilo nobenih očitnih farmakokinetičnih razlik.
The majority of these side effects were mild in intensity.
Večina teh neželenih učinkov je bilo blagih.
Your doctor will monitor your response to treatment and may change your dose (up or down) over time.
Vaš zdravnik bo nadzoroval odziv na zdravljenje in lahko sčasoma zviša ali zniža odmerek.
In treatment-naïve patients, the majority of infusion-related reactions occurred during the first 6 months of treatment.
Pri bolnikih, ki še niso prejemali nadomestnega encimskega zdravljenja, se je večina reakcij, povezanih z infundiranjem, pojavila v prvih 6 mesecih zdravljenja.
This enzymatic deficiency causes an accumulation of glucocerebroside primarily in macrophages, giving rise to foam cells or "Gaucher cells".
Pomanjkanje encima povzroča akumulacijo glukocerebrozida predvsem v makrofagih, kar povzroči nastanek penastih celic ali »Gaucherjevih celic«.
Each vial will contain an extractable volume of 4.0 ml (100 Units/ml).
Volumen, ki ga lahko odvzamete iz ene viale je 4,0 ml (100 enot/ml).
The most common adverse reactions were infusion-related reactions.
Najpogostejši neželeni učinki so bile reakcije, povezane z infundiranjem.
Study 058 was an open-label clinical safety study in 211 patients including 205 patients previously treated with imiglucerase 6 treatment-naïve patients and 57 patients aged 65 years or older (56/57 had switched from imiglucerase to velaglucerase alfa).
Študija 058 je bila odprta klinična študija varnosti pri 211 bolnikih, vključno z 205 bolniki, ki so se predhodno zdravili z imiglucerazo, 6 bolniki, ki še niso prejemali nobenega zdravljenja, in 57 bolniki, starimi 65 let ali več (56/57 jih je z imiguceraze prešlo na velaglucerazo alfa).
• Manual for patients with Gaucher Disease who receive home infusion;
• vodnik za bolnike z Gaucherjevo boleznijo, ki prejemajo infuzije na domu;
Each 400 Units vial of this medicine contains 12.15 mg sodium.
Ena viala s 400 enotami tega zdravila vsebuje 12,15 mg natrija.
In Study 034, 25 of 40 patients received home therapy at least once during the 12-month study.
V študiji 034 je 25 od 40 bolnikov prejelo zdravljenje na domu vsaj enkrat v 12 mesecih zdravljenja.
• Annex: Package Leaflet, Infusion diary, Patient Reconstitution Guide, Emergency plan.
• priloge: navodilo za uporabo, dnevnik infuzij, vodnik za bolnike glede rekonstitucije, načrt za nujne primere.