natgillin/translations-raw huggingface dataset:
The majority of the related adverse events in the clinical trials were classified as infusion-associated reactions (IARs), experienced by 53% of the patients in the Phase 3 study (treated for up to 4 years) and 35% of the patients in the under 5 study (up to 1 year of treatment).
Večino z zdravilom povezanih neželenih dogodkov v kliničnih preskušanjih so opredelili kot reakcije, povezane z infuzijami (infusion associated reactions, IARs)), do katerih je prišlo pri 53 % bolnikov v tretji fazi študije (zdravljenje do 4 let) in 35 % bolnikov mlajših od 5 let (zdravljenje do 1 leta).
After intravenous administration of laronidase with an infusion time of 240 minutes and at a dose of 100 U/kg body weight pharmacokinetic properties were measured at Weeks 1, 12 and 26.
Po intravenski uporabi laronidaze s časom infundiranja 240 minut in z odmerkom 100 e/kg telesne mase so merili farmakokinetične lastnosti v 1., 12. in 26. tednu zdravljenja.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1 VIAL, 10 VIALS, 25 VIALS)
PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (1 VIALA, 10 VIAL, 25 VIAL)
The proportion of patients with mild left ventricular hypertrophy decreased from 53% (10/19) to 17% (3/18), and mean left ventricular mass normalized for body surface area decreased by 0.9 Z-Score (n=17).
Odstotek bolnikov z blago hipertropijo na levem prekatu se je znižal s 53 % (10/19) na 17 % (3/18), srednja masa levega prekata se je normalizirala, saj se je telesna površina znižala za 0,9 Z-Score (n=17).
Four patients underwent dosage increases to 200 U/kg for the last 26 weeks because of elevated urinary GAG levels at Week 22.
Pri štirih bolnikih se je zadnjih 26 tednov študije odmerek povišal na 200 e/kg zaradi zvišanih vrednosti GAG v urinu v 22. tednu.
The 200 U/kg IV every 2 weeks regimen may be an acceptable alternative for patients with difficulty receiving weekly infusions; however, there is no evidence that the long term clinical efficacy of these two dose regimens is equivalent.
vsaka 2 tedna je sprejemljivi alternativni režim za bolnike, ki imajo težave pri tedenskih infuzijah, vendar pa ni dokazov o ekvivalentnosti dolgotrajnejše klinične učinkovitosti teh dveh režimov odmerjanja.
Because there are no data available in neonates exposed to laronidase via breast milk, it is recommended to stop breast-feeding during Aldurazyme treatment.
Ker ni podatkov o novorojenčkih, ki so z materinim mlekom prejemali laronidazo, materam priporočamo, da med zdravljenjem z zdravilom Aldurazyme prekinejo dojenje.
Laronidase may be excreted in milk.
Obstaja verjetnost, da se laronidaza izloča v materino mleko.
Based on the Phase 3 clinical trial, almost all patients are expected to develop IgG antibodies to laronidase, mostly within 3 months of initiation of treatment.
Po izsledkih tretje faze kliničnega preskušanja lahko pričakujemo, da se bodo pri skoraj vseh bolnikih razvila protitelesa IgG za laronidazo, večinoma v prvih treh mesecih zdravljenja.
By the end of the Phase 3 study (or at time of early study withdrawal), 13/45 patients had no detectable antibodies by radioimmunoprecipitation (RIP) assay, including 3 patients that had never seroconverted.
Do zaključka tretje faze študije (ali ob času zgodnjega umika iz študije) pri 13 bolnikih (od 45 bolnikov) radioimunološki obarjalni preskus (RIP) ni zaznal protiteles, vključno pri 3 bolnikih, pri katerih ni nikoli prišlo do serokonverzije.
Purified laronidase is a glycoprotein with a molecular weight of approximately 83 kDa. Laronidase is comprised of 628 amino acids after cleavage of the N-terminus.
Očiščena laronidaza je glikoprotein z molekularno maso približno 83 kDa. Laronidaza je po odcepitvi N-terminala sestavljena iz 628 aminokislin.
For information on pre-treatment, see section 4.4.
Informacije glede predhodnega zdravljenja so v poglavju 4.4.
Severe hypersensitivity (e.g. anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see sections 4.4 and 4.8).
Huda preobčutljivost (npr. anafilaktična reakcija) na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavji 4.4 in 4.8).
The primary efficacy endpoints were changes in percent of predicted normal FVC and absolute distance travelled in the six-minute walk test (6MWT).
Osnovna merila učinkovitosti so bile spremembe v odstotku predvidene normalne forsirane vitalne kapacitete in absolutne razdalje, ki so jo bili zmožni prehoditi v 6-minutnem preizkusu (6MWT).
As there is little experience on resumption of treatment following prolonged interruption, use caution due to the theoretical increased risk of hypersensitivity reaction after treatment interruption.
Izkušenj z nadaljevanjem zdravljenja po daljši prekinitvi je malo, zato bodite previdni, saj obstaja teoretična nevarnost pojava preobčutljivostnih reakcij po prekinitvi zdravljenja.
Aldurazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis I (MPS I; α-L-iduronidase deficiency) to treat the nonneurological manifestations of the disease (see section 5.1).
Zdravilo Aldurazyme je namenjeno dolgoročni terapiji z nadomestnimi encimi pri bolnikih s potrjeno diagnozo mukopolisaharidoze tipa I (MPS I; pomanjkanje α-L-iduronidaze), in sicer za zdravljenje nenevroloških znakov bolezni (glejte poglavje 5.1).
The third study was conducted to evaluate the pharmacodynamics and safety of different dose regimens of Aldurazyme.
Tretja klinična študija pa je ocenjevala farmakodinamiko in varnost različnih režimov odmerjanja zdravila Aldurazyme.
Renal elimination of laronidase is considered to be a minor pathway for clearance (see section 4.2).
Za laronidazo velja, da se skozi ledvice izloča le v manjši meri (glejte poglavje 4.2).
The safety and efficacy of Aldurazyme in patients older than 65 years have not been established and no dosage regimen can be recommended in these patients.
Varnost in učinkovitost zdravila Aldurazyme pri bolnikih, starejših od 65 let, nista bili dokazani, zato pri teh bolnikih ne moremo priporočati režima odmerjanja.
Almost all patients developed IgG antibodies to laronidase.
Pri skoraj vseh bolnikih je prišlo do tvorbe protiteles IgG na laronidazo.
What Aldurazyme is and what it is used for What you need to know before you are given Aldurazyme How Aldurazyme is given
Kaj je zdravilo Aldurazyme in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo Aldurazyme Kako boste prejeli zdravilo Aldurazyme Možni neželeni učinki
Most patients seroconverted within 3 months of initiation of treatment; although seroconversion in patients under 5 years old with a more severe phenotype occurred mostly within 1 month (mean 26 days versus 45 days in patients 5 years and older).
Pri večini bolnikov se je pojavila serokonverzija v 3 mesecih od začetka zdravljenja; čeprav se je serokonverzija pri bolnikih, mlajših od 5 let, s hujšo obliko fenotipa pojavila predvsem v prvem mesecu (povprečno 26 dni proti 45 dni pri bolnikih, starih 5 let in več).
PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion.
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala s koncentratom za raztopino za infundiranje.
Sodium chloride,
Natrijev klorid,
The molecule contains 6 N-linked oligosaccharide modifications sites.
Molekula vsebuje 6 mest za reakcije z oligosaharidi, vezanih z dušikom.
Antibody status should be regularly monitored and reported.
Redno preverjajte stanje protiteles in o tem poročajte.
Each vial of 5 ml contains 1.29 mmol sodium.
Ena 5 ml viala vsebuje 1,29 mmol natrija.
The frequency of severe allergic reaction (anaphylactic reaction) and swelling of the face is considered common and may affect up to 1 in 10 people.
Alergične (anafilaktične) reakcije in otekanje obraza spadajo med pogoste neželene učinke in se lahko pojavijo pri 1 od 10 bolnikov.
If you miss an infusion of Aldurazyme If you have missed an Aldurazyme infusion, please contact your doctor.
Če niste dobili infuzije zdravila Aldurazyme Če niste dobili infuzije zdravila Aldurazyme, se posvetujte s svojim zdravnikom.
If clinically indicated, administration of pre-treatment medications with subsequent infusions of Aldurazyme should be considered.
Če je to klinično indicirano, premislite o predhodni terapiji z zdravili in poznejšimi infuzijami zdravila Aldurazyme.
You should not be given this medicine after the expiry date which is stated on the label after the letters EXP.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini za oznako EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
A phase 4 study was conducted to evaluate the pharmacodynamic effects on urinary GAGs, liver volume, and 6MWT, of different Aldurazyme dose regimens.
V 4. fazi študije so ocenjevali farmakodinamične učinke vrednosti GAG v urinu, volumen jeter in vrednosti 6MWT pri različnih režimih odmerjanja zdravila Aldurazyme.
Therefore Aldurazyme should not be used during pregnancy unless clearly necessary.
Zato zdravila Aldurazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
Severe IARs have been reported in patients with pre-existent severe underlying upper airway involvement and therefore specifically these patients should continue to be closely monitored and only be infused with Aldurazyme in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Hude reakcije so se ob infuziji pojavile pri bolnikih, ki so imeli že prej močno prizadeta zgornja dihala, zato je treba te bolnike nenehno skrbno opazovati, zdravilo Aldurazyme pa se jim lahko infundira le v ustrezni klinični ustanovi, kjer imajo pri roki opremo za oživljanje za reševanje nujnih zdravstvenih primerov.
This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6).
To zdravilo vsebuje natrij; zdravilo infundirajte v obliki 0,9 % intravenske raztopine natrijevega klorida (glejte poglavje 6.6).
The presence of antibodies did not appear to be related to the incidence of IARs, although the onset of IARs typically coincided with the formation of IgG antibodies.
Ni dokazov, da bi bila prisotnost protiteles povezana s pojavom reakcij povezanih z infuzijo, čeprav so se reakcije ob infuziji navadno pojavile skupaj s tvorbo IgG protiteles.
Laronidase is a protein and is expected to be metabolically degraded through peptide hydrolysis.
Laronidaza je beljakovina in naj bi se presnavljala s hidrolizo peptidov.
Only clear and colourless solutions without visible particles should be used.
Uporabite lahko le bistro in brezbarvno raztopino brez vidnih delcev.
The current medical standards for emergency treatment are to be observed.
Pri tem se zgledujte po trenutnih zdravstvenih standardih za oskrbo nujnih primerov.
The safety and efficacy of Aldurazyme in patients with renal or hepatic insufficiency have not been evaluated and no dosage regimen can be recommended in these patients.
Varnost in učinkovitost zdravila Aldurazyme pri bolnikih z jetrno ali ledvično okvaro ni ocenjena, zato pri teh bolnikih ne moremo priporočati režima odmerjanja.
If these reactions occur, the Aldurazyme infusion should be stopped immediately and appropriate treatment will be started by your doctor.
Če se pojavijo te reakcije, morate nemudoma prenehati z infundiranjem zdravila Aldurazyme, vaš zdravnik pa bo pričel z ustreznim zdravljenjem.
Reduced or absent α-L-iduronidase activity results in the accumulation of the GAGs, dermatan sulfate and heparan sulfate in many cell types and tissues.
Zmanjšano delovanje ali odsotnost -L-iduronidaze povzroča kopičenje glikozaminoglikanov, dermatan sulfata in heparan sulfata v mnogih vrstah celic in tkiv.
This medicinal product contains 1.29 mmol sodium per vial.
To zdravilo vsebuje 1,29 mmol natrija na vialo.
No information is available on the effects of Aldurazyme on fertility.
Ni podatkov o učinku zdravila Aldurazyme na plodnost..
A Phase 2 open-label, 1-year study was conducted that mainly assessed the safety and pharmacokinetics of Aldurazyme in 20 patients less than 5 years of age at the time of enrolment (16 patients with the severe phenotype and 4 with the intermediate phenotype).
Opravljena je bila druga faza odprte enoletne študije, v kateri je bila ocenjena predvsem varnost in farmakokinetika zdravila Aldurazyme pri 20 bolnikih, ki so bili v času vključitve v študijo mlajši od 5 let (16 bolnikov je imelo hudo, 4 pa srednjo obliko fenotipa bolezni).
Consequently, impaired liver function is not expected to affect the pharmacokinetics of laronidase in a clinically significant way.
Zato ni verjetno, da bi poslabšano delovanje jeter v klinično pomembni meri vplivalo na farmakokinetiko laronidaze.
Each vial of 5 ml contains 500 U of laronidase.
Vsaka 5 ml viala vsebuje 500 e laronidaze.
One clinical study focussed mainly on assessing the effect of Aldurazyme on the systemic manifestations of MPS I such as poor endurance, restrictive lung disease, upper airway obstruction, reduced joint range of motion, hepatomegaly and visual impairment.
Ena klinična študija je bila osredotočena predvsem na ocenjevanje učinka zdravila Aldurazyme na sistemske znake mukopolisaharidoze I, kot so slaba vzdržljivost, , restriktivna pljučna bolezen, obstrukcija zgornjih dihalnih poti, zmanjšan obseg gibanja sklepov, hepatomegalija in poslabšanje vida.
In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol/ibuprofen should be considered.
Če se pojavi enkratna težka reakcija ob infuziji, morate zdravljenje z infuzijo prekiniti, dokler so simptomi prisotni, in razmisliti o zdravljenju z antihistaminiki ter s paracetamolom ali ibuprofenom.
It is recommended that the diluted Aldurazyme solution be administered to patients using an infusion set equipped with an 0.2 µm in-line filter.
Priporočamo, da pripravljeno raztopino zdravila Aldurazyme infundirate z uporabo kompleta za infuzijo, opremljenega z 0,2 µm vmesnim filtrom.
Although patients representing the full range of the disease spectrum were enrolled, the majority of the patients were of the intermediate phenotype, with only one patient exhibiting the severe phenotype.
Bolniki, ki so sodelovali v študiji, so sicer predstavljali celoten spekter bolezni, vendar jih je večina imela srednji fenotip bolezni, samo en bolnik pa težjo obliko.
Preparation of the Aldurazyme Infusion (Use Aseptic Technique) Determine the number of vials to be diluted based on the individual patient's weight.
Priprava infuzije zdravila Aldurazyme (z uporabo aseptične tehnike) Število vial, ki jih boste uporabili, določite glede na bolnikovo maso.
It is not known whether Aldurazyme appears in breast milk.
Ni znano, ali se zdravilo Aldurazyme izloča v materino mleko.
The concentrate for solution for infusion has to be diluted before administration and is for intravenous use (see information for health care professionals).
Navodila za uporabo - priprava raztopine in uporaba Koncentrat za pripravo raztopine za infundiranje je pred uporabo treba razredčiti; namenjen je intravenski uporabi (glejte informacije za zdravstveno osebje).
The initial infusion rate of 2 U/kg/h may be gradually increased every fifteen minutes, if tolerated, to a maximum of 43 U/kg/h.
Začetna hitrost infuzije 2 e/kg/h se lahko postopoma povečuje vsakih petnajst minut, če to dobro prenašate, do največje hitrosti 43 e/kg/h.
Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Motnje v shranjevanju mukopolisaharidov povzroča pomanjkanje specifičnih lizosomskih encimov, potrebnih za katabolni metabolizem glikozaminoglikanov.
In clinical studies IARs were usually manageable by slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol or ibuprofen), thus enabling the patient to continue treatment.
V kliničnih študijah so reakcije ob infuziji navadno uspeli ublažiti s počasnejšim infundiranjem in (predhodnim) zdravljenjem z antihistaminiki in/ali antipiretiki (paracetamolom ali ibuprofenom), tako da je bolnik lahko nadaljeval zdravljenje.
Administration of Aldurazyme should be carried out in an appropriate clinical setting where resuscitation equipment to manage medical emergencies would be readily available.
Zdravilo Aldurazyme se mora uporabljati v ustreznem kliničnem okolju, kjer je na razpolago oprema za oživljanje za primere, ko je potrebna nujna zdravniška oskrba.
Very common symptoms (may affect more than 1 in 10 people) which were not serious include headache, nausea, abdominal pain, rash, joint disease, joint pain, back pain, pain in arms or legs, flushing, fever, chills, increased heart rate, increased blood pressure, and reaction at the infusion site.
Zelo pogosti simptomi (pojavijo se lahko pri več kot 1 od 10 bolnikov), ki niso resni, so: glavobol, slabost, bolečine v trebuhu, izpuščaji, bolezni sklepov, bolečine v sklepih, hrbtu, rokah ali nogah, navali vročine, vročina, mrzlica, povečan srčni utrip, zvišan krvni tlak in reakcija na mestu infuzije.
For instruction on dilution of the medicinal product before administration, see section 6.6.
Za navodila glede redčenja zdravila pred dajanjem, glejte poglavje 6.6.
However, severe systemic allergic reaction (anaphylactic reaction) has been observed in patients during or up to 3 hours after Aldurazyme infusions.
Vendar so pri bolnikih med infuzijami zdravila Aldurazyme ali do 3 ure po njih opazili hudo sistemsko alergično (anafilaktično) reakcijo.
What Aldurazyme looks like and contents of the pack Aldurazyme is supplied as a concentrate for solution for infusion.
Izgled zdravila Aldurazyme in vsebina pakiranja Zdravilo Aldurazyme je v obliki koncentrata za pripravo raztopine za infundiranje.
What Aldurazyme contains - The active substance is laronidase.
Kaj vsebuje zdravilo Aldurazyme - Zdravilna učinkovina je laronidaza.
5 ml concentrate for solution in a vial (type I glass) with a stopper (siliconised chlorobutyl rubber) and a seal (aluminium) with a flip-off cap (polypropylene).
5 ml koncentrata za pripravo raztopine v viali (steklo vrste I) z zamaškom iz silikonizirane klorobutilne gume, aluminijastim tesnilom in polipropilensko zaporko Flip-Off.
A single patient with pre-existing airway compromise developed a severe reaction three hours from the start of the infusion (at week 62 of treatment) consisting of urticaria and airway obstruction, requiring tracheostomy.
Pri bolniku z že obstoječo boleznijo dihal je tri ure po začetku infuzije (v 62. tednu zdravljenja) prišlo do hude reakcije v obliki koprivnice in oviranega pretoka zraka, zaradi katere je bila potrebna traheostomija.
Aldurazyme should not be administered simultaneously with chloroquine or procaine due to a potential risk of interference with the intracellular uptake of laronidase.
Zdravila Aldurazyme ne smete dajati sočasno s klorokinom ali prokainom, ker obstaja nevarnost pojava motenj v znotrajceličnem privzemu laronidaze.
Due to the small patient population, an ADR reported in a single patient is classified as common.
Zaradi majhnega vzorca bolnikov je bil neželeni učinek zdravila, ki se je pojavil pri enem samem bolniku, označen kot pogost.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA ODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.
Marketing Authorisation Holder: Genzyme Europe B.V.
Imetnik dovoljenja za promet z zdravilom: Genzyme Europe B.V.
If these reactions occur, immediate discontinuation of Aldurazyme is recommended and appropriate medical treatment should be initiated.
Če pride do teh reakcij, priporočamo takojšnjo prekinitev zdravljenja z zdravilom Aldurazyme in ustrezne zdravstvene ukrepe.
Additionally, a few patients who had a prior history of severe MPS I- related upper airway and pulmonary involvement, experienced severe reactions including bronchospasm, respiratory arrest, and facial oedema (see section 4.4).
Poleg tega so se pri nekaj bolnikih, ki so imeli zaradi MPS I hudo prizadeta zgornja dihala in pljuča, pojavile hude reakcije, vključno z bronhospazmom, zastankom dihanja in obraznim edemom (glejte poglavje 4.4).
Patients with absent to low antibody levels showed a robust reduction in urinary GAG level, whereas patients with high antibody titers showed variable reduction in urinary GAG.
Pri bolnikih brez protiteles ali z nizkimi vrednostmi protiteles so se GAG vrednosti v urinu izrazito znižale, medtem ko so se pri bolnikih z visokimi titri protiteles vrednosti GAG v urinu različno nižale.
Percent Predicted FVC (percentage point)
Interval zaupanja predvideni odstotek FVC
Aldurazyme treatment should be supervised by a physician experienced in the management of patients with MPS I or other inherited metabolic diseases.
Zdravljenje z zdravilom Aldurazyme mora nadzorovati zdravnik, ki ima izkušnje pri zdravljenju bolnikov z mukopolisaharidozo tipa I ali drugimi dednimi boleznimi presnove.
You should not be given Aldurazyme
Ne smete prejeti zdravila Aldurazyme
With initial administration of Aldurazyme or upon re-administration following interruption of treatment, it is recommended that patients be administered pre-treatment medicines (antihistamines and/or antipyretics) approximately 60 minutes prior to the start of the infusion, to minimise the potential occurrence of IARs.
Ob začetku uporabe zdravila Aldurazyme ali ob ponovni uporabi po prekinitvi zdravljenja priporočamo predhodno zdravljenje bolnika z antihistaminiki in/ali antipiretiki (približno 60 minut pred infuzijo), kar bo zmanjšalo možnosti pojava reakcij ob infuziji.
MedDRA System Organ Class
razred organskega sistema (po MedDRA)
Based on its metabolism, laronidase is an unlikely candidate for Cytochrome P450 mediated interactions.
Glede na metabolizem laronidaze ni verjetno, da bi pri uporabi te učinkovine prišlo do interakcij, povezanih s citokromom P450.
MPS I is a heterogeneous and multisystemic disorder characterised by the deficiency of α-L-iduronidase, a lysosomal hydrolase which catalyses the hydrolysis of terminal α-L-iduronic residues of dermatan sulfate and heparan sulfate.
Mukopolisaharidoza tipa I je heterogena in multisistemska motnja, za katero je značilno pomanjkanje -L-iduronidaze, lizosomske hidrolaze, ki katalizira hidrolizo -L-iduronskih ostankov dermatan sulfata in heparan sulfata.
SUMMARY OF PRODUCT CHARACTERISTICS
PRILOGA POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity and toxicity to reproduction.
Neklinični podatki, na osnovi običajnih študij farmakološke varnosti,, toksičnosti enojnega odmerka, toksičnosti pri ponavljajočih se odmerkih in vpliva na sposobnost razmnoževanja, ne kažejo posebnega tveganja za človeka.
MARKETING AUTHORISATION NUMBER(S) EU/1/03/253/001 1 Vial
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/03/253/001 1 Viala
EU/1/03/253/002 10 Vials
EU/1/03/253/002 10 Vial
SPECIAL STORAGE CONDITIONS Store in a refrigerator (2°C - 8°C).
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku (2 C - 8 C).
It is a solution that is clear to slightly opalescent, and colourless to pale yellow.
Raztopina je bistra do rahlo opalescentna, brezbarvna do bledo rumene barve.
Infusion 26 Mean± SD
Infuzija 26 Srednja vrednost ± SD
There is not enough experience of the use of Aldurazyme in pregnant women.
Z uporabo zdravila Aldurazyme pri nosečnicah ni dovolj izkušenj.
MARKETING AUTHORISATION HOLDER Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, The Netherlands.
Imetnik dovoljenja za promet Genzyme Europe B.V., Paasheuvelweg 25, 1105 BP Amsterdam, Nizozemska.
Driving and using machines The effects on the ability to drive and to use machines have not been studied.
Vpliv na sposobnost upravljanja vozil in strojev Študije vpliva na sposobnost upravljanja vozil in strojev niso bile opravljene.