natgillin/translations-raw huggingface dataset:
Any unused product or waste material is to be disposed of in accordance with local requirements.
Vsa neporabljena količina zdravila ali odpadni material morata biti odstranjena v skladu z lokalnimi predpisi.
Very Common
zelo pogosti
If these reactions occur, immediate discontinuation of Naglazyme is recommended and appropriate medical treatment should be initiated.
V primeru takšne reakcije je priporočljivo takoj prekiniti aplikacijo Naglazyma in uvesti ustrezno zdravljenje.
Final CSP Study Report: 31 July activities.
Končno študijsko poročilo CPS: 31. julij 2020
Warnings and precautions - If you are treated with Naglazyme, you may develop infusion-associated reactions.
Opozorila in previdnostni ukrepi - Če se zdravite z Naglazymom, se lahko pri vas razvijejo z infundiranjem zdravila povezano reakcije.
The MAH must ensure that the system of pharmacovigilance, presented in Module 1.8.1. of the Marketing Authorisation , is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, kot je predložen v modulu 1.8.1. vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje pred in med prisotnostjo zdravila na trgu.
Information will also be collected on clinical status, adverse events, assessments of immunogenicity and potential effects on antibody formation.
Zbirali se bodo tudi podatki o kliničnem statusu, neželenih učinkih, ocenitvi imunogenosti in možnih učinkov na nastajanje protiteles.
6.6 Special precautions for disposal and other handling Each vial of Naglazyme is intended for single use only.
6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Vsaka viala Naglazymaz je namenjena samo za enkratno uporabo.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 002 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal raziskave in dodatne farmakovigilančne aktivnosti, podrobno opredeljene v farmakovigilančnem načrtu, sprejetem v različici 002 Načrta za obvladovanje tveganja (RMP), predloženem v modulu 1.8.2. vloge za pridobitev dovoljenja za promet z zdravilom in vseh nadaljnjih posodobitvah RMP, v soglasju z Odborom za zdravila za uporabo v humani medicini (CHMP).
Peri- and post-natal toxicity has not been investigated.
Obporodna in poporodna toksičnost nista bili raziskani.
Institution of positive-airway pressure during sleep as well as potential tracheostomy in clinically appropriate situations should also be considered.
Razmisliti je treba tudi, da se zagotoviti pozitivni tlak v dihalnih poteh med spanjem in tudi možnost traheostomije v ustreznih kliničnih situacijah.
After intravenous infusion, galsulfase is rapidly removed from the circulation and taken up by cells into lysosomes, most likely via mannose-6 phosphate receptors.
Po intravenski infuziji se galsulfaza hitro odstrani iz krvnega obtoka in preide v lizosome v celicah, večinoma preko manoza-6-fosfatnih receptorjev.
Common reactions have a frequency of 1/100 to <1/10.
Pogosti neželeni učinki se pojavijo pri 1/100 do <1/10 bolnikov.
In four patients <1 year of age, the overall safety profile of a higher dose (2 mg/kg/week) did not differ in a clinically meaningful manner from that of the recommended 1 mg/kg/week dose, and was consistent with the safety profile of Naglazyme in older children.
Pri štirih bolnikih, mlajših od 1 leta, se skupni varnostni profil višjega odmerka (2 mg/kg/teden) ni klinično pomembno razlikoval od varnostnega profila priporočenega odmerka 1 mg/kg/teden in je bil skladen z varnostnim profilom zdravila Naglazyme pri starejših otrocih.
Infusion reactions, defined as adverse reactions occurring during Naglazyme infusions or until the end of the infusion day, were observed in 33 (56%) of the 59 patients treated with Naglazyme across five clinical studies.
Reakcije na infuzijo, opredeljene kot neželeni učinki, ki so se pojavili med infundiranjem zdravila Naglazyme ali do konca dneva infundiranja, so opazili pri 33 (56 %) od 59 bolnikov, zdravljenih z zdravilom Naglazyme v petih kliničnih študijah.
Each 5 ml vial contains 0.8 mmol (18.4 mg) of sodium.
Vsaka 5 ml viala vsebuje 0,8 mmol (18,4 mg) natrija.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB08
Farmakoterapevtska skupina: Druga zdravila za bolezni prebavil in presnove - encimi, oznaka ATC: A16AB08.
The majority of the patients presented with short stature, impaired endurance, and musculoskeletal symptoms.
Večina bolnikov je imela majhno postavo, okrnjeno vzdržljivost in mišično-kostne simptome.
It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.
Ni poznano, ali se galsulfaza izloča v mleko, zato je treba med zdravljenjem z Naglazymom dojenje prekiniti.
To evaluate the long-term safety and efficacy data from Naglazyme treatment a Clinical Surveillance Program (CSP) will be conducted.
Izvedena bo ocean podatkov dolgoročne varnosti in učinkovitosti zdravljenja z zdravilom Naglazyme (Clinical Surveillance Program - CSP).
MARKETING AUTHORISATION NUMBER(S) EU/1/05/324/001
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/05/324/001
For information on pre-treatment see section 4.4 and for further instructions see section 6.6.
Za informacije o predpripravi bolnika glejte poglavje 4.4 in za nadaljnja navodila poglavje 6.6. 4.3 Kontraindikacije
For Naglazyme, no clinical data on exposed pregnancies are available.
Za zdravilo Naglazyme ni na voljo kliničnih podatkov za nosečnice, izpostavljene zdravilu.
The safety and efficacy of Naglazyme was assessed in a randomised, double blind, placebo controlled, Phase 3 study of 39 MPS VI patients, ranging in age from 5 to 29 years.
Varnost in učinkovitost zdravila Naglazyme je bila ocenjena v randomizirani, dvojno slepi, s placebom nadzorovani klinični raziskavi faze III na 39 bolnikih z MPS VI v starosti od 5 do 29 let.
You must not receive this medicine - If you have experienced severe or life-threatening allergic (hypersensitive) reactions to galsulfase or any of the other ingredients of Naglazyme and re-administration of the medicine was not successful.
Ne uporabljajte tega zdravila - Če ste imeli hudo ali življenjsko nevarno alergijsko (preobčutljivostno) reakcijo na galsulfazo ali katerokoli sestavino zdravila Naglazyme in ponovno dajanje zdravila ni bilo uspešno.
The cause of clinical relevance of the hepatic toxicity (bile duct hyperplasia / periportal inflammation) seen at clinically relevant doses in the repeated dose monkey toxicity study is not known.
Vzrok klinične pomembnosti toksičnega vpliva na jetra (hiperplazija žolčevoda, periportalno vnetje), opaženega pri klinično pomembnih odmerkih pri študijah toksičnosti ponavljajočih se odmerkov na opicah ni poznan.
Spinal/cervical cord compression (SCC) with resultant myelopathy is a known and serious complication that can be due to MPS VI.
Kompresija hrbtenice/hrbtenjače, ki povzroči mielopatijo, je znan in resen zaplet, ki je lahko posledica MPS VI.
5 years of age will be treated with the 1 mg/kg dose for at least one year.
starih manj kot 5 let starosti, zdravljenih z odmerkom 1 mg/kg vsaj eno leto.
An infusion associated reaction is any side effect occurring during the infusion or until the end of the infusion day (see section 4 “Possible Side Effects”).
Z infundiranjem zdravila povezana reakcija je vsak stranski učinek, ki se pojavi med infundiranjem ali do izteka dne prejema infuzije (glejte poglavje 4 »Možni stranski učinki«).
How this medicine is given
Kako se daje to zdravilo
Caution must be exercised in the management and treatment of patients with compromised airways by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Posebno pozornost je treba posvetiti vodenju in zdravljenju bolnikov s prizadetimi dihalnimi potmi in upoštevati omejitev ali pazljivo nadzorovati uporabo antihistaminikov ali drugih zdravil s sedativnim delovanjem.
For the first hour the infusion rate will be slow (approximately 2.5% of the total solution), with the remaining volume (approximately 97.5%) being taken over the next 3 hours.
V prvi uri bo infuzija potekala počasi (približno 2,5% celotne raztopine), preostali volumen raztopine (približno 97,5%) pa se vnese v naslednjih 3 urah.
Thirty-eight patients subsequently enrolled in an Open Label extension study where they received 1 mg/kg of galsulfase every week.
38 bolnikov je bilo nato vključenih v odprto nadaljevalno študijo, v kateri so vsak teden prejeli galsulfazo v odmerku 1 mg/kg.
Likewise, antibody development is not predictive of decreased efficacy although subjects with limited response in endurance parameters or urinary glycosaminoglycans (GAGs) tended to have higher peak anti-galsulfase titres than those with good response.
Prav tako tudi ni mogoče predvideti razvoja protiteles na osnovi zmanjšane učinkovitosti, čeprav so bolniki z omejenim odzivom pri parametrih vzdržljivosti ali pri vrednostih glikozaminoglikanov v urinu (GAG) kazali večjo tendenco za višje vrednosti protiteles proti galsulfazi kot tisti z dobrim odzivom.
From a microbiological safety point of view, the product is to be used immediately.
Z mikrobiološkega vidika je treba Naglazyme uporabiti takoj.
Other measures (urinary GAG, antibodies) are assessed more frequently.
Drugi ukrepi (vrednosti GAG v urinu, protitelesa) bodo ocenjeni pogosteje.
In an additional Phase 4, randomised, two-dose level study, four MPS VI patients <1 year of age were treated at 1 or 2 mg/kg/week for 53 to 153 weeks.
V dodatni randomizirani raziskavi faze IV z dvemi višinami odmerka so štiri bolnike z MPS VI , mlajše od 1 leta, 53 do 153 tednov zdravili z odmerki 1 ali 2 mg/kg/teden.
Reactions of unknown frequency were reported post-marketing.
O reakcijah z neznano pogostnostjo so poročali v obdobju po začetku trženja.
Data collected in the post-marketing phase will also be examined to determine if a suitable Naglazyme maintenance dose can be recommended relative to the efficacy endpoints used in the clinical studies.
Preučili se bodo tudi podatki, zbrani po prihodu zdravila na trg, da se ugotovi, ali je mogoče priporočiti ustrezen vzdrževalni odmerek zdravila Naglazyme glede na učinkovitost opazovanih dogodkov v kliničnih študijah.
Treatment has been shown to improve walking and stairclimbing ability, and to reduce the levels of glycosaminoglycans in the body.
Pokazalo se je, da zdravljenje izboljšuje sposobnost hoje in vzpenjanja po stopnicam in zmanjšuje ravni glikozaminoglikanov v telesu.
53/54 patients (98%) were positive for IgG antibodies to galsulfase.
53 od 54 (98 %) bolnikov je razvilo IgG protitelesa proti galsulfazi.
In patients who have experienced allergic reactions during infusion with Naglazyme, caution should be exercised upon rechallenge; appropriately trained personnel and equipment for emergency resuscitation (including epinephrine) should be available during infusions.
Pri bolnikih, ki so ob infundiranju zdravila Naglazyme imeli alergijske reakcije, je potrebna po ponovni aplikaciji previdnost; med infundiranjem mora biti pripravljeno ustrezno usposobljeno osebje in oprema za oživljanje (vključno z epinefrinom).
Evaluate the effect of Naglazyme on pregnancy and lactation.
Oceniti učinek zdravila Naglazyme na nosečnost in dojenje.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 mg/5 ml
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 5 mg/5 ml
Patients should be monitored for signs and symptoms of spinal/cervical cord compression (including back pain, paralysis of limbs below the level of compression, urinary and faecal incontinence) and given appropriate clinical care.
Bolnike je treba nadzirati za znake in simptome kompresije hrbtenice/hrbtenjače (vključno z bolečinami v hrbtu, paralizo okončin nad ravnijo kompresije, inkontinenco blata in urina) in jih ustrezno klinično zdraviti.
Naglazyme should not be given during pregnancy unless clearly necessary.
Zdravila Naglazyme se ne sme dajati med nosečnostjo, razen če je nujno potrebno.
Patients treated with Naglazyme have developed infusion-associated reactions (IARs), defined as any adverse reactions occurring during the infusion or until the end of the infusion day (see section 4.8).
Bolniki, zdravljeni z Naglazymom, so razvili z infundiranjem zdravila povezane reakcije (IAR»infusion-associated reaction«), definirane kot katere koli neželene reakcije, ki se pojavijo med infuzijo ali do konca dne, v katerem je bila infuzija aplicirana (glejte poglavje 4.8).
The initial infusion rate is adjusted so that approximately 2.5% of the total solution is infused during the first hour, with infusion of the remaining volume (approximately 97.5%) over the next 3 hours.
Začetna hitrost infuzije naj bo prilagojena tako, da se približno 2,5% celotne raztopine infundira v prvi uri, preostali volumen raztopine (približno 97,5%) pa v naslednjih 3 urah.
1Reactions reported more frequently in the active arm of the placebo-controlled study than the placebo arm; frequency determined from 39 patients of the blinded Phase 3 study.
1Reakcije, o katerih so pogosteje poročali v aktivnem kraku s placebom kontrolirane študije, kot v kraku s placebom; pogostnost ugotovljena na podlagi 39 bolnikov iz slepe študije 3. faze.
• Poor reflexes
• počasni refleksi
In the Naglazyme clinical trials, IARs were usually manageable by interrupting or slowing the rate of infusion and by (pre-) treating the patient with antihistamines and/or antipyretics (paracetamol), thus enabling the patient to continue treatment.
V fazi kliničnega preizkušanja Naglazyma so bile IAR običajno obvladljive z upočasnitvijo ali prekinitvijo infuzije in s (predhodnim) zdravljenjem bolnika z antihistaminiki in/ali antipiretiki (paracetamolom), kar je bolniku omogočilo nadaljevanje zdravljenja.
Naglazyme is used to treat patients with MPS VI disease (Mucopolysaccharidosis VI).
Naglazyme se uporablja za zdravljenje bolnikov z boleznijo MPS VI (mukopolisaharidozo VI).
After 24 weeks of treatment the mean ( Standard Deviation [SD]) maximum plasma concentration (Cmax) was 2,357 (± 1,560) ng/ml and the mean ( SD) area under the plasma concentration-time curve (AUC0-t) was 5,860 ( 4,184) h  ng/ml.
Po 24 tednih zdravljenja je bila povprečna ( standardni odklon [SD - »standard deviation«]) najvišja plazemska koncentracija 2,357 (1,560) ng/ml in povprečna (SD) površina pod plazemsko koncentracijsko krivuljo (AUC0-t) 5,860 (4,184) h x ng/ml.
Other reactions with known frequency were reported from 59 patients treated with Naglazyme from all five clinical trials.
O drugih reakcijah z znano pogostnostjo so poročali za 59 bolnikov, zdravljenih z zdravilom Naglazyme, iz vseh petih kliničnih preskušanj.
Each vial of Naglazyme is intended for single use only.
Vsaka viala Naglazyma je namenjena samo za enkratno uporabo.
Interim results will be provided in the CSP Annual Reports.
Vmesni rezultati bodo predloženi v letnem poročilu CSP.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3).
Študije na živalih niso zadostne za oceno vpliva na nosečnost ali razvoj zarodka/plodu (glejte poglavje 5.3).
It is recommended that the diluted Naglazyme solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.
Priporočljivo je, da se razredčena raztopina Naglazyma aplicira bolnikom z infuzijskim setom, ki je opremljen z 0,2m "in-line" filtrom.
The safety and efficacy of Naglazyme in patients with renal or hepatic insufficiency have not been evaluated (see section 5.2) and no alternative dose regimen can be recommended in these patients.
Varnosti in učinkovitosti zdravila Naglazyme pri bolnikih z motnjami v delovanju ledvic ali jeter niso ocenjevali (glejte poglavje 5.2Pri teh bolnikih ni mogoče priporočati drugačnega režima odmerjanja.
Adverse reactions are listed in Table 1 by System Organ Class.
Neželeni učinki so navedeni v preglednici 1 po organskih sistemih.
The pharmacokinetics of galsulfase were evaluated in 13 patients with MPS VI who received 1 mg/kg of galsulfase as a 4 hour infusion.
Farmakokinetika galsulfaze je bila ovrednotena na 13 bolnikih z MPS VI, ki so prejeli galsulfazo v odmerku 1 mg/kg telesne mase v obliki 4-urne infuzije.
Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of glycosaminoglycans (GAGs).
Motnje shranjevanja mukopolisaharidov so povzročene s pomanjkanjem specifičnih lizosomalnih encimov, potrebnih za razgradnjo glikozaminoglikanov (GAG).
The recommended dose is 1 mg/kg body weight administered once every week through a drip into a vein (by intravenous infusion).
Priporočeni odmerek je 1 mg/kg telesne mase enkrat tedensko prek infuzije v žilo (z intravensko infuzijo).
SPECIAL STORAGE CONDITIONS Store in a refrigerator Do not freeze
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte v hladilniku
Severe, or potentially life-threatening hypersensitivity is a contraindication to rechallenge, if hypersensitivity is not controllable.
Huda ali potencialno življenjsko nevarna preobčutljivost je kontraindikacija za ponovno aplikacijo, če preobčutljivost ni pod nadzorom.
Not all package sizes may be marketed.
Na trgu ni vseh navedenih pakiranj.
PHARMACEUTICAL FORM AND CONTENTS 1 vial of concentrate for solution for infusion 6 vials of concentrate for solution for infusion 5 mg/5 ml
FARMACEVTSKA OBLIKA IN VSEBINA 1 viala koncentrata za raztopino za infundiranje 6 vial koncentrata za raztopino za infundiranje 5 mg/5 ml
Naglazyme is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine 4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1).
Zdravilo Naglazyme je indicirano za dolgotrajno encimsko nadomestno zdravljenje pri bolnikih s potrjeno diagnozo mukopolisaharidoze VI (MPS VI; primanjkljaj N-acetilgalaktozamin-4-sulfataze; Maroteaux-Lamy sindrom) (glejte poglavje 5.1).
Patients who present with an acute febrile or respiratory illness may need to have their Naglazyme infusions delayed.
Pri bolnikih z akutno vročinsko ali respiratorno boleznijo je lahko potreben zamik infuzije Naglazyma.
- If you have a fever, or if you are having difficulty breathing before this medicine is given, talk with your doctor about delaying your Naglazyme infusion.
- Če imate vročino ali težave z dihanjem se pogovorite z zdravnikom o odlogu infuzije zdravuka Naglazym.
Very common side effects (these may affect more than 1 in 10 people):
Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov):
The mean ( SD) volume of distribution (Vz) was 316 ( 752) ml/kg and the mean ( SD) plasma clearance (CL) was 7.9 ( 14.7) ml/min/kg.
Povprečni (SD) volumen porazdelitve je znašal 316 ( 752) ml/kg in povprečni plazemski očistek (Cl) je znašal 7,9 ( 14,7) ml/min/kg.
This medicinal product contains 0.8 mmol (18.4 mg) sodium per vial and is administered in sodium chloride 9 mg/ml solution for injection (see section 6.6).
To zdravilo vsebuje 0,8 mmol (18,4 mg) natrija na vialo in se daje v natrijevem kloridu 9 mg/ml raztopini za injiciranje (glejte poglavje 6.6).
Out of the 59 patients treated with Naglazyme in the clinical studies, 54 were tested for IgG antibodies.
54 od 59 bolnikov, zdravljenih z zdravilom Naglazyme v kliničnih študijah, je bilo testiranih za protitelesa IgG.
Due to the low number of patients in clinical trials, adverse event (AE) data from all Naglazyme studies have been pooled and reviewed in a single, clinical trial safety analysis.
Zaradi majhnega števila bolnikov, vključenih v klinična preskušanja, so bili podatki o neželenih učinkih iz vseh študij z zdravilom Naglazyme združeni in preučeni v eni sami analizi varnosti kliničnih preskušanj.
Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensitivity is not controllable.
Huda ali življenjsko nevarna preobčutljivost na zdravilno učinkovino ali katerokoli pomožno snov, če preobčutljivost ni pod nadzorom.
The infusion can be restarted with a reduction of the infusion rate to 50% - 25% of the rate at which the reaction occurred.
Po končani prekinitvi infuzije je treba njeno hitrost zmanjšati na 50% do 25% hitrosti, pri kateri se je reakcija pojavila.
Vial (type I glass) with a stopper (siliconized chlorobutyl rubber) and a seal (aluminium) with a flipoff cap (polypropylene).
Viala (steklo tipa I) z zamaškom (silikoniziran klorobutilni kavčuk) in aluminijsko zaporko z varnostnim mehanizmom (polipropilen).
Naglazyme treatment should be supervised by a physician experienced in the management of patients with MPS VI or other inherited metabolic diseases.
Zdravljenje z Naglazymom mora nadzorovati zdravnik z izkušnjami pri zdravljenju bolnikov z MPS VI ali drugimi dednimi boleznimi presnove.
The most serious side effects were swollen face and fever (very common); longer than normal gaps between breaths, difficulty breathing, asthma and hives (common); and swelling of the tongue and throat, and serious allergic reaction to this medicine (unknown frequency).
Najresnejši neželeni učinki so bili otekanje obraza in zvišana telesna temperatura (zelo pogosti), daljši premori med dihanjem, kot običajno, težave z dihanjem, astma in koprivnica (pogosti) in otekanje jezika in grla ter hude alergijske reakcije na to zdravilo (neznana pogostnost).
If a physician suspects an IgE mediated reaction they have been advised in the protocol to request IgE antibody presence to be conducted by the MAH.
Če zdravnik posumi na z IgE povzročeno reakcijo ima v protokolu navodilo, da od MAH zahteva izvedbo prisotnosti protiteles IgE.
Do not take use this medicine after the expiry date which is stated on the vial after EXP.
Zdravila Naglazyme ne smete prejeti po datumu izteka roka uporabnosti, ki je naveden na viali poleg oznake Upor.
Hypertension1
Žilne bolezni hipertenzija1
Patients who could walk more than 5 meters (m) but less than 250 m in 6 minutes of a 12 Minute Walk test or less than 400 m at the 12 minute time point at baseline were enrolled in the study.
V študijo so bili vključeni bolniki, ki so v 12 minutnem testu hoje lahko prehodili več kot 5 metrov in manj kot 250 metrov v 6 minutah ali manj kakor 400 metrov v 12 minutah.
The number of vials to be diluted based on the individual patient's weight must be determined and removed from the refrigerator approximately 20 minutes in advance in order to allow them to reach room temperature.
Število vial, ki jih bo treba razredčiti, se določi na osnovi bolnikove telesne mase in vzame iz hladilnika približno 20 minut pred pripravo, da lahko do priprave dosežejo sobno temperaturo.
Reduced or absent N-acetylgalactosamine 4-sulfatase activity results in the accumulation of dermatan sulfate in many cell types and tissues.
Primanjkljaj ali odsotnost N-acetil-galaktozamin-4-sulfataze vodi v kopičenje dermatan sulfata v mnogih tipih celic in v tkivih.
• Low blood pressure
• nizek krvni tlak
Driving and using machines No studies on the effects on the ability to drive and use machines have been performed.
Vpliv na sposobnost upravljanja vozil in strojev Študije o vplivu na sposobnost vožnje in upravljanja s stroji niso bile izvedene.
The secondary efficacy endpoints were the rate of stairs climbed in three minutes and the urinary glycosaminoglycan excretion of treated patients compared to placebo at Week 24.
Sekundarni kazalci učinkovitosti so bili število prehojenih stopnic v treh minutah in količina v urinu izločenega glikozaminoglikana v primerjavi s placebom v 24. tednu.
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako