natgillin/translations-raw huggingface dataset:
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
Reproduction studies have been performed in rats and rabbits at doses up to 3 mg/kg/day and have revealed no evidence of impaired fertility or harm to the embryo or foetus due to Naglazyme. 
Raziskave vpliva zdravila Naglazyme na razmnoževanje, ki so bile opravljene pri podganah in kuncih z odmerki do 3 mg/kg/dan, niso dokazale zmanjšane plodnosti ali škodljivih posledic za zarodek ali plod.
In case of a mild or moderate IAR, treatment with antihistamines and paracetamol should be considered and/or a reduction in the infusion rate to half the rate at which the reaction occurred. 
V primeru blage ali zmerne IAR je treba razmisliti o zdravljenju z antihistaminiki in paracetamolom in/ali zmanjšati hitrost infuzije na polovično hitrost od tiste, pri kateri se je reakcija pojavila.
• Bluish skin 
• bledica kože
Naglazyme should not be used during pregnancy unless clearly necessary. 
Zdravila Naglazyme ne smete uporabljati med nosečnostjo, razen če je nujno potrebno.
EU/1/05/324/001 1 vial EU/1/05/324/002 6 vials 
EU/1/05/324/002 6 vial
Several patients have received their total dose of Naglazyme at approximately twice the recommended infusion rate without apparent adverse events. 
Nekaj bolnikov je brez očitnih neželenih učinkov prejelo svoj celotni odmerek zdravila Naglazyme pri hitrosti infuzije, ki je bila približno dvakrat hitrejša od priporočene.
Galsulfase is a protein and is expected to be metabolically degraded through peptide hydrolysis. 
Galsulfaza je beljakovina, zato je pričakovano, da se po presnovni poti razgradi s hidrolizo beljakovin.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Clear type 1, 5 ml VIAL 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH prozorna 1,5 ml viala
Bradycardia, tachycardia, cyanosis 
Srčne bolezni bradikardija, tahikardija, cianoza neznana
Purified galsulfase, a recombinant form of human N-acetylgalactosamine 4-sulfatase, is a glycoprotein with a molecular weight of approximately 56 kD. Galsulfase is comprised of 495 amino acids after cleavage of the N-terminus. 
Prečiščena galsulfaza, rekombinantna oblika humane N-acetilgalaktozamin-4-sulfataze, je glikoprotein z molekulsko maso približno 56 kD. Galsulfaza vsebuje po cepitvi na N-terminalnem delu 495 aminokislin.
A comprehensive antibody analysis based on data from three clinical studies has been carried out in 48 patients. 
Pri 48 bolnikih so izvedli celovito analizo protiteles na osnovi podatkov iz treh kliničnih študij.
Interim results will be provided in the annual re-assessment reports. 
Vmesni rezultati bodo predloženi v letnem poročilu o ponovni oceni.
The primary efficacy endpoint was the numbers of meters walked in 12 minutes at Week 24 compared to the number of meters walked at baseline. 
Primarni kazalec učinkovitosti je bilo število metrov, prehojenih v 12 minutah v 24. tednu v primerjavi s prehojenim izhodiščnim številom metrov na začetku zdravljenja.
Side effects were mainly seen while patients were being given the medicine or shortly after (“infusion associated reactions”). 
Neželeni učinki, ki so jih opazili v glavnem pri bolnikih med dajanjem zdravila ali tik za tem (»neželeni učinki, povezani z infundiranjem«).
• Shock 
• šok
MPS VI is a heterogeneous and multisystemic disorder characterized by the deficiency of N-acetylgalactoasamine 4-sulfatase, a lysosomal hydrolase which catalyses the hydrolysis of sulfate moiety of the glycosaminoglycan, dermatan sulfate. 
MPS VI je heterogena in multisistemska motnja, za katero je značilen primanjkljaj N-acetilgalaktozamin-4-sulfataze, lizosomalne hidrolaze, ki katalizira hidrolizo sulfatnega dela glikozaminoglikana, dermatan sulfata.
There have been post-marketing reports of patients treated with Naglazyme who experienced the onset or worsening of SCC requiring decompression surgery. 
Obstajajo poročila iz obdobja trženja za bolnike, zdravljene z zdravilom Naglazyme, ki so doživeli nastanek ali poslabšanje kompresije hrbtenice/hrbtenjače, zaradi česar je bil potreben dekompresijski poseg.
PSURs The MAH will continue to submit yearly PSURs, unless otherwise specified by the CHMP. 
Imetnik dovoljenja za promet z zdravilom bo še naprej oddajal letna periodična poročila o varnosti, razen če CHMP ne določi drugače.
When you experience such a reaction, you should immediately contact your doctor. 
Če opazite tako reakcijo, takoj obvestite svojega zdravnika.
The solution is to be mixed gently before infusion. 
Raztopino je treba pred pričetkom infuzije rahlo pretresti.
Store in a refrigerator Do not freeze 
DRUGI PODATKI Shranjujte v hladilniku Ne zamrzujte
How to store this medicine 
Shranjevanje tega zdravila
People with MPS VI disease have either a low level, or no level, of an enzyme called N-acetylgalactosamine 4-sulfatase, which breaks down specific substances (glycosaminoglycans) in the body. 
Osebe z MPS VI imajo bodisi nizko vrednost ali pa sploh nimajo encima, ki se imenuje N-acetilgalaktozamin 4-sulfataza, ki razgrajuje določene snovi (glikozaminoglikane) v telesu.
Severe and serious liver toxicities will be assessed through the PSUR but also through analysis of these events in the CSP database. 
S PSUR-om, pa tudi z analizo teh dogodkov v podatkovni bazi CSP se bo ocenila resna in huda toksičnost za jetra.
In case of a recurrent moderate IAR or re-challenge after a single severe IAR, pre-treatment should be considered (antihistamines and paracetamol and/or corticosteroids) and a reduction of the infusion rate to 50% - 25% of the rate at which the previous reaction occurred. 
V primeru ponovitve zmerne IAR ali ponovni posamezni hudi IAR je treba razmisliti o premedikaciji bolnika (z antihistaminiki in paracetamolom in/ali kortikosteroidi) in zmanjšati hitrost infuzije na 50% - 25% hitrosti, pri kateri se je pojavila prejšnja reakcija.
One vial of 5 ml contains 5 mg galsulfase. 
Ena 5 ml viala vsebuje 5 mg galsulfaze.
Preparation of the Naglazyme infusion (aseptic technique is to be used) 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. 
Priprava zdravila Naglazyme raztopine za infundiranje (po aseptičnem postopku) 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.
The recommended dose regimen for galsulfase is 1 mg/kg body weight administered once every week as an intravenous infusion over 4 hours. 
Priporočen režim odmerjanja za galsulfazo je 1 mg/ kg telesne mase enkrat tedensko v obliki 4-urne intravenske infuzije.
The three clinical studies performed with Naglazyme focused on assessing the systemic manifestations of MPS VI such as endurance, joint mobility, joint pain and stiffness, upper airway obstruction, manual dexterity and visual acuity. 
Tri klinične raziskave, izvedene z zdravilom Naglazyme, so se osredotočile na ocenitev sistemskih manifestacij MPS VI kot so vzdržljivost, gibljivost sklepov, bolečina v sklepih in otrdelost sklepov, obstrukcija zgornjih dihalnih poti, ročna spretnost in ostrina vida.
Marketing Authorization Holder BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 
Imetnik dovoljenja za promet z zdravilom BioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298
Talk to your doctor if you have kidney or liver insufficiency. 
Povejte svojemu zdravniku, če imate motnje v delovanju ledvic ali jeter.
For single use only Any unused solution should be discarded 
Vso neporabljeno raztopino je treba zavreči
• Cloudy eyes 
• motne oči
The clear to slightly opalescent and colourless to pale yellow concentrate must be free of visible particles. 
Bistra do rahlo opalescentna in brezbarvna do bledo rumena raztopina mora biti brez vidnih delcev.
Although a larger proportion of subjects with high total antibody titres experienced recurrent infusion reactions, neither frequency nor severity could be predicted based on the anti-galsulfase antibody titre. 
Čeprav je pri večjem deležu bolnikov z visokimi ravnmi skupnih protiteles prišlo do ponavljajočih, z infuzijo povezanih reakcij, pa na osnovi ravni protiteles proti galsulfazi ni bilo moč sklepati na pogostost in na resnost teh reakcij.
- The active substance is galsulfase. 
- Zdravilna učinkovina je galsulfaza.
Following 24 weeks of therapy, Naglazyme-treated patients experienced a 92 ± 40 m improvement in the distance walked in 12 minutes relative to placebo-treated patients (p = 0.025). 
Po 24 tednih zdravljenja so z zdravilom Naglazyme zdravljeni bolniki v primerjavi s placebo skupino dosegli 92  40 m izboljšanje razdalje, prehojene v 12 minutah.
DATE OF REVISION OF THE TEXT 
DATUM ZADNJE REVIZIJE BESEDILA MM/YYYY
The safety and efficacy of Naglazyme in patients older than 65 years has not been established, and no alternative dose regimen can be recommended in these patients. 
Varnosti in učinkovitosti zdravila Naglazyme pri bolnikih, starejših od 65 let, niso ugotavljali.
How this medicine works 
Kako to zdravilo deluje
Only clear and colourless solutions without visible particles should be used. 
Uporabiti se sme samo bistro in brezbarvno raztopino brez vidnih delcev.
100 ml infusion bags should be considered for patients who are susceptible to fluid volume overload and weigh less than 20 kg; in this case the infusion rate (ml/min) should be decreased so that the total duration remains no less than 4 hours. 
Pri bolnikih, ki so občutljivi na vnos prevelikega volumna tekočine in tehtajo manj kot 20 kg, pridejo v poštev 100 ml infuzijske vrečke; v tem primeru je treba hitrost infuzije (ml/min) zmanjšati tako, da celotni postopek infundiranja traja najmanj 4 ure.
Galsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture. 
Galsulfaza je rekombinantna oblika humane N-acetilgalaktozamin-4-sulfataze in je izdelana z rekombinantno DNA tehnologijo z uporabo sesalske celične kulture ovarijskih celic kitajskega hrčka (CHO).
Treated patients also experienced a mean decrease in urinary glycosaminoglycan excretion of 238 ± 17.8 μg/mg creatinine ( Standard Error [SE]) following 24 weeks of treatment relative to placebo-treated patients. 
Zdravljeni bolniki so v primerjavi s placebo skupino po 24 tednih zdravljenja izločali manj glikozaminoglikanov v urinu, in sicer povprečno za 238  17,8 g kreatinina ( standardna napaka [SE - »standard error«]).
Common symptoms of infusion reactions were pruritus, vomiting, abdominal pain, nausea, hypertension, headache, chest pain, erythema, cough, hypotension, angioedema, respiratory distress, tremor, conjunctivitis, malaise, bronchospasm and arthralgia. 
Pogosti simptomi reakcij na infundiranje so bili pruritus, bruhanje, bolečina v trebuhu, navzea, hipertenzija, glavobol, bolečina v prsnem košu, eritem, kašelj, hipotenzija, angioedem, dihalna stiska, tremor, konjunktivitis, splošno slabo počutje, bronhospazem in artralgija.
Treated patients experienced a 5.7 stair per minute improvement in the 3 Minute Stair Climb relative to placebo-treated patients. 
Zdravljeni bolniki so v primerjavi s placebo skupino dosegli za 5,7 stopnic na minuto boljši rezultat v triminutnem testu hoje po stopnicah.
All patients treated with NAGLAZYME (59/59) reported at least one AE. 
Vsi bolniki, zdravljeni z zdravilom NAGLAZYME (59/59), so poročali o vsaj enem neželenem učinku.
Diluted solutions: Chemical and physical in-use stability has been demonstrated for up to 4 days at room temperature (23C - 27C). 
Razredčene raztopine: Dokazano je bilo, da je pripravljena raztopina pri sobni temperaturi (23 C27 C) kemijsko in fizikalno stabilna do 4 dni.
Patients received either 1 mg/kg of galsulfase or placebo every week for a total of 24 weeks. 
Bolniki so 24 tednov vsak teden prejeli bodisi galsulfazo v odmerku 1mg/kg telesne mase, bodisi placebo.
Pharyngitis1, gastroenteritis1 
Infekcijske in parazitske bolezni faringitis1, gastroenteritis1
Other medicines and Naglazyme 
Druga zdravila in zdravilo Naglazyme
QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of solution contains 1 mg galsulfase. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml raztopine vsebuje 1 mg galsulfaze.
Common side effects (these may affect up to 1 in 10 people): 
Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov):
GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription. 
NAČIN IZDAJANJA ZDRAVILA Izdaja zdravila je le na recept
- The other ingredients are: sodium chloride, sodium phosphate monobasic, monohydrate, sodium phosphate dibasic, heptahydrate, polysorbate 80, water for injections. 
- Pomožne snovi so: natrijev klorid, natrijev dihidrogenfosfat monohidrat, natrijev hidrogenfosfat heptahidrat, polisorbat 80, voda za injekcije.
Your doctor or nurse will administer Naglazyme to you. 
Zdravilo Naglazyme vam bo dal vaš zdravnik ali sestra.
A MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE 
A IZDELOVALEC BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE