natgillin/translations-raw huggingface dataset:
This medicine contains a recombinant enzyme called galsulfase. 
To zdravilo vsebuje rekombinantni encim, ki se imenuje galsulfaza.
Specific Obligations: 
Posebne zahteve:
Other side effects with an unknown frequency: 
Drugi neželeni učinki z neznano pogostnostjo:
Growth rate remained normal over this limited follow-up period. 
V omejenem obdobju spremljanja je bila stopnja rasti normalna.
This can replace the natural enzyme which is lacking in MPS VI patients. 
Ta lahko nadomesti naravni encim, ki bolnikom z boleznijo MPS VI primanjkuje.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. 
Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
What you need to know before you are given this medicine 
Kaj morate vedeti, preden boste prejeli to zdravilo
As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. 
Kot pri vseh lizosomskih genetskih motnjah je zlasti pri težjih oblikah primarnega pomena, da se zdravljenje začne čim prej, še preden se pojavijo nereverzibilne klinične manifestacije bolezni.
The current medical standards for emergency treatment are to be observed. 
Upoštevati je treba veljavne standarde za nudenje nujne medicinske pomoči.
Several measures will be implemented to assess the Naglazyme dose. 
Uvedeni bodo številni ukrepi za oceno odmerka zdravila Naglazyme.
The majority (42/59; 71%) of patients experienced at least one Adverse Drug Reaction. 
Večina bolnikov (42/59; 71 %) je poročala o vsaj enem neželenem učinku na zdravilo.
• Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached 
• v roku 60 dni po dosegu pomembnega farmakovigilančnega mejnika ali mejnika zmanjševanja tveganja);
Although limited by the very small number of patients that were enrolled, the conclusions that can be drawn from this study are the following: 
Kljub omejitvi zaradi izredmo majhnega števila vklučenih bolnikov, lahko iz te raziskave potegnemo naslednje zaključke:
Renal elimination of galsulfase is considered a minor pathway for clearance (see section 4.2). 
Izločanje skozi ledvice velja za manj pomembno pot za očistek galsulfaze (glejte poglavje 4.2).
- This medicine has not been tested in patients with kidney or liver problems. 
- Tega zdravila pri bolnikih z ledvičnimi ali jetrnimi težavami niso preizkušali.
Samples for total antibody will be collected at specific intervals. 
Vzorci za skupna protitelesa se bodo jemali na določen interval.
As there is little experience on resumption of treatment following prolonged interruption, caution is to be used due to the theoretical increased risk of hypersensitivity reaction. 
Ker obstaja le malo izkušenj o ponovnem pričetku zdravljenja po daljši prekinitvi, je treba posvetiti posebno pozornost teoretično povečanemu tveganju za razvoj preobčutljivostne reakcije.
Consequently, impaired liver function is not expected to affect the pharmacokinetics of galsulfase in a clinically significant way. 
Posledično se ne pričakuje, da bi okvarjeno delovanje jeter vplivalo na farmakokinetiko galsulfaze v klinično pomembni obliki.
A key issue is to treat children aged <5 years suffering from a severe form of the disease, even though children <5 years were not included in the pivotal phase 3 study. 
Ključni namen je zdraviti mlade bolnike pred dopolnjenim petim letom starosti, ki trpijo za težko obliko bolezni, čeprav bolniki, mlajši od 5 let, niso bili vključeni v ključno klinično raziskavo faze III.
The molecule contains 6 N-linked oligosaccharide modification sites. 
Molekula vsebuje 6 na N vezanih oligosaharidnih modifikacijskih mest.
If you get any of these symptoms, or other symptoms not listed in this leaflet, tell your doctor immediately. 
Če opazite kateri koli simptom ali simptome, ki niso navedeni v tem navodilu, to takoj povejte svojemu zdravniku.
Sodium chloride 
Natrijev klorid,
Pharmacokinetic parameters in Phase 1 patients have remained stable over the long term (through at least 194 weeks). 
Farmakokinetični parametri pri bolnikih, ki so sodelovali v kliničnih raziskavah faze I so ostali stabilni dolgo časa (skozi najmanj 194 tednov).
This leaflet was last revised in MM/YYYY 
Navodilo je bilo nazadnje revidirano dne MM/YYYY
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
Kakor vsa zdravila ima lahko tudi to zdravilo neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
As with any intravenous protein medicinal product, severe allergic-type hypersensitivity reactions are possible. 
Kot pri vseh beljakovinskih zdravilih za intravensko uporabo so možne resne preobčutljivostne reakcije alergijskega tipa.
Pack sizes: 1 and 6 vials. 
Velikosti pakiranj: 1 ali 6 vial.
Higher antibody levels (≥ 65610 Dilution Fraction) will be compared with the subject's urinary GAG values with a view to assess potential impacts on efficacy. 
Višje ravni protiteles (≥ 65610 frakcije redčenja (DF - dilution fraction)) bodo primerjane z vrednostmi GAG v urinu tega bolnika z namenom oceniti morebitni vpliv na učinkovitost.
The mean ( SD) elimination half-life (t1/2) was 22.8 ( 10.7) minutes at Week 24. 
Povprečni (SD) razpolovni čas izločanja (t1/2) v tednu 24 je bil 22,8 ( 10,7) minut.
This medicine may improve the symptoms of MPS VI. 
To zdravilo lahko izboljša simptome MPS VI.
Management of infusion-associated reactions 
Obvladovanje z infundiranjem povezanih reakcij
The CSP data will be analysed at yearly intervals and results will be submitted as annual reports. 
Podatki CSP se bodo analizirali v letnih intervalih, rezultati pa bodo predloženi kot letna poročila.
The rationale for enzyme replacement therapy is to restore a level of enzymatic activity sufficient to hydrolyze the accumulated substrate and to prevent further accumulation. 
Osnovni princip encimskega nadomestnega zdravljenja je ponovno vzpostaviti nivo encimske aktivnosti, ki je zadostna za hidrolizo nakopičenega substrata in preprečitev nadaljnjega kopičenja.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu 
Podrobne informacije o tem izdelku so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu.
Infusion reactions began as early as Week 1 and as late as Week 146 of Naglazyme treatment, and occurred during multiple infusions though not always in consecutive weeks. 
Reakcije na infuzije so se lahko začele že v 1. tednu ali šele v 146. tednu zdravljenja z zdravilom Naglazyme, pojavile pa so se med več infundiranji, čeprav ne vedno v zaporednih tednih.
Based on data obtained during Naglazyme clinical trials, the majority of patients are expected to develop IgG antibodies to galsulfase within 4-8 weeks of treatment initiation. 
Na osnovi podatkov, pridobljenih v času kliničnih preizkušanj Naglazyma, se za večino bolnikov pričakuje, da bodo razvili IgG protitelesa na galsulfazo v 4 - 8 tednih po pričetku zdravljenja.
See leaflet for further information. 
Glejte navodila za nadaljnje informacije
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any updated RMP should be submitted at the same time as the following Periodic Safety Update Report (PSUR). 
V skladu s smernicami CHMP glede sistema obvladovanja tveganja za zdravila za uporabo v humani medicini, mora biti vsak posodobljen RMP predložen sočasno z naslednjim periodičnim poročilom o varnosti zdravila(PSUR).
Adverse reactions reported during the Post Marketing period are included at a frequency category of “unknown”. 
Neželeni učinki, o katerih so poročali v obdobju po začetku trženja, so zajeti v kategoriji pogostnosti »neznana pogostnost«.
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan. 
Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo izvajal študije in dodatne farmakovigilančne aktivnosti, podrobno opisane v načrtu farmakovigilance.
This medicine contains Sodium 
To zdravilo vsebuje natrij
If you are given more Naglazyme than you should Naglazyme is administered under the supervision of a nurse or doctor, he or she will check that the correct dose has been given and act accordingly if necessary. 
Če ste prejeli večji odmerek zdravila Naglazyme, kot bi smeli Naglazyme se daje pod nadzorom sestre ali zdravnika; eden ali drugi bo preveril, da ste prejeli pravilni odmerek in ustrezno ukrepal, če bo potrebno.
It did not prevent the progression of skeletal dysplasia and development of hernias and did not prevent the progression of corneal clouding. 
Zdravljenje ni preprečilo napredovanja skeletne displazije in razvoja hernij ter ni preprečilo napredovanja motnjave roženice.
Limited data are available in patients < 1 year of age (see section 5.1). 
Pri bolnikih, mlajših od 1 leta, je na razpolago le malo podatkov (glejte poglavje 5.1).
They accumulate in many tissues in the body, which causes the symptoms of MPS VI. 
Zaradi tega se nabirajo v mnogih telesnih tkivih, kar povzroča simptome MPS VI.
Due to the small patient population, an adverse reaction in a single patient is classified as common. 
Zaradi majhne populacije bolnikov je neželen učinek pri enem bolniku razvrščen med pogoste.
46 Galli Drive, Novato, CA 94949 United States of America 
BioMarin Pharmaceutical Inc., 46 Galli Drive, Novato, CA 94949 Združene države Amerike
In case of a single severe IAR, the infusion should be stopped until the symptoms are resolved and treatment with antihistamines and paracetamol should be considered. 
V primeru posamezne hude IAR, je treba infuzijo prekiniti, dokler simptomi ne izzvenijo in razmisliti o zdravljenju z antihistaminiki in paracetamolom.
- Please talk to your doctor if you experience muscle pain, numbness in your arms or legs, or any bowel or bladder problems as these may be caused by pressure on your spinal cord. 
- Povejte svojemu zdravniku, če imate mišične bolečine, otrplost rok ali nog ali težave s črevesjem ali mehurjem, saj jih morda povzroča pritisk na vašo hrbtenjačo.
When using 100 ml bags, the volume of Naglazyme may be added directly to the infusion bag. 
Pri uporabi vsebnikov s 100 ml se lahko volumen zdravila Naglazyme dodaja neposredno v infuzijsko vrečko.
You may need to be given additional medicines to prevent an allergic reaction (e.g. antihistamines and/or corticosteroids) or to reduce fever (antipyretics). 
Morda boste morali vzeti dodatna zdravila, ki bodo preprečila alergijsko reakcijo (npr. antihistaminiki in/ali kortikosteroidi) ali znižala povišano telesno temperaturo (antipiretiki).
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.