natgillin/translations-raw huggingface dataset:
The patients were randomized in a blinded manner into 4 groups: 3 patients received vestronidase alfa immediately for 48 weeks (Group A), 3 patients received placebo for 8 weeks then vestronidase alfa for 40 weeks (Group B), 3 patients received placebo for 16 weeks then vestronidase alfa for 32 weeks (Group C), and 3 patients received placebo for 24 weeks then vestronidase alfa for 24 weeks (Group D). 
Bolniki so bili zaslepljeno randomizirani v 4 skupine: 3 bolniki so takoj začeli zdravljenje z vestronidazo alfa, ki je trajalo 48 tednov (skupina A), 3 bolniki so 8 tednov dobivali placebo in nato 40 tednov vestronidazo alfa (skupina B), 3 bolniki so 16 tednov dobivali placebo in nato 32 tednov vestronidazo alfa (skupina C), in 3 bolniki so 24 tednov dobivali placebo in nato 24 tednov vestronidazo alfa (skupina D).
Mepsevii contains an enzyme called vestronidase alfa. 
Zdravilo Mepsevii vsebuje encim, imenovan vestronidaza alfa.
Infusion should be avoided if the patient has an acute febrile or respiratory illness at the time. 
Infundiranje se odsvetuje, če ima bolnik sočasno akutno vročinsko bolezen ali bolezen dihal.
Other medicines and Mepsevii 
Druga zdravila in zdravilo Mepsevii
The safety and efficacy of vestronidase alfa in patients with renal or hepatic impairment have not been evaluated. 
Varnosti in učinkovitosti vestronidaze alfa pri bolnikih z okvaro ledvic ali jeter niso ocenili.
Due to lack of human data, vestronidase alfa should only be administered to a breast-feeding woman if the potential benefit of vestronidase alfa to the mother and the benefit of breast-feeding to the infant outweighs the potential theoretical risks to the infant. 
Zaradi pomanjkanja podatkov, pridobljenih pri ljudeh, se sme vestronidaza alfa dajati doječim ženskam samo, če je možna korist vestronidaze alfa za mater in korist dojenja za otroka večja od morebitnih teoretičnih tveganj za otroka.
- Store in a refrigerator (2°C to 8°C). 
- Shranjujte v hladilniku (2 °C-8 °C).
Any dead space in the lines should be accounted for to ensure 2.5% of the total infusion volume is delivered into the patient's bloodstream during the first hour of infusion. 
Upoštevati je treba morebitni mrtvi prostor v infuzijskih linijah za zagotovitev, da se v prvi uri infuzije v bolnikov krvni obtok infundira 2,5 % celotnega odmerka.
- Without enough beta-glucuronidase, parts of these sugars build up in cells, leading to damage in the body. 
- Ob premajhni količini beta-glukuronidaze se del teh sladkorjev začne kopičiti v celicah, kar povzroči poškodbe različnih tkiv v telesu.
- Your doctor or nurse will give Mepsevii to you by an infusion (drip) into a vein. 
- Zdravnik ali medicinska sestra vam bosta dala zdravilo Mepsevii z infundiranjem v veno.
As a precautionary measure, it is preferable to avoid the use of vestronidase alfa during pregnancy, unless the potential benefit to the mother outweighs the potential theoretical risks to the foetus. 
Zaradi previdnosti je bolje, če se vestronidaza alfa ne uporablja med nosečnostjo, razen če potencialne koristi za mater odtehtajo morebitna teoretična tveganja za plod.
The rate of infusion should be as follows: in the first hour, 2.5% of the total volume will be infused, with the balance infused over the subsequent three hours. 
Hitrost infundiranja mora biti naslednja: v prvi uri se infundira 2,5 % celotne količine, preostanek pa se enakomerno infundira v naslednjih treh urah.
Of the 12 patients enrolled in the UX003-CL301, 4 were male and 8 were female and ranged in ages from 8 to 25 years (median 14 years). 
Med 12 bolniki, ki so sodelovali v študiji UX003-CL301, so bili 4 moški in 8 žensk v starosti od 8 do 25 let (mediana 14 let).
The limited pharmacokinetic data at steady state suggest dose proportional increase in exposure of vestronidase alfa over the dose range of 1 - 4 mg/kg every other week. 
Omejeni farmakokinetični podatki v stanju dinamičnega ravnovesja kažejo sorazmerno večanje izpostavljenosti vestronidazi alfa v razponu odmerkov od 1 do 4 mg/kg vsak drugi teden.
The most common adverse reactions from 4 clinical trials in 23 patients treated with vestronidase alfa were anaphylactoid reaction (13%), urticaria (13%), infusion site swelling (13%), infusion site extravasation (8.7%), pruritus (8.7%), diarrhoea (8.7%) and rash (8.7%). 
Najpogostejši neželeni učinki v 4 kliničnih preskušanjih pri 23 bolnikih, zdravljenih z vestronidazo alfa, so bili anafilaktoidna reakcija (13 %), urtikarija (13 %), oteklina na mestu infundiranja (13 %), ekstravazacija na mestu infundiranja (8,7 %), pruritus (8,7 %), driska (8,7 %) in izpuščaj (8,7 %).
Determine the number of vials to be diluted based on the patient's actual weight and the recommended dose of 4 mg/kg, using the following calculations (a-b): 
Ugotovite, kakšno število vial je treba razredčiti glede na telesno maso bolnika in priporočeni odmerek 4 mg/kg, pri čemer uporabite naslednje izračune (a-b):
Infusion site swelling** Infusion site extravasation 
Oteklina na mestu infundiranja** Ekstravazacija na mestu infundiranja
Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome). 
Zdravilo Mepsevii je indicirano za zdravljenje nenevroloških manifestacij mukopolisaharidoze VII (MPS VII, Slyev sindrom).
Vestronidase alfa is a recombinant human enzyme and is therefore eliminated by proteolytic degradation into small peptides and amino acids. 
Vestronidaza alfa je rekombinantni humani encim in se zato proteolitsko razgradi v majhne peptide in aminokisline.
Mucopolysaccharidosis VII is a lysosomal storage disorder characterized by the deficiency of betaglucuronidase (GUS) that results in glycosaminoglycans (GAGs) accumulation in cells throughout the body leading to multisystem tissue and organ damage. 
Mukopolisaharidoza VII je motnja lizosomskega shranjevanja, za katero je značilno pomanjkanje beta-glukuronidaze (GUS) in posledično kopičenje glikozaminoglikanov (GAG) v celicah po vsem telesu, ki povzročajo poškodbe različnih tkiv in organov.
Animal studies with vestronidase alfa do not indicate any impact on male or female fertility (see section 5.3). 
Študije na živalih z vestronidazo alfa niso pokazale nobenega vpliva na plodnost samcev ali samic (glejte poglavje 5.3).
a. Total dose (mg) = Patient's weight (kg) x 4 mg/kg (recommended dose) 
a. Celotni odmerek (mg) = bolnikova telesna masa (kg) x 4 mg/kg (priporočeni odmerek)
After the first hour, the rate can be increased to infuse the remainder of the solution for infusion over 3 hours as tolerated according to the recommended rate guidelines in Table 2. 
Po prvi uri se lahko hitrost poveča, da se preostanek raztopine za infundiranje infundira v 3 urah, odvisno od bolnikovega prenašanja zdravila in skladno s priporočenim razporedom odmerjanja v preglednici 2.
Pack size: 1 vial containing 5 mL of concentrate for solution for infusion. 
Velikost pakiranja: 1 viala, ki vsebuje 5 ml koncentrata za raztopino za infundiranje.
The total infusion volume is based on the total Mepsevii dose and volume (refer to Table 2). 
Celotni volumen infuzije temelji na celotnem odmerku in volumnu zdravila Mepsevii (glejte preglednico 2).
After 24 weeks of vestronidase alfa treatment, the overall MDRI results, both pre-specified and post-hoc (6 MDRI domains plus fatigue domain) analyses, were positive with an increase of +0.5 domains (p=0.0527) and +0.8 domains (p=0.0433) including fatigue, respectively (t-test). 
Po 24 tednih zdravljenja z vestronidazo alfa so bile analize splošnih rezultatov MDRI, tako vnaprej določenih kot post-hoc (6 domen MDRI in domena utrujenosti), pozitivni, z domenami s povečanjem + 0,5 (p = 0,0527) in domenami s povečanjem + 0,8 (p = 0,0433), vključno z utrujenostjo
The colourless to slightly yellow concentrate must be free of visible particles. 
Brezbarvni do rahlo rumeni koncentrat ne sme vsebovati vidnih delcev.
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single-dose toxicity in rats, repeated dose toxicity in MPS VII mice and juvenile monkeys, fertility and embryo-foetal development in rats or rabbits, and pre- and postnatal development in rats. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti enkratnih odmerkov pri podganah, toksičnosti ponavljajočih se odmerkov pri miših in mladih opicah z MPS VII, plodnosti in razvoja zarodka/plodu pri podganah ali kuncih ter pred- in postnatalnega razvoja pri podganah ne kažejo posebnega tveganja za človeka.
Febrile convulsion* 
Vročinski krči*
What Mepsevii is and what it is used for What Mepsevii is 
Kaj je zdravilo Mepsevii in za kaj ga uporabljamo Kaj je zdravilo Mepsevii
MPS VII diagnosis was confirmed by GUS enzyme activity assay for 5 patients, by genotyping for 3 patients, and via both enzyme assay and genotyping for 4 patients. 
Diagnozo MPS VII so pri 5 bolnikih potrdili s preskusom encimske aktivnosti GUS, pri 3 bolnikih z določitvijo genotipa ter pri 4 bolnikih z encimskim testom in določitvijo genotipa.
b. Total number of vials = Total dose (mg) divided by 10 mg/vial 
b. Celotno število vial = celotni odmerek (mg), deljen z 10 mg/vialo
Mepsevii is supplied as a concentrate for solution for infusion (sterile concentrate). 
Zdravilo Mepsevii je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (sterilen koncentrat).
Contains sodium, see package leaflet for further information. 
Vsebuje natrij; dodatne informacije so v navodilu za uporabo.
- Hives (urticaria) - Swelling at the infusion site including leaking into the tissue around the vein (infusion site swelling or infusion site extravasation) 
- oteklina na mestu infundiranja, vključno z uhajanjem zdravila v tkivo okoli vene (oteklina na mestu infundiranja ali ekstravazacija na mestu infundiranja)
After repeated dosing of 4 mg/kg every other week, the maximal serum concentration (Cmax) was 20.0 ± 8.1 µg/mL (mean ± s.d.; range: 6.6 to 34.9 µg/mL) and the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) was 57.4 ± 23.9 µg*h/mL (mean ± s.d.; range: 18.8 to 97.0 µg*h/mL). 
Po večkratnem odmerjanju 4 mg/kg vsak drugi teden je bila najvišja serumska koncentracija (Cmax) 20,0 ± 8,1 µg/ml (srednja vrednost ± s.o.; razpon: od 6,6 do 34,9 µg/ml) in površina pod krivuljo plazemske koncentracije po času od nič do zadnje merljive koncentracije (AUC0-t) je bila 57,4 ± 23,9 µg*h/ml (srednja vrednost ± s.o.; razpon: od 18,8 do 97,0 µg*h/ml).
Because it is a recombinant human protein and its enzyme action is within the lysosome, vestronidase alfa is not expected to interact with other medicinal products. 
Ker je vestronidaza alfa rekombinantni humani protein z encimsko aktivnostjo znotraj lizosoma, ni pričakovati medsebojnega delovanja z drugimi zdravili.
There are no data on the use of vetronidase alfa in pregnant women. 
Podatkov o uporabi vestronidaze alfa pri nosečnicah ni.
This amount is equivalent to 1.8% of the WHO recommended maximum daily intake for sodium (2 g). 
Ta količina ustreza 1,8 % največjega dnevnega vnosa natrija (2 g), ki ga priporoča SZO.
Patients with MPS VII receiving vestronidase alfa should be monitored for signs and symptoms of spinal cord compression or neck instability including neck or back pain, weakness of limbs, changes in reflexes or urinary and faecal incontinence. 
Bolnike z MPS VII, ki prejemajo vestronidazo alfa, je treba spremljati zaradi znakov in simptomov kompresije hrbtenjače ali nestabilnosti vratu, vključno z bolečino v vratu ali hrbtu, šibkostjo okončin,
To minimise the risk of hypersensitivity reactions, a non-sedating antihistamine with or without an antipyretic medicinal product should be administered 30-60 minutes prior to the start of the infusion (see section 4.4). 
Za zmanjšanje tveganja preobčutljivostnih reakcij mora bolnik od 30 do 60 minut pred začetkom infundiranja dobiti nesedativen antihistaminik z antipiretikom ali brez njega (glejte poglavje 4.4).
A sufficiently large needle (18 gauge) should be used to minimise bubbles in the solution. 
Za zmanjšanje prisotnosti mehurčkov v raztopini morate uporabiti dovolj veliko iglo (velikost 18).
This is because there is no experience on the use of Mepsevii during pregnancy. 
Z uporabo zdravila Mepsevii med nosečnostjo namreč ni nobenih izkušenj.
Management of hypersensitivity reactions should be based on the severity of the reaction and include temporary interruption or discontinuation of the infusion and/or administration of additional antihistamines, antipyretics, and/or corticosteroids for mild to moderate reactions. 
Zdravljenje preobčutljivostnih reakcij mora temeljiti na resnosti reakcije ter vključevati začasno prekinitev ali opustitev infundiranja in/ali dajanje dodatnih antihistaminikov,
Concentrate for solution for infusion 1 vial (5 mL) 
koncentrat za raztopino za infundiranje 1 viala (5 ml)
After dilution: Chemical and physical in-use stability of the diluted medicinal product has been demonstrated for up to 36 hours under refrigeration at 2°C - 8°C followed by up to 6 hours at room temperature up to a maximum of 25°C. 
Po razredčitvi: Za razredčeno zdravilo je dokazana kemična in fizikalna stabilnost med uporabo do 36 ur, če je zdravilo shranjeno pri 2-8 °C, in nato največ 6 ur pri sobni temperaturi, ki ne sme presegati 25 °C.
- If you have neck or back pain, feel numb in your arms or legs, or experience lack of control over passing water (urine) or stools, tell your doctor straight away. 
- Če imate bolečine v vratu ali hrbtu, otrple roke ali noge ali slab nadzor nad izločanjem vode
Mepsevii must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique according to the steps described below. 
Zdravilo Mepsevii je treba razredčiti z 0,9-odstotno raztopino natrijevega klorida (9 mg/ml) za injiciranje z uporabo aseptične tehnike in ob upoštevanju spodaj opisanih korakov.
For the clinical (secondary) endpoints, beneficial responses were observed although not in all patients. 
Ključni sekundarni opazovani dogodek: Večdomenski indeks kliničnega odziva (MDRI) V okviru kliničnih (sekundarnih) opazovanih dogodkov so opazili koristne odzive, vendar ne pri vseh bolnikih.
The total diluted volume of the solution for infusion should be administered with a rate titration regimen over approximately 4 hours. 
Skupni razredčeni volumen raztopine za infundiranje je treba dajati v režimu s postopnim večanjem odmerka, pri čemer infundiranje traja približno 4 ure.
Animal studies with vestronidase alfa do not indicate direct or indirect harmful effects with respect to pregnancy or embryo-foetal development (see section 5.3). 
Študije vestronidaze alfa, opravljene pri živalih, niso pokazale neposrednih ali posrednih škodljivih učinkov na gestacijo in razvoj zarodka/plodu (glejte poglavje 5.3).
The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment. 
Bolnik je pozneje ponovno prejemal vestronidazo alfa in nadaljeval zdravljenje brez ponovitve.
Genotoxicity studies and carcinogenicity studies have not been performed with vestronidase alfa. 
Z vestronidazo alfa niso izvedli študij genotoksičnosti in kancerogenosti.
This medicine contains 17.8 mg sodium (main component of cooking/table salt) in each 5-mL vial, and is administered with sodium chloride 9 mg/mL as a diluent. 
To zdravilo vsebuje 17,8 mg natrija (glavna sestavina namizne soli) v vsaki 5 ml viali in se daje z natrijevim kloridom 9 mg/ml kot razredčilom.
Patient Weight Range (kg) 
Razpon telesne mase bolnika (kg)
It should be considered that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities). 
Upoštevati je treba, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
Name and address of the manufacturer(s) of the biological active substance(s) 
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin) Rentschler Biopharma SE
In a multi-centre, randomized, placebo-controlled, Blind-Start, single-crossover Phase 3 trial (Study UX003-CL301, referred to as Study 301), 12 patients with MPS VII received vestronidase alfa 4 mg/kg every two weeks for 24 to 48 weeks. 
V večcentričnem, randomiziranem, s placebom nadzorovanem preskušanju faze 3 s slepim začetkom in enim prehodom (študija UX003-CL301, imenovana študija 301) je 12 bolnikov z MPS VII od 24 do 48 tednov prejemalo 4 mg/kg vestronidaze alfa na vsaka dva tedna.
The recommended dose of vestronidase alfa is 4 mg/kg of body weight administered by intravenous infusion every two weeks. 
Priporočeni odmerek vestronidaze alfa je 4 mg/kg telesne mase bolnika in se daje kot intravenska infuzija na vsaka dva tedna.
Pack size: 1 vial of 5 mL 
Velikost pakiranja: 1 viala po 5 ml
Very common side effects (may affect more than 1 in 10 people): - Severe allergic reaction (anaphylactoid reaction) - Symptoms of severe allergic reaction may include shortness of breath, wheezing, difficulty breathing, and swelling of the face and tongue. 
- Huda alergijska reakcija (anafilaktoidna reakcija) - med simptomi hude alergijske reakcije so lahko zasoplost, piskanje v pljučih, težko dihanje ter oteklost obraza in jezika.
One patient receiving a vestronidase alfa dose of 4 mg/kg experienced a febrile convulsion during treatment at the week 66, within 3 days of diphtheria, tetanus, pertussis vaccination. 
En bolnik, ki je prejemal vestronidazo alfa v odmerku 4 mg/kg, je v 66. tednu zdravljenja doživel vročinski krč v treh dneh po cepljenju proti davici, tetanusu in oslovskemu kašlju.
It is supplied in a clear glass vial with a rubber stopper and an aluminium seal with a plastic cap. 
Na voljo je v viali iz brezbarvnega stekla z gumijastim zamaškom in aluminijastim tesnilom s plastično zaporko.
No human data are available on the effect of vestronidase alfa on fertility. 
Podatki o učinku vestronidaze alfa na plodnost pri ljudeh niso na voljo.
Two other patients with baseline hepatosplenomegaly had reduction in liver volume (24% and 53%) and spleen volume (28% and 47%) after 36 weeks of treatment. 
36 tednih zdravljenja ugotovili zmanjšanje volumna jeter (24 % in 53 %) in volumna vranice (28 % in 47 %).
There is no definitive correlation between the antibody titre and neutralizing antibody development. 
Med titrom protiteles in razvojem nevtralizirajočih protiteles ni očitne korelacije.
Package leaflet: Information for the user Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa This medicine is subject to additional monitoring. 
Navodilo za uporabo Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje vestronidaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
What Mepsevii looks like and contents of the pack 
Izgled zdravila Mepsevii in vsebina pakiranja
It is recommended that premedication with non-sedating antihistamines with or without antipyretics be administered 30-60 minutes prior to the start of the infusion (see section 4.2). 
Od 30 do 60 minut pred začetkom infundiranja se priporoča premedikacija z nesedativnimi antihistaminiki z antipiretiki ali brez njih (glejte poglavje 4.2).
The Mepsevii concentrate solution for infusion should be colourless to slightly yellow. 
Raztopina za infundiranje, pripravljena s koncentratom zdravila Mepsevii, mora biti brezbarvna do rahlo rumena.
Recommended infusion rate schedule by patient weight for administration of Mepsevii at recommended dose of 4 mg/kg Patient Weight Range (kg) 
Priporočeni razpored infundiranja glede na telesno maso bolnika pri uporabi zdravila Mepsevii v priporočenem odmerku 4 mg/kg
Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap. 
tip I) z gumijastim zamaškom, obloženim s fluorovo smolo, ter aluminijastim tesnilom s plastično zaporko.
Based on mechanism of action, rhGUS is not expected to be tumorigenic. 
Na podlagi mehanizma delovanja ni pričakovati, da bo humana rekombinantna beta-glukuronidaza (rhGUS) tumorogena.
It should be considered by the treating physician that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities). 
Lečeči zdravnik mora upoštevati, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
The pharmacokinetics of vestronidase alfa are time independent with repeat dosing. 
Pri ponavljajočem se odmerjanju je farmakokinetika vestronidaze alfa neodvisna od časa.
- The active substance is vestronidase alfa. 
- Učinkovina je vestronidaza alfa.
After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation the total volume of distribution (Vss) was 0.26 ± 0.13 L/kg (range: 0.10 to 0.60 L/kg). 
Po ponavljajočem se odmerjanju 4 mg/kg vsak drugi teden pri bolnikih z MPS VII je bil srednji ± standardni odklon v skupnem volumnu porazdelitve (Vss) 0,26 ± 0,13 l/kg (razpon: od 0,10 do 0,60 l/kg).
The diluted solution for infusion should be administered to patients using a low-protein binding infusion bag and set (a non di (2-ethylhexyl) phthalate [DEHP] bag could be used) and the application of an infusion set equipped with an in-line, low-protein binding 0.2 μm filter is recommended. 
Razredčeno raztopino za infundiranje je treba dajati bolnikom z uporabo infuzijske vrečke in kompleta, ki malo vežeta beljakovine (uporabite lahko vrečko brez di-(2-etilheksil)ftalata [DEHP]).
Do not heat, microwave or shake vials. 
Vial ne segrevajte, ne izpostavljajte mikrovalovom in ne stresajte.
Vestronidase alfa is a recombinant form of human GUS and is intended to provide exogenous GUS enzyme for uptake into cellular lysosomes and subsequent catabolism of accumulated GAGs in affected tissues. 
Vestronidaza alfa je rekombinantna oblika humane beta-glukuronidaze in zagotavlja eksogeni encim beta-glukuronidazo za privzem v celične lizosome in poznejši katabolizem nakopičenih glikozaminoglikanov v prizadetih tkivih.
Vestronidase alfa is not expected to be eliminated through renal or faecal excretion. 
Ni pričakovati, da se bo vestronidaza alfa izločala po ledvični ali fekalni poti.
The above calculated dose diluted 1:1 in sodium chloride 9 mg/mL (0.9%) solution for injection should be added to a new empty infusion bag. 
Zgornji izračunani odmerek, razredčen v razmerju 1 : 1 z 0,9-odstotno raztopino (9 mg/ml) za injiciranje je treba dodati v novo prazno infuzijsko vrečko.
For the management of adverse reactions, see sections 4.4 and 4.8. 
Izkušenj s prevelikim odmerjanjem vestronidaze alfa ni. Za obvladovanje neželenih učinkov glejte poglavji 4.4 in 4.8.
Mepsevii contains sodium 
Zdravilo Mepsevii vsebuje natrij
Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia. 
Razmislite o hitrem infundiranju 0,9-odstotne raztopine natrijevega klorida (9 mg/ml), če ima bolnik znižan krvni tlak, in o dovajanju kisika pri hipoksiji.
Due to the low infusion rate, additional sodium chloride 9 mg/mL (0.9%) solution for infusion may be added through a separate line (piggyback or Y tube) to maintain sufficient intravenous flow. 
Zaradi nizke hitrosti infundiranja se lahko po ločeni liniji dodaja 0,9-odstotna raztopina natrijevega klorida (9 mg/ml) (sekundarna infuzija (»komplementarna infuzija«) ali cev Y), da se ohrani zadosten pretok infuzijske tekočine.
The key secondary endpoint was the multi-domain clinical responder index (MDRI) score consisting of six domains [six-minute walk test (6MWT), forced vital capacity (FVC), shoulder flexion, visual acuity, Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) fine motor and gross motor function] after 24 weeks of treatment and fatigue total score as measured by the Pediatric Quality of Life Multidimensional Fatigue Scale (PedsQL). 
[6-minutni test hoje (6MWT), forsirana vitalna kapaciteta (FVC), fleksija ramen, ostrina vida, test Bruininks-Oseretsky (BOT-2) finih in grobih motoričnih spretnosti] po 24 tednih zdravljenja in skupna ocena utrujenosti, merjena z večdimenzionalno lestvico utrujenosti in kakovosti življenja pri pediatričnih bolnikih (PedsQL).
Total Mepsevii Volume (rounded) (mL) 
Celotni volumen zdravila Mepsevii (zaokrožen) (ml)