FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes, ATC code: A16AB18
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi; oznaka ATC: A16AB18
English: The dose you will receive is based on how much you weigh.
Slovenian: Odmerek, ki ga boste dobili, bo izračunan na podlagi vaše telesne mase.
English: You will not be given Mepsevii if you are pregnant unless treatment is clearly necessary.
Slovenian: Če ste noseči, ne boste dobili zdravila Mepsevii, razen če je zdravljenje nedvomno nujno.
English: Treatment should be supervised by a healthcare professional experienced in the management of patients with MPS VII or other inherited metabolic disorders.
Slovenian: Zdravljenje mora nadzorovati zdravnik z izkušnjami z zdravljenjem bolnikov z MPS VII ali drugimi dednimi presnovnimi boleznimi.
English: Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
Slovenian: (od ≥ 1/100 do < 1/10), občasni (od ≥ 1/1.000 do < 1/100), redki (od ≥ 1/10.000 do < 1/1.000) in zelo redki (< 1/10.000).
English: It is important to administer vestronidase alfa according to the recommended infusion rate schedule (see Table 2 in section 6.6).
Slovenian: Pomembno je, da se vestronidaza alfa daje skladno s priporočenim razporedom infundiranja (glejte preglednico 2 v poglavju 6.6).
English: - The dose is given every two weeks through a drip into a vein (intra-venous infusion).
Slovenian: - Zdravilo se daje vsaka dva tedna neposredno v veno (intravenska infuzija).
English: Sixteen out of 23 patients (70%) from 4 clinical trials developed anti-recombinant human betaglucuronidase (rhGUS) antibodies (ADA), nine of whom further developed neutralizing antibodies (NAb) on at least one occasion, but not consistently over time.
Slovenian: Šestnajst od 23 bolnikov (70 %) v 4 kliničnih preskušanjih je razvilo protitelesa proti humani rekombinantni beta-glukuronidazi (rhGUS) (ADA), od katerih jih je devet razvilo nevtralizirajoča protitelesa (NAb) vsaj enkrat, vendar ne časovno dosledno.
English: Block-7, City North Business Campus Stamullen, Co. Meath, Ireland
Slovenian: Millmount Healthcare Ltd. Block-7, City North Business Campus Stamullen, Co. Meath, Irska
English: If severe hypersensitivity reactions occur, immediately stop the infusion of vestronidase alfa and initiate appropriate treatment.
Slovenian: Če se pojavijo hude preobčutljivostne reakcije, takoj ustavite infundiranje vestronidaze alfa in uvedite ustrezno zdravljenje.
English: Most adverse reactions were mild to moderate in severity.
Slovenian: Neželeni učinki so bili večinoma blagi do zmerni.
English: This should be taken into consideration during dilution of the medicinal product for patients on a controlled sodium diet or for those patients with congestive heart failure needing to restrict sodium and total water intake.
Slovenian: To je treba upoštevati pri redčenju zdravila za bolnike, ki so na dieti z nadzorovanim vnosom natrija, ali za bolnike s kongestivnim srčnim popuščanjem, ki morajo omejevati vnos natrija in skupni vnos vode.
English: During enzyme replacement therapy, spinal cord injury can occur due to improved neck and spine mobility.
Slovenian: Med nadomestnim encimskim zdravljenjem lahko zaradi izboljšane mobilnosti vratu in hrbtenice pride do poškodb hrbtenjače.
English: Anaphylactoid reaction Very common
Slovenian: Anafilaktoidna reakcija Zelo pogosti
English: Round to the next whole vial and remove the required number of vials (refer to Table 2) from the refrigerator to allow them to reach room temperature up to a maximum of 25°C.
Slovenian: Število zaokrožite na naslednjo celo vialo in vzemite potrebno število vial (glejte preglednico 2) iz hladilnika, da dosežejo sobno temperaturo, največ 25 °C.
English: No alternative dose regimen is recommended in these patients.
Slovenian: Pri teh bolnikih se ne priporoča drugačen režim odmerjanja.
English: - Each infusion will be given over about 4 hours.
Slovenian: - Posamezna infuzija traja približno 4 ure.
English: Each vial dosed is therefore equivalent to 1.8% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: Vsaka odmerjena viala torej ustreza 1,8 % priporočenega največjega dnevnega vnosa natrija za odrasle.
English: Adverse reactions are presented by System Organ Class and frequency.
Slovenian: Neželeni učinki so razvrščeni po organskih sistemih in pogostnosti.
English: Clinical endpoints were not assessable in some patients due to their extent of disease, age or level of cognition (23 out of 72 assessments [~32%] in 6 domains for 12 patients were non-assessable at baseline).
Slovenian: Kliničnih opazovanih dogodkov pri nekaterih bolnikih ni bilo mogoče oceniti zaradi obsežnosti bolezni, starosti ali ravni kognicije (ob izhodišču ni bilo mogoče izvesti 23 od 72 ocen [~32 %] iz 6 domen pri 12 bolnikih).
English: Infusion Rate for Subsequent 3 Hours
Slovenian: Hitrost infuzije v naslednjih 3 urah
English: Mepsevii has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Mepsevii nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: In most patients, a pattern of attenuated immunogenicity with chronic exposure was suggested by declining antibody titres over time on continuous treatment.
Slovenian: Pri večini bolnikov je bil navidez prisoten vzorec oslabljene imunogenosti ob kronični izpostavljenosti, pri čemer so se titri protiteles ob nadaljevanju zdravljenja sčasoma zmanjšali.
English: Spinal or cervical cord compression is a known and serious complication of MPS VII.
Slovenian: Kompresija (vratne) hrbtenjače je znan in resen zaplet pri MPS VII.
English: Gently rock the infusion bag to ensure proper distribution of Mepsevii.
Slovenian: Infuzijsko vrečko previdno obračajte, da zagotovite pravilno porazdelitev zdravila Mepsevii.
English: This belongs to a group of medicines called enzyme replacement therapies.
Slovenian: Ta spada v skupino zdravil, namenjenih »nadomestnemu encimskemu zdravljenju«.
English: This medicine replaces beta-glucuronidase - this helps to break down the sugars that collect in the tissues of people with MPS VII.
Slovenian: To zdravilo nadomešča beta-glukuronidazo, s čimer pomaga razgraditi sladkorje, ki se kopičijo v tkivih ljudi z MPS VII.
English: The presence of ADA (non-NAb and NAb) does not appear to affect reduction in the pharmacodynamic marker, urinary glycosaminoglycans (uGAGs).
Slovenian: Zdi se, da prisotnost ADA (ne-NAb in NAb) ne vpliva na zmanjšanje ravni farmakodinamičnega označevalca, urinarnih glikozaminoglikanov (uGAG).
English: The European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Slovenian: Evropska agencija za zdravila bo vsako leto pregledala vse nove podatke, ki bodo na voljo.
English: The lowest rate administered to a patient in the clinical development program was 0.5 mL/hour during the first 30 minutes of infusion, followed by 1 mL/hour over the next 30 minutes, equalling 0.75 mL as the lowest total volume infused during the first hour.
Slovenian: Najnižja hitrost infundiranja, ki je bila uporabljena pri bolniku v programu kliničnega razvoja, je bila 0,5 ml/h v prvih 30 minutah infuzije in 1 ml/h v naslednjih 30 minutah, kar ustreza 0,75 ml kot najmanjši skupni količini, infundirani v prvi uri.
English: Patients with MPS VII who received Hematopoietic Stem Cell Transplant therapy were excluded in this study.
Slovenian: Bolniki z MPS VII, ki so se zdravili s presaditvijo krvotvornih matičnih celic, niso mogli sodelovati v tej študiji.
English: - Mucopolysaccharides are made in the body and they help build bones, cartilage, skin, and tendons.
Slovenian: - Mukopolisaharidi nastajajo v telesu ter so gradniki kosti, hrustanca, kože in kit.
English: - The other ingredients are: sodium dihydrogen phosphate dihydrate, sodium chloride, histidine, polysorbate 20, and water for injections (for sodium, see section 2 under “Mepsevii contains sodium”).
Slovenian: - Druge sestavine so: natrijev dihidrogenfosfat dihidrat, natrijev klorid, histidin, polisorbat 20 in voda za injekcije (za informacije o natriju glejte poglavje 2 »Zdravilo Mepsevii vsebuje natrij«).
English: As end organ damage progresses over time, it is more difficult for the treatment to reverse the damage or to show improvements.
Slovenian: Ker poškodbe tarčnih organov sčasoma napredujejo, je s poznejšim zdravljenjem težje odpraviti poškodbe ali doseči izboljšanje stanja.
English: Vestronidase alfa, at the exposure observed in humans, is not expected to cross the blood-brain-barrier and therefore it is not likely to impact the neurological manifestations of the disease.
Slovenian: Ni pričakovati, da bo vestronidaza alfa pri izpostavljenosti, opaženi pri ljudeh, prehajala skozi krvno možgansko pregrado, zato verjetno ne bo vplivala na nevrološke manifestacije bolezni.
English: Table 1 lists the adverse reactions reported from 4 clinical trials in 23 patients treated with Mepsevii.
Slovenian: V preglednici 1 so našteti neželeni učinki, o katerih so poročali v 4 kliničnih preskušanjih pri 23 bolnikih, zdravljenih z zdravilom Mepsevii.
English: Contents of the pack and other information What Mepsevii contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Mepsevii
English: Do not use this medicine after the expiry date which is stated on the carton after ‘EXP'.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli poleg oznake »Uporabno do:«.
English: No excretion studies have been conducted in humans.
Slovenian: Pri ljudeh niso opravili nobenih študij izločanja.
English: Tell your doctor straight away if you notice any of the following side effects - you may need urgent medical treatment:
Slovenian: Če opazite katerega od naslednjih neželenih učinkov, nemudoma povejte zdravniku - morda boste potrebovali nujno zdravniško pomoč:
English: MPS VII is an illness that runs in families, where the body does not produce enough of an enzyme called beta-glucuronidase.
Slovenian: MPS VII je dedna bolezen, pri kateri telo ne proizvaja dovolj encima beta-glukuronidaze.
English: Do not flush the line containing vestronidase alfa to avoid a rapid bolus of infused enzyme.
Slovenian: Ne izpirajte linije, ki vsebuje vestronidazo alfa, da ne pride do hitrega bolusa infundiranega encima.
English: Mepsevii is not likely to affect you being able to drive or use machines.
Slovenian: Ni verjetno, da bi zdravilo Mepsevii vplivalo na vašo sposobnost za vožnjo ali uporabo strojev.
English: It is used in adults and children of all ages with MPS VII to treat nonneurological manifestations of the disease (mucopolysaccharidosis VII, also known as Sly Syndrome).
Slovenian: Uporablja se pri odraslih in otrocih vseh starosti z MPS VII za zdravljenje nenevroloških manifestacij bolezni (mukopolisaharidoza VII, imenovana tudi Slyev sindrom).
English: Discuss with your doctor if the benefits of using Mepsevii are greater than the possible risks to your unborn baby.
Slovenian: Pogovorite se z zdravnikom, ali so koristi uporabe zdravila Mepsevii večje od možnih tveganj za vašega nerojenega otroka.
English: After 120 weeks of exposure to vestronidase alfa, one patient demonstrated a 21% improvement over baseline in forced vital capacity (FVC% predicted) on pulmonary function testing in addition to a 105 meter improvement in the 6MWT.
Slovenian: Po 120 tednih izpostavljenosti vestronidazi alfa je en bolnik pri testiranju delovanja pljuč pokazal 21-odstotno izboljšanje forsirane vitalne kapacitete (predvideni % FVC) glede na izhodiščno vrednost in izboljšanje 6MWT za 105 metrov.
English: There was a single adverse reaction of febrile convulsion observed in one patient (4.3%); the patient recovered without sequelae.
Slovenian: Opazili so en sam primer vročinskih krčev, ki so se kot neželeni učinek pojavili pri enem bolniku (4,3 %); bolnik je okreval brez posledic.
English: What you need to know before you are given Mepsevii You must not be given Mepsevii:
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Mepsevii Zdravila Mepsevii ne smete dobiti:
English: Life-threatening hypersensitivity (anaphylactic reaction) to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).
Slovenian: Življenjsko nevarna preobčutljivost (anafilaktična reakcija) na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 (glejte poglavje 4.4).
English: 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).
Slovenian: 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).
English: Mepsevii contains an enzyme called vestronidase alfa.
Slovenian: Zdravilo Mepsevii vsebuje encim, imenovan vestronidaza alfa.
English: Infusion should be avoided if the patient has an acute febrile or respiratory illness at the time.
Slovenian: Infundiranje se odsvetuje, če ima bolnik sočasno akutno vročinsko bolezen ali bolezen dihal.
English: Other medicines and Mepsevii
Slovenian: Druga zdravila in zdravilo Mepsevii
English: The safety and efficacy of vestronidase alfa in patients with renal or hepatic impairment have not been evaluated.
Slovenian: Varnosti in učinkovitosti vestronidaze alfa pri bolnikih z okvaro ledvic ali jeter niso ocenili.
English: 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.
Slovenian: 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.
English: - Store in a refrigerator (2°C to 8°C).
Slovenian: - Shranjujte v hladilniku (2 °C-8 °C).
English: 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.
Slovenian: 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.
English: - Without enough beta-glucuronidase, parts of these sugars build up in cells, leading to damage in the body.
Slovenian: - Ob premajhni količini beta-glukuronidaze se del teh sladkorjev začne kopičiti v celicah, kar povzroči poškodbe različnih tkiv v telesu.
English: - Your doctor or nurse will give Mepsevii to you by an infusion (drip) into a vein.
Slovenian: - Zdravnik ali medicinska sestra vam bosta dala zdravilo Mepsevii z infundiranjem v veno.
English: 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.
Slovenian: Zaradi previdnosti je bolje, če se vestronidaza alfa ne uporablja med nosečnostjo, razen če potencialne koristi za mater odtehtajo morebitna teoretična tveganja za plod.
English: 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.
Slovenian: Hitrost infundiranja mora biti naslednja: v prvi uri se infundira 2,5 % celotne količine, preostanek pa se enakomerno infundira v naslednjih treh urah.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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.
English: 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%).
Slovenian: 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 %).
English: 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):
Slovenian: 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):
English: Infusion site swelling** Infusion site extravasation
Slovenian: Oteklina na mestu infundiranja** Ekstravazacija na mestu infundiranja
English: Mepsevii is indicated for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome).
Slovenian: Zdravilo Mepsevii je indicirano za zdravljenje nenevroloških manifestacij mukopolisaharidoze VII (MPS VII, Slyev sindrom).
English: Vestronidase alfa is a recombinant human enzyme and is therefore eliminated by proteolytic degradation into small peptides and amino acids.
Slovenian: Vestronidaza alfa je rekombinantni humani encim in se zato proteolitsko razgradi v majhne peptide in aminokisline.
English: 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.
Slovenian: 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.
English: Animal studies with vestronidase alfa do not indicate any impact on male or female fertility (see section 5.3).
Slovenian: Študije na živalih z vestronidazo alfa niso pokazale nobenega vpliva na plodnost samcev ali samic (glejte poglavje 5.3).
English: a. Total dose (mg) = Patient's weight (kg) x 4 mg/kg (recommended dose)
Slovenian: a. Celotni odmerek (mg) = bolnikova telesna masa (kg) x 4 mg/kg (priporočeni odmerek)
English: 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.
Slovenian: 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.
English: Pack size: 1 vial containing 5 mL of concentrate for solution for infusion.
Slovenian: Velikost pakiranja: 1 viala, ki vsebuje 5 ml koncentrata za raztopino za infundiranje.
English: The total infusion volume is based on the total Mepsevii dose and volume (refer to Table 2).
Slovenian: Celotni volumen infuzije temelji na celotnem odmerku in volumnu zdravila Mepsevii (glejte preglednico 2).
English: 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).
Slovenian: 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
English: The colourless to slightly yellow concentrate must be free of visible particles.
Slovenian: Brezbarvni do rahlo rumeni koncentrat ne sme vsebovati vidnih delcev.
English: 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.
Slovenian: 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.
English: Febrile convulsion*
Slovenian: Vročinski krči*
English: What Mepsevii is and what it is used for What Mepsevii is
Slovenian: Kaj je zdravilo Mepsevii in za kaj ga uporabljamo Kaj je zdravilo Mepsevii
English: 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.
Slovenian: 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.
English: b. Total number of vials = Total dose (mg) divided by 10 mg/vial
Slovenian: b. Celotno število vial = celotni odmerek (mg), deljen z 10 mg/vialo
English: Mepsevii is supplied as a concentrate for solution for infusion (sterile concentrate).
Slovenian: Zdravilo Mepsevii je na voljo v obliki koncentrata za pripravo raztopine za infundiranje (sterilen koncentrat).
English: Contains sodium, see package leaflet for further information.
Slovenian: Vsebuje natrij; dodatne informacije so v navodilu za uporabo.
English: - Hives (urticaria) - Swelling at the infusion site including leaking into the tissue around the vein (infusion site swelling or infusion site extravasation)
Slovenian: - oteklina na mestu infundiranja, vključno z uhajanjem zdravila v tkivo okoli vene (oteklina na mestu infundiranja ali ekstravazacija na mestu infundiranja)
English: 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).
Slovenian: 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).
English: 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.
Slovenian: Ker je vestronidaza alfa rekombinantni humani protein z encimsko aktivnostjo znotraj lizosoma, ni pričakovati medsebojnega delovanja z drugimi zdravili.
English: There are no data on the use of vetronidase alfa in pregnant women.
Slovenian: Podatkov o uporabi vestronidaze alfa pri nosečnicah ni.