FrancophonIA/ELRC3.0 huggingface dataset:
English: This amount is equivalent to 1.8% of the WHO recommended maximum daily intake for sodium (2 g).
Slovenian: Ta količina ustreza 1,8 % največjega dnevnega vnosa natrija (2 g), ki ga priporoča SZO.
English: 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.
Slovenian: 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,
English: 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).
Slovenian: 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).
English: A sufficiently large needle (18 gauge) should be used to minimise bubbles in the solution.
Slovenian: Za zmanjšanje prisotnosti mehurčkov v raztopini morate uporabiti dovolj veliko iglo (velikost 18).
English: This is because there is no experience on the use of Mepsevii during pregnancy.
Slovenian: Z uporabo zdravila Mepsevii med nosečnostjo namreč ni nobenih izkušenj.
English: 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.
Slovenian: Zdravljenje preobčutljivostnih reakcij mora temeljiti na resnosti reakcije ter vključevati začasno prekinitev ali opustitev infundiranja in/ali dajanje dodatnih antihistaminikov,
English: Concentrate for solution for infusion 1 vial (5 mL)
Slovenian: koncentrat za raztopino za infundiranje 1 viala (5 ml)
English: 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.
Slovenian: 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.
English: - 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.
Slovenian: - Če imate bolečine v vratu ali hrbtu, otrple roke ali noge ali slab nadzor nad izločanjem vode
English: Mepsevii must be diluted with sodium chloride 9 mg/mL (0.9%) solution for injection using aseptic technique according to the steps described below.
Slovenian: 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.
English: For the clinical (secondary) endpoints, beneficial responses were observed although not in all patients.
Slovenian: Ključni sekundarni opazovani dogodek: Večdomenski indeks kliničnega odziva (MDRI) V okviru kliničnih (sekundarnih) opazovanih dogodkov so opazili koristne odzive, vendar ne pri vseh bolnikih.
English: The total diluted volume of the solution for infusion should be administered with a rate titration regimen over approximately 4 hours.
Slovenian: Skupni razredčeni volumen raztopine za infundiranje je treba dajati v režimu s postopnim večanjem odmerka, pri čemer infundiranje traja približno 4 ure.
English: 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).
Slovenian: Študije vestronidaze alfa, opravljene pri živalih, niso pokazale neposrednih ali posrednih škodljivih učinkov na gestacijo in razvoj zarodka/plodu (glejte poglavje 5.3).
English: The patient subsequently was re-challenged without recurrence and continued on vestronidase alfa treatment.
Slovenian: Bolnik je pozneje ponovno prejemal vestronidazo alfa in nadaljeval zdravljenje brez ponovitve.
English: Genotoxicity studies and carcinogenicity studies have not been performed with vestronidase alfa.
Slovenian: Z vestronidazo alfa niso izvedli študij genotoksičnosti in kancerogenosti.
English: Sodium dihydrogen phosphate dihydrate Sodium chloride
Slovenian: natrijev dihidrogenfosfat dihidrat natrijev klorid histidin polisorbat 20 voda za injekcije
English: 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.
Slovenian: 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.
English: Patient Weight Range (kg)
Slovenian: Razpon telesne mase bolnika (kg)
English: It should be considered that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Slovenian: Upoštevati je treba, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
English: Name and address of the manufacturer(s) of the biological active substance(s)
Slovenian: Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine (učinkovin) Rentschler Biopharma SE
English: 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.
Slovenian: 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.
English: The recommended dose of vestronidase alfa is 4 mg/kg of body weight administered by intravenous infusion every two weeks.
Slovenian: Priporočeni odmerek vestronidaze alfa je 4 mg/kg telesne mase bolnika in se daje kot intravenska infuzija na vsaka dva tedna.
English: Pack size: 1 vial of 5 mL
Slovenian: Velikost pakiranja: 1 viala po 5 ml
English: 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.
Slovenian: - Huda alergijska reakcija (anafilaktoidna reakcija) - med simptomi hude alergijske reakcije so lahko zasoplost, piskanje v pljučih, težko dihanje ter oteklost obraza in jezika.
English: 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.
Slovenian: 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.
English: It is supplied in a clear glass vial with a rubber stopper and an aluminium seal with a plastic cap.
Slovenian: Na voljo je v viali iz brezbarvnega stekla z gumijastim zamaškom in aluminijastim tesnilom s plastično zaporko.
English: No human data are available on the effect of vestronidase alfa on fertility.
Slovenian: Podatki o učinku vestronidaze alfa na plodnost pri ljudeh niso na voljo.
English: 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.
Slovenian: 36 tednih zdravljenja ugotovili zmanjšanje volumna jeter (24 % in 53 %) in volumna vranice (28 % in 47 %).
English: There is no definitive correlation between the antibody titre and neutralizing antibody development.
Slovenian: Med titrom protiteles in razvojem nevtralizirajočih protiteles ni očitne korelacije.
English: Package leaflet: Information for the user Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje vestronidaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: What Mepsevii looks like and contents of the pack
Slovenian: Izgled zdravila Mepsevii in vsebina pakiranja
English: 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).
Slovenian: Od 30 do 60 minut pred začetkom infundiranja se priporoča premedikacija z nesedativnimi antihistaminiki z antipiretiki ali brez njih (glejte poglavje 4.2).
English: The Mepsevii concentrate solution for infusion should be colourless to slightly yellow.
Slovenian: Raztopina za infundiranje, pripravljena s koncentratom zdravila Mepsevii, mora biti brezbarvna do rahlo rumena.
English: Recommended infusion rate schedule by patient weight for administration of Mepsevii at recommended dose of 4 mg/kg Patient Weight Range (kg)
Slovenian: Priporočeni razpored infundiranja glede na telesno maso bolnika pri uporabi zdravila Mepsevii v priporočenem odmerku 4 mg/kg
English: Type I) with a rubber stopper with fluoro-resin coating, and an aluminium over seal with a plastic flip-off cap.
Slovenian: tip I) z gumijastim zamaškom, obloženim s fluorovo smolo, ter aluminijastim tesnilom s plastično zaporko.
English: Based on mechanism of action, rhGUS is not expected to be tumorigenic.
Slovenian: Na podlagi mehanizma delovanja ni pričakovati, da bo humana rekombinantna beta-glukuronidaza (rhGUS) tumorogena.
English: It should be considered by the treating physician that the administration of vestronidase alfa does not affect the irreversible complications (e.g. skeletal deformities).
Slovenian: Lečeči zdravnik mora upoštevati, da dajanje vestronidaze alfa ne vpliva na nepopravljive zaplete (npr. deformacije okostja).
English: The pharmacokinetics of vestronidase alfa are time independent with repeat dosing.
Slovenian: Pri ponavljajočem se odmerjanju je farmakokinetika vestronidaze alfa neodvisna od časa.
English: - The active substance is vestronidase alfa.
Slovenian: - Učinkovina je vestronidaza alfa.
English: 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).
Slovenian: 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).
English: 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.
Slovenian: 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]).
English: Do not heat, microwave or shake vials.
Slovenian: Vial ne segrevajte, ne izpostavljajte mikrovalovom in ne stresajte.
English: 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.
Slovenian: 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.
English: Vestronidase alfa is not expected to be eliminated through renal or faecal excretion.
Slovenian: Ni pričakovati, da se bo vestronidaza alfa izločala po ledvični ali fekalni poti.
English: 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.
Slovenian: 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.
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Slovenian: Izkušenj s prevelikim odmerjanjem vestronidaze alfa ni. Za obvladovanje neželenih učinkov glejte poglavji 4.4 in 4.8.
English: Mepsevii contains sodium
Slovenian: Zdravilo Mepsevii vsebuje natrij
English: Consider rapid sodium chloride 9 mg/mL (0.9%) solution for infusion for decreased blood pressure and oxygen for hypoxia.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: [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).
English: Total Mepsevii Volume (rounded) (mL)
Slovenian: Celotni volumen zdravila Mepsevii (zaokrožen) (ml)
English: Study UX003-CL201 (referred to as Study 201) was a single arm, open-label, dose exploration trial that enrolled three MPS VII patients, ranging in age from 5 years to 25 years.
Slovenian: Druge študije Študija UX003-CL201 (imenovana študija 201) je bila odprto preskušanje za raziskavo odmerjanja z eno skupino, ki je vključevala tri bolnike z MPS VII, stare od 5 let do 25 let.
English: Total Mepsevii Dose Range (mg)
Slovenian: Celotni razpon odmerkov zdravila Mepsevii (mg)
English: a. Volume (mL) of calculated dose = Total dose (mg) divided by the 2 mg/mL concentration
Slovenian: a. Volumen (ml) izračunanega odmerka = celotni odmerek (mg), deljen s koncentracijo
English: Each vial contains 17.8 mg sodium.
Slovenian: Pomožne snovi z znanim učinkom Ena viala vsebuje 17,8 mg natrija.
English: The assessment of adverse reactions was based on the exposure of 23 patients from 4 clinical trials, aged 5 months to 25 years, who received vestronidase alfa at doses up to 4 mg/kg once every two weeks for up to 132 weeks.
Slovenian: Ocena neželenih učinkov je temeljila na izpostavljenosti 23 bolnikov v 4 kliničnih preskušanjih, starih od 5 mesecev do 25 let, ki so do 132 tednov prejemali vestronidazo alfa v odmerkih do 4 mg/kg enkrat na dva tedna.
English: The infusion was stopped, the patient received anticonvulsants, antipyretics and antibiotics, and the febrile convulsion resolved.
Slovenian: Vročinski krči so ponehali po ustavitvi infundiranja ter dajanju antikonvulzivov, antipiretikov in antibiotikov.
English: Discuss with your doctor if the benefits of using Mepsevii are greater than the potential risk to your baby while breast-feeding.
Slovenian: Pogovorite se z zdravnikom, ali so koristi uporabe zdravila Mepsevii med dojenjem večje od možnih tveganj za vašega otroka.
English: Each vial of 5 mL concentrate contains 10 mg vestronidase alfa (10 mg/ 5 mL).
Slovenian: Ena viala s 5 ml koncentrata vsebuje 10 mg vestronidaze alfa (10 mg/5 ml).
English: Mepsevii 2 mg/mL sterile concentrate vestronidase alfa
Slovenian: Mepsevii 2 mg/ml, sterilen koncentrat vestronidaza alfa
English: Patients who were enrolled in Study 301 were eligible to roll over to Study UX003-CL202 (referred to as Study 202), an open-label extension trial in which patients received additional doses of vestronidase alfa at 4 mg/kg intravenously every other week for up to 144 weeks.
Slovenian: Bolniki, ki so sodelovali v študiji 301, so lahko prešli na odprto podaljšanje preskušanja UX003-CL202 (študija 202), v katerem so do 144 tednov vsak drugi teden prejemali dodatne intravenske odmerke vestronidaze alfa 4 mg/kg.
English: How Mepsevii works
Slovenian: Kako deluje zdravilo Mepsevii
English: Dilute the calculated dose 1:1 using equal volume of sodium chloride 9 mg/mL (0.9%) solution for injection for intravenous infusion.
Slovenian: Izračunani odmerek razredčite v razmerju 1 : 1 z enako količino 0,9-odstotne raztopine natrijevega klorida (9 mg/ml) za intravensko infuzijo.
English: It is not known whether vestronidase alfa is excreted in human milk, but systemic exposure via breast-milk is not expected.
Slovenian: Podatkov iz študij pri doječih ženskah ni. Ni znano, ali se vestronidaza alfa izloča v materino mleko, vendar se ne pričakuje, da bo prek materinega mleka prišlo do sistemske izpostavljenosti.
English: Your doctor may also give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Slovenian: Zdravnik vam bo morda dal (ali vam je že dal) tudi druga zdravila, denimo antihistaminik ali kortikosteroid za zdravljenje alergijske reakcije ali antipiretik za znižanje zvišane telesne temperature.
English: Slowly withdraw Mepsevii from the appropriate number of vials using caution to avoid excessive agitation and any air or frothing.
Slovenian: Počasi odvzemite zdravilo Mepsevii iz ustreznega števila vial ter pazite, da vial ne stresate preveč in da se vsebina ne peni.
English: Key Secondary Endpoint: Multi-Domain Clinical Responder Index (MDRI)
Slovenian: Ključni sekundarni opazovani dogodek je bil večdomenski indeks kliničnega odziva (MDRI), sestavljen iz šestih domen
English: The pharmacokinetics of vestronidase alfa were evaluated in a total of 19 MPS VII patients including 15 paediatric patients and 4 adults from 3 clinical trials.
Slovenian: Farmakokinetiko vestronidaze alfa so ocenili pri skupaj 19 bolnikih z MPS VII, vključno s
English: *Vestronidase alfa is a recombinant form of human beta-glucuronidase (rhGUS) and is produced in Chinese Hamster Ovary cell culture by recombinant DNA technology.
Slovenian: * Vestronidaza alfa je rekombinantna oblika humane beta-glukuronidaze (rhGUS).
English: Rentschler Biopharma SE Erwin-Rentschler-Strasse 21 88471 Laupheim Germany
Slovenian: Erwin-Rentschler-Strasse 21
English: Patients should be observed for a minimum of 60 minutes after completing the infusion of vestronidase alfa.
Slovenian: Po koncu infundiranja vestronidoze alfa je treba bolnike opazovati še najmanj 60 minut.
English: Other Investigations
Slovenian: DRUGI PODATKI
English: Your doctor may give (or have given) you other medicines to manage the allergic reaction such as an antihistamine or corticosteroid or an antipyretic, a medicine to reduce fever.
Slovenian: - Zdravnik vam bo morda dal (ali vam je že dal) še druga zdravila, denimo antihistaminik ali kortikosteroid za zdravljenje alergijske reakcije ali antipiretik za znižanje zvišane telesne temperature.
English: Mepsevii 2 mg/mL concentrate for solution for infusion.
Slovenian: Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje
English: Do not use if the solution is discoloured or if there is particulate matter in the solution.
Slovenian: Raztopine ne uporabljajte, če je drugačne barve ali če vsebuje tujke.
English: Minimal important differences (MIDs) were pre-specified for the six MDRI domains plus fatigue, which are: 6MWT (≥23 meters and ≥10% change from baseline), FVC (5% absolute change or 10% relative change from baseline in FVC%pred), shoulder flexion (20 degree change of both shoulder range of motion), visual acuity (3 lines (corrected, both eyes), BOT-2 fine motor (fine motor precision: change of 0.72, and manual dexterity: change of 1.47), BOT-2 gross motor (balance: 0.57, and running speed and agility: 0.59), and fatigue (10 points of total score).
Slovenian: (sprememba območja gibanja obeh ramen za 20 stopinj), ostrina vida (3 linije (korigirano za obe očesi)), fine motorične spretnosti BOT-2 (natančnost fine motorike: sprememba za 0,72; ročna spretnost: sprememba za 1,47), grobe motorične spretnosti BOT 2 (ravnotežje: 0,57; hitrost in gibljivost pri teku: 0,59) ter utrujenost (celotni rezultat 10 točk).
English: The primary endpoint was the percent reduction in urinary GAG excretion (Dermatan Sulfate, DS) before and after 24 weeks of treatment with vestronidase alfa.
Slovenian: Primarni opazovani dogodek je bil odstotek zmanjšanja izločanja GAG z urinom (dermatansulfat, DS)
English: This event was assessed as possibly related to vestronidase alfa due to the temporal association with the infusion.
Slovenian: Zaradi časovne povezave z infuzijo je ta dogodek ocenjen kot morebiti povezan z vestronidazo alfa.
English: Serious hypersensitivity reactions, including anaphylaxis, have been reported with vestronidase alfa; therefore, appropriate medical support should be readily available when vestronidase alfa is administered.
Slovenian: Preobčutljivostne reakcije, vključno z anafilaksijo Pri uporabi vestronidaze alfa so poročali o resnih preobčutljivostnih reakcijah, vključno z anafilaksijo;
English: MedDRA Preferred Term
Slovenian: Prednostni izraz (MedDRA)
English: - You may have side effects while you are being given Mepsevii or for up to a day afterwards.
Slovenian: - Med prejemanjem zdravila Mepsevii ali v enem dnevu po njem se lahko pri vas pojavijo neželeni učinki.
English: After 24 weeks of treatment with vestronidase alfa, a rapid and sustained, highly significant reduction in uGAG (DS) excretion was achieved with a LS mean (±SE) percentage change of -64.82% (±2.468%) (p<0.0001).
Slovenian: Po 24 tednih zdravljenja z vestronidazo alfa je bilo doseženo hitro, trajno in zelo pomembno zmanjšanje izločanja uGAG (DS) z odstotno spremembo v mediani najmanjših kvadratov
English: Mepsevii 2 mg/mL concentrate for solution for infusion vestronidase alfa
Slovenian: Mepsevii 2 mg/ml koncentrat za raztopino za infundiranje vestronidaza alfa
English: Urticaria Rash Pruritus
Slovenian: - koprivnica (urtikarija)
English: Total Number of Mepsevii Vials
Slovenian: Celotno število vial zdravila Mepsevii
English: After repeated dosing of 4 mg/kg every other week in MPS VII patients, the mean ± standard deviation of the total clearance (CL) was 0.079 ± 0.045 L/h/kg (range: 0.038 to 0.20 L/h/kg); the mean ± standard deviation of the elimination half-life (t1/2) was 2.6 ± 0.6 hours (range: 0.9 to 3.6 hours).
Slovenian: Po ponavljajočem se odmerjanju 4 mg/kg vsak drugi teden pri bolnikih z MPS VII je bil srednji ± standardni odklon v skupnem očistku (CL) 0,079 ± 0,045 l/h/kg (razpon: od 0,038 do 0,20 l/h/kg);
English: Table 1 Adverse reactions reported in patients treated with Mepsevii MedDRA System Organ Class
Slovenian: Preglednica 1 Neželeni učinki, o katerih so poročali pri bolnikih, zdravljenih z zdravilom
English: Common *Refer to description of selected adverse reactions for details on the febrile convulsion reported in 1 of 23 trial patients.
Slovenian: * Glejte opis izbranih neželenih učinkov za podrobnosti o vročinskih krčih, o katerih so poročali pri
English: Description of selected adverse reactions
Slovenian: Opis izbranih neželenih učinkov Vročinski krči
English: IV use after dilution
Slovenian: Za IV uporabo po razredčitvi.