FrancophonIA/ELRC3.0 huggingface dataset:
English: Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies.
Croatian: Lamzede sadrži djelatnu tvar velmanazu alfa, koja pripada skupini lijekova pod nazivom enzimska nadomjesna terapija.
English: Lamzede is administered through intravenous infusion.
Croatian: Lamzede se primjenjuje putem intravenske infuzije.
English: Consequently hepatic and renal impairment are not expected to affect the pharmacokinetic of velmanase alfa.
Croatian: Posljedično tome, ne očekuje se da će oštećenje funkcije jetre i bubrega utjecati na farmakokinetiku velmanaze alfa.
English: There are no clinical data on the effects of velmanase alfa on fertility.
Croatian: Nema kliničkih podataka o učincima velmanaze alfa na plodnost.
English: To further evaluate the relationship, in instances of development of severe IRRs or lack or loss of treatment effect, patients should be tested for the presence of anti-velmanase alfa antibodies.
Croatian: Radi daljnje procjene tog odnosa, u slučajevima razvoja teških reakcija povezanih s infuzijom ili izostanka ili gubitka terapijskog učinka, bolesnike je potrebno testirati na prisutnost protutijela na velmanazu alfa.
English: Lamzede should be reconstituted and administrated by a healthcare professional.
Croatian: Lamzede mora rekonstituirati i primijeniti zdravstveni radnik.
English: A post-hoc multiparametric responders analysis supports the benefit of longer treatment with velmanase alfa in 87.9% of responders in at least 2 domains at last observation (table 4).
Croatian: Post-hoc višeparametarska analiza bolesnika s terapijskim odgovorom govori u prilog koristi duljeg liječenja velmanazom alfa u 87,9% bolesnika s terapijskim odgovorom u najmanje 2 domene prilikom zadnjeg opažanja (tablica 4).
English: Lamzede is a white to off-white powder for solution for infusion, supplied in a glass vial.
Croatian: Lamzede je bijeli do gotovo bijeli prašak za otopinu za infuziju, koji se isporučuje u staklenoj bočici.
English: The maximum dose of velmanase alfa in clinical studies was a single administration of 100 units/kg (approximately corresponding to 3.2 mg/kg).
Croatian: Maksimalna doza velmanaze alfa u kliničkim ispitivanjima iznosila je jednokratno primijenjenih 100 jedinica/kg (što približno odgovara 3,2 mg/kg).
English: Antibodies may play a role in treatment-related reactions observed with the use of velmanase alfa.
Croatian: Protutijela mogu igrati ulogu u reakcijama povezanima s liječenjem opaženima uz primjenu velmanaze alfa.
English: 3MSCT (steps/min)
Croatian: 3MSCT (stepenica/minuti)
English: A total of 33 patients (20 males and 13 females, ranging in age from 6 to 35 years) were exposed to velmanase alfa in five clinical studies.
Croatian: Ukupno su 33 bolesnika (20 muških i 13 ženskih, u dobi od 6 do 35 godina) bila izložena velmanazi alfa u pet kliničkih ispitivanja.
English: This means that due to the rarity of the disease, it has not been possible to obtain complete information on this medicinal product.
Croatian: To znači da s obzirom na malu učestalost bolesti nije bilo moguće doći do potpunih informacija o ovom lijeku.
English: - The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine.
Croatian: - Drugi sastojci su: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, manitol i glicin.
English: There is no experience with overdose of velmanase alfa.
Croatian: Nema iskustva s predoziranjem velmanazom alfa.
English: Forcefully ejecting the water for injections from the syringe onto the powder should be avoided to minimise foaming.
Croatian: Potrebno je izbjegavati snažno ubrizgavanje vode za injekcije iz štrcaljke u prašak kako bi se smanjilo stvaranje pjene.
English: If not used immediately, the reconstituted solution may be stored up to 24 hours at 2°C to 8°C.
Croatian: Ako se ne primijeni odmah, rekonstituiranu otopinu može se čuvati do 24 sata na temperaturi od 2°C do 8°C.
English: In case the patient's condition deteriorates during ERT, cessation of treatment should be considered.
Croatian: U slučaju pogoršanja stanja bolesnika tijekom enzimske nadomjesne terapije, potrebno je razmotriti prestanak liječenja.
English: Paediatric Study rhLAMAN-08.
Croatian: Pedijatrijsko ispitivanje rhLAMAN-08.
English: Use of velmanase alfa in the age group 6 to 17 years is supported by evidence from clinical studies in paediatric (19 out of 33 patients) and adult patients.
Croatian: Primjena velmanaze alfa u dobnoj skupini od 6 do 17 godina potkrijepljena je dokazima iz kliničkih ispitivanja u pedijatrijskih (19 od 33 bolesnika) i odraslih bolesnika.
English: Functional Domain Response Combined
Croatian: Odgovor u funkcionalnoj domeni
English: The long-term efficacy and safety of velmanase alfa was investigated in the uncontrolled, open label, phase 3 clinical study rhLAMAN-10 in 33 subjects (19 paediatrics and 14 adults, from 6 to 35 years at treatment initiation) who previously participated in velmanase alfa studies.
Croatian: Dugoročna djelotvornost i sigurnost velmanaze alfa ispitana je mjera u ispitivanju rhLAMAN-10, nekontroliranom, otvorenom kliničkom ispitivanju faze 3, u 33 ispitanika (19 pedijatrijskih i 14 odraslih, u dobi od 6 do 35 godina na početku liječenja) koji su prethodno sudjelovali u ispitivanjima velmanaze alfa.
English: Store and transport refrigerated.
Croatian: POSEBNE MJERE ČUVANJA Čuvati i prevoziti na hladnom.
English: Hyperhidrosis(1)
Croatian: hiperhidroza(1)
English: For the management of adverse reactions, see sections 4.4 and 4.8.
Croatian: Za zbrinjavanje nuspojava, vidjeti dijelove 4.4 i 4.8.
English: *Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant DNA technology.
Croatian: *Velmanaza alfa proizvodi se u stanicama jajnika kineskog hrčka pomoću tehnologije rekombinantne
English: Overall effects of treatment were evaluated in the domains of pharmacodynamics (reduction of serum oligosaccharides), functional (three-minute stair climbing test (3MSCT), six-minute walking test (6MWT), and forced vital capacity (FVC) % predicted) and quality of life (childhood health assessment questionnaire (CHAQ) disability index (DI) and CHAQ VAS pain (visual analogue scale)).
Croatian: Ukupni učinci liječenja bili su procijenjeni u domenama farmakodinamike (sniženje oligosaharida u serumu), funkcionalnosti (3-minutni test uspinjanja stepenicama (engl. three-minute stair climbing test, 3MSCT), šestominutni test hodanja (engl. six-minute walking test, 6MWT) i postotak predviđenog forsiranog vitalnog kapaciteta (FVC)) i kvalitete života (indeks onesposobljenosti (engl. disability index, DI) i vizualno-analogna ljestvica za bol (engl. visual analogue scale, VAS) na Upitniku za procjenu zdravlja djece (engl. childhood health assessment questionnaire, CHAQ)).
English: No dose adjustment is necessary for patients with renal or hepatic impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: Lamzede requires reconstitution and is intended for intravenous infusion only.
Croatian: Lamzede se mora rekonstituirati i namijenjen je samo za primjenu intravenskom infuzijom.
English: Each vial is reconstituted by slowly injecting 5 mL of water for injections to the inside of the wall of each vial.
Croatian: Sadržaj svake bočice rekonstituira se polaganim ubrizgavanjem 5 ml vode za injekcije uz unutarnju stijenku svake bočice.
English: Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis treated with velmanase alfa
Croatian: Tablica 1: Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika s alfa-manozidozom liječenih velmanazom alfa
English: The most common adverse reactions observed were weight increase (18%), IRRs (9%), diarrhoea (12%), headache (9%), arthralgia (9%), increased appetite (6%) and pain in extremity (6%).
Croatian: (9%), proljev (12%), glavobolja (9%), artralgija (9%), pojačan apetit (6%) i bol u ekstremitetu (6%).
English: Weight increase
Croatian: - povećanje tjelesne težine
English: A volume of 10 mL sodium chloride solution should be administered through the infusion system to infuse the remaining fraction of Lamzede in the line to the patient.
Croatian: Volumen od 10 ml otopine natrijevog klorida treba primijeniti kroz infuzijski sustav kako bi se bolesniku infundirao dio lijeka Lamzede koji je preostao u infuzijskom setu.
English: Aseptic technique is to be used during preparation.
Croatian: Tijekom pripreme se mora primijeniti aseptični postupak.
English: After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
Croatian: Nakon rekonstitucije, jedan ml otopine sadrži 2 mg velmanaze alfa (10 mg / 5 ml).
English: Patient's weight (44 kg) × dose (1 mg/kg) = Patient dose (44 mg) 44 mg divided by 10 mg/vial = 4.4 vials, therefore, 5 vials should be reconstituted.
Croatian: Tjelesna težina bolesnika (44 kg) × doza (1 mg/kg) = doza za bolesnika (44 mg) 44 mg podijeljeno s 10 mg/bočica = 4,4 bočice; stoga je potrebno rekonstituirati sadržaj
English: Velmanase alfa is a protein and is predicted to be metabolically degraded into amino acids.
Croatian: Velmanaza alfa je protein te se predviđa da se metabolički razgrađuje na aminokiseline.
English: d) The reconstituted solution is to be slowly withdrawn from each vial with caution to avoid foaming in the syringe.
Croatian: d) Rekonstituiranu otopinu treba polako i oprezno izvući iz svake bočice kako bi se izbjeglo stvaranje pjene u štrcaljki.
English: At steady-state after weekly infusion administration of 1 mg/kg of velmanase alfa, the mean maximum plasma concentration was about 8 µg/mL and was reached at 1.8 hours after the start of administration corresponding to the mean infusion duration time.
Croatian: U stanju dinamičke ravnoteže nakon primjene infuzije velmanaze alfa u dozi od 1 mg/kg svakog tjedna, srednja vrijednost najveće koncentracije u plazmi bila je oko 8 µg/ml i postignuta je 1,8 sati nakon početka primjene, što odgovara srednjoj vrijednosti trajanja infuzije.
English: The clearance of velmanase alfa from plasma (mean 6.7 mL/h/kg) is consistent with a rapid cellular uptake of velmanase alfa via mannose receptors.
Croatian: Klirens velmanaze alfa iz plazme (srednja vrijednost 6,7 ml/sat/kg) sukladan je brzom preuzimanju velmanaze alfa u stanice preko manoznih receptora.
English: IRRs include hypersensitivity in 3 patients and anaphylactoid reaction in 1 patient.
Croatian: Reakcije povezane s infuzijom uključivale su preosjetljivost u 3 bolesnika i anafilaktoidnu reakciju u 1 bolesnika.
English: Final Study report:
Croatian: Završno izvješće ispitivanja: studeni 2020.
English: Lamzede can be used during breastfeeding.
Croatian: Lamzede se može primjenjivati tijekom dojenja.
English: Immunogenicity
Croatian: Imunogeničnost
English: Administration of velmanase alfa may result in an IRR, including anaphylactoid reaction (see section 4.8).
Croatian: Kao posljedica primjene velmanaze alfa može nastati reakcija povezana s infuzijom, uključujući anafilaktoidnu reakciju (vidjeti dio 4.8).
English: b) The powder should be reconstituted in the vial by a slow drop-wise addition of the water for injections down the inside of the vial and not directly onto the lyophilised powder.
Croatian: b) Prašak se rekonstituira u bočici tako da se voda za injekcije sporo dodaje, kap po kap, niz unutrašnju stijenku bočice, a ne izravno u liofilizirani prašak.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Mannitol
Croatian: natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat manitol glicin
English: In the phase 3 pivotal multi-centre, double-blind, randomised, placebo-controlled, parallel group study rhLAMAN-05, the efficacy and safety of repeated administrations of velmanase alfa over 52 weeks at a dose of 1 mg/kg given weekly as intravenous infusion were investigated.
Croatian: U ispitivanju rhLAMAN-05, pivotalnom, multicetričnom, dvostruko slijepom, randomiziranom, placebom kontroliranom ispitivanju faze 3 na usporednim skupinama, tijekom 52 tjedna ispitivane su djelotvornost i sigurnost ponavljane primjene velmanaze alfa u dozi od 1 mg/kg koja se davala jedanput tjedno kao intravenska infuzija.
English: The patient should be observed for IRRs for at least one hour after the infusion according to clinical conditions and the physician's judgment.
Croatian: Bolesnika je potrebno promatrati zbog reakcija povezanih s infuzijom najmanje jedan sat nakon infuzije, sukladno kliničkom stanju bolesnika i procjeni liječnika.
English: As with other enzyme replacement therapies, velmanase alfa does not cross the blood-brain-barrier.
Croatian: Velmanaza alfa, kao ni druge enzimske nadomjesne terapije, ne prelazi krvno-moždanu barijeru.
English: - The active substance is velmanase alfa.
Croatian: - Djelatna tvar je velmanaza alfa.
English: Each vial is for single use only.
Croatian: Jedna bočica je samo za jednokratnu primjenu.
English: 10 mg velmanase alfa
Croatian: 10 mg velmanaze alfa
English: If you experience any side effect like these, please tell your doctor immediately.
Croatian: Ako imate bilo koju nuspojavu poput ovih, odmah obavijestite svog liječnika.
English: Patients
Croatian: Bolesnici
English: This medicine must not be used if the reconstituted solution contains opaque particles or is discoloured.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da rekonstituirana otopina sadrži neprozirne čestice ili je promijenila boju.
English: Based on this criteria mild to moderate patients, presenting heterogeneous severity with ability to perform endurance tests, large variability of clinical manifestations and age of onset were enrolled.
Croatian: Na temelju ovih kriterija, uključeni su bili bolesnici s blagim do umjerenim oblikom bolesti, koji su pokazivali heterogenu težinu bolesti, ali su bili sposobni obaviti testove izdržljivosti i u kojih su se kliničke manifestacije i dob u kojoj je bolest nastupila jako razlikovali.
English: SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: In case symptoms such as angioedema (tongue or throat swelling), upper airway obstruction or hypotension occur during or immediately after infusion, anaphylaxis or an anaphylactoid reaction should be suspected.
Croatian: U slučaju da se tijekom ili neposredno nakon infuzije pojave simptomi kao što su angioedem (oticanje jezika ili grla), opstrukcija gornjih dišnih puteva ili hipotenzija, potrebno je posumnjati na anafilaksiju ili anafilaktoidnu reakciju.
English: Responders Rates rhLAMAN-05 study n=25
Croatian: Stope odgovora Ispitivanje rhLAMAN-05 n=25
English: The typical manifestations of the disease include distinctive facial features, mental retardation, difficulty in controlling movements, difficulties in hearing and speaking, frequent infections, skeletal problems, muscle pain and weakness.
Croatian: Obično se bolest očituje prepoznatljivim crtama lica, mentalnom retardacijom, otežanom kontrolom pokreta, poteškoćama sa sluhom i govorom, učestalim infekcijama, problemima s kostima, boli u mišićima i slabošću.
English: 10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap.
Croatian: Bočica od 10 ml (staklo tipa I) s čepom od bromobutilne gume, aluminijskim prstenom i polipropilenskim zatvaračem.
English: Alpha-mannosidosis disease is a rare genetic disorder caused by a lack of an enzyme named alpha-mannosidase, which is needed to break down certain sugar compounds (called ‘mannose-rich oligosaccharides') in the body.
Croatian: Bolest alfa-manozidoza rijetki je genetski poremećaj uzrokovan nedostatkom enzima koji se naziva alfa-manozidaza, a koji je potreban za razgradnju određenih vrsta šećera (koji se nazivaju
English: Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
Croatian: Enzimska nadomjesna terapija za liječenje manifestacija bolesti koje nisu neurološke naravi u bolesnika s blagom do umjerenom alfa-manozidozom.
English: Velmanase alfa is intended to supplement or replace natural alpha-mannosidase, an enzyme that catalyses the sequential degradation of hybrid and complex high-mannose oligosaccharides in the lysosome, reducing the amount of accumulated mannose-rich oligosaccharides.
Croatian: Velmanaza alfa namijenjena je nadomještanju ili zamjeni prirodne alfa-manozidaze, enzima koji katalizira postupnu razgradnju hibridnih i kompleksnih visokomanoznih oligosaharida u lizosomu,
English: Overall, 58% of patients (19 out of 33) with alpha-mannosidosis receiving velmanase alfa in clinical studies were aged 6 to 17 years at the start of the study.
Croatian: Ukupno je 58% bolesnika (19 od 33) s alfa-manozidozom koji su u kliničkim ispitivanjima primali velmanazu alfa bilo u dobi od 6 do
English: Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05)
Croatian: Tablica 2: Rezultati placebom kontroliranog kliničkog ispitivanja rhLAMAN-05 (izvorni podaci: rhLAMAN-05)
English: In the clinical studies, one patient experienced acute renal failure considered possibly related to the study treatment.
Croatian: U kliničkim je ispitivanjima u jednog bolesnika nastupilo akutno zatajenje bubrega čija se povezanost s ispitivanim liječenjem smatrala mogućom.
English: The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary.
Croatian: Europska agencija za lijekove svake će godine procjenjivati sve nove informacije koje postanu dostupne te će se tekst sažetka opisa svojstava lijeka ažurirati prema potrebi.
English: The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase.
Croatian: Slijed aminokiselina u tom monomernom proteinu identičan je enzimu alfa-manozidazi, prirodno prisutnom u ljudskom organizmu.
English: The vials should reach ambient temperature (between 15°C and 25°C) prior to reconstitution.
Croatian: Prije rekonstitucije bočice moraju postići sobnu temperaturu (između 15°C
English: It is unknown whether velmanase alfa or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuju li se velmanaza alfa ili njezini metaboliti u majčino mlijeko.
English: Lamzede contains sodium
Croatian: Lamzede sadrži natrij
English: (1) Preferred terms considered as IRR as described in the section below (2) Selected adverse reaction as described in the section below
Croatian: (1) Preporučeni pojmovi koji su se smatrali reakcijama povezanima s infuzijom kako je opisano u odlomku niže.
English: It is not known whether velmanase alfa passes into breast milk.
Croatian: Nije poznato prelazi li velmanaza alfa u majčino mlijeko.
English: In the clinical studies at any time under treatment, 8 patients out of 33 (24%) developed IgG-class antibodies to velmanase alfa.
Croatian: U kliničkim je ispitivanjima 8 bolesnika od njih 33 (24%), u različito vrijeme tijekom liječenja, razvilo protutijela klase IgG na velmanazu alfa.
English: The metabolic pathway of velmanase alfa is predicted to be similar to other natural occurring proteins that degrade into small peptides and finally into amino acids.
Croatian: Predviđa se da je metabolički put velmanaze alfa sličan putu drugih proteina koji su prirodno prisutni u organizmu, a koji se razgrađuju na male peptide te, naposljetku, na aminokiseline.
English: Powder for solution for infusion.
Croatian: Prašak za otopinu za infuziju.
English: The solution should be clear and not used if opaque particles are observed or if the solution is discoloured.
Croatian: Otopina mora biti bistra i ne smije se primijeniti ako se opaze neprozirne čestice ili je otopina promijenila boju.
English: Velmanase alfa, the active substance of Lamzede, is a recombinant form of human alpha-mannosidase.
Croatian: Mehanizam djelovanja Velmanaza alfa, djelatna tvar u lijeku Lamzede, rekombinantni je oblik ljudske alfa-manozidaze.
English: An integrated database was created by pooling cumulative databases from all studies with velmanase alfa.
Croatian: Objedinjavanjem kumulativnih baza podataka iz svih ispitivanja velmanaze alfa stvorena je integrirana baza podataka.
English: Once it has been made up, the medicine will be given by infusion pump (drip) into a vein over a period of at least 50 minutes under your doctor's supervision.
Croatian: Kad bude pripremljen, lijek će se dati infuzijskom pumpom (dripom) u venu u trajanju od najmanje
English: Lamzede 10 mg powder for solution for infusion
Croatian: Lamzede 10 mg prašak za otopinu za infuziju
English: All patients who experienced IRRs recovered.
Croatian: Svi su se bolesnici koji su imali reakciju povezanu s infuzijom oporavili.
English: <18 years(2) ≥18 years(2) 6MWT (metres) Overall(1)
Croatian: < 18 godina (2) ≥ 18 godina(2) 6MWT (metara) Ukupno(1)
English: For intravenous infusion use only.
Croatian: Samo za intravensku infuziju.
English: Patients were not routinely pre-medicated prior to infusion of velmanase alfa during clinical studies.
Croatian: Tijekom kliničkih ispitivanja, bolesnici nisu rutinski primali premedikaciju prije infuzije velmanaze alfa.
English: Approximately 30 minutes prior to reconstitution, the required number of vials should be removed from the refrigerator.
Croatian: Potreban broj bočica mora se izvaditi iz hladnjaka približno 30 minuta prije rekonstitucije.
English: Reconstituted solution for infusion
Croatian: Rekonstituirana otopina za infuziju
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
English: Feeling hot(1)
Croatian: osjećaj vrućine(1)
English: Table 3: Change of clinical endpoints from baseline to the last observation in rhLAMAN-10 study (source data: rhLAMAN-10)
Croatian: Tablica 3: Promjena kliničkih mjera ishoda od početnih vrijednosti do zadnjeg opažanja u ispitivanju rhLAMAN-10 (izvorni podaci: rhLAMAN-10) Parametar
English: Pharmacodynamic Domain Response
Croatian: Odgovor u farmakodinamičkoj domeni Oligosaharidi
English: Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10)
Croatian: Tablica 4: Višeparametarska analiza bolesnika s terapijskim odgovorom: MCID(1) stopa odgovora prema mjerama ishoda i domenama (izvor podataka: rhLAMAN-05; rhLAMAN-10)
English: A 24 month multi-center, open label phase II trial investigating the safety and efficacy of repeated velmanase alfa (recombinant human alpha-mannosidase) treatment in paediatric patients <6 years of age with alpha-mannosidosis.
Croatian: Otvoreno, multicentrično ispitivanje faze II u trajanju od 24 mjeseca kojim se ispituje sigurnost i djelotvornost višestruke primjene velmanaze alfa (rekombinantne ljudske alfa-manozidaze) u pedijatrijskih bolesnika s alfa-manozidozom mlađih od 6 godina.
English: (1) For overall: adjusted mean change and adjusted mean difference estimated by ANCOVA model are presented (2) By age: unadjusted mean and SD are presented.
Croatian: (1) Za ukupno: prikazane su promjena prilagođene srednje vrijednosti i razlika prilagođene srednje vrijednosti procijenjene modelom ANCOVA.
English: e) The reconstituted solution should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 μm filter.
Croatian: e) Rekonstituiranu otopinu treba primijeniti pomoću kompleta za infuziju opremljenog pumpom i ugrađenim filterom veličine pora od 0,22 μm i niske sposobnosti vezanja proteina.
English: Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease.
Croatian: Svrha velmanaze alfa je nadomještanje nedostatka tog enzima u bolesnika s alfa-manozidozom.