natgillin/translations-raw huggingface dataset:
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. 
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.
Store and transport refrigerated. 
POSEBNE MJERE ČUVANJA Čuvati i prevoziti na hladnom.
Hyperhidrosis(1) 
hiperhidroza(1)
For the management of adverse reactions, see sections 4.4 and 4.8. 
Za zbrinjavanje nuspojava, vidjeti dijelove 4.4 i 4.8.
*Velmanase alfa is produced in mammalian Chinese Hamster Ovary (CHO) cells using recombinant DNA technology. 
*Velmanaza alfa proizvodi se u stanicama jajnika kineskog hrčka pomoću tehnologije rekombinantne
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)). 
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)).
No dose adjustment is necessary for patients with renal or hepatic impairment. 
Nije potrebna prilagodba doze u bolesnika s oštećenjem funkcije bubrega ili jetre.
Lamzede requires reconstitution and is intended for intravenous infusion only. 
Lamzede se mora rekonstituirati i namijenjen je samo za primjenu intravenskom infuzijom.
Each vial is reconstituted by slowly injecting 5 mL of water for injections to the inside of the wall of each vial. 
Sadržaj svake bočice rekonstituira se polaganim ubrizgavanjem 5 ml vode za injekcije uz unutarnju stijenku svake bočice.
Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis treated with velmanase alfa 
Tablica 1: Nuspojave zabilježene u kliničkim ispitivanjima u bolesnika s alfa-manozidozom liječenih velmanazom alfa
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%). 
(9%), proljev (12%), glavobolja (9%), artralgija (9%), pojačan apetit (6%) i bol u ekstremitetu (6%).
Weight increase 
- povećanje tjelesne težine
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. 
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.
Aseptic technique is to be used during preparation. 
Tijekom pripreme se mora primijeniti aseptični postupak.
After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL). 
Nakon rekonstitucije, jedan ml otopine sadrži 2 mg velmanaze alfa (10 mg / 5 ml).
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. 
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
Velmanase alfa is a protein and is predicted to be metabolically degraded into amino acids. 
Velmanaza alfa je protein te se predviđa da se metabolički razgrađuje na aminokiseline.
d) The reconstituted solution is to be slowly withdrawn from each vial with caution to avoid foaming in the syringe. 
d) Rekonstituiranu otopinu treba polako i oprezno izvući iz svake bočice kako bi se izbjeglo stvaranje pjene u štrcaljki.
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. 
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.
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. 
Klirens velmanaze alfa iz plazme (srednja vrijednost 6,7 ml/sat/kg) sukladan je brzom preuzimanju velmanaze alfa u stanice preko manoznih receptora.
IRRs include hypersensitivity in 3 patients and anaphylactoid reaction in 1 patient. 
Reakcije povezane s infuzijom uključivale su preosjetljivost u 3 bolesnika i anafilaktoidnu reakciju u 1 bolesnika.
Final Study report: 
Završno izvješće ispitivanja: studeni 2020.
Lamzede can be used during breastfeeding. 
Lamzede se može primjenjivati tijekom dojenja.
Immunogenicity 
Imunogeničnost
Administration of velmanase alfa may result in an IRR, including anaphylactoid reaction (see section 4.8). 
Kao posljedica primjene velmanaze alfa može nastati reakcija povezana s infuzijom, uključujući anafilaktoidnu reakciju (vidjeti dio 4.8).
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. 
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.
Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Mannitol 
natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat manitol glicin
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. 
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.
The patient should be observed for IRRs for at least one hour after the infusion according to clinical conditions and the physician's judgment. 
Bolesnika je potrebno promatrati zbog reakcija povezanih s infuzijom najmanje jedan sat nakon infuzije, sukladno kliničkom stanju bolesnika i procjeni liječnika.
As with other enzyme replacement therapies, velmanase alfa does not cross the blood-brain-barrier. 
Velmanaza alfa, kao ni druge enzimske nadomjesne terapije, ne prelazi krvno-moždanu barijeru.
- The active substance is velmanase alfa. 
- Djelatna tvar je velmanaza alfa.
Each vial is for single use only. 
Jedna bočica je samo za jednokratnu primjenu.
10 mg velmanase alfa 
10 mg velmanaze alfa
If you experience any side effect like these, please tell your doctor immediately. 
Ako imate bilo koju nuspojavu poput ovih, odmah obavijestite svog liječnika.
Patients 
Bolesnici
This medicine must not be used if the reconstituted solution contains opaque particles or is discoloured. 
Ovaj lijek se ne smije upotrijebiti ako primijetite da rekonstituirana otopina sadrži neprozirne čestice ili je promijenila boju.
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. 
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.
SPECIFIC OBLIGATION TO COMPLETE POSTAUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES 
POSEBNE OBVEZE ZA ISPUNJAVANJE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
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. 
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.
Responders Rates rhLAMAN-05 study n=25 
Stope odgovora Ispitivanje rhLAMAN-05 n=25
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. 
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.
10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap. 
Bočica od 10 ml (staklo tipa I) s čepom od bromobutilne gume, aluminijskim prstenom i polipropilenskim zatvaračem.
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. 
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
Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis. 
Enzimska nadomjesna terapija za liječenje manifestacija bolesti koje nisu neurološke naravi u bolesnika s blagom do umjerenom alfa-manozidozom.
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. 
Velmanaza alfa namijenjena je nadomještanju ili zamjeni prirodne alfa-manozidaze, enzima koji katalizira postupnu razgradnju hibridnih i kompleksnih visokomanoznih oligosaharida u lizosomu,
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. 
Ukupno je 58% bolesnika (19 od 33) s alfa-manozidozom koji su u kliničkim ispitivanjima primali velmanazu alfa bilo u dobi od 6 do
Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05) 
Tablica 2: Rezultati placebom kontroliranog kliničkog ispitivanja rhLAMAN-05 (izvorni podaci: rhLAMAN-05)
In the clinical studies, one patient experienced acute renal failure considered possibly related to the study treatment. 
U kliničkim je ispitivanjima u jednog bolesnika nastupilo akutno zatajenje bubrega čija se povezanost s ispitivanim liječenjem smatrala mogućom.
The European Medicines Agency will review any new information which may become available every year and this SmPC will be updated as necessary. 
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.
The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase. 
Slijed aminokiselina u tom monomernom proteinu identičan je enzimu alfa-manozidazi, prirodno prisutnom u ljudskom organizmu.
The vials should reach ambient temperature (between 15°C and 25°C) prior to reconstitution. 
Prije rekonstitucije bočice moraju postići sobnu temperaturu (između 15°C
It is unknown whether velmanase alfa or its metabolites are excreted in human milk. 
Nije poznato izlučuju li se velmanaza alfa ili njezini metaboliti u majčino mlijeko.
Lamzede contains sodium 
Lamzede sadrži natrij
(1) Preferred terms considered as IRR as described in the section below (2) Selected adverse reaction as described in the section below 
(1) Preporučeni pojmovi koji su se smatrali reakcijama povezanima s infuzijom kako je opisano u odlomku niže.
It is not known whether velmanase alfa passes into breast milk. 
Nije poznato prelazi li velmanaza alfa u majčino mlijeko.
In the clinical studies at any time under treatment, 8 patients out of 33 (24%) developed IgG-class antibodies to velmanase alfa. 
U kliničkim je ispitivanjima 8 bolesnika od njih 33 (24%), u različito vrijeme tijekom liječenja, razvilo protutijela klase IgG na velmanazu alfa.
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. 
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.
Powder for solution for infusion. 
Prašak za otopinu za infuziju.
The solution should be clear and not used if opaque particles are observed or if the solution is discoloured. 
Otopina mora biti bistra i ne smije se primijeniti ako se opaze neprozirne čestice ili je otopina promijenila boju.
Velmanase alfa, the active substance of Lamzede, is a recombinant form of human alpha-mannosidase. 
Mehanizam djelovanja Velmanaza alfa, djelatna tvar u lijeku Lamzede, rekombinantni je oblik ljudske alfa-manozidaze.
An integrated database was created by pooling cumulative databases from all studies with velmanase alfa. 
Objedinjavanjem kumulativnih baza podataka iz svih ispitivanja velmanaze alfa stvorena je integrirana baza podataka.
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. 
Kad bude pripremljen, lijek će se dati infuzijskom pumpom (dripom) u venu u trajanju od najmanje
Lamzede 10 mg powder for solution for infusion 
Lamzede 10 mg prašak za otopinu za infuziju
All patients who experienced IRRs recovered. 
Svi su se bolesnici koji su imali reakciju povezanu s infuzijom oporavili.
<18 years(2) ≥18 years(2) 6MWT (metres) Overall(1) 
< 18 godina (2) ≥ 18 godina(2) 6MWT (metara) Ukupno(1)
For intravenous infusion use only. 
Samo za intravensku infuziju.
Patients were not routinely pre-medicated prior to infusion of velmanase alfa during clinical studies. 
Tijekom kliničkih ispitivanja, bolesnici nisu rutinski primali premedikaciju prije infuzije velmanaze alfa.
Approximately 30 minutes prior to reconstitution, the required number of vials should be removed from the refrigerator. 
Potreban broj bočica mora se izvaditi iz hladnjaka približno 30 minuta prije rekonstitucije.
Reconstituted solution for infusion 
Rekonstituirana otopina za infuziju
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
PROIZVOĐAČ BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE
Feeling hot(1) 
osjećaj vrućine(1)
Table 3: Change of clinical endpoints from baseline to the last observation in rhLAMAN-10 study (source data: rhLAMAN-10) 
Tablica 3: Promjena kliničkih mjera ishoda od početnih vrijednosti do zadnjeg opažanja u ispitivanju rhLAMAN-10 (izvorni podaci: rhLAMAN-10) Parametar
Pharmacodynamic Domain Response 
Odgovor u farmakodinamičkoj domeni Oligosaharidi
Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10) 
Tablica 4: Višeparametarska analiza bolesnika s terapijskim odgovorom: MCID(1) stopa odgovora prema mjerama ishoda i domenama (izvor podataka: rhLAMAN-05; rhLAMAN-10)
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. 
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.
(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. 
(1) Za ukupno: prikazane su promjena prilagođene srednje vrijednosti i razlika prilagođene srednje vrijednosti procijenjene modelom ANCOVA.
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. 
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.
Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease. 
Svrha velmanaze alfa je nadomještanje nedostatka tog enzima u bolesnika s alfa-manozidozom.
Common side effects (may affect up to 1 in 10 people) - loss of consciousness (fainting, which may be preceded by feeling dizzy, lightheaded or confused) - acute renal insufficiency (kidney problems which can be recognised from fluid retention, swelling in legs, ankles or feet, drowsiness, shortness of breath or fatigue) - hypersensitivity and serious allergic reaction (symptoms including localised or diffuse skin itching, dizziness, difficulty breathing, chest pain, gastrointestinal symptoms such as nausea, vomiting, diarrhea or intestinal pain, swelling of the throat, face, lips or tongue) 
- gubitak svijesti (nesvjestica, kojoj mogu prethoditi omaglica, ošamućenost ili smetenost) - akutno zatajenje bubrega (problemi s bubrezima koji se mogu prepoznati po zadržavanju tekućine, oticanju nogu, gležnjeva ili stopala, omamljenosti, nedostatku zraka ili umoru) - preosjetljivost i ozbiljna alergijska reakcija (simptomi uključuju lokaliziran ili proširen svrbež kože, omaglicu, otežano disanje, bol u prsnom košu, probavne simptome kao što su mučnina,
The IRRs observed in clinical studies of velmanase alfa were characterised by a rapid onset of symptoms and were of mild to moderate severity. 
Reakcije povezane s infuzijom opažene u kliničkim ispitivanjima velmanaze alfa bile su obilježene brzim nastupom simptoma i blagom do umjerenom težinom.
5 vials 
5 bočica.
<18 years(2) ≥18 years(2) 3MSCT (steps/min) Overall(1) 
< 18 godina(2) ≥ 18 godina(2) 3MSCT (stepenica/minuti) Ukupno(1)
The reconstituted solution of Lamzede should be administered using an infusion set equipped with a pump and an in-line low protein-binding 0.22 µm filter. 
Rekonstituiranu otopinu lijeka Lamzede potrebno je primijeniti pomoću kompleta za infuziju opremljenog pumpom i ugrađenim filtrom veličine pora od 0,22 µm i niske sposobnosti vezanja proteina.
The recommended dose of 1 mg/kg is determined using the following calculation: Patient's weight (kg) × dose (mg/kg) = Patient dose (in mg) Patient dose (in mg) divided by 10 mg/vial (content of one vial) = number of vials to reconstitute. 
Tjelesna težina bolesnika (kg) × doza (mg/kg) = doza za bolesnika (u mg) Doza za bolesnika (u mg) podijeljena s 10 mg/bočica (sadržaj jedne bočice) = broj bočica za rekonstituciju.
Cardiac disorders 
Srčani poremećaji bradikardija
Administration of Lamzede should be carried out by a healthcare professional with the ability to manage ERT and medical emergencies. 
Primjenu lijeka Lamzede treba provoditi zdravstveni radnik koji može voditi enzimsku nadomjesnu terapiju i zbrinuti hitne slučajeve.
How Lamzede is used 
Kako primjenjivati Lamzede
The patient should be kept under observation for IRRs for one hour or longer after the infusion, according to the treating physician's judgement. 
Bolesnik mora biti pod nadzorom zbog reakcija povezanih s infuzijom jedan sat nakon infuzije ili dulje, sukladno procjeni nadležnog liječnika.
Adverse reactions are classified by system organ class and preferred term according to the MedDRA frequency convention. 
Nuspojave su kategorizirane prema klasifikaciji organskih sustava i preporučenim pojmovima prema MedDRA-inim kategorijama učestalosti.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'. 
Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'. 
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po doznoj jedinici, tj. zanemarive količine natrija.
Maximum infusion rate (mL/h) 
Najveća brzina infuzije (ml/sat)
There are no data from the use of velmanase alfa in pregnant women. 
Trudnoća Nema podataka o primjeni velmanaze alfa u trudnica.
Very common side effects (may affect more than 1 in 10 people) - diarrhoea - weight increase - fever/increased body temperature 
Vrlo česte nuspojave (mogu se javiti u više od 1 na 10 osoba) - proljev
Pharmacodynamic 
Farmakodinamička
Combined 
Kombinirano
QoL Domain 
Tri domene
Lamzede 10 mg powder for solution for infusion velmanase alfa 
Lamzede 10 mg prašak za otopinu za infuziju velmanaza alfa
It is used to treat patients with mild to moderate alpha-mannosidosis disease. 
Primjenjuje se za liječenje bolesnika s blagom do umjerenom alfa-manozidozom.
Name and address of the manufacturer responsible for batch release 
Njemačka Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
Oligosaccharides 20.0% 100% 
Nijedna domena 40,0% 0
Each mL of reconstituted solution contains 2 mg of velmanase alfa. 
Jedan ml rekonstituirane otopine sadrži 2 mg velmanaze alfa.
Vomiting(1) 
povraćanje(1)
Tel: + 420 261221745 
Chiesi CZ s.r.o. Tel: + 420 261221745
Common side effects (may affect up to 1 in 10 people) - low heart beat (bradycardia) - psychotic behaviour (mental illness with hallucinations, difficulty in thinking clearly and understanding reality, anxiety), initial difficulty in sleeping - confused state, fainting, tremor, dizziness, headache - intestinal (abdominal) pain, irritation of the stomach caused by digestive acids (reflux gastritis), 
- psihotično ponašanje (duševna bolest s halucinacijama, poteškoćama s jasnim razmišljanjem i razumijevanjem stvarnosti, tjeskobom), početno otežano spavanje - smeteno stanje, nesvjestica, drhtanje, omaglica,glavobolja
Domain 
Domena
The treatment should be supervised by a physician experienced in the management of patients with alpha-mannosidosis or in the administration of other enzyme replacement therapies (ERT) for lysosomal storage disorder. 
4.2 Doziranje i način primjene Liječenje mora nadzirati liječnik s iskustvom u zbrinjavanju bolesnika s alfa-manozidozom ili primjeni drugih enzimskih nadomjesnih terapija (ENT) za lizosomske bolesti nakupljanja.
The results (serum oligosaccharide concentration, 3MSCT, 6MWT and FVC%) are presented in table 2. 
Rezultati (koncentracija oligosaharida u serumu, 3MSCT, 6MWT i FVC%) su prikazani u tablici 2. Dokazan je farmakodinamički učinak sa statistički značajnim sniženjem oligosaharida u serumu u usporedbi s placebom.
Loss of consciousness(2) 
Poremećaji živčanog sustava stanje smetenosti gubitak svijesti(2)
[95% CI] p-value p=0.692 
[95% CI] p-vrijednost p=0,692