FrancophonIA/ELRC3.0 huggingface dataset:
English: The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase.
Slovenian: Aminokislinsko zaporedje monomernega proteina je enako naravno prisotnemu humanemu encimu alfa-manozidaza.
English: No dose adjustment is necessary for patients with renal or hepatic impairment.
Slovenian: Prilagajanje odmerkov pri bolnikih z okvaro ledvic ali jeter ni potrebno.
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.
Slovenian: Očistek velmanaze alfa iz plazme (povprečna vrednost 6,7 ml/h/kg) je v skladu s hitrim celičnim privzemom velmanaze alfa prek manoznih receptorjev.
English: Approximately 30 minutes prior to reconstitution, the required number of vials should be removed from the refrigerator.
Slovenian: Potrebno število vial je treba vzeti iz hladilnika približno 30 minut pred rekonstitucijo.
English: No clinical data are available in children below the age of 6 years.
Slovenian: Za otroke, stare manj kot 6 let, ni kliničnih podatkov.
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.
Slovenian: Dolgoročna učinkovitost in varnost velmanaze alfa sta bili raziskani v nenadzorovani, odprti klinični študiji 3. faze, rhLAMAN-10, pri 33 preskušancih (19 pediatričnih in 14 odraslih, ki so bili ob začetku zdravljenja stari od 6 do 35 let), ki so že sodelovali v študijah o velmanazi alfa.
English: Each vial is reconstituted by slowly injecting 5 mL of water for injections to the inside of the wall of each vial.
Slovenian: Vsaka viala se rekonstituira s 5 ml vode za injekcije, ki se počasi vbrizga vzdolž stene viale.
English: The solution should be clear and not used if opaque particles are observed or if the solution is discoloured.
Slovenian: Raztopina mora biti bistra in je ne smete uporabiti, če opazite motne delce ali če je raztopina obarvana.
English: 10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap.
Slovenian: 10 ml viala (steklo tipa I), zaprta z zamaškom iz brombutilne gume, z aluminijastim tesnilom in polipropilensko dvižno zaporko.
English: Lamzede requires reconstitution and is intended for intravenous infusion only.
Slovenian: Zdravilo Lamzede je treba rekonstituirati in je namenjeno samo za intravensko infundiranje.
English: If not used immediately, the reconstituted solution should be stored in a refrigerator for no longer than 24 hours.
Slovenian: Če ga ne porabite nemudoma, lahko rekonstituirano raztopino hranite v hladilniku največ 24 ur.
English: 3MSCT (steps/min)
Slovenian: 3MSCT (koraki/min)
English: - The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine.
Slovenian: - Druge sestavine zdravila so: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, manitol in glicin.
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.
Slovenian: Presnovna pot velmanaze alfa je predvidoma podobna kot pri drugih naravnih proteinih, ki se razgradijo v majhne peptide in nazadnje v aminokisline.
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.
Slovenian: ≥ 18 let(2) (1) Za celokupno vrednost: prikazani sta prilagojena srednja sprememba in prilagojena srednja razlika, ocenjena z modelom ANCOVA (2) Po starosti: prikazani sta neprilagojena srednja vrednost in vrednost SD.
English: Hyperhidrosis(1)
Slovenian: hiperhidroza(1)
English: Lamzede is supplied in a vial as a powder for infusion which will be made up with water for injections before being given.
Slovenian: Zdravilo Lamzede je na voljo v viali kot prašek za raztopino za infundiranje, ki se pred dajanjem pripravi z vodo za injekcije.
English: The recommended dose of Lamzede is 1 mg/kg of body weight given once every week.
Slovenian: Priporočeni odmerek zdravila Lamzede je 1 mg/kg telesne mase enkrat na teden.
English: Velmanase alfa exhibited a linear (i.e. first-order) pharmacokinetic profile, and Cmax and AUC increased proportionally to the dose with doses ranging from 0.8 to 3.2 mg/kg (corresponding to 25 and 100 units/kg).
Slovenian: Velmanaza alfa je pokazala linearni (tj. prvega reda) farmakokinetični profil, vrednosti Cmax in AUC pa sta se zvišali sorazmerno z odmerkom, pri čemer so bili odmerki v razponu od 0,8 do 3,2 mg/kg
English: If not used immediately, the reconstituted solution may be stored up to 24 hours at 2°C to 8°C.
Slovenian: Če ga ne porabite nemudoma, lahko rekonstituirano raztopino hranite največ 24 ur pri temperaturi od 2 °C do 8 °C.
English: During the infusion with this higher dose, fever of mild intensity and short duration (5 hours) was observed in one patient.
Slovenian: Med infundiranjem tega večjega odmerka so pri enem bolniku opazili blago in kratkotrajno (5 ur) povišano telesno temperaturo.
English: 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.
Slovenian: Zdravljenje mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem bolnikov z alfa manozidozo ali izkušnje z uporabo drugih encimskih nadomestnih zdravljenj (ERT- enzyme replacement therapies ) za motnje lizosomskega shranjevanja.
English: Last observation % change from baseline (SD)
Slovenian: Zadnje opazovanje % spremembe od izhodišča
English: Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis treated with velmanase alfa
Slovenian: Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih študijah pri bolnikih z alfa manozidozo, zdravljenih z velmanazo alfa Organski sistem
English: Forcefully ejecting the water for injections from the syringe onto the powder should be avoided to minimise foaming.
Slovenian: Treba je preprečiti silovito vbrizganje vode za injekcije iz brizge na prašek, da zmanjšate penjenje.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Slovenian: Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi.
English: There are no data from the use of velmanase alfa in pregnant women.
Slovenian: Podatkov o uporabi velmanaze alfa pri nosečnicah ni.
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.
Slovenian: Skupno 58 % bolnikov (19 od 33) z alfa manozidozo, ki so v kliničnih študijah prejemali velmanazo alfa, je bilo ob začetku študije starih od 6 to 17 let.
English: Concomitant long-term treatment with high doses of ibuprofen was noted as a potentially causative contributor to the occurrence of the event.
Slovenian: Ugotovili so, da lahko potencialno k pojavu tega dogodka prispeva sočasno dolgotrajno zdravljenje z visokimi odmerki ibuprofena.
English: Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
Slovenian: Encimsko nadomestno zdravljenje ne-nevroloških manifestacij pri bolnikih z blago do zmerno alfamanozidozo.
English: - Infusion-related reactions include dizziness, headache, nausea, low blood pressure, tiredness and fever.
Slovenian: - Reakcije, povezane z infuzijo, vključujejo omotico, glavobol, siljenje na bruhanje, nizek krvni tlak, utrujenost in povišano telesno temperaturo.
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.
Slovenian: V multicentrični, dvojno slepi, randomizirani, s placebom in z vzporedno skupino nadzorovani ključni študiji 3. faze, rhLAMAN-05, so raziskovali učinkovitost in varnost 52-tedenske ponavljajoče uporabe velmanaze alfa v odmerku 1 mg/kg enkrat tedensko v obliki intravenske infuzije.
English: Disodium phosphate dihydrate Sodium dihydrogen phosphate dihydrate Mannitol
Slovenian: natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat dihidrat manitol glicin
English: The numerical improvement of most clinical endpoints over placebo (2 to 8 %) observed in the year of observation could be suggestive of the ability of velmanase alfa to slow down the existing disease progression.
Slovenian: (2 do 8 %), ki so ga opazili v letu opazovanja, bi lahko kazalo na sposobnost velmanaze alfa, da upočasni napredovanje obstoječe bolezni.
English: Adjusted mean difference
Slovenian: Prilagojena srednja razlika
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
Slovenian: Neželeni učinki so razvrščeni po organskem sistemu in prednostnem izrazu z navedbo pogostnosti po MedDRA. Pogostnost je opredeljena kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do
English: The infusion duration should be calculated individually considering a maximum infusion rate of 25 mL/hour to control the protein load.
Slovenian: Trajanje infundiranja je treba preračunati posamično, vendar je zaradi nadzora nalaganja proteinov največja hitrost infundiranja 25 ml/uro.
English: Acute renal failure
Slovenian: Akutna odpoved ledvic
English: Table 3: Change of clinical endpoints from baseline to the last observation in rhLAMAN-10 study (source data: rhLAMAN-10)
Slovenian: Preglednica 3: Sprememba kliničnih ciljev študije od izhodišča do zadnjega opazovanja v študiji rhLAMAN-10 (vir podatkov: rhLAMAN-10) Parameter
English: 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.
Slovenian: Bolnikova telesna masa (kg) × odmerek (mg/kg) = odmerek za bolnika (v mg) Odmerek za bolnika (v mg) deljeno z 10 mg/vialo (vsebina ene viale) = število vial za rekonstitucijo.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na enoto odmerka, kar v bistvu pomeni „brez natrija“.
English: p-value [95% CI]
Slovenian: Vrednost p [95-odstotni IZ]
English: Serum oligosaccharide concentration (µmol/L)
Slovenian: Koncentracija oligosaharidov v serumu (µmol/l)
English: QoL Domain
Slovenian: Področje QoL
English: After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
Slovenian: Po rekonstituciji en ml raztopine vsebuje 2 mg velmanaze alfa (10 mg/5 ml).
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.
Slovenian: V stanju dinamičnega ravnovesja je bila po dajanju 1 mg/kg velmanaze alfa enkrat tedensko povprečna največja koncentracija v plazmi približno 8 µg/ml, ki je bila dosežena 1,8 ure po začetku dajanja, kar ustreza povprečnemu času trajanja infundiranja.
English: Hypersensitivity reactions have been reported in patients in clinical studies.
Slovenian: Pri bolnikih v kliničnih študijah so poročali o preobčutljivostnih reakcijah.
English: Powder for solution for infusion 1 vial
Slovenian: prašek za raztopino za infundiranje 1 viala
English: Velmanase alfa, the active substance of Lamzede, is a recombinant form of human alpha-mannosidase.
Slovenian: Velmanaza alfa, učinkovina zdravila Lamzede, je rekombinantna oblika humanega encima alfamanozidaze.
English: There were no apparent pharmacokinetic gender differences in patients with alpha-mannosidosis disease.
Slovenian: Pri bolnikih z alfa manozidozo ni bilo očitnih farmakokinetičnih razlik med spoloma.
English: Linearity/(Non)linearity
Slovenian: Linearnost/nelinearnost
English: - The active substance is velmanase alfa.
Slovenian: - Učinkovina je velmanaza alfa.
English: 10 mg velmanase alfa
Slovenian: 10 mg velmanaze alfa
English: Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease.
Slovenian: Velmanaza alfa je namenjena nadomeščanju odsotnega encima pri bolnikih z alfa manozidozo.
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.
Slovenian: 24-mesečno, multicentrično, odprto preskušanje faze II za preučitev varnosti in učinkovitosti ponavljajočega zdravljenja z velmanazo alfa (rekombinantna oblika humanega encima alfa manozidaze) pri pediatrični populaciji, stari < 6 let z, z alfa manozidozo.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni „brez natrija“.
English: Responders Rates rhLAMAN-05 study n=25
Slovenian: Stopnje odzivnih oseb Študija rhLAMAN-05 N = 25
English: There is no experience with overdose of velmanase alfa.
Slovenian: Ni izkušenj s prevelikim odmerjanjem velmanaze alfa.
English: Lamzede can be used during breastfeeding.
Slovenian: Zdravilo Lamzede se lahko uporablja med dojenjem.
English: Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10)
Slovenian: Preglednica 4: Multiparametrična analiza odzivnih oseb: stopnje odzivnih oseb MCID(1) po opazovanih dogodkih in področjih (vir podatkov: rhLAMAN-05; rhLAMAN-10)
English: If you are treated with Lamzede, you may experience a side effect during or immediately following the drip (infusion) used to give the medicine (see section 4).
Slovenian: Pri zdravljenju z zdravilom Lamzede lahko med kapljičnim dajanjem zdravila (infundiranjem) ali neposredno po njem dobite neželene učinke (glejte poglavje 4).
English: Functional
Slovenian: Funkcija
English: The total volume of infusion is determined by the patient's weight and should be administrated over a minimum of 50 minutes.
Slovenian: Skupno količino infuzije se določi glede na telesno maso bolnika in jo je treba aplicirati najmanj
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.
Slovenian: Pripravljeno zdravilo boste prejeli z infuzijsko črpalko (kapljanjem) v obliki 50-minutne infuzije v veno, ki bo potekala pod zdravniškim nadzorom.
English: It is unknown whether velmanase alfa or its metabolites are excreted in human milk.
Slovenian: Ni znano, ali se velmanaza alfa ali njeni presnovki izločajo v materino mleko.
English: The adverse reactions reflecting exposure of 33 patients treated with velmanase alfa in clinical studies are listed in the table 1 below.
Slovenian: Seznam neželenih učinkov v obliki preglednice Neželeni učinki, ki odražajo izpostavljenost 33 bolnikov, ki so bili v kliničnih študijah zdravljeni z velmanazo alfa, so navedeni spodaj v preglednici 1.
English: Patients were not routinely pre-medicated prior to infusion of velmanase alfa during clinical studies.
Slovenian: Bolniki v kliničnih študijah, pred infundiranjem velmanaze alfa, niso rutinsko prejemali predhodnega zdravljenja.
English: Lamzede 10 mg powder for solution for infusion
Slovenian: Lamzede 10 mg prašek za raztopino za infundiranje
English: Renal failure acute(2)
Slovenian: Bolezni sečil akutna odpoved ledvic(2)
English: For intravenous infusion use only.
Slovenian: Samo za intravensko uporabo z infundiranjem.
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.
Slovenian: e) Rekonstituirano raztopino je treba aplicirati s kompletom za infundiranje s črpalko in z linijskim filtrom z nizko vezavo proteinov z velikostjo por 0,22 µm.
English: 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.
Slovenian: Rekonstituirano raztopino zdravila Lamzede je treba aplicirati s pomočjo kompleta za infundiranje s črpalko in z linijskim filtrom z nizko vezavo proteinov z velikostjo por 0,22 µm.
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.
Slovenian: V kolikor se med zdravljenjem ali takoj po njem pojavijo simptomi, kot so angioedem (otekanje jezika ali žrela), obstrukcija zgornjih dihalnih poti ali hipotenzija, je treba posumiti na anafilaksijo ali anafilaktoidno reakcijo.
English: Lamzede is administered through intravenous infusion.
Slovenian: Zdravilo Lamzede se daje v obliki intravenske infuzije.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Lamzede in one or more subsets of the paediatric population in the treatment of alpha-mannosidosis disease (see section 4.2 for information on paediatric use).
Slovenian: Lamzede za eno ali več podskupin pediatrične populacije za zdravljenje alfa manozidoze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: It is used to treat patients with mild to moderate alpha-mannosidosis disease.
Slovenian: Uporablja se za zdravljenje bolnikov z blago do zmerno alfa manozidozo.
English: Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies.
Slovenian: Zdravilo Lamzede vsebuje učinkovino velmanaza alfa, ki sodi v skupino zdravil za encimsko nadomestno zdravljenje.
English: Cardiac disorders
Slovenian: Srčne bolezni bradikardija
English: No clear correlation was found between antibody titres (velmanase alfa IgG antibody level) and reduction in efficacy or occurrence of anaphylaxis or other hypersensitivity reactions.
Slovenian: (koncentracija protiteles IgG proti velmanazi alfa) in zmanjšano učinkovitostjo ali pojavom anafilaksije ali drugih preobčutljivostnih reakcij niso ugotovili.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA
English: c) An immediate visual inspection of the solution for particulate matter and discoloration should be performed after reconstitution.
Slovenian: c) Po rekonstituciji je treba raztopino nemudoma pregledati glede trdnih delcev in obarvanja.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Velmanase alfa is a protein and is predicted to be metabolically degraded into amino acids.
Slovenian: Velmanaza alfa je protein in se med presnovo predvidoma razgradi v aminokisline.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Nemčija Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: November 2020
Slovenian: Končno poročilo o študiji: november 2020
English: How Lamzede is used
Slovenian: Kako uporabljati zdravilo Lamzede
English: [95% CI] p-value p=0.692
Slovenian: [95-odstotni IZ] vrednost p p = 0,692
English: Combined
Slovenian: Kombinirano
English: After reconstitution, the medicine should be used immediately.
Slovenian: Zdravilo je treba uporabiti nemudoma po rekonstituciji.
English: Table 2: Results from placebo-controlled clinical study rhLAMAN-05 (source data: rhLAMAN-05)
Slovenian: Preglednica 2: Rezultati s placebom nadzorovane klinične študije rhLAMAN-05 (vir podatkov:
English: Lamzede should be reconstituted and administrated by a healthcare professional.
Slovenian: Zdravilo Lamzede smejo rekonstituirati in dajati zdravstveni delavci.
English: What Lamzede looks like and contents of the pack
Slovenian: Izgled zdravila Lamzede in vsebina pakiranja
English: Absolute change from baseline Mean
Slovenian: Absolutna sprememba od izhodišča Povprečna vrednost
English: [95% CI] p-value p=0.278
Slovenian: [95-odstotni IZ] vrednost p p = 0,278
English: These medicines may include medicines used to treat allergies (antihistamines), medicines used to treat fever (antipyretics) and medicines to control inflammation (corticosteroids).
Slovenian: (antihistaminiki), zdravila za zdravljenje povišane telesne temperature (antipiretiki) in zdravila za nadzor vnetja (kortikosteroidi).
English: Package leaflet: Information for the patient Lamzede 10 mg powder for solution for infusion velmanase alfa This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo Lamzede 10 mg prašek za raztopino za infundiranje velmanaza alfa Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Loss of consciousness(2)
Slovenian: Bolezni živčevja zmedenost izguba zavesti(2)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, juvenile toxicity and toxicity to reproduction and development.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, toksičnosti za mladostnike ter vpliva na sposobnost razmnoževanja in razvoja ne kažejo posebnega tveganja za človeka.
English: Velmanase alfa vs. placebo
Slovenian: Velmanaza alfa v primerjavi s placebom
English: The results (serum oligosaccharide concentration, 3MSCT, 6MWT and FVC%) are presented in table 2.
Slovenian: Rezultati (koncentracija oligosaharidov v serumu, 3MSCT, 6MWT in
English: All but one patient were naïve to the treatment with velmanase alfa.
Slovenian: Razen enega bolnika predhodno nobeden od njih ni bil zdravljen z velmanazo alfa.
English: A total of 25 patients were enrolled, including 12 paediatric subjects (age range: 6 to 17 years; mean: 10.9 years) and 13 adult subjects (age range: 18 to 35 years; mean: 24.6).
Slovenian: Vključenih je bilo skupaj 25 bolnikov, od tega 12 pediatričnih oseb (razpon starosti od 6 do 17 let; povprečna vrednost:
English: Store and transport refrigerated.
Slovenian: Zdravilo shranjujte in prevažajte na hladnem.
English: Name and address of the manufacturer of the biological active substance
Slovenian: SPROŠČANJE SERIJ Ime in naslov izdelovalca biološke učinkovine
English: Talk to your doctor before Lamzede is used.
Slovenian: Pred začetkom uporabe zdravila Lamzede se posvetujte z zdravnikom.
English: In order to obtain long-term data on effectiveness and safety of treatment with Lamzede and to characterize the entire alpha-mannosidosis population, including variability of clinical manifestation, progression and natural history, the MAH is requested to submit the results of a study based on adequate source of data deriving from a registry of patients with alpha-mannosidosis.
Slovenian: vključno z variabilnostjo klinične manifestacije, napredovanja in naravnega poteka bolezni, mora imetnika dovoljenja za promet z zdravilom predložiti rezultate študije na podlagi ustreznih izvornih podatkov, izpeljanih iz registra bolnikov z alfa manozidozo.
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih glavobol zaradi posega
English: Serum oligosaccharide concentration (μmol/l) Overall(1)
Slovenian: Koncentracija oligosaharidov v serumu (μmol/l)
English: Dose (mL)
Slovenian: Odmerek (ml)