natgillin/translations-raw huggingface dataset:
What you need to know before Lamzede is used Lamzede must not be used:
Kaj morate vedeti, preden boste prejeli zdravilo Lamzede Zdravila Lamzede ne smete uporabljati:
While under treatment with Lamzede, you may experience some of the following reactions:
Med zdravljenjem z zdravilom Lamzede lahko dobite nekatere izmed naslednjih neželenih učinkov:
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.
Za natančnejšo oceno povezave je treba v primeru razvoja resnih IRR ali ob pomanjkanju ali izgubi učinka zdravljenja, bolnike testirati za prisotnost protiteles proti velmanazi alfa.
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.
Tipični znaki bolezni vključujejo značilne obrazne poteze, duševno zaostalost, težave pri nadziranju gibov, težave s sluhom in govorom, pogoste okužbe, skeletne težave, mišične bolečine in šibkost.
As with other enzyme replacement therapies, velmanase alfa does not cross the blood-brain-barrier.
Kot pri drugih encimskih nadomestnih zdravljenjih tudi velmanaza alfa ne prehaja skozi krvno-možgansko pregrado.
After the end of the infusion, velmanase alfa plasma concentrations fell in a biphasic fashion with a mean terminal elimination half-life of about 30 hours.
Po koncu infundiranja so koncentracije velmanaze alfa v plazmi padle v dveh fazah, s povprečnim končnim razpolovnim časom izločanja približno 30 ur.
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)).
Skupne učinke zdravljenja so ocenili na področju farmakodinamike (zmanjšanje oligosaharidov v serumu), funkcije (triminutna hoja po stopnicah (3MSCT- three-minute stair climbing test)), šestminutna hoja (6MWT- six-minute walking test)) in predvidena forsirana vitalna kapaciteta v % (FVC-forced vital capacity) ter kakovost življenja (indeks nezmožnosti (DI- disability index) po vprašalniku za oceno zdravstvenega stanja otrok (CHAQ-childhood health assessment questionnaire) in vizualna analogna lestvica za merjenje (VAS- visual analogue scale) bolečine po CHAQ).
The recommended dose regimen is 1 mg/kg of body weight administered once every week by intravenous infusion at a controlled speed.
Odmerjanje Priporočeni režim odmerjanja je 1 mg/kg telesne mase enkrat na teden v obliki intravenske infuzije z nadzorovano hitrostjo.
These reactions were non-serious and mild to moderate in intensity.
Te reakcije niso bile resne ter so bile po jakosti blage do zmerne.
In one patient, loss of consciousness considered related to the study treatment with recovery after a few seconds was reported.
Poročali so o enem bolniku, ki je izgubil zavest v povezavi z zdravljenjem v študiji in je okreval v nekaj sekundah.
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) Prašek je treba rekonstituirati v viali s počasnim kapljanjem vode za injekcije vzdolž notranje stene viale in ne neposredno na liofilizirani prašek.
It should be considered by the treating physician that the administration of velmanase alfa does not affect the irreversible complications (i.e. skeletal deformities, disostosis multiplex, neurological manifestations and impaired cognitive function).
Zdravnik mora upoštevati, da dajanje velmanaze alfa ne vpliva na nepopravljive zaplete (tj. okvare okostja, gargoilizem, nevrološke manifestacije in okvarjena kognitivna funkcija).
Paediatric Study rhLAMAN-08.
Pediatrična študija rhLAMAN-08.
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 je namenjena dodajanju ali nadomeščanju naravnega encima alfa-manozidaze, ki katalizira zaporedno razgradnjo hibrida in kompleksnih oligosaharidov z veliko manoze v lizosomu, z zmanjšanjem količine nakopičenih oligosaharidov, bogatih z manozo.
Pack sizes of 1, 5 or 10 vials per carton.
Velikosti pakiranj 1, 5 ali 10 vial v škatli.
Elderly No data are available and no relevant use in elderly patients is described.
Starostniki Podatkov ni na voljo in zdravilo ni namenjeno za uporabo pri starejših bolnikih.
Maximum infusion rate (mL/h)
Največja hitrost infundiranja (ml/h)
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 podlagi tega kriterija so bili vključeni bolniki z blago do zmerno obliko bolezni, s heterogeno resnostjo in sposobnostjo opraviti preskuse vzdržljivosti, veliko variabilnostjo klinične manifestacije in starosti ob pojavu bolezni.
There are no clinical data on the effects of velmanase alfa on fertility.
Ni kliničnih podatkov o učinkih velmanaze alfa na plodnost.
Instructions for reconstitution and administration
Navodila za rekonstitucijo in uporabo
d) The reconstituted solution is to be slowly withdrawn from each vial with caution to avoid foaming in the syringe.
d) Rekonstituirano raztopino je treba iz vsake viale povleči počasi in previdno, da preprečite penjenje v brizgi.
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.
Alfa manozidoza je redka genetska motnja, ki jo povzroča pomanjkanje encima, imenovanega alfa manozidaza, ki ga potrebujemo za razgradnjo nekaterih sestavin sladkorja (imenovanih oligosaharidi, bogati z manozo) v telesu.
Store and transport refrigerated (2°C - 8°C).
Zdravilo shranjujte in prevažajte na hladnem (2 °C-8 °C).
FVC (% of predicted) Overall
FVC (% predvidene)
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.
Skupno 33 bolnikov (20 moških in 13 žensk z razponom starosti od 6 do 35 let) je bilo izpostavljenih velmanazi alfa v petih kliničnih študijah.
For the calculation of the infusion rate and the infusion time based on body weight see the table in section 6.6.
Za preračunavanje hitrosti infundiranja in časa infundiranja glede na telesno maso glejte preglednico v poglavju 6.6.
It is not known whether velmanase alfa passes into breast milk.
Ni znano, ali velmanaza alfa prehaja v materino mleko.
The amino acid sequence of the monomeric protein is identical to the naturally occurring human enzyme, alpha-mannosidase.
Aminokislinsko zaporedje monomernega proteina je enako naravno prisotnemu humanemu encimu alfa-manozidaza.
No dose adjustment is necessary for patients with renal or hepatic impairment.
Prilagajanje odmerkov pri bolnikih z okvaro ledvic ali jeter ni potrebno.
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.
Očistek velmanaze alfa iz plazme (povprečna vrednost 6,7 ml/h/kg) je v skladu s hitrim celičnim privzemom velmanaze alfa prek manoznih receptorjev.
Approximately 30 minutes prior to reconstitution, the required number of vials should be removed from the refrigerator.
Potrebno število vial je treba vzeti iz hladilnika približno 30 minut pred rekonstitucijo.
No clinical data are available in children below the age of 6 years.
Za otroke, stare manj kot 6 let, ni kliničnih podatkov.
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.
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.
Each vial is reconstituted by slowly injecting 5 mL of water for injections to the inside of the wall of each vial.
Vsaka viala se rekonstituira s 5 ml vode za injekcije, ki se počasi vbrizga vzdolž stene viale.
The solution should be clear and not used if opaque particles are observed or if the solution is discoloured.
Raztopina mora biti bistra in je ne smete uporabiti, če opazite motne delce ali če je raztopina obarvana.
10 mL vial (Type I glass) with a bromobutyl rubber stopper, an aluminium seal and a polypropylene flip off cap.
10 ml viala (steklo tipa I), zaprta z zamaškom iz brombutilne gume, z aluminijastim tesnilom in polipropilensko dvižno zaporko.
Lamzede requires reconstitution and is intended for intravenous infusion only.
Zdravilo Lamzede je treba rekonstituirati in je namenjeno samo za intravensko infundiranje.
If not used immediately, the reconstituted solution should be stored in a refrigerator for no longer than 24 hours.
Če ga ne porabite nemudoma, lahko rekonstituirano raztopino hranite v hladilniku največ 24 ur.
3MSCT (steps/min)
3MSCT (koraki/min)
- The other ingredients are: disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, mannitol and glycine.
- Druge sestavine zdravila so: natrijev hidrogenfosfat dihidrat, natrijev dihidrogenfosfat dihidrat, manitol in glicin.
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.
Presnovna pot velmanaze alfa je predvidoma podobna kot pri drugih naravnih proteinih, ki se razgradijo v majhne peptide in nazadnje v aminokisline.
(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.
≥ 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.
Lamzede is supplied in a vial as a powder for infusion which will be made up with water for injections before being given.
Zdravilo Lamzede je na voljo v viali kot prašek za raztopino za infundiranje, ki se pred dajanjem pripravi z vodo za injekcije.
The recommended dose of Lamzede is 1 mg/kg of body weight given once every week.
Priporočeni odmerek zdravila Lamzede je 1 mg/kg telesne mase enkrat na teden.
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).
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
If not used immediately, the reconstituted solution may be stored up to 24 hours at 2°C to 8°C.
Če ga ne porabite nemudoma, lahko rekonstituirano raztopino hranite največ 24 ur pri temperaturi od 2 °C do 8 °C.
During the infusion with this higher dose, fever of mild intensity and short duration (5 hours) was observed in one patient.
Med infundiranjem tega večjega odmerka so pri enem bolniku opazili blago in kratkotrajno (5 ur) povišano telesno temperaturo.
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.
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.
Last observation % change from baseline (SD)
Zadnje opazovanje % spremembe od izhodišča
Table 1: Adverse reactions reported in clinical studies in patients with alpha-mannosidosis treated with velmanase alfa
Preglednica 1: Neželeni učinki, o katerih so poročali v kliničnih študijah pri bolnikih z alfa manozidozo, zdravljenih z velmanazo alfa Organski sistem
Forcefully ejecting the water for injections from the syringe onto the powder should be avoided to minimise foaming.
Treba je preprečiti silovito vbrizganje vode za injekcije iz brizge na prašek, da zmanjšate penjenje.
Pharmacotherapeutic group: Other alimentary tract and metabolism products, enzymes.
Farmakoterapevtska skupina: druga zdravila za bolezni prebavil in presnove, encimi.
There are no data from the use of velmanase alfa in pregnant women.
Podatkov o uporabi velmanaze alfa pri nosečnicah ni.
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.
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.
Concomitant long-term treatment with high doses of ibuprofen was noted as a potentially causative contributor to the occurrence of the event.
Ugotovili so, da lahko potencialno k pojavu tega dogodka prispeva sočasno dolgotrajno zdravljenje z visokimi odmerki ibuprofena.
Enzyme replacement therapy for the treatment of non-neurological manifestations in patients with mild to moderate alpha-mannosidosis.
Encimsko nadomestno zdravljenje ne-nevroloških manifestacij pri bolnikih z blago do zmerno alfamanozidozo.
- Infusion-related reactions include dizziness, headache, nausea, low blood pressure, tiredness and fever.
- Reakcije, povezane z infuzijo, vključujejo omotico, glavobol, siljenje na bruhanje, nizek krvni tlak, utrujenost in povišano telesno temperaturo.
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.
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.
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.
(2 do 8 %), ki so ga opazili v letu opazovanja, bi lahko kazalo na sposobnost velmanaze alfa, da upočasni napredovanje obstoječe bolezni.
Adjusted mean difference
Prilagojena srednja razlika
common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare
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
The infusion duration should be calculated individually considering a maximum infusion rate of 25 mL/hour to control the protein load.
Trajanje infundiranja je treba preračunati posamično, vendar je zaradi nadzora nalaganja proteinov največja hitrost infundiranja 25 ml/uro.
Acute renal failure
Akutna odpoved ledvic
Table 3: Change of clinical endpoints from baseline to the last observation in rhLAMAN-10 study (source data: rhLAMAN-10)
Preglednica 3: Sprememba kliničnih ciljev študije od izhodišča do zadnjega opazovanja v študiji rhLAMAN-10 (vir podatkov: rhLAMAN-10) Parameter
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.
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.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na enoto odmerka, kar v bistvu pomeni „brez natrija“.
p-value [95% CI]
Vrednost p [95-odstotni IZ]
Serum oligosaccharide concentration (µmol/L)
Koncentracija oligosaharidov v serumu (µmol/l)
QoL Domain
Področje QoL
After reconstitution, one mL of the solution contains 2 mg of velmanase alfa (10 mg / 5 mL).
Po rekonstituciji en ml raztopine vsebuje 2 mg velmanaze alfa (10 mg/5 ml).
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.
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.
Hypersensitivity reactions have been reported in patients in clinical studies.
Pri bolnikih v kliničnih študijah so poročali o preobčutljivostnih reakcijah.
Powder for solution for infusion 1 vial
prašek za raztopino za infundiranje 1 viala
Velmanase alfa, the active substance of Lamzede, is a recombinant form of human alpha-mannosidase.
Velmanaza alfa, učinkovina zdravila Lamzede, je rekombinantna oblika humanega encima alfamanozidaze.
There were no apparent pharmacokinetic gender differences in patients with alpha-mannosidosis disease.
Pri bolnikih z alfa manozidozo ni bilo očitnih farmakokinetičnih razlik med spoloma.
- The active substance is velmanase alfa.
- Učinkovina je velmanaza alfa.
Velmanase alfa is designed to replace the missing enzyme in patients with alpha-mannosidosis disease.
Velmanaza alfa je namenjena nadomeščanju odsotnega encima pri bolnikih z alfa manozidozo.
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.
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.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni „brez natrija“.
Responders Rates rhLAMAN-05 study n=25
Stopnje odzivnih oseb Študija rhLAMAN-05 N = 25
There is no experience with overdose of velmanase alfa.
Ni izkušenj s prevelikim odmerjanjem velmanaze alfa.
Lamzede can be used during breastfeeding.
Zdravilo Lamzede se lahko uporablja med dojenjem.
Table 4: Multiparametric responder analysis: MCID(1) Responders Rates by Endpoints and Domains (source data: rhLAMAN-05; rhLAMAN-10)
Preglednica 4: Multiparametrična analiza odzivnih oseb: stopnje odzivnih oseb MCID(1) po opazovanih dogodkih in področjih (vir podatkov: rhLAMAN-05; rhLAMAN-10)
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).
Pri zdravljenju z zdravilom Lamzede lahko med kapljičnim dajanjem zdravila (infundiranjem) ali neposredno po njem dobite neželene učinke (glejte poglavje 4).
Functional
Funkcija
The total volume of infusion is determined by the patient's weight and should be administrated over a minimum of 50 minutes.
Skupno količino infuzije se določi glede na telesno maso bolnika in jo je treba aplicirati najmanj
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.
Pripravljeno zdravilo boste prejeli z infuzijsko črpalko (kapljanjem) v obliki 50-minutne infuzije v veno, ki bo potekala pod zdravniškim nadzorom.
It is unknown whether velmanase alfa or its metabolites are excreted in human milk.
Ni znano, ali se velmanaza alfa ali njeni presnovki izločajo v materino mleko.
The adverse reactions reflecting exposure of 33 patients treated with velmanase alfa in clinical studies are listed in the table 1 below.
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.
Patients were not routinely pre-medicated prior to infusion of velmanase alfa during clinical studies.
Bolniki v kliničnih študijah, pred infundiranjem velmanaze alfa, niso rutinsko prejemali predhodnega zdravljenja.
Lamzede 10 mg powder for solution for infusion
Lamzede 10 mg prašek za raztopino za infundiranje
Renal failure acute(2)
Bolezni sečil akutna odpoved ledvic(2)
For intravenous infusion use only.
Samo za intravensko uporabo z infundiranjem.
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) 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.
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.
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.
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.
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.
Lamzede is administered through intravenous infusion.
Zdravilo Lamzede se daje v obliki intravenske infuzije.
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).
Lamzede za eno ali več podskupin pediatrične populacije za zdravljenje alfa manozidoze (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
It is used to treat patients with mild to moderate alpha-mannosidosis disease.
Uporablja se za zdravljenje bolnikov z blago do zmerno alfa manozidozo.
Lamzede contains the active substance velmanase alfa which belongs to a group of medicines known as enzyme replacement therapies.
Zdravilo Lamzede vsebuje učinkovino velmanaza alfa, ki sodi v skupino zdravil za encimsko nadomestno zdravljenje.
Cardiac disorders
Srčne bolezni bradikardija
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.
(koncentracija protiteles IgG proti velmanazi alfa) in zmanjšano učinkovitostjo ali pojavom anafilaksije ali drugih preobčutljivostnih reakcij niso ugotovili.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA