natgillin/translations-raw huggingface dataset:
Infantile-onset Pompe disease; clinical trial in patients aged 6 months to 3.5 years A second open-label clinical trial also assessed the safety and efficacy of Myozyme in 21 patients with predominantly a non-typical form of infantile-onset Pompe disease who ranged in age from 6 months to 3.5 years at initiation of treatment.
Druga odprta klinična raziskava je prav tako ocenjevala varnost in učinkovitost zdravila Myozyme pri 21 bolnikih s pretežno netipično obliko Pompejeve bolezni z zgodnjim nastopom, ob začetku zdravljenja pa so bili stari od 6 mesecev do 3, 5 let.
Patients received 20 mg/ kg Myozyme every other week for 52 weeks except for 8 patients who received 40 mg/ kg after at least 26 weeks of treatment.
Bolniki so prejemali 20 mg/ kg zdravila Myozyme vsak drugi teden 52 tednov, razen 8 bolnikov, ki so prejemali 40 mg/ kg po najmanj 26 tednih zdravljenja.
8 The primary endpoint of the pivotal trial was the proportion of patients who were alive.
Glavni cilj osrednjega preskušanja je bil delež živih bolnikov.
After 52 weeks of treatment, 16 of 21 patients (76.2%) treated with Myozyme were alive.
Po 52 tednih zdravljenja je bilo živih 16 izmed 21 bolnikov (76, 2%), zdravljenih z zdravilom Myozyme.
After 104 weeks of treatment, 14 of 21 patients (66.7%) were alive and 1 patient was alive but had discontinued from the study.
Po 104 tednih zdravljenja je bilo živih 14 izmed 21 bolnikov (66, 7%) in 1 bolnik je bil živ, vendar je prenehal s sodelovanjem v študiji.
In the untreated historical cohort 5 of 47 patients (10.6%) for whom data were available, were alive at age 30 months (2.5 years).
V nezdravljeni historični kohorti je bilo živih 5 izmed 47 bolnikov (10, 6%), za katere so bili na voljo podatki, pri starosti 30 mesecev (2, 5 let).
Table 3:
8 Tabela 3:
N=21
n=48
N=48
n=21
Subjects ranged in age from 6 months to 3.5 years at initiation of treatment.
Ob pričetku zdravljenja so bile osebe stare od 6 mesecev do 3, 5 let.
At 104 weeks of treatment LVM assessments were available for 10 patients, of which 9 decreased to within normal limits.
Pri 104. tednu zdravljenja so bile na voljo ocene LVM za 10 bolnikov, od katerih se je 9- im znižala na normalne vrednosti.
9 Late-onset Pompe disease An open-label clinical trial assessed the safety and efficacy of Myozyme in 5 patients with late-onset Pompe disease who ranged in age from 5 to 15 years at initiation of treatment.
Pozen nastop Pompejeve bolezni Odprta klinična raziskava je ocenjevala varnost in učinkovitost zdravila Myozyme pri 5 bolnikih s poznim nastopom Pompejeve bolezni, ob začetku zdravljenja pa so bili stari od 5 do 15 let.
Patients received 20 mg/ kg Myozyme every other week for 26 weeks.
Bolniki so prejemali 20 mg/ kg zdravila Myozyme vsak drugi teden 26 tednov.
All patients were freely ambulatory and all but one patient did not require any form of ventilator support (1 patient required nocturnal non-invasive ventilation).
Vsi bolniki so bili zdravljeni ambulantno in razen enega, nihče ni potreboval kakršnekoli oblike respiracijske pomoči (1 bolnik je potreboval nočno ne- invazivno predihavanje).
Of the 3 patients with significant pulmonary involvement at screening/ baseline (percentage predicted forced vital capacity in the sitting position ranging from 58-67%), two demonstrated clinically meaningful improvements in FVC (+11.5% and +16.0%) in the sitting position by Week 26.
Izmed treh bolnikov s hudo pljučno prizadetostjo ob 9 pregledu/ izhodiščni vrednosti (odstotek predvidene forsirane vitalne kapacitete v sedečem položaju od 58 - 67%) so se pri dveh do 26. tedna pokazale klinično pomembne izboljšave pri FVC (+11, 5% in +16, 0%) v sedečem položaju.
Ten patients with advanced late-onset Pompe disease (i. e. wheelchair-bound for 10/ 10 and ventilator- dependent for 9/ 10) aged 9-54 years were treated in expanded access programs with alglucosidase alfa 20-40 mg/ kg every 2 weeks for various periods of time between 6 months and 2.5 years.
Deset bolnikov z napredujočo Pompejevo boleznijo s poznim nastopom (npr. na invalidskem vozičku 10/ 10 in odvisnih od respiratorja 9/ 10) starih od 9- 54 let so zdravili v programih z razširjenim dostopom z alglukozidazo alfa v odmerkih 20- 40 mg/ kg vsaka 2 tedna v različnih časovnih obdobjih med 6 meseci in 2, 5 leta.
The pulmonary benefits observed in patients included a clinically meaningful improvement in FVC of 35% in one patient, and significant reductions in the number of hours of ventilator support needed in 2 patients.
Pljučne izboljšave, ki jih je bilo opaziti pri bolnikih, so vključevale klinično pomembne napredke v FVC za 35% pri enem bolniku in občutno zmanjšanje potrebnega števila ur podpore respiratorja pri 2 bolnikih.
Pompe Registry Medical or healthcare professionals are encouraged to register patients who are diagnosed with Pompe disease at www. PompeRegistry. com.
Medicinsko ali strokovno zdravstveno osebje je treba spodbujati k vodenju registra bolnikov z diagnozo Pompejeve bolezni dostopen na www. PompeRegistry. com.
The objectives of the “ Pompe Registry” are to enhance the understanding of Pompe disease and to monitor patients and their response to enzyme replacement therapy over time, with the ultimate goal of improving clinical outcomes for these patients.
Cilji » Pompejevega registra « so povečati razumevanje Pompejeve bolezni in spremljati bolnike in njihove odzive na encimsko nadomestno terapijo v daljšem časovnem obdobju s končnim ciljem izboljšave kliničnih rezultatov za te bolnike.
In a pivotal trial including 18 patients, the pharmacokinetics of Myozyme were evaluated in 15 patients with infantile-onset Pompe disease (all aged less than 6 months at treatment-onset) who received doses of 20 mg/ kg or 40 mg/ kg alglucosidase alfa as an approximate 4 to 6.5-hour infusion, respectively.
V osrednji raziskavi, ki je vključevala 18 bolnikov je bila farmakokinetika zdravila Myozyme ovrednotena pri 15 bolnikih z zgodnjim nastopom Pompejeve bolezni (vsi pri starosti manj kot 6 mesecev ob začetku zdravljenja) in so prejemali odmerke zdravila alglukozidaze alfa 20 mg/ kg ali 40 mg/ kg v približno 4 oziroma 6, 5- ur trajajočem infundiranju.
Pharmacokinetics were dose proportional and did not change over time.
Farmakokinetika je bila sorazmerna z odmerkom in se v tem času ni spremenila.
After the first and sixth infusion of Myozyme, mean maximum plasma concentrations (Cmax) ranged from 178.2 to 263.7 μ g/ ml for the 20 mg/ kg and 40 mg/ kg dose groups respectively.
Po prvi in šesti infuziji zdravila Myozyme je bila srednja vrednost maksimalne koncentracije v plazmi (Cmax) v razponu od 178, 2 do 263, 7 μg/ ml za skupini, ki sta prejemali odmerke 20 mg/ kg oziroma 40 mg/ kg.
The mean area under the plasma concentration-time curve (AUC∞) ranged from 977.5 to 1,872.5 μ g• hr/ mL for the 20 mg/ kg and 40 mg/ kg dose groups.
Srednja vrednost površine pod krivuljo plazemske koncentracije v odvisnosti od časa (AUC∞) je bila v razponu od 977, 5 do 1872, 5 μg• ur/ ml za skupini, ki sta prejemali odmerke 20 mg/ kg in 40 mg/ kg.
Mean plasma clearance (CL) was 21.9 mL/ hr/ kg and mean volume of distribution at steady state (Vss) was 66.2 mL/ kg for both dose groups with small between-subject variability of 15% and 11%, respectively.
Srednja vrednost plazemskega očistka (CL) je bila 21, 9 ml/ ur/ kg in srednja vrednost volumna porazdelitve v stanju dinamičnega ravnotežja (Vss) 66, 2 ml/ kg v obeh skupinah, z majhno spremenljivostjo med posamezniki, ki je znašala 15% oziroma 11%.
Mean plasma elimination half-life (t1/ 2) was 2.75 hours for the two dose groups.
Srednja vrednost razpolovnega časa (t1/ 2) izločanja iz plazme je bila 2, 75 ure v obeh skupinah.
The pharmacokinetics of Myozyme were also evaluated in a separate trial in 21 patients with infantile- onset Pompe disease (all aged between 6 months and 3.5 years at treatment-onset) who received doses of 20 mg/ kg of alglucosidase alfa.
Farmakokinetika zdravila Myozyme je bila ovrednotena tudi v ločenem preskušanju z 21 bolniki z zgodnjim nastopom Pompejeve bolezni (vsi so bili stari od 6 mesecev do 3, 5 let ob začetku zdravljenja), ki so prejemali alglukozidazo alfa v odmerkih 20 mg/ kg.
In 12 patients with available data the AUC∞ and Cmax were approximately equivalent to those observed for the 20 mg/ kg dose group in the pivotal trial.
Pri 12 bolnikih z razpoložljivimi podatki sta bila AUC∞ in Cmax približno enakovredna tistim, opaženim pri skupinah, ki so prejemale odmerke 20 mg/ kg v osrednji raziskavi.
The t½ of approximately 2-3 hours was also similar in this group of patients.
Razpolovna doba (t½) približno 2- 3 ure v tej skupini bolnikov je bila prav tako podobna.
The pharmacokinetics of Myozyme were evaluated in a trial in 5 patients with late-onset Pompe disease aged 6-15 years who received 20 mg/ kg alglucosidase alfa every 2 weeks.
Farmakokinetika zdravila Myozyme je bila ovrednotena v preskušanju s 5 bolniki, starimi od 6- 15 let, s poznim nastopom Pompejeve bolezni, ki so vsaka 2 tedna prejemali 20 mg/ kg zdravila alglukozidaze alfa.
There was no difference in the pharmacokinetic profile of Myozyme in late-onset patients compared to infantile- onset patients.
V farmakokinetičnem profilu zdravila Myozyme ni bilo razlike med bolniki s poznim nastopom bolezni v primerjavi z bolniki z zgodnjim nastopom bolezni.
Preclinical data reveal no special hazards for humans based on studies of safety pharmacology, single and repeat dose toxicity.
Predklinični podatki na osnovi študij farmakološke varnosti, toksičnosti pri posameznih in ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
No significant adverse findings were observed in a mouse embryofoetal
V študiji na zarodkih miši ni bilo zabeleženih pomembnih neželenih učinkov.
Data from a mouse fertility and early embryonic development study were not conclusive.
Podatki iz študije plodnosti in zgodnjega razvoja zarodka pri miših niso bili dokončni.
The potential effects on reproductive and developmental functions have not been fully characterised.
Morebitni učinki na razmnoževalne in razvojne funkcije niso bili v celoti opredeljeni.
Mannitol Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80
manitol monohidrat natrijevega dihidrogenfosfata heptahidrat natrijevega hidrogenfosfata polisorbat 80
However, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C when stored under protection from light.
Vendar je bila dokazana kemična in fizikalna stabilnost za 24 ur pri 2 °C do 8 °C, če je zdravilo shranjeno v temnem prostoru.
50 mg of powder in a vial (Clear Type 1 glass) with a stopper (siliconised butyl) and a seal (aluminium) with a flip-off cap (plastic).
50 mg praška v viali (steklo tipa 1) z zamaškom (silikoniziran butilen) in zaščitnim ovojem (aluminijast) z odstranljivim pokrovčkom (plastičen).
Myozyme has to be reconstituted with water for injections, then diluted with 9 mg/ ml (0.9%) sodium chloride solution and then administered by intravenous infusion.
Myozyme rekonstituirajte z vodo za injekcije, nato ga razredčite z 9 mg/ ml (0, 9%) raztopino natrijevega klorida in nato uporabite za intravensko infuzijo.
Therefore, a 0.2 micron low protein binding in-line filter should be used for administration.
Zato morate uporabiti 0, 2 mikronski filter, ki veže nizkomolekularne beljakovine.
It was demonstrated that the use of a 0.2 micron in-line filter removes visible particles and does not result in an apparent loss of protein or activity.
Dokazano je bilo, da se z uporabo 0, 2 mikronskega filtra odstranijo vidni delci in ne pride do očitne izgube beljakovin ali učinkovitosti.
Determine the number of vials to be reconstituted based on the individual patient’ s dose regimen (mg/ kg) and remove the required vials from the refrigerator in order to allow them to reach room temperature (approximately 30 minutes).
Število vial za rekonstituiranje določite na podlagi režima odmerjanja za posameznega bolnika (mg/ kg), nato potrebne viale vzemite iz hladilnika, da bodo dosegle sobno temperaturo (približno 30 minut).
As Myozyme does not contain a preservative, each vial of Myozyme is for single use only.
Ker Myozyme ne vsebuje konzervansov, je vsaka viala zdravila Myozyme namenjena le enkratni uporabi.
11 Use Aseptic Technique
11 Uporabite aseptično tehniko.
Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections.
Vsako 50 mg vialo zdravila Myozyme rekonstituirajte z 10, 3 ml vode za injekcije.
Add the water for injections by slow drop-wise addition down the side of the vial and not directly onto the lyophilized cake.
Vodo za injekcije dodajajte s počasnim spuščanjem kapljic po steni viale in ne neposredno na liofilizirano pogačo.
The reconstituted volume is 10.5 ml containing 5 mg/ ml, and appears as a clear, colourless to pale yellow solution which may contain particles in the form of thin white strands or translucent fibres.
Volumen rekonstituirane vsebine je 10, 5 ml z vsebnostjo 5 mg/ ml in je videti kot bistra brezbarvna do bledorumena raztopina, ki lahko vsebuje delce v obliki tankih belih nitk ali prosojnih vlaken.
The pH of the reconstituted solution is approximately 6.2.
Ne uporabljajte, če ob takojšnjem pregledu opazite tujke, ki niso opisani zgoraj, ali če je raztopina spremenila barvo. pH rekonstituirane raztopine je približno 6, 2.
The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial.
Rekonstituirana vsebina omogoča natančen odvzem 10, 0 ml (kar odgovarja 50 mg) iz vsake viale.
This should then be further diluted as follows:
Nato je potrebno nadaljnje redčenje, kot je opisano v nadaljevanju:
Slowly withdraw the reconstituted solution from each vial until the volume for the patient’ s dose is obtained.
Počasi odvzemajte rekonstituirano raztopino iz vsake viale, dokler ne dosežete količine za bolnikov odmerek.
The recommended final concentration of alglucosidase in the infusion bags ranges from 0.5 mg/ ml to 4 mg/ ml.
Priporočljiva končna koncentracija alglukozidaze v infuzijskih vrečkah se giblje od 0, 5 mg/ ml do 4 mg/ ml.
Also remove an equal volume of 0.9% sodium chloride, that will be replaced with reconstituted Myozyme.
Odstranite tudi enako količino 0, 9% natrijevega klorida, ki ga bo nadomestil rekonstituiran Myozyme.
Slowly inject the reconstituted Myozyme directly into the 0.9% sodium chloride solution.
Počasi vbrizgavajte rekonstituiran Myozyme neposredno v 0, 9% raztopino natrijevega klorida.
Genzyme Europe B. V., Gooimeer 10, NL-1411 DD Naarden, The Netherlands
Genzyme Europe B. V., Gooimeer 10, NL- 1411 DD, Naarden, Nizozemska
Genzyme Corp., 500 Soldiers Field Road, Allston, MA 02134, USA Genzyme Corp.
Genzyme Corp., 500 Soldiers Field Road, Allston, MA 02134, ZDA Genzyme Corp.
45, 51, 76 and 80 New York Avenue, Framingham, MA 01701, USA
45, 51, 76 and 80 New York Avenue, Framingham, MA 01701, ZDA
Medicinal product subject to restricted medical prescription (See Annex I:
Izdaja zdravila je le na recept (glejte dodatek I:
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 14 April 2008 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Farmakovigilančni sistem Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je farmakovigilančni sistem, kot je opisan v različici z dne 14. aprila 2008, ki je predstavljena v modulu 1. 8. 1 vloge za pridobitev dovoljenja za promet z zdravilom, vzpostavljen in deluje, preden da zdravilo na trg in toliko časa, kolikor bo zdravilo v prometu.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Načrt o obvladovanju tveganja Imetnik dovoljenja za promet z zdravilom se zavezuje, da bo opravil študije in dodatne dejavnosti farmakovigilance, podrobno opisane v farmakovigilančnem načrtu, sprejetem v različici 1 načrta o obvladovanju tveganja (RMP), predstavljeni v modulu 1. 8. 2 vloge za pridobitev dovoljenja za promet z zdravilom, in vseh nadaljnjih spremembah načrta o obvladovanju tveganja, ki jih je odobril Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skladno s smernico CHMP o sistemih za obvladovanje tveganja pri zdravilih za humano uporabo mora biti posodobljeni načrt o obvladovanju tveganja predložen sočasno s periodičnim poročilom o varnosti (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljeni načrt o obvladovanju tveganja predložiti • Kadar imetnik dovoljenja za promet z zdravilom prejme nove informacije, ki bi lahko vplivale na trenutno varnostno specifikacijo, farmakovigilančni načrt ali dejavnosti za zmanjševanje tveganja • V 60 dneh, potem ko je dosežen pomemben mejnik (farmakovigilanca ali zmanjševanje tveganja) • Na zahtevo Evropske agencije za zdravila (EMEA)
Myozyme 50 mg powder for concentrate for solution for infusion Alglucosidase alfa
Myozyme 50 mg prašek za koncentrat za raztopino za infundiranje Alglukozidaza alfa
Each vial contains 50 mg of alglucosidase alfa
Ena viala vsebuje 50 mg alglukozidaze alfa
After reconstitution, the solution contains 5 mg of alglucosidase alfa/ ml and after dilution, the concentration varies from 0.5 mg to 4 mg/ ml.
Po rekonstituciji raztopina vsebuje 5 mg alglukozidaze alfa/ ml in po redčenju koncentracija variira od 0, 5 mg do 4 mg/ ml.
Mannitol Sodium phosphate monobasic monohydrate Sodium phosphate dibasic heptahydrate Polysorbate 80
Pomožne snovi: manitol monohidrat natrijevega dihidrogenfosfata heptahidrat natrijevega hidrogenfosfata polisorbat 80
25 vials of powder for concentrate for solution for infusion.
1 viala praška za koncentrat za raztopino za infundiranje 10 vial praška za koncentrat za raztopino za infundiranje 25 vial praška za koncentrat za raztopino za infundiranje
Intravenous use Read the package leaflet before use.
Pred uporabo preberite priloženo navodilo.
Store at 2°C-8°C (in a refrigerator)
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku).
Any unused product should be discarded
Neporabljeno zdravilo morate zavreči.
Gooimeer 10 NL-1411 DD Naarden The Netherlands
Gooimeer 10 NL - 1411 DD Naarden Nizozemska
50 mg per vial
50 mg na vialo
Store at 2°C-8°C (in a refrigerator) Genzyme Europe B. V. -NL
Shranjujte pri temperaturi med 2 °C in 8 °C (v hladilniku) Genzyme Europe B. V. - NL
What Myozyme is and what it is used for 2.
Kaj je zdravilo Myozyme in za kaj ga uporabljamo 2.
Before you use Myozyme 3.
Kaj morate vedeti, preden boste uporabili zdravilo Myozyme 3.
How to use Myozyme 4.
Kako uporabljati zdravilo Myozyme 4.
How to store Myozyme 6.
Shranjevanje zdravila Myozyme 6.
WHAT MYOZYME IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO MYOZYME IN ZA KAJ GA UPORABLJAMO
Myozyme is used to treat patients who have a confirmed diagnosis of Pompe disease.
Zdravilo Myozyme se uporablja za zdravljenje bolnikov s potrjeno diagnozo Pompejeve bolezni.
People with Pompe disease have low levels of an enzyme called α -glucosidase.
Osebe s Pompejevo boleznijo imajo nizko raven encima, imenovanega alfa- glukozidaza.
Glycogen provides the body with energy, but in Pompe disease the levels can get too high.
Pri Pompejevi bolezni se lahko njegove ravni preveč zvišajo.
Myozyme is an artificial enzyme called alglucosidase alfa – this can replace the natural enzyme which is lacking in Pompe disease.
Zdravilo Myozyme je umetni encim, ki se imenuje alglukozidaza alfa – nadomesti lahko naravni encim, ki ga primanjkuje pri Pompejevi bolezni.
The benefits of Myozyme in patients with late onset Pompe disease are not known yet.
Koristi zdravila Myozyme pri bolnikih s poznim nastopom Pompejeve bolezni niso znane.
BEFORE YOU USE MYOZYME
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO MYOZYME
Do not use Myozyme If you are allergic (hypersensitive) to alglucosidase alfa or any of the other ingredients of Myozyme.
Ne uporabljajte zdravila Myozyme Če ste alergični na (preobčutljivi za) alglukozidazo alfa ali katerokoli sestavino zdravila Myozyme.
Take special care with Myozyme If you are treated with Myozyme, you may experience a reaction while you are being given the medicine or during the next 2 hours.
Bodite posebno pozorni pri uporabi zdravila Myozyme Če se zdravite z zdravilom Myozyme, se lahko reakcije pojavijo med dajanjem tega zdravila ali v naslednjih 2 urah.
This is known as an infusion-associated reaction and can sometimes be very severe.
Gre za reakcije, povezane z infuzijo, ki so lahko včasih zelo hude.
You may need to be given additional medicines to prevent an allergic reaction (e. g. antihistamines and/ or corticosteroids) or antipyretics.
Morda boste morali vzeti dodatna zdravila za preprečevanje alergijske reakcije (npr. antihistaminike in/ ali kortikosteroide) ali antipiretike.
Different groups of patients using Myozyme The information in this leaflet applies to all patient groups including children, adolescents, adults and the elderly.
Različne skupine bolnikov, ki uporabljajo zdravilo Myozyme Informacije v tem navodilu veljajo za vse skupine bolnikov, vključno z otroki, mladostniki, odraslimi ali starejšimi bolniki.
Using other medicines
Uporaba drugih zdravil Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta.
21 Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
21 Nosečnost in dojenje Ni izkušenj z uporabo zdravila Myozyme pri nosečnicah.
Ask you doctor or pharmacist for advice before taking any medicine.
Posvetujte se z zdravnikom ali farmacevtom preden vzamete katerokoli zdravilo.
HOW TO USE MYOZYME
KAKO UPORABLJATI ZDRAVILO MYOZYME
Instructions for proper use Myozyme is given through a drip into a vein (by intravenous infusion).
Navodila za pravilno uporabo Zdravilo Myozyme se daje v veno (z intravenskim infundiranjem).
Myozyme is only used under the supervision of a doctor who is knowledgeable in the treatment of Pompe disease.
Zdravilo Myozyme se lahko uporablja le pod nadzorom zdravnika z znanjem o zdravljenju Pompejeve bolezni.
The recommended dosage of Myozyme is 20 mg/ kg body weight given once every 2 weeks.
Priporočen odmerek zdravila Myozyme je 20 mg/ kg telesne mase, ki se daje enkrat na dva tedna.
If you use more Myozyme than you should There are no cases of overdose reported.
Če ste uporabili večji odmerek zdravila Myozyme, kot bi smeli O primerih prevelikega odmerjanja niso poročali.
If you forget to use Myozyme If you have missed an infusion, please contact your doctor.
Če ste pozabili uporabiti zdravilo Myozyme Če ste izpustili infuzijo, obvestite svojega zdravnika.
Like all medicines, Myozyme can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi zdravilo Myozyme neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Side effects were mainly seen while patients were being given the medicine or shortly after (“ infusion related effects”).
Neželene učinke so večinoma opazili med dajanjem tega zdravila ali takoj po njem (» učinki, povezani z infundiranjem «).
Some of these infusion related side effects became serious.
Nekateri neželeni učinki, povezani z infundiranjem, postanejo hudi.