FrancophonIA/ELRC3.0 huggingface dataset:
English: Symptoms of life-threatening allergic reactions include, but are not limited to, low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial swelling, hives or rash.
Slovenian: Simptomi življenjsko nevarnih alergijskih reakcij med drugim vključujejo tudi (vendar ne izključno) nizek krvni tlak, zelo hiter srčni utrip, težave pri dihanju, bruhanje, otekanje obraza, koprivnico ali izpuščaje.
English: Any unused product should be discarded.
Slovenian: Neporabljeno zdravilo morate zavreči.
English: If you experience severe ulcerative lesions of your skin, please inform your doctor.
Slovenian: Če se na koži pojavijo hude razjede, morate obvestiti zdravnika.
English: After reconstitution it is a clear, colourless to pale yellow solution, which may contain particles.
Slovenian: Po rekonstituciji je bistra brezbarvna do bledorumena raztopina, ki lahko vsebuje delce.
English: There is no evidence for special considerations when Myozyme is administered to paediatric patients of all ages or older people.
Slovenian: Ni dokazov, da bi bila pri uporabi zdravila Myozyme pri pediatričnih bolnikih vseh starosti ali starejših osebah potrebna posebna previdnost.
English: Sanofi Tel +44 (0) 845 372 7101
Slovenian: Tel +44 (0) 845 372 7101
English: Infantile-onset Pompe disease; clinical trial in patients aged 6 months or less The safety and efficacy of Myozyme was assessed in a pivotal, randomised, open-label, historicallycontrolled clinical trial of 18 non-ventilated infantile-onset patients aged 6 months or less at the onset of treatment.
Slovenian: Zgodnji nastop Pompejeve bolezni; klinično preskušanje pri bolnikih starih 6 mesecev ali manj Varnost in učinkovitost zdravila Myozyme so ocenili v osrednji, randomizirani, odprti, sledeni klinični študiji 18 bolnikov brez predihavanja z zgodnjim nastopom bolezni, starih 6 mesecev ali manj ob začetku zdravljenja.
English: Reconstitute each 50 mg vial of Myozyme with 10.3 ml water for injections using a syringe with a needle diameter not larger than 20 gauge.
Slovenian: Vsako 50 mg vialo zdravila Myozyme rekonstituirajte z 10,3 ml vode za injekcije z uporabo injekcijske brizge z iglo premera največ 20 G (gauge).
English: Six of the 11 patients with available data continued to make motor development gains beyond Week 52 (with individual patient treatment durations ranging from 58 to 168 weeks; mean follow-up period of 121 weeks), including 3 patients ambulatory and 3 patients with only functional sitting skills by the last study visit.
Slovenian: Šest izmed 11 bolnikov, za katere so na voljo podatki, je motorično napredovalo tudi po 52. tednu (s trajanjem zdravljenja pri posameznih bolnikih v razponu med 58 in 168 tednov; povprečno obdobje sledenja 121 tednov); vključno s 3 ambulantnimi bolniki in 3 bolniki s samo funkcionalno sposobnostjo sedenja do zadnjega obiska v študiji.
English: After 52 weeks of treatment, LVM decreased from baseline in all 12 patients with available data and was within normal limits in 6 of 12 patients.
Slovenian: Po 52. tednih zdravljenja, se je vrednost LVM znižala od izhodiščne pri vseh 12 bolnikih, za katere so na voljo podatki, in je bila v mejah normalnih vrednosti pri 6 od 12 bolnikov.
English: • One study in Italy enrolled 74 late-onset patients with up to 48 months follow up.
Slovenian: • V študijo v Italiji z obdobjem spremljanja do 48 mesecev so vključili 74 bolnikov s poznim nastopom bolezni.
English: • One study in Germany enrolled 38 late-onset patients with 36 months follow up.
Slovenian: • V študijo v Nemčiji z obdobjem spremljanja do 36 mesecev so vključili 38 bolnikov s poznim nastopom bolezni.
English: Myozyme is a powder for concentrate for solution for infusion in a vial (50 mg/vial).
Slovenian: Zdravilo Myozyme 50 mg je prašek za koncentrat za raztopino za infundiranje v viali (50 mg/viala).
English: If you are treated with Myozyme, you may experience an infusion-associated reaction while you are being given the medicine or during the hours following the infusion.
Slovenian: Če se zdravite z zdravilom Myozyme, se lahko infuzijske reakcije pojavijo med dajanjem tega zdravila ali v nekaj urah po infundiranju.
English: There was no evidence that IgG antibodies to alglucosidase alfa affected pharmacokinetics.
Slovenian: Ni bilo zaznano, da bi protitelesa IgG na alglukozidazo alfa vplivala na farmakokinetiko.
English: As measured by motor performance age-equivalent scores of the Alberta Infant Motor Scale (AIMS), seven of the 18 patients made motor development gains during the study and were walking independently by the last study assessment (with individual patient treatment durations ranging from 52 to 130 weeks; mean follow-up period of 94 weeks).
Slovenian: Rezultati meritev starosti ustreznih motoričnih sposobnosti po lestvici Alberta Infant Motor Scale (AIMS) kažejo, da je sedem izmed 18 bolnikov motorično napredovalo tekom študije in so samostojno hodili do zadnje ocene študije (s trajanjem zdravljenja pri posameznih bolnikih v razponu od 52 do 130 tednov; povprečno obdobje sledenja 94 tednov).
English: The infantile-onset form of Pompe disease is characterised by massive deposition of glycogen in the heart, and skeletal muscle always resulting in rapidly progressive cardiomyopathy, generalised muscle weakness and hypotonia.
Slovenian: Za zgodnji nastop Pompejeve bolezni je značilno obilno kopičenje glikogena v srcu in skeletnih mišicah, kar se vedno odraža v hitro napredujoči kardiomiopatiji, generalizirani oslabelosti mišic in hipotoniji.
English: • sodium dihydrogen phosphate monohydrate (E339)
Slovenian: • natrijev dihidrogenfosfat monohidrat (E339)
English: Symptoms of such reactions include low blood pressure, very fast heart rate, difficulty breathing, vomiting, facial, lip or tongue swelling, hives or rash.
Slovenian: Simptomi takih reakcij vključujejo nizek krvni tlak, zelo hiter srčni utrip, težave pri dihanju, bruhanje, otekanje obraza, ustnic ali jezika, koprivnico ali izpuščaje.
English: • disodium phosphate heptahydrate (E339)
Slovenian: • natrijev hidrogenfosfat heptahidrat (E339)
English: The recommended dosage of Myozyme is 20 mg per kg of body weight.
Slovenian: Priporočen odmerek zdravila Myozyme je 20 mg na kg telesne mase.
English: It is therefore recommended to perform periodic urinalysis among patients with high IgG antibody titres.
Slovenian: Zato je pri bolnikih z visokimi titri protiteles IgG priporočljiva redna analiza urina.
English: Adverse reactions reported in at least 2 patients are listed in Table 1.
Slovenian: Neželeni učinki zdravila (ADRs), o katerih so poročali pri najmanj 2 bolnikih, so navedeni v tabeli 1.
English: Late-onset Pompe disease; other clinical trials and analyses Three independent, open-label, single arm, investigator-initiated studies with Myozyme were conducted:
Slovenian: Pozen nastop Pompejeve bolezni; druga klinična preskušanja in analize Na pobudo raziskovalca so izvedli tri neodvisne, odprte študije z zdravilom Myozyme z eno skupino preiskovancev:
English: Table 4: Change from baseline: efficacy outcomes in the placebo-controlled study
Slovenian: Tabela 4: Sprememba od izhodiščne vrednosti: izidi učinkovitosti v klinični študiji, kontrolirani s placebom zdravilo Myozyme (N = 60)
English: After 52 weeks of treatment, LVM decreased from baseline in all 14 patients with available data and was within normal limits in 3 of 14 patients.
Slovenian: Po 52. tednih zdravljenja, se je vrednost LVM znižala glede na izhodiščno vrednost pri vseh 14 bolnikih, za katere so na voljo podatki, in je bila v mejah normalnih vrednosti pri 3 izmed 14 bolnikov.
English: 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.
Slovenian: 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.
English: A tendency was observed in infantile patients treated with a higher dose (40 mg/kg) to experience more symptoms when developing IARs.
Slovenian: Pri bolnikih z zgodnjim nastopom bolezni, zdravljenih z višjim odmerkom (40 mg/kg), je bilo opaziti več simptomov pri razvoju infuzijskih reakcij.
English: At 104 weeks of treatment LVM assessments were available for 8 patients, of which 5 decreased to within normal limits.
Slovenian: Pri 104. tednu zdravljenja so bile na voljo ocene vrednosti LVM za 8 bolnikov; od katerih se je 5 bolnikom vrednost LVM znižala do normalnih vrednosti.
English: Nephrotic syndrome was observed in a few patients with Pompe disease treated with alglucosidase alfa and who had high IgG antibody titres (≥ 102,400) (see section 4.8).
Slovenian: Pri nekaj bolnikih s Pompejevo boleznijo, ki so se zdravili z alglukozidazo alfa in so imeli visoke titre protiteles IgG (≥102.400), so opazili nefrotski sindrom (glejte poglavje 4.8).
English: The reconstituted volume is 10.5 ml containing 5 mg enzyme/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.
Slovenian: Rekonstituirana vsebina je 10,5 ml s 5 mg encima/ml in je videti kot bistra brezbarvna do bledorumena raztopina, ki lahko vsebuje delce v obliki tankih belih nitk ali prosojnih vlaken.
English: Patients should be monitored for signs and symptoms of systemic immune-mediated reactions involving skin and other organs while receiving alglucosidase alfa.
Slovenian: Bolnike je treba med prejemanjem alglukozidaze alfa spremljati glede znakov in simptomov sistemskih imunsko posredovanih reakcij na koži in v drugih organih.
English: Sodium dihydrogen phosphate monohydrate (E339) Disodium phosphate heptahydrate (E339) Polysorbate 80 (E433)
Slovenian: 6.1 Seznam pomožnih snovi manitol (E421) natrijev dihidrogenfosfat monohidrat (E339) natrijev hidrogenfosfat heptahidrat (E339) polisorbat 80 (E433)
English: The recommended dose regimen of Myozyme is 20 mg/kg of body weight administered once every 2 weeks as an intravenous infusion.
Slovenian: Priporočen odmerek zdravila Myozyme je 20 mg/kg telesne mase in ga dajemo enkrat na 2 tedna kot intravensko infuzijo.
English: Myozyme 50 mg powder for concentrate for solution for infusion Alglucosidase alfa
Slovenian: Myozyme 50 mg prašek za koncentrat za raztopino za infundiranje alglukozidaza alfa
English: If upon immediate inspection foreign particles other than those described above are observed, or if the solution is discoloured, do not use.
Slovenian: Ne uporabljajte, če ob takojšnjem pregledu opazite tujke, ki niso opisani zgoraj, ali če je raztopina spremenila barvo.
English: EU/1/06/333/001 EU/1/06/333/002 EU/1/06/333/003
Slovenian: EU/1/06/333/002
English: -The active substance is alglucosidase alfa.
Slovenian: - Učinkovina je alglukozidaza alfa.
English: In the second year of treatment, 15 out of 17 patients had further improved weight-for-age percentiles (with individual patient treatment durations ranging from 78 to 142 weeks; mean follow-up period of 111 weeks), 10 out of 16 patients had further improved length-for-age percentiles (with individual patient treatment durations ranging from 90 to 130 weeks; mean follow-up period of 113 weeks) and
Slovenian: V drugem letu zdravljenja je 15 izmed 17 bolnikov še nadalje izboljšalo odstotek telesne mase glede na starost (s trajanjem zdravljenja pri posameznih bolnikih v razponu od 78 do 142 tednov; povprečno obdobje sledenja 111 tednov), 10 izmed 16 bolnikov je še nadalje izboljšalo odstotek višine glede na starost (s trajanjem zdravljenja pri posameznih bolnikih v razponu od 90 do 130 tednov; povprečno obdobje sledenja 113 tednov) ter 11 izmed 15 bolnikov je še nadalje izboljšalo odstotek obsega glave glede na starost (s trajanjem zdravljenja pri posameznih bolnikih v razponu od 90 do 130 tednov; povprečno obdobje sledenje 110 tednov).
English: Cardiac arrest Bradycardia Tachycardia Cyanosis
Slovenian: Srčne bolezni zelo pogosti tahikardija pogosti cianoza neznana zastoj srca bradikardija tahikardija cianoza
English: Method of administration Myozyme should be administered as an intravenous infusion.
Slovenian: Način uporabe Zdravilo Myozyme morate dati z intravensko infuzijo.
English: The recommended dose regimen of alglucosidase alfa is 20 mg/kg of body weight administered once every 2 weeks.
Slovenian: Priporočen odmerek zdravila alglukozidaze alfa je 20 mg/kg telesne mase in ga dajemo enkrat na dva tedna.
English: • One study in the Netherlands enrolled 69 late-onset patients with a median follow-up of 23
Slovenian: • V študijo na Nizozemskem z mediano spremljanja 23 mesecev so vključili 69 bolnikov s poznim nastopom bolezni.
English: Nephrotic syndrome as well as severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa including ulcerative and necrotizing skin lesions (see section 4.4).
Slovenian: Pri uporabi alglukozidaze alfa so ugotovili nefrotski sindrom in hude kožne reakcije, verjetno imunsko posredovane, vključno z ulcerativnimi in nekrotizirajočimi kožnimi lezijami (glejte poglavje 4.4).
English: It is recommended that the infusion begin at an initial rate of 1 mg/kg/h and be gradually increased by 2 mg/kg/h every 30 minutes if there are no signs of IARs (Infusion Associated Reactions) until a maximum rate of 7 mg/kg/h is reached.
Slovenian: Postopno jo povečujemo za 2 mg/kg/h vsakih 30 minut, če ni prisotnih infuzijskih reakcij (IAR - infusion associated reactions), dokler ni dosežena najvišja hitrost 7 mg/kg/h.
English: What you need to know before you are given Myozyme Do not use Myozyme:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Myozime
English: • Agitation
Slovenian: • utrujenost
English: Marketing Authorisation Holder Genzyme Europe B.V.
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Genzyme Europe B.V.
English: Severe cutaneous reactions, possibly immune mediated, have been reported with alglucosidase alfa, including ulcerative and necrotizing skin lesions (see section 4.8).
Slovenian: Pri uporabi alglukozidaze alfa so ugotovili hude kožne reakcije, verjetno imunsko posredovane, vključno z ulcerativnimi in nekrotizirajočimi kožnimi lezijami (glejte poglavje 4.8).
English: For single use only Read the package leaflet before use.
Slovenian: POSTOPEK UPORABE Pred uporabo preberite priloženo navodilo!
English: Tilt and roll each vial gently.
Slovenian: Vsako vialo nežno nagnite in zazibajte.
English: Confidence Interval p-value
Slovenian: Razmerje med učinkom in tveganostjo zdravljenja interval zaupanja p-vrednost n=21
English: -The other ingredients are
Slovenian: - Pomožne snovi so:
English: Infusions should be administered incrementally.
Slovenian: Infundiranje mora potekati rastoče.
English: Myozyme has to be reconstituted with water for injections, then diluted with sodium chloride 9 mg/ml (0.9%) solution for injection and then administered by intravenous infusion.
Slovenian: Zdravilo Myozyme je treba rekonstituirati z vodo za injekcije, razredčiti z natrijevim kloridom 9 mg/ml (0,9 %), raztopino za injiciranje, in nato uporabiti za intravensko infundiranje.
English: • Severe ulcerative lesions of the skin
Slovenian: • hude razjede na koži
English: If you have missed an infusion, please contact your doctor.
Slovenian: Če ste pozabili uporabiti zdravilo Myozyme Če ste izpustili infuzijo, obvestite svojega zdravnika.
English: Patients received 20 mg/kg Myozyme once every two weeks for 26 weeks.
Slovenian: Bolniki so prejemali 20 mg/kg zdravila Myozyme enkrat na vsaka dva tedna v obdobju 26 tednov.
English: Careful consideration should be given to the patient's clinical status prior to administration of Myozyme.
Slovenian: Pred uporabo zdravila Myozyme je treba temeljito preučiti bolnikovo klinično stanje.
English: The pharmacokinetics of alglucosidase alfa 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.
Slovenian: Farmakokinetika alglukozidaze alfa 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.
English: Thus seroconversion is expected to occur in most patients treated with Myozyme.
Slovenian: Zato se pri večini bolnikov, zdravljenih z zdravilom Myozyme, pričakuje pojav serokonverzije.
English: How to store Myozyme
Slovenian: Kako uporabljati zdravilo Myozyme
English: In a pivotal trial including 18 patients, the pharmacokinetics of alglucosidase alfa were evaluated in 15 patients with infantile-onset Pompe disease (all less than 6 months of age 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.
Slovenian: V osrednji raziskavi, ki je vključevala 18 bolnikov je bila farmakokinetika alglukozidaze alfa ovrednotena pri 15 bolnikih z zgodnjim nastopom Pompejeve bolezni (vsi stari 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.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine
Slovenian: O neželenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V*.
English: Tremor Headache
Slovenian: neznana drhtenje glavobol
English: Slowly inject the reconstituted Myozyme directly into the sodium chloride 9 mg/ml (0.9%) solution for injection.
Slovenian: Počasi vbrizgavajte rekonstituirano zdravilo Myozyme neposredno v natrijev klorid 9 mg/ml (0,9 %), raztopino za injiciranje .
English: • Administration
Slovenian: • Uporaba
English: Sanofi Belgium Tél/Tel: + 32 2 710 54 00
Slovenian: België/Belgique/Belgien/ Luxembourg/Luxemburg Sanofi Belgium Tél/Tel: + 32 2 710 54 00
English: The pharmacokinetics of alglucosidase alfa were studied in a population analysis of 32 late-onset Pompe disease patients from the randomized, double-blind, placebo-controlled study ranging in age from 21 to 70 years who received Myozyme 20 mg/kg once every two weeks.
Slovenian: Farmakokinetiko alglukozidaze alfa so raziskali v dvojno slepi klinični študiji, kontrolirani s placebom, z naključno razporeditvijo, in analizirali pri populaciji 32 bolnikov s poznim nastopom Pompejeve bolezni v starosti od 21 do 70 let, ki so prejemali 20 mg/kg zdravila Myozyme enkrat na vsaka dva tedna.
English: Recurrent reactions consisting of flu-like illness or a combination of events such as fever, chills, myalgia, arthralgia, pain, or fatigue occurring post-infusion and lasting usually for a few days, have been observed in some patients treated with alglucosidase alfa.
Slovenian: Pri nekaterih bolnikih, ki so bili zdravljeni z alglukozidazo alfa, so opazili ponavljajoče se reakcije, ki vključujejo gripi podobno bolezen ali kombinacijo dogodkov, kot so zvišana telesna temperatura, mrzlica, mialgija, artralgija, bolečine ali utrujenost, ki se pojavijo po infundiranju in lahko trajajo nekaj dni.
English: The pharmacokinetics of alglucosidase alfa were evaluated in a trial in 5 patients with late-onset Pompe disease aged 6-15 years who received 20 mg/kg alglucosidase alfa once every two weeks.
Slovenian: Farmakokinetika alglukozidaze alfa je bila ovrednotena v preskušanju s 5 bolniki, starimi od 6-15 let, s poznim nastopom Pompejeve bolezni, ki so enkrat na vsaka dva tedna prejemali 20 mg/kg zdravila alglukozidaze alfa.
English: • Wheezing
Slovenian: • Redčenje
English: Urticaria
Slovenian: Redčenje
English: Diarrhoea Vomiting
Slovenian: • mišični krči
English: The study data demonstrated that prophylactic ITI prevents or reduces the occurrence of antibodies against alglucosidase alfa over time, which may maintain clinical benefit of ERT and improve survival in CRIM-negative IOPD patients.
Slovenian: Podatki študije so pokazali, da profilaktična ITI prepreči ali zmanjša pojavljanje protiteles proti alglukozidazi alfa skozi čas.
English: For the full list of excipients, see section 6.1.
Slovenian: Pomožne snovi z znanim učinkom: Za celoten seznam pomožnih snovi glejte poglavje 6.1.
English: Myozyme 50 mg powder for concentrate for solution for infusion
Slovenian: IME ZDRAVILA Myozyme 50 mg prašek za koncentrat za raztopino za infundiranje
English: Glycogen provides the body with energy, but in Pompe disease the levels of glycogen can get too high.
Slovenian: Pri Pompejevi bolezni se lahko njegove ravni preveč zvišajo.
English: Oxygen saturation decreased common Heart rate increased Blood pressure increased
Slovenian: Preiskave zelo pogosti zmanjšana nasičenost s kisikom pogosti pospešen srčni utrip zvišan krvni tlak zvišana telesna temperatura zvišan krvni tlak neznana zmanjšana nasičenost s kisikom pospešen srčni utrip
English: Mean ± s.d.
Slovenian: Vistor hf.
English: • Mottled skin
Slovenian: • rdečica kože
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu, kjer lahko najdete tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: Excipients:
Slovenian: NN:
English: Serious and life-threatening anaphylactic reactions, including anaphylactic shock, have been reported in infantile- and late-onset patients during Myozyme infusions (see section 4.8).
Slovenian: Med infundiranjem zdravila Myozyme so pri bolnikih z zgodnjim in poznim nastopom bolezni poročali o resnih in življenjsko nevarnih anafilaktičnih reakcijah, vključno z anafilaktičnim šokom (glejte poglavje 4.8).
English: The reconstituted volume allows accurate withdrawal of 10.0 ml (equal to 50 mg) from each vial.
Slovenian: Po zgoraj opisani rekonstituciji rekonstituirana raztopina v viali vsebuje 5 mg alglukozidaze alfa na ml. Rekonstituirana količina omogoča natančen odvzem 10,0 ml (enakovredno 50 mg) iz vsake viale.
English: Muscle spasms Muscle twitching Myalgia not known
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva pogosti mišični krči mišično trzanje mialgija neznana artralgija
English: The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Slovenian: Pozen nastop Pompejeve bolezni; ključni klinični preskus Varnost in učinkovitost zdravila Myozyme so ocenili v dvojno slepi klinični študiji, kontrolirani s placebom, z naključno razporeditvijo pri 90 bolnikih s poznim nastopom Pompejeve bolezni, ki so bili stari od 10 do 70 let ob začetku zdravljenja ter predhodno niso prejemali nadomestnega encimskega zdravljenja.
English: Hypertension Hypotension Vasoconstriction Pallor
Slovenian: Bolezni živčevja pogosti drhtenje omotica parestezija glavobol3
English: 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.
Slovenian: Po rekonstituciji raztopina vsebuje 5 mg alglukozidaze alfa/ml in po redčenju koncentracija variira od 0,5 mg do 4 mg/ml.
English: Infantile-onset Pompe disease1
Slovenian: Zgodnji nastop Pompejeve bolezni1
English: There is no experience with overdose of Myozyme.
Slovenian: Če ste uporabili večji odmerek zdravila Myozyme, kot bi smeli S prevelikim odmerjanjem zdravila Myozyme ni izkušenj.
English: Wilcoxon-Mann-Whitney Test p-value Forced Vital Capacity (Percent of predicted normal) Pre-treatment Baseline
Slovenian: povprečna ± s.d. povprečje preizkus Wilcoxon-MannWhitney p-vrednost forsirana vitalna kapaciteta (odstotek predvidene normalne vrednosti) izhodišče pred zdravljenjem povprečna ± s.d. povprečje 78. teden / zadnje opazovanje povprečna ± s.d. povprečje sprememba od izhodišča do 78. tedna / zadnje opazovanje*