FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 lists adverse reactions reported for the 177 patients treated with Replagal in clinical trials, including 21 patients with history of end stage renal disease, 24 paediatric patients (7 to 17 years of age) and 17 female patients, and from post-marketing spontaneous reports.
Slovenian: Seznam neželenih reakcij v obliki preglednice V preglednici 1 so navedene neželene reakcije, o katerih so poročali pri 177 bolnikih, ki so jih v kliničnih preskušanjih zdravili z zdravilom Replagal; med njimi je bilo 21 bolnikov z anamnezo ledvične bolezni v končni fazi, 24 pediatričnih bolnikov (7-17 let) in 17 žensk, ter neželene reakcije, o katerih so spontano poročali v obdobju trženja.
English: Side effects reported in children were, in general, similar to those reported in adults.
Slovenian: Neželeni učinki, o katerih so poročali pri otrocih, so bili v splošnem podobni tistim pri odraslih.
English: Treatment with the enzyme has been shown to reduce accumulation of Gb3 in many cell types including endothelial and parenchymal cells.
Slovenian: da zdravljenje s tem encimom zmanjša kopičenje Gb3 v različnih vrstah celic, vključno z endotelijskimi in parenhimalnimi celicami.
English: Agalsidase alfa is a form of the human enzyme α-galactosidase.
Slovenian: Agalzidaza alfa je oblika človeškega encima α-galaktozidaze.
English: Consistent with the clinical effects of Replagal, treatment with the enzyme reduced accumulation of Gb3 in many cell types, including renal glomerular and tubular epithelial cells, renal capillary endothelial cells (cardiac and dermal capillary endothelial cells were not examined) and cardiac myocytes.
Slovenian: Skladno s kliničnimi učinki zdravila Replagal je encimsko zdravljenje zmanjšalo kopičenje Gb3 v številnih vrstah celic, vključno z ledvičnimi glomerulnimi in tubulnimi epitelijskimi celicami, celicami kapilarnega endotelija ledvic (celic kapilarnega endotelija srca in kože niso pregledali) in srčnimi mišičnimi celicami.
English: Most undesirable effects were mild to moderate in severity.
Slovenian: Neželeni učinki so bili večinoma blagi do zmerni.
English: What Replagal looks like and contents of the pack
Slovenian: Izgled zdravila Replagal in vsebina pakiranja
English: Two patients with right bundle branch block in the studies conducted reverted to normal following therapy with Replagal.
Slovenian: Pri dveh bolnikih z blokado desne veje srčnega prevodnega sistema, ki sta sodelovala v opravljenih študijah, se je stanje po zdravljenju z zdravilom Replagal normaliziralo.
English: Metabolism and nutrition disorders peripheral oedema
Slovenian: Presnovne in prehranske motnje periferni edem
English: Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Slovenian: Zdravljenje z zdravilom Replagal mora nadzorovati zdravnik, ki ima izkušnje z obravnavo bolnikov s Fabryjevo boleznijo ali drugimi dednimi presnovnimi boleznimi.
English: In clinical studies, neuropathic pain medicinal products (such as carbamazepine, phenytoin and gabapentin) were administered concurrently to most patients without any evidence of interaction.
Slovenian: V kliničnih študijah ob sočasni uporabi zdravila Replagal in zdravil proti nevropatični bolečini (kot so karbamazepin, fenitoin in gabapentin) pri večini bolnikov ni bilo znakov interakcij.
English: It is produced by switching on the gene for α-galactosidase A in cells.
Slovenian: Pridobiva se z vklopom gena za α-galaktozidazo v celicah.
English: However, infusion related reactions (pyrexia, dyspnoea, chest pain) and pain exacerbation occurred more frequently.
Slovenian: Vendar pa so bile reakcije, povezane z infundiranjem (pireksija, dispneja, bolečina v prsnem košu), in eksacerbacija bolečine pogostejše.
English: If mild or moderate acute infusion reactions occur, medical attention must be sought immediately and appropriate actions instituted.
Slovenian: Če se pojavijo blage ali zmerne akutne infuzijske reakcije, mora bolnik takoj poiskati medicinsko pomoč in je treba uvesti ustrezne ukrepe.
English: After 12 to 18 months of maintenance therapy, Replagal improved renal function as measured by inulin based glomerular filtration rate by 8.7 ± 3.7 ml/min.
Slovenian: Po 12 do 18 mesecih vzdrževalnega zdravljenja je zdravilo Replagal izboljšalo delovanje ledvic, merjeno s stopnjo glomerulne filtracije, temelječe na inulinu, za 8,7 ± 3,7 ml/min (p = 0,030).
English: Adverse drug reactions reported in the paediatric population (children and adolescents) were, in general, similar to those reported in adults.
Slovenian: Neželeni učinki zdravila, o katerih so poročali pri pediatričnih bolnikih (otrocih in mladostnikih), so bili na splošno podobni neželenim učinkom, o katerih so poročali pri odraslih.
English: Replagal has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja s stroji Zdravilo Replagal nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: Once diluted, the solution should be mixed gently but not shaken.
Slovenian: Po redčenju morate raztopino nežno premešati, vendar je ne smete stresati.
English: Twelve to 18 months of treatment with Replagal resulted in improvement in quality of life (QoL), as measured by validated instruments.
Slovenian: 12 do 18 mesecev zdravljenja z zdravilom Replagal je izboljšalo kakovost življenja, izmerjeno s preverjenimi metodami.
English: As α-galactosidase A is itself an enzyme, it would be an unlikely candidate for cytochrome P450 mediated drug-drug interactions.
Slovenian: Ker je sama α-galaktozidaza A encim, je malo verjetno, da bi lahko prihajalo do interakcij z drugimi zdravili s pomočjo posredovanja citokroma P450.
English: The recommended dose is an infusion of 0.2 mg for every kg you weigh.
Slovenian: Priporočeni odmerek je infuzija 0,2 mg na vsak kilogram telesne mase.
English: Treatment with Replagal resulted in an 11.5 g decrease in left ventricular mass as measured by magnetic resonance imaging (MRI) in the controlled study, while patients receiving placebo exhibited an increase in left ventricular mass of 21.8 g. In addition, in the first study involving 25 patients, Replagal effected a significant reduction in cardiac mass after 12 to 18 months of maintenance therapy (p<0.001).
Slovenian: V kontrolirani študiji je zdravljenje z zdravilom Replagal povzročilo zmanjšanje mase levega prekata za 11,5 g (izmerjeno z magnetnoresonančnim slikanjem (MRI), pri bolnikih, ki so prejemali placebo, pa je prišlo do povečanja mase levega prekata za 21,8 g. Tudi v prvi študiji, v katero je bilo vključenih 25 bolnikov, je zdravilo Replagal po 12 do 18 mesecih vzdrževalnega zdravljenja povzročilo pomembno zmanjšanje srčne mase (p < 0,001).
English: Infusion related reactions involving the heart including heart rhythm problems, heart muscle ischemia and heart failure, may occur in patients with Fabry disease involving the heart structures (frequency “not known” (cannot be estimated from the available data)).
Slovenian: Pri bolnikih s Fabryjevo boleznijo, ki zajema tudi strukture srca, se lahko pojavijo reakcije srca, povezane z infuzijo, vključno s težavami s srčnim ritmom, ishemijo srčne mišice in popuščanjem srca (pogostost »neznana« (ni mogoče oceniti iz razpoložljivih podatkov)).
English: The safety and efficacy of Replagal was assessed in two randomised, double blind, placebo controlled studies and open label extension studies, in a total of forty patients with a diagnosis of Fabry Disease based on clinical and biochemical evidence.
Slovenian: Varnost in učinkovitost zdravila Replagal so ovrednotili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah in odprtih nadaljevalnih študijah, pri 40 bolnikih z diagnozo
English: In subsequent studies, in male paediatric patients above the age of 7, a reduction in pain was observed after 9 and 12 months of Replagal therapy compared to pretreatment baseline.
Slovenian: V nadaljnjih študijah pri moških pediatričnih bolnikih , starejših od 7 let, so zmanjšanje bolečine opazili po 9 in 12 mesecih zdravljenja z zdravilom Replagal, v primerjavi z izhodiščnimi vrednostmi.
English: 3.5 ml of concentrate for solution for infusion in a 5 ml vial (Type I glass) with a stopper (fluoro-resin coated butyl rubber), a one piece seal (aluminium) and flip-off cap.
Slovenian: 3,5 ml koncentrata za raztopino za infundiranje v 5 ml viali (steklo tipa 1) z zamaškom iz butilne gume s fluorovo smolnato prevleko in enodelno aluminijasto zaporko s ploščico.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/01/189/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/01/189/001
English: This would be about 14 mg or 4 vials (glass bottles) of Replagal for an average size (70 kg) individual.
Slovenian: (70 kg) je to približno 14 mg ali 4 viale (stekleničke) zdravila Replagal.
English: Reproduction toxicity studies in female rats and rabbits have shown no effect on pregnancy or the developing foetus.
Slovenian: Študije vpliva na sposobnost razmnoževanja pri samicah podgan in kuncev niso pokazale nobenega vpliva na brejost in na razvijajoči se zarodek.
English: Limited data are available in patients on dialysis or post-kidney transplantation, no dose adjustment is recommended.
Slovenian: Pri bolnikih na dializi ali po presaditvi ledvic so na voljo omejeni podatki.
English: In children (aged 7-18 years), Replagal administered at 0.2 mg/kg was cleared faster from the circulation than in adults.
Slovenian: Pri otrocih, starih od 7 do 18 let, je bil očistek zdravila Replagal iz obtoka pri odmerku 0,2 mg/kg hitrejši kot pri odraslih.
English: Hypersensitivity reactions have been reported.
Slovenian: Poročali so o preobčutljivostnih reakcijah.
English: Serious infusion reactions have been reported uncommonly; symptoms reported include pyrexia, rigors, tachycardia, urticaria, nausea/vomiting, angioneurotic oedema with throat tightness, stridor and swollen tongue.
Slovenian: O resnih infuzijskih reakcijah so poročali občasno; med njihovimi simptomi so bili zvišanje telesne temperature, okorelost, tahikardija, urtikarija, navzea/bruhanje, angionevrotski edem s stiskanjem grla, stridor in otekanje jezika.
English: In male paediatric Fabry patients plasma Gb3 decreased 40-50% after 6 months of Replagal therapy 0.2 mg/kg and this reduction persisted after a total 4 years of treatment in 11 patients.
Slovenian: Pri moških pediatričnih bolnikih s Fabryjevo boleznijo se je po 6 mesecih zdravljenja z zdravilom Replagal v odmerku 0,2 mg/kg vrednost Gb3 v plazmi zmanjšala za 40-50 %; to zmanjšanje pa se je pri 11 bolnikih ohranilo tudi po 4 letih zdravljenja.
English: Longer term therapy (48-54 months) resulted in stabilisation of GFR in male patients with normal baseline GFR (≥ 90 mL/min/1.73 m2) and with mild to moderate renal dysfunction (GFR 60 to < 90 mL/min/1.73 m2), and in slowing of the rate of decline in renal function and progression to end-stage renal disease in male Fabry patients with more severe renal dysfunction (GFR 30 to < 60 mL/min/1.73 m2).
Slovenian: GFR (≥ 90 ml/min/1,73 m2) in z blago do zmerno ledvično okvaro (GFR 60 do < 90 ml/min/1,73 m2) povzročilo stabilizacijo vrednosti GFR, pri moških bolnikih s Fabryjevo boleznijo s hujšo ledvično okvaro (GFR 30 do < 60 ml/min/1,73 m2) pa upočasnilo slabšanje delovanja ledvic in napredovanje do končne faze ledvične bolezni.
English: Following a single intravenous dose of 0.2 mg/kg, agalsidase alfa had a biphasic distribution and elimination profile from the circulation.
Slovenian: Po enem intravenskem odmerku 0,2 mg/kg je bil profil porazdelitve in izločanja agalzidaze alfa iz krvnega obtoka dvofazen.
English: This pain reduction persisted through 4 years of Replagal therapy in 9 patients (in patients 7 - 18 years of age).
Slovenian: bolnikih trajalo 4 leta zdravljenja z zdravilom Replagal (pri bolnikih 7 - 18 let).
English: Vascular disorders flushing hypertension hypotension
Slovenian: Žilne bolezni pordelost hipertenzija hipotenzija
English: What you need to know before Replagal is given
Slovenian: Kaj morate vedeti, preden boste dobili zdravilo Replagal Zdravila Replagal ne smete dobiti
English: Eye disorders corneal reflex decreased, lacrimation increased
Slovenian: Očesne bolezni zmanjšan refleks roženice, povečano solzenje
English: Most side effects are mild to moderate.
Slovenian: Neželeni učinki so večinoma blagi do zmerni.
English: Based on limited data this percentage has been found to be lower (7%) in the male paediatric population.
Slovenian: Na podlagi navedenih podatkov je ta odstotek manjši
English: Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes.
Slovenian: Zdravilo Replagal se daje v odmerku 0,2 mg/kg telesne mase vsak drugi teden s 40-minutno intravensko infuzijo.
English: Infusion-related symptoms may also include dizziness, hyperhidrosis, hypotension, cough, vomiting and fatigue.
Slovenian: Simptomi, povezani z infundiranjem, lahko vključujejo tudi omotico, hiperhidrozo, hipotenzijo, kašelj, bruhanje in utrujenost.
English: Single doses ranging from 0.007 - 0.2 mg enzyme per kg body weight were administered to adult male patients as 20 - 40 minute intravenous infusions while female patients received 0.2 mg enzyme per kg body weight as 40 minute infusions.
Slovenian: Odrasli bolniki so prejeli posamezne odmerke v razponu od 0,007 do 0,2 mg encima na kilogram telesne mase v obliki 20 do 40-minutnih intravenskih infuzij, medtem ko so bolnice prejele 0,2 mg encima na kilogram telesne mase v obliki 40-minutnih intravenskih infuzij.
English: Tell your doctor if you use any medicines containing chloroquine, amiodarone, benoquin or gentamicin.
Slovenian: Če uporabljate katero koli zdravilo, ki vsebuje klorokin, amiodaron, benokvin ali gentamicin, morate o tem obvestiti zdravnika.
English: Hypersensitivity, including anaphylaxis, has been reported.
Slovenian: Poročali so o preobčutljivosti, vključno z anafilaksijo.
English: After the first 6 months of therapy mean decreases of approximately 20 - 50 % were observed in plasma, urine sediment, liver, kidney, and heart biopsy samples.
Slovenian: Po prvih 6 mesecih zdravljenja so opažali srednje zmanjšanje kopičenja Gb3 v plazmi, sedimentu seča ter vzorcih biopsije jeter, ledvic in srca za približno 20 do 50%.
English: Among 9 boys with left ventricular mass (LVMI) indexed to height2.7 within the normal range for children (<39 g/m2.7 in boys) at baseline, LVMI remained stable at levels below the left ventricular hypertrophy
Slovenian: Pri 9 dečkih, ki so ob izhodišču imeli maso levega prekata (LVMI), indeksirano na telesno višino2.7, v normalnem razponu za otroke (< 39 g/m2.7 pri dečkih), je LVMI
English: Replagal was also associated with improved myocardial contractility, a decrease in mean QRS duration and a concomitant decrease in septal thickness on echocardiography.
Slovenian: Uporaba zdravila Replagal je bila povezana tudi z izboljšanjem krčljivosti srčne mišice, zmanjšanjem srednje dolžine QRS kompleksa in s hkratnim zmanjšanjem debeline septuma, kar je bilo vidno pri ehokardiografiji.
English: Patients with hepatic impairment No studies have been performed in patients with hepatic impairment.
Slovenian: Bolniki z jetrno okvaro Pri bolnikih z jetrno okvaro študije niso bile opravljene.
English: After one year of treatment with agalsidase alfa 0.2 mg/kg every other week, the abnormally high eGFR decreased from 143.4 ± 6.8 to 121.3 ± 5.6 mL/min/1.73 m2 in this subgroup and these eGFRs stabilized in the normal range during 4 years of
Slovenian: 0,2 mg/kg vsak drugi teden se je abnormalno visoka raven receptorjev EGF v tej podskupini zmanjšala s 143,4 ± 6,8 na 121,3 ± 5,6 ml/min/1,73 m2.
English: Patients with renal disease
Slovenian: Bolniki z boleznijo ledvic
English: 13.7% of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Slovenian: Idiosinkratične reakcije, povezane z infundiranjem 13,7 % odraslih bolnikov, zdravljenih z zdravilom Replagal v kliničnih preskušanjih, je izkusilo idiosinkratične reakcije, povezane z infundiranjem.
English: Mean clearance of Replagal in children aged (7-11 years), in adolescents (aged 12-18 years), and adults was 4.2 ml/min/kg, 3.1 ml/min/kg, and 2.3 ml/min/kg, respectively.
Slovenian: Srednja vrednost očistka zdravila Replagal pri otrocih, starih od 7 do 11 let, je bila 4,2 ml/min/kg, pri mladostnikih, starih od 12 do 18 let, 3,1 ml/min/kg, pri odraslih pa
English: Clearance normalised for body weight was 2.66 and 2.10 ml/min/kg for males and females, respectively.
Slovenian: Očistek, normaliziran na telesno maso, je bil približno 2,66 za bolnice in 2,10 ml/min/kg za bolnike.
English: Four of 17 (23.5%) paediatric patients ≥7 years of age enrolled in clinical trials experienced at least one infusion reaction over a period of 4.5 years of treatment (mean duration of approx. 4 years).
Slovenian: 7 let ali več in vključenih v klinična preskušanja, so imeli vsaj eno reakcijo na infundiranje v 4,5 letih zdravljenja (srednje trajanje približno 4 leta).
English: Replagal has to be diluted in 9 mg/ml (0.9%) sodium chloride solution before use.
Slovenian: Pred uporabo je treba zdravilo Replagal razredčiti z 9 mg/ml (0,9 %) raztopino natrijevega klorida.
English: In each treatment group, LVMI remained stable over the treatment period of the study.
Slovenian: V obeh zdravljenih skupinah je ostal indeks mase levega prekata stalen skozi obdobje zdravljenja v okviru študije.
English: Sodium phosphate monobasic, monohydrate polysorbate 20 sodium chloride sodium hydroxide water for injections
Slovenian: natrijev dihidrogenfosfat monohidrat polisorbat 20 natrijev klorid natrijev hidroksid voda za injekcije
English: Fabry Disease is a glycosphingolipid storage disorder that is caused by deficient activity of the lysosomal enzyme α-galactosidase A, resulting in accumulation of globotriaosylceramide (Gb3 or GL-3, also known as ceramidetrihexoside (CTH)), the glycosphingolipid substrate for this enzyme.
Slovenian: Fabryjeva bolezen je motnja skladiščenja glikosfingolipidov, ki jo povzroča premajhna aktivnost lizosomskega encima α-galaktozidaze A, kar povzroči kopičenje globotriaozilceramida (Gb3 ali GL-3,
English: Borderline IgE antibody positivity not associated with anaphylaxis has been reported in clinical trials in a very limited number of patients.
Slovenian: V kliničnih preskušanjih so poročali o mejni pozitivnosti za protitelesa IgE, nepovezani z anafilaksijo, pri zelo omejenem številu bolnikov.
English: Non-clinical data reveal no special hazard for humans based on studies of repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi študij toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: After 6 months of therapy Replagal stabilised renal function compared with a decline in placebo treated patients.
Slovenian: Po 6 mesecih zdravljenja je zdravilo Replagal stabiliziralo delovanje ledvic v nasprotju z upadom ledvične funkcije pri bolnikih, ki so prejemali placebo.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Replagal Vsebina pakiranja in dodatne informacije
English: Patients with renal impairment No dose adjustment is necessary in patients with renal impairment.
Slovenian: Bolniki z ledvično okvaro Pri bolnikih z ledvično okvaro prilagajanje odmerkov ni potrebno.
English: After 12 to 18 months treatment a reduction of 5080% was observed in plasma and urine sediment.
Slovenian: Po 12 do 18 mesecih zdravljenja so opazili za 50 do 80% zmanjšanje kopičenja Gb3 v plazmi in sedimentu seča.
English: If you experience a severe allergic (anaphylactic-type) reaction, the administration of Replagal will be immediately discontinued and an appropriate treatment will have to be initiated by your doctor.
Slovenian: Če boste imeli hudo alergijsko (anafilaktično) reakcijo, bo infundiranje zdravila Replagal takoj prekinjeno, zdravnik pa bo začel ustrezno zdravljenje.
English: Each time you are treated it will take 40 minutes for Replagal to be given to you in a vein.
Slovenian: Vsakič, ko prejmete zdravilo, bo intravenska infuzija zdravila Replagal trajala 40 minut.
English: However, infusion related reactions (fever, difficulty breathing, chest pain) and pain aggravated occurred more frequently.
Slovenian: Vendar so se pogosteje pojavile reakcije, povezane z infuzijo (povišana telesna temperatura, težave pri dihanju, bolečine v prsih), in močnejše bolečine.
English: What Replagal contains
Slovenian: Kaj vsebuje navodilo
English: Based on the analysis of pre- and post-dose liver biopsies in males with Fabry Disease, the tissue halflife has been estimated to be in excess of 24 hours and hepatic uptake of the enzyme estimated to be 10% of administered dose.
Slovenian: Pri moških bolnikih s Fabryjevo boleznijo so na osnovi analize vzorcev jetrne biopsije pred in po odmerku ocenili, da razpolovni čas zdravila v tkivih presega 24 ur, privzem zdravila v jetra pa so ocenili na 10% prejetega odmerka.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON / 3.5 ML VIAL
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA / 3,5-MILILITRSKA VIALA
English: You may drive and use machines whilst on Replagal.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev V obdobju uporabe zdravila Replagal lahko vozite in uporabljate stroje.
English: Each ml of Replagal contains 1 mg of agalsidase alfa.
Slovenian: En ml zdravila Replagal vsebuje 1 mg agalzidaze alfa.
English: Your doctor may stop the infusion temporarily (5 - 10 min) until the symptoms go away and then begin the infusion again.
Slovenian: Zdravnik lahko začasno prekine infundiranje (5 - 10 min), dokler simptomi ne izginejo, nato pa infundiranje nadaljuje.
English: Ear and labyrinth disorders tinnitus, tinnitus aggravated
Slovenian: vključno z motnjami labirinta tinitus, poslabšanje tinitusa
English: In an open‐label randomised study, there were no statistically significant differences between adult patients treated for 52 weeks with 0.2 mg/kg intravenously every other week (n=20) and those treated with 0.2 mg/kg weekly (n=19) in mean change from baseline LVMI or other endpoints (cardiac functional status, renal function, and pharmacodynamic activity).
Slovenian: zdravljenimi 52 tednov z intravenskim odmerkom 0,2 mg/kg vsak drugi teden (n = 20), in tistimi, ki so dobivali po 0,2 mg/kg tedensko (n = 19), kar zadeva srednjo spremembo od izhodišča v indeksu mase levega prekata (LVMI) ali drugih opazovanih dogodkih (delovanje srca, delovanje ledvic in farmakodinamično delovanje).
English: Cardiac disorders tachycardia, palpitations cardiac arrhythmias (atrial fibrillation, ventricular extrasystoles, tachyarrhythmia), myocardial ischaemia, heart failure
Slovenian: (atrijska fibrilacija, ventrikularne ekstrasistole, tahiaritmija), miokardna ishemija, srčna odpoved
English: The infusion can be temporarily interrupted (5 to 10 minutes) until symptoms subside and the infusion may then be restarted.
Slovenian: Infuzijo lahko začasno prekinete (za 5 do 10 minut), dokler simptomi ne izzvenijo, potem pa lahko nadaljujete z njo.
English: The reductions in LV mass observed by echocardiography in both male and female Fabry patients over 24 to 36 months of Replagal treatment were associated with meaningful symptom improvement as measured using the NYHA and CCS in Fabry patients with severe heart failure or anginal symptoms at baseline.
Slovenian: Zaporedne odprte študije so pokazale, da je bilo pomembno zmanjšanje mase levega prekata, izmerjeno z ehokardiografijo, pri moških in ženskah s Fabryjevo boleznijo po 24 do 36 mesecih zdravljenja z zdravilom Replagal povezano s pomembnim izboljšanjem simptomov; zmanjšanje mase je bilo pri začetni vrednosti izmerjeno glede na klasifikaciji NYHA in CCS bolnikov s Fabryjevo boleznijo in hudo srčno odpovedjo ali simptomi angine.
English: Replagal reduced left ventricle mass in treated patients compared to placebo treated patients.
Slovenian: Zdravilo Replagal je pri zdravljenih bolnikih zmanjšalo maso levega prekata v primerjavi s tistimi, ki so dobivali placebo.