FrancophonIA/ELRC3.0 huggingface dataset:
English: A review of cardiac events showed that infusion reactions may be associated with hemodynamic stress triggering cardiac events in patients with pre-existing cardiac manifestations of Fabry disease.
Croatian: Revizija kardioloških događaja pokazala je da reakcije povezane s infuzijom mogu biti povezane s hemodinamskim stresom koji aktivira kardiološke događaje u pacijenata s postojećim kardiološkim manifestacijama Fabryjeve bolesti.
English: An analysis showed that serious adverse events were reported in 39.4% of those patients who switched from agalsidase beta compared to 31.0% in those who were naïve to therapy prior to study entry.
Croatian: Analiza je pokazala da su ozbiljne nuspojave prijavljene kod 39,4 % bolesnika koji su prešli s agalzidaze beta u usporedbi s 31,0 % kod onih koji prije početka kliničkog ispitivanja nisu bili liječeni.
English: Replagal should not be co-administered with chloroquine, amiodarone, benoquin or gentamicin since these substances have the potential to inhibit intra-cellular α-galactosidase activity.
Croatian: Replagal se ne smije primjenjivati istodobno s klorokinom, amiodaronom, benokvinom ili gentamicinom s obzirom na to da te tvari potencijalno mogu inhibirati intracelularnu aktivnost α-galaktozidaze.
English: Your treatment will be supervised by a doctor who specialises in the treatment of Fabry Disease.
Croatian: Vaše liječenje će nadgledati liječnik koji je specijaliziran za liječenje Fabryjeve bolesti.
English: Other infusion-related symptoms may include dizziness and hyperhidrosis.
Croatian: Ostali simptomi povezani s infuzijom mogu uključivati omaglicu i hiperhidrozu.
English: It is expected that its metabolic degradation will follow the pathways of other proteins, i.e. peptide hydrolysis.
Croatian: Očekuje se da se razgrađuje metaboličkim putem kao i drugi proteini, primjerice hidrolizom peptida.
English: In clinical trials doses up to 0.4 mg/kg weekly were used, and their safety profile was not different from the recommended dose of 0.2 mg/kg biweekly.
Croatian: U kliničkim ispitivanjima korištene su doze do 0,4 mg/kg tjedno, a njihov sigurnosni profil nije različit od preporučene doze od 0,2 mg/kg svaki drugi tjedan.
English: A low titre IgG antibody response has been observed in approximately 24% of the male patients treated with Replagal.
Croatian: Odgovor niskim titrom IgG protutijela opažen je kod oko 24 % muških bolesnika liječenih Replagalom.
English: The recommended dose is an infusion of 0.2 mg for every kg you weigh.
Croatian: Preporučena doza je infuzija od 0,2 mg za svaki kilogram Vaše težine.
English: In a second study, fifteen patients with left ventricular hypertrophy completed a 6 month placebocontrolled study and entered an extension study.
Croatian: U drugom ispitivanju, 15 bolesnika s hipertrofijom lijevog ventrikula završilo je šestomjesečno placebom kontrolirano kliničko ispitivanje i uključilo se u produžetak ispitivanja.
English: The adverse reactions categorized as incidence “not known (cannot be estimated from the available data)” are derived from post-marketing spontaneous reports.
Croatian: Nuspojave čija je incidencija navedena kao „nepoznato (ne može se procijeniti iz dostupnh podataka)“ sakupljene su na temelju spontanih prijava nakon stavljanja gotovog lijeka u promet.
English: Most of the time you can still be given Replagal even if these symptoms occur.
Croatian: većini slučajeva primjena Replagala može se nastaviti čak i ako se pojave navedeni simptomi.
English: Mild and transient effects may not require medical treatment or discontinuation of the infusion.
Croatian: Blage i prolazne reakcije obično ne zahtijevaju medicinsko liječenje ni prekid infuzije.
English: There is very limited data on pregnancies exposed to Replagal.
Croatian: Postoje vrlo ograničeni podaci o primjeni Replagala u trudnoći.
English: Following six months of Replagal treatment 12 of 28 male patients showed altered pharmacokinetics including an apparent increase in clearance.
Croatian: Nakon 6 mjeseci liječenja Replagalom kod 12 od 28 muških bolesnika uočena je promjena u farmakokinetici lijeka uključujući i prividno povećanje klirensa.
English: • Since no preservative is present, it is recommended that administration is started as soon as possible after dilution.
Croatian: • S obzirom da nema konzervansa, preporučuje se započeti s primjenom lijeka što je prije moguće nakon razrjeđivanja.
English: Patients switched from agalsidase beta to Replagal had a safety profile consistent with that observed in other clinical experience.
Croatian: Bolesnici koji su prešli s agalzidaze beta na Replagal imali su sigurnosni profil dosljedan s onim zabilježenim u kliničkoj praksi.
English: The presence of extensive renal damage (eGFR <60mL/min) may limit the renal response to enzyme replacement therapy.
Croatian: Opsežno oštećenje bubrega (eGFR <60 ml/min) može ograničiti odgovor bubrega na enzimsku nadomjesnu terapiju.
English: Very limited clinical data on pregnancies exposed to Replagal have shown no adverse effects on the mother and newborn child.
Croatian: Vrlo ograničeni klinički podaci o primjeni Replagala u trudnoći nisu pokazali nuspojave u majke i novorođenčeta.
English: Do not infuse Replagal concomitantly in the same intravenous line with other agents.
Croatian: Nemojte davati infuziju Replagala istodobno s drugim lijekovima u istoj intravenskoj liniji.
English: These changes were associated with the development of low titre antibodies to agalsidase alfa but no clinically significant effects on safety or efficacy were observed in the patients studied.
Croatian: Ta promjena povezana je s razvojem niskog titra protutijela na agalzidazu alfa, ali nisu uočeni klinički značajni učinci na sigurnost ili djelotvornost kod promatranih bolesnika.
English: In this study, only one patient had LVH at baseline and remained stable over time.
Croatian: U tom ispitivanju, samo je jedan bolesnik imao LVH na početku ispitivanja i ostao je stabilan tijekom vremena.
English: The enzyme is then removed from the cells and made into a sterile concentrate for solution for infusion.
Croatian: Nakon toga se enzim uklanja iz stanica i pretvara u sterilni koncentrat otopine za infuziju.
English: The presence of extensive renal damage may limit the renal response to enzyme replacement therapy, possibly due to underlying irreversible pathological changes.
Croatian: Opsežna bubrežna oštećenja mogu ograničiti bubrežni odgovor na enzimsku nadomjesnu terapiju, vjerojatno zbog prisutnih ireverzibilnih patoloških promjena.
English: Metabolism and nutrition disorders peripheral oedema
Croatian: Poremećaji metabolizma i prehrane periferni edem
English: • Calculate the dose and number of Replagal vials needed.
Croatian: • Izračunajte dozu i potreban broj bočica Replagala.
English: Agalsidase alfa has been produced in a human cell line to provide for a human glycosylation profile that can influence uptake by mannose-6-phosphate receptors on the surface of target cells.
Croatian: Agalzidaza alfa stvara se na ljudskim staničnim linijama kako bi se postigao humani profil glikozilacije koji može utjecati na preuzimanje receptorima manoze-6 fosfata na površini ciljnih stanica.
English: Hypersensitivity reactions have been reported.
Croatian: Prijavljene su reakcije preosjetljivosti.
English: - if you are allergic to agalsidase alfa or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte primati Replagal - ako ste alergični na agalzidazu alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Administer the infusion solution over a period of 40 minutes using an intravenous line with an integral filter.
Croatian: Infuzijsku otopinu primijenite u razdoblju od 40 minuta pomoću intravenske linije s ugrađenim filterom.
English: Since no preservative is present, it is recommended that administration is started as soon as possible.
Croatian: S obzirom da u preparatu nema konzervansa, preporučuje se započeti s primjenom lijeka što je prije moguće.
English: Replagal is used to treat adult patients, as well as adolescents and children from the age of 7, with confirmed diagnosis of Fabry Disease.
Croatian: Replagal se primjenjuje za liječenje odraslih bolesnika te adolescenata i djece od 7 godina naviše, s potvrđenom dijagnozom Fabryjeve bolesti.
English: Compared with placebo, treatment with Replagal also reduced accumulation of Gb3.
Croatian: U usporedbi s placebom liječenje Replagalom smanjilo je nakupljanje Gb3.
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.
Croatian: Sigurnost i djelotvornost Replagala ispitani su u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja i u produženom otvorenom ispitivanju na ukupno 40 bolesnika s klinički i biokemijski dokazanom Fabryjevom bolešću.
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza „EXP“ ili Rok valjanosti.
English: Side effects reported in children were, in general, similar to those reported in adults.
Croatian: Nuspojave prijavljene kod djece općenito su slične onima prijavljenima kod odraslih.
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Croatian: Za uputu o razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
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.
Croatian: 3,5 ml koncentrata za otopinu za infuziju u bočici od 5 ml (staklo tip I) s čepom (butilna guma obložena fluororezinom), jednodijelnim zaštitnim zatvaračem (aluminij) i „flip-off“ kapicom.
English: Replagal is administered at a dose of 0.2 mg/kg body weight every other week by intravenous infusion over 40 minutes.
Croatian: Replagal se primjenjuje u dozi od 0,2 mg/kg tjelesne težine svaki drugi tjedan intravenskom infuzijom tijekom 40 minuta.
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.
Croatian: Tablici 1 prikazane su nuspojave zabilježene kod 177 bolesnika koji su u kliničkim ispitivanjima liječeni Replagalom, uključujući 21 bolesnika sa završnim stadijem bubrežne bolesti u anamnezi, 24 pedijatrijska bolesnika (od 7 do 17 godina) i 17 bolesnica i iz spontanih prijava nakon stavljanja gotovog lijeka u promet.
English: Agalsidase alfa catalyses the hydrolysis of Gb3, cleaving a terminal galactose residue from the molecule.
Croatian: Agalzidaza alfa katalizira hidrolizu Gb3 odvajajući terminalnu galaktozu od molekule.
English: Twenty-five patients completed the first study and entered an extension study.
Croatian: Dvadeset i pet bolesnika završilo je prvi dio kliničkog ispitivanja i nastavilo liječenje u produžetku ispitivanja.
English: However, infusion related reactions (fever, difficulty breathing, chest pain) and pain aggravated occurred more frequently.
Croatian: Ipak, reakcije povezane s infuzijom (vrućica, otežano disanje, bol u prsnom košu) i pogoršavanje boli pojavljivale su se češće.
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.
Croatian: Srednji klirens Replagala kod djece (dob 7 - 11 godina), adolescenata (dob 12 - 18 godina) i odraslih bio je 4,2 ml/min/kg, 3,1 ml/min/kg i 2,3 ml/min/kg.
English: After dilution Replagal is given in a vein.
Croatian: Nakon razrjeđivanja, Replagal se primjenjuje u venu.
English: No studies have been conducted with respect to parturition or peri/post-natal development.
Croatian: Nisu provedena ispitivanja koja bi pokazala učinak na porođaj ili perinatalni/postnatalni razvoj.
English: 13.7% of adult patients treated with Replagal in clinical trials have experienced idiosyncratic infusion related reactions.
Croatian: U 13,7 % odraslih bolesnika koji su liječeni Replagalom u sklopu kliničkih ispitivanja uočene su idiosinkrazijske reakcije povezane s infuzijom.
English: The selection of 0.2 mg/kg dose (infused over 40 minutes) for the registration clinical studies was intended to temporarily saturate the ability of the mannose-6phosphate receptors to internalize the agalsidase alfa in the liver and allow distribution of enzyme to other relevant organ tissues.
Croatian: Odabir doze od 0,2 mg/kg (primjenjivane infuzijom tijekom 40 minuta) za klinička ispitivanja za registraciju lijeka bio je namijenjen privremenom zasićivanju sposobnosti receptora za manozu-6-fosfat za unos agalzidaze alfa u jetru i omogućivanju distribucije enzima u druga relevantna organska tkiva.
English: Agalsidase alfa is a form of the human enzyme α-galactosidase.
Croatian: Agalzidaza alfa je oblik ljudskog enzima αgalaktozidaze.
English: Calculate the dose and number of Replagal vials needed.
Croatian: Izračunajte dozu i potreban broj bočica Replagala.
English: This was associated with a significant reduction in chronic neuropathic pain medication use and number of days on pain medication.
Croatian: Ovo je povezano sa značajnim smanjenjem primjene lijekova za ublažavanje kronične neuropatske boli i smanjenjem broja dana na analgeticima.
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.
Croatian: Fabryjeve bolesti koncentracija Gb3 u plazmi smanjila se za 40 - 50% nakon šest mjeseci terapije Replagalom 0,2 mg/kg i ovo smanjenje se zadržalo nakon ukupno 4 godine liječenja kod 11 bolesnika.
English: How Replagal is given
Croatian: Kako se Replagal daje
English: Based on the similarity of pharmacokinetic properties of agalsidase alfa in both males and females, tissue distribution in major tissues and organs is also expected to be comparable in male and female patients.
Croatian: S obzirom na slična farmakokinetička svojstva agalzidaze alfa kod muškaraca i žena može se pretpostaviti da je distribucija u tkiva i organe za ženske i muške bolesnike usporediva.
English: Patients received the recommended dosage of 0.2 mg/kg of Replagal.
Croatian: Bolesnici su primali preporučenu dozu od 0,2 mg/kg Replagala.
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)).
Croatian: Reakcije povezane s infuzijom na račun srca, uključujući probleme srčanog ritma, ishemiju srčanog mišića i zatajivanje srca, mogu se pojaviti kod bolesnika s kardiološkim simptomima Fabryjeve bolesti (učestalost „nepoznato“ (ne može se procijeniti iz dostupnih podataka)).
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.
Croatian: Ako se javi teška alergijska reakcija (anafilaktičkog tipa), primjena Replagala bit će odmah prekinuta i Vaš liječnik će morati započeti potrebno liječenje.
English: This will usually be in your arm.
Croatian: Uobičajeno se primjenjuje u venu na ruci.
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).
Croatian: Dugotrajnija terapija (48 - 54 mjeseca) rezultirala je stabilizacijom GFR-a kod muških bolesnika s normalnom početnom vrijednošću GFR-a (≥90 ml/min/1,73 m2) i s blagom do umjerenom disfunkcijom bubrega (GFR 60 do <90 ml/min/1,73 m2) te usporavanjem stope pogoršanja funkcije bubrega i progresije do završnog stadija bubrežne bolesti kod muškaraca oboljelih od Fabryjeve bolesti s težom bubrežnom disfunkcijom (GFR 30 do <60 ml/min/1,73 m2).
English: Replagal is indicated for long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry Disease (α-galactosidase A deficiency).
Croatian: Replagal se primjenjuje u dugotrajnoj enzimskoj nadomjesnoj terapiji kod bolesnika s dokazanom dijagnozom Fabryjeve bolesti (deficijencija enzima α-galaktozidaze A).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of concentrate for solution for infusion contains 1 mg of agalsidase alfa*.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV 1 ml koncentrata za otopinu za infuziju sadrži 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.
Croatian: Vaš liječnik može privremeno zaustaviti infuziju (5 - 10 min) dok simptomi ne nestanu te nakon toga ponovno nastaviti infuziju.
English: Three of 8 (37.5%) paediatric patients <7 years of age experienced at least one infusion related reaction over a mean observation time of 4.2 years.
Croatian: Kod 3 od 8 (37,5 %) pedijatrijskih bolesnika mlađih od 7 godina uočena je barem jedna reakcija povezana s infuzijom tijekom srednjeg vremena promatranja od 4,2 godine.
English: Kidney biopsy specimens revealed a significant increase in the fraction of normal glomeruli and a significant decrease in the fraction of glomeruli with mesangial widening in patients treated with Replagal in contrast to the patients treated with placebo.
Croatian: Uzorci biopsije bubrega pokazali su značajno povećanje frakcije normalnih glomerula i značajno smanjenje frakcije glomerula s proširenjem mezangija kod bolesnika koji su primali Replagal za razliku od bolesnika koji su liječeni placebom.
English: Adverse drug reactions reported in the paediatric population (children and adolescents) were, in general, similar to those reported in adults.
Croatian: Nuspojave prijavljene kod pedijatrijskih bolesnika (djeca i adolescenti) općenito su slične onima prijavljenim kod odraslih bolesnika.
English: In children (aged 7-18 years), Replagal administered at 0.2 mg/kg was cleared faster from the circulation than in adults.
Croatian: Kod djece (dob 7 - 18 godina) Replagal primijenjen u dozi od 0,2 mg/kg imao je brži klirens iz cirkulacije nego kod odraslih.
English: Care must be taken to ensure the sterility of the prepared solutions since Replagal does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Croatian: Mora se paziti da se osigura sterilnost pripremljenih otopina te se mora primijeniti aseptička tehnika s obzirom da Replagal ne sadrži konzervanse ni bakteriostatske agense.
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.
Croatian: Pojedinačne doze u rasponu od 0,007 - 0,2 mg enzima na kilogram tjelesne težine primijenjene su kod odraslih muških bolesnika kao 20 - 40-minutna intravenska infuzija, dok su bolesnice primile 0,2 mg enzima na kg tjelesne težine u 40-minutnoj infuziji.
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).
Croatian: Kod 4 od 17 (23,5 %) pedijatrijskih bolesnika u dobi od 7 i više godina uključenih u klinička ispitivanja uočena je barem jedna reakcija povezana s infuzijom tijekom razdoblja od 4,5 godina liječenja (srednje vrijeme trajanja otprilike 4 godine).
English: No increase in the incidence of adverse events was detected for this patient.
Croatian: Kod tog bolesnika nije otkrivena povećana incidencija nuspojava.
English: However, infusion related reactions (pyrexia, dyspnoea, chest pain) and pain exacerbation occurred more frequently.
Croatian: Ipak, reakcije povezane s infuzijom (pireksija, dispneja, bol u prsištu) i egzacerbacija boli pojavljivale su se češće.
English: In male paediatric Fabry patients ≥ 7 years of age, hyperfiltration can be the earliest manifestation of renal involvement in the disease.
Croatian: Pedijatrijska populacija Kod muških pedijatrijskih bolesnika s Fabryjevom bolešću u dobi od 7 i više godina, hiperfiltracija može biti najranija manifestacija zahvaćenosti bubrega bolešću.
English: After 12 to 18 months treatment a reduction of 5080% was observed in plasma and urine sediment.
Croatian: Nakon 12 - 18 mjeseci liječenja opaženo je smanjenje u plazmi i sedimentu urina za 50 do 80%.
English: Hypersensitivity, including anaphylaxis, has been reported.
Croatian: Prijavljena je preosjetljivost, uključujući anafilaksiju.
English: Renal elimination of agalsidase alfa is considered to be a minor clearance pathway since pharmacokinetic parameters are not altered by impaired renal function.
Croatian: Eliminacija agalzidaze alfa bubrezima smatra se sporednim putem s obzirom da oštećenje funkcije bubrega ne utječe na farmakokinetičke parametre.
English: Fertility No effects on male fertility were seen in reproductive studies in male rats.
Croatian: U istraživanjima reproduktivnosti nisu opaženi učinci na plodnost mužjaka u štakora.
English: If mild or moderate acute infusion reactions occur, medical attention must be sought immediately and appropriate actions instituted.
Croatian: slučaju blage ili srednje teške akutne infuzijske reakcije odmah se mora potražiti liječnička pomoć i primijeniti odgovarajuće mjere.
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).
Croatian: U otvorenom, randomiziranom ispitivanju, nije bilo statistički značajne razlike između odraslih bolesnika liječenih tijekom 52 tjedna s 0,2 mg/kg intravenski svaki drugi tjedan (n=20) i bolesnika liječenih s 0,2 mg/kg tjedno (n=19) u prosječnoj promjeni u odnosu na početne vrijednosti indeksa mase lijevog ventrikula ili ostale mjere ishoda (srčani funkcionalni status, funkcija bubrega i farmakodinamička aktivnost).
English: Infusion-related symptoms may also include dizziness, hyperhidrosis, hypotension, cough, vomiting and fatigue.
Croatian: Simptomi povezani s infuzijom mogu također uključivati omaglicu, hiperhidrozu, hipotenziju, kašalj, povraćanje i umor.
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.
Croatian: Fabryjeva bolest poremećaj je nakupljanja glikosfingolipida uzrokovanog nedostatnom aktivnošću lizosomskog enzima α-galaktozidaze A, što dovodi do nakupljanja njegovog glikosfingolipidnog supstrata globotriaosilceramida (Gb3 ili GL-3, poznat i kao ceramidtriheksozid (CTH)).
English: If treatment with Replagal makes your body produce antibodies this will not stop Replagal from working and the antibodies may disappear with time.
Croatian: Ako Vaše tijelo tijekom liječenja Replagalom stvori protutijela, to neće zaustaviti učinak Replagala.
English: Replagal treatment should be supervised by a physician experienced in the management of patients with Fabry Disease or other inherited metabolic diseases.
Croatian: Liječenje Replagalom mora nadzirati liječnik s iskustvom u liječenju bolesnika s Fabryjevom bolešću ili drugim nasljednim metaboličkim bolestima.