FrancophonIA/ELRC3.0 huggingface dataset:
English: This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Croatian: Ishod se značajno razlikovao od placeba za bolesnike liječene jednom tjedno (p=0,0049).
English: Pack sizes of 1, 4 and 10 vials.
Croatian: Veličine pakiranja od 1, 4 i 10 bočica.
English: Store in a refrigerator (2C - 8C).
Croatian: Čuvati u hladnjaku (2°C - 8°C).
English: In individual cases, socalled ‘neutralising antibodies' may develop, which may diminish activity of Elaprase and your response to treatment.
Croatian: U pojedinim slučajevima mogu se razviti takozvana „neutralizirajuća protutijela“, koja mogu smanjiti aktivnost lijeka Elaprase i Vaš odgovor na liječenje.
English: Heterozygous females were not studied in the clinical trials.
Croatian: U kliničkim ispitivanjima nisu proučavane heterozigotne žene.
English: The overall neutralizing antibody rate was 26/107 patients (24%).
Croatian: Ukupna stopa neutralizirajućih protutijela bila je 26/107 bolesnika (24%).
English: P-value (compared with placebo)
Croatian: P-vrijednost (u usporedbi s placebom)
English: Paediatric population The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.
Croatian: Pedijatrijska populacija Doza za djecu i adolescente je ista kao i za odrasle, 0,5 mg/kg tjelesne težine jednom tjedno.
English: The current medical standards for emergency treatment are to be observed.
Croatian: Obvezno je pratiti trenutačno važeće medicinske standarde za liječenje u hitnim slučajevima.
English: You may be given additional medicines such as antihistamines and corticosteroids to treat or help prevent allergic-type reactions.
Croatian: Možda ćete morati primiti dodatne lijekove poput antihistaminika i kortikosteroida za liječenje ili pomoć kod sprječavanja reakcija alergijskog tipa.
English: Urine GAG levels were normalized below the upper limit of normal (defined as 126.6 µg GAG/mg creatinine) in 50% of the patients receiving weekly treatment.
Croatian: Razine urinarnog GAG-a su se normalizirale ispod gornje granice normale (definirane kao 126,6 µg GAG/mg kreatinina) kod 50% bolesnika koji su primali lijek jednom tjedno.
English: What Elaprase is and what it is used for
Croatian: Što je Elaprase i za što se koristi
English: These data will be re-evaluated annually and outcomes reported and discussed within the Annual Reassessments.
Croatian: Ti će se podaci ponovno procjenjivati na godišnjoj razini, a o ishodima će se izvještavati i raspravljati unutar godišnjih procjena.
English: Related reactions in the placebo group were similar in nature and severity to those in the treated group.
Croatian: Povezane reakcije u placebo skupini po prirodi i težini bile su slične onima u liječenoj skupini.
English: As a precautionary measure, it is preferable to avoid the use of idursulfase during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu idursulfaze tijekom trudnoće.
English: Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting distribution of the protein.
Croatian: Nakon internalizacije u stanice, lokalizira se unutar staničnih lizosoma čime ograničava distribuciju proteina.
English: FVC absolute volume (L)
Croatian: Apsolutni volumen FVC-a (L)
English: In some patients glycosaminoglycan accumulates also in the brain.
Croatian: U nekih bolesnika glikozaminoglikan se nakuplja također u mozgu.
English: Do not infuse Elaprase concomitantly in the same intravenous line with other medicinal products.
Croatian: Nemojte davati infuziju lijeka Elaprase istodobno u istoj intravenskoj liniji s drugim lijekovima.
English: Elaprase is administered at a dose of 0.5 mg/kg body weight every week by intravenous infusion over a 3 hour period, which may be gradually reduced to 1 hour if no infusion-associated reactions are observed (see section 4.4).
Croatian: Elaprase se daje u dozi od 0,5 mg/kg tjelesne težine jednom tjedno intravenskom infuzijom tijekom razdoblja od 3 sata, što se postupno može smanjivati na 1 sat ako se ne pojave reakcije povezane s infuzijom (vidjeti dio 4.4).
English: The solution should not be shaken.
Croatian: Otopina se ne smije tresti.
English: After dilution
Croatian: Nakon razrijeđivanja
English: Dizziness, tremor
Croatian: Omaglica, tremor
English: These patients should be closely monitored and infused in an appropriate clinical setting.
Croatian: Te se bolesnike mora pažljivo promatrati i davati im infuziju u prikladnom kliničkom okruženju.
English: Adverse reactions only reported during the post marketing period are also included in the table with a frequency “not known” (cannot be estimated from the available data).
Croatian: Nuspojave prijavljene samo nakon stavljanja lijeka u promet također su obuhvaćene u tablici, a njihova je učestalost označena kao „nepoznata“ (ne može se procijeniti iz dostupnih podataka).
English: What Elaprase looks like and contents of the pack
Croatian: Kako Elaprase izgleda i sadržaj pakiranja
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Croatian: Budući je ovo odobrenje za stavljanje lijeka u promet u iznimnim okolnostima, sukladno članku 14. stavku 8. Uredbe (EZ) br. 726/2004, nositelj odobrenja dužan je unutar navedenog vremenskog roka provesti sljedeće mjere:
English: Instructions for use, handling and disposal
Croatian: Upute za uporabu, rukovanje i zbrinjavanje
English: If you use more Elaprase than you should
Croatian: Ako primijenite više lijeka Elaprase nego što ste trebali
English: Of these 6 (40%) had normalised LVM by the end of the study.
Croatian: Od tih, 6 (40%) su imala normaliziran LVM na kraju ispitivanja.
English: After 105 weeks of exposure to idursulfase, neither antibody status nor genotype affected reductions in liver and spleen size or distance walked in the 6-minute walk test or forced vital capacity measurements.
Croatian: Nakon 105 tjedana izloženosti idursulfazi ni status protutijela ni genotip nisu utjecali na smanjenje veličine jetre ili slezene ili udaljenost prohodanu u 6-minutnom testu hodanja ili mjerenjima forsiranog vitalnog kapaciteta.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Croatian: U ispitivanjima na životinjama nisu utvrđeni izravni ni neizravni štetni učinci na trudnoću, embrionalni/fetalni razvoj, porod ili postnatalni razvoj.
English: The occurrence of an adverse reaction in a single patient is defined as common in view of the number of patients treated.
Croatian: Pojava nuspojava u pojedinog bolesnika definira se kao česta s obzirom na broj liječenih bolesnika.
English: Infusion at home may be considered for patients who have received several months of treatment in the clinic and who are tolerating their infusions well.
Croatian: Infuzija u kućnim uvjetima može se razmotriti kod bolesnika koji su lijek primali nekoliko mjeseci u bolnici na klinici i koji su dobro podnosili infuzije lijeka.
English: Results from pivotal clinical study at 0.5 mg/kg per week (Study TKT024).
Croatian: Rezultati iz pivotalnog kliničkog ispitivanja pri 0,5 mg/kg tjedno (Ispitivanje TKT024).
English: Four patients experienced a hypoxic episode during one or several infusions, which necessitated oxygen therapy in 3 patients with severe underlying obstructive airway disease (2 with a pre-existing tracheostomy).
Croatian: Četiri su bolesnika doživjela hipoksičnu epizodu tijekom jedne ili više infuzija, zbog čega je bilo potrebno liječenje kisikom 3 bolesnika s teškom predležećom bolešću dišnih putova (2 s već postojećom traheostomom).
English: If severe allergic reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment.
Croatian: Ako dođe to teških alergijskih reakcija, Vaš liječnik će odmah zaustaviti infuziju i početi s odgovarajućim liječenjem.
English: Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age.
Croatian: Kliničko ispitivanje HGT-ELA-038 ocjenjivalo je imunogenost u djece u dobi od 16 mjeseci do 7,5 godina.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from idursulfase therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja idursulfazom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: Specific Obligation 4 - To submit data regarding immunogenicity after reexposure to idursulfase within Annual Reassessments.
Croatian: Posebna obveza 4 - Potrebno je podnijeti podatke o imunogenosti nakon ponovne izloženosti idursulfazi u sklopu godišnjih procjena.
English: Nervous system disorders Headache
Croatian: Poremećaji živčanog sustava Glavobolja
English: Institution of positive-airway pressure may be necessary in some cases.
Croatian: U pojedinim će slučajevima možda biti nužno uvođenje pozitivnog tlaka zraka.
English: - The number of vials to be diluted should be determined based on the individual patient's weight and the recommended dose of 0.5 mg/kg.
Croatian: Potrebno je odrediti broj bočica koje treba razrijediti na temelju individualne težine bolesnika i preporučene doze od 0,5 mg/kg.
English: Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Croatian: Elaprase je indiciran za dugotrajno liječenje bolesnika s Hunterovim sindromom (mukopolisaharidoza II, MPS II).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB09.
Croatian: Farmakoterapijska skupina: drugi lijekovi za probavni sustav i metabolizam - enzimi, ATK oznaka: A16AB09.
English: What Elaprase contains
Croatian: Što Elaprase sadrži
English: The nature of your genotype (a genetic make up of all active genes in human cells, which determines one's specific, individual characteristics) may influence your therapeutic response to this medicine, as well as your risk of developing antibodies and infusion-related side effects.
Croatian: Priroda Vašeg genotipa (genetski sastav svih aktivnih gena u ljudskim stanicama, koji određuje specifične, individualne karakteristike pojedinca) može utjecati na terapijski odgovor na ovaj lijek, kao i na rizik od razvoja protutijela i nuspojava povezanih s infuzijom.
English: Chemical and physical in-use stability has been demonstrated for 8 hours at 25°C.
Croatian: Dokazana kemijska i fizička stabilnost u primjeni iznosi 8 sati pri 25 °C.
English: In the fourth patient, who had less severe underlying disease, spontaneous resolution occurred shortly after the infusion was interrupted.
Croatian: Kod četvrtog bolesnika, koji je imao manje tešku predležeću bolest, spontani se oporavak dogodio nedugo nakon prekida infuzije.
English: Care must be taken to ensure the sterility of the prepared solutions since Elaprase does not contain any preservative or bacteriostatic agent; aseptic technique must be observed.
Croatian: Potrebno je osigurati sterilnost pripremljene otopine jer Elaprase ne sadrži konzervanse ni bakteriostatske agense; mora se primijeniti aseptička tehnika.
English: Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single dose toxicity, repeated dose toxicity, toxicity to reproduction and development and to male fertility.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jedne doze, toksičnosti ponovljenih doza, reproduktivne i razvojne toksičnosti te toksičnosti za mušku plodnost.
English: Idursulfase is produced in a human cell line by genetic engineering technology (it involves the introduction of genetic information into human cells in the lab, which will then produce the desired product).
Croatian: Idursulfaza se proizvodi tehnologijom genetičkog inženjerstva na staničnoj liniji ljudskog podrijetla (obuhvaća uvođenje genetičke informacije u ljudske stanice u laboratoriju, koje potom proizvode željeni lijek).
English: The recommended dose is an infusion of 0.5 mg (half a milligram) for every kg you weigh
Croatian: Preporučena doza je infuzija od 0,5 mg (pola miligrama) za svaki kilogram Vaše težine.
English: Additional clinical benefit analyses were performed on individual components of the primary endpoint composite score, absolute changes in FVC, changes in urine GAG levels, liver and spleen volumes, measurement of forced expiratory volume in 1 second (FEV1), and changes in left ventricular mass (LVM).
Croatian: Dodatne analize kliničke koristi provedene su na individualnim komponentama mjere primarnog ishoda kompozitnog rezultata, apsolutnim promjenama u FVC-u, promjenama u razinama urinarnog GAG-a, volumena jetre i slezene, mjerenjima forsiranog ekspiratornog volumena u 1. sekundi (FEV1), i promjenama u masi lijevog ventrikula (LVM).
English: If you have problems breathing, with or without bluish skin, tell your doctor straight away and seek immediate medical assistance.
Croatian: Ako imate problema s disanjem, uz pojavu plavkaste boje kože ili bez nje, odmah obavijestite liječnika i odmah potražite liječničku pomoć.
English: Home infusions should be performed under the surveillance of a physician or other healthcare professional.
Croatian: Infuzije u kućnim uvjetima moraju biti pod nadzorom liječnika ili drugog zdravstvenog radnika.
English: If you have missed an Elaprase infusion, please contact your doctor.
Croatian: Ako ste propustili infuziju lijeka Elaprase, molimo obavijestite svog liječnika.
English: % Change in spleen volume
Croatian: % promjene volumena slezene
English: Patients were classified into the following groups: missense (13), complete deletion/large rearrangement (8), and frameshift/ splice site mutations (5).
Croatian: Bolesnici su bili klasificirani u sljedeće skupine: mutacije „missense“ (mutacije krivog smisla) (13), potpuna delecija/znatno preslagivanje (8) i „frameshift“ (pomak okvira čitanja)/„splice site“ (mjesto izrezivanja) (5).
English: This medicine is a concentrate for solution for infusion.
Croatian: Ovaj lijek je koncentrat za otopinu za infuziju.
English: Urine GAG levels (μg GAG/mg creatinine)
Croatian: Razine urinarnog GAG-a (μg GAG/mg kreatinina)
English: Mean treatment difference compared with placebo (SE)
Croatian: Srednja vrijednost razlike liječenja u usporedbi s placebom (SE)
English: Caution must be exercised in the management and treatment of such patients by limitation or careful monitoring of antihistamine and other sedative medicinal product use.
Croatian: Obvezan je oprez u zbrinjavanju i liječenju takvih bolesnika ograničavanjem ili pažljivim nadgledanjem uporabe antihistaminika i ostalih sedativnih lijekova.
English: Elaprase should not be infused with other medicinal products in the infusion tubing.
Croatian: Elaprase se ne smije primijeniti infuzijom s drugim lijekovima u cjevčici za infuziju.
English: The most severe episode occurred in a patient with a febrile respiratory illness and was associated with hypoxia during the infusion, resulting in a short seizure.
Croatian: Najteža epizoda dogodila se bolesniku oboljelom od febrilne respiratorne bolesti i bila je povezana s hipoksijom tijekom infuzije, što je uzrokovalo kratkotrajni napadaj.
English: Patients using supplemental oxygen should have this treatment readily available during infusion in the event of an infusion-related reaction.
Croatian: Bolesnicima koji koriste dopunski kisik ovo liječenje uvijek mora biti dostupno tijekom infuzije u slučaju reakcije povezane s infuzijom.
English: There is no experience with overdoses of this medicine.
Croatian: Nema iskustva s predoziranjem ovim lijekom.
English: Patients in the TKT024 and HGT-ELA-038 studies were also stratified across five weight categories; as shown in the following table:
Croatian: Bolesnici u ispitivanjima TKT024 i HGT-ELA-038 također su stratificirani u pet kategorija po težini, kao što je prikazano u sljedećoj tablici:
English: The study included patients with a documented deficiency in iduronate-2sulfatase enzyme activity, a percent predicted FVC <80%, and a broad spectrum of disease severity.
Croatian: Ispitivanje je uključivalo bolesnike s dokumentiranom deficijencijom aktivnosti enzima iduronat-2-sulfataze, postotak predviđenog FVC <80% i širokim spektrom težine bolesti.
English: • Difficulty breathing, cough, low oxygen levels in your blood
Croatian: • Poteškoće u disanju, kašalj, niske razine kisika u krvi
English: This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 0,6 % preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Croatian: Pedijatrijska populacija Nuspojave prijavljene u pedijatrijskoj populaciji općenito su bile slične onima u odraslih.
English: Most side effects are mild to moderate and associated with the infusion, however some side effects may be serious.
Croatian: Većina nuspojava je blaga do umjerena i povezana s infuzijom, no neke nuspojave mogu biti ozbiljne.
English: Patients experiencing severe or refractory anaphylactoid/anaphylactic reactions may require prolonged clinical monitoring.
Croatian: Bolesnici s teškim ili refraktornim anafilaktoidnim/anafilaktičkim reakcijama možda će trebati produženi klinički nadzor.
English: The fifth patient, who had preexisting cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Croatian: Petom bolesniku, kod kojeg je već postojala kardiopatija, tijekom ispitivanja dijagnosticirani su preuranjeni ventrikularni kompleksi i plućna embolija.
English: After dilution this medicine is given through a vein (drip feed).
Croatian: Nakon razrjeđivanja, ovaj lijek Vam se daje kroz venu (unos kapanjem).
English: The most common were infusion-related reactions, 202 of which were reported in 22 out of 32 patients following administration of a total of 1580 infusions.
Croatian: Najčešće su to bile reakcije povezane s infuzijom: 202 su bile prijavljene u 22 od 32 bolesnika nakon primjene ukupno 1580 infuzija.
English: The frequency of infusion-related reactions decreased over time with continued treatment.
Croatian: Učestalost reakcija povezanih s infuzijom smanjivala se tijekom vremena uz kontinuirano liječenje.
English: If you forget to use Elaprase
Croatian: Ako ste zaboravili primijeniti Elaprase
English: Antibodynegative patients were found exclusively in the missense mutation genotype group (see sections 4.4 and 5.1).
Croatian: Bolesnici negativni na protutijela zabilježeni su isključivo u skupini s „missense“ mutacijom u genotipu (vidjeti dijelove 4.4 i 5.1).
English: Elaprase is supplied in pack sizes of 1, 4 and 10 vials per carton.
Croatian: Elaprase je dostupan u veličini pakiranja od 1, 4 ili 10 bočica u kutiji.
English: If you suffer from Hunter syndrome, a carbohydrate called glycosaminoglycan which is normally broken down by your body, is not broken down and slowly accumulates in various organs in your body.
Croatian: Ako bolujete od Hunterovog sindroma, ugljikohidrat koji se naziva glikozaminoglikan i koji se uobičajeno razgrađuje u Vašem tijelu, se ne razgrađuje i sporo se nakuplja u različitim organima Vašeg tijela.
English: 1.4 to 7.5 (n=27)
Croatian: 1,4 do 7,5 (n=27)
English: Calculate the total dose to be administered and number of Elaprase vials needed.
Croatian: Izračunajte ukupnu dozu koju treba primijeniti i potreban broj bočica lijeka Elaprase.
English: This medicine contains 11.1 mg sodium (main component of cooking/table salt) in each vial.
Croatian: Ovaj lijek sadrži 11,1 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici.
English: Elaprase is used as enzyme replacement therapy to treat children and adults with Hunter syndrome (Mucopolysaccharidosis II) when the level of the enzyme iduronate-2-sulfatase in the body is lower than normal, helping improve the symptoms of the disease.
Croatian: Elaprase se koristi kao nadomjesna enzimska terapija za liječenje djece i odraslih s Hunterovim sindromom (mukopolisaharidozom II) kada je razina enzima iduronat-2-sulfataze u tijelu manja od normalne, a pomaže u ublažavanju simptoma bolesti.
English: The longer term effects of antibody development on response to treatment have not been established.
Croatian: Dugotrajni učinci razvoja protutijela na odgovor na liječenje nisu ustanovljeni.
English: A total of 108 male Hunter syndrome patients with a broad spectrum of symptoms were enrolled in the two randomized, placebo-controlled clinical studies, 106 continued treatment in two open-label, extension studies.
Croatian: Ukupno je 108 muških bolesnika s Hunterovim sindromom sa širokim spektrom simptoma bilo uključeno u dva randomizirana, placebom kontrolirana klinička ispitivanja, 106 ih je nastavilo liječenje u dva otvorena nastavka kliničkih ispitivanja.
English: If you have experienced severe or potentially life-threatening allergic-type reactions to idursulfase or any of the other ingredients of this medicine (listed in section 6) and these cannot be controlled with appropriate medical treatment.
Croatian: Ako ste imali teške ili potencijalno po život opasne reakcije preosjetljivosti alergijskog tipa na idursulfazu ili neki drugi sastojak ovog lijeka (naveden u dijelu 6) i one se ne mogu kontrolirati odgovarajućim liječenjem.
English: 5 to 11 (n=11)
Croatian: 5 do 11 (n=11)
English: Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.5% (maximum at Month 30).
Croatian: Raspon srednjih vrijednosti bio je od 0,07 l do 0,31 l, a postotci su bili u rasponu od 6,3% do 25,5% (najviše u 30. mjesecu).
English: This causes cells to function abnormally, thereby causing problems for various organs in your body which can lead to tissue destruction and organ malfunction and failure.
Croatian: To uzrokuje nepravilnu funkciju stanica i probleme s različitim organima u Vašem tijelu, što može dovesti do oštećenja tkiva, oštećenja funkcije i zatajenja organa.
English: Available data in animals have shown excretion of idursulfase in milk (see section 5.3).
Croatian: Dostupni podaci u životinja pokazuju da se idursulfaza izlučuje u mlijeko (vidjeti dio 5.3).
English: % Change in liver volume
Croatian: % promjene volumena jetre
English: The decreases in mean liver volume were seen regardless of age, disease severity, IgG antibody status or neutralising antibody status.
Croatian: Smanjivanje srednje vrijednosti volumena jetre uočeno je bez obzira na dob, težinu bolesti, status IgG protutijela ili status neutralizirajućih protutijela.
English: Do not use Elaprase
Croatian: Nemojte primjenjivati Elaprase
English: Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction.
Croatian: Simptomi koji se javljaju s odgodom i znakovi anafilaktoidnih/anafilaktičkih reakcija uočeni su čak 24 sata nakon početne reakcije.
English: Mannose-6-phosphate (M6P) residues on the oligosaccharide chains allow specific binding of the enzyme to the M6P receptors on the cell surface, leading to cellular internalization of the enzyme, targeting to intracellular lysosomes and subsequent catabolism of accumulated GAG.
Croatian: Ostaci manoza-6-fosfata (M6P) na oligosaharidnim lancima omogućuju specifično vezanje enzima na M6P receptore na površini stanice, što dovodi do stanične internalizacije enzima ciljajući unutarstanične lizosome i naknadni katabolizam akumuliranog GAG-a.
English: What you need to know before you use Elaprase
Croatian: Što morate znati prije nego počnete primjenjivati Elaprase
English: Management of patients must be decided on an individual basis (see section 4.8).
Croatian: O liječenju bolesnika mora se odlučiti ovisno o pojedinačnim slučajevima (pogledajte dio 4.8.)
English: There are no data or limited amount of data from the use of idursulfase in pregnant women.
Croatian: Nema podataka ili su podaci o primjeni idursulfaze u trudnica ograničeni.