FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were classified into the following groups: missense (13), complete deletion/large rearrangement (8), and frameshift/ splice site mutations (5).
Slovenian: Bolniki so bili razvrščeni v naslednje skupine: missense mutacija (13), popolna delecija/obsežna preureditev (8) ter mutacija frameshift/splice site (5).
English: There is no known interaction of this medicine with other medicines.
Slovenian: Ni znanih interakcij tega zdravila z drugimi zdravili.
English: The infusion will normally last for 1 to 3 hours and will be given every week.
Slovenian: Infundiranje ponavadi traja od 1 do 3 ur, zdravilo pa vam dajejo enkrat tedensko.
English: From a microbiological safety point of view, the diluted product should be used immediately.
Slovenian: Z vidika mikrobiološke varnosti morate zdravilo porabiti takoj.
English: Heterozygous females were not studied in the clinical trials.
Slovenian: Heterozigotskih žensk v kliničnih preskušanjih niso preučevali.
English: Adverse reaction (preferred term)
Slovenian: Neželeni učinek (priporočeni izraz)
English: Pack sizes of 1, 4 and 10 vials.
Slovenian: Velikosti pakiranja: 1, 4 in 10 vial.
English: Paediatric population The dose for children and adolescents is the same as for adults, 0.5 mg/kg body weight weekly.
Slovenian: Pediatrična populacija Odmerek za otroke in mladostnike je enak kot za odrasle, 0,5 mg/kg telesne mase na teden.
English: In individual cases, socalled ‘neutralising antibodies' may develop, which may diminish activity of Elaprase and your response to treatment.
Slovenian: V posameznih primerih se lahko razvijejo tako imenovana »nevtralizirajoča protitelesa«, ki lahko zmanjšajo delovanje zdravila Elaprase in odziv na zdravljenje.
English: • Difficulty breathing, cough, low oxygen levels in your blood
Slovenian: • težave pri dihanju, kašelj, nizka raven kisika v krvi
English: P-value (compared with placebo)
Slovenian: Vrednost P (v primerjavi s placebom)
English: Do not infuse Elaprase concomitantly in the same intravenous line with other medicinal products.
Slovenian: Zdravila Elaprase ne infundirajte skupaj v isti intravenski liniji z drugimi zdravili.
English: If you have problems breathing, with or without bluish skin, tell your doctor straight away and seek immediate medical assistance.
Slovenian: Če imate težave pri dihanju, s pomodrelo kožo ali brez nje, se takoj posvetujte z zdravnikom in poiščite takojšno zdravniško pomoč.
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).
Slovenian: Idursulfaza se izdeluje v humani celični liniji s tehnologijo genskega inženiringa (ki vključuje uvajanje genetskih informacij v človeške celice v laboratoriju, ki bo izdelal želeno zdravilo).
English: Mean changes from 0.07 l to 0.31 l and percent ranged from 6.3% to 25.5% (maximum at Month 30).
Slovenian: Srednje spremembe so bile od 0,07 l do 0,31 l, odstotni delež pa od 6,3 % do 25,5 % (največji je bil v 30. mesecu).
English: Specific Obligation 4 - To submit data regarding immunogenicity after reexposure to idursulfase within Annual Reassessments.
Slovenian: Posebna obveznost 4 - Predložiti podatke o imunogenosti po ponovni izpostavitvi idursulfazi z vsakoletnimi ponovnimi ocenami.
English: This medicine has been authorised under “exceptional circumstances”.
Slovenian: Zdravilo je pridobilo dovoljenje za promet v „izjemnih okoliščinah“.
English: Table 1: Adverse reactions from clinical trials and post-marketing experience in patients treated with Elaprase.
Slovenian: Tabela 1: Neželeni učinki iz kliničnih preskušanj in obdobja trženja pri bolnikih, zdravljenih z zdravilom Elaprase.
English: This endpoint differed significantly from placebo for patients treated weekly (p=0.0049).
Slovenian: Ta končna točka se je bistveno razlikovala pri bolnikih, ki so prejemali placebo, in bolnikih, ki so enkrat tedensko prejemali zdravilo (p = 0,0049).
English: The occurrence of an adverse reaction in a single patient is defined as common in view of the number of patients treated.
Slovenian: Pojav neželenega učinka pri enem bolniku je zaradi števila sodelujočih bolnikov opredeljen kot pogost.
English: Upon internalization by cells, it is localized within cellular lysosomes, thereby limiting distribution of the protein.
Slovenian: Po internalizaciji v celicah je encim nameščen v lizosomih, zaradi česar je porazdelitev beljakovine omejena.
English: Adverse reactions reported in the paediatric population were, in general, similar to those reported in adults.
Slovenian: Neželeni učinki, o katerih so poročali pri pediatrični populaciji, so bili na splošno podobni kot neželeni učinki, o katerih so poročali pri odraslih.
English: Overall, there was no apparent trend in either systemic exposure or clearance rate of idursulfase with respect to either age or body weight.
Slovenian: Na splošno ni bilo očitnih trendov v sistemski izpostavljenosti ali stopnji očistka idursulfaze v povezavi s starostjo ali telesno maso.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products - enzymes, ATC code: A16AB09.
Slovenian: Farmakoterapevtska skupina: druga zdravila za zdravljenje bolezni prebavil in presnove - encimi, oznaka ATC: A16AB09.
English: This medicine contains 11.1 mg sodium (main component of cooking/table salt) in each vial.
Slovenian: To zdravilo vsebuje 11,1 mg natrija (glavne sestavine kuhinjske/jedilne soli) v eni viali.
English: Elaprase is indicated for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
Slovenian: Zdravilo Elaprase je indicirano za dolgotrajno zdravljenje bolnikov s Hunterjevim sindromom (mukopolisaharidoza II, MPS II).
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.
Slovenian: Narava vašega genotipa (genske sestave vseh aktivnih genov v človeških celicah, ki določa posameznikove posebne, individualne značilnosti) lahko vpliva na terapevtski odziv na to zdravilo ter na tveganje za razvoj protiteles in pojav neželenih učinkov, povezanih z infuzijo.
English: Management of patients must be decided on an individual basis (see section 4.8).
Slovenian: Zdravljenje je treba določiti za vsakega bolnika posebej (glejte poglavje 4.8).
English: In order to improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj.
English: Late emergent symptoms and signs of anaphylactoid/anaphylactic reactions have been observed as long as 24 hours after an initial reaction.
Slovenian: Pozne simptome in znake anafilaktoidnih/anafilaktičnih reakcij so opazili tudi 24 ur po prvi reakciji.
English: Over time the number of these infusion-associated reactions decreases.
Slovenian: Sčasoma se število teh učinkov, povezanih z infundiranjem, zmanjšuje.
English: If you use more Elaprase than you should
Slovenian: Če ste uporabili večji odmerek zdravila Elaprase, kot bi smeli
English: Composite (6MWT and %FVC)
Slovenian: Sestavljeni rezultat (6MWT in %FVK)
English: This is equivalent to 0.6% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 0,6 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: The fifth patient, who had preexisting cardiopathy, was diagnosed with ventricular premature complexes and pulmonary embolism during the study.
Slovenian: Pri petem bolniku z obstoječo kardiopatijo so med študijo diagnosticirali prezgodnje ventrikularne komplekse in pljučno embolijo.
English: If severe allergic reactions occur, your doctor will stop the infusion immediately, and start giving you suitable treatment.
Slovenian: Če se pojavijo hude alergijske reakcije, bo zdravnik prekinil infundiranje in takoj začel ustrezno zdravljenje.
English: Clinical study HGT-ELA-038 evaluated immunogenicity in children 16 months to 7.5 years of age.
Slovenian: V klinični študiji HGT-ELA-038 so ocenili imunogenost pri otrocih, starih od 16 mesecev do 7,5 leta.
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).
Slovenian: Pri štirih bolnikih je med enim ali več infundiranji prišlo do hipoksične epizode, zaradi katerih je bilo zdravljenje s kisikom nujno pri treh bolnikih z obstoječo obstruktivno boleznijo dihalnih poti (dva s predhodno traheotomijo).
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.
Slovenian: Po 105 tednih izpostavljenosti idursulfazi stanje protiteles in genotip nista vplivala na zmanjšanje velikosti jeter ter vranice, razdaljo, prehojeno pri 6-minutnem testu hoje, in forsirane meritve vitalne kapacitete.
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.
Slovenian: To povzroči nenormalno delovanje celic, kar povzroča težave v različnih organih v telesu, to pa lahko povzroči uničenje tkiv ter nepravilno delovanje in odpoved organov.
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.
Slovenian: Pri zdravljenju takšnih bolnikov je treba biti previden in omejiti ali skrbno nadzorovati uporabo antihistaminikov in drugih sedativov.
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.
Slovenian: - če ste doživeli hude ali potencialno smrtno nevarne alergijske reakcije na idursulfazo ali katero koli sestavino tega zdravila (navedeno v poglavju 6) in jih ni mogoče nadzorovati z ustreznim zdravljenjem.
English: Specific Obligation 1 - Hunter Outcome Survey (HOS): available data and updates will be provided within Annual Reassessments.
Slovenian: Posebna obveznost 1 - Raziskava rezultatov pri Hunterjevem sindromu (HOSHunter Outcome Survey): dostopni podatki in posodobitve se bodo predložili z vsakoletnimi ponovnimi ocenami.
English: Results from pivotal clinical study at 0.5 mg/kg per week (Study TKT024).
Slovenian: Rezultati iz ključne klinične študije ob uporabi odmerka 0,5 mg/kg na teden (študija TKT024).
English: The overall neutralizing antibody rate was 26/107 patients (24%).
Slovenian: Nevtralizirajoča protitelesa so se razvila pri skupno 26/107 bolnikov (24 %).
English: It is not known whether idursulfase is excreted in human breast milk.
Slovenian: Ni znano, ali se idursulfaza izloča v materino mleko.
English: ▼This medicine is subject to additional monitoring.
Slovenian: ▼Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: % Change in spleen volume
Slovenian: % spremembe prostornine vranice
English: Do not use this medicine after the expiry date which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake »Uporabno do«.
English: If you forget to use Elaprase
Slovenian: Če ste pozabili uporabiti zdravilo Elaprase
English: As a precautionary measure, it is preferable to avoid the use of idursulfase during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi idursulfaze bolje izogibati.
English: The higher the urinary GAG levels at baseline, the greater the magnitude of decreases in urinary GAG with idursulfase treatment.
Slovenian: Višje kot so ravni GAG v urinu na izhodišču, večje je zmanjšanje ravni GAG v urinu ob zdravljenju z idursulfazo.
English: The frequency of infusion-related reactions decreased over time with continued treatment.
Slovenian: Pogostnost učinkov, povezanih z infundiranjem, se je ob nadaljevanju zdravljenja sčasoma manjšala.
English: In some patients glycosaminoglycan accumulates also in the brain.
Slovenian: Pri nekaterih bolnikih se glikozaminoglikan kopiči tudi v možganih.
English: The longer term effects of antibody development on response to treatment have not been established.
Slovenian: Dolgoročni učinki razvoja protiteles na odziv na zdravljenje še niso ugotovljeni.
English: Most side effects are mild to moderate and associated with the infusion, however some side effects may be serious.
Slovenian: Večina neželenih učinkov je blagih do zmernih in povezanih z infundiranjem, nekateri neželeni učinki so lahko resni.
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.
Slovenian: Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z idursulfazo, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
English: Across clinical studies, serious adverse reactions were reported in a total of 5 patients who received 0.5 mg/kg weekly or every other week.
Slovenian: V vseh kliničnih študijah so o resnih neželenih učinkih poročali pri skupaj petih bolnikih, ki so prejemali 0,5 mg/kg na teden ali na dva tedna.
English: FVC absolute volume (L)
Slovenian: Absolutna prostornina FVK (l)
English: Since more than one infusion-related reaction may have occurred during any single infusion, the above numbers are likely to overestimate the true incidence of infusion reactions.
Slovenian: Med enim infundiranjem se lahko pojavi več kot en učinek, povezan z infundiranjem, zato so navedene številke verjetno večje od dejanske incidence učinkov pri infundiranju.
English: Calculate the total dose to be administered and number of Elaprase vials needed.
Slovenian: Izračunajte skupni odmerek, ki ga boste uporabili, in število potrebnih vial zdravila Elaprase.
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).
Slovenian: Dodatne analize klinične koristi so opravili na posameznih komponentah sestavljenega rezultata primarnega cilja študije, absolutnih spremembah FVK, spremembah ravni GAG v urinu, prostornini jeter in vranice, meritvah forsiranega ekspiracijskega volumna v prvi sekundi (FEV1) in spremembi mase levega ventrikla (LVM).
English: What Elaprase is and what it is used for
Slovenian: Kaj je zdravilo Elaprase in za kaj ga uporabljamo
English: Patients with the most severe pulmonary impairment at baseline (as measured by % predicted FVC) tended to show the least improvement.
Slovenian: Pri bolnikih z najhujšo pljučno odpovedjo na izhodišču (merjeno z odstotkom predvidene FVK) se je pokazalo najmanjše izboljšanje.
English: In addition, mean liver volume decreased to a near maximum extent by Month 8 in all patients previously treated, with a slight increase observed at Month 36.
Slovenian: Poleg tega se je srednja prostornina jeter zmanjšala na skoraj najmanjšo možno do osmega meseca pri vseh bolnikih, ki so jih predhodno zdravili, pri čemer so v 36. mesecu opazili rahlo povečanje.
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.
Slovenian: V študiji so sodelovali bolniki z dokumentiranim pomanjkanjem dejavnosti encima iduronat-2-sulfataze, z odstotkom pričakovane vrednosti FVK < 80 % in širokim spektrom stopenj bolezni.
English: 1.4 to 7.5 (n=27)
Slovenian: 1,4 do 7,5 (n=27)
English: 5 to 11 (n=11)
Slovenian: 5 do 11 (n=11)
English: Available data in animals have shown excretion of idursulfase in milk (see section 5.3).
Slovenian: Razpoložljivi podatki pri živalih kažejo na izločanje idursulfaze v mleko (glejte poglavje 5.3).
English: These patients should be closely monitored and infused in an appropriate clinical setting.
Slovenian: Te bolnike je treba pozorno spremljati, infundiranje pa mora biti opravljeno v ustrezno opremljenih prostorih.
English: Idursulfase has no or negligible influence on the ability to drive and use machines.
Slovenian: Idursulfaza nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
English: This medicine is a concentrate for solution for infusion.
Slovenian: To zdravilo je koncentrat za raztopino za infundiranje.
English: Adverse reactions are listed in table 1 with information presented by system organ class and frequency.
Slovenian: Neželeni učinki na zdravilo so navedeni v tabeli 1, podatki pa so prikazani po organskih sistemih in pogostnosti.
English: The decreases in liver and spleen volumes observed at the end of study TKT024 (week 53) were maintained during the extension study (TKT024EXT) in all patients regardless of the prior treatment they had been assigned.
Slovenian: Zmanjšanje prostornine jeter in vranice, opaženo na koncu študije TKT024 (53. teden), se je vzdrževalo med podaljšano študijo (TKT024EXT) pri vseh bolnikih, ne glede na predhodno obliko zdravljenja, ki jim je bila dodeljena.
English: Severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1 if hypersensitivity is not controllable.
Slovenian: Huda ali smrtno nevarna preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, če preobčutljivosti ni mogoče nadzorovati.
English: Patients in the TKT024 and HGT-ELA-038 studies were also stratified across five weight categories; as shown in the following table:
Slovenian: Bolnike v študijah TKT024 in HGT-ELA-038 so razvrstili tudi v pet kategorij telesne mase, kot je prikazano v spodnji preglednici:
English: Uncommon side effects (may affect up to 1 in 100 people) are: • Quickened breathing
Slovenian: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov) so: • pospešeno dihanje
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.
Slovenian: Zdravilo Elaprase se uporablja kot encimsko nadomestno zdravljenje za zdravljenje otrok in odraslih s Hunterjevim sindromom (mukopolisharidozo II), kadar je količina encima iduronat-2-sulfataze v telesu manjša od normalne, za izboljšanje simptomov bolezni.
English: - The calculated volume of Elaprase should be withdrawn from the appropriate number of vials.
Slovenian: - Vzemite izračunani volumen zdravila Elaprase iz ustreznega števila vial.
English: The longer-term effects of antibody development on clinical outcomes have not been established.
Slovenian: Dolgotrajnih učinkov razvoja protiteles na klinične izide niso ugotovili.
English: This medicine has no or negligible influence on the ability to drive and use machines.
Slovenian: To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost upravljanja vozil in strojev.
English: What you need to know before you use Elaprase
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Elaprase
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.
Slovenian: Najhujša epizoda se je pojavila pri bolniku s febrilno boleznijo dihal, povezana pa je bila s hipoksijo med infundiranjem, ki je povzročila kratek epileptični napad.
English: Other medicines and Elaprase
Slovenian: Druga zdravila in zdravilo Elaprase
English: In the fourth patient, who had less severe underlying disease, spontaneous resolution occurred shortly after the infusion was interrupted.
Slovenian: Četrti bolnik, ki je imel manj hudo obstoječo bolezen, je kmalu po prekinitvi infundiranja spontano okreval.
English: Liver volume normalised by Month 24 for 73% (52 out of 71) of patients with hepatomegaly at baseline.
Slovenian: Prostornina jeter se je do 24. meseca normalizirala pri 73 % (52 od 71) bolnikov s hepatomegalijo na izhodišču.
English: Idursulfase has a molecular weight of approximately 76 kD.
Slovenian: Molska masa idursulfaze je približno 76 kD.
English: 12 to 18 (n=8)
Slovenian: 12 do 18 (n=8)
English: Spleen volume normalised by Months 12 and 24 for 9.7% of patients in the TKT024 Weekly group with splenomegaly.
Slovenian: Prostornina vranice se je do 12. in 24. meseca normalizirala pri 9,7 % bolnikov s splenomegalijo v skupini TKT024 enkrat na teden.
English: Antibodynegative patients were found exclusively in the missense mutation genotype group (see sections 4.4 and 5.1).
Slovenian: Negativne izvide testov za protitelesa so dobili izključno v skupini bolnikov z genotipom z »missense« (drugačnosmiselno) mutacijo (glejte poglavji 4.4 in 5.1).
English: The safety and efficacy of Elaprase has been shown in three clinical studies: two randomised, placebo-controlled clinical studies (TKT008 and TKT024) in adults and children above the age of 5 years and one open-label, safety study (HGT-ELA-038) in children between the age of 16 months and 7.5 years.
Slovenian: Varnost in učinkovitost zdravila Elaprase so dokazali v treh kliničnih študijah: dveh randomiziranih, s placebom nadzorovanih kliničnih študijah (TKT008 in TKT024) pri odraslih in otrocih, starejših od 5 let, in eni odprti študiji varnosti (HGT-ELA-038) pri otrocih, starih od 16 mesecev do 7,5 leta.
English: Excipient with known effect Each vial contains 0.482 mmol of sodium.
Slovenian: Pomožna snov z znanim učinkom Ena viala vsebuje 0,482 mmol natrija.
English: This medicine will be given to you under the supervision of a doctor or nurse who is knowledgeable in the treatment of Hunter syndrome or other inherited metabolic disorders.
Slovenian: To zdravilo boste prejeli pod nadzorom zdravnika ali medicinske sestre z izkušnjami pri zdravljenju Hunterjevega sindroma ali drugih dednih presnovnih bolezni.
English: The primary efficacy endpoint was a two-component composite score based on the sum of the ranks of the change from baseline to the end of the study in the distance walked during six minutes (6minute walk test or 6MWT) as a measure of endurance, and % predicted forced vital capacity (FVC) as a measure of pulmonary function.
Slovenian: Primarni cilj študije je bil dvokomponentni rezultat, ki je temeljil na vsoti ranga spremembe razdalje, prehojene v 6 minutah (6-minutni preizkus s hojo ali 6MWT - „6 minute walk test“) kot mere za vzdržljivost in odstotka pričakovane forsirane vitalne kapacitete (FVK) kot mere za delovanje pljuč.
English: Among all patients, mean % predicted FVC was significantly increased at Month 16, although by Month 36, it was similar to the baseline.
Slovenian: Pri vseh bolnikih je bil srednji odstotek predvidene FVK pomembno povečan v 16. mesecu, čeprav je bil do 36. meseca podoben kot na izhodišču.
English: Method of administration For instructions on dilution of the medicinal product before administration, see section 6.6.
Slovenian: Način uporabe Za navodila glede redčenja zdravila pred dajanjem glejte poglavje 6.6.