FrancophonIA/ELRC3.0 huggingface dataset:
English: Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient.
Slovenian: Paziti je treba, da kri ne vstopi v brizgo, napolnjeno z zdravilom, saj obstaja tveganje, da kri v brizgi koagulira in bi fibrinski strdek lahko aplicirali bolniku.
English: • If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients
Slovenian: • če ste alergični na učinkovino (albutrepenonakog alfa) ali katero koli sestavino tega zdravila
English: • If you are allergic to hamster proteins.
Slovenian: • če ste alergični na proteine hrčka.
English: After a bleeding episode during prophylaxis, patients should maintain their prophylaxis regimen as closely as possible, with 2 doses of IDELVION being administered at least 24 hours apart but longer as deemed suitable for the patient.
Slovenian: Po epizodah krvavitev med profilakso se morajo bolniki čimbolj držati svoje sheme profilakse z 2 odmerkoma zdravila IDELVION, ki sta dana vsaj 24 ur narazen, vendar dlje kot se smatra primerno za bolnika.
English: IDELVION (50 (IU/kg)) (N=22)
Slovenian: IDELVION (50 (i.e./kg)) (N=22)
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takih primerih je priporočljivo, da se obrnete na specializirani center za hemofilijo.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovenian: Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Patients < 12 years of age
Slovenian: Bolniki, stari < 12 let
English: You may develop an inhibitor (neutralising antibody) to factor IX, in which case factor IX will not work properly any more.
Slovenian: Lahko razvijete inhibitorje (nevtralizirajoča protitelesa) proti faktorju IX in v tem primeru faktor IX ne bo več deloval pravilno.
English: Paediatric Population Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Slovenian: Pediatrična populacija Pričakuje se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enake kot pri odraslih.
English: Inhibitor development was reported in an ongoing clinical study with previously untreated patients.
Slovenian: O razvoju inhibitorjev so poročali v potekajoči klinični študiji s predhodno nezdravljenimi bolniki.
English: Prolongation of the half-life of IDELVION and the enhanced systemic exposure are achieved by fusion with recombinant albumin.
Slovenian: Podaljšanje razpolovne dobe zdravila IDELVION in večja sistemska izpostavljenost sta dosežena s fuzijo z rekombinantnim albuminom.
English: • The formation of inhibitors (neutralising antibodies) is a known complication that has been reported during treatment with IDELVION, which stops the treatment from working properly.
Slovenian: • Nastanek inhibitorjev (nevtralizirajočih protiteles) je znan zaplet o katerem so poročali med zdravljenjem z zdravilom IDELVION ter ustavi ustrezno delovanje zdravljenja.
English: - Do not use solutions that are cloudy or have deposits.
Slovenian: - Ne uporabljajte raztopin, ki so motne ali imajo usedline.
English: The vials must not be heated above body temperature (37 °C).
Slovenian: Vial ne smete segrevati na temperaturo, ki je višja od telesne (37 ºC).
English: Maintenance dose after 24 - 72 hours if there is further evidence of bleeding.
Slovenian: Vzdrževalni odmerek po 24 - 72 urah, če obstajajo znaki nadaljnje krvavitve.
English: Haemostasis was maintained throughout the study duration.
Slovenian: Ves čas trajanja študije je bila hemostaza ohranjena.
English: The safety and efficacy of using IDELVION for immune tolerance induction has not been established.
Slovenian: Varnost in učinkovitost uporabe zdravila IDELVION za indukcijo imunske tolerance nista bili dokazani.
English: Inject the reconstituted solution slowly (as comfortable for you, up to a maximum of 5 ml/min) into the vein following the instructions given to you by your doctor.
Slovenian: Pripravljeno raztopino injicirajte počasi (tako, da vam je udobno, in sicer do največ 5 ml/min) v veno po navodilih, ki vam jih je dal zdravnik.
English: The following side effects have been reported but it is not known how many people may be affected: • Development of neutralising antibodies (inhibitors) to IDELVION
Slovenian: Poročali so o naslednjih neželenih učinkih, vendar ni znano pri koliko bolnikov so se pojavili: • razvoj nevtralizirajočih protiteles (inhibitorjev) proti zdravilu IDELVION.
English: • The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
Slovenian: • Prašek je treba zmešati z vehiklom (tekočino) in raztopino pod aseptičnimi pogoji posesati iz viale.
English: The perprotocol efficacy analysis includes 15 surgeries performed in 12 patients between 8 and 51 years of age undergoing major or minor surgical, dental or other surgical invasive procedures.
Slovenian: Analiza učinkovitosti po protokolu je vključevala 15 kirurških posegov pri 12 bolnikih, starih od 8 do 51 let, pri katerih so opravili večje ali manjše kirurške posege, zobozdravstvene ali druge kirurške invazivne posege.
English: • Allergic reactions (Hypersensitivity)
Slovenian: • alergijske reakcije (preobčutljivost),
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4).
Slovenian: V nekaterih primerih so te reakcije napredovale do hude anafilaksije in so nastopile v časovni povezavi s pojavom inhibitorjev faktorja IX (glejte tudi poglavje 4.4).
English: The following side effects occurred uncommonly (may affect up to 1 in 100 people):
Slovenian: Naslednji neželeni učinki so se pojavili občasno (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: 21 PTPs remained on the extended 14 day prophylaxis interval for additional treatment duration of 98 to 575 (median 386) days.
Slovenian: 21 predhodno zdravljenih bolnikov je ostalo na podaljšani 14 dnevni profilaksi za dodatno zdravljenje, ki je trajalo 98 do 575 (mediana 386) dni.
English: If your bleeding is not being controlled with IDELVION, tell your doctor immediately.
Slovenian: Če vaša krvavitev z zdravilom IDELVION ni pod nadzorom, nemudoma obvestite zdravnika.
English: It is strongly recommended that every time that IDELVION is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Slovenian: Zelo priporočljivo je, da se vsakič, ko bolnik dobi zdravilo IDELVION, zabeležita ime in serija zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
English: Individual patients may vary in their responses to factor IX, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko med seboj razlikujejo pri svojem odzivu na faktor IX, kar se kaže z različnimi razpolovnimi dobami in različnimi ravnmi povrnitve aktivnosti.
English: Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin.
Slovenian: Aktivirani faktor IX, v kombinaciji z aktiviranim faktorjem VIII, aktivira faktor X. Ta sodeluje pri pretvorbi protrombina v trombin.
English: One pack with 250, 500 or 1000 IU containing: 1 vial with powder
Slovenian: Ena škatla z 250, 500 ali 1000 i.e. vsebuje: 1 vialo s praškom
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodnja preglednica je pripravljena v skladu s klasifikacijo organskih sistemov MedDRA (organski sistem in najustreznejši izraz).
English: You should be monitored carefully for the development of inhibitors.
Slovenian: Potreben bo skrben nadzor glede nastanka inhibitorjev.
English: From those subjects, 8 (38%) experienced at least one bleeding during the 14 day-prophylaxis, while they had no bleeding events during once weekly prophylaxis.
Slovenian: Od teh preiskovancev se je 8 (38 %) preiskovancem pojavila vsaj ena krvavitev med 14 dnevno profilakso, medtem ko niso imeli nobene krvavitve med profilakso enkrat na teden.
English: Treatment should be under the supervision of a physician experienced in the treatment of haemophilia B.
Slovenian: Zdravljenje je treba uvesti pod nadzorom zdravnika, izkušenega v zdravljenju hemofilije B.
English: Animal reproduction studies have not been conducted with factor IX.
Slovenian: Študije na živalih o vplivu na sposobnost razmnoževanja s faktorjem IX niso bile opravljene.
English: The reconstituted solution should be administered by slow intravenous injection.
Slovenian: Rekonstituirano raztopino je treba injicirati počasi intravensko.
English: IDELVION has no influence on the ability to drive and use machines.
Slovenian: Zdravilo IDELVION nima vpliva na sposobnost vožnje in upravljanja strojev.
English: If you stop using IDELVION Do not stop using IDELVION without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo IDELVION Ne prenehajte uporabljati zdravilo IDELVION brez posvetovanja z zdravnikom.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja IX ustreza količini faktorja IX v enem ml normalne humane plazme.
English: Osmolality:
Slovenian: Osmolarnost:
English: The recombinant factor IX portion is identical to the Thr148 allelic form of plasmaderived factor IX.
Slovenian: Delež rekombinantnega faktorja IX je enak alelni obliki Thr148 iz plazme pridobljenega faktorja IX.
English: Four open label clinical studies included 107 subjects with at least one exposure to IDELVION reporting 13 adverse reactions in 7 subjects.
Slovenian: Štiri odprte klinične študije, ki so vključevale 107 preiskovancev z vsaj enim odmerjanjem zdravila IDELVION, so poročale o 13 neželenih učinkih pri 7 preiskovancih.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with IDELVION in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom IDELVION za predhodno nezdravljene bolnike za zdravljenje in preprečevanje krvavitev pri hemofiliji B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestna terapija s faktorjem IX poveča srčno-žilno tveganje.
English: Patients ≥ 12 years of age
Slovenian: Bolniki, stari ≥ 12 let
English: • The solution should be clear or slightly opalescent, yellow to colourless, i.e. it might be sparkling when held up to the light but must not contain any obvious particles.
Slovenian: • Raztopina mora biti bistra ali nekoliko opalescentna, rumena do brezbarvna, kar pomeni, da se lahko svetlika, če jo pogledate proti svetlobi, ne sme pa vsebovati vidnih delcev.
English: A subgroup of patients switched to extended treatment intervals (every 10 or 14 days) with a recommended dose of 75 IU/kg and individual adjustments.
Slovenian: Podskupina bolnikov je prešla na daljši interval (vsakih 10 ali 14 dni) odmerjanja s priporočenim odmerkom 75 i.e./kg in individualnimi prilagoditvami.
English: For injection of IDELVION, only the provided administration sets should be used because treatment failure can occur as a consequence of factor IX adsorption to the internal surface of some injection equipment.
Slovenian: Za injiciranje zdravila IDELVION je treba uporabiti le priloženi komplet za uporabo, saj je lahko zdravljenje neuspešno zaradi adsorpcije faktorja IX na notranje površine nekaterih vrst opreme za injiciranje.
English: Minor or moderate Haemarthrosis, muscle bleeding (except iliopsoas) or oral bleeding
Slovenian: Manjša ali zmerna hemartroza, krvavitev v mišico (razen mišice iliopsoas) ali krvavitev v ustni votlini
English: • your clinical condition and response • your body weight
Slovenian: • vašega kliničnega stanja in odziva,
English: All 27 subjects received weekly prophylaxis treatment with IDELVION for a mean time on study of 13.1 months (9, 18 months).
Slovenian: Vseh 27 preiskovancev je prejemalo zdravilo IDELVION za profilakso enkrat na teden v povprečju 13,1 meseca (9, 18 mesecev).
English: The reconstituted preparation should be injected slowly intravenously at a rate comfortable for the patient up to a maximum of 5 ml/min.
Slovenian: Rekonstituirano zdravilo je treba injicirati počasi intravensko s hitrostjo, udobno za bolnika do največ 5 ml/min.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Slovenian: Aktivnost faktorja IX v plazmi je izražena bodisi kot odstotek (glede na normalno humano plazmo) bodisi v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
English: • During pregnancy and breast-feeding, IDELVION should be given only if it is clearly needed.
Slovenian: • Zdravilo IDELVION uporabljamo med nosečnostjo in dojenjem le, če je nujno potrebno.
English: The genetic fusion of the cDNA of human albumin to the cDNA of human coagulation factor IX enables the protein to be produced as a single recombinant protein and assures product homogeneity by avoiding chemical conjugation.
Slovenian: Genska fuzija cDNA humanega albumina na cDNA humanega koagulacijskega faktorja IX omogoča beljakovini, da nastane kot samostojna rekombinantna beljakovina in z izogibanjem kemijski konjugaciji zagotavlja homogenost izdelka.
English: IDELVION is used to prevent or to halt bleeding caused by the lack of factor IX in patients of all age groups with haemophilia B (also called congenital factor IX deficiency or Christmas disease).
Slovenian: Zdravilo IDELVION se uporablja za preprečevanje ali zaustavljanje krvavitve, ki jo povzroča pomanjkanje faktorja IX pri bolnikih vseh starostnih skupin s hemolijo B (imenovano tudi kongenitalno pomanjkanje faktorja IX ali Christmasova bolezen).
English: Haemophilia B is a sex linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija B je spolno vezana dedna motnja strjevanja krvi, ki nastane zaradi zmanjšane koncentracije faktorja IX in povzroči obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontane ali kot posledica nezgode ali kirurške travme.
English: Genetic fusion of recombinant coagulation factor IX with albumin extends the half-life of factor IX (see section 5.2).
Slovenian: Genska fuzija rekombinantnega koagulacijskega faktorja IX z albuminom podaljša razpolovno dobo faktorja IX (glejte poglavje 5.2).
English: The rate of administration should be determined by the patient's comfort level, up to a maximum of 5 ml/min.
Slovenian: Hitrost dajanja je treba določiti na podlagi bolnikovega počutja, in sicer do največ 5 ml/min.
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Slovenian: Glejte, da odstranite le pretisni omot in ne tudi seta Mix2Vial.
English: Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerek zdravila in trajanje nadomestne terapije sta odvisna od stopnje pomanjkanja faktorja IX, mesta in obsega krvavitve ter bolnikovega kliničnega stanja.
English: Median Annualised Bleeding Rate (ABR) on 7 day prophylaxis with IDELVION for all bleeds was 0.0 (range 0-6) and on 14 day-prophylaxis it was 1.08 (range 0-9.1).
Slovenian: Mediana letne stopnje krvavitve (ABR - Annual Bleeding Rate) je bila pri 7 dnevni profilaksi z zdravilom IDELVION za vse krvavitve 0,0 (razpon 0-6) in pri 14 dnevni profilaksi 1,08 (razpon 0-9,1).
English: What you need to know before you use IDELVION
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo IDELVION
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Slovenian: Podatki iz literature navajajo povezavo med pojavnostjo inhibitorjev faktorja IX in alergijskimi reakcijami.
English: If this happens, you should stop using the medicine immediately and contact your doctor.
Slovenian: Če se to zgodi, nemudoma prenehajte uporabljati zdravilo in se posvetujte z zdravnikom.
English: It is strongly recommended that every time IDELVION is given, the date of administration, the batch number and the injected volume is recorded in the treatment diary.
Slovenian: Priporočamo, da se vsakokrat, ko prejmete odmerek zdravila IDELVION, zabeleži datum dajanja, serijo zdravila in injiciran volumen v vaš dnevnik zdravljenja.
English: In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity level (in % of normal or in IU/dl) in the corresponding period.
Slovenian: V primeru spodaj navedenih vrst krvavitev aktivnost faktorja IX ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v določenem obdobju.
English: In each of these situations, the benefit of treatment with IDELVION should be weighed against the risk of these complications.
Slovenian: V vsakem od teh primerov moramo pretehtati razmerje koristi in tveganja za nastanek zapletov pri zdravljenju z zdravilom IDELVION.
English: Other medicines and IDELVION
Slovenian: Druga zdravila in zdravilo IDELVION
English: What IDELVION is and what it is used for
Slovenian: Kaj je zdravilo IDELVION in za kaj ga uporabljamo
English: There is no information on the effects of factor IX on fertility.
Slovenian: O učinku faktorja IX na plodnost ni podatkov.
English: • Side effects in children and adolescents Side effects in children are expected to be the same as in adults.
Slovenian: Pričakuje se, da bodo neželeni učinki pri otrocih enaki kot pri odraslih.
English: If symptoms of allergic reactions occur, you should stop using the medicine immediately and contact your doctor.
Slovenian: Če se pojavijo simptomi alergijske reakcije, nemudoma prenehajte z uporabo zdravila in pokličite svojega zdravnika.
English: The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Slovenian: Število danih enot faktorja IX je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard WHO za zdravila faktorja IX.
English: 12 to <18 years (N=5)
Slovenian: 12 do <18 let (N=5)
English: IDELVION is presented as a pale yellow to white powder and is supplied with water for injections as solvent.
Slovenian: Zdravilo IDELVION je v obliki bledo rumenega do belega praška in je pakiran skupaj z vodo za injekcije kot vehikel.
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Slovenian: Medsebojna delovanja zdravil humanega koagulacijskega faktorja IX (rDNA) z drugimi zdravili niso znana.
English: 1 to <6 years (N=12)
Slovenian: 1 do <6 let (N=12)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: The cleavable linker between the recombinant factor IX and albumin molecules is derived from the endogenous “activation peptide” in native factor IX.
Slovenian: Odcepni povezovalec med rekombinantnim faktorjem IX in molekulami albumina je pridobljen iz endogenega “aktivacijskega peptida” v naravnem faktorju IX.
English: One previously untreated patient (PUP) from the ongoing clinical trial developed high titre inhibitor against factor IX.
Slovenian: En predhodno nezdravljen bolnik, udeležen v tekočem kliničnem preskušanju, je razvil visok titer inhibitorja faktorja IX.
English: What IDELVION is and what it is used for What you need to know before you use IDELVION How to use IDELVION
Slovenian: Kaj je zdravilo IDELVION in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo IDELVION Kako uporabljati zdravilo IDELVION Možni neželeni učinki
English: The following side effects have been observed with factor IX medicines:
Slovenian: Pri uporabi zdravil s faktorjem IX so se pojavili naslednji stranski učinki:
English: All subjects had severe (FIX level <1%) or moderately severe (FIX level ≤ 2%) haemophilia B. Forty PTPs received IDELVION for prophylaxis.
Slovenian: Vsi preiskovanci so imeli hudo (raven faktorja IX < 1 %) ali zmerno hudo (raven faktorja IX ≤ 2 %) hemofilijo B. Štirideset predhodno zdravljenih bolnikov je prejelo zdravilo IDELVION za profilakso.
English: No symptoms of overdose with IDELVION have been reported.
Slovenian: Ni poročil o simptomih prevelikega odmerjanja zdravila IDELVION.
English: Factor IX is activated by factor VII/tissue factor complex in the extrinsic pathway as well as factor XIa in the intrinsic coagulation pathway.
Slovenian: Faktor IX je v ekstrinzični koagulacijski poti aktiviran s kompleksom faktorja VII/tkivnega faktorja, kot tudi s faktorjem XIa v intrinzični koagulacijski poti.
English: If needed, maintenance dose can be provided after 24 - 72 hours until bleeding stops and healing is achieved.
Slovenian: Če je potrebno, se lahko po 24 - 72 urah uporabi vzdrževalni odmerek, dokler krvavitev ne preneha in pride do celjenja.
English: Allergic type hypersensitivity reactions are possible with IDELVION.
Slovenian: Možne so preobčutljivostne reakcije alergijskega tipa po uporabi zdravila IDELVION.
English: Previously untreated patients The safety and efficacy of IDELVION in previously untreated patients have not yet been established.
Slovenian: Varnost in učinkovitost zdravila IDELVION pri predhodno nezdravljenih bolnikih še nista bili dokazani.
English: For long-term prophylaxis against bleeding in patients with severe hemophilia B, the usual doses are 35 to 50 IU/kg once weekly.
Slovenian: Za dolgotrajno profilakso krvavitev pri bolnikih s hudo hemofilijo B so običajni odmerki 35 do 50 i.e./kg enkrat na teden.
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are in the responsibility of the user.
Slovenian: • Če zdravila ne damo takoj, je za trajanje in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: No investigations on carcinogenicity and reproductive toxicology have been conducted.
Slovenian: Raziskave kancerogenosti, okvar plodnosti in toksičnih učinkov na razvoj ploda niso bile opravljene.
English: The calculation of the required dose of factor IX is based on the empirical finding that 1 International Unit (IU) factor IX per kg body weight is expected to increase the circulating level of factor IX by an average of 1.3 IU/dl (1.3 % of normal) in patients ≥ 12 years of age and by 1.0 IU/dl (1.0 % of normal) in patients < 12 years of age.
Slovenian: Izračun potrebnega odmerka faktorja IX temelji na empirični ugotovitvi, da 1 mednarodna enota (i.e.) faktorja IX na kg telesne mase zviša raven cirkulirajočega faktorja IX v plazmi za približno 1,3 i.e./dl (1,3 % normalne ravni) pri bolnikih ≥ 12 let in za 1,0 i.e./dl (1,0 % normalne ravni) pri bolnikih < 12 let.