FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety and efficacy of using IDELVION for immune tolerance induction has not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka IDELVION za indukciju imunološke tolerancije nisu ustanovljene.
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.
Croatian: Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora IX, mjestu i opsegu krvarenja te kliničkom stanju bolesnika.
English: Do not use the solution if it is cloudy or if it contains flakes or particles.
Croatian: Nemojte primijeniti otopinu ako je zamućena ili sadrži pahuljice ili čestice.
English: What IDELVION looks like and contents of the pack
Croatian: Kako IDELVION izgleda i sadržaj pakiranja
English: Elimination t1/2 (h)
Croatian: Poluvijek eliminacije (t1/2) (h)
English: 21 PTPs remained on the extended 14 day prophylaxis interval for additional treatment duration of 98 to 575 (median 386) days.
Croatian: 21 prethodno liječeni bolesnik ostao je na produljenom 14dnevnom intervalu profilakse zbog dodatnog trajanja liječenja od 98 do 575 (medijan 386) dana.
English: • Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.
Croatian: • Neiskorišteni lijek ili otpadni materijal valja zbrinuti sukladno lokalnim propisima i uputama liječnika.
English: • If you are allergic to hamster proteins.
Croatian: • ako ste alergični na proteine hrčka.
English: Osmolality:
Croatian: Osmolalnost:
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Dozu koja se temelji na tjelesnoj težini možda će biti potrebno prilagoditi u pothranjenih bolesnika ili bolesnika s prekomjernom tjelesnom težinom.
English: What IDELVION is and what it is used for What you need to know before you use IDELVION How to use IDELVION
Croatian: Što je IDELVION i za što se koristi Što morate znati prije nego počnete primjenjivati IDELVION
English: No symptoms of overdose with IDELVION have been reported.
Croatian: Nije prijavljen nijedan simptom predoziranja lijekom IDELVION.
English: The vials must not be heated above body temperature (37 °C).
Croatian: Bočice se ne smiju zagrijavati na temperaturu veću od tjelesne temperature (37ºC).
English: What is IDELVION?
Croatian: Što je IDELVION?
English: Bring the solvent to room temperature (below 25 °C).
Croatian: Zagrijte otapalo na sobnu temperaturu (ispod 25°C).
English: IDELVION has no influence on the ability to drive and use machines.
Croatian: IDELVION ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: What IDELVION is and what it is used for
Croatian: Što je IDELVION i za što se koristi
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).
Croatian: Europska Agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka IDELVION u prethodno neliječenih bolesnika, za indikaciju liječenja i profilakse krvarenja u bolesnika oboljelih od hemofilije B (za podatke o pedijatrijskoj upotrebi vidjeti dio 4.2).
English: The rate of administration should be determined by the patient's comfort level, up to a maximum of 5 ml/min.
Croatian: Brzinu primjene treba odrediti prema razini podnošljivosti u bolesnika, do najviše 5 ml/min.
English: Factor IX level required (%) (IU/dl)
Croatian: Potrebna vrijednost faktora IX (%) (IU/dl)
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.
Croatian: Treba paziti da krv ne dospije u štrcaljku s lijekom jer tada postoji rizik da ona u štrcaljki koagulira i da se bolesniku injiciraju fibrinski ugrušci.
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).
Croatian: U nekim su slučajevima te reakcije uznapredovale do teške anafilaksije, a njihov je nastup bio vremenski blisko povezan s razvojem inhibitora faktora IX (vidjeti i dio 4.4).
English: Individual patients may vary in their responses to factor IX, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu imati različite odgovore na faktor IX, pri čemu se postižu različiti poluvjekovi i različite razine povrata.
English: One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma.
Croatian: Jedna internacionalna jedinica (IU) aktivnosti faktora IX jednaka je količini faktora IX u jednom ml normalne ljudske plazme.
English: 1 filter transfer device 20/20
Croatian: 1 sustav za prijenos s filtrom 20/20
English: After filtering or withdrawal (see below) the solution should be checked by eye, before it is used.
Croatian: Nakon filtriranja ili izvlačenja (pogledajte u nastavku), otopinu prije primjene treba vizualno pregledati.
English: The IDELVION solution must not be diluted.
Croatian: IDELVION otopina se ne smije razrjeđivati.
English: If your bleeding is not being controlled with IDELVION, tell your doctor immediately.
Croatian: Ako primjenom lijeka IDELVION ne uspijevate kontrolirati krvarenje, odmah o tome obavijestite svog liječnika.
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.
Croatian: • Nastanak inhibitora (neutralizirajućih protutijela) poznata je komplikacija koja se može javiti tijekom liječenja i učiniti ga nedjelotvornim.
English: The recombinant factor IX portion is identical to the Thr148 allelic form of plasmaderived factor IX.
Croatian: Dio koji čini rekombinantni faktor IX identičan je alelnom obliku Thr148 faktora IX dobivenog iz plazme.
English: If not used immediately, in-use storage times and conditions prior to use are in the responsibility of the user.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja lijeka odgovornost su korisnika.
English: • Injection site reactions
Croatian: • reakcije na mjestu primjene
English: • Allergic reactions (Hypersensitivity)
Croatian: • alergijeske rekacije (preosjetljivost)
English: Pale yellow to white powder and clear, colourless solvent for solution for injection.
Croatian: Prašak svjetložute do bijele boje i bistro, bezbojno otapalo za otopinu za injekciju.
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.
Croatian: Podskupina bolesnika bila je prebačena na produljeni interval (svakih 10 ili 14 dana) s preporučenom dozom od 75 IU/kg te individualnom prilagodbom.
English: You may develop an inhibitor (neutralising antibody) to factor IX, in which case factor IX will not work properly any more.
Croatian: Može se razviti inhibitor faktora IX (neutralizirajuće protutijelo) i tada faktor IX više neće pravilno djelovati.
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.
Croatian: U slučaju sljedećih događaja krvarenja, aktivnost faktora IX ne smije pasti ispod navedene razine aktivnosti u plazmi (izražene u % normalne vrijednosti ili u IU/dl) u odgovarajućem razdoblju.
English: Paediatric Population Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava u djece biti slične kao i u odraslih.
English: Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed.
Croatian: Bolesnici s hemofilijom B imaju nedostatak faktora IX što znači da im se krv ne zgrušava dovoljno brzo pa postoji povećana sklonost krvarenju.
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.
Croatian: Izrazito se preporučuje pri svakoj primjeni lijeka IDELVION u bolesnikov karton upisati naziv i broj serije lijeka kako bi se održala veza između bolesnika i serije lijeka.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, pečenje i peckanje na mjestu infuzije, zimicu, navale vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) primijećene su rijetko, a u nekim slučajevima mogu uznapredovati do teške anafilaksije (uključujući šok).
English: General instructions - The reconstituted solution should be clear or slightly opalescent, yellow to colourless.
Croatian: Opće upute - Rekonstituirana otopina mora biti bistra ili blago opalescentna te žuta do bezbojna.
English: No interactions of human coagulation factor IX products with other medicinal products have been reported.
Croatian: Nisu prijavljene interakcije između lijekova koji sadrže ljudski koagulacijski faktor IX i drugih lijekova.
English: • Allergic (hypersensitivity) reactions are possible.
Croatian: • Moguće su alergijske reakcije (reakcije preosjetljivosti).
English: What you need to know before you use IDELVION
Croatian: Što morate znati prije nego počnete primjenjivati IDELVION
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Croatian: Nakon ponovljenog liječenja lijekovima koji sadrže humani koagulacijski faktor IX, bolesnike je potrebno nadzirati zbog mogućeg razvoja neutralizirajućih protutijela (inhibitora), čiju količinu treba odrediti u Bethesda jedinicama (BU) uz pomoć odgovarajućih bioloških testova.
English: The cleavable linker between the recombinant factor IX and albumin molecules is derived from the endogenous “activation peptide” in native factor IX.
Croatian: Raskidiva poveznica između molekule rekombinantnog faktora IX i molekule albumina dobivena je od endogenog “aktivacijskog peptida” u nativnom faktoru IX.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim faktorima kardiovaskularnog rizika nadomjesna terapija faktorom IX može povećati kardiovaskularni rizik.
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.
Croatian: Izrazito se preporučuje da se svaki puta kad se primijenjuje IDELVION u dnevnik liječenja zabilježi datum primjene, broj serije i injicirani volumen lijeka.
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).
Croatian: IDELVION se koristi za sprječavanje ili zaustavljanje krvarenja koje uzrokuje nedostatna količina faktora IX u bolesnika svih dobnih skupina s hemofilijom B (koja se još naziva i prirođenim nedostatkom faktora IX ili Christmasovom bolešću).
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.
Croatian: Hemofilija B je spolno vezan nasljedni poremećaj koagulacije krvi uslijed smanjenih vrijednosti faktora IX, a uzrokuje obilno krvarenje u zglobove, mišiće ili unutarnje organe, koje može nastati spontano ili kao posljedica slučajne ili kirurške traume.
English: Driving and using machines IDELVION does not effect your ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima IDELVION ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab.
Croatian: Pažljivo uklonite zaštitne zatvarače s bočica te očistite izložene gumene čepove tupferom natopljenim alkoholom.
English: All 27 subjects received weekly prophylaxis treatment with IDELVION for a mean time on study of 13.1 months (9, 18 months).
Croatian: Svih 27 bolesnika primali su tjednu profilaksu s lijekom IDELVION sa srednjom vrijednosti vremena ispitivanja od 13,1 mjesec (9,18 mjeseci).
English: IDELVION remains intact in the circulation until factor IX is activated, whereupon albumin is cleaved, releasing activated factor IX (FIXa) when it is needed for coagulation.
Croatian: IDELVION ostaje u krvotoku u nepromijenjenom obliku sve dok se ne aktivira faktor IX. Nakon toga se albumin odcjepljuje, oslobađajući aktivirani faktor IX (FIXa) kada je on potreban za koagulaciju.
English: The following side effects have been observed with factor IX medicines:
Croatian: Sljedeće su nuspojave primijećene kod primjene lijekova koji sadrže faktor IX:
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable.
Croatian: Osobito u slučaju većih kirurških zahvata, prijeko je potrebno precizno pratiti nadomjesnu terapiju uz pomoć analize koagulacije (određivanja aktivnosti faktora IX u plazmi).
English: 12 to <18 years (N=5)
Croatian: 12 do < 18 godina (N=5)
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Croatian: Postoji mogući rizik od epizoda tromboembolije nakon primjene lijekova koji sadrže faktor IX; taj je rizik viši kod primjene pripravaka niske čistoće.
English: What IDELVION contains
Croatian: Što IDELVION sadrži
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.
Croatian: Za injiciranje lijeka IDELVION treba koristiti samo priložene setove za primjenu; u protivnom liječenje može biti neuspješno zbog adsorpcije faktora IX na unutarnju površinu nekih pribora za injekciju.
English: Genetic fusion of recombinant coagulation factor IX with albumin extends the half-life of factor IX (see section 5.2).
Croatian: Genska fuzija rekombinantnog koagulacijskog faktora IX s rekombinantnim albuminom produljuje poluvijek faktora IX (vidjeti dio 5.2).
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).
Croatian: Annualised Bleeding Rate) 7. dana profilakse s lijekom IDELVION za sva krvarenja bio je 0,0 (raspon 0-6) te 14. dana profilakse 1,08 (raspon 0-9,1).
English: By replacement therapy the plasma levels of factor IX is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom povećavaju se vrijednosti faktora IX u plazmi, čime se omogućuje privremena korekcija nedostatka faktora te korekcija sklonosti krvarenju.
English: For long-term prophylaxis against bleeding in patients with severe hemophilia B, the usual doses are 35 to 50 IU/kg once weekly.
Croatian: Za dugoročnu profilaksu protiv krvarenja u bolesnika s teškom hemofilijom B, uobičajene doze su 35 do 50 IU/kg jednom tjedno.
English: • the severity of your disease
Croatian: • težini bolesti
English: Four open label clinical studies included 107 subjects with at least one exposure to IDELVION reporting 13 adverse reactions in 7 subjects.
Croatian: Tijekom četiri otvorena klinička ispitivanja provedena u 107 ispitanika u kojih je najmanje jednom primijenjen lijek IDELVION, prijavljeno je 13 nuspojava u 7 ispitanika.
English: • If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients
Croatian: • ako ste alergični na djelatnu tvar (albutrepenonakog alfa) ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Treatment and prophylaxis of bleeding in patients with haemophilia B (congenital factor IX deficiency).
Croatian: Liječenje i profilaksa krvarenja u bolesnika s hemofilijom B (urođenim nedostatkom faktora IX).
English: • The reconstituted product should preferably be used immediately.
Croatian: • Poželjno je odmah primijeniti pripremljeni lijek.
English: 1 non-sterile plaster
Croatian: 1 nesterilan flaster
English: During the course of treatment, appropriate determination of factor IX levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom liječenja preporučuje se odgovarajuće određivanje vrijednosti faktora IX kako bi se mogla odrediti doza koju treba primijeniti i učestalost ponavljanja infuzija.
English: IDELVION was administered by bolus injection.
Croatian: IDELVION je bio primijenjen bolusnom injekcijom.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Pažljivo uklonite blister pakiranje sa seta Mix2Vial držeći ga za rub i povlačeći okomito prema gore.
English: What is IDELVION used for?
Croatian: Za što se IDELVION koristi?
English: The pharmacokinetics (PK) of IDELVION were evaluated following an intravenous injection of a single dose of 25, 50 and 75 IU/kg.
Croatian: Farmakokinetika lijeka IDELVION ocjenjivala se nakon intravenske injekcije jednokratne doze od 25, 50 i 75 IU/kg.
English: • your clinical condition and response • your body weight
Croatian: • Vašem kliničkom stanju i odgovoru
English: Pharmacokinetic (PK) parameters of IDELVION were evaluated in adolescents (12 to <18 years of age) and children (1 to <12 years of age) following an intravenous injection of a single dose of
Croatian: Farmakokinetički parametri lijeka IDELVION ocjenjivali su se u adolescenata (u dobi od 12 do < 18 godina) i djece (u dobi od 1 do < 12 godina) nakon intravenske injekcije jednokratne doze od 50 IU/kg.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica u nastavku prikazuje nuspojave prema MedDRA klasifikaciji organskih sustava (organski sustav i razina preporučenog pojma).
English: If this happens, you should stop using the medicine immediately and contact your doctor.
Croatian: Ako se to dogodi, odmah prestanite primjenjivati lijek i javite se svom liječniku.
English: PK simulations suggest the time to reach 5% plasma FIX activity following a single injection of 50 IU/kg IDELVION to be 7 days for 1-<6years, 9 days for 6-<12 years and 11 days for 12-<18 years of age).
Croatian: Farmakokinetičke simulacije ukazuju da vrijeme potrebno za postizanje 5 % aktivnosti FIX u plazmi nakon jednokratne injekcije od 50 IU/kg lijekom IDELVION iznosi 7 dana za 1 - <6 godina, 9 dana za 6 - <12 godina i 11 dana za 12 - <18 godina starosti.
English: 1 to <6 years (N=12)
Croatian: 1 do < 6 godina (N=12)
English: • Side effects in children and adolescents Side effects in children are expected to be the same as in adults.
Croatian: Očekuje se da će nuspojave u djece biti iste kao i u odraslih.
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Croatian: Prijavljen je nefrotski sindrom nakon pokušaja indukcije imunološke tolerancije u bolesnika oboljelih od hemofilije B koji su imali inhibitore faktora IX i alergijske reakcije u anamnezi.
English: 6 to <12 years (N=15)
Croatian: 6 do < 12 godina (N=15)
English: For routine prophylaxis the recommended dose regimen for paediatric subjects is 35 to 50 IU/kg once weekly (see sections 5.1 and 5.2).
Croatian: Preporučen režim doziranja za rutinsku profilaksu u pedijatrijskih bolesnika je 35 do 50 IU/kg jednom tjedno (vidjeti dio 5.1 i 5.2).
English: One inner box containing:
Croatian: Jedno unutarnje pakiranje sadrži:
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Croatian: Treba napomenuti da bolesnici s inhibitorima faktora IX mogu imati povećan rizik od anafilaksije pri ponovnom izlaganju faktoru IX.
English: There are insufficient data to provide information on inhibitor incidence in PUPs.
Croatian: Nema dovoljno podataka da bi se mogle dati informacije o incidenciji inhibitora u prethodno neliječenih bolesnika.
English: • If you need a central venous access device (CVAD for injection of IDELVION), the risk of complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Croatian: • Ako Vam treba centralni venski kateter (CVAD za injekciju lijeka IDELVIO), Vaš liječnik mora uzeti u obzir rizik od komplikacija, uključujući lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili (tromboza) u koju je uveden kateter.
English: Repeat every 24 - 72 hours for the first week, and then maintenance dose 1 - 2 times per week until bleeding stops and healing is achieved.
Croatian: Ponavljati svakih 24 - 72 sata tijekom prvih tjedan dana, a zatim primjenjivati dozu održavanja 1 - 2 puta na tjedan dok se ne zaustavi krvarenje i postigne zacjeljenje.
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are in the responsibility of the user.
Croatian: • Ako se pripremljeni lijek ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka odgovornost su korisnika.
English: The reconstituted preparation should be injected slowly intravenously at a rate comfortable for the patient up to a maximum of 5 ml/min.
Croatian: Rekonstituirani pripravak treba primijeniti u obliku spore intravenske injekcije brzinom koja je ugodna za bolesnika i koja ne smije biti veća od 5 ml/min.
English: Hypersensitivity to the active substance (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)) or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar (rekombinantni fuzijski protein koji povezuje koagulacijski faktor IX s albuminom (rIX-FP)) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: • If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications.
Croatian: • Ako patite od bolesti jetre ili srca ili ako ste nedavno imali veći kirurški zahvat, obavijestite o tome
English: Use the venipuncture kit supplied with the product, insert the needle into a vein.
Croatian: Upotrijebite set za venepunkciju (ubadanje igle u venu) koji dolazi s lijekom i uvedite iglu u venu.