FrancophonIA/ELRC3.0 huggingface dataset:
English: If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX, the rate of infusion should be decreased or the infusion stopped (see sections 4.4 and 4.8).
Croatian: Ako dođe do suspektne reakcije preosjetljivosti za koju se smatra da je povezana s primjenom BeneFIX-a, brzinu infuzije treba smanjiti ili infuziju treba prekinuti (vidjeti dijelove 4.4 i 4.8).
English: In some cases, these reactions have progressed to severe anaphylaxis.
Croatian: U nekim su slučajevima te reakcije napredovale do teške anafilaksije.
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 spolno je vezan nasljedni poremećaj zgrušavanja krvi zbog sniženih razina faktora IX i rezultira obilnim krvarenjem u zglobove, mišiće ili unutarnje organe, bilo spontano ili kao rezultat slučajne ili kirurške traume.
English: In case of severe allergic reactions, alternative therapy should be considered.
Croatian: U slučaju teške alergijskih reakcija, potrebno je razmotriti drugu terapiju.
English: Although BeneFIX contains only factor IX, the risk of thrombosis and disseminated intravascular coagulation (DIC) should be recognised.
Croatian: Iako BeneFIX sadrži samo faktor IX, potrebno je prepoznati rizik od tromboze i diseminirane intravaskularne koagulacije (DIK).
English: Uncommon ≥ 1/1,000 to
Croatian: Manje često ≥1/1000 i
English: Close monitoring of factor IX plasma activity should be performed as clinically indicated, as well as calculation of pharmacokinetic parameters such as recovery and half-life, in order to adjust doses as appropriate.
Croatian: Potrebno je pomno pratiti aktivnost faktora IX u plazmi kako je klinički indicirano i izračunavati farmakokinetičke parametre, kao što su povrat i poluvijek, da bi se doze odgovarajuće prilagodile.
English: BeneFIX, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Croatian: BeneFIX, nakon rekonstitucije, sadrži polisorbat-80, za koji se zna da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinil klorida (PVC).
English: • Chest discomfort (including chest pain)
Croatian: • nelagoda u prsima (uključujući bol u prsima)
English: • one sterile infusion set
Croatian: • jedan sterilni set za infuziju
English: - After reconstitution with the supplied solvent (0.234% sodium chloride solution), each vial contains 50, 100, 200, 300, 400 or 600 IU/ml (see Table 1).
Croatian: - Nakon pripreme s priloženim otapalom (0,234% otopina natrijevog klorida), jedna bočica sadrži 50, 100, 200, 300, 400 ili 600 IU/ml (vidjeti tablicu 1).
English: Allergic reactions may occur together with the development of factor IX inhibitor (see also “Warnings and precautions”).
Croatian: Alergijske reakcije mogu nastati zajedno s razvojem inhibitora faktora IX (pogledajte također “Upozorenja i mjere opreza”).
English: No adverse events have been reported in association with this observation.
Croatian: Nisu prijavljeni štetni događaji povezani s ovim opažanjem.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim dopunama Plana.
English: There is limited documentation of on-demand treatment and surgery in paediatric patients less than 6 years of age treated with BeneFIX.
Croatian: Nema dovoljno podataka o liječenju kad se pojavi krvarenje i kod kirurških zahvata u pedijatrijskih bolesnika u dobi manjoj od 6 godina liječenih BeneFIX-om.
English: Adolescents 12 to < 18
Croatian: Adolescenti 12 do < 18
English: Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product.
Croatian: Bolesnike za koje se zna da imaju velike delecijske mutacije u genu za faktor IX potrebno je pažljivo promatrati zbog znakova i simptoma akutnih reakcija preosjetljivosti, osobito tijekom ranih faza početne izloženosti ovom lijeku.
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Croatian: Nisu prijavljene interakcije lijekova koji sadrže ljudski koagulacijski faktor IX (rDNA) s drugim lijekovima.
English: • Hypersensitivity/allergic reactions
Croatian: • reakcije preosjetljivosti/alergijske reakcije
English: Cases of peripheral thrombophlebitis (pain and redness of the veins) and deep venous thrombosis (blood clots in the extremities) have also been reported; in most of these cases, BeneFIX was administered via continuous infusion, which is not an approved method of administration.
Croatian: Prijavljeni su slučajevi perifernog tromboflebitisa (bol i crvenilo vena) i duboke venske tromboze (krvni ugrušci u udovima); u većini tih slučajeva, BeneFIX je bio primijenjen kontinuiranom infuzijom, što nije odobren način primjene.
English: BeneFIX should be injected intravenously over several minutes.
Croatian: BeneFIX treba injicirati u venu tijekom nekoliko minuta.
English: The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 224 subjects.
Croatian: Učestalosti se temelje na štetnim događajima svih uzroka nastalim tijekom liječenja u objedinjenim kliničkim ispitivanjima s 224 ispitanika.
English: In younger patients, shorter dosage intervals or higher doses may be necessary.
Croatian: U mlađih bolesnika su možda potrebni kraći intervali doziranja ili više doze.
English: If any suspected hypersensitivity reaction takes place that is thought to be related to the administration of BeneFIX see sections 4.2 and 4.4.
Croatian: Ako se pojavi suspektna reakcija preosjetljivosti za koju se smatra da je povezana s primjenom BeneFIX-a, vidjeti dijelove 4.2 i 4.4.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica u nastavku u skladu je s klasifikacijom organskih sustava po MedDRA-i (klasifikacija organskih sustava i razina preporučenog pojma).
English: - If you are allergic to hamster proteins.
Croatian: - ako ste alergični na proteine hrčka.
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 razine faktora IX u plazmi, čime se omogućuje privremena korekcija nedostatka faktora i korekcija sklonosti krvarenju.
English: This includes any possible side effect not listed in this leaflet.
Croatian: Ovo uključuje i svaku moguću nuspojavu koja nije navedena u ovoj uputi.
English: It has a primary amino acid sequence that is comparable to the Ala allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule.
Croatian: Njegov primarni slijed aminokiselina usporediv je s Ala alelnim oblikom faktora IX dobivenog iz plazme, dok su neke postranslacijske modifikacije rekombinantne molekule različite od onih u molekuli dobivenoj iz plazme.
English: Slowly draw back all the solution into the syringe.
Croatian: Polako uvucite svu otopinu u štrcaljku.
English: Nonacog alfa is a purified protein that has 415 amino acids in a single chain.
Croatian: Nonakog alfa je pročišćeni protein koji se sastoji od jednog lanca s 415 aminokiselina.
English: You can use one of the peel-off labels found on the vial to document the batch number in your diary or for reporting any side effects.
Croatian: Možete zalijepiti jednu od naljepnica s bočice kako bi dokumentirali broj serije u svom dnevniku ili za prijavljivanje bilo koje nuspojave.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, see section 4.4.
Croatian: Postoji potencijalan rizik od tromboembolijskih epizoda koje su uslijedile nakon primjene lijekova koji sadrže faktor IX, vidjeti dio 4.4.
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully replaced.
Croatian: Napomena: Ako nećete odmah primijeniti otopinu, trebate pažljivo vratiti poklopac na štrcaljku.
English: Patients can affix one of the peel-off labels found on the vial to document the batch number in their diary or for reporting any side effects.
Croatian: Bolesnici mogu zalijepiti jednu od naljepnica s bočice kako bi dokumentirali broj serije u svom dnevniku ili za prijavljivanje bilo koje nuspojave.
English: • Infusion-site reaction (including itching and redness at the infusion site), infusion-site pain and discomfort
Croatian: • reakcije na mjestu infuzije (uključujući svrbež i crvenilo na mjestu infuzije), bol i nelagoda na mjestu infuzije
English: In a randomized, cross-over pharmacokinetic study, BeneFIX reconstituted in 0.234% sodium chloride diluent was shown to be pharmacokinetically equivalent to the previously marketed BeneFIX (reconstituted with sterile water) in 24 previously treated patients (≥12 years) at a dose of 75 IU/kg.
Croatian: U randomiziranom, ukriženom famakokinetičkom ispitivanju, BeneFIX rekonstituiran u 0,234%-tnoj otopini natrijeva klorida pokazao se farmakokinetički ekvivalentan prethodno dostupnom BeneFIX-u na tržištu (rekonstituiranom sa sterilnom vodom) u 24 prethodno liječena bolesnika (≥ 12 godina) dozom od 75 IU/kg.
English: Administration by continuous infusion has not been approved and is not recommended (see also sections 4.4 and 6.6).
Croatian: Kontinuirana infuzija Primjena kontinuiranom infuzijom nije odobrena i ne preporučuje se (vidjeti također dijelove 4.4 i
English: The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use.
Croatian: U tablici je naveden popis nuspojava prijavljenih u kliničkim ispitivanjima prethodno liječenih bolesnika i onih utvrđenih tijekom primjene nakon stavljanja lijeka u promet.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 250 IU
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: - Sufficient data have not been obtained from clinical studies on the treatment of previously untreated patients (patients who have never received a previous infusion of factor IX), with BeneFIX.
Croatian: - Iz kliničkih ispitivanja nije se dobilo dovoljno podataka o liječenju prethodno neliječenih bolesnika (bolesnika koji nikad prije nisu primili infuziju faktora IX) BeneFIX-om.
English: Amount of BeneFIX per 1 ml of prepared solution for injection
Croatian: Količina BeneFIX-a po 1 ml pripremljene otopine za injekciju
English: • Anaphylactic reaction
Croatian: • anafilaktička reakcija
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim faktorima rizika za kardiovaskularne događaje, zamjenska terapija faktorom IX može povećati kardiovaskularni rizik.
English: BeneFIX should be administered immediately or within 3 hours after reconstitution.
Croatian: BeneFIX treba primijeniti odmah ili unutar 3 sata nakon pripreme.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available.
Croatian: Budući da se hemofilija B rijetko javlja u žena, nije dostupno iskustvo s primjenom faktora IX tijekom trudoće i dojenja.
English: This is a verbatim term.
Croatian: To je doslovan pojam kako je prijavljeno.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane slijedom u opadajućoj ozbiljnosti.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Croatian: U pojedinim slučajevima, naročito u bolesnika mlađe dobi, mogu biti nužni kraći intervali između doziranja ili veće doze.
English: Infants
Croatian: Dojenčad
English: The solvent syringe should be removed, leaving the vial adapter in place, and a separate large luer lock (a device that connects the syringe to the vial) syringe may be used to draw back the reconstituted contents of each individual vial.
Croatian: Štrcaljku s otapalom treba ukloniti, ostavljajući nastavak za bočicu na mjestu, a zasebni veliki luer lock (naprava koja spaja štrcaljku s bočicom) za štrcaljku može se uporabiti za izvlačenje pripremljenog sadržaja iz pojedinih bočica.
English: Do not touch the syringe tip or the inside of the cap.
Croatian: Nemojte dodirivati vrh štrcaljke ili unutrašnjost poklopca.
English: - The other ingredients are sucrose, glycine, L-histidine, polysorbate 80.
Croatian: - Drugi sastojci su saharoza, glicin, L-histidin, polisorbat 80.
English: Pharmacokinetic Parameter Estimates for BeneFIX (75 IU/kg) at Baseline and Month 6 in Previously Treated Patients with Haemophilia B
Croatian: Procijenjene vrijednosti farmakokinetičkih parametara BeneFIX-a (75 IU/kg) na početku i u 6. mjesecu u prethodno liječenih bolesnika s hemofilijom B Parametar
English: Do not use this medicine after the expiry date which is stated on the outer box and vial label.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice.
English: Since the use of factor IX complex concentrates has historically been associated with the development of thromboembolic complications, the use of factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation (DIC).
Croatian: Budući da se primjena koncentrata kompleksa faktora IX inače povezuje s razvojem tromboembolijskih komplikacija, primjena lijekova koji sadrže faktor IX može biti potencijalno opasna u bolesnika sa znakovima fibrinolize i u bolesnika s diseminiranom intravaskularnom koagulacijom (DIK).
English: Do not touch the inside of the cap or the syringe tip.
Croatian: Nemojte dodirivati unutrašnjost poklopca ili vršak štrcaljke.
English: Children 2 to < 6
Croatian: Djeca 2 do < 6
English: No side effects have been reported in association with this observation.
Croatian: Nisu prijavljene nikakve nuspojave povezane s ovim opažanjem.
English: Solvent Sodium chloride solution
Croatian: Otapalo otopina natrijevog klorida
English: If allergic/anaphylactic reactions occur, stop the infusion immediately and contact your doctor or seek emergency medical care immediately.
Croatian: Ako nastane alergijska/anafilaktička reakcija, odmah prekinite infuziju i obratite se liječniku ili odmah potražite hitnu medicinsku pomoć.
English: You may notice a difference in the dose you receive if you are changing from a plasma-derived factor IX product to BeneFIX.
Croatian: Možete opaziti razliku u dozi koju primate ako umjesto lijeka s faktorom IX dobivenim iz plazme počnete primjenjivati BeneFIX.
English: Each vial of BeneFIX contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU of nonacog alfa.
Croatian: Jedna bočica BeneFIX-a sadrži nominalno 250, 500, 1000, 1500, 2000 ili 3000 IU nonakoga alfa.
English: Lot See front label (Lot, Exp.)
Croatian: Vidjeti prednju naljepnicu (Serija, Rok valjanosti)
English: There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1).
Croatian: Budući da nema dovoljno podataka, ne mogu se dati informacije o incidenciji inhibitora u prethodno neliječenih bolesnika (vidjeti također dio 5.1).
English: It should be noted that patients with a factor IX inhibitor may be at an increased risk of anaphylaxis during future treatment with BeneFIX.
Croatian: Potrebno je naglasiti da bolesnici s inhibitorom faktora IX mogu biti pod povećanim rizikom od anafilaksije tijekom budućeg liječenja BeneFIX-om.
English: Allow the vial of lyophilised (freeze-dried) BeneFIX and the pre-filled syringe to reach room temperature.
Croatian: Ostavite bočicu s liofiliziranim (osušenim zamrzavanjem) BeneFIX-om i napunjenu štrcaljku da dosegnu sobnu temperaturu.
English: - If allergic or anaphylactic-type reactions occur, stop the infusion immediately and contact a doctor or seek emergency medical care immediately.
Croatian: Ako nastane alergijski ili anafilaktički tip reakcije, odmah prekinite infuziju i obratite se liječniku ili odmah potražite hitnu medicinsku pomoć.
English: Because the use of BeneFIX by continuous infusion (drip) has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Croatian: Budući da primjena BeneFIX-a kontinuiranom infuzijom (dripom) nije procijenjena, BeneFIX se ne smije miješati s otopinama za infuziju niti davati u obliku dripa.
English: Remove the plastic flip-top cap from the BeneFIX vial to expose the central portion of the rubber stopper.
Croatian: Uklonite plastični poklopac s bočice BeneFIX-a kako biste izložili središnji dio gumenog čepa.
English: Baseline n = 24 Mean ± SD
Croatian: Na početku n = 24 Srednja vrijednost ± SD
English: Example: For a recovery of 0.8 IU/dL, the formula reads: Number of factor IX IU required
Croatian: Primjer: Za povrat 0,8 IU/dl slijedi formula:
English: In case of severe allergic reactions, alternative haemostatic measures should be considered.
Croatian: U slučaju teških alergijskih reakcija, nužno je razmotriti druge hemostatske mjere.
English: * ADR identified post-marketing a including cellulitis b low-titer transient inhibitor formation c including drug hypersensitivity, angioedema, bronchospasm, wheezing, dyspnoea, and laryngospasm d including migraine, sinus headache e including scintillating scotoma and blurred vision f including heart rate increased, sinus tachycardia g including hot flush, feeling hot, skin warm h including blood pressure decreased i superior vena cava (SVC) syndrome in critically ill neonates, while receiving continuous-infusion of BeneFIX through a central venous catheter j including productive cough k including rash macular, rash papular, rash maculopapular l developed in a hepatitis C antibody-positive patient 12 days after a dose of BeneFIX for a bleeding episode.
Croatian: * nuspojava utvrđena nakon stavljanja lijeka u promet uključujući celulitis stvaranje prolaznih inhibitora niskog titra uključujući preosjetljivost na lijek, angioedem, brohnospazam, piskanje, dispneju i laringospazam uključujući migrenu, sinusnu glavobolju uključujući scintilirajući skotom i zamagljen vid uključujući povećanje srčane frekvencije, sinusnu tahikardiju uključujući navale vrućine, osjećaj vrućine, toplinu kože uključujući smanjeni krvni tlak sindrom gornje šuplje vene u kritično bolesne novorođenčadi uslijed primanja BeneFIX-a kontinuiranom infuzijom putem centralnog venskog katetera uključujući produktivni kašalj uključujući makularni osip, papularni osip, makulopapularni osip razvio se u bolesnika pozitivnog na protutijelo na hepatitis C, 12 dana nakon doze BeneFIX-a radi epizode krvarenja.
English: Recombinant coagulation factor IX is a glycoprotein that is secreted by genetically engineered mammalian cells derived from a Chinese hamster ovary (CHO) cell line.
Croatian: Rekombinantni koagulacijski faktor IX je glikoprotein kojeg izlučuju genetski modificirane stanice sisavaca dobivene iz stanične linije jajnika kineskog hrčka (CHO).
English: CL (mL/hr/kg) Recovery (IU/dL per IU/kg)
Croatian: CL (ml/hr/kg) Povrat (IU/dl po IU/kg)
English: Tél: +33 (0)1 58 07 34 40
Croatian: Pfizer Tél: +33 (0)1 58 07 34 40
English: • Renal infarct (interruption to the blood supply to the kidney)
Croatian: • infarkt bubrega (prekid dotoka krvi u bubrege)
English: This is done by bending the cap up and down until the perforation is broken.
Croatian: To ćete napraviti tako da savijate poklopac gore dolje sve dok ne pukne duž perforacije.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Croatian: Kada se upotrebljava in vitro jednofazni test zgrušavanja krvi temeljen na tromboplastinskom vremenu (aPTT, aktivirano parcijalno tromboplastinsko vrijeme) za određivanje aktivnosti faktora IX u uzorcima krvi bolesnika, na rezultate aktivnosti faktora IX u plazmi mogu značajno utjecati i vrsta aPTT reagensa i referentni standard korišten u testu.
English: Τηλ: +357 22 817690 Latvija
Croatian: Τηλ: +357 22 817690
English: Because the use of BeneFIX by continuous infusion has not been evaluated, BeneFIX should not be mixed with infusion solutions or be given in a drip.
Croatian: Budući da primjena BeneFIX-a kontinuiranom infuzijom nije procijenjena, BeneFIX se ne smije miješati s otopinama za infuziju niti davati u obliku dripa.
English: BeneFIX is used for the treatment and prevention of bleeding in patients with haemophilia B (congenital factor IX deficiency) in all age groups.
Croatian: BeneFIX se primjenjuje za liječenje i sprječavanje krvarenja u bolesnika s hemofilijom B (urođeni nedostatak faktora IX) u svim dobnim skupinama.
English: No symptoms of overdose have been reported with recombinant coagulation factor IX products.
Croatian: Nisu prijavljeni simptomi predoziranja s lijekovima koji sadrže rekombinantni koagulacijski faktor IX.
English: Side effects with unknown frequency (frequency cannot be estimated from the available data)
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka)
English: There have been reports of severe blood clotting events, including life-threatening blood clots in critically ill babies, while receiving continuous-infusion BeneFIX through a central venous catheter.
Croatian: Prijavljeni su teški događaji zbog krvnih ugrušaka, uključujući životno opasne krvne ugruške u kritično bolesne djece dok su primala BeneFIX kontinuiranom infuzijom kroz centralni venski kateter.
English: - Research has shown a link between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: - Istraživanja su pokazala povezanost između pojave inhibitora faktora IX i alergijskih reakcija.
English: Factor IX activity is absent or greatly reduced in patients with haemophilia B and substitution therapy may be required.
Croatian: U bolesnika s hemofilijom B nedostaje ili je jako smanjena aktivnost faktora IX pa može biti potrebna nadomjesna terapija.
English: Use the reconstituted solution immediately or within 3 hours.
Croatian: Pripremljenu otopinu primijenite odmah ili u roku od 3 sata.
English: The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development.
Croatian: Jedina ozbiljna nuspojava povezana s liječenjem BeneFIX-om prijavljena je u jednog prethodno neliječenog bolesnika kod kojeg su se pojavili preosjetljivost i razvoj inhibitora.
English: The active ingredient in BeneFIX is nonacog alfa.
Croatian: Djelatna tvar u BeneFIX-u je nonakog alfa.
English: LIST OF EXCIPIENTS Sucrose, glycine, L-histidine, sodium chloride, polysorbate 80.
Croatian: Saharoza, glicin, L-histidin, natrijev klorid i polisorbat 80.
English: - Because of the risk of allergic reactions with factor IX, your initial administrations of BeneFIX should be performed under medical observation where proper medical care for allergic reactions can be provided.
Croatian: - Zbog rizika od alergijskih reakcija na faktor IX, prvih nekoliko primjena BeneFIX-a trebalo bi provesti pod medicinskim nadzorom na mjestu gdje se može pružiti odgovarajuća medicinska skrb u slučaju alergijske reakcije.