FrancophonIA/ELRC3.0 huggingface dataset:
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http://www.ema.europa.eu
English: Inject your next dose immediately and continue at regular intervals as advised by your doctor.
Croatian: Ubrizgajte odmah sljedeću dozu te nastavite uzimati lijek u redovitim vremenskim razmacima koje Vam je odredio liječnik.
English: This applies also for modified long acting factor VIII products.
Croatian: To vrijedi i za lijekove s modificiranim faktorom VIII produljenog djelovanja.
English: • 30-40 IU per kg body weight two times per week.
Croatian: • 30-40 IU po kg tjelesne težine dva puta tjedno.
English: Repeated PK measurements did not indicate any relevant changes in PK characteristics after long-term treatment.
Croatian: Ponovljena farmakokinetička mjerenja nisu pokazala nikakve relevantne promjene farmakokinetičkih svojstava nakon dugotrajnog liječenja.
English: Forty-two out of 110 in the prophylaxis arms (38.2%) experienced no bleeding episode.
Croatian: Četrdeset dvoje od 110 ispitanika u skupinama koje su primale profilaksu (38,2 %) nije imalo nijednu epizodu krvarenja.
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Croatian: Klinički značaj razvoja inhibitora ovisit će o titru inhibitora, pri čemu inhibitori u niskom titru predstavljaju manji rizik za pojavu nedovoljnog kliničkog odgovora u odnosu na inhibitore u visokom titru.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to confirm that adequate FVIII levels have been achieved.
Croatian: Tijekom trajanja liječenja savjetuje se odgovarajuće određivanje razina faktora VIII kako bi se potvrdilo da su postignute odgovarajuće razine FVIII.
English: The powder is dry, and white to slightly yellow.
Croatian: Prašak je suh i bijel do žućkast.
English: After reconstitution the solution is clear and colourless and then drawn back into the syringe.
Croatian: Nakon rekonstitucije dobije se bistra i bezbojna otopina koja se tada se uvlači natrag u štrcaljku.
English: ≥ 18 years N=133
Croatian: ≥ 18 godina N=133
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in IU (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili kao postotak (u odnosu na normalnu ljudsku plazmu) ili, po mogućnosti, u IU (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: 11 patients in the age group < 6 years dropped out due to an immune response to PEG associated with loss of efficacy and/or hypersensitivity reaction during the first four ED.
Croatian: Isključeno je 11 bolesnika u dobnoj skupini < 6 godina zbog imunološkog odgovora na PEG povezanog s gubitkom djelotvornosti i/ili reakcijama preosjetljivosti tijekom prva četiri ED.
English: FVIII inhibitors
Croatian: Inhibitori FVIII
English: • Obligation to conduct post-authorisation measures
Croatian: • Obveza provođenje mjera nakon davanja odobrenja
English: What Jivi contains
Croatian: Što Jivi sadrži
English: Hypersensitivity reactions could also be related to antibodies against PEG (see paragraph Immune response to polyethylene glycol (PEG)).
Croatian: Reakcije preosjetljivosti također mogu biti povezane s protutijelima na PEG (vidjeti odlomak Imunološki odgovor na polietilenglikol (PEG)).
English: To prevent bleeding your doctor will select an appropriate dose and frequency depending on your need:
Croatian: Za sprječavanje krvarenja, liječnik će odabrati odgovarajuću dozu i učestalost davanja lijeka ovisno o Vašim potrebama:
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Za uvjete čuvanja nakon rekonstitucije lijeka, vidjeti dio 6.3.
English: During the extension study, 24 patients were treated 2x/week, 37 patients every 5-days, 29 patients every 7 days and 17 patients changed treatment regimen.
Croatian: Tijekom nastavka ispitivanja, 24 bolesnika bila su liječena 2x tjedno, 37 bolesnika svakih 5 dana, 29 bolesnika svakih 7 dana, a 17 bolesnika promijenilo je režim liječenja.
English: 12-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain factor VIII activity of 30-60% (IU/dL).
Croatian: Ponoviti dozu svakih 12 - 24 sata do odgovarajućeg zacjeljivanja rane, zatim terapija još najmanje 7 dana kako bi se aktivnost faktora VIII održala na razini od 30 - 60 % (IU/dl).
English: One IU of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Croatian: Jedna IU aktivnosti faktora VIII jednaka je količini faktora VIII u jednom ml normalne ljudske plazme.
English: Duration of treatment Usually Jivi treatment for haemophilia is needed lifelong.
Croatian: Trajanje liječenja Liječenje hemofilije lijekom Jivi obično traje tijekom cijelog života.
English: • local reactions at the injection site such as bleeding under the skin, intense itching, swelling,
Croatian: • lokalne reakcije na mjestu primjene injekcije kao što su krvarenje pod kožu, jak svrbež,
English: In distribution and excretion studies in rats, the 60 kDa PEG moiety of Jivi was shown to be widely distributed to and eliminated from organs and tissues, and excreted in urine (68.4% up to day 231 after administration) and faeces (13.8% up to day 168 after administration).
Croatian: U ispitivanjima distribucije i ekskrecije u štakora pokazalo se da se PEG dio lijeka Jivi od 60 kDa široko distribuira u organe i tkiva te se iz njih eliminira i izlučuje urinom (68,4 % do 231. dana nakon primjene) i fecesom (13,8 % do 168. dana nakon primjene).
English: Damoctocog alfa pegol is a PEGylated form of rFVIII.
Croatian: Damoktokog alfa pegol je pegilirani oblik rFVIII.
English: The median total dose for major surgeries was 219 IU/kg (range: 50-1500 IU/kg, including postoperative period up to 3 weeks).
Croatian: Medijan ukupne doze kod velikih kirurških zahvata iznosio je 219 IU/kg (raspon: 50-1500 IU/kg, uključujući postoperativno razdoblje u trajanju do 3 tjedna).
English: In 10 of 44 patients (23%) in the age group of younger than 6 years of age loss of drug effect due to neutralising anti-PEG antibodies during the first 4 exposure days was observed.
Croatian: U 10 od 44 (23 %) bolesnika u dobnoj skupini mlađih od 6 godina zabilježen je gubitak učinka lijeka zbog neutralizirajućih protutijela anti-PEG tijekom prva 4 dana izloženosti.
English: If you store it at room temperature it expires after 6 months, or the expiry date if this is earlier.
Croatian: Ako ga čuvate na sobnoj temperaturi, rok valjanosti mu istječe nakon 6 mjeseci ili nakon datuma isteka roka valjanosti ako on istječe prije ovog 6-mjesečnog roka.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Opažene su preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, pečenje i bockanje na mjestu primjene injekcije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsnom košu, trnce, povraćanje, piskanje pri disanju) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: One-hundred and fifty nine (159) subjects were ≥ 12 years of age,
Croatian: Sto pedeset devet (159) ispitanika bilo je u dobi
English: Each single package of Jivi contains:
Croatian: Jedno pojedinačno pakiranje lijeka Jivi sadrži:
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal) in the corresponding period.
Croatian: U slučaju sljedećih događaja krvarenja aktivnost faktora VIII ne smije pasti ispod zadane razine aktivnosti u plazmi (u % normalne vrijednosti) tijekom odgovarajućeg razdoblja.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels or absence of factor VIII:C that results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija A spolno je vezani nasljedni poremećaj koagulacije krvi zbog smanjene razine ili nedostatka faktora VIII:C, koji uzrokuje krvarenje u zglobovima, mišićima i unutrašnjim organima, bilo spontano ili uzrokovano slučajnom ili kirurškom traumom.
English: Jivi has no influence on the ability to drive and use machines.
Croatian: Jivi ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Remove the protective cap from the vial (A).
Croatian: Uklonite zaštitni zatvarač s bočice (A).
English: The medicinal product may contain traces of mouse and hamster proteins.
Croatian: Lijek može sadržavati proteine miša i hrčka u tragovima.
English: Post Authorisation Safety Study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study according to an agreed protocol.
Croatian: Ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): Kako bi se ispitali potencijalni učinci akumulacije PEG-a u koroidnom pleksusu mozga i drugim tkivima/organima, nositelj odobrenja dužan je provesti i priložiti rezultate neintervencijskog ispitivanja sigurnosti primjene nakon dobivanja odobrenja za stavljanje lijeka u promet, sukladno dogovorenom protokolu.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Jivi (see section 5.1).
Croatian: Do razvoja neutralizirajućih protutijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući Jivi (vidjeti dio 5.1).
English: For treatment of bleeds, 84.4 % of the bleeds were resolved with 1 injection, and 91.9% of the bleeds were resolved with 1 or 2 injections.
Croatian: Za liječenje krvarenja, 84,4 % krvarenja zaustavljeno je 1 injekcijom, a 91,9 % krvarenja 1 ili 2 injekcijama.
English: Total (≥ 12 years) N=145
Croatian: Ukupno (≥ 12 godina) N=145
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu različito reagirati na faktor VIII, pokazujući različitu duljinu poluvijeka i oporavka (engl. recovery).
English: In the repeat dose systemic toxicity studies in rats and rabbits with Jivi, treatment related effects on male reproductive organs were not seen (see section 5.3).
Croatian: U ispitivanjima sistemske toksičnosti ponovljenih doza lijeka Jivi u štakora i zečeva nisu opaženi utjecaji na muške reproduktivne organe (vidjeti dio 5.3).
English: shortness of breath, low blood pressure, for early symptoms see above)
Croatian: piskanja pri disanju, nedostatka zraka, niskog krvnog tlaka; za rane simptome, pogledajte prethodni tekst)
English: On demand and prophylactic treatment dosing in adolescent patients is the same as for adult patients.
Croatian: Doza za liječenje kod krvarenja i doza za profilaksu u adolescenata ista je kao i za odrasle bolesnike.
English: Repeat injection every 24-48 hours for 3 to 4 days or more until pain and acute disability are resolved.
Croatian: Ponoviti injekciju svaka 24 - 48 sati tijekom 3 do 4 dana ili dulje do prestanka boli i akutne onesposobljenosti.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days (ED) but continues throughout life although the risk is uncommon.
Croatian: Rizik od razvoja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, i najveći je unutar prvih 50 dana izloženosti (engl. exposure days, ED), ali je prisutan cijelog života, premda je manje čest.
English: AUC: area under the curve; AUC, norm: dose normalized AUC Cmax: maximum drug concentration; , t½: terminal half¬life; MRT IV : mean residence time after an intravenous administration; VSS: apparent volume distribution at steady¬state; CL: clearance
Croatian: AUC: površina ispod krivulje; AUC, norm: AUC normaliziran prema dozi; Cmaks: maksimalna koncentracija lijeka; t½: terminalni poluvijek; MRTIV: srednja vrijednost vremena zadržavanja nakon i.v. primjene; VSS: prividni volumen distribucije u stanju dinamičke ravnoteže; CL: klirens
English: A population PK model was developed based on all available factor VIII measurements (from dense PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK parameters for subjects in the various studies.
Croatian: Model populacijske farmakokinetike razvijen je na temelju svih dostupnih mjerenja faktora VIII (od učestalog uzorkovanja za procjenu farmakokinetike i svih uzoraka za procjenu oporavka) u sva 3 klinička ispitivanja, što je omogućilo izračun farmakokinetičkih parametara za ispitanike u različitim ispitivanjima.
English: In case of anaphylaxis or shock, the current medical standards for treatment should be implemented.
Croatian: U slučaju anafilaksije ili šoka treba primijeniti liječenje u skladu s važećim medicinskim standardima.
English: Jivi is not known to influence or be influenced by other medicines.
Croatian: Nije poznato da Jivi utječe na druge lijekove ili da drugi lijekovi utječu na njega.
English: Laboratories intending to measure Jivi activity should check their procedures for accuracy.
Croatian: Laboratoriji u kojima će se mjeriti aktivnost lijeka Jivi moraju provjeriti preciznost korištenih metoda.
English: Interactions of human coagulation factor VIII (rDNA) products with other medicinal products have not been reported.
Croatian: Nisu zabilježene interakcije lijekova koji sadrže ljudski koagulacijski faktor VIII (rDNK) s drugim lijekovima.
English: • The product must be used within 3 hours.
Croatian: • Lijek se mora primijeniti unutar 3 sata.
English: Immunogenicity was evaluated during clinical trials with Jivi in 159 (including surgery patients) previously treated adolescents (≥ 12 years of age) and adults diagnosed with severe haemophilia A (FVIII:C < 1%), and ≥ 150 previous exposure days.
Croatian: Imunogenost je bila procijenjena tijekom kliničkih ispitivanja lijeka Jivi u 159 (uključujući kirurške bolesnike) prethodno liječenih adolescenata (u dobi ≥ 12 godina) i odraslih s dijagnozom teške hemofilije A (FVIII:C < 1 %) i koji su prethodno imali ≥ 150 dana izloženosti.
English: The PEG-linker moiety was also tested in a standard set of in vivo and in vitro genotoxicity studies and they did not indicate a potential for genotoxicity.
Croatian: Ispitan je i povezivač PEG-dijela standardnim nizom in vivo i in vitro ispitivanja genotoksičnosti i oni nisu pokazali da postoji genotoksični potencijal.
English: Use only the components (vial adapter, pre-filled syringe containing solvent and venipuncture set) provided with each package of this medicine.
Croatian: Koristite samo pribor (nastavak za bočicu, napunjenu štrcaljku s otapalom i pribor za venepunkciju) koji je priložen u svakom pakiranju ovog lijeka.
English: For 53 patients who completed the main study, the median (Q1; Q3) annualised bleeding rate was 2.87 (1.1; 6.1) and the spontaneous ABR was 0.0 (0.0; 2.6).
Croatian: Za 53 bolesnika koji su završili glavno ispitianje, medijan (Q1; Q3) anualizirane stope krvarenja bio je 2,87 (1,1; 6,1), a spontani ABR bio je 0,0 (0,0; 2,6).
English: For prophylaxis the dose is 45-60 IU/kg every 5 days.
Croatian: Doza za profilaksu je 45-60 IU/kg svakih 5 dana.
English: • previously developed factor VIII inhibitors to a different product.
Croatian: • ste prethodno razvili inhibitore faktora VIII na drugi lijek.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterijemija i tromboza na mjestu postavljenog katetera.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom povećava se razina faktora VIII u plazmi što omogućuje privremenu korekciju nedostatka faktora te korekciju sklonosti krvarenju.
English: In a long-term, 6-months chronic toxicity study no indication of PEG accumulation or other effects related to administration of Jivi were seen.
Croatian: U dugotrajnom, 6-mjesečnom ispitivanju kronične toksičnosti nisu opaženi znakovi nakupljanja PEG-a ili drugih učinaka povezanih s primjenom lijeka Jivi.
English: Jivi should be injected intravenously over a period of 2 to 5 minutes depending on the total volume.
Croatian: Jivi se injicira intravenski tijekom 2 do 5 minuta, ovisno o ukupnom volumenu.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of injection: 2.5 mL/min).
Croatian: Brzina primjene određuje se prema razini ugodnosti za bolesnika (maksimalna brzina injekcije je 2,5 ml/min).
English: • a reduction in blood pressure, which may make you feel faint upon standing
Croatian: • sniženje krvnog tlaka zbog čega prilikom ustajanja možete imati osjećaj da ćete se onesvijestiti
English: Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observed in one patient.
Croatian: Zabilježena je imunogenost na PEG uz razvoj specifičnih IgM protutijela na PEG (anti-PEG) u jednog bolesnika.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breastfeeding is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena, nema iskustava s primjenom faktora VIII tijekom trudnoće i dojenja.
English: It should be noted that there can be significant discrepancies between assay results obtained by specific reagents used in the aPTTbased one stage clotting assay and the chromogenic assay.
Croatian: Treba napomenuti da može doći do značajnih razlika između rezultata testa dobivenih uz specifične reagense korištene u jednostupanjskom testu koagulacije temeljenom na aPTV-u i kromogenom testu.
English: For patients who have received previous treatment with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Croatian: U bolesnika koji su prethodno bili liječeni faktorom VIII (više od 150 dana liječenja) može manje često (u manje od 1 na 100 bolesnika) doći do nastanka inhibicijskih protutijela (pogledajte dio 2).
English: • 60 IU per kg body weight every 7 days or
Croatian: • 60 IU po kg tjelesne težine svakih 7 dana ili
English: You may be at risk of device-related complications where the catheter is inserted including:
Croatian: Možete imati povećan rizik od komplikacija povezanih s mjestom postavljanja centralnog venskog katetera uključujući:
English: How Jivi is prepared for injection
Croatian: Kako se lijek Jivi priprema za injekciju
English: Do not use solutions that are cloudy or contain visible particles.
Croatian: Nemojte primjenjivati otopine koje su zamućene ili sadrže vidljive čestice.
English: The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its action in the body.
Croatian: Bjelančevina u damaktagog alfa pegolu promijenjena je (pegilirana) kako bi se produljilo njezino djelovanje u tijelu.
English: If the calculated dose fails to attain the expected factor VIII levels or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating factor VIII-inhibitor or anti-PEG antibodies in the patient should be suspected (see section 4.4).
Croatian: Ako izračunata doza ne postigne očekivane razine faktora VIII ili ako se krvarenje ne zaustavi nakon primjene izračunate doze, u bolesnika treba posumnjati na prisutnost cirkulirajućeg inhibitora faktora VIII ili protutijela anti-PEG (vidjeti dio 4.4).
English: Jivi is for intravenous use.
Croatian: Jivi je namijenjen za intravensku primjenu.
English: • where the bleeding is and how serious it is
Croatian: • mjesto i ozbiljnost krvarenja
English: Site-specific PEGylation reduces clearance of factor VIII resulting in an extended half-life while maintaining the normal functions of the B-domain deleted rFVIII molecule (see section 5.2).
Croatian: Pegilacija na specifičnom položaju smanjuje klirens faktora VIII i dovodi do produljenja poluvijeka dok se zadržavaju normalne funkcije molekule rFVIII s uklonjenom B-domenom (vidjeti dio 5.2).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6 i uputu o lijeku.
English: Children Jivi is not for use in children younger than 12 years of age.
Croatian: Djeca Jivi nije za primjenu u djece mlađe od 12 godina.
English: These make Jivi less effective at preventing and controlling bleeding.
Croatian: Ona smanjuju djelotvornost lijeka Jivi u sprečavanju i zaustavljanju krvarenja.
English: Symptomatic treatment for hypersensitivity should be instituted as appropriate.
Croatian: Potrebno je uvesti odgovarajuće simptomatsko liječenje preosjetljivosti.
English: There was one case of overdose in the clinical trials.
Croatian: U kliničkim ispitivanjima zabilježen je jedan slučaj predoziranja.
English: Damoctocog alfa pegol does not contain von Willebrand factor.
Croatian: Damoktokog alfa pegol ne sadrži von Willebrandov faktor.
English: You may have developed antibodies against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG).
Croatian: Moguće je da ste razvili protutijela na faktor VIII (inhibitore) ili protutijela na polietilenglikol (PEG).
English: burning sensation, temporary redness
Croatian: oticanje, osjećaj pečenja, privremeno crvenilo
English: • to use a central venous access device for this medicine.
Croatian: • morate imati postavljen centralni venski kateter zbog ovog lijeka.
English: Your doctor may switch you back to your previous factor VIII treatment, if needed.
Croatian: Ako je potrebno, liječnik Vas može vratiti na lijek s faktorom VIII koji ste prethodno primali.
English: Your doctor may carry out tests to confirm this and ensure that your Jivi dose provides adequate factor VIII levels.
Croatian: Vaš liječnik može provesti pretrage kako bi se to potvrdilo te osiguralo da doza lijeka Jivi koju primate omogući dostatne razine faktora VIII.
English: Phase II/III: The pharmacokinetics, safety and efficacy of Jivi for on demand treatment, prophylaxis with three regimens (two times per week 30-40 IU/kg, every 5-days 45-60 IU/kg and every 7-days 60 IU/kg) and haemostasis during major surgeries were evaluated in a multinational, open-label, uncontrolled, partially randomized study which was performed in compliance with the agreed Paediatric Investigation Plan.
Croatian: Faza II/III: Farmakokinetika, sigurnost i djelotvornost lijeka Jivi za liječenje kod krvarenja, profilaksu u tri režima (30-40 IU/kg dvaput tjedno, 45-60 IU/kg svakih 5 dana i 60 IU/kg svakih 7 dana) i hemostazu tijekom velikih kirurških zahvata bile su procijenjene u multinacionalnom, otvorenom, nekontroliranom, djelomično randomiziranom ispitivanju provedenom u skladu s dogovorenim Planom pedijatrijskog ispitivanja.