FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhibitor rates in these studies range from 15 to 38% for all inhibitors and 9 to 22.6% for high titre inhibitors; i.e. within the range of ‘very common'.
Croatian: Raspon stopa pojave inhibitora u tim ispitivanjima kreće se od 15 % do 38 % za sve inhibitore te od 9 % do 22,6 % za inhibitore visokog titra, tj. u rasponu učestalosti „vrlo često”.
English: Although the clinical studies for some individual products have identified limited numbers of cases of inhibitor development, these tend to be small studies with methodological limitations, or studies not adequately designed to evaluate this risk.
Croatian: Iako je u kliničkim ispitivanjima pojedinih lijekova utvrđen ograničen broj slučajeva razvoja inhibitora, riječ je uglavnom o malim ispitivanjima s metodološkim ograničenjima ili ispitivanjima čija izvedba nije primjerena za procjenu tog rizika.
English: If the inhibitor is present at levels less than 10 Bethesda Units (BU) per mL, administration of additional recombinant coagulation factor VIII may neutralise the inhibitor and permit continued clinically effective therapy with KOGENATE Bayer.
Croatian: Ako je prisutna razina inhibitora manja od 10 Bethesda jedinica (BU) po ml, dodatna primjena rekombinantnog koagulacijskog faktora VIII mogla bi neutralizirati inhibitor te omogućiti nastavak klinički učinkovite terapije lijekom KOGENATE Bayer.
English: Therefore, KOGENATE Bayer should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: KOGENATE Bayer stoga se u trudnoći i tijekom dojenja smije koristiti samo ako za to postoje jasne indikacije.
English: KOGENATE Bayer is used for treatment and prophylaxis of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency).
Croatian: KOGENATE Bayer koristi se za liječenje i prevenciju krvarenja u odraslih, adolescenata i djece bilo koje dobi s hemofilijom A (nasljedni nedostatak faktora VIII).
English: It is uncertain whether the findings of SIPPET can be extrapolated to the risk of inhibitors in PUPs in current clinical practice in the EU as treatment modality and intensity have been suggested as risk factors for inhibitor development in previous studies.
Croatian: Nije sigurno mogu li se nalazi ispitivanja SIPPET ekstrapolirati na rizik od inhibitora u prethodno neliječenih bolesnika u trenutačnoj kliničkoj praksi u EU-u jer su modalitet i intenzitet liječenja u prethodnim ispitivanjima navedeni kao mogući čimbenici rizika za razvoj inhibitora.
English: In the case of the haemorrhagic events listed, the factor VIII activity should not fall below the given level (in % of normal) in the corresponding period:
Croatian: U slučaju navedenih događaja s krvarenjem ili rizikom krvarenja aktivnost faktora VIII ne smije pasti ispod zadane razine (u % od normalne vrijednosti) tijekom navedenog razdoblja:
English: The safety and efficacy of KOGENATE Bayer in children of all ages have been established.
Croatian: Sigurnost i djelotvornost lijeka KOGENATE Bayer ustanovljena je u djece svih dobi.
English: Do not remove the adapter from the plastic housing.
Croatian: Nastavak nemojte vaditi iz plastičnog kućišta.
English: KOGENATE Bayer is not likely to affect the fertility in male or female patients, as the active substance is naturally occurring in the body.
Croatian: Nije vjerojatno da KOGENATE Bayer utječe na plodnost bolesnika i bolesnica, s obzirom na to da je djelatna tvar normalno prisutna u organizmu.
English: The degree and duration of aPTT normalisation observed after administration of KOGENATE Bayer is similar to that achieved with plasma-derived factor VIII.
Croatian: Stupanj i vrijeme normalizacije APTV-a zabilježeni nakon primjene lijeka KOGENATE Bayer slični su vrijednostima postignutima primjenom faktora VIII dobivenog iz plazme.
English: The primary and secondary outcomes assessed in the study were the incidence of all inhibitors (≥0.4 BU/ml) and the incidence of high-titre inhibitors (≥5 BU/ml), respectively.
Croatian: Primarni i sekundarni ishodi procjenjivani u ispitivanju bili su incidencija svih inhibitora (≥ 0,4 BU/ml), odnosno incidencija inhibitora visokog titra (≥ 5 BU/ml).
English: The PRAC considered the views expressed by experts during an ad-hoc meeting.
Croatian: PRAC je tijekom ad hoc sastanka razmotrio stajališta stručnjaka.
English: The dose, frequency and duration of the substitution therapy must be individualised according to the patient's needs (weight, severity of disorder of the haemostatic function, the site and extent of the bleeding, the presence of inhibitors, and the factor VIII level desired).
Croatian: Doza, učestalost primjene i trajanje nadomjesnog liječenja moraju se odrediti zasebno za svakog bolesnika prema njegovim/njenim potrebama (tjelesna težina, ozbiljnost hemostatskog poremećaja, mjesto i jačina krvarenja, prisutnost inhibitora i željena razina faktora VIII).
English: Inhibitors developed in 29 of the 125 patients treated with pdFVIII (20 patients had high-titre inhibitors) and in 47 of the 126 patients treated with rFVIII (30 patients had high-titre inhibitors).
Croatian: Inhibitori su se razvili u 29 od 125 bolesnika liječenih faktorom VIII dobivenim iz plazme (20 bolesnika imalo je inhibitore visokog titra) i u 47 od 126 bolesnika liječenih rekombinantnim faktorom VIII (30 bolesnika imalo je inhibitore visokog titra).
English: Haemophilic patients with cardiovascular risk factors or diseases may be at the same risk to develop cardiovascular events as non-haemophilic patients when clotting has been normalised by treatment with FVIII.
Croatian: Bolesnici s hemofilijom i kardiovaskularnim čimbenicima rizika ili bolestima mogu imati isti rizik od razvoja kardiovaskularnih događaja kao i bolesnici bez hemofilije kad se zgrušavanje krvi normalizira pomoću liječenja FVIII.
English: a) By bolus infusions Repeat infusion every 8 - 24 hours until adequate wound healing occurs, then continue with therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Croatian: Ponoviti infuziju svakih 8 - 24 sata do odgovarajućeg zacjeljivanja rane, a zatim nastaviti liječenje još najmanje 7 dana da bi se aktivnost faktora VIII održavala na razini od 30% do 60% (IU/dl).
English: Treatment of patients who have developed inhibitors requires careful individual management and can be resistant to therapy.
Croatian: Liječenje bolesnika koji su razvili inhibitore potrebno je pažljivo prilagoditi pojedincu te je moguća rezistencija na terapiju.
English: VWF is not present in rFVIII, but there is significant heterogeneity within the rFVIII class for instance due to the different manufacturing processes used, with a wide range of products from different manufacturers produced over the past 20 years.
Croatian: Von Willebrandov faktor ne nalazi se u rekombinantnom faktoru VIII, ali postoji znatna heterogenost unutar razreda lijekova s rekombinantnim faktorom VIII, na primjer zbog različitih proizvodnih procesa i širokog raspona lijekova koje su različiti proizvođači proizveli tijekom posljednjih 20 godina.
English: Some experimental studies have suggested a role for VWF in protecting FVIII epitopes from recognition by the antigen-presenting cells, thereby reducing immunogenicity, although this remains theoretical.
Croatian: Neka eksperimentalna ispitivanja ukazala su na ulogu VWF-a u sprječavanju antigen prezentirajućih stanica u prepoznavanju epitopa faktora VIII, čime se smanjuje imunogenost, iako je to i dalje spekulativno.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Croatian: Ako se jave simptomi preosjetljivosti, bolesnike se mora savjetovati da odmah prestanu uzimati ovaj lijek i obrate se svom liječniku.
English: KOGENATE Bayer contains low level of polysorbate-80 as an excipient, which is known to increase the rate of di-(2-ethylhexyl)phthalate (DEHP) extraction from polyvinyl chloride (PVC) materials.
Croatian: KOGENATE Bayer kao pomoćnu tvar sadrži malu količinu polisorbata 80, za koji je poznato da povećava brzinu ekstrakcije di-(2-etilheksil)ftalata (DEHP) iz polivinilkloridnih (PVC) materijala.
English: Therefore, it remains uncertain whether the same differential risk of inhibitor development observed in the SIPPET study would be apparent in patient populations treated in routine care in other countries where the modality of treatment (i.e. primary prophylaxis) is different from that in the study.
Croatian: Stoga nije sigurno bi li razlike u pogledu rizika od razvoja inhibitora zabilježene u ispitivanju SIPPET bile vidljive u populacijama bolesnika na standardnom liječenju u drugim zemljama u kojima se modalitet liječenja (tj. primarna profilaksa) razlikuje od one u ispitivanju.
English: However, despite the lack of robust evidence to support differential risks between rFVIII products, differential risks cannot be excluded, as this is a heterogeneous product class with differences in composition and formulations.
Croatian: Međutim, unatoč nedostatku pouzdanih dokaza koji podupiru razlike u pogledu rizika između lijekova s rekombinantnim faktorom VIII, ne mogu se isključiti razlike u rizicima jer je riječ o heterogenom razredu lijekova različitih sastava i formulacija.
English: If you use more KOGENATE Bayer than you should No cases of overdose with recombinant coagulation factor VIII have been reported.
Croatian: Ako primijenite više lijeka KOGENATE Bayer nego što ste trebali Nije zabilježen niti jedan slučaj predoziranja rekombinantnim koagulacijskim faktorom VIII.
English: The statistical concerns include the fact that no pre-specified primary analysis has been published and the fact that the study was stopped early following the publication of the RODIN study indicating that Kogenate FS might be associated with an increased risk of inhibitor formation.
Croatian: Nedoumice u pogledu statistike odnose se na činjenicu da nije objavljena prethodno specificirana primarna analiza i činjenicu da je ispitivanje prekinuto u ranoj fazi nakon objave ispitivanja RODIN u kojem je navedeno da bi lijek Kogenate FS mogao biti povezan s povećanim rizikom od stvaranja inhibitora.
English: Inhibitors are less likely to occur in previously-treated patients (PTPs).
Croatian: Manja je vjerojatnost nastanka inhibitora u prethodno liječenih bolesnika (PTP-ovi).
English: You may be at risk of CVAD-related 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.
Croatian: Možete imati rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili (tromboza) u koju je uveden kateter.
English: Data on Immune Tolerance Induction have been collected in patients with haemophilia A who had developed inhibitors to FVIII.
Croatian: Podaci o izazivanju imunološke tolerancije prikupljeni su u bolesnika s hemofilijom A koji su razvili inhibitore na FVIII.
English: Filtering can be achieved by following the reconstitution and/or administration steps as described in the package leaflet provided with KOGENATE Bayer.
Croatian: Filtriranje se može postići tako da se slijede koraci za pripremu i/ili primjenu kako je opisano u Uputi o lijeku priloženoj uz KOGENATE Bayer.
English: Treatment of bleeding
Croatian: Liječenje pri krvarenju
English: Your doctor will calculate the dose of this medicine and how frequently you should use it to get the necessary level of factor VIII activity in your blood.
Croatian: Liječnik će izračunati dozu i učestalost uzimanja ovog lijeka potrebne za postizanje željene razine aktivnosti faktora VIII u krvi.
English: If a further dose needs to be administered, use a new syringe with product reconstituted as described above.
Croatian: Ako je potrebno primijeniti drugu dozu, uzmite novu štrcaljku s lijekom pripremljenim prema gore navedenom postupku.
English: What KOGENATE Bayer looks like and content of the pack
Croatian: Kako KOGENATE Bayer izgleda i sadržaj pakiranja
English: KOGENATE Bayer should be injected intravenously over 2 to 5 minutes.
Croatian: KOGENATE Bayer injicira se intravenski tijekom 2 do 5 minuta.
English: The experts also agreed that the degree of immunogenicity of different products was adequately described overall with the amendments to the SmPC proposed by the PRAC highlighting the clinical relevance of inhibitor development (in particular low compared to high titre inhibitors), as well as the frequency of ‘very common' in PUPs and ‘uncommon' in PTPs.
Croatian: Stručnjaci su također smatrali da je stupanj imunogenosti različitih lijekova u cijelosti primjereno opisan uz izmjene u sažetku opisa svojstava lijeka koje je PRAC predložio, u kojima je istaknuta klinička relevantnost razvoja inhibitora (osobito inhibitora niskog titra u odnosu na inhibitore visokog titra), kao i raspon učestalosti „vrlo često” u prethodno neliječenih bolesnika i „manje često” u prethodno liječenih bolesnika.
English: Each vial contains nominally 250/500/1000/2000/3000 IU human coagulation factor VIII (INN: octocog alfa).
Croatian: Svaka bočica sadrži nominalnu količinu od 250/500/1000/2000/3000 IU ljudskog koagulacijskog faktora VIII (INN: oktokog alfa).
English: Treatment of congenital haemophilia is currently based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII).
Croatian: Liječenje prirođene hemofilije trenutačno se temelji na preventivnoj ili prema potrebi, na zamjenskoj terapiji koagulacijskim faktorom VIII (FVIII).
English: Swirl vial gently until all material is dissolved (H).
Croatian: Polako okrećite bočicu dok se sav sadržaj ne rastopi (H).
English: The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Croatian: Napunjena štrcaljka sadržava vodu za injekciju koja se koristi za pripremu sadržaja bočice.
English: What you need to know before you use KOGENATE Bayer
Croatian: Što morate znati prije nego počnete primjenjivati KOGENATE Bayer
English: Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik,ljekarnik ili medicinska sestra.
English: Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao Vaš liječnik, ljekarnik ili medicinska sestra.
English: Required IU = body weight (kg) × desired factor VIII rise (% of normal) × 0.5 II.
Croatian: Potreban broj IU = tjelesna težina (kg) × željeni porast faktora VIII (% od normalne vrijednosti) × 0,5
English: After reconstitution, from a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se nakon pripreme za primjenu treba odmah primijeniti.
English: Elevation of FVIII levels following administration, in particular with existing cardiovascular risk factors, might put a patient into the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Croatian: Povišenje razine FVIII nakon primjene, posebice s postojećim kardiovaskularnim faktorima rizika, može staviti bolesnika najmanje u isti rizik za začepljenje krvne žile ili infarkt miokarda kao i u populaciji osoba koje nemaju hemofiliju.
English: The potency (IU) is determined using the one-stage clotting assay against the FDA Mega standard which was calibrated against WHO standard in International Units (IU).
Croatian: Potentnost (IU) se određuje pomoću jednofaznih testova zgrušavanja prema Mega standardu Američke uprave za hranu i lijekove (FDA), kalibriranom prema standardu Svjetske zdravstvene organizacije u međunarodnim jedinicama (IU).
English: Importantly, the EU SmPCs do not include modified prophylaxis (as defined in the SIPPET study) as an authorised posology, and the impact of the apparent imbalance in the unspecified other combinations of treatment modality on the SIPPET findings is unclear.
Croatian: Važno je napomenuti da sažetci opisa svojstava lijekova u EU-u ne uključuju izmijenjenu profilaksu (kako je utvrđeno u ispitivanju SIPPET) kao odobreno doziranje te da nije jasan učinak očite neravnoteže neodređenih drugih kombinacija modaliteta liječenja na nalaze ispitivanja SIPPET.
English: This should be considered for a continuous infusion administration.
Croatian: To je potrebno uzeti u obzir prilikom primjene kontinuirane infuzije.
English: May be stored at temperatures up to 25°C for up to 12 months within the expiry date indicated on the label.
Croatian: Lijek se može čuvati na temperaturi do 25 °C najviše 12 mjeseci unutar razdoblja roka valjanosti navedenog na naljepnici
English: There are no fertility data available.
Croatian: Nema podataka o utjecaju na plodnost.
English: • The FVIII products are heterogenous, and the plausibility of different rates of inhibitor development between individual products cannot be excluded.
Croatian: • Lijekovi s faktorom VIII su heterogeni te se ne može isključiti vjerojatnost različitih stopa razvoja inhibitora između pojedinih lijekova.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection (Bio-Set System).
Croatian: OBLIK Prašak i otapalo za otopinu za injekciju (Bio-Set sustav).
English: FVIII Inhibition (PUPs)*
Croatian: Inhibicija faktora VIII (PUPs)*
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and the package leaflet.
Croatian: Za uputu o pripremi za primjenu lijeka prije primjene, vidjeti dio 6.6 i u uputi o lijeku.
English: b) By continuous infusion Raise factor VIII activity presurgery with an initial bolus infusion and immediately follow with continuous infusion (in IU/kg/h) adjusting according to patient's daily clearance and desired factor VIII levels for at least 7 days.
Croatian: b) Kontinuiranom infuzijom Povećati aktivnost faktora VIII prije operacije početnom infuzijom u obliku bolusa, a zatim odmah nastaviti s kontinuiranom infuzijom (u IU/kg/h) tijekom najmanje 7 dana uz prilagodbu prema dnevnoj dozvoljenoj dozi za bolesnika i željenoj razini faktora VIII.
English: This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.
Croatian: Lijek ne sadrži von Willebrandov faktor te stoga nije indiciran za von Willebrandovu bolest.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with KOGENATE Bayer.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući KOGENATE Bayer.
English: FVIII replacement therapy can be generally categorised into two broad classes of products; plasma derived (pdFVIII) and recombinant (rFVIII) FVIII.
Croatian: Zamjenska terapija faktorom VIII može se općenito razvrstati na dva velika razreda lijekova, one s faktorom VIII dobivenim iz plazme (pdFVIII) i s rekombinantnim faktorom VIII (rFVIII).
English: When infused into a haemophilic patient, factor VIII binds to vWF in the patient's circulation.
Croatian: Kada se infuzijom primijeni na bolesnika s hemofilijom, faktor VIII vezuje se s vWF-om u bolesnikovu krvotoku.
English: The MAHs provided an analysis of low and high titre inhibitor development in PUPs with severe haemophilia A (FVIII < 1%) from all clinical trials and observational studies conducted with their products, along with critical discussion on the limitations of these studies.
Croatian: Nositelji odobrenja za stavljanje u promet dostavili su analizu razvoja inhibitora niskog i visokog titra u prethodno neliječenih bolesnika s teškom hemofilijom A (faktor VIII < 1 %) iz svih kliničkih i opservacijskih ispitivanja njihovih lijekova, zajedno s kritičkom raspravom o ograničenjima tih ispitivanja.
English: Children and adolescents The listed warnings and precautions apply to patients of all ages, adults and children.
Croatian: Djeca i adolescenti Navedena upozorenja i mjere opreza odnose se na sve dobne skupine, odrasle i djecu.
English: Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Croatian: Dozu ovog lijeka koju uzimate nemojte povećavati bez dogovora s liječnikom.
English: In relation to section 5.1, any reference to inhibitor development studies in PUPs and PTPs should be deleted unless the studies were conducted in compliance with a Paediatric Investigation Plan or the studies provide robust evidence of a frequency of inhibitors in PUP which is less than ‘very common' or for PTPs which is different from ‘uncommon' (as laid down in the attachments of the PRAC AR).
Croatian: U pogledu dijela 5.1., treba ukloniti sva upućivanja na ispitivanja razvoja inhibitora u prethodno neliječenih bolesnika i prethodno liječenih bolesnika, osim ako su ispitivanja provedena u skladu s Planom istraživanja u pedijatrijskoj populaciji ili ako ispitivanja navode pouzdane dokaze o učestalosti inhibitora u prethodno neliječenih bolesnika koja je manja od „vrlo često” ili se za prethodno liječene bolesnike razlikuje od „manje često” (kako je utvrđeno u prilozima izvješća o procjeni dokumentacije o lijeku PRAC-a).
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor VIII djeluje kao kofaktor za aktivirani faktor IX te pospješuje pretvaranje faktora X u aktivirani faktor X.
English: Human coagulation factor VIII is produced by recombinant DNA technology (rDNA) in baby hamster kidney cells containing the human factor VIII gene.
Croatian: Ljudski koagulacijski faktor VIII proizvodi se tehnologijom rekombinantne DNK (rDNK) u bubrežnim stanicama mladunčadi hrčka koje sadrže gen ljudskog faktora VIII.
English: There was also evidence for an increased risk with Refacto AF (another 3rd generation rFVIII) vs Advate, but only for all inhibitor development.
Croatian: Također su utvrđeni dokazi povećanog rizika povezanog s lijekom Refacto AF (još jedna treća generacija rekombinantnog faktora VIII) u usporedbi s lijekom Advate, ali samo za razvoj svih inhibitora.
English: Skin associated hypersensitivity reactions, (pruritus, urticaria and rash)
Croatian: Reakcije preosjetljivosti na koži (svrbež, urtikarija i osip)
English: The risk of inhibitor development is multifactorial (aside from any putative product-specific risk), and such studies have not always been able to collect information on relevant covariates and to adjust the analyses accordingly; residual confounding is inevitably a significant uncertainty.
Croatian: Rizik od razvoja inhibitora ovisi o više uzroka (pored mogućih specifičnih rizika lijeka), a takva ispitivanja nisu uvijek bila uspješna u prikupljanju informacija o relevantnim kovarijablama i odgovarajućoj prilagodbi analize.
English: It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Croatian: Potrebno je povremeno provođenje laboratorijskih testova na plazmi kako bi se osiguralo postizanje i održavanje odgovarajuće razine faktora VIII.
English: If this occurs, stop administering the product immediately and seek medical advice.
Croatian: U tom slučaju odmah prestanite primjenjivati lijek i zatražite liječničku pomoć.
English: Determine the point of injection, clean the skin with an alcohol swab, and prepare site of injection antiseptically as advised by your doctor.
Croatian: Odredite mjesto injiciranja, očistite kožu tupferom natopljenom alkoholom te antiseptički pripremite mjesto za injiciranje prema uputama liječnika.