FrancophonIA/ELRC3.0 huggingface dataset:
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, for human plasma derived and recombinant coagulation factor VIII containing medicinal products (see Annex I and Annex A).
Croatian: • PRAC je razmotrio postupak u skladu sa člankom 31. Direktive 2001/83/EZ iz podataka za farmakovigilanciju za lijekove s faktorom VIII dobivene iz ljudske plazme i lijekove s rekombinantnim koagulacijskim faktorom VIII (vidi prilog I. i Prilog A).
English: 4.7 Effects on ability to drive or use machines
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: If you notice any of the following symptoms during injection/infusion:
Croatian: Ako tijekom ubrizgavanja/infuzije primijetite bilo koji od sljedećih simptoma:
English: • The SIPPET study has methodological limitations, with particular uncertainty around whether the randomisation process (block size of 2) may have introduced a selection bias in the study.
Croatian: • Ispitivanje SIPPET ima metodološka ograničenja, a posebno je nesigurno je li postupak randomizacije (veličina bloka = 2) doveo do pristranosti u odabiru.
English: This product is indicated for adults, adolescents and children of all ages.
Croatian: Ovaj lijek je indiciran za odrasle, adolescente i djecu bilo koje dobi.
English: • two dry swabs
Croatian: • dva suha rupčića
English: Warm the unopened powder vial and the solvent syringe in your hands until they feel as warm as your hands.
Croatian: Neotvorenu bočicu s praškom i štrcaljku s otapalom ugrijte u rukama dok ne postanu jednako tople kao i ruke.
English: Of the larger and more relevant studies for pdFVIII products, inhibitor rates observed (often not stated if high or low titre) ranged from 3.5 to 33%, with most around 10-25%.
Croatian: U većim i relevantnijim ispitivanjima lijekova s faktorom VIII dobivenim iz plazme, zabilježene stope pojave inhibitora (često nije navedeno jesu li niskog ili visokog titra) bile su u rasponu od 3,5 % do 33 %, s većim dijelom u rasponu od 10 % do 25 %.
English: Data show that KOGENATE Bayer has been used to induce immune tolerance.
Croatian: Podaci pokazuju da se KOGENATE Bayer primjenjivao za izazivanje imunološke tolerancije.
English: Common (may affect up to 1 in 10 users):
Croatian: Često (mogu se javiti u do 1 na 10 korisnika)
English: The reconstituted solution must be used within 3 hours.
Croatian: Pripremljena otopina mora se primijeniti u roku od 3 sata.
English: On 6 July 2016 Paul-Ehrlich-Institut Germany initiated a referral under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data, and requested the PRAC to assess the potential impact of the results of the SIPPET study on the marketing authorisations of relevant FVIII products and to issue a recommendation on whether these should be maintained, varied, suspended or revoked and whether any risk minimisation measures should be implemented.
Croatian: Njemački institut Paul-Ehrlich-pokrenuo je 6. srpnja 2016. postupak upućivanja na temelju članka 31. Direktive 2001/83/EZ na temelju farmakovigilancijskih podataka te zatražio od PRAC-a da ocijeni mogući utjecaj ispitivanja SIPPET na odobrenja za stavljanje u promet odgovarajućih lijekova s faktorom VIII te da izda preporuku o tome treba li ih zadržati, izmijeniti, obustaviti ili opozvati i treba li provesti mjere za smanjivanje rizika.
English: Nervous System Disorders
Croatian: Poremećaji živčanog sustava
English: Place the vial on a rigid, non-slip surface and hold it firmly with one hand.
Croatian: Postavite bočicu na čvrstu neklizavu podlogu te je čvrsto držite jednom rukom.
English: Furthermore, the PRAC examined clinical trials and the scientific literature for de novo inhibitors in PTPs.
Croatian: Nadalje, PRAC je pregledao klinička ispitivanja i znanstvenu literaturu o de novo inhibitorima u prethodno liječenih bolesnika.
English: • Patient-related risk factors include type of F8 gene mutation, severity of haemophilia, ethnicity, family history of inhibitor development and possibly HLA-DR (Human Leukocyte Antigen - antigen D Related) constitution.
Croatian: • Čimbenici rizika povezani s bolesnicima uključuju mutaciju gena F8, težinu hemofilije, etnicitet, obiteljsku povijest razvoja inhibitora i možda građu HLA DR-a (ljudski leukocitni antigen DR).
English: Warm both an unopened vial and a syringe in your hands to a comfortable temperature (do not exceed 37 °C).
Croatian: Neotvorenu bočicu i štrcaljku ugrijte rukama do ugodne temperature (ne više od 37 °C).
English: The SIPPET study
Croatian: Ispitivanje SIPPET
English: Remove the cap from the powder vial by gently moving it from side to side several times, whilst at the same time pulling upwards.
Croatian: Uklonite zatvarač s bočice s praškom tako da ga oprezno nekoliko puta pomičete lijevo-desno i istodobno povlačite prema gore.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti faktora VIII jednaka je količini faktora VIII u jednom ml normalne ljudske plazme.
English: This included published literature (SIPPET study6), data generated in individual clinical trials and a range of observational studies submitted by the marketing authorisation holders, including the data generated in large multicentre cohort studies, data submitted by the national competent authorities of the EU Member States as well as responses provided by the Authors of the SIPPET study.
Croatian: To obuhvaća objavljenu literaturu (ispitivanje SIPPET6), podatke izrađene u pojedinim kliničkim ispitivanjima i niz opservacijskih ispitivanja koje su dostavili nositelji odobrenja za stavljanje u promet, uključujući podatke izrađene u velikim multicentričnim kohortnim ispitivanjima, podatke koje su dostavila nacionalna nadležna tijela država članica, kao i odgovore koje su pružili autori ispitivanja SIPPET.
English: In particular, only 13 patients (10% of the FVIII arm) received a third generation rFVIII product.
Croatian: Konkretno, samo je 13 bolesnika (10 % od skupine koja je primila faktor VIII) primilo treću generaciju lijeka s rekombinantnim faktorom VIII.
English: What KOGENATE Bayer is and what it is used for What you need to know before you use KOGENATE Bayer How to use KOGENATE Bayer Possible side effects
Croatian: Što je KOGENATE Bayer i za što se koristi Što morate znati prije nego što počnete primjenjivati KOGENATE Bayer Kako primjenjivati KOGENATE Bayer Moguće nuspojave
English: Infusion rate IU/h/kg
Croatian: Brzina infuzije IU/h/kg
English: 2 plasters
Croatian: 2 flastera
English: The most serious side effects are hypersensitivity reactions or anaphylactic shock (rare side effect).
Croatian: Najozbiljnije nuspojave su reakcije preosjetljivosti ili anafilaktički šok (rijetka nuspojava).
English: Follow the directions given by your doctor closely and use the detailed instructions for reconstitution and administration provided at the end of this leaflet.
Croatian: Pažljivo slijedite upute koje Vam je dao liječnik i koristite detaljne upute za pripremu za primjenu i primjenu, koje se nalaze na kraju ove upute.
English: Inhibitors developed in 76 patients, 50 of whom had high-titre inhibitors (≥5 BU).
Croatian: Inhibitori su se razvili u 76 bolesnika, od kojih je 50 imalo inhibitore visokog titra (≥ 5 BU).
English: Allergic type hypersensitivity reactions are possible with KOGENATE Bayer.
Croatian: Reakcije alergijskog tipa preosjetljivosti moguće su na lijek KOGENATE Bayer.
English: These compatible filters are luer adaptor-type of Polyacrylic housing with integrated filter element of a Polyamide screen of 5 - 20 micrometer mesh size.
Croatian: Ovi su kompatibilni filteri tipa luer-adapter s poliakrilnim kućištem i ugrađenim elementom za filtriranje od poliamidne zaštitne rešetke veličine pora od 5 - 20 mikrometara.
English: If you want to stop using KOGENATE Bayer Do not stop using KOGENATE Bayer without consulting your doctor.
Croatian: Ako prestanete primjenjivati KOGENATE Bayer Nemojte prestati uzimati KOGENATE Bayer bez savjetovanja s liječnikom.
English: Do not use this medicine after the expiry date which is stated on labels and cartons.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i pakiranjima.
English: In situations where the venipuncture set provided cannot be used (e.g. when infusing into a peripheral or central line), a separate filter compatible with KOGENATE Bayer should be used.
Croatian: U situacijama kada se priloženi komplet za venepunkciju ne može uporabiti (npr. kad se infuzija daje u periferni ili centralni venski put), potrebno je uporabiti zaseban filter kompatibilan s lijekom KOGENATE Bayer.
English: Table 1: Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/
Croatian: Tablica 1: Vodič za epizode krvarenja i kirurške zahvate Jačina krvarenja / vrsta kirurškog zahvata
English: Prior to the current referral, it was noted that PRAC had already considered the implications of the RODIN/Pednet, the UKHCDO and the FranceCoag studies for the EU marketing authorisations for FVIII products.
Croatian: Prije trenutačnog upućivanja zabilježeno je da je PRAC već razmatrao implikacije ispitivanja RODIN/Pednet, UKHCDO i FranceCoag za odobrenja za stavljanje u promet lijekova s faktorom VIII u EU-u.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Sljedeća tablica prikazana je prema MedDRA klasifikaciji organskih sustava (SOC i preporučeni izrazi).
English: Determination of activated partial thromboplastin time (aPTT) is a conventional in vitro assay method for biological activity of factor VIII.
Croatian: Određivanje aktiviranog parcijalnog tromboplastinskog vremena (APTV) uobičajena je metoda in vitro određivanja biološke aktivnosti faktora VIII.
English: For the calculation of the initial infusion rate, clearance can be obtained by performing a pre-surgery decay curve, or by starting from an average population value (3.0-3.5 mL/h/kg) and then adjust accordingly.
Croatian: Za izračun početne brzine infuzije klirens se može postići izradom preoperativne krivulje opadanja ili započeti s prosječnom populacijskom vrijednošću (3,0 - 3,5 ml/h/kg), a zatim je prilagođavati.
English: This will usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, given every 2 to 3 days.
Croatian: Doze su najčešće u rasponu od 20 do 40 IU oktokoga alfa po kilogramu tjelesne težine svaka 2 do 3 dana.
English: KOGENATE Bayer has no influence on the ability to drive or to use machines.
Croatian: KOGENATE Bayer ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Published observational studies
Croatian: Objavljena opservacijska ispitivanja
English: What KOGENATE Bayer is and what it is used for
Croatian: Što je KOGENATE Bayer i za što se koristi
English: * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously untreated patients
Croatian: * Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients)
English: Any unused solution must be discarded.
Croatian: Neiskorištena se otopina mora baciti.
English: Although this could not have been prevented, an early termination of an open label trial raises the possibility of investigator bias and inflation of the probability of detecting an effect that is not present.
Croatian: Iako se to nije moglo spriječiti, prekid otvorenog ispitivanja u ranoj fazi ukazuje na mogućnost pristranosti ispitivača i povećanu vjerojatnost da se utvrdi nepostojeći učinak.
English: The amount to be administered and the frequency of administration should always be adapted according to the clinical effectiveness in the individual case.
Croatian: Količinu i učestalost primjene uvijek je potrebno prilagoditi u skladu s kliničkom učinkovitošću za svaki pojedinačni slučaj.
English: If you have been told by your doctor that you have developed factor VIII inhibitors you may need to use a larger amount of this medicine to control bleeding.
Croatian: Ako Vas je liječnik obavijestio da su se razvili inhibitori faktora VIII, možda će za zaustavljanje krvarenja biti potrebna veća količina ovog lijeka.
English: • Individual studies have identified a wide range of inhibitor development across products, but the direct comparability of study results is questionable based on diversity of study methods and patient populations over time.
Croatian: • U pojedinim ispitivanjima utvrđen je širok raspon razvoja inhibitora za različite lijekove, no izravna usporedivost rezultata ispitivanja je upitna jer su tijekom vremena korištene raznolike metode ispitivanja i populacije bolesnika.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min).
Croatian: Brzina primjene određuje se prema stupnju tolerancije bolesnika (maksimalna je brzina infuzije 2 ml/min).
English: No interactions of KOGENATE Bayer with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijeka KOGENATE Bayer s drugim lijekovima.
English: If any component of the package is opened or damaged, do not use it.
Croatian: Ako je bilo koja komponenta iz pakiranja otvorena ili oštećena, nemojte ju koristiti.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR BIO-SET SYSTEM
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - ZA BIO-SET SUSTAV
English: Other medicines and KOGENATE Bayer
Croatian: Drugi lijekovi i KOGENATE Bayer
English: However, in the presence of an inhibitor the doses required are variable and must be adjusted according to clinical response and monitoring of plasma factor VIII activity.
Croatian: No potrebne se doze u prisutnosti inhibitora razlikuju te ih je potrebno prilagoditi u skladu s kliničkim odgovorom i nadzorom aktivnosti faktora VIII u plazmi.
English: Overall, the expert group supported the PRAC initial conclusions and agreed that the proposed product information provides an adequate level of information to appropriately communicate to prescribers and patients about the risk of inhibitor development.
Croatian: Ukupno gledano, stručna skupina poduprla je početne zaključke PRAC-a te je donijela zaključak da je u predloženim informacijama o lijeku navedena dostatna razina informacija kako bi se propisivače lijeka i bolesnike na odgovarajući način izvijestilo o riziku od razvoja inhibitora.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse 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 faktora VIII:C te uzrokuje krvarenje u zglobovima, mišićima i unutrašnjim organima, bilo spontano ili uzrokovano slučajnom ili kirurškom traumom.
English: The PRAC recommended changes to the product information accordingly.
Croatian: Sukladno tome, PRAC je preporučio izmjene informacija o lijeku.
English: • local reactions where you injected the medication (e.g. burning sensation, temporary redness)
Croatian: • lokalne reakcije na mjestu injiciranja lijeka (npr. osjećaj peckanja, privremeno crvenilo)
English: The known risk factors for inhibitor development can be grouped into patient and treatment-related factors:
Croatian: Poznati čimbenici rizika za razvoj inhibitora mogu se grupirati prema čimbenicima povezanima s bolesnicima i s liječenjem:
English: Having considered the abovementioned results from SIPPET, the published literature and all the information submitted by the MAHs, as well as the views expressed by experts expressed at the ad-hoc expert meeting, the PRAC concluded that:
Croatian: Nakon što je razmotrio prethodno navedene rezultate ispitivanja SIPPET, objavljenu literaturu i sve informacije koji su nositelji odobrenja za stavljanje u promet dostavili, kao i stajališta stručnjaka iznesena na ad hoc sastanku stručne skupine, PRAC je zaključio sljedeće:
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: U djece koja ranije nisu bila liječena lijekovima koji sadrže faktor VIII, vrlo često (u više od 1 na 10 bolesnika) mogu nastati inhibitorna antitijela (vidjeti dio 2); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100 bolesnika).
English: Infusion rate for 75 kg patient mL/h
Croatian: Brzina infuzije za bolesnika težine 75 kg ml/h
English: PRAC conclusions
Croatian: Zaključci PRAC-a
English: Life threatening haemorrhages (such as intracranial bleed, throat bleed, severe abdominal bleed)
Croatian: Krvarenja opasna po život (kao što je intrakranijalno krvarenje, krvarenje u grlu, jako abdominalno krvarenje)
English: 60 % (0.6 IU/mL) 1.8 40 % (0.4 IU/mL) 1.2
Croatian: 100% (1 IU/ml) 60% (0,6 IU/ml) 40% (0,4 IU/ml)
English: It has been shown in a clinical study performed with adult haemophilia A patients who undergo a major surgery that KOGENATE Bayer can be used for continuous infusion in surgeries (pre-, during and postoperative).
Croatian: Kliničko ispitivanje provedenu u odraslih bolesnika s hemofilijom A u kojih se radi veliki kirurški zahvat pokazalo je da se KOGENATE Bayer može koristiti za kontinuiranu infuziju kod operacije (prije, tijekom i poslije operacije).
English: Mean baseline clearance for 14 adult patients undergoing major surgeries with continuous infusion are 188 mL/h corresponding to 3.0 mL/h/kg (range 1.6-4.6 mL/h/kg).
Croatian: Srednji ishodni klirens 14 odraslih bolesnika podvrgnutih opsežnim kirurškim zahvatima uz kontinuiranu infuziju iznosio je 188 ml/h, što odgovara 3,0 ml/h/kg (raspon od 1,6 do 4,6 ml/h/kg).
English: If you cannot use the venipuncture set provided, use a separate filter as your nurse or doctor has instructed.
Croatian: Ako ne možete uporabiti priloženi komplet za venepunkciju, uporabite zasebni filter prema uputama Vašeg liječnika ili medicinske sestre.
English: • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
Croatian: • blagu hipotenziju (blago sniženje krvnog tlaka zbog čega prilikom ustajanja možete imati osjećaj da ćete se onesvijestiti)
English: Documentation
Croatian: Dokumentiranje
English: If this dose does not control your bleeding your doctor may consider giving you an additional product, factor VIIa concentrate or (activated) prothrombin complex concentrate.
Croatian: Ako se krvarenje ne zaustavi ni većom dozom, liječnik će Vam možda dati dodatni lijek - koncentrat faktora VIIa ili (aktivirani) koncentrat protrombinskog kompleksa.
English: • two plasters
Croatian: • dva flastera
English: Infusion rate (in IU/kg/h) = Clearance (in mL/h/kg) × desired factor VIII level (in IU/mL)
Croatian: Brzina infuzije (u IU/kg/h) = klirens (u ml/h/kg) × željena razina faktora VIII (u IU/ml)
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in all population groups except for the inhibitor formation.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava, osim stvaranja inhibitora, u djece biti iste kao i u svim populacijskim skupinama.
English: This result is similar to the reported values for factor VIII derived from human plasma.
Croatian: Ti su rezultati slični zabilježenim vrijednostima prilikom primjene faktora VIII dobivenog iz humane plazme.
English: Infusion site reaction
Croatian: Reakcija na mjestu infuzije
English: Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle.
Croatian: Ubrizgavajte otopinu u venu kroz 2 do 5 minuta, pazeći cijelo vrijeme na položaj igle.
English: No case of overdose with recombinant coagulation factor VIII has been reported.
Croatian: Nije zabilježen nijedan slučaj predoziranja rekombinantnim koagulacijskim faktorom VIII.
English: Your doctor may carry out tests to ensure that your current dose of this medicine provides adequate factor VIII levels.
Croatian: Liječnik može obaviti pretrage kako bi se osiguralo da se s trenutnom dozom ovog lijeka postižu odgovarajuće razine faktora VIII.
English: If you have used more KOGENATE Bayer than you should, please inform your doctor.
Croatian: Ako uzmete više lijeka KOGENATE Bayer nego što ste trebali, obavijestite svojeg liječnika.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of KOGENATE Bayer per kg body weight at intervals of 2 to 3 days.
Croatian: Za dugotrajnu profilaksu krvarenja u bolesnika s teškom hemofilijom A uobičajene su doze 20 do 40 IU lijeka KOGENATE Bayer po kilogramu tjelesne težine u razmacima od 2 do 3 dana.
English: Further to the assessment of the totality of the responses submitted by the MAH for susoctocog alfa (Obizur), the PRAC is of the opinion that the outcome of this article 31 referral procedure does not apply to this product in view of the indication of Obizur (acquired haemophilia A due to inhibitory antibodies to endogenous FVIII) and the different target population.
Croatian: Nastavno na procjenu svih odgovora koje je nositelj odobrenja za stavljanje u promet dostavio za susoktokog alfa (Obizur), PRAC je mišljenja da se ishod ovog postupka upućivanja iz članka 31. ne odnosi na ovaj lijek s obzirom na indikaciju lijeka Obizur (stečena hemofilija A uzrokovana inhibicijskim protutijelima na endogeni faktor VIII) i različitu ciljnu populaciju.
English: In patients with inhibitor titres above 10 BU or with high anamnestic response, the use of (activated) prothrombin complex concentrate (PCC) or recombinant activated factor VII (rFVIIa) preparations has to be considered.
Croatian: U bolesnika s titrom inhibitora većim od 10 BU ili s jakim anamnestičkim odgovorom potrebno je razmotriti mogućnost upotrebe lijeka (aktiviranog) koncentrata protrombinskog kompleksa (PCC-a) ili rekombinantnog aktiviranog faktora VII (rFVIIa).
English: Do not use KOGENATE Bayer if you notice visible particulate matter or turbidity.
Croatian: KOGENATE Bayer nemojte koristiti ako zamijetite vidljive čestice ili zamućenje.
English: The data came from a very wide range of heterogenous studies across products and over time.
Croatian: Podatci su prikupljeni iz vrlo širokog raspona heterogenih ispitivanja različitih lijekova provedenih tijekom vremena.
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Croatian: Držite štrcaljku uspravno te potiskujte klip dok se iz štrcaljke ne izbaci sav zrak.
English: In this study heparin was used to prevent thrombophlebitis at the infusion site as with any other long term intravenous infusions.
Croatian: U tom se ispitivanju heparin koristio za sprječavanje tromboflebitisa na mjestu davanja infuzije, kao i kod svake druge dugotrajne intravenske infuzije.
English: Results of clinical studies not sufficiently robust (e.g. suffering from methodolical limitations) should not be reflected in the product information on FVIIII products.
Croatian: Rezultate kliničkih ispitivanja koja nisu dostatno pouzdana (npr. koja podliježu metodološkim ograničenjima) treba izostaviti iz informacija o lijeku za lijekove s faktorom VIII.
English: FVIII Inhibition (PTPs)*
Croatian: Inhibicija faktora VIII (PTPs)*
English: The following table provides a guide for factor VIII minimum blood levels.
Croatian: U tablici u nastavku navedene su smjernice za minimalne razine faktora VIII u krvi.