FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor.
Slovenian: Če menite, da je učinek tega zdravila premočan ali prešibak, se posvetujte z zdravnikom.
English: Following the adoption of the PRAC recommendation during the May 2017 PRAC meeting, the MAH LFB Biomedicaments expressed their disagreement with the initial PRAC recommendation.
Slovenian: Po sprejetju priporočila odbora PRAC maja 2017 na seji odbora PRAC je imetnik dovoljenja za promet z zdravilom LFB Biomedicaments izrazil nestrinjanje s prvotnim priporočilom odbora PRAC.
English: Do not increase your dose of medicine you use to control your bleeding without consulting your doctor.
Slovenian: Ne povečajte odmerka zdravila, ki ga uporabljate za nadzor krvavitev, ne da bi se posvetovali z zdravnikom.
English: Differences between products in each FVIII class and consequently differential risks between individual products, are biologically plausible.
Slovenian: Razlike med zdravili v vsakem razredu FVIII in posledično različna tveganja med posameznimi zdravili so biološko verjetne.
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.
Slovenian: Na splošno je strokovna skupina podprla prvotne zaključke odbora PRAC in se strinjala, da predlagane informacije o zdravilu zagotavljajo ustrezno raven podatkov, s katero primerno obvestijo zdravnika in bolnike o tveganju za pojav zaviralcev.
English: Warnings and precautions Take special care with KOGENATE Bayer and talk to your doctor or pharmacist if:
Slovenian: Opozorila in previdnostni ukrepi Bodite posebno pozorni pri uporabi zdravila KOGENATE Bayer in se posvetujte z zdravnikom ali farmacevtom, če:
English: The data came from a very wide range of heterogenous studies across products and over time.
Slovenian: Podatki so izhajali iz zelo širokega nabora heterogenih študij z različnimi zdravili in v različnih obdobjih.
English: If any component of the package is opened or damaged, do not use it.
Slovenian: Če je kateri koli sestavni del pakiranja odprt ali poškodovan, ga ne uporabite.
English: The experts also suggested studies which could further characterise the immunogenic properties of the factor VIII medicinal products (e.g. mechanistic, observational studies).
Slovenian: Strokovnjaki so predlagali tudi študije, s katerimi bi lahko dodatno pojasnili imunogene lastnosti zdravil s faktorjem VIII (npr. mehanistične, opazovalne študije).
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.
Slovenian: Čeprav so klinične študije za nekatera posamezna zdravila ugotovile omejeno število primerov pojava zaviralcev, gre za majhne študije z metodološkimi omejitvami ali študije, ki niso ustrezno zasnovane za ovrednotenje tega tveganja;
English: Place the vial on a rigid, non-slip surface and hold it firmly with one hand.
Slovenian: Vialo postavite na trdno nedrsečo površino in jo z eno roko močno držite.
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.
Slovenian: Rezultati kliničnih študij, ki niso dovolj robustni (npr. imajo metodološke omejitve), se ne smejo odražati v informacijah o zdravilih s FVIIII.
English: The pre-filled syringe contains water for injections to be used to reconstitute the contents of the vial.
Slovenian: Napolnjene injekcijske brizge vsebujejo vodo za injekcije, ki se uporablja za rekonstitucijo vsebine viale.
English: The infusion rate should be calculated based on the clearance and the desired FVIII level.
Slovenian: Hitrost infundiranja je treba izračunati glede na očistek in želeno raven FVIII.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the medicinal product immediately and contact their physician.
Slovenian: Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, da naj takoj prenehajo uporabljati zdravilo in se posvetujejo z zdravnikom.
English: • nausea this can constitute an early warning for hypersensitivity and anaphylactic reactions.
Slovenian: • občutek siljenja na bruhanje to lahko pomeni zgodnje opozorilo za pojav preobčutljivosti in anafilaktičnih reakcij.
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.
Slovenian: Družba Paul-Ehrlich-Institut iz Nemčije je 6. julija 2016 sprožila napotitev na podlagi člena 31 Direktive 2001/83/ES in podatkov o farmakovigilanci in zaprosila odbor PRAC, da oceni možen učinek rezultatov študije SIPPET na dovoljenja za promet z ustreznimi zdravili s FVIII in izda priporočilo, ali je treba ta dovoljenja ohraniti, spremeniti, začasno prekiniti ali preklicati ali pa je treba izvajati ukrepe za zmanjšanje tveganja.
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.
Slovenian: Vendar kljub pomanjkanju robustnih dokazov v podporo različnega tveganja med zdravili z rFVIII slednjega ni mogoče izključiti, saj gre za heterogen razred zdravil z razlikami v sestavi in formulacijah.
English: This should be considered for a continuous infusion administration.
Slovenian: To je treba upoštevati pri uporabi kontinuirane infuzije.
English: These studies have yielded different results and suffer from the limitations of observational studies, and in particular from possible selection bias.
Slovenian: Te študije so prinesle različne rezultate in imajo omejitve opazovalnih študij, zlasti zaradi morebitne napake pri izbiri.
English: Under certain circumstances larger amounts than those calculated may be required, especially in the case of the initial dose.
Slovenian: V določenih primerih so lahko potrebni večji odmerki od izračunanih, še posebej na začetku zdravljenja.
English: The specific activity of KOGENATE Bayer is approximately 4000 IU/mg protein.
Slovenian: Specifična aktivnost zdravila KOGENATE Bayer je približno 4000 i.e./mg beljakovine.
English: Factor VIII level required (%) (IU/dl)
Slovenian: Potrebna raven faktorja VIII (%) (i.e./dl)
English: Consequently, patients should be evaluated and monitored for cardiac risk factors.
Slovenian: Pri bolnikih je treba oceniti in spremljati dejavnike tveganja za srčnožilne bolezni.
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.
Slovenian: Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospešuje pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X pretvori protrombin v trombin.
English: The known risk factors for inhibitor development can be grouped into patient and treatment-related factors:
Slovenian: Znane dejavnike tveganja za pojav zaviralcev lahko združimo v dejavnike, povezane z bolniki in zdravljenjem:
English: Remove the protective cap from the vial (A) and wipe the rubber stopper on the vial with a alcohol swab and allow it to air dry before use.
Slovenian: Odstranite zaščitno zaporko z viale (A) in očistite gumijasti zamašek na viali z alkoholnim tamponom ter pustite, da se pred uporabo osuši na zraku.
English: This medicine must not be mixed with other infusion solutions.
Slovenian: Tega zdravila ne smete mešati z drugimi raztopinami za infundiranje.
English: Re-examination procedure
Slovenian: Postopek ponovne proučitve
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%.
Slovenian: Pri večjih in bolj relevantnih študij za zdravila s pdFVIII so bile opažene stopnje pojava zaviralcev (pogosto ni bila navedena raven titrov) v razponu od 3,5 do 33 %, pri večini približno 10-25 %.
English: • mild hypotension (mildly reduced blood pressure, which may make you feel faint upon standing)
Slovenian: • blaga hipotenzija (blago znižanje krvnega tlaka, zaradi česar se vam lahko vrti, ko vstanete)
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.
Slovenian: V primerih, ko priloženega pribora za vensko punkcijo ni mogoče uporabiti (npr. pri infundiranju v periferni ali centralni kanal) je treba uporabiti ločen filter, ki je združljiv z zdravilom KOGENATE Bayer.
English: >), the above frequency for PUPs should not be implemented.
Slovenian: >), zgoraj navedene pogostnosti za predhodno nezdravljene bolnike ne bi smeli uveljaviti.
English: If you cannot use the venipuncture set provided, use a separate filter as your nurse or doctor has instructed.
Slovenian: Če priloženega pribora za vensko punkcijo ne morete uporabiti, uporabite ločen filter, kot vam je svetovala medicinska sestra ali zdravnik.
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'.
Slovenian: Stopnje pojava zaviralcev v teh študijah se gibljejo od 15 do 38 % za vse titre zaviralcev in od 9 do 22,6 % za visoke titre zaviralcev; tj. v območju „zelo pogosti“.
English: 60 % (0.6 IU/mL) 1.8 40 % (0.4 IU/mL) 1.2
Slovenian: 100 % (1 i.e./ml) 3,0 60 % (0,6 i.e./ml) 1,8 40 % (0,4 i.e./ml) 1,2
English: As the evidence suggests that all human FVIII products carry a risk of inhibitor development such statements should be removed.
Slovenian: Ker dokazi kažejo, da imajo vsa zdravila s FVIII v humani medicini tveganje za pojav zaviralcev, je treba take izjave odstraniti.
English: The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and vWF) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja (vWF) je sestavljen iz dveh molekul (faktor VIII in vWF) z različnim fiziološkim delovanjem.
English: Any unused solution must be discarded.
Slovenian: Neuporabljeno raztopino je treba zavreči.
English: If you have any questions about this medicine and compatible separate filters, contact your doctor.
Slovenian: Če imate kakršna koli vprašanja o tem zdravilu in z njim združljivih ločenih filtrih, se posvetujte z zdravnikom.
English: Do not shake the vial!
Slovenian: Ne stresajte viale!
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.
Slovenian: Velikost odmerka bo običajno od 20 do 40 i.e. oktokoga alfa na kilogram telesne mase, danega vsakih 2 do 3 dni.
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).
Slovenian: a) z bolusnimi infuzijami Ponavljajte infuzijo vsakih 8 do 24 ur, dokler se rana ustrezno ne zaceli; nato nadaljujte zdravljenje vsaj še naslednjih 7 dni za vzdrževanje aktivnosti faktorja VIII na 30 do 60 % (i.e./dl).
English: If allergic or anaphylactic reactions occur, the injection/infusion should be stopped immediately.
Slovenian: Če se pojavijo alergijske ali anafilaktične reakcije je treba takoj prenehati z injiciranjem/infundiranjem.
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.
Slovenian: To je obsegalo objavljeno literaturo (študija SIPPET6), podatke, pridobljene v posameznih kliničnih preskušanjih, in vrsto opazovalnih študij, ki so jih predložili imetniki dovoljenja za promet, vključno s podatki, pridobljenimi v velikih multicentričnih kohortnih študijah, podatke, ki so jih predložili pristojni nacionalni organi držav članic EU, ter odzive avtorjev študije SIPPET.
English: In patients where immune tolerance was achieved the bleedings could be prevented or controlled with KOGENATE Bayer again, and the patients could continue with prophylactic treatment as maintenance therapy.
Slovenian: Pri bolnikih, pri katerih je bila imunska toleranca dosežena, je bilo mogoče krvavitev znova preprečiti ali nadzorovati z zdravilom KOGENATE Bayer, bolniki pa so lahko nadaljevali s profilaktičnim zdravljenjem kot vzdrževalnim zdravljenjem.
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.
Slovenian: Pričakuje se, da so pogostnost, vrsta in resnost neželenega učinka pri otrocih enaki kot pri ostalih populacijah bolnikov, razen glede nastanka zaviralcev.
English: patients (<6 years, male, severe haemophilia A, no previous treatment with any FVIII concentrate or only minimal treatment with blood components) were included from 42 sites.
Slovenian: Vključeni so bili primerni bolniki (< 6 let, moški, huda hemofilija A, brez predhodnega zdravljenja s katerim koli koncentratom FVIII ali le minimalno zdravljeni s krvnimi komponentami) iz 42 ustanov.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Slovenian: Če se zdravila ne uporabi takoj po rekonstituciji, je za trajanje in pogoje shranjevanja pred uporabo odgovoren uporabnik.
English: There are no fertility data available.
Slovenian: Podatkov o vplivu na plodnost ni.
English: Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Slovenian: Zdravnik vam bo svetoval, kako pogosto in v kakšnih presledkih morate uporabljati to zdravilo.
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and disability are resolved.
Slovenian: Ponavljajte vsakih 12 do 24 ur, 3 do 4 dni ali več, dokler ne mineta bolečina in onesposobljenost.
English: Do not remove the adapter from the plastic housing.
Slovenian: Ne odstranite adapterja s plastičnega ohišja.
English: KOGENATE Bayer has no influence on the ability to drive or to use machines.
Slovenian: Zdravilo KOGENATE Bayer nima vpliva na sposobnost vožnje in upravljanja strojev.
English: FVIII replacement therapy can be generally categorised into two broad classes of products; plasma derived (pdFVIII) and recombinant (rFVIII) FVIII.
Slovenian: Nadomestno zdravljenje s FVIII je na splošno mogoče razvrstiti v dve široki skupini izdelkov; plazemski (pdFVIII) in rekombinantni (rFVIII) FVIII.
English: The reconstituted medicinal product is a clear and colourless solution.
Slovenian: Rekonstituirano zdravilo je bistra in brezbarvna raztopina.
English: The PRAC also considered interim results submitted by the MAHs from ongoing studies from CSL (CRD019_5001) and Bayer (Leopold KIDS, 13400, part B.).
Slovenian: Odbor PRAC je obravnaval tudi vmesne rezultate iz študij, ki potekajo, in sta jih predložila imetnika dovoljenj za promet z zdravilom CSL (CRD019_5001) in Bayer (Leopold KIDS, 13400, del B.).
English: Continuous Infusion
Slovenian: Kontinuirana infuzija
English: Data show that KOGENATE Bayer has been used to induce immune tolerance.
Slovenian: Podatki kažejo, da se zdravilo KOGENATE Bayer uporablja za indukcijo imunske tolerance.
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).
Slovenian: Zaviralci so se pojavili pri 29 od 125 bolnikov, zdravljenih s pdFVIII (20 bolnikov je imelo visoke titre zaviralcev), in pri 47 od 126 bolnikov, zdravljenih z rFVIII (30 bolnikov je imelo visoke titre zaviralcev).
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Vpliva na sposobnost vožnje in upravljanja strojev niso opazili.
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.
Slovenian: • v posameznih študijah so odkrili širok razpon pojavljanja zaviralcev med zdravili, vendar je neposredna primerljivost rezultatov študije vprašljiva zaradi razlik v metodologiji študij in populacijah bolnikov v odvisnosti od časa;
English: Rare / not known
Slovenian: Zelo redki / neznana pogostnost
English: Treatment of congenital haemophilia is currently based on prophylactic or on-demand replacement therapy with coagulation factor VIII (FVIII).
Slovenian: Zdravljenje kongenitalne hemofilije trenutno temelji na profilaktični ali nadomestni terapiji na zahtevo s koagulacijskim faktorjem VIII (FVIII).
English: Set the syringe aside for further use.
Slovenian: Injekcijsko brizgo dajte na stran za kasnejšo uporabo.
English: Immune Tolerance Induction (ITI)
Slovenian: Indukcija imunske tolerance (ITI - Immune Tolerance Induction)
English: Example: for a 75 kg patient with a clearance of 3 mL/h/kg, the initial infusion rate would be 3 IU/h/kg to achieve a FVIII level of 100%.
Slovenian: Primer: za bolnika težkega 75 kg z očistkom 3 ml/h/kg bi bila začetna hitrost infundiranja 3 i.e./h/kg, da bi dosegli 100 % raven FVIII.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko različno odzivajo na faktor VIII, kar se kaže v različnem razpolovnem času zdravila in času okrevanja.
English: If you are using KOGENATE Bayer to prevent bleeding (prophylaxis), your doctor will calculate the dose for you.
Slovenian: Če zdravilo KOGENATE Bayer uporabljate za preprečevanje krvavitev (profilakso), bo velikost odmerka za vas izračunal zdravnik.
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.
Slovenian: • dejavniki tveganja, povezani z bolniki, obsegajo vrsto mutacije gena F8, resnost hemofilije, etnično pripadnost, družinsko anamnezo pojava zaviralcev in morda sestavo HLA-DR (humani levkocitni antigen - povezan z antigenom D);
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.
Slovenian: Pred trenutno napotitvijo je bilo ugotovljeno, da je odbor PRAC že preučil posledice študij RODIN/Pednet, UKHCDO in FranceCoag za dovoljenja za promet z zdravili s FVIII v EU.
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.
Slovenian: Nekatere eksperimentalne študije so nakazale, da VWF prepreči antigenpredstavitvenim celicam, da bi prepoznale epitope FVIII, s čimer se imunogenost zmanjša, čeprav je to še vedno teoretično.
English: The reconstituted solution must be used within 3 hours.
Slovenian: Rekonstituirano raztopino je treba uporabiti v 3 urah.
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.
Slovenian: Tveganje za pojav zaviralca je posledica več dejavnikov (poleg vseh domnevnih tveganj, povezanih s posameznim zdravilom) in takšne študije niso vedno zmogle zbrati informacij o ustreznih kovariatah ter ustrezno prilagoditi analize; preostale begave spremenljivke so neizogibna velika negotovost.
English: You are filtering by following the reconstitution and/or administration steps as described below.
Slovenian: Pri filtriranju upoštevajte postopek za rekonstitucijo in/ali uporabo, kot je opisano spodaj.
English: The listed warnings and precautions apply both to adults and children.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo za odrasle in otroke.
English: The product contains traces of mouse and hamster proteins and human proteins other than factor VIII (see section 5.1).
Slovenian: Zdravilo vsebuje sledi beljakovin miši in hrčkov ter poleg faktorja VIII tudi sledi humanih beljakovin (glejte poglavje 5.1).
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.
Slovenian: Statistični zadržki obsegajo dejstvo, da ni bila objavljena predhodno določena primarna analiza in dejstvo, da je bila študija predčasno ustavljena po objavi študije RODIN, ki je pokazala, da bi lahko bilo zdravilo Kogenate FS povezano s povečanim tveganjem za pojav zaviralcev.
English: No conclusions can be drawn on any role of VWF in protecting against inhibitor development.
Slovenian: Ni mogoče sklepati o vlogi VWF pri zaščiti pred pojavom zaviralcev.
English: This product is indicated for adults, adolescents and children of all ages.
Slovenian: Zdravilo je indicirano za odrasle, mladostnike in otroke vseh starosti.
English: Information submitted by the lead authors of the SIPPET study during the course of the referral was also taken into consideration by PRAC in reaching its conclusion.
Slovenian: Informacije, ki so jih predložili vodilni avtorji študije SIPPET med napotitvijo, je odbor PRAC upošteval pri oblikovanju mnenja.
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.
Slovenian: Zaporko na viali s praškom odstranite tako, da jo večkrat rahlo premaknete z ene na drugo stran, istosočasno pa jo vlecite navzgor.
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: After the initial 24 hours of continuous infusion, the clearance should be recalculated every day using the steady state equation with the measured FVIII level and the rate of infusion using the following equation: clearance = infusion rate/actual FVIII level.
Slovenian: Po začetni 24-urni kontinuirani infuziji, je treba vsak dan preračunati očistek na podlagi izmerjene ravni FVIII in hitrosti infundiranja z uporabo naslednje enačbe: očistek = hitrost infundiranja/dejanska raven FVIII.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% to 2.5% of normal activity.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da ena mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase, poveča aktivnost faktorja VIII v plazmi za 1,5 - 2,5 % normalne aktivnosti.