FrancophonIA/ELRC3.0 huggingface dataset:
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Slovenian: Standardni ukrepi za preprečevanje okužb, ki jih povzroča uporaba zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo izbiro darovalcev, presejanje posameznih donacij in zbirov plazme za specifične označevalce okužbe ter vključevanje učinkovitih proizvodnih korakov za inaktivacijo/odstranjevanje virusov.
English: VWF and FVIII are involved in blood clotting.
Slovenian: VWF in FVIII sta vključena v strjevanje krvi.
English: • you notice any symptoms of an impaired perfusion in your extremities (e.g. cold and pale extremities) or vital organs (e.g. severe chest pain)
Slovenian: • opazite kakršen koli simptom oslabljene perfuzije v vaših okončinah (npr. hladne in blede okončine) ali vitalnih organih (npr. hude bolečine v prsih).
English: Furthermore patients may develop inhibitors to FVIII and VWF.
Slovenian: Poleg tega lahko bolniki razvijejo inhibitorje proti FVIII in VWF.
English: Other medicines and Voncento
Slovenian: Druga zdravila in zdravilo Voncento
English: Activated FVIII 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 FVIII deluje kot kofaktor aktiviranemu faktorju IX, ki pospeši pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X pretvori protrombin v trombin.
English: The reconstituted preparation should be injected/infused slowly intravenously at a rate comfortable for the patient.
Slovenian: Pripravljeno zdravilo je treba injicirati/infundirati počasi intravensko s hitrostjo, udobno za bolnika.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora prvo redno posodobljeno poročilo o varnosti zdravila za to zdravilo predložiti v šestih mesecih po pridobitvi dovoljenja za promet.Zatem jih mora predložiti v skladu z zahtevami, določenimi v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in objavljenem na evropskem spletnem portalu o zdravilih.
English: DO NOT expose the vials to direct heat.
Slovenian: NE izpostavljajte vial neposredni vročini.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare
Slovenian: Pogostnosti so bile ocenjene v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Experience in the treatment of pregnant or breast-feeding women is not available.
Slovenian: Izkušnje zdravljenja pri nosečnicah ali doječih materah niso na voljo.
English: An initial dose of 80 IU/kg VWF:RCo may be required, especially in patients with type 3 VWD where maintenance of adequate levels may require greater doses than in other types of VWD.
Slovenian: Morda bo potreben začetni odmerek 80 i.e./kg VWF:RCo, zlasti pri bolnikih s tipom 3 VWB, kjer lahko vzdrževanje zadostnih ravni zahteva večje odmerke kot pri drugih tipih VWB.
English: Therefore, patients at risk must be monitored for early signs of thrombosis.
Slovenian: Zato moramo bolnike s tveganjem spremljati glede zgodnjih znakov tromboze.
English: What Voncento is and what it is used for
Slovenian: Kaj je zdravilo Voncento in za kaj ga uporabljamo
English: Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
Slovenian: Zdravilo Voncento vsebuje približno 128,2 mmol/l (2,95 mg/ml) natrija.
English: See section 2 “Voncento contains sodium”.
Slovenian: Glejte poglavje 2 “Zdravilo Voncento vsebuje natrij“.
English: The other ingredients are:
Slovenian: Druge sestavine so:
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Slovenian: V splošnem je treba vse bolnike, zdravljene z zdravili s koagulacijskim faktorjem VIII, skrbno spremljati glede nastanka zaviralcev z ustreznim kliničnim opazovanjem in z laboratorijskimi testi.
English: For safety with respect to transmissible agents, see section 4.4.
Slovenian: Za podatke o varnosti glede prenosljivih povzročiteljev, glejte poglavje 4.4.
English: Treatment of bleeding
Slovenian: Zdravljenje krvavitev
English: The risk of developing inhibitors is correlated to the severity of the disease as well as exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Slovenian: Tveganje za nastanek zaviralcev je odvisno od resnosti bolezni in izpostavljenosti faktorju VIII - največje je v prvih 50 dneh izpostavljenosti, vendar se nadaljuje vse življenje, čeprav je tveganje redko.
English: Virus safety
Slovenian: Varnost pred virusi
English: Inject/infuse the reconstituted solution slowly (at a rate not more than 6 ml per minute) into the vein following the instructions given to you by your doctor.
Slovenian: Pripravljeno raztopino injicirajte/infundirajte počasi (s hitrostjo, ki ni večja od 6 ml na minuto) v veno po navodilih, ki vam jih je dal zdravnik.
English: Therefore, Voncento should be used during pregnancy and breast-feeding only if clearly indicated.
Slovenian: Zato se lahko zdravilo Voncento uporablja med nosečnostjo in dojenjem le, če je jasno indicirano.
English: Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.
Slovenian: Zdravnik vam bo morda priporočil, da razmislite o cepljenju proti hepatitisu A in B, če redno/večkrat prejemate zdravila, pridobljena iz človeške plazme, kot je zdravilo Voncento.
English: Your treatment should be monitored by a doctor who is experienced in the treatment of blood clotting disorders.
Slovenian: Vaše zdravljenje mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem krvnih motenj strjevanja.
English: Factor VIII level required (% or IU/dl)
Slovenian: Potrebna raven faktorja VIII (% ali i.e./dl)
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Slovenian: • Nastanek zaviralcev (protiteles) je znan zaplet, ki se lahko pojavi med zdravljenjem z vsemi zdravili s faktorjem VIII.
English: The listed warnings and precautions apply both to adults and paediatrics.
Slovenian: Našteta opozorila in previdnostni ukrepi veljajo tako za odrasle kot za pediatrično populacijo.
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Slovenian: • preiskovanje vsake darovane in zbrane plazme za znake virusa/okužb,
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Slovenian: Zaradi teh zaviralcev, zlasti v visokih koncentracijah, zdravilo ne deluje več pravilno, zato bodo vas ali vašega otroka skrbno spremljali glede nastanka teh zaviralcev.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko med seboj razlikujejo pri svojem odzivu na faktor VIII, kar se kaže z različnimi razpolovnimi dobami in različnimi ravnmi povrnitve aktivnosti.
English: If you have a known risk of developing blood clots, you must be monitored for early signs of thrombosis (blood clotting).
Slovenian: Če imate znano tveganje za nastanek krvnih strdkov, vas je treba nadzorovati za primer zgodnjih znakov tromboze (strjevanje krvi).
English: Therefore, patients experiencing an anaphylactic reaction should be evaluated for the presence of an inhibitor.
Slovenian: Zato moramo bolnike z anafilaktično reakcijo ovrednotiti glede navzočnosti inhibitorja.
English: Prophylaxis and treatment of bleeding in patients with haemophilia A.
Slovenian: Profilaksa in zdravljenje krvavitev pri bolnikih s hemofilijo A.
English: In some cases it may progress to a serious allergic reaction (anaphylaxis) that causes severe difficulty in breathing, dizziness or shock.
Slovenian: V nekaterih primerih lahko napredujejo do hude alergijske reakcije (anafilaksije), ki povzroči hude težave pri dihanju, omotico ali šok.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.1.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili, topili ali vehikli, razen s tistimi, ki so omenjena v poglavju 6.1.
English: Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.
Slovenian: Pustite, da se viali posušita, preden odprete zavoj Mix2Vial (ki vsebuje pripravo s filtrom za prenos raztopine), nato sledite spodnjim navodilom.
English: Five cases of overdose have been reported from clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o petih primerih prevelikega odmerjanja.
English: The solvent will automatically flow into the product vial.
Slovenian: Vehikel bo samodejno stekel v vialo z zdravilom.
English: Such antibodies are precipitating and may occur concomitantly to anaphylactic reactions.
Slovenian: Taka protitelesa so precipitirajoča in se lahko pojavijo sočasno z anafilaktičnimi reakcijami.
English: However, in these cases the initially reconstituted solution of Voncento should not be diluted any further.
Slovenian: Vendar pa v tem primeru prvotno rekonstituirane raztopine zdravila Voncento ne smemo dodatno redčiti.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Slovenian: Med potekom zdravljenja je priporočljivo ustrezno določanje ravni faktorja VIII, kot vodilo za določanje odmerka in pogostnosti ponavljajočih se injekcij.
English: One inner box containing:
Slovenian: Ena notranja škatla vsebuje:
English: If your or your child's bleeding is not being controlled with Voncento, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom Voncento ni obvladana, morate to nemudoma povedati zdravniku.
English: You may develop an inhibitor (neutralising antibody) to VWF, in which case VWF will not work properly any more.
Slovenian: Pri vas se lahko razvijejo zaviralci (nevtralizirajoča protitelesa) proti VWF in v tem primeru VWF ne bo več deloval pravilno.
English: 2 alcohol swabs
Slovenian: 2 alkoholni blazinici
English: General instructions
Slovenian: Splošna navodila
English: If you stop using Voncento Do not stop using Voncento without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo Voncento Ne prenehajte uporabljati zdravilo Voncento brez posvetovanja z zdravnikom.
English: Uncommon (PTPs)** Very common (PUPs)**
Slovenian: občasni (PZB)** zelo pogosti (PNB)**
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Slovenian: • skrbna izbira darovalcev krvi in plazme, da se zagotovi izključitev tveganj za prenos okužb,
English: Side effects in children and adolescents are expected to be the same as in adults.
Slovenian: Pričakuje se, da bodo neželeni učinki pri otrocih in mladostnikih enaki kot pri odraslih.
English: • Voncento must not be mixed with other medicines, diluents or solvents except those mentioned in section 6.
Slovenian: • Zdravila Voncento ne smemo mešati z drugimi zdravili, topili ali vehikli, razen s tistimi, ki so navedeni v poglavju 6.
English: Administer the solution slowly intravenously (see section 4.2), taking care to ensure that no blood enters the syringe filled with product.
Slovenian: Raztopino injicirajte počasi intravensko (glejte poglavje 4.2), poskrbite, da v brizgo, napolnjeno z zdravilom, ne vstopi kri.
English: CSL Behring AG Wankdorfstrasse 10 3014 Bern SWITZERLAND
Slovenian: CSL Behring AG Wankdorfstrasse 10 3014 Bern ŠVICA
English: No interaction of VWF and FVIII with other medicinal products have been studied.
Slovenian: Študij medsebojnega delovanja med VWF in FVIII z drugimi zdravili niso izvedli.
English: Draw air into an empty, sterile syringe.
Slovenian: Vsrkajte zrak v prazno sterilno injekcijsko brizgo.
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestna terapija s faktorjem VIII poveča srčno-žilno tveganje.
English: If your doctor thinks you could administer Voncento yourself, appropriate instructions will be provided to you by your doctor.
Slovenian: Če zdravnik meni, da bi si lahko zdravilo Voncento dali sami, boste s strani zdravnika prejeli ustrezna navodila.
English: Prevention of haemorrhage in case of surgery:
Slovenian: Preprečevanje krvavitev v primeru kirurškega posega:
English: If such inhibitors occur, the condition will manifest itself as an inadequate clinical response.
Slovenian: Če se pojavijo taki inhibitorji, se bo stanje pokazalo kot nezadosten klinični odziv.
English: The ratio between FVIII:C and VWF:RCo in a vial is approximately 1:2.4.
Slovenian: Razmerje med FVIII:C in VWF:Rco v viali je približno 1:2,4.
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Slovenian: Glejte, da odstranite le pretisni omot in ne tudi kompleta Mix2Vial.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Če se pojavijo simptomi preobčutljivosti, moramo bolnikom svetovati, da nemudoma prenehajo z uporabo zdravila in se posvetujejo s svojim zdravnikom.
English: In patients with high levels of inhibitor, therapy may not only be ineffective but also lead to anaphylactoid reactions and other therapeutic options should be considered.
Slovenian: Pri bolnikih z visoko ravnijo inhibitorja zdravljenje ne bo le neučinkovito, temveč lahko vodi tudi do anafilaktoidnih reakcij in je treba razmisliti o drugih možnostih zdravljenja.
English: • The solution should be clear or slightly opalescent, i.e. it might be sparkling when held up to the light but must not contain any obvious particles.
Slovenian: • Raztopina mora biti bistra ali nekoliko opalescentna, kar pomeni, da se lahko svetlika, če jo pogledate proti svetlobi, ne sme pa vsebovati očitnih delcev.
English: Haemophilia A (congenital FVIII deficiency)
Slovenian: Hemofilija A (prirojeno pomanjkanje FVIII)
English: The listed warnings and precautions apply to children and adolescents.
Slovenian: Našteta opozorila in previdnostni ukrepi veljajo za otroke in mladostnike.
English: The solution should be clear or slightly opalescent.
Slovenian: Splošna navodila Raztopina mora biti bistra ali nekoliko opalescentna.
English: The relative content of HMW (high molecular weight) VWF multimers in Voncento is on average 86 % when compared to normal human plasma (NHP).
Slovenian: Relativna HMW (visoka molekulska masa) VWF multimerov zdravila Voncento v primerjavi z normalno humano plazmo je v povprečju 86 %.
English: Haemophilia A
Slovenian: Hemofilija A
English: For injection of Voncento only the provided administration sets should be used because treatment failure can occur as a consequence of FVIII adsorption to the internal surfaces of some injection/infusion equipment.
Slovenian: Za injiciranje zdravila Voncento je treba uporabiti le priloženi komplet za uporabo, saj je lahko zdravljenje neuspešno zaradi adsopcije FVIII na notranje površine nekaterih vrst opreme za injiciranje/infundiranje.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.
Slovenian: Če zdravila ne uporabimo takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C.
English: There is a risk of formation of blood clots (thrombosis), particularly in patients with known risk factors (see also section 2).
Slovenian: Obstaja tveganje za nastanek krvnih strdkov (tromboza), zlasti pri bolnikih z znanimi dejavniki tveganja (glejte tudi poglavje 2).
English: In some cases, especially in younger patients, higher doses may be needed.
Slovenian: V nekaterih primerih, zlasti pri mlajših bolnikih, bodo morda potrebni višji odmerki.
English: The replacement of VWF and FVIII by Voncento will temporarily repair the blood clotting mechanisms.
Slovenian: Nadomestitev VWF in FVIII z zdravilom Voncento bo začasno popravila mehanizem strjevanja krvi.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available.
Slovenian: Na podlagi redke pojavnosti hemofilije A pri ženskah, podatki o izkušnjah glede uporabe FVIII med nosečnostjo in dojenjem niso na voljo.
English: It is strongly recommended that every time that Voncento is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Slovenian: Zelo priporočljivo je, da se vsakič, ko bolnik dobi zdravilo Voncento, zabeležita ime in serijska številka zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
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.
Slovenian: Klinični pomen nastanka zaviralcev je odvisen od titra zaviralca, pri čemer zaviralci z nizkim titrom pomenijo manjše tveganje za nezadosten klinični odziv kot zaviralci z visokim titrom.
English: If any reaction takes place that might be related to the administration of Voncento, the rate of injection should be decreased or the application should be stopped, as required by the clinical condition of the patient (see also section 4.4).
Slovenian: Če se pojavi kakršna koli reakcija, ki bi lahko bila povezana z dajanjem zdravila Voncento, je treba hitrost injiciranja upočasniti ali prekiniti dajanje zdravila, kot zahteva klinično stanje bolnika (glejte tudi poglavje 4.4).
English: Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
Slovenian: Predkliničnih študij z dajanjem ponovljenih odmerkov (toksičnosti pri ponavljajočih odmerkih, kancerogenega potenciala in mutagenosti) v uveljavljenih živalskih modelih ni moč opraviti zaradi nastanka protiteles po dajanju heterolognih humanih beljakovin.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Slovenian: Okužba s parvovirusom B19 je lahko nevarna za nosečnice (okužba ploda) in za posameznike s pomanjkljivim imunskim odzivom ali s povečano eritropoezo (npr. pri hemolitični anemiji).
English: It is important to calculate the dose using the number of IU of VWF:RCo specified.
Slovenian: Pomembno je, da odmerek izračunamo z uporabo števila i.e. določenega VWF:RCo.
English: Ristocetin Cofactor, FVIII:C = Factor VIII: Coagulant
Slovenian: ristocetinski kofaktor, FVIII:C = Faktor VIII: koagulant
English: Inject air into the product vial.
Slovenian: Vbrizgajte zrak v vialo z zdravilom.
English: • Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.
Slovenian: • Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi in navodili zdravnika.
English: Required units = body weight [kg] x desired factor VIII rise [% or IU/dl] x 0.5.
Slovenian: Potrebno št. enot = telesna masa [kg] x želeni dvig faktorja VIII [% ali i.e./dl] x 0,5.
English: In patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary.
Slovenian: Pri bolnikih z gastrointestinalnimi krvavitvami ali menoragijo so lahko potrebni krajši razmiki med odmerki ali višji odmerki.
English: • the site and intensity of the bleeding
Slovenian: • mesta in obsega krvavitve,
English: One pack contains:
Slovenian: Eno pakiranje vsebuje:
English: By replacement therapy the plasma level of FVIII is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendency.
Slovenian: Z nadomestnim zdravljenjem zvečamo plazemsko raven FVIII in tako omogočimo začasno popravo pomanjkanja faktorja in nagnjenosti h krvavitvam.
English: When medicines are made from human blood or plasma, certain measures are put in place by the manufacturer to prevent infections being passed on to patients.
Slovenian: Kadar se zdravila proizvajajo iz človeške krvi ali plazme, mora izdelovalec uvesti nekatere ukrepe za preprečevanje okužb oziroma njihovega prenosa na bolnike.
English: Voncento is used for all age groups to prevent or to halt bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in haemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective alone or cannot be given.
Slovenian: Zdravilo Voncento se uporablja pri vseh starostnih skupinah za preprečevanje ali zaustavitev krvavitve, ki jo povzroča pomanjkanje VWF pri von Willebrandovi bolezni (VWB) in pomanjkanje FVIII pri hemofiliji A. Zdravilo Voncento se uporablja samo takrat, ko zdravljenje z drugim zdravilom, dezmopresinom, sámo ni učinkovito ali pri vas ne pride v poštev.
English: The decision on the use of the product at home for patients with VWD and with haemophilia A should be made by the treating physician who should ensure that appropriate training is provided and the use is reviewed at intervals.
Slovenian: Odločitev o tem, ali se sme uporabljati zdravilo za bolnike s VWB in hemofilijo A doma, mora sprejeti lečeči zdravnik, ki mora tudi poskrbeti za ustrezno izobraževanje ter uporabo v določenih časovnih presledkih tudi preverjati.
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Slovenian: • Če so vam povedali, da imate bolezen srca ali da pri vas obstaja tveganje za bolezni srca,
English: If you have any side effects that might be related to the administration of Voncento, the injection or infusion should be stopped (see also section 2).
Slovenian: Če se pojavijo neželeni učinki, ki bi lahko bili povezani z dajanjem zdravila Voncento, je treba injiciranje ali infuzijo ustaviti (glejte tudi poglavje 2).
English: • Allergic (hypersensitivity) reactions are possible.
Slovenian: • Možne so alergijske (preobčutljivostne) reakcije.
English: In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable..
Slovenian: Zlasti pri velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja VIII v plazmi).