FrancophonIA/ELRC3.0 huggingface dataset:
English: Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Opozoriti moramo, da letni delež krvavitev (ABR - annualised bleeding rate) med različnimi koncentracijami faktorja in med različnimi kliničnimi študijami ni primerljiv.
English: Repeat infusion every 8 to 24 hours until threat is resolved
Slovenian: Infuzijo ponavljajte na 8 do 24 ur, dokler ogroženost ne mine.
English: If severe, sudden allergic reactions (anaphylactic reactions) occur (very rare), the injection must be stopped immediately.
Slovenian: Če se pojavijo hude, nenadne alergijske (anafilaktične) reakcije (ki so zelo redke), morate injiciranje zdravila nemudoma prekiniti.
English: Inject slowly over 2 to 5 minutes.
Slovenian: • Injicirajte počasi, v času od 2 do 5 minut.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observation and laboratory test.
Slovenian: Na splošno je treba vse bolnike, zdravljene z zdravili s koagulacijskim faktorjem VIII, skrbno spremljati glede pojava zaviralcev z ustreznim kliničnim opazovanjem in laboratorijskimi preiskavami.
English: A total of 30 surgeries were performed in 25 patients of which 26 were major surgeries and 4 were minor.
Slovenian: Pri 25 bolnikih je bilo opravljenih 30 kirurških posegov; 26 od teh je bilo večjih in 4 manjši.
English: You should tell your doctor if you have been previously treated with factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.
Slovenian: Zdravniku morate povedati, če ste se že kdaj zdravili z zdravili s faktorjem VIII, zlasti če so se vam pojavili zaviralci, kajti v takšnem primeru je verjetneje, da se to lahko zgodi znova.
English: The recommended infusion rate for NovoEight is 1-2 ml/min.
Slovenian: Priporočena hitrost infundiranja zdravila NovoEight je 1-2 ml/min.
English: Do not use the equipment if you suspect it is contaminated.
Slovenian: Opreme ne uporabite, če sumite, da je onesnažena (kontaminirana).
English: Adolescents (above the age of 12) can use the same dose as adults.
Slovenian: Mladostniki (starejši od 12 let) lahko uporabijo enak odmerek kot odrasli.
English: In adults and adolesents (>12 years) a less frequent regimen (40-60 IU/kg every third day or twice weekly) may be applicable.
Slovenian: Pri odraslih in mladostnikih (> 12 let) je primeren tudi manj pogost režim zdravljenja (40-60 i.e./kg vsak tretji dan ali 2-krat na teden).
English: Do not mix NovoEight with any other intravenous infusions or medicines.
Slovenian: • Zdravila NovoEight ne mešajte z nobeno drugo intravensko infuzijo ali zdravili.
English: Elderly There is no experience in patients >65 years.
Slovenian: Izkušenj pri bolnikih, starejših od 65 let, ni.
English: Talk to your doctor if you think that your bleed is not being controlled with the dose you receive, as there can be several reasons for this.
Slovenian: Posvetujte se z zdravnikom, če menite, da se krvavitev po odmerku, ki ste ga prejeli, ni ustavila, kajti za to je lahko več razlogov.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl)
Slovenian: Ponovite infuzijo na 8 do 24 ur do ustrezne zacelitve rane, potem zdravite še vsaj nadaljnjih 7 dni, da bo aktivnost faktorja VIII od 30 do 60 % (i.e./dl).
English: Of the 3,293 reported bleeds observed in 298 of the patients, 2,902 (88.1%) of the bleeds were resolved with 1-2 infusions of NovoEight.
Slovenian: Od opaženih 3.293 krvavitev pri 298 bolnikih jih je bilo 2.902 (88,1 %) ustavljenih z 1 do 2 infuzijama zdravila NovoEight.
English: It is strongly recommended that every time that NovoEight 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 medicinal product.
Slovenian: Zelo priporočljivo je, da vsakokrat, ko bolniku injicirate zdravilo NovoEight, zapišete ime in številko serije zdravila, da se tako ohrani povezava med bolnikom in serijo zdravila.
English: Do not disassemble the equipment before disposal.
Slovenian: Opreme pred odstranitvijo ne razstavite.
English: FVIII level required (%) (IU/dl)
Slovenian: Potrebna koncentracija FVIII (%) (i.e./dl)
English: All pharmacokinetic (PK) studies with NovoEight were conducted after i.v.
Slovenian: Vse farmakokinetične (FK) študije z zdravilom NovoEight so izvedli po i.v.
English: Activated factor VIII acts as a co-factor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Slovenian: Aktiviran faktor VIII deluje kot kofaktor aktiviranega faktorja IX in pospeši pretvorbo faktorja X v aktiviran faktor X. Aktiviran faktor X pretvarja protrombin v trombin.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Slovenian: V primeru velikih kirurških posegov je še posebej nujno potrebno natančno nadziranje nadomestnega zdravljenja v smislu analize koagulacije (aktivnost plazemskega faktorja VIII).
English: For paediatric patients above the age of 12 the dose recommendations are the same as for adults.
Slovenian: Pri pediatričnih bolnikih, starejših od 12 let, so priporočila za odmerjanje enaka kot za odrasle.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCA BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Slovenian: katetre Opozorilo: Napolnjena injekcijska brizga je izdelana iz stekla in zasnovana tako, da je združljiva s standardnimi luer-lock nastavki.
English: You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters.
Slovenian: Potrebovali boste tudi komplet za injiciranje (cevko in iglo z metuljčkom), sterilne alkoholne lističe, zložence gaze in obliže.
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Slovenian: Nekateri brezigelni konektorji z notranjo konico niso združljivi z napolnjeno injekcijsko brizgo.
English: Check the expiry date.
Slovenian: • Preverite datum izteka roka uporabnosti.
English: Minor surgery including tooth extraction
Slovenian: Kirurški posegi manjši kirurški posegi, vključno z ekstrakcijo zoba
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Slovenian: Injiciranje raztopine preko pripomočka za centralni venski dostop (CVAD - Central Venous Access Device), kot sta centralni venski kateter ali podkožni port:
English: Known allergic reaction to hamster proteins.
Slovenian: Znana alergijska reakcija na beljakovine hrčkov.
English: Do not use NovoEight if either of the above applies to you.
Slovenian: Ne uporabite zdravila NovoEight, če kaj od tega velja za vas.
English: Mean residence time (h)
Slovenian: Povprečen čas zadrževanja (h)
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Spodnja preglednica je pripravljena glede na razvrstitev organskih sistemov po MedDRA (organski sistem in raven prednostnega izraza).
English: Abbreviations: AUC = area under the factor VIII activity time profile; CL = clearance; t1/2 = terminal half-life; Vss = volume of distribution at steady-state; Cmax = maximum factor VIII activity.
Slovenian: Okrajšave: AUC = površina pod krivuljo časovnega profila aktivnosti faktorja VIII (area under the factor VIII activity time profile); CL = očistek; t1/2 = končni razpolovni čas; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja; Cmax = največja aktivnost faktorja VIII.
English: Taken out of refrigerator: _____________Stored at ≤30°C __ Stored at 30°C up to 40°C __
Slovenian: Zdravilo ste vzeli iz hladilnika: ___________ Shranjevanje pri ≤ 30 °C __ Shranjevanje pri 30 °C40 °C __
English: Three of these trials were performed in previously treated patients and the fourth in previously untreated patients.
Slovenian: Od teh so bila 3 preskušanja izvedena pri predhodno zdravljenih bolnikih in eno pri predhodno nezdravljenih bolnikih.
English: If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom NovoEight ni obvladana, morate to nemudoma povedati zdravniku.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Slovenian: Če pričakovana stopnja aktivnosti faktorja VIII v plazmi ni dosežena ali če z ustreznim odmerkom ne obvladate krvavitve, je treba opraviti preiskave glede prisotnosti zaviralcev faktorja VIII.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Slovenian: • Pri injiciranju zdravila v CVAD boste za odvzem pripravljene raztopine morda morali uporabiti sterilno 10-ml plastično injekcijsko brizgo.
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to NovoEight.
Slovenian: Obstaja majhna možnost, da se vam pojavi anafilaktična reakcija (huda, nenadna alergijska reakcija) na zdravilo NovoEight.
English: In some cases, especially in younger patients, more frequent injections or higher doses may be needed.
Slovenian: V nekaterih primerih, še posebej pri mlajših bolnikih, so lahko potrebne pogostejše injekcije ali večji odmerki.
English: If not used straight away the medicine may no longer be sterile and could cause infection.
Slovenian: Če zdravilo ni uporabljeno takoj, lahko ni več sterilno in bi lahko povzročilo okužbo.
English: The assay performance of NovoEight in FVIII:C assays was evaluated and compared to a marketed full length recombinant FVIII product.
Slovenian: Učinkovitost preizkusa zdravila NovoEight v preizkusu FVIII:C so ovrednotili in primerjali z rekombinantnim zdravilom s polno dolžino FVIII, ki je na trgu.
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 različnih razpolovnih časih in različnih časih okrevanja.
English: The pharmacokinetic parameters were comparable between paediatric patients below 6 years of age and the paediatric patients from 6 to below 12 years of age.
Slovenian: Farmakokinetični parametri so bili pri pediatričnih bolnikih, mlajših od 6 let, primerljivi s tistimi pri pediatričnih bolnikih, starih od 6 do 12 let.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Slovenian: O medsebojnem delovanju med zdravili s humanim koagulacijskim faktorjem VIII (rDNA) in drugimi zdravili niso poročali.
English: In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.
Slovenian: Če potrebujete le del celotne viale, uporabite merilo na brizgi, da boste videli, koliko pripravljene raztopine ste izvlekli, tako kot sta vam naročila zdravnik ali medicinska sestra.
English: The tyrosine sulphation site present at Tyr1680 (native full length), which is important for the binding to von Willebrand factor, has been found to be fully sulphated in the turoctocog alfa molecule.
Slovenian: Ugotovljeno je, da je sulfatacijsko mesto tirozina, prisotno na Tyr1680 (nativna polna dolžina), ki je pomembno za vezavo von Willebrandovega faktorja, na molekuli turoktokoga alfa povsem sulfatirano.
English: • Use a clean and germ free (aseptic) technique.
Slovenian: • Uporabite čist in aseptičen (brez klic) postopek.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerke, ki temeljijo na telesni masi, bo pri bolnikih s premajhno ali s prekomerno telesno maso morda treba prilagoditi.
English: • swelling of the lips and tongue
Slovenian: • oteklost ustnic in jezika,
English: Factor VIII is a protein naturally found in the blood that helps it to clot.
Slovenian: Faktor VIII je beljakovina, ki jo najdemo v krvi in je pomembna v procesu strjevanja krvi.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Slovenian: Zelo redko so opažali pojav protiteles proti hrčkovim beljakovinam in s tem povezane preobčutljivostne reakcije.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede priprave zdravila pred dajanjem glejte poglavje 6.6.
English: The powder in the vial appears as a white or slightly yellow powder.
Slovenian: Prašek v viali je bele ali rumenkaste barve.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme biti nižja od navedene stopnje aktivnosti v plazmi (v % od normale ali i.e./dl) v ustreznem časovnem obdobju.
English: Solvent for NovoEight Sodium chloride 9 mg/ml
Slovenian: Vehikel za zdravilo NovoEight natrijev klorid 9 mg/ml
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Slovenian: Če se pojavi kateri od teh simptomov, nemudoma prekinite injiciranje zdravila in se posvetujte z zdravnikom.
English: AUC ((IU*h)/dl) 1860 (700) 2730 (860)
Slovenian: AUC ((i.e.*h)/dl) 1.860 (700) 2.730 (860)
English: NovoEight contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa.
Slovenian: NovoEight vsebuje nominalno 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e. turoktokoga alfa.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 (IU/kg per IU/dl).
Slovenian: Potrebno število enot = telesna masa (kg) x želeno zvišanje faktorja VIII (%) (i.e./dl) x 0,5 (i.e./kg na i.e./dl)
English: What NovoEight is and what it is used for
Slovenian: Kaj je zdravilo NovoEight in za kaj ga uporabljamo
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one stage clotting assay and the chromogenic assay according to Ph. Eur.
Slovenian: Prav tako lahko pride do velikih odstopanj med rezultati preizkušanja, pridobljenimi z enostopenjskim preizkusom strjevanja na osnovi aPTČ, in rezultati, pridobljenimi s kromogenim preizkusom po Ph. Eur.
English: Inject the reconstituted solution as instructed by your doctor or nurse.
Slovenian: • Pripravljeno raztopino injicirajte, kot sta vam naročila zdravnik ali medicinska sestra.
English: (pre- and postoperative)
Slovenian: (pred posegom in po njem)
English: The rate should be determined by the patient's comfort level.
Slovenian: Hitrost je treba določiti glede na bolnikovo počutje.
English: If you stop using NovoEight you may no longer be protected against bleeding or a current bleed may not stop.
Slovenian: Če ste prenehali uporabljati zdravilo NovoEight Če prenehate uporabljati zdravilo NovoEight, morda ne boste več zaščiteni pred krvavitvami oziroma se lahko zgodi, da se trenutna krvavitev ne bo ustavila.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Slovenian: Če za svoj odmerek potrebujete več kot eno vialo, ponavljajte korake od A do J z dodatnimi vialami, nastavki za viale in napolnjenimi injekcijskimi brizgami, dokler ne dosežete potrebnega odmerka.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Slovenian: Druga zdravila in zdravilo NovoEight Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Do not touch the rubber stopper with your fingers as this can transfer germs.
Slovenian: • Ne dotikajte se gumijastega zamaška s prsti, ker lahko tako prenesete klice.
English: Animal reproduction studies have not been conducted with NovoEight.
Slovenian: Študij na živalih o vplivu zdravila NovoEight na sposobnost razmnoževanja niso izvedli.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Slovenian: Našteta opozorila in varnostni ukrepi veljajo za odrasle in otroke.
English: The activity of factor VIII in plasma is expressed either as percentage (relative to normal level human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je lahko izražena v odstotkih (glede na koncentracijo v normalni človeški plazmi) ali v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
English: Lightly squeeze the protective cap with your thumb and index finger as shown.
Slovenian: Rahlo stisnite zaščitni pokrovček s palcem in kazalcem, kot je prikazano.
English: The most frequently reported adverse reaction was Factor VIII inhibition, see section 4.4.
Slovenian: Najpogosteje opisan neželeni učinek je bilo zaviranje faktorja VIII (glejte poglavje 4.4).
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru normalne človeške plazme.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: V redkih primerih so opažali preobčutljivostne ali alergijske reakcije (med njimi so lahko angioedem, pekoč občutek in zbadanje na mestu infundiranja, mrzlica, zardevanje, generalizirana urtikarija, glavobol, koprivnica, hipotenzija, letargija, navzea, nemir, tahikardija, tiščanje v prsih, mravljinčenje, bruhanje, piskajoče dihanje), ki lahko v nekaterih primerih napredujejo v hudo anafilaksijo (vključno s šokom).
English: Sodium chloride Water for injections
Slovenian: natrijev klorid voda za injekcije
English: In children (below the age of 12) higher doses or more frequent injections may be needed.
Slovenian: Otroci (mlajši od 12 let) lahko potrebujejo večje odmerke ali pogostejše injiciranje.
English: Do not increase the total dose of NovoEight to control your bleed without talking to your doctor.
Slovenian: Ne povečajte odmerka zdravila NovoEight, da bi obvladali krvavitev, ne da bi se posvetovali z zdravnikom.
English: Older children
Slovenian: Starejši otroci
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and the patient's clinical condition.
Slovenian: Odmerek zdravila in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja VIII, mesta in obsega krvavitve ter od bolnikovega kliničnega stanja.
English: If, at any point, there is too much air in the syringe, inject the air back into the vial.
Slovenian: Če je kadar koli v brizgi preveč zraka,
English: See ‘Instructions on how to use NovoEight' for more information.
Slovenian: Za več informacij glejte "Navodila za uporabo zdravila NovoEight".
English: In clinical trials involving 63 previously treated paediatric patients between 0 and 12 years of age and 24 adolescents between 12 and 18 years of age with severe haemophilia A no difference in the safety profile of NovoEight was observed between paediatric patients and adults.
Slovenian: V kliničnih preskušanjih, ki so zajela 63 predhodno zdravljenih pediatričnih bolnikov, starih od 0 do 12 let, in 24 mladostnikov, starih od 12 do 18 let, ki so imeli hudo hemofilijo A, pri pediatričnih bolnikih niso ugotovili razlik v varnostnih značilnostih zdravila NovoEight v primerjavi z odraslimi.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Slovenian: Zdravilo vsebuje 30,5 mg natrija (glavne sestavine kuhinjske soli) na pripravljeno vialo.
English: During clinical trial in PUPs, 21 patients were treated with ITI and 18 (86%) patients completed ITI with a negative inhibitor test result.
Slovenian: Med kliničnim preskušanjem pri predhodno nezdravljenih bolnikih (PNB) je bilo 21 bolnikov zdravljenih z ITI in 18 bolnikov (86 %) je dokončalo ITI z negativnim rezultatom testa zaviralcev.
English: In patients with haemophilia A, factor VIII is missing or not working properly.
Slovenian: Pri bolnikih s hemofilijo A faktorja VIII ni ali pa ne deluje pravilno.
English: What you need to know before you use NovoEight Do not use NovoEight:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo NovoEight Ne uporabljajte zdravila NovoEight:
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breastfeeding is not available.
Slovenian: Hemofilija A je pri ženskah zelo redka in izkušenj z uporabo faktorja VIII med nosečnostjo in dojenjem ni.
English: The higher CL and the shorter t½ seen in paediatric patients compared to adult patients with haemophilia A may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Slovenian: Večji očistek in krajši t1/2 pri pediatričnih bolnikih v primerjavi z odraslimi bolniki s hemofilijo A sta lahko deloma posledica znanega večjega volumna plazme na kilogram telesne mase pri mlajših bolnikih.
English: d Hepatic enzymes increased include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and bilirubin.
Slovenian: d Zvišana raven jetrnih encimov alanin-aminotransferaze, aspartat-aminotransferaze, gamaglutamiltransferaze in bilirubina.
English: • difficulty in breathing, shortness of breath or wheezing
Slovenian: • težave pri dihanju, kratka sapa ali piskajoče dihanje,
English: NovoEight has no influence on the ability to drive and use machines.
Slovenian: Zdravilo NovoEight nima vpliva na sposobnost vožnje in upravljanja strojev.
English: NovoEight can be used for all age groups.
Slovenian: Uporablja se ga lahko v vseh starostnih skupinah.
English: If this happens you may need a higher dose of NovoEight or a different medicine to control your bleed.
Slovenian: Če se to zgodi, boste za obvladanje krvavitve morda potrebovali večji odmerek zdravila NovoEight ali pa kakšno drugo zdravilo.
English: The equipment in this package is designed to reconstitute and inject NovoEight.
Slovenian: Sestavni deli tega pakiranja so izdelani za pripravo in injiciranje zdravila NovoEight.
English: Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors).
Slovenian: Pri nekaterih ljudeh, ki uporabljajo to zdravilo, se lahko pojavijo protitelesa proti faktorju VIII (imenujemo jih tudi zaviralci faktorja VIII).
English: If a larger dose is needed, repeat steps A to J with additional vials, vial adapters and pre-filled syringes.
Slovenian: Če je potreben večji odmerek, ponavljajte korake od A do J z dodatnimi vialami, nastavki za viale in napolnjenimi injekcijskimi brizgami.
English: In patients with existing cardiovascular risk factors, substitiution therapy with FVIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestno zdravljenje s faktorjem VIII poveča tveganje za srčno-žilne dogodke.