FrancophonIA/ELRC3.0 huggingface dataset:
English: This prevents the virus from attaching to the surface of human cells and infecting them.
Slovenian: To preprečuje, da bi se virus vezal na površino človeških celic in jih okužil.
English: On average, the patients had been given an average of 12 antiviral medicines over a seven-year period.
Slovenian: Povprečno so bolniki prejeli 12 protivirusnih zdravil v sedemletnem obdobju.
English: Fuzeon was originally authorised under ‘Exceptional Circumstances', because for scientific reasons it had not been possible to obtain complete information on the medicine.
Slovenian: Zdravilo Fuzeon je bilo prvotno odobreno v „izjemnih okoliščinah“, ker zaradi znanstvenih razlogov ni bilo mogoče pridobiti vseh informacij o zdravilu Fuzeon.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fuzeon to Roche Registration Limited on 27 May 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Fuzeon, veljavno po vsej Evropski uniji, odobrila družbi Roche Registration Limited dne 27. maja 2003.
English: Other information about Fuzeon:
Slovenian: Druge informacije o zdravilu Fuzeon:
English: Fuzeon has also been studied in 39 children aged between three and 16 years.
Slovenian: Zdravilo Fuzeon so preučevali tudi pri 39 otrocih, starih med tri in 16 let.
English: The dose for children aged six to 16 years depends on body weight.
Slovenian: Odmerek za otroke, stare med šest in 16 let, je odvisen od telesne mase.
English: The main measure of effectiveness was the change in the levels of HIV in the blood (viral load) after 48 weeks of treatment.
Slovenian: Glavno merilo učinkovitosti je bila sprememba koncentracije virusa HIV v krvi (virusnega bremena) po 48 tednih zdravljenja.
English: In clinical studies, injection site reactions have been reported in 98% of patients, mostly occurring within the first week of treatment.
Slovenian: V kliničnih študijah so o reakcijah na mestu injiciranja poročali pri 98 % bolnikih, pretežno v prvem tednu zdravljenja.
English: It caused mild to moderate pain or discomfort, which did not increase during treatment.
Slovenian: Povezane so bile z blago do zmerno bolečino ali neugodjem, ki se med zdravljenjem ni povečalo.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FUZEON EPAR summary for the public
Slovenian: EVROPSKO JAVNO POROČILO O OCENI ZDRAVILA (EPAR) FUZEON Povzetek EPAR za javnost
English: What benefit has Fuzeon shown during the studies?
Slovenian: Kakšne koristi je zdravilo Fuzeon izkazalo med študijami?
English: The Committee recommended that Fuzeon be given marketing authorisation.
Slovenian: Odbor je priporočil, da se za zdravilo Fuzeon odobri dovoljenje za promet.
English: The values in the second study were 96 and 78%, respectively.
Slovenian: V drugi študiji so bile vrednosti za prvo skupino bolnikov 96 %, za drugo pa 78 %.
English: What is the risk associated with Fuzeon?
Slovenian: Kakšna tveganja so povezana z zdravilom Fuzeon?
English: It is for use in patients who have stopped responding to, or cannot take, other antiviral medicines.
Slovenian: Namenjeno je uporabi pri bolnikih, ki so se nehali odzivati na druga protivirusna zdravila ali jih ne smejo jemati.
English: Fuzeon should be prescribed by a doctor who has experience in the treatment of HIV infection.
Slovenian: Zdravilo Fuzeon mora predpisati zdravnik, ki ima izkušnje z zdravljenjem okužb s HIV.
English: The two main studies of Fuzeon included 1,013 patients aged 16 years or over who were infected with HIV and had taken, or were not responding to, other antiviral medicines.
Slovenian: V dve glavni študiji zdravila Fuzeon je bilo vključenih 1013 bolnikov, starih 16 let ali več, ki so bili okuženi s HIV in so jemali druga protivirusna zdravila ali se nanje niso odzivali.
English: Fuzeon does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Fuzeon ne ozdravi okužbe s HIV ali AIDS-a, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z AIDS-om.
English: Fuzeon binds to a protein on the surface of HIV.
Slovenian: Zdravilo Fuzeon se veže na beljakovino na površini virusa HIV.
English: Doctors should only prescribe Fuzeon once they have looked at the antiviral medicines the patient has taken before and the likelihood that the virus will respond to the medicine.
Slovenian: Zdravniki smejo predpisati zdravilo Fuzeon šele potem, ko se seznanijo s protivirusnimi zdravili, ki jih je bolnik jemal prej, in verjetnostjo, da se bo virus odzval na zdravilo.
English: In the first study, viral loads fell by an average of 98% in the patients taking Fuzeon, compared with 83% in the patients not taking Fuzeon.
Slovenian: V prvi študiji se je pri bolnikih, ki so jemali zdravilo Fuzeon, virusno breme zmanjšalo za povprečno 98 % v primerjavi s 83 % pri bolnikih, ki niso jemali zdravila Fuzeon.
English: The approved dose of Fuzeon in children brings about similar levels of the active substance in the blood to the approved dose in adults.
Slovenian: Odobreni odmerek zdravila Fuzeon za otroke zagotavlja približno enako koncentracijo zdravilne učinkovine v krvi kot odobreni odmerek pri odraslih.
English: Fuzeon should not be used in people who may be hypersensitive (allergic) to enfuvirtide or any of the other ingredients.
Slovenian: Zdravila Fuzeon ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) enfuvirtid ali katero koli drugo sestavino zdravila.
English: Fuzeon is not recommended for use in children under six years of age.
Slovenian: Uporaba zdravila Fuzeon pri otrocih, mlajših od šest let, ni priporočljiva.
English: As HIV can only reproduce itself within cells, Fuzeon, taken in combination with other antiviral medicines, reduces the level of HIV in the blood and keeps it at a low level.
Slovenian: Ker se lahko virus HIV razmnožuje samo v celicah, zdravilo Fuzeon, če ga jemljemo v kombinaciji z drugimi protivirusnimi zdravili, zmanjša koncentracijo virusa HIV v krvi in jo ohranja na nizki ravni.
English: It is used in combination with other antiviral medicines for the treatment of patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
English: In adults, it is given as one 90-mg injection twice a day, injected under the skin of the upper arm, upper thigh or abdomen (tummy).
Slovenian: Pri odraslih se daje v obliki ene 90-miligramske injekcije dvakrat na dan, injicirane pod kožo nadlakti, zgornjega dela stegna ali trebuha.
English: Fuzeon is an antiviral medicine.
Slovenian: Zdravilo Fuzeon je protivirusno zdravilo.
English: The most common side effects with Fuzeon (seen in more than 1 patient in 10) are injection site reactions (pain and inflammation at the site of injection), peripheral neuropathy (damage to the nerves in the extremities causing tingling or numbness in the hands and feet) and weight loss.
Slovenian: Najpogostejši neželeni učinki zdravila Fuzeon (opaženi pri več kot 1 bolniku od 10) so reakcije na mestu injiciranja (bolečina in vnetje na mestu injiciranja), periferna nevropatija (poškodba živcev v okončinah, ki povzroči mravljinčenje ali odrevenelost rok in nog) ter izguba telesne mase.
English: Both studies compared the effects of Fuzeon, in combination with ‘optimised background therapy' (a combination of other antiviral medicines chosen for each patient as they had the best chances of reducing the levels of HIV in the blood), compared with optimised background therapy without Fuzeon.
Slovenian: V obeh študijah so učinke zdravila Fuzeon v kombinaciji z „optimiziranim osnovnim zdravljenjem“ (kombinacijo drugih protivirusnih zdravil, izbranih za posameznega bolnika, ki je obetala največjo verjetnost za zmanjšanje koncentracije virusa HIV v krvi) primerjali z optimiziranim osnovnim zdravljenjem brez zdravila Fuzeon.
English: The site of injection must be changed for each injection.
Slovenian: Za vsako injekcijo je treba izbrati drugo mesto injiciranja.
English: As with all other anti-HIV medicines, patients taking Fuzeon may be at risk of osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Slovenian: Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki jemljejo zdravilo Fuzeon, tveganje za osteonekrozo (odmiranje kostnega tkiva) ali sindrom imunske reaktivacije (simptome okužbe, ki jo povzroči imunski sistem med okrevanjem).
English: Why has Fuzeon been approved?
Slovenian: Zakaj je bilo zdravilo Fuzeon odobreno?
English: Patients who have problems with their liver may be at an elevated risk of liver damage when taking treatment for HIV infection.
Slovenian: Pri bolnikih, ki imajo težave z jetri, obstaja pri jemanju zdravila proti okužbi s HIV povečano tveganje za poškodbe jeter.
English: Taking Fuzeon with optimised background therapy was more effective at reducing viral loads than optimised background therapy alone.
Slovenian: Jemanje zdravila Fuzeon z optimiziranim osnovnim zdravljenjem je bilo pri zmanjševanju virusnega bremena učinkovitejše od samostojnega optimiziranega osnovnega zdravljenja.
English: For the full list of all side effects reported with Fuzeon, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Fuzeon, glejte navodilo za uporabo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Fuzeon's benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following classes, protease inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Fuzeon v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov, okuženih s HIV-1 in neuspešno zdravljenih z režimi zdravljenja, ki so vsebovali vsaj eno od zdravil iz vsakega od naslednjih razredov: zaviralci proteaz, nenukleozidni zaviralci reverzne transkriptaze in nukleozidni zaviralci reverzne transkriptaze, ali bolnikov, ki prejšnjih protiretrovirusnih režimov zdravljenja ne prenašajo, večje od z njim povezanih tveganj.
English: These must include at least one medicine from each of the following classes of medicine used to treat HIV infection: protease inhibitors; non-nucleoside reverse transcriptase inhibitors; and nucleoside reverse transcriptase inhibitors.
Slovenian: Med temi mora biti vsaj eno zdravilo iz vsakega od naslednjih razredov zdravil, ki se uporabljajo za zdravljenje okužb s HIV: zaviralci proteaze, nenukleozidni zaviralci reverzne transkriptaze in nukleozidni zaviralci reverzne transkriptaze.
English: The active substance in Fuzeon, enfuvirtide, is a fusion inhibitor.
Slovenian: Zdravilna učinkovina zdravila Fuzeon, enfuvirtid, je zaviralec zlitja.
English: Fuzeon can be injected by the patient or by a carer, provided that the person giving the injection follows the detailed instructions given in the Package Leaflet.
Slovenian: Zdravilo Fuzeon si lahko injicira bolnik sam ali mu ga injicira negovalec, če oseba, ki daje injekcijo, natančno upošteva napotke v navodilu za uporabo.
English: Fuzeon is a powder that is made up into a solution for injection.
Slovenian: Zdravilo Fuzeon je prašek za pripravo raztopine za injiciranje.
English: What is Fuzeon used for?
Slovenian: Za kaj se zdravilo Fuzeon uporablja?
English: How has Fuzeon been studied?
Slovenian: Kako je bilo zdravilo Fuzeon raziskano?
English: How does Fuzeon work?
Slovenian: Kako zdravilo Fuzeon deluje?
English: The full EPAR for Fuzeon can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Fuzeon je na voljo tukaj.
English: What is Fuzeon?
Slovenian: Kaj je zdravilo Fuzeon?
English: How is Fuzeon used?
Slovenian: Kako se zdravilo Fuzeon uporablja?
English: Pharmaceutical Form Route of Administration Packaging
Slovenian: Številka EU Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina (koncentracija) velikost pakiranja
English: 1 vial + 1 vial
Slovenian: 1 viale + 1 viale
English: 2 vials + 2 vials
Slovenian: 2 vial + 2 vial
English: Strength Pharmaceutical Form Route of Administration
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: You will also need:
Slovenian: Potrebovali boste tudi:
English: This should be done right after step J.
Slovenian: To morate storiti takoj po koraku J.
English: Always wash your hands and ensure that the area around you is clean.
Slovenian: Vedno si umijte roke in poskrbite, da je okolica okrog vas čista.
English: b Calculation based on 67 profiles.
Slovenian: b Osnova izračuna je 67 profilov.
English: The package contains:
Slovenian: Pakiranje vsebuje:
English: You can do this by holding them in your hands until they feel as warm as your hands, see figure A.
Slovenian: To lahko storite tako, da ju držite v dlaneh, dokler ne postaneta enako topli kot vaše dlani (glejte sliko A).
English: From a microbiological point of view, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj.
English: Always use an aseptic technique.
Slovenian: Vedno uporabljajte aseptičen postopek.
English: • Check the name, strength and colour of the package to make sure it contains the correct product.
Slovenian: • Preverite ime, jakost in barvo pakiranja, da se prepričate, da vsebuje pravo zdravilo.
English: Osmolality: 590 mOsmol/kg.
Slovenian: Osmolalnost: 590 mOsmol/kg.
English: Repeat after 24 hours if necessary
Slovenian: Po potrebi ponovitev po 24 urah.
English: The equipment is for single use only.
Slovenian: Pripomočki so namenjeni samo za enkratno uporabo.
English: Protective paper
Slovenian: zaščitni papir
English: Use a new package instead.
Slovenian: V tem primeru uporabite novo pakiranje.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in serijsko številko uporabljenega zdravila.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Slovenian: Faktor VIII se sme med nosečnostjo in v obdobju dojenja uporabljati le, če je to jasno indicirano.
English: • Wash your hands and dry them properly using a clean towel or let them air dry.
Slovenian: • Umijte si roke in jih popolnoma osušite s čisto brisačo ali na zraku.
English: Do not use Esperoct if either of the above applies to you.
Slovenian: Ne uporabite zdravila Esperoct, če katera od zgornjih navedb velja za vas.
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru šoka je treba izvesti standardne postopke za zdravljenje šoka.
English: • Inject slowly over approximately 2 minutes.
Slovenian: • Injicirajte počasi, v okvirnem času 2 minut.
English: • Place the vial on a flat and solid surface.
Slovenian: • Vialo postavite na ravno in trdno površino.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden uporabite to zdravilo.
English: New Hampshire
Slovenian: West Lebanon New Hampshire
English: Frequency of doses (hours)
Slovenian: Pogostnost odmerkov (ure)
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Slovenian: To je zlasti pomembno v primeru menjave laboratorija in/ali menjave reagentov, uporabljanih za preizkus.
English: The product contains traces of hamster proteins, which in some patients may cause allergic reactions.
Slovenian: Zdravilo vsebuje sledi beljakovin hrčkov, ki lahko nekaterim bolnikom povzročijo alergijske reakcije.
English: • Check the expiry date.
Slovenian: • Preverite datum izteka roka uporabnosti.
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, ponovite korake od A do J z uporabo dodatnih vial, nastavkov za vialo in napolnjenih injekcijskih brizg, dokler ne dosežete potrebnega odmerka.
English: • if you are allergic to hamster proteins.
Slovenian: • če ste alergični na beljakovine hrčkov.
English: • You will be monitored carefully for development of these inhibitors
Slovenian: • Zdravniki vas bodo skrbno spremljali glede nastanka teh zaviralcev.
English: In general, there was a trend of increasing incremental recovery and decreasing clearance (mL/h/kg) with age.
Slovenian: Na splošno se je s starostjo pokazal trend dviganja postopnega izboljšanja in nižanja očistka (ml/h/kg).
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Slovenian: Opozorilo: Napolnjena injekcijska brizga je izdelana iz stekla in je zasnovana tako, da je združljiva s standardnimi luer-lock nastavki.
English: If such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Če se pojavijo takšni zaviralci, se to lahko kaže kot nezadosten klinični odziv.
English: Tell your doctor if you have used factor VIII medicines before, especially if you developed inhibitors (antibodies) against the medicine, since there might be a risk that it happens again.
Slovenian: Zdravniku povejte, če ste se že kdaj zdravili z zdravili s faktorjem VIII, zlasti če so se vam pojavili zaviralci (protitelesa) proti zdravilu, saj obstaja tveganje, da se bo to ponovilo.
English: When you prepare and inject medicine directly into a vein, it is important to use a clean and germ- free (aseptic) technique.
Slovenian: Pri pripravi in injiciranju zdravila neposredno v veno je pomembno, da uporabite čisto in sterilno (aseptično) tehniko.
English: Before reconstitution (before the powder is mixed with the solvent):
Slovenian: Pred pripravo (preden prašek zmešate z vehiklom):
English: Treatment monitoring
Slovenian: Nadzorovanje zdravljenja
English: Your doctor will calculate your dose for you.
Slovenian: Vaš odmerek bo izračunal zdravnik.
English: Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)
Slovenian: Razmislite o nadaljevanju zdravljenja še nadaljnjih 7 dni za ohranjanje aktivnost faktorja VIII od 30 % do 60 % (i.e./dl).
English: • These inhibitors, especially at high levels, stop the treatment working properly
Slovenian: • Ti zaviralci, zlasti v velikih koncentracijah, lahko preprečijo uspešno zdravljenje.
English: After reconstitution (after the powder has been mixed with the solvent): Once you have reconstituted Esperoct, it should be used immediately.
Slovenian: Po pripravi (po tem, ko ste prašek zmešali z vehiklom): Ko je zdravilo Esperoct pripravljeno, ga je treba uporabiti takoj.
English: This corresponds to a higher volume of distribution per kilo body weight in children compared to adults (table 4).
Slovenian: To je skladno z večjim volumnom porazdelitve na kilogram telesne mase pri otrocih glede na odrasle (preglednica 4).
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Slovenian: Opozoriti moramo, da letni delež krvavitev (ABR) med različnimi koncentrati faktorjev in med različnimi kliničnimi študijami ni primerljiv.
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: 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: To prevent bleeding
Slovenian: Preprečevanje krvavitev
English: If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop.
Slovenian: Če prenehate z uporabo zdravila Esperoct, morda ne boste več zaščiteni pred pojavom krvavitve ali pa se trenutna krvavitev morda ne bo ustavila.
English: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000); not known (cannot be estimated from the available data).
Slovenian: občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in ni znano
English: This will depend on your body weight and whether it is used to prevent or to treat a bleeding.
Slovenian: Odmerek je odvisen od vaše telesne mase in od tega, ali boste zdravilo uporabljali za preprečevanje ali za zdravljenje krvavitev.
English: Prophylaxis in children (below 12 years)
Slovenian: Profilaksa pri otrocih (mlajših od 12 let)
English: If this happens, you should contact your doctor immediately.
Slovenian: Če pride do tega, takoj pokličite zdravnika.
English: • redness and/or swelling of the lips, tongue, face or hands
Slovenian: • rdečina in/ali otekanje ustnic, jezika, obraza ali rok
English: Pharmacokinetic parameters
Slovenian: Farmakokinetični parametri
English: • If you do not need to use all of the reconstituted medicine from the vial,
Slovenian: • Če vam ni treba porabiti vsega pripravljenega zdravila iz viale, s
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin nato pretvori fibrinogen v fibrin in tako lahko nastane krvni strdek.
English: The single dose pharmacokinetic parameters determined after 28 weeks of prophylactic treatment with Esperoct were consistent with the initial pharmacokinetic parameters.
Slovenian: Farmakokinetični parametri po enkratnem odmerku, ugotovljeni po 28 tednih profilaktičnega zdravljenja z zdravilom Esperoct, so bili skladni z začetnimi farmakokinetičnimi parametri.
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: 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: Patients received a single dose of 50 IU/kg, and blood samples were collected prior to dosing and at multiple time points up to 96 hours after dosing.
Slovenian: Bolniki so prejeli enkratni odmerek 50 i.e./kg, vzorci krvi pa so bili odvzeti pred odmerjanjem in ob različnih trenutkih v časovnem okviru do 96 ur po odmerjanju.
English: * PTPs: Previously-treated patients.
Slovenian: * PZB: Predhodno zdravljeni bolniki
English: For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja pri sobni temperaturi in za pogoje shranjevanja po pripravi zdravila glejte poglavje 6.3.
English: Of the 175 adults/adolescents on prophylaxis, 70 (40%) did not have any bleeds.
Slovenian: Med 175 odraslimi/mladostniki na profilaksi jih 70 (40 %) ni imelo nobenih krvavitev.
English: Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.
Slovenian: Faktor VIII je beljakovina, ki je naravno prisotna v krvi ter pomaga pri preprečevanju in zaustavljanju krvavitev.
English: Do not mix Esperoct with any other intravenous injections or medicines.
Slovenian: Zdravila Esperoct ne mešajte z nobeno drugo intavensko injekcijo ali zdravilom.