FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are the responsibility of the the user and should not exceed 24 hours at 2 to 8 °C.
Slovenian: • Če zdravila ne damo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek, ki temelji na telesni masi, je morda treba prilagoditi pri bolnikih s prenizko ali prekomerno telesno težo.
English: Patients aged 12 to 18 years old: Dosing is based on the same guidelines as for adults.
Slovenian: Bolniki, stari 12 do 18 let: Odmerjanje temelji na istih smernicah, kot veljajo za odrasle.
English: The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products.
Slovenian: Število danih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard koncentrata WHO za zdravila s faktorjem VIII.
English: Based on a pharmacokinetic study with 12 subjects ≥12 years with VWD, the following pharmacokinetic characteristics for VWF:RCo, VWF:Ag, VWF:CB and FVIII:C were observed:
Slovenian: Na podlagi farmakokinetične študije z 12 preiskovanci ≥ 12 let z VWB so opazili naslednje farmakokinetične karakteristike za VWF:Rco, VWF:Ag, VWF:CB in FVIII:C:
English: Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.
Slovenian: Preprečevanje in zdravljenje krvavitev ali kirurških krvavitev pri bolnikih s VWB, ko samo zdravljenje z dezmopresinom (DDAVP) ni učinkovito ali je kontraindicirano.
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) within the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v ustreznem obdobju.
English: Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab.
Slovenian: Previdno odstranite zaščitni zaporki z vial in očistite izpostavljena gumijasta zamaška z alkoholno blazinico.
English: Administered intravenously, VWF binds to endogenous FVIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Slovenian: Ko ga damo intravensko, se VWF veže na endogeni FVIII (ki ga bolnik normalno izdeluje) in ga stabilizira ter tako prepreči njegovo hitro razgradnjo.
English: Voncento has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Voncento nima vpliva na sposobnost vožnje in upravljanja strojev.
English: If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding.
Slovenian: Če pride do tega, zdravilo pri vas ali vašem otroku ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: The frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Pogostost uporabe zdravila mora vedno temeljiti na klinični učinkovitosti v posameznem primeru.
English: Repeat infusion every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% - 60% (IU/dl).
Slovenian: Ponovite infundiranje na vsakih 824 ur, dokler se rana zadovoljivo ne zaceli, potem nadaljujte zdravljenje še vsaj 7 dni za vzdrževanje aktivnosti faktorja VIII 30 % - 60 % (i.e./dl).
English: Name and address of the manufacturer(s) responsible for batch release CSL Behring GmbH
Slovenian: Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij CSL Behring GmbH
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors.
Slovenian: Obstaja tveganje za pojav trombotičnih dogodkov, zlasti pri bolnikih z znanimi kliničnimi ali laboratorijskimi dejavniki tveganja.
English: See section “The following information is intended for healthcare professionals only” for further information.
Slovenian: Za dodatne informacije glejte poglavje “Naslednje informacije so namenjene samo zdravstvenemu osebju“.
English: 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Slovenian: Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (pri manj kot 1 od 100 bolnikov).
English: Because of this, administration of pure VWF (VWF product with a low FVIII level) restores the FVIII:C level to normal as a secondary effect after the first infusion with a slight delay.
Slovenian: Zato uporaba čistega VWF (zdravilo VWF z nizko ravnijo FVIII) povrne raven FVIII:C na normalno, kot sekundarni učinek, s krajšo zakasnitvijo po prvem infundiranju.
English: Allergic type hypersensitivity reactions are possible.
Slovenian: Možne so preobčutljivostne reakcije alergijskega tipa.
English: Elderly No dose adjustment is necessary for the older people.
Slovenian: Starejši Prilagajanje odmerkov pri starejših bolnikih ni potrebno.
English: Levels of VWF:RCo of > 0.6 IU/ml (60 %) and of FVIII:C of > 0.4 IU/ml (40 %) should be achieved.
Slovenian: Dosegli naj bi raven VWF:RCo > 0,6 i.e./ml (60 %) in FVIII:C > 0,4 i.e./ml (40 %).
English: For prevention of excessive bleeding during or after surgery the application should start 1 - 2 hours before the surgical procedure.
Slovenian: Za preprečevanje čezmerne krvavitve med kirurškim posegom ali po njem je treba z injiciranjem pričeti 1 do 2 uri pred kirurškim posegom.
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV).
Slovenian: Uvedeni ukrepi so učinkoviti proti virusom z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV), ter proti virusu brez ovojnice, virusu hepatitisa A (HAV).
English: Treatment monitoring
Slovenian: Spremljanje zdravljenja
English: • your body weight (see also section “The following information is intended for healthcare professionals only”).
Slovenian: (glejte tudi poglavje “Naslednje informacije so namenjene samo zdravstvenemu osebju”).
English: Hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain)
Slovenian: Bolezni imunskega sistema preobčutljivost (vključno s tahikardijo, bolečino v prsih, tiščanjem v prsih in bolečino v hrbtu)
English: The measures taken are considered effective for so-called “enveloped” viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (which cause inflammation of the liver), and for the “non-enveloped” hepatitis A virus (which also causes inflammation of the liver).
Slovenian: Uvedeni ukrepi so učinkoviti proti tako imenovanim virusom "z ovojnico", kot so virus humane imunske pomanjkljivosti (HIV, virus AIDS-a), virus hepatitisa B in virus hepatitisa C (ki povzročita vnetje jeter), in proti virusu "brez ovojnice", virusu hepatitisa A (ki tudi povzroči vnetje jeter).
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma, using the modified assay.
Slovenian: Nastanek protiteles, ki nevtralizirajo faktor VIII (zaviralci), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti zaviralci so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
English: If you have VWD your doctor will prescribe you Voncento with the number of units of VWF specified.
Slovenian: Če imate VWB, vam bo zdravnik predpisal zdravilo Voncento z določenim številom enot VWF.
English: In patients with VWD, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors.
Slovenian: Pri bolnikih s VWB obstaja tveganje pojava trombemboličnih dogodkov, zlasti pri bolnikih z znanimi kliničnimi ali laboratorijskimi dejavniki tveganja.
English: - Administration of a FVIII:C containing VWF preparation restores the FVIII:C level to normal immediately after the first infusion.
Slovenian: - Dajanje pripravka VWF, ki vsebuje FVIII:C, povrne raven FVIII:C na normalno nemudoma po prvem infundiranju.
English: These include hives, generalised skin rash, tightness of the chest, wheezing, fall in blood pressure and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, or dizziness).
Slovenian: Ti vključujejo koprivnico, kožne izpuščaje po vsem telesu, tiščanje v prsih, piskanje v pljučih, padec krvnega tlaka ter anafilaksijo (resno alergijsko reakcijo, ki povzroči hude težave z dihanjem ali omotico).
English: Minor surgery including tooth extraction
Slovenian: Kirurški posegi Manjši kirurški poseg, vključno z izruvanjem zoba
English: Based on a pharmacokinetic study with 16 subjects ≥ 12 years of age with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed:
Slovenian: Na podlagi farmakokinetične študije s 16 preiskovanci ≥ 12 let s hemofilijo A so opazili naslednje farmakokinetične karakteristike za FVIII:C:
English: Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF.
Slovenian: Bolniki z VWB, zlasti bolniki s tipom 3, lahko razvijejo nevtralizirajoča protitelesa (inhibitorje) proti VWF.
English: Place the product vial on an even and firm surface.
Slovenian: Postavite vialo z zdravilom na ravno in trdno podlago.
English: Voncento should be administered to pregnant or breast-feeding VWF deficient women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients.
Slovenian: Zdravilo Voncento se lahko daje nosečnicam in doječim materam s pomanjkanjem VWF le, če je jasno indicirano, ob upoštevanju dejstva, da porod pri teh bolnicah pomeni povečano tveganje za krvavitve.
English: How to use Voncento
Slovenian: Kako uporabljati zdravilo Voncento
English: In all such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V vseh takih primerih priporočamo, da se obrnete na specializirani center za hemofilijo.
English: Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Slovenian: Kljub tem ukrepom pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti prenosa okužbe.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of FVIII and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na spolni kromosom vezana dedna motnja strjevanja krvi zaradi znižane ravni FVIII in posledica so obsežne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano bodisi kot posledice nezgod ali kirurških poškodb.
English: Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %).
Slovenian: Na splošno 1 i.e./kg VWF:RCo dvigne raven VWF:RCo v krvnem obtoku za 0,02 i.e./ml (2 %).
English: Use the venipuncture kit supplied with the product, insert the needle into a vein.
Slovenian: Uporabite komplet za punkcijo vene, ki je priložen v pakiranju zdravila, vstavite iglo v žilo.
English: The pharmacokinetics of Voncento have been evaluated in VWD patients in the non-bleeding state.
Slovenian: Farmakokinetiko zdravila Voncento so vrednotili pri bolnikih z VWB, ko niso krvaveli.
English: If the expected VWF:RCo activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an appropriate assay should be performed to determine if a VWF inhibitor is present.
Slovenian: Če ne dosegamo pričakovane ravni aktivnosti VWF:RCo v plazmi ali krvavitve ne obvladamo z ustreznim odmerkom, opravimo ustrezno preiskavo, da določimo navzočnost inhibitorja VWF.
English: Name and address of the manufacturer(s) of the biological active substances
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
English: Withdrawal and Application
Slovenian: Izsesanje in apliciranje
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Slovenian: Pri bolnikih z veliko koncentracijo zaviralca zdravljenje s faktorjem VIII morda ne bo učinkovito, zato je treba razmisliti o drugih možnostih zdravljenja.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Slovenian: • Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Administration of VWF allows correction of the haemostatic abnormalities exhibited by patients who suffer from VWF deficiency (VWD) at two levels: - VWF re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium and to the platelet membrane), providing primary haemostasis as shown by the shortening of the bleeding time.
Slovenian: Dajanje VWF omogoča izboljšanje hemostatskih motenj, ki so prisotne pri bolnikih s pomanjkanjem VWF (VWB), na dveh ravneh: - VWF ponovno vzpostavi adhezijo trombocitov na žilni subendotelij na mestu poškodbe žile (s tem, ko se veže na žilni subendotelij in na membrano trombocitov), kar omogoči primarno hemostazo, ki je vidna s skrajšanjem časa krvavitve.
English: What you need to know before you use Voncento Do not use Voncento
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Voncento Ne uporabljajte zdravila Voncento
English: 1 non-sterile plaster
Slovenian: 1 nesterilen obliž
English: * The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: * Aktivnost (i.e.) FVIII je določena s pomočjo kromogenega preskusa po Evropski farmakopeji.
English: Like all medicines, Voncento can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Voncento neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: Obravnavo takih bolnikov mora voditi zdravnik z izkušnjami z zdravljenjem hemofilije in zaviralci faktorja VIII.
English: The specific VWF activity of Voncento, prior to the addition of stabiliser, is approximately 100 IU of VWF/mg protein.
Slovenian: Specifična aktivnost VWF zdravila Voncento, pred dodatkom stabilizatorja, je približno 100 i.e. VWF/mg beljakovin.
English: The use of plastic disposable syringes is recommended as the ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
Slovenian: Priporočamo uporabo plastičnih brizg za enkratno uporabo, ker se na mlečno-steklene površine vseh steklenih brizg te vrste raztopine lepijo.
English: In patients receiving FVIII-containing VWF products, sustained excessive FVIII:C plasma levels may increase the risk of thromboembolic events (see also section 4.4).
Slovenian: Pri bolnikih, ki prejemajo zdravila VWF, ki vsebujejo FVIII, lahko dlje časa trajajoča čezmerna plazemska raven FVIII:C poveča tveganje za trombembolične dogodke (glejte tudi poglavje 4.4).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Bolnike moramo poučiti o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo izpuščaj, generalizirano urtikarijo, tiščanje v prsih, piskanje v pljučih, hipotenzijo ter anafilaksijo.
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Slovenian: Če ste pozabili uporabiti zdravilo Voncento • Takoj nadaljujte z vašim naslednjim odmerkom in nadaljujte z rednimi intervali, ki vam jih je predlagal zdravnik.
English: • If for the administration of Voncento you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Slovenian: • Če je za vnos zdravila Voncento potreben centralni venski kateter (CVK), mora zdravnik upoštevati možnost zapletov, povezanih s CVK, kot so lokalne okužbe, prisotnost bakterij v krvi (bakteriemija) in nastanek krvnih strdkov v krvnih žilah (tromboza) na mestu vstavitve katetra.
English: What Voncento looks like and contents of the pack
Slovenian: Izgled zdravila Voncento in vsebina pakiranja
English: In case large volumes of Voncento are required, it is possible to pool several vials of Voncento together, via a commercially available infusion set (e.g. a syringe pump for giving medicines into a vein).
Slovenian: V primeru, da so potrebni veliki volumni zdravilaVoncento, je mogoče združiti več vial zdravila Voncento preko komercialno dostopnih infuzijskih kompletov (npr. črpalke za brizgo za dajanje zdravila v veno).
English: Voncento contains sodium
Slovenian: Zdravilo Voncento vsebuje natrij
English: For intravenous use.
Slovenian: Način uporabe za intravensko uporabo
English: VWF inhibition
Slovenian: inhibicija VWF
English: 1 IU of factorVIII activity is equivalent to that quantity of factor VIII in 1 ml of normal human plasma.
Slovenian: Aktivnost 1 i.e. faktorja VIII ustreza količini faktorja VIII v 1 ml normalne humane plazme.
English: Voncento contains FVIII and VWF as active ingredients which are derived from human plasma and act like endogenous constituents of plasma.
Slovenian: Zdravilo Voncento vsebuje FVIII in VWF kot učinkovini, pridobljeni iz humane plazme, ki delujeta kot endogeni sestavini plazme.
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Slovenian: Nalahno vrtite vialo z zdravilom skupaj s pritrjenim prozornim adapterjem, dokler se vsebina popolnoma ne raztopi.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for FVIII inhibitor presence should be performed.
Slovenian: Če aktivnost faktorja VIII ne doseže pričakovane ravni v plazmi ali če krvavitve z ustreznim odmerkom ne zaustavite, morate opraviti test prisotnosti zaviralca faktorja VIII.
English: Take care not to get any blood in the syringe containing the product.
Slovenian: Poskrbite, da v brizgo, napolnjeno z zdravilom, ne vstopi kri.
English: Catheter-related complications
Slovenian: Zapleti, povezani z uporabo katetrov
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton administration set (inner box)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla s setom za dajanje (notranja škatla)
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je izražena bodisi kot odstotek (glede na normalno humano plazmo) bodisi preferenčno v mednarodnih enotah (glede na Mednarodni standard za količino faktorja VIII v plazmi).
English: If you have haemophilia A your doctor will prescribe you Voncento with the number of units of FVIII specified.
Slovenian: Če imate hemofilijo A, vam bo zdravnik predpisal zdravilo Voncento z določenim številom enot FVIII.
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Slovenian: Medtem ko pritiskate na bat injekcijske brizge, obrnite sistem na glavo in nato posesajte raztopino v brizgo, tako da počasi izvlečete bat.
English: Baseline-adjusted initial PK parameters of VWF and FVIII:C in subjects <6 (N=9) and 6-12 years old (N=5)
Slovenian: Farmakokinetični parametri VWF in FVIII:C (prilagojeni na izhodiščne vrednosti) pri preiskovancih, starih <6 (N=9) in 6-12 let (N=5)
English: The product is made from human plasma (the liquid part of the blood) and contains the active substances called human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF).
Slovenian: Kaj je zdravilo Voncento in za kaj ga uporabljamo Zdravilo je narejeno iz človeške plazme (tekoči del krvi) in vsebuje učinkovini humani koagulacijski faktor VIII (FVIII) in humani von Willebrandov faktor (VWF).
English: AUSTRALIA
Slovenian: AVSTRALIJA
English: No side effects have been associated with these reports.
Slovenian: S tem prevelikim odmerjanjem niso bili povezani nobeni neželeni učinki.
English: Store below 25 °C.
Slovenian: Shranjujte pri temperaturi do 25 °C.
English: If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Slovenian: Pri nastanku teh zaviralcev se stanje lahko kaže kot nezadosten klinični odziv.
English: It is strongly recommended that every time Voncento is given, you record the date of administration, the batch number and the injected volume in your treatment diary.
Slovenian: Priporočamo, da se vsakokrat, ko prejmete odmerek zdravila Voncento, v vaš dnevnik zdravljenja zabeleži datum prejetja, serijska številka zdravila in vbrizgana količina.
English: After filtering or withdrawal (see below) the solution should be checked by eye, before it is used.
Slovenian: Po filtraciji ali izsesanju (glejte spodaj) je treba raztopino pred dajanjem vizualno preveriti.
English: • During pregnancy and breast-feeding, Voncento should be given only if it is clearly needed.
Slovenian: • Zdravilo Voncento uporabljamo med nosečnostjo in dojenjem le, če je nujno potrebno.
English: Allergic reactions may include the following symptoms: Swollen face, tongue, mouth or throat, difficulty in breathing and swallowing, hives, wheezing, burning and stinging where the infusion was given, chills, flushing, skin rash over the whole body, headache, fall in blood pressure, restlessness, faster heart beat, tightness of the chest (including chest pain and chest discomfort), back pain, tiredness (lethargy), nausea, vomiting, tingling.
Slovenian: otekanje obraza, jezika, ustnic ali grla, težave pri dihanju in požiranju, koprivnica, sopenje, pekoč občutek in zbadanje na mestu injiciranja ali infundiranja, mrazenje, vročinske oblive, kožni izpuščaj po celem telesu, glavobol, padec krvnega tlaka, nemir, pospešen srčni utrip, tiščanje v prsih (vključno z bolečino v prsih in nelagodjem v prsih), bolečino v hrbtu, utrujenost (letargijo), siljenje na bruhanje, bruhanje, mravljinčenje.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zaviranje faktorja FVIII
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 on the patient's clinical condition.
Slovenian: Odmerek in trajanje nadomestnega zdravljenja sta odvisna od resnosti pomanjkanja faktorja VIII, mesta in obsega krvavitve ter bolnikovega kliničnega stanja.
English: White powder and clear, colourless solvent for solution for injection/infusion.
Slovenian: Bel prašek in bister, brezbarven vehikel za raztopino za injiciranje/infundiranje.