FrancophonIA/ELRC3.0 huggingface dataset:
English: The dose depends on: - body weight, - the site of the bleeding - intensity of the bleeding, - your clinical condition, - the required surgery - the VWF activity levels in your blood after surgery - the severity of your disease
Slovenian: Odmerek je odvisen od: - telesne mase, - mesta krvavitve, - intenzivnosti krvavitve, - vašega klinično stanje, - potrebnega kirurškega posega, - ravni aktivnosti VWF v krvi po posegu, - resnosti vaše bolezni.
English: VEYVONDI has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo VEYVONDI nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Treatment of bleeding episodes (On demand treatment)
Slovenian: Zdravljenje krvavitev (zdravljenje po potrebi)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with VEYVONDI in all subsets of the paediatric population in the treatment of von Willebrand Disease (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom VEYVONDI za vse podskupine pediatrične populacije za zdravljenje von Willebrandove bolezni (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Point the needle up and remove any air bubbles by gently tapping the syringe with your finger and slowly and carefully pushing air out of the syringe and needle.
Slovenian: Iglo usmerite navzgor in odstranite morebitne zračne mehurčke tako, da s prsti narahlo potrkate po brizgi ter počasi in previdno potisnite bat, da odstranite zrak iz brizge in igle.
English: After reconstitution For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Po rekonstituciji Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
English: Major b
Slovenian: Večja b
English: For comfort, a winged (butterfly) infusion set is preferred.
Slovenian: Zaradi udobja je priporočen infuzijski komplet s krilci (metuljčkom).
English: VWF:RCo x BW (kg) /IR
Slovenian: VWF:RCo x TM (kg)/IR
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za zagotovitev sledljivosti biološkega zdravila, si natančno zabeležite ime in serijsko številko uporabljenega zdravila.
English: Such antibodies may occur in close association with hypersensitivity or anaphylactic reactions.
Slovenian: Taka protitelesa se lahko pojavijo v tesni povezavi s preobčutljivostjo ali anafilaktičnimi reakcijami.
English: If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately.
Slovenian: Če ste kdaj imeli težave s krvnimi strdki ali zamašitvijo žil (trombembolični zapleti), morate to nemudoma povedati zdravniku.
English: The contents of each reconstituted product of VEYVONDI can be drawn in a single syringe.
Slovenian: Vsebino vsakega rekonstituiranega zdravila VEYVONDI lahko povlečete v eno brizgo.
English: Administered intravenously, VEYVONDI binds to endogenous factor VIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Slovenian: Z intravenskim dajanjem se zdravilo VEYVONDI veže na endogeni faktor VIII (ki ga bolnik tvori normalno) in ga stabilizira ter tako prepreči njegovo hitro razgradnjo.
English: The solution should be slowly administered intravenously (see section 4.2) not exceeding 4 mL/min.
Slovenian: Raztopino počasi intravensko injicirajte (glejte poglavje 4.2) in pazite, da ne presežete hitrosti 4 ml/min.
English: Haemostasis cannot be ensured until Factor VIII coagulant activity (FVIII:C) is at least 0.4 IU/mL (≥ 40% of normal activity).
Slovenian: Hemostaze ni mogoče zagotoviti, dokler aktivnost koagulacijskega faktorja VIII (FVIII:C) ne dosega vsaj 0,4 i.e./ml (≥ 40 % normalne aktivnosti).
English: 3 Open the Mix2Vial device package by completely peeling away the lid, without touching the inside of the package.
Slovenian: 3 Pakiranje pripomočka Mix2Vial odprite tako, da popolnoma odlepite pokrov, ne da bi se dotaknili notranjosti.
English: Treatment of VWD patients who have high-titer binding antibodies (due to previous treatment with pdVWF) may require a higher dose to overcome the binding antibody effect and such patients could be managed clinically by administration of higher doses of vonicog alfa based on the PK data for each individual patient.
Slovenian: Za zdravljenje bolnikov z VWB, ki imajo visok titer vezavnih protiteles (zaradi predhodnega zdravljenja s pdVWF), je morda potreben večji odmerek, da se premaga učinek vezavnih protiteles; taki bolniki se lahko klinično vodijo z dajanjem večjih odmerkov vonikoga alfa glede na farmakokinetične podatke posameznega bolnika.
English: However, in these cases the initially reconstituted solution should not be diluted any further.
Slovenian: Vendar pa v tem primeru prvotno rekonstituirane raztopine zdravila ne smete dodatno redčiti.
English: In patients with high levels of anti-VWF antibodies, von Willebrand factor therapy may not be effective and other therapeutic options should be considered.
Slovenian: Pri bolnikih z visoko ravnijo protiteles proti VWF zdravljenje z von Willebrandovim faktorjem morda ne bo učinkovito, zato je treba razmisliti o drugih možnostih zdravljenja.
English: If any reaction, such as tachycardia, occurs that might be related to the administration of the product, the rate of infusion should be reduced or stopped as required by the clinical condition of the patient.
Slovenian: Če se pojavi kakršna koli reakcija, ki bi lahko bila povezana z dajanjem zdravila, kot je tahikardija, je treba hitrost infundiranja zmanjšati ali infundiranje ustaviti, kot zahteva klinično stanje bolnika.
English: 6 Gently and continuously swirl the connected vials or allow the reconstituted product to stand for 5 minutes then gently swirl to ensure the powder is completely dissolved.
Slovenian: 6 Nežno in brez prekinitev vrtite priključeni viali oziroma pustite rekonstituirano zdravilo 5 minut, nato pa ga rahlo vrtite, da se prepričate, da se je prašek popolnoma raztopil.
English: See section 2 “VEYVONDI contains sodium”.
Slovenian: Glejte poglavje 2 „Zdravilo VEYVONDI vsebuje natrij“.
English: No investigations on carcinogenicity, fertility impairment and fetal development have been conducted.
Slovenian: Raziskave karcinogenosti, okvar plodnosti in učinkov na razvoj ploda niso bile opravljene.
English: VWF is the carrier molecule for coagulation factor VIII and is involved in blood clotting making platelets stick to wounds and so helps to form a blood clot.
Slovenian: VWF je nosilna molekula za koagulacijski faktor VIII in je vključena v strjevanje krvi tako, da prispeva k lepljenju krvnih ploščic na rano in tako pripomore k nastanku krvnega strdka.
English: If you have previously been treated with plasma-derived VWF concentrates you may have reduced response to VEYVONDI due to pre-existing antibodies.
Slovenian: Če ste se predhodno zdravili s koncentrati VWF, pridobljenimi iz plazme, je vaš odziv na zdravilo VEYVONDI zaradi obstoječih protiteles lahko zmanjšan.
English: The contents of each vial of rVWF and rFVIII can be drawn into a single syringe by using a separate unused reconstitution device (see 6.2 for incompatibilities).
Slovenian: Vsebino posamezne viale rVWF in rFVIII lahko povlečete v eno brizgo, in sicer z uporabo ločenih, še neuporabljenih pripomočkov za rekonstitucijo (glede inkompatibilnosti glejte poglavje 6.2).
English: The filter included in the Mix2Vial device removes those particles completely.
Slovenian: Filter, vključen v pripomočku Mix2Vial, popolnoma odstrani te delce.
English: Number and Frequency by Subject a
Slovenian: Število in pogostnost po preiskovanc ih a
English: Table 4 Summary of Adverse Reactions reported in Clinical Trials with VEYVONDI in von Willebrand Disease
Slovenian: Preglednica 4 Povzetek neželenih učinkov, o katerih so poročali iz kliničnih preskušanj z zdravilom VEYVONDI pri von Willebrandovi bolezni
English: In addition, one post-marketing case of DVT has been reported spontaneously for an elderly patient.
Slovenian: Poleg tega je o GVT spontano poročal starejši bolnik v obdobju trženja.
English: - VEYVONDI produces delayed correction of the associated factor VIII deficiency.
Slovenian: - Zdravilo VEYVONDI povzroči zakasnjeno izboljšanje povezanega pomanjkanja faktorja VIII.
English: A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events.
Slovenian: Kombinirana zdravila s FVIII, ki vsebujejo VWF, povečajo tveganje trombotičnih dogodkov.
English: You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings.
Slovenian: Morda boste za obvladovanje krvavitev potrebovali večji odmerek zdravila VEYVONDI ali faktorja VIII ali celo drugo zdravilo.
English: Mean (95% CI) SD
Slovenian: povprečje (95-odstotni IZ) SD
English: Dosing guidelines for treatment of minor and major haemorrhages are provided in Table 1.
Slovenian: Smernice za odmerjanje za zdravljenje manjših in večjih krvavitev so v preglednici 1.
English: The first dose of VEYVONDI should be 40 to 80 IU/kg body weight.
Slovenian: Prvi odmerek zdravila VEYVONDI mora znašati od 40 do 80 i.e./kg telesne mase.
English: An exploratory analysis of combined data from studies 070701 and 071001 indicated a statistically significantly (at the 5% level) longer mean residence time, a statistically significantly (at the 5% level) longer terminal half-life and statistically significantly (at the 5% level) larger AUC0-inf regarding VWF:RCo following administration with VEYVONDI (50 IU/kg VWF:RCo) and combined administration of VEYVONDI and octocog alfa (50 IU/kg VWF:RCo and 38.5 IU/kg rFVIII) than after administration of pdVWF and pdFVIII (50 IU/kg pdVWF:RCo and 38.5 IU/kg pdFVIII).
Slovenian: Raziskovalna analiza združenih podatkov iz študij 070701 in 071001 je pokazala statistično značilno daljši (na 5-odstotni ravni) povprečni čas zadrževanja, statistično značilno daljšo (na 5-odstotni ravni) končno razpolovno dobo in statistično značilno večjo (na 5-odstotni ravni) vrednost AUC0-inf za VWF:RCo po dajanju zdravila VEYVONDI (50 i.e./kg VWF:RCo) ter po sočasnem dajanju zdravila VEYVONDI in oktokoga alfa (50 i.e./kg VWF:RCo in 38,5 i.e./kg rFVIII) v primerjavi z vrednostmi po dajanju pdVWF in pdFVIII (50 i.e./kg pdVWF:RCo in 38,5 i.e./kg pdFVIII).
English: The mean duration of infusion was 16.5 minutes (SD ± 3.51 minutes) for 50 IU/kg (PK50) and 11.8 minutes (± 2.86 minutes) for 80 IU/kg VWF:RCo (PK80).
Slovenian: Povprečno trajanje infundiranja je bilo 16,5 minute (SD ± 3,51 minute) zar 50 i.e./kg (FK50) in 11,8 minute (± 2,86 minute) za 80 i.e./kg VWF:RCo (FK80).
English: VEYVONDI should be administered to pregnant woment only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients.
Slovenian: Zdravilo VEYVONDI se lahko daje nosečnicam le, če je jasno indicirano, ob upoštevanju dejstva, da porod pri teh bolnicah pomeni povečano tveganje za krvavitve.
English: Fertility The effects of VEYVONDI on fertility have not been established.
Slovenian: Plodnost Učinki zdravila VEYVONDI na plodnost niso znani.
English: Table 1 Dosing recommendations for the treatment of minor and major haemorrhages
Slovenian: Preglednica 1 Priporočila za odmerjanje za zdravljenje manjših in večjih krvavitev
English: 7 Disconnect the two sides of the Mix2Vial from each other by holding the clear plastic side of the Mix2Vial device attached to the VEYVONDI vial with one hand and the blue plastic side of the Mix2Vial device attached to the solvent vial with the other hand.
Slovenian: 7 Ločite dva dela pripomočka Mix2Vial tako, da z eno roko primete prozorni plastični del pripomočka Mix2Vial, ki je pritrjen na vialo zdravila VEYVONDI, z drugo roko pa modri plastični del pripomočka Mix2Vial, ki je pritrjen na vialo z vehiklom.
English: When coadministration of rVWF and rFVIII is considered necessary, they can be pre-mixed in a single syringe to achieve the appropriate dose.
Slovenian: Če je potrebno sočasno dajanje rVWF in rFVIII, ju lahko predhodno zmešate v eni brizgi in tako dosežete ustrezni odmerek.
English: Hypersensitivity reactions (including anaphylaxis) may occur.
Slovenian: Lahko se pojavijo preobčutljivostne reakcije (vključno z anafilakso).
English: If your dose requires multiple syringes, attach and administer each additional syringe of VEYVONDI one at a time.
Slovenian: Če vaš odmerek zahteva več brizg, namestite in uporabite vsako dodatno brizgo zdravila VEYVONDI drugo za drugo.
English: In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier.
Slovenian: V perfuzijskem modelu človeške placente ex vivo je bilo dokazano, da zdravilo VEYVONDI ne prehaja skozi placento.
English: Replacement levels of VWF:RCo > 0.6 IU/mL (60%) and FVIII:C > 0.4 IU/mL (40%) should be achieved.
Slovenian: Doseči je treba nadomestne ravni VWF:RCo > 0,6 i.e./ml (60 %) in FVIII:C > 0,4 i.e./ml (40 %).
English: This is to be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
English: Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Slovenian: Iglo izvlecite iz vene in s sterilno gazo nekaj minut pritiskajte na mesto infundiranja.
English: Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes.
Slovenian: Z zdravilom uporabljajte plastične brizge, saj se beljakovine v zdravilu običajno lepijo na površine steklenih brizg.
English: Frequency by Subject: Total number of subjects experiencing the AE (related and unrelated) divided by total number of subjects (N) and multiplied by 100.
Slovenian: Število in pogostnost po preiskovancih: Skupno število preiskovancev, pri katerih se je pojavil neželeni učinek (povezava dokazana ali ne), deljeno s celotnim številom preiskovancev (N) ter pomnoženo s 100.
English: What you need to know before you use VEYVONDI Do not use VEYVONDI: - if you are allergic to vonicog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins If you are unsure about this, ask your doctor.
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo VEYVONDI Ne uporabljajte zdravila VEYVONDI: - če ste alergični na vonikog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če ste alergični na beljakovine miši ali hrčka.
English: However, in these cases the initially reconstituted solution of VEYVONDI should not be diluted any further.
Slovenian: Vendar pa v tem primeru prvotno rekonstituirane raztopine zdravila VEYVONDI ne smete dodatno redčiti.
English: If any of these symptoms occur, stop the infusion immediately and contact your doctor.
Slovenian: Če opazite katerega koli izmed teh simptomov, nemudoma prekinite infundiranje in se posvetujte z zdravnikom.
English: Allow the rubber stoppers to dry.
Slovenian: Počakajte, da se gumijasti zamašek posuši.
English: 10 Hold the vial with one hand and use the other hand to push all the air from the syringe into the vial.
Slovenian: 10 Z eno roko držite vialo in z drugo roko potisnite celotno količino zraka iz brizge v vialo.
English: - Proceed with the next infusion as scheduled and continue as advised by your doctor.
Slovenian: • Naslednji odmerek infundirajte po razporedu in nadaljujte po navodilu zdravnika.
English: If the IR is not available, assume an IR of 0.02 IU/mL per IU/kg.
Slovenian: Če IR ni na voljo, predpostavimo vrednost IR 0,02 i.e./ml na i.e./kg.
English: If recombinant factor VIII has been prescribed, administer recombinant factor VIII within 10 minutes after infusion of VEYVONDI has been completed.
Slovenian: Če vam je zdravnik predpisal rekombinantni faktor VIII, uporabite rekombinantni faktor VIII v 10 minutah po infuziji zdravila VEYVONDI.
English: Discard after three hours.
Slovenian: Zdravilo zavrzite po treh urah.
English: Minor
Slovenian: Manjši
English: The solution in the syringe should not be used if it is cloudy or contains flakes or particles after filtration.
Slovenian: Raztopine v brizgi ne smete uporabiti, če je zdravilo po filtriranju motno ali vsebuje kosmiče ali delce.
English: What VEYVONDI is and what it is used for
Slovenian: Kaj je zdravilo VEYVONDI in za kaj ga uporabljamo
English: - Do not mix vonicog alfa with other medicinal products except for rFVIII.
Slovenian: Vonikoga alfa ne mešajte z drugimi zdravili, razen z rFVIII.
English: During treatment with VEYVONDI the following adverse reactions may occur: Hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF.
Slovenian: Med zdravljenjem z zdravilom VEYVONDI lahko pride do naslednjih neželenih učinkov: preobčutljivostne ali alergijske reakcije, tromboembolični zapleti, nastanek zaviralcev proti VWF.
English: Apply a tourniquet and get the infusion site ready by wiping the skin well with a sterile alcohol swab (or other suitable sterile solution suggested by your doctor or haemophilia treatment center).
Slovenian: Namestite zažemko in pripravite mesto infundiranja tako, da kožo dobro obrišete s sterilnim alkoholnim tamponom (ali drugo ustrezno sterilno raztopino, ki jo predlaga zdravnik ali center za zdravljenje hemofilije).
English: Shelf-life after reconstitution:
Slovenian: Rok uporabnosti po rekonstituciji:
English: You can store the reconstituted product at room temperature not to exceed 25° C for up to three hours.
Slovenian: Rekonstituirano zdravilo lahko hranite največ tri ure pri sobni temperaturi, ki ne presega 25 °C.
English: Calculation of rVWF dose (to be administered within 1 hour prior to surgery) (IU VWF:RCo required)
Slovenian: Izračun odmerka rVWF (uporabiti v 1 uri pred kirurškim posegom) (potrebna količina i.e. VWF: RCo)
English: Generally, 1 IU/kg (VWF:RCo/VEYVONDI/vonicog alfa) raises the plasma VWF:RCo by 0.02 IU/mL (2%).
Slovenian: Na splošno 1 i.e./kg (VWF:RCo/VEYVONDI/vonikog alfa) zviša raven VWF:RCo v plazmi za 0,02 i.e. (2 %).
English: In clinical trials, one case of clinically asymptomatic deep vein thrombosis (DVT) was reported for a subject in the surgery study who had total hip replacement.
Slovenian: V kliničnih preskušanjih so poročali o enem primeru klinično asimptomatske globoke venske tromboze (GVT) pri preiskovancu iz kirurške študije po popolni zamenjavi kolka.
English: Initial Dose a
Slovenian: Začetni odmerek a
English: Adequate medical treatment and provisions should be available for immediate use for a potential anaphylactic reaction, especially for patients with a history of allergic reactions.
Slovenian: Za primer morebitne anafilaktične reakcije morajo biti na voljo primerna zdravniška oskrba in ukrepi, zlasti pri bolnikih z anamnezo alergijskih reakcij.
English: Insert the needle into the vein and remove the tourniquet.
Slovenian: Uvedite iglo v veno in odstranite zažemko.
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors including low ADAMTS13 levels.
Slovenian: Obstaja tveganje za trombotične dogodke, zlasti pri bolnikih z znanimi klinično ali laboratorijsko opredeljenimi dejavniki tveganja, vključno z nizkimi vrednostmi ADAMTS13.
English: However, if an immediate rise in FVIII:C is not necessary, or if the baseline FVIII:C level is sufficient to ensure haemostasis, the physician may decide to omit the co-administration of rFVIII at the first infusion with VEYVONDI.
Slovenian: Če pa takojšnje zvišanje ravni FVIII:C ni potrebno ali če izhodiščna raven FVIII:C zadostuje za zagotovitev hemostaze, se zdravnik lahko odloči, da opusti sočasno dajanje rFVIII pri prvem infundiranju zdravila VEYVONDI.
English: In actively bleeding patients it is recommended to co-administer a FVIII product with VEYVONDI as a first line treatment and depending on the FVIII activity levels (see section 4.2).
Slovenian: Pri aktivnih krvavitvah je priporočljivo sočasno dajati zdravilo s FVIII in zdravilo VEYVONDI kot zdravljenje prve izbire in glede na raven aktivnosti FVIII (glejte poglavje 4.2).
English: Treatment of bleeding episodes
Slovenian: Zdravljenje krvavitev
English: Clinical and compatibility studies were conducted to administer vonicog alfa (human von Willebrand factor) with octocog alfa (human coagulation factor) in the same syringe.
Slovenian: Klinične študije in študije kompatibilnosti so bile izvedene z dajanjem vonikoga alfa (humanega von Willebrandovega faktorja) z oktokogom alfa (humanim koagulacijskim faktorjem) v isti brizgi.
English: 8 Draw air into the empty, sterile disposable plastic syringe by pulling back on the plunger.
Slovenian: 8 Zrak povlecite v prazno, sterilno plastično brizgo za enkratno uporabo tako, da povlečete bat.
English: Do not use after the expiry date stated on the labels and carton.
Slovenian: Zdravila ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
English: The rVWF and rFVIII can be pre-mixed in a single syringe to achieve the appropriate dose (see section 4.2 for mode of administration).
Slovenian: rVWF in rFVIII lahko predhodno zmešate v eni brizgi in tako dosežete ustrezni odmerek (za način dajanja glejte poglavje 4.2).
English: - If your bleeding is not controlled with VEYVONDI, tell your doctor immediately.
Slovenian: - Če krvavitev pri vas z zdravilom VEYVONDI ni obvladana, morate to nemudoma povedati zdravniku.
English: Every 12-24 hrs / every other day
Slovenian: Vsakih 1224 ur/vsak drugi dan
English: One of the 80 subjects who received VEYVONDI peri-operatively in clinical studies developed treatment-emergent binding antibodies against VWF following a surgery for whom no adverse events or lack of haemostatic efficacy has been reported.
Slovenian: Pri enem od 80 preiskovancev, ki so v kliničnih študijah perioperativno prejeli zdravilo VEYVONDI, so se po zdravljenju pojavila vezavna protitelesa proti VWF po kirurškem posegu; pri njem niso poročali o neželenih učinkih ali odsotnosti hemostatske učinkovitosti.
English: VEYVONDI is used to treat and control bleeding episodes and to prevent bleeding during surgery in adult patients (aged 18 years and older) with von Willebrand disease.
Slovenian: Zdravilo VEYVONDI se uporablja za zdravljenje in obvladovanje krvavitev ter za preprečevanje krvavitev pri kirurških posegih pri odraslih bolnikih (starih 18 let ali več) z diagnozo von Willebrandove bolezni.
English: Slowly infuse VEYVONDI.
Slovenian: Počasi infundirajte zdravilo VEYVONDI.
English: There is a risk of occurrence of thrombotic events if you have known clinical or laboratory risk factors.Therefore your doctor will monitor you for early signs of thrombosis.
Slovenian: Če imate prepoznane klinične ali laboratorijske dejavnike tveganja, obstaja tveganje za nastanek trombotičnih dogodkov, zato vas bo zdravnik spremljal za zgodnje znake tromboze.
English: Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period.
Slovenian: Bolnika je treba ves čas trajanja infundiranja skrbno spremljati in opazovati za pojav morebitnih simptomov.
English: VEYVONDI is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the - Treatment of haemorrhage and surgical bleeding - Prevention of surgical bleeding.
Slovenian: Zdravilo VEYVONDI je indicirano pri odraslih (starost 18 let in več) z von Willebrandovo boleznijo (VWB), kadar zdravljenje samo z dezmopresinom (DDAVP) ni učinkovito ali ni indicirano - za zdravljenje krvavitev in kirurških krvavitev - preprečevanje kirurških krvavitev.
English: Do not touch the end of the plastic connector attached to the VEYVONDI vial containing the dissolved product.
Slovenian: Ne dotikajte se konca plastičnega priključka na viali zdravila VEYVONDI, ki vsebuje raztopljeno zdravilo.