FrancophonIA/ELRC3.0 huggingface dataset:
English: The solvent vial now has the Mix2Vial device connected to it and is ready to be connected to the VEYVONDI vial.
Slovenian: Viala z vehiklom je zdaj povezana s pripomočkom Mix2Vial in je pripravljena za priključitev na vialo zdravila VEYVONDI.
English: 12 Do not push and pull solution back and forth between syringe and vial.
Slovenian: 12 Ne potiskajte in vlecite raztopine med brizgo in vialo.
English: In case of major bleeding events or major surgeries requiring repeated, frequent infusions, monitoring of FVIII:C levels is recommended, to decide if rFVIII is required for subsequent infusions to avoid excessive rise of FVIII:C.
Slovenian: Pri večjih krvavitvah ali večjih kirurških posegih, ki zahtevajo ponavljajoče se in pogoste infuzije, je priporočljivo spremljanje ravni FVIII:C, da se presodi, ali je rFVIII potreben pri nadaljnjih infuzijah, in prepreči prekomerno zvišanje ravni FVIII:C.
English: If you infuse more VEYVONDI than recommended, tell your doctor as soon as possible.
Slovenian: Če ste infundirali večji odmerek zdravila VEYVONDI, kot je priporočeno, se čimprej posvetujte z zdravnikom.
English: In patients requiring frequent doses of VEYVONDI in combination with recombinant factor VIII, plasma levels for FVIII:C activity should be monitored to avoid sustained excessive FVIII:C plasma levels, which may increase the risk of thrombotic events.
Slovenian: Pri bolnikih, ki potrebujejo pogoste odmerke zdravila VEYVONDI v kombinaciji z rekombinantnim faktorjem VIII, je treba spremljati ravni aktivnosti FVIII:C v plazmi, da se preprečijo trajne, previsoke ravni FVIII:C v plazmi, ki lahko povečajo tveganje za trombotične dogodke.
English: Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIA
Slovenian: Baxter AG Industriestraße 67 A-1221 Dunaj AVSTRIJA
English: Within 1 hour prior to surgery, patients should receive a dose of VEYVONDI based on the assessment 3 hours before surgery.
Slovenian: V 1 uri pred kirurškim posegom morajo bolniki prejeti odmerek zdravila VEYVONDI na podlagi ocene 3 ure pred kirurškim posegom.
English: Frequency of dosing
Slovenian: Pogostnost odmerjanja
English: This is equivalent to 2.2% of the recommended maximum daily dietary intake of sodium for an adult, assuming 70 kg body weight and 80 IU/kg body weight.
Slovenian: To je enako 2,2 % priporočenega največjega dnevnega vnosa natrija s hrano za odraslo osebo, ob predpostavki telesne mase 70 kg in odmerku 80 i.e./kg telesne mase.
English: The pharmacokinetics (PK) of VEYVONDI were determined in three clinical studies by assessing the plasma levels of VWF:RCo, von Willebrand Factor Antigen (VWF:Ag), and von Willebrand Collagen Binding Activity (VWF:CB).
Slovenian: Farmakokinetiko (FK) zdravila VEYVONDI so ovrednotili v treh kliničnih študijah z določanjem plazemskih koncentracij VWF:RCo, antigena von Willebrandovega faktorja (VWF:Ag) in aktivnosti vezave von Willebrandovega faktorja na kolagen (VWF:CB).
English: After reconstitution, when drawn into the syringe, the solution is clear, colourless in appearance and free from flakes or other foreign particles.
Slovenian: Ko ga po rekonstituciji povlečete v brizgo, je raztopina bistra, na izgled brezbarvna in brez kosmičev ali tujkov.
English: If the FVIII:C levels are not at the recommended target, a dose of VEYVONDI alone should be administered within 1 hour prior to the procedure.
Slovenian: Če ravni FVIII:C niso v priporočljivem ciljnem območju, se mora odmerek zdravila VEYVONDI samega dati 1 uro pred posegom.
English: Subsequent infusions
Slovenian: Naslednje infuzije
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestraße 67
Slovenian: Imetnik dovoljenja za promet z zdravilom Baxalta Innovations GmbH Industriestraße 67
English: When ready to infuse, disconnect the syringe by turning it counterclockwise.
Slovenian: Ko ste pripravljeni za infundiranje, snemite brizgo tako, da jo zavrtite v nasprotni smeri vrtenja urnega kazalca.
English: Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.
Slovenian: Zdravljenje z zdravilom VEYVONDI bo nadzoroval zdravnik z izkušnjami pri obravnavi bolnikov z von Willebrandovo boleznijo.
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors for thrombosis including low ADAMTS13 levels.
Slovenian: Obstaja tveganje za trombotične dogodke, zlasti pri bolnikih z znanimi klinično ali laboratorijsko opredeljenimi dejavniki tveganja za trombozo, vključno z nizkimi vrednostmi ADAMTS13.
English: If you feel that VEYVONDI is not working well enough, talk to your doctor.
Slovenian: Če imate občutek, da zdravilo VEYVONDI ne učinkuje dovolj, se posvetujte z zdravnikom.
English: Manufacturer Baxter AG Industriestraße 67 A-1221 Vienna Austria
Slovenian: Izdelovalec Baxter AG Industriestraße 67 A-1221 Dunaj Avstrija
English: Administration of VEYVONDI allows correction of the haemostatic abnormalities exhibited by patients who suffer from von Willebrand factor deficiency (von Willebrand's disease) at two levels: - VEYVONDI re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium matrix (e.g. collagen) and to the platelet membrane), providing primary haemostasis as shown by the shortening of the bleeding time.
Slovenian: Uporaba zdravila VEYVONDI omogoča izboljšanje hemostatskih motenj, ki so prisotne pri bolnikih s pomanjkanjem von Willebrandovega faktorja (von Willebrandova bolezen), na dveh ravneh: - Zdravilo VEYVONDI ponovno vzpostavi adhezijo trombocitov na žilni subendotelij na mestu poškodbe žile (s tem, ko se veže na matriks žilnega subendotelija (npr. kolagen) in na membrano trombocitov), kar omogoči primarno hemostazo, ki se kaže s skrajšanjem časa krvavitve.
English: Do not recap the needle.
Slovenian: Na iglo ne nameščajte znova pokrovčka.
English: If the expected plasma levels of (VWF:RCo) are not attained, or if bleeding is not controlled with an appropriate dose, an appropriate assay should be performed to determine if a von Willebrand factor inhibitor is present.
Slovenian: Če (VWF:RCo) ne doseže pričakovane ravni v plazmi ali če krvavitve ne obvladamo z ustreznim odmerkom, opravimo ustrezno preiskavo, da določimo navzočnost inhibitorja von Willebrandovega faktorja.
English: The immunogenicity of VEYVONDI was assessed in clinical trials by monitoring the development of neutralizing antibodies against VWF and FVIII, as well as binding antibodies against VWF, Furin, Chinese Hamster Ovary (CHO) protein and mouse IgG.
Slovenian: Imunogenost zdravila VEYVONDI so ocenjevali v kliničnih preskušanjih tako, da so spremljali razvoj nevtralizirajočih protiteles proti VWF in FVIII ter vezavnih protiteles proti VWF, furinu, beljakovinam celic jajčnika kitajskega hrčka (CHO) in mišjim IgG.
English: No symptoms of overdose with von Willebrand factor have been reported.
Slovenian: O simptomih prevelikega odmerjanja von Willebrandovega faktorja niso poročali.
English: Grip the package at its edge and lift it off the Mix2Vial device.
Slovenian: Ovojnino primite na robu in jo snemite s pripomočka Mix2Vial.
English: VEYVONDI contains trace amounts of mouse immunoglobulin G (MuIgG) and Hamster proteins (less than or equal to 2 ng/IU VEYVONDI).
Slovenian: Zdravilo VEYVONDI vsebuje sledi mišjega imunoglobulina G (MuIgG) in hrčkovih beljakovin (manj kot ali enako 2 ng/i.e.
English: Minor (e.g. epistaxis, oral bleeding, menorrhagia)
Slovenian: Manjša (npr. epistaksa, krvavitev v ustni votlini, menoragija)
English: Inspect the prepared solution in the syringe for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from particles).
Slovenian: Pripravljeno raztopino v brizgi pred uporabo preglejte glede prisotnosti delcev in sprememb barve (raztopina mora biti bistra, brezbarvna in brez delcev).
English: VEYVONDI contains trace amounts of recombinant coagulation factor VIII.
Slovenian: Zdravilo VEYVONDI vsebuje sledi rekombinantnega koagulacijskega faktorja VIII.
English: The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO).
Slovenian: Aktivnost ristocetinskega kofaktorja rekombinantnega humanega von Willebrandovega faktorja je bila določena glede na mednarodni standard koncentrata von Willebrandovega faktorja (SZO).
English: - Use the reconstituted product within 3 hours to avoid the risk of microbial contamination because the product does not contain preservatives.
Slovenian: - Rekonstituirano zdravilo uporabite v 3 urah, da se izognete tveganju mikrobne kontaminacije,
English: e[(h*IU/dL)/(IU VWF:RCo/kg)] f[VWF:RCo assays with different sensitivity and working ranges were used: Phase 1: automated assay 0.081.50 IU/mL and sensitive manual assay 0.01 - 0.08 IU/mL; Phase 3: automated assay 0.08 - 1.50 IU/mL g This trial was done using ADVATE, a recombinant factor VIII
Slovenian: AUC0inf/odmereke a[ure], b[dl/kg/ure], c[(i.e./dl)/(e. VWF:RCo/kg)] d[(h*i.e./dl)] e[(h*i.e./dl)/(i.e. VWF:RCo/kg)] [uporabljeni so bili testi za VWF:RCo z različnimi občutljivostmi in koncentracijskimi območji: faza 1: samodejni test 0,08-1,50 i.e./ml in občutljivo ročno testiranje 0,01-0,08 i.e./ml; faza 3: samodejni test 0,08-1,50 i.e./ml g
English: INFORMATION IN BRAILLE VEYVONDI 650 IU
Slovenian: PODATKI V BRAILLOVI PISAVI VEYVONDI 650 i.e.
English: Do not use if the vacuum has been lost and the solvent does not flow into the VEYVONDI vial.
Slovenian: Zdravila ne uporabljajte, če je vakuum popustil in vehikel ne teče v vialo zdravila VEYVONDI.
English: Patients with von Willebrand disease, especially Type 3, may very rarely develop neutralising antibodies (inhibitors) to von Willebrand factor.
Slovenian: Pri bolnikih z von Willebrandovo boleznijo, zlasti tipa 3, se lahko zelo redko pojavijo nevtralizirajoča telesa (zaviralci) proti von Willebrandovemu faktorju.
English: The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg protein.
Slovenian: Specifična aktivnost zdravila VEYVONDI je približno 110 i.e. VWF:RCo/mg beljakovin.
English: Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.
Slovenian: Dajanje von Willebrandovega faktorja (VWF) omogoča zmanjšanje pomanjkanja von Willebrandovega faktorja.
English: Within 1 hour prior to surgery, you will receive a dose of VEYVONDI based on the assessment 3 hours before surgery.
Slovenian: V 1 uri pred kirurškim posegom boste prejeli odmerek zdravila VEYVONDI na podlagi ocene 3 ure pred kirurškim posegom.
English: Prevention of bleeding in case of elective surgery
Slovenian: Preprečevanje krvavitev in zdravljenje v primeru načrtovanega kirurškega posega:
English: Treatment of von Willebrand disease (VWD) should be supervised by a physician experienced in the treatment of haemostatic disorders.
Slovenian: Zdravljenje von Willebrandove bolezni (VWB) je treba uvesti pod nadzorom zdravnika, izkušenega v zdravljenju hemostatskih bolezni.
English: 2 Disinfect each stopper with a separate sterile alcohol swab (or other suitable sterile solution suggested by your doctor or haemophilia treatment center) by wiping the stopper for several seconds.
Slovenian: 2 Oba zamaška razkužite, vsakega z drugim sterilnim alkoholnim tamponom (ali drugo ustrezno sterilno raztopino, ki jo predlaga zdravnik ali center za zdravljenje hemofilije) tako, da z njim nekaj sekund brišete zamašek.
English: Frequency Category by Subject
Slovenian: Kategorija pogostnosti po preiskovancih
English: Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor von Willebrand factor.
Slovenian: Farmakoterapevtska skupina: Antihemoragiki: krvni koagulacijski faktorji, von Willebrandov faktor.
English: No treatment-emergent development of neutralizing antibodies against human VWF or neutralizing antibodies against human rFVIII was observed.
Slovenian: Niso ugotovili razvoja nevtralizirajočih protiteles proti humanemu VWF ali nevtralizirajočih protiteles proti humanemu rFVIII zaradi zdravljenja.
English: Driving and using machines VEYVONDI is not likely to affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo je verjetno, da bi zdravilo VEYVONDI vplivalo na sposobnost vožnje in upravljanja strojev.
English: No interactions of human von Willebrand factor products with other medicinal products are known.
Slovenian: Medsebojno delovanje zdravil s humanim von Willebrandovim faktorjem z drugimi zdravili ni znano.
English: - Keep the vial in the outer carton in order to protect from light.
Slovenian: - Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: This should be done right away to keep the liquid free of germs.
Slovenian: To morate storiti takoj, da v tekočino ne vstopijo mikroorganizmi.
English: During and After Surgery:
Slovenian: Med kirurškim posegom in po njem:
English: Do not remove the Mix2Vial device from the package.
Slovenian: Ne jemljite pripomočka Mix2Vial iz ovojnine.
English: Check that all the solvent has transferred.
Slovenian: Preverite, ali je iztekla vsa vsebina vehikla.
English: Phase 1 PK50 VEYVONDI with octocog alfag
Slovenian: Parameter Faza 1 FK50 zdravilo VEYVONDI z oktokogom alfag
English: If your plasma VWF or factor VIII fail to reach the expected levels with VEYVONDI based on the test results followed by your doctor, or if bleeding is not adequately controlled, it could be due to the presence of VWF or factor VIII antibodies.
Slovenian: Če VWF ali faktor VIII v vaši plazmi, izmerjena s preiskavo, ki jo naroči zdravnik, ne dosežeta pričakovane ravni za zdravilo VEYVONDI ali če krvavitev ni ustrezno obvladovana, gre morda za posledico pojava protiteles proti VWF ali faktorju VIII.
English: The recommended minimum target levels are 0.4 IU/mL for minor and oral surgery and 0.8 IU/mL for major surgery.
Slovenian: Priporočena ciljna raven je 0,4 i.e./ml pri manjših in oralnih kirurških posegih in 0,8 i.e./ml pri večjih kirurških posegih.
English: Subsequent Dose
Slovenian: Naslednji odmerek
English: INFORMATION IN BRAILLE VEYVONDI 1300 IU
Slovenian: PODATKI V BRAILLOVI PISAVI VEYVONDI 1300 i.e.
English: Dosage and frequency of administration must be individualized according to clinical judgement and based on the patient´s weight, type and severity of the bleeding episodes/surgical intervention and based on monitoring of appropriate clinical and laboratory measures.
Slovenian: Odmerjanje in pogostnost dajanja je treba po klinični presoji prilagoditi bolniku glede na telesno maso, vrsto in resnost krvavitev/kirurških posegov ter glede na rezultate ustreznih kliničnih in laboratorijskih meritev.
English: Prior to Surgery:
Slovenian: Pred kirurškim posegom:
English: The potency of VWF (IU) is measured using the European Pharmacopeia ristocetin cofactor activity assay (VWF: RCo).
Slovenian: Učinkovitost VWF (i.e.) se meri s pomočjo preskusa aktivnosti ristocetinskega kofaktorja po Evropski farmakopeji (VWF: RCo).
English: This is equivalent to 2.2% of the WHO recommended maximum daily intake of 2 g sodium for an adult, assuming a body weight of 70 kg and a dose of 80 IU/kg body weight.
Slovenian: To je enako 2,2 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča SZO in znaša 2 g, ob predpostavki telesne mase 70 kg in odmerku 80 i.e./kg telesne mase.
English: Do not mix VEYVONDI with other medicinal products except for rFVIII.
Slovenian: Zdravila VEYVONDI se ne sme mešati z drugimi zdravili (razen z rFVIII).
English: For minor bleeding (e.g. nose bleed, oral bleeding, menorrhagia), each initial dose is usually 40 to 50 IU/kg and for major bleeding (severe or refractory nose bleed, menorrhagia, gastrointestinal bleeding, Central nervous system trauma, haemarthrosis, or traumatic haemorrhage), each initial dose is 50 to 80 IU/kg.
Slovenian: V primeru manjših krvavitev (npr. krvavitev iz nosu, krvavitev v ustni votlini, čezmerna menstruacija) je začetni odmerek običajno od 40 do 50 i.e./kg, v primeru večjih krvavitev (npr. hude ali neodzivne krvavitve iz nosu, čezmerna menstruacija, krvavitev v prebavilih, travma v osrednjem živčevju, hemartroza ali travmatska krvavitev) pa je začetni odmerek od 50 do 80 i.e./kg.
English: Therefore, any FVIII product that would be administered in combination with VEYVONDI should be a pure FVIII product.
Slovenian: Zato mora biti katerokoli zdravilo s FVIII, ki bi ga uporabljali v kombinaciji z zdravilom VEYVONDI, zdravilo z izključno FVIII.
English: (e.g. severe or refractory epistaxis, menorrhagia, Gastrointestinal bleeding, Central nervous system trauma, haemarthrosis, or traumatic haemorrhage)
Slovenian: (npr. huda ali refraktarna epistaksa, menoragija, krvavitev v prebavilih, poškodba v osrednjem živčnem sistemu, hemartroza ali travmatska krvavitev)
English: A total of 92 unique subjects (80 unique subjects with VWD in studies 070701, 071001 and 071101 and 12 subjects with Haemophilia A in study 071104) were exposed to VEYVONDI during clinical development.
Slovenian: V kliničnem razvoju je bilo zdravilu VEYVONDI izpostavljenih 92 posameznih preiskovancev (80 posameznih preiskovancev z VWB v študijah 070701, 071001 in 071101 ter 12 preiskovancev s hemofilijo A v študiji 071104).
English: Be careful not to touch the clear plastic spike.
Slovenian: Ne dotikajte se prozorne plastične konice.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1298/001
English: What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder.
Slovenian: Izgled zdravila VEYVONDI in vsebina pakiranja Zdravilo VEYVONDI je bel do belkast prašek.
English: VEYVONDI behaves in the same way as endogenous von Willebrand factor.
Slovenian: Zdravilo VEYVONDI se obnaša enako kot endogeni von Willebrandov faktor.
English: The most common post-marketing ADRs reported in association with rVWF/vonicog alfa treatment include “infusion-related reaction” (IRR) clinically manifested by the following symptoms: tachycardia, flushing, rash, dyspnea, and blurred vision.
Slovenian: Najpogostejši neželeni učinki po začetku trženja, ki so bili sporočeni v povezavi z zdravljenjem z rVWF/vonikogom alfa, vključujejo z infuzijo povezano reakcijo (IRR), ki je bila klinično zaznana na podlagi teh simptomov: tahikardija, pordelost, izpuščaj, dispneja in zamegljen vid.
English: This medicine contains 5.2 mg sodium in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial.
Slovenian: To zdravilo vsebuje 5,2 mg natrija v vsaki viali s 650 i.e. ali 10,4 mg natrija v vsaki viali s 1300 i.e.
English: Subsequent doses (as clinically required) are 40 to 50 IU/kg every 8 to 24 hours for minor bleeds as long as deemed clinically necessary and for major bleeds 40 to 60 IU/kg for approximately 2-3 days.
Slovenian: Sledeči odmerki (če so klinično potrebni) znašajo 40 do 50 i.e./kg na vsakih 8 do 24 ur v primeru manjših krvavitev in če je klinično potrebno v primeru večjih krvavitev od 40 do 60 i.e./kg v naslednjih 2 do 3 dneh.
English: It behaves in the same way as natural human von Willebrand factor (VWF) in the body.
Slovenian: V telesu se obnaša na enak način kot naravni humani von Willebrandov faktor (VWF).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1298/002
English: Depending on the patient's baseline FVIII:C levels, a single infusion of rVWF will, in a majority of patients, lead to an increase above 40% in endogenous FVIII:C activity within 6 hours and will result in sustaining this level up to 72 hours post infusion.
Slovenian: Pri večini bolnikov, odvisno od bolnikovih izhodiščnih ravni FVIII:C, eno infundiranje rVWF v 6 urah zviša endogeno aktivnost FVIII:C nad 40 % in ohranja to raven do 72 ur po infundiranju.
English: Fully insert the clear plastic spike into the VEYVONDI vial stopper by firmly pushing straight down.
Slovenian: Popolnoma uvedite prozorno plastično konico v zamašek viale z zdravilom VEYVONDI tako, da jo odločno potisnete naravnost navzdol.
English: The dose depends on VWF and FVIII levels of the patient, the type and severity of the bleeding.
Slovenian: Odmerek je odvisen od bolnikovih ravni VWF in FVIII ter vrste in resnosti krvavitve.
English: Place the VEYVONDI vial on a flat work surface.
Slovenian: Postavite vialo zdravila VEYVONDI na ravno delovno površino.
English: Animal reproduction studies have not been conducted with VEYVONDI.
Slovenian: Študije vpliva zdravila VEYVONDI na razmnoževanje pri živalih niso bile opravljene.
English: Type of Surgery
Slovenian: Vrsta kirurškega posega
English: Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
Slovenian: Med rekonstitucijo uporabljajte antiseptično tehniko (čisti pogoji z nizko ravnijo mikroorganizmov) in ravno delovno površino.
English: The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.
Slovenian: Odmerek je odvisen od bolnikovih ravni VWF in FVIII ter vrste in resnosti predvidene krvavitve.
English: Instructions for Reconstitution and application
Slovenian: Navodila za rekonstitucijo in uporabo
English: Your doctor may test your blood to make sure that you have adequate levels of von Willebrand factor.
Slovenian: Zdravnik bo morda opravil pregled krvi, da bo preveril, ali je raven von Willebrandovega faktorja ustrezna.
English: Be sure to keep the syringe plunger pressed in.
Slovenian: Prepričajte se, da je bat brizge pritisnjen.
English: A subsequent dose of 40 IU to 60 IU/kg of VEYVONDI should be infused every 8 to 24 hours as per the dosing ranges in Table 1, or as long as clinically appropriate.
Slovenian: Naslednji odmerek 40 i.e. do 60 i.e./kg zdravila VEYVONDI je treba infundirati vsakih 8 do 24 ur v skladu z razponi odmerjanja v preglednici 1 ali dokler je klinično primerno.
English: Side effects that have been reported with VEYVONDI that can occur commonly (up to 1 in 10 patients) are: nausea, vomiting, tingling or burning at infusion site, chest discomfort, dizziness, vertigo, blood clots, hot flushes, itching, high blood pressure, muscle twitching, unusual taste, and increased heart rate.
Slovenian: Neželeni učinki, o katerih so poročali pri uporabi zdravila VEYVONDI in ki se lahko pojavijo pogosto (pri 1 od 10 bolnikov), so: siljenje na bruhanje, bruhanje, mravljinčenje ali pekoč občutek na mestu infundiranja, nelagodje v prsnem košu, omotica, vrtoglavica, krvni strdki, navali vročine, srbenje, visok krvni tlak, trzanje mišic, nenavaden okus in zvišan srčni utrip.
English: Surgery PK50 VEYVONDI (Study 071101)
Slovenian: Kirurgija FK50 zdravilo VEYVONDI (študija 071101)
English: Table 6 summarizes the PK of VEYVONDI after 50 IU/kg VWR:RCo (PK50) or 80 IU/kg VWF:RCo (PK80) infusions .
Slovenian: V preglednici 5 je povzeta FK zdravila VEYVONDI po infuzijah 50 i.e./kg VWF:RCo (FK50) ali 80 i.e./kg VWF:RCo (FK80).
English: Treatment of bleeding episodes (On-demand treatment) Dosage and frequency must be individualized based on clinical judgment, taking into account of severity of bleeding episode, site of bleeding, patient's medical history, monitoring of appropriate clinical and laboratory measures (both VWF:RCo and FVIII:C levels).
Slovenian: Odmerjanje in pogostnost je treba po klinični presoji prilagoditi posamezniku glede na resnost krvavitve, mesto krvavitve, bolnikovo anamnezo in spremljanje rezultatov ustreznih kliničnih in laboratorijskih meritev (ravni VWF:RCo in FVIII:C).
English: The rFVIII dose should be calculated according to the difference between the patient's baseline plasma FVIII:C level, and the desired peak FVIII:C level to achieve an appropriate plasma FVIII:C level based on the approximate mean recovery of 0.02 (IU/mL)/(IU/kg).
Slovenian: Odmerek rFVIII je treba izračunati glede na razliko med izhodiščno ravnijo FVIII:C v plazmi bolnika in želeno najvišjo ravnijo FVIII:C ter ob upoštevanju približnega srednjega izkoristka 0,02 (i.e./ml)/(i.e./kg), da se doseže ustrezno koncentracijo FVIII:C v plazmi.