natgillin/translations-raw huggingface dataset:
The filter included in the Mix2Vial device removes those particles completely.
Filter, vključen v pripomočku Mix2Vial, popolnoma odstrani te delce.
Number and Frequency by Subject a
Število in pogostnost po preiskovanc ih a
Table 4 Summary of Adverse Reactions reported in Clinical Trials with VEYVONDI in von Willebrand Disease
Preglednica 4 Povzetek neželenih učinkov, o katerih so poročali iz kliničnih preskušanj z zdravilom VEYVONDI pri von Willebrandovi bolezni
In addition, one post-marketing case of DVT has been reported spontaneously for an elderly patient.
Poleg tega je o GVT spontano poročal starejši bolnik v obdobju trženja.
- VEYVONDI produces delayed correction of the associated factor VIII deficiency.
- Zdravilo VEYVONDI povzroči zakasnjeno izboljšanje povezanega pomanjkanja faktorja VIII.
A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events.
Kombinirana zdravila s FVIII, ki vsebujejo VWF, povečajo tveganje trombotičnih dogodkov.
You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings.
Morda boste za obvladovanje krvavitev potrebovali večji odmerek zdravila VEYVONDI ali faktorja VIII ali celo drugo zdravilo.
Mean (95% CI) SD
povprečje (95-odstotni IZ) SD
Dosing guidelines for treatment of minor and major haemorrhages are provided in Table 1.
Smernice za odmerjanje za zdravljenje manjših in večjih krvavitev so v preglednici 1.
The first dose of VEYVONDI should be 40 to 80 IU/kg body weight.
Prvi odmerek zdravila VEYVONDI mora znašati od 40 do 80 i.e./kg telesne mase.
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).
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).
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).
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).
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.
Zdravilo VEYVONDI se lahko daje nosečnicam le, če je jasno indicirano, ob upoštevanju dejstva, da porod pri teh bolnicah pomeni povečano tveganje za krvavitve.
Fertility The effects of VEYVONDI on fertility have not been established.
Plodnost Učinki zdravila VEYVONDI na plodnost niso znani.
Table 1 Dosing recommendations for the treatment of minor and major haemorrhages
Preglednica 1 Priporočila za odmerjanje za zdravljenje manjših in večjih krvavitev
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.
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.
When coadministration of rVWF and rFVIII is considered necessary, they can be pre-mixed in a single syringe to achieve the appropriate dose.
Če je potrebno sočasno dajanje rVWF in rFVIII, ju lahko predhodno zmešate v eni brizgi in tako dosežete ustrezni odmerek.
Hypersensitivity reactions (including anaphylaxis) may occur.
Lahko se pojavijo preobčutljivostne reakcije (vključno z anafilakso).
If your dose requires multiple syringes, attach and administer each additional syringe of VEYVONDI one at a time.
Če vaš odmerek zahteva več brizg, namestite in uporabite vsako dodatno brizgo zdravila VEYVONDI drugo za drugo.
In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier.
V perfuzijskem modelu človeške placente ex vivo je bilo dokazano, da zdravilo VEYVONDI ne prehaja skozi placento.
Replacement levels of VWF:RCo > 0.6 IU/mL (60%) and FVIII:C > 0.4 IU/mL (40%) should be achieved.
Doseči je treba nadomestne ravni VWF:RCo > 0,6 i.e./ml (60 %) in FVIII:C > 0,4 i.e./ml (40 %).
This is to be taken into consideration by patients on a controlled sodium diet.
To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Iglo izvlecite iz vene in s sterilno gazo nekaj minut pritiskajte na mesto infundiranja.
Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes.
Z zdravilom uporabljajte plastične brizge, saj se beljakovine v zdravilu običajno lepijo na površine steklenih brizg.
Frequency by Subject: Total number of subjects experiencing the AE (related and unrelated) divided by total number of subjects (N) and multiplied by 100.
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.
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.
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.
However, in these cases the initially reconstituted solution of VEYVONDI should not be diluted any further.
Vendar pa v tem primeru prvotno rekonstituirane raztopine zdravila VEYVONDI ne smete dodatno redčiti.
If any of these symptoms occur, stop the infusion immediately and contact your doctor.
Če opazite katerega koli izmed teh simptomov, nemudoma prekinite infundiranje in se posvetujte z zdravnikom.
Allow the rubber stoppers to dry.
Počakajte, da se gumijasti zamašek posuši.
10 Hold the vial with one hand and use the other hand to push all the air from the syringe into the vial.
10 Z eno roko držite vialo in z drugo roko potisnite celotno količino zraka iz brizge v vialo.
- Proceed with the next infusion as scheduled and continue as advised by your doctor.
• Naslednji odmerek infundirajte po razporedu in nadaljujte po navodilu zdravnika.
If the IR is not available, assume an IR of 0.02 IU/mL per IU/kg.
Če IR ni na voljo, predpostavimo vrednost IR 0,02 i.e./ml na i.e./kg.
If recombinant factor VIII has been prescribed, administer recombinant factor VIII within 10 minutes after infusion of VEYVONDI has been completed.
Če vam je zdravnik predpisal rekombinantni faktor VIII, uporabite rekombinantni faktor VIII v 10 minutah po infuziji zdravila VEYVONDI.
Discard after three hours.
Zdravilo zavrzite po treh urah.
Minor
Manjši
The solution in the syringe should not be used if it is cloudy or contains flakes or particles after filtration.
Raztopine v brizgi ne smete uporabiti, če je zdravilo po filtriranju motno ali vsebuje kosmiče ali delce.
What VEYVONDI is and what it is used for
Kaj je zdravilo VEYVONDI in za kaj ga uporabljamo
- Do not mix vonicog alfa with other medicinal products except for rFVIII.
Vonikoga alfa ne mešajte z drugimi zdravili, razen z rFVIII.
During treatment with VEYVONDI the following adverse reactions may occur: Hypersensitivity or allergic reactions, thromboembolic events, inhibitor formation against VWF.
Med zdravljenjem z zdravilom VEYVONDI lahko pride do naslednjih neželenih učinkov: preobčutljivostne ali alergijske reakcije, tromboembolični zapleti, nastanek zaviralcev proti VWF.
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).
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).
Shelf-life after reconstitution:
Rok uporabnosti po rekonstituciji:
You can store the reconstituted product at room temperature not to exceed 25° C for up to three hours.
Rekonstituirano zdravilo lahko hranite največ tri ure pri sobni temperaturi, ki ne presega 25 °C.
Calculation of rVWF dose (to be administered within 1 hour prior to surgery) (IU VWF:RCo required)
Izračun odmerka rVWF (uporabiti v 1 uri pred kirurškim posegom) (potrebna količina i.e. VWF: RCo)
Generally, 1 IU/kg (VWF:RCo/VEYVONDI/vonicog alfa) raises the plasma VWF:RCo by 0.02 IU/mL (2%).
Na splošno 1 i.e./kg (VWF:RCo/VEYVONDI/vonikog alfa) zviša raven VWF:RCo v plazmi za 0,02 i.e. (2 %).
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.
V kliničnih preskušanjih so poročali o enem primeru klinično asimptomatske globoke venske tromboze (GVT) pri preiskovancu iz kirurške študije po popolni zamenjavi kolka.
Initial Dose a
Začetni odmerek a
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.
Za primer morebitne anafilaktične reakcije morajo biti na voljo primerna zdravniška oskrba in ukrepi, zlasti pri bolnikih z anamnezo alergijskih reakcij.
Insert the needle into the vein and remove the tourniquet.
Uvedite iglo v veno in odstranite zažemko.
There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors including low ADAMTS13 levels.
Obstaja tveganje za trombotične dogodke, zlasti pri bolnikih z znanimi klinično ali laboratorijsko opredeljenimi dejavniki tveganja, vključno z nizkimi vrednostmi ADAMTS13.
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.
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.
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).
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).
Treatment of bleeding episodes
Zdravljenje krvavitev
Clinical and compatibility studies were conducted to administer vonicog alfa (human von Willebrand factor) with octocog alfa (human coagulation factor) in the same syringe.
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.
8 Draw air into the empty, sterile disposable plastic syringe by pulling back on the plunger.
8 Zrak povlecite v prazno, sterilno plastično brizgo za enkratno uporabo tako, da povlečete bat.
Do not use after the expiry date stated on the labels and carton.
Zdravila ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli.
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).
rVWF in rFVIII lahko predhodno zmešate v eni brizgi in tako dosežete ustrezni odmerek (za način dajanja glejte poglavje 4.2).
- If your bleeding is not controlled with VEYVONDI, tell your doctor immediately.
- Če krvavitev pri vas z zdravilom VEYVONDI ni obvladana, morate to nemudoma povedati zdravniku.
Every 12-24 hrs / every other day
Vsakih 1224 ur/vsak drugi dan
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.
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.
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.
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.
Slowly infuse VEYVONDI.
Počasi infundirajte zdravilo VEYVONDI.
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.
Če imate prepoznane klinične ali laboratorijske dejavnike tveganja, obstaja tveganje za nastanek trombotičnih dogodkov, zato vas bo zdravnik spremljal za zgodnje znake tromboze.
Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period.
Bolnika je treba ves čas trajanja infundiranja skrbno spremljati in opazovati za pojav morebitnih simptomov.
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.
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.
Do not touch the end of the plastic connector attached to the VEYVONDI vial containing the dissolved product.
Ne dotikajte se konca plastičnega priključka na viali zdravila VEYVONDI, ki vsebuje raztopljeno zdravilo.
The solvent vial now has the Mix2Vial device connected to it and is ready to be connected to the VEYVONDI vial.
Viala z vehiklom je zdaj povezana s pripomočkom Mix2Vial in je pripravljena za priključitev na vialo zdravila VEYVONDI.
12 Do not push and pull solution back and forth between syringe and vial.
12 Ne potiskajte in vlecite raztopine med brizgo in vialo.
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.
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.
If you infuse more VEYVONDI than recommended, tell your doctor as soon as possible.
Če ste infundirali večji odmerek zdravila VEYVONDI, kot je priporočeno, se čimprej posvetujte z zdravnikom.
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.
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.
Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIA
Baxter AG Industriestraße 67 A-1221 Dunaj AVSTRIJA
Within 1 hour prior to surgery, patients should receive a dose of VEYVONDI based on the assessment 3 hours before surgery.
V 1 uri pred kirurškim posegom morajo bolniki prejeti odmerek zdravila VEYVONDI na podlagi ocene 3 ure pred kirurškim posegom.
Frequency of dosing
Pogostnost odmerjanja
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.
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.
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).
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).
After reconstitution, when drawn into the syringe, the solution is clear, colourless in appearance and free from flakes or other foreign particles.
Ko ga po rekonstituciji povlečete v brizgo, je raztopina bistra, na izgled brezbarvna in brez kosmičev ali tujkov.
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.
Če ravni FVIII:C niso v priporočljivem ciljnem območju, se mora odmerek zdravila VEYVONDI samega dati 1 uro pred posegom.
Subsequent infusions
Naslednje infuzije
Marketing Authorisation Holder Baxalta Innovations GmbH Industriestraße 67
Imetnik dovoljenja za promet z zdravilom Baxalta Innovations GmbH Industriestraße 67
When ready to infuse, disconnect the syringe by turning it counterclockwise.
Ko ste pripravljeni za infundiranje, snemite brizgo tako, da jo zavrtite v nasprotni smeri vrtenja urnega kazalca.
Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.
Zdravljenje z zdravilom VEYVONDI bo nadzoroval zdravnik z izkušnjami pri obravnavi bolnikov z von Willebrandovo boleznijo.
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.
Obstaja tveganje za trombotične dogodke, zlasti pri bolnikih z znanimi klinično ali laboratorijsko opredeljenimi dejavniki tveganja za trombozo, vključno z nizkimi vrednostmi ADAMTS13.
If you feel that VEYVONDI is not working well enough, talk to your doctor.
Če imate občutek, da zdravilo VEYVONDI ne učinkuje dovolj, se posvetujte z zdravnikom.
Manufacturer Baxter AG Industriestraße 67 A-1221 Vienna Austria
Izdelovalec Baxter AG Industriestraße 67 A-1221 Dunaj Avstrija
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.
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.
Do not recap the needle.
Na iglo ne nameščajte znova pokrovčka.
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.
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.
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.
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.
No symptoms of overdose with von Willebrand factor have been reported.
O simptomih prevelikega odmerjanja von Willebrandovega faktorja niso poročali.
Grip the package at its edge and lift it off the Mix2Vial device.
Ovojnino primite na robu in jo snemite s pripomočka Mix2Vial.
VEYVONDI contains trace amounts of mouse immunoglobulin G (MuIgG) and Hamster proteins (less than or equal to 2 ng/IU VEYVONDI).
Zdravilo VEYVONDI vsebuje sledi mišjega imunoglobulina G (MuIgG) in hrčkovih beljakovin (manj kot ali enako 2 ng/i.e.
Minor (e.g. epistaxis, oral bleeding, menorrhagia)
Manjša (npr. epistaksa, krvavitev v ustni votlini, menoragija)
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).
Pripravljeno raztopino v brizgi pred uporabo preglejte glede prisotnosti delcev in sprememb barve (raztopina mora biti bistra, brezbarvna in brez delcev).
VEYVONDI contains trace amounts of recombinant coagulation factor VIII.
Zdravilo VEYVONDI vsebuje sledi rekombinantnega koagulacijskega faktorja VIII.
The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO).
Aktivnost ristocetinskega kofaktorja rekombinantnega humanega von Willebrandovega faktorja je bila določena glede na mednarodni standard koncentrata von Willebrandovega faktorja (SZO).
- Use the reconstituted product within 3 hours to avoid the risk of microbial contamination because the product does not contain preservatives.
- Rekonstituirano zdravilo uporabite v 3 urah, da se izognete tveganju mikrobne kontaminacije,
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
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
INFORMATION IN BRAILLE VEYVONDI 650 IU
PODATKI V BRAILLOVI PISAVI VEYVONDI 650 i.e.