FrancophonIA/ELRC3.0 huggingface dataset:
English: Children and adolescents VEYVONDI is not approved for use in children or adolescents below 18 years.
Slovenian: Otroci in mladostniki Uporaba zdravila VEYVONDI pri otrocih in mladostnikih, mlajših od 18 let, ni dovoljena.
English: (IU VWF:RCo/kg body weight)
Slovenian: (i.e. VWF:RCo/kg telesne mase)
English: Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor.
Slovenian: Zdravnik bo opravil preiskave, s katerimi bo preveril, ali je raven von Willebrandovega faktorja ustrezna.
English: Attach the infusion needle to a syringe containing VEYVONDI solution.
Slovenian: Iglo za infundiranje pritrdite na brizgo, ki vsebuje raztopino zdravila VEYVONDI.
English: Other medicines and VEYVONDI Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: - Do not refrigerate the solution after preparation.
Slovenian: - Raztopine po pripravi ne shranjujte v hladilniku.
English: Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Slovenian: Preverite datum izteka roka uporabnosti in poskrbite, da sta prašek VEYVONDI in voda za injekcije (vehikel) pred pripravo ogreta na sobno temperaturo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1300 IU)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (1300 i.e.)
English: VEYVONDI contains sodium
Slovenian: Zdravilo VEYVONDI vsebuje natrij
English: Prevention of bleeding/haemorrhage and treatment in case of elective surgery Assess FVIII:C levels prior to initiation of any surgical procedure.
Slovenian: Preprečevanje krvavitev in zdravljenje v primeru načrtovanega kirurškega posega Ocenite raven FVIII:C pred začetkom vsakega kirurškega posega.
English: Thrombosis and Embolism
Slovenian: Tromboza in embolija
English: There is a possibility of developing hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, rhinoconjunctivitis, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) which may in some cases progress to anaphylaxis (including shock).
Slovenian: Obstaja možnost pojava preobčutljivostnih ali alergijskih reakcij (vključno z angioedemom, pekočim občutkom in zbadanjem na mestu infundiranja, mrzlico, pordelostjo, rinokonjunktivitisom, generalizirano urtikarijo, glavobolom, koprivnico, hipotenzijo, letargijo, navzeo, nemirnostjo, tahikardijo, tiščanjem v prsih, ščemenjem, bruhanjem in piskanjem v pljučih), ki lahko v nekaterih primerih napredujejo do anafilaksije (vključno s šokom).
English: Shaking will adversely affect the product.
Slovenian: Stresanje bo negativno vplivalo na zdravilo.
English: Specific activity: approx. 110 IU VWF:RCo/mg protein
Slovenian: Specifična aktivnost: približno 110 i.e. VWF:RCo/mg beljakovin
English: Patients with VWD, especially Type 3, may develop neutralising antibodies (inhibitors) to von Willebrand factor.
Slovenian: Pri bolnikih z VWB, zlasti tipa 3, se lahko pojavijo nevtralizirajoča protitelesa (zaviralci) proti von Willebrandovemu faktorju.
English: Because of this, administration of VEYVONDI restores the FVIII:C level to normal as a secondary effect after the first infusion Administration of the FVIII:C rises above 40% within 6 hours and peaks within 24 hours in a majority of patients, depending on the baseline FVIII:C level.
Slovenian: Po prvi infuziji se raven FVIII:C v 6 urah dvigne nad 40 % in doseže vrh v 24 urah pri večini bolnikov, odvisno od izhodiščne ravni FVIII:C.
English: Use in children and adolescents VEYVONDI is not approved for use in children and adolescents below 18 years.
Slovenian: Uporaba pri otrocih in mladostnikih Uporaba zdravila VEYVONDI pri otrocih in mladostnikih, mlajših od 18 let, ni dovoljena.
English: - Do not use this medicine after the expiry date which is stated on the label after EXP.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: After the initiation of the surgical procedure, the VWF:RCo and FVIII:C plasma levels should be monitored and the intra- and post-operative substitution regimen should be individualised according to the PK results, intensity and duration of the haemostatic challenge, and the institution's standard of care.
Slovenian: Po začetku kirurškega posega moramo spremljati ravni VWF:RCo in FVIII:C v plazmi ter shemo med- in pooperativnega nadomeščanja prilagoditi posameznemu bolniku glede na rezultate FK, intenzivnost in trajanje hemostatskega problema ter standarda oskrbe v ustanovi.
English: aIf rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions.
Slovenian: aČe se daje rFVIII, glejte navodilo za rekonstitucijo in uporabo v navodilu za uporabo zdravila z rFVIII.
English: After 72 hours post surgery
Slovenian: Po 72 urah po kirurškem posegu
English: Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
Slovenian: Dodatni odmerki rFVIII bodo morda potrebni za doseganje priporočene ciljne najvišje ravni FVIII:C v plazmi.
English: Your doctor should inform you about early signs of severe allergic reactions such as increased heart rate, rash, hives, wheals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness in the chest, fast heartbeat, stuffy nose, red eyes,general feeling of being unwell, and dizziness.
Slovenian: Zato vas mora zdravnik poučiti o zgodnjih znakih hudih alergijskih reakcij, med katere sodijo pospešeno bitje srca, izpuščaj, koprivnica, gnojni mehurčki, srbenje po celem telesu, otekanje ustnic in jezika, težave z dihanjem, piskanje v pljučih, tiščanje v prsnem košu, hitro bitje srca, zamašen nos, pordele oči, splošno slabo počutje in omotica.
English: To ensure pre-operative endogenous FVIII levels of at least 0.4 IU/mL for minor and oral and 0.8 IU/mL for major surgery, a dose of 40-60 IU/kg VEYVONDI may be administered 12-24 hours (pre-operative dose) prior to initiating elective surgery.
Slovenian: Za zagotavljanje predoperativnih endogenih ravni FVIII (vsaj 0,4 i.e./ml pri manjših in oralnih kirurških posegih in 0,8 i.e./ml pri večjih kirurških posegih) se lahko uporabi odmerek zdravila VEYVONDI 40-60 i.e./kg 12-24 ur pred začetkom izbirnega kirurškega posega (predoperativni odmerek).
English: Please refer to Table 3 for treatment recommendations for subsequent maintenance doses.
Slovenian: Glejte priporočila glede nadaljnjih vzdrževalnih odmerkov v preglednici 3.
English: VEYVONDI should be administered with recombinant factor VIII if the FVIII:C levels are < 40%, or are unknown, to control bleeding.
Slovenian: Za obvladovanje krvavitev je treba zdravilo VEYVONDI dajati z rekombinantnim faktorjem VIII, če so ravni FVIII:C < 40 % ali niso znane.
English: Phase 3 PK50 VEYVONDI (Study 071001)
Slovenian: Faza 3 FK50 zdravilo VEYVONDI (študija 071001)
English: Draw the VEYVONDI into the syringe by pulling plunger back slowly.
Slovenian: Povlecite zdravilo VEYVONDI v brizgo tako, da počasi povlečete bat.
English: How to use VEYVONDI
Slovenian: Kako uporabljati zdravilo VEYVONDI
English: Do not remove butterfly needle until all syringes have been infused and do not touch the Luer port that connects to the syringe.
Slovenian: Ne odstranite igle z metuljčkom, dokler ne infundirate vsebine vseh brizg.
English: Calculating dose: VEYVONDI dose [IU] = dose [IU/kg] x weight [kg]
Slovenian: Izračun odmerka: Odmerek zdravila VEYVONDI [i.e.] = odmerek [i.e./kg] x telesna masa [kg]
English: If your FVIII level is inadequate your doctor may give you a dose of 40-60 IU/kg VEYVONDI 12-24 hours (pre-operative dose) prior to initiating elective surgery in order to raise FVIII levels to the target level (0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery).
Slovenian: Če vaša raven FVIII ni zadostna, lahko prejmete odmerek zdravila VEYVONDI 4060 i.e./kg 12-24 ur pred začetkom izbirnega kirurškega posega (predoperativni odmerek), da se bodo vaše ravni zvišale na ciljne vrednosti (0,4 i.e./ml za manjše in vsaj 0,8 i.e./ml za večje kirurške posege).
English: 9 Leaving the VEYVONDI vial (containing the dissolved product) on your flat work surface, connect the syringe to the clear plastic connector by attaching and turning the syringe clockwise.
Slovenian: 9 Vialo zdravila VEYVONDI (ki vsebuje raztopljeno zdravilo) položite na ravno delovno površino, priključite brizgo na prozorni plastični konektor tako, da brizgo namestite in zavrtite v smeri vrtenja urnega kazalca.
English: ANNEX II
Slovenian: Preglednica 2
English: Δ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo cIR = Incremental Recovery as measured in the subject.
Slovenian: Δ = Ciljna najvišja raven VWF:RCo v plazmi - izhodiščna raven VWF:RCo v plazmi c IR = postopna povrnitev aktivnosti (incremental recovery), kot je izmerjena pri preiskovancu.
English: Do not stop using VEYVONDI without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo VEYVONDI Uporabe zdravila VEYVONDI ne smete prekiniti brez posvetovanja z zdravnikom.
English: Calculating dose VEYVONDI dose [IU] = dose [IU/kg] x weight [kg]
Slovenian: Izračun odmerka Odmerek zdravila VEYVONDI [i.e.] = odmerek [i.e./kg] x telesna masa [kg]
English: Up to 72 hours post surgery
Slovenian: Do 72 ur po kirurškem posegu
English: If the FVIII:C levels are not at the recommended target levels, rFVIII should be administered in addition to vonicog alfa to raise VWF:RCo and FVIII:C. Please refer to (Table 2) for FVIII:C recommended target levels.
Slovenian: Če ravni FVIII:C niso v priporočljivem ciljnem območju, moramo vonikog alfa dati skupaj z rFVIII, da zvišamo ravni VWF:RCo in FVIII:C. Glejte priporočljive ciljne ravni FVIII:C v preglednici 2.
English: Patients and/or their caregivers should be informed of the early signs of hypersensitivity reactions, which may include but are not limited to tachycardia, tightness of the chest, wheezing and/or acute respiratory distress, hypotension, generalised urticaria, pruritus, rhinoconjunctivitis, angioedema, lethargy, nausea, vomiting, paresthesia, restlessness, and may progress to anaphylactic shock.
Slovenian: Bolnike in/ali njihove negovalce moramo obvestiti o zgodnjih znakih preobčutljivostnih reakcij, ki lahko vključujejo med drugim tahikardijo, tiščanje v prsih, piskanje in/ali akutno respiratorno stisko, hipotenzijo, generalizirano urtikarijo, pruritus, rinokonjunktivitis, angioedem, letargijo, navzeo, bruhanje, parestezijo, nemir in ki lahko napredujejo v anafilaktični šok.
English: Steps
Slovenian: Koraki
English: 4 Turn the package with the Mix2Vial device upside down and place it over the top of the solvent vial.
Slovenian: 4 Pakiranje s pripomočkom Mix2Vial obrnite na glavo in ga poveznite preko zgornjega dela viale z vehiklom.
English: 5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI concentrate.
Slovenian: 5 Če želite vialo z vehiklom povezati z vialo zdravila VEYVONDI, obrnite vialo vehikla in jo namestite na vrh viale, ki vsebuje koncentrat VEYVONDI.
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial, 1 vial with solvent (5 mL), 1 Mix2Vial device
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje Vsebina: 1 viala s praškom, 1 viala z vehiklom (5 ml), 1 pripomoček Mix2Vial
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje Vsebina: 1 viala s praškom, 1 viala z vehiklom (10 ml), 1 pripomoček Mix2Vial
English: c a Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
Slovenian: c a Dodatni odmerki rFVIII bodo morda potrebni za doseganje priporočene ciljne najvišje ravni FVIII:C v plazmi.
English: Excipients: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80, and water for injections.
Slovenian: Pomožne snovi: natrijev citrat, glicin, trehaloza dihidrat, manitol, polisorbat 80 in voda za injekcije.
English: 1 Remove the caps from the VEYVONDI powder and solvent vials to expose the center of the rubber stoppers.
Slovenian: 1 Snemite pokrovček s praška VEYVONDI in viale z vehiklom, da razkrijete osrednji del gumijastih zamaškov.
English: 11 Flip connected syringe and VEYVONDI vial so the vial is on top.
Slovenian: 11 Nameščeno brizgo in vialo zdravila VEYVONDI obrnite tako, da je viala na vrhu.
English: 1 IU/mL
Slovenian: 1 i.e./ml
English: During and After Surgery
Slovenian: Med kirurškim posegom in po njem
English: In patients with inadequate levels of FVIII, a dose of 40-60 IU/kg VEYVONDI should be administered 12-24 hours prior to initiating elective surgery (pre-operative dose), to ensure preoperative endogenous FVIII levels of at least 0.4 IU/mL for minor and at least 0.8 IU/mL for major surgery.
Slovenian: Bolnikom z nezadostnimi ravnmi FVIII je treba dati odmerek zdravila VEYVONDI 40-60 i.e./kg 1224 ur pred začetkom izbirnega kirurškega posega (predoperativni odmerek), da se zagotovi predoperativne ravni endogenega FVIII (vsaj 0,4 i.e./ml pri manjših kirurških posegih in 0,8 i.e./ml pri večjih kirurških posegih).
English: If the patient's baseline plasma FVIII:C level is < 40% or is unknown and in all situations where a rapid correction of haemostasis should be achieved, such as treatment of an acute haemorrhage, severe trauma or emergency surgery, it is necessary to administer a recombinant factor VIII product with the first infusion of VEYVONDI, in order to achieve a haemostatic plasma level of FVIII:C.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika, vrste in resnosti krvavitve ter ravni VWF:RCo in FVIII:C. Če je bolnikova izhodiščna raven FVIII:C v plazmi < 40 % ali neznana in v vseh primerih, v katerih je treba hitro popraviti hemostazo, kot je zdravljenje akutne krvavitve ali hude poškodbe ali nujen kirurški poseg, je treba s prvo infuzijo zdravila VEYVONDI uporabiti zdravilo z rekombinantnim faktorjem VIII, da se doseže hemostatska raven FVIII:C v plazmi.
English: Turn the blue plastic side counterclockwise and gently pull the two vials apart.
Slovenian: Modri plastični del zavrtite v nasprotni smeri vrtenja urnega kazalca in previdno povlecite viali narazen.
English: 5 To connect the solvent vial to the VEYVONDI vial, turn the solvent vial over and place it on top of the vial containing VEYVONDI powder.
Slovenian: 5 Če želite vialo z vehiklom povezati z vialo zdravila VEYVONDI, obrnite vialo vehikla in jo namestite na vrh viale, ki vsebuje prašek VEYVONDI.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (650 IU)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (650 i.e.)
English: Reconstituted product should not be refrigerated.
Slovenian: Rekonstituiranega zdravila ne shranjujte v hladilniku.
English: Ensure that the VEYVONDI powder vial and the Sterilised Water for Injections (solvent) are at room temperature prior to preparation.
Slovenian: Poskrbite, da se viala s praškom VEYVONDI in sterilizirana voda za injekcije (vehikel) pred pripravo ogrejeta na sobno temperaturo.
English: 40 to 50 IU/kg every 8 to 24 hours (or as long as deemed clinically necessary)
Slovenian: od 40 do 50 i.e./kg od 40 do 50 i.e/kg vsakih 8 do 24 ur (ali dokler je klinično primerno)
English: Place the needle, syringe, and empty VEYVONDI and solvent vial(s) in a hard-walled sharps container for proper disposal.
Slovenian: Iglo, brizgo in prazne viale zdravila VEYVONDI in vehikla pravilno odstranite tako, da jih odložite v posodo za ostre predmete s trdno steno.
English: If you stop using VEYVONDI
Slovenian: Če ste pozabili uporabiti zdravilo VEYVONDI
English: The solvent will flow into the VEYVONDI vial by vacuum.
Slovenian: Vakuum bo posesal vehikel v vialo zdravila VEYVONDI.
English: Thromboembolic events may occur in case of major overdose.
Slovenian: V primeru skrajno visokega odmerjanja se lahko pojavijo tromboembolični dogodki.
English: There may be a risk of developing blood clots (thrombosis) in case of an accidental high dose.
Slovenian: V primeru nenamernega velikega odmerka se lahko pojavi tveganje za nastanek krvnih strdkov (tromboze).
English: VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
Slovenian: VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje Vsaka viala praška vsebuje nominalno 650 mednarodnih enot (i.e.) vonikoga alfa.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja generaliziran pruritus pogosti
English: • Use the reconstitution steps above (2 to 8) to prepare the additional vial of VEYVONDI using a fresh Mix2Vial device for each vial.
Slovenian: • Z uporabo drugega pripomočka Mix2Vial za vsako vialo pripravite dodatno vialo zdravila VEYVONDI po zgornjih korakih rekonstitucije (2 do 8).
English: VWF:RCo Target Peak Plasma Level
Slovenian: VWF:RCo v plazmi
English: VEYVONDI 650 IU powder and solvent for solution for injection VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa
Slovenian: VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa
English: Patients developing inhibitors
Slovenian: Bolniki, pri katerih se pojavijo zaviralci
English: The product contains only trace amounts of human recombinant coagulation factor VIII (≤ 0.01 IU FVIII / IU VWF: RCo) as determined using the European Pharmacopoeia chromogenic assay for factor VIII (FVIII).
Slovenian: Zdravilo vsebuje le sledi humanega rekombinantnega koagulacijskega faktorja VIII (≤ 0,01 i.e. FVIII/i.e.
English: Firmly insert the blue plastic spike of the device into the center of the solvent vial stopper by pushing straight down.
Slovenian: Uvedite modro plastično konico pripomočka v sredino zamaška viale z vehiklom tako, da jo odločno potisnete naravnost navzdol.
English: Dosing guidance should be done based on the IR. b Δ = Target peak plasma VWF:RCo - baseline plasma VWF:RCo IR = Incremental Recovery as measured in the subject.
Slovenian: Navodila za odmerjanje morajo temeljiti na IR. b Δ = Ciljna najvišja raven VWF:RCo v plazmi - izhodiščna raven VWF:RCo v plazmi c
English: For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery.
Slovenian: Preprečevanje krvavitev pri izbirnih kirurških posegih Za preprečevanje čezmerne krvavitve bo zdravnik ocenil vrednosti FVIII:C v 3 urah pred kirurškim posegom.
English: VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa.
Slovenian: VEYVONDI 1300 i.e. prašek in vehikel za raztopino za injiciranje Vsaka viala praška vsebuje nominalno 1300 mednarodnih enot (i.e.) vonikoga alfa.
English: It is unknown whether VEYVONDI is excreted in human milk.Therefore, VEYVONDI should be administered to lactating von Willebrand factor deficient women only if clearly indicated.
Slovenian: Zato je treba zdravilo VEYVONDI dajati doječim materam s pomanjkanjem von Willebrandovega faktorja le, če je jasno indicirano.
English: Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Slovenian: Vonikog alfa je prečiščen rekombinantni humani von Willebrandov faktor (rVWF).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for VEYVONDI
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo VEYVONDI voda za injekcije
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 650 IU powder vonicog alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE VEYVONDI 650 i.e. prašek vonikog alfa i.v.
English: 40 to 60 IU/kg every 8 to 24 hours for approximately 23 days (or as long as deemed clinically necessary)
Slovenian: od 50 do 80 i.e./kg od 40 do 60 i.e/kg vsakih 8 do 24 ur približno 2-3 dni (ali dokler je klinično primerno)
English: 1 vial contains1300 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 10 mL Water for Injections
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 viala vsebuje 1300 i.e. vonikoga alfa, približno 130 i.e./ml po rekonstituciji z 10 ml vode za injekcije
English: NOTE: When pushing air into a second vial of VEYVONDI to be pooled into a syringe, position the vial and connected syringe so that the vial is on top.
Slovenian: OPOMBA: Ko potisnete zrak v drugo vialo zdravila VEYVONDI, ki jo želite združiti v brizgo, namestite vialo in nameščeno brizgo tako, da je viala na vrhu.
English: Do not refrigerate after reconstitution.
Slovenian: Zdravila po rekonstituciji ne shranjujte v hladilniku.
English: If the FVIII:C levels are not at the recommended target levels, rFVIII should be administered in addition to vonicog alfa to raise VWF:RCo and FVIII:C, within 1 hour prior to the procedure.
Slovenian: Če ravni FVIII:C niso v priporočljivem ciljnem območju, moramo v 1 uri pred posegom vonikog alfa dati skupaj z rFVIII, da zvišamo ravni VWF:RCo in FVIII:C. Glejte priporočljive ciljne ravni FVIII:C v preglednici 2.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 1300 IU powder vonicog alfa
Slovenian: IME ZDRAVILA IN POT(I) UPORABE VEYVONDI 1300 i.e. prašek vonikog alfa i.v.
English: It is not uncommon for a few flakes or particles to remain in the product vial after reconstitution.
Slovenian: Občasno v viali z zdravilom po rekonstituciji ostane nekaj kosmičev ali delcev.
English: Table 2 VWF:RCo and FVIII:C Target Levels Recommended Target Peak Plasma Levels of VWF:RCo and FVIII:C be Achieved Prior to Surgery for the Prevention of Excessive Bleeding During and After Surgery
Slovenian: Ciljne ravni VWF:RCo in FVIII:C Priporočene ciljne najvišje ravni VWF:RCo in FVIII:C v plazmi, ki jih je treba doseči pred kirurškim posegom, da se prepreči čezmerno krvavitev med posegom in po njem
English: Trehalose dihydrate Mannitol
Slovenian: Prašek natrijev citrat glicin trehaloza dihidrat manitol polisorbat 80
English: You must stop the infusion and contact your doctor immediately if you have any of the following early symptoms of severe allergic reactions: - rash or hives, itching all over the body, - tightness of the throat, chest pain or chest tightness, - difficulty breathing, light headedness, fast heartbeat, - dizziness, nausea or fainting.
Slovenian: Če opazite katerega koli izmed naslednjih zgodnjih simptomov hudih alergijskih reakcij, prekinite infundiranje in se nemudoma posvetujte z zdravnikom: - izpuščaj ali koprivnica, srbenje po celem telesu, - tiščanje v grlu, bolečine v prsnem košu ali tiščanje v prsnem košu, - težave z dihanjem, omotica, pospešen srčni utrip, - omotica, siljenje na bruhanje ali omedlevica.
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Slovenian: VEYVONDI 650 i.e. prašek in vehikel za raztopino za injiciranje vonikog alfa (rekombinantni humani von Willebrandov faktor)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL LABEL
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: VEYVONDI is a recombinant human von Willebrand factor (rVWF).
Slovenian: Zdravilo VEYVONDI je rekombinantni humani von Willebrandov faktor (rVWF).
English: Do not increase the total dose of VEYVONDI to control your bleeding without consulting your doctor.
Slovenian: Brez posveta z zdravnikom ne povečujte skupnega odmerka zdravila VEYVONDI za obvladovanje krvavitev.
English: Minimum Duration of treatment
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA