FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: Ako je bolesnikova početna razina FVIII:C u plazmi < 40% ili je nepoznata te u svim situacijama kada je potrebno postići brzu korekciju hemostaze, kao što je liječenje akutnog krvarenja, teška trauma ili hitni kirurški zahvat, nužno je primijeniti lijek s rekombinantnim faktorom VIII s prvom infuzijom lijeka VEYVONDI, kako bi se postigla hemostatska razina FVIII:C u plazmi.
English: 40 to 50 IU/kg
Croatian: 40 do 50 IU/kg
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.
Croatian: Ako se ne postignu očekivane razine (VWF:RCo) u plazmi ili ako se krvarenje ne može kontrolirati primjenom odgovarajuće doze, potrebno je napraviti odgovarajuće ispitivanje kako bi se utvrdilo je li prisutan inhibitor von Willebrandova faktora.
English: FVIII products may contain varying amounts of VWF.
Croatian: Lijekovi koji imaju FVIII mogu sadržavati promjenjive količine VWF-a.
English: 10 Hold the vial with one hand and use the other hand to push all the air from the syringe into the vial.
Croatian: 10 Držite bočicu jednom rukom, a drugom rukom istisnite cijelu količinu zraka iz štrcaljke u bočicu.
English: (e.g. severe or refractory epistaxis, menorrhagia, gastrointestinal bleeding, central nervous system trauma, haemarthrosis, or traumatic haemorrhage)
Croatian: (npr. teška ili refraktorna epistaksa, menoragija, gastrointestinalno krvarenje, trauma središnjeg živčanog sustava, hemartroza ili traumatsko krvarenje)
English: If you stop using VEYVONDI
Croatian: Ako prestanete primjenjivati VEYVONDI
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.
Croatian: U bolesnika kojima je potrebna učestala doza lijeka VEYVONDI u kombinaciji s rekombinantnim faktorom VIII, plazmatske razine FVIII:C aktivnosti trebaju se pratiti kako bi se izbjegle neprekinute prekomjerne razine FVIII:C u plazmi koje mogu povećati rizik od trombotskih događaja.
English: INFORMATION IN BRAILLE VEYVONDI 1300 IU
Croatian: 16. PODACI NA BRAILLEOVOM PISMU VEYVONDI 1300 IU
English: No symptoms of overdose with von Willebrand factor have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja von Willebrandovim faktorom.
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.
Croatian: Imunogenost lijeka VEYVONDI procijenjena je u kliničkim ispitivanjima praćenjem razvoja neutralizirajućih antitijela na VWF-a i FVIII, kao i vezujućih antitijela na VWF-a, furin, protein stanica jajnika kineskog hrčka (CHO) i mišji IgG-a.
English: 72 hours Every 12-24 hrs / every other day
Croatian: 72 sata Svakih 12 - 24 h / svaki drugi dan
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.
Croatian: 7 Razdvojite dvije strane uređaja Mix2Vial držeći jednom rukom prozirnu plastičnu stranu uređaja Mix2Vial spojenu na bočicu s lijekom VEYVONDI, a drugom rukom plavu plastičnu stranu uređaja Mix2Vial spojenu na bočicu s otapalom.
English: • Leave the syringe attached to the vial until an additional vial is prepared.
Croatian: • Ostavite štrcaljku spojenu na bočicu dok ne pripremite sljedeću bočicu.
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.
Croatian: Naknadne doze (prema kliničkoj potrebi) su 40 do 50 IU/kg svakih 8 do 24 sata za manja krvarenja ili dok god se smatra klinički potrebnim te za veća krvarenja 40 do 60 IU/kg za približno 2 do 3 dana.
English: VEYVONDI contains sodium
Croatian: VEYVONDI sadrži natrij
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).
Croatian: Farmakokinetika (PK) lijeka VEYVONDI bila je utvrđena u tri klinička ispitivanja procjenom razina VWF:RCo, antigena von Willebrandova faktora (VWF:Ag) i aktivnosti von Willebrandova kolagenskog vezivanja (VWF:CB) u plazmi.
English: INFORMATION IN BRAILLE VEYVONDI 650 IU
Croatian: 16. PODACI NA BRAILLEOVOM PISMU VEYVONDI 650 IU
English: Children and adolescents VEYVONDI is not approved for use in children or adolescents below 18 years.
Croatian: Djeca i adolescenti VEYVONDI nije odobren za primjenu u djece ili adolescenata mlađih od 18 godina.
English: VEYVONDI is usually infused into a vein (intravenously) by your doctor or nurse.
Croatian: VEYVONDI će obično Vaš liječnik ili medicinska sestra infuzijom primijeniti u venu (intravenski).
English: Administration of von Willebrand factor (VWF) allows for correction of von Willebrand factor deficiency.
Croatian: Primjena von Willebrandova faktora (VWF) omogućuje korekciju nedostatka Willebrandova faktora.
English: Treatment of von Willebrand disease (VWD) should be supervised by a physician experienced in the treatment of haemostatic disorders.
Croatian: Liječenje von Willebrandove bolesti (VWD) treba provoditi pod nadzorom liječnika koji ima iskustva u liječenju hemostatskih poremećaja.
English: The specific activity of VEYVONDI is approximately 110 IU VWF:RCo/mg protein.
Croatian: Specifična aktivnost lijeka VEYVONDI je otprilike 110 IU VWF:RCo/mg proteina.
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.
Croatian: U slučaju velikog krvarenja ili većih operacija koje zahtijevaju opetovane, česte infuzije, preporučuje se praćenje razina FVIII:C kako bi se odlučilo je li rFVIII potreban za naknadne infuzije kako bi se izbjeglo pretjerano povišenje razina FVIII:C.
English: However, in these cases the initially reconstituted solution of VEYVONDI should not be diluted any further.
Croatian: No, u takvim se slučajevima inicijalno rekonstituirana otopina lijeka VEYVONDI ne smije dodatno razrjeđivati.
English: Your doctor will perform tests to make sure that you have adequate levels of von Willebrand factor.
Croatian: Vaš će liječnik provesti odgovarajuće laboratorijske pretrage kako bi bio siguran da imate dovoljne razine von Willebrandova faktora.
English: Place the VEYVONDI vial on a flat work surface.
Croatian: Stavite bočicu VEYVONDI na ravnu radnu površinu.
English: Specific activity: approx. 110 IU VWF:RCo/mg protein
Croatian: Specifična aktivnost: približno 110 IU VWF:RCo/mg proteina
English: The dose and duration of the treatment depend on the clinical status of the patient, the type and severity of the bleeding, and both VWF:RCo and FVIII:C levels.
Croatian: Doza i trajanje liječenja ovise o kliničkom statusu bolesnika, vrsti i težini krvarenja i razinama VWF:RCo i FVIII:C.
English: Thrombolism and embolism
Croatian: Tromboza i embolija
English: Patients with von Willebrand disease, especially Type 3, may very rarely develop neutralising antibodies (inhibitors) to von Willebrand factor.
Croatian: Bolesnici s von Willebrandovom bolešću, posebno tipa 3, mogu vrlo rijetko razviti neutralizirajuća antitijela (inhibitore) na von Willebrandov faktor.
English: If the IR is not available, assume an IR of 0.02 IU/mL per IU/kg.
Croatian: Ako IR nije dostupan, uzmite IR od 0,02 IU/ml po IU/kg.
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestraße 67
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Baxalta Innovations GmbH Industriestraße 67
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.
Croatian: Za manje krvarenje (npr. krvarenje iz nosa, iz usta, menoragija), svaka početna doza obično iznosi 40 do 50 IU/kg te za veće krvarenje (npr. teško krvarenje nosa ili krvarenje iz nosa koje ne odgovara na uobičajeno liječenje, menoragija, gastrointestinalno krvarenje, trauma središnjeg živčanog sustava, hemartroza (krvarenje u zglobovima) ili traumatsko krvarenje), svaka početna doza je 50 do 80 IU/kg.
English: VEYVONDI behaves in the same way as endogenous von Willebrand factor.
Croatian: VEYVONDI se ponaša jednako kao i endogeni von Willebrandov faktor.
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
Croatian: Vaš će liječnik izračunati Vašu dozu lijeka VEYVONDI (u međunarodnim jedinicama ili IU) ovisno o: - tjelesnoj težini, - mjestu krvarenja - intenzitetu krvarenja, - Vašem zdravstvenom stanju, - potrebnom kirurškom zahvatu - razini aktivnosti VWF-a u Vašoj krvi nakon kirurškog zahvata - težini Vaše bolesti
English: The ristocetin cofactor activity of recombinant human von Willebrand factor was determined against the International Standard for von Willebrand factor concentrate (WHO).
Croatian: Aktivnost kofaktora ristocetina za rekombinantni ljudski von Willebrandov faktor utvrđena je prema međunarodnom standardu za koncentrat von Willebrandovog faktora (WHO).
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).
Croatian: Lijek sadrži rekombinantni ljudski koagulacijski VIII samo u tragovima (≤ 0.01 IU FVIII / IU VWF: RCo) kako je određeno pomoću kromogenog testa za faktor VIII (FVIII) prema Europskoj farmakopeji.
English: 40 to 50 IU/kg every 8 to 24 hours (or as long as deemed clinically necessary)
Croatian: 40 do 50 IU/kg svakih 8 do 24 sata (ili dok god se smatra klinički potrebnim)
English: It is manufactured by recombinant DNA (rDNA) technology in the Chinese Hamster Ovary (CHO) cell line without the addition of any exogenous human-or animal-derived protein in the cell culture process, purification or final formulation.
Croatian: Chinese hamster ovary, CHO) bez dodavanja bilo kakvih egzogenih proteina ljudskog ili životinjskog podrijetla tijekom postupka kultiviranja stanica, pročišćavanja ili konačne formulacije.
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.
Croatian: Doziranje i učestalost primjene moraju se odrediti na temelju kliničke procjene i na temelju tjelesne težine bolesnika, vrsti i težini epizode krvarenja / kirurške intervencije i na temelju praćenja odgovarajućih kliničkih i laboratorijskih parametara.
English: This should be done right away to keep the liquid free of germs.
Croatian: To odmah treba napraviti kako bi se tekućina zaštitila od mikroorganizama.
English: Use in children and adolescents VEYVONDI is not approved for use in children and adolescents below 18 years.
Croatian: Primjena u djece i adolescenata VEYVONDI nije odobren za primjenu u djece i adolescenata mlađih od 18 godina.
English: When ready to infuse, disconnect the syringe by turning it counterclockwise.
Croatian: Ako ste spremni za infuziju, odvojite štrcaljku okretanjem u smjeru suprotnom od kazaljke na satu.
English: Every 12-24 hrs / every other day
Croatian: Svakih 12 - 24 h / svaki drugi dan
English: In case large volumes of VEYVONDI are required, it is possible to pool two vials of VEYVONDI together.
Croatian: U slučaju ako su potrebne velike količine lijeka VEYVONDI, moguće je zajedno povući sadržaj dvije bočice lijeka VEYVONDI.
English: 13 If you need more than one vial of VEYVONDI to make up your dose:
Croatian: 13 Ako je za dozu potrebno više od jedne bočice lijeka VEYVONDI:
English: The contents of each reconstituted product of VEYVONDI can be drawn in a single syringe.
Croatian: Sadržaj pojedinačnih bočica s rekonstituiranim lijekom VEYVONDI može se uvući u jednu štrcaljku.
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.
Croatian: Najčešća nuspojava nakon stavljanja lijeka u promet prijavljena vezano uz liječenje s rVWF/vonikogom alfa uključuju „reakciju povezanu s infuzijom“ (IRR) koja se klinički manifestira sljedećim simptomima: tahikardija, navala crvenila, osip, dispneja i zamućeni vid.
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.
Croatian: No, ako hitno povišenje FVIII:C nije potrebno ili ako je početna razina FVIII:C dovoljna za osiguranje hemostaze, liječnik može donijeti odluku o izostavljanju istodobne primjene rFVIII pri prvoj infuziji lijeka VEYVONDI.
English: Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes.
Croatian: S ovim lijekom koristite plastične štrcaljke jer se proteini iz ovog lijeka mogu zalijepiti na površinu staklenih štrcaljki.
English: Within 1 hour prior to surgery, you will receive a dose of VEYVONDI based on the assessment 3 hours before surgery.
Croatian: Unutar 1 sata prije kirurškog zahvata, primit ćete dozu lijeka VEYVONDI na temelju procjene provedene 3 sata prije kirurškog zahvata.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1300 IU)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (1300 IU)
English: Patients with VWD, especially Type 3, may develop neutralising antibodies (inhibitors) to von Willebrand factor.
Croatian: Bolesnici s VWD-om, posebno tipa 3, mogu razviti neutralizirajuća antitijela (inhibitore) na von Willebrandov faktor.
English: This should be taken into consideration if you are on a controlled sodium diet.
Croatian: To se mora uzeti u obzir ako ste na prehrani s ograničenjem unosa natrija.
English: Do not recap the needle.
Croatian: Na iglu nemojte vraćati kapicu.
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.
Croatian: Ako razine FVIII:C nisu pri preporučenim ciljnim vrijednostima, dozu lijeka VEYVONDI samog treba primijeniti unutar 1 sata prije zahvata.
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors including low ADAMTS13 levels.
Croatian: Postoji opasnost od pojave trombotskih događaja, posebno u bolesnika s poznatim kliničkim ili laboratorijskim čimbenicima rizika uključujući niske razine ADAMTS13.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (650 IU)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (650 IU)
English: This medicine contains 5.2 mg sodium in each 650 IU vial or 10.4 mg sodium in each 1300 IU vial.
Croatian: Ovaj lijek sadrži 5,2 mg natrija u svakoj bočici sa 650 IU ili 10,4 mg natrija u svakoj bočici sa 1300 IU.
English: Prior to Surgery:
Croatian: Prije kirurškog zahvata:
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).
Croatian: Postavite podvez i pripremite mjesto infuzije tako da kožu dobro obrišete sterilnim alkoholnim tupferom (ili drugom odgovarajućom sterilnom otopinom koju preporučuje
English: Animal reproduction studies have not been conducted with VEYVONDI.
Croatian: Nisu provedena ispitivanja utjecaja na reprodukciju životinja za lijek VEYVONDI.
English: Your treatment with VEYVONDI will be supervised by a doctor who is experienced in the care of patients with von Willebrand disease.
Croatian: Liječenje lijekom VEYVONDI nadgledat će liječnik koji ima iskustva u liječenju bolesnika s von Willebrandovom bolešću.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva Generalizirani pruritus
English: Within 1 hour prior to surgery, patients should receive a dose of VEYVONDI based on the assessment 3 hours before surgery.
Croatian: Unutar 1 sata prije kirurškog zahvata, pacijenti će primiti dozu lijeka VEYVONDI na temelju procjene 3 sata prije kirurškog zahvata.
English: - Use plastic syringes with this product because proteins in the product tend to stick to the surface of glass syringes.
Croatian: - S ovim lijekom koristite plastične štrcaljke jer se proteini iz ovog lijeka mogu zalijepiti na površinu staklenih štrcaljki.
English: Additional rFVIII may be required to attain the recommended FVIII:C target peak plasma levels.
Croatian: Možda će biti potreban dodatni rFVIII za postizanje preporučenih ciljnih vršnih razina FVIII:C u plazmi.
English: Other medicines and VEYVONDI Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
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.
Croatian: Postoji opasnost od pojave trombotskih događaja, posebno u bolesnika s poznatim kliničkim ili laboratorijskim čimbenicima rizika za trombozu, uključujući niske razine ADAMTS13.
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.
Croatian: 6 Lagano i neprekidno kružite spojenim bočicama ili ostavite rekonstituirani lijek da stoji 5 minuta, a zatim lagano kružite kako bi se prašak potpuno otopio.
English: • Use the reconstitution steps above (2 to 8) to prepare the additional vial of VEYVONDI using a fresh Mix2Vial device for each vial.
Croatian: • Pomoću prethodnih koraka za rekonstituciju (2 do 8) pripremite sljedeću bočicu lijeka VEYVONDI pomoću novog Mix2Vial uređaja za svaku bočicu.
English: Allow the rubber stoppers to dry.
Croatian: Pričekajte da se čepovi osuše.
English: - Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
Croatian: - Upotrijebite antiseptičku tehniku (čisti uvjeti s malim brojem mikroorganizama) i ravnu radnu površinu tijekom postupka rekonstitucije.
English: Place the vials on a flat surface.
Croatian: Stavite bočice na ravnu površinu.
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.
Croatian: Ako se primjenom lijeka VEYVONDI ne postignu očekivane razine VWF-a ili faktora VIII u plazmi, a na temelju rezultata pretrage prema zahtjevu liječnika, ili ako se krvarenje ne može odgovarajuće kontrolirati, to može biti zbog prisutnosti antitijela na VWF-a ili na faktor VIII.
English: Allow the rubber stopper to dry.
Croatian: Pričekajte da se čep osuši.
English: The solvent vial now has the Mix2Vial device connected to it and is ready to be connected to the VEYVONDI vial.
Croatian: Na bočicu s otapalom sada je spojen uređaj Mix2Vial i spremna je za spajanje na bočicu s lijekom VEYVONDI.
English: Subsequent Dose
Croatian: Naknadna doza
English: The potency of VWF (IU) is measured using the European Pharmacopeia ristocetin cofactor activity assay (VWF: RCo).
Croatian: Potentnost VWF-a (IU) mjeri se pomoću testa za aktivnost kofaktora ristocetina (VWF: RCo) prema Europskoj farmakopeji.
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).
Croatian: Liječenje epizoda krvarenja (liječenje prema potrebi) Doziranje i učestalost moraju se individualizirati na temelju kliničke procjene, uzevši u obzir težinu krvarenja, mjesto krvarenja, povijest bolesti bolesnika, praćenje odgovarajućih kliničkih i laboratorijskih parametara (razine VWF:RCo i FVIII:C).
English: Do not use if the vacuum has been lost and the solvent does not flow into the VEYVONDI vial.
Croatian: Ne koristite ako je vakuum nestao i ako otapalo ne otječe u bočicu s lijekom VEYVONDI.
English: Driving and using machines VEYVONDI is not likely to affect your ability to drive and use machines.
Croatian: VEYVONDI vrlo vjerojatno neće utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Morate prekinuti infuziju i odmah kontaktirati svojeg liječnika ako se pojavi neki od sljedećih ranih simptoma teških alergijskih reakcija: - osip ili koprivnjača, svrbež po cijelom tijelu, - stezanje u grlu, bol ili stezanje u prsištu, - otežano disanje, ošamućenost, brzi otkucaji srca - omaglica, mučnina ili nesvjestica.
English: Calculating dose VEYVONDI dose [IU] = dose [IU/kg] x weight [kg]
Croatian: Izračun doze Doza lijeka VEYVONDI [IU] = doza [IU/kg] x težina [kg]
English: The recommended minimum target levels are 0.4 IU/mL for minor and oral surgery and 0.8 IU/mL for major surgery.
Croatian: Preporučene minimalne ciljane razine su 0,4 IU/ml za manje i oralne kirurške zahvate i 0,8 IU/ml za veće kirurške zahvate.
English: Insert the needle into the vein and remove the tourniquet.
Croatian: Umetnite iglu u venu i uklonite podvez.
English: Pharmacotherapeutic group: Antihaemorrhagics: blood coagulation factor von Willebrand factor.
Croatian: Farmakoterapijska skupina: Antihemoragici: von Willebrandov faktor koagulacije.
English: VEYVONDI should be administered with recombinant factor VIII if the FVIII:C levels are < 40%, or are unknown, to control bleeding.
Croatian: VEYVONDI treba primijeniti s rekombinantnim faktorom VIII ako su razine FVIII:C <40% ili su nepoznate, kako bi se kontroliralo krvarenje.
English: • Use the reconstitution steps above (2 to 8) to prepare the additional vial of VEYVONDI using a fresh Mix2Vial for each vial 14 The contents of two vials may be drawn into a single syringe.
Croatian: • Pomoću prethodnih koraka za rekonstituciju (2 do 8) pripremite sljedeću bočicu lijeka VEYVONDI pomoću novog Mix2Vial uređaja za svaku bočicu 14 Sadržaj dvije bočice može se uvući u jednu štrcaljku.