FrancophonIA/ELRC3.0 huggingface dataset:
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.
Croatian: To odgovara 2,2 % maksimalnog dnevnog unosa natrija prema preporukama za odraslu osobu, pod pretpostavkom da je masa tijela 70 kg, a doza 80 IU/kg tjelesne mase.
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: 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: Minor (e.g. epistaxis, oral bleeding, menorrhagia)
Croatian: Manje (npr. epistaksa, krvarenje usne šupljine, menoragija)
English: Do not touch the end of the plastic connector attached to the VEYVONDI vial containing the dissolved product.
Croatian: Ne dodirujte kraj plastičnog priključka pričvrščenog na bočicu VEYVONDI koja sadrži otopljeni lijek.
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.
Croatian: Ako razine FVIII:C nisu pri preporučenim ciljnim razinama, rFVIII treba primijeniti kao dodatak vonikogu alfa kako bi se povisile razine VWF:RCo i FVIII:C, unutar 1 sat prije postupka.
English: 4 Turn the package with the Mix2Vial device upside down and place it over the top of the solvent vial.
Croatian: 4 Okrenite pakiranje s uređajem Mix2Vial naopako i postavite ga iznad vrha bočice s otapalom.
English: Turn the blue plastic side counterclockwise and gently pull the two vials apart.
Croatian: Okrenite plavu plastičnu stranu u smjeru suprotnom od kretanja kazaljke na satu i lagano razdvojite dvije bočice.
English: 40 to 60 IU/kg every 8 to 24 hours for approximately 23 days (or as long as deemed clinically necessary)
Croatian: 40 do 60 IU/kg svakih 8 do 24 sata oko 2 - 3 dana (ili dok god se smatra klinički potrebnim)
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).
Croatian: Postoji opasnost razvoja preosjetljivosti ili alergijskih reakcija (koje mogu uključivati angioedem, pečenje i žarenje na mjestu infuzije, zimicu, navale crvenila, rinokonjunktivitis, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) koje u nekim slučajevima mogu napredovati do anafilaksije (uključujući šok).
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.
Croatian: Liječnik Vas treba upoznati s ranim znakovima teških alergijskih reakcija kao što su brži otkucaji srca, osip, koprivnjača, urtike, svrbež po cijelom tijelu, oticanje usana i jezika, otežano disanje, piskanje pri disanju, stezanje u prsima, brz srčani ritam, začepljen nos, crvene oči, opće loše osjećanje i omaglica.
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.
Croatian: To odgovara 2,2 % maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu, pod pretpostavkom da je masa tijela 70 kg, a doza 80 IU/kg tjelesne mase.
English: Firmly insert the blue plastic spike of the device into the center of the solvent vial stopper by pushing straight down.
Croatian: Čvrsto umetnite plavi plastični šiljak uređaja u središte čepa bočice s otapalom tako da ga gurnete ravno prema dolje.
English: Frequency Category by Subject
Croatian: Kategorija učestalosti po ispitaniku
English: VEYVONDI is indicated in adults (age 18 and older) with von Willebrand Disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or not indicated for the - Treatment of haemorrhage and surgical bleeding - Prevention of surgical bleeding.
Croatian: VEYVONDI je indiciran u odraslih (u dobi od 18 i više godina) s von Willebrandovom bolešću (VWD) kada liječenje samo desmopresinom (DDAVP) nije učinkovito ili nije indicirano za liječenje:
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.
Croatian: Nuspojave koje su prijavljene za lijek VEYVONDI koje se mogu pojaviti često (u do 1 na 10 bolesnika): mučnina, povraćanje, trnci ili pečenje na mjestu infuzije, nelagoda u prsištu, omaglica, vrtoglavica, krvni ugrušci, navale vrućine, svrbež, visok krvni tlak, trzanje mišića, neobičan okus i ubrzani otkucaji srca.
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.
Croatian: Za osiguranje preoperativnih endogenih razina FVIII od barem 0,4 IU/ml za manje i oralne i 0,8 IU/ml za veće kirurške zahvate doza od 40 - 60 IU/kg lijeka VEYVONDI može se primijeniti 12 - 24 sata (preoperativna doza) prije započinjanja elektivnog kirurškog zahvata.
English: Initial Dose a
Croatian: Početna doza a
English: No interactions of human von Willebrand factor products with other medicinal products are known.
Croatian: Nisu poznate interakcije lijekova koji sadrže ljudski von Willebrandov faktor s drugim lijekovima.
English: Place the needle, syringe, and empty VEYVONDI and solvent vial(s) in a hard-walled sharps container for proper disposal.
Croatian: Iglu, štrcaljku i praznu(e) bočicu(e) lijeka VEYVONDI i otapala stavite u spremnik za oštre predmete s tvrdim stijenkama za pravilno zbrinjavanje.
English: Table 1 Dosing recommendations for the treatment of minor and major haemorrhages
Croatian: Tablica 1 Preporuke za doziranje pri liječenju manjih i većih krvarenja
English: Electrocardiogram T wave inversion
Croatian: Inverzija T vala na elektrokardiogramu
English: The mean duration of infusion was 16.5 minutes (SD ± 3.51 minutes) for 50 IU/kg (PK50) and 11.8 minutes (± 2.86 minutes) for 80 IU/kg VWF:RCo (PK80).
Croatian: Tablica 5 sažima PK lijeka VEYVONDI nakon infuzije 50 IU/kg VWF:RCo (PK50) ili 80 IU/kg VWF:RCo (PK80) . Srednja vrijednost infuzije iznosila je 16,5 minuta (SD ± 3,51 minuta) za 50 IU/kg (PK50) i 11,8 minuta (± 2,86 minuta) za 80 IU/kg VWF:RCo (PK80).
English: Attach the infusion needle to a syringe containing VEYVONDI solution.
Croatian: Spojite infuzijsku iglu na štrcaljku koja sadrži otopinu lijeka VEYVONDI.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for VEYVONDI
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za VEYVONDI
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).
Croatian: Ako vaša razina FVIII, nije odgovarajuća vaš liječnik vam može dati dozu od 4060 IU/kg lijeka VEYVONDI 12 - 24 sata (preoperativna doza) prije započinjanja elektivnog kirurškog zahvata kako bi povisio endogene razine FVIII na ciljnu razinu (0,4 IU/ml za manji i barem 0,8 IU/ml za veći kirurški zahvat).
English: Therefore, any FVIII product that would be administered in combination with VEYVONDI should be a pure FVIII product.
Croatian: Stoga svaki lijek koji sadrži FVIII, a koji se primjenjuje u kombinaciji s lijekom VEYVONDI treba biti čist FVIII lijek.
English: Phase 1 PK50 VEYVONDI with octocog alfag
Croatian: Parametar PK50 faze 1 VEYVONDI i oktokog alfa g
English: Heart rate increased
Croatian: Povećana srčana frekvencija
English: Inspect the syringe visually for particulate matter; the solution in the syringe should be clear.
Croatian: Štrcaljku treba pregledati kako biste provjerili sadrži li strane čestice; otopina u štrcaljki treba biti prozirna.
English: For prevention of excessive bleeding your doctor will assess the FVIII:C levels within 3 hours before surgery.
Croatian: Vaš liječnik će procijeniti razine FVIII:C unutar 3 sata prije kirurškog zahvata.
English: Table 1 Dosing recommendations for the treatment of Minor and Major Haemorrhages
Croatian: Tablica 1: Preporuke za doziranje pri liječenju manjih i većih krvarenja
English: 1 vial contains1300 IU vonicog alfa, approx. 130 IU/mL after reconstitution with 10 mL Water for Injections
Croatian: 1 bočica sadrži 1300 IU vonikoga alfa, otprilike 130 IU/ml nakon rekonstitucije s 10 ml vode za injekcije
English: VEYVONDI 650 IU powder and solvent for solution for injection VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa
Croatian: VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju vonikog alfa
English: 11 Flip connected syringe and VEYVONDI vial so the vial is on top.
Croatian: 11 Okrenite spojenu štrcaljku i bočicu s lijekom VEYVONDI kako bi bočica bila na vrhu.
English: Fully insert the clear plastic spike into the VEYVONDI vial stopper by firmly pushing straight down.
Croatian: Do kraja umetnite prozirni plastični šiljak u čep bočice VEYVONDI tako da ga čvrsto gurnete ravno prema dolje.
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.
Croatian: Pri potiskivanju zraka u drugu bočicu lijeka VEYVONDI za uvlačenje u štrcaljku, usmjerite bočicu i spojenu štrcaljku tako da bočica bude na vrhu.
English: Instructions for Reconstitution and application
Croatian: Upute za rekonstituciju i primjenu
English: Major
Croatian: Veće
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.
Croatian: 2 Dezinficirajte svaki čep zasebnim sterilnim alkoholnim tupferima (ili drugom odgovarajućom sterilnom otopinom koju preporučuje
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS POWDER VIAL LABEL
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S PRAŠKOM
English: 1 Remove the caps from the VEYVONDI powder and solvent vials to expose the center of the rubber stoppers.
Croatian: 1 Skinite zatvarače s bočica VEYVONDI praška i otapala kako biste oslobodili središnji dio gumenih čepova.
English: Please refer to Table 2 for FVIII:C recommended target levels.
Croatian: Pogledajte Tablicu 2 za preporučene ciljne doze FVIII:C.
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.
Croatian: U bolesnika s neodgovarajućim razinama FVIII, doza od 40 do 60 IU/kg lijeka VEYVONDI treba se primijeniti 12 do 24 sata prije početka elektivnog kirurškog zahvata (predoperativna doza) kako bi se osigurale preoperativne razine endogenog FVIII ili barem 0,4 IU/ml za manji i najmanje 0,8 IU/ml za veći kirurški zahvat.
English: General Instructions - Check the expiry date, and ensure that the VEYVONDI powder and water for injections (solvent) are at room temperature prior to preparation.
Croatian: Opće upute - Provjerite rok valjanosti i osigurajte da su VEYVONDI prašak i voda za injekciju (otapalo) na sobnoj temperaturi prije pripreme.
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.
Croatian: Bolesnike i/ili njihove skrbnike treba informirati o ranim znakovima reakcija preosjetljivosti koje uključuju, između ostalog, tahikardiju, stezanje u prsima, piskanje pri disanju i/ili akutni respiratorni distres, hipotenziju, generaliziranu urtikariju, pruritus, rinokonjunktivitis, angioedem, letargiju, mučninu, povraćanje, paresteziju, nemir, a mogu napredovati u anafilaktički šok.
English: Store in the original package in order to protect from light
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti
English: Prevention of bleeding in case of elective surgery
Croatian: Sprečavanje krvarenja u slučaju elektivnog kirurškog zahvata:
English: VEYVONDI 1300 IU powder and solvent for solution for injection.
Croatian: VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju.
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 individualized according to the PK results, intensity and duration of the haemostatic challenge, and the institution's standard of care.
Croatian: Nakon započinjanja kirurškog zahvata, razine VWF:RCo i FVIII:C u plazmi trebaju se nadzirati, potrebno je individualizirati intraoperativni i postoperativni režim nadoknade u skladu s PK rezultatima, intenzitetom i trajanjem hemostatskog izazova i standardnom skrbi ustanove.
English: The dose depends on VWF and FVIII levels of the patient, the type and severity of the bleeding.
Croatian: Doza ovisi o razinama VWF i FVIII u pacijenta, vrsti i ozbiljnosti krvarenja.
English: aIf rFVIII is administered, see rFVIII package insert for reconstitution and administration instructions.
Croatian: Ako se primjenjuje rFVIII, pogledati rFVIII uputu o rekonstituciji i primjeni lijeka.
English: Name and address of the manufacturers responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Baxter AG
English: This is to be taken into consideration by patients on a controlled sodium diet.
Croatian: To je potrebno uzeti u obzir kod bolesnika na prehrani s ograničenjem unosa natrija.
English: The dose depends on VWF and FVIII levels of the patient, the type and severity of the expected bleeding.
Croatian: Doza ovisi o VWF i FVIII razinama pacijenta, vrsti i ozbiljnosti očekivanog krvarenja.
English: Administer a subsequent dose of 40 IU to 60 IU/kg of VEYVONDI infused every 8 to 24 hours as per the dosing ranges in Table 1, as long as clinically required.
Croatian: Primijenite naknadnu dozu od 40 IU do 60 IU/kg lijeka VEYVONDI infuzijom svakih 8 do 24 sata prema rasponima doze iz Tablice 1, dok god je to klinički potrebno.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1298/001
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.
Croatian: Naknadnu dozu od 40 IU do 60 IU/kg lijeka VEYVONDI treba infuzijom primijeniti svakih 8 do 24 sata prema rasponima doze iz Tablice 1 ili dok god je to klinički primjereno.
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.
Croatian: Stoga VEYVONDI treba primijeniti u dojilja s nedostatkom von Willebrandova faktora samo ako je to jasno indicirano.
English: - Keep the vial in the outer carton in order to protect from light.
Croatian: - Bočicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: How to use VEYVONDI
Croatian: Kako primjenjivati VEYVONDI
English: Be sure to keep the syringe plunger pressed in.
Croatian: Klip štrcaljke trebate držati pritisnutim.
English: Any FVIII that would be administered along with VEYVONDI should be a pure FVIII product.
Croatian: Svaki lijek koji sadrži FVIII, a koji se primjenjuje u kombinaciji s lijekom VEYVONDI treba biti čist FVIII lijek.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 650 IU powder vonicog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VEYVONDI 650 IU prašak vonikog alfa
English: VEYVONDI is a recombinant human von Willebrand factor (rVWF).
Croatian: VEYVONDI je rekombinantni ljudski von Willebrandov faktor (rVWF).
English: VWF:RCo Target Peak Plasma Level
Croatian: VWF:RCo Ciljna najniža razina u plazmi
English: What VEYVONDI looks like and contents of the pack VEYVONDI is a white to off-white powder.
Croatian: VEYVONDI je prašak bijele do bjelkaste boje.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (10 mL)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICU NA BOČICI S OTAPALOM (10 ml)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION VEYVONDI 1300 IU powder vonicog alfa
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA VEYVONDI 1300 IU prašak vonikog alfa
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).
Croatian: Pripremljenu otopinu u štrcaljki pregledajte prije primjene kako biste isključili prisutnost bilo kakvih stranih čestica ili promjenu boje (otopina treba biti bistra, bezbojna i bez vidljivih čestica).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1298/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/18/1298/002
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.
Croatian: Primjena FVIII:C diže razinu iznad 40% u roku od 6 sati i doseže vršnu vrijednost u roku od 24 sata u većine bolesnika, ovisno o početnoj razini FVIII:C.
English: VEYVONDI 1300 IU powder and solvent for solution for injection Each vial of powder contains nominally 1300 International Units (IU) vonicog alfa.
Croatian: VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju Svaka bočica praška nominalno sadrži 1300 međunarodnih jedinica (IU) vonikoga alfa.
English: The patient should be observed for any immediate reaction.
Croatian: Bolesnika treba pratiti kako bi se uočila pojava svake rane reakcije.
English: What you need to know before you use VEYVONDI 3.
Croatian: Što je VEYVONDI i za što se koristi Što morate znati prije nego počnete primjenjivati VEYVONDI Kako primjenjivati VEYVONDI Moguće nuspojave
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.
Croatian: 9 Bočicu s lijekom VEYVONDI (koja sadrži otopljeni lijek) ostavite na ravnoj radnoj površini, a štrcaljku spojite na prozirni plastični priključak spajanjem i okretanjem štrcaljke u smjeru kazaljke na satu.
English: Excipients: Sodium citrate, glycine, trehalose dihydrate, mannitol, polysorbate 80 and water for injections.
Croatian: Pomoćne tvari: natrijev citrat, glicin, trehaloza dihidrat, manitol, polisorbat 80 i voda za injekcije.
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
Croatian: OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju Sadržaj: 1 bočica s praškom, 1 bočica s otapalom (5 ml), 1 Mix2Vial uređaj
English: VEYVONDI 650 IU powder and solvent for solution for injection Each vial of powder contains nominally 650 International Units (IU) vonicog alfa.
Croatian: VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju Jedna bočica praška nominalno sadrži 650 međunarodnih jedinica (IU) vonikoga alfa.
English: VEYVONDI contains the active substance vonicog alfa, which is a recombinant human von Willebrand factor (rVWF).
Croatian: VEYVONDI sadrži djelatnu tvar vonikog alfa, a to je rekombinantni ljudski von Willebrandov faktor (rVWF).
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.
Croatian: Da biste spojili bočicu otapala na bočicu s lijekom VEYVONDI, okrenite bočicu otapala i postavite je na vrh bočice koja sadrži VEYVONDI koncentrat.
English: Inspect the syringe visually for particulate matter; the solution should be clear and colourless.
Croatian: Štrcaljku treba pregledati kako biste provjerili sadrži li strane čestice; otopina treba biti bistra i bezbojna.
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
Croatian: Tablica 2: Ciljne razine VWF:RCo i FVIII:C Preporučene ciljne vršne plazmatske razine VWF:RCo i FVIII:C koje treba postići prije kirurškog zahvata za sprečavanje prekomjernog krvarenja tijekom i nakon kirurškog zahvata
English: PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection Contents: 1 powder vial , 1 vial with solvent (10ml), 1 Mix2Vial device
Croatian: OBLIK I SADRŽAJ Prašak i otapalo za otopinu za injekciju Sadržaj: 1 bočica s praškom, 1 bočica s otapalom (10 ml),, 1 Mix2Vial uređaj
English: 9 Leaving the VEYVONDI vial (containing the reconsituted product) on your flat work surface, connect the syringe to the clear plastic connector and turning the syringe clockwise.
Croatian: 9 Bočicu s lijekom VEYVONDI (koja sadrži rekonstituirani lijek) ostavite na ravnoj radnoj površini, a štrcaljku spojite na prozirni plastični priključak i okrenite štrcaljku u smjeru kazaljke na satu.
English: Vonicog alfa is a purified recombinant human von Willebrand factor (rVWF).
Croatian: Vonikog alfa je pročišćen rekombinantni ljudski von Willebrandov faktor (rVWF).
English: Inhibitors (antibodies) against the VWF may occur in some patients receiving the medicine.These inhibitors, especially at high levels, could cause the treatment to stop working properly.
Croatian: Inhibitori (antitijela) koji djeluju protiv VWF-a mogu se javiti u nekih bolesnika koji primaju lijek.
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 1300 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Croatian: VEYVONDI 1300 IU prašak i otapalo za otopinu za injekciju vonikog alfa (rekombinantni ljudski von Willebrandov faktor)
English: Always use this medicine exactly as your doctor has told you.
Croatian: Ako primijenite više lijeka VEYVONDI nego što ste trebali Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: NAME OF THE MEDICINAL PRODUCT VEYVONDI 650 IU powder and solvent for solution for injection vonicog alfa (recombinant human von Willebrand factor)
Croatian: VEYVONDI 650 IU prašak i otapalo za otopinu za injekciju vonikog alfa (rekombinantni ljudski von Willebrandov faktor)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT VIAL LABEL (5mL)
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA BOČICI S OTAPALOM (5 ml)
English: Cardiac disorders
Croatian: Srčani poremećaji Tahikardija