FrancophonIA/ELRC3.0 huggingface dataset:
English: Allergic reactions may include the following symptoms: Swollen face, tongue, mouth or throat, difficulty in breathing and swallowing, hives, wheezing, burning and stinging where the infusion was given, chills, flushing, skin rash over the whole body, headache, fall in blood pressure, restlessness, faster heart beat, tightness of the chest (including chest pain and chest discomfort), back pain, tiredness (lethargy), nausea, vomiting, tingling.
Croatian: Alergijske reakcije mogu uključivati sljedeće simptome: otečeno lice, jezik, usta ili grlo, otežano disanje i gutanje, koprivnjača, piskanje, pečenje i bockanje na mjestu infuzije, zimica, navale crvenila, osip po koži po cijelom tijelu,
English: CSL Behring s.r.o.
Croatian: Česká republika CSL Behring s.r.o.
English: Keep vials in the outer carton in order to protect from light.
Croatian: Bočice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Izraženija hemartroza, krvarenje u mišiće ili hematom
English: (h*IU/mL) MRT (h)
Croatian: (h*IU/mL) MRT
English: One pack with 500 IU/1200 IU or 1000 IU/2400 IU containing: - 1 vial with powder - 1 vial with 10 ml water for injections - 1 filter transfer device 20/20 - One inner box containing:
Croatian: Jedno pakiranje od 500 IU/1200 IU ili 1000 IU/2400 IU sadrži: - 1 bočicu s praškom - 1 bočicu s 10 ml vode za injekcije - 1 sustav za prijenos s filterom 20/20
English: 1000 IU FVIII and 2400 IU VWF per vial; after reconstitution with 10 ml of water for injection approx. 100 IU/ml FVIII and 240 IU/ml VWF.
Croatian: 1000 IU FVIII i 2400 IU VWF po bočici; nakon pripreme za primjenu s 10 ml vode za injekcije približno 100 IU/ml FVIII i 240 IU/ml VWF.
English: Treatment of VWD and haemophilia A should be supervised by a physician experienced in the treatment of haemostatic disorders.
Croatian: Liječenje von Willebrandove bolesti i hemofilije A treba nadzirati liječnik iskusan u liječenju hemostatskih poremećaja.
English: Do not shake.
Croatian: Nemojte tresti bočicu.
English: Voncento is supplied as a white powder and solvent for solution for injection/infusion.
Croatian: Voncento se isporučuje u obliku bijelog praška i s vodom za injekcije/infuziju.
English: Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package!
Croatian: Nemojte vaditi Mix2Vial iz blister pakiranja!
English: The risk of thromboembolic events cannot be excluded in case of major overdose, especially in patients with VWD.
Croatian: Rizik od tromboembolijskih događaja ne može se isključiti u slučaju teškog predoziranja posebice u bolesnika s von Willebrandovom bolešću.
English: Hypersensitivity or allergic reactions, thromboembolic events, pyrexia, headache, dysgeusia and abnormal liver function test levels.
Croatian: Tijekom liječenja Voncentom mogu se pojaviti sljedeće nuspojave: preosjetljivost ili alergijske reakcije, tromboembolijski događaji, pireksija, glavobolja, disgeuzija i odstupanja u rezultatima testova jetrene funkcije.
English: Degree of haemorrhage / Type of surgical procedure
Croatian: Stupanj krvarenja/tip kirurškog zahvata
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, posebice u mlađih bolesnika, mogu biti potrebni kraći intervali ili više doze.
English: If you stop using Voncento Do not stop using Voncento without consulting your doctor.
Croatian: Voncento bez savjetovanja s liječnikom.
English: The pharmacokinetics of Voncento have been evaluated in haemophilia A patients in the non-bleeding state.
Croatian: Voncenta procijenjena je u bolesnika s hemofilijom A u stanju bez krvarenja.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Croatian: Bacite bočicu s otapalom s pričvršćenim plavim nastavkom Mix2Vial.
English: When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. After 24 - 48 hours of treatment, in order to avoid an excessive rise in FVIII:C, reduced doses and/or prolongation of the dose interval or the use of a VWF product containing a low level of FVIII should be considered.
Croatian: Nakon 24-48 sati liječenja, kako bi se izbjegao prekomjerni porast u FVIII:C, potrebno je razmotriti smanjenje doze i/ili produljenje intervala doziranja ili uporabu lijeka s VWF koji sadrži niske razine FVIII.
English: Presentations with 250 IU FVIII / 600 IU VWF (5 ml solvent) and 500 IU FVIII / 1200 VWF IU (5 ml solvent): contain up to 14.75 mg (0.64 mmol) sodium per vial, equivalent to 0.74% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Pakiranje lijeka od 250 IU FVIII / 600 IU VWF (5 ml otapala) i 500 IU FVIII / 1200 IU VWF (5 ml otapala): sadrži do 14,75 mg (0.64 mmol) natrija po bočici, što odgovara 0,74 % maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
English: 5.2 Pharmacokinetic properties von Willebrand disease
Croatian: 5.2 Farmakokinetička svojstva
English: Тел: +359 2 850 8617
Croatian: Новимед Фарма EООД Тел: +359 2 850 8617
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Croatian: Dok je bočica s lijekom u uspravnom položaju, spojite štrcaljku na navojni spoj (luer lock) kompleta Mix2Vial navijanjem u smjeru kazaljke na satu.
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Croatian: • testiranje svake donacije i udružene plazme na znakove prisutnosti virusa/infekcija, • uključivanje postupaka deaktivacije ili uklanjanja virusa iz krvi ili plazme prilikom obrade.
English: After filtering or withdrawal (see below) the solution should be checked by eye, before it is used.
Croatian: Nakon filtriranja/izvlačenja (vidjeti u nastavku)
English: Baseline-adjusted initial PK parameters of FVIII:C in subjects <6 (N=15) and 6-12 years old (N=16) FVIII:C
Croatian: Inicijalni PK parametri FVIII:C prilagođeni za početnu vrijednost među ispitanicima <6 (N=15) i 6-12
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 500 IU/1200 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija 500 IU/1200 IU
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 250 IU/600 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija 250 IU/600 IU
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Croatian: Unatoč tome, mogućnost prijenosa infektivnih agensa lijekovima dobivenim iz ljudske krvi ili plazme ne može se u potpunosti isključiti.
English: 2 alcohol swabs
Croatian: 2 jastučića od vate natopljena alkoholom
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: 13. BROJ SERIJE<OZNAKE DONACIJE I PROIZVODA>
English: The presentations 500 IU FVIII /1200 IU VWF (10 ml solvent) and 1000 IU FVIII /2400 IU VWF (10 ml solvent) contain up to 29.50 mg sodium per vial (main component of cooking/table salt).
Croatian: Pakiranja 500 IU FVIII /1200 IU VWF (10 ml otapala) i 1000 IU FVIII / 2400 IU VWF (10 ml otapala) sadrže do 29,50 mg natrija po bočici (glavni sastojak kuhinjske soli).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 1000 IU/2400 IU
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija 1000 IU/2400 IU
English: - 1000 IU* human coagulation factor VIII** (FVIII).
Croatian: - 1000 IU* ljudskog koagulacijskog faktora VIII** (FVIII).
English: Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion Voncento 500 IU FVIII / 1200 IU VWF(10 ml solvent) powder and solvent for solution for injection/infusion Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII, human von Willebrand factor
Croatian: Voncento 250 IU FVIII / 600 IU VWF (5 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 500 IU FVIII / 1200 VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 500 IU FVIII / 1200 VWF (5 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 1000 IU FVIII / 2400 VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju humani faktor zgrušavanja VIII, humani von Willebrandov faktor
English: Presentations with 500 IU FVIII / 1200 IU VWF (10 ml solvent) and 1000 IU FVIII / 2400 IU VWF (10 ml solvent): contain up to 29.50 mg (1.28 mmol) sodium per vial, equivalent to 1.48% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Pakiranje lijeka od 500 IU FVIII / 1200 IU VWF (10 ml otapala) i 1000 IU FVIII / 2400 IU VWF (10 ml otapala): sadrži do 29,50 mg (1,28 mmol) natrija po bočici, što odgovara 1,48 % maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
English: In some cases shorter dose intervals or higher doses may be necessary.
Croatian: U nekim slučajevima bi mogli biti potrebni kraći razmaci doziranja ili veće doze.
English: Powder and solvent for solution for injection/infusion.
Croatian: Prašak i otapalo za otopinu za injekciju/infuziju.
English: When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. After 24 - 48 hours of treatment, in order to avoid an excessive rise in FVIII:C, reduced doses and/or prolongation of the dose interval or the use of a VWF product containing a low level of FVIII should be considered (see section 5.2).
Croatian: Nakon 24-48 sati liječenja, kako bi se izbjegao prekomjerni porast u FVIII:C, potrebno je razmotriti smanjenje doze i/ili produljenje intervala doziranja ili uporabu lijeka s VWF koji sadrži niske razine FVIII (vidjeti dio
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Croatian: Lagano okrećite bočicu s lijekom s pričvršćenim prozirnim nastavkom sve dok se prašak potpuno ne otopi.
English: 500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
Croatian: 500 IU FVIII i 1200 IU VWF po bočici; nakon pripreme za primjenu s 5 ml vode za injekcije približno
English: - 500 IU* human coagulation factor VIII** (FVIII).
Croatian: - 500 IU* ljudskog koagulacijskog faktora VIII** (FVIII).
English: Repeat infusion every 8 - 24 hours until threat is resolved.
Croatian: Ponovite infuziju svakih 8 - 24
English: • Abnormal liver function test
Croatian: Odstupanja u rezultatima testova jetrene funkcije
English: - 250 IU* human coagulation factor VIII** (FVIII).
Croatian: - 250 IU* ljudskog koagulacijskog faktora VIII** (FVIII).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 10 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici za otapalo 10 ml
English: What Voncento is and what it is used for What you need to know before you use Voncento How to use Voncento
Croatian: Što morate znati prije nego počnete primjenjivati Voncento Kako primjenjivati Voncento
English: Paediatric population von Willebrand disease
Croatian: Pedijatrijska populacija s Von Willebrandovom bolesti
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Croatian: 2. Bočicu s otapalom stavite na ravnu, čistu površinu i čvrsto je uhvatite.
English: Attach the syringe to the threaded, locking end of the venipuncture kit.
Croatian: Pričvrstite štrcaljku na navojni, blokadni kraj kompleta za venepunkciju.
English: 1 vial with 10 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočica s 10 ml vode za injekcije 1 sustav za prijenos s filterom 20/20
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Croatian: 1 bočica s 5 ml vode za injekcije 1 sustav za prijenos s filterom 20/20
English: - 600 IU*** human von Willebrand factor** (VWF).
Croatian: - 600 IU*** ljudskog von Willebrandova faktora** (VWF).
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: 5 ml otapala u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem (aluminij).
English: 10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Croatian: 10 ml otapala u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem (aluminij).
English: CSL Behring S.A. Tél: + 33 -(0)-1 53 58 54 00
Croatian: Tél: + 33 -(0)-1 53 58 54 00
English: AM Mangion Ltd. Tel: +356 2397 6333
Croatian: Tel: +356 2397 6333
English: • von Willebrand disease
Croatian: • Von Willebrandova bolest
English: Haemorrhage
Croatian: Sljedivost
English: - 1200 IU*** human von Willebrand factor** (VWF).
Croatian: - 1200 IU*** ljudskog von Willebrandova faktora** (VWF).
English: - 2400 IU*** human von Willebrand factor** (VWF).
Croatian: - 2400 IU*** ljudskog von Willebrandova faktora** (VWF).
English: Following infusion, peak concentrations of VWF markers (VWF:RCo, VWF:Ag, and VWF:CB) and FVIII:C were achieved immediately with a median IR of 0.012-0.016 (IU/mL)/(IU/kg) for VWF markers and 0.018-0.020 (IU/mL)/(IU/kg) for FVIII:C. The median elimination t1/2 of VWF markers was between 10.00 and 13.48 h whereas FVIII:C had a longer t1/2 between 11.40 and 19.54 h due to a plateau effect that may represent the net effect of decreasing levels of exogenous FVIII, combined with increasing endogenous FVIII levels.
Croatian: Vršne koncentracije VWF markera (VWF:RCo, VWF:Ag, i VWF:CB) i FVIII:C postignute su odmah nakon infuzije sa medijanom IR vrijednosti od 0,012-0,016 (IU/mL)/(IU/kg) za VWF markere i 0,018-0,020
English: Administered intravenously, VWF binds to endogenous FVIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Croatian: Kad se primijeni intravenski VWF se veže za endogeni FVIII (koji se inače stvara u organizmu bolesnika) te se,
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Croatian: Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: AUC = area under the curve; Cmax = maximum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration occurs; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor: Collagen Binding; VWF:RCo = von Willebrand factor:
Croatian: AUC = površina ispod krivulje; Cmax = maksimalna koncentracija u plazmi; IU = međunarodna jedinica; MRT = srednje vrijeme zadržavanja; N = broj ispitanika; tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; VWF:Ag = Von Willebrandov factor: Antigen; VWF:CB = Von Willebrandov factor: kolagen vezajući; VWF:RCo = Von Willebrandov factor: Ristocetin kofaktor; FVIII:C= faktor VIII:koagulans
English: Voncento is used for all age groups to prevent or to halt bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in haemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective alone or cannot be given.
Croatian: Voncento se koristi za sve dobne skupine za sprječavanje ili prekid krvarenja uzrokovan manjkom von Willebrandova faktora (von Willebrandova bolest) i faktora VIII (hemofilija A) u krvi.
English: Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended in paediatric patients to treat a bleed.
Croatian: Von Willebrandov factor (VWF:RCo) od 40-80 IU/kg koji odgovara 20 - 40 IU FVIII:C/kg tjelesne težine su obično preporučeni za liječenje krvarenja kod pedijatrijskih bolesnika.
English: AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration; Vss = volume of distribution at steady state; FVIII:C = Factor VIII: Coagulant
Croatian: AUC = površina ispod krivulje; Cmax = maksimalna plazmatska koncentracija; Cmin = minimalna plazmatska koncentracija; IU = međunarodna jedinica; MRT = prosječno vrijeme zadržavanja; N = broj ispitanika; Tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; FVIII:C= faktor VIII:koagulans
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 5 ml
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici za otapalo 5 ml
English: • Headache
Croatian: • Glavobolja.
English: Total clearance (mL/(h*kg))
Croatian: Ukupni klirens (mL/(h*kg))
English: Inject air into the product vial.
Croatian: Istisnite zrak u bočicu s lijekom.
English: For long term prophylaxis in patients with VWD, a dose of 25 - 40 IU VWF:RCo /kg body weight should be considered at a frequency of 1 to 3 times per week.
Croatian: 25 - 40 IU VWF:RCo/kg tjelesne težine 1 do 3 puta tjedno.
English: This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 1000 IU/2400 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 1000 IU/2400 IU
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 250 IU/600 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 250 IU/600 IU
English: Total clearance (mL/(h*kg)
Croatian: Ukupni klirens (mL/(h*kg)
English: coagulation factor VIII 1000 IU von Willebrand factor 2400 IU
Croatian: faktor zgrušavanja VIII 1000 IU von Willebrandov faktor 2400 IU
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.
Croatian: Kad je otopina prenesena u štrcaljku čvrsto uhvatite tijelo štrcaljke (dok je klip štrcaljke okrenut prema dolje) i odspojite prozirni nastavak
English: Please contact your doctor immediately if: • you notice symptoms of allergic reactions
Croatian: Odmah se obratite liječniku ako:
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Croatian: Preokrenite bočicu s otapalom s pričvršćenim kompletom Mix2Vial i gurnite šiljak na kraju prozirnog nastavka ravno prema dolje kroz čep bočice s lijekom.
English: After reconstitution with the 5 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Croatian: Nakon rekonstitucije s 5 ml vode za injekcije koja je priložena, otopina sadrži 50 IU/ml FVIII i 120 IU/ml VWF.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 500 IU/1200 IU
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 500 IU/1200 IU
English: • Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati Voncento • Lijek čuvajte izvan pogleda i dohvata djece.
English: After reconstitution with the 10 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Croatian: Nakon rekonstitucije s 10 ml vode za injekcije koja je priložena, otopina sadrži 100 IU/ml FVIII i 240 IU/ml VWF.
English: Administration set
Croatian: Set za primjenu
English: The pharmacokinetics of Voncento have been evaluated in VWD patients in the non-bleeding state.
Croatian: Voncenta procijenjena je u bolesnika s von Willebrandovom bolešću u stanju bez krvarenja.
English: Solvent Water for injections
Croatian: Trometamol Otapalo voda za injekcije
English: AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects;tmax = time to maximum concentration; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor:
Croatian: AUC = površina ispod krivulje; Cmax = maksimalna plazmatska koncentracija; Cmin = minimalna plazmatska koncentracija; IU = međunarodna jedinica; MRT = prosječno vrijeme zadržavanja; N = broj ispitanika; Tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezni kolagen; VWF:RCo = von Willebrandov faktor: ristocetin kofaktor, FVIII:C = faktor VIII: koagulans.
English: After reconstitution with the 10 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Croatian: Nakon rekonstitucije s 10 ml vode za injekcije koja je priložena, otopina sadrži 50 IU/ml FVIII i 120 IU/ml VWF.
English: coagulation factor VIII 250 IU von Willebrand factor 600 IU
Croatian: faktor zgrušavanja VIII 250 IU von Willebrandov faktor 600 IU
English: Name and address of the manufacturer(s) of the biological active substances
Croatian: Naziv i adresa proizvođača bioloških djelatnih tvari CSL Behring AG
English: human coagulation factor VIII 1000 IU human von Willebrand factor 2400 IU
Croatian: ljudski koagulacijski faktor VIII 1000 IU ljudski von Willebrandov faktor 2400 IU
English: von Willebrand disease
Croatian: Von Willebrandova bolest
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Croatian: Mix2Vial držeći ga za rub i povlačeći ga okomito prema gore.
English: Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Croatian: Obično se za postizanje hemostaze preporučuje 40 - 80 IU/kg von Willebrandova faktora (VWF:RCo), što odgovara 20 - 40 IU FVIII:C po kg tjelesne težine.
English: human coagulation factor VIII 250 IU human von Willebrand factor 600 IU
Croatian: ljudski koagulacijski faktor VIII 250 IU ljudski von Willebrandov faktor 600 IU
English: Cmax (IU/mL)
Croatian: Cmax (IU/mL) Tmax (sati) Cmin (IU/mL)
English: human coagulation factor VIII 500 IU human von Willebrand factor 1200 IU
Croatian: ljudski koagulacijski faktor VIII 500 IU ljudski von Willebrandov faktor 1200 IU
English: CSL Behring GmbH, 35041 Marburg, Germany
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CSL Behring GmbH, 35041 Marburg, Njemačka
English: After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: rekonstituirani lijek treba vizualno pregledati na prisutnost čestica i promjenu boje prije same primjene.
English: powder and solvent for solution for injection/infusion 1 vial with powder
Croatian: prašak i otapalo za injekciju/infuziju
English: • If you get any side effects talk to your doctor, nurse or pharmacist.
Croatian: • Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.1.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima,
English: Voncento 1000 IU FVIII / 2400 IU VWF powder for solution for injection/infusion ForIV use
Croatian: Voncento 1000 IU FVIII / 2400 IU VWF prašak i otapalo za otopinu za injekciju/infuziju