FrancophonIA/ELRC3.0 huggingface dataset:
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for FVIII inhibitor presence should be performed.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili ako se krvarenje ne može kontrolirati primjenom odgovarajuće doze, potrebno je napraviti ispitivanje na prisutnost inhibitora faktora VIII.
English: The replacement of VWF and FVIII by Voncento will temporarily repair the blood clotting mechanisms.
Croatian: Nadomještanje VWF i faktora VIII lijekom Voncento, privremeno će korigirati mehanizme zgrušavanja.
English: Repeat infusion every 8 - 24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30 %60 % (IU/dl).
Croatian: Ponovite infuziju svakih 8 - 24 sata sve dok se ne postigne odgovarajuće cijeljenje rane, a potom nastavite s liječenjem tijekom najmanje 7 dodatnih dana kako biste održali aktivnost faktora VIII od 30% do 60% (IU/dl)
English: AUSTRALIA
Croatian: AUSTRALIJA
English: 1 IU of factorVIII activity is equivalent to that quantity of factor VIII in 1 ml of normal human plasma.
Croatian: 1 međunarodna jedinica (IU) aktivnosti faktora VIII odgovara toj količini faktora VIII u 1 ml normalne ljudske plazme.
English: Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF.
Croatian: Bolesnici s von Willebrandovom bolešću, a posebice bolesnici s tipom 3 te bolesti, mogu razviti neutralizirajuća protutijela (inhibitore) na VWF.
English: CSL Behring AG Wankdorfstrasse 10 3014 Bern SWITZERLAND
Croatian: Wankdorfstrasse 10 3014 Bern
English: If you have haemophilia A your doctor will prescribe you Voncento with the number of units of FVIII specified.
Croatian: Ako imate hemofiliju A liječnik će Vam propisati Voncento s navedenim brojem jedinica FVIII.
English: Prophylaxis and treatment of bleeding in patients with haemophilia A.
Croatian: Hemofilija A (prirođeni manjak FVIII) Profilaksa i liječenje krvarenja u bolesnika s hemofilijom A.
English: No side effects have been associated with these reports.
Croatian: U vezi s ovim slučajevima nije uočena nijedna nuspojava.
English: The following side effects have been observed uncommonly (may affect up to 1 in 100 people):
Croatian: Sljedeće nuspojave opažene su manje često (mogu se javiti u do 1 na 100 osoba):
English: If you have a known risk of developing blood clots, you must be monitored for early signs of thrombosis (blood clotting).
Croatian: Ako Vam je utvrđen rizik od razvoja krvnih ugrušaka (trombotičkih događaja) mora Vas se nadzirati zbog moguće pojave prvih znakova tromboze.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovise o težini manjka faktora VIII, o lokaciji i opsegu krvarenja i o bolesnikovom kliničkom stanju.
English: In some cases, especially in younger patients, higher doses may be needed.
Croatian: U nekim slučajevima, posebice kod mlađih bolesnika, mogle bi biti potrebne veće doze.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest (including chest pain and chest discomfort), back pain, tingling, vomiting, wheezing) have been observed, and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Uočeni su preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, pečenje ili žarenje na mjestu infuzije, zimicu, crvenilo praćeno osjećajem vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu (uključujući bol i nelagodu u prsištu), bol u leđima, trnce, povraćanje, sipnju) te u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years
Croatian: N medijan (raspon) <6 godina 6-12 godina <6 godina 6-12 godina <6 godina 6-12 godina <6 godina 6-12 godina
English: The product is made from human plasma (the liquid part of the blood) and contains the active substances called human coagulation factor VIII (FVIII) and human von Willebrand factor (VWF).
Croatian: Što je Voncento i za što se koristi Lijek se dobiva iz ljudske plazme (plazma je tekući dio krvi) i sadrži aktivne tvari koje se nazivaju ljudski faktor zgrušavanja VIII (FVIII) i ljudski von Willebrandov faktor (VWF) kao djelatne tvari.
English: The use of plastic disposable syringes is recommended as the ground glass surfaces of all-glass syringes tend to stick with solutions of this type.
Croatian: Za injekciju Voncenta preporučuje se uporaba plastičnih štrcaljki za jednokratnu uporabu jer staklene površine štrcaljki od svih tipova stakla adsorbiraju otopine ovog tipa.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for FVIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se kao postotak (u odnosu na normalnu ljudsku plazmu) ili radije u međunarodnim jedinicama (u odnosu na međunarodni standard za FVIII u plazmi).
English: 100 IU/ml FVIII and 240 IU/ml VWF.
Croatian: 100 IU/ml FVIII i 240 IU/ml VWF.
English: 50 IU/ml FVIII and 120 IU/ml VWF.
Croatian: 50 IU/ml FVIII i 120 IU/ml VWF.
English: FVIII inhibition
Croatian: Inhibicija FVIII
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Croatian: Bolesnike treba upoznati s ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, sipnju, hipotenziju i anafilaksiju.
English: Repeat infusion every 24 hours for at least 1 day, until healing is achieved.
Croatian: Ponovite infuziju svaka 24 sata tijekom najmanje 1 dana sve dok se ne postigne cijeljenje.
English: • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
Croatian: • Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete ovaj lijek.
English: The solvent will automatically flow into the product vial.
Croatian: Otapalo će automatski protjecati u bočicu s lijekom.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se kao postotak (u odnosu na normalnu ljudsku plazmu) ili radije u međunarodnim jedinicama (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: How to use Voncento
Croatian: Kako primjenjivati Voncento
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Croatian: Ponovite infuziju svakih 8 - 24 sata sve dok se ne ukloni opasnost po život.
English: 1 disposable 10 ml syringe 1 venipuncture set
Croatian: 1 jednokratnu štrcaljku od 10 ml 1 set za venipunkciju
English: Other ingredients: calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
Croatian: Drugi sastojci su: kalcijev klorid, ljudski albumin, natrijev klorid, natrijev citrat, saharoza, trometamol.
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Croatian: Držeći klip štrcaljke pritisnutim, okrenite sustav naopako i izvucite otopinu u štrcaljku polaganim povlačenjem klipa prema nazad.
English: PK of single dose of 50 IU FVIII/kg body weight was evaluated in 31 paediatric subjects less than 12 years of age with Haemophilia A (see Table below).
Croatian: PK pojedinačne doze od 50 IU FVIII/kg tjelesne težine ocijenjeni su u 31 pedijatrijskog ispitanika u dobi mlađoj od 12 godina s hemofilijom A (vidi tablicu ispod).
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteremia and catheter site thrombosis should be considered.
Croatian: Ako je potrebno postaviti centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterijemija i tromboza na mjestu uvođenja katetera.
English: Calcium chloride Human albumin Sodium chloride Sodium citrate Sucrose
Croatian: Kalcijev klorid Ljudski albumin Natrijev klorid Natrijev citrat
English: Based on a pharmacokinetic study with 16 subjects ≥ 12 years of age with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed:
Croatian: Na temelju farmakokinetičkih ispitivanja u 16 ispitanika ≥ 12 godina starosti s hemofilijom A uočene su sljedeće farmakokinetičke karakteristike:
English: Deutschland
Croatian: NJEMAČKA
English: The risk of developing blood clots (thrombosis) cannot be excluded in case of an extremely high dose, especially in patients with VWD.
Croatian: Rizik od pojave krvnih ugrušaka (tromboze) ne može se isključiti u slučaju izrazito visoke doze, posebice u bolesnika s von Willebrandovom bolešću.
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Croatian: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Njemačka
English: 6.6 Special precautions for disposal and other handling
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom Opće upute
English: The dose and duration of treatment will depend on the clinical status of the patient, as well as their VWF:RCo and FVIII:C plasma levels.
Croatian: Doza i trajanje liječenja ovisit će o kliničkom stanju bolesnika i o razini VWF:RCo i FVIII:C u plazmi.
English: In patients with VWD, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors.
Croatian: U bolesnika s von Willebrandovom bolešću postoji rizik od pojave tromboembolijskih događaja posebice u bolesnika s poznatim kliničkim ili laboratorijskim čimbenicima rizika.
English: If your or your child's bleeding is not being controlled with Voncento, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka Voncento, odmah se obratite liječniku.
English: Virus safety
Croatian: Sigurnost od prijenosa virusa
English: In case large volumes of Voncento are required, it is possible to pool several vials of Voncento via a commercially available infusion set (e.g. a syringe pump for intravenous application of medicinal products).
Croatian: U slučaju potrebe za velikim volumenima Voncenta moguće je udružiti nekoliko bočica Voncenta u komercijalno dostupan komplet za infuziju (primjerice, pumpa za štrcaljku za intravensku primjenu lijeka).
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava Disgeuzija
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Croatian: Uzmite Mix2Vial zajedno s blister pakiranjem i gurnite šiljak na kraju plavog nastavka ravno prema dolje kroz čep bočice s otapalom.
English: • If you have further questions, ask your doctor, your nurse or your pharmacist.
Croatian: • Ako imate dodatnih pitanja, obratite se liječniku, ljekarniku ili medicinskoj sestri.
English: * Adverse events assessed as related to administration of the Voncento **Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients.
Croatian: ** Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients) ***Opaženo tijekom postmarketinškog nadzora, nije opaženo u kliničkim ispitivanjima
English: Voncento contains FVIII and VWF as active ingredients which are derived from human plasma and act like endogenous constituents of plasma.
Croatian: 5.3 Neklinički podaci o sigurnosti primjene Voncento sadrži FVIII i VWF kao djelatne tvari koje se dobivaju iz ljudske plazme i djeluju kao endogeni konstituenti plazme.
English: If such inhibitors occur, the condition will manifest itself as an inadequate clinical response.
Croatian: U slučaju pojave inhibitora stanje će se očitovati kao nedostatan klinički odgovor.
English: The following side effect has been observed very commonly (may affect more than 1 in 10 people):
Croatian: Sljedeće nuspojave opažene su često (mogu se javiti u do 1 na 10 osoba):
English: Patients aged <12 years old: Based on results from a clinical trial in which paediatric patients under 12 years of age were shown to have lower exposure of VWF, a prophylactic dose range of 40 - 80 IU VWF:RCo/kg body weight 1 to 3 times a week should be considered.
Croatian: <12 godina: Prema rezultatima kliničkog ispitivanja u kojem su pedijatrijski bolesnici u dobi mlađoj od 12 godina ispoljili niže razine VWF, potrebno je razmotriti raspon doze od 40 - 80 IU VWF:RCo/kg tjelesne težine 1 do 3 puta tjedno (vidjeti dio 5.2).
English: The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products.
Croatian: Broj jedinica primijenjenog faktora VIII izražava se u međunarodnim jedinicama (IU) koje su usklađene s važećim međunarodnim standardom Svjetske zdravstvene organizacije (SZO) za koncentrat faktora VIII.
English: - Administration of a FVIII:C containing VWF preparation restores the FVIII:C level to normal immediately after the first infusion.
Croatian: - Primjena FVIII:C koji sadrži pripravak VWF ponovno uspostavlja normalnu razinu FVIII:C
English: It is strongly recommended that every time Voncento is given, you record the date of administration, the batch number and the injected volume in your treatment diary.
Croatian: Izričito se preporučuje da si nakon svake primjene lijeka Voncento u svoj dnevnik liječenja zabilježite datum primjene, broj serije i volumen injiciranog lijeka.
English: The measures taken are considered effective for so-called “enveloped” viruses such as human immunodeficiency virus (HIV, the AIDS virus), hepatitis B virus and hepatitis C virus (which cause inflammation of the liver), and for the “non-enveloped” hepatitis A virus (which also causes inflammation of the liver).
Croatian: Poduzete mjere smatraju se djelotvornim za takozvane viruse s ovojnicom poput virusa humane imunodeficijencije (HIV, virus AIDS-a), virusa hepatitisa B i hepatitisa C (koji izazivaju upalu jetre) te za viruse hepatitisa
English: In case large volumes of Voncento are required, it is possible to pool several vials of Voncento together, via a commercially available infusion set (e.g. a syringe pump for giving medicines into a vein).
Croatian: U slučaju potrebe za velikim volumenima Voncenta moguće je udružiti nekoliko bočica Voncenta u komercijalno dostupan komplet za infuziju (primjerice, pumpa za štrcaljku za lijekove u venu).
English: ** produced from plasma of human donors ***The VWF activity is determined using the WHO Standard for VWF.
Croatian: ***Aktivnost VWF određena je na temelju standarda Svjetske zdravstvene organizacije (SZO) za von
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, tipu i težini krvarenja te razinama VWF:RCo i FVIII:C.
English: Thromboembolic event
Croatian: Tromboembolijski događaj
English: Parvovirus B19 infection may be serious • for pregnant women (as there is a risk of infection of the unborn child) and
Croatian: • za trudnice (postoji rizik od prijenosa infekcije na nerođeno dijete) i
English: Do not use the solution if it is visibly cloudy or if it contains flakes or particles.
Croatian: Nemojte primijeniti otopinu koja je vidno zamućena ili sadrži komadiće ili čestice.
English: Uncommon (PTPs)** Very common (PUPs)**
Croatian: Vrlo često (PUPs)**
English: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows
Croatian: CSL Behring (Australia) Pty Ltd
English: PK of single dose of 80 IU VWF:RCo/kg body weight was evaluated in paediatric subjects less than 12 years of age with severe VWD (see Table below).
Croatian: PK pojedinačne doze od 80 IU VWF:RCo/kg tjelesne težine izvedena je za pedijatrijske ispitanike u dobi mlađoj od 12 godina s teškom Von Willebrandovom bolesti (vidi tablicu ispod).
English: Repeat infusion every 12-24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Croatian: Ponovite infuziju svakih 12 - 24 sata tijekom 3 - 4 dana ili više sve dok se ne izliječe bol ili akutna onesposobljenost.
English: For long term prophylaxis in patients with severe haemophilia A, the usual dose is 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Croatian: Za dugoročnu profilaksu u bolesnika s teškom hemofilijom A uobičajena doza iznosi 20 do 40 IU faktora VIII po kg tjelesne težine u intervalima od 2 do 3 dana.
English: • If for the administration of Voncento you will require a central venous access device (CVAD), the risk of CVAD-related complications including local infections, bacteria in the blood (bacteremia) and the formation of a blood clot in the blood vessel (thrombosis) where the catheter is inserted should be considered by your doctor.
Croatian: • Ako Vam je zbog primjene lijeka Voncento potrebno postaviti centralni venski kateter, Vaš liječnik treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterije u krvi (bakterijemija) i stvaranje krvnog ugruška u krvnoj žili
English: White powder and clear, colourless solvent for solution for injection/infusion.
Croatian: Bijeli prašak i bistro, bezbojno otapalo za otopinu za injekciju/infuziju.
English: Voncento can be used for all age groups.
Croatian: 4.1 Terapijske indikacije Voncento može biti korišten za sve dobne skupine.
English: In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the cardiovascular risk.
Croatian: Kardiovaskularni događaji Kod bolesnika sa postojećim faktorima rizika od kardiovaskularnih bolesti, nadomjesna terapija sa
English: The immediate container of product and solvent vial consists of glass vial with a rubber stopper, plastic disc, and aluminium cap.
Croatian: Unutarnje pakiranje lijeka i bočica otapala sastoje se od staklene bočice s gumenim čepom, plastičnim diskom i aluminijskim zatvaračem.
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew the set carefully counterclockwise into two pieces to avoid excessive build-up of foam when dissolving the product.
Croatian: Pažljivo odvijte spoj u smjeru suprotnom od kazaljke na satu tako da se komplet razdvoji u dva dijela, pri čemu pazite da izbjegnete prekomjerno nakupljanje pjene prilikom otapanja lijeka.
English: Repeat infusion every 8-24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% - 60% (IU/dl).
Croatian: sata sve dok se ne postigne odgovarajuće cijeljenje rane, a potom nastavite s liječenjem tijekom najmanje 7 dodatnih dana kako biste održali aktivnost faktora VIII od 30% do 60%. (IU/dl).
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma, using the modified assay.
Croatian: Ti inhibitori su obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova količina se određuje u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: Dosing in children and adolescents aged < 18 years is based on body weight and is therefore generally based on the same instructions as for adults.
Croatian: <18 godina temelji se na tjelesnoj težini te uglavnom na istim uputama kao i za odrasle.
English: • Keep the vial in the outer carton in order to protect from light.
Croatian: • Bočice čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika te normalno ne bi trebali biti dulji od 24 sata pri temperaturi od 2 do 8 °C. 6.4 Posebne mjere pri čuvanju lijeka Ne čuvati na temperaturi iznad 25 °C.
English: For long term prophylaxis in patients with severe haemophilia A, the usual dose is 20 to 40 IU of FVIII per kg body weight at intervals of 2 to 3 days.
Croatian: Za dugoročnu profilaksu u bolesnika s teškom hemofilijom A uobičajena doza iznosi 20 do 40 IU FVIII po kg tjelesne težine u intervalima od 2 do 3 dana.
English: The decision on the use of the product at home for patients with VWD and with haemophilia A should be made by the treating physician who should ensure that appropriate training is provided and the use is reviewed at intervals.
Croatian: Odluku o kućnoj upotrebi lijeka s von Willebrandovom bolesti i hemofilijom A treba donijeti liječnik koji će osigurati prethodno uvježbavanje primjene liječenja, a samo liječenje treba procjenjivati u određenim vremenskim razmacima.
English: On demand treatment
Croatian: Liječenje prema potrebi
English: CSL Behring NV Tél/Tel: +32 15 28 89 20
Croatian: Luxembourg/Luxemburg CSL Behring NV Tél/Tel: +32 15 28 89 20
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. In patients receiving FVIII-containing VWF products, plasma levels of FVIII:C should be monitored to avoid sustained excessive FVIII:C plasma levels which may increase the risk of thrombotic events, and antithrombotic measures should be considered (see also section 5.2).
Croatian: U bolesnika koji primaju VWF lijekove, koji sadrže FVIII potrebno je nadzirati razine FVIII:C kako bi se izbjeglo održavanje prekomjernih plazmatskih razina FVIII:C koje mogu povećati rizik od trombotičkih događaja te je potrebno poduzeti mjere protiv stvaranja tromba (vidjeti također dio 5.2).
English: Reconstitution and application
Croatian: Rekonstitucija i primjena
English: Allergic type hypersensitivity reactions are possible.
Croatian: Preosjetljivost Moguće su reakcije preosjetljivosti alergijskog tipa.
English: Incremental recovery (IU/mL)/(IU/kg) Half-life (h)
Croatian: Inkrementalni oporavak (IU/mL)/(IU/kg) Poluvijek (sati)
English: Repeat infusion every 12 - 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Ponovite infuziju svakih 12 - 24 sata tijekom najmanje 1 dana sve dok se ne riješi bolna epizoda krvarenja ili ne postigne zacjeljivanje.
English: Animal reproduction studies have not been conducted with Voncento.
Croatian: 4.6 Plodnost, trudnoća i dojenje Nisu provedena ispitivanja reprodukcije u životinja s lijekom Voncento.