FrancophonIA/ELRC3.0 huggingface dataset:
English: The relative content of HMW (high molecular weight) VWF multimers in Voncento is on average 86 % when compared to normal human plasma (NHP).
Croatian: Relativni sadržaj HMW (visoka molekularna masa) VWF multimera lijeka Voncento u usporedbi s normalnom ljudskom plazmom (NHP) iznosi u prosjeku 86%.
English: The table presented below is according to the MedDRA system organ classification.
Croatian: Ispod navedena tablica predstavlja nuspojave prema MedDRA klasifikaciji organskih sustava.
English: Therefore, patients at risk must be monitored for early signs of thrombosis.
Croatian: Stoga bolesnike pod rizikom treba nadzirati zbog moguće pojave prvih znakova tromboze.
English: If such inhibitors occur, the condition may manifest itself as an insufficient clinical response.
Croatian: Ako se pojave takvi inhibitori, stanje se može manifestirati kao nedovoljan klinički odgovor.
English: It is important to calculate the dose using the number of IU of VWF:RCo specified.
Croatian: Važno je izračunati dozu uporabom broja IU navedenog VWF:RCo.
English: The listed warnings and precautions apply both to adults and paediatrics.
Croatian: Navedena upozorenja i mjere opreza odnose se i na odraslu i pedijatrijsku populaciju.
English: Required units = body weight [kg] x desired factor VIII rise [% or IU/dl] x 0.5.
Croatian: potrebne jedinice = tjelesna težina [kg] x željeni porast faktora VIII [% ili IU/dl] x 0,5.
English: Therefore, Voncento should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se Voncento smije koristiti tijekom trudnoće i dojenja samo ako je to prijeko potrebno.
English: • Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Drugi lijekovi i Voncento • Obavijestite svog liječnika ili ljekarnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: Administer the solution slowly intravenously (see section 4.2), taking care to ensure that no blood enters the syringe filled with product.
Croatian: Primijenite otopinu polako intravenski (vidjeti dio 4.2) vodeći računa da krv ne uđe u štrcaljku ispunjenu lijekom.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) within the corresponding period.
Croatian: U slučaju sljedećih hemoragijskih događaja aktivnost faktora VIII ne smije pasti ispod navedene razine plazmatske aktivnosti (izraženo kao % u odnosu na normalnu ili u IU/dl) unutar odgovarajućeg razdoblja.
English: • If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist.
Croatian: • Ako ste imali ili imate bolest srca ili imate povećan rizik od bolesti srca, obratite se svom liječniku ili ljekarniku.
English: DO NOT expose the vials to direct heat.
Croatian: NEMOJTE izlagati bočice izravnom izvoru topline.
English: The ratio between FVIII:C and VWF:RCo in a vial is approximately 1:2.4.
Croatian: Omjer između FVIII:C i VWF:RCo u bočici iznosi približno 1:2,4.
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U takvim slučajevima se preporučuje kontaktirati specijalizirani centar za hemofiliju.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton administration set (inner box)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Set za primjenu u kartonskoj kutiji (unutarnja kutija)
English: Patients aged 12 to 18 years old: Dosing is based on the same guidelines as for adults.
Croatian: Bolesnici u dobi od 12 do 18 godina: Doziranje se temelji na uputi za odrasle bolesnike.
English: However, in these cases the initially reconstituted solution of Voncento should not be diluted any further.
Croatian: Međutim, u tim slučajevima prethodno rekonstituirana otopina lijeka Voncento se više ne smije razrjeđivati.
English: • If the reconstituted product is not administered immediately, storage times and conditions prior to use are the responsibility of the the user and should not exceed 24 hours at 2 to 8 °C.
Croatian: • Ako se pripremljeni lijek ne primijeni odmah vrijeme čuvanja i uvjeti čuvanja prije uporabe odgovornost su korisnika i ne smiju biti dulji od 24 sata pri temperaturi od 2 do 8 °C.
English: • careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded,
Croatian: • pomni odabir darivatelja krvi i plazme kako bi se zajamčilo da su isključene osobe za koje postoji rizik od prijenosa infekcija,
English: Your doctor may recommend that you consider being vaccinated against hepatitis A and B if you regularly/repeatedly receive human plasma-derived medicines such as Voncento.
Croatian: Liječnik Vam može preporučiti da razmislite o cijepljenju protiv hepatitisa A i B ako redovito/opetovano primate lijekove dobivene iz ljudske plazme, kao što je Voncento.
English: Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab.
Croatian: Pažljivo uklonite zaštitne kapice s bočica i očistite izložene gumene čepove alkoholnim blazinicama.
English: When medicines are made from human blood or plasma, certain measures are put in place by the manufacturer to prevent infections being passed on to patients.
Croatian: Prilikom dobivanja lijekova iz ljudske krvi ili plazme proizvođač poduzima određene mjere kako bi spriječio prijenos infekcija na bolesnike.
English: Because of this, administration of pure VWF (VWF product with a low FVIII level) restores the FVIII:C level to normal as a secondary effect after the first infusion with a slight delay.
Croatian: Iz tog razloga, primjena čistog VWF (lijek s VWF i niskom razinom FVIII) ponovno uspostavlja normalnu razinu FVIII:C kao sekundarni učinak nakon prve infuzije s malom odgodom.
English: (pre- and postoperative)
Croatian: (prije i nakon kirurškog zahvata)
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Croatian: U slučaju dodatnih pitanja o uporabi ovog lijeka, obratite se liječniku ili ljekarniku.
English: Treatment monitoring
Croatian: Nadzor liječenja
English: Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %).
Croatian: U pravilu, 1 IU/kg VWF:RCo podiže razinu cirkulirajućeg VWF:RCo za 0,02 IU/ml (2%).
English: Make sure that you only pull away the blister package and not the Mix2Vial set.
Croatian: Pazite da odvojite samo blister pakiranje, a ne i komplet
English: Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations.
Croatian: Treba uspostaviti mjere sprječavanja venskog tromboembolizma u skladu s važećim preporukama.
English: VWF and FVIII are involved in blood clotting.
Croatian: VWF i FVIII sudjeluju u zgrušavanju krvi (koagulacija).
English: In patients with high levels of inhibitor, therapy may not only be ineffective but also lead to anaphylactoid reactions and other therapeutic options should be considered.
Croatian: U bolesnika s visokim razinama inhibitora liječenje može biti ne samo neučinkovito nego i uzrokovati anafilaktoidne reakcije te je potrebno uzeti u obzir druge terapijske opcije.
English: One pack contains:
Croatian: Jedno pakiranje sadrži:
English: For injection of Voncento only the provided administration sets should be used because treatment failure can occur as a consequence of FVIII adsorption to the internal surfaces of some injection/infusion equipment.
Croatian: Za injiciranje Voncenta treba koristiti samo priložene komplete za primjenu jer se neuspjeh u liječenju može dogoditi kao posljedica adsorpcije ljudskog faktora VIII na unutarnje površine neke opreme za injiciranje/infundiranje.
English: Voncento does not affect your ability to drive and use machines.
Croatian: Voncento ne bi smio utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: In patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary.
Croatian: Kod bolesnika sa gastrointestinalnim krvarenjem ili menoragijom, mogli bi biti potrebni kraći razmaci doziranja ili veće doze.
English: Bring the solvent to room temperature.
Croatian: Zagrijte otapalo na sobnu temperaturu.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količinu koju će se primijeniti i učestalost primjene treba uvijek određivati ovisno o kliničkoj učinkovitosti u pojedinom slučaju.
English: If you have VWD your doctor will prescribe you Voncento with the number of units of VWF specified.
Croatian: Ako imate VWD liječnik će Vam propisati Voncento s navedenim brojem jedinica VWF.
English: See section “The following information is intended for healthcare professionals only” for further information.
Croatian: Za više informacija vidjeti dio “Sljedeće informacije namijenjene su samo zdravstvenim radnicima“.
English: One inner box containing:
Croatian: Jedna unutarnja kutija sadrži:
English: Voncento contains sodium
Croatian: Voncento sadrži natrij
English: Activated FVIII acts as a cofactor for activated factor IX accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Akitivirani FVIII djeluje kao kofaktor za faktor IX ubrzavajući konverziju faktora X u aktivirani faktor X.
English: N median range
Croatian: N medija n raspon
English: Levels of VWF:RCo of > 0.6 IU/ml (60 %) and of FVIII:C of > 0.4 IU/ml (40 %) should be achieved.
Croatian: Treba postići razine VWF:RCo od > 0,6 IU/ml (60%) i FVIII:C od > 0,4 IU/ml (40%).
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Croatian: U bolesnika s visokim razinama inhibitora, terapija faktorom VIII možda neće biti učinkovita te je potrebno razmotriti druge terapijske opcije.
English: Exogenously administered human plasma-derived VWF behaves in the same way as endogenous VWF.
Croatian: Egzogeno primijenjeni VWF dobiven iz ljudske plazme ponaša se na isti način kao i endogeni VWF.
English: When infused into a haemophiliac patient, FVIII binds to VWF in the patient's circulation.
Croatian: Kad se infundira u bolesnika s hemofilijom, FVIII se veže na VWF u krvotoku bolesnika.
English: If any reaction takes place that might be related to the administration of Voncento, the rate of injection should be decreased or the application should be stopped, as required by the clinical condition of the patient (see also section 4.4).
Croatian: U slučaju reakcije koja bi mogla biti povezana s primjenom lijeka Voncento, brzinu injiciranja treba smanjiti ili prekinuti primjenu u skladu s kliničkim statusom bolesnika (vidjeti također dio 4.4).
English: If you have any side effects that might be related to the administration of Voncento, the injection or infusion should be stopped (see also section 2).
Croatian: Ako opazite neku nuspojavu koja bi mogla biti povezana s primjenom lijeka Voncento, potrebno je prekinuti injekciju ili infuziju (vidjeti također dio 2.).
English: There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors.
Croatian: Postoji rizik od pojave trombotičkih događaja posebice u bolesnika s poznatim kliničkim ili laboratorijskim čimbenicima rizika.
English: Side effects in children and adolescents are expected to be the same as in adults.
Croatian: Očekuje se da će nuspojave u djece i adolescenata biti jednake nuspojavama u odraslih.
English: Hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain)
Croatian: Preosjetljivost (uključujući tahikardiju, bol u prsištu, nelagodu u prsištu i bol u leđima)
English: If the expected VWF:RCo activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, an appropriate assay should be performed to determine if a VWF inhibitor is present.
Croatian: Ako se ne postignu očekivane razine aktivnosti VWF:RCo u plazmi ili ako krvarenje nije stavljeno pod kontrolu odgovarajućom dozom, potrebno je provesti testiranje kako bi se ustanovilo je li prisutan inhibitor VWF.
English: In the case of major surgical interventions in particular, a precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable..
Croatian: Posebice u slučaju većih kirurških zahvata, neophodno je precizno praćenje nadomjesne terapije analizom koagulacije (aktivnost plazmatskog FVIII).
English: The measures taken may be of limited value against non-enveloped viruses such as parvovirus B19.
Croatian: Poduzete mjere mogu biti ograničene djelotvornosti u borbi protiv virusa bez ovojnice poput parvovirusa B19.
English: 1 non-sterile plaster
Croatian: 1 nesterilni flaster
English: It is strongly recommended that every time that Voncento is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Croatian: Izričito se preporučuje da se prilikom svake primjene lijeka Voncento bolesniku, zabilježe naziv i broj serije primijenjenog lijeka kako bi se održala poveznica između bolesnika i serije lijeka.
English: Prevention of haemorrhage in case of surgery
Croatian: Prevencija krvarenja u slučaju kirurškog zahvata
English: What you need to know before you use Voncento Do not use Voncento
Croatian: Što morate znati prije nego počnete primjenjivati Voncento Nemojte primjenjivati Voncento
English: Based on a pharmacokinetic study with 12 subjects ≥12 years with VWD, the following pharmacokinetic characteristics for VWF:RCo, VWF:Ag, VWF:CB and FVIII:C were observed:
Croatian: Na temelju farmakokinetičkog ispitivanja u 12 ispitanika ≥12 godina s von Willebrandovom bolešću opažene su sljedeće farmakokinetičke karakteristike za VWF:RCo, VWF:Ag, VWF:CB i FVIII:C:
English: Administration of VWF allows correction of the haemostatic abnormalities exhibited by patients who suffer from VWF deficiency (VWD) at two levels: - VWF re-establishes platelet adhesion to the vascular sub-endothelium at the site of vascular damage (as it binds both to the vascular sub-endothelium and to the platelet membrane), providing primary haemostasis as shown by the shortening of the bleeding time.
Croatian: Primjena VWF omogućava korekcije poremećaja hemostaze u bolesnika koji pate od manjka VWF (von Willebrandova bolest) na dvije razine: - VWF ponovno uspostavlja adheziju trombocita na subendotel krvne žile na mjestu oštećenja žile (jer se veže i na žilni subendotel i na membranu trombocita) osiguravajući primarnu hemostazu što se očituje skraćivanjem vremena krvarenja.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Voncento.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući Voncento.
English: Do not use visibly cloudy solutions or solutions still containing flakes or particles.
Croatian: Nemojte koristiti otopine s vidljivim zamućenjima ili otopine koje još uvijek sadrže komadiće ili čestice.
English: Prevention of haemorrhage in case of surgery:
Croatian: Prevencija krvarenja u slučaju kirurškog zahvata:
English: PK parameters from the repeat PK evaluation were similar to those from initial PK. Voncento exposure and disposition were comparable between <6-year-old and 6-12-year-old subjects.
Croatian: PK parametri iz ponovljene PK evaluacije bili su slični parametrima dobivenim inicijalnom evaluacijom PK. Izloženost i dispozicija lijeka Voncento bili su usporedivi između ispitanika u dobi od <6 godina i 6-12 godina.
English: Name and address of the manufacturer(s) responsible for batch release CSL Behring GmbH
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet CSL Behring GmbH
English: If you forget to use Voncento
Croatian: Ako ste zaboravili primijeniti Voncento
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava u djece biti ista kao u odraslih.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of FVIII and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija A je uz spolne kromosome vezani nasljedni poremećaj zgrušavanja krvi zbog smanjene razine FVIII te rezultira u intenzivnom krvarenju u zglobove, mišiće ili unutarnje organe, bilo spontano ili kao rezultat slučajne ili kirurške traume.
English: Use the venipuncture kit supplied with the product, insert the needle into a vein.
Croatian: Upotrijebite komplet za venepunkciju koji je priložen s ovim lijekom te stavite iglu u venu.
English: These include hives, generalised skin rash, tightness of the chest, wheezing, fall in blood pressure and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, or dizziness).
Croatian: Oni uključuju koprivnjaču, generalizirani kožni osip, stezanje u prsima, piskanje, pad tlaka krvi i anafilaksiju (ozbiljnu alergijsku reakciju koja uzrokuje vrlo otežano disanje ili omaglicu).
English: An initial dose of 80 IU/kg VWF:RCo may be required, especially in patients with type 3 VWD where maintenance of adequate levels may require greater doses than in other types of VWD.
Croatian: Može biti potrebna početna doza od 80 IU/kg VWF:RCo, posebice u bolesnika s tipom 3 von Willebrandove bolesti, gdje održavanje odgovarajućih razina može zahtijevati veće doze od onih u drugim tipovima te bolesti.
English: Voncento has no influence on the ability to drive and use machines.
Croatian: Voncento nema utjecaja na sposobnost upravljanja vozilima i rada sa strojevima.
English: The specific FVIII activity of Voncento, prior to the addition of stabiliser, is approximately 70 IU of FVIII/mg protein.
Croatian: Specifična aktivnost FVIII lijeka Voncento prije dodatka stabilizatora iznosi približno 70 IU FVIII/mg proteina.
English: Baseline-adjusted initial PK parameters of VWF and FVIII:C in subjects <6 (N=9) and 6-12 years old (N=5)
Croatian: Inicijalni PK parametri VWF i FVIII:C među ispitanicima <6 (N=9) i 6-12 godina (N=5)
English: Common Very common
Croatian: Često Vrlo često
English: The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV), and for the non-enveloped hepatitis A virus (HAV).
Croatian: Poduzete mjere smatraju se djelotvornim za viruse s ovojnicom poput virusa humane imunodeficijencije (HIV), virusa hepatitisa B (HBV) i hepatitisa C (HCV) te za viruse hepatitisa
English: • The solution should be clear or slightly opalescent, i.e. it might be sparkling when held up to the light but must not contain any obvious particles.
Croatian: • Otopina treba biti bistra ili blago svjetlucava tj. može se sjajiti kad se drži prema svjetlu, ali ne smije sadržavati nikakve vidljive čestice.
English: Such antibodies are precipitating and may occur concomitantly to anaphylactic reactions.
Croatian: Takva se protutijela talože i mogu se pojaviti istovremeno s anafilaktičnom reakcijom.
English: In patients receiving FVIII-containing VWF products, sustained excessive FVIII:C plasma levels may increase the risk of thromboembolic events (see also section 4.4).
Croatian: U bolesnika koji primaju VWF lijekove koji sadrže FVIII trajne prekomjerne plazmatske razine FVIII mogu povećati rizik od tromboembolijskih događaja (vidjeti također dio 4.4).
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor VIII/VWF products.
Croatian: Treba razmotriti mogućnost odgovarajućeg cijepljenja (protiv hepatitisa A i B) za bolesnike koji redovito/opetovano primaju lijekove koji sadrže faktor VIII/VWF dobivene iz ljudske plazme.
English: • Allergic (hypersensitivity) reactions are possible.
Croatian: • Moguće su reakcije (preosjetljivosti) alergijskog tipa.
English: Ensure powder and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
Croatian: Pobrinite se da su kapice bočica s praškom i otapalom uklonjene, a da su čepovi očišćeni antiseptičkom otopinom i da su dovoljno suhi prije otvaranja pakiranja Mix2Vial.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To se također odnosi na nepoznate ili novootkrivene viruse te na druge patogene.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by about 2 % of normal activity (in vivo recovery 2 IU/dl).
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskom saznanju da 1 IU faktora VIII po kg tjelesne težine podiže aktivnost faktora VIII za približno 2% u odnosu na normalnu aktivnost (in vivo povrat 2 IU/dl).
English: The specific VWF activity of Voncento, prior to the addition of stabiliser, is approximately 100 IU of VWF/mg protein.
Croatian: Specifična aktivnost VWF lijeka Voncento prije dodatka stabilizatora iznosi približno 100 IU VWF/mg proteina.
English: Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.
Croatian: Profilaksa i liječenje krvarenja ili krvarenja kod kirurških zahvata u bolesnika s von Willebrandovom bolešću kad je liječenje samim dezmopresinom (DDAVP) nedjelotvorno ili kontraindicirano.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Croatian: Liječenje takvih bolesnika trebaju voditi liječnici s iskustvom u liječenju hemofilije i inhibitora faktora VIII.
English: Marketing Authorization Holder and Manufacturer
Croatian: Nositelj odobrenja za stavljanje lijeka u promet i proizvođač
English: No adverse reactions have been associated with these reports.
Croatian: Nuspojava u svezi s ovim slučajevima nije bilo.
English: * The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: * Jačina FVIII (IU) određena je kromogenim testom prema Europskoj farmakopeji.
English: Place the product vial on an even and firm surface.
Croatian: Bočicu s lijekom stavite na ravnu i čvrstu površinu.
English: VWF inhibition
Croatian: Inhibicija VWF
English: 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: U djece koja ranije nisu bila liječena lijekovima koji sadrže faktor VIII, vrlo često (u više od 1 na 10 bolesnika) mogu nastati inhibitorna antitijela (vidjeti dio 2); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100 bolesnika).
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated infusions.
Croatian: Tijekom trajanja liječenja preporučuje se odgovarajuće određivanje razina faktora VIII kao smjernica za dozu koju treba primijeniti i učestalost ponavljanja infuzija.
English: The reconstituted solution should be clear to slightly opalescent, i.e. it might sparkle when held up to the light but must not contain any obvious particles.
Croatian: Pripremljena otopina treba biti bistra do blago opalescentna, tj. može se sjajiti kad se drži prema svjetlu, ali ne smije sadržavati nikakve vidljive čestice.