natgillin/translations-raw huggingface dataset:
The listed warnings and precautions apply to children and adolescents. 
Našteta opozorila in previdnostni ukrepi veljajo za otroke in mladostnike.
The solution should be clear or slightly opalescent. 
Splošna navodila Raztopina mora biti bistra ali nekoliko opalescentna.
The relative content of HMW (high molecular weight) VWF multimers in Voncento is on average 86 % when compared to normal human plasma (NHP). 
Relativna HMW (visoka molekulska masa) VWF multimerov zdravila Voncento v primerjavi z normalno humano plazmo je v povprečju 86 %.
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. 
Za injiciranje zdravila Voncento je treba uporabiti le priloženi komplet za uporabo, saj je lahko zdravljenje neuspešno zaradi adsopcije FVIII na notranje površine nekaterih vrst opreme za injiciranje/infundiranje.
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. 
Če zdravila ne uporabimo takoj, je za čas shranjevanja med uporabo in pogoje shranjevanja pred uporabo odgovoren uporabnik in običajno ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C.
There is a risk of formation of blood clots (thrombosis), particularly in patients with known risk factors (see also section 2). 
Obstaja tveganje za nastanek krvnih strdkov (tromboza), zlasti pri bolnikih z znanimi dejavniki tveganja (glejte tudi poglavje 2).
In some cases, especially in younger patients, higher doses may be needed. 
V nekaterih primerih, zlasti pri mlajših bolnikih, bodo morda potrebni višji odmerki.
The replacement of VWF and FVIII by Voncento will temporarily repair the blood clotting mechanisms. 
Nadomestitev VWF in FVIII z zdravilom Voncento bo začasno popravila mehanizem strjevanja krvi.
Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available. 
Na podlagi redke pojavnosti hemofilije A pri ženskah, podatki o izkušnjah glede uporabe FVIII med nosečnostjo in dojenjem niso na voljo.
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. 
Zelo priporočljivo je, da se vsakič, ko bolnik dobi zdravilo Voncento, zabeležita ime in serijska številka zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors. 
Klinični pomen nastanka zaviralcev je odvisen od titra zaviralca, pri čemer zaviralci z nizkim titrom pomenijo manjše tveganje za nezadosten klinični odziv kot zaviralci z visokim titrom.
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). 
Če se pojavi kakršna koli reakcija, ki bi lahko bila povezana z dajanjem zdravila Voncento, je treba hitrost injiciranja upočasniti ali prekiniti dajanje zdravila, kot zahteva klinično stanje bolnika (glejte tudi poglavje 4.4).
Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins. 
Predkliničnih študij z dajanjem ponovljenih odmerkov (toksičnosti pri ponavljajočih odmerkih, kancerogenega potenciala in mutagenosti) v uveljavljenih živalskih modelih ni moč opraviti zaradi nastanka protiteles po dajanju heterolognih humanih beljakovin.
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). 
Okužba s parvovirusom B19 je lahko nevarna za nosečnice (okužba ploda) in za posameznike s pomanjkljivim imunskim odzivom ali s povečano eritropoezo (npr. pri hemolitični anemiji).
It is important to calculate the dose using the number of IU of VWF:RCo specified. 
Pomembno je, da odmerek izračunamo z uporabo števila i.e. določenega VWF:RCo.
Ristocetin Cofactor, FVIII:C = Factor VIII: Coagulant 
ristocetinski kofaktor, FVIII:C = Faktor VIII: koagulant
Inject air into the product vial. 
Vbrizgajte zrak v vialo z zdravilom.
• Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor. 
• Neuporabljeno zdravilo ali odpadni material zavrzite v skladu z lokalnimi predpisi in navodili zdravnika.
Required units = body weight [kg] x desired factor VIII rise [% or IU/dl] x 0.5. 
Potrebno št. enot = telesna masa [kg] x želeni dvig faktorja VIII [% ali i.e./dl] x 0,5.
In patients with gastrointestinal bleeds or menorrhagia, shorter dose intervals or higher doses may be necessary. 
Pri bolnikih z gastrointestinalnimi krvavitvami ali menoragijo so lahko potrebni krajši razmiki med odmerki ali višji odmerki.
• the site and intensity of the bleeding 
• mesta in obsega krvavitve,
One pack contains: 
Eno pakiranje vsebuje:
By replacement therapy the plasma level of FVIII is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendency. 
Z nadomestnim zdravljenjem zvečamo plazemsko raven FVIII in tako omogočimo začasno popravo pomanjkanja faktorja in nagnjenosti h krvavitvam.
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. 
Kadar se zdravila proizvajajo iz človeške krvi ali plazme, mora izdelovalec uvesti nekatere ukrepe za preprečevanje okužb oziroma njihovega prenosa na bolnike.
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. 
Zdravilo Voncento se uporablja pri vseh starostnih skupinah za preprečevanje ali zaustavitev krvavitve, ki jo povzroča pomanjkanje VWF pri von Willebrandovi bolezni (VWB) in pomanjkanje FVIII pri hemofiliji A. Zdravilo Voncento se uporablja samo takrat, ko zdravljenje z drugim zdravilom, dezmopresinom, sámo ni učinkovito ali pri vas ne pride v poštev.
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. 
Odločitev o tem, ali se sme uporabljati zdravilo za bolnike s VWB in hemofilijo A doma, mora sprejeti lečeči zdravnik, ki mora tudi poskrbeti za ustrezno izobraževanje ter uporabo v določenih časovnih presledkih tudi preverjati.
• If you have been told you have heart disease or are at risk for heart disease, tell your doctor or pharmacist. 
• Če so vam povedali, da imate bolezen srca ali da pri vas obstaja tveganje za bolezni srca,
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). 
Če se pojavijo neželeni učinki, ki bi lahko bili povezani z dajanjem zdravila Voncento, je treba injiciranje ali infuzijo ustaviti (glejte tudi poglavje 2).
• Allergic (hypersensitivity) reactions are possible. 
• Možne so alergijske (preobčutljivostne) reakcije.
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.. 
Zlasti pri velikih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo koagulacije (aktivnosti faktorja VIII v plazmi).
• 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. 
• Če zdravila ne damo takoj, je za čas in pogoje shranjevanja pred uporabo odgovoren uporabnik in ne bi smeli trajati dlje kot 24 ur pri 2 °C do 8 °C.
Dose based on bodyweight may require adjustment in underweight or overweight patients. 
Odmerek, ki temelji na telesni masi, je morda treba prilagoditi pri bolnikih s prenizko ali prekomerno telesno težo.
Patients aged 12 to 18 years old: Dosing is based on the same guidelines as for adults. 
Bolniki, stari 12 do 18 let: Odmerjanje temelji na istih smernicah, kot veljajo za odrasle.
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. 
Število danih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard koncentrata WHO za zdravila s faktorjem VIII.
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: 
Na podlagi farmakokinetične študije z 12 preiskovanci ≥ 12 let z VWB so opazili naslednje farmakokinetične karakteristike za VWF:Rco, VWF:Ag, VWF:CB in FVIII:C:
Prophylaxis and treatment of haemorrhage or surgical bleeding in patients with VWD, when desmopressin (DDAVP) treatment alone is ineffective or contraindicated. 
Preprečevanje in zdravljenje krvavitev ali kirurških krvavitev pri bolnikih s VWB, ko samo zdravljenje z dezmopresinom (DDAVP) ni učinkovito ali je kontraindicirano.
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. 
V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v ustreznem obdobju.
Carefully remove the protective caps from the vials, and clean the exposed rubber stoppers with an alcohol swab. 
Previdno odstranite zaščitni zaporki z vial in očistite izpostavljena gumijasta zamaška z alkoholno blazinico.
Administered intravenously, VWF binds to endogenous FVIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation. 
Ko ga damo intravensko, se VWF veže na endogeni FVIII (ki ga bolnik normalno izdeluje) in ga stabilizira ter tako prepreči njegovo hitro razgradnjo.
Voncento has no influence on the ability to drive and use machines. 
Zdravilo Voncento nima vpliva na sposobnost vožnje in upravljanja strojev.
If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding. 
Če pride do tega, zdravilo pri vas ali vašem otroku ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
The frequency of administration should always be oriented to the clinical effectiveness in the individual case. 
Pogostost uporabe zdravila mora vedno temeljiti na klinični učinkovitosti v posameznem primeru.
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). 
Ponovite infundiranje na vsakih 824 ur, dokler se rana zadovoljivo ne zaceli, potem nadaljujte zdravljenje še vsaj 7 dni za vzdrževanje aktivnosti faktorja VIII 30 % - 60 % (i.e./dl).
Name and address of the manufacturer(s) responsible for batch release CSL Behring GmbH 
Ime in naslov izdelovalca (izdelovalcev), odgovornega (odgovornih) za sproščanje serij CSL Behring GmbH
There is a risk of occurrence of thrombotic events, particularly in patients with known clinical or laboratory risk factors. 
Obstaja tveganje za pojav trombotičnih dogodkov, zlasti pri bolnikih z znanimi kliničnimi ali laboratorijskimi dejavniki tveganja.
See section “The following information is intended for healthcare professionals only” for further information. 
Za dodatne informacije glejte poglavje “Naslednje informacije so namenjene samo zdravstvenemu osebju“.
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). 
Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (pri manj kot 1 od 100 bolnikov).
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. 
Zato uporaba čistega VWF (zdravilo VWF z nizko ravnijo FVIII) povrne raven FVIII:C na normalno, kot sekundarni učinek, s krajšo zakasnitvijo po prvem infundiranju.
Allergic type hypersensitivity reactions are possible. 
Možne so preobčutljivostne reakcije alergijskega tipa.
Elderly No dose adjustment is necessary for the older people. 
Starejši Prilagajanje odmerkov pri starejših bolnikih ni potrebno.
Levels of VWF:RCo of > 0.6 IU/ml (60 %) and of FVIII:C of > 0.4 IU/ml (40 %) should be achieved. 
Dosegli naj bi raven VWF:RCo > 0,6 i.e./ml (60 %) in FVIII:C > 0,4 i.e./ml (40 %).
For prevention of excessive bleeding during or after surgery the application should start 1 - 2 hours before the surgical procedure. 
Za preprečevanje čezmerne krvavitve med kirurškim posegom ali po njem je treba z injiciranjem pričeti 1 do 2 uri pred kirurškim posegom.
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). 
Uvedeni ukrepi so učinkoviti proti virusom z ovojnico, kot so virus humane imunske pomanjkljivosti (HIV), virus hepatitisa B (HBV) in virus hepatitisa C (HCV), ter proti virusu brez ovojnice, virusu hepatitisa A (HAV).
Treatment monitoring 
Spremljanje zdravljenja
• your body weight (see also section “The following information is intended for healthcare professionals only”). 
(glejte tudi poglavje “Naslednje informacije so namenjene samo zdravstvenemu osebju”).
Hypersensitivity (including tachycardia, chest pain, chest discomfort and back pain) 
Bolezni imunskega sistema preobčutljivost (vključno s tahikardijo, bolečino v prsih, tiščanjem v prsih in bolečino v hrbtu)
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). 
Uvedeni ukrepi so učinkoviti proti tako imenovanim virusom "z ovojnico", kot so virus humane imunske pomanjkljivosti (HIV, virus AIDS-a), virus hepatitisa B in virus hepatitisa C (ki povzročita vnetje jeter), in proti virusu "brez ovojnice", virusu hepatitisa A (ki tudi povzroči vnetje jeter).
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. 
Nastanek protiteles, ki nevtralizirajo faktor VIII (zaviralci), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti zaviralci so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
If you have VWD your doctor will prescribe you Voncento with the number of units of VWF specified. 
Če imate VWB, vam bo zdravnik predpisal zdravilo Voncento z določenim številom enot VWF.
In patients with VWD, there is a risk of occurrence of thromboembolic events, particularly in patients with known clinical or laboratory risk factors. 
Pri bolnikih s VWB obstaja tveganje pojava trombemboličnih dogodkov, zlasti pri bolnikih z znanimi kliničnimi ali laboratorijskimi dejavniki tveganja.
- Administration of a FVIII:C containing VWF preparation restores the FVIII:C level to normal immediately after the first infusion. 
- Dajanje pripravka VWF, ki vsebuje FVIII:C, povrne raven FVIII:C na normalno nemudoma po prvem infundiranju.
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). 
Ti vključujejo koprivnico, kožne izpuščaje po vsem telesu, tiščanje v prsih, piskanje v pljučih, padec krvnega tlaka ter anafilaksijo (resno alergijsko reakcijo, ki povzroči hude težave z dihanjem ali omotico).
Minor surgery including tooth extraction 
Kirurški posegi Manjši kirurški poseg, vključno z izruvanjem zoba
Based on a pharmacokinetic study with 16 subjects ≥ 12 years of age with haemophilia A, the following pharmacokinetic characteristics for FVIII:C were observed: 
Na podlagi farmakokinetične študije s 16 preiskovanci ≥ 12 let s hemofilijo A so opazili naslednje farmakokinetične karakteristike za FVIII:C:
Patients with VWD, especially type 3 patients, may develop neutralising antibodies (inhibitors) to VWF. 
Bolniki z VWB, zlasti bolniki s tipom 3, lahko razvijejo nevtralizirajoča protitelesa (inhibitorje) proti VWF.
Place the product vial on an even and firm surface. 
Postavite vialo z zdravilom na ravno in trdno podlago.
Voncento should be administered to pregnant or breast-feeding VWF deficient women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients. 
Zdravilo Voncento se lahko daje nosečnicam in doječim materam s pomanjkanjem VWF le, če je jasno indicirano, ob upoštevanju dejstva, da porod pri teh bolnicah pomeni povečano tveganje za krvavitve.
How to use Voncento 
Kako uporabljati zdravilo Voncento
In all such cases, it is recommended that a specialised haemophilia centre be contacted. 
V vseh takih primerih priporočamo, da se obrnete na specializirani center za hemofilijo.
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. 
Kljub tem ukrepom pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti prenosa okužbe.
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. 
Hemofilija A je na spolni kromosom vezana dedna motnja strjevanja krvi zaradi znižane ravni FVIII in posledica so obsežne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano bodisi kot posledice nezgod ali kirurških poškodb.
Generally, 1 IU/kg VWF:RCo raises the circulating level of VWF:RCo by 0.02 IU/ml (2 %). 
Na splošno 1 i.e./kg VWF:RCo dvigne raven VWF:RCo v krvnem obtoku za 0,02 i.e./ml (2 %).
Use the venipuncture kit supplied with the product, insert the needle into a vein. 
Uporabite komplet za punkcijo vene, ki je priložen v pakiranju zdravila, vstavite iglo v žilo.
The pharmacokinetics of Voncento have been evaluated in VWD patients in the non-bleeding state. 
Farmakokinetiko zdravila Voncento so vrednotili pri bolnikih z VWB, ko niso krvaveli.
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. 
Če ne dosegamo pričakovane ravni aktivnosti VWF:RCo v plazmi ali krvavitve ne obvladamo z ustreznim odmerkom, opravimo ustrezno preiskavo, da določimo navzočnost inhibitorja VWF.
Name and address of the manufacturer(s) of the biological active substances 
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
Withdrawal and Application 
Izsesanje in apliciranje
In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered. 
Pri bolnikih z veliko koncentracijo zaviralca zdravljenje s faktorjem VIII morda ne bo učinkovito, zato je treba razmisliti o drugih možnostih zdravljenja.
• If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, 
• Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
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. 
Dajanje VWF omogoča izboljšanje hemostatskih motenj, ki so prisotne pri bolnikih s pomanjkanjem VWF (VWB), na dveh ravneh: - VWF ponovno vzpostavi adhezijo trombocitov na žilni subendotelij na mestu poškodbe žile (s tem, ko se veže na žilni subendotelij in na membrano trombocitov), kar omogoči primarno hemostazo, ki je vidna s skrajšanjem časa krvavitve.
What you need to know before you use Voncento Do not use Voncento 
Kaj morate vedeti, preden boste uporabili zdravilo Voncento Ne uporabljajte zdravila Voncento
1 non-sterile plaster 
1 nesterilen obliž
* The FVIII potency (IU) is determined using the European Pharmacopoeia chromogenic assay. 
* Aktivnost (i.e.) FVIII je določena s pomočjo kromogenega preskusa po Evropski farmakopeji.
Like all medicines, Voncento can cause side effects, although not everybody gets them. 
Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Voncento neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors. 
Obravnavo takih bolnikov mora voditi zdravnik z izkušnjami z zdravljenjem hemofilije in zaviralci faktorja VIII.
The specific VWF activity of Voncento, prior to the addition of stabiliser, is approximately 100 IU of VWF/mg protein. 
Specifična aktivnost VWF zdravila Voncento, pred dodatkom stabilizatorja, je približno 100 i.e. VWF/mg beljakovin.
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. 
Priporočamo uporabo plastičnih brizg za enkratno uporabo, ker se na mlečno-steklene površine vseh steklenih brizg te vrste raztopine lepijo.
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). 
Pri bolnikih, ki prejemajo zdravila VWF, ki vsebujejo FVIII, lahko dlje časa trajajoča čezmerna plazemska raven FVIII:C poveča tveganje za trombembolične dogodke (glejte tudi poglavje 4.4).
Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. 
Bolnike moramo poučiti o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo izpuščaj, generalizirano urtikarijo, tiščanje v prsih, piskanje v pljučih, hipotenzijo ter anafilaksijo.
• Proceed with your next dose immediately and continue at regular intervals as advised by your doctor. 
Če ste pozabili uporabiti zdravilo Voncento • Takoj nadaljujte z vašim naslednjim odmerkom in nadaljujte z rednimi intervali, ki vam jih je predlagal zdravnik.