FrancophonIA/ELRC3.0 huggingface dataset:
English: Place the solvent vial on an even, clean surface and hold the vial tight.
Slovenian: Postavite vialo z vehiklom na ravno, čisto podlago in jo trdno držite.
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.
Slovenian: Bolniki, mlajši od 12 let: Na podlagi rezultatov kliničnega preskušanja, v katerem se je izkazalo, da so imeli pediatrični bolniki, mlajši od 12 let, manjšo izpostavljenost VWF, se priporoča profilaktično odmerjanje v razponu 40 - 80 i.e. VWF:RCo na kilogram telesne mase 1-krat do 3-krat na teden.
English: Bring the solvent to room temperature.
Slovenian: Vehikel segrejte na sobno temperaturo.
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.
Slovenian: Za dolgotrajno profilakso krvavitev pri bolnikih s hudo hemofilijo A so običajni odmerki 20 do 40 i.e. faktorja VIII na kg telesne mase v intervalih 2 do 3 dni.
English: The risk of developing blood clots (thrombosis) cannot be excluded in case of an extremely high dose, especially in patients with VWD.
Slovenian: V primeru skrajno visokega odmerjanja ni možno izključiti tveganja za nastanek krvnih strdkov (trombozo), zlasti pri bolnikih s VWB.
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.
Slovenian: Z eno roko primite komplet Mix2Vial na tisti strani, kjer je viala z zdravilom, z drugo pa na strani vehikla in z odvijanjem v nasprotni smeri urinega kazalca previdno razstavite komplet na dva dela, da se izognete pretiranemu nastajanju pene pri raztapljanju zdravila.
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.
Slovenian: Prepričajte se, da sta zunanji zaščitni zaporki viale s praškom in viale z vehiklom odstranjeni, zamaška pa obrisana z antiseptično raztopino in osušena še pred odprtjem zavoja Mix2Vial.
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pri uporabi zdravil, pripravljenih iz človeške krvi ali plazme, ni mogoče popolnoma izključiti nevarnosti prenosa povzročiteljev infekcijskih bolezni.
English: (h*IU/mL) MRT (h)
Slovenian: (h*i.e./mL) MRT (h)
English: • If you have further questions, ask your doctor, your nurse or your pharmacist.
Slovenian: • Če imate dodatna vprašanja, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Paediatric VWD population
Slovenian: Pediatrična populacija s VWB
English: In such cases, it is recommended that a specialised haemophilia centre be contacted.
Slovenian: V takih primerih priporočamo, da se obrnete na specialistični center za zdravljenje hemofilije.
English: • Do not store above 25 °C.
Slovenian: • Shranjujte pri temperaturi do 25 °C.
English: Prophylaxis treatment
Slovenian: Profilaktično zdravljenje
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: Začetna hemartroza, krvavitev v mišico ali krvavitev v ustni votlini
English: Repeat infusion every 24 hours for at least 1 day, until healing is achieved.
Slovenian: Ponovite infundiranje na vsakih 24 ur vsaj 1 dan, dokler se ne zaceli.
English: Calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
Slovenian: kalcijev klorid, humani albumin, natrijev klorid, natrijev citrat, saharoza, trometamol.
English: Exogenously administered human plasma-derived VWF behaves in the same way as endogenous VWF.
Slovenian: Eksogeno apliciran VWF, pridobljen iz človeške plazme, se vede enako kot endogeni VWF.
English: Parvovirus B19 infection may be serious • for pregnant women (as there is a risk of infection of the unborn child) and
Slovenian: • za nosečnice (ker obstoja tveganje za okužbo nerojenega otroka) in
English: powder and solvent for solution for injection/infusion 1 vial with powder
Slovenian: prašek in vehikel za raztopino za injiciranje/infundiranje 1 viala s praškom
English: Prophylaxis against venous thromboembolism should be instituted, according to the current recommendations.
Slovenian: Skladno s trenutnimi priporočili začnemo profilakso proti venskim trombembolizmom.
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).
Slovenian: Farmakokinetiko enkratnega odmerka 50 i.e.FVIII/kg telesne mase so vrednotili pri 31 pediatričnih preiskovancih, mlajših od 12 let, s hemofilijo A (glejte spodnjo preglednico).
English: Calcium chloride Human albumin Sodium chloride Sodium citrate Sucrose
Slovenian: Prašek kalcijev klorid humani albumin natrijev klorid natrijev citrat saharoza trometamol
English: Exogenously administered human plasma-derived FVIII behaves in the same way as endogenous FVIII.
Slovenian: Eksogeno apliciran FVIII, pridobljen iz človeške plazme, se obnaša enako kot endogeni FVIII.
English: The immediate container of product and solvent vial consists of glass vial with a rubber stopper, plastic disc, and aluminium cap.
Slovenian: Stično ovojnino viale zdravila in vehikla predstavlja steklena viala z gumijastim zamaškom, plastično okroglo ploščico in aluminijasto zaporko.
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.
Slovenian: (i.e./ml)/(i.e./kg) za VWF markerje in 0,018-0,020 (i.e./ml)/(i.e./kg) za FVIII:C. Mediani razpolovni čas izločanja (t ½) za VWF markerje je bil med 10,00 in 13,48 ur, pri čemer je bil t ½ za FVIII:C daljši in je bil med 11,40 in 19,54 ur zaradi plato učinka, kar lahko predstavlja neto učinek zmanjšanih ravni eksogeno uporabljenega FVIII, v kombinaciji s povečanjem ravni endogeno uporabljenega FVIII.
English: CSL Behring (Australia) Pty Ltd 189-209 Camp Road Broadmeadows
Slovenian: CSL Behring (Australia) Pty Ltd
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).
Slovenian: Opazili so preobčutljivostne ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in zbadanje na mestu infuzije, mrazenje, rdečico, generalizirano urtikarijo, glavobol, izpuščaj, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsih (vključno z bolečino v prsih in nelagodnjem v prsih), bolečino v hrbtu, mravljinčenje, bruhanje, piskanje v pljučih).
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.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika ter njegovih plazemskih ravni VWF:RCo in FVIII:C.
English: The pharmacokinetics of Voncento have been evaluated in haemophilia A patients in the non-bleeding state.
Slovenian: Farmakokinetiko zdravila Voncento so vrednotili pri bolnikih s hemofilijo A, ko niso krvaveli.
English: Check yourself for any side effects that might happen straight away.
Slovenian: Opazujte se za primer pojava takojšnjih neželenih učinkov.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
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.
Slovenian: Vzemite Mix2Vial skupaj s pretisnim omotom in porinite konico modrega adapterja naravnost navzdol skozi zamašek viale z vehiklom.
English: In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, zlasti pri mlajših bolnikih, bodo morda potrebni krajši razmiki med odmerki ali višji odmerki.
English: If you have been prescribed Voncento to use at home, your doctor will make sure that you are shown how to inject it and how much to use.
Slovenian: Če so vam zdravilo Voncento predpisali za uporabo doma, bo zdravnik poskrbel, da boste poučeni,
English: Contents of the pack and other information What Voncento contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Voncento Učinkovina je:
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.
Slovenian: Izpostavljenost zdravilu Voncento in dispozicija zdravila sta bili pri preiskovancih, starih <6 let in 6-12 let, primerljivi.
English: The specific FVIII activity of Voncento, prior to the addition of stabiliser, is approximately 70 IU of FVIII/mg protein.
Slovenian: Specifična aktivnost FVIII zdravila Voncento, pred dodatkom stabilizatorja, je približno 70 i.e.
English: Voncento 1000 IU / 2400 IU
Slovenian: Voncento 1000 i.e./2400 i.e.
English: In some cases shorter dose intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, so lahko potrebni krajši razmiki med odmerki ali večji odmerki.
English: Degree of haemorrhage / Type of surgical procedure
Slovenian: Stopnja krvavitve/ vrsta kirurškega posega
English: Treatment of VWD and haemophilia A should be supervised by a physician experienced in the treatment of haemostatic disorders.
Slovenian: Zdravljenje VWB in hemofilije A naj nadzoruje zdravnik z izkušnjami pri zdravljenju motenj hemostaze.
English: When infused into a haemophiliac patient, FVIII binds to VWF in the patient's circulation.
Slovenian: Če ga infundiramo hemofiliku, se v krvnem obtoku bolnika FVIII veže na VWF.
English: One pack with 250 IU/600 IU or 500 IU/1200 IU containing: - 1 vial with powder - 1 vial with 5 ml water for injections - 1 filter transfer device 20/20 - One inner box containing:
Slovenian: Ena škatla z 250 i.e./600 i.e. ali 500 i.e./1200 i.e.vsebuje: - 1 vialo s praškom - 1 vialo s 5 ml vode za injekcije - 1 priprava za prenos s filtrom 20/20 - Ena notranja škatla vsebuje:
English: Voncento 250 IU / 600 IU
Slovenian: Voncento 250 i.e./600 i.e.
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).
Slovenian: Aktivnost faktorja VIII v plazmi je izražena bodisi kot odstotek (glede na normalno humano plazmo) bodisi preferenčno v mednarodnih enotah
English: The following side effect has been observed very commonly (may affect more than 1 in 10 people):
Slovenian: Naslednji neželeni učinki so se pojavili zelo pogosto (pojavijo se lahko pri več kot 1 od 10 bolnikov):
English: Cmin (IU/mL)
Slovenian: Cmin (i.e./mL)
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.
Slovenian: Uporaba pri otrocih in mladostnikih Odmerjanje pri otrocih in mladostnikih < 18 let temelji na telesni masi in zato na splošno temelji na enakih navodilih kot pri odraslih.
English: N median range N median range N median range N median range
Slovenian: (razpon) N mediana (razpon) N mediana (razpon) N mediana (razpon) N mediana (razpon) N mediana (razpon) N mediana (razpon) N mediana
English: Voncento 500 IU / 1200 IU
Slovenian: Voncento 500 i.e./1200 i.e.
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:
Slovenian: Eno pakiranje s 500 i.e. /1200 i.e. ali 1000 i.e. /2400 i.e. vsebuje: - 1 viala s praškom - 1 viala z 10 ml vode za injekcije - 1 priprava za prenos s filtrom 20/20 - Ena notranja škatla vsebuje:
English: Other ingredients: calcium chloride, human albumin, sodium chloride, sodium citrate, sucrose, trometamol.
Slovenian: SEZNAM POMOŽNIH SNOVI Druge sestavine: kalcijev klorid, humani albumin, natrijev klorid, natrijev citrat, saharoza, trometamol.
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.
Slovenian: ** Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A. PZB = predhodno zdravljeni bolniki, PNB = predhodno nezdravljeni bolniki *** Neželeni učinki o katerih so poročali po prihodu zdravila na trg in jih niso opazili v kliničnih preskušanjih.
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).
Slovenian: Farmakokinetiko enkratnega odmerka 80 i.e.VWF:RCo na kilogram telesne mase so vrednotili pri pediatričnih preiskovancih, mlajših od 12 let, s hudo von Willebrandovo boleznijo (glejte preglednico spodaj).
English: Liver function test abnormal
Slovenian: Preiskave nenormalni rezultati preiskav jetrne funkcije občasni
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).
Slovenian: Pri uporabi zdravila VWF, ki vsebuje FVIII, se mora lečeči zdravnik zavedati, da lahko pride pri nadaljnem zdravljenju do čezmernega dviga FVIII:C. Pri bolnikih, ki prejemajo zdravila VWF, ki vsebujejo FVIII, moramo spremljati plazemsko raven FVIII:C, da se izognemo dlje časa trajajoči čezmerni plazemski ravni FVIII:C, ki lahko poveča tveganje za trombotične dogodke, in upoštevamo protitrombotične ukrepe (glejte tudi poglavje 5.2).
English: von Willebrand disease (VWD)
Slovenian: Von Willebrandova bolezen (VWB)
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).
Slovenian: (i.e.) faktorja VIII na kg telesne mase zviša aktivnost faktorja VIII v plazmi za približno 2 % normalne aktivnosti (in vivo povrnitev 2 i.e./dl).
English: Nervous system disorders
Slovenian: Bolezni živčevja disgevzija občasni
English: The risk of thromboembolic events cannot be excluded in case of major overdose, especially in patients with VWD.
Slovenian: V primeru skrajno visokega odmerjanja ne moremo izključiti tveganja za trombembolične dogodke, še zlasti pri bolnikih s VWB.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Voncento Vsebina pakiranja in dodatne informacije
English: The following side effects have been observed uncommonly (may affect up to 1 in 100 people):
Slovenian: Naslednji neželeni učinki so se pojavili občasno (pojavijo se lahko pri največ 1 od 100 bolnikov):
English: Voncento is supplied as a white powder and solvent for solution for injection/infusion.
Slovenian: Zdravilo Voncento je na voljo v obliki belega praška in vehikla za raztopino za injiciranje/infundiranje.
English: • Keep the vial in the outer carton in order to protect from light.
Slovenian: • Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Cmax (IU/mL)
Slovenian: Cmax (i.e./mL)
English: Do not use visibly cloudy solutions or solutions still containing flakes or particles.
Slovenian: Vidno motnih raztopin ali raztopin, ki tudi po filtraciji vsebujejo kosmiče ali delce, ne uporabite.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Za vodilo pri odmerjanju pri krvavitvah ali kirurških posegih lahko uporabimo spodnjo tabelo:
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
Slovenian: Voncento 250 i.e. FVIII/600 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje Voncento 500 i.e. FVIII/1200 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje Voncento 500 i.e. FVIII/1200 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje Voncento 1000 i.e. FVIII/2400 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
English: (IU/mL)
Slovenian: (i.e./mL)
English: • Abnormal liver function test
Slovenian: • sprememba okusa (disgevzija) • nenormalni rezultati preiskav jetrne funkcije
English: During treatment with Voncento the following adverse reactions may occur:
Slovenian: Alergijske reakcije lahko vključujejo naslednje simptome:
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.
Slovenian: 1000 i.e. FVIII in 2400 i.e. VWF na vialo; po pripravi s 10 ml vode za injekcije vsebuje približno 100 i.e./ml FVIII in 240 i.e./ml VWF.
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.
Slovenian: Ob uporabi zdravila VWF, ki vsebuje tudi FVIII, se mora lečeči zdravnik zavedati, da lahko podaljšano zdravljenje povzroči čezmeren dvig FVIII:C. Po 24 - 48 urah zdravljenja je treba razmisliti o zmanjšanju odmerkov in/ali podaljšanju časovnega razmaka med odmerki ali pa uporabi zdravila VWF, ki vsebuje nizko količino faktorja FVIII, da se izognemo čezmernemu porastu FVIII:C.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Količino danega zdravila in pogostnost dajanja vedno določamo glede na klinično učinkovitost pri posameznem bolniku.
English: Open the Mix2Vial package by peeling off the lid. Do not remove the Mix2Vial from the blister package!
Slovenian: Ne odstranite Mix2Vial iz pretisnega omota!
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.
Slovenian: Ko je raztopina v injekcijski brizgi, trdno primite tulec injekcijske brizge (bat naj bo še vedno obrnjen navzdol) in snemite komplet Mix2Vial z injekcijske brizge z odvijanjem v nasprotni smeri urinega kazalca,
English: Keep vials in the outer carton in order to protect from light.
Slovenian: Viali shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
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.
Slovenian: Profilaktično zdravljenje Za dolgotrajno profilakso krvavitev pri bolnikih s VWB se priporoča odmerek 25 - 40 i.e. VWF:RCo na kilogram telesne mase 1- do 3-krat na teden.
English: Repeat infusion every 8 to 24 hours until threat is resolved.
Slovenian: Ponovite infundiranje na vsakih 824 ur, dokler nevarnost ne preneha.
English: Collagen Binding; VWF:RCo = von Willebrand factor: Ristocetin Cofactor, FVIII:C = Factor VIII: Coagulant
Slovenian: von Willebrandov faktor: ristocetinski kofaktor, FVIII:C = Faktor VIII: koagulant
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.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika, vrste in resnosti krvavitve ter ravni obeh faktorjev VWF:RCo in
English: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany
Slovenian: Emil-von-Behring-Str. 76 35041 Marburg
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Тел: +359 2 850 8617
Slovenian: Новимед Фарма EООД Тел: +359 2 850 8617
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).
Slovenian: Ob uporabi zdravila VWF, ki vsebuje tudi FVIII, se mora lečeči zdravnik zavedati, da lahko podaljšano zdravljenje povzroči čezmeren dvig FVIII:C. Po 24 - 48 urah zdravljenja je treba razmisliti o zmanjšanju odmerkov in/ali podaljšanju časovnega razmaka med odmerki ali pa uporabi zdravila VWF, ki vsebuje nizko količino faktorja FVIII, da se izognemo čezmernemu porastu FVIII:C (glejte poglavje 5.2).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 500 IU/1200 IU
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla 500 i.e./ 1200 i.e.
English: Adverse Reaction*
Slovenian: Neželeni učinki*
English: CSL Behring GmbH Emil-von-Behring-Straße 76 35041 Marburg Germany
Slovenian: Emil-von-Behring-Straße 76 35041 Marburg
English: N median range
Slovenian: N mediana
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.
Slovenian: Pakiranje z 250 i.e. FVIII / 600 i.e. VWF (5 ml vehikel) in 500 i.e. FVIII / 1200 i.e. VWF (5 ml vehikel): vsebuje do 14,75 mg (0,64 mmol) natrija na vialo, kar je enako 0,74 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča WHO in znaša 2 g.
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Slovenian: Zavrzite vialo z vehiklom skupaj z modrim adapterjem, pritrjenim na Mix2Vial.
English: • If you get any side effects talk to your doctor, nurse or pharmacist.
Slovenian: • Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: Total clearance (mL/(h*kg)
Slovenian: skupni očistek (mL/(h*kg)