FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Voncento
Slovenian: Shranjevanje zdravila Voncento
English: • von Willebrand disease
Slovenian: • Von Willebrandova bolezen
English: Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived factor VIII/VWF products.
Slovenian: Pri bolnikih, ki redno/večkrat prejemajo FVIII/VWF zdravila, pridobljena iz človeške plazme, je treba razmisliti o ustreznem cepljenju (proti hepatitisu A in B).
English: Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Slovenian: Za doseganje hemostaze običajno priporočamo 40 - 80 i.e./kg von Willebrandovega faktorja (VWF:RCo) kar ustreza 20 - 40 i.e. FVIII:C/kg telesne mase (TM).
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.
Slovenian: 24 ur, vsaj 1 dan, dokler krvavitev, sodeč po bolečini, ne preneha ali dokler se ne zaceli.
English: 100 IU/ml FVIII and 240 IU/ml VWF.
Slovenian: Voncento 1000 i.e. FVIII/2400 i.e VWF.
English: Presentations with 500 IU FVIII / 1200 IU VWF (10 ml solvent) and 1000 IU FVIII / 2400 IU VWF (10 ml solvent): contain up to 29.50 mg (1.28 mmol) sodium per vial, equivalent to 1.48% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Pakiranje s 500 i.e. FVIII / 1200 i.e. VWF (10 ml vehikel) in 1000 i.e. FVIII / 2400 i.e. VWF (10 ml vehikel): vsebuje do 29,50 mg (1,28 mmol) natrija na vialo, kar je enako 1,48 % največjega dnevnega vnosa natrija za odrasle osebe, ki ga priporoča WHO in znaša 2 g. Pediatrična populacija
English: The presentations 500 IU FVIII /1200 IU VWF (10 ml solvent) and 1000 IU FVIII /2400 IU VWF (10 ml solvent) contain up to 29.50 mg sodium per vial (main component of cooking/table salt).
Slovenian: Pakiranje s 500 i.e. FVIII /1200 i.e. VWF (10 ml vehikel) in 1000 i.e. FVIII /2400 i.e. VWF (10 ml vehikel) vsebuje do 29,50 mg natrija na vialo (glavne sestavine kuhinjske soli).
English: - 1200 IU*** human von Willebrand factor** (VWF).
Slovenian: - 1200 i.e.*** humanega von Willebrandovega faktorja** (VWF).
English: This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Voncento.
Slovenian: Inhibicija FVIII Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom Voncento, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: - 2400 IU*** human von Willebrand factor** (VWF).
Slovenian: - 2400 i.e.*** humanega von Willebrandovega faktorja** (VWF).
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.
Slovenian: Če je potreben centralni venski kateter (CVK), je treba upoštevati možnost lokalnih okužb,
English: - 600 IU*** human von Willebrand factor** (VWF).
Slovenian: - 600 i.e.*** humanega von Willebrandovega faktorja** (VWF).
English: The presentations 250 IU FVIII /600 IU VWF (5 ml solvent) and 500 IU FVIII /1200 IU VWF (5 ml solvent) contain up to 14.75 mg sodium per vial (main component of cooking/table salt).
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 natrija na vialo (glavne sestavine kuhinjske soli).
English: Reconstitution and application
Slovenian: Priprava (rekonstitucija) in apliciranje
English: Animal reproduction studies have not been conducted with Voncento.
Slovenian: 4.6 Plodnost, nosečnost in dojenje Študije na živalih o vplivu na sposobnost razmnoževanja z zdravilom Voncento niso bile opravljene.
English: AM Mangion Ltd. Tel: +356 2397 6333
Slovenian: Tel: +356 2397 6333
English: Inhibitors
Slovenian: Broadmeadows
English: CSL Behring GmbH, 35041 Marburg, Germany
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM CSL Behring GmbH, 35041 Marburg, Nemčija
English: Repeat infusion every 8 - 24 hours until threat is resolved.
Slovenian: Ponovite infundiranje na vsakih 8 - 24 ur,
English: von Willebrand disease
Slovenian: Von Willebrandova bolezen
English: AUC0-48(h*IU/mL)
Slovenian: AUC0-48(h*i.e./mL) MRT (h)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton 250 IU/600 IU
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla 250 i.e./ 600 i.e.
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Slovenian: Medtem ko je viala z zdravilom v pokončnem položaju, priključite injekcijsko brizgo na »Luerjev zaklop« na kompletu Mix2Vial s privijanjem v smeri urinega kazalca.
English: AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration; Vss = volume of distribution at steady state; FVIII:C = Factor VIII: Coagulant
Slovenian: AUC = površina pod krivuljo (area under the curve); Cmax = maksimalna koncentracija v plazmi; Cmin = minimalna koncentracija v plazmi; i.e. = mednarodne enote; MRT = povprečni čas zadrževanja (mean residence time); N = število preiskovancev; tmax = čas do maksimalne koncentracije; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (steady state); FVIII:C = Faktor VIII: koagulant
English: Repeat infusion every 12 - 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: 24 ur, 3 - 4 dni ali dlje, dokler bolečina in akutna nezmožnost ne izzvenita.
English: Hypersensitivity or allergic reactions, thromboembolic events, pyrexia, headache, dysgeusia and abnormal liver function test levels.
Slovenian: Povzetek varnostnega profila Med zdravljenjem z zdravilom Voncento se lahko pojavijo naslednji neželeni učinki: preobčutljivostne ali alergijske reakcije, trombembolični dogodki, zvišana telesna temperatura, glavobol, disgevzija in nenormalni rezultati preiskav jetrne funkcije.
English: Dosing in in haemophilia A in children and adolescents aged ˂ 18 years is based on body weight and is therefore generally based on the same guidelines as for adults.
Slovenian: Odmerjanje pri hemofiliji A pri otrocih in mladostnikih, starih < 18 let, temelji na telesni masi in zato na splošno temelji na istih smernicah, kot veljajo za odrasle.
English: Incremental recovery (IU/mL)/(IU/kg) Half-life (h)
Slovenian: 6-12 let postopna povrnitev aktivnosti (i.e./mL)/(i.e./kg) Half-life (h)
English: CSL Behring NV Tél/Tel: +32 15 28 89 20
Slovenian: Tél/Tel: +32 15 28 89 20
English: Powder and solvent for solution for injection/infusion.
Slovenian: prašek in vehikel za raztopino za injiciranje/infundiranje
English: -not applicable
Slovenian: Navedba smiselno ni potrebna
English: 5.2 Pharmacokinetic properties von Willebrand disease
Slovenian: 5.2 Farmakokinetične lastnosti
English: Pharmacotherapeutic group: antihaemorrhagics,blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, ATC code: B02BD06
Slovenian: Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktorji, kombinacija von
English: Exp. date
Slovenian: DRUGI PODATKI
English: Attach the syringe to the threaded, locking end of the venipuncture kit.
Slovenian: Pritrdite injekcijsko brizgo na navojni, zaklepalni konec kompleta za punkcijo vene.
English: On demand treatment
Slovenian: Zdravljenje po potrebi
English: AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects;tmax = time to maximum concentration; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor:
Slovenian: AUC = površina pod krivuljo (area under the curve); Cmax = maksimalna koncentracija v plazmi; Cmin = minimalna koncentracija v plazmi; i,,e, = mednarodne enote; MRT = povprečni čas zadrževanja (mean residence time); N = število preiskovancev; tmax = čas do maksimalne koncentracije; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (steady state); VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezava na kolagen; VWF:RCo =
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).
Slovenian: Voncento preko komercialno dostopnih infuzijskih kompletov (npr. črpalke za brizgo za intravensko aplikacijo zdravil).
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Slovenian: 1 viala s 5 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
English: human coagulation factor VIII 1000 IU human von Willebrand factor 2400 IU
Slovenian: humani koagulacijski faktor VIII 1000 i.e. humani von Willebrandov faktor 2400 i.e.
English: Administration set
Slovenian: Set za dajanje
English: Haemorrhage
Slovenian: Zaviralci
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.
Slovenian: lahko se svetlika, če jo držite proti svetlobi, vendar v njej ne sme biti vidnih delcev.
English: coagulation factor VIII 1000 IU von Willebrand factor 2400 IU
Slovenian: koagulacijski faktor VIII 1000 i.e. von Willebrandov faktor 2400 i.e.
English: Repeat infusion every 12 to 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Slovenian: ur, vsaj 1 dan, dokler krvavitev, sodeč po bolečini, ne preneha ali dokler se ne zaceli.
English: Paediatric haemophilia A population
Slovenian: Pediatrična populacija s hemofilijo A
English: 1 vial with 10 ml water for injections 1 filter transfer device 20/20
Slovenian: 1 viala s 10 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
English: If symptoms of hypersensitivity occur, you should stop using the medicine immediately and contact your doctor.
Slovenian: Če se pojavijo simptomi preobčutljivosti, nemudoma prenehajte z uporabo zdravila in pokličite svojega zdravnika.Vaš zdravnik vas bo poučil o zgodnjih znakih preobčutljivostnih reakcij.
English: 1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs
Slovenian: 1 injekcijska brizga (10 ml) za enkratno uporabo 1 komplet za punkcijo vene 2 alkoholni blazinici
English: Talk to your doctor, nurse or pharmacist before taking Voncento.
Slovenian: Pred začetkom uporabe zdravila Voncento se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
English: 10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: 10 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko
English: Baseline-adjusted initial PK parameters of FVIII:C in subjects <6 (N=15) and 6-12 years old (N=16) FVIII:C
Slovenian: (N=15) in 6-12 let (N=16)
English: Following infusion, peak concentrations of FVIII:C were achieved immediately with a median IR of approximately 0.016 (IU/mL)/(IU/kg) for FVIII:C. The median elimination t1/2 of FVIII:C was approximately 10 h. 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: (i.e./mL)/(i.e./kg) za FVIII:C. Mediani razpolovni čas t1/2 za FVIII:C je znašal približno 10 h.
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: 5 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko
English: human coagulation factor VIII 250 IU human von Willebrand factor 600 IU
Slovenian: humani koagulacijski faktor VIII 250 i.e. humani von Willebrandov faktor 600 i.e.
English: Immune system disorders
Slovenian: MedDRA glede na organske sisteme
English: After reconstitution with the 5 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Slovenian: Po rekonstituciji s priloženimi 5 ml vode za injekcije vsebuje raztopina 50 i.e./ml FVIII in 120 i.e./ml VWF.
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section
Slovenian: Pri otrocih, ki se predhodno še niso zdravili s faktorjem VIII, se lahko zelo pogosto (pri več kot
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Slovenian: Mix2Vial, tako da ga primete za obod in potegnete navpično navzgor.
English: AUC = area under the curve; Cmax = maximum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration occurs; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor: Collagen Binding; VWF:RCo = von Willebrand factor:
Slovenian: MRT = povprečni čas zadrževanja (mean residence time); N = število preiskovancev; tmax = čas do maksimalne koncentracije; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (steady state); VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezava na kolagen; VWF:RCo = von Willebrandov faktor:
English: coagulation factor VIII 250 IU von Willebrand factor 600 IU
Slovenian: koagulacijski faktor VIII 250 i.e. von Willebrandov faktor 600 i.e.
English: human coagulation factor VIII 500 IU human von Willebrand factor 1200 IU
Slovenian: humani koagulacijski faktor VIII 500 i.e. humani von Willebrandov faktor 1200 i.e.
English: DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Slovenian: Obrnite vialo z vehiklom, na katero je pritrjen komplet Mix2Vial, in porinite konico prozornega adapterja naravnost navzdol skozi zamašek viale z zdravilom.
English: After reconstitution with the 10 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Slovenian: Po rekonstituciji s priloženimi 10 ml vode za injekcije vsebuje raztopina 100 i.e./ml FVIII in 240 i.e./ml VWF.
English: Half-life (h)
Slovenian: razpolovni čas (h)
English: After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Po filtraciji/izsesanju (glejte spodaj) pred dajanjem preverite videz pripravljenega zdravila, da ne vsebuje delcev ali da ni obarvanj.
English: After reconstitution with the 10 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Slovenian: Po rekonstituciji s priloženimi 10 ml vode za injekcije vsebuje raztopina 50 i.e./ml FVIII in 120 i.e./ml VWF.
English: Incremental recovery (IU/mL)/(IU/kg)
Slovenian: N mediana razpon postopna povrnitev aktivnosti (i.e./mL)/(i.e./kg)
English: Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
Slovenian: Voncento 1000 i.e. FVIII/ 2400 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
English: Voncento 1000 IU FVIII / 2400 IU VWF powder for solution for injection/infusion ForIV use
Slovenian: Voncento 1000 i.e. FVIII/ 2400 i.e. VWF prašek in vehikel za raztopino za injiciranje/infundiranje
English: CSL Behring AB Puh/Tel: +46 8 544 966 70
Slovenian: Puh/Tel: +46 8 544 966 70
English: Voncento 250 IU FVIII / 600 IU VWF (5 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 humani koagulacijski faktor VIII/humani von Willebrandov faktor
English: Repeat infusion every 12-24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: ur, 3 - 4 dni ali dlje, dokler bolečina in akutna nezmožnost ne izzvenita.
English: Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Slovenian: Voncento 250 i.e. FVIII/ 600 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
English: coagulation factor VIII 500 IU von Willebrand factor 1200 IU
Slovenian: koagulacijski faktor VIII 500 i.e. von Willebrandov faktor 1200 i.e.
English: After reconstitution with the 5 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Slovenian: Po rekonstituciji s priloženimi 5 ml vode za injekcije vsebuje raztopina 100 i.e./ml FVIII in 240 i.e./ml VWF.
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
Slovenian: N mediana razpon N mediana razpon <6 let
English: Fertility
Slovenian: Odmerek
English: Voncento 500 IU FVIII /1200 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
Slovenian: Voncento 500 i.e. FVIII/ 1200 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
English: CSL Behring AB Tlf: +46 8 544 966 70
Slovenian: Tlf: +46 8 544 966 70
English: Voncento 500 IU FVIII / 1200 IU VWF(10 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII/human von Willebrand factor
Slovenian: Voncento 500 i.e. FVIII /1200 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
English: Major surgery
Slovenian: Večji kirurški poseg
English: Usually 40 - 80 IU/kg of VWF (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Slovenian: (VWF:RCo) kar ustreza 20 - 40 i.e. FVIII:C/kg telesne mase (TM).
English: Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Slovenian: Voncento 500 i.e. FVIII/ 1200 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
English: Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Slovenian: Voncento 500 i.e. FVIII/1200 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
English: Voncento 250 IU FVIII / 600 IU VWF powder for solution for injection/infusion For IV use
Slovenian: Voncento 250 i.e. FVIII/600 i.e. VWF prašek za raztopino za injiciranje/infundiranje za i.v.
English: Voncento 250 IU FVIII / 600 IU VWF powder and solvent for solution for injection/infusion Powder (250 IU/600 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: Prašek (250 i.e./600 i.e.) v viali (steklo tipa I) z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: Voncento 500 IU FVIII / 1200 IU VWF powder and solvent for solution for injection/infusion Powder (500 IU/1200 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: Prašek (500 i.e./1200 i.e.) v viali (steklo tipa I) z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: It may harm them, even if their signs of illness are the same as yours.
Slovenian: Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
English: Posology von Willebrand disease
Slovenian: Odmerjanje von Willebrandova bolezen
English: Voncento 500 IU FVIII / 1200 IU VWF powder for solution for injection/infusion For IV use
Slovenian: Voncento 500 i.e. FVIII/1200 i.e. VWF prašek za raztopino za injiciranje/infundiranje za i.v.
English: Voncento 1000 IU FVIII / 2400 IU VWF powder and solvent for solution for injection/infusion Powder (1000 IU/2400 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: Voncento 1000 i.e. FVIII/ 2400 i.e. VWF prašek in vehikel za raztopino za injiciranje/infundiranje Ena viala s praškom vsebuje nominalno: - 1000 i.e.* humanega koagulacijskega faktorja VIII** (FVIII).
English: Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Slovenian: 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 prašek in vehikel za raztopino za injiciranje/infundiranje
English: CSL Behring S.p.A. Tel: +39 02 34964 200
Slovenian: Tel: +39 02 34964 200
English: 1 disposable 10 ml syringe 1 venipuncture set
Slovenian: 1 injekcijska brizga (10 ml) za enkratno uporabo 1 komplet za punkcijo vene
English: Common Very common
Slovenian: skupni očistek
English: 250 IU FVIII and 600 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
Slovenian: 250 i.e. FVIII in 600 i.e. VWF na vialo; po pripravi s 5 ml vode za injekcije vsebuje približno 50 i.e./ml FVIII in 120 i.e./ml VWF.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 5 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
English: More extensive haemarthrosis, muscle bleeding or haematoma 30 - 60
Slovenian: krvavitev v mišico ali hematom
English: 1 disposable 10 ml syringe
Slovenian: Viala z vehiklom 10 ml
English: CSL Behring AB Sími: +46 8 544 966 70
Slovenian: Sími: +46 8 544 966 70
English: Presentations
Slovenian: uporabo
English: The dose and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika ter njegovih plazemskih ravni
English: The following side effects have been observed commonly (may affect up to 1 in 10 people): • Increase in body temperature
Slovenian: Naslednji neželeni učinki so se pojavili pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov):
English: 500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
Slovenian: 500 i.e. FVIII in 1200 i.e. VWF na vialo; po pripravi s 5 ml vode za injekcije vsebuje približno 100 i.e./ml FVIII in 240 i.e./ml VWF.
English: 500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 10 ml of water for injection approx.
Slovenian: 500 i.e. FVIII in 1200 i.e. VWF na vialo; po pripravi s 10 ml vode za injekcije vsebuje približno 50 i.e./ml FVIII in 120 i.e./ml VWF.
English: CSL Behring BV Tel: + 31 85 111 96 00
Slovenian: Slovenská republika CSL Behring s.r.o.Tel: +421 911 653 862
English: --1 Per 1 ml dose: purified p45 FeLV-envelope antigen, minimum quantity 102 µg
Slovenian: --1 Na odmerek 1 ml: minimalna količina prečiščenega antigena ovojnice p 45FeLV 102 µg
English: EU (MA) number Invente d name
Slovenian: EU (MA) številka
English: The European Commission granted a marketing authorisation valid throughout the European Union for Lyxumia on 1 February 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Lyxumia, veljavno po vsej Evropski uniji, izdala 1. februarja 2013.
English: Lyxumia is injected once a day, in the hour before the same meal every day.
Slovenian: Zdravilo Lyxumia se injicira enkrat na dan, vsakič eno uro pred istim obrokom.
English: These side effects were mostly mild and usually resolved over time.
Slovenian: Ti neželeni učinki so bili večinoma blagi in so s časom izzveneli.