Voncento

Country: European Union

Language: Romanian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
13-05-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
13-05-2022
Public Assessment Report Public Assessment Report (PAR)
16-01-2018

Active ingredient:

Factorul VIII de coagulare uman, uman von willebrand

Available from:

CSL Behring GmbH

ATC code:

B02BD06

INN (International Name):

human coagulation factor VIII / human von willebrand factor

Therapeutic group:

Blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, Antihemorrhagics

Therapeutic area:

Hemophilia A; von Willebrand Diseases

Therapeutic indications:

Boala Von Willebrand (VWD)Profilaxia și tratamentul hemoragiei sau chirurgical sângerare la pacienții cu VWD, când desmopresina (DDAVP) tratamentul singură este ineficientă sau contraindicată. Hemofilie a (deficit congenital de factor VIII deficit)Profilaxia și tratamentul hemoragiilor la pacienții cu hemofilie a.

Product summary:

Revision: 15

Authorization status:

Autorizat

Authorization date:

2013-08-12

Patient Information leaflet

                                42
B. PROSPECTUL
43
PROSPECT: INFORMAŢII PENTRU UTILIZATOR
VONCENTO 250 UI FVIII/600 UI FVW (SOLVENT 5 ML) PULBERE ŞI SOLVENT
PENTRU SOLUŢIE INJECTABILĂ/
PERFUZABILĂ
VONCENTO 500 UI FVIII / 1200 UI FVW (SOLVENT 10 ML) PULBERE ŞI
SOLVENT PENTRU SOLUŢIE INJECTABILĂ/
PERFUZABILĂ
VONCENTO 500 UI FVIII / 1200 UI FVW (SOLVENT 5 ML) PULBERE ŞI SOLVENT
PENTRU SOLUŢIE INJECTABILĂ/
PERFUZABILĂ
VONCENTO 1000 UI FVIII / 2400 UI FVW (SOLVENT 10 ML) PULBERE ŞI
SOLVENT PENTRU SOLUŢIE
INJECTABILĂ/ PERFUZABILĂ
factor uman de coagulare VIII
factor uman von Willebrand
CITIŢI CU ATENŢIE ŞI ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A
ÎNCEPE SĂ UTILIZAŢI ACEST MEDICAMENT
DEOARECE CONŢINE INFORMAŢII IMPORTANTE PENTRU DUMNEAVOASTRĂ.

Păstraţi acest prospect. S-ar putea să fie necesar să-l recitiţi.

Dacă aveţi orice întrebări suplimentare, adresaţi-vă medicului
dumneavoastră, farmacistului sau
asistentei medicale.

Acest medicament a fost prescris numai pentru dumneavoastră. Nu
trebuie să-l daţi altor
persoane. Le poate face rău, chiar dacă au aceleaşi semne de boală
ca dumneavoastră.

Dacă manifestaţi orice reacţii adverse, adresaţi-vă medicului
dumneavoastră, farmacistului
sau asistentei medicale. Acestea includ orice posibile reacţii
adverse nemenţionate în acest
prospect. Vezi pct. 4.
CE GĂSIŢI ÎN ACEST PROSPECT:
1.
Ce este Voncento şi pentru ce se utilizează
2.
Ce trebuie să ştiţi înainte să utilizaţi Voncento
3.
Cum să utilizaţi Voncento
4.
Reacţii adverse posibile
5.
Cum se păstrează Voncento
6.
Conţinutul ambalajului şi alte informaţii
1.
CE ESTE VONCENTO ŞI PENTRU CE SE UTILIZEAZĂ
Medicamentul este fabricat din plasmă umană (partea lichidă a
sângelui) şi conţine substanţele active
denumite factor uman de coagulare VIII (FVIII) şi factor uman von
Willebrand (FVW).
Voncento este utilizat la pacienți de orice vârstă pentru
prevenirea sau oprirea sângerării cauzate de lipsa
FVW în boala von Willebrand (BVW) şi de lipsa FVIII în h
                                
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Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
Voncento 250 UI FVIII / 600 UI FVW (5 ml solvent) pulbere şi solvent
pentru soluţie
injectabilă/perfuzabilă
Voncento 500 UI FVIII /1200 UI FVW (10 ml solvent) pulbere şi solvent
pentru soluţie
injectabilă/perfuzabilă
Voncento 500 UI FVIII / 1200 UI FVW (5 ml solvent) pulbere şi solvent
pentru soluţie
injectabilă/perfuzabilă
Voncento 1000 UI FVIII / 2400 UI FVW (10 ml solvent) pulbere şi
solvent pentru soluţie
injectabilă/perfuzabilă
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
Voncento 250 UI FVIII / 600 UI FVW pulbere şi solvent pentru soluţie
injectabilă/perfuzabilă
Un flacon de pulbere conţine nominal:
-
250 UI* factor uman de coagulare VIII** (FVIII)
-
600 UI*** factor uman von Willebrand** (FVW)
După reconstituire cu 5 ml de solvent, soluţia conţine FVIII 50
UI/ml şi FVW 120 UI/ml.
Voncento 500 UI FVIII /1200 UI FVW pulbere şi solvent pentru soluţie
injectabilă/perfuzabilă
Un flacon de pulbere conţine nominal:
-
500 UI* factor uman de coagulare VIII** (FVIII)
-
1200 UI*** factor uman von Willebrand** (FVW)
După reconstituire cu 10 ml de solvent, soluţia conţine FVIII 50
UI/ml şi FVW 120 UI/ml.
Voncento 500 UI FVIII / 1200 UI FVW pulbere şi solvent pentru
soluţie injectabilă/perfuzabilă
Un flacon de pulbere conţine nominal:
-
500 UI* factor uman de coagulare VIII** (FVIII)
-
1200 UI*** factor uman von Willebrand** (FVW)
După reconstituire cu 5 ml de solvent, soluţia conţine FVIII 100
UI/ml şi FVW 240 UI/ml.
Voncento 1000 UI FVIII / 2400 UI FVW pulbere şi solvent pentru
soluţie injectabilă/perfuzabilă
Un flacon de pulbere conţine nominal:
-
1000 UI* factor uman de coagulare VIII** (FVIII)
-
2400 UI*** factor uman von Willebrand** (FVW)
După reconstituire cu 10 ml de solvent, soluţia conţine FVIII 100
UI/ml şi FVW 240 UI/ml.
Excipient cu efect cunoscut:
Voncento conține aproximativ 128,2 mmol/l (2,95 mg/ml) de sodiu.
Pentru lista tuturor excipienţilor, vezi pct. 6.1.

                                
                                Read the complete document

Similar products

Active ingredient Factorul VIII de coagulare uman, uman von willebrand

Factorul VIII de coagulare uman, uman von willebrand

ATC code B02BD06

B02BD06

Marketed by CSL Behring GmbH

CSL Behring GmbH

INN (International Name) human coagulation factor VIII / human von willebrand factor

human coagulation factor VIII / human von willebrand factor

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 13-05-2022
Public Assessment Report Public Assessment Report Bulgarian 16-01-2018
Patient Information leaflet Patient Information leaflet Spanish 13-05-2022
Summary of Product characteristics Summary of Product characteristics Spanish 13-05-2022
Public Assessment Report Public Assessment Report Spanish 16-01-2018
Patient Information leaflet Patient Information leaflet Czech 13-05-2022
Summary of Product characteristics Summary of Product characteristics Czech 13-05-2022
Public Assessment Report Public Assessment Report Czech 16-01-2018
Patient Information leaflet Patient Information leaflet Danish 13-05-2022
Summary of Product characteristics Summary of Product characteristics Danish 13-05-2022
Public Assessment Report Public Assessment Report Danish 16-01-2018
Patient Information leaflet Patient Information leaflet German 13-05-2022
Summary of Product characteristics Summary of Product characteristics German 13-05-2022
Public Assessment Report Public Assessment Report German 16-01-2018
Patient Information leaflet Patient Information leaflet Estonian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Estonian 13-05-2022
Public Assessment Report Public Assessment Report Estonian 16-01-2018
Patient Information leaflet Patient Information leaflet Greek 13-05-2022
Summary of Product characteristics Summary of Product characteristics Greek 13-05-2022
Public Assessment Report Public Assessment Report Greek 16-01-2018
Patient Information leaflet Patient Information leaflet English 13-05-2022
Summary of Product characteristics Summary of Product characteristics English 13-05-2022
Public Assessment Report Public Assessment Report English 16-01-2018
Patient Information leaflet Patient Information leaflet French 13-05-2022
Summary of Product characteristics Summary of Product characteristics French 13-05-2022
Public Assessment Report Public Assessment Report French 16-01-2018
Patient Information leaflet Patient Information leaflet Italian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Italian 13-05-2022
Public Assessment Report Public Assessment Report Italian 16-01-2018
Patient Information leaflet Patient Information leaflet Latvian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Latvian 13-05-2022
Public Assessment Report Public Assessment Report Latvian 16-01-2018
Patient Information leaflet Patient Information leaflet Lithuanian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 13-05-2022
Public Assessment Report Public Assessment Report Lithuanian 16-01-2018
Patient Information leaflet Patient Information leaflet Hungarian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 13-05-2022
Public Assessment Report Public Assessment Report Hungarian 16-01-2018
Patient Information leaflet Patient Information leaflet Maltese 13-05-2022
Summary of Product characteristics Summary of Product characteristics Maltese 13-05-2022
Public Assessment Report Public Assessment Report Maltese 16-01-2018
Patient Information leaflet Patient Information leaflet Dutch 13-05-2022
Summary of Product characteristics Summary of Product characteristics Dutch 13-05-2022
Public Assessment Report Public Assessment Report Dutch 16-01-2018
Patient Information leaflet Patient Information leaflet Polish 13-05-2022
Summary of Product characteristics Summary of Product characteristics Polish 13-05-2022
Public Assessment Report Public Assessment Report Polish 16-01-2018
Patient Information leaflet Patient Information leaflet Portuguese 13-05-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 13-05-2022
Public Assessment Report Public Assessment Report Portuguese 16-01-2018
Patient Information leaflet Patient Information leaflet Slovak 13-05-2022
Summary of Product characteristics Summary of Product characteristics Slovak 13-05-2022
Public Assessment Report Public Assessment Report Slovak 16-01-2018
Patient Information leaflet Patient Information leaflet Slovenian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 13-05-2022
Public Assessment Report Public Assessment Report Slovenian 16-01-2018
Patient Information leaflet Patient Information leaflet Finnish 13-05-2022
Summary of Product characteristics Summary of Product characteristics Finnish 13-05-2022
Public Assessment Report Public Assessment Report Finnish 16-01-2018
Patient Information leaflet Patient Information leaflet Swedish 13-05-2022
Summary of Product characteristics Summary of Product characteristics Swedish 13-05-2022
Public Assessment Report Public Assessment Report Swedish 16-01-2018
Patient Information leaflet Patient Information leaflet Norwegian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 13-05-2022
Patient Information leaflet Patient Information leaflet Icelandic 13-05-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 13-05-2022
Patient Information leaflet Patient Information leaflet Croatian 13-05-2022
Summary of Product characteristics Summary of Product characteristics Croatian 13-05-2022
Public Assessment Report Public Assessment Report Croatian 16-01-2018

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Voncento