BeneFIX

Country: European Union

Language: Danish

Source: EMA (European Medicines Agency)

Buy It Now

Patient Information leaflet Patient Information leaflet (PIL)
17-10-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
17-10-2022
Public Assessment Report Public Assessment Report (PAR)
30-10-2015

Active ingredient:

Nonacog alfa

Available from:

Pfizer Europe MA EEIG

ATC code:

B02BD04

INN (International Name):

nonacog alfa

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hæmofili B

Therapeutic indications:

Behandling og profylakse af blødning hos patienter med hæmofili B (medfødt faktor-IX-mangel).

Product summary:

Revision: 42

Authorization status:

autoriseret

Authorization date:

1997-08-27

Patient Information leaflet

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 250 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka 50 IE
nonacog alfa.
BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 500 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
100 IE nonacog alfa.
BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 1000 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
200 IE nonacog alfa.
BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 1500 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
300 IE nonacog alfa.
BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 2000 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
400 IE nonacog alfa.
BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 3000 IE nonacog alfa (rekombinan
                                
                                Read the complete document

Summary of Product characteristics

                                1
BILAG I
PRODUKTRESUMÉ
2
1.
LÆGEMIDLETS NAVN
BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning
BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning
2.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING
BeneFIX 250 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 250 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka 50 IE
nonacog alfa.
BeneFIX 500 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 500 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
100 IE nonacog alfa.
BeneFIX 1000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 1000 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
200 IE nonacog alfa.
BeneFIX 1500 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 1500 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
300 IE nonacog alfa.
BeneFIX 2000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 2000 IE nonacog alfa (rekombinant
koagulationsfaktor IX). Efter
opløsning i de medfølgende 5 ml (0,234%)
natriumchloridinjektionsvæske indeholder 1 ml cirka
400 IE nonacog alfa.
BeneFIX 3000 IE pulver og solvens til injektionsvæske, opløsning
Hvert hætteglas indeholder nominelt 3000 IE nonacog alfa (rekombinan
                                
                                Read the complete document

Similar products

Active ingredient Nonacog alfa

Nonacog alfa

ATC code B02BD04

B02BD04

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) nonacog alfa

nonacog alfa

Documents in other languages

Patient Information leaflet Patient Information leaflet Bulgarian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 17-10-2022
Public Assessment Report Public Assessment Report Bulgarian 30-10-2015
Patient Information leaflet Patient Information leaflet Spanish 17-10-2022
Summary of Product characteristics Summary of Product characteristics Spanish 17-10-2022
Public Assessment Report Public Assessment Report Spanish 30-10-2015
Patient Information leaflet Patient Information leaflet Czech 17-10-2022
Summary of Product characteristics Summary of Product characteristics Czech 17-10-2022
Public Assessment Report Public Assessment Report Czech 30-10-2015
Patient Information leaflet Patient Information leaflet German 17-10-2022
Summary of Product characteristics Summary of Product characteristics German 17-10-2022
Public Assessment Report Public Assessment Report German 30-10-2015
Patient Information leaflet Patient Information leaflet Estonian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Estonian 17-10-2022
Public Assessment Report Public Assessment Report Estonian 30-10-2015
Patient Information leaflet Patient Information leaflet Greek 17-10-2022
Summary of Product characteristics Summary of Product characteristics Greek 17-10-2022
Public Assessment Report Public Assessment Report Greek 30-10-2015
Patient Information leaflet Patient Information leaflet English 17-10-2022
Summary of Product characteristics Summary of Product characteristics English 17-10-2022
Public Assessment Report Public Assessment Report English 30-10-2015
Patient Information leaflet Patient Information leaflet French 17-10-2022
Summary of Product characteristics Summary of Product characteristics French 17-10-2022
Public Assessment Report Public Assessment Report French 30-10-2015
Patient Information leaflet Patient Information leaflet Italian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Italian 17-10-2022
Public Assessment Report Public Assessment Report Italian 30-10-2015
Patient Information leaflet Patient Information leaflet Latvian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Latvian 17-10-2022
Public Assessment Report Public Assessment Report Latvian 30-10-2015
Patient Information leaflet Patient Information leaflet Lithuanian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 17-10-2022
Public Assessment Report Public Assessment Report Lithuanian 30-10-2015
Patient Information leaflet Patient Information leaflet Hungarian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 17-10-2022
Public Assessment Report Public Assessment Report Hungarian 30-10-2015
Patient Information leaflet Patient Information leaflet Maltese 17-10-2022
Summary of Product characteristics Summary of Product characteristics Maltese 17-10-2022
Public Assessment Report Public Assessment Report Maltese 30-10-2015
Patient Information leaflet Patient Information leaflet Dutch 17-10-2022
Summary of Product characteristics Summary of Product characteristics Dutch 17-10-2022
Public Assessment Report Public Assessment Report Dutch 30-10-2015
Patient Information leaflet Patient Information leaflet Polish 17-10-2022
Summary of Product characteristics Summary of Product characteristics Polish 17-10-2022
Public Assessment Report Public Assessment Report Polish 30-10-2015
Patient Information leaflet Patient Information leaflet Portuguese 17-10-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 17-10-2022
Public Assessment Report Public Assessment Report Portuguese 30-10-2015
Patient Information leaflet Patient Information leaflet Romanian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Romanian 17-10-2022
Public Assessment Report Public Assessment Report Romanian 30-10-2015
Patient Information leaflet Patient Information leaflet Slovak 17-10-2022
Summary of Product characteristics Summary of Product characteristics Slovak 17-10-2022
Public Assessment Report Public Assessment Report Slovak 30-10-2015
Patient Information leaflet Patient Information leaflet Slovenian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 17-10-2022
Public Assessment Report Public Assessment Report Slovenian 30-10-2015
Patient Information leaflet Patient Information leaflet Finnish 17-10-2022
Summary of Product characteristics Summary of Product characteristics Finnish 17-10-2022
Public Assessment Report Public Assessment Report Finnish 30-10-2015
Patient Information leaflet Patient Information leaflet Swedish 17-10-2022
Summary of Product characteristics Summary of Product characteristics Swedish 17-10-2022
Public Assessment Report Public Assessment Report Swedish 30-10-2015
Patient Information leaflet Patient Information leaflet Norwegian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 17-10-2022
Patient Information leaflet Patient Information leaflet Icelandic 17-10-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 17-10-2022
Patient Information leaflet Patient Information leaflet Croatian 17-10-2022
Summary of Product characteristics Summary of Product characteristics Croatian 17-10-2022
Public Assessment Report Public Assessment Report Croatian 30-10-2015

Search alerts related to this product

Alerts BeneFIX Nonacog alfa

BeneFIX Nonacog alfa

View documents history

Documents history Documents history

BeneFIX