BeneFIX

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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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:

Hemofilija B

Therapeutic indications:

Liječenje i profilaksu krvarenja kod bolesnika s hemofilijom B (nedostatak prirođenih faktora IX).

Product summary:

Revision: 42

Authorization status:

odobren

Authorization date:

1997-08-27

Patient Information leaflet

                                1
PRILOG I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
BeneFIX 250 IU prašak i otapalo za otopinu za injekciju
BeneFIX 500 IU prašak i otapalo za otopinu za injekciju
BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju
BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju
BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju
BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
BeneFIX 250 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 250 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 50 IU nonakoga alfa.
BeneFIX 500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 500 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 100 IU nonakoga alfa.
BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 1000 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 200 IU nonakoga alfa.
BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 1500 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 300 IU nonakoga alfa.
BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 2000 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 400 IU nonakoga alfa.
BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 30
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
BeneFIX 250 IU prašak i otapalo za otopinu za injekciju
BeneFIX 500 IU prašak i otapalo za otopinu za injekciju
BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju
BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju
BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju
BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
BeneFIX 250 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 250 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 50 IU nonakoga alfa.
BeneFIX 500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 500 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 100 IU nonakoga alfa.
BeneFIX 1000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 1000 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 200 IU nonakoga alfa.
BeneFIX 1500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 1500 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 300 IU nonakoga alfa.
BeneFIX 2000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 2000 IU nonakoga alfa (rekombinantnog
koagulacijskog faktora IX).
Nakon rekonstitucije s 5 ml (0,234%) priložene otopine natrijevog
klorida za injekciju, jedan ml
otopine sadrži približno 400 IU nonakoga alfa.
BeneFIX 3000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica sadrži nominalno 30
                                
                                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 Danish 17-10-2022
Summary of Product characteristics Summary of Product characteristics Danish 17-10-2022
Public Assessment Report Public Assessment Report Danish 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
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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

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