ReFacto AF

Country: European Union

Language: Croatian

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
08-11-2022
Summary of Product characteristics Summary of Product characteristics (SPC)
08-11-2022
Public Assessment Report Public Assessment Report (PAR)
29-09-2016

Active ingredient:

moroctokog alfa

Available from:

Pfizer Europe MA EEIG

ATC code:

B02BD02

INN (International Name):

moroctocog alfa

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemofilija A

Therapeutic indications:

Liječenje i profilaksu krvarenja u bolesnika s hemofilijom A (nedostatak prirođenih faktora VIII). ReFacto AF nisu pogodne za korištenje kod odraslih i djece svih dobnih skupina, uključujući i novorođenčad. ReFacto AF ne sadrži pozadinu-Виллебранда faktor, i, stoga, nije navedeno kada bolest pozadina Виллебранда .

Product summary:

Revision: 40

Authorization status:

odobren

Authorization date:

1999-04-13

Patient Information leaflet

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 250 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU
moroktokoga alfa.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 500 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 125 IU
moroktokoga alfa.
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 1000 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 250 IU
moroktokoga alfa.
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 2000 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 500 IU
moroktokoga alfa.
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
Jedna napunjena štrcaljka nominalno sadrži 250 IU* moroktokoga
alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU
moroktokoga alfa.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
Jedna napunjena štrcaljka nominalno sadrži 500 IU* moroktokoga
alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 125 I
                                
                                Read the complete document

Summary of Product characteristics

                                1
PRILOG I.
SAŽETAK OPISA SVOJSTAVA LIJEKA
2
1.
NAZIV LIJEKA
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju.
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
ReFacto AF 3000 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
2.
KVALITATIVNI I KVANTITATIVNI SASTAV
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 250 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU
moroktokoga alfa.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 500 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 125 IU
moroktokoga alfa.
ReFacto AF 1000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 1000 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 250 IU
moroktokoga alfa.
ReFacto AF 2000 IU prašak i otapalo za otopinu za injekciju
Jedna bočica nominalno sadrži 2000 IU* moroktokoga alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 500 IU
moroktokoga alfa.
ReFacto AF 250 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
Jedna napunjena štrcaljka nominalno sadrži 250 IU* moroktokoga
alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 62,5 IU
moroktokoga alfa.
ReFacto AF 500 IU prašak i otapalo za otopinu za injekciju u
napunjenoj štrcaljki
Jedna napunjena štrcaljka nominalno sadrži 500 IU* moroktokoga
alfa**.
Nakon rekonstitucije, jedan ml otopine sadrži približno 125 I
                                
                                Read the complete document

Similar products

Active ingredient moroctokog alfa

moroctokog alfa

ATC code B02BD02

B02BD02

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) moroctocog alfa

moroctocog alfa

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Patient Information leaflet Patient Information leaflet Bulgarian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Bulgarian 08-11-2022
Public Assessment Report Public Assessment Report Bulgarian 29-09-2016
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Summary of Product characteristics Summary of Product characteristics Spanish 08-11-2022
Public Assessment Report Public Assessment Report Spanish 29-09-2016
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Public Assessment Report Public Assessment Report Czech 29-09-2016
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Summary of Product characteristics Summary of Product characteristics Danish 08-11-2022
Public Assessment Report Public Assessment Report Danish 29-09-2016
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Summary of Product characteristics Summary of Product characteristics German 08-11-2022
Public Assessment Report Public Assessment Report German 29-09-2016
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Public Assessment Report Public Assessment Report Estonian 29-09-2016
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Summary of Product characteristics Summary of Product characteristics Greek 08-11-2022
Public Assessment Report Public Assessment Report Greek 29-09-2016
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Summary of Product characteristics Summary of Product characteristics English 08-11-2022
Public Assessment Report Public Assessment Report English 29-09-2016
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Summary of Product characteristics Summary of Product characteristics French 08-11-2022
Public Assessment Report Public Assessment Report French 29-09-2016
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Public Assessment Report Public Assessment Report Hungarian 29-09-2016
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Public Assessment Report Public Assessment Report Romanian 29-09-2016
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Public Assessment Report Public Assessment Report Slovak 29-09-2016
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ReFacto AF