ReFacto AF

Country: European Union

Language: Romanian

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:

moroctocog alfa

Available from:

Pfizer Europe MA EEIG

ATC code:

B02BD02

INN (International Name):

moroctocog alfa

Therapeutic group:

hemostatice

Therapeutic area:

Hemofilia A

Therapeutic indications:

Tratamentul și profilaxia hemoragiei la pacienții cu hemofilie A (deficit congenital de factor VIII). ReFacto AF este adecvat pentru utilizare la adulți și copii de toate vârstele, inclusiv nou-nascuti. ReFacto AF nu contine von Willebrand, și, prin urmare, nu este indicat la von Willebrand boala.

Product summary:

Revision: 40

Authorization status:

Autorizat

Authorization date:

1999-04-13

Patient Information leaflet

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
ReFacto AF 3000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 250 UI* de moroctocog
alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 62,5
UI moroctocog alfa.
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 500 UI* de moroctocog
alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 125
UI moroctocog alfa.
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 1000 UI* de
moroctocog alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 250
UI moroctocog alfa.
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 2000 UI* de
moroctocog alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 500
UI moroctocog alfa.
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
Fiecare seringă preumplută conţine o cantitate nominală de 250 UI*
de moroctocog alfa**.
După reconstituire, fiecare ml de soluţie con
                                
                                Read the complete document

Summary of Product characteristics

                                1
ANEXA I
REZUMATUL CARACTERISTICILOR PRODUSULUI
2
1.
DENUMIREA COMERCIALĂ A MEDICAMENTULUI
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
ReFacto AF 3000 UI pulbere şi solvent pentru soluţie injectabilă
în seringă preumplută
2.
COMPOZIŢIA CALITATIVĂ ŞI CANTITATIVĂ
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 250 UI* de moroctocog
alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 62,5
UI moroctocog alfa.
ReFacto AF 500 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 500 UI* de moroctocog
alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 125
UI moroctocog alfa.
ReFacto AF 1000 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 1000 UI* de
moroctocog alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 250
UI moroctocog alfa.
ReFacto AF 2000 UI pulbere şi solvent pentru soluţie injectabilă
Fiecare flacon conţine o cantitate nominală de 2000 UI* de
moroctocog alfa**.
După reconstituire, fiecare ml de soluţie conţine aproximativ 500
UI moroctocog alfa.
ReFacto AF 250 UI pulbere şi solvent pentru soluţie injectabilă în
seringă preumplută
Fiecare seringă preumplută conţine o cantitate nominală de 250 UI*
de moroctocog alfa**.
După reconstituire, fiecare ml de soluţie con
                                
                                Read the complete document

Similar products

Active ingredient moroctocog alfa

moroctocog alfa

ATC code B02BD02

B02BD02

Marketed by Pfizer Europe MA EEIG

Pfizer Europe MA EEIG

INN (International Name) moroctocog alfa

moroctocog alfa

Documents in other languages

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
Patient Information leaflet Patient Information leaflet Spanish 08-11-2022
Summary of Product characteristics Summary of Product characteristics Spanish 08-11-2022
Public Assessment Report Public Assessment Report Spanish 29-09-2016
Patient Information leaflet Patient Information leaflet Czech 08-11-2022
Summary of Product characteristics Summary of Product characteristics Czech 08-11-2022
Public Assessment Report Public Assessment Report Czech 29-09-2016
Patient Information leaflet Patient Information leaflet Danish 08-11-2022
Summary of Product characteristics Summary of Product characteristics Danish 08-11-2022
Public Assessment Report Public Assessment Report Danish 29-09-2016
Patient Information leaflet Patient Information leaflet German 08-11-2022
Summary of Product characteristics Summary of Product characteristics German 08-11-2022
Public Assessment Report Public Assessment Report German 29-09-2016
Patient Information leaflet Patient Information leaflet Estonian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Estonian 08-11-2022
Public Assessment Report Public Assessment Report Estonian 29-09-2016
Patient Information leaflet Patient Information leaflet Greek 08-11-2022
Summary of Product characteristics Summary of Product characteristics Greek 08-11-2022
Public Assessment Report Public Assessment Report Greek 29-09-2016
Patient Information leaflet Patient Information leaflet English 08-11-2022
Summary of Product characteristics Summary of Product characteristics English 08-11-2022
Public Assessment Report Public Assessment Report English 29-09-2016
Patient Information leaflet Patient Information leaflet French 08-11-2022
Summary of Product characteristics Summary of Product characteristics French 08-11-2022
Public Assessment Report Public Assessment Report French 29-09-2016
Patient Information leaflet Patient Information leaflet Italian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Italian 08-11-2022
Public Assessment Report Public Assessment Report Italian 29-09-2016
Patient Information leaflet Patient Information leaflet Latvian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Latvian 08-11-2022
Public Assessment Report Public Assessment Report Latvian 29-09-2016
Patient Information leaflet Patient Information leaflet Lithuanian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Lithuanian 08-11-2022
Public Assessment Report Public Assessment Report Lithuanian 29-09-2016
Patient Information leaflet Patient Information leaflet Hungarian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Hungarian 08-11-2022
Public Assessment Report Public Assessment Report Hungarian 29-09-2016
Patient Information leaflet Patient Information leaflet Maltese 08-11-2022
Summary of Product characteristics Summary of Product characteristics Maltese 08-11-2022
Public Assessment Report Public Assessment Report Maltese 29-09-2016
Patient Information leaflet Patient Information leaflet Dutch 08-11-2022
Summary of Product characteristics Summary of Product characteristics Dutch 08-11-2022
Public Assessment Report Public Assessment Report Dutch 29-09-2016
Patient Information leaflet Patient Information leaflet Polish 08-11-2022
Summary of Product characteristics Summary of Product characteristics Polish 08-11-2022
Public Assessment Report Public Assessment Report Polish 29-09-2016
Patient Information leaflet Patient Information leaflet Portuguese 08-11-2022
Summary of Product characteristics Summary of Product characteristics Portuguese 08-11-2022
Public Assessment Report Public Assessment Report Portuguese 29-09-2016
Patient Information leaflet Patient Information leaflet Slovak 08-11-2022
Summary of Product characteristics Summary of Product characteristics Slovak 08-11-2022
Public Assessment Report Public Assessment Report Slovak 29-09-2016
Patient Information leaflet Patient Information leaflet Slovenian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Slovenian 08-11-2022
Public Assessment Report Public Assessment Report Slovenian 29-09-2016
Patient Information leaflet Patient Information leaflet Finnish 08-11-2022
Summary of Product characteristics Summary of Product characteristics Finnish 08-11-2022
Public Assessment Report Public Assessment Report Finnish 29-09-2016
Patient Information leaflet Patient Information leaflet Swedish 08-11-2022
Summary of Product characteristics Summary of Product characteristics Swedish 08-11-2022
Public Assessment Report Public Assessment Report Swedish 29-09-2016
Patient Information leaflet Patient Information leaflet Norwegian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Norwegian 08-11-2022
Patient Information leaflet Patient Information leaflet Icelandic 08-11-2022
Summary of Product characteristics Summary of Product characteristics Icelandic 08-11-2022
Patient Information leaflet Patient Information leaflet Croatian 08-11-2022
Summary of Product characteristics Summary of Product characteristics Croatian 08-11-2022
Public Assessment Report Public Assessment Report Croatian 29-09-2016

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ReFacto AF