Cevenfacta

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

Eptacog beta (activated)

Tilgjengelig fra:

Laboratoire Francais du Fractionnement et des Biotechnologies

ATC-kode:

B02BD08

INN (International Name):

Eptacog beta (activated)

Terapeutisk gruppe:

Antihemorrhagics

Terapeutisk område:

Hemophilia A; Hemophilia B

Indikasjoner:

CEVENFACTA is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU)); in patients with congenital haemophilia with low titre inhibitors (BU

Autorisasjon status:

Authorised

Autorisasjon dato:

2022-07-15

Informasjon til brukeren

34
B. PACKAGE LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEVENFACTA 1 MG (45 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
CEVENFACTA 2 MG (90 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
CEVENFACTA 5 MG (225 KIU) POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION
eptacog beta (activated)
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What CEVENFACTA is and what it is used for
2.
What you need to know before you use CEVENFACTA
3.
How to use CEVENFACTA
4.
Possible side effects
5.
How to store CEVENFACTA
6.
Contents of the pack and other information
7.
CEVENFACTA Instructions For Use
1.
WHAT CEVENFACTA IS AND WHAT IT IS USED FOR
CEVENFACTA contains the active substance eptacog beta (activated), a
recombinant human
coagulation Factor VIIa (rhFVIIa).
CEVENFACTA is used in adults and adolescents (12 years of age or
older) who were born with
haemophilia A or B and who have developed inhibitors (antibodies). It
is used for:
-
the treatment of bleeding episodes,
-
the management of bleeding during surgery.
HOW CEVENFACTA WORKS
This medicine works by making the blood clot at the site of bleeding,
when the body’s own clotting
factors are not working.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CEVENFACTA
_ _
DO NOT USE CEVENFACTA
-
if you are allergic to eptacog beta (activated),

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection
CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection
CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CEVENFACTA 1 mg (45 KIU) powder and solvent for solution for injection
Each vial contains nominally 1 mg eptacog beta (activated) (45
KIU/vial) corresponding to a
concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted
with 1.1 mL of water for
injections.
CEVENFACTA 2 mg (90 KIU) powder and solvent for solution for injection
Each vial contains nominally 2 mg eptacog beta (activated) (90
KIU/vial) corresponding to a
concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted
with 2.2 mL of water for
injections.
CEVENFACTA 5 mg (225 KIU) powder and solvent for solution for
injection
Each vial contains nominally 5 mg eptacog beta (activated)(225
KIU/vial) corresponding to a
concentration of approximately 1 mg/mL (45 KIU/mL) when reconstituted
with 5.2 mL of water for
injections.
The potency (IU) is determined using a clotting assay. 1 KIU equals 1
000 IU (International Units).
Eptacog beta (activated) is a recombinant coagulation Factor VIIa
(rFVIIa) with a molecular mass of
approximately 50 000 Daltons produced from rabbit milk by recombinant
DNA technology.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white lyophilised powder.
Solvent: clear and colourless solution.
The solution has a pH of approximately 6. The osmolality is
approximately 290 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
3
CEVENFACTA is indi