NovoSeven
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
05-01-2023
Produktets egenskaber
(SPC)
05-01-2023
Offentlige vurderingsrapport
(PAR)
26-07-2022
Aktiv bestanddel:
eptacog alfa (activated)
Tilgængelig fra:
Novo Nordisk A/S
ATC-kode:
B02BD08
INN (International Name):
eptacog alfa (activated)
Terapeutisk gruppe:
Antihemorrhagics
Terapeutisk område:
Hemophilia B; Thrombasthenia; Factor VII Deficiency; Hemophilia A
Terapeutiske indikationer:
NovoSeven is indicated 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 inhibitors to coagulation factors VIII or IX > 5 Bethesda units (BU);in patients with congenital haemophilia who are expected to have a high anamnestic response to factor-VIII or factor-IX administration;in patients with acquired haemophilia;in patients with congenital factor-VII deficiency;in patients with Glanzmann's thrombasthenia with antibodies to platelet glycoprotein (GP) IIb-IIIa and / or human leucocyte antigens (HLA), and with past or present refractoriness to platelet transfusions.in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.
Produkt oversigt:
Revision: 38
Autorisation status:
Authorised
Autorisation dato:
1996-02-23
Indlægsseddel
37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOSEVEN 1 MG (50 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOSEVEN 2 MG (100 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOSEVEN 5 MG (250 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
NOVOSEVEN 8 MG (400 KIU) POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
eptacog alfa (activated)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS INJECTION
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.
•
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 NovoSeven is and what it is used for
2.
What you need to know before you use NovoSeven
3.
How to use NovoSeven
4.
Possible side effects
5.
How to store NovoSeven
6.
Contents of the pack and other information
Overleaf: Instructions on how to use NovoSeven
1.
WHAT NOVOSEVEN IS AND WHAT IT IS USED FOR
NovoSeven is a blood coagulation factor. It works by making the blood
clot at the site of bleeding,
when the body's own clotting factors are not working.
NovoSeven is used
to treat bleeding, and to prevent excessive bleeding after surgery or
other
important treatments. Early treatment with NovoSeven reduces how much
you bleed and for how long.
It works in all types of bleeds, including joint bleeds. This reduces
the need for hospitalisation and
days absent from work and school.
It is used in certain groups of people:
•
If you were
_born with haemophilia_
and do not respond normally to factors VIII or IX treatment
•
If you have
_acquired haemophilia_
•
If you have
_Factor VII deficiency_
•
If you have
_Glanzmann’s thrombasthenia_
(a bleeding disorder) and your condition cannot be
treated effectively
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection
NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection
NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoSeven 1 m
g (50 KIU)
NovoSeven is presented as powder and solvent for solution for
injection containing 1 mg eptacog alfa
(activated) per vial (corresponds to 50 KIU/vial).
NovoSeven 2 m
g (100 KIU)
NovoSeven is presented as powder and solvent for solution for
injection containing 2 mg eptacog alfa
(activated) per vial (corresponds to 100 KIU/vial).
NovoSeven 5 m
g (250 KIU)
NovoSeven is presented as powder and solvent for solution for
injection containing 5 mg eptacog alfa
(activated) per vial (corresponds to 250 KIU/vial).
NovoSeven 8 mg (400 KIU)
NovoSeven is presented as powder and solvent for solution for
injection containing 8 mg eptacog alfa
(activated) per vial (corresponds to 400 KIU/vial).
1 KIU equals 1,000 IU (International Units).
eptacog alfa (activated) is recombinant coagulation factor VIIa
(rFVIIa) with a molecular mass of
approximately 50,000 Daltons produced in baby hamster kidney cells
(BHK Cells) by recombinant
DNA technology.
After reconstitution, the product contains 1 mg/ml eptacog alfa
(activated) when reconstituted with
solvent.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White lyophilised powder. Solvent: clear colourless solution. The
reconstituted solution has a pH of
approximately 6.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NovoSeven is indicated 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 inhibitors to coagulation
factors VIII or
IX
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