NOVOSEVEN RT 5 MGVIAL

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EPTACOG ALFA (ACTIVATED)

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

B02BD08

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

EPTACOG ALFA (ACTIVATED) 5 MG/VIAL

Administration route:

I.V

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic group:

EPTACOG ALFA (ACTIVATED)

Therapeutic area:

EPTACOG ALFA (ACTIVATED)

Therapeutic indications:

NovoSeven ® RT 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 FVII deficiency •in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet transfusions, or where platelets are not readily available.Severe postpartum haemorrhageNovoSeven RT is indicated for the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis

Authorization date:

2015-01-31

Patient Information leaflet

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
NOVOSEVEN
® RT 1 MG (50 KIU)
NOVOSEVEN
® RT 2 MG (100 KIU)
NOVOSEVEN
® RT 5 MG (250 KIU)
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT: EPTACOG ALFA (ACTIVATED)
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important information about some of
this medicine’s ingredients’ and section 6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise
information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their illness is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
NovoSeven RT is intended to treat bleeding and to prevent excessive
bleeding after surgery or other
invasive treatments in the following specific groups of patients:
•
if you were born with hemophilia and do not respond normally to
treatment with coagulation
factors VIII or IX
•
if you have acquired hemophilia
•
if you have Factor VII deficiency
•
if you have Glanzmann’s thrombasthenia (a bleeding disorder) and
your condition cannot be
treated effectively with platelet transfusion, or if no platelets are
available.
THERAPEUTIC GROUP: blood coagulation factors.
NovoSeven RT 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. Early treatment
with NovoSeven RT reduces
how much you bleed and for how long. It works in all types of bleeds,
including in bleeding joints. This
reduces the need for hospitalization and days absent from work and
school.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitive (allergic) to eptacog alfa or any of the other
ingredients in this medicine
(listed in section

Summary of Product characteristics

NovoSeven RT IL SPC JAN21-Notification
Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
NovoSeven
®
RT
1
MG/VIAL
NovoSeven
®
RT 2 MG/VIAL
NovoSeven
®
RT
5 MG/VIAL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
NovoSeven RT 1 mg (50 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 1 mg eptacog
alfa (activated) per vial (corresponds to 50 KIU/vial).
NovoSeven
RT 2 mg (100 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 2 mg eptacog
alfa (activated) per vial (corresponds to 100 KIU/vial).
NovoSeven RT 5 mg (250 KIU)
NovoSeven RT is presented as powder and solvent for solution for
injection containing 5 mg eptacog
alfa (activated) per vial (corresponds to 250 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 RT 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 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 FVII deficiency
•
in patients with Glanzmann’s thrombasthenia with past or present
refractoriness to platelet
transfusions, or where pl