NovoSeven 8mg (400,000units) powder and solvent for solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Eptacog alfa activated

Available from:

400,000units

ATC code:

B02BD08

INN (International Name):

Eptacog alfa activated

Dosage:

400000unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5017954001958

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOVOSEVEN
®
1 MG (50 KIU)
2 MG (100 KIU)
5 MG (250 KIU)
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 with platelet transfusion.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NOVOSEVEN
®
DO NOT USE NOVOSEVEN
®
•
If you are
ALLERGIC TO EPTACOG ALFA
(active compound

Summary of Product characteristics

OBJECT 1
NOVOSEVEN 1 MG (50KIU) POWDER AND SOLVENT FOR
SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 20-Jan-2017 | Novo Nordisk
Limited
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 mg (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 mg (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 mg (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 pat