NovoSeven 4.8 mg (240 KIU) - powder and solvent for solution forinjection

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 episodes and to prevent excessive bleeding connected with surgery or other invasive procedures:

• if you are born with haemophilia and do not respond normally to factors VIII or IX (due to inhibitors to coagulation factors VIII or IX or patients who are at risk of responding to factor VIII or factor IX injection with a rapid and substantial increase in inhibitors against these products)
• if you have acquired haemophilia
• if you have Factor VII deficiency
• if you have Glanzmann?s thrombasthenia (a bleeding disorder) which can not be treated effectively with platelet transfusion.

Do not use NovoSeven?

• if you are allergic to any ingredient in NovoSeven, or
• if you are allergic to mouse, hamster or cow proteins

Take special care with NovoSeven and make sure your doctor knows...

• if you have just had surgery
• if you recently had a crush injury
• if your arteries are narrowed by disease
• if you have severe liver disease
• if you have a serious blood infection

Patients predisposed to disseminate intravascular coagulation (DIC, a condition where blood clots develop throughout the blood stream) should be carefully monitored.

If bleeding is not kept under control, contact your doctor immediately.
If any of these apply to you, talk to your doctor before using the injection.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Simultaneous use of NovoSeven and coagulation factor concentrates should be avoided.

Experience with simultaneous use of NovoSeven and medicines used to reduce the dissolving of blood clots is limited and if you are taking such medicines you should talk to your doctor before taking NovoSeven.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, ask your doctor for advice before you use NovoSeven.

NovoSeven needs to be injected into a vein. In case of severe bleeds NovoSeven will be administered by a doctor or nurse in the surgery or hospital. In case of mild or moderate bleeding episodes, it may be given you to use at home if required.

Do not treat yourself for longer than 24 hours without consulting your doctor:

• Each time you use NovoSeven, tell your doctor or hospital at the earliest possible opportunity so that your progress can be monitored
• If bleeding is not controlled, you will need hospital care.

Dosage

The dose will be worked out by your doctor, based on your body weight and your condition.

If you have haemophilia:
The usual dose is 90 -g for every 1 kg you weigh, at each injection. As an alternative your doctor may recommend a single dose of 270 µg for every 1 kg you weigh, however, there is no clinical experience in elderly using this dose.
The home therapy should not exceed 24 hours.

If you have Factor VII deficiency:
The usual dose rangeis 15 to 30 -g for every 1 kg you weigh, at each injection.

If you have Glanzmann?s thrombasthenia:
The usual dose is 90 ?g (range is 80 to 120 -g) for every 1 kg you weigh, at each injection.

For all use of NovoSeven

• Talk to your doctor about when to use the injections and how long to keep using them
• The first dose should be given as early as possible after bleeding has started
• Your doctor might change the dose

If you inject more NovoSeven than you should
If you inject too much NovoSeven, get medical advice at once.

If you forget an injection of NovoSeven

If you forget an injection, or if you want to stop the treatment, get your doctor's advice.

Making up the injection and injecting the solution

See overleaf for detailed instructions.

Like all medicines, NovoSeven can cause side effects, although not everybody gets them.

Serious side effects
Hypersensitivity reactions are rarely reported (between 1 in 10,000 and 1 in 1,000 doses). Furthermore, there have also been reports on the following serious side effects:

• Blood clots in arteries leading to heart attack or stroke
• Blood clots in the veins in lungs, legs or at site of injection
• Blood clots in liverpredominantly in patients with liver disease or undergoing liver surgery
• Anaphylactic reactions

In the vast majority of cases reported on blood clots, the patients were predisposed to thrombotic disorders due to pre-existing risk factors.
Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully.

Less serious side effects
Side effects as allergic skin reactions; fever and instances with inadequate response to treatment have been uncommonly observed (between 1 in 1,000 and 1 in 100 doses).

Blood tests showing changes in the way the liver functions, and nausea have been rarely reported (between 1 in 10,000 and 1 in 1,000 doses).

Tell your doctor if you notice any undesirable side effects, whether or not they are mentioned in this leaflet.

• Keep out of the reach and sight of children
• Store NovoSeven in a refrigerator (2°C - 8°C)
• Store in original package in order to protect from light
• Do not freeze, to prevent damage to the solvent vial
• Do not use the product after the expiry date which is stated on the outer carton and labels. The expiry date refers to the last day of that month.
• Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection. If you do not use it immediately after mixing, you should store the vial with the syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do not store the solution without your doctor?s advice.

What NovoSeven contains

• The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, hydrochloric acid and sodium hydroxide. The solvent is water for injections.

The powder for solution for injection contains: 1.2 mg/vial (corresponding to 60 KIU/vial), 2.4 mg/vial (corresponding to 120 KIU/vial) or 4.8 mg/vial (corresponding to 240 KIU/vial). After reconstitution 1 ml of the solution contains 0.6 mg eptacog alfa (activated).
1 KIU equals 1000 IU (International Units).

What NovoSeven looks like and contents of the pack

The powder vial contains white powder and the water vial contains a clear colourless solution. The reconstituted solution for injection is colourless. Do not use the reconstituted solution if particle formation or discolouration is noticed.

Each NovoSeven pack contains:

• 1 vial with white powder (NovoSeven) for solution for injection
• 1 vial with water (Water for injections) for reconstitution
• 1 sterile vial adapter for reconstitution
• 1 sterile disposable syringe for reconstitution and administration
• 1 sterile infusion set
• 2 alcohol swabs.

Pack sizes: 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU).
Please refer to outer packaging for present pack size.

Marketing authorisation holder and manufacturer

Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

This leaflet was last approved in

NOVOSEVEN USER INSTRUCTIONS

Water vial Powder vial Infusion set Alcohol swabsPlastic cap Plastic cap Rubber stopper Rubber stopper NeedleCap SheathSyringe Vial adapterPlungerTip Spik

Preparing the solution

Wash your hands. Bring the NovoSeven powder and water vials to room temperature (but not above 37°C). You can do this by holding them in your hands. Remove the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean the rubber stoppers on the vials with the alcohol swabs and allow them to dry before use.

A

Remove the protective paper from the vial adapter without taking the vial adapter out of the protective cap. Attach the vial adapter to the water vial. Take care not to touch the spike on the vial adapter.

Once attached, remove the protective cap from the vial adapter.

B

Pull the plunger to draw in a volume of air that is equal to the amount of water in the water vial (ml equals cc on the syringe).

C

Screw the syringe tightly onto the vial adapter on the water vial. Inject air into the vial by pushing the plunger until you feel a clear resistance.

D

Hold the syringe with the water vial upside down and pull the plunger to draw the water into the syringe.

E

Remove the empty water vial by tipping the syringe with the vial adapter.

F

Click the vial adapter, still attached to the syringe, onto the powder vial. Hold the syringe slightly tilted with the vial facing downwards. Push the plunger slowly to inject the water into the powder vial. Make sure not to aim the stream of water directly at the NovoSeven powder as this will cause foaming.

G

Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause foaming. Check the solution for visible particles and discolouration. If you notice either, do not use it.

Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to avoid infection. If you do not use it immediately after mixing, you should store the vial with the syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do not store the solution without your doctor?s advice.

Injecting the solution

H

Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have been pushed out by the pressure in the syringe). Hold the syringe with the vial upside down and pull the plunger to draw all the solution into the syringe.

I

Unscrew the vial adapter with the empty vial.

NovoSeven is now ready for injection. Follow the injection procedure as instructed by your health care professional.

J

Safely dispose of the syringe, vial adapter, vials, infusion set and any unused product as instructed by your health care professional.