NOVOSEVEN 2 mg (100 IU) POWDER AND SOLVENT FOR INJECTION

Introduction

Package Leaflet: Information for the User

NovoSeven 1mg (50KUI) powder and solvent for solution for injection

NovoSeven 2mg (100KUI) powder and solvent for solution for injection

NovoSeven 5mg (250KUI) powder and solvent for solution for injection

NovoSeven 8mg (400KUI) powder and solvent for solution for injection

eptacog alfa (activated)

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.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms 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.

Contents of the pack

1. What is NovoSeven and what is it used for
2. What you need to know before you use NovoSeven
3. How to use NovoSeven
4. Possible side effects
5. Storage of NovoSeven
6. Contents of the pack and further information

On the back: Instructions for use of NovoSeven

1. What is NovoSeven and what is it used for

NovoSeven is a blood clotting factor. It works by activating the blood clotting system in the site of bleeding when the patient's own clotting factors do not work.

NovoSeven is used to treat bleeding and prevent excessive bleeding after surgical procedures or other major treatments. Early treatment with NovoSeven reduces the amount and duration of bleeding. It works in all types of bleeding, including joint bleeding. This reduces the need for hospitalization and days off work or school.

It is used in certain groups of people:

• If you have congenital hemophilia and do not respond normally to treatment with 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 disease cannot be effectively treated with platelet transfusion, or if platelets are not readily available.

NovoSeven may also be given to you by a doctor to treat heavy bleeding after childbirth, even if you do not have a bleeding disorder.

2. What you need to know before you use NovoSeven

Do not use NovoSeven

• If you are allergic to eptacog alfa (the active substance of NovoSeven) or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to mouse, hamster or bovine proteins (such as cow's milk).

If any of these apply to you, do not use NovoSeven. Talk to your doctor.

Warnings and precautions

Before starting treatment with NovoSeven, make sure your doctor knows:

• If you have recently undergone surgery
• If you have recently suffered a crush injury
• If your arteries are narrower due to disease (atherosclerosis)
• If you have a higher risk of blood clot formation (thrombosis)
• If you have severe liver disease
• If you have severe septicemia
• If you are prone to disseminated intravascular coagulation (DIC, a condition in which blood clots form in the bloodstream) you should be closely monitored.

If any of these apply to you, tell your doctor before using this product.

Other medicines and NovoSeven

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Do not use NovoSeven at the same time as prothrombin complex concentratesor rFXIII. You should consult your doctor before using NovoSeven if you are also using factor VIII or IX.

There is limited experience of using NovoSeven with other medicines called antifibrinolytics (such as aminocaproic acid or tranexamic acid) which are also used to control bleeding. You should consult your doctor before using NovoSeven with these medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using NovoSeven.

Driving and using machines

There are no studies on the effects of NovoSeven on the ability to drive and use machines. However, there is no medical reason to think it could affect your ability.

NovoSeven contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. it is essentially "sodium-free".

3. How to use NovoSeven

NovoSeven powder must be reconstituted with the solvent and injected intravenously. See the detailed instructions on the back.

When to treat

Start treatment of a bleed as soon as possible, ideally within the first 2 hours.

• In case of a mild or moderate bleed, you should treat yourself as soon as possible, preferably at home.
• In case of a severe bleed you should contact your doctor. Normally, severe bleeds are treated in hospital and you can give yourself the first dose of NovoSeven on the way there.

You must not treat for more than 24 hours without consulting your doctor.

• Each time you use NovoSeven, you must inform your doctor or hospital as soon as possible.
• If the bleed is not controlled within the first 24 hours, contact your doctor immediately. You will usually need hospital attention.

Dose

The first dose should be given as soon as possible after the start of the bleed. Ask your doctor when injections should be given and how long you should continue using them.

Your doctor will decide your dose, based on your body weight, condition and type of bleed.

To get the best results, follow the prescribed dose carefully. Your doctor may change the dose.

If you have hemophilia:

The normal dose is 90 micrograms per kilogram of body weight; you can repeat the injection every 2-3 hours until the bleed is controlled.

Your doctor may recommend a single dose of 270 micrograms per kilogram of body weight. There is no clinical experience of using this single dose in people over 65 years of age.

If you have Factor VII deficiency:

The normal dose range is 15-30 micrograms per kilogram of body weight, for each injection.

If you have Glanzmann's thrombasthenia:

The usual dose is 90 micrograms (range 80 to 120 micrograms) per kilogram of body weight, for each injection.

If you inject more NovoSeven than you should

If you inject too much NovoSeven, contact your doctor immediately.

If you forget to inject a dose of NovoSeven

If you forget to inject a dose of NovoSeven or want to stop treatment, contact your doctor immediately.

4. Possible side effects

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

Serious side effects

Rare (may affect up to 1 in 1,000 episodes treated)

• Allergy, hypersensitivity or anaphylactic reactions. Symptoms may include skin rash, itching, redness and hives; chest noises or difficulty breathing; feeling dizzy or faint, and severe swelling of the lips or throat, or at the injection site.
• Blood clots in the arteries of the heart (which could lead to a heart attack or angina), in the brain (which could lead to a stroke) or in the intestine and kidneys. Symptoms may include severe chest pain, difficulty breathing, confusion, difficulty speaking or moving (paralysis) or abdominal pain.

Uncommon (may affect up to 1 in 100 episodes treated)

• Blood clots in the veins of the lungs, legs, liver, kidneys or at the injection site. Symptoms may include difficulty breathing, painful swelling of the leg and abdominal pain.
• Lack of efficacy or reduced response to treatment.

If you get any of these serious side effects, seek medical help immediately. Tell them that you have been using NovoSeven.

Remember to tell your doctor if you have a history of allergic reactions as you may need closer monitoring. In the vast majority of cases reported of thrombosis, patients had a predisposition to thrombotic disorders.

Other rare side effects

(may affect up to 1 in 1,000 episodes treated)

• Nausea (feeling sick)
• Headache
• Changes in some blood test and liver results.

Other uncommon side effects

(may affect up to 1 in 100 episodes treated)

• Skin rash, including rash, itching and hives
• Fever.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of NovoSeven

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.
• Store the powder and solvent below 25°C.
• Store the powder and solvent protected from light.
• Do not freeze.
• Use NovoSeven immediately after mixing the powder with the solvent to avoid infections. If you cannot use it immediately, after mixing, you must store it in the vial with the vial adapter and with the syringe still in place, in the refrigerator between 2°C and 8°C, for a maximum of 24 hours. Do not freeze the reconstituted NovoSeven solution and keep it protected from light. Do not store the solution without consulting your doctor or nurse.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of NovoSeven

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

The powder for solution for injection contains: 1 mg/vial (which corresponds to 50 KUI/vial), 2 mg/vial (which corresponds to 100 KUI/vial), 5 mg/vial (which corresponds to 250 KUI/vial), or 8 mg/vial (which corresponds to 400 KUI/vial).

After reconstitution, 1 ml of the solution contains 1 mg of eptacog alfa (activated).

1 KUI is equal to 1,000 IU (International Units).

Appearance of NovoSeven and Container Contents

The vial of powder contains white powder, and the pre-filled syringe contains a clear and colorless solution. The reconstituted solution is colorless. Do not use the reconstituted solution if particles appear or if it is discolored.

Each NovoSeven package contains:

• 1 vial with white powder for solution for injection
• 1 vial adapter
• 1 pre-filled syringe with solvent for reconstitution
• 1 plunger

Presentation: 1 mg (50 KUI), 2 mg (100 KUI), 5 mg (250 KUI), and 8 mg (400 KUI).

The current presentation is indicated on the outer packaging.

Marketing Authorization Holder and Manufacturer

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd, Denmark

Date of Last Revision of this Leaflet:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.