NOVOEIGHT 2000 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

NovoEight250UI powder and solvent for solution for injection

NovoEight500UI powder and solvent for solution for injection

NovoEight1000UI powder and solvent for solution for injection

NovoEight1500UI powder and solvent for solution for injection

NovoEight2000UI powder and solvent for solution for injection

NovoEight3000UI powder and solvent for solution for injection

turoctocog alfa (human coagulation factor VIII (rDNA))

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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is NovoEight and what is it used for

NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein that is naturally found in the blood and helps it to clot.

NovoEight is used to treat and prevent bleeding episodes in patients with haemophilia A (congenital factor VIII deficiency) and can be used in all age groups.

In patients with haemophilia A, factor VIII is missing or does not work properly. NovoEight replaces the missing or non-functioning factor VIII and helps the blood to form clots at the site of bleeding.

2. What you need to know before you use NovoEight

Do not use NovoEight:

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to hamster proteins.

Do not use NovoEight in any of the above cases. If you are not sure, talk to your doctor before using this medicine.

Warnings and precautions

Talk to your doctor before using NovoEight.

There is a small chance that an anaphylactic reaction (a sudden and severe allergic reaction) to NovoEight may occur. The first signs of an allergic reaction are rash, hives, itching, swelling of the lips and tongue, difficulty breathing, wheezing, chest tightness, feeling of faintness and dizziness.

If any of these symptoms occur, stop the injection immediately and contact your doctor.

Talk to your doctor if you think that bleeding is not controlled with the dose you are given, as there may be different reasons for this. Some people using this medicine may develop antibodies against factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors reduce the effectiveness of NovoEight to prevent or control bleeding. If this happens, you may need a higher dose of NovoEight or another medicine to control bleeding. Do not increase the total dose of NovoEight to control bleeding without talking to your doctor. You should tell your doctor if you have been previously treated with factor VIII medicines, especially if you have developed inhibitors, as the risk of this happening again is higher.

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially in large quantities, prevent the treatment from working properly, so you and your child will be carefully monitored for the development of such inhibitors. If your bleeding or your child's bleeding is not controlled with NovoEight, contact your doctor immediately.

Other medicines and NovoEight

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

NovoEight has no influence on the ability to drive and use machines.

NovoEight contains sodium

This medicine contains 30.5 mg of sodium (the main component of cooking/table salt) per reconstituted vial. This is equivalent to 1.5% of the maximum recommended daily intake of sodium for an adult.

If you are on a low sodium diet, talk to your doctor.

3. How to use NovoEight

Treatment with NovoEight should be started by a doctor who has experience in the treatment of patients with haemophilia A. Follow the instructions for administration of this medicine exactly as told by your doctor. If you are not sure, talk to your doctor again.

Your doctor will calculate the dose for you based on your weight and what the medicine is being used for.

Prevention of bleeding

The usual dose of NovoEight is 20 to 50 international units (IU) per kg body weight. The injection is given every 2 or 3 days. In some cases, especially in younger patients, more frequent injections or higher doses may be needed.

Treatment of bleeding

The dose of NovoEight is calculated based on body weight and the desired factor VIII levels. The desired level of factor VIII depends on the severity and location of the bleeding.

Use in children and adolescents

NovoEight can be used in children of all ages. In children (under 12 years) higher doses or more frequent injections may be needed. Adolescents (over 12 years) can use the same dose as adults.

How NovoEight is given

NovoEight must be injected into a vein. See “Instructions for use of NovoEight” for further information.

If you use more NovoEight than you should

If you use more NovoEight than you should, contact your doctor or go to a hospital immediately.

If you forget to use NovoEight

If you miss a dose and do not know what to do, contact your doctor.

If you stop using NovoEight

If you stop using NovoEight you will no longer be protected against bleeding or an existing bleed may not stop. Do not stop using NovoEight without talking to your doctor first.

If you have any further questions on the use of this medicine, ask your doctor.

4. Possible side effects

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

If anaphylactic reactions (severe and sudden allergic reactions) occur (rarely), the injection must be stopped immediately. If you experience any of the following symptoms, contact your doctor immediately:

• difficulty breathing, wheezing
• chest tightness
• swelling of the lips and tongue
• rash, hives, itching
• feeling of dizziness or fainting
• low blood pressure (pale and cold skin, palpitations).

Severe symptoms, including difficulty swallowing or breathing and redness and swelling of the face or hands, require immediate treatment.

If you experience a severe allergic reaction, your doctor may change your medicine.

In previously untreated children with factor VIII deficiency, inhibitor antibodies (see section 2) may occur very frequently (more than 1 in 10 patients); however, in patients who have received previous treatment with factor VIII (more than 150 days of treatment), the risk is uncommon (less than 1 in 100 patients). If this happens to you or your child, the treatment may stop working properly and you or your child may experience persistent bleeding. If this happens, contact your doctor immediately.

Common side effects (may affect up to 1 in 10 people)

• blood tests showing changes in liver function
• reactions (redness and itching) at the injection site.

Common side effects (may affect up to 1 in 10 people) in previously untreated patients with factor VIII deficiency

• redness of the skin
• vein inflammation
• joint bleeding
• muscle bleeding
• cough
• redness around the injection site
• vomiting.

Uncommon side effects (may affect up to 1 in 100 people)

• feeling tired
• headache
• feeling dizzy
• difficulty sleeping (insomnia)
• palpitations
• high blood pressure
• rash
• fever
• feeling hot
• muscle stiffness
• muscle pain
• pain in arms and legs
• swelling of arms and legs
• joint disease
• bruising
• heart attack.

Side effects in children and adolescents

The side effects seen in children and adolescents are the same as those seen in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. 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 NovoEight

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 and on the labels of the vial and the pre-filled syringe after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Before reconstitution, the NovoEight powder can be stored for:

• up to 9 months at room temperature (≤30°C)

or

• up to 3 months at temperatures above room temperature (30°C to 40°C).

Once the product is removed from the refrigerator, it must not be refrigerated again.

Please note the start date of storage and storage temperature on the product carton.

After reconstitution, NovoEight must be used immediately. If you cannot use the reconstituted NovoEight solution immediately, you must use it within:

• 24 hours when stored in a refrigerator (2°C to 8°C)
• 4 hours when stored at ≤30°C, for product that has been stored for a single period of up to 9 months at room temperature (≤30°C).
• 4 hours when stored up to 40°C, for product that has been stored for a single period of up to 3 months above room temperature (30°C to 40°C).

If you are not going to use the reconstituted medicine immediately, store it in the vial. Otherwise, it will no longer be sterile and may cause an infection. Do not store the solution unless you follow the advice of your doctor.

The powder in the vial is a white or slightly yellow powder. If the colour of the powder has changed, do not use it.

The reconstituted solution will be clear to slightly opalescent. Do not use this medicine if you notice it is cloudy or contains visible particles.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Package Contents and Additional Information

Composition of NovoEight

• The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)). Each vial of NovoEight contains 250, 500, 1000, 1500, 2000 or 3000 IU of turoctocog alfa.
• The other components are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide, and hydrochloric acid.
• The components of the solvent are sodium chloride and water for injections.

After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) injection solution), the prepared injection solution contains 62.5, 125, 250, 375, 500 or 750 IU of turoctocog alfa per ml respectively (based on the turoctocog alfa concentration, i.e., 250, 500, 1000, 1500, 2000 or 3000 IU).

Appearance of the Product and Package Contents

NovoEight is a powder and solvent for solution for injection. Each package of NovoEight contains a vial with white or slightly yellow powder, a pre-filled syringe with 4 ml of a colorless and transparent solution, a plunger rod, and a vial adapter.

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.