This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use NOVOEIGHT 250 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 experience 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

What is NovoEight and what is it used for
What you need to know before you use NovoEight
How to use NovoEight
Possible side effects
Storage of NovoEight
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 face, lips, tongue or throat, difficulty breathing, wheezing, chest tightness, 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 being 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 in preventing or controlling 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 amounts, prevent the treatment from working properly, so you and your child will be carefully monitored for the development of such inhibitors. If you or your child's bleeding is not being 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 (a major 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

A doctor experienced in the treatment of patients with haemophilia A will start treatment with NovoEight. 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 have missed a dose and do not know how to make up for it, 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 other 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 (sudden and severe allergic reactions) occur (rarely), the injection must be stopped immediately. If you experience any of the following symptoms, contact your doctor immediately:

difficulty breathing, breathlessness or wheezing
chest tightness
swelling of the lips and tongue
rash, hives, itching or generalised itching
feeling of dizziness or loss of consciousness
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 urgent treatment.

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

In previously untreated children with factor VIII medicines, inhibitor antibodies (see section 2) may be formed very commonly (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 medicines

redness of the skin
vein inflammation
bleeding into the joints
bleeding into the muscle tissue
cough
redness around the infusion 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 label 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)

up to 3 months 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 and storage temperature on the product carton.

Once reconstituted, NovoEight should be used immediately. If you cannot use the reconstituted NovoEight solution immediately, you can store it for:

24 hours when stored in a refrigerator (2°C to 8°C)
4 hours when stored at ≤30°C, for the 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 the 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. Container 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 and Container Contents of the Product

NovoEight is a powder and solvent for solution for injection. Each NovoEight container 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 Authorisation 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.

Instructions for Use of NovoEight

READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.

NovoEight is supplied as a powder. Before injection (administration), it must be reconstituted with the supplied solvent in the syringe. The solvent is a sodium chloride 9 mg/ml (0.9%) solution. Reconstituted NovoEight must be injected into a vein (intravenous injection). The components of this container are designed to reconstitute and inject NovoEight.

You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze, and bandages. These devices are not included in the NovoEight container.

Do not use the equipment without having received proper training from your doctor or nurse.

Always wash your hands and ensure the area around you is clean.

When preparing and injecting the medicine directly into the veins, it is essential to use a clean and germ-free (aseptic) technique.Inadequate technique can introduce germs that can infect the blood.

Do not open the equipment until you are ready to use it.

Do not use the equipment if it has been dropped or damaged.Use a new container instead.

Do not use the equipment if it has expired.Use a new container instead. The expiration date is printed on the outer packaging, the vial, the vial adapter, and the pre-filled syringe after EXP.

Do not use the equipment if you suspect it is contaminated.Use a new container instead.

Do not discard any component until the reconstituted solution has been injected.

The equipment is for single use only.

Contents

The container contains:

1 vial with NovoEight powder
1 vial adapter
1 pre-filled syringe with solvent
1 plunger rod (located under the syringe)

Clear glass vial with white NovoEight powder, rubber stopper covered by a light blue plastic cap Vial adapter with transparent protective cover and visible spike under the protective paper

Transparent syringe with plunger and stopper, labeled tip, visible graduation scale and solvent inside the cylinder Long rod with thread at one end and wide end at the other, labeled with arrows and explanatory text

Prepare the vial and syringe

Prepare the required number of NovoEight containers.

Check the expiration date.

Check the name, concentration, and color of the container to ensure it contains the correct product.

Wash your hands and dry them properly with a clean towel or air.

Remove the vial, vial adapter, and pre-filled syringe from the container. Leave the plunger rod untouched in the container.

Bring the vial and pre-filled syringe to room temperature. You can do this by holding both in your hands until you feel they are at the same temperature as your hands.

Do not use any other system to heat the vial and pre-filled syringe.

Two hands holding a white cylinder and a blue cap preparing for injection

Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial.

Clean the rubber stopper with a sterile alcohol swab and let it air dry for a few seconds before using it to ensure it is as germ-free as possible.

Do not touch the rubber stopper with your fingers, as this can transfer germs.

Hand holding a medicine vial with a needle inserted into the top stopper and an arrow indicating direction

Attach the vial adapter

Remove the protective paper from the vial adapter.

If the protective paperis not fully sealed or is broken, do not use the vial adapter.

Do not remove the vial adapter from the protective cover with your fingers.If you touch the spike of the vial adapter, you can transfer germs from your fingers.

Hands holding a medicine vial with a needle inserted and an arrow indicating the direction of withdrawal

Place the vial on a flat, hard surface.

Place the protective cover of the vial adapter upside down and attach the vial adapter to the vial by pressing.

Once attached, do not remove the vial adapter from the vial.

Hand holding a pre-filled injection device with a blue arrow pointing down and a vial below

Slightly compress the protective cover between your thumb and index finger as shown.

Remove the protective coverfrom the vial adapter.

Do not remove the vial adapterwhen removing the protective cover.

Hand holding an applicator with a needle over a medicine vial and an arrow indicating direction upwards

Attach the plunger rod and syringe

Hold the plunger rod by the wide end and remove it from the container. Do not touch the sides or thread of the plunger rod. If you touch the sides or thread, you can transfer germs from your fingers.

Immediately attach the plunger rod to the syringe by turning it to the right inside the plunger in the pre-filled syringe until you feel resistance.

Hands holding an auto-injector with a curved blue arrow indicating the direction of rotation

Remove the cap from the pre-filled syringe by folding it downwards until the perforation breaks.

Do not touch the tip of the pre-filled syringe under the syringe cap. If you touch the tip of the pre-filled syringe, you can transfer germs from your fingers.

If the syringe cap is loose or missing, do not use the pre-filled syringe.

Hands holding a pre-filled injection device and a needle connecting with an arrow indicating direction

Tightly screw the pre-filled syringe onto the vial adapter until you feel resistance.

Hands holding two connected medicine cartridges with a blue arrow indicating rotation

Reconstitute the powder with the solvent

Hold the pre-filled syringe slightly inclined with the vial pointing downwards.

Press the plunger rod to inject all the solvent into the vial.

Hand holding a pre-filled syringe with a blue arrow indicating the direction of needle insertion

Keep the plunger rod pressed and gently remove the vial until the powder is dissolved.

Do not shake the vial, as this would create foam.

Check the reconstituted solution. It should be transparent or slightly opalescent (slightly less transparent). If it appears cloudy or contains visible particles, do not use it. Use a new container instead.

Hand turning an auto-injector with the needle downwards over a dark surface indicating the injection process

It is recommended to use NovoEight immediately after reconstitution,as, if left, the medicine may lose its sterility and could cause infections.

If you cannot use the reconstituted NovoEight solution immediately,you must use it within 4 hours if stored at room temperature or up to 40°C, or within 24 hours if stored between 2°C and 8°C. Store the reconstituted product in the vial.

Do not freeze the reconstituted NovoEight solution or store it in syringes.

Do not store the solution without the advice of your doctor.

Store the reconstituted NovoEight solution away from direct light.

If your dose requires more than one vial, repeat steps Ato Jwith additional vials, vial adapters, and pre-filled syringes until the required dose is reached.

Keep the plunger rod fully pushed in.

Hold the syringe with the vial upside down.

Stop pressing the plunger rod and let it retract by itself while the reconstituted solution fills the syringe.

Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.

If you only need part of the vial, use the syringe scale to see the amount of reconstituted solution you have withdrawn, as indicated by your doctor or nurse.

If there is too much air in the syringe at any time, inject the air back into the vial.

While holding the vial upside down, gently tap the syringe to allow any bubbles to rise to the top.

Slowly push the plunger rod until all bubbles have been eliminated.

Hand holding a pre-filled syringe with transparent medicine and descending plunger indicated by a blue arrow

Unscrew the adapter with the vial.

Do not touch the tip of the syringe. If you touch the tip of the syringe, you can transfer germs from your fingers.

Hands holding an auto-injector with a connected needle and blue arrows indicating the injection movement

Inject the reconstituted solution

NovoEight is now ready to be injected into a vein.

Inject the reconstituted solution following the instructions of your doctor or nurse.

Inject slowly over 2 to 5 minutes.

Do not mix NovoEight with any other infusion or intravenous medication.

Injection of NovoEight through needleless connectors for intravenous (IV) catheters

Precaution:the pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections. Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. This incompatibility can prevent the administration of the medicine and/or damage the needleless connector.

Injection of the solution through a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:

Use a clean and germ-free (aseptic) technique. Follow the instructions for the proper use of your connector and CVAD with the advice of your doctor or nurse.
Injection into a CVAD may require using a sterile 10 ml plastic syringe to withdraw the reconstituted solution. This should be done immediately after step J.
If it is necessary to flush the CVAD line before or after the injection of NovoEight, use a sodium chloride 9 mg/ml injection solution.

Disposal

After injection, safely discard any unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter, and other waste following the instructions of your pharmacist.

Do not dispose of them as ordinary household waste.

Blue vial with cap, needle inserting into a rubber stopper, and small vial with transparent liquid

Do not disassemble the equipment before disposing of it.

Do not reuse the equipment.

NOVOEIGHT 250 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION