NovoEight 500 IU powder and solvent for solution for injection

• 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.

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

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

Do not use NovoEight if either of the above applies to you. If you are not sure, talk to your doctor before using this medicine.

Talk to your doctor before using NovoEight.

There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to NovoEight. Early signs of allergic reactions are rash, hives, weals, generalised itching, swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.

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

Talk to your doctor if you think that your bleed is not being controlled with the dose you receive, as there can be several reasons for this. Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors). Factor VIII inhibitors make NovoEight less effective in preventing or controlling bleeding. If this happens you may need a higher dose of NovoEight or a different medicine to control your bleed. Do not increase the total dose of NovoEight to control your bleed without talking to your doctor. You should tell your doctor if you have been previously treated with factor VIII products, especially if you developed inhibitors, since there might be a higher risk that it happens again.

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors. If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

If you are pregnant or breastfeeding, think that you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.

This is equivalent to 1.5% of the recommended maximum dietary intake of sodium for an adult.

Talk to your doctor if you are on a controlled sodium diet.

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

The dose of NovoEight is calculated depending on your body weight and the factor VIII levels to be achieved. The target factor VIII levels will depend on the severity and location of the bleeding.

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

NovoEight is given as an injection into a vein. See ‘Instructions on how to use NovoEight’ for more information.

If you use more NovoEight than you should, tell your doctor or go to a hospital straight away.

You should contact your doctor if you have missed a dose and do not know how to compensate for this.

If you stop using NovoEight you may no longer be protected against bleeding or a current bleed may not stop. Do not stop using NovoEight without talking to your doctor.

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

If you get 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

Great Britain

or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

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

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

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

The package contains:

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

• Take out the number of NovoEight packages you need.
• Check the expiry date.
• Check the name, strength and colour of the package, to make sure it contains the correct product.
• Wash your hands and dry them properly using a clean towel or air dry.
• Take the vial, the vial adapter and the pre-filled syringe out of the carton.
  Leave the plunger rod untouched in the carton.
• Bring the vial and the pre-filled syringe to room temperature. You can do this by holding them in your hands until they feel as warm as your hands.
• Do not use any other way to heat the vial and pre-filled syringe.

• Remove the plastic cap from the vial.
  If the plastic cap is loose or missing, do not use the vial.
• Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
• Do not touch the rubber stopper with your fingers as this can transfer germs.

• Remove the protective paper from the vial adapter.
  If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
  Do not take the vial adapter out of the protective cap with your fingers.
  If you touch the spike on the vial adapter, germs from your fingers can be transferred.

• Place the vial on a flat and solid surface.
• Turn over the protective cap, and snap the vial adapter onto the vial.
  Once attached, do not remove the vial adapter from the vial.

• Lightly squeeze the protective cap with your thumb and index finger as shown.
  Remove the protective cap from the vial adapter.
  Do not lift the vial adapter from the vial when removing the protective cap.

• Grasp the plunger rod by the wide top end and take it out of the carton. Do not touch the sides or the thread of the plunger rod. If you touch the sides or the thread, germs from your fingers can be transferred.
• Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.

• Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
• Do not touch the syringe tip under the syringe cap. If you touch the syringe tip, germs from your fingers can be transferred.
  If the syringe cap is loose or missing, do not use the pre-filled syringe.

• Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.

• Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
• Push the plunger rod to inject all the solvent into the vial.

• Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
  Do not shake the vial as this will cause foaming.
• Check the reconstituted solution. It must be clear to slightly opalescent (slightly unclear). If you notice visible particles or discolouration, do not use it. Use a new package instead.

NovoEight is recommended to be used immediately after it has been reconstituted. This is because if left, the medicine may no longer be sterile and could cause infections.

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

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

Do not store the solution without your doctor’s advice.

Keep reconstituted NovoEight solution out of direct light.

If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.

• Keep the plunger rod pushed completely in.
• Turn the syringe with the vial upside down.
• Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
• Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
• In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse.
  If, at any point, there is too much air in the syringe, inject the air back into the vial.
• While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
• Push the plunger rod slowly until all air bubbles are gone.

• Unscrew the vial adapter with the vial.
• Do not touch the syringe tip. If you touch the syringe tip, germs from your fingers can be transferred.

NovoEight is now ready to be injected into your vein.

• Inject the reconstituted solution as instructed by your doctor or nurse.
• Inject slowly over 2 to 5 minutes.
• Do not mix NovoEight with any other intravenous infusions or medicines.

Caution: 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 may prevent administration of the medicine and/or result in damage to the needleless connector.

Injecting the solution via 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 proper use for your connector and CVAD in consultation with your doctor or nurse.
• Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution. This should be done right after step J.
• If the CVAD line needs to be flushed before or after NovoEight injection, use sodium chloride 9 mg/ml solution for injection.

• After injection, safely dispose of all unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
  Do not throw it out with the ordinary household waste.

Do not disassemble the equipment before disposal.

Do not reuse the equipment.