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

NovoThirteen contains the active substance catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood clotting. NovoThirteen replaces the missing factor XIII and helps to stabilise the initial blood clot by producing a mesh around the clot.

NovoThirteen is used to prevent bleeding in patients who do not have enough or are missing part of factor XIII (that is called A-subunit).

• If you are allergic to catridecacog or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, ask your doctor before using this medicine.

Talk to your doctor before using NovoThirteen:

• If you have or have ever had a higher risk of blood clots forming (thrombosis), as NovoThirteen may increase the severity of a pre-existing blood clot.
• If you have or have ever had liver damage.

• If you experience bleeding during your treatment with NovoThirteen occurring spontaneously and/or requiring treatment.
• If you experience an allergic reaction to NovoThirteen. The signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (signs include paleness and coldness of skin, rapid heartbeat), feeling dizzy and sweating.

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

It is not recommended to use NovoThirteen and recombinant coagulation factor VIIa (another blood clotting factor) together.

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

This medicine contains less than 1 mmol sodium (23 mg) per injection, i.e. essentially ‘sodium-free’.

For children weighing less than 24 kg the reconstituted NovoThirteen should be further diluted with 6 ml of sodium chloride 0.9%, solution for injection to be able to handle the dosing of small children. For more information see section ‘NovoThirteen user instructions - Instructions of how to dilute the reconstituted NovoThirteen’.

The dose volume for the reconstituted NovoThirteen diluted with 6 ml sodium chloride 0.9%, solution for injection can be calculated from this formula:

Dose volume in millilitres = 0.117 x body weight in kilograms.

NovoThirteen can be used in children and adolescents in the same way as in adults for both prevention of bleeds and if you experience a bleed.

There is limited information on overdose with NovoThirteen. None of the reported cases have shown any signs of illness. Contact your doctor if you have injected more NovoThirteen than you have been instructed.

If you forget an injection of NovoThirteen, talk to your doctor. Do not take a double dose to make up for a forgotten dose.

If you stop using NovoThirteen, you are not protected against bleeding. Do not stop using NovoThirteen without talking to your doctor. Your doctor will explain what might happen if you stop treatment and discuss other options with you.

Common (may affect up to 1 in 10 people):

• Headache (most common side effect)
• Pain where the injection is given
• Pain in the legs and arms
• Increased amount of small protein fragments caused by break down of blood clots
• A drop in the number of some types of white blood cells. This means your body may be more prone to infections
• Development of antibodies against factor XIII which have no influence on the effect of the drug.

The side effects observed in children are the same as also observed in adults but the side effects may be more common in children than 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 catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml, after reconstitution, corresponding to a concentration of 833 IU/ml.
• The other ingredients are for the powder sodium chloride, sucrose and polysorbate 20, L-histidine, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH adjustment) and for the solvent water for injections.

NovoThirteen is supplied as a powder and solvent for solution for injection (2500 IU powder in a vial and 3.2 ml solvent in a vial, with a vial adapter).

Pack size of 1.

The powder is white and the solvent is clear and colourless.

To dilute the reconstituted NovoThirteen the following tools are needed: a vial containing sodium chloride 0.9%, solution for injection, a 10 ml syringe and alcohol swabs.

General instructions for dilution

The dilution should be performed in accordance with aseptic rules.

Carefully draw exactly 6 ml sodium chloride 0.9%, solution for injection, into the 10 ml syringe.

Slowly inject the 6 ml sodium chloride 0.9%, solution for injection, into the reconstituted NovoThirteen vial.

Gently swirl the vial to mix the solution.

The diluted solution is a clear, colourless solution. Check the injection solution for particulate matter and for discolouration. If either is noticed, please discard.

After dilution proceed to step H.

Any residual material of the diluted product has to be discarded immediately.

In case of any questions ask your doctor or nurse.