Product Information for the User

NovoThirteen 2.500UI Powder and Solvent for Injectable Solution

catridecacog (recombinant coagulation factor XIII)

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

–Keep this product information, as you may need to read it again.

–If you have any questions, consult your doctor.

–This medication has been prescribed to you alone, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

–If you experience any adverse effects, consult your doctor, even if they are not listed in this product information. See section 4.

1.What is NovoThirteen and what it is used for

2.What you need to know before starting to use NovoThirteen

3.How to use NovoThirteen

4.Possible adverse effects

5.Storage of NovoThirteen

6.Contents of the package and additional information

What is NovoThirteen

NovoThirteencontains the active ingredient catridecacog, which is identical to human coagulation factor XIII, an enzyme necessary for blood coagulation. NovoThirteen replaces the missing factor XIII and promotes the stabilization of the initial blood clot by creating a mesh around it.

What is NovoThirteen used for

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

It is essential to use NovoThirteen for injectable solution immediately after preparation.

Do not use NovoThirteen

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

If you are unsure, consult your doctor before starting to use this medication.

Warnings and precautions

Consult your doctor before starting to use NovoThirteen:

•If you have or have had an increased risk of blood clot formation (thrombosis), as NovoThirteen may increase the severity of an existing blood clot.

•If you have or have had any liver damage.

Contact your doctor immediately:

•If you experience bleeding during treatment with NovoThirteen and these occur spontaneously and/or require treatment.

•If you experience an allergic reaction to NovoThirteen. Symptoms may include: urticaria, itching, swelling, difficulty breathing, hypotension (symptoms include paleness and cold skin, rapid pulse), dizziness, and sweating.

Other medications and NovoThirteen

Inform your doctor if you are using, have used recently, or may need to use any other medication.

NovoThirteen is not recommended to be used concurrently with recombinant coagulation factor VIIa (another blood clotting factor).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

NovoThirteen contains sodium

This medication contains less than 23mg (1mmol) of sodium per injection, making it essentially “sodium-free.”

Your treatment with NovoThirteen should be initiated by a doctor with experience in the treatment of rare bleeding disorders.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Before using NovoThirteen for injection, you need to reconstitute the product. See the usage instructions for NovoThirteen.

NovoThirteen is administered intravenously. The dose will depend on your body weight. The usual dose for preventing bleeding is 35 UI per kilogram of body weight. The injections are administered once a month (every 28 ± 2 days).

If you experience bleeding, you should contact your doctor who will decide if you need an injection.

NovoThirteen should be injected at a rate not exceeding 2 ml/minute.

The dose volume for the injection (in milliliters) can be calculated with the following formula according to the concentration of the NovoThirteen solution:

Dose volume in milliliters = 0.042 x your body weight in kilograms.

You should only use the prescribed and calculated dose by your doctor, taking into account that the usual dose and concentration of NovoThirteen are different from those of other medications containing factor XIII.

Your doctor may adjust the dose if necessary.

Use in young children

For children weighing less than 24 kg, reconstituted NovoThirteen should be diluted with 6 ml of 0.9% sodium chloride injection solution to adjust the dose for young children. For more information, see the section “NovoThirteen usage instructions – Instructions on how to dilute reconstituted NovoThirteen”.

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

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

Use in children and adolescents (over 24 kg)

NovoThirteen can be used in adolescents and children in the same way as in adults, both for preventing bleeding and if bleeding occurs.

If you use more NovoThirteen than you should

The information about NovoThirteen overdose is limited. None of the reported cases have shown symptoms of illness.Contact your doctor if you have injected a higher amount of NovoThirteen than indicated.

If you forgot to use NovoThirteen

Consult your doctor if you forgot to administer an injection of NovoThirteen.Do not use a double dose to compensate for the missed doses.

If you interrupt treatment with NovoThirteen

If you interrupt treatment with NovoThirteen, you will no longer be protected against bleeding. Do not interrupt treatment with NovoThirteen without consulting your doctor, who will explain the consequences of interrupting treatment and offer other options.

If you have any other questions about the use of this medication, ask your doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The adverse effects include:

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

•Headache (the most frequent adverse effect)

•Pain at the injection site

•Pain in legs and arms

•Increased number of small protein fragments due to the dissolution of blood clots

•Reduction in the number of some types of leukocytes. This means that your body may be more prone to infections

•Development of antibodies against factor XIII. These antibodies do not affect the medication's effect.

Adverse effects in children:

The adverse effects observed in children are the same as those observed in adults, but adverse effects may be more frequent in children than in adults.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the label and outer box after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

Once prepared, NovoThirteen injectable must be used immediately.

The solution is transparent and colorless. Do not use this medication if you observe particles or it changes color when reconstituted.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of NovoThirteen

•The active ingredient is catridecacog (recombinant factor XIII): 2,500UI/3 ml, after reconstitution, corresponding to a concentration of 833UI/ml.

•The other components are, for the powder: sodium chloride, sucrose, and polisorbate 20, L-histidine, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and for the solvent: water for injection.

Aspect of the product and contents of the package

NovoThirteen is supplied as a powder and solvent for injectable solution(2,500UI ofpowder in a vial and 3.2ml of solvent in a vial, with a vial adapter).

Package size of 1.

The powder is white and the solvent is transparent and colorless.

Holder of the marketing authorization and manufacturer responsible

Novo Nordisk A/S

Novo Allé

DK-2880 Bagsværd

Denmark

Last review date of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

Instructions for use of NovoThirteen

To reconstitute and administer this medicine, the following materials are needed: a 10ml syringe or a syringe of the appropriate size for the injection volume, alcohol-impregnated swabs, the vial adapter included, and an infusion set (tubes, butterfly needle).

Preparation of the solution

Always use aseptic technique. Before starting, wash your hands.Bring the powder and solvent vials to a temperature not exceeding 25°C, holding the vials in your hands until you feel they are at the same temperature as your hands. Remove the plastic caps from the 2 vials. Do not use the vials if the caps are loose or missing. Clean the rubber stoppers of the vials with an alcohol-impregnated swab and let them dry before use.

The medicine is reconstituted using the vial adapter included.

Remove the paper seal from the vial adapter without removing it from the protective cap. Place the vial adapter on the solvent vial (water for injection). Be careful not to touch the spike of the vial adapter.

Once attached, remove the protective cap from the vial adapter.

Pull the plunger of the syringe to draw a volume of air equivalent to the total volume of solvent contained in the solvent vial.

Tighten the syringe firmly onto the vial adapter attached to the solvent vial.Inject air into the vial by pressing the plunger until you feel a clear resistance.

Hold the syringe with the solvent vial upside down.Pull the plunger to extract the solvent and pass it to the syringe.

Remove the empty solvent vial by tilting the syringe attached to the vial adapter.

Adjust the vial adapter, still attached to the syringe, to the powder vial until you hear a click.Hold the syringe slightly tilted with the vial down.Press the plunger slowly to inject the solvent into the powder vial.Make sure not to direct the solvent jet directly onto the powder, as this would produce foam.

Make gentle circular movements with the vial until all the powder is dissolved. Do not shake the vial, as this would produce foam.

NovoThirteen should be visually inspected for foreign particles (external) and discoloration before administration. If either case occurs, discard the medicine.

NovoThirteen reconstituted is a transparent and colorless solution.

If a higher dose is needed, repeat the procedure in another syringe separately until the required dose is reached.

Important information

Once prepared, NovoThirteen injectable must be used immediately.

If a dilution of NovoThirteen reconstituted is needed, refer to the section “Dilution of the reconstituted product with sodium chloride 0.9% injectable solution”.

Make sure the plunger is pressed to the bottom before turning the syringe (air may have been expelled from the vial). Hold the syringe with the vial upside down and pull the plunger to load the calculated amount for the injection.

Remove the vial adapter from the vial.

Now the medicine is ready to be injected into a vein. Follow the injection procedure indicated by your doctor.

After injection

Dispose of the syringe, vial adapter, infusion set, and vials safely. The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.

Instructions for diluting NovoThirteen reconstituted

To dilute NovoThirteen reconstituted, the following materials are needed: a vial containing sodium chloride 0.9% injectable solution, a 10ml syringe, and alcohol-impregnated swabs.

General instructions for dilution

The dilution must be carried out following aseptic techniques.

Carefully load exactly 6ml of sodium chloride 0.9% injectable solution into the 10ml syringe.

Lentily inject the 6ml of sodium chloride 0.9% injectable solution into the vial of NovoThirteen reconstituted.

Make gentle circular movements with the vial to mix the solution.

The diluted solution is a transparent and colorless solution. Check the injectable solution for particles and discoloration. If you observe either, please discard it.

After dissolution, refer to step H.

Any residual material from the diluted product must be discarded immediately.

If you have any doubts, ask your doctor or nurse.