Novothirteen

Package leaflet: Information for the user

NovoThirteen 2500 UI powder and solvent for injectable solution

catridecacog (recombinant coagulation factor XIII)
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What NovoThirteen is and what it is used for

What NovoThirteen is
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 stabilize the initial blood clot by forming a network around it.

What NovoThirteen is used for
NovoThirteen is used to prevent bleeding in patients who are deficient or partially deficient in
factor XIII (called the A subunit).

2. What you should know before using NovoThirteen

It is important that NovoThirteen be used for injection immediately after preparation.
Do not use NovoThirteen

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

If you have any doubts, contact your doctor before using this medicine.
Warnings and precautions
Talk to your doctor before using NovoThirteen:

• If you are or have been at increased risk of developing blood clots (thrombosis), as NovoThirteen may increase the severity of a pre-existing clot
• If you have or have ever had liver damage

Contact your doctor immediately:

• If, during treatment with NovoThirteen, you experience spontaneous bleeding and/or bleeding requiring treatment.
• If you are allergic to NovoThirteen. Signs may include: hives, itching, swelling, difficulty breathing, low blood pressure (symptoms include paleness and cold skin, rapid heartbeat), dizziness and sweating.

Other medicines and NovoThirteen
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
It is recommended not to combine NovoThirteen and rFVIIa (another blood coagulation factor).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
ask your doctor for advice before using this medicine.
NovoThirteen contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per injection, i.e. it is practically
"sodium-free".

3. How to use NovoThirteen

Treatment with NovoThirteen must be initiated by a physician experienced in the treatment of
rare bleeding disorders.
Use this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor.
Before injecting NovoThirteen, you must reconstitute the medicine. See the Instructions for use of

NovoThirteen.

NovoThirteen is administered by intravenous injection. The dose depends on body weight.
The usual dose for prevention of bleeding is 35 IU per kilogram of body weight.
Injections are given once a month (every 28 ± 2 days).
If bleeding occurs, you must contact your doctor, who will decide whether an injection is needed.
Reconstituted NovoThirteen must be injected at a rate no faster than 2 ml/min.
Based on the concentration of the NovoThirteen solution, the volume of the dose (in millilitres) to be administered can be calculated using the following formula:
Dose volume in ml = 0.042 x patient's body weight in kilograms.
You must use only the dose prescribed by your doctor calculated using this formula, as the usual dose and concentration of NovoThirteen differ from those of other factor XIII-containing products.
Your doctor may adjust the dose if necessary.

Use in young children
In children weighing less than 24 kg, to allow accurate dosing in small children, reconstituted NovoThirteen must be further diluted with 6.0 ml of 0.9% sodium chloride solution for injection. For more information, see 'Instructions for use of NovoThirteen – Instructions for diluting reconstituted NovoThirteen'.
The dose volume for reconstituted NovoThirteen diluted with 6.0 ml of 0.9% sodium chloride solution for injection can be calculated using the following formula:
Dose volume in millilitres = 0.117 x body weight in kilograms.

Use in children and adolescents (body weight above 24 kg)
NovoThirteen may be used in children and adolescents in the same way as in adults, both for prevention of bleeding and for treatment of bleeding episodes.

If you use more NovoThirteen than you should
Information on overdose with NovoThirteen is limited. None of the reported cases showed adverse effects. If you have injected more NovoThirteen than you should, contact your doctor.

If you forget to use NovoThirteen
If you miss an injection of NovoThirteen, contact your doctor. Do not use a double dose to make up for the missed dose.

If you stop using NovoThirteen
If you stop using NovoThirteen, you are no longer protected against bleeding. Do not stop treatment with NovoThirteen without first discussing it with your doctor. Your doctor will explain what may happen if you stop treatment and will discuss possible alternative options with you.

If you have any questions about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects include:
Common side effects (may affect from 1 to 10 people)

• Headache (the most common side effect)
• Pain at the injection site
• Pain in legs and arms
• Increase in the amount of small protein fragments resulting from the breakdown of blood clots
• Decrease in the number of certain types of white blood cells. This means your body may become more susceptible to infections
• Development of antibodies against factor XIII that do not affect the medicine's efficacy.

Side effects in children:
Side effects observed in children are the same as those observed in adults, but side effects may be more frequent in children than in adults.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NovoThirteen

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and outer packaging following "EXP:". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C–8°C).
Do not freeze.
Keep the medicine in the original packaging to protect it from light.
After reconstitution, NovoThirteen solution for injection must be used immediately.
The solution is clear and colourless. Do not use NovoThirteen if particles are present in the solution or if there are changes in colour after the product has been reconstituted.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What NovoThirteen contains

• The active substance is catridecacog (recombinant coagulation factor XIII: 2500 IU/3 ml; after reconstitution corresponds to 833 IU/ml).
• The other ingredients in the powder are sodium chloride, sucrose, polysorbate 20, L-histidine, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and for the solvent, water for injections.

Description of the appearance of NovoThirteen and contents of the pack
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: 1.
The powder is white and the solvent is clear and colourless.
Marketing Authorisation Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd
Denmark
More detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu .
INSTRUCTIONS FOR USE OF NOVOTHIRTEEN
The following items are required to reconstitute and administer this product: a 10 ml syringe or one of appropriate size depending on the injection volume, alcohol swabs, the provided vial adapter, and an infusion set (tubing, butterfly needle).

Preparation of the solution
Always use aseptic technique. Before starting, it is important to wash your hands. Allow the vials of powder and solvent to reach a temperature not exceeding 25°C by holding them in your hands until they feel warm to the touch. Remove the plastic caps from both vials. Do not use the vials if the caps are missing or loose. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use.

The product is reconstituted using the provided vial adapter.
Remove the protective seal from the vial adapter without removing the adapter from its protective cap. Attach the vial adapter to the solvent vial (water for injections). Be careful not to touch the tip of the adapter.
Once attached, remove the protective cap from the vial adapter.

Pull the plunger to draw an amount of air equal to the volume of solvent into the syringe from the solvent vial.

Screw the syringe securely onto the vial adapter attached to the solvent vial. Inject the air into the vial by pushing the plunger until firm resistance is met.

Keep the syringe and solvent vial inverted. Pull the plunger to draw the solvent into the syringe.

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

Connect (with a click) the vial adapter, still attached to the syringe, to the powder vial. Hold the syringe slightly tilted with the vial pointing downward. Slowly push the plunger to inject the solvent into the powder vial. Ensure that the stream of solvent is not directed directly onto the NovoThirteen powder to avoid foaming.

Gently rotate the vial until all the powder is completely dissolved. Do not shake the vial to avoid foaming.
Before administration, inspect NovoThirteen for particles or discoloration. If either is observed, discard the product. Reconstituted NovoThirteen is a clear, colourless solution.
If a higher dose is required, repeat the procedure with another syringe until the required dose is achieved.
Important information
Once NovoThirteen has been prepared for injection, it must be used immediately.
If dilution of reconstituted NovoThirteen is required, proceed as described in the section ‘Dilution of reconstituted product with 0.9% sodium chloride for injection’.

Ensure the plunger is fully depressed before inverting the syringe (it may have been pushed outward by pressure in the vial). Keep the syringe and vial inverted and pull the plunger to draw up the calculated amount for injection.

Unscrew the adapter with the vial.
The product is now ready for injection. Follow the injection procedure as instructed by your doctor.
After injection

Dispose of the syringe, vial adapter, infusion set, and vials safely. Any unused medicinal product and waste materials derived from it must be disposed of in accordance with local regulations.
Instructions for diluting reconstituted NovoThirteen
The following items are required to dilute reconstituted NovoThirteen: a vial containing 0.9% sodium chloride for injection, a 10 ml syringe, and alcohol swabs.
General instructions for dilution
Dilution must be performed using aseptic techniques.
Carefully draw exactly 6 ml of 0.9% sodium chloride for injection into the 10 ml syringe.
Slowly inject 6 ml of 0.9% sodium chloride for injection into the vial of reconstituted NovoThirteen.
Gently swirl the vial to mix the solution.
The diluted solution is clear and colourless. Check that the injectable solution does not contain solid particles or show any discolouration. If so, discard the solution.
After dilution, proceed as described in section H.
Any remaining material from the diluted product must be discarded immediately.
If you have any doubts, consult your doctor or nurse.