Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - novothirteen

Document Subject

Generated Narrative: MedicinalProductDefinition mp85f7c08e568d2cd0fc2ac32155c57714

identifier: http://ema.europa.eu/identifier/EU/1/12/775/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: NovoThirteen 2500 IU powder and solvent for solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-85f7c08e568d2cd0fc2ac32155c57714

identifier: http://ema.europa.eu/identifier/EU/1/12/775/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - novothirteen

Attesters

What is in this leaflet:

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.

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 to stabilise the initial blood clot by producing a mesh around the clot.

What NovoThirteen is used for 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).

It is important that you use NovoThirteen for injection immediately after preparation.

Do not use NovoThirteen

• 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.

Warnings and precautions 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.

Contact your doctor immediately:

• 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.

Other medicines and NovoThirteen 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.

Pregnancy and breast-feeding 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.

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

Your treatment with NovoThirteen should be initiated by a doctor experienced in the treatment of rare bleeding disorders. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Before you can use NovoThirteen for injection you need to reconstitute the product. Please see NovoThirteen user instructions.

NovoThirteen is given as an injection into a vein. Your dose will depend on your body weight. The usual dose for prevention of bleeds is 35 IU for each kilogram of body weight. The injections are given once a month (every 28 2 days). If you experience a bleed, you should contact your doctor who will decide if an injection is needed.
NovoThirteen should be injected at a rate not higher than 2 ml/minute.

Based on the concentration of NovoThirteen solution, the dose volume to be injected (in millilitres) can be calculated from this formula:
Dose volume in millilitres = 0.042 x your body weight in kilograms.

You should only use the prescribed dose calculated by your doctor from this formula considering that the usual dose and the concentration of NovoThirteen are different from those of the other products which contain factor XIII.
Your doctor may adapt the dose if this is deemed necessary.

Use in small children 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.

Use in children and adolescents (weighing more than 24 kg) 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.

If you use more NovoThirteen than you should 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 to use NovoThirteen 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 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.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects include: 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.

Side effects in children: 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.

Reporting of side effects 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 the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 label and the outer carton after EXP. . The expiry date refers to the last day of that month. Store in a refrigerator (2 C 8 C). Do not freeze.

Store in the original package in order to protect from light.

Once prepared, NovoThirteen for injection should be used immediately.

The solution is clear and colourless. Do not use this medicine if there are particles in it or it is discoloured when reconstituted.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What NovoThirteen contains

• 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.

What NovoThirteen looks like 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 of 1. The powder is white and the solvent is clear and colourless.

Marketing Authorisation Holder and Manufacturer Novo Nordisk A/S Novo All
DK-2880 Bagsv rd Denmark

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: