COAGADEX 250 IU POWDER AND SOLVENT FOR INJECTABLE SOLUTION

2. What you need to know before you use Coagadex

Do not use Coagadex:

• if you are allergic to human coagulation factor X or to any of the other ingredients of this medicine (listed in section 6).

Check with your doctor if this applies to you.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with Coagadex:

• if you have more intense or prolonged bleeding than usual and if the bleeding does not stop after injection of Coagadex;
• if you are taking a medicine to prevent blood clots that works by blocking factor Xa. These medicines may make Coagadex not work.

Some patients with insufficient factor X may develop inhibitors (antibodies) to factor X during treatment, which could prevent the medicine from working properly. Your doctor will regularly check for the presence of these antibodies, especially before surgery. Before and after treatment with this medicine, especially during the first cycle, your doctor will likely perform tests to check your factor X level in the blood.

Viral safety

When administering medicines derived from human blood or plasma, certain measures must be taken to prevent the transmission of infections to the recipient. These measures include:

• careful selection of blood and plasma donors to exclude those who may transmit infections,
• analysis of donated plasma for viruses/infections,
• inclusion of steps that inactivate or remove viruses when processing blood or plasma.

These measures are considered effective for the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus, and parvovirus B19. Despite these measures, when administering medicines derived from human blood or plasma, the possibility of transmitting infections cannot be completely excluded. This also applies to unknown or emerging viruses and other types of infections.

It is strongly recommended that each time you receive a dose of Coagadex, you note the name and batch number of the product in order to maintain a record of the batches used.

If you regularly or repeatedly receive products with factor X derived from human plasma, your doctor may recommend that you consider vaccination against hepatitis A and B.

Children and adolescents

The warnings and precautions for adults mentioned also apply to children (2 to 11 years old) and adolescents (12 to 18 years old).

Using Coagadex with other medicines

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No effects on the ability to drive or use machines have been observed.

Coagadex contains sodium

This medicine contains up to 9.2 mg of sodium (a major component of table/cooking salt) in each milliliter of solution. This is equivalent to 0.0046% of the maximum daily recommended sodium intake for an adult.

3. How to use Coagadex

Treatment should be initiated by a doctor experienced in the treatment of coagulation disorders.

Follow the administration instructions for this medicine exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Coagadex must be injected directly into a vein. Before injecting this product at home, a healthcare professional must have provided training on how to do it.

Your doctor will explain how much to use, when to use it, and for how long. The dose indicated by your doctor will generally be the number of complete vials that contain the appropriate dose for you. Do not administer more than 60 UI/kg daily in any age group.

Use in adults

How much Coagadex is administered to treat a bleed or to prevent future bleeds?Your doctor will tell you how much Coagadex to administer to treat a bleed and to prevent future bleeds; the required dose will depend on your normal factor X levels in the blood.

How much is administered before, during, and after major surgery?

Before:The dose of Coagadex used should be sufficient to increase the factor X in the blood to a level between 70 and 90 units/dl. The dose you need will depend on your normal factor X levels in the blood and will be calculated by your doctor.

After:During the first days after surgery, the factor X concentration in plasma will be regularly monitored. It is recommended that your factor X level in the blood be maintained above 50 units/dl. Your doctor will calculate the dose you need.

If your blood factor X concentration is too low (your doctor will assess this), or if it decreases more rapidly than expected, it may be due to the presence of a factor X inhibitor that prevents the medicine from working properly. Your doctor will order the appropriate clinical tests to see if this is the case.

How much is administered regularly for long-term prevention of bleeds?

Your doctor will tell you if this use is suitable for your case and, if so, the corresponding dose.

Use in children and adolescents

Your doctor will recommend a suitable dose for you or your child. Doses for children under 12 years old are generally higher than doses for adolescents and adults. Doses for adolescents will be similar to those for adults.

When to inject Coagadex

• The medicine should be injected when the first sign of bleeding appears.
• The injection should be repeated as necessary to stop the bleeding.
• The severity of each bleed should be judged individually.
• The first time you use this medicine, you will be supervised by your doctor.

Dissolving the medicine before use

Your medicine must onlybe dissolved in the solvent provided with the product.

Coagadex is provided with the amount of solvent as shown in the table.

You can dissolve this medicine using the Mix2Vial needle-free transfer device included in the pack.

Place the Coagadex vials at room temperature before mixing. Constitute the medicine as follows:

Do not use this medicine:

• if the solvent does not pass into the vial (this indicates loss of vacuum in the vial, in which case the powder should not be used).

• if the dissolved powder and solvent form a gel or clot (if this happens, inform your healthcare provider, reporting the batch number printed on the vial).

If you use more Coagadex than you should

If you administer more of this medicine than prescribed by your doctor, you may develop a blood clot. If you think you are using too much product, stop the injections and consult your doctor, pharmacist, or nurse. If you know you have used too much, inform your doctor, pharmacist, or nurse as soon as possible.

If you forget to use Coagadex

Do not use a double dose to make up for forgotten doses. Inject your normal dose when you remember and continue the administration as indicated by your doctor.

If you stop treatment with Coagadex

Always consult your doctor before deciding to stop your treatment.

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

4. Possible side effects

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

Allergic reactions (hypersensitivity reactions) have occurred rarely (may affect up to 1 in 1,000 people) in the treatment of coagulation disorders with similar medicines, and have sometimes progressed to shock. These can be signs of hives, tingling, flushing, nausea, vomiting, headache, wheezing, chest tightness, chills, rapid heart rate, dizziness, lethargy, restlessness, facial swelling, throat tightness, and discomfort at the infusion site. If you experience any of these side effects, contact your doctor.

The following side effects have been reported with Coagadex.

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

• pain or redness at the infusion site
• fatigue
• back pain

Side effects in children and adolescents

It is expected that the side effects in children will be the same as in adults.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that the side effects are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Coagadex

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 cartons after “EXP”. The expiry date refers to the last day of the month shown.

Do not store above 30°C. Do not freeze.

Store the pack in the outer carton to protect from light.

Do not use this medicine if you notice small particles in the dissolved product. Once constituted, Coagadex must be used within one hour.

Medicines should not be disposed of via wastewater or household waste. Your treatment center will provide a special container for disposing of any remaining solution, used syringes, needles, and empty vials. This will help protect the environment.

6. Container contents and additional information

Coagadex composition

• The active ingredient is human coagulation factor X. One vial contains 250 IU or 500 IU of nominal human coagulation factor X.
• The other components are: citric acid, disodium phosphate dihydrate, sodium chloride,
• sodium hydroxide, and sucrose (see section 2 for more information on the components).

Solvent: water for injectable preparations.

Appearance of Coagadex and container contents

Coagadex is a white or off-white powder, packaged in quantities of 250 IU and 500 IU. Once constituted, the solution is colorless, transparent, or pearlescent (opalescent). Before injection, examine the solution. If it is turbid or contains particles, do not use it.

A Mix2Vial transfer device is also provided.

Contents of the 250 IU container

1 vial with 250 IU of powder

1 vial with 2.5 ml of water for injectable preparations

1 transfer device (Mix2Vial)

Contents of the 500 IU container

1 vial with 500 IU of powder

1 vial with 5 ml of water for injectable preparations

1 transfer device (Mix2Vial)

Only certain container sizes may be marketed.

Marketing authorization holder

BPL Bioproducts Laboratory GmbH

Dornhofstraße 34, 63263 Neu-Isenburg

Germany

Manufacturer

PharmaKorell GmbH, Georges-Köhler-Str. 2, 79539 Lörrach, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of last revision of this leaflet:

Detailed information on this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.