Product Information for the User

CEPROTIN500UI powder and solvent for injectable solution.

Human C protein

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 or pharmacist.
• This medication has been prescribed only to you, 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 or pharmacist, even if they are not listed in this product information. See section4.

1.What is CEPROTIN and how it is used

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

3.How to use CEPROTIN

4.Possible adverse effects

5.Storage of CEPROTIN

6.Contents of the package and additional information

CEPROTIN belongs to a class of medications known as antithrombotics. This medication contains Protein C, a naturally occurring protein synthesized in the liver and present in the blood. Protein C plays an important role in preventing excessive clot formation, and is thereforeused to prevent and/or treat intravascular thrombosis.

CEPROTIN is used in the treatment and prevention of thrombotic and hemorrhagic lesions (known as fulminant purpura) in patients with severe congenital deficiency of protein C. Additionally, CEPROTIN may be used to treat a rare complication of a medication that prevents blood clot formation (an anticoagulant medication known as coumarin) that can lead to severe skin lesions (necrosis).

Furthermore, CEPROTIN is used to prevent thrombosis in patients with severe congenital deficiency of protein C if any of the following situations occur:

• if surgery or invasive therapy is imminent
• while initiating coumarin therapy (anticoagulant medication)
• when coumarin therapy is insufficient
• when coumarin therapy is not possible

Do not use CEPROTIN

• If you are allergic to human Protein C or any of the other components of this medication (listed in section 6), including mouse protein or heparin.

However, in case of life-threatening thrombotic complications, your doctor will decide whether to continue treatment with CEPROTIN or not.

Warnings and precautions

Consult your doctor before starting to use CEPROTIN.Take special care with CEPROTIN, if you experience symptoms of an allergy. Allergy symptoms include rash, urticaria, difficulty breathing, low blood pressure, chest tightness, and shock. If such symptoms occur during CEPROTIN administration, the injection should be stopped. Such symptoms may constitute an allergic reaction to any of the components, mouse protein, or heparin. The medication may contain trace elements of heparin and/or mouse protein as a result of the manufacturing process. If such reactions occur, your doctor will decide on the most appropriate treatment.

When medications are prepared from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include a careful selection of plasma and blood donors to ensure that those at risk of being carriers of infections are excluded, and control of individual donations and plasma banks for signs of viruses/infections. Manufacturers of these medications also include stages in the processing of blood or plasma that may inactivate or eliminate viruses. Despite this, when administering medications prepared from human blood or plasma, it is not possible to completely rule out the transmission of infectious diseases. This also applies to unknown or emerging viruses or other possible types of infection.

The measures taken are considered effective for encapsulated viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV), and for non-encapsulated hepatitis A virus. The measures taken may not be sufficient against non-encapsulated viruses, such as parvovirus B19. Parvovirus B19 infection can be severe for pregnant women (fetal infection) and for individuals with a weakened immune system or some type of anemia (e.g., hemolytic anemia).

Your doctor may recommend an appropriate vaccination against hepatitis A and B if you frequently receive human plasma-derived factor VIII.

Use of CEPROTIN with other medications

There is currently no known interaction with other medications.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

If you change treatment with oral anticoagulants, CEPROTIN treatment should continue until the blood level of the oral anticoagulant medication is adequate and stable.

Use of CEPROTIN with food and beverages

Not applicable.

Pregnancy and breastfeeding

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

Your doctor will decide whether CEPROTIN can be used during pregnancy or breastfeeding.

Driving and operating machinery

CEPROTIN has no influence on the ability to drive or operate machinery.

Important information about some components of CEPROTIN

Since the daily maximum dose may exceed 200 mg of sodium, it may be harmful for individuals on a low-sodium diet.

CEPROTIN is intended for intravenous administration (infusion into a vein). It will be administered under the close supervision of an experienced physician in coagulation factor substitution/anticoagulant therapy where monitoring of protein C activity is possible. Dosage will vary depending on your condition and body weight.

Dosage

Dosage, administration frequency, and treatment duration depend on the severity of protein C deficiency as well as your clinical status and plasma protein C levels. These should be adjusted based on clinical efficacy and laboratory results.

Initially, an activity of protein C of100%should be achieved, and the activity should be maintained above25%throughout the treatment duration.

A starting dose of60to80UI/kg should be administered. Your physician will obtain several blood samples to determine how long protein C remains in your body.

It is recommended to measure protein C activity using chromogenic substrates for determination of plasma protein C levels before and during treatment with CEPROTIN.

Dosage should be determined based on protein C activity measured in the laboratory. In the case of acute thrombotic event, determination should be performed every6hours until the patient stabilizes, then twice a day, and always immediately before the next injection. It should be noted that the half-life of protein C can be severely shortened in certain clinical situations such as acute thrombosis with fulminant purpura and cutaneous necrosis.

If you have liver or kidney disease, please inform your physician, as your treatment will need to be adjusted accordingly.

If you switch to permanent prophylaxis with oral anticoagulants, protein C substitution will onlybe discontinued when stable anticoagulation is achieved (see "Important information about some of the components of CEPROTIN").

If you receive prophylactic administration of protein C, higher trough levels may be required in situations with increased risk of thrombosis (such as infection, trauma, or surgical intervention).

Your physician may adjust your treatment as needed if you have resistance to PCA, whichconstitutes a thromboembolic risk factor present in up to5%of the European population.

Administration

CEPROTIN will be administered by intravenous injection after reconstituting the lyophilized powder for injectable solution with sterile water for injectable preparations. It is strongly recommended to record the name and batch number of the product each time you receive a dose of CEPROTIN to maintain a record of the batches used.

Reconstitute the lyophilized powder of CEPROTIN for injectable solution with the supplied solvent (sterile water for injectable preparations) using the sterile transfer needle. Gently rotate the vial until the powder is fully dissolved.

Once reconstituted, the solution is extracted with the sterile filter needle and passed to a sterile disposable syringe. A new sterile filter needle should be used for each vial of reconstituted CEPROTIN. The solution should be discarded if it contains visible particles.

The reconstituted solution should be administered immediately by intravenous injection.

CEPROTIN should be administered at a maximum injection rate of2ml per minute. In children with a body weight below10kg, the injection rate should not exceed0.2ml/kg/min.

Unused solution, empty vials, and used needles and syringes should be disposed of properly.

Treatment frequency and duration depend on the severity of your protein C deficiency, laboratory results for protein C levels in your plasma, as well as the location and extent of thrombosis.

In the case of acute thrombosis, CEPROTIN may be administered every6hours. As the tendency to form thrombi decreases, the frequency may be reduced.

If you use more CEPROTIN than you should

It is recommended to follow the recommended dosage level and administration frequency as advised by your physician. If you administer more CEPROTIN than recommended, inform your physician as soon as possible.

If you forgot to use CEPROTIN

Not applicable.

If you interrupt treatment with CEPROTIN

Do not stop using CEPROTIN without consulting your physician.

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

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

You may notice one or more of the following adverse effects after administration of CEPROTIN:

• As with any medication administered by intravenous infusion, it is possible (although not seen with CEPROTIN) that severe allergic reactions, including life-threatening anaphylaxis, may occur.
  In any case, you should be aware of the initial signs of allergic reactions such as burning and itching at the injection site, chills, flushing, rash, urticaria, difficulty breathing, nausea, headache, drowsiness, decreased blood pressure, and chest tightness.
• The following adverse effects were observed very rarely during clinical trials (less than 1 case per 10,000 administrations provided to patients): fever (pyrexia), increased C-reactive protein, inflammatory patches (urticaria), itching (pruritus), rash, and dizziness.
• In post-marketing experience, restlessness, chest hemorrhage, increased sweating, pain, and redness at the injection site have been observed.

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 on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

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

Store in refrigerator (between2°C and8°C). Do not freeze. Store the packaging in the original outer packaging to protect it from light.

The reconstituted solution must be used immediately.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of CEPROTIN

Powder:

• The active ingredient is Human C Protein
• The other components are Human Albumin, Sodium Chloride, and Sodium Citrate. 2H2O. Solvent: Sterile Water for Injection.

Appearance of the product and contents of the package

CEPROTIN is presented as a powder and solvent for injectable solution and is a white or off-white powder that is easily crushable. After reconstitution, the solution is colorless to slightly yellowish and transparent to slightly opalescent and essentially free of visible particles.

Each package also contains a transfer needle and a filter needle.

Holder of the marketing authorization and responsible manufacturer

BAXTER AG

Industriestrasse 67

A-1221 Vienna Austria

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

Date of the last review of this leaflet:

The detailed information on this medication is available on the website of the European Medicines Agencyhttp://www.ema.europapa.eu.