Haemoctin 250

Package Leaflet: Information for the User

Haemoctin 250

Haemoctin 500

Haemoctin 1000

Powder and solvent for solution for injection
Human coagulation factor VIII

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

• 1. What Haemoctin is and what it is used for
• 2. Before you use Haemoctin
• 3. How to use Haemoctin
• 4. Possible side effects
• 5. How to store Haemoctin
• 6. Contents of the pack and other information

1. What Haemoctin is and what it is used for

Haemoctin is a medicine made from human plasma. It contains factor VIII, a protein necessary for blood clotting. After dissolving the powder in water for injection, the solution is ready for intravenous injection. Haemoctin is used to treat and prevent bleeding in patients with haemophilia A (congenital factor VIII deficiency). Haemoctin does not contain von Willebrand factor in amounts that are pharmacologically effective, and therefore it is not intended for the treatment of von Willebrand's disease.

2. Before you use Haemoctin

When not to use Haemoctin

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include a rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Warnings and precautions

The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines. These inhibitors, especially at high levels, can disrupt the normal treatment and the patient will be closely monitored for the development of these inhibitors. If the patient's bleeding is not properly controlled with Haemoctin, you should immediately inform your doctor. If the patient has existing risk factors for cardiovascular diseases, treatment with Haemoctin may increase the risk of cardiovascular events. In case of doubt, consult your doctor. Complications resulting from the introduction of a venous catheter: If a central venous access device (CVAD) is required, consider the risk of complications associated with CVAD, including local infections, bacteremia, and thrombosis at the catheter insertion site. Viral safetyWhen medicinal products are made from human blood or plasma, certain measures are taken to prevent the transmission of infections to patients. These include:

• careful selection of blood and plasma donors to ensure the exclusion of donors who may be carriers of infections,
• testing of all donated samples and plasma pools for the presence of viruses/infections,
• implementation of steps in the blood or plasma processing procedure that are designed to inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of transmitting infections cannot be completely excluded. This also applies to unknown or newly discovered viruses or other types of infections.

These measures are considered effective against enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as non-enveloped viruses such as hepatitis A virus. The measures taken may have limited effectiveness against non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be serious for pregnant women (fetal infection) and for individuals with weakened immune systems or with certain types of anemia (e.g., sickle cell or hemolytic anemia). Your doctor may recommend considering vaccination against hepatitis A and B if you regularly/repeatedly receive products containing factor VIII made from human plasma. It is strongly recommended that every time you receive a dose of Haemoctin, you record the name and batch number of the medicine to keep track of the batches used. Children and adolescentsThe warnings and precautions for use listed for adults should also be taken into account for children and adolescents.

Haemoctin with other medicines

Tell your doctor about all the medicines you are taking, have recently taken or might take, as well as any medicines you plan to take. No interactions between Haemoctin and other medicinal products have been reported.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Due to the rare occurrence of haemophilia A in women, there is limited experience with the use of factor VIII during pregnancy or breastfeeding. No animal studies have been conducted during pregnancy or breastfeeding.

Driving and using machines

Haemoctin has no or negligible influence on the ability to drive and use machines.

Haemoctin contains sodium

Haemoctin 250 contains a maximum of 16.1 mg (0.70 mmol) of sodium (the main component of common salt) per vial. This corresponds to 0.81% of the maximum recommended daily intake of sodium in the diet for adults. Haemoctin 500/1000 contains a maximum of 32.2 mg (1.40 mmol) of sodium (the main component of common salt) per vial. This corresponds to 1.61% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Haemoctin

Haemoctin is intended for intravenous administration. Treatment should be under the supervision of a doctor experienced in the treatment of haemophilia A. Haemoctin should always be administered according to the doctor's instructions. In case of doubt, consult your doctor. The dose and duration of treatment depend on the degree of factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. The doctor will determine the dose suitable for the patient. Sterile working conditions must be ensured during all stages of the procedure. Fig. 1a Fig. 1b Fig. 1c Fig. 2 Fig. 3

Fig. 4 Fig. 5 Fig. 6 Fig. 7 Fig. 8

Reconstitution of the concentrate:

• Allow the solvent (water for injection) and the product to reach room temperature in unopened vials. When using a water bath for warming, be very careful not to let the water come into contact with the vial caps or stoppers. Otherwise, contamination of the medicine may occur.
• Very importantfor proper use of the transfer system: before opening, make sure that the white lower part of the transfer system is seated directly on the blister base (Fig. 1a: correct / Fig. 1b: incorrect). If incorrect: press the transfer system down into the blister until the white lower part of the transfer system is seated directly on the blister base (Fig. 1c).
• Remove the caps from the solvent vial and the product vial to expose the central part of the rubber stoppers (Fig. 2). Clean the rubber stoppers of the product and solvent vials with a disinfectant.
• Pull off the top of the transfer system packaging (Fig. 3).
• Place the solvent vial on a flat surface. Place the blue part of the transfer system straight onto the upright solvent vial (Fig. 4). Do not twist the transfer system!
• Pull off the remaining part of the blister from the transfer system. Do not squeeze the blister! Now the white part of the transfer system is exposed (Fig. 5).
• Place the product vial on a flat surface.
• Turn the connected transfer system and solvent vial upside down. Press the spike of the white adapter part vertically down through the stopper of the product vial (Fig. 6). The vacuum in the product vial causes the solvent to flow into the product vial.
• Gentle rocking of the product vial helps to dissolve the powder. Do not shake vigorously, avoid foaming! The solution is clear or slightly opalescent.
• Then unscrew the blue part of the transfer system together with the solvent vial in the opposite direction of the clock hands (Fig. 7). Discard the solvent vial with the attached blue part of the transfer system. Now the luer-lock connection is visible.

The ready-to-use solution should be used immediately after reconstitution. Do not use solutions that are cloudy or contain solid particles.

Administration:

• After reconstituting the powder as described above, attach the provided syringe to the luer-lock connection of the product vial with the white part of the transfer system (Fig. 8). This allows for easy withdrawal of the reconstituted medicine (Haemoctin 250: total volume 2.5 ml, Haemoctin 500/1000: total volume 5 ml) into the syringe. A separate filter is not required, as the transfer system is equipped with an integrated filter.
• Carefully detach the product vial with the white part of the transfer system from the syringe. Slowly administer the product intravenously using the provided butterfly needle. It is recommended not to administer more than 2-3 ml/minute.
• After using the butterfly needle, it can be secured with a protective cap.

Overdose of Haemoctin

If you think you have received too much Haemoctin, you should consult your doctor, who will decide on further treatment.

Missed dose of Haemoctin

In this case, your doctor will decide whether further treatment is necessary.

Stopping Haemoctin treatment

Do not stop using Haemoctin without consulting your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If you notice any of the following, tell your doctor immediately:

• redness of the skin,
• feeling of burning and stinging at the injection site,
• chills,
• sudden redness of the face,
• headache,
• hives,
• low blood pressure,
• drowsiness,
• nausea,
• restlessness,
• rapid heartbeat,
• chest tightness,
• tingling,
• vomiting,
• wheezing. This may be an allergic reaction or a severe allergic reaction (anaphylactic shock) or hypersensitivity reaction.

The following side effects have been observed with Haemoctin

Unknown: frequency cannot be estimated from the available data

• anaphylactic shock, allergic reaction
• redness of the skin, itching, hives

In children who have not been previously treated with factor VIII medicines, inhibitory antibodies (see section 2) may develop very frequently (more than 1 in 10 patients). However, in patients who have previously been treated with factor VIII (more than 150 days of treatment), the risk is not very common (less than 1 in 100 patients). If this happens, the patient's medicines may stop working properly and the patient may experience persistent bleeding. If this happens, you should contact your doctor immediately. Side effects in children and adolescentsExcept for the development of inhibitors (antibodies), it is expected that side effects in children are the same as 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 to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Haemoctin

Keep this medicine out of the sight and reach of children. Store the vials in the outer packaging to protect from light. Do not store above 25°C. Do not freeze. Do not use this medicine after the expiry date stated on the vial label and outer packaging after: Expiry date. Any unused product or waste material should be disposed of in accordance with local requirements. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Haemoctin contains

• The active substance is: human coagulation factor VIII.
• The other ingredients are: glycine, sodium chloride, sodium citrate, and calcium chloride.
• The solvent vial contains water for injection.

What Haemoctin looks like and contents of the pack

Haemoctin is provided as a lyophilized powder (lyophilisate). Water for injection is used as a solvent. The reconstituted product is clear or slightly opalescent. Haemoctin 250 contains 1 vial with 250 IU and 1 vial with 2.5 ml water for injection (100 IU/ml) Haemoctin 500 contains 1 vial with 500 IU and 1 vial with 5 ml water for injection (100 IU/ml) Haemoctin 1000 contains 1 vial with 1000 IU and 1 vial with 5 ml water for injection (200 IU/ml) Each pack contains

• one syringe for single use
• one transfer system with integrated filter
• one butterfly needle

Marketing authorization holder and manufacturer:

Biotest Pharma GmbH, Landsteinerstrasse 5, 63303 Dreieich, Germany, Tel.: +49 6103 801-0, Fax: +49 6103 801-150, Email: [email protected]

Date of last revision of the leaflet: 30.12.2024

Information intended for healthcare professionals only:

Monitoring of treatment

To determine the dose to be administered and the frequency of repeated infusions, it is recommended to monitor the factor VIII levels during treatment. Individual patients may vary in their response to factor VIII, showing different half-lives and recovery levels. The dose based on body weight may need to be adjusted in patients with low body weight or obesity. Especially in the case of major surgical procedures, precise control of replacement therapy through coagulation testing (factor VIII activity in plasma) is necessary. When using a one-stage in vitro coagulation test based on activated partial thromboplastin time (aPTT) to determine factor VIII activity in patient blood samples, both the type of aPTT reagent and the reference standard used in the test may have a significant impact on the results of factor VIII activity measurements in plasma. There may also be significant differences between the results of one-stage aPTT-based coagulation tests and chromogenic tests according to the European Pharmacopoeia. This is particularly important when changing laboratories and/or reagents used in the test.

Dosing

The dose and duration of replacement therapy depend on the degree of factor VIII deficiency, the location and extent of the bleeding, and the patient's clinical condition. The amount of factor VIII administered is expressed in international units (IU), which are related to the current WHO standard for factor VIII concentrates. Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in international units (relative to the international standard for factor VIII in plasma). One international unit (IU) of factor VIII activity corresponds to the amount of factor VIII in one milliliter of normal human plasma. On-demand treatmentThe calculation of the required dose of factor VIII is based on the empirical observation that 1 international unit (IU) of factor VIII per kilogram of body weight increases the factor VIII activity in plasma by 1 to 2% of normal activity. The required dose is determined based on the following formula:

Required number of units = body weight (kg) × desired factor VIII increase (%) × 0.5

The required amount to be administered and the frequency of administration should always be adjusted to the clinical efficacy in individual cases. For the following types of bleeding, factor VIII activity in plasma should not fall below the specified level of activity (% of normal) during the relevant period. To determine the dose based on the type of bleeding and surgical procedure, the following table can be used:

Bleeding severity /

Type of surgical procedure

Required factor VIII level (%)

Dose frequency (hours) /

Duration of therapy (days)

Bleeding

Early bleeding into joints, muscles or bleeding from the mouth

• 20 - 40 Repeat every 12-24 hours. At least 1 day, until pain caused by bleeding subsides or until wound healing. More severe bleeding into joints, muscles or bleeding
• 30 - 60 Repeat every 12-24 hours for 3-4 days or longer until pain and acute joint disability subside. Life-threatening bleeding
• 60 - 100 Repeat every 8-24 hours until the threat has passed.

Surgical procedures

Minor surgical procedureincluding tooth extraction

• 30 - 60 Every 24 hours, at least 1 day, until wound healing. Major surgical procedure
• 80 - 100 (pre- and post-operative) Repeat every 8-24 hours until adequate wound healing is achieved, and then continue for at least 7 days to maintain factor VIII activity at 30-60%.

ProphylaxisIn long-term prophylaxis of bleeding in patients with severe haemophilia A, the usual doses of factor VIII are 20-40 IU/kg body weight at intervals of 2-3 days. In some cases, especially in younger patients, shorter intervals between doses or higher doses may be necessary.

Method of administration:

Intravenous administration. It is recommended not to administer more than 2-3 ml/minute. Only use the provided infusion set, as adsorption of factor VIII onto the inner surfaces of some infusion sets may lead to treatment failure. Do not mix Haemoctin with other medicinal products.