Prospect: information for the user

Haemoctin 500

Haemoctin 1000

Powder and solvent for injectable solution

Human plasma-derived coagulation factor VIII

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms of illness as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1. What Haemoctin is and for what it is used

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

3.How to use Haemoctin

4.Possible adverse effects

5.Storage of Haemoctin

6.Contents of the package and additional information

Haemoctin is a medication derived from human plasma. It contains the factor VIII coagulation factor, which is necessary for the normal course of blood coagulation. After reconstitution of the powder with water for injectable preparations, the solution is ready for intravenous injection.

Haemoctin is used for the treatment and prevention of bleeding in patients with hemophilia A (congenital deficiency of factor VIII).

Haemoctin does not contain von Willebrand factor in pharmacologically effective amounts, so it is not suitable for the treatment of von Willebrand disease.

Do not use Haemoctin

• If you are allergic to factor VIII coagulation or any of the other components of this medication (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing, or swelling of the face, lips, throat, or tongue.

Warnings and precautions

Formation of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII medications. These inhibitors, especially in large quantities, prevent the treatment from working properly, so you and your child will be closely monitored for the development of these inhibitors. If your bleeding or your child's bleeding is not being controlled with Haemoctin, consult your doctor immediately.

If you have cardiovascular risk factors, treatment with Haemoctin may increase cardiovascular risk. If you are unsure, you should discuss this with your doctor.

Complications related to the use of a central venous catheter: If a central venous catheter (CVC) is required, the risk of complications associated with it, including local infections, bacteremia, and thrombosis at the catheter insertion site, should be considered.

Viral safety

When administering human plasma or blood-derived medications, certain measures must be taken to prevent the transmission of infections to patients. These measures include:

• A careful selection of donors, excluding those at risk of being carriers of infectious diseases,
• Analysis of specific virus/infection markers in individual donations and plasma mixtures,
• Inclusion of stages in the manufacturing process to eliminate/inactivate viruses.

Despite this, when administering human blood or plasma-derived medications, the possibility of transmission of infectious agents cannot be entirely ruled out. This also applies to emerging or unknown viruses or other types of infections.

These measures are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, and for non-enveloped viruses such as hepatitis A virus. The measures taken may have limited value against other non-enveloped viruses such as parvovirus B19. Parvovirus B19 infection can be severe for a pregnant woman (fetal infection) and for individuals with immunocompromised systems or certain types of anemia (e.g., hemolytic anemia).

Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly/repeatedly receive human plasma-derived factor VIII products.

It is highly recommended that each time you receive a dose of Haemoctin, you record the name of the medication and batch number administered to maintain a record of the batches used.

Children and adolescents

The warnings and precautions for use mentioned for adults should also be considered for children and adolescents.

Other medications and Haemoctin

Inform your doctor if you are using, have used recently, or may need to use any other medication.

No interactions between Haemoctin and other medications have been reported.

Pregnancy, breastfeeding, and fertility

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

Due to the low incidence of hemophilia A in women, there is no experience with the use of factor VIII during pregnancy or breastfeeding. No animal studies have been conducted during pregnancy or breastfeeding.

Driving and operating machinery

The influence of Haemoctin on the ability to drive and operate machinery is negligible or insignificant.

Haemoctin contains sodium

Haemoctin 500/1000: contains up to 32.2 mg (1.40 mmol) of sodium (main component of table salt/for cooking) in each vial. This corresponds to 1.61% of the maximum daily sodium intake recommended for an adult.

Haemoctin is prepared for intravenous administration (injection into a vein). Treatment should be administered under the supervision of a doctor experienced in the treatment of hemophilia A. Follow exactly the administration instructions for Haemoctin indicated by your doctor. Consult your doctor if you have any doubts.

Thedose and duration of treatment depend on the severity of factor VIII deficiency, the location and extent of the hemorrhage, and your clinical condition. Your doctor will determine the appropriate dose for you.

Ensure that you work in sterile conditions at all stages of the process.

Dissolution of the concentrate:

• Temper the closed vials of the solvent (water for injection) and the product to room temperature. If a water bath is used for tempering, be careful to avoid the water coming into contact with the closure capsules or stoppers of the vials. Otherwise, the medication could become contaminated.
• It is very important to use the transfer system correctly: before opening it, ensure that the lower white part of the transfer system is directly supported on the bottom of the blister (Fig.1a: correct/ Fig.1b: incorrect). If not correct: push the transfer system downwards in the blister until the lower white part of the transfer system is directly supported on the bottom of the blister (Fig.1c).
• Remove the closure capsules from the solvent vial and the product vial to expose the central parts of the rubber stoppers (Fig.2).Clean the rubber stoppers of the product and the solvent with a disinfectant.
• Remove the remaining packaging from the transfer system (Fig.3).
• Place the solvent vial on a flat surface.Attach the blue part of the transfer system from inside the blister to the solvent vial placed in a vertical position (Fig.4).Do not twist the transfer system!
• Remove the remaining blister from the transfer system. Do not press the blister! Now the white part of the transfer system is visible (Fig.5).
• Place the product vial on a flat surface.
• Place the transfer system set with the solvent vial upside down. Insert the tip of the white part of the adapter into the product vial through the stopper (Fig.6). The vacuum present inside the product vial causes the solvent to be transferred to the product vial.
• Agitate the product vial gently to help dissolve the powder. Do not agitate vigorously, to avoid foam formation! The solution should be transparent or slightly opalescent.
• Next, unscrew the blue part of the transfer system along with the solvent vial by turning it clockwise (Fig.7). Dispose of the solvent vial along with the blue part of the transfer system.The Luer-Lock connector is now visible.

The ready-to-use solution must be administered immediately after dissolution.Do not use turbid or particle-containing solutions.

Injection:

• When the powder has dissolved as indicated, screw the included syringe onto the Luer-Lock connector of the product vial with the white part of the transfer system (Fig.8). This will allow the dissolved medication to be easily transferred to the syringe. A separate filter is not required because the transfer system already has its own built-in filter.
• Disconnect the syringe from the vial with the white part of the transfer system. Using the included butterfly needle, administer immediately by slow intravenous injection. The injection rate should not exceed 2-3ml/minute.
• After using the butterfly needle, you can place the protective cap as a safety measure.

If you use more Haemoctin than you should:

If you think you have been given too much Haemoctin, inform your doctor, who will decide on the treatment.

If you forget to use Haemoctin:

In this caseyour doctor will decide if further treatment is necessary.

If you interrupt treatment with Haemoctin:

Do not stop treatment with Haemoctin without consulting your doctor.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

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

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

• skin redness,

• burning and itching sensation at the infusion site,
• chills,
• redness,
• headache,
• rashes,
• hypotension,
• lethargy,
• nausea,
• anxiety,
• tachycardia,
• chest tightness,
• tingling,
• vomiting,
• high-pitched breathing.

This may be a severe allergic reaction (anaphylactic shock) or a hypersensitivity reaction.

The following adverse reactions have also been reported with Haemoctin

Unknown: the frequency cannot be estimated from the available data

• Anaphylactic shock, allergic reaction
• Redness of the skin, itching, rashes

In children who have not received previous treatment with factor VIII medications, the production of inhibitor antibodies (see section 2) may occur very frequently (more than 1 in 10 patients); however, in patients who have received previous treatment with factor VIII (more than 150 days of treatment), the risk is rare (less than 1 in 100 patients). If this happens, the medications you or your child take may not work properly and you or your child may experience persistent bleeding. In that case, contact your doctor immediately.

Adverse effects in children and adolescents

Except for the production of inhibitors (antibodies), it is expected that adverse reactions in children will be the same as in adults.

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 that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Store the vials in the outer packaging to protect them from light.

Do not store at a temperature above 25°C. Do not freeze.

Do not useHaemoctinafter the expiration date that appears on the vial label and on the box.

The disposal of unused medication and all materials that have come into contact with it, will be carried out in accordance with local regulations. Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help to protect the environment.

Composition ofHaemoctin

• The active principle is human coagulation factor VIII.
• The other components are glycine, sodium chloride, sodium citrate, and calcium chloride.
• The vial of solvent contains water for injectable preparations.

Aspect of theproductand contents of the package

Haemoctin is supplied as a lyophilized powder. Water for injectable preparations is used as a solvent. The dissolved product is transparent or slightly opalescent.

Haemoctin 500: contains 1 vial with 500UI and 1 vial with 5ml of water for injectable preparations (100 UI/ml)

Haemoctin 1000: contains 1 vial with 1000UI and 1 vial with 5ml of water for injectable preparations (200 UI/ml)

Each package contains:

• A disposable syringe
• A transfer system with integrated filter
• A butterfly needle

Marketing authorization holder and manufacturer responsible

Biotest Pharma GmbH

Landsteinerstrasse 5

63303 Dreieich

Germany

Phone: +49 6103 801-0

Fax: +49 6103 801-150

Email: [email protected]

For more information about this medication, contact the local representative of the marketing authorization holder:

Grifols Movaco, S.A.

Can Guasc, s/n– Parets del Vallès

08150 Barcelona

Spain

Last review date of this leaflet: 04/2023

This information is intended solely for healthcare professionals:

Treatment monitoring

During treatment, it is recommended to adequately control factor VIII levels to determine the dose to be administered and the frequency of repeated infusions. Each patient's response to factor VIII may vary and may achieve different half-lives and recoveries. The dose based on body weight may need to be adjusted in patients with low body weight or obesity. In the case of major surgery, it is essential to monitor the substitution therapy with precision using coagulation tests (plasma activity of factor VIII).

When using a one-stage coagulation test based on thromboplastin time (TTPa)invitroto determine the activity of factor VIII in patient blood samples, the results of plasma activity of factor VIII may be significantly affected by the type of TTPa reagent used and the reference pattern used in these tests. Significant discrepancies may also exist between the results of one-stage coagulation tests based on TTPa and those of the chromogenic assay according to the European Pharmacopoeia. This is especially important when changing laboratories and/or reagents used in the analyses.

Dosage

The dose and duration of substitution therapy depend on the severity of factor VIII deficiency, the location and extent of the hemorrhage, and the patient's clinical condition.

The number of units of factor VIII administered is expressed in International Units (UI), which correspond to the current standard concentration of the WHO for products containing factor VIII. Plasma activity of factor VIII may be expressed either as a percentage (referenced to normal human plasma) or preferably, in International Units (referenced to an International Standard for plasma factor VIII).

One International Unit (UI) of factor VIII activity corresponds to the amount of factor VIII in 1 ml of normal human plasma.

On-demand treatment

The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (UI) of factor VIII per kg of body weight increases plasma activity of factor VIII by 1% to 2% of normal activity.

The required dose is determined using the following formula:

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

The amount to be administered and the frequency of administration must always be directed towards clinical efficacy in each individual case.

In subsequent hemorrhagic episodes, the activity of factor VIII should not be less than the plasma activity level indicated (in % of normal level), during the corresponding period. The following table may be used as a guide for dosage in hemorrhagic episodes and surgery:

Prophylaxis

For long-term prophylaxis of hemorrhages, in patients with severe hemophilia A, the usual doses are 20 to 40 UI of factor VIII per kg of body weight, at intervals of 2 or 3 days. In certain cases, especially in young patients, it may be necessary to shorten the intervals between administrations or use higher doses.

Administration form:

Intravenous administration. It is recommended not to administer more than 2-3ml per minute.

Only the equipment for infusion provided should be used, as failure of treatment may occur due to adsorption of human coagulation factor VIII to the inner surface of some infusion equipment.

Haemoctin should not be mixed with other medications.