Label: information for the user

Octanate LV 100 UI/ml, powder and solvent for solution for injection

Human coagulation factor VIII

Octanate LV 200 UI/ml, powder and solvent for solution for injection

Human coagulation factor VIII

6. Contents of the pack and additional information

Octanate LV belongs to a group of medications called coagulation factors and contains human coagulation factor VIII. This is a special protein involved in blood clotting.

Octanate LV is used to treat and prevent bleeding in patients with hemophilia A. This is a condition in which bleeding may last longer than expected. It is due to an inherited absence of the coagulation factor VIII.

It is highly recommended that each time you receive a dose of Octanate LV, you note the name and batch number of the productin order to maintain a record of the lots used.

Your doctor may recommend that you consider vaccination (against hepatitis A and B), if you regularly or repeatedly receive human Factor VIII products.

Do not use Octanate LV:

if you are allergic to human coagulation factor VIII or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Octanate LV.

Octanate LV contains very small amounts of other human proteins. Any medication that contains proteins and is injected through a vein (administered intravenously) may produce allergic reactions (see section 4. “Possible side effects”).

The formation of inhibitors (antibodies) is a known complication that may occur during treatment with all factor VIII composite 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 Octanate LV, consult your doctor immediately.

Information about the blood and plasma used for Octanate LV

When administering medications derived from human plasma or blood, certain measures must be taken to prevent infections from being transmitted to patients. Such measures include a careful selection of donors, excluding those who are at risk of being carriers of infectious diseases,analysis of specific markers of infections inindividual donations and in plasma mixtures, as well as the inclusion of stages in the manufacturing process to eliminate / inactivate viruses. Despite this, when administering medications derived from human blood or plasma, the possibility of transmission of infectious agents cannot be ruled out entirely. This also applies toemerging virusesor of unknown nature or other types of infections.

These measures are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) and for non-enveloped hepatitis A virus (HAV). The measures taken may have limited value against non-enveloped viruses, such as parvovirus B19.

Parvovirus B19 infection can be severe for a pregnant woman (fetal infection) and for individuals whose immune system is depressed or for patients with some type of anemia (for example, hemolytic disease or abnormal destruction of red blood cells).

Use of Octanate LV with other medications:

Inform your doctor or pharmacist if you are using or have used recently or may need to use other medications, even those obtained without a prescription.

No interactions of human coagulation factor VIII with other medications are known. However, Octanate LV should not be combined with other medications during infusion.

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

Driving and operating machinery:

No effects on the ability to drive or operate machinery have been observed.

Octanate LV contains

up to 40 mg of sodium (main component of table salt/for cooking) per vial. This is equivalent to 2% of the maximum daily sodium intake recommended for an adult.

Octanate LV should be administered intravenously once reconstituted with the provided solvent.

The treatment should be initiated under medical supervision.

Dose to prevent bleeding.If you have severe hemophilia A, you should be injected with 20 to 40 units of factor VIII per kilogram of body weight every two or three days for long-term prevention. Your dose will be adjusted based on your response. In some cases, shorter administration intervals or higher doses may be required.

Calculation of the dose:

Follow the administration instructions for Octanate LV indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The factor VIII activity refers to the amount of factor VIII present in the plasma. It is expressed as a percentage (relative to normal human plasma) or in International Units (UI). The factor VIII dose is expressed in UI.

One International Unit (UI) of factor VIII activity is equivalent to the amount of factor VIII in 1 ml of normal human plasma. One UI of factor VIII per kilogram of body weight increases plasma factor VIII activity by 1.5% to 2% of normal activity. To calculate the dose you need, the level of factor VIII activity in plasma must be determined. This will indicate the amount of this activity that needs to be increased. Ask your doctor if you have any doubts about how much factor VIII activity you need to increase or how to calculate your dose.

The required dosage is determined using the following formula:

Units needed = body weight (kg)?desired factor VIII increase (%) (UI/dl)?0.5

The amount to be administered and the frequency of administration should always be directed towards clinical efficacy for each individual patient.

In the case of the following episodes of bleeding, the factor VIII activity should not fall below the given plasma activity level (in % of normal) within the corresponding period.

The following table can be used as a dosage guide for bleeding episodes and surgery:

Your doctor will indicate the dose and frequency at which you should use Octanate LV.

Your response to factor VIII products may vary. Therefore, factor VIII levels should be determined during treatment to calculate the correct dose and appropriate perfusion frequency.

Use in children

Clinical studies did not identify any special dosing requirements for children. Both for treatment and prophylaxis, the dosage is the same for adults and children.

Instructions for outpatient treatment

• Please read all instructions carefully and follow them.
• Do not use Octanate LV after the expiration date appearing on the packaging.
• During the procedure described below, maintain sterility.
• Visually inspect the reconstituted medication to check for particles or color change before administration.
• The solution should be clear or slightly opalescent.Do not use cloudy or sediment-containing solutions.

• Use the solution immediately prepared to avoid microbial contamination.
• Use only the infusion equipment provided. Using other injection/infusion equipment may pose an additional risk and treatment failure.

Instructions forpreparingthesolution:

1.Do not use the product directly from the refrigerator.Leave the solvent and powderin the closed vials until they reach room temperature.

1. Remove the flip-off caps from the vials and clean the rubber stoppers withone of the alcohol-impregnated swabsprovided.
2. The transfer device is represented in Figure 1. Place the solvent vial on a flat surface and hold it firmly in place. Pick up the transfer device and turn it over. Place the blue part of the transfer device on top of the solvent vial and press firmly until you hear a click (Fig. 2 + 3). Do not turn it while attaching.

Instructions for injection:

As a precaution, your pulse rate should be measured before and during injection. If your pulse rate increases significantly, reduce the injection rate or interrupt administration for a brief period.

1. Attach the syringe to the white part of the transfer device. Turn the vial over and extract the solution into the syringe (Fig.6).The solutionshould be clear or slightly opalescent.
   Once the solution has been transferred, hold the syringe plunger firmly in place (keeping it down) and remove the syringe from the transfer device (Fig. 7).Dispose of the empty vialalong with the white part of the transfer device.

1. Clean the area where the injection will be given with one of the alcohol-impregnated swabs provided.
2. Attach the infusion equipment provided to the syringe.

.

1. Insert the injection needle into the selected vein. If you used a tourniquet to make the vein more visible, this tourniquet should be released before starting to inject Octanate LV.

1. There should be no blood flowing into the syringe due to the risk of fibrin clot formation.

1. Inject the solution into the vein at a slow rate, not exceeding 2-3 ml per minute.

If you use more than one vial of Octanate LV powder for treatment, you can use the same injection kit and syringe. The transfer device is for single use.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

If you use more Octanate LV than you should

No symptoms of overdose have been reported with human coagulation factor VIII. However, it is recommended not to exceed the recommended dose.

If you forgot to use Octanate LV

Do not take a double dose to compensate for a missed dose. Proceed to administer the next dose immediately and follow the recommendations of your doctor or pharmacist.

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

Like all medicines, Octanate LV can cause side effects, although not everyone will experience them.

Althoughvery rare(affects 1 to 10 patients out of every 10,000), hypersensitivity or allergic reactions have been observed in patients treated with products containing factor VIII.

Contact your doctor if you experience any of the following symptoms:

uncomfort (vomiting), irritation and itching at the injection site, chest tightness, chills, rapid heart rate (tachycardia), nausea, pins and needles (paresthesia), hot flashes, headache, urticaria, decreased blood pressure (hypotension), skin eruptions, restlessness, facial swelling, lip, mouth, tongue, or throat swelling that may cause difficulty swallowing or breathing (angioedema), fatigue (lethargy), hissing sounds.

In very rare cases(affects fewer than 1 patient out of 10,000), this hypersensitivity can lead to a life-threatening severe allergic reaction called anaphylaxis, which may include shock, as well as some or all of the symptoms described above. In this case, contact your doctor immediately or call an ambulance.

Other rare side effects (affects 1 to 10 patients out of every 10,000)

Fever

In children who have not received prior treatment with factor VIII-containing medications, inhibitors (see section 2) may occur very frequently (more than 1 in 10 patients); however, in patients who have received prior treatment with factor VIII (more than 150 days of treatment), the risk is infrequent (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 this case, contact your doctor immediately.

For information on viral safety, see section 2. (Be especially careful with Octanate LV – information on the blood and plasma used for Octanate LV).

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet.

You can also report them directly to theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Store in a refrigerator (between +2 - 8°C).

Do not freeze.

Keep the vials within the outer packaging to protect them from light.

UseOctanate LVimmediately after reconstitution and on a single occasion.

Do not use this medication if you observe cloudy solutions or those that are not completely dissolved.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Octanate LV

The active ingredient is human coagulation factor VIII.

Volume and concentrations:

Theother componentsare:

For the powder: sodium citrate, sodium chloride, calcium chloride and glycine.

For the solvent: water for injection.

Appearance of the product and contents of the package

Octanate LV is presented as powder and solvent for injectable solution.

The powder is white or pale yellow, or also with a friable mass appearance.

The solvent is a clear and colorless liquid.

The available package sizes differ in the amount of human coagulation factor VIII and solvent:

100 UI/ml powder and solvent:

• Powder, 500 UI, in a vial, with a stopper and a flip-off cap.
• Solvent, 5 ml in a vial, with a stopper and a flip-off cap.
• 1 intravenous injection equipment kit (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol wipes.

200 UI/ml powder and solvent:

• Powder, 1000 UI, in a vial, with a stopper and a flip-off cap.
• Solvent, 5 ml in a vial, with a stopper and a flip-off cap.
• 1 intravenous injection equipment kit (1 transfer set, 1 infusion set, 1 disposable syringe)
• 2 alcohol wipes.

Not all package sizes may be available.

Marketing Authorization Holder

Octapharma S.A.

Avda. Castilla, 2. (P.E. San Fernando)

Ed. Dublin, 2nd Floor

28830 San Fernando de Henares

Madrid

Responsible for manufacturing:

Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Str. 235
A-1100 Vienna
Austria

or

Octapharma S.A.S
70 - 72 Rue du Maréchal Foch
BP 33,F -67381Lingolsheim
France

or

Octapharma AB
Lars Forssells gata 23, 112 75 Stockholm
Sweden

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

• Octanate LV: Austria, Cyprus, Denmark, France, Netherlands, Malta, Poland, Romania, Spain, Sweden, United Kingdom.
• Octafil LV: Finland
• Octanate: Belgium, Czech Republic, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, Portugal
• Octanate Kons: Republic of Slovenia

Last review date of this leaflet: December 2022

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob. es/