PROSPECTO: INFORMATION FOR THE USER

OctaplasmaLG (A) 45-70 mg/ml solution for infusion

OctaplasmaLG (B) 45-70 mg/ml solution for infusion

OctaplasmaLG (AB) 45-70 mg/ml solution for infusion

OctaplasmaLG (0) 45-70 mg/ml solution for infusion

Human plasma proteins, with ABO blood group specificity

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor.
• 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 adverse effects, consult your doctor, even if they do not appear in this prospectus. See section 4.

1.What is OctaplasmaLG and for what it is used

2.What you need to knowbeforestarting touse OctaplasmaLG

3.How to use OctaplasmaLG

4.Possible adverse effects

5Storage of OctaplasmaLG

6.Contents of the package and additional information

OctaplasmaLG is treated and mixed human plasma for viral inactivation. Human plasma is the liquid part of human blood where cells are found. It contains very important human plasma proteins to maintain normal coagulation characteristics and is used in the same way as fresh frozen plasma (FFP).

OctaplasmaLG helps in case of complex coagulation factor deficiencies that may be caused by severe liver failure or massive transfusion. OctaplasmaLG can also be administered in emergency situations when a coagulation factor concentrate (such as factor V or factor XI) is not available or laboratory diagnosis is not possible.

It can also be administered to rapidly reverse the effects of oral anticoagulants (of the type coumarin or indandione), when vitamin K is insufficient due to altered liver function or in emergency situations.

OctaplasmaLG can be administered to patients undergoing plasma exchange to restore the balance of coagulation factors.

No use OctaplasmaLG:

• If you are allergic (hypersensitive) to human plasma proteins or to any of the other components of this medication (listed in section 6).
• If you know you have antibodies against the immunoglobulin called IgA.
• If you have previously experienced reactions to human plasma preparations or PFC.
• If you know you have a low level of protein S (a blood protein that depends on vitamin K).

Warnings and precautions

Consult your doctor before starting to use OctaplasmaLG.

Inform your doctor if you have any other illness.

Be especially careful with OctaplasmaLG

• If you have a low level of immunoglobulin A.
• If you have previously had reactions to plasma protein, including PFC.
• If you have heart failure or have fluid in your lungs (pulmonary edema).
• If you know you are at risk of blood clotting complications (thrombotic) due to a possible increase in the risk of venous thromboembolism (clots that form in the veins).
• In case of increased coagulation inhibition (fibrinolysis).

OctaplasmaLG is not generally recommended for the treatment of von Willebrand disease.

Viral safety

When administering medications prepared with plasma or human blood, certain measures are taken to prevent the transmission of infections to patients. This involves a careful selection of blood and plasma donors to ensure the exclusion of those at risk of infection, and the analysis of each donation and plasma mixtures to detect signs of viruses or infections. Manufacturers of these products also include steps in the processing of blood or plasma that can inactivate or eliminate viruses. Despite these measures, when administering medications prepared with plasma or human blood, it is not possible to completely rule out the possibility of transmission of infectious diseases. This also applies to any unknown or emerging viruses, as well as other types of infections.

The measures adopted are considered effective for enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus.

These measures may have limited value against certain non-enveloped viruses, such as hepatitis A virus, hepatitis E virus, and parvovirus B19.

It is strongly recommended that the name and batch number of the product be recorded each time a dose of OctaplasmaLG is administered in order to maintain a record of the batch used.

Your doctor may recommend that you be vaccinated against hepatitis A and B viruses if you regularly or repeatedly receive human plasma-derived products.

Children

Some cases of low calcium levels, possibly caused by citrate binding, have been observed during therapeutic plasma exchange in children. It is recommended to monitor calcium levels during the use of OctaplasmaLG.

Use of OctaplasmaLG with other medications

During clinical trials, OctaplasmaLG has been administered with various medications and no interactions have been detected.

When receiving OctaplasmaLG, you may receive substances (e.g., pregnancy hormone) that can cause a false positive result in tests (e.g., positive pregnancy test without being pregnant).

OctaplasmaLG should not be mixed with other intravenous liquids or medications except red blood cells and platelets.

To avoid the possibility of blood clots, solutions containing calcium should not be administered through the same intravenous route as OctaplasmaLG.

No interactions with other medications are known.

Inform your doctor if you are using, have used recently, or may need to use any other medication, including those obtained without a prescription.

Use of OctaplasmaLG with food and beverages

No effects have been observed.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor before using this medication. You will receive OctaplasmaLG if your doctor considers it necessary for you.

Driving and operating machinery

No effects have been observed on the ability to drive or operate machinery. You are the only one responsible for deciding whether you are fit to drive a vehicle or perform tasks that require a lot of concentration.

Important information about some components of OctaplasmaLG

For a list of components, see section 6.

This medication contains a maximum of 920 mg of sodium (main component of table salt/for cooking) in each bag. This is equivalent to a maximum of 46% of the recommended daily maximum sodium intake for an adult.

A healthcare professional will administer OctaplasmaLG to you through a venous infusion.

Your dose will depend on your clinical condition and body weight. Your doctor will determine the appropriate amount you should receive.

• Before administering OctaplasmaLG through infusion, a blood group ABO compatibility test must be performed.
• In emergency cases, the AB blood group of OctaplasmaLG can be administered to all patients.

It is essential that the infusion rate does not exceed 1ml of OctaplasmaLG per kg of body weight per minute. Calcium gluconate can be administered in another vein to minimize the negative effects of citrate contained in OctaplasmaLG.

You should be under observation for at least 20 minutes after administration in case you develop an allergic reaction (anaphylactic reaction) or shock, in which case the infusion should be stopped immediately.

Use in children and adolescents

Data on use in children and adolescents (0-16 years) are limited.

If you use more OctaplasmaLG than you should

A high dose may cause fluid overload, pulmonary edema, and/or cardiac problems.

If you forgot to use OctaplasmaLG

Your doctor should monitor the administration and maintain your laboratory values within the specified range.

If you interrupt treatment with OctaplasmaLG

Depending on laboratory values, your doctor will decide when to stop administering OctaplasmaLG and assess potential risks.

Do not use after the expiration date indicated on the label.

There are different options for thawing frozen OctaplasmaLG

- Water bath:

Thaw with the outer packaging in a water bath with good circulation for at least 30 minutes at a temperature between +30 and +37°C. You may need to use a bag as an additional wrapper for extra protection.

Avoid contaminating the port of entry with water. The minimum thawing time is 30 minutes at 37°C. The water bath temperature should never exceed +37°C and should not be less than +30°C.

The thawing time will depend on the number of bags in the water bath. If multiple bags are thawed simultaneously, the time can be extended, but not more than 60 minutes.

- Use of a dry heat warming system such as SAHARA-III:

Place the OctaplasmaLG bags in the agitation tray following the manufacturer's instructions and thaw the plasma with the rapid warming function. If the screen showing the temperature indicates a temperature of +37°C for the hemoderivative, end the warming process and remove the bags.

During the thawing of OctaplasmaLG using a dry heat warming system, it is recommended to use the printer protocol to maintain a record of the temperature evolution of the hemoderivative and error messages in case of failure.

- Others:

Other thawing systems for frozen OctaplasmaLG can be used provided they are validated for this purpose.

Allow the contents of the bag to warm up to approximately +37°C before performing the infusion. The temperature of OctaplasmaLG should not exceed +37°C. Remove the outer packaging and check that the bag has no cracks or leaks.

Avoid shaking the bag.

After thawing, the resulting solution is transparent or slightly opalescent and free of solid particles or gelatinous substances.

Do not use solutions that are turbid or have sediment and/or discoloration.

Thawed OctaplasmaLG cannot be refrozen. Dispose of unused product.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Rarely, hypersensitivity reactions may be observed. These will usually be mild allergic reactions consisting of skin redness, urticaria, or itching. More severe forms may lead to complications such as decreased blood pressure or facial or tongue inflammation. Severe allergic reactions throughout the body could have a rapid onset and be severe. Symptoms include: decreased blood pressure, increased heart rate, difficulty breathing, wheezing, coughing, shortness of breath, nausea, vomiting, diarrhea, abdominal or back pain. Severe reactions can lead to shock, loss of consciousness, respiratory failure, and very rarely even death.

The citrate contained in OctaplasmaLG can cause negative effects and be related to low calcium levels, especially if the perfusion rate is high, if you have liver function disorders, or if you are undergoing plasma exchange procedures. You may experience symptoms such as: fatigue, tingling sensation (paresthesia), tremors, decreased calcium values.

OctaplasmaLG may increase the risk of blood clots in the veins of:

• extremities, causing pain and swelling in the extremities;
• lungs, causing chest pain and difficulty breathing;
• brain, causing weakness and/or loss of sensation in one side of the body;
• heart, causing chest pain;

In all patients at risk of increased blood coagulation, special precautions should be taken and appropriate measures should be considered.

In rare cases, incompatibility between OctaplasmaLG antibodies and blood antigens can cause destruction of red blood cells (hemolytic transfusion reactions). Symptoms include: chills; fever; irritating cough; difficulty breathing; skin rash and internal bleeding.

OctaplasmaLG perfusion may increase certain coagulation factor antibodies.

A high dose or perfusion rate may cause an increase in blood volume; fluid in the lungs and/or heart failure.

Acute respiratory difficulties have been reported during or after OctaplasmaLG perfusion.

During clinical trials with the predecessor product of OctaplasmaLG and its post-authorization use, the following adverse effects have been identified:

§Spontaneous reporting data

Depending on the type and severity of adverse reactions, the infusion rate should be reduced or the perfusion interrupted. Your doctor will take the necessary measures.

Inform your doctor or pharmacist if you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus.

Pediatric population

In the course of plasma exchange procedures, low calcium levels may be observed in children, especially in patients with liver function disorders or in cases of high perfusion rates. It is recommended to monitor calcium levels during the use of OctaplasmaLG.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, even if it is a possible adverse reaction that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the label.

Store and transport frozen (at ≤ -18°C).

Store in the original packaging to protect it from light.

After thawing, physical and chemical stability in use has been demonstrated for 5 days between +2 and +8 °C or up to 8 hours at room temperature (between +20 and +25 °C).

From a microbiological standpoint, unless the opening method prevents the risk of microbial contamination, the product should be used immediately. If not used immediately, storage times and conditions will be the responsibility of the user.

Do not use this medication if you observe that the solution is cloudy or contains sediment and/or discoloration.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of OctaplasmaLG

• The active principle is human plasma proteins with ABO blood group specificity. A 200 ml bag contains: 9-14 g (45 - 70mg/ml).
• The other components are:

Sodium citrate dihydrate, sodium dihydrogen phosphate dihydrate, and glycine.

Appearance of the product and contents of the packaging

OctaplasmaLG is presented as a perfusion solution.

200 ml blood bags.

Packaging size 1 or 10 bags.

The frozen solution is (slightly) yellow.

Marketing Authorization Holder:

Octapharma S.A.

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

Ed. Dublin, 2nd Floor

28830 San Fernando de Henares, Madrid

Manufacturer:

Octapharma AB

SE-112 75 Stockholm, Sweden

Last review date of this leaflet: 11/2024

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

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

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This information is intended solely for healthcare professionals:

Dosage and administration

Dosage

The dose depends on the clinical situation and underlying disorder, but the initial dose is usually between 12 and 15ml of OctaplasmaLG/kg of body weight. This dose should increase the patient's plasma coagulation factor levels by approximately 25%.

It is essential to monitor the response, both clinically and through measurements, for example, of activated partial thromboplastin time (aPTT), prothrombin time (PT), and/or specific coagulation factor assays.

Dosage for coagulation factor deficiencies:

Adequate hemostatic effect in minor and moderate bleeding or in interventions in patients with coagulation factor disorder is usually achieved after a perfusion of between 5 and 20ml of OctaplasmaLG/kg of body weight. This dose should increase the patient's plasma coagulation factor levels by approximately 10-33%. In cases of major bleeding or surgical intervention, consult a hematologist.

Dosage for PTT (thrombotic thrombocytopenic purpura)and bleeding in intensive plasma exchange:

To perform therapeutic plasma exchange procedures, seek expert advice from a hematologist.

In patients with PTT,the total volume of plasma exchangedshould be replaced with OctaplasmaLG.

Administration form

OctaplasmaLG should be administered specifically for the blood group. In emergency cases, the AB blood group of OctaplasmaLG can be considered as universal plasma, as it can be administered to all patients regardless of their blood group.

After thawing, OctaplasmaLG should be administered through intravenous perfusion using a perfusion device with filters. Aseptic technique should be used during perfusion.

Toxicity from citrate may occur if more than 0.02-0.025mmol of citrate per kg and minute are administered. Therefore, the perfusion rate of OctaplasmaLG should not exceed 1ml per kg and minute.

The citrate toxicity effects can be minimized by administering calcium gluconate intravenously in another vein.

Warnings and precautions for administration:

Perfusion should be stopped immediately in case of anaphylactic reaction or shock. Treatment should follow guidelines for treating shock.

Patients should be observed for at least 20minutes after administration.

Incompatibilities:

• OctaplasmaLG can be mixed with red blood cells and platelets if ABO compatibility is respected in both preparations.
• OctaplasmaLG should not be mixed with other medications, as inactivation and precipitation may occur.
• To avoid the possibility of clot formation, solutions containing calcium should not be administered through the same intravenous line as OctaplasmaLG.

Interference with serological tests:

Passive transmission of plasma components from OctaplasmaLG (e.g., human chorionic gonadotropin β; β-hCG) may cause false laboratory results in the recipient. For example, false positives have been reported in pregnancy test results due to passive transmission of β-hCG.