Octaplas® [Human plasma proteins]

The solution for infusion "Octaplas LH" (blood group O (I)) is indicated for use with the following indications:

• complex deficiency of blood coagulation factors, in particular coagulopathy, due to severe liver failure or massive blood transfusion;
• replacement therapy with a deficiency of coagulation factors, when a concentrate of a specific coagulation factor (for example, factor V or factor XI) is not available for use, or in emergency situations when an accurate laboratory diagnosis is not possible;
• rapid neutralization of the action of oral anticoagulants (coumarin or indandion type) when the prothrombin complex concentrate is not available for use or the administration of vitamin K is insufficient due to impaired liver function, or in emergency situations;
• potentially dangerous bleeding during fibrinolytic therapy using, for example, tissue plasminogen activators in patients who do not respond to routine activities;
• therapeutic procedures of plasma clearance, including with thrombotic thrombocytopenic purpura (TTP).

Structure

The active substance is human plasma proteins (1 ml of an infusion solution contains 45-70 mg of human blood plasma proteins; 1 container (200 ml) contains 9-14 g of human blood plasma proteins).

Excipients: sodium citrate, dihydrate; sodium dihydrogen phosphate, dihydrate; glycine.

Contraindications

• IgA deficiency with the described antibodies against IgA;
• hypersensitivity to the active substance or to the components of the drug;
• severe protein S deficiency

Mode of application

The dosage depends on the clinical situation and the underlying disease, but 12-15 ml of Octaplas LH / kg of body weight is a generally accepted initial dose. This should increase the level of coagulation factor in the patient by about 25%. It is important to control the reaction both by clinical indicators and by measuring, for example, the level of activated partial thromboplastin time (APTT), prothrombin time (PV) and / or analysis of specific coagulation factors.

Dosing for deficiency of coagulation factors. Adequate hemostatic effect for minor and moderate bleeding or surgery in patients with a deficiency of blood coagulation factor, as a rule, is achieved after infusion of 5-20 ml of the drug Octaplas LH / kg body weight. This should increase the level of coagulation factor in the patient by about 10-33%. In case of major bleeding or surgery, seek professional advice from a hematologist.

Dosing with TTP and bleeding with intense plasma clearance. For therapeutic plasma clearance procedures, you should seek professional advice from a hematologist. In patients with TTP, the entire plasma volume required for replacement should be replaced with the Octaplas LH drug.

The introduction of the drug "Octaplas LH" should be based on the specificity of the blood group according to the ABO system. In emergency cases, “Octaplas LH” with AB blood group can be considered as a universal plasma, since it can be used by all patients, regardless of blood type. Octaplas LH should be administered by infusion after thawing, as described below, using a filter infusion set. Infusion must be carried out under aseptic conditions.

Due to the risk of citrate toxicity, the injection rate should not exceed 0.020-0.025 mmol citrate / kg / min, which is ≤ 1 ml Octaplas LH / kg / min. The toxic effects of citrate can be minimized by administering calcium gluconate intravenously to another vein.

Octaplas LH is supplied as a frozen solution, which may be (slightly) yellow.

Options for thawing the frozen preparation "Octaplas LH"

Water bath.Defrost in a bag with polyamide / plastic film in a water bath with good circulation at a temperature of 30 ° C to 37 ° C. Water must be prevented from entering the inlet. The temperature of the water bath should not exceed 37 ° C and be below 30 ° C. The thawing procedure should not last more than 30 minutes.

Use a dry defrosting machine such as Sahara-III. Place “Octaplas LG” in a bag with polyamide / plastic film on a propaganda tile in accordance with the manufacturers instructions and defrost the plasma using the heating function. When the temperature of the blood component + 37 ° C is indicated on the temperature display, the heating process should be completed and the package removed. When defrosting the Octaplas LH preparation using a dry defrosting machine, it is recommended that you use a protocol printer to record the temperature of the blood component and error messages in the event of a malfunction.

Other methods. Other systems for thawing the frozen preparation "Octaplas LH" can be used provided that they are tested for this.

Allow the contents of the packet to warm to approximately 37 ° C before infusion. The temperature of the drug "Octaplas LH" should not exceed 37 ° C. Remove the bag and check the container for cracks or leaks.

Do not shake.

Do not use a turbid solution or a solution with mechanical impurities.

Thawed Octaplas LG cannot be frozen again. Unused drug should be destroyed.

Unused product or waste material should be disposed of in accordance with approved requirements.

Application features

Pregnant women

The safety of the use of the drug "Octaplas LH" for pregnant women has not been established in controlled clinical trials. It is not known whether this drug may affect reproductive function. The drug should be administered to a pregnant woman or woman who feeds only if alternative methods of treatment are considered inappropriate.

Children

The effectiveness and safety of the use of the drug "Octaplas LH" for children have not been evaluated. Data on the use of Octaplas LH for premature infants is very limited.

Drivers

After using the drug on an outpatient basis, the patient should be at rest for one hour. Octaplas LG does not have or has a slight effect on the ability to drive vehicles and work with mechanisms.

Overdose

High doses or a high rate of administration can lead to hypervolemia, pulmonary edema and / or heart failure, to the development of cardiovascular effects, as a result of the toxic effects of citrate (due to a decrease in the level of calcium ions), especially in patients with impaired liver function.

Side effects

Often there may be an acute minor allergic reaction due to hypersensitivity to protein infusion, which is characterized by urticaria, fever, chills, nausea, vomiting, abdominal or back pain.

Acute, but sometimes severe allergic (anaphylactic aboanaphylactoid) reactions are rarely possible, characterized by redness of the skin, hypotension, chest pain, bronchospasm, shortness of breath and cardiorespiratory collapse.

Interaction

Octaplas LH should not be mixed with drugs that can inactivate or cause precipitation. Avoid the formation of blood clots solutions; solutions that contain calcium should not be administered through the same system as Octaplas LH.

Storage conditions

Store at a temperature of ≤ -18 ° C, in a dark place and out of the reach of children.

Shelf life - 4 years at a temperature of ≤ -18 ° C in a dark place.

After thawing the Oktaplas LH infusion solution, it can be stored for up to 24 hours at a temperature of 2 ° C to 8 ° C or up to 8 hours at a temperature of 20 ° C to 25 ° C.

After opening the container, the drug should be used immediately.