Octaplas LG A (II) solution for infusions 45-70 mg. 200 ml.

Description

Octaplas LG composition
active substance: human plasma proteins;
1 ml of solution for infusion contains 45 ̵ 70 mg of human plasma proteins;
1 container (200 ml) contains 9 ̵ 14 g of human plasma proteins;
excipients: sodium, dihydrate; sodium dihydrogen phosphate, dihydrate; glycine.

Dosage form
Solution for infusion.

Packaging
200 ml of solution in a sterile, plasticized polyvinyl chloride blood container. 1 container in a bag with transparent polyamide / polyethylene film.
1 bag in a cardboard box.

Octaplas LG is packed in separate containers for the following blood types:

• Blood group A (II);
• Blood group B (III);
• Blood group AB (IV);
• Blood group O (I).

Pharmacological properties
The content and distribution of plasma proteins in the Octaplas LG preparation remain in the final product at similar levels in the fresh frozen plasma (FFP) available in the raw material, that is, 45-70 mg / ml, the level of the main blood plasma proteins is within the concentration in the blood of healthy donors ( see table 1). The average value of the total protein content is 58 mg / ml, albumin is 50% (29 mg / ml), while the immunoglobulin classes G, A, M are present in the amount of 8.1, 1.6 and 0.8 mg / ml respectively. As a result of solvent-detergent treatment and purification, the content of lipids and lipoproteins decreases. It does not matter within the limits of indications for the drug.
During the production process, differences in the quantitative content of plasma proteins between donors are smoothed out and the functional state of plasma proteins is preserved. Has the same clinical properties as fresh frozen plasma from individual donors, but the drug is more standardized. The finished product is tested for coagulation factors V, VIII and XI for inhibitors of protein C, protein S and antiplasmin. A minimum of 0.5 IU / ml is purchased for each of the three clotting factors, while inhibitor levels are guaranteed to be equal to or greater than 0.7, 0.3 and 0.2 IU / ml. The fibrinogen content ranges from 1.5 to 4.0 mg / ml. In conventional manufacturing, all clinically important parameters are within the 2.5-97.5 percentile of the normal range of a single FFP donor, with the exception of a plasmin inhibitor (also known as a 2-antiplasmin), which is slightly lower (Table 1). Octaplas LG displays the same von Willebrand factor in a multidimensional pattern as conventional plasma.

Indications:

• Complex deficiency of clotting factors, in particular coagulopathy, due to severe liver failure or massive blood transfusion.
• Replacement therapy for clotting factor deficiencies, when a concentrate of a specific clotting factor (eg, 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 indandione type), when the prothrombin complex concentrate is not available for use or the administration of vitamin K is insufficient due to liver dysfunction, 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.
• Plasma replacement therapy, including for thrombotic thrombocytopenic purpura (TTP).

Contraindications:

• deficiency of IgA with the described antibodies against IgA;
• hypersensitivity to the active substance or to the components of the drug;
• severe protein S deficiency;
• Octaplas LH should not be used;
• to restore blood volume;
• in case of bleeding caused by a deficiency of clotting factors, when a specific concentrate of the factor is available for use;
• for the correction of hyperfibrinolysis in liver transplantation or other conditions of complex hemostasis disorders caused by a deficiency of a plasmin inhibitor, also known as a 2-antiplasmin.

Octaplas LG should be used with caution in the following cases:

• IgA deficiency;
• allergy to plasma proteins;
• previous experience with reactions to fresh frozen plasma (FFP) or Octaplas LG;
• overt or latent heart failure;
• pulmonary edema.

Children
The efficacy and safety of using the drug in children have not been evaluated.

Application during pregnancy or lactation
The safety of using Octaplas LG in pregnant women has not been established in controlled clinical trials. It is not known if Octaplas LG can affect fertility. The drug should be administered to a pregnant woman or a woman who is breastfeeding only if alternative therapies are considered inappropriate.

Method of administration and dosage
The dosage depends on the clinical situation and the underlying disease, but 12-15 ml of Octaplas LG / kg body weight is the generally accepted starting dose. This should increase the patient’s clotting factor levels by about 25%.
It is important to monitor the response both clinically and by measurement, for example, activated partial thromboplastin time (APTT), prothrombin time (PT), and / or specific coagulation factor analyzes.
Dosing for coagulation factor deficiency
Adequate hemostatic effect in minor to moderate bleeding or surgery in patients with clotting factor deficiency is usually achieved after infusion of 5-20 ml of Octaplas LG / kg body weight. This should increase the patient’s clotting factor levels by about 10-33%. In case of major bleeding or surgery, you should seek professional advice from a hematologist.
Dosing for TTP and bleeding with intense plasma replacement
For therapeutic procedures plasma replacement, you should seek professional advice from a hematologist.
In patients with TTP, the entire volume of plasma required for replacement should be replaced with Octaplas LG.
Mode of application
Administration of Octaplas LG should be based on the ABO blood group specificity. In urgent cases, Octaplas LG with blood group AB can be considered as a universal plasma, since it can be applied to all patients, regardless of blood group.
Octaplas LG should be administered by infusion after thawing using a filter infusion set. Infusion must be performed 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 LG / kg / min. The toxic effects of citrate can be minimized by intravenous administration of calcium gluconate into another vein.
Octaplas LG is supplied as a frozen solution which may be (slightly) yellow in color.

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

Adverse reactions:

• From the side of the vessels: Lowered blood pressure;
• From the respiratory system, chest and mediastinal organs: bronchospasm;
• From the gastrointestinal tract: nausea, vomiting;
• On the part of the skin and subcutaneous tissues: rashes, itching, urticaria, fever;
• Complications of a general nature and reactions at the injection site: chills, fever, localized edema.

Shelf life
4 years at -18 ° C, protected from light.
After thawing, it can be stored up to 24 hours at 2 to 8 ° C or until 8:00 at 20 to 25 ° C.
After opening the container, the drug should be used immediately.

Storage conditions
Store at -18 ° C in a dark place.
Keep out of the reach of children.