Plasm (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Ivanovo Regional Blood Transfusion Station SIH (Russia)

ATC Code

B05AA01 (Albumin)

Dosage Forms

	Plasm	Lyophilisate for preparation of solution for infusion 4 g: bottle
		Lyophilisate for preparation of solution for infusion 14 g: bottle

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for infusion as a dry porous mass of light yellow color.

14 g – bottles with a capacity of 250 ml (1) – cardboard packs.

Lyophilisate for preparation of solution for infusion as a dry porous mass of light yellow color.

4 g – bottles with a capacity of 100 ml (1) – cardboard packs.

Clinical-Pharmacological Group

Plasma substitute

Pharmacotherapeutic Group

Plasma substitute

Pharmacological Action

Plasm is a protein preparation made from donor plasma tested for the absence of antibodies to human immunodeficiency viruses (HIV 1, HIV 2), antibodies to hepatitis C virus, surface antigen of hepatitis B virus (HBs Ag), with a normal level of ALT (alanine aminotransferase).

Plasm has a hemodynamic, detoxifying, stimulating effect and eliminates protein deficiency.

Indications

• Shock;
• Intoxication;
• Dystrophy of various origins;
• Protein deficiency;
• As a stimulating agent.

ICD codes

Dosage Regimen

The drug is used taking into account ABO blood group and Rh factor compatibility. Water for injections, isotonic 0.9% sodium chloride solution or 5% glucose solution in the amount indicated on the plasma label are used as a solvent.

Before dissolution, the condition of the closure, the integrity of the bottles with plasma and solvent, and the labels are carefully checked. The covering is removed from the bottle neck, the cap is treated with 96% ethyl alcohol, and its flaps are bent back with sterile tweezers. The rubber stopper is lubricated with iodine solution and pierced with two short sterile needles. One needle is connected to the filter, the other connects the plasma bottle to the solvent. Plasma powder can be diluted to different concentrations, preparing hypertonic, isotonic or hypotonic solutions as indicated.

The plasma solution should not contain flakes, clots, or insoluble suspensions after filtration through a standard blood transfusion system. The solution is used for transfusion immediately after dissolution. Before plasma transfusion, a biological test for individual compatibility is performed. For this purpose, 15-20 drops of the drug are administered to the patient, then 10 ml and 20 ml with a 3-minute break between each administration. If there is no reaction in the patient, the entire dose is administered.

In shock, depending on hemodynamic parameters, from 500 to 2000 ml is administered intravenously (by stream or drip); as a detoxifying agent – intravenously (by stream or drip) 250-500 ml; for protein deficiency – intravenously (by drip), repeatedly 250-500 ml (daily or every other day) until a therapeutic effect is achieved; for dystrophy – intravenously (by drip), repeatedly 250 ml until a therapeutic effect is achieved. For the edematous form of dystrophy, transfusion of plasma powder solutions concentrated 2-3 times is recommended.

These solutions can be used for skull injuries occurring with cerebral hypertension, as well as for injuries of other locations where large fluid administration is contraindicated.

To obtain a stimulating effect, it is recommended to infuse 100-250 ml of plasma (repeatedly if necessary).

Adverse Reactions

In some cases, allergic reactions may occur due to increased individual sensitivity of the recipient. In these cases, the transfusion should be stopped and, without removing the needle from the vein, symptomatic therapy should be carried out as indicated.

Contraindications

• Thromboembolic diseases;
• Increased sensitivity of the patient to the administration of protein preparations.

Storage Conditions

The drug should be stored in a dry place, protected from light, out of the reach of children, in a well-ventilated room at a temperature from 5 to 20°C (68°F).

Shelf Life

Shelf life – 5 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.