Cultures of diploid human cells for replacement therapy (HUMAN DIPLOID CELL CULTURE FOR REPLACEMENT THERAPY)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCell culture [for therapeutic purposes]Cell culture [for therapeutic purposes]
Dosage form: & nbspa monolayer of cell culture for the preparation of a suspension for external and topical administration.
Composition:

The drug is a morphologically homogeneous population of cells strain LET-4/81 with a limited life span, a certain tissue origin, preserving a stable karyotype (2n not less than 75 % cells), free from foreign agents and not showing irritating, general toxic, immunotoxic action, allergic, mutagenic and carcinogenic properties, cultivated on artificial nutrient media up to 25 passage. The strain LECH-4/81 is certified in accordance with WHO requirements and is stored in the form of a seed bank of cells at the level of 4-6 passage, collection code 020510 / 135B.

Description:

The drug is a continuous layer of cells, covered with a transparent or slightly opalescent nutrient medium from orange-red to pinkish with a pH of 7.0-7.4.

Pharmacotherapeutic group:Human cells
ATX: & nbsp

V.07.A   Other non-medicinal products

Indications:For replacement therapy. In case of damage associated with malfunctioning of mucous membranes and skin, muscle and bone tissues, with thermal and chemical burns, frostbite and injuries of various origins.
Contraindications:

Hypersensitivity to the components of the drug, increased bacterial contamination of the wound, a complicated course of the disease is a decompensated septic state (multi-organ failure in more than 5 systems).

Dosing and Administration:

Work with the drug should be carried out in aseptic conditions. Before opening bottles (bottles) pay attention to their integrity, transparency and color of the nutrient medium.

In the case of existing cracks in the bottle (bottle), opacification of the preparation or non-conformity of the color of the nutrient medium, the cell culture is not used in the work.

To obtain a suspension of cells, the bottle (bottle) with the drug is burned with an alcohol torch, opened and drained off the nutrient medium, into a sterile container / Then into the vial (bottle), a mixture of equal amounts of 0.02% Vershen solution and 0.25% trypsin solution before coating the monolayer for 2-3 minutes, after which the liquid is poured into a waste container. In a bottle (bottle) with cells of 10, 50, 100, 250 ml capacity, respectively, 1, 5, 10, 25 ml of nutrient medium and shake thoroughly until a homogeneous suspension is formed. The resulting cell suspension is immediately applied by a sterile syringe (or other method) to the clean wound surface. If necessary, a sterile bandage is applied using a Voskopran mesh pad.

The recommended daily dose is 0.5 million cells per 10 cm2 wound surface.

At the discretion of the attending physician, the drug can be applied repeatedly.

Possible application in conjunction with anesthetics and other medications.

Side effects:Not installed.
Special instructions:For treatment and prevention institutions.
Form release / dosage:A monolayer of cell culture for the preparation of a suspension for external and topical application.
Packaging:

For 0.5 million cells in bottles of glass with a capacity of 10 ml.

2.5 million cells, 5.0 million cells, 11.0 million cells in glass bottles for blood, transfusion and infusion preparations with a capacity of 50,100 and 250 ml, respectively.

For 1 bottle (bottle) in a pack of cardboard with instructions for use.

Storage conditions:

The preparation is stored and transported at a temperature of 5 to 25 ° C under conditions that exclude freezing.

Shelf life:

7 days from the date of manufacture.

The culture of cells with expired shelf life is not subject to application.

Terms of leave from pharmacies:For hospitals
Registration number:P N001402 / 01-2002
Date of registration:09.10.2008
Expiration Date:Unlimited
The owner of the registration certificate:EKATERINBURG RESEARCH INSTITUTE OF VIRAL INFECTIONS MH RF EKATERINBURG RESEARCH INSTITUTE OF VIRAL INFECTIONS MH RF Russia
Manufacturer: & nbsp
Information update date: & nbsp07.02.2018
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