Instruction for use: Bestim

Dosage form: Lyophilizate for the preparation of a solution for intramuscular administration; Solution for intramuscular administration; Substance-powder

Active substance: Gamma-D-glutamyl-L-tryptophanum

ATX

L03AX Other immunostimulants

Pharmacological group:

Other immunomodulators

The nosological classification (ICD-10)

A16.9 Tuberculosis of respiratory organs of unspecified site without reference to bacteriological or histological confirmation: Hemoptysis in tuberculosis; Cough with tuberculosis; Pleural effusion in tuberculosis

A41.9 Septicemia, unspecified: Septic diseases; Septicemia / bacteremia; Toxico-infectious shock; Endotoxin shock; Bacterial septicemia; Bacterial infections of severe course; Generalized infections; Generalized systemic infections; Infections generalized; Wound sepsis; Septiccopymia; Septic-toxic complications; Septicemia; Septic conditions; Septic shock; Septic condition; Septic shock

A74.9 Chlamydial infection, unspecified: Chlamydial infections; Uncomplicated chlamydia; Chlamydiasis; Chlamydial infection; Chlamydial infections; Extragenital chlamydia; Chlamydia

B19 Viral hepatitis, unspecified: Anemia without hepatitis; Viral hepatitis; Viral hepatitis in children; Infection of the liver; Acute liver infection

D84.8 Other specified immunodeficiency disorders: Immunodeficiency due to loss of protein; Immunodeficiency states secondary; Immunodeficiency states with protein loss; Secondary Immune Deficiency; Secondary immunodeficiency status; Secondary immunodeficiency states; Secondary immunodeficiency; Acquired immunodeficiency; Syndrome of secondary immunodeficiency; Secondary immunodeficiencies; Immunodeficiency states primary

Z54.0 Recovery period after surgical intervention: Conditions after neurosurgical operations; Conditions after removal of gallstones; Conditions after surgery; Restorative period after surgical interventions; Recovery period after operations; The rehabilitation period after surgical interventions; The rehabilitation period after surgical operations; Reconvalence after surgery; Reconvalence after surgical intervention; Reconvalescence in the postoperative period; Recovery period after surgery in front of eyes; Period after hemorrhoidectomy; Postoperative period; Period of postoperative rehabilitation; The rehabilitation period after injuries

Composition

Lyophilizate for solution for intramuscular injection 1 amp.

active substance: Bestim® (gamma-D-glutamyl-tryptophan sodium) 100 μg

Auxiliary substances: sodium chloride - 1 mg; Mannitol 9 mg

Description of dosage form

White powder or porous mass without a smell.

Pharmachologic effect

Mode of action - immunomodulating.

Pharmacodynamics

Gamma-D-glutamyl-tryptophan sodium is a dipeptide with immunostimulating action. Stimulates cellular and humoral immunity. Increases antibacterial and antiviral resistance. The pharmacological action is determined by increased differentiation and proliferation of T lymphocyte progenitors, stimulation of IL-2 production, increased expression of IL-2 receptors and T cell differentiation markers, restoration of the immunoregulatory index. The use of the preparation BESTIM® in the complex therapy of diseases accompanied by secondary immunodeficiency significantly improves its effectiveness. The drug is effective when included in the complex therapy of viral diseases, accompanied by a lack of cellular immunity.

Pharmacokinetics

The distribution of the drug in the body is limited by the extracellular water phase. The drug is rapidly excreted from the systemic circulation - the average time of its circulation is 10-11 min; The elimination rate is characterized by high clearance - 25-30 ml / kg / min. From the body the drug is excreted in the form of metabolites with urine and feces.

Indication of the Bestim

In adults, in the complex therapy of the following diseases and conditions:

Secondary immunodeficiency states, developing after severe trauma on the background of purulent-septic and purulent-destructive processes;

After extensive surgical interventions;

Chronic septic states with phenomena of anergy;

Infectious diseases (viral hepatitis, tuberculosis, chlamydia).

Contraindications

Individual intolerance to the drug;

Allergic and autoimmune diseases (hives, Quincke's edema, Lyell's syndrome, systemic connective tissue diseases);

pregnancy;

Lactation period;

childhood.

Side effects

In some cases, nausea and dizziness may occur. If any of the side effects listed in the manual are aggravated or the patient has noticed any other side effects not listed in the instructions, you should notify the doctor.

Dosing and Administration

IM, 100 mcg per 1 ml of water for injection, once a day every day. The course of treatment - 5 injections.

Overdose

To date, no cases of overdose, accompanied by any clinical symptoms. However, as with an overdose of any drug, symptomatic therapy should be performed with monitoring the functions of vital organs and regular monitoring of the patient's condition.

Special instructions

Given the possibility of dizziness, care should be taken when driving vehicles and working with precise mechanisms.

Release Form

Lyophilizate for the preparation of solution for intramuscular injection. 100 mcg in a vial of colorless glass. 5 amp. In a cassette contour pack. 1 cassette contour mesh packaging is placed in a pack of cardboard.

Manufacturer

Federal State Unitary Enterprise "State Research Institute of Highly Pure Biopreparations" of the Federal Federal Medical and Biological Agency of the Medical and Biological Agency (FSUE "GosNIIII OCHB", FMBA of Russia).

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Bestim

In the dark place at a temperature of 2-10 ° C.

Keep out of the reach of children.

Shelf life of the drug Bestim

2 years.

Do not use after the expiry date printed on the package.