Bestim (Lyophilisate) Instructions for Use

Marketing Authorization Holder

State Research Institute of Occupational Health FMBA, FSUE (Russia)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Gamma-D-glutamyl-D-tryptophan (Grouping name)

Dosage Form

Bestim®

Lyophilisate for preparation of solution for intramuscular administration 100 mcg: amp. 5 pcs.

Dosage Form, Packaging, and Composition

100 mcg – glass ampoules (5) – contour cell packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulating agent

Pharmacological Action

Gamma-D-glutamyl-tryptophan sodium is a dipeptide with immunostimulating action. It stimulates cellular and humoral immunity. It increases antibacterial and antiviral resistance.

The pharmacological action is determined by the enhancement of differentiation and proliferation of T-lymphocyte precursors, stimulation of interleukin-2 production, increased expression of interleukin-2 receptors and T-cell differentiation markers, and restoration of the immunoregulatory index.

The use of the drug Bestim in the complex therapy of diseases accompanied by secondary immunodeficiencies significantly increases its effectiveness. The drug is effective when included in the complex therapy of viral diseases accompanied by insufficiency of the cellular immunity component.

Pharmacokinetics

The distribution of the drug in the body is limited to the extracellular aqueous phase. The drug is rapidly eliminated from the systemic circulation – its average circulation time is 10-11 minutes; the elimination rate is characterized by a high clearance – 25-30 ml/kg/min.

The drug is eliminated from the body in the form of metabolites with urine and feces.

Indications

In adults in the complex therapy of secondary immunodeficiency states developing

• After severe injuries against the background of purulent-septic and purulent-destructive processes;
• After extensive surgical interventions;
• In chronic septic conditions with anergy phenomena;
• In infectious diseases (viral hepatitis, tuberculosis, chlamydia).

ICD codes

Dosage Regimen

Administer the drug intramuscularly only.

Reconstitute the 100 mcg lyophilisate in 1 ml of water for injection to achieve the final solution.

Inject the entire 1 ml volume, containing 100 mcg of the active substance.

Administer the injection once daily.

Adhere to a daily administration schedule without interruption.

The standard course of treatment consists of five injections.

Complete the full five-day course unless otherwise directed by a physician.

Use the prepared solution immediately after reconstitution; do not store it.

Follow aseptic techniques during the preparation and administration of the solution.

Adverse Reactions

In some cases, nausea and dizziness may be observed.

If any of the side effects mentioned in the instructions get worse, or you notice any other side effects not listed in the instructions, inform your doctor.

Contraindications

• Allergic and autoimmune diseases (urticaria, angioedema, Lyell’s syndrome, systemic connective tissue diseases);
• Pregnancy and lactation period;
• Childhood;
• Individual intolerance to the drug.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

Contraindicated in childhood.

Special Precautions

Considering the possibility of dizziness, caution should be exercised when driving vehicles and working with precision machinery.

Overdose

To date, no cases of overdose accompanied by any clinical symptoms have been described.

However, as with an overdose of any drug, symptomatic therapy should be carried out with monitoring of the functions of vital organs and regular control of the patient’s condition.

Drug Interactions

With simultaneous use, Bestim increases the clinical efficacy of anti-tuberculosis drugs (isoniazid, rifampicin, pyrazinamide, ethambutol, ciprofloxacin) in the complex therapy of pulmonary tuberculosis; antibiotics of various groups (azithromycin, roxithromycin, doxycycline) and antimicrobial drugs of the fluoroquinolone group (lomefloxacin, sparfloxacin) in the complex therapy of urogenital chlamydia; the antiviral drug ribavirin in the complex therapy of viral hepatitis C.

Storage Conditions

In a place protected from light, at a temperature of 2 to 10°C (50°F). Keep out of the reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed 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.