Thymalin^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Samson-Med LLC (Russia)

ATC Code

L03AX (Other immunostimulants)

Active Substance

Thymus extract (Grouping name)

Dosage Form

Thymalin®

Lyophilisate for the preparation of solution for intramuscular administration 10 mg: vial 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for the preparation of solution for intramuscular administration in the form of a lyophilized mass in the form of a tablet, whole, partially or completely crumbled, white or white with a yellowish tint; the reconstituted solution is clear, colorless or yellowish in color.

* obtained from the thymus glands of calves and young cattle under one year of age.

Excipients: glycine – 20 mg.

Glass vials with a capacity of 5 ml (5) – cardboard packs.
Glass vials with a capacity of 5 ml (10) – cardboard packs.

Clinical-Pharmacological Group

Immunostimulating drug

Pharmacotherapeutic Group

Immunostimulants; other immunostimulants

Pharmacological Action

It restores impaired immunological reactivity (regulates the number and ratio of T- and B-lymphocytes and their subpopulations, stimulates cellular immune responses, enhances phagocytosis), stimulates regeneration and hematopoiesis processes when they are suppressed, and also improves the course of cellular metabolism processes.

Indications

Immunodeficiency states in adults and children aged from 6 months to 14 years with

• Infectious purulent and septic processes;
• Persistent impairment of thymus function (radiation sickness, neoplastic processes of the thymus, surgical removal of the thymus);
• Acute and chronic viral and bacterial infections;
• Impaired regenerative processes;
• Suppression of immunity and hematopoiesis after chemotherapy or radiation therapy in patients with oncological diseases.

ICD codes

Dosage Regimen

Administered intramuscularly daily in the following doses: adults 5-20 mg (30-100 mg per course), children aged from 6 months to 1 year – 1 mg; children aged 1-3 years – 1.5-2 mg; children aged 4-6 years – 2-3 mg; children aged 7-14 years – 3-5 mg for 3-10 days depending on the severity of immune disorders.

If necessary, a repeat course is conducted (after 1-6 months).

For prophylactic purposes, it is used intramuscularly daily, adults 5-10 mg, children – 1-5 mg for 3-5 days.

Data on dosing features in patients with impaired renal function, hepatic function, elderly patients are not available.

Adverse Reactions

Possible allergic reactions.

Contraindications

• Hypersensitivity to the active substance or excipients of the drug used;
• Pregnancy;
• Period of breastfeeding.

With caution

Patients with a burdened allergic history.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and the period of breastfeeding.

Pediatric Use

Used in children aged from 6 months.

Special Precautions

A relative contraindication to the use of drugs based on peptides isolated from the thymus of cattle is the perimenstrual period, some endocrine syndromes (pituitary adenoma, acromegaly).

The use of drugs based on peptides isolated from the thymus of cattle in patients with severe endocrine disorders and in women in the second phase of the menstrual cycle may more often cause side effects.

It is not recommended to consume alcoholic beverages during the use of the drug.

Influence on the ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Drug Interactions

Thymus extract is compatible with isoniazid, immunostimulating drugs, glucocorticoid drugs, rifampicin, and analgesics.

Simultaneous use of drugs with a mechanism of action similar to this agent should be avoided. Synergism with some pituitary hormones (GH, LH) and with estrogens is possible.

The action of this agent is antagonistic to the effects of progestins, androgens, and adrenal hormones in terms of their influence on the lymphatic system and bone marrow.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.