TIMALEEN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TYMALIN (TYMALIN)

Composition:

Active substance: 1 vial contains not less than 1.5 mg of dry purified thymus extract (from cattle thymus gland), calculated as polypeptides;

Excipient: glycine.

Pharmaceutical form. Lyophilisate for solution for injection.

Main physicochemical properties: amorphous powder or porous mass, white or white with a yellowish tint.

Pharmacotherapeutic group. Immunostimulants. ATC code L03A X.

Pharmacological properties.

Pharmacodynamics.

Regulates the number and ratio of T- and B-lymphocytes and their subpopulations, stimulates cellular immune responses, enhances phagocytosis, stimulates regeneration and hematopoiesis in case of their suppression, and also improves the course of cellular metabolism processes.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications.

Complex treatment of diseases accompanied by reduced cellular immunity:

• acute and chronic purulent-inflammatory diseases of bones and soft tissues;
• impaired regenerative processes (bone fractures, burns, frostbite, trophic ulcers, radiation-induced tissue necrosis, gastric and duodenal ulcers);
• acute and chronic bacterial and viral infections, multiple sclerosis, obliterative atherosclerosis, rheumatoid arthritis;
• immunosuppression and hematopoietic suppression following radiation therapy or chemotherapy, or use of high-dose antibiotics.

Contraindications. Hypersensitivity to the components of the drug. Autoimmune diseases.

Interaction with other medicinal products and other types of interactions. Compatible with biostimulants and immunostimulating agents, rifampicin, isoniazid, and glucocorticoid preparations. Concomitant use of Thymalin and T-activin, thymactid, thymogen, or timoptin—drugs with a similar mechanism of action—should be avoided.

Special precautions for use

Treatment with Timogen should be carried out with regular monitoring of immunological parameters. Use with caution in patients with IgE-dependent pathology. Timogen may potentiate allergic reactions to other medicinal products when used concomitantly.

Use during pregnancy or breastfeeding. There are no clinical data on the efficacy and safety of the medicinal product during pregnancy or breastfeeding. The drug is contraindicated in pregnant women. Breastfeeding should be discontinued during treatment with this drug.

Ability to influence reaction rate while driving or operating machinery. Not studied.

Administration and Dosage

Before use, dissolve the contents of the vial in 1–2 mL of 0.9% sodium chloride solution.

The Timallin dosage regimen should be determined by a clinical immunologist based on clinical and laboratory evaluation of the patient.

Administer intramuscularly daily in the following doses: for adults and children aged 14 years and older – 5–20 mg (30–100 mg per course) for 3–10 days, depending on the manifestations of immune disturbances.

Children. The drug may be used in pediatric practice.

Use only as prescribed and under medical supervision when impaired (suppressed) cellular immunity is confirmed.

Administer intramuscularly daily as follows: children under 1 year of age – 1 mg; 1–3 years – 1–2 mg; 4–6 years – 2–3 mg; 7–14 years – 3–5 mg, for 3–10 days depending on the manifestations of immune disturbances. If necessary, repeat the treatment course (after 1–6 months).

Overdose. Increased incidence of adverse reactions.

Adverse reactions.

Immune system side effects: allergic reactions, skin rashes, hyperemia, skin itching.

Local reactions at the injection site: possible reactions at the injection site.

Shelf life. 3 years.

Storage conditions. Store in the original packaging to protect from light at a temperature not exceeding 25°C. Keep out of reach of children.

Incompatibility. Use only the recommended solvent. Do not mix the prepared solution with other medicinal products. Use immediately after preparation.

Packaging. 30 mg of the drug in a vial. 5 vials per blister pack, 2 blisters per carton.

Prescription status. Prescription only.

Manufacturer. LLC "FZ "STADA", Ukraine.

Manufacturer's location and address of business activity.
Ukraine, 09100, Bila Tserkva, Kyiv Oblast, 37 Kyivska Street.