Thymalin lyophilized powder for solution for injection 10 mg ampoule No. 10

Instructions for use: Thymalin lyophilized powder for solution for injection 10 mg ampoule No. 10

Composition

active ingredient: 1 ampoule (1 bottle) contains 10 mg of dry purified extract of bovine thymus;

excipient: glycine.

Dosage form

Lyophilisate for solution for injection.

Main physicochemical properties: amorphous powder or porous mass of white or white with a yellowish tinge.

Pharmacotherapeutic group

Immunostimulants. ATX 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 processes in case of their inhibition, and also improves the course of cellular metabolism.

Pharmacokinetics

Didn't study.

Indication

Comprehensive treatment of diseases accompanied by a decrease in cellular immunity:

- acute and chronic purulent-inflammatory diseases of bones and soft tissues;

- disorders of regenerative processes (bone fractures, burns, frostbite, trophic ulcers, radiation necrosis of tissues, gastric and duodenal ulcers);

- acute and chronic bacterial and viral infections, multiple sclerosis, atherosclerosis obliterans, rheumatoid arthritis;

- suppression of immunity and hematopoiesis after radiation therapy or chemotherapy, use of large doses of antibiotics.

Contraindication

Hypersensitivity to the components of the drug. Autoimmune diseases.

Interaction with other medicinal products and other types of interactions

Compatible with biostimulants and immunostimulants, rifampicin, isoniazid, glucocorticoid drugs. Simultaneous use of Thymalin and

T-activin, thymactide, thymogen or thymoptin, which have a similar mechanism of action.

Application features

Treatment with Thymalin should be carried out under regular monitoring of immunological parameters. It should be prescribed with caution to patients with IgE-dependent pathology. Thymalin may potentiate allergic reactions to other drugs when used simultaneously.

Use during pregnancy or breastfeeding

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

Ability to influence reaction speed when driving vehicles or other mechanisms

Not studied.

Method of administration and doses

Before use, dissolve the contents of the ampoule (vial) in
1-2 ml of 0.9% sodium chloride solution.

The dosage regimen of Thymalin is determined by a clinical immunologist based on the patient's clinical and laboratory examination.

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

Children. The drug can be used in pediatric practice.

Use only as prescribed and under the supervision of a physician in cases of proven disorders (suppression) of cellular immunity.

Administer intramuscularly daily to 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 disorders. If necessary, repeat the course of treatment (after 1-6 months).

Overdose

Increased adverse reactions.

Adverse reactions

On the part of the immune system: allergic reactions, skin rashes, hyperemia, itching of the skin are possible.

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

Expiration date

3 years.

Storage conditions

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

Incompatibility

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

Packaging

30 mg of the drug in an ampoule (vial). 10 ampoules (vials) in a pack.

30 mg of the drug in an ampoule (vial). 5 ampoules (vials) in a blister, 2 blisters in a pack.

Vacation category

According to the recipe.

Producer

PrJSC "BIOPHARMA", Ukraine; LLC "FZ "BIOPHARMA". Ukraine.

Location of the manufacturer and its business address

Ukraine, 03680, Kyiv, M. Amosova St., 9;

Ukraine, 09100, Kyiv region, Bila Tserkva, Kyivska st., 37.