Instruction for use: Stemokine

Dosage form: Nasal drops; Solution for intramuscular injection; Nasal dosing spray; Substance-powder

ATX

L03 Immunostimulants

Pharmacological group:

Immunomodulator [Other immunomodulators]

The nosological classification (ICD-10)

L02 Abscess of skin, furuncle and carbuncle: Furuncle of external auditory canal; Furuncle of the auricle; Furuncles; Abscess; Abscess of skin; Carbuncle; Carbuncle skin; Furuncle; Skin furuncle; Furunculosis Chronic recurrent furunculosis

Composition

Solution for intramuscular injection 1 ml

active substance: Stemokine® (L-isoleucyl-L-glutamyl-L-tryptophan sodium salt) 0.1 mg

(The amount of active substance is given in terms of dry matter)

Auxiliary substances: sodium chloride - 9 mg; Sodium hydroxide solution 1M - to pH 6.0-7.7; Water for injection - up to 1 ml

Spray nasal dosed 1 liter

active substance: Stemokine® (L-isoleucyl-L-glutamyl-L-tryptophan sodium salt) 0.25 g

(The amount of active substance is given in terms of dry matter)

Auxiliary substances: sodium chloride - 9 g; Sodium hydroxide solution 1M - to pH 6.0-7.7; Benzalkonium chloride 0.1 g; Water for injection - up to 1 liter

Description of dosage form

Colorless transparent liquid. A characteristic odor is allowed.

Pharmachologic effect

Mode of action - immunomodulating.

Pharmacodynamics

Stemokine® is the sodium salt of a synthetic peptide consisting of L-amino acid residues of isoleucine, glutamic acid and tryptophan. Stimokine® has an immunomodulatory effect, increases the resistance of the organism to local and generalized infections, causes normalization of the changed immunological parameters (relative and absolute number of lymphocytes, CD3 +, CD8 +, CD19 +, CD16 + lymphocytes, monocyte absorbance relative to St. aureus) and an increase Indices of spontaneous chemiluminescence and affinity for the total antigenic determinant of antibodies, the amount of HLA-DR + lymphocytes. The maximum tropicity of the drug is revealed to the bone marrow.

The mechanism of action of Stemokine® is based on the direct effect of the drug on the process of proliferation and differentiation of early hematopoiesis precursor cells, the regulatory effect on the responses of cellular and humoral immunity, and the nonspecific resistance of the organism. The drug affects the processes of differentiation of lymphoid cells, inducing the expression of differentiation antigens on leukocytes. After exposure to radiation, the use of cytotoxic drugs, Stemokine® accelerates the recovery of the population of committed and pluripotent hematopoietic progenitor cells. Along with the immunomodulating effect it has a pronounced detoxification activity, which is determined by the structure and molecular nature of the drug. The drug is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

Pharmacokinetics

When parenteral administration of Cmax in the blood is achieved after 5 minutes; In the bone marrow, liver, kidneys, lymph nodes - 30-40 minutes after administration. With intranasal administration, the drug is rapidly absorbed, Cmax in the blood is reached after 10-15 minutes. In the bone marrow, liver, kidneys, lymph nodes Cmax observed after 30-40 minutes after administration.

T1 / 2 of the drug is 24 hours, completely eliminated from the body within 72 hours from the time of administration. Metabolites of the drug are excreted mainly with urine - up to 60%, up to 20% - with feces.

Indications Stemokine

Treatment and prevention of chronic recurrent furunculosis in adults. Application in children is not studied.

Contraindications

Hypersensitivity to the components of the drug;

pregnancy.

Application in pregnancy and breastfeeding

Women in the period of breastfeeding Stemokin® should be prescribed only if the expected benefit exceeds the possible risk to the child.

Side effects

In rare cases, allergic reactions are possible.

Interaction

Data on interactions with other drugs are not available.

Dosing and Administration

IM. For adults, take 1-2 ml of the solution daily for 10 days. If necessary, the dose and duration of the drug may be increased.

In the remission phase, the drug is prescribed in the IM daily for 1 ml of the solution for 5-7 days.

Intranasally. Stemokine® spray - adults 1-2 doses in each nasal passage 1-2 times a day for 7-10 days.

If necessary, the dose and duration of the drug may be increased.

Overdose

Data on overdose are absent.

Special instructions

Features of medical use for patients with chronic diseases

It is not recommended to use Stemokine® in children and adults with chronic liver and kidney disease due to the lack of safety data for the use of the drug in these patient groups.

Influence on ability to drive vehicles, mechanisms. The drug does not affect the coordination of movement, however, during the period of application of the drug, care should be taken when carrying out potentially dangerous activities requiring special attention and quick reactions (vehicle management, working with moving mechanisms, dispatcher and operator work).

Release form

Solution for intramuscular injection, 0.1 mg / ml. 1 ml in ampoules of neutral glass. At 5 amp. In a contoured cell pack of PVC film.

1 or 2 contour squares with an ampoule or ampoule ampoule are placed in a pack of cardboard. When you pack the ampoules with a ring or break point, the ampoule or ampoule scalers do not insert the knives.

Spray nasal dosed, 25 mcg / dose. For 3, 5 or 10 ml in glass bottles. The vials are sealed with aluminum caps or plastic caps equipped with a dispensing pump with a plastic casing, a nozzle and a protective cap. Each label is labeled with writing paper or label paper, or self-adhesive. On 1 fl. Put in a pack of cardboard box.

Manufacturer

Solution for intramuscular injection, 0.1 mg / ml

FSUE "Moscow Endocrine Plant"

Spray nasal dosed, 25 mcg / dose

CJSC MBNPK "Tsitomed"

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Stemokine

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Stemokine

3 years.

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