Imodin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IMOGEN

Composition:

Active substance: leucocyte dialysate;

1 dose (contents of one ampoule) of lyophilised medicinal product contains:

200 × 106 leucocytes (lyophilised dialysate from 200 million leucocytes);

Excipients: none.

Pharmaceutical form.

Powder and solvent for solution for injection.

Main physicochemical characteristics: powder or porous mass ranging from white to yellowish in color.

Pharmacotherapeutic group.

Immunostimulants. ATC code L03A X.

Pharmacological Properties.

Pharmacodynamics.

The medicinal product IMOGEN is a mixture of biologically active immunomodulating substances, whose chemical action has not yet been sufficiently defined.

The active substances contained in the medicinal product IMOGEN affect the proliferation and differentiation of various cell types, i.e., their maturation to stages at which they are capable of functioning. For example, bone marrow hematopoietic progenitor cells, where the active substances primarily influence the progenitors' ability to respond to a number of cytokines. Similarly, they affect lymphocytes bearing CD4+ and CD8+ markers. Administration of the medicinal product IMOGEN leads, in particular, to increased production of gamma interferon and interleukin-1-2, thereby shifting the balance towards the Th1 subpopulation and the cytokine profile produced by these cells.

One of the mechanisms by which the medicinal product IMOGEN affects cellular metabolism and function is through influencing calcium ion (Ca++) flux across cell membranes, i.e., release or binding depending on the cell type and state (lymphocytes and macrophages). The medicinal product IMOGEN also enhances oxidative metabolism in liver cells.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

The medicinal product IMODIN is indicated for individual prescription, particularly in cases of proven cellular immune deficiency, in individuals aged 18 years and older.

For treatment, use is recommended in the following conditions:

• recurrent chronic infections;
• severe septic conditions;
• atopic dermatitis, psoriasis;
• chronic fatigue syndrome caused by immune dysfunction;
• severe allergic conditions, when a defect in cellular immunity has been demonstrated and conventional immunotherapy (e.g. hyposensitizing therapy) is ineffective.

For prophylaxis, use is recommended:

• in individuals whose other treatments (cytostatic and radiation therapy) cause suppression of cellular immunity;
• during preoperative preparation of individuals with proven cellular immune deficiency;
• in cases of severe trauma.

Contraindications.

Pregnancy and conditions in which increased cellular immunity is undesirable.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted.

Special precautions for use.

Subcutaneous administration of the medicinal product causes local pain of varying intensity, which usually disappears within 15 minutes. At the injection site, erythema and infiltration may occur, which resolve within 24 hours.

IMODIN is a low-molecular-weight substance isolated from the dialysate of a homogenate of leukocytes from peripheral blood obtained from healthy donors who have been tested for the absence of antibodies to HIV types I and II, hepatitis C virus antigen, hepatitis B surface antigen, and syphilis. The safety of the preparation is ensured by donor selection, filtration through a membrane with a molecular weight cutoff of 10 kilodaltons, as well as by sterilizing filtration followed by thermal inactivation (pasteurization).

Use during pregnancy or breastfeeding.

The use of the medicinal product is contraindicated during pregnancy. During breastfeeding, the use of the medicinal product is not contraindicated.

Ability to influence reaction rate when driving or operating machinery.

The ability to affect reaction speed when driving or operating machinery is unlikely.

Dosage and Administration

One dose of the medicinal product (the contents of one ampoule) corresponds to the amount of active substance contained in 200 million donor leukocytes. The required dose is determined individually based on previous evaluation of the patient's immune status. In cases of mild immune system disorders, administration of 3 primary doses at weekly intervals is sufficient for the patient. The fourth dose should be administered one month after the third dose. Such dosing regimen ensures prolonged (over six months) correction of T-lymphocyte levels in most cases. In more severe manifestations of immunodeficiency, therapy with the medicinal product IMOGEN is replacement and long-term, depending on the results of immune system evaluation. In septic conditions resistant to antibiotics, intensive treatment is recommended, with administration of 3–5 doses of the medicinal product within one week.

Preparation of the Solution

Lyophilized medicinal product should be dissolved immediately before use in 4 mL of water for injections.

Administration

The reconstituted medicinal product should be administered by deep subcutaneous injection. Due to the relatively large volume of the solution, the dose may be divided and administered at multiple sites.

During treatment, parameters of cellular immunity should be monitored.

Children

Due to lack of sufficient clinical experience, the medicinal product is not recommended for use in children (under 18 years of age).

Overdose

No cases of overdose have been reported.

Adverse reactions.

Transient local pain at the injection site, erythema and infiltration, which disappear within 24 hours.

Shelf life.

Lyophilized preparation – 24 months.

Use immediately after dilution (reconstitution)!

Storage conditions.

Store in a refrigerator at a temperature of 2 to 8 °C!

Store in the original packaging to protect from light.

Store out of the reach of children!

Incompatibility.

Do not mix with other medicinal products. Do not administer simultaneously with other medicinal products.

Packaging.

1 dose of powder in glass ampoules.

4 ml of solvent (water for injections) in glass ampoules.

One ampoule with powder and one ampoule with solvent or five ampoules with powder and five ampoules with solvent, ampoule opener in a cardboard box with a polymer tray.

Prescription category.

Prescription only.

Manufacturers.

IMUNA PHARMA, a.s., Slovak Republic.

SEVAPHARMA, a.s., Czech Republic.

Manufacturers' addresses.

Jarkova 269/17, 082 22 Sariske Michalany, Slovak Republic.

Vltavska 53, buildings 101 and 102, Roztoky, 252 63, Czech Republic.

Date of latest review.