Expiration date: 06/2025

The composition and form of issue:

Suppositories for rectal application. 1 supp. contains:

bacterial lipopolysaccharide 50, 100, 150 or 200 mcg

excipients: cocoa butter, lanolin, purified water 

in the package contour set of 12 PCs (3 supp. at 50 micrograms, 3 supp. 100 µg, 3 supp. 150 µg, 3 supp. 200 µg) in the paper cartons 1 package.

Solution for intramuscular injection. 1 ml contains:

bacterial lipopolysaccharide for intramuscular 10, 25, 50  or 100 mcg

excipients: phosphate buffer solution (pH = 6,7–7,3) 

in ampoules of 1 ml (complete with a knife ampulnam), in cardboard box of 10 vials.

Description pharmaceutical form:

Suppositories yellowish-white, smooth, cylindrical shape with pointed end, of a diameter not exceeding 10 mm.

Feature:

Pirogenal is a lipopolysaccharide (LPS) isolated from Salmonella typhi cells.

Pharmacokinetics:

With the introduction of pyrogenal in the body up to 85-90% is fixed on the surface of circulating leukocytes in the blood, about 10% remains in the circulating plasma and about 5% is adsorbed on the membranes of red blood cells.

Excreted in the urine.

Description pharmacological action:

Immunomodulator broad spectrum. The main mechanism of immunomodulatory action is the activation of the hypothalamic-pituitary-adrenal cortex, and reticuloendothelial and fibrinolytic systems. Influencing the function of the adrenal cortex, increases the concentration of corticosteroid in the blood.

Pirogenal has adjuvant, desensitizing and anti-inflammatory effects, and increases the overall specific resistance of the body, affects the thermoregulatory centers of the hypothalamus that creates adjustable pyrogenic effect.

Acting on the cells of the phagocytic system, activates phagocytosis, secretion of oxygen radicals, synthesis of IL-1, IL-2, tumor necrosis factor (TNF&alpha), interferon (IFN&alpha), stimulates the kinin system.

Prevents the synthesis of collagen by fibroblasts, accelerates the maturation of the fibroblasts. Stimulation of the activity of hyaluronidase and the suppression of formation of collagen fibers in fibroblasts increases permeability of tissues, improving fibrinolytic properties of blood and accelerate the penetration of drugs into the lesion. Promotes the resorption foci of inflammation, restoration of blood circulation, inhibits the formation of new and smooths out the earlier formed dense scars in areas of damage. Inhibits the formation and accelerates the resorption of formed adhesions. Has a regenerating effect, helps to restore lost functions of organs.

Indications:

For both dosage forms

Nonspecific therapy of diseases such as:

• chronic liver disease
  
• stricture of the urethra and ureters
  
• chronic prostatitis and urethritis
  
• inflammation of the uterine appendages
  
• secondary infertility
  
• adhesive disease of the abdominal cavity
  
• burn disease
  
• sexually transmitted diseases.
  

Suppositories

Nonspecific therapy of such diseases and conditions as:

• human papillomavirus infection
  
• immunoprophylaxis and immunorehabilitation with incomplete recovery after acute bacterial and viral diseases.
  

Solution for injection

Nonspecific therapy of such diseases and conditions as:

• traumatic injuries of the Central and peripheral nervous system
  
• sluggish tuberculosis in the phase of resorption
  
• uveitis
  
• iridocyclitis
  
• herpes viral infection of the eye
  
• corneal opacity
  
• chronic skin diseases, including psoriasis
  
• the need for pyrotherapy (as the pyrogenic preparation).
  

Contraindications:

• hypersensitivity
  
• heart failure
  
• hepatic and/or renal failure
  
• autoimmune diseases (in history)
  
• pregnancy
  
• lactation.
  

Application of pregnancy and breast-feeding:

Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.

Side effects:

Suppositories

Increasing the temperature to 37-37,6 °C, in rare cases, flu-like symptoms (fever, headache, fatigue, myalgia, chills, arthralgia, anorexia, nausea).

Solution for injection

Hyperthermia to 37.5 °C, accompanied by mild fever and slight malaise. This condition can last from 3 to 8 h. In this case, the dose that caused a similar reaction in the following days, repeat until termination of the reaction at its introduction (1-3 injections), after which the dose is successively increased.

In rare cases, individuals may experience severe chills, fever up to 39.5 °C, headache, pain in the lower back. These reactions are continuing normally from 6 to 8 hours, after which the temperature is reduced, and the side effects disappear. In these cases it is recommended to reduce the dose of the drug.

When using the drug for pyrotherapy, the above reactions are valid.

Drug interactions:

The product is compatible and goes well with all drugs used in the treatment mentioned in the testimony of many diseases and conditions. Enhances the effectiveness of chemotherapy drugs in the complex therapy.

Method of application and dose:

Rectal. Single dose — 1 supp. a day. Introduction suppositories are made daily or every other day, depending on the prescription.

The initial single dose — 50 mcg. The maximum single dose — 200 micrograms.

Recommended treatment according to the following scheme: 3 times 50 mg 3 times 100 µg 3 times 150 mcg 3 times 200 mg or individually by the doctor (12 supp. in the course of treatment).

When applying suppositories monotherapy for immunoprophylaxis and immunorehabilitation with incomplete recovery after acute bacterial and viral diseases it is recommended to use suppositories, 50 or 100 micrograms. The course of treatment — from 5 to 10 suppositories.

V/m 1 time per day. Injections every day. If necessary, diluted with 0.9% sodium chloride solution for injection. The drug in the opened ampoule must not be stored.

Initial single dose of 2.5 mcg. In the following days, gradually increase the dose by 2.5–5 mcg. The maximum single dose 100 mcg. Full course — 10 to 30 injections.

If necessary, repeat courses of injections for at least 2-3 months.

When assigning pirogenala for pyrotherapy drug injected I/m 1 time per day, starting with 10-25 mcg, with a gradual increase in dose up to 100-150 mg. Injections produce in 1 or 2 days by the doctor.

On prescription it is also possible the combined use of the/m injection with the introduction of the suppositories.

Special instructions:

The solution for injection. In the presence of convulsive readiness of febrile convulsions or a history of drug or prescribe, or administered under the guise of anticonvulsant therapy.