Prostatilen

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTATILEN® (PROSTATILEN®)

Composition:

Active substance: prostatilen;

1 ampoule (2 ml of solution) contains 2 mg of prostatilen (aqueous extract from the prostate glands of sexually mature bulls), calculated as peptides;

Excipients: glycine, sodium chloride, water for injections.

Pharmaceutical form. Injection solution.

Main physicochemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Agents used in urology. Agents used in benign prostatic hyperplasia.

ATC code G04C X.

Pharmacological properties.

Pharmacodynamics.

Prostatislen exerts a specific organotropic effect on the prostate gland. In diseases of the prostate, the drug, as a pathogenetic therapy agent, normalizes microcirculation and platelet-vascular hemostasis processes, reduces or eliminates tissue edema and leukocyte infiltration (including reducing the number of leukocytes in gland secretion), exerts an indirect bacteriostatic effect on the microflora of the secretion, reduces the titer of detected pathogens to complete sterility or suppresses the viability of microorganisms. Prostatislen normalizes spermatogenesis (increases the number and motility of spermatozoa), exerts a modulating effect on the status of T- and B-lymphocytes, enhances the body's nonspecific resistance, and regulates the tone of urinary bladder muscles, including detrusor tone.

Pharmacokinetics.

As a peptide drug, Prostatislen is degraded by cellular proteases into amino acids. Prostatislen and its metabolites are excreted in urine. The drug has no cumulative properties.

Clinical characteristics.

Indications.

Chronic prostatitis.

Benign prostatic hyperplasia, age-related disturbances of its functions and associated disorders of urination.

Postoperative complications following prostate surgery.

Interoceptive copulative dysfunction.

Male infertility.

Contraindications.

Increased individual sensitivity to the components of the medicinal product and to proteins of bovine prostate gland.

Interaction with other medicinal products and other forms of interaction.

Not studied.

Special precautions for use.

When treating with the drug, it is recommended to monitor clinical indicators of prostate gland activity.

Use with caution in patients with atherosclerosis or an increased risk of thromboembolism. During prolonged use of the drug, blood coagulation time should be monitored.

Use during pregnancy or breastfeeding.

The medicinal product is not intended for use in women.

Ability to affect reaction rate when driving or operating machinery.

Not studied.

Method of administration and dosage.

For use in adult males, including elderly patients. Administered intramuscularly.

The drug is administered daily, 1–2 vials once a day.

The treatment course lasts 5–10 days.

If necessary, a repeated course may be conducted (after 1–6 months).

Children.

The medicinal product is not used in children.

Overdose.

Cases of overdose have not been reported to date.

Possible adverse effects include dyspeptic disorders, fatigue, general weakness, headache, creatinuria, increased creatine kinase activity, elevated serum cholesterol and triglyceride levels, decreased serum thyroxine and triiodothyronine concentrations, and increased urinary estrogen and androgen levels. There is no specific antidote. Treatment is symptomatic.

Side effects.

Allergic-type reactions are possible.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Incompatibility.

The medicinal product must not be mixed with other drugs in the same syringe.

Packaging.

2 ml in an ampoule; 100 ampoules per pack or 5 ampoules per blister, 1 or 2 blisters per pack.

Prescription status.

Prescription only.

Manufacturer.

Private Joint-Stock Company "Lekhim-Kharkiv".

Manufacturer's address and place of business.

36 Severina Pototskogo Street, Kharkiv, Kharkiv Oblast, 61115, Ukraine.