Afalase, tablets 100 pcs

Pharmacodynamics

It was shown experimentally and clinically that antibodies to prostate-specific antigen (PSA) affinity purified modify the functional activity of endogenous PSA, altered in benign prostatic hyperplasia, which is accompanied by strengthening of the regulatory effect of this antigen on functional and metabolic processes in the prostate tissue, have a pronounced anti-inflammatory and anti-edema effect.

Antibodies to endothelial NO-synthase affinity purified promotes an increase in the rate of blood flow, including in the vessels of the penis and prostate, has a protective effect in relation to the endothelium (helps reduce vascular reactivity, decrease
vascular spasm and improve peripheral microcirculation).

The combined use of the components in the complex preparation “Afalase” is accompanied by a synergetic effect: antibodies to endothelial NO-synthase increase antiproliferative and anti-inflammatory activity of antibodies to PSA due to their endothelioprotective effect and improvement of vascularization. The synergistic effect is probably also due to nonspecific
mechanisms of enhancing intracellular signal transduction by dilutions of antibodies to endothelial NO synthase.

In patients with benign prostatic hyperplasia (BPH) the preparation if used for 12 months facilitates the reduction of the prostate volume, improvement of urodynamic parameters (decrease of residual urine volume, increase of maximum urine velocity), significant decrease of dysuric disorders severity without affecting PSA level. The drug improves quality of life of patients with BPH.

Pharmacokinetics

The sensitivity of modern physico-chemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, chromatography-mass spectrometry) does not allow to estimate the content of active substances of the drug Afalase in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics.

Indications

Afalaza® is indicated for use in adults.
Benign prostatic hyperplasia.
Dysuric disorders (as part of complex therapy): frequent urge to urinate, difficulty urinating, pain and discomfort in the perineal area accompanying benign prostatic hyperplasia.

Pharmacological effect

Pharmacotherapeutic group

Benign prostate hyperplasia treatment.

ATX code

G04CX.

Pharmacological properties

Pharmacodynamics

It has been experimentally and clinically shown that affinity-purified antibodies to prostate-specific antigen (PSA) modify the functional activity of endogenous PSA, altered in benign prostatic hyperplasia, which is accompanied by an increased regulatory effect of this antigen on the functional and metabolic processes in prostate tissue, and have a pronounced anti-inflammatory and anti-edematous effect.

Affinity purified antibodies to endothelial NO synthase help increase blood flow speed, including in the vessels of the penis and prostate gland; have a protective effect on the endothelium (help reduce vascular reactivity, reduce vascular spasm and improve peripheral microcirculation).

The anti-inflammatory effect of antibodies to PSA has been clinically demonstrated in the treatment of chronic abacterial prostatitis. Antibodies to endothelial NO synthase have shown clinical efficacy in the treatment of erectile dysfunction.

The combined use of components in the complex drug Afalase® is accompanied by a synergistic effect: antibodies to endothelial NO synthase, due to their endothelial protective effect and improved vascularization, enhance the antiproliferative and anti-inflammatory activity of antibodies to PSA. The synergistic effect is probably also due to nonspecific mechanisms of enhancing intracellular signal transduction by dilutions of antibodies to endothelial NO synthase.

In patients with benign prostatic hyperplasia (BPH), the drug, when used for 12 months, helps to reduce the volume of the prostate gland, improve urodynamic parameters (decrease in residual urine volume, increase in maximum urine flow rate), and significantly reduce the severity of dysuric disorders, without affecting PSA levels. The drug helps improve the quality of life of patients with BPH.

Pharmacokinetics

The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, gas chromatography-mass spectrometry) does not allow assessing the content of active substances of the drug Afalase® in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics.

Special instructions

Patients with rare hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this drug.

Impact on the ability to drive vehicles and machinery
The drug Afalaza® does not affect the ability to drive vehicles and other potentially dangerous mechanisms.

Active ingredient

Antibodies

Composition

Active ingredients:

affinity purified antibodies to endothelial NO synthase – 10,000 EMD*,

affinity purified antibodies to prostate-specific antigen – 10,000 EMD*.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

* EMD – units of modifying action.

Pregnancy

Afalaza® is not intended for use in women.

Contraindications

Increased individual sensitivity to the components of the drug.
Age up to 18 years.
Lactase deficiency, hereditary galactose intolerance, glucose-galactose malabsorption.

Side Effects

Individual hypersensitivity reactions to the components of the drug are possible.

Interaction

No cases of incompatibility with other drugs have been reported to date.

Overdose

In case of overdose, dyspepsia may occur due to the excipients included in the drug.

Storage conditions

At a temperature not exceeding 25 °C.
Keep out of the reach of children.

Shelf life

3 years.
Do not use after expiration date.

Manufacturer

Materia Medica Holding, Russia