Product Overview
Composition
Active substances:
Antibodies to affinity-purified endothelial NO synthase - 0.006 g *,
Antibodies to affinity-purified prostate-specific antigen - 0.006 g *.
Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.
* are applied to lactose monohydrate in the form of a mixture of three active water-alcohol dilutions of a substance diluted 10012, 10030, 100200 times, respectively.
Antibodies to affinity-purified endothelial NO synthase - 0.006 g *,
Antibodies to affinity-purified prostate-specific antigen - 0.006 g *.
Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.
* are applied to lactose monohydrate in the form of a mixture of three active water-alcohol dilutions of a substance diluted 10012, 10030, 100200 times, respectively.
pharmachologic effect
Pharmacodynamics
It has been experimentally and clinically shown that antibodies to a prostate-specific antigen (PSA) affinity-purified modify the functional activity of endogenous PSA, altered by benign prostatic hyperplasia, which is accompanied by an increase in the regulatory effect of this antigen on functional and metabolic processes in the tissue of the prostate gland, have a pronounced anti-inflammatory and decongestant action.
Antibodies to affinity-purified endothelial NO synthase increase the blood flow velocity, including in the vessels of the penis and prostate gland; has a protective effect against endothelium (helps to reduce vascular reactivity, reduce
vascular spasm and improved peripheral microcirculation).
The combined use of the components in the complex preparation “Afalase” is accompanied by a synergistic effect: antibodies to endothelial NO synthase due to 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 for enhancing intracellular signal transduction by dilutions of antibodies to endothelial NO synthase.
In patients with benign prostatic hyperplasia (BPH), the drug, when applied for 12 months, helps to reduce the volume of the prostate gland, improve urodynamics (decrease in the volume of residual urine, increase the maximum
speed of urine), significantly reduce the severity of dysuric disorders without affecting the level of PSA. The drug helps to 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, chromatography-mass spectrometry) does not allow us to evaluate the content of active substances of the drug Afalase in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics.
It has been experimentally and clinically shown that antibodies to a prostate-specific antigen (PSA) affinity-purified modify the functional activity of endogenous PSA, altered by benign prostatic hyperplasia, which is accompanied by an increase in the regulatory effect of this antigen on functional and metabolic processes in the tissue of the prostate gland, have a pronounced anti-inflammatory and decongestant action.
Antibodies to affinity-purified endothelial NO synthase increase the blood flow velocity, including in the vessels of the penis and prostate gland; has a protective effect against endothelium (helps to reduce vascular reactivity, reduce
vascular spasm and improved peripheral microcirculation).
The combined use of the components in the complex preparation “Afalase” is accompanied by a synergistic effect: antibodies to endothelial NO synthase due to 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 for enhancing intracellular signal transduction by dilutions of antibodies to endothelial NO synthase.
In patients with benign prostatic hyperplasia (BPH), the drug, when applied for 12 months, helps to reduce the volume of the prostate gland, improve urodynamics (decrease in the volume of residual urine, increase the maximum
speed of urine), significantly reduce the severity of dysuric disorders without affecting the level of PSA. The drug helps to 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, chromatography-mass spectrometry) does not allow us to evaluate the content of active substances of the drug Afalase in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics.
Indications
Afalase is indicated for use in adults.
Benign prostatic hyperplasia.
Dysuric disorders (as part of complex therapy): frequent urination, difficulty urinating, pain and discomfort in the perineum, accompanying benign prostatic hyperplasia.
Benign prostatic hyperplasia.
Dysuric disorders (as part of complex therapy): frequent urination, difficulty urinating, pain and discomfort in the perineum, accompanying benign prostatic hyperplasia.
Pregnancy and lactation
Afalase is not intended for use in women.
Contraindications
Increased individual sensitivity to the components of the drug.
Age to 18 years.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Age to 18 years.
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Side effects
Possible reactions of increased individual sensitivity to the components of the drug.
Interaction
Cases of incompatibility with other drugs have not yet been reported.
How to take, course of administration and dosage
Inside. 2 tablets, 2 times a day, in the morning and in the evening (keep in your mouth until completely dissolved - outside the meal).
For dysuric disorders, the drug is recommended to be taken within 16 weeks.
On the recommendation of a doctor for severe pain and dysuric disorders in the first 2-3 weeks of therapy, the drug is indicated up to 4 times a day.
To prevent prostate growth in patients with BPH and reduce the risk of disease progression, it is recommended to take the drug 2 times a day, in the morning and in the evening for 12 months.
For dysuric disorders, the drug is recommended to be taken within 16 weeks.
On the recommendation of a doctor for severe pain and dysuric disorders in the first 2-3 weeks of therapy, the drug is indicated up to 4 times a day.
To prevent prostate growth in patients with BPH and reduce the risk of disease progression, it is recommended to take the drug 2 times a day, in the morning and in the evening for 12 months.
Overdose
In case of accidental overdose, dyspeptic symptoms are possible due to excipients that are part of the drug.
Description
Tablets are flat-cylindrical, with a notch and a bevel, from white to almost white. MATERIA MEDICA is inscribed on the flat side with the risk, AFALAZA is inscribed on the other flat side.
Special instructions
The composition of the drug includes lactose monohydrate, and therefore it is not recommended for patients with congenital galactosemia, glucose malabsorption syndrome or with congenital lactase deficiency.
Storage conditions
In the dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Keep out of the reach of children.
Shelf life
3 years. Do not use after the expiration date.
