Vezusten (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Peptidpro, LLC (Russia)

Manufactured By

Samson-Med LLC (Russia)

Contact Information

PEPTIDPRO LLC (Russia)

ATC Code

G04BD (Drugs for the treatment of frequent urination and urinary incontinence)

Active Substance

Cattle bladder polypeptides (Grouping name)

Dosage Form

Vezusten

Lyophilizate for preparation of solution for intramuscular injection 5 mg: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular injection in the form of a tablet, whole, partially or completely crumbled, white, white with a yellowish tint or yellowish in color; reconstituted solution: a clear, colorless or slightly yellowish solution.

Excipients: glycine – 20 mg.

Glass vials (5) – contour cell packaging (2) – cardboard packs.

Clinical-Pharmacological Group

Peptide regulator that reduces bladder hyperreflexia

Pharmacotherapeutic Group

Drugs used in urology; drugs for the treatment of frequent urination and urinary incontinence

Pharmacological Action

The drug Vezusten is a complex of polypeptides isolated from the bladder of cattle.

The drug Vezusten is a peptide regulator and has an organotropic effect on the bladder.

In experiments using organotypic cultures of various tissues of laboratory animals, the drug Vezusten demonstrated tissue-specific activity towards bladder tissues, exerting a stimulating effect on the growth of their cells, without affecting cultures of tissues from other organs.

Preclinical studies indicate the absence of acute and chronic toxicity; the drug Vezusten does not possess carcinogenic, embryotoxic, mutagenic, immunotoxic, or teratogenic properties, nor does it have local irritant or allergenic effects.

Experimental studies have shown that the drug Vezusten has a regulatory effect on the contractile activity of the muscles of the bladder wall and sphincter, reducing bladder hyperreflexia.

Conducted clinical studies have shown that the use of the drug Vezusten reduces the severity of symptoms in patients with overactive bladder (OAB). Due to its pathogenetic action, the drug Vezusten reduces the number of urinary incontinence episodes, the frequency and urgency of urination, and also has a positive effect on the quality of life of patients with OAB.

Pharmacokinetics

The composition of the drug Vezusten does not allow for pharmacokinetic analysis of individual components. In tissues, peptides are rapidly broken down by cellular proteases into amino acids, as a result, the determined amount of peptides and their metabolites does not correlate with the therapeutic effect of the drug.

Indications

• Treatment of overactive bladder (OAB) in adult patients.

ICD codes

Dosage Regimen

Administered intramuscularly, to adults at a dose of 5 mg (1 vial) once daily, 3 times a week. The course of treatment is 10 injections. The need for repeated courses is determined by the attending physician.

If an injection is missed, it is not recommended to administer a double dose; the next dose of the drug Vezusten should be administered at the usual time of the next scheduled day.

The contents of the vial are dissolved in 1-2 ml of water for injection or 0.9% sodium chloride solution before injection. When introducing the solvent, direct the needle towards the wall of the vial to avoid foaming.

Use of the drug in special clinical patient groups

Children and adolescents

The use of the drug Vezusten in children and adolescents under 18 years of age is contraindicated (due to the lack of data on efficacy and safety in this age population).

Adverse Reactions

Within the conducted clinical studies, the drug Vezusten demonstrated a favorable safety profile. The registered adverse reactions (ARs) associated with the administration of the drug Vezusten were mild in severity and did not require any corrective measures. Not a single case of a serious AR was registered. The ARs observed during the clinical studies of the drug are distributed by system-organ classes with an indication of their frequency of occurrence according to the WHO classification: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), frequency unknown (cannot be estimated from the available data)

If any of the ARs mentioned in the instructions worsen, or any other ARs not mentioned in the instructions are noted, you should inform your doctor.

Contraindications

• Hypersensitivity to the active substance and/or excipient in the drug composition;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years.

Use in Pregnancy and Lactation

Due to the lack of clinical data on the safety and efficacy of the drug Vezusten, its use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

The use of the drug Vezusten in children and adolescents under 18 years of age is contraindicated (due to the lack of data on efficacy and safety in this age population).

Special Precautions

Storage of the vial with the dissolved drug and delayed administration of the reconstituted solution is unacceptable.

Special precautions for the disposal of unused medicinal products are not required.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Cases of overdose are unknown.

Drug Interactions

Drug interactions of the drug have not been described.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the packaging.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.