Verajinaks

INSTRUCTIONS for medical use of the medicinal product Veragynax

Composition:

Active substances: neomycin sulfate, polymyxin B sulfate, nystatin;

1 capsule contains neomycin sulfate 35,000 IU, polymyxin B sulfate 35,000 IU, nystatin 100,000 IU;

Excipients: capsule core: dimethicone 1000 cSt, Teffoz® 63, hydrogenated soybean oil; capsule shell: gelatin; purified water; glycerol, refined glycerin; dimethicone 1000 cSt.

Pharmaceutical form. Vaginal soft capsules.

Main physicochemical properties: pale yellow, opaque, soft oval-shaped capsules containing a pale yellow, paste-like substance.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Antibiotics. Nystatin, combinations. ATC code G01AA51.

Pharmacological properties.

Pharmacodynamics.

Combination of neomycin, polymyxin B, and nystatin.

Mechanism of action

Neomycin is an aminoglycoside antibiotic. The target of neomycin is the 30S ribosomal subunit, which induces inhibition of bacterial protein synthesis, resulting in the production of non-functional proteins.

Aberrant proteins penetrate the cell membrane, alter its permeability, and disrupt other vital processes of bacteria, thereby providing bactericidal activity.

Polymyxin B is a polypeptide antibiotic. Polymyxin B interacts with microbial membrane phospholipids (lipopolysaccharides of Gram-negative bacteria), leading to membrane disorganization and subsequent destruction of the bacterial cell.

Nystatin is a polyene antifungal agent active against Candida spp. Nystatin binds to sterols in the fungal cell membrane, altering membrane permeability and causing leakage of intracellular contents, which leads to cell death.

Antibacterial spectrum of Verajinax

In vitro studies performed using the dilution/neutralization method under conditions simulating the vaginal environment demonstrated the bactericidal effect of the three-component combination in Verajinax against the main bacteria responsible for bacterial vaginosis (anaerobic bacteria) and bacterial vaginitis (aerobic bacteria). Assessments were conducted at 1 hour and 4 hours after exposure.

Susceptibility of various strains was determined based on the logarithmic reduction in bacterial load observed for each strain. The susceptibility criteria distinguishing susceptible strains from those with intermediate susceptibility and resistant strains are as follows: S: log reduction ≥ 3; R: log reduction < 2.

The susceptibility of various strains to Verajinax is presented in the following table:

Note. This table lists bacteria commonly associated with bacterial vaginosis/vaginitis, but it is not exhaustive. This list does not challenge the individual antimicrobial spectra of each active ingredient in the medicinal product Verajinax against other bacterial strains.

Synergistic activity of polymyxin B and neomycin

In vitro studies have shown that the two antibiotics contained in Verajinax have complementary spectra, resulting in a more uniform activity against the four main bacterial strains responsible for bacterial vaginosis/vaginitis (Staphylococcus aureus, Escherichia coli, Streptococcus agalactiae, Gardnerella vaginalis), and that their combined effect is at least additive.

Antifungal spectrum of the medicinal product Verajinax

An in vitro study was conducted to evaluate the susceptibility of Candida strains by determining the minimum inhibitory concentrations (MIC) of nystatin. The results presented in the table below confirm that susceptibility to nystatin remains identical for both Candida albicans and Candida non-albicans strains.

MIC50: MIC inhibits 50% of isolates; MIC90: MIC inhibits 90% of isolates.

Effect on lactobacilli

An in vitro study was conducted to evaluate the effect of the combination of three active substances of the medicinal product Verajinax on the main lactobacilli found in vaginal flora under physiological conditions (Lactobacillus crispatus, Lactobacillus gasseri, and Lactobacillus jensenii).

The results show that Verajinax, when used at recommended doses, does not affect the number of these three lactobacilli species at concentrations that may be present in the vaginal environment.

Pharmacokinetics.

Not sufficiently studied.

Clinical characteristics.

Indications.

Local treatment of vaginitis caused by microorganisms sensitive to the components of the drug (bacterial vaginitis, vulvovaginitis caused by Candida albicans and Candida non-albicans, mixed vaginitis), and bacterial vaginosis.

Official recommendations regarding appropriate use of antibacterial agents should be taken into account.

Contraindications.

This medicinal product is contraindicated in cases of:

• hypersensitivity to the active substances or excipients (or hypersensitivity to the corresponding group of substances);
• peanut or soy allergy, due to the presence of soybean oil in the formulation;
• use of polyurethane male condoms, female condoms, or diaphragms.

It is not recommended to use in combination with spermicides.

Interaction with other medicinal products and other forms of interaction.

Contraindicated combinations

Polyurethane male condoms, female condoms, and diaphragms, due to the risk of rupture.

Not recommended combinations

Spermicides. Any local vaginal treatment may inactivate local contraception with spermicides.

Special precautions for use.

Warning

If local intolerance or allergic reaction occurs, treatment must be discontinued. Sensitization of the body following local administration of antibiotics may subsequently lead to allergic reactions upon systemic use of the same or a related antibiotic.

Precautionary measures during use

Treatment duration should be limited due to the risk of developing microbial resistance to the components of the drug or the development of superinfection.

Due to the lack of data regarding absorption of neomycin and polymyxin B through mucous membranes, there is a risk of systemic effects, especially in the presence of renal insufficiency.

This medicinal product contains soybean oil, which may cause hypersensitivity reactions (urticaria, anaphylactic shock).

Use during pregnancy or breastfeeding.

Pregnancy

Due to the presence of the aminoglycoside antibiotic neomycin in the medicinal product Verajinax, there is a potential risk of ototoxic effects, as systemic absorption of neomycin cannot be excluded. Therefore, use of medicinal products containing neomycin during pregnancy should be avoided. Clinical studies and long-term post-marketing surveillance have not reported cases of developmental abnormalities or fetotoxicity.

Breastfeeding

Due to the immaturity of the newborn's gastrointestinal tract and insufficient data on the passage of the drug into breast milk, use during breastfeeding is not recommended.

Ability to affect reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The medication is intended for adults. Administer 1 capsule intravaginally once daily in the evening before bedtime for 12 consecutive days. Insert the capsule deeply into the vagina, preferably while lying down.

Dosage

One vaginal capsule in the evening for 12 consecutive days.

Practical Recommendations

• Patients should be informed about maintaining proper personal hygiene (wearing cotton underwear, avoiding douching and/or use of tampons during treatment) and, whenever possible, eliminating unfavorable factors that may have contributed to the condition.
• The need for partner treatment should be evaluated on a case-by-case basis.
• Treatment should not be interrupted during menstruation.
• The treatment is compatible with latex and polyisoprene male condoms.

Children

This medication is intended for adult use only.

Overdose

Excessive and prolonged use may lead to systemic effects (on the auditory organs and kidneys), particularly in patients with renal insufficiency. Prolonged use is also associated with an increased risk of developing allergic eczema.

Side effects.

Side effects are classified according to their impact on systems and organs. The frequency of adverse reactions reported in spontaneous reports is unknown (cannot be estimated from the available data).

Possible presence of increased sensitivity of patients to the excipient of the drug, soybean oil.

Reporting of adverse reactions

Reporting of adverse reactions after registration of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the use of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store at temperatures not exceeding 25 °C, in a place inaccessible to children.

Packaging.

6 capsules per blister, 1 or 2 blisters per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

Phil Inter Pharma Co., Ltd.

Phil Inter Pharma Co., Ltd.

Manufacturer's address and location of operations.

No. 20, Huu Nghi Boulevard, Vietnam-Singapore Industrial Park (VSIP), Thuan An Town, Binh Duong Province, Vietnam.

No. 20, Huu Nghi boulevard, Vietnam-Singapore Industrial Park (VSIP), Thuan An town, Binh Duong province, Vietnam.

Marketing Authorization Holder.

Amaxa Ltd.

Amaxa Ltd.

Address of the Marketing Authorization Holder.

31 John Islip Street, London SW1P 4FE, United Kingdom.

31 John Islip Street, London SW1P 4FE, United Kingdom.