Virotek clinic

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIROTEK CLINIC

Composition:

Active substance: 100 g of solution contains 0.05 g of benzalkonium chloride (calculated as 00% dry substance);

Excipients: phenoxyethanol, disodium edetate (Trilon B), sodium hydroxide, purified water.

Pharmaceutical form. Solution for external use.

Main physicochemical properties: clear, colorless liquid, which slightly foams upon shaking.

Pharmacotherapeutic group.

Antiseptics and disinfectants. Quaternary ammonium compounds. Benzalkonium. ATC code D08AJ01.

Pharmacological properties.

Pharmacodynamics.

The medicinal product exerts bacteriostatic and bactericidal effects against Gram-positive and Gram-negative, aerobic and anaerobic bacteria, such as staphylococci, streptococci, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa, Clostridia, Bacillus subtilis, etc. It is more effective against Gram-positive bacteria. The preparation exerts fungistatic and fungicidal effects against pathogenic fungi, particularly Candida species. It reduces bacterial and fungal resistance to antibiotics. It is effective against hospital-acquired microorganisms exhibiting polyresistance to chemotherapeutic agents. It is effective against pathogens of sexually transmitted infections (Treponema spp., Neisseria gonorrhoeae, Trichomonas spp., Chlamydia spp., Ureaplasma spp.), as well as against certain viruses, including human immunodeficiency virus (HIV) and Herpes simplex. Maintains antimicrobial activity in the presence of blood, pus, various secretions, and organic substances.

Exerts a spermicidal effect: the effect develops in two stages—first, destruction of the spermatozoa flagellum, followed by rupture of the sperm head, thereby preventing fertilization.

Pharmacokinetics.

When applied locally, benzalkonium chloride is not absorbed through the skin or mucous membranes of the vagina, urethra, etc., and does not produce any resorptive effects. It is adsorbed onto the walls of the vagina and urethra and is excreted with physiological secretions or removed by washing with water.

Clinical characteristics.

Indications.

Prevention of suppuration and treatment of purulent wounds. Treatment of purulent-inflammatory processes of the musculoskeletal system. Treatment of superficial and deep second-degree and third-degree A burns, preparation of burn wounds for skin grafting.

Pre- and postoperative skin treatment, antiseptic treatment of skin before injections, blood collection, punctures, minor surgical procedures, as well as in minor injuries and skin infections of bacterial and fungal etiology.

Hygienic and surgical skin treatment of hands.

Antiseptic treatment of skin during suture removal and dressing materials.

Preparation of skin for intra-articular injection, cannulation, arthroscopy, and puncture.

Prevention and treatment of postpartum wound infection, perineal and vaginal injuries, infection of birth canals, inflammatory diseases of female genital organs (vulvovaginitis, endometritis).

Local contraception in women of reproductive age: in the presence of contraindications to the use of oral contraceptives or intrauterine devices, in the postpartum period, breastfeeding period, after termination of pregnancy, in the premenopausal period, with irregular sexual activity, missed or delayed intake of continuously used oral contraceptives.

Treatment and prevention of pyoderma, dermatomycoses, cutaneous and mucosal candidiasis, tinea pedis, and fungal infections of large skin folds.

Treatment and prevention of infectious-inflammatory diseases of the oral cavity: stomatitis, gingivitis, periodontitis, periapical periodontitis. Hygienic care of removable prostheses.

Complex treatment of sinusitis, tonsillitis, laryngitis.

Contraindications.

Hypersensitivity to any component of the medicinal product, vaginitis, ulcers and irritation of the vaginal and cervical mucosa.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with systemic antibiotics, enhances their antimicrobial activity and promotes reduction of microbial resistance to antibiotics.

Chemically incompatible with soaps and other anionic surfactants (SAA), as well as with iodine preparations. Non-ionic surfactants reduce or eliminate the antimicrobial effect of benzalkonium chloride.

Special precautions for use.

The medicinal product contains benzalkonium chloride, which may cause irritation and skin reactions. The product must not be allowed to enter the eyes. In case of accidental contact with eyes, rinse thoroughly with boiled water and consult a physician.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy, except for use as a local contraceptive in women of reproductive age.

Benzalkonium chloride does not pass into breast milk; therefore, the product may be used during breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

No influence.

Method of Administration and Dosage

The medicinal product should be applied externally to the skin or affected surfaces and locally to mucous membranes.

For prophylactic and therapeutic purposes, the solution should be used to irrigate affected skin surfaces, wounds, and burns; wounds and fistulous tracts should be loosely packed with tampons soaked in the solution. Sterile gauze pads or swabs moistened with the preparation should be applied to affected skin, wounds, or burns and secured with a bandage or adhesive plaster. This treatment should be repeated 2–3 times daily for 3–5 days. An especially effective method for active drainage of wounds and cavities involves using up to 1 liter of the preparation per day.

For use before and after childbirth to prevent infection of the birth canal, vaginal tampons moistened with the preparation should be applied, with an exposure time of 2 hours, for 5 days. In women undergoing cesarean section, the vagina should be treated immediately before surgery; in the postoperative period, vaginal tampons soaked in the solution should be used with an exposure time of 2 hours for 7 days.

Treatment of inflammatory diseases of female genital organs should be carried out over 2 weeks by intravaginal administration of tampons soaked in the preparation.

Contraceptive effect is achieved if the tampon is inserted into the vagina immediately after coitus.

In purulent maxillary sinusitis, the maxillary sinus should be irrigated with a sufficient amount of the solution during puncture. Tonsillitis and laryngitis should be treated by repeated rinsing of the throat with the solution 3–4 times daily. The amount of preparation for one rinse is 10–15 ml.

For stomatitis, gingivitis, and periodontitis, rinsing of the oral cavity with 10–15 ml of the preparation 3–4 times daily is recommended (remove the spray nozzle before use).

Children

The medicinal product should not be used in children.

Overdose

No cases of acute intoxication have been reported following excessive single topical application of the medicinal product over a large skin or mucous membrane area (vagina and urethra). If any adverse local reactions occur, the product should be washed off with water.

In accidental oral ingestion, lethal doses of benzalkonium chloride in humans are considered to be 1–3 g, equivalent to 5–15 liters of a 0.02% solution of the preparation. Oral intake may lead to adverse effects, including vomiting, collapse, and coma. Toxic doses may result in paralysis of respiratory muscles, dyspnea, and cyanosis. In case of accidental oral ingestion of large doses of benzalkonium chloride, vomiting should be induced, the stomach should be washed out with water, and activated charcoal should be administered.

Side effects.

The risk of developing side effects during use of the medicinal product is minimal. However, in patients with increased sensitivity to benzalkonium chloride, local irritation may occur after prolonged skin contact, and in rare cases, hypersensitivity reactions. With intravaginal administration, allergic reactions, irritation, pruritus, stinging, sensation of warmth at the site of application, contact dermatitis, itching, burning in the vagina or in the partner's penis, and dysuria may occur. In such cases, the use of the product should be discontinued.

In isolated cases, a mild burning sensation at the site of application on mucous membranes may occur, which usually resolves spontaneously and does not require discontinuation of the product. If necessary, the product can be rinsed off with water.

If any adverse reactions occur, use of the product should be discontinued and medical advice should be sought.

Reporting of adverse reactions after product registration is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging. 250 g in a bottle; 1 bottle per carton.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

LLC "Multispray".

Manufacturer's address and location of operations.

24, Valeriy Petrosov St., lit. "A-2", Kharkiv, Kharkiv region, 61052, Ukraine.

Marketing Authorization Holder.

LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder.

60, Hrushevskoho St., Chayky, Kyiv-Sviatoshyn district, Kyiv region, 08135, Ukraine.