Elgyfluor (Gel) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Médicament, CJSC (Russia)

Manufactured By

Pierre Fabre Medicament (France)

ATC Code

A01AA30 (Combined drugs for the prevention of caries)

Dosage Form

Elgyfluor

Gel for sensitive teeth: tube 75 ml

Dosage Form, Packaging, and Composition

75 ml – plastic tubes (1) – cardboard packs.

Therapeutic Category

Drug for the prevention of caries for topical application

Properties

Antiseptic agent with a predominantly bactericidal action. Chlorhexidine, depending on the concentration used, exhibits bacteriostatic or bactericidal action against gram-positive and gram-negative bacteria. Bacteriostatic action is manifested at a concentration of 0.01% or less; bactericidal action – at a concentration of 0.01% at a temperature of 22°C (71.6°F) and exposure for 1 minute; fungicidal action at a concentration of 0.05%, temperature of 22°C (71.6°F) and exposure for 10 minutes; virucidal action (against lipophilic viruses) is manifested at a concentration of 0.01-1%.

It acts on bacterial spores only at elevated temperatures. It is stable; after skin treatment, it remains on it in some quantity sufficient to manifest a bactericidal effect. It retains activity (although somewhat reduced) in the presence of blood, pus, various secretions, and organic substances.

It does not have a damaging effect on items made of glass, plastic, and metals.

Scope of Application

As a therapeutic and prophylactic agent for various infections, for aseptic treatment and disinfection.

For external use: treatment of wounds, burn wounds and surfaces; disinfection of the patient’s skin.

For external and local use: bacterial and fungal diseases of the skin and mucous membranes in surgery, urology, obstetrics and gynecology, dentistry (gingivitis, stomatitis, aphthae, periodontitis, alveolitis); prevention of venereal diseases (including gonorrhea, syphilis, trichomoniasis, chlamydia, ureaplasmosis).

For use in dentistry and ENT practice: gingivitis, stomatitis, aphthae, periodontitis, alveolitis, disinfection of removable dentures; angina; postoperative care for patients in ENT and dentistry departments.

For vaginal use: trichomonas colpitis, cervical erosion, vulvar itching, prevention of venereal diseases (including gonorrhea, syphilis, trichomoniasis, chlamydia, ureaplasmosis); prevention of infectious and inflammatory complications in obstetrics and gynecology (before surgical treatment of gynecological diseases, before childbirth, abortion, before and after insertion of an IUD, before and after diathermocoagulation of the cervix, before intrauterine examinations); treatment of bacterial vaginosis, colpitis (including nonspecific, mixed, trichomonas).

Treatment of the surgeon’s hands, medical personnel, and the operating field before diagnostic manipulations and surgery.

Disinfection of working surfaces of instruments (including thermometers) and equipment for which thermal treatment is undesirable.

In the form of an alcohol solution

Hygienic treatment of the hands of medical personnel, surgeons’ hands, for treatment of the skin of the operating and injection fields, the elbow bend of a donor; disinfection of small-area surfaces of medical products, including dental instruments (for which thermal treatment is undesirable) in healthcare facilities. Hygienic hand treatment in healthcare facilities. Hygienic hand treatment of medical personnel in institutions of various profiles and purposes.

ICD codes

Dosage Regimen

Apply a pea-sized amount of gel to a dry toothbrush.

Brush teeth thoroughly for two minutes twice daily, typically in the morning and evening.

After brushing, spit out the excess gel. Do not rinse your mouth to allow the active ingredients to remain on the teeth.

Avoid eating or drinking for at least 30 minutes after application.

For the management of dentin hypersensitivity, use consistently as part of your daily oral hygiene routine.

For the prevention of caries, ensure the gel contacts all tooth surfaces, paying particular attention to fissures and interdental spaces.

This regimen is intended for long-term use under dental supervision.

Use only for oral hygiene; the gel is not for systemic use.

In case of accidental ingestion of large amounts, seek medical attention immediately.

For children under 12 years of age, use only under the direct guidance of a dentist or physician.

If gingival irritation occurs, discontinue use and consult your dentist.

Side Effects

Depending on the dosage form used, the following side reactions very rarely develop.

Allergic reactions: skin rash, itching, severe allergic reactions, including anaphylaxis.

Skin and subcutaneous tissue disorders: dry skin, itching, dermatitis, photosensitivity.

Local reactions: staining of tooth enamel, tartar deposition, taste disturbance.

With vaginal use, allergic reactions (rash, itching), burning are possible; very rarely – anaphylactic reactions; in some cases – bloody discharge from the vagina.

Contraindications

Hypersensitivity to chlorhexidine.

Use During Pregnancy and Lactation

If it is necessary to use during pregnancy and during breastfeeding, the expected benefit of therapy for the mother and the possible risk to the fetus should be weighed.

Special Instructions

Avoid getting chlorhexidine into the eyes (except for a special dosage form intended for use in ophthalmology), as well as contact with the meninges and the auditory nerve.

With intravaginal use, in case of bloody discharge from the vagina, the use of chlorhexidine should be discontinued.

Drug Interactions

It is used in a neutral environment; at pH 5-8 the difference in activity is small; at pH above 8 a precipitate forms.

It is not used in combination with anionic compounds, including soap.

It is incompatible with carbonates, chlorides, phosphates, borates, sulfates, and citrates.

The use of hard water reduces bactericidal properties.

It is compatible with medicinal products containing a cationic group (benzalkonium chloride, cetrimonium bromide).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.