BioAseptik (Solution) Instructions for Use

Marketing Authorization Holder

Bryntsalov-A, JSC (Russia)

ATC Code

D08AC02 (Chlorhexidine)

Active Substance

Chlorhexidine (Rec.INN WHO registered)

Dosage Form

BioAseptik

Solution for external use (alcoholic) 20 ml/1 l: 50 ml, 100 ml, 200 ml, 250 ml, 500 ml, or 1 l bottles 1 pc., 5 l or 10 l canisters 1 pc.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) colorless, transparent or slightly opalescent, with a characteristic odor of alcohol.

Excipients : ethanol 95% – 718.5 ml, purified water – up to 1000 ml.

50 ml – plastic bottles.
100 ml – plastic bottles.
100 ml – light-protective glass bottles.
200 ml – plastic bottles (for hospitals).
250 ml – plastic bottles (for hospitals).
500 ml – plastic bottles (for hospitals).
1 l – plastic bottles (for hospitals).
5 l – polyethylene canisters (for hospitals).
10 l – polyethylene canisters (for hospitals).

Clinical-Pharmacological Group

Antiseptic for external and topical use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic agent with a predominantly bactericidal action. Chlorhexidine, depending on the concentration used, exhibits a bacteriostatic or bactericidal effect against gram-positive and gram-negative bacteria.

A bacteriostatic effect is manifested at a concentration of 0.01% or less; a bactericidal effect – at a concentration of 0.01% at a temperature of 22°C (71.6°F) and exposure for 1 minute; a fungicidal effect at a concentration of 0.05%, temperature of 22°C (71.6°F) and exposure for 10 minutes; a virucidal effect (against lipophilic viruses) is manifested at a concentration of 0.01-1%.

It acts on bacterial spores only at elevated temperatures. It is stable, and after skin treatment, it remains on it in a certain amount 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.

Pharmacokinetics

When applied externally and topically, it is not absorbed into the systemic circulation and does not have a systemic effect.

Indications

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

Hygienic treatment of the hands of medical personnel, surgeons’ hands, for treatment of the surgical and injection fields, the elbow bend of a donor; disinfection of small-area surfaces of medical products, including dental instruments (thermal treatment of which 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 the solution externally or topically without dilution. Use the appropriate concentration and volume for the specific indication.

For surgical hand disinfection, wash hands with soap and water, dry thoroughly. Apply 5 ml of solution to hands and forearms. Rub for 2 minutes. Repeat the procedure. Use a sterile brush for cleaning nails.

For preoperative skin preparation, apply the solution generously to the surgical site. Rub the solution into the skin for at least 2 minutes. Allow to air dry. Apply a second time using a sterile gauze swab.

For disinfection of small medical equipment surfaces and dental instruments, wipe or immerse the items completely in the solution for a minimum of 1 minute. Ensure all surfaces are in contact with the antiseptic.

For hygienic hand disinfection of medical personnel, apply 3 ml of solution to dry hands. Rub thoroughly over the entire surface of hands and wrists until completely dry, for approximately 30 seconds.

For treatment of the donor’s elbow bend, apply the solution using a sterile gauze swab using a circular motion, moving from the center to the periphery. Allow to dry completely.

For treatment of the injection field, apply the solution to the skin using a sterile cotton or gauze swab. Use a sufficient volume to cover the entire intended area.

Avoid contact with eyes, meninges, and the auditory nerve. Do not use on large areas of damaged skin or for body cavity irrigation. Do not combine with soap or other anionic compounds.

Adverse Reactions

Allergic reactions: skin rash, itching.

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

Contraindications

Hypersensitivity to chlorhexidine.

Use in Pregnancy and Lactation

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

Pediatric Use

Use with caution in children.

Special Precautions

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.

Drug Interactions

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

Incompatible with carbonates, chlorides, phosphates, borates, sulfates, and citrates.

The use of hard water reduces bactericidal properties.

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

Over-the-Counter

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.