Bactoderm (Solution) Instructions for Use

Marketing Authorization Holder

Laboratoire Innotech International (France)

Manufactured By

Laboratoires Chemineau (France)

Quality Control Release

INNOTHERA CHOUZY (France)

ATC Code

D08AC52 (Chlorhexidine in combination with other drugs)

Active Substances

Chlorhexidine (Rec.INN registered by WHO)

Benzalkonium chloride (Rec.INN registered by WHO)

Dosage Form

Bactoderm

Solution for topical and external use 500 mg+200 mg/100 ml: bottle 125 ml or 300 ml

Dosage Form, Packaging, and Composition

Solution for topical and external use in the form of a colorless, transparent, slightly viscous liquid; foams upon shaking, with a characteristic odor.

Excipients: cocoalkyldimethylbetaine 30% solution – 2400 mg, ethylene oxide and propylene oxide copolymer – 2400 mg, hydroxyethylcellulose – 200 mg, citric acid monohydrate – 109 mg, sodium citrate – q.s. to pH 5.3-5.7, purified water – q.s.p. 100 ml.

125 ml – plastic bottles (1) – cardboard boxes.
300 ml – plastic bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

A drug with antibacterial action for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

Benzalkonium chloride and chlorhexidine are broad-spectrum antiseptics, have a bactericidal effect on gram-positive and gram-negative microorganisms, have a fungicidal effect on pathogenic fungi, including yeast-like fungi of the genus Candida albicans, and exhibit antiviral activity.

Benzalkonium chloride and chlorhexidine retain activity (somewhat reduced) in the presence of blood, pus, various secretions, and other organic substances.

The solution cleanses and disinfects the skin without compromising the integrity of the skin, and is practically not absorbed from the skin surface.

Indications

Treatment of infected lesions of the skin and mucous membranes, prevention of infection of the skin and mucous membranes.

ICD codes

Dosage Regimen

Apply the solution externally or topically one to two times per day.

Use the solution for treatment of infected skin lesions and mucous membranes, and for prevention of infection.

Apply a sufficient quantity to cover the entire affected area.

Gently rub the solution into the skin until fully absorbed.

For surgical hand disinfection, wash hands with soap and water, rinse, and dry thoroughly.

Apply 5 ml of the solution to dry hands and forearms and rub for two minutes.

For preoperative skin preparation, apply the solution to the surgical site and allow it to dry completely.

Repeat the application for a second time if necessary.

For general hand hygiene, wash hands, apply 3 ml of the solution, and rub until dry.

Do not rinse the treated area with water after application.

Avoid contact with the eyes and middle ear.

Do not use for irrigation of body cavities.

In pediatric patients, exercise caution when treating large skin areas.

For premature newborns and infants, avoid use under occlusive dressings or diapers.

Discontinue use immediately if signs of skin irritation or allergic reaction occur.

Adverse Reactions

Possible: dryness of the skin and mucous membranes, itching, dermatitis, skin irritation, allergic reactions, contact eczema.

Frequency unknown chemical burns in newborns.

Contraindications

Hypersensitivity to the components of this combination; dermatitis.

The agent should not be used for rinsing the mucous membrane of the eyes and the ear canal.

Avoid getting the agent inside the wound in patients with open craniocerebral trauma, spinal cord injuries, perforation of the eardrum.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible when the intended benefit to the mother outweighs the potential risk to the fetus or child. The solution should not be used to treat the skin of the breast during breastfeeding.

Pediatric Use

Caution should be exercised when treating large areas of the skin in children.

Special care should be taken when using on the skin of a premature newborn or infant (due to occlusion under diapers, burns may occur).

Special Precautions

The agent should be used with caution when treating a large area of the skin surface, especially in children.

Special care should be taken when using on the skin of a premature newborn or infant (due to occlusion under diapers, burns may occur).

Do not use the agent for eye irrigation.

Avoid getting the agent into the tympanic cavity.

Do not use the agent for disinfection of surgical instruments and equipment.

Do not use excessive amounts of the agent and avoid accumulation of the solution in skin folds or under the patient’s body, as well as dripping it onto surgical linen or other materials that come into direct contact with the patient.

If it is necessary to use occlusive dressings on areas previously treated with this agent, before applying the dressing, make sure that there is no excess agent on this area.

Drug Interactions

The agent is pharmaceutically incompatible with soap, alkalis, and other anionic compounds (colloids, gum arabic, carboxymethylcellulose).

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.