Panthenol-zdorovya aerosol

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PANTHENOL-ZDOROVYE AEROSOL

Composition:

Active substance: dexpanthenol;

1 g of the preparation (excluding propellant 134a) contains 50 mg of dexpanthenol;

Excipients: Euxyl® PE 9010 containing 90% phenoxyethanol and 10% ethylhexylglycerin, DL-pantolactone, cetyl stearyl alcohol, potassium cetyl phosphate, glycerin, dimethicone DM 100, purified water, propellant 134a.

Pharmaceutical form. Topical foam.

Main physicochemical properties: the preparation forms a white foam upon release from the container.

Pharmacotherapeutic group. Agents for treatment of wounds and ulcers. ATC code D03A X03.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the medicinal product is dexpanthenol — a provitamin B5, which has the same biological efficacy as pantothenic acid due to intermediate metabolism. In skin cells, dexpanthenol is rapidly converted into pantothenic acid. Pantothenic acid and its salts are water-soluble vitamins that, in the form of coenzyme A, participate in numerous metabolic processes. Pantothenic acid is essential for the formation and healing of damaged skin and mucous membranes.

Topical application of dexpanthenol may compensate for the increased demand of damaged skin and/or mucous membranes for pantothenic acid.

Pharmacokinetics.

The active substance is absorbed through the skin. More detailed studies on the metabolism of the active ingredient in the skin and mucous membranes have not been conducted.

Clinical characteristics.

Indications.

Apply for various skin and mucous membrane injuries, including abrasions, burns, aseptic postoperative wounds, skin grafts, bullous and pemphigoid dermatitis.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

When used according to indications, interaction with other medicinal products is unknown.

Special precautions for use

The aerosol can is under pressure; therefore, avoid dropping, impact, exposure to direct sunlight, and heating above 50 °C.

After the medicinal product has been used, do not pierce or burn the canister. Do not spray the product near open flame or onto hot surfaces. Avoid contact with eyes. In case of accidental contact with eyes, rinse thoroughly with water.

The medicinal product can be used in all age groups.

When using the medicinal product in patients with bronchial asthma or bronchopulmonary diseases, inhalation of the propellant should be avoided, as it may irritate mucous membranes or even provoke an asthma attack.

Cetostearyl alcohol may cause local skin reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding

Dexpanthenol crosses the placental barrier via an active transport process and is excreted into breast milk in proportion to its absorption.

Since systemic availability of dexpanthenol after topical application is unknown, when treatment over large skin areas is required during pregnancy or breastfeeding, the potential benefit of the product for the mother should be carefully weighed against the possible risk for the fetus/infant. During pregnancy, the product may be used only as directed by a physician. When used to treat nipple fissures during breastfeeding, the product should be washed off before nursing.

Ability to influence reaction rate while driving or operating machinery

No special precautions are required. Studies investigating such effects have not been conducted. Given the adverse reaction profile, no influence on reaction speed while driving or operating machinery is expected.

Method of Administration and Dosage

The medicinal product should be evenly sprayed onto the affected area one or several times daily. When spraying the medication, hold the can vertically with the nozzle pointing upwards. To obtain a proper foam, the can must be shaken vigorously before each use, especially if it has not been used for an extended period. When the medication is used for the first time, only gas may be released initially before the foam forms.

The duration of treatment depends on the type and course of the disease and should be determined after consultation with a physician.

When applying the medication to the facial area, do not spray it directly onto the face. It is recommended to spray the medication onto the hand first and then apply it to the appropriate area of the face. Avoid spraying the medication into the eyes, mouth, or nose.

Children

The medicinal product should be used in children only as prescribed by a physician and under adult supervision.

Overdose

Overdose is unlikely when the medicinal product is used according to the instructions.

In case of accidental ingestion of a large amount of the medication, toxic effects are not expected. If gastrointestinal disturbances occur, symptomatic treatment should be administered.

Side effects.

Allergic reactions: very rarely, allergic contact dermatitis and skin irritation may occur, manifesting as symptoms such as itching, erythema, eczema, rash, urticaria, and blisters.

If any adverse reactions occur, discontinue use of the medicinal product and consult a physician.

Shelf life.

3 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.

58.5 g or 117 g in a can with a nozzle and protective cap in a box.

Availability.

Over-the-counter.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

Ukraine, 61013, Kharkiv region, city of Kharkiv, Shevchenka Street, building 22.