KAMETON-ZDOROVYA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT KAMETON-ZDOROVYE (CAMETON-ZDOROVYE)

Composition:

Active substances: 1 g of the preparation contains chlorobutanol hemihydrate (calculated as chlorobutanol) 0.01 g, racemic camphor 0.01 g, menthol (levomenthol) 0.01 g, eucalyptus oil 0.01 g;

Excipient: isopropyl myristate.

Pharmaceutical form. Nasal and oromucosal spray.

Main physicochemical properties: clear, colorless or slightly yellowish, oily liquid with a characteristic aromatic odor.

Pharmacotherapeutic group. Drugs acting on the respiratory system. Preparations used in throat diseases. Antiseptics. ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics. A combination drug whose action is determined by the components contained in its formulation. Chlorobutanol hemihydrate and eucalyptus oil provide antimicrobial activity; chlorobutanol hemihydrate and camphor provide mild local anesthetic effect. Menthol constricts blood vessels and induces a local sensation of cold, which also contributes to the local anesthetic effect and reduction of hyperemia and swelling in the affected area. When applied topically, the drug exhibits antimicrobial, anti-inflammatory, and mild local anesthetic actions, promotes normalization of respiration, and also provides a deodorizing effect. The drug base exerts a moisturizing effect on the mucous membrane due to the occlusive effect associated with the presence of the hydrophobic solvent isopropyl myristate. The combination of these pharmacological properties provides comprehensive pathogenetic therapy for inflammatory diseases of the upper respiratory tract.

Pharmacokinetics. Not studied.

Clinical characteristics.

Indications. Local treatment of acute and chronic (mainly in the stage of exacerbation) infectious-inflammatory diseases of the throat and nose: tonsillitis, pharyngitis, laryngitis, rhinitis.

Contraindications. Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction. Not described. If simultaneous use of any medicinal products is necessary, consult a physician.

Special precautions for use.

When using the nasal spray, do not tilt the head backward or turn the canister upside down. It is not recommended for several individuals to use the same canister to avoid the spread of infection. Avoid contact with eyes during spraying. Patients who are prone to allergies should consult a physician before using the medication. After application, replace the protective cap on the spray nozzle.

Do not disassemble the medication canister and keep out of reach of children. Protect from impact.

Use with caution in children, as bronchospasm may develop. Treatment of children should be conducted under medical supervision.

Before administering the medication into the nasal cavity, clear the nose of mucus. When treating mucous membranes of the throat, apply the medication after eating; rinse the mouth with warm boiled water before application. In cases of burns, remove necrotic debris from affected areas using a sterile swab.

Use during pregnancy or breastfeeding. No contraindications for using the medication during pregnancy or breastfeeding have been identified; however, it should be used during these periods only as directed by a physician.

Ability to affect reaction rate when driving or operating machinery. Data are lacking.

Method of Administration and Dosage

For use in adults and children aged 5 years and older.

Apply the preparation locally to the mucous membranes and affected areas of the throat and nasal cavities. The single dose for adults and adolescents aged 15 years and older is 2–3 sprays into the throat cavity and 1–2 sprays into each nostril. For children aged 5 to 12 years, the single dose is 1–2 sprays into the throat cavity and 1 spray into each nostril. For children aged 12 to 15 years, the single dose is 2 sprays into the throat cavity and 1 spray into each nostril. Each spray delivers approximately 0.046 g of the preparation.

Apply the preparation 3–4 times daily. The duration of treatment is determined individually by a physician and depends on the intensity of therapy (usually 3–10 days). The preparation should not be used for longer than 2 weeks.

Instructions for Using the Aerosol Canister

1. Remove the protective cap from the canister and, after ensuring the spray nozzle is clean, attach it to the valve stem.
2. Shake the canister for 1 minute and perform no more than 5 actuations of the spray nozzle until a fine mist appears. If no mist appears, the procedure may be repeated.
3. Insert the free end of the spray nozzle into the nasal cavity to a depth of 0.5 cm or direct it toward the affected area of the throat and press the spray nozzle. Do not use the canister in an inverted position.
4. After completing the application, cover the canister with the protective cap to prevent contamination.
5. Keep the spray nozzle clean; after use, it is recommended to rinse it under a stream of warm water and then dry it in a warm place.

Children. Use in children aged 5 years and older under medical supervision.

Overdose. Overdose may lead to an intensification of adverse effects and allergic reactions. Treatment: discontinue use of the preparation and provide symptomatic therapy.

Side effects.

The product is usually well tolerated, but reactions due to increased individual sensitivity to the components of the product may occasionally occur, including a burning sensation/irritation in the throat, swelling at the site of contact, dryness of the nasal/mucous membranes of the throat, shortness of breath, swelling of the face, tongue, skin rashes, urticaria, itching.

If any adverse reactions occur, discontinue use of the product and consult a doctor immediately.

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. 25 g in a bottle with a protective cap, nasal spray nozzle with protective cap and oral spray in a carton.

Availability. Over-the-counter (without prescription).

Manufacturer. Limited liability company "Pharmaceutical Company "Zdorovia".

Manufacturer's address. 22 Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.