Lorosan

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LOROSAN (LOROSAN)

Composition:

Active substance: liquid extract (60:100) of sunflower flowers (flores helianthi) (extractant – 70% ethanol);

1 ml of the preparation contains 330 mg of liquid extract (60:100) of sunflower flowers (flores helianthi) (extractant – 70% ethanol);

Excipients: propylene glycol; methylparaben (E 218); propylparaben (E 216); sodium saccharin; citric acid monohydrate; purified water.

Pharmaceutical form. Oromucosal spray, solution.

Main physico-chemical properties: clear yellow-brown liquid with a characteristic odor.

Pharmacotherapeutic group.

Preparations used in throat diseases. Various antiseptics.

ATC code R02A A20.

Pharmacological properties.

Pharmacodynamics.

Sunflower flower extract is a natural-origin antibacterial agent. Biologically active substances contained therein inhibit the growth of certain bacteria (Staphylococcus aureus, Staphylococcus epidermidis, Bacillus subtilis) as well as the vesicular stomatitis virus. In addition, when applied topically, the drug exerts a pronounced wound-healing effect.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Acute respiratory diseases, tonsillitis, laryngitis, pharyngitis, prevention of vesicular stomatitis.

Contraindications.

Increased individual sensitivity to the components of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

The medicinal product enhances the effect of other antibacterial agents.

Instructions for use.

Shake the bottle for 1 minute and press the nozzle no more than 5 times until a fine mist appears. If no spray appears, the procedure may be repeated once. Then insert the free end of the nebulizer into the oral cavity and press the valve stem for 1–2 seconds, holding the bottle vertically.

Excipients may cause allergic reactions (possibly delayed), and in individual cases — bronchospasm.

Use during pregnancy or breastfeeding.

Since no studies on the use of the medicinal product during pregnancy or breastfeeding have been conducted, its use is not recommended.

Ability to influence reaction rate when driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

Apply locally by spraying onto the mucous membranes of the oral cavity and pharynx. Adults should spray 3–4 times per day. The duration of use depends on the intensity of therapy and usually lasts from 3 to 7 days.

Children.

Studies on use in children have not been conducted; therefore, the medicinal product is not recommended for children.

Overdose.

Not observed.

Adverse Reactions.

Excipients may cause allergic reactions (possibly delayed), and in individual cases — bronchospasm. A sensation of burning in the posterior part of the throat may occur, which does not require discontinuation of the medicinal product.

If any adverse events occur, consult a physician immediately!

Reporting of adverse reactions.

Reporting of adverse reactions following registration of the medicinal product is of great importance. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

2 years.

Storage conditions.

Store at temperatures not exceeding 25 °C in the original packaging. Keep out of reach and sight of children.

Packaging.

30 mL in a bottle with a pump-dosing device and spray nozzle; 1 bottle per cardboard box.

Availability category.

Over-the-counter (without prescription).

Manufacturer.

JSC "Biolyk".

Manufacturer's location and address of business activity.

131, Nezalezhnosti St., Ladizhin, Vinnytsia region, Ukraine, 24321.

Marketing Authorization Holder.

LLC "Ukrainian Pharmaceutical Company".

Address of the Marketing Authorization Holder.

1U, Starosilska St., Kyiv, Ukraine, 02660.