Lipoflavon-oftha

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LIPOLAVON-OFTA (LIPOFLAVON-OFTA)

Composition:

Active substances: 1 vial of the preparation contains: lecithin-standard (calculated as lecithin) – 27.5 mg; quercetin (calculated as dry substance) – 0.75 mg;

Excipient: lactose monohydrate;

solvent: sodium chloride solution 9 mg/mL.

Pharmaceutical form. Eye drops, lyophilisate and solvent for emulsion.

Main physicochemical properties: LIPOLAVON-OFTA – amorphous mass of light yellow color with a characteristic odor; solvent – clear colorless liquid.

Pharmacotherapeutic group. Agents used in ophthalmology.

ATC code S01X A.

Pharmacological properties.

Pharmacodynamics.

An anti-inflammatory, wound-healing, and angioprotective agent. Quercetin, belonging to the group of bioflavonoids, has antioxidant and antiviral effects, inhibits the synthesis of leukotrienes, reduces pathologically increased vascular-tissue permeability, and promotes normalization of tissue trophism. Lecithin (phosphatidylcholine) possesses antioxidant, anti-hypoxic, and membrane-stabilizing properties, promoting tissue repair. The liposomal structure of LIPOFLAVON-OPTH ensures solubility and ophthalmic bioavailability upon instillation in the form of eye drops.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Corneal injuries (penetrating and non-penetrating).

Postoperative corneal wounds (after cataract extraction).

Keratitis of various etiologies.

Inflammatory diseases of the anterior segment of the eye.

Contraindications.

Individual hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

When using several locally applied ophthalmic medicinal products simultaneously, they should be administered with an interval of 10–15 minutes. Ophthalmic ointments should be used last.

Special precautions for use

Before each instillation, the vial should be held in the palm of the hand to warm the preparation to body temperature. The vial should then be shaken for 1 minute until a homogeneous emulsion is formed. If eye pain, blurred vision, worsening of vision, or persistent redness and irritation occurring within 72 hours after administration of the drug do not resolve, discontinue use and consult a physician.

During treatment, soft contact lenses should not be worn. Rigid contact lenses must be removed before instilling the eye drops. Contact lenses may be reinserted no sooner than 20 minutes after administration.

Use during pregnancy or breastfeeding

Due to limited information available, LIPOMATON-OHTA is not recommended during pregnancy or breastfeeding.

Effect on the ability to drive or operate machinery

Blurred vision or temporary loss of visual acuity may occur after instillation. In such cases, driving or operating machinery should be avoided until vision is fully restored.

Method of Administration and Dosage

Wash hands before use. Open the vial containing the lyophilisate and the vial containing the solvent. Carefully pour the solvent into the vial with the lyophilisate, then close the vial with a stopper. Holding the bottom and stopper of the vial with the thumb and index finger, shake vigorously for 1 minute until a homogeneous emulsion is formed. Then remove the stopper and attach the dropper cap to the vial. Do not touch the dropper tip to any surfaces, including hands or eyes, to avoid contamination which may lead to eye infections.

For adults and children aged 12 years and older, instill 1–2 drops into the conjunctival sac of the affected eye 6–8 times daily. After the acute inflammatory process has subsided, instill 3–4 times daily until full recovery.

The duration of treatment depends on the severity of the disease. The average treatment course is 10 days. If necessary, the treatment course may be extended up to 1 month.

Children.

Due to lack of clinical experience, use is not recommended in children under 12 years of age.

Overdose.

No cases of overdose have been reported.

Side effects.

Allergic reactions and temporary loss of visual clarity are possible in individuals hypersensitive to the components of the medicinal product.

Shelf life. 1 year.

Storage conditions.

LIPOLAVON-OFTA, lyophilisate, store in the original packaging in the freezer at a temperature below 0 °C. The prepared emulsion should be stored at 2 °C to 8 °C for no more than 2 days.

The solvent for LIPOLAVON-OFTA should be stored at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

1 vial of lyophilisate in a cardboard individual pack; 1.5 mL of solvent in a vial with a dropper cap in a cardboard individual pack.

Supply category. Over-the-counter (without prescription).

Manufacturer.

LLC "BIOLIK PHARMA".

Manufacturer's location and address of its place of business.

Legal entity location:

Ukraine, 61070, Kharkiv region, city of Kharkiv, Pomirky, building 70.

Place of business address:

Ukraine, 61070, Kharkiv region, city of Kharkiv, Pomirky-70, building b/n.