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Dosage form: & nbspeye drops
Composition:

1 ml of the drug:

Active substances:

Polyvinyl alcohol 14 mg, Povidone 6 mg,

Excipients: benzalkonium chloride 0.1 mg, disodium edetate 1.0 mg, sodium chloride 8.4 mg, water for injection up to 1 ml.

Description:Transparent, colorless or slightly yellowish solution.
Pharmacotherapeutic group:Keratoprotector
ATX: & nbsp
  • Artificial tears and other indifferent drugs
  • Pharmacodynamics:

    The drug has a protective effect on the cornea with reduced secretion of tear fluid or with increased evaporation of the tear film.

    Polyvinyl alcohol and povidone have the properties of lubricant, which reduces irritation and redness of the eye. These substances reduce the stress of the surface of the tear film, easily covering the surface of the eye, and prevent the occurrence of tear film rupture sites. Polyvinyl alcohol has properties similar to mucin, produced by conjunctival glands. It helps to soften and lubricate (moisturize) the surface of the eye, increases the stability of tear film.

    Pharmacokinetics:Through the study of the bioavailability it has been found that after instillation Oftolik® two drops in each eye component concentration of drug in plasma after 4 hours after use remains lower possible limit of quantitation (10 ng / ml).This allows us to conclude that the systemic absorption of the components of the drug from the surface of the eye with the use of Ophthalmic eye drops is minimal.
    Indications:

    1. Feeling of burning, irritation and discomfort caused by dry eyes.

    2. As a substitute for tears in the case of a decrease in the secretion of tear fluid.

    3. Dry eye syndrome or any other condition requiring softening and moistening of the cornea.

    Contraindications:Hypersensitivity to the components of the drug.
    Pregnancy and lactation:

    Sufficient experience before the drug during pregnancy and lactation is not present. Use in pregnant and lactating mothers is possible only for the purpose of the doctor in charge, if the expected therapeutic effect exceeds the risk of developing possible side effects.

    Dosing and Administration:

    1-2 drops 3-4 times a day in both eyes, depending on the severity of the symptoms. Wash hands before applying the product.

    Shake the vial and remove the lid. Make sure that the tip of the pipette does not touch the skin or the surface of the eye to prevent infection.

    Throw back his head, pull the lower eyelid down,turn the bottle and drip the required amount of drops into the conjunctival sac.

    Side effects:Allergic reactions to the components of the drug are possible.
    Interaction:

    Polyvinyl alcohol undergoes esterification reactions, characteristic of compounds with secondary hydroxy groups. It breaks down in strong acids and softens or dissolves in weak acids and alkalis. In high concentrations, the substance is incompatible with inorganic salts, especially phosphates and sulfates. The formation of a 5% precipitate of polyvinyl alcohol can be caused by the reaction with phosphates. The formation of a gel from a solution of polyvinyl alcohol may be present with borax.

    The solution of povidone is compatible with many inorganic salts, natural and synthetic resins and other substances. Interacts in solution with sulfatiazole, sodium salicylate, salicylic acid, phenobarbital, tannin and other substances. The effectiveness of some preservatives, for example, such as thiomersal, may decrease due to the formation of complexes with povidone.

    Special instructions:

    Do not use the drug if the color of the solution has changed or it has become cloudy.

    Ensure that the tip of the vial during application does not touch any surfaces. After use, close the vial with a lid.

    Discontinue use of drops and consult a doctor if:

    - when using drops, the pain intensifies;

    - eyesight deteriorates;

    - symptoms persist for more than 72 hours;

    redness and irritation of the eyes remain.

    Drops contain benzalkonium chloride, so you can not wear contact lenses for 20 minutes after using drops.

    Form release / dosage:Eye drops.
    Packaging:For 10 ml of the drug in a plastic bottle-dropper with a screw cap. Each vial-dropper along with the instruction for use is placed in a cardboard box.
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C. Do not freeze. After instillation it is necessary to close the bottle tightly.

    Keep out of the reach of children.

    Shelf life:3 years. Drops should be used within 45 days after opening the vial. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-001359/08
    Date of registration:29.02.2008 / 14.04.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Sentiss Pharma Pvt. Ltd.Sentiss Pharma Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSENTISS RUSS LLCSENTISS RUSS LLCRussia
    Information update date: & nbsp20.06.2017
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