Ottagel® (Oftagel®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCarbomerCarbomer
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  • Ottagel®
    gel d / eye 
    Santen, AO     Finland
    • Dosage form: & nbspeye gel
    Composition:

    1 g of eye gel contains:

    active substance: Carbomer 974P 2.50 mg;

    Excipients: benzalkonium chloride 0.06 mg, sorbitol 45.00 mg, lysine monohydrate 4.70 mg, sodium acetate 0.70 mg, polyvinyl alcohol 5.00 mg, water for injection 942.04 mg.

    Description:

    Colorless or slightly opalescent gel.

    Pharmacotherapeutic group:Keratoprotective agent
    ATX: & nbsp

    S.01.X.A.20   Artificial tears and other indifferent drugs

    Pharmacodynamics:
    Ottagel® contains carbomer, which is a high molecular weight carboxyvinylpolymer (polyacrylate). Carbomer increases the viscosity of the tear, forming a protective moisturizing film on the surface of the cornea, thickens the mucinous and aqueous layers of the tear film. Oftagel® reduces irritation symptoms caused by the "dry eye" syndrome. Symptoms of "dry eyes" may include compensatory lacrimation, itching, burning, sensation of foreign body in the eye and visual fatigue. Prolonged contact of the tear film with the cornea has a beneficial effect when the secretion of tears is reduced.Oftagel® can prolong the absorption of other eye preparations with simultaneous application.
    Pharmacokinetics:With topical application of the drug, penetration through the cornea and into the systemic blood flow is unlikely because of the relatively large size of the carbomer molecule.
    Indications:

    Dry keratoconjunctivitis and other diseases accompanied by a syndrome "dry eye", which is expressed in lacrimation, itching and burning, sensation foreign body in the eye. Including, eye irritation (as a result of exposure to dust, smoke, while working with a computer - "office eye syndrome"), insufficient lacrimation, Stevens-Johnson syndrome, Sjogren's disease, eyelid diseases, resulting in inadequate contact of the cornea with a tear (ectroplon, entropion, blepharitis), rehabilitation therapy after laser and surgical interventions on the cornea.

    Contraindications:

    Hypersensitivity to one of the components of the drug, as well as infectious diseases of the eyelids, conjunctiva and cornea.

    Pregnancy and lactation:

    There were no adequate controlled trials of the drug with pregnant women.The use of the drug during pregnancy and lactation is possible only according to the doctor's prescription, if the expected therapeutic effect for the mother justifies the potential risk to the fetus and the baby.

    Dosing and Administration:

    1 drop of Ophthalgel ® 1-4 times a day, depending on the severity of the symptoms before they disappear completely.

    Before instilling the drug, wash your hands. Tilt your head back. Pull the lower eyelid and drip one drop of gel into the conjunctival sac between the lower eyelid and the eye. Do not touch the eye and eyelids with the tip of the pipette. Close the vial. Please, remember that the bottle with eye gel is intended for use only by one person.

    Side effects:

    Immediately after instillation, a transient fogging of vision, a brief burning sensation and local eye irritation are possible.

    Overdose:

    No cases of overdose were reported.

    Interaction:

    The drug interaction of Oftagel® with other drugs has not been studied.

    Special instructions:

    Benzalkonium chloride can be absorbed and discolored contact lenses. Before instillation of the drug, they should be removed and reinstalled 30 minutes after instillation of the drug.

    When appointing more than one type of Ophagel® drops, the last one should be digested with an interval of at least 15 minutes.
    Effect on the ability to drive transp. cf. and fur:

    Eye Ophagel® gel may cause temporary blurring of vision. Before start driving a car or work with a mechanical wait until the visual acuity is fully restored.

    Form release / dosage:

    Eye gel 0.25%.

    Packaging:For 10 g in a transparent bottle with a capacity of 10 ml, made of low-density polyethylene. The bottle is sealed with a pipette, with a screw cap and a ring to control the opening of the vial.
    The bottle with the instruction is placed in a cardboard box.
    Storage conditions:

    In the dark place at a temperature of 15 ° C to 25 ° C.

    Between instillations the vial should be stored in a cardboard bundle in an inverted form to facilitate the receipt of the gel.

    Keep out of the reach of children.

    Shelf life:

    30 months. Use within 1 month after opening the vial.

    Do not use the product after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:П N012493 / 01
    Date of registration:28.09.2011
    Expiration Date:Unlimited
    The owner of the registration certificate: Santen, AO Santen, AO Finland
    Manufacturer: & nbsp
    Representation: & nbspSANTEN AS SANTEN AS Finland
    Information update date: & nbsp20.06.2017
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