Active substanceCromoglycic acidCromoglycic acid
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  • Dosage form: & nbspeye drops
    Composition:

    1 ml of eye drops contains:

    Active substance: sodium cromoglycate (20.0 mg).

    Excipients: benzalkonium chloride, sodium chloride, disodium edetate, sorbitol liquid, non-crystallized, sodium dihydrogen phosphate dihydrate, disodium hydrogen phosphate to decahydrate, sodium hydroxide, water for injection.

    Description:Transparent colorless to slightly yellowish solution without mechanical inclusions.
    Pharmacotherapeutic group:Antiallergic agent - stabilizer of membranes of mast cells
    ATX: & nbsp

    S.01.G.X.01   Cromoglycic acid

    R.03.B.C.01   Cromoglycic acid

    Pharmacodynamics:

    Antiallergic, has a membrane-stabilizing effect, blocks the entry of calcium ions into the mast cell, preventing its degranulation and release of histamine, bradykinin, prostaglandins, leukotrienes (including slow reacting substances) and other biologically active substances. The drug is most effective as a means of prevention. A noticeable clinical effect occurs within a few days or weeks after admission.

    Pharmacokinetics:

    Absorption through the mucous membrane of the eye is negligible. Systemic bioavailability - less than 0.03%. The half-life is 5-10 minutes. Relationship with plasma proteins - 65%. It is not metabolized, excreted by the kidneys and through the intestines in unchanged form (approximately in equal amounts within 24 hours after application).

    Indications:

    Prevention and treatment:

    - allergic conjunctivitis;

    - allergic keratitis, keratoconjunctivitis;

    - irritation of the mucous membrane of the eye, due to allergic reactions (environmental factors, occupational hazards, household chemicals, cosmetics, ophthalmic medicinal forms, plants and domestic animals).

    Contraindications:

    - hypersensitivity to sodium cromoglycate or to any other component of the drug

    - children under 2 years old

    Carefully:

    - children up to 4 years old

    - pregnancy and lactation

    Pregnancy and lactation:carefully.
    Dosing and Administration:

    Adults and children over the age of 2 years instilled 1-2 drops in each conjunctival sac 4 times a day at intervals of 4-6 hours. If necessary, the dose can be increased to 6-8 instillations.

    After achieving the therapeutic effect, the frequency of application of the drug can be reduced and used Cromohexal only in contact with allergens (house dust, spores of fungi, pollen).

    Side effects:Violation of the clarity of visual perception, burning in the eye, edema of the conjunctiva, sensation of foreign body, dry eyes, lacrimation, meibomite (barley); superficial lesion of the corneal epithelium.
    Overdose:

    Data on drug overdose are absent.

    Interaction:

    Reduces the need for ophthalmic drugs containing glucocorticosteroids.

    Special instructions:

    When using drops, because of the content of benzalkonium chloride, you should avoid wearing soft contact lenses; Strict contact lenses should be removed 15 minutes before instillation and dress after 15 minutes. The bottle must be closed after each use. Do not touch the tip of the pipette to the eye.

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Eye drops 2 %.

    For 10 ml in polyethylene bottles - droppers with a screw cap and a ring of the first opening. Bottle and instructions for use in a cardboard pack.
    Storage conditions:

    At a temperature of no higher than 25 ° C in a dark place. Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiry date stated on the package. Open vials can be used within 6 weeks.

    Terms of leave from pharmacies:On prescription
    Registration number:П N012390 / 01
    Date of registration:11.08.2008
    The owner of the registration certificate:HEXAL AG HEXAL AG Germany
    Manufacturer: & nbsp
    HEXAL AG Germany
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp30.06.2010
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