Ivinac-Solofarm, eye drops 0.09% 5 ml

Indications

Treatment of non-infectious inflammatory diseases of the anterior segment of the eye and postoperative inflammation (after cataract extraction, etc.).

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Active ingredient

Bromfenac

Composition

Active ingredient: Bromfenac sodium sesquihydrate 1.035 mg, in terms of bromfenac 0.9 mg

Auxiliary substances:

• Benzalkonium chloride 0.01 mg
• Hydroxypropyl betadex 20.0 mgBoric acid 12.5 mg
• Sodium tetraborate decahydrate 12.5 mg
• Polysorbate 80 1.5 mg
• Dinatrium edetate dihydrate 0.2 mg
• Sodium hydroxide solution10 M sodium hydroxide solution or 1 M hydrochloric acid solution to pH 8.3
• Water for injection up to 1 ml

How to take, the dosage

Instillation into the conjunctival sac.

1 to 2 drops of the drug in the conjunctival sac twice daily for no more than 15 days.

If a dose of the drug is missed, it should be used as soon as possible in the dosage indicated in the instructions for use. If a missed dose of the medication is about 24 hours, the medication should be used at the next scheduled time, without doubling the dose to compensate for the missed dose.

Treatment of postoperative inflammation: one drop once a day. Treatment begins 1 day before surgery and continues for the first 14 days of the postoperative period (including the day of surgery).

Treatment of non-infectious inflammatory diseases of the anterior segment of the eye: one drop twice a day. The course of treatment is determined by the doctor depending on the severity of the condition.

Performance of the bottle (without the stopper):

1. Turn the vial counterclockwise and remove the cap.
2. Carefully, without touching the tip of the vial with your fingers, turn the vial over, fix it between the thumb and forefinger of one hand.
3. Tilt your head back, place the tip of the vial over your eye and with the index finger of your other hand pull down the lower eyelid. Press the vial down slightly and drop the desired amount into the conjunctival sac of the eye.
   To avoid contact of the tip of the open vial with the eye surface and your hands.
4. After use, place the cap back on the vial and close with a clockwise rotating motion.

Performance with Bottle with Stopper:

1. Get the stopper and the bottle out of the pack.
2. Turn the bottle counter-clockwise to open with the stopper and remove the cap.
3. Carefully, without touching the tip of the bottle with your fingers, place the stopper on the neck of the bottle.
4. Tilt your head back, place the stopper on the eyelid so that the tip of the bottle is against the eyeball, press the bottle slightly and drop the desired amount of product.
5. Take the stopper off the neck of the bottle, place the cap on the bottle and close clockwise. At the end of this period the product should be discarded.

   The product should not be used if the vial is visibly damaged.

Interaction

Studies of interaction of bromfenac with other medicines have not been conducted.

Special Instructions

The drug should be used for symptomatic treatment, not for etiotropic therapy.

The drug should only be used as eye drops.

All topical NSAIDs may delay or delay healing similar to topical glucocorticosteroids. Combined use of NSAIDs and topical steroids may increase the likelihood of healing problems.

Cross-sensitivity

There is a possibility of cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs. Therefore, caution should be exercised when treating individuals who have a history of sensitivity to these drugs, and the potential risks and benefits should be carefully evaluated.

Special patient groups

. In susceptible patients, long-term use of topical NSAIDs, including bromfenac, may result in epithelial tearing, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events can threaten vision loss. Patients with signs of corneal epithelial destruction should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Consequently, in patients at risk, concomitant use of ophthalmic corticosteroids with NSAIDs may result in an increased risk of corneal adverse events.

Post-registration experience

. Post-registration experience with topical NSAIDs indicates that patients with complications from ophthalmic surgery, corneal denervation, corneal epithelial defects, diabetes and superficial eye disease, rheumatoid arthritis, or repeated ophthalmic surgery performed within a short period of time may have an increased risk of corneal adverse events that may become threatening visual loss. Topical NSAIDs should be used with caution in these patients.

It has been reported that ophthalmic NSAIDs may cause increased ocular tissue bleeding (including hyphema) in conjunction with ophthalmic surgery. Topical NSAIDs should be used with caution in patients with a history of bleeding tendencies or if patients are receiving other medications that may increase clotting time.

Eye infections

The use of the drug should be carefully monitored and patients with inflammation caused by infections should be prescribed with caution, as the drug may mask the symptoms of eye infections.

Contact lens use

In general, contact lens wear is not recommended during drug treatment. Because of this, patients are not recommended to wear contact lenses unless clearly instructed by their physician.

Associates

Benzalkonium chloride, which is often used in ophthalmic preparations as a preservative, may cause pitting keratopathy and/or toxic ulcerative keratopathy. Because the drug contains benzalkonium chloride, close monitoring is required for frequent or prolonged use in patients with dry eye syndrome or in cases of corneal damage. Benzalkonium chloride may discolor soft contact lenses. It is necessary to remove soft contact lenses before application and put them on again 15 minutes after injection.

Influence on ability to drive vehicles and machinery

Transient blurring of vision may occur after instillation. If blurred vision develops after instillation, refrain from driving vehicles and machinery until clarity of vision is restored.

Synopsis

Transparent solution of greenish-yellow color.

Contraindications

The drug is contraindicated in patients with a history of hypersensitivity to any component of the drug.

The drug is contraindicated in patients with attacks of bronchial asthma, urticaria and symptoms of acute rhinitis when taking acetylsalicylic acid and other NSAIDs.

The age under 18 years (the safety and effectiveness in children has not been studied).

Side effects

Adverse reactions to the drug were reported in 72 of 3,843 patients (1.87%) reported in clinical trials or during post-registration use. Serious adverse reactions included corneal erosion in 16 cases (0.42%), conjunctivitis (including conjunctival injection and conjunctival follicles) in 11 cases (0.29%), blepharitis in 9 cases (0.23%) irritation in 8 cases (0.21%), ocular pain [transient] in 8 cases (0.21%), superficial pitting keratitis in 6 cases (0.16%), itching in 6 cases (0.16%), corneal epithelial detachment in 1 case (0.03%) and burning sensation [eyelids] in 1 case (0.03%).

Overdose

There is currently no information on overdose when administered topically in humans.

According to foreign reports, serious liver function abnormalities (including deaths) have been observed in patients who have taken bromfenac sodium orally in a total dose exceeding 1500 mg for an extended period of more than 1 month. Therefore, if abnormalities that are suspected to be associated with early symptoms of liver failure are detected, treatment with this drug should be discontinued and appropriate measures taken.

Pregnancy use

Sufficient data on the use of bromfenac in pregnant women are not available. Animal studies have demonstrated reproductive toxicity. The potential risk to humans is unknown. Because systemic effects after treatment with the drug in nonpregnant women are negligible, the risk during pregnancy can be considered low.

Similarities

Broxinac