Description
Latin name
Visine Allergy
Release form
Eye drops 0.05%.
4 ml of the drug in a bottle of low density polyethylene with a drip device and a screw cap made of high density polyethylene with control of the first opening.
For 1 bottle with instructions for use in a cardboard box.
Packaging
In a plastic dropper bottle 4 ml of a solution of eye drops. In a cardboard bundle 1 bottle.
Indications
Allergic conjunctivitis.
Contraindications
Hypersensitivity to the drug, wearing contact lenses, up to 12 years of age, lactation period.
WARNING
Elderly, impaired renal function.
Use in pregnancy and lactation
In preclinical studies in animals, levocabastine when administered systemically at doses up to 2500 times (in terms of mg / kg) did not cause embryotoxic and teratogenic effects in humans for topical application.
In animals with systemic administration of levocabastine in doses more than 5000 times (in terms of mg / kg) exceeding the recommended maximum dose for topical administration in humans, teratogenic properties and / or increased embryo death were noted.
There are no data on the use of levocabastine in pregnant women.
Therefore, it is not recommended to use Vizin ® Allergy eye drops during pregnancy, unless the expected benefit to the mother outweighs the potential risk to the fetus.
The drug passes into breast milk, therefore, during the treatment period, breast-feeding should be discontinued.
Composition
Active ingredient:
levocabastine hydrochloride (0.54 mg / ml) in terms of levocabastine 0.5 mg / ml (0.05%)
Excipients:
propylene glycol 48.26 μl,
sodium hydrophosphate 66 mg,
sodium hydrogen phosphate monohydrate 5, 38 mg,
hypromellose (2910 3 mPa.s) 2.50 mg,
polysorbate 80 1.00 mg,
benzalkonium chloride 0.15 mg (as a 50% solution of 0.03 ml),
disodium edetate 0.15 mg,
water for injection up to 1.0 ml.
Dosage and Administration
Topically. For adults and children over 12 years: 1 drop in each eye twice a day (if necessary – 3-4 times a day). Treatment should be continued until the symptoms disappear.
Since Vizin ® Allergy eye drops are a suspension, the vial must be shaken before each use.
Using a dropper bottle
Remove the cap from the dropper bottle and turn the bottle over.
Do not touch the tip of the vial to any surface.
After use, screw on the cap of the dropper bottle.
Side effects
Adverse events observed in patients during clinical and post-marketing studies
Very often (> 1/10), often (> 1/100, <1/10), infrequently (> 1/1000, <1 / 100), rarely (> 1/10000, <1/1000), very rarely (<1/10000, including individual messages), the frequency is unknown (the frequency of occurrence cannot be estimated based on available data). Disorders of the heart: very rarely: palpitations. Disorders of the organ of vision: often: pain in the eye area, blurred vision infrequently: edema of the eyelid is very rare: conjunctivitis, blepharitis, edema of the conjunctiva, conjunctival hyperemia, lacrimation. General disorders and disorders at the injection site: often: burning sensation in the eyes, eye irritation very rarely: conjunctival hyperemia, pain in the eye area, conjunctival edema, itching in the eye area, lacrimation, blurred vision. Immune system disorders: very rare: anaphylactic shock, angioedema, hypersensitivity. Disorders of the skin and subcutaneous tissue: very rare: contact dermatitis, urticaria. Disorders of the nervous system: very rare: headache. There have been reports of severe corneal injury, and extremely rare cases of corneal decalcification when using the drug in combination with ophthalmic solutions containing phosphates. Drug interaction Not studied. Overdose Symptoms of Reduced blood pressure, tachycardia, severe sedation may be caused by accidental ingestion. Treatment Forced diuresis. Storage conditions Store at a temperature not exceeding 25 ° C. Keep out of the reach of children. Expiration 2 years. Do not use the medicine after the expiry date. Visin ® Allergy Eye Drops should be used within one month of opening. Dosage form dosage form eye drops
