Visine drops alerdzhi Ch. 0.05% 4ml vial

Description

Composition
Active substance:
1 ml of solution contains: levocabastine hydrochloride (0.54 mg / ml) based on levocabastine 0.5 mg / ml (0.05%) ;.
Excipients:
Propylene glycol 48.26 uL, 8.66 mg disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate 5.38 mg hypromellose (3 2910 mPa. S) 2.50 mg Polysorbate 80 1.00 mg Benzalkonium chloride 0.15 mg (as 50% solution 0.03 mL) disodium edetate 0.15 mg water for injection to 1.0 ml.
Description:
White homogeneous suspension.
Product form:
Eye drops 0.05%.
4 ml vial formulation of low density polyethylene with drop device and a screw cap of high density polyethylene with a first control opening. 1 bottle with instructions for use in a cardboard box.
Contraindications
Hypersensitivity to the drug, contact lens wear, age 12 years, the period of lactation.
CAREFULLY
Advanced age, impaired renal function.
Dosage
0.05%
Indications
Allergic conjunctivitis.
Interaction with other drugs
Not studied.
Overdose
symptoms
In case of accidental ingestion may decrease blood pressure, tachycardia, severe sedation.
Treatment
Forced diuresis.
pharmachologic effect
Pharmacological group:
Antiallergic agent-H1-histamine receptor blocker.
Pharmacodynamics:
Levocabastine – selective blocker of H1-histamine receptor with long duration of action. A local effect occurs within 5 minutes. Vizin® Alerdzhi eliminates the typical symptoms of allergic conjunctivitis (itching, redness, swelling of the conjunctiva and the eyelids, lacrimation). The action continues until 12 hours.
Pharmacokinetics:
Upon instillation in the eye in a dose of 15 mcg / drop absorbed approximately 6 micrograms levocabastine, and the maximum plasma concentration is reached after about 6 hours. Levocabastine binds to plasma proteins, about 55%.
The major metabolite levocabastine, atsilglyukuronid is formed by glucuronidation, which is the main by the formation of metabolites.
Levocabastine excreted mainly by the kidneys in unchanged form (about 70% of the absorbed amount). Levocabastine half-life of about 39-70 hours.
Pregnancy and breast-feeding
In preclinical animal studies levocabastine when administered systemically in doses up to 2,500 times (in terms of mg / kg) above the recommended maximum dosage for topical use in humans did not cause embryotoxic and teratogenic effects. In animals when administered systemically in doses levocabastine, more than 5,000 times (in terms of mg / kg) exceeding the maximum recommended dose for topical application in humans, marked teratogenic properties and / or increase in embryo death.
There are no data on the use of levocabastine in pregnant women. Therefore it is not recommended to use eye drops Vizin® Alerdzhi during pregnancy except in cases where the expected benefit to the mother outweighs the potential risk to the fetus.
The drug passes into breast milk, so the period of treatment should stop breastfeeding.
Conditions of supply of pharmacies
Without recipe.
side effects
Adverse events that were reported in patients in clinical studies and post-marketing
Very common (> 1/10), common (> 1/100,
special instructions
The period of treatment is not recommended to use soft (hydrophilic) contact lenses – possibly interacting with the drug included benzalkonium chloride.
To prevent microbial contamination should avoid touching the pipette century and tightly close the bottle.
If the drug has come into disrepair or expiration date – do not pour it! Place the drug in the bag and place in the trash. These measures will help protect the environment!
Effects on ability to driving and using machinery
Eye drops Vizin® Alerdzhi no sedative effect of and do not affect the speed of psychomotor reactions. Reported adverse reactions, which may lead to visual impairment – such as eye irritation, pain, swelling, itching, redness, burning sensation, tearing and blurred vision. Therefore, during the use of the drug should be careful when driving and operating machinery.
Storage conditions
Store at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
Locally. 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 symptoms disappear.
Since eyedrops Vizin® Alerdzhi represent suspension vial should be shaken before each use.
Using a dropper bottle
Remove the cap from the dropper bottle and turn the bottle.
Do not touch the tip of the bottle to any surface.
After application to screw-cap vial dropper.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist