FORM OF RELEASE, COMPOSITION AND PACKAGING
◊ Eye drops
in the form of a clear, colorless solution.
| 1 ml | |
| hypromellose | 3 mg |
| dextran 70 | 1 mg |
Excipients:
glycerol - 2 mg, boric acid - 3 mg, sodium tetraborate decahydrate - 350 mcg, potassium chloride - 1.2 mg, sodium chloride - 6.2 mg, disodium edetate dihydrate - 500 mcg, benzalkonium chloride - 75 mcg, sodium hydroxide 1M solution or hydrochloric acid 1M solution - up to pH 7.4±0.1, purified water - up to 1 ml = 1.00645 g.
15 ml - polymer dropper bottle (1) - cardboard packs.
PHARMACHOLOGIC EFFECT
Keratoprotective drug. Slesin is an artificial tear that improves corneal hydration and increases the stability of the tear film on the surface of the cornea.
Slesin contains a water-soluble polymer system that, in combination with the eye's natural tear fluid, improves corneal hydration by providing hydrophilicity to the corneal surface through normal adsorption processes at the interface between the tear fluid film and the corneal surface. The drug physiologically mixes with the tear fluid film, increasing its stability on the surface of the cornea. Reduces irritation symptoms associated with dry eye syndrome and protects the cornea from drying out. After a single instillation, the effect of the drug lasts for 90 minutes.
Slezin eye drops 3 mg/ml+1 mg/ml 15 ml fl-cap/pack card x1
SLEZIN Representative office: ROMFARM COMPANY S.R.L. ATX code: S01XA20 Registration certificate holder: SC ROMPHARM Company, SRL hypromellose + dextran 70 Release form, composition and packaging Transparent, colorless eye drops. 1 ml hypromellose 3 mg dextran 70 1 mg Excipients: glycerol - 2 mg, boric acid - 3 mg, sodium tetraborate decahydrate - 350 mcg, potassium chloride - 1.2 mg, sodium chloride - 6.2 mg, disodium edetate dihydrate - 500 mcg, benzalkonium chloride - 75 mcg, sodium hydroxide 1M solution or hydrochloric acid 1M solution - up to pH 7.4±0.1, purified water - up to 1 ml = 1.00645 g. 15 ml - polymer dropper bottle (1) - cardboard packs.
Clinical and pharmacological group: Drug for moisturizing and protecting the cornea Registration No.: • eye drops 3 mg+1 mg/1 ml: dropper bottle. 15 ml 1 - LP-000947, 10/18/11. Active. ——————————————————————————— Description of the drug SLEZIN is based on the officially approved instructions for use of the drug SLEZIN for specialists and approved by the manufacturer for the 2011 edition of the year. ——————————————————————————— Pharmacological action | Pharmacokinetics | Indications | Dosage regimen | Side effect | Contraindications | Pregnancy and lactation | Special instructions | Overdose | Drug interactions | Terms of release from pharmacies | Storage conditions and expiration dates —————————————————————————— Pharmacological action Slezin is an artificial tear, improves hydration of the cornea, increases the stability of the tear film on the surface of the cornea . Slesin contains a water-soluble polymer system that, in combination with the eye's natural tear fluid, improves corneal hydration by providing hydrophilicity to the corneal surface through normal adsorption processes at the interface between the tear fluid film and the corneal surface. The drug physiologically mixes with the tear fluid film, increasing its stability on the surface of the cornea. Reduces irritation symptoms associated with dry eye syndrome and protects the cornea from drying out. After a single instillation, the effect of the drug lasts for 90 minutes.
Pharmacokinetics Hypromellose has a high molecular weight (86,000 Daltons) and is therefore absorbed slowly. Hypromellose is a metabolically inert material.
Indications for use of the drug SLEZIN: dry eye syndrome.
Dosage regimen Local. 1-2 drops into the conjunctival sac of each affected eye as needed several times a day or as prescribed by a doctor. The duration of treatment depends on the severity of the disease and is prescribed by the doctor. If there is no effect, you should stop instilling the drug.
Side effects Uncommon (0.1-1%): blurred vision, eye discomfort (burning, tingling). Rarely (0.01-0.1%): eye redness, lacrimation, eye fatigue. Allergic reactions may develop.
Contraindications to the use of the drug SLEZIN - children under 18 years of age (there is no data on the possibility of using the drug in children), - hypersensitivity to hypromellose, dextran or any component of the drug.
Use of the drug SLEZIN during pregnancy and breastfeeding The use of the drug during pregnancy and lactation (breastfeeding) is possible only when the expected benefit to the mother outweighs the potential risk to the fetus or child. Adequate and strictly controlled clinical studies on the safety and effectiveness of the drug during pregnancy and lactation (breastfeeding) have not been conducted.
Use in children Contraindicated in children under 18 years of age.
Special instructions When wearing contact lenses before instilling the drug, they should be removed and reinstalled no earlier than 15 minutes after using the drug. The drug Slesin should not be used for injection. If there is no improvement after 2-3 days of using the drug, it is recommended to interrupt treatment.
Effect on the ability to drive vehicles and operate machinery Due to possible blurred vision, during the treatment period it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Overdose Currently, no cases of overdose of Slesin have been reported. If excess ophthalmic solution gets into your eyes, rinse your eyes with warm water.
Drug interactions Slezin is not compatible with eye drops containing metal salts (zinc sulfate, etc.).
Conditions for dispensing from pharmacies The drug is approved for use as an over-the-counter product.
Conditions and periods of storage Store the drug in a place protected from light, at a temperature not exceeding 25°C, out of the reach of children. Shelf life: 3 years. After opening the bottle, the drops should be used within 4 weeks. Do not use after expiration date.
SPECIAL INSTRUCTIONS
When wearing contact lenses, before instilling the drug, they should be removed and reinserted no earlier than 15 minutes after using the drug.
The drug Slesin should not be used for injection.
If there is no improvement after 2-3 days of using the drug, it is recommended to interrupt treatment.
Impact on the ability to drive vehicles and operate machinery
Due to possible blurred vision, during treatment it is necessary to be careful when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
Slezin eye drops solution 0.5% 10ml No. 1
Name
Slesin.
Description
Opalescent solution without visible particles.
Main active ingredient
Hypromellose.
Release form
Drops.
Dosage
10ml.
pharmachologic effect
Other drugs used in ophthalmology. Artificial tears and other indifferent agents. ATX CODE S01XA20.
Pharmacokinetics
Hypromellose is an inert substance and does not have pharmacological activity.
Indications for use
Used topically to relieve symptoms of dry eye and eye irritation associated with insufficient tear production (eg, in patients with rheumatoid arthritis, keratoconjunctivitis sicca, and xerophthalmia).
Directions for use and doses
The medicine is intended for topical use only. Unless otherwise prescribed by a doctor, apply one to two drops into the conjunctival sac of the eye(s) three times a day. The dosage regimen and duration of use of the drug are determined by the doctor, taking into account the characteristics of the disease, the achieved effect and tolerability of the drug. Instructions for using eye drops Wash your hands before use. Open the bottle. Turn the bottle upside down, holding the bottle between your thumb and forefinger. Tilt your head back. Pull the lower eyelid down slightly to create a “pocket” between the eyelid and the eye into which the drop should fall. Hold the bottle upside down over your eye and gently squeeze the bottle to squeeze a drop into your eye. Do not squeeze the bottle too hard. Do not touch the tip of the dropper to any surface (eyelids, eye area, eyelashes, or other surfaces). Blot your eye to remove excess eye drops. Close the bottle after each use of eye drops.
Use during pregnancy and lactation
Pregnancy There are no or limited data on the use of hypromellose in the form of ophthalmic medicinal products in pregnant women. The systemic effect of hypromellose after local administration into the conjunctival sac is insignificant; the drug is pharmacologically inert. Lactation There is no data on the penetration of hypromellose and its metabolites into breast milk when the drug is applied topically to women who are breastfeeding. No effect on breastfed infants is expected since systemic exposure to hypromellose is negligible and hypromellose is a pharmacologically inert substance. Before using the drug Slesin, pregnant or lactating women are advised to consult a doctor. Effect on the ability to drive vehicles and operate machinery After using the drug, temporary visual disturbances are possible, which may negatively affect the ability to drive a car or other potentially dangerous mechanisms. You should refrain from driving and other potentially hazardous activities until your vision is restored.
Interaction with other drugs
There is no information about possible interactions. In case of simultaneous use of other drugs, you should consult your doctor. When prescribing the drug Slesin with other drugs, it is necessary to maintain an interval between instillations of at least 15 minutes.
Contraindications
Hypersensitivity to any substance included in the drug.
Compound
1 ml of the drug contains: Active ingredient: hypromellose 5.0 mg. Excipients: disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride, sodium edetate dihydrate, benzalkonium chloride, purified water.
Overdose
Based on the properties of the drug, toxic effects are not expected in case of overdose when applied topically or in case of accidental ingestion of the contents of one bottle. Special instructions If, while using the drug, the symptoms persist or the condition worsens (headache, eye pain appears or worsens, in case of blurred vision, redness of the conjunctiva, etc.), you must stop using the drug and consult a doctor. To maintain the sterility of the medicine, do not touch the dropper to your eyes or any other surface. This medicine contains benzalkonium chloride, which may cause discoloration of soft contact lenses. The drug should not be used by patients who wear contact lenses. It is necessary to remove contact lenses before using the drug and put them back no earlier than after 15 minutes. Use in children There is no sufficient experience with the use of the drug Slezin in children, so prescribing to children is possible only if the expected therapeutic effect exceeds the risk of side effects.
Side effect
After topical use of the drug, the following adverse reactions are possible (the incidence of adverse reactions is not known (cannot be determined based on available data)): eye disorders: visual disturbances, eye pain, foreign body sensation in the eyes, burning or irritation , ocular hyperemia, sensation of eyelids sticking together. Hypersensitivity reactions (allergic reactions) are possible. Very rarely, cases of corneal calcification have been reported after the use of eye drops containing phosphates in patients with corneal damage. If any adverse reactions occur, including those not listed in this instruction, you must stop using the drug and consult a doctor.
Storage conditions
Store at a temperature of 15-25°C in original packaging. Keep out of the reach of children.
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