Instructions for use of a medical device Moisturizing and lubricating solution for eye protection "TEALOS"
Moisturizing and protecting the eyes in the treatment of dry eye syndrome.
Compound:
Trehalose - 3 g,
sodium chloride, trometamol, hydrochloric acid,
Water for injection up to 100 ml
REGISTRATION CERTIFICATE: No. RZN 2013/1031 dated 18.09.2013
INDICATIONS:
TEALOS is recommended in cases of dry eyes (discomfort, burning, irritation) and fatigue as a result of external factors such as wind, smoke, air pollution, dust, dry air from heaters, air conditioning, air travel, prolonged work at the computer.
TEALOS does not contain preservatives and can be used while wearing contact lenses. It quickly provides comfort for wearers of contact lenses during the day.
PROPERTIES:
TEALOS is a sterile, isotonic ophthalmic solution without preservatives and neutral pH. Its main component, trehalose, is a naturally occurring substance found in many plants and animals that can survive in extremely dry conditions.
Trehalose has physico-chemical characteristics that provide protective, antioxidant and moisturizing properties. For these reasons, it is an important element in the anhydrobiotic mechanism observed in certain microorganisms (a state of slow metabolism that allows them to survive in conditions of dehydration)
Trehalose also has properties that contribute to the protection and stabilization of the cell membrane by preventing protein modification and lipid damage, in addition, it exhibits antioxidant functions.
MODE OF APPLICATION:
Used in ophthalmology
TEALOS is supplied in a multi-dose ABAC vial. This patented system delivers eye drops by first passing them through a 0.2 µm membrane filter, thus preventing any bacterial contamination of the solution.
The solution in this type of packaging is suitable for up to 8 weeks after the first opening of the vial.
The bottle contains 300 drops of solution, has a neutral pH value and does not contain preservatives, which is why it is usually well tolerated by patients.
DOSAGE:
One drop in each eye throughout the day as needed.
Thealosis can be used while wearing contact lenses.
RECOMMENDATIONS FOR USE:
-Wash your hands thoroughly before use
- avoid contact of the lens surface and the tip of the vial, especially if eye infections are suspected,
- instill 1 drop into the conjunctival sac, slightly pulling down the lower eyelid, and looking up. Close the vial after use.
- Do not use for injection or oral administration.
- do not use the product if the protective ring is damaged.
Tealoz eye drops are used in ophthalmic practice. They have a moisturizing and lubricating effect when applied topically. They relieve discomfort and dry eyes.
Thealose eye drops contain the active ingredient trehalose.
Excipients are: trometamol, sodium chloride, water for injection, hydrochloric acid.
Thealoz eye drops are produced in a 10 ml multi-dose plastic bottle in a carton. The ABAK bottle has a membrane filter (0.2 µm) that prevents bacterial contamination of the drug solution.
Trehalose is a disaccharide that is made up of glucose. Trehalose is of limited use in the human diet, as it is considered a component of fungi. This substance has been investigated for various therapeutic applications due to its ability to stimulate apoptosis (self-destruction of cells) in an atypical manner. It was found that the introduction of trehalose for medicinal purposes is quite effective. It was also determined that trehalose in the intestine under the influence of the enzyme trehalase is broken down to glucose. This enzyme is determined in the human liver and blood, therefore, getting there, trehalose is also broken down to glucose and loses its therapeutic effects, not reaching the cells of the body.
The only way to get a therapeutic effect when using trehalose is to avoid oral (through the mouth) application, and to prescribe it for topical treatment. It has a beneficial effect on the protective function of the skin, as well as the mucous membrane of the eyes and strengthens the protective structure of the hair. Medical studies have determined the therapeutic properties of trehalose in the treatment of patients diagnosed with dry eye. This substance was used as eye drops. As it turned out, the drug is much more effective than other commercially available drugs with similar pharmacological effects.
With further study of the substance trehalose, a hypothesis was put forward that it is able to occupy its niche in the treatment of ophthalmological patients, since it has anti-desiccating properties. A number of studies have been conducted showing the effectiveness of trehalose in laboratory mice. In one trial, mice were placed in an environment conducive to the onset of dry eye symptoms, namely low humidity and high air temperature. The experiment lasted three weeks and showed as a result that much less symptoms of dry eyes and apoptosis were observed in those animals that were regularly dripped eye drops with trehalose (the concentration of the active substance was 30 mg/ml).
It has been proven that the cells of the mucous membrane of the eyes experience significantly less negative effects of UV radiation in the presence of the substance trehalose, the concentration of which is precisely 30 mg / ml. The healing time of damages while protecting the mucous membrane of the eye, even after special UV-induced cell damage, is significantly shortened. Trehalose is also considered safe enough for direct (topical) use, as it is already included in two pharmaceutical formulations (Avastin and Lucentis). These drugs are used to treat eye diseases by injection into the vitreous body.
Another study was conducted using trehalose in the form of eye drops, but at two different concentrations: 100 mg / ml or 200 mg / ml of the active ingredient in saline. These eye drops were prescribed up to six times a day for four weeks. Both concentrations were found to be beneficial for dry eyes, but surprisingly, the 100mg/mL solution outperformed the higher (200mg/mL) doses in reducing lacrimation duration.
This benefit has been noted in a number of other studies showing that trehalose eye drops are superior to similar pharmacological formulations containing hyaluronic acid (Hyalein) or hydroxyethylcellulose (MyTear). Eye drops containing trehalose have been shown to be effective in two studies in patients with dry eye symptoms.
Despite the fact that trehalose is synthesized by a large number of different fungi, plants, bacteria and insects in the cells of the mammalian body, it is believed that trehalose is not formed in the human body.
Pharmacodynamics of eye drops Thealoz
Thealose is an isotonic sterile solution that is prepared without the addition of preservatives. It has a neutral pH value. The main component of the drug is trehalose, a substance of natural origin present in the body of animals and plants that are able to survive in extreme conditions of a very dry environment.
The physicochemical characteristics of trehalose provide its antioxidant, protective and moisturizing properties. This allows us to consider it a very important link in the anhydrobiotic (anti-drying) mechanism that is observed in some microorganisms (this is a slowdown in metabolism, allowing them to successfully survive in rather extreme conditions of dehydration).
Trehalose has properties that provide protection and relative stabilization of cell membranes by preventing the conversion of proteins (proteins) and damage to lipids (fats). At the same time, it also exhibits antioxidant functions.
Since Thealose eye drops are made without preservatives, they can be used successfully in contact lens wearers.
After the instillation of drops, after a few minutes their effect becomes noticeable, the mucous membrane of the eye is moistened. The effect can last up to 8 hours after a single application.
Thealoz eye drops do not have a systemic effect, as they practically do not enter the general bloodstream. As a rule, eye drops with trehalose are gradually removed from the surface of the eye through the lacrimal canals, from where they enter the nasal cavity and then into the external environment.
In the case of using Thealoz eye drops, moderate eye irritation can very rarely be observed.
In medical practice, there have been no recorded cases of overdose with topical preparations containing trehalose. Taking into account the route of administration (local application - instillation into the eye cavity) and the fact that trehalose practically does not penetrate into the systemic circulation, it can be concluded that an overdose of this drug is practically excluded.
Tealoz eye drops can be used in combination with any other ophthalmic drugs and drugs prescribed in other branches of medicine. The only condition is to observe an interval of 10 minutes between the use of Thealoz and other eye drops.
Tealoz eye drops are prescribed to patients with a feeling of discomfort, a foreign body, sand in the eyes, dryness, irritation, burning of the eyes, their significant fatigue as a result of exposure to environmental factors: dust, dry air, smoke, pollution, during air travel, work in air-conditioned rooms, long and hard work in front of a computer monitor.
Thealoz eye drops quickly provide a feeling of comfort during long-term contact lens wear.
Tealoz eye drops can be used in the complex treatment of erosive damage to the cellular structure of the cornea of the eyes that occurs with keratoconjunctivitis and other degenerative pathologies of the cornea. Trehalose moisturizing eye drops may also be given as an adjunct in the treatment of eye infections, along with antiviral, antimicrobial, or antifungal therapy (depending on the type of pathogen).
Tealoz drops for dry eyes can be effectively used as a preventive measure in people who are exposed to the harmful effects of external factors and who have a hereditary predisposition to dry eye syndrome.
The appointment of eye drops from dryness Thealoz is contraindicated in those patients who had allergic reactions to any components of the drug before, or to the introduction of the first doses of the drug at the time of the current treatment.
The drug is available in a plastic multi-dose vial of the ABAK system. This patented system is distinguished by the use of eye drops that are previously passed through a special membrane filter. This filter prevents any possible bacterial contamination of the solution from the external environment.
The bottle contains 300 drops of eye drops. The solution has a neutral pH value and is produced without the addition of preservatives. Due to this, as a rule, the drug is quite easily tolerated by patients.
Before using the drug, wash your hands thoroughly with soap and water.
It is not recommended to touch the tip of the vial to the surface of contact lenses and eyes, especially if an infectious process is suspected.
The drug should be instilled 1 drop directly into the conjunctival cavity. For convenience, you need to slightly pull the lower eyelid and at the same time raise your eyes up. At the end of the procedure, tightly close the vial.
It is strictly forbidden to use the solution by injection or orally (through the mouth).
Thealoz is a topical ophthalmic preparation that has a lubricating and moisturizing effect. Tealoz drops are applied to the sensation of dryness and discomfort in the eyes.
Tealoz eye drops contain the active ingredient trehalose, as well as excipients: sodium chloride, trometamol, hydrochloric acid, water for injection.
Available in 10 ml vials. The ABAK multi-dose vial has a 0.2 µm membrane filter that prevents bacterial contamination of the solution.
Thealose is a sterile isotonic solution for ophthalmic use without preservatives, named neutral pH value. Its main component is trehalose, a plant-derived substance found in many plants and animals that are adapted to life in extremely dry conditions.
Trehalose has physico-chemical characteristics that provide protective, moisturizing, antioxidant properties. That is why this substance is an important component of the ahydrobiotic mechanism that allows certain species to survive dehydration. Trehalose also contributes to the stabilization of cell membranes by preventing the modification of proteins and the destruction of lipids, and has an antioxidant effect.
Tealoz eye drops are used for dryness, discomfort, irritation, burning of the eyes, their fatigue as a result of external factors: smoke, pollution, dust, dry air, including in air-conditioned rooms, during air travel, long work at the computer. The drug does not contain preservatives, therefore it can be used by patients using. Quickly provides a feeling of comfort during continuous lens wear.
Thealoz should be instilled into each eye one drop; the multiplicity is determined individually depending on the sensations. Before using the drug, wash your hands thoroughly. When instilled, contact of the vial with the skin or conjunctiva should be avoided. After instillation, the bottle must be tightly closed. If the protective ring is damaged, the drops cannot be used.
The use of Thealose is contraindicated in case of allergic reactions to the components, including a history.
It is extremely rare for eye irritation to develop.
Cases of an overdose of Thealoz have not been reported.
When using other local ophthalmic preparations, an interval of 10 minutes between instillations should be observed.
At the end of the expiration date, it must be disposed of. Store at room temperature for up to eight weeks after opening the vial.
Trometamol, water as auxiliary components, up to 100 ml.
Plastic bottle with dispenser 10 ml.
Moisturizing, lubricating the conjunctiva of the eye.
Thealoz eye drops are a sterile, hypotonic moisturizing solution with a neutral pH. They are used in ophthalmology to eliminate dry eyes and in situations where additional moisture is needed.
This ophthalmic solution quickly provides comfort for the eyes, eliminates dry mucous membranes, burning and irritation. These symptoms occur when you stay at the computer for a long time, when exposed to the environment (wind, dust, smoke, sun, dry air).
The main component of the solution - trehalose disaccharide with moisturizing, protective and antioxidant properties. It has a triple mechanism of action: it protects and stabilizes cell membranes, prevents the breakdown of proteins, and in the cell inhibits the oxidation of unsaturated fatty acids . Its membrane-stabilizing and protective properties have been proven experimentally. It reduces the severity of damage under the action of UV radiation, and also reduces inflammation of the cornea. Embedding between phospholipids of cell membranes, trehalose prevents their perforation and loss of water by the cell. Cell membranes retain their properties and protect cells from external factors.
Thealoz duo additionally contains . It is this combination that provides longer-lasting protection, hydration of the eyes and maximum long-term comfort. This solution can also be used while wearing contact lenses as it is compatible with any material. Both drugs are packaged in a dosed vial of the ABAK system with a filter membrane, which provides additional filtration in case of possible bacterial contamination. This patented system allows no preservatives to be used in the solution and the solution can be used safely for up to 3 months after opening the vial.
After instillation, the effect lasts up to 8 hours. It does not have a systemic effect, it is excreted through the lacrimal canals from the surface of the eye into the nasal cavity.
Tealoz drops are used for:
The drug is also used in complex treatment keratoconjunctivitis , erosive, infectious eye diseases of viral, microbial or fungal etiology against the background of specific treatment.
The use of the drug is contraindicated in case of hypersensitivity to its components.
In rare cases, there is no pronounced eye irritation.
Wash hands before use. Make one drop in each eye, pulling the lower eyelid. You can apply 4-6 times a day. Can be applied to the eye with a contact lens in place. Do not touch the eye with the tip of the vial. Close the vial tightly until next use.
The dose and frequency of use of this drug does not differ.
Cases of overdose are not known. Given that the active substance does not penetrate into the systemic circulation, an overdose of the drug is excluded.
When using other ophthalmic solutions, it is necessary to take a 10-minute break between their use.
Without recipe.
Temperature up to 25°С.
2 years. Use the solution after opening the bottle for up to 3 months.
Structural analogues of Thealoz eye drops containing the same active substance are not available. A similar effect is exerted by: Hilabak , Slezin , Aistil , Vizalin , Vial Tear .
Many who have to work a lot at the computer feel discomfort in the eyes, manifested by pain, a feeling of a foreign body, and redness. often occurs in the postoperative period - during cataract surgery or laser correction. Discomfort is also experienced by people using contact lenses. In all these cases, moisturizing eye drops are recommended, which stabilize the tear film and significantly reduce the intensity of symptoms.
Given that the preservative itself causes dry eye syndrome, the use of drugs with a preservative is undesirable. The advantage of this drug is precisely in the absence of a preservative and the unique composition - the presence of natural disaccharide which provides cells anhydrobiosis – resistance to drying and survival in dry climates.
Instructions for use
trehalose 3.0, sodium chloride, trometamol, hydrochloric acid, water for injection up to 100 ml.
Trehalose provides protective, antioxidant and moisturizing properties of the solution, helps protect and stabilize the cell membrane.
The main component of the solution is the disaccharide trehalose, which has moisturizing, protective and antioxidant properties. It has a triple mechanism of action: it protects and stabilizes cell membranes, prevents the breakdown of proteins, and inhibits the oxidation of unsaturated fatty acids in the cell. Its membrane-stabilizing and protective properties have been proven experimentally. It reduces the severity of damage under the action of UV radiation, and also reduces inflammation of the cornea. Embedding between the phospholipids of cell membranes, trehalose prevents their perforation and loss of water by the cell. Cell membranes retain their properties and protect cells from external factors.
In rare cases, there is no pronounced eye irritation.
Without a license
Individual intolerance to the components.
Mode of application
