For inflammation and dry eyes, doctors recommend trehalose drops. Thealoz eye drops - instructions for use for the eyes When use is contraindicated

general information

Tealoz eye drops are used in ophthalmic practice. They have a moisturizing and lubricating effect when applied topically. They relieve discomfort and dry eyes.

Composition and form of release

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 also been noted in a number of other studies showing that trehalose eye drops are superior to similar pharmacological formulations containing hyaluronic acid (Hyalein) or hydroxyethyl cellulose (MyTear). Eye drops containing trehalose have been shown to be effective in two studies in patients with dry eye symptoms.

biological significance

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.

pharmachologic effect

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.

Pharmacokinetics of eye drops Thealoz

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.

Side effect

In the case of using Thealoz eye drops, moderate eye irritation can very rarely be observed.

Overdose

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.

Interaction with other drugs

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.

Special instructions and precautions

Thealoz should be discarded at the end of its expiration date.
Store eye drops at room temperature, but not more than 25 ° C. The drug is suitable for no more than eight weeks from the moment of opening (breaking the tightness) of the vial. Keep Thealoz eye drops in a place that is inaccessible to children.

Pregnancy and lactation

The use of Thealoz eye drops during pregnancy is not recommended, as is the use of any other pharmacological preparations. This is due to the fact that medicinal substances can adversely affect the child's body and pregnancy in general. But it is worth noting the fact that many ophthalmologists tend to consider trehalose eye drops safe. Indeed, when applied topically, their entry into the systemic circulation and the overall effect on the body are insignificant and cannot carry a potential danger. There are no studies showing whether the drug passes into breast milk, but given the pharmacodynamics of the drug, it can be assumed that these concentrations are negligible or completely absent.
Pregnant and breastfeeding women should consult a specialist before using Thealoz eye drops.

Price

The cost of the drug Tealoz in the pharmacy chains of Moscow starts from 520 rubles.

Indications

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.

Contraindications

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.

Thealosis is used in diseases:

Mode of application

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.

Thealoz eye drops technique

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 eye drops are a solution for the symptomatic treatment of dry eyes. It has a moisturizing effect when applied topically, protects against pathogenic effects, promotes cell regeneration. The drug is prescribed for adults and children of any age without restrictions.

The review contains information about the composition and mechanism of action of drops, indications and contraindications, forms of release and cost. Attached instructions for use, as well as reviews of doctors and patients.

Composition and mechanism of action

The main active ingredient of the drug is the polysaccharide trehalose. This carbohydrate protects proteins from drying out and decay. The component is found in the composition of plants, fungi and microorganisms that accumulate it in cells to prevent drying. The effect is preserved only when applied topically: for example, trehalose forms glucose in the human intestine.

Another property of carbohydrate is an antioxidant effect, protection against free radicals. These are unstable chemical compounds that react with human cells, destroy membranes and activate the aging process. Antioxidants suppress the course of such reactions, promote regeneration and normalize water-lipid metabolism.

The excipients in Thealoz eye drops are trometamol, sterile water, sodium chloride and hydrochloric acid.

Indications for use

• dust, chemical air pollution;
• wearing contact lenses;
• exposure to wind or smoke;
• diseases of the visual apparatus, which are accompanied by inflammation;
• deformation of the eyelids, due to which the complete closure of the palpebral fissure is impossible;
• the use of medicines (diuretics);
• prolonged work behind the monitor.

Solution can be used during the day in conjunction with lenses.

Manufacturers, release forms, cost

The only manufacturer of Tealoz drops is the French company Excelvision.

The drug is produced in plastic dropper bottles with a volume of 10 ml. This container contains 300 drops of solution. The package contains 1 bottle of suspension, as well as instructions for use. The average price is 520 rubles.

There is another form of release - Tealoz Duo, which contains additional components.

It contains sodium hyaluronate, which, under normal conditions, is produced by connective tissue and protects cells from moisture loss. On the surface of the mucosa, hyaluronic acid creates a protective shell that does not allow the liquid to evaporate. The cost of a bottle of Tealoz Duo (10 ml) is 600 rubles.

The shelf life of the sealed vial is 2 years from the date of manufacture. Keep it out of the reach of children in a dry, dark place at a temperature not exceeding 25°C. After opening, the drug is valid for no more than 8 weeks, storage conditions remain the same.

Thealoz Duo relieves discomfort.

Dosage and reception

Tealoz is convenient to use at home, in the workplace, on a trip, as well as in any other conditions. Basic recommendations regarding the method of application and dosage:

1. Before the procedure, wash your hands and try not to touch the pipette tip.
2. If you wear contact lenses, you can leave them on before using the drug.
3. For convenience, pull the lower eyelid and look up, the product should fall into the conjunctival sac.
4. Place 1 drop in each eye throughout the day.

The solution is safe for long-term use, therefore, the manufacturer does not provide data on the maximum allowable course of treatment.

Contraindications and side effects

The only contraindication to the use of Tealoz drops is an allergy to their individual components. Symptoms of the manifestation of hypersensitivity reactions are a short-term burning sensation and redness of the mucosa, which occurs immediately after instillation.

Interaction with other drugs

The tool can be part of a comprehensive course of treatment of inflammatory eye diseases.

When co-administering different drops, keep an interval of 10-15 minutes between instillations.

Drops reviews

Feedback from practitioners and patients will help to obtain additional information about the drug.

Irina Novikova, ophthalmologist of the highest category, recommends:

“Many people underestimate the importance of timely diagnosis of dry eye syndrome. The disease can begin with a slight reddening of the mucosa and lead to dangerous consequences: ulcers, corneal perforation, and even complete blindness. I prescribe Thealoz to patients who experience dryness and burning in the eyes after working at a monitor, wearing lenses, or exposure to other factors. The first improvements are already noticeable after a few applications.

The drug will help with the syndrome of "dry eye".

Sergey, 35 years old, underwent a course of treatment as prescribed by a doctor:

“I have been wearing contact lenses for 5 years now. I had to temporarily abandon them in favor of glasses, because my eyes were very tired and reddened. I turned to an ophthalmologist I knew for help, and he prescribed me to drip drops of Thealoz without removing the lenses. They helped, now I wear lenses all the time and do not feel dryness and discomfort. ”

Maria, 23 years old, programmer, left her review:

“I spend 6 to 18 hours a day at the computer. I love my job, but my eyes get very tired, dry, and red. The pharmacy advised me drops of Tealoz, recommended to bury according to the instructions. I dripped 1 drop every day, and now I feel the change. It seems to me that if I had not used this remedy and had not protected my eyes, I could have spoiled my eyesight very soon.

Analogues

Thealoz is not the only drug for moisturizing and protecting the structures of the eye, presented in pharmacies. You can choose one of the analogues with a similar effect.

• Zaditen - eye drops based on ketotifen, which are prescribed for allergic inflammation. The tool is not recommended for use with contact lenses, because it can cause clouding of their material. The dosage and duration of the course of treatment is determined by the doctor. The average price for a bottle of 10 ml is 400 rubles.
• Optiv is a drug that used for dry and tired eyes. In its composition and mechanism of action, it is an analogue of tears (the active ingredients are carmellose sodium and glycerol). Among the contraindications are the age of up to 18 years, the period of pregnancy and breastfeeding. The cost of 10 ml of solution is 440 rubles.
• protect the cornea from drying out by mimicking the action of tears. The main component in its composition is hypromellose, a cellulose derivative. This drug is inexpensive, its price in pharmacies is 50 rubles per 10 ml bottle.

An analogue of Tealoz is Defislez.

• Khilozar-Komod are drops based on hyaluronic acid and panthenol, which moisturize, nourish the structures of the eye, relieve inflammation. The average cost of 10 ml is 550 rubles.
• has a protective effect due to hypromellose, saturates the mucous membrane with moisture. The price for 10 ml of solution is 450 rubles.
• Stillavite is eye drops with moisturizing and anti-inflammatory action. Due to the complex composition (sodium hyaluronate and panthenol), the drug binds water molecules, retains a large amount of moisture. On the surface of the mucous membrane, it creates a protective film that prevents drying out. The cost of a 10 ml bottle is 360 rubles.

When choosing one of the remedies that have a similar effect, it is better to consult a doctor. Some eye drops are less safe than Thealoz and have a number of contraindications, including age-related ones.

Summing up

Tealoz eye drops are used in ophthalmology for symptoms such as dryness of the cornea, its redness and irritation caused by various factors. The solution can be used to prevent dystrophic changes in the structures of the eye if you wear contact lenses or spend most of your time at the monitor. The drug has no contraindications, except for individual sensitivity, and does not cause side effects. It can be bought at a pharmacy without a doctor's prescription and used at any age according to the instructions.

Elizabeth Kobeleva

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.

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.

Composition, release form

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.

pharmachologic effect

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.

Indications for use

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.

Dosage and administration

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.

Contraindications

The use of Thealose is contraindicated in case of allergic reactions to the components, including a history.

Side effects

It is extremely rare for eye irritation to develop.

Overdose

Cases of an overdose of Thealoz have not been reported.

Interaction with other means

When using other local ophthalmic preparations, an interval of 10 minutes between instillations should be observed.

Storage conditions and special instructions

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.

Dryness, irritation of the conjunctiva of the eyes is a frequent occurrence in people who spend a long time at work on a computer and similar devices.

Thealosis- a local preparation for relieving dryness, irritation of the eyes with a protective antioxidant effect.

This is a sterile isotonic solution without the content of dyes, preservatives. Side effects, contraindications are practically absent.

Composition and form of release

The drug is produced in plastic bottles + dispenser (10 ml).

As part of trehalose and excipients:

• trometamol;
• purified water;
• hydrochloric acid;
• sodium chloride.

Drug properties

Active thealose is a natural disaccharide, antioxidant:

• moisturizes the cornea of ​​​​the eye;
• beneficial effect on the body as a whole;
• protects the cell membrane;
• prevents protein conversion.

Sodium hyaluronate has a moisturizing, lubricating effect on the membrane of the visual organ. Tolerability of the drug is good.

The combination of substances in Thealoz eye drops helps to moisturize and heal the damaged cornea, and protects it from negative external influences.

The action of drops

Eye drops Thealoz - keratoprotector. It contains only natural ingredients of animal origin.

The main actions of the drug:

• stabilization of the natural production of lipid proteins;
• active destruction of atypical cells;
• providing an anti-drying effect;
• an obstacle to the destruction of lipids;
• prevention of protein modification;
• natural protection of cell membranes;
• neutralization of the harmful effects of viruses, microorganisms that enter the eyes.

The composition of the drops is thoughtful, so the effectiveness is observed immediately after the initial instillation. The duration of action is 8-10 hours.

Indications for use

• burning, itching, corneas;
• incomplete closure of the palpebral fissure;
• deformation and .

Main indications for use:

Contraindications

Thealoz application is unacceptable:

• children up to a year;
• women during pregnancy, lactation;
• with intolerance to the active components.

Instructions for use

Dosage

Optimal frequency of application - 5-6 times a day with the possibility of instillation into the eyes when installing contact lenses. This is a convenient drug with a dispenser for use at home, travel, at the workplace.

The dosage for children is the same as for adults. In particular, the treatment regimen is the same. Use the drug orally, injection is prohibited.

How to use

How to use the drug:

Use during pregnancy and lactation

The composition of these eye drops contains components that can harm the organs of the child during their formation, therefore, the use of women during pregnancy and lactation is prohibited.

According to ophthalmologists, drops in the composition with trehalose are absolutely safe, do not enter the systemic circulation, cannot adversely affect the body as a whole and lead to potential danger.

Studies on whether the components of Thealose pass into breast milk have not been conducted.

It is impossible to use the drug during breastfeeding without consulting a doctor. Although according to pharmacodynamics, the concentration of substances in breast milk is unlikely to be overestimated.

Application in childhood

The active components of Tealoz do not enter the bloodstream, do not lead to side effects, although it is undesirable for children under 3 years of age, especially if the cornea of ​​​​the eye is excessively sensitive to substances in the solution.

When prescribed for medical reasons, installations are recommended to be carried out under the supervision of a doctor (oculist, ophthalmologist).

If drops are prescribed for children from 1 year old, then only with severe dryness of the membrane of the eye, inflammation of the conjunctiva.

Side effects

Rarely, but may appear:

• Cutting, burning in the eye;
• Temporary loss of field of vision.
• are observed in patients with abnormal sensitivity to the components of the drug or when the prescribed dose is exceeded, namely more than 6 times a day. Perhaps the reason is the incorrect use of the drug or an expired drug indicated on the package.

If side effects appear, you should postpone the use of the drug and consult an ophthalmologist.

Overdose

Active particles do not enter the systemic circulation, as a result, an overdose is impossible. In the practice of medicine, cases with local, proper use of Thealoz containing trehalose have not been identified.

REFERENCE! Irritation of the conjunctiva, allergy of the mucous membrane of the eye are rare phenomena, since the drug is herbal, does not contain preservatives, does not enter the systemic circulation. If you had to accidentally swallow the remedy, then the active substances will be broken down by gastrointestinal enzymes. An overdose of drops is excluded.

drug interaction

Thealoz is an absolutely harmless, approved drug for use with any other means in ophthalmology for the treatment of eyes, the prevention of eye diseases.

The main thing is to observe the intervals during complex therapy, to withstand 10-15 minutes between doses of eye drops.

Analogues

Thealosis- the only drug of its kind in composition, recommended by manufacturers as a moisturizing, protective agent for the conjunctiva in case of dryness.

Analogues with a similar effect:

1. optiv- to relieve fatigue, dryness of the cornea. In the composition with glycerol, carmellose as active ingredients. Contraindications are pregnancy and lactation, and age up to 18 years. Price - 440 rub.(10 ml solution).
2. Zaditen- with ketotifen in the composition to relieve allergic inflammation. Use together with contact lenses is unacceptable. The course of treatment, dosages are prescribed by a doctor. Price - 400 rub.(10 ml vial).
3. - with hypromellose in the composition. Imitates the effect of tears, protects the cornea from drying out. Price - 50 rub.(10 ml in a vial).
4. Balarpan - with the provision of a regenerating, restoring and healing effect. Promotes cleaning of the cornea during long-term wearing of contact lenses. Price 450 rub.
5. VitA-POS- gel to relieve unpleasant manifestations against the background of long-term eye strain. Price from 210 rub.

Price

Thealosis is not a cheap drug. Average cost 525 rub. for 10 ml of solution. But it is equipped with a special filter to prevent infection. It is considered harmless even if the rules of use are not followed.

special instructions

When using Tealoz, be sure to consider the following information:

Storage conditions and shelf life

Be sure to follow the rules for storing the drug, namely, it is recommended to store at temperatures up to + 25 degrees. Shelf life in sealed form is 2 years.

According to the instructions, after the first opening of the vial, the solution can be stored for up to 3 months. It is not recommended to allow direct sunlight on the vial. Keep in a cool place and out of the reach of children.