Ranostop

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RANOSTOP® (RANOSTOP)

Composition:

Active substance: povidone-iodine;

1 g of ointment contains povidone-iodine (equivalent to 10 mg/g of free active iodine) 100 mg;

Excipients: polyethylene glycols (macrogols), poloxamer 338, sodium phosphate dodecahydrate, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: brown-colored ointment with a specific odor. The ointment should be homogeneous in appearance.

Pharmacotherapeutic group. Antiseptics and disinfectants. Iodine preparations. Povidone-iodine.

ATC code D08AG02.

Pharmacological properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and the polymer polyvinylpyrrolidone, which releases iodine over a certain period of time after application to the skin. Free iodine exerts a bactericidal effect and has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi, and protozoa.

Mechanism of action: free iodine provides a rapid bactericidal effect, while the polymer acts as an iodine depot.

Upon contact with skin and mucous membranes, significant amounts of iodine are released from the polymer.

Iodine reacts with oxidizable — sulfhydryl (SH) and hydroxyl (OH) — groups of amino acids that are part of enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed in vitro within less than one minute, with the primary destructive effect occurring within the first 15–30 seconds. During this process, iodine becomes decolorized, so a change in the intensity of the brown color serves as an indicator of its effectiveness.

The active substance of the medicinal product Ranostop® has a broad antimicrobial spectrum of activity, namely: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), fungal spores (sporicidal), as well as certain protozoa (protozoicidal). Due to its mechanism of action, resistance to the drug, including secondary resistance during prolonged use, is not expected.

The preparation dissolves in water and is easily washed off with water.

Prolonged application of the preparation to large wound surfaces or severe burns, as well as to mucous membranes, may lead to absorption of a significant amount of iodine. Usually, as a result of prolonged use, iodine concentration in the blood rises rapidly. The concentration returns to baseline levels within 7–14 days after the last application of the drug.

In patients with normal thyroid gland function, increased iodine stores do not cause clinically significant changes in thyroid hormonal status.

Pharmacokinetics.

Absorption and renal excretion of povidone-iodine depend on its molecular weight; since this varies between 35,000–50,000, retention of the substance is possible.

Absorption of povidone-iodine or iodide is the same as that of iodine from other sources.

The volume of distribution is approximately 38% of body weight. The biological half-life after vaginal administration is about 2 days. Normal total plasma iodine levels are approximately 3.8–6 µg/dL, while inorganic iodine levels range from 0.01–0.5 µg/dL.

The drug is primarily excreted via the kidneys, with a clearance rate of 15 to 60 mL/min, depending on plasma iodine levels and creatinine clearance (normal: 100–300 µg iodine per 1 g creatinine).

Clinical characteristics.

Indications.

For the prevention of infections in minor cuts and abrasions, minor burns, and minor surgical procedures.

For the treatment of fungal and bacterial skin infections, as well as infected pressure sores and trophic ulcers.

Contraindications.

• Hypersensitivity to iodine or to any of the excipients.
• Thyroid dysfunction (nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis).
• Hyperthyroidism or other acute thyroid disorders.
• Dermatitis herpetiformis Duhring.
• Use before, during, or after diagnostic or therapeutic procedures involving radioactive iodine administration.
• Concomitant use of medicinal products containing mercury — due to the formation of substances capable of damaging the skin.
• Age under 1 year.
• Renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

The povidone-iodine complex is active against microorganisms at pH levels ranging from 2.0 to 7.0.

Proteins and other organic compounds reduce its activity.

Concomitant use of Ranostop® and enzymatic ointments for wound treatment reduces the efficacy of both medicinal products. Medicinal products containing mercury, silver, hydrogen peroxide, or taurolidine may interact with the povidone-iodine complex, potentially reducing their efficacy; therefore, concomitant topical use is not recommended. The povidone-iodine complex should not be used simultaneously with reducing agents, alkaline salts, or acid-reactive substances.

Tincture of benzoin: leads to a decrease in pH, which may cause a burning sensation, especially if the wound is bandaged.

Regular use of Ranostop® ointment should be avoided in patients concurrently receiving lithium, due to the potential for a synergistic hypothyroid effect.

Mercury-containing preparations: should not be used due to the risk of forming mercuric iodide.

Simultaneous or immediate sequential use of povidone-iodine with antiseptics containing octenidine may lead to the development of dark necrotic lesions at the application site.

Caution!

Due to its oxidizing properties, povidone-iodine may cause false-positive results in certain diagnostic tests (e.g., toluidine blue test or guaiac resin test for occult blood in feces or urine, or urine glucose tests).

When povidone-iodine is used, iodine uptake by the thyroid gland may be reduced. This may affect the results of certain diagnostic tests (e.g., thyroid scintigraphy, measurement of protein-bound iodine, radioactive iodine uptake tests). Additionally, povidone-iodine may interfere with iodine used for thyroid therapy.

A new scintigraphic examination should be performed no sooner than 4 weeks after the end of treatment.

Special precautions for use

The medicinal product is intended for topical use only.

Prolonged use of povidone-iodine may cause skin irritation and, occasionally, severe skin reactions. If such symptoms occur, application of the medicinal product Ranostop® should be discontinued. Povidone-iodine may cause temporary discoloration of the skin at the site of application due to the coloring of the medicinal product.

Use of Ranostop® may reduce iodine uptake by the thyroid gland, which may affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures involving radioactive iodine), thereby making it impossible to plan treatment of thyroid disorders with iodine-containing drugs. A break of at least 4 weeks should be made in the use of Ranostop® prior to such procedures.

The medicinal product should not be used in patients before, during, or after treatment of thyroid cancer with radioactive iodine or during scintigraphy with radioactive iodine.

Significant amounts of iodine may cause hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, these patients should limit the duration of ointment use and the surface area of skin treated.

With prolonged use (more than 14 days) over large areas of skin (over 10% of body surface area), such as extensive burns or wounds, a significant amount of iodine may be absorbed, potentially leading to hyperthyroidism in susceptible patients.

During prolonged use in all patients, thyroid function should be monitored.

Iodine absorption varies individually among patients; therefore, no precise recommendations can be provided. Thus, thyroid function tests and physicians’ advice are crucial.

If symptoms of hyperthyroidism develop during treatment, thyroid function should be evaluated.

After completion of treatment, patients should be monitored for early signs of hyperthyroidism, and thyroid function should be checked.

Contact of the medicinal product with the eyes should be avoided. If the product is not intended for treatment of the hands, hands should be washed after each application.

Ranostop® ointment is contraindicated in children under 1 year of age and is not recommended for children aged 1 to 2 years.

Regular use of the ointment should be avoided in patients receiving lithium preparations.

The oxidizing effect of Ranostop® may cause corrosion of metals, whereas plastics and synthetic materials are generally resistant to povidone-iodine. In some cases, discoloration may occur, but color usually returns to normal. Ranostop® can be easily removed from textiles and other materials with warm soapy water. Stubborn stains should be treated with ammonia solution or sodium thiosulfate.

The oxidizing action of povidone-iodine may lead to false-positive results in diagnostic tests (e.g., toluidine and guaiac tests for occult blood in feces or urine, or glucose in urine).

Do not heat before use. Keep out of reach of children.

If signs of illness do not begin to improve, or if the condition worsens or adverse reactions occur, use of the medicinal product should be discontinued and medical advice should be sought regarding further treatment.

Use during pregnancy or breastfeeding

Povidone-iodine should be used only as directed by a physician and in the smallest possible doses. Iodine crosses the placental barrier and may pass into breast milk, thus posing a risk of hypersensitivity of the fetus or newborn to iodine. The concentration of povidone-iodine in breast milk is higher than in blood serum. Therefore, the drug may cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Thyroid function testing in infants is recommended.

Ranostop® has no teratogenic effects.

The product is contraindicated after the second month of pregnancy and during breastfeeding.

Iodine crosses the placental barrier and may pass into breast milk; therefore, breastfeeding should be discontinued during treatment.

Ability to influence reaction speed when driving or operating machinery

Ranostop® ointment does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medicinal product is for topical use only.

The affected skin should be cleaned and dried.
For treatment of infection: apply 1–2 times daily.
For prevention of infection: apply 1–2 times per week, as long as necessary.
Apply a thin layer of ointment to the affected skin surface. A dressing may be applied over the treated area—this depends on the extent and severity of the injury.

Duration of treatment should not exceed 14 days.

Do not use the medicinal product for longer than the specified period without consulting a physician.

Children.

Ranostop® ointment is contraindicated in children under 1 year of age and is not recommended for children aged 1 to 2 years. If use of Ranostop® ointment is necessary, it should be applied very sparingly and only after a strict assessment by a physician of benefit versus risk. The skin of young children has higher permeability, and hypersensitivity to iodine is more common, increasing the risk of hyperthyroidism. Povidone-iodine should therefore be used in small amounts in such patients. Thyroid function should be monitored in children if necessary.

Overdose.

Symptoms of acute iodine intoxication include:

• Metallic taste in the mouth, increased salivation, sensation of burning or pain in the mouth or throat;
• Irritation and swelling of the eyes;
• Skin reactions;
• Gastrointestinal disturbances and diarrhea;
• Kidney dysfunction and anuria;
• Circulatory failure;
• Laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Systemic toxicity may lead to kidney dysfunction (including anuria), tachycardia, hypotension, circulatory failure, swelling of the vocal cords leading to asphyxia or pulmonary edema, seizures, fever, and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.

At the first signs of overdose, any remaining ointment should be removed or washed off the skin, and

immediate medical attention should be sought.

Treatment: symptomatic and supportive therapy should be administered, with special attention to electrolyte balance, kidney function, and thyroid function.

In cases of severe hypotension, intravenous fluids should be administered; vasopressors should be used if necessary.

Endotracheal intubation may be required if upper airway edema causes significant swelling and obstruction.

Do not induce vomiting. The patient should be positioned to keep the airway clear and to prevent aspiration (in case of vomiting).

If irritation of the upper respiratory tract causes significant swelling and edema, endotracheal intubation may be necessary.

Do not induce vomiting. The patient should be positioned to keep the airway clear and to prevent aspiration (in case of vomiting).

If the patient is not vomiting and is able to ingest, consumption of starchy foods (e.g., potatoes, flour, starch, bread) may help convert iodine into less toxic iodide. In the absence of signs of intestinal perforation, gastric lavage with a starch solution via a nasogastric tube may be performed (the gastric effluent will appear blue-violet; this color can be used to determine when to stop lavage).

Iodine is effectively removed by hemodialysis, which should be used in severe cases of iodine poisoning, especially in the presence of renal failure. Continuous venous hemodiafiltration is less effective than hemodialysis.

Side effects

The frequency of adverse reactions is defined according to the following categories: very common (≥ 1/10), common (≥ 1/100, but < 1/10), uncommon (≥ 1/1,000, but < 1/100), rare (≥ 1/10,000, but < 1/1,000), very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).

In case of any adverse reactions, it is mandatory to consult a physician regarding further use of the medicinal product.

Reporting of adverse reactions following registration of the medicinal product is highly important. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

20 g, 40 g, or 100 g in tubes; 1 tube per pack.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM" (responsible for batch release, excluding batch control/testing).

Manufacturer's address and location of manufacturing activities.

17 Chumatska Street, Boryspil, Kyiv region, 08303, Ukraine.

Marketing Authorization Holder.

JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoї Rady Boulevard, Kyiv, 02100, Ukraine, 3rd floor, room 18.

In case of adverse reactions or questions regarding safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at +38 (044) 390 52 96.

INSTRUCTION

for medical use of the medicinal product

RANOSTOP®

(RANOSTOP)

Composition:

Active ingredient: povidone-iodine;

1 g of ointment contains povidone-iodine (corresponding to 10 mg/g of free active iodine) 100 mg;

Excipients: polyethylene glycols (macrogols), poloxamer 338, sodium phosphate dodecahydrate, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: brown-colored ointment with a specific odor. The ointment should be homogeneous in appearance.

Pharmacotherapeutic group. Antiseptics and disinfectants. Iodine preparations. Povidone-iodine.

ATC code D08AG02.

Pharmacological properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and the polymer polyvinylpyrrolidone, which releases iodine gradually over a period of time after application to the skin. Free iodine exerts a bactericidal effect and has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi, and protozoa.

Mechanism of action: free iodine provides a rapid bactericidal effect, while the polymer acts as an iodine reservoir.

Upon contact with skin and mucous membranes, significant amounts of iodine are released from the polymer.

Iodine reacts with oxidizable — sulfhydryl (SH) and hydroxyl (OH) — groups of amino acids that are part of enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed in vitro within less than one minute, with the primary destructive effect occurring within the first 15–30 seconds. During this process, iodine is decolorized, so a change in the intensity of the brown color serves as an indicator of its effectiveness.

The active ingredient of the medicinal product Ranostop® has a broad antimicrobial spectrum of activity, namely: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), fungal spores (sporicidal), as well as certain protozoa (protozoicidal). Due to its mechanism of action, resistance to the drug, including secondary resistance during prolonged use, is not expected.

The preparation is water-soluble and easily washed off with water.

Prolonged application of the preparation to large wound surfaces or severe burns, as well as to mucous membranes, may lead to the absorption of significant amounts of iodine. Typically, prolonged use of the preparation results in a rapid increase in blood iodine levels. The concentration returns to baseline levels within 7–14 days after the last administration.

In patients with normal thyroid gland function, increased iodine stores do not cause clinically significant changes in thyroid hormone status.

Pharmacokinetics.

Absorption and renal excretion of povidone-iodine depend on its molecular weight; since the molecular weight ranges between 35,000–50,000, retention of the substance is possible.

Absorption of povidone-iodine or iodide is similar to that of iodine from other sources.

The volume of distribution is approximately 38% of body weight. The biological half-life after vaginal administration is about 2 days. The normal total plasma iodine level is approximately 3.8–6 µg/dL, while the level of inorganic iodine is 0.01–0.5 µg/dL.

The drug is primarily excreted by the kidneys, with a clearance rate of 15 to 60 mL/min, depending on plasma iodine levels and creatinine clearance (normal: 100–300 µg iodine per 1 g creatinine).

Clinical characteristics.

Indications.

For the prevention of infections in minor cuts and abrasions, minor burns, and minor surgical procedures.

For the treatment of fungal and bacterial skin infections, as well as infected pressure ulcers and trophic ulcers.

Contraindications.

• Hypersensitivity to iodine or to any of the components of the medicinal product.
• Thyroid dysfunction (nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis).
• Hyperthyroidism or other acute thyroid disorders.
• Dermatitis herpetiformis Duhring.
• Use before, during, or after diagnostic or therapeutic procedures involving radioactive iodine administration.
• Concomitant use of medicinal products containing mercury—due to the formation of substances capable of damaging the skin.
• Age under 1 year.
• Renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

The povidone-iodine complex is active against microorganisms at pH levels ranging from 2.0 to 7.0.

Proteins and other organic compounds reduce its activity.

Concomitant use of the medicinal product Ranostop® and enzymatic ointments for wound treatment reduces the efficacy of both medicinal products. Medicinal products containing mercury, silver, hydrogen peroxide, or taurolidine may interact with the povidone-iodine complex, potentially reducing their efficacy; therefore, combined topical use is not recommended. The povidone-iodine complex should not be used simultaneously with reducing agents, alkaline salts, or acid-reactive substances.

Tincture of benzoin: leads to a decrease in pH, which may cause a burning sensation, especially if the wound is bandaged.

Regular use of Ranostop® ointment should be avoided in patients concurrently receiving lithium, due to the potential for a synergistic hypothyroid effect.

Mercury-containing preparations: must not be used due to the risk of forming mercuric iodide.

Simultaneous or immediate sequential use of povidone-iodine with antiseptics containing octenidine may result in the development of dark necrotic lesions at the application site.

Caution!

Due to its oxidizing properties, povidone-iodine may cause false-positive results in certain diagnostic tests (e.g., toluidine blue test or guaiac resin test for detecting occult blood in feces or urine, or urine glucose tests).

When povidone-iodine is used, iodine uptake by the thyroid gland may be reduced. This may affect the results of certain diagnostic tests (e.g., thyroid scintigraphy, measurement of protein-bound iodine, or radioactive iodine uptake). Additionally, povidone-iodine may interfere with iodine used for thyroid therapy.

A new scintigraphic examination should be performed no sooner than 4 weeks after completion of treatment.

Special precautions for use

The medicinal product is intended for topical use only.

Prolonged use of povidone-iodine may cause skin irritation and, occasionally, severe skin reactions. If such symptoms occur, application of the medicinal product Ranostop® should be discontinued. Povidone-iodine may cause temporary discoloration of the skin at the site of application due to the coloring of the medicinal product.

Use of Ranostop® may reduce iodine uptake by the thyroid gland, which may affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures involving radioactive iodine), thereby making it impossible to plan treatment of thyroid disorders with iodine-containing drugs. A break of at least 4 weeks should be made before using Ranostop®.

The medicinal product should not be used in patients before, during, or after treatment of thyroid cancer with radioactive iodine or during radioactive iodine scintigraphy.

Significant amounts of iodine may cause hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, such patients should limit the duration of ointment use and the surface area of treated skin.

When used for prolonged periods (more than 14 days) over large areas of skin (more than 10% of body surface area), such as extensive burns or wounds, a significant amount of iodine may be absorbed, potentially leading to hyperthyroidism in susceptible patients.

During prolonged use in all patients, thyroid function should be monitored.

Iodine absorption varies individually among patients; therefore, no precise recommendations can be given. Thus, thyroid function tests and physicians' advice are crucial.

If symptoms of hyperthyroidism occur during treatment, thyroid function should be evaluated.

After completion of treatment, patients should be monitored for early signs of hyperthyroidism, and thyroid function should be controlled.

Avoid contact of the medicinal product with the eyes. If the product is not intended for hand skin treatment, hands should be washed after each application.

Ranostop® ointment is contraindicated in children under 1 year of age and is not recommended for children aged 1 to 2 years.

Regular use of the ointment should be avoided in patients receiving lithium preparations.

The oxidizing effect of Ranostop® may cause corrosion of metals, whereas plastics and synthetic materials are generally resistant to povidone-iodine. In some cases, discoloration may occur, but color usually returns to normal. Ranostop® can be easily removed from textiles and other materials with warm soapy water. Stubborn stains should be treated with ammonia solution or sodium thiosulfate.

The oxidizing effect of povidone-iodine may lead to false-positive results in diagnostic tests (e.g., toluidine and guaiac tests for detecting occult blood in feces or urine, or glucose in urine).

Do not heat before use. Keep out of reach of children.

If signs of illness do not begin to improve, or if the patient's condition worsens or adverse effects occur, use of the medicinal product should be discontinued and medical advice should be sought regarding further treatment.

Use during pregnancy or breastfeeding

Povidone-iodine should be used only as prescribed by a physician and in the smallest possible doses. Iodine crosses the placental barrier and may pass into breast milk, thus posing a risk of hypersensitivity to iodine in the fetus or newborn. The concentration of povidone-iodine is higher in breast milk than in blood serum. Therefore, the drug may cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Thyroid function in infants should be checked.

Ranostop® has no teratogenic effects.

The product is contraindicated after the 2nd month of pregnancy and during breastfeeding.

Iodine crosses the placental barrier and may pass into breast milk; therefore, breastfeeding should be discontinued during treatment.

Ability to influence reaction speed when driving vehicles or operating machinery

Ranostop® ointment does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage

The medicinal product is for topical use only.

The affected skin should be cleaned and dried. For treatment of infection: apply 1–2 times daily. For prevention of infection: apply 1–2 times per week, as long as necessary. Apply a thin layer of ointment to the affected skin surface. A dressing may be applied over the treated area—this depends on the extent and severity of the injury.

Duration of treatment should not exceed 14 days.

Do not use the medicinal product for longer than the recommended period without consulting a physician.

Children.

Ranostop® ointment is contraindicated in children under 1 year of age and is not recommended for children aged 1 to 2 years. If use of Ranostop® ointment is necessary, it should be applied sparingly and only after a strict assessment by a physician of the benefit-risk ratio. The skin of young children has higher permeability, and hypersensitivity to iodine occurs more frequently, increasing the risk of hyperthyroidism. Povidone-iodine should be used in small amounts in such patients. Thyroid function should be monitored in children when necessary.

Overdose.

Symptoms of acute iodine intoxication include:

• metallic taste in the mouth, increased salivation, sensation of burning or pain in the mouth or throat;
• eye irritation and swelling;
• skin reactions;
• gastrointestinal disturbances and diarrhea;
• kidney dysfunction and anuria;
• circulatory failure;
• laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Systemic toxicity may lead to kidney dysfunction (including anuria), tachycardia, hypotension, circulatory failure, swelling of the vocal cords leading to asphyxia or pulmonary edema, seizures, fever, and metabolic acidosis. Hyperthyroidism or hypothyroidism may also develop.

Upon the first signs of overdose, any remaining ointment on the skin should be removed or washed off, and

medical help should be sought immediately.

Treatment: symptomatic and supportive therapy should be administered, with special attention to electrolyte balance, kidney function, and thyroid function.

In cases of severe hypotension, intravenous fluids should be administered; vasopressors should be used if necessary.

Endotracheal intubation may be required if upper airway edema causes significant swelling and obstruction.

Vomiting should not be induced. The patient should be positioned to maintain clear airways and to prevent aspiration (in case of vomiting).

If irritation of the upper respiratory tract causes significant swelling and edema, endotracheal intubation may be necessary.

Vomiting should not be induced. The patient should be positioned to maintain clear airways and to prevent aspiration (in case of vomiting).

If the patient is not vomiting and is able to ingest food, consumption of starchy foods (e.g., potatoes, flour, starch, bread) may help convert iodine into less toxic iodide. In the absence of intestinal perforation signs, gastric lavage with a starch solution via a nasogastric tube may be performed (the gastric contents will appear blue-violet; this color change can be used to determine when to stop lavage).

Iodine is effectively removed by hemodialysis, which should be used in severe cases of iodine poisoning, especially when renal failure is present. Continuous venovenous hemodiafiltration is less effective than hemodialysis.

Adverse reactions.

The frequency of adverse effects is defined according to the following categories: very common (≥ 1/10), common (≥ 1/100, but < 1/10), uncommon (≥ 1/1000, but < 1/100), rare (≥ 1/10 000, but < 1/1 000), very rare (< 1/10 000), not known (frequency cannot be estimated from the available data).

In case of any adverse reactions, it is essential to consult a physician regarding further use of the medicinal product.

Reporting of adverse reactions after registration of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

20 g, 40 g, or 100 g in tubes; 1 tube per carton.

Prescription status.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Manufacturer's address.

2 Sybits'ka Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder.

JSC "FITOPHARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Boulevard, Kyiv, 02100, Ukraine, floor 3, room 18.

If adverse reactions occur or if you have any questions regarding the safety, quality, or efficacy of the medicinal product, please contact the Pharmacovigilance Department of JSC "FITOPHARM" at +38 (044) 390 52 96.