Aquazan instructions for use of the drug

Release form, packaging and composition of the drug Clinical-pharmacological group Pharmaco-therapeutic group Pharmacological action Indications for use Method of administration and doses Side effects Contraindications for use Use in children Special instructions Drug interactions

Registration Certificate Holder:

IODINE TECHNOLOGIES AND MARKETING, LLC (Russia)

ATX Code:

D08AG02

Active substance:

povidone-iodine

Dosage form:

Aquazan

pharmachologic effect

Antiseptic. It is iodine in the form of polyvinylpyrrolidone iodine complex. The concentration of active iodine is from 0.1% to 1%. Has a wide spectrum of antimicrobial action. Active against bacteria (including Mycobacterium tuberculosis), fungi, viruses, protozoa. Polyvinylpyrrolidone iodine is an iodophor that binds iodine. Upon contact with the skin and mucous membranes, iodine is gradually and evenly released, exerting a bactericidal effect on microorganisms. At the site of application of povidone-iodine preparations, a thin colored layer remains, which remains until all the iodine is released, after which its effect ceases.

Aquazan solution for external and local use fl 10ml

Compound

Povidone-iodine 30/06 105 g; sodium phosphate solution saturated to pH 2.5-3.5, purified water up to 1 liter.

Indications for use

• Treatment and prevention of infection of wounds, abrasions, burns, trophic ulcers, bedsores;
• treatment of pyoderma, acne, infectious dermatitis, ringworm, skin reaction after insect bites;
• treatment of mucous membranes, including for local treatment of gynecological diseases and in obstetric practice;
• for rinsing the mouth and throat for infections of the nasopharynx and diseases of the oral cavity (stomatitis, periodontitis, etc.);
• skin treatment before and after operations or manipulations associated with skin disorders (injections, punctures, biopsies, blood collection, catheterization, etc.);
• hygienic treatment of patients;
• pre- and postoperative treatment of the hands of the surgeon and medical personnel; hand hygiene when caring for infectious patients; processing of instruments and patient care items.

Contraindications

• Hypersensitivity to iodine;
• thyrotoxicosis;
• thyroid adenoma;
• Dühring's dermatitis herpetiformis;
• simultaneous use of radioactive iodine;
• the neonatal period, especially in premature infants.

With caution: In case of chronic renal failure, pregnancy (II-III trimester), during lactation.

Directions for use and doses

The drug is used externally and locally. Depending on the area of ​​application, Aquazan is used both without dilution and in the form of aqueous solutions at a dilution of 1:2, 1:10 or 1:100.

For treating minor wounds, abrasions, burns, etc. Aquazan is used undiluted by lubricating the surface or as a wet pad.

For disinfection of healthy areas of skin before puncture, blood collection, biopsy, etc. use the undiluted drug with an exposure of 1-2 minutes.

To disinfect the skin and mucous membranes before operations and invasive interventions (including in obstetric and gynecological practice), the surgical field is treated with the undiluted drug twice with an exposure time of 2 minutes.

To treat the hands of surgical personnel, 5 ml of undiluted drug is rubbed with palms up to the elbows for 5 minutes, then rinsed thoroughly. The procedure is repeated twice.

To treat infections of the skin and mucous membranes, the drug is used undiluted by treating the surface for 1-2 minutes.

Rinse the mouth and throat with undiluted or diluted (5 ml per 1/2 cup of water) preparation.

For hygienic treatment of the patient before surgery, during the so-called “disinfectant bathing,” Aquazan is used in a dilution of 1:100 by wiping the patient with a sponge soaked in the solution.

For the prevention and treatment of complications after invasive manipulations, in the treatment of purulent wounds, the drug is used without dilution or in a 1:2 dilution, applied to the surface as a lubricant or as a wet pad.

When treating burns, depending on the condition of the wound, Aquazan is used without dilution or in a dilution of 1:10. The dressing material is impregnated with undiluted preparation.

For the treatment of bacterial or fungal dermatitis, Aquazan is used in a dilution of 1:10.

At home, for treating skin on healthy areas or when treating small wounds, scratches, burns, bacterial and fungal skin lesions, Aquazan is recommended to be used undiluted.

Dilution of Aquazan must be done immediately before use. A diluted solution of Aquazan in a ratio of 1:2 and 1:10 is stored for no more than 10 days, in a ratio of 1:100 for no more than 3 days.

Storage conditions

In a place protected from light and out of reach of children at a temperature not exceeding 30 °C.

Best before date

3 years. Do not use after expiration date.

special instructions

Avoid contact of the drug with the eyes.

Light and temperatures above 40°C accelerate the decrease in the activity of the drug.

The drug solution should have a dark brown color.

Discoloration of the solution indicates the destruction of the polyvinylpyrrolidone-iodine complex and a decrease in the effectiveness of the drug.

In the presence of blood, the bactericidal effect of the drug may decrease.

Description

Antiseptic.

Pharmacodynamics

The antiseptic is a 10% solution of iodine-polyvinylpyrrolidone (iodine complex with polyvinylpyrrolidone).
Contains 1% active iodine. The drug has a wide spectrum of antimicrobial action. It has an antiseptic, disinfectant, antifungal and antiprotozoal effect. Blocks amino groups of cellular proteins.

Polyvinylpyrrolidone-iodine belongs to iodophors, in which iodine is in a bound state, and is gradually and evenly released upon contact with the skin and mucous membranes, exerting a bactericidal effect on microorganisms.

Due to the sorption properties of povidone, Aquazan partially binds toxic products of microbial and tissue breakdown and has a dehydrating effect on tissues.

A thin colored layer remains at the site of application of the drug, which remains until the entire amount of active iodine is released from the complex, after which the effect of the drug ceases.

The drug does not have a local irritating effect, since iodine is present in it in the form of a complex.

Side effects

Allergic reactions, local reactions (itching, hyperemia at the application site).

Use during pregnancy and breastfeeding

The use of povido-iodine is not recommended from the 3rd month of pregnancy and during lactation (breastfeeding). If necessary, in these cases, treatment is possible under individual medical supervision.

Interaction

Pharmaceutically incompatible with disinfectants containing mercury; oxidizing agents, reducing agents, alkalis and acids.

Overdose

Possible increased side effects, including allergic reactions.

Indications for use

For treating the patient’s skin before and after operations, research (biopsy, puncture, blood drawing, injections, etc.), pre- and postoperative treatment of the hands of surgeons, medical personnel, hygienic treatment of hands when caring for infected patients, treatment of instruments and patient care items.

For local use: infections of the nasopharynx, treatment of infected skin lesions (burns, wounds, ulcers, abrasions), prevention of infection of wound surfaces, treatment of nonspecific vaginitis, trichomoniasis.

Release form and composition

Dosage form – solution for local and external use 10%: a film-forming liquid of dark brown color with or without a specific weak odor, mixed with ethyl alcohol, water, polyethylene glycol, etc. in any proportions (10, 50, 100, 500 and 1000 ml in dark glass bottles; 10, 15, 25, 100, 250, 330, 500 and 4500 ml in polyethylene terephthalate bottles).

1 ml of Aquazan solution contains:

• Active ingredient: povidone-iodine 30/06 – 105 mg;
• Auxiliary components: trisodium phosphate (solution saturation to pH 2.5-3.5), purified water.

Aquazan solution for topical and external use approx 10% 100 ml x1

INSTRUCTIONS for medical use of the drug

Aquazan®

Registration number: P N003063/01 Trade name of the drug: Aquazan® International nonproprietary name: Povidone-Iodine Chemical name of the active substance: Poly[(2-oxo-1-pyrrolidinyl)ethylene]iodine Dosage form: solution for external and local use Composition: Povidone-iodine, 30/06, , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , up to pH 2.5-3.5 Purified water , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , up to 1 l Description: Film-forming dark brown liquid, odorless or with a weak specific odor, miscible with water in all proportions. Pharmacotherapeutic group: Antiseptic agent ATC code, [D08AG02] PHARMACOLOGICAL ACTION Pharmacodynamics: Antiseptic agent, is a 10% solution of iodine-polyvinylpyrrolidone

(iodine complex with polyvinylpyrrolidone). Contains 1% active iodine. , , , , , The drug has a wide spectrum of antimicrobial action. It has an antiseptic, disinfectant, antifungal and antiprotozoan effect. Blocks amino groups of cellular proteins. , , , , , Polyvinylpyrrolidone-iodine refers to iodoforms in which iodine is in a bound state and is gradually and evenly released upon contact with the skin and mucous membranes, exerting a bactericidal effect on microorganisms. , , , , , Due to the sorption properties of povidone, Aquazan partially binds toxic products of microbial and tissue decay and has a dehydrating effect on tissues. , , , , , At the site of application of the drug, a thin colored layer remains, which remains until the entire amount of active iodine is released from the complex, after which the effect of the drug ceases. , , , , , The drug does not have a local irritating effect, since iodine is present in it in the form of a complex. INDICATIONS FOR USE: - treatment and prevention of infection of wounds, abrasions, burns, trophic ulcers, bedsores, - treatment of pyoderma, acne, infectious dermatitis, dermatomycosis, skin reaction after insect bites, - treatment of mucous membranes, including for local treatment of gynecological diseases and in obstetric practice, - for rinsing the mouth and throat for infections of the nasopharynx and diseases of the oral cavity (stomatitis, periodontitis, etc.), - skin treatment before and after operations or manipulations associated with skin disorders (injections, punctures, biopsy, blood collection, catheterization, etc.), - hygienic treatment of patients, - pre- and postoperative treatment of the hands of a surgeon, medical personnel, hygienic treatment of hands when caring for infectious patients, treatment of instruments and patient care items. CONTRAINDICATIONS: - hypersensitivity to iodine, - thyrotoxicosis, - thyroid adenoma, - Dühring's dermatitis herpetiformis, - simultaneous use of radioactive iodine, - neonatal period, especially in premature infants.

With caution: in case of chronic renal failure, pregnancy (II-III trimester), during lactation.

DOSAGE AND APPLICATION: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

The drug is used externally and locally. Depending on the area of ​​application, Aquazan is used both without dilution and in the form of aqueous solutions at a dilution of 1:2, 1:10 or 1:100. , , , , , , , For the treatment of minor wounds, abrasions, burns, etc. Aquazan is used undiluted by lubricating the surface or as a wet pad. , , , , , , , For disinfection of healthy areas of skin before puncture, blood collection, biopsy, etc. use the undiluted drug with an exposure of 1-2 minutes. , , , , , , , To disinfect the skin and mucous membranes before operations and invasive interventions (including in obstetric and gynecological practice), the surgical field is treated with the undiluted drug twice with an exposure time of 2 minutes. , , , , , , , , , To treat the hands of surgical personnel, rub 5 ml of undiluted drug with palms up to the elbows for 5 minutes, then rinse thoroughly. The procedure is repeated twice. , , , , , , , , , For the treatment of infections of the skin and mucous membranes, the drug is used undiluted by treating the surface for 1-2 minutes. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , Rinse the mouth and throat with the drug undiluted or diluted (5 ml per ½ glass of water). , , , , , , , , , For hygienic treatment of the patient before surgery, during the so-called “disinfecting bathing”, Aquazan is used in a dilution of 1:100 by wiping the patient with a sponge soaked in the solution. , , , , , , , , , For the prevention and treatment of complications after invasive manipulations, in the treatment of purulent wounds, the drug is used without dilution, or in a 1:2 dilution, applied to the surface by lubricating or in the form of a wet pad. , , , , , , , , , When treating burns, depending on the condition of the wound, Aquazan is used without dilution or in a dilution of 1:10. The dressing material is impregnated with undiluted preparation. , , , , , , , , , For the treatment of bacterial or fungal dermatitis, Aquazan is used in a dilution of 1:10.

, , , , , , , , , , , , , , At home, for treating the skin on healthy areas or when treating small wounds, scratches, burns, bacterial and fungal skin lesions, Aquazan is recommended to be used undiluted. , , , , , , , , , , , , , , , Dilution of Aquazan must be done immediately before use. A diluted solution of Aquazan in a ratio of 1:2 and 1:10 is stored for no more than 10 days, in a ratio of 1:100 for no more than 3 days. SIDE EFFECTS: , , , , , , , , , , , Allergic reactions, local reactions (itching, hyperemia at the site of application). OVERDOSE: , , , , , , , , , , Possible increased side effects, including allergic reactions. Interaction with other drugs: , , , , , , , , , , Pharmaceutically, incompatible with disinfectants containing mercury, oxidizing agents, reducing agents, alkalis and acids. SPECIAL INSTRUCTIONS: , , , , , , , , , , Avoid contact of the drug with the eyes. , , , , , , , , , , , , , , , Light and temperature above 40ºС accelerates the decrease in the activity of the drug. , , , , , , , , , , , , , The drug solution should have a dark brown color. Discoloration of the solution indicates the destruction of the polyvinylpyrrolidone-iodine complex and a decrease in the effectiveness of the drug. , , , , , , , , , In the presence of blood, the bactericidal effect of the drug may decrease. RELEASE FORM: , , , , , , , , , Solution for external and local use 10%. 10 ml in orange glass bottles with a screw neck, sealed with polyethylene threaded caps with a brush stick.

, , , , , , , , , 50 ml, 100 ml, 500 ml and 1000 ml of the drug in orange glass bottles with a screw neck, sealed with polyethylene stoppers and screw-on plastic caps. 250 ml in orange glass bottles, sealed with polymer screw caps.

, , , , , , , , , , 10 ml, 15 ml, 25 ml, 100 ml, 250 ml, 330 ml, 500 ml, 1000 ml and 4500 ml in polyethylene terephthalate bottles, sealed with perforated polyethylene screw caps. The bottles can be equipped with medical attachments (sprayers/dispensers) for medicines, non-sterile with or without protective caps.

, , , , , , , , , Each bottle of 10 ml, 15 ml, 25 ml, 50 ml and 100 ml, together with instructions for use, is placed in a cardboard pack.

, , , , , , , , , , , Packs are placed in corrugated boxes or packed in shrink film.

, , , , , , , , , , Bottles along with an equal number of instructions for use are packed in cardboard boxes or packed in shrink film: 250 ml - 20 pcs., 330 ml - 16 pcs., 500 ml - 12 pcs. , 1000 ml – 8 pcs., 4500 ml – 4 pcs. (for hospitals).

, , , , , , , , , , , , , , , , , , , , Labels are applied to bottles, packs and group packaging. It is allowed to print instructions for use on the pack.

SHELF LIFE: , , , , , , , , , 3 years. Do not use after expiration date. STORAGE CONDITIONS: , , , , , , , , , , Protected from light and out of reach of children at a temperature not exceeding +30ºС. CONDITIONS FOR DISCHARGE FROM PHARMACIES: , , , , , , , , , , Without a prescription. Name, address of the manufacturer of the medicinal product and address of the place of production of the medicinal product

Iodine Technologies and Marketing LLC, Russia , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

115280, Moscow, st. Leninskaya Sloboda, 19, floor 1, room. 41x1d. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Tel./fax, 727-05-03.

249717, Kaluga region, Kozelsky district, village. Frolovskoe. , , , , , , , , , , , , , , , , , , , ,

Tel./fax, 727-05-03.

Organization receiving complaints

Iodine Technologies and Marketing LLC, Russia , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

115280, Moscow, st. Leninskaya Sloboda, 19, floor 1, room. 41x1d. , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Tel./fax, 727-05-03.

,

Directions for use and dosage

Aquazan is intended for external and local use in the form of application or lubrication.

The solution is used without dilution or in the form of aqueous solutions in a ratio of 1:2, 1:10 or 1:100. Dilution of the drug must be done immediately before use. A solution diluted in a ratio of 1:2 and 1:10 can be used for ten days, in a ratio of 1:100 - no more than three days.

Directions for use and concentration:

• Treatment of abrasions, minor wounds, burns and other skin damage: without dilution, the wound surface is lubricated with a solution or a gauze pad moistened with Aquazan is applied to it;
• Disinfection of healthy areas of the skin before manipulations associated with violation of the integrity of the skin (puncture, blood sampling, biopsy and others): without dilution, with an exposure of 1-2 minutes;
• Disinfection of the skin, mucous membranes before surgery and invasive interventions (including obstetrics and gynecology): without dilution, with an exposure of 2 minutes; the surgical field is treated with the solution twice;
• Rinse mouth and throat: aqueous solution, dilution 1:10, 4-5 times a day; for washing lacunae of the tonsils with chronic tonsillitis, the drug is diluted in a ratio of 1:5;
• Treatment of the hands of surgical personnel: without dilution, 5 ml for each hand, rub with palms for 5 minutes from hands to elbows, after thorough rinsing, repeat the procedure;
• Treatment of infectious pathologies of mucous membranes and skin: without dilution, treat the problem area for 1-2 minutes;
• Hygienic treatment of the patient before surgery: in a ratio of 1:100, the patient’s body is wiped with a sponge soaked in the solution;
• Prevention and treatment of complications after invasive manipulations, treatment of purulent wounds: without dilution or in a 1:2 ratio, lubricating the affected area of ​​the skin or applying an application;
• Treatment of burns: without dilution or in a ratio of 1:10, taking into account the condition of the wound, the dressing material should be soaked in an undiluted solution;
• Treatment of bacterial and fungal dermatitis: the solution is diluted in a ratio of 1:10;
• Treatment of scratches, small wounds, burns, fungal and bacterial skin lesions at home, including treatment of healthy skin areas: without dilution.

Side effects

• Local reactions: transient burning sensation at the site of application of the drug;
• Hypersensitivity reactions: skin rash, contact dermatitis, itching.

In case of overdose (use over a large area of ​​mucous membranes, skin, wounds, burns, as well as prolonged and frequent use), neutropenia, hypothyroidism, goiter, and iodism phenomena (urticaria, rhinitis, increased salivation, Quincke's edema) may develop. If the above symptoms occur, the drug should be discontinued.