Betadine solution for local and external use 10% (polyethylene dropper bottle) 120ml # 1

Release form, composition and packaging

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Solution for local and external use 10% dark brown, free of suspended or precipitated particles.

1 ml

povidone iodine 100 mg

glycerol (glycerin), nonoxynol 9, anhydrous citric acid, disodium hydrogen phosphate, sodium hydroxide 10% solution (m / v) (to adjust the pH), purified water.

30 ml - polyethylene dropper bottles (1) - cardboard packs.

120 ml - polyethylene dropper bottles (1) - cardboard packs.

1000 ml - polyethylene dropper bottles.

pharmachologic effect

Antiseptic and disinfectant preparation.

Released from the complex with polyvinylpyrrolidone upon contact with skin and mucous membranes, iodine forms iodamine cells with proteins, coagulates them and causes the death of microorganisms.

Has a fast bactericidal effect on gram-positive and gram-negative bacteria (with the exception of Mycobacterium tuberculosis).

Effective against fungi, viruses, protozoa.

Pharmacokinetics

When applied topically, iodine is almost not absorbed.

Indications for use

- treatment and prevention of wound infections in surgery, traumatology, combustiology, dentistry

- treatment of bacterial, fungal and viral skin infections, prevention of superinfection in dermatological practice

- Treatment of bedsores, trophic ulcers, diabetic foot

- disinfection of the skin and mucous membranes of patients in preparation for surgical interventions, invasive studies (including puncture, biopsy, injections)

- disinfection of the skin around drains, catheters, probes

- disinfection of the oral cavity during dental operations

- disinfection of the birth canal, during small" gynecological operations (including artificial termination of pregnancy, IUD insertion, coagulation of erosion and polyp).

Contraindications for use

- dysfunction of the thyroid gland (hyperthyroidism)

- adenoma of the thyroid gland

- Duhring's dermatitis herpetiformis

- simultaneous use of radioactive iodine

- premature and newborn babies

- hypersensitivity to iodine and other components of the drug.

The drug is used with caution in chronic renal failure, pregnancy and lactation (breastfeeding).

Dosage regimen

For the treatment of skin and mucous membranes, Betadine® solution is used undiluted for lubrication, rinsing, or as a wet compress.

For use in drainage systems, a 10% solution is diluted 10 to 100 times.

The solution is prepared immediately before use diluted solutions are not stored.

Overdose

Data on an overdose of Betadine® are not provided.

Side effect

With frequent use on a large area of ​​the wound surface and mucous membranes, systemic reabsorption of iodine may occur, which may affect the tests of the functional activity of the thyroid gland.

Hypersensitivity reactions to the drug, possible manifestations of an allergic reaction (hyperemia, burning, itching, swelling, pain), which requires discontinuation of the drug.

Drug interactions

Betadine® is incompatible with other antiseptics, especially those containing alkalis, enzymes and mercury.

In the presence of blood, the bactericidal effect may decrease, however, with an increase in the concentration of the solution, the bactericidal activity may be increased.

Application during pregnancy and lactation

The use of Betadine® is not recommended from 3 months of pregnancy and during lactation (breastfeeding).

If necessary, in these cases, treatment is possible under individual medical supervision.

Special instructions In case of dysfunction of the thyroid gland, the use of the drug is possible only under the strict supervision of a doctor.

The use of the drug in newborns is possible only if absolutely necessary, according to

Name ENG

BETADINE

Clinical and pharmacological group

Antiseptic for external and local use

ATX code

Povidone-iodine

Dosage

10% x 120ml

Structure

1 ml of solution contains 100 mg of povidone iodine

auxiliary substances: glycerin, nonoxynol 9, anhydrous citric acid, disodium dihydrogen phosphate, 10% sodium hydroxide solution (m / v) for pH adjustment, purified water.

Indications

treatment of the patient's skin before and after surgery (including injections, punctures, biopsy, blood sampling)

treatment of wounds, burns, trophic ulcers, bedsores, superinfectious dermatitis

hygienic treatment of patients

Contraindications

hyperthyroidism

, adenoma of the thyroid gland

, Dühring's dermatitis herpetiformis

, the simultaneous use of radioactive iodine

, children under 8 years old

, hypersensitivity to iodine and other components of the drug,

The drug should be used with caution during pregnancy and lactation (breastfeeding).

INN / Active ingredient

povidone iodine

Storage conditions and periods

In a dry, dark place, at a temperature not exceeding 30 degrees.

Expiration date: 3 years

Specifications

Scope of the drug

General

Release form

Solution

Manufacturer country

Hungary

Package quantity, pcs

one

Minimum age from

8 years

Way of introduction

On the skin

Vacation conditions

Without recipe

Volume, ml.

20 ml

Brand name

Egis

The amount of the dosage form in the primary package

120 ml

Primary packaging type

Polyethylene dropper bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antiseptic

Anatomical and therapeutic characteristics

D08AG02 Povidone-Iodine

Dosage form

Solution for local and external use

Expiration date in days

1095

The target audience

Children

Package weight, g

155

Category

:

Antibiotics

,

Antiseptics and disinfectants

,

Disinfectants

Mode of application

:

The Betadine solution can be used without dilution or as an aqueous solution at a dilution of 1:10 or 1: 100.

For disinfection of the skin in its healthy areas, a solution is used undiluted with an exposure of 1-2 minutes.

When treating wounds, burns, bacterial and fungal skin lesions, an aqueous solution of Betadine is used at a dilution of 1:10.

For hygienic treatment of the patient, an aqueous solution of Betadine is used at a dilution of 1: 100.

Information on technical characteristics, delivery set, country of manufacture "