Betadine - Solution for external and local use

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Instructions for use BETADINE

Long-term use of povidone-iodine preparations may result in the absorption of significant amounts of iodine. In some cases, mainly in persons with pre-existing thyroid pathology, iodine-induced hyperthyroidism was observed. Therefore, if it is necessary to use Betadine suppositories in such patients, the course of treatment should be as short as possible.

Particular caution is required when using the drug regularly in patients with renal failure.

Long-term use of Betadine vaginal suppositories should be avoided in patients receiving lithium preparations.

With the use of povidone-iodine, there may be a decrease in iodine uptake by the thyroid gland, which may affect the results of diagnostic studies (thyroid scintigraphy, determination of protein-bound iodine, measurements using radioactive iodine) or may interfere with iodine therapy of the thyroid gland. After prolonged use of povidone-iodine, an interval of 1 to 4 weeks should be observed before performing the above procedures.

The oxidative effects of povidone-iodine may cause false-positive results in some diagnostic tests, such as occult blood in stool and urine, or glucose in urine.

The use of Betadine suppositories in childhood before reaching puberty is contraindicated.

The doctor must decide on the possibility of using the drug in virgins and administer the suppository for the first time.

Do not allow children to accidentally ingest the suppository.

Impact on the ability to drive vehicles and operate machinery

Betadine does not affect the ability to drive vehicles and other activities that require high concentration and speed of psychomotor reactions.

Experimental results

Preclinical safety studies have shown that symptoms of acute toxicity in animals were observed only when administered systemically at doses significantly higher than those administered topically in humans. When studying chronic toxicity, also with systemic administration in high doses, a completely reversible dose-dependent increase in protein-bound serum iodine and nonspecific histopathological changes in the thyroid glands were detected.

Povidone-iodine does not have a mutagenic effect.

Given the long clinical experience with iodine, long-term studies of carcinogenic properties in animals have not been conducted.

Modern Pharmaceuticals of Russia

IODOPIRONE 1% aqueous solution for HOSPITAL RESIDENTS

INN:
Povidone-Iodine+[Potassium Iodide]
DESCRIPTION:
A modern pharmaceutical preparation with disinfectant, antiseptic and wound-healing properties.

Currently, only one is producing this drug in the form of a 1% solution, with an extended shelf life of 2 years, on the Russian market.

With its help, purulent wounds are successfully healed and areas of the skin are disinfected.

Doctors treat their hands with a solution of iodopyrone, both during surgical operations and during medical procedures. The spectrum of its action is extensive and this allows us to confidently call this solution a unique product!

Unfortunately, many people do not know about this drug, and those who do often have difficulty purchasing it due to its shortage on pharmacy shelves.

People from all over Russia very often contact us with a request to send the drug cash on delivery, because they cannot find it on sale at a time when people close to them are suffering. Unfortunately, we, as manufacturers, cannot solve this problem on our own.

It is for this reason that we are constantly looking for new partners who are ready to purchase even small quantities of this drug for their regions.

Why should iodopirone be in every first aid kit at home?
Yes, if only because for everyday injuries of various kinds, a faster effect of the drug is important, and, accordingly, faster relief, help and healing. APPLICATION:
When applied topically, the drug has a bactericidal, anti-inflammatory and fungicidal effect.

Iodopirone successfully fights gram-positive and gram-negative bacteria, antibiotic-resistant strains of Escherichia coli, Staphylococcus aureus and Proteus.

As practice shows, it behaves more efficiently than analogues from this pharmaceutical group.

Iodopirone cures acute purulent diseases that are in the first phase of the wound process: felons, carbuncles and boils, post-injection abscesses, lipomas, paraproctitis and suppurating atheromas.

The drug is widely used in surgery and traumatology. Heals trophic ulcers, thermal burns, bedsores.

It is used to treat 2-3 degree burns, purulent and infected wounds.

Iodopirone solution is used in proctology, obstetrics and gynecology during preoperative preparation, for the sanitation of the birth canal and the prevention of suppuration. In plastic surgery this drug is also preferred.

The drug is used for hygienic treatment of hands, post-operative and injection areas, by the general public, at home, for treating abrasions and cuts, for wiping insect bites (relieves discomfort and itching), for comprehensive skin protection from microbes in public places and in nature.
In addition, iodopyrone is widely used in veterinary medicine. PACKAGING
100 ml in orange glass bottles with a screw neck, sealed with a polyethylene threaded cap made of low-density polyethylene.

50 ml, 100 ml, 250 ml in bottles made of low-density polyethylene and a polyethylene threaded cap made of low-density polyethylene, or equipped with a plastic push-button spray pump and a protective cap made of polyethylene.

100 ml, 200 ml, 205 ml, 210 ml, 215 ml, 220 ml, 225 ml, 230 ml, 235 ml, 240 ml, 245 ml, 250 ml, 400 ml, 405 ml, 410 ml, 415 ml, 420 ml, 425 ml, 430 ml, 435 ml, 440 ml, 445 ml and 450 ml in glass bottles, sealed with rubber stoppers and aluminum caps for sealing medicines (for hospitals).

500 ml, 1000 ml in polyethylene terephthalate bottles, sealed with perforated polyethylene screw caps (for hospitals).

500 ml, 1000 ml in low-density polyethylene bottles sealed with perforated polyethylene screw caps (for hospitals).

3L and 5L in canisters made of low-density polyethylene, sealed with screw-on plastic caps with gaskets (for hospitals). Labels made of label or writing paper, or labels made of self-adhesive paper are glued onto the canisters.

Labels made of label or writing paper, or labels made of self-adhesive paper are glued onto vials and bottles.

Orange glass bottles of 100 ml, polyethylene bottles of 50 ml, 100 ml and 250 ml, glass bottles of 250 ml and 450 ml, together with an equal number of instructions for use, are placed in a pack of boxed or chrome-ersatz cardboard.

It is allowed to print the instruction text on the pack.

Glass bottles of 100 ml, 200 ml, 205 ml, 210 ml, 215 ml, 220 ml, 225 ml, 230 ml, 235 ml, 240 ml, 245 ml, 250 ml, 400 ml, 405 ml, 410 ml are allowed. 415 ml, 420 ml, 425 ml, 430 ml, 435 ml, 440 ml, 445 ml and 450 ml, together with an equal number of instructions for use, should be packaged in polyethylene shrink film or in boxes with partitions and grids made of corrugated cardboard (for hospitals) according to 4,6,8,12,25,50 bottles.

It is allowed to pack bottles of 500 ml, 1000 ml made of polyethylene terephthalate or polyethylene, together with an equal number of instructions for use, in polyethylene shrink film or in boxes with partitions and lattices made of corrugated cardboard (for hospitals) of 4,6,8,12 bottles each.

Labels made of label or writing paper, or labels made of self-adhesive paper are glued onto packaging made of polyethylene shrink film or onto boxes made of corrugated cardboard.

BARCODES
Individual

Group

INSTRUCTIONS for the use of the medicinal product for medical use
Registration number:

LP-002565

Trade name of the drug:

Iodopyrone

Group name:

Povidone-Iodine + [Potassium iodide]

Dosage form:

solution for external use

Compound:

1000 ml of solution contains:

Active substances:

Iodine 99.5% 14.10 g.

Excipients:

Potassium iodide 99.5% 13.80 g, low molecular weight povidone 122.10 g, purified water up to 1000 ml.

Description:

film-forming dark brown liquid, odorless or with a weak specific odor.

Pharmacotherapeutic group:

antiseptic.

ATX Code:

[D08AG]

Pharmacological properties:

Iodine in the form of polyvinylpyrrolidone iodine complex. The concentration of active iodine is not less than 1%. An antiseptic, when applied externally, has a bactericidal (against a wide range of gram-positive and gram-negative microorganisms, including antibiotic-resistant strains of Escherichia coli, Staphilococcus aureus and Proteus), antifungal effect.

Indications for use:

Disinfection of the surgeon's hands, surgical field, surgical gloves and elbow bends of donors, burns, purulent and infected wounds, osteomyelitis.

Contraindications

Hypersensitivity to the components of the drug, hyperthyroidism, Dühring's dermatitis herpetiformis, thyroid adenoma, renal failure, before radioactive iodine therapy; neonatal period (especially in premature babies).

Carefully:

Childhood, pregnancy, breastfeeding period.

Use during pregnancy and breastfeeding:

The use of the drug during pregnancy and breastfeeding is not recommended (if necessary, use is possible under individual medical supervision).

Directions for use and dosage:

Externally. 0.1-0.5% aqueous solutions are prepared from a 1% solution immediately before use. 0.1% (active iodine) solutions (5 ml) are used as an antiseptic to treat the surgeon’s hands; the surgical field is wiped with a napkin soaked in the solution. For extensive burns, the patient is immersed in a bath with a solution of 1:32 or 1:50 for 10-15 minutes. For complex treatment of purulent and infected wounds, osteomyelitis, decontamination of surgical gloves and treatment of donor elbows - 0.5% and 1% (based on active iodine) solutions of Iodopirone.

Side effect:

Dry skin, allergic reactions (itching, hyperemia at application sites, urticaria). When applied to a large wound surface, a quickly passing burning sensation is possible.

Overdose:

Symptoms of overdose: irritation at the site of application.

Treatment: symptomatic.

Long-term use (more than 7-10 days) can cause the phenomenon of iodism (“metallic” taste in the mouth, increased salivation, swelling of the eyes or larynx, etc.), if this occurs, you should stop using the drug and consult a doctor.

Accidental ingestion of iodine may damage the mucous membrane of the gastrointestinal tract (GIT). The stomach should be rinsed with a 0.5% sodium thiosulfate solution; activated charcoal, starch paste, flour broth, mucous drink, milk and/or 10 ml of a 10% sodium thiosulfate solution are used orally every 4 hours as an antidote, as well as symptomatic therapy.

Interaction with other drugs:

Pharmaceutically incompatible with disinfectants containing mercury, oxidizing agents, alkali salts and acidic substances, with drugs for external use containing enzymes (iodine reduces enzyme activity). In the presence of blood, the bactericidal effect may be reduced. When used simultaneously with lithium preparations, a synergistic hypothyroid effect is possible.

Special instructions:

Avoid getting the solution into your eyes.

Do not heat before use.

Do not use for bites from insects, domestic or wild animals.

During use, indicator papers to detect occult bleeding in stool and urine may show false-positive results due to the strong oxidative effect of povidone-iodine.

Coloring on leather and fabrics is easily washed off with water.

Impact on the ability to drive vehicles and operate machinery:

The use of the drug does not affect driving or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Release form:

Solution for external use 1%.

100 ml in orange glass bottles with a screw neck, sealed with a polyethylene threaded cap made of low-density polyethylene.

50 ml, 100 ml, 250 ml in bottles made of low-density polyethylene and a polyethylene threaded cap made of low-density polyethylene, or equipped with a plastic push-button spray pump and a protective cap made of polyethylene.

100 ml, 200 ml, 205 ml, 210 ml, 215 ml, 220 ml, 225 ml, 230 ml, 235 ml, 240 ml, 245 ml, 250 ml, 400 ml, 405 ml, 410 ml, 415 ml, 420 ml, 425 ml, 430 ml, 435 ml, 440 ml, 445 ml and 450 ml in glass bottles, sealed with rubber stoppers and aluminum caps for sealing medicines (for hospitals).

500 ml, 1000 ml in polyethylene terephthalate bottles, sealed with perforated polyethylene screw caps (for hospitals).

500 ml, 1000 ml in bottles made of low-density polyethylene, sealed with polyethylene screw caps with perforations (for hospitals).

3 l and 5 l in canisters made of low-density polyethylene, sealed with screw-on plastic caps with gaskets (for hospitals).

Labels made of label or writing paper or labels made of self-adhesive paper are glued onto the canisters.

Labels made of label or writing paper or labels made of self-adhesive paper are glued onto vials and bottles.

Orange glass bottles of 100 ml, polyethylene bottles of 50 ml, 100 ml and 250 ml, glass bottles of 250 ml and 450 ml, together with instructions for use, are placed in a pack of boxed or chrome-ersatz cardboard.

It is allowed to print instructions for use on the pack.

Glass bottles of 100 ml, 200 ml, 205 ml, 210 ml, 215 ml, 220 ml, 225 ml, 230 ml, 235 ml, 240 ml, 245 ml, 250 ml, 400 ml, 405 ml, 410 ml are allowed. 415 ml, 420 ml, 425 ml, 430 ml, 435 ml, 440 ml, 445 ml and 450 ml, together with an equal number of instructions for use, should be packaged in polyethylene shrink film or in boxes with partitions and grids made of corrugated cardboard (for hospitals) according to 4, 6, 8, 12, 25, 50 bottles.

Bottles of 500 ml are allowed. 1000 ml of polyethylene terephthalate or polyethylene, together with an equal number of instructions for use, should be packaged in polyethylene shrink film or in boxes with partitions and grids made of corrugated cardboard (for hospitals) of 4, 6, 8, 12 bottles.

Labels made of label or writing paper or labels made of self-adhesive paper are glued onto packaging made of polyethylene shrink film or onto boxes made of corrugated cardboard.

Storage conditions:

In a place protected from light at a temperature not exceeding 25 ºС. Keep out of the reach of children.

Best before date:

2 years. Do not use after the expiration date stated on the packaging.

Conditions for dispensing from pharmacies:

Dispensed without a prescription.