EGIS

BETADINE SURGICAL SOAP 75MG/ML X

Composition. The active substance is povidone iodine. One ml of solution contains 75 mg of povidone iodine corresponding to 7.5 mg of active iodine. The other ingredients are: nonylphenoxypoly(oxyethylene) ethanol ester, diethanolamide of superlauric acid, ethoxylated lanolin, hypromellose 4000, sodium hydroxide (10% solution), purified water.

Therapeutic indications. Betadine contains povidone iodine which is a disinfectant substance, used for hygienic or preoperative disinfection of the hands and preoperative disinfection of the skin (a drug with action against bacteria, fungi, selective viruses and protozoa).

Betadine is soluble in water and can be easily removed by washing

Dosage and method of administration.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Talk to your doctor or pharmacist if you are not sure.

Betadine is always used in concentrated form, undiluted.

Preoperative disinfection of the hands: wash your hands and forearms under running warm water. Apply 5 ml of Betadine to the palm of your hand using the dispenser and spread evenly over your hands and forearms. If necessary, use an additional amount of warm water to form a thin foam and continue rubbing for 2.5 minutes. You can also use a brush, especially for cleaning your nails. Then rinse your hands and forearms lightly under running warm tap water. Repeat this procedure once more, then rinse your hands and forearms with distilled water and dry with sterile towels.

Hygienic disinfection of the hands: wash your hands and forearms under running warm tap water, then apply 5 ml of Betadine to the palm of your hand and spread evenly over both hands and forearms. If necessary, use an additional amount of water to form a thin foam and continue rubbing lightly for 1 minute. Afterwards, rinse your hands and forearms lightly under running warm tap water.

Preoperative disinfection of the skin: Wash the skin surface with water. Apply Betadine (1 ml for approximately 20 cm²) and rub the surface until a yellow-gold foam is formed (if necessary add an additional amount of water). Then rinse with water.

Betadine is for external use only. The solution should not be mixed with hot water. Betadine is not intended for oral use or for direct application to wounds.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist..

Precautions.

Before using Betadine, talk to your doctor or pharmacist.

In preoperative preparation, avoid prolonged contact with the patient's skin. Prolonged exposure to the solution can cause irritation or rarely serious skin reactions. Chemical burns to the skin can occur due to prolonged contact. Discontinue treatment if skin irritation, contact dermatitis or hypersensitivity reactions occur.

Do not heat the medicine before use.

Keep out of the reach of children.

When administering large amounts of iodine, patients with goiter, thyroid nodules, or other non-acute thyroid conditions are at risk of developing hyperthyroidism (overactive thyroid function). In the absence of strict indications, in this category of patients, the application of povidone iodine solution should not be done for a long period of time and on a large area of the skin. Even after the end of treatment, the possible appearance of symptoms of hyperthyroidism should be monitored and if necessary the thyroid function should be monitored.

Treatment should not be used before or after radioiodine scintigraphy or radioiodine treatment for the treatment of thyroid carcinoma.

It is recommended to avoid administration in patients with renal insufficiency.

In people with more sensitive skin, a transient skin rash may rarely occur. To avoid this phenomenon, the use of Betadine should be tested before regular use.

Avoid contact with eyes. After use, rinse hands thoroughly.

Oxidizing properties can cause deterioration of some metals, while plastic or textile material is resistant to povidone iodine. In some cases, discoloration may occur, most often reversible. Betadine stains can be removed from textiles by washing with warm water and soap, and for persistent stains, sodium thiosulfate or ammonia solution should be used.

Special warnings.

Pregnancy and breastfeeding

During pregnancy and breastfeeding, povidone iodine should only be used if strictly indicated and for a minimum period of time. During pregnancy and breastfeeding, large amounts of povidone iodine should not be administered because iodine crosses the placenta and into breast milk and can thus increase the sensitivity of the fetus or newborn to iodine. Moreover, the concentration of iodine is higher in breast milk compared to the concentration in serum. The use of povidone iodine can induce transient hypothyroidism (reduced thyroid gland activity) in the fetus or newborn. Thyroid function monitoring of the child may be necessary. Possible oral ingestion of the solution by the infant must be avoided.

Driving and using machines

Betadine does not affect the ability to drive or operate machinery.

Packaging. A 1000 ml brown PE bottle of cutaneous solution, fitted with a dropper.

 

Page updated on: 08.06.2021