Each ml of Betaiodine, 7.5% liquid soap, contains:

active ingredient: povidone iodine – 75mg;

excipients: sodium hydroxide, citric acid, sodium laureth sulfate, sodium chloride, cocamide DEA, water purified.

2-Pyrrolidinone, 1-ethenyl-, homopolymer, compd. with iodine; 25655-41-8.

Antiseptic; D08AG02; G01AX11.

Betaiodine – povidone-iodine – is an iodophore that is used as a disinfectant and antiseptic mainly for the treatment of contaminated wounds and pre-operative preparation of the skin and mucous membranes as well as for the disinfection of equipment.

Iodophores are loose complexes of iodine and carrier polymers. Solutions of povidone-iodine gradually release iodine to exert an effect against bacteria, fungi, viruses, protozoa, cysts, and spores; povidone-iodine is thus less potent than preparations containing free iodine but it is less toxic.

Betaiodine surgical liquid soap is used as an antiseptic skin cleanser for pre-operative liquid soapbing and washing by surgeons and theatre staff and pre-operative preparation of patients’ skin. In the presence of blood, serum, purulent exudate and necrotic (dead) tissue, its action persists while the colour remains. Bactericidal effect usually develops within 15 – 60.

Iodine is slightly absorbed when applied to the skin. After contact with skin and mucous membrane the complex of polyvinylpyrrolidone iodine 30%, convertes into iodide and the rest part – into bactericidal active iodine. When taken by mouth, iodine preparations (which are converted to iodide) are transported to, and concentrated in, the thyroid gland. Iodides not taken up by the thyroid are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva, and sweat. They cross the placenta and are distributed into breast milk.

• Preoperative and postoperative, hygienic liquid soapbing by operating personne.

– Wet hands with water. Pour 5 ml on the palm of the hand and spread over both hands. Without adding more water, rub the liquid soap thoroughly over all areas for about 5 minutes. Use a soft brush if desired. Clean thoroughly under fingernails. Add a little water to develop copious suds. Rinse thoroughly under running water. Complete the wash by liquid soapbing with another 5 ml if desired.

• Preoperative use on patients (injections, puncture, biopsy, the blood drawing).

– Wet the operative area with water. Apply liquid soap (1 ml is sufficient to cover an area of 50-70 cm and rub thoroughly for about 5 minutes. After removing the foam skin is being washed with undiluted solution “Betaiodine, 10% solution for topical use” and leave to dry.

• for preparation of the skin prior to surgery;
• helps to reduce bacteria that potentially can cause skin infection;
• for handwashing to reduce bacteria on the skin;
• significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

Betaiodine can cause hypersensitivity reactions and irritation of the skin and mucous membranes, although severe reactions are rare and povidone-iodine is considered to be less irritant than iodine.

The application of Betaiodine to severe burns or to large areas otherwise denuded of skin may produce the systemic adverse effects associated with iodine and metabolic acidosis, hypernatraemia, and renal impairment, which may cause neutropenia. Hyperthyroidism or hypothyroidism may occur after ingestion or absorption of large quantities. Hypothyroidism has occurred in neonates both as a result of absorption of iodine from Betaiodine applied to the neonate and also to the mother during pregnancy or breast feeding. Betaiodine application is contraindicated in premature neonates or those weighing less than 1.5 kg. With prolonged use (more than 7-10 days) phenomenon of iodism may appear (including a metallic taste in the mouth, excessive salivation, swelling of the eyelids or larynx).

Regular or prolonged use should be avoided in patients with thyroid disorders or those receiving lithium therapy.

• Broken skin; renal impairment.
• This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.
• If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
• In severe renal impairment, avoid regular application to inflamed or broken skin or mucosa.
• The application of Betaiodine to large wounds or severe burns may produce systemic adverse effects such as metabolic acidosis, hypernatraemia and impairment of renal function. Patients should be warned about the need to stop using the preparation and consult with a doctor if there are signs of iodism.
• Solutions of iodine applied to the skin should not be covered with occlusive dressings. The disinfectant activity of iodine is reduced by alkalis as well as by protein.
• As povidone iodine can affect the thyroid gland, its use may interfere with tests of thyroid function.
• Before the systematic application of Betaiodine do the test of its use. Do not use Betaiodine in combination with other antiseptics and ointments.

Warnings!

• For external use only
• Do not use this product in the eyes! In case of contact – wash immediately with water.

Treatment: reduction of frequency usage or full failure of preparation application.

• Avoid regular use in patients with hyperthyroidism, adenoma of thyroid disorders or those receiving lithium therapy.
• Renal failure
• Preterm neonate gestational age under 32 weeks.
• Pregnancy, breast-feeding.
• Increased sensitivity to the ingredients of the preparation.

Iodine is concentrated by the mammary gland into breast milk to ensure an adequate supply to the breast-fed infant. Second, third trimesters: sufficient iodine may be absorbed to affect the fetal thyroid.

The BNFC (British National Formulary for Children) considers treatment with povidone- iodine to be a contra-indication to breast feeding.

Betadine is not compatible with other disinfectants. Alkaline medium, the presence of fat, blood, pus, substances with an acidic reaction reduce antiseptic activity.

The effects of povidone-iodine on the thyroid may be altered by other compounds including amiodarone and lithium.

A brown colored liquid having a characteristic iodine odor.

Liquid soap for topical use is filled into 140 ml plasticbottles or 3 litrers plastic containers (inside package).

3 years.

Store in a cool and dry place, out of the reach of children. Protect from light.

To be dispensed withоut prescription.