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.

– 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.

– 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.

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.

Warnings!

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

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.